ITEM 1. BUSINESS
APTALIS PHARMA INC., a Delaware corporation incorporated on November 28, 2007 as Axcan Intermediate Holdings Inc., is a leading specialty pharmaceutical company concentrating in the field of gastroenterology and cystic fibrosis, with operations in the United States (U.S.), Canada and the European Union (EU).
Our website address is www.aptalispharma.com. Information on our website is not incorporated herein by reference. Our reports filed with the Securities and Exchange Commission, or SEC, are available free of charge on the SEC’s website, http://www.sec.gov, or at the SEC’s Public Reference Room at 100 F Street, NE, Washington, DC 20549. You may also obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. These reports may also be accessed through, the “Investor Relations” section of the Company’s website as soon as reasonably practicable after we file or furnish such material with or to the SEC. In addition, copies of these reports will be made available free of charge, upon written request to Jim Porter, Senior Director, Communications, Aptalis Pharma, 100 Somerset Corporate Boulevard, Bridgewater, NJ 08807, USA. APTALIS PHARMA INC.’s corporate office is located at 22 Inverness Center Parkway, Suite 310, Birmingham, AL 35242.
Unless the context requires otherwise, references in this Annual Report on Form 10-K to “we”, “our”, “us”, the “Company”, “API”, “Aptalis” and “Axcan” mean APTALIS PHARMA INC., and all of its subsidiaries.
Overview
Aptalis Pharma Inc. is a privately held, leading specialty pharmaceutical company providing innovative, effective therapies for unmet medical needs including cystic fibrosis and gastrointestinal disorders. We have manufacturing and commercial operations in the United States, the European Union and Canada, and our products include ZENPEP®, CANASA®, CARAFATE®, PYLERA®, PANZYTRAT®, LACTEOL®, DELURSAN®, and SALOFALK®. Our vision is to become the reference specialty pharma company providing innovative, effective therapies for unmet medical needs, including cystic fibrosis and gastrointestinal disorders, and we hope to achieve this through our mission: to improve health and quality of care by providing specialty therapies for patients around the world. We will strive to improve patient quality of care thanks to a broad range of products in cystic fibrosis and gastrointestinal disorders, a robust pipeline, technology platform, manufacturing capabilities and a skilled team of professionals with deep understanding of our customers’ needs.
We also formulate and clinically develop enhanced pharmaceutical and biopharmaceutical products for itself and others using its proprietary pharmaceutical technology (“PT”) platforms including bioavailability enhancement of poorly soluble drugs, custom release profiles, and taste-masking/orally disintegrating tablet (ODT) formulations.
We intend to enhance our position as the leading specialty pharmaceutical company concentrating in the field of cystic fibrosis and gastroenterology by pursuing the following strategic initiatives: 1) growing sales of existing products; 2) launching new products; 3) selectively acquiring or in-licensing complementary late stage or in-market products from third parties; 4) pursuing growth opportunities through development pipeline and through our pharmaceutical technologies capabilities; and 5) expanding internationally.
INDUSTRY AND COMPANY
Industry Overview
Gastrointestinal (“GI”) disorders are quite diverse affecting not only the GI tract but also different parts of the alimentary tract such as the pancreas, oropharynx, the liver and biliary systems and the alimentary canal. Disorders of the gastrointestinal tract are fairly common and occur in people of all ages. Causes of these disorders vary and could include genetic anomalies, the effect of certain toxins and drugs, infections, cancer and often unknown causes. GI disorders take up a significant share of the disease burden in developed economies and the gravity of the problem is further accentuated by the difficulty that they pose in effective management. The GI tract therapeutic area consists of some indications that can be treated through pharmacologic interventions, though significant unmet needs still exist, particularly for indications such as irritable bowel syndrome (IBS), Crohn’s disease (CD) and ulcerative colitis (UC).
According to a report entitled “The Gastrointestinal Market Outlook To 2014: Market Dynamics, Competitive Landscape, Emerging Therapies” (published by Business Insights, December 2009 and retrieved from Research and Markets, a leading source for international market research and market data), the gastrointestinal market was valued at $49.9 billion in 2008 and U.S. took the largest share of this market (37.8%) with sales amounting to $18.8 billion.
According to a report entitled “Opportunities & Challenges in Digestive Diseases Research” (U.S. Department of Health and Human Services, National Institutes of Health -March 2009), at least 60 to 70 million Americans are affected each year by digestive diseases, placing a burden on society that exceeds $100 billion in direct medical costs in the U.S. Annually, in the U.S., about 14 million hospitalizations -10% of the total- and 15% of all in-patient hospital procedures are attributed to treatment of digestive diseases. In addition, in the U.S., 105 million visits to doctors’ offices occur each year for digestive diseases, frequently in response to symptoms such as abdominal pain, diarrhea, vomiting or nausea. Prescription drugs for the treatment of certain digestive diseases such as gastroesophageal reflux disease (GERD) rank among the most commonly used pharmaceutical drugs in the U.S. Even more worrying, digestive diseases are associated with significant mortality, morbidity and loss of quality of life. Digestive diseases, including cancer, are named as a primary cause of approximately 236,000 deaths in the U.S. each year. Moreover, digestive disorders, even conditions that are not immediately life-threatening, can severely affect patients’ quality of life and cause significant disability even for conditions that are not immediately life-threatening. Debilitating symptoms-such as chronic pain, discomfort, bloating, diarrhea, constipation, and incontinence, not to mention social stigma or embarrassment associated with many GI disorders can affect patients’ ability to work or engage in daily activities. Collectively, these diseases account for over $44 billion in indirect costs associated with disability and mortality each year in the U.S.
Exocrine Pancreatic Insufficiency (“EPI”) is caused by a deficiency of digestive enzymes normally produced by the pancreas and secreted into the digestive track. Pancreatic secretions primarily consist of three enzymes - lipases for the digestion of fat, proteases for the digestion of proteins and amylases for the digestion of sugars. A normally functioning human pancreas secretes eight enzymes that are required for the effective and efficient digestion and absorption of food. Scientific evidence indicates that, in addition to these eight key digestive enzymes, several coenzymes and cofactors are also required for absorption of essential nutrients. Porcine-derived pancreatic enzyme products (“PEPs”) are comparable in composition to human pancreatic secretions and apparently contain the key enzymes, coenzymes and cofactors necessary for proper digestion. If the pancreas is not able to produce and secrete sufficient amounts of these enzymes, food cannot be digested and the appropriate levels of nutrients cannot be absorbed into the bloodstream. Maldigestion and malabsorption associated with pancreatic insufficiency cause malnutrition, which can lead to impaired growth, impaired immune response and shortened life expectancy.
EPI is a condition resulting from various diseases, such as cystic fibrosis, chronic pancreatitis, pancreatic cancer, cytomegalovirus infection and HIV/AIDS. In addition, EPI can result from surgical procedures, including open gastric bypass, extensive small bowel resection and pancreatectomy. The primary users of PEPs are patients with pancreatic insufficiency secondary to cystic fibrosis and chronic pancreatitis.
Cystic fibrosis is a life-threatening genetic disease that, because of a defective gene, causes the body to produce a faulty protein that leads to abnormally thick, sticky mucus that clogs the lungs and obstructs ducts in the pancreas. When cystic fibrosis affects the pancreas, as it does in the majority of cystic fibrosis patients, the body does not absorb sufficient nutrients to grow and thrive. Cystic fibrosis is one of the most prevalent genetic diseases among Caucasians in the U.S. The disease affects an estimated 30,000 adults and children in the U.S. and some 100,000 patients worldwide, an estimated 85% to 90% of whom suffer from pancreatic insufficiency.
Chronic pancreatitis (CP) is a slow, clinically silent disease that gradually destroys the pancreas and is most often caused by excessive alcohol consumption, but may also result from other conditions such as hyperlipidemia, hyperparathyroidism, injuries or obstructions. Because CP is not necessarily characterized by inflammation or pain, it often goes undiagnosed and therefore its exact prevalence is unknown. Based on survey data reported in Medscape General Medicine, we believe chronic pancreatitis results in more than 500,000 physician visits per year in the U.S. See “Risk Factors - Risks Related to ZENPEP® - Even though ZENPEP has received regulatory approval for marketing in the U.S., and we have met significant milestones necessary to achieve marketing authorization in several venues, we may not succeed in obtaining regulatory approval for ZENPEP from other regulatory agencies. Without regulatory approval from other regulatory agencies, we will be unable to commercialize ZENPEP to its full potential and our growth prospects will be materially impaired.”
Acquisition of Eurand
On February 11, 2011, Axcan Holdings Inc., which subsequently changed its name to Aptalis Holdings Inc. (“Aptalis Holdings”), our indirect parent, and Axcan Pharma Holding B.V., an indirect subsidiary of ours, pursuant to the Share Purchase Agreement dated November 30, 2010 (as amended) acquired the outstanding equity of Eurand N.V. (“Eurand”) for total consideration of approximately $589.6 million equity(for a more complete description of the Transactions, see “-Transactions”). As a result of the acquisition, Eurand has become an indirect subsidiary.
Eurand utilized its proprietary pharmaceutical technologies to develop novel products that it believed had advantages over existing products or addressed unmet medical needs. Through its collaboration arrangements, Eurand has successfully applied its technologies to drug products in a diverse range of therapeutic areas, including cardiovascular, GI, pain, nutrition and respiratory. Eurand had six products approved by the FDA since 2001. Its technology platforms include bioavailability enhancement of poorly soluble drugs, custom release profiles and taste-masking/orally disintegrating tablet (ODT) formulations. Eurand was simultaneously developing and commercializing its own portfolio of therapeutic products to address conditions associated with CF and GI disorders.
Using its own sales and marketing team, Eurand commercialized a portfolio of products for CF and GI patients in the United States. On August 27, 2009, the FDA approved Eurand’s lead product EUR-1008, or ZENPEP, for sale in the United States for the treatment of individuals suffering from EPI due to CF or other conditions. Eurand launched ZENPEP (pancrelipase) Delayed-Release Capsules in the United States in the fourth quarter of 2009 and expanded and supplemented its sales force immediately prior to launch to address both the GI and CF communities.
Eurand also had manufacturing and research facilities in the United States and Italy, and a manufacturing facility in France. Eurand manufactured and supplies over 40 different products for sale in the world’s largest pharmaceutical markets. Eurand traditionally generated revenues through three primary sources: the manufacture and supply of products, development and sales of out-licensed products, and fees related to Eurand’s formulation and product development work.
The acquisition of Eurand enables us to leverage the combination of two leading specialty pharmaceutical players, expand our gastroenterology product portfolio and provide us with a proprietary R&D growth engine and technology platforms supported by an extensive patent portfolio to meaningfully diversify its business, and expand its geographic and manufacturing footprint.
The aggregate equity purchase price of $589.6 million plus acquisition costs (including related fees and expenses) were funded by cash equity contributions, made through Aptalis Holdings, amounting to $140.0 million from affiliates of TPG Capital L.P. and certain co-investors, the proceeds from the Senior Secured Term Loan Facility (as defined below) under our amended and restated credit agreement and related security and other agreements and cash on hand from Aptalis and Eurand.
The amended and restated credit agreement and related security and other agreements is composed of (i) a senior secured revolving credit facility in an aggregate principal amount of $147.0 million (the “Senior Secured Revolving Credit Facility”) and (ii) a $750.0 million senior secured term loan facility (the “Senior Secured Term Loan Facility” and, together with the Senior Secured Revolving Credit Facility, collectively, the “Amended and Restated Senior Secured Credit Facilities”). The Senior Secured Revolving Credit Facility is comprised of $115.0 million of existing revolving credit commitments that were extended or issued on February 11, 2011 (the “ Extended Commitments”) and $32.0 million of existing revolving credit commitments that were not extended (the “ Unextended Commitments”) pursuant to the Senior Secured Revolving Credit Facility.
We borrowed $500.0 million of the amount available under the Senior Secured Term Loan Facility at the closing of the acquisition. The Senior Secured Revolving Credit Facility remained undrawn at the closing of the acquisition. A portion of the proceeds of the equity and debt financings, together with cash on hand of Axcan and Eurand, were used to repay the outstanding term loan portion amounting to $125.7 million of the our prior senior secured credit facilities and to pay related fees and expenses. The remaining amount of $250.0 million of the Senior Secured Term Loan Facility was used on March 15, 2011 to redeem 100% of our existing 9.25% senior secured notes due 2015.
Acquisition of Mpex
On April 11, 2011, Aptalis Holdings and Axcan Lone Star Inc. (“Merger Sub”), affiliates of ours, entered into a series of agreements with Mpex Pharmaceuticals Inc. (“Mpex”) for the acquisition and development of Aeroquin™ (the “Aeroquin Transaction”), a proprietary aerosol formulation of levofloxacin, which is currently in Phase 3 clinical trials for the treatment of pulmonary infections in patients with cystic fibrosis (CF). Subsequently on August 31, 2011, under the terms of these agreements, Aptalis Holdings and Merger Sub acquired all of Mpex’s assets related to Aeroquin™ in a merger of Mpex with and into Merger Sub, with Mpex being the surviving corporation and a direct, wholly-owned subsidiary of us. Prior to the merger, Mpex transferred all of its assets and liabilities not related to Aeroquin™ to Rempex Pharmaceuticals, Inc. (“Rempex”), a newly formed company that is owned primarily by the previous Mpex stockholders (the “Divestiture”).
As a result of the Aeroquin Transaction, we made an initial non-contingent payment of $12.0 million on April 21, 2011. Additional consideration in relation with the Aeroquin Transaction consists of (i) remaining time-based, non-contingent payments amounting to $33.0 million and an additional $17.5 million of time-based payments will be paid in a number of installments, of which the final installment is due on April 1, 2014, plus, (ii) contingent payments of up to $195.0 million if certain regulatory and commercial milestones are met related to Aeroquin™, and (iii) earn-out payments based on net sales of Aeroquin™. Indemnity obligations of the Mpex security holders will be satisfied by set-off against a portion of the foregoing merger consideration payments.
The further development of Aeroquin™ is being conducted pursuant to the terms of the Development Agreement dated April 11, 2011 among Aptalis Holdings, Merger Sub, and Mpex. Since the completion of the divestiture of assets and liabilities unrelated to Aeroquin™ (the “Divestiture”) to Rempex, Rempex has assumed all of Mpex’s obligations under the Development Agreement. Under the Development Agreement, Rempex is paid for the actual development costs of Aeroquin™ and has primary responsibility for conducting day-to-day development activities. We are required to pay in advance development costs estimated for the next three months based on a rolling three months forecast. Aptalis Holdings and Mpex have input regarding development strategy. Pursuant to the Development Agreement, on April 12, 2011 Mpex was paid $8.7 million for development expenses incurred by Mpex from November 15, 2010, to March 31, 2011, which has been expensed as acquired in-process research and an additional $9.9 million for estimated development costs to be incurred during the first three months of the Development Agreement, of which $8.5 million has been expensed as research and development. All payments under the Development Agreement, Option Agreement and Merger Agreement to Mpex or Mpex security holders, as applicable, were made by or on behalf of Merger Sub prior to the closing of the Aeuroquin Transaction, and are being made on behalf of Mpex since the closing of the Aeroquin Transaction.
During the year ended September 30, 2011, we expensed $65.5 million as acquired in-process research and development reflecting the initial non-contingent payment of $12.0 million, the discounted value of future time-based non-contingent payments payable under the Option and Merger agreements of $44.8 million (with a corresponding liability) and the payment for certain pre-agreement incurred development expenses of $8.7 million. As of September 30, 2011, $7.8 million, which reflects forecasted development costs for the next three months has been included in prepaid expenses and other current assets.
Equity investment in Aptalis Holdings
Simultaneous with the execution of the Mpex agreements, Aptalis Holdings received the proceeds of a $55.0 million equity investment from funds managed by Investor Growth Capital Limited. Aptalis Holdings contributed the proceeds of the equity investment to its subsidiaries to fund a portion of the cost of the Mpex transactions and a partial repayment on our $133.1 million note receivable from our parent company.
Competitive Strengths
We believe we have a number of competitive strengths that will enable us to further enhance our position in the gastroenterology and cystic fibrosis markets.
Diversified Portfolio of Branded Products. We currently market branded products in various product categories that treat a broad range of GI and CF diseases and disorders. During fiscal year 2011, two product lines, CANASA and CARAFATE, contributed 42% of our revenues, but no single product line accounted for more than 23% of our revenues. Our portfolio of products is also geographically diverse, with approximately 30% of our revenues being generated from sales outside the U.S. in fiscal year 2011.
Leading Competitive Positions in Attractive Gastroenterology Markets. We have a strong track record of leveraging a product line’s unique market position to drive performance. ZENPEP, CANASA and CARAFATE are our main products in the U.S.; ZENPEP is used to treat pancreatic insufficiency and is the second leading pancreatic enzyme replacement therapy (PERT) in the US. It is 1 of only 3 FDA approved PEPS in the US. CANASA is used to treat ulcerative proctitis and colitis and accounted for 65.0% of the U.S. market for rectally-administered mesalamine products in terms of sales in fiscal year 2011; CARAFATE is the only branded suspension-form sucralfate product in its market in the U.S. It accounted for 30.9% of the U.S. market sales for sucralfate products in fiscal year 2011. We believe that certain of our products are often the first line of treatment prescribed by physicians for these diseases and disorders. Additionally, CF and many of the GI diseases and disorders that our products are used to treat are chronic, and as a result, we believe that physicians tend to be reluctant to change a patient’s treatment program once the patient has been treated with and becomes accustomed to a particular product. As a result, we believe that our products experience a high degree of patient loyalty, allowing us to maintain leading competitive positions in the markets in which we participate.
Non-Patent Hurdles to Entry. Despite having limited long-term patent protection, we believe that our core product lines benefit from a variety of regulatory, clinical, sourcing and manufacturing hurdles to entry, including, depending upon the product line and the product, the requirement to conduct clinical trials, availability of various forms of regulatory exclusivity and the know-how required to manufacture certain dosage forms. We believe that these hurdles make it more difficult for generic competitors to introduce and market generic versions of certain of our products, including products from our ZENPEP, CANASA, CARAFATE, ULTRASE MT and VIOKASE product lines. See “Item 1A.
ITEM 1A. RISK FACTORS
This report contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those discussed in this report. Factors that could cause or contribute to these differences include, but are not limited to, those discussed below and elsewhere in this report.
If any of the following risks, or other risks are not presently known to us or that we currently believe to not be significant, develop into actual events, then our business, financial condition, results of operations or prospects could be materially adversely affected. If that happens, the market value of our bonds could decline, and bond holders could lose all or part of their investment.
RISKS RELATED TO OUR BUSINESS
We currently depend on four categories of products for a large portion of our revenues; any material decline in the sales of any of them would have an adverse impact on our business.
Any factor that adversely affects the sale or price of our key products could significantly decrease our sales and profits. Pancreatic Enzyme Replacement Therapies (ZENPEP and PANZYTRAT) accounted for 17.8 % of our net product sales for fiscal year 2011. Ursodiol products (URSO, URSO 250, URSO DS, URSO FORTE and DELURSAN), mesalamine products (CANASA and SALOFALK) and sucralfate products (CARAFATE and SULCRATE) accounted for 12.6%, 28.4% and 24.4%, respectively, of our net product sales for fiscal year 2010 and for 9.5%, 25.5% and 23.5%, respectively, of our net product sales for fiscal year 2011. With the exception of ursodiol products that now face generic competition both in the U.S. and Canada, we believe that sales of other groups of products will continue to constitute a significant portion of our total revenues until we launch additional products. Any significant setback with respect to any one of these products, including shipping, manufacturing, regulatory issues, product safety, marketing, government licenses and approvals, intellectual property rights problems, or generic or other forms of competition, could have a material adverse effect on our financial position, cash flows or overall trends in results of operations.
ZENPEP competes with currently marketed PEPs and our competitors may have more resources available to them than us.
ZENPEP competes with currently marketed products for exocrine pancreatic insufficiency. This competition, and the increased competition should ULTRASE MT and/or VIOKASE be approved by the FDA and relaunched into the market, could affect the market acceptance of ZENPEP or require us to lower the price of ZENPEP, which would negatively impact our margin and our ability to achieve profitability of the ZENPEP franchise. Other companies with existing PEPs include Solvay Pharmaceuticals acquired by Abbott Laboratories or Solvay/Abbott; and McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson. In addition, we understand that other commercial entities have or have had synthetic product candidates in clinical development that could compete with ZENPEP. These and other companies may have greater resources available than we do to support their products.
Solvay/Abbott’s CREON (approved in May 2009) and Johnson & Johnson’s PANCREAZE (approved in April 2010) compete with ZENPEP. In addition, if SOLPURA (liprotamase), Eli Lilly’s lead candidate for the treatment of exocrine pancreatic insufficiency associated with CF and pancreatectomy, or if PANCRECARB, Digestive Care’s PEP, are approved by the FDA, the competition ZENPEP faces will significantly increase.
The entry of generics versions of our CARAFATE and CANASA products in the U.S. could have a material adverse impact on our financial position, cash flows or overall trends in results of operations.
CANASA
CANASA does not have any patent protection in the U.S. On November 5, 2007, clinical investigation exclusivity previously granted pursuant to the Hatch-Waxman Act, covering a change in the formulation of this drug from a 500 mg formulation to a 1,000 mg suppository formulation, expired. As a result, if a generic mesalamine suppository were to be launched, it could have a significant negative impact on sales of CANASA in the U.S.
In June 2007, the FDA published draft guidance on the requirements it expects manufacturers seeking approval of a mesalamine suppository to meet in order to obtain approval of mesalamine suppositories. This draft guidance specifies that a request for regulatory approval of a mesalamine suppository product must be supported by placebo and reference-drug controlled clinical studies with clinical endpoints demonstrating safety and effectiveness in patients with ulcerative proctitis. We cannot provide assurances that the FDA requirements reflected in this draft guidance will be applied by the FDA or will be formally adopted in their current form.
In a July 2010 posting on clinicaltrial.gov that was updated in November 2010, Sandoz Inc. disclosed that it had initiated in June 2010 a clinical trial to establish therapeutic equivalence of a 1,000 mg rectal mesalamine suppository product to CANASA rectal suppositories, for the treatment of mild to moderate ulcerative proctitis. The disclosure states that the trial is being conducted in India and has an estimated duration of 18 months. Cadila Healthcare Inc. also recently disclosed that it is conducting a similar clinical study in India to establish therapeutic equivalence of a 1,000 mg rectal mesalamine suppository product to CANASA.
CARAFATE
CARAFATE does not have any patent protection or regulatory exclusivity in the United States.
There are no generic versions of the CARAFATE oral suspension product that are commercially available in the U.S. or Canada. However, we are aware that a third party has filed an Abbreviated New Drug Application, or ANDA, for the approval to engage in the commercial manufacture and sale of 1gm/10mL sucralfate suspension, the active pharmaceutical ingredient in our CARAFATE oral suspension product. If a generic version of CARAFATE oral suspension was to be launched, it could have a significant negative impact on sales of CARAFATE oral suspension in the U.S.
Generic competition against any of our products could potentially lower prices and unit sales and could have a material adverse impact on our financial position, cash flows or overall trends in results of operations.
The launch of a product that competes with our ursodiol product line in France could have a material adverse impact on our financial position, cash flows or overall trends in results of operations.
We reported net sales of $26.2 million, $23.4 million and $20.8 million for DELURSAN in fiscals 2011, 2010, and 2009, respectively. (In local currency, net sales of DELURSAN were 18.7 million, 17.3 million and 15.4 million in fiscal years 2011, 2009 and 2008, respectively).
DELURSAN mainly competes with URSOLVAN® (Sanofi-Aventis S.A.). However, we expect another branded competitor to be launched in France in 2012. A request for marketing approval was submitted by Mayoli Spindler for CHOLURSO® 250mg and 500mg, based on well-established use. Additionally, on December 1, 2011, we learned that a generic UDCA (ursodeoxycholic acid) 250mg was being assessed by Afssaps (Agence francaise de securite sanitaire des produits de santé). If these other ursodiol products are launched, they could have a significant negative impact on sales of DELURSAN in France.
Branded and generic competition to DELURSAN, which made up approximately 5.7% of our net product sales in fiscal year 2011, could have a material adverse effect on our results of operations and financial condition.
Some of our key products face competition from generic or unbranded products.
Some of our key products, including products from our URSO and CANASA lines, currently face competition from generic or unbranded products (such as ACTIGALL™, its generics and the launched generic in the case of URSO, and other mesalamine rectal dosage forms in the case of CANASA). Third-party payors and pharmacists can substitute generic or unbranded products for our products even if physicians prescribe our products by name. Particularly in the U.S., government agencies and third-party payors often put pressure on patients to purchase generic products instead of brand-name products as a way to reduce health-care costs.
Generic competition against any of our products could lower prices and unit sales and could therefore have a material adverse effect on our results of operations and financial condition.
Future sales of our marketed products might be less than expected.
The degree of continued market acceptance of our products among physicians, patients, health-care payors and the medical community will depend upon a number of factors including
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the timing of regulatory approvals and product launches by us or competitors, and any generic or over-the-counter competitors;
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perceptions by physicians and other members of the health-care community regarding the safety and efficacy of the products;
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price increases, and the price of our products relative to other drugs or competing treatments;
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patient and physician demand;
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adverse side effects or unfavorable publicity regarding our products or other drugs in our class;
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the results of product development efforts for new indications;
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the scope and timing of additional marketing approvals and favorable reimbursement programs for expanded uses;
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availability of sufficient commercial quantities of the products; and
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our success in getting other companies to distribute our products outside our target markets.
The concentration of our product sales to only a few wholesale distributors increases the risk that we will not be able to effectively distribute our products if we need to replace any of these distributors, which would cause our sales to decline.
The majority of our sales are to a small number of pharmaceutical wholesale distributors, which in turn sell our products primarily to retail pharmacies, which ultimately dispense our products to the end consumers. In fiscal year 2011, sales to our main customer, Customer A, accounted for 26.3% of our net product sales, sales to Customer B accounted for 25.5% of our net product sales, and sales to Customer C accounted for 10.0% of our net product sales.
If any of these distributors cease doing business with us for any or all of our products, or materially reduce the amount of product they purchase from us and we cannot conclude agreements with replacement wholesale distributors on commercially reasonable terms, we might not be able to effectively distribute our products through retail pharmacies. The possibility of this occurring is exacerbated by the consolidation occurring in the wholesale drug distribution industry, including through mergers and acquisitions among wholesale distributors and the growth of large retail drugstore chains. As a result, a small number of large wholesale distributors control a significant share of the market. However, this risk is mitigated by the fact that we now have DSAs with our three largest U.S. wholesalers.
Wholesaler buying patterns may change, and this could have a detrimental effect on our future revenue and financial condition.
Since fiscal year 2005, some wholesalers have changed their business model from one depending on drug price inflation to a fee-for-service arrangement, whereby manufacturers pay wholesalers a fee for inventory management and other services. These fees typically are a percentage of the wholesaler’s purchases from the manufacturer or a fixed charge per item or per unit. The fee-for-service approach results in wholesalers’ compensation being more stable and volume-based as opposed to price-increase-based. As a result of the move to a fee-for-service business model, many wholesalers are no longer investing in inventory ahead of anticipated price increases and have reduced their inventories from their historical levels. Under the new model, the consequence of manufacturers using wholesalers is that they now realize the benefit of price increases more rapidly in return for paying wholesalers for the services they provide, on a fee-for-service basis. Fees resulting from distribution service agreements, or DSAs, are deducted from gross sales. We have DSAs with our three largest U.S. wholesalers, which provide that these wholesalers will maintain the levels of inventory of our products that they carry within specific agreed upon target levels. A reduction in inventory levels by a pharmaceutical wholesale distributor would result in a reduction in our sales to that wholesale distributor for the period during which the reduction occurs, and would have a negative effect on our results of operations for the period.
We deduct DSA fees, which totaled approximately $5.6 million and $9.0 million for fiscal year 2010 and fiscal year 2011, respectively, from our total revenues. If we enter into DSAs with additional wholesalers, we will likely have to pay them DSA fees, which will further reduce our revenue in future periods.
Generally, changes in wholesaler buying patterns may occur in the future, and these changes could result in a reduction in our revenues and could have a detrimental effect on our overall financial condition or results of operations.
We have historically used third parties to manufacture and test certain of our products and product candidates. This may increase the risk of not having sufficient quantity of our products or product candidates, quantity at an acceptable cost or product with acceptable quality or in compliance with standards and specifications. This could adversely affect sales of our products or result in the clinical development or commercialization of our products or product candidates being delayed, prevented or impaired.
We manufacture the finished product for ZENPEP, SALOFALK, ULTRASE, and LACTEOL and other Pharmaceutical Technology products. With the exception for products manufactured by us, or products developed by us for collaborators using our pharmaceutical technologies platforms, we do not expect to engage directly in the manufacturing of products, but will continue to contract with third-party organizations. There are a limited number of manufacturers capable of manufacturing our marketed products and our product candidates. We could fail to contract or renew contracts with the relevant manufacturers or could contract with manufacturers under terms and conditions that may not be entirely acceptable to us.
We currently rely, and expect to continue to rely, on third parties for (i) the supply and testing of the active pharmaceutical ingredients and other materials used in our products and product candidates, and (ii) the manufacturing, packaging and testing of certain of our finished products. The current manufacturers of our products and product candidates and likely future third-party manufacturers with whom we would enter into an agreement, are or could be sole suppliers of our products and product candidates for a given period of time. These manufacturers are commonly referred to as single-source suppliers. Our agreements for the manufacturing of our core products expire at various dates over the next three to five years. Should we be unable to renew these agreements under favorable terms or find suitable alternates, our business may be adversely affected. Some of our contracts prohibit us from using alternate manufacturers or suppliers for the products supplied under these contracts, which prevents us from reducing dependence on single sources of supply. In addition, we currently purchase materials and clinical supplies for some of our products and product candidates from third-party manufacturers on a purchase order basis. Should any of these manufacturers be unable to supply us for any reason, we may be delayed in identifying and qualifying replacements. In any event, identifying and qualifying a new supplier or third-party manufacturer could involve significant cost, is associated with the transfer of the active pharmaceutical ingredient or finished-product manufacturing process. In addition, any change in manufacturing generally requires formal approval by the regulatory agency, e.g. the FDA, prior to proceeding with manufacturing at the new site. This approval process typically takes a minimum of 12 to 18 months and during that time we may face a shortage of supply of our products.
Reliance on third-party manufacturers entails risks, without being limited to, the following:
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Manufacturing of products may be difficult to scale up when required, which could result in delays, inefficiencies and poor or low yields of quality products.
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Some of our contracts contain purchase commitments that require us to make minimum purchases that might exceed needs or limit the ability to negotiate with other manufacturers, which might increase costs.
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Cost involved in manufacturing certain products may lead to such products being prohibitively expensive.
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Delays in site transfers or scale-up to commercial quantities and any difficulty in manufacturing could delay clinical studies, regulatory submissions, approval and commercialization or continued commercialization of our products.
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In the event of a manufacturing change, the FDA and other comparable country regulators require testing and compliance inspections; new manufacturers may have to be educated to our products’ production process, which requires time.
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There are a limited number of manufacturers that operate under current good manufacturing practices (“cGMP”) regulations and that are both capable of manufacturing for us and willing to do so. If the third parties that we engage to manufacture and/or test a product for commercial sale or for our clinical trials were to cease to continue to do so for any reason, we could experience delays in obtaining sufficient quantities of our products for us to meet commercial demand or in advancing production of our commercial products or our clinical trials while we identify and qualify replacement suppliers.
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If, for any reason, we were not able to obtain adequate supply of our product and product candidates or the drug substances used to manufacture them, it would be difficult for us to develop, transfer or manufacture our products ourselves and compete effectively.
Our current and anticipated future dependence upon others for the manufacturing and testing of our products and product candidates may adversely affect our profit margins and our ability to develop products and commercialize additional products that receive regulatory approval in a timely and competitive manner.
For example, the deficiencies raised by the FDA with respect to ULTRASE MT and VIOKASE were with respect to the manufacturing and control processes at a third party manufacturer of the active ingredient for these products. See “-Risks Related to Our Pancreatic Enzyme Products” below for information on deficiencies raised by the FDA with respect to the manufacturer of the active ingredient in ULTRASE MT and VIOKASE.
In September 2010, one of our subsidiaries, and our indirect parent, received notice of Sanofi-Aventis U.S. LLC’s (“SA”) complaint filed with the Superior Court of New Jersey, Somerset County, requesting certain remedies in connection with SA’s stated intention to close its Kansas City facility where CARAFATE product is currently manufactured. The supply agreement with SA, as amended, provides that the CARAFATE product’s manufacturing site may not be changed without our subsidiary’s prior written consent. Pursuant to the complaint filed, SA was seeking an order for specific performance compelling the defendants to consent to the transfer of the manufacturing site of CARAFATE product to an alleged SA facility located in Laval, Canada and to execute related documentation, and for a declaration that SA will not be liable, including for lost profits, for any interruption in supply by reason of the current site’s closure or by reason of a site transfer to Laval. Our subsidiary removed the case to the United States District Court for the District of New Jersey; SA had moved to remand the case back to the Superior Court of New Jersey. The defendants believe that SA’s claims lack merit, and that under the supply agreement as amended, our subsidiary is entitled to have CARAFATE product continue to be manufactured at the Kansas City site until the expiry of that agreement, as amended, which, assuming our subsidiary exercises its option to extend the term, as amended, will be in August 2016. Later, SA decided to transfer the manufacturing of CARAFATE to a different site other than the Laval site. On June 13, 2011 SA filed a notice of voluntary dismissal with the Court, which automatically effectuates that dismissal. Subsequently, we were notified that SA will be keeping the Kansas City facility open to manufacture CARAFATE at least through the expiry of the supply agreement.
We rely on our third-party manufacturers and our own manufacturing operations for compliance with applicable regulatory requirements. This may increase the risk of sanctions being imposed on us or on a manufacturer of our products or product candidates, which could result in our inability to provide sufficient quantities of these products or product candidates.
Manufacturers are subject to the FDA’s cGMP regulations and similar foreign standards, and we do not have control over compliance with these regulations by our third-party manufacturers. We and our third-party manufacturers may not be able to comply with cGMP regulations or other regulatory requirements or similar regulatory requirements outside the U.S.
We and our third-party manufacturers are subject to unannounced inspections by the FDA, state regulators and similar regulators outside the U.S. Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including
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fines;
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injunctions;
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civil penalties;
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failure of regulatory authorities to grant marketing approval of our product candidates;
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delays, suspension or withdrawal of approvals;
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suspension of manufacturing operations;
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license revocation;
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seizures or recalls of products or product candidates;
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operating restrictions; and
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criminal prosecutions.
Any of these sanctions could significantly and adversely affect supplies of our products and product candidates and might adversely affect our profit margins and our ability to develop product candidates and commercialize any additional products that receive regulatory approval on a timely and competitive basis.
We rely on third parties to conduct, supervise and monitor our clinical trials, and those third parties may perform in an unsatisfactory manner, such as by failing to meet established deadlines for the completion of such trials.
We rely on third parties such as contract research organizations, medical institutions and clinical investigators to enroll qualified patients and conduct, supervise and monitor our clinical trials. Our reliance on these third parties for clinical development activities reduces our control over these activities. Our reliance on these third parties, however, does not relieve us of our regulatory responsibilities, including ensuring that our clinical trials are conducted in accordance with good clinical practice regulations, and the investigational plan and protocols contained in the relevant regulatory application, such as the investigational new drug (“IND”) application. In addition, such third parties may not complete activities on schedule, or may not conduct our preclinical studies or clinical trials in accordance with regulatory requirements or our trial design. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, our efforts to obtain regulatory approvals for, and to commercialize, our product candidates may be delayed or prevented.
Our business could suffer as a result of adverse drug reactions to the products we market.
Unexpected adverse drug reactions by patients to any of our products could negatively impact utilization or market availability of our product.
Absence of long-term safety data may also limit the approved uses of our products, if any. If we fail to comply with the regulatory requirements of the FDA and other applicable regulatory authorities, or if previously unknown problems with any approved commercial products, manufacturers or manufacturing processes are discovered, we could be subject to administrative or judicially imposed sanctions or other setbacks, including
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restrictions on the products, manufacturers or manufacturing processes;
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warning letters and untitled letters;
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civil penalties and criminal prosecutions and penalties;
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fines;
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injunctions;
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product seizures or detentions;
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import or export bans or restrictions;
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voluntary or mandatory product recalls and related publicity requirements;
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suspension or withdrawal of regulatory approvals;
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total or partial suspension of production; and
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refusal to approve pending applications for marketing approval of new products or of supplements to approved applications.
The publication of negative results of studies or clinical trials may adversely impact our sales revenue.
Studies or clinical trials on various aspects of pharmaceutical products are conducted by us and also by academics or others, including government agencies. The results of these studies or trials, when published, may have a dramatic effect on the market for the pharmaceutical product that is the subject of the study. The publication of negative results of studies or clinical trials related to our products or the therapeutic areas in which our products compete could adversely affect our sales, the prescription trends for our products and the reputation of our products. In the event of the publication of negative results of studies or clinical trials related to our products or the therapeutic areas in which our products compete, our business, financial condition, results of operation and cash flows could be materially adversely affected.
We may not realize the benefits of the acquisition, including anticipated cost-savings, and will incur significant costs in connection with the integration of Axcan and Eurand into a single business.
The acquisition of Eurand involved the integration of two companies that have previously operated independently. The acquisition of Eurand diversifies the business in which we operate (including with respect to pharmaceutical technologies) and expands the number of products under development, as well as increases the number of collaborations and partnerships we will need to manage, the number of our employees and the number of our facilities and the regions in which we operate, thereby presents us with significant challenges as we work to manage the substantial increases in scale resulting from the acquisition. We can give no assurance that the acquisition will perform in accordance with our expectations or that our expectations with respect to integration and synergies as a result of the acquisition will materialize.
The integration of Axcan and Eurand is expected to result in financial and operational benefits, including increased revenues and a substantial amount of synergies from cost-savings and other financial and operational benefits. We do not expect to achieve the full amount of such synergies in the year following the transactions, and there can be no assurance regarding when or the extent to which we will be able to realize these increased revenues, cost-savings or other benefits. This integration may also be difficult, unpredictable, and subject to delay. The acquisition is the most complex that we have tried to integrate and, as a result, we must integrate a large number of systems, platforms, technologies, functions and processes, which could prove to be more difficult than we anticipate. Difficulties associated with integrating the two companies could have a material adverse effect on us. The focus on integration may place a significant burden on our management and internal resources, and the diversion of management attention and any difficulties encountered in the transition and integration process could harm our businesses, financial conditions and operating results. In addition, events outside of our control, including but not limited to regulatory changes or developments, could also adversely affect our ability to realize the anticipated benefits and synergies from the acquisition.
We have incurred and expect to continue to incur significant costs in connection with integrating our operations, products and personnel. These costs may include costs for employee redeployment, relocation or severance, reorganization or closure of facilities, outside consulting fees related to integration, rebranding as well as combination of research and development functions and integration of information systems. We expect to incur a majority of such costs in advance of achieving expected synergies and cost-savings. Additional unanticipated costs may also be incurred in the integration. Although we expect that the elimination of duplicative costs, as well as the realization of other efficiencies related to the integration of the businesses, may offset incremental transaction and transaction-related costs over time, this net benefit will not be achieved in the near term, and may not be achieved at all. There can be no assurance that we will be successful in these integration efforts.
Uncertainty related to the acquisition could harm our business.
We are highly dependent on the continuing efforts of its management team and key personnel. As a result of the integration, current employees could experience uncertainty about their future roles. This uncertainty may adversely affect our ability to attract and retain key management, sales, marketing and R&D personnel. Uncertainty about the effect of the acquisition by customers and suppliers could also have an adverse effect on us. These uncertainties could cause customers, suppliers and others who deal with us to seek to change existing business relationships.
We may not realize the benefits of, and will incur significant costs in connection with, the acquisition of MPEX and AEROQUIN.
The acquisition of MPEX involved the investment to date of $81 million. The acquisition of MPEX and AEROQUIN will help to further diversify our portfolio and expands the number of products under development, but will require the additional investment for clinical studies, and marketing and sales costs. We can give no assurance that the acquisition will perform in accordance with our expectations or AEROQUIN will be approved by the various regulatory agencies.
We intend to continue to pursue additional acquisitions in the future as part of our strategy, which will present certain risks to us.
A significant component of our strategy will continue to be growth through acquisitions of products or businesses. However, we cannot be certain that we will be able to identify appropriate acquisition candidates. Even if an acquisition candidate is identified, there can be no assurance we will be able to successfully negotiate any such acquisition on favorable terms or at all, finance such an acquisition or integrate such an acquired product or business into our existing business. We face significant competition from other pharmaceutical companies for acquisition candidates, which makes it more difficult to find attractive transaction opportunities for
products or companies on acceptable terms. Furthermore, the negotiation of potential acquisitions and the integration of such acquired products or businesses could divert management’s time and resources and require significant financial resources to consummate. To consummate any acquisition, we may need to incur additional debt or issue additional equity securities and, depending on market conditions, we may not be able to obtain necessary financing for any acquisitions on terms acceptable to us, or at all. We may also be required to pay external costs such as legal advisory, market research consultancy and due diligence fees related to our pursuit and evaluation of potential acquisitions, even if the acquisitions are never consummated. Failure to acquire new products may diminish our rate of growth and adversely affect our competitive position.
Any acquisition transactions involve various inherent risks, such as assessing the value, strengths, weaknesses, contingent and other liabilities, and potential profitability of the acquisition; the potential loss of key personnel of an acquired business; the ability to achieve operating and financial synergies anticipated to result from an acquisition and unanticipated changes in business, industry or general economic conditions that affect the assumptions underlying the acquisition. Any one or more of these factors could cause us not to realize the anticipated benefits from the acquisition of businesses or products.
There is no assurance that we will continue to be successful in our licensing and third-party marketing operations.
Certain of our products are sold and marketed by third parties and collaboration or co-development partners. Such third-party arrangements may not be successfully negotiated in the future. Any such arrangements may not be available on commercially reasonable terms. Even if acceptable and timely marketing arrangements are available, the products we develop may not be accepted in the marketplace, and even if such products are initially accepted, sales may thereafter decline. Additionally, our clients or marketing partners may make important marketing and other commercialization decisions with respect to products we develop that are not within our control. Our clients or marketing partners could also merge with or be acquired by another company, or experience financial or other setbacks unrelated to our arrangement that could affect their ability to perform their obligations under their agreement with us. As a result, many of the variables that may affect our revenues, cash flows and net income are not exclusively within our control. Furthermore, disputes may arise between us and a customer, licensee or marketing collaborator and may involve the issue of the obligations of the customer, licensee or marketing collaborator to continue to purchase our products and pay royalties on the sale of our products. Such a dispute could result in expensive arbitration or litigation, which may not be resolved in our favor.
The success of our strategic investments, partnerships or development alliances and collaborators, particularly those involving our pharmaceutical technologies, depends upon the performance of the companies in which we invest, or with which we partner or co-develop products.
Our arrangements with collaboration partners and licensees are critical to our success in bringing certain of our products and product candidates to market. In particular, we have invested and expect to continue investing significant time and financial resources in the development of our co-development products. We depend on our collaboration partners to conduct preclinical studies and clinical trials, as may be necessary, and to provide funding for our development of these product candidates. Furthermore, in most instances, we rely on collaborators to commercialize our co-development products. If we or a significant number of our collaborators are unable to commercialize our co-development products or experience significant delays in such commercialization, our growth prospects will be materially harmed. The successful commercialization of a product or product candidate will depend on numerous events or factors, including:
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successfully completing preclinical studies and clinical trials and any additional trials and tests required by the FDA, the European Marketing Authority (“EMA”) or other applicable regulatory authorities;
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receiving marketing approvals, to the extent required, from the FDA, the EMA or other applicable regulatory authorities; and
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obtaining commercial acceptance, if approved, from the medical community and third-party payors.
We cannot control our collaborators’ or licensees’ performance or the resources they devote to our projects, and some of our collaborators can terminate their agreements with us for no reason and on limited notice. If a collaborator fails to perform as expected, we may have to use funds, personnel, laboratories and other resources that we have not budgeted for, or we may not be able to continue the particular project affected.
We generally expect a number of the new co-development agreements we enter into to terminate without significant development activity. A collaboration partner may choose to use its own or one of our competitors’ technologies to develop a way to reformulate its drug and thus withdraw its support of our product candidate. Alternatively, we may develop a proprietary product candidate that competes directly with products that we currently manufacture for a collaboration partner. In addition, a collaboration partner could merge with or be acquired by another company, or experience financial or other setbacks unrelated to our collaboration that could jeopardize the co-development project. The loss of collaborators or projects could materially adversely affect our business, growth prospects and financial condition.
Economic, governmental, industry and internal company factors outside our control affect each of the companies in which we may invest or with which we may partner or co-develop products. Some of the material risks relating to such companies include:
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the ability of these companies to successfully develop, manufacture and obtain necessary governmental approvals for the products that serve as the basis for our investments in, or relationship with, such companies;
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the ability of competitors of these companies to develop similar or more effective products, making the drugs developed by these companies difficult or impossible to market;
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the ability of these companies to adequately secure patents for their products and protect their proprietary information;
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the ability of these companies to enter the marketplace without infringing upon competitors’ patents;
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the ability of these companies to finance their operations;
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the ability of these companies to remain technologically competitive; and
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the dependence of these companies upon key scientific and managerial personnel.
Our operations could be disrupted if our information systems fail or if we are unsuccessful in implementing necessary upgrades.
Our business depends on the efficient and uninterrupted operation of our computer and communications systems and networks, hardware and software systems, and other information technology. If our systems were to fail or we were unable to successfully expand the capacity of these systems, or we were unable to integrate new technologies, or integrate acquired companies such as in the case of Eurand, into our existing systems, our operations and financial results could suffer.
Our quarterly results may fluctuate.
Our quarterly operating results have fluctuated in the past and may continue to fluctuate in the future. Factors that could cause quarterly operating results to decline, many of which are not within our control, include, for example, the size and timing of product orders, which can be affected by customer budgeting and buying patterns, or the size and timing of expenses associated with our development and marketing programs and the fluctuation in the timing of certain integration expenses. As a result, if customer buying patterns cause revenue shifts from one fiscal quarter to another, or if the development and marketing of our products causes our expenses to change from one fiscal quarter to another, our net quarterly income may fluctuate. In particular, revenue from the pharmaceutical technologies business is based on completion of relevant milestones and, therefore, is prone to a significant fluctuation over time, which may have an adverse effect on our results of operations.
Our business depends on key scientific, sales and managerial personnel for continued success.
Much of our success to date has resulted from the skills of certain of our officers, scientific personnel and sales force. High demand exists for senior management and other key personnel in the pharmaceutical industry. The loss of any of these people may negatively impact our ability to manage our company effectively and to carry out our business plan. If these individuals were no longer employed by us, we might not be able to attract or retain employees with similar skills or carry out our business plan. In particular, we rely on the contributions of our senior management team, and their continued service is critical to our success. Our senior management team is responsible for the development and implementation of our business strategy. The loss of service of any member of our senior
management team or key personnel could delay or prevent the successful completion of our planned clinical trials or the commercialization of our product candidates. Of our senior management team, only five have employment agreements. Such employee retention may be challenging as employees may experience uncertainty about their future roles until, or even after, strategies with regard to the combined company are announced or implemented. If, despite retention efforts, key employees depart because of issues relating to the uncertainty and difficulty of integration, our ongoing business could be harmed. Additionally, the potential distraction of the integration may adversely affect our ability to attract, motivate and retain executives and other key employees and keep them focused on corporate strategies and goals, which could have an adverse impact on our business.
We could face labor disruptions that would interfere with our operations, as we are subject to collective bargaining or other labor agreements or arrangements.
Certain of our employees located in Canada, Italy and France are represented by collective bargaining or other labor agreements or arrangements that may provide greater bargaining or other rights to employees than do the laws of the United States. Such employment rights require us to expend greater time and expense in making changes to employees’ terms of employment or carrying out staff reductions. In addition, national strikes occur, and our employees may strike even if they do not have a grievance against us. While we believe that our relations with our employees are satisfactory, worker disruption on a local or national level or a significant dispute with our employees (including those resulting from or related to integration) could have a material adverse effect on our business, financial position, results of operations and cash flows.
RISKS RELATED TO OUR PANCREATIC ENZYME PRODUCTS (PEPs)
Our ULTRASE MT and VIOKASE PEPs may never be approved in the U.S.
We ceased distributing our ULTRASE and VIOKASE product lines in the United States effective April 28, 2010. ULTRASE and VIOKASE have accounted for 24.0% of our net product sales in fiscal year 2009 and for 15.1% of our net product sales in fiscal year 2010. This action was taken because we did not receive FDA approval for ULTRASE MT or VIOKASE by April 28, 2010, the date mandated by the FDA to obtain approval for pancreatic enzyme products. In April 2004, the FDA mandated that all manufacturers of PEPs file an NDA and receive approval for their products by April 2008 or be subject to regulatory action. In October 2007, the FDA published a notice in the Federal Register extending the deadline within which to obtain marketing approval for PEPs until April 28, 2010, for those companies that (a) were marketing unapproved PEPs as of April 28, 2004; (b) submitted NDAs on or before April 28, 2009; and (c) continued diligent pursuit of regulatory approval.
The NDA for ULTRASE MT was filed in 2007 and FDA Complete Responses were received on the following dates: July 1, 2008 (approvable letter), September 9, 2009, May 5, 2010 and the latest on November 28, 2010. The last letter requires that unresolved deficiencies raised with respect to the manufacturing and control processes (including those identified in a FDA inspection) at the manufacturer of the active ingredient for ULTRASE MT be addressed before approval can be granted. On September 1, 2011 we filed our response to the FDA’s Complete Response letter. We have a PDUFA date of March 1, 2012.
The VIOKASE NDA rolling submission was completed in the first quarter of fiscal 2010 and a FDA Complete Responses was received on November 28, 2010. The letter required that unresolved deficiencies raised with respect to the manufacturing and control processes (including those identified in a FDA inspection) at the manufacturer of the active ingredient for ULTRASE MT be addressed before approval can be granted. On September 1, 2011, we filed our response to the FDA’s Complete Response letter. We have a PDUFA date of March 1, 2012.
We are in ongoing discussions with the FDA regarding both ULTRASE MT and VIOKASE and continue to work with the manufacturer of the active pharmaceutical ingredient to address any issues identified by the FDA, as soon as possible. However, no additional clinical studies are required. If ULTRASE MT and VIOKASE are not approved, it may continue to adversely affect our financial position, cash flows or overall trends in results of operations.
If ULTRASE MT and VIOKASE are approved and relaunched, competition in the PEP market at that time could be more intense than at the time when we ceased their distribution or at present.
If approved and relaunched, the level of competition that ULTRASE MT and VIOKASE will face in the United States will be more intense than before April 28, 2010, when we ceased distributing these products, or at present. In addition to ZENPEP, other branded PEPs have been approved and are currently marketed in the United States: CREON (Solvay/Abbott) and PANCREAZE (McNeil Pharmaceutical, Inc.). To relaunch ULTRASE MT and VIOKASE, we will need to re-establish the market position for these products and succeed in having customers using other marketed products start or restart using our products, which may prove difficult or impractical. These efforts will likely result in increased marketing and other expenses. If we are not successful, this would have a material adverse effect on our business and our financial results.
Furthermore, the relaunch of ULTRASE MT and VIOKASE, directly or indirectly, also could lead to a decrease in sales of ZENPEP, which would compete with ULTRASE MT and VIOKASE in the PEP market. If such a decrease cannot be offset by increased sales of ULTRASE MT or VIOKASE, it could have a material adverse effect on our business and results of operations.
If ULTRASE MT and VIOKASE are approved and relaunched, our future revenues and profitability will be adversely affected if governmental, private third-party payors and other third-party payors, including Medicare and Medicaid, do not sufficiently defray the cost of ULTRASE MT and VIOKASE to the consumer.
Our future revenues and profitability will be adversely affected if governmental, private third-party payors and other third-party payors, including Medicare and Medicaid, do not sufficiently defray the cost of ULTRASE MT and VIOKASE to the consumer. If these entities do not provide coverage and reimbursement for ULTRASE MT and VIOKASE or determine to provide an insufficient level of coverage and reimbursement, ULTRASE MT and VIOKASE may be too costly for general use, and physicians may not prescribe it. Many third-party payors cover only selected drugs, making drugs that are not preferred by such payor more expensive for patients, and often require prior authorization or failure on another type of treatment before covering a particular drug.
In addition to potential restrictions on coverage, the amount of reimbursement for our products may adversely affect results of operations. In the United States, there have been, and we expect there will continue to be, actions and proposals to control and reduce healthcare costs. Government and other third-party payors are challenging the prices charged for healthcare products and increasingly limiting and attempting to limit both coverage and level of reimbursement for prescription drugs.
If adequate coverage and reimbursement by third-party payors does not continue to be available, our ability to successfully relaunch ULTRASE MT and VIOKASE may be adversely impacted. Any limitation on the use of ULTRASE and VIOKASE or any decrease in the price of ULTRASE MT and VIOKASE may have a material adverse effect on our business.
Additional Risks Related Pharmaceutical Technology and Manufacturing Operations
In addition to the risk factors described elsewhere in this section, we are subject to additional risks relating to the Pharmaceutical Technology operations, including those described below.
We may not achieve or maintain profitability of Pharmaceutical Technology operations.
Eurand had incurred significant net losses since its formation in 1999, when it was established as a company independent of American Home Products, now Pfizer. Even if developing and commercializing one or more of the PT product candidates is successful, PT operations may not contribute to our overall profitability. Maintaining operating profitability of PT and achieving its profitability in the future will depend on our ability to generate revenues that exceed expenses. Even if achieved, profitability of PT may not be sustained or increased on a quarterly or annual basis or at all.
Any difficulties with, or interruptions of, our manufacturing operations could delay our output of products and harm our relationships with our collaborators. If we are unable to continue to manufacture our existing products, our results of operations and future prospects will suffer.
Any difficulties with or interruptions of our acquired manufacturing operations could delay our output of products and harm our relationships with our collaborators. We manufacture several products at facilities in Milan, Italy, Houdan, France, Mont St. Hilaire Canada and Dayton, Ohio. Due to regulatory and technical requirements, we will have limited ability to shift production among our facilities or to outsource any part of our manufacturing activities to third parties. Damage to any of our manufacturing facilities caused by human error, physical or electronic security breaches, power loss or other failures or circumstances beyond our control, including acts of God, fire, explosion, flood, war, insurrection or civil disorder, acts of, or authorized by, any government, terrorism, accident, labor trouble or shortage, or inability to obtain material, equipment or transportation, could interrupt or delay our manufacturing or other operations. Furthermore, all of our employees in Europe are subject to collective bargaining agreements, and national labor disputes could result in a work stoppage or strike by employees that could delay or interrupt our output of products. Due to the nature of these collective bargaining agreements, we will have no control over such work stoppages or strikes by our employees in Europe, and a strike may occur even if our employees do not have any grievances against us. Any interruption in manufacturing, whether due to limitations in manufacturing capacity or arising from factors outside our control, could result in delays in meeting contractual obligations and could have a material adverse effect on our relationships with our collaborators and on our revenues.
The FDA, the EMA and other applicable authorities periodically inspect our manufacturing facilities to ensure compliance with various regulations, including those relating to current good manufacturing practice, or cGMP. In addition, the U.S. Drug Enforcement Administration, or DEA, applicable EU authorities and other applicable regulatory authorities must approve our facilities and processes for handling controlled substances. Those agencies may monitor our use of controlled substances and we may be subject to inspections evaluating our compliance with the use and handling of controlled substances. Our failure to comply with such requirements and standards of these agencies could result in the suspension of our manufacturing or closure of our facilities, which could have a material adverse effect on our business. In addition, we currently manufacture for commercial distribution a number of drugs that are the subject of NDAs that have been approved or other applicable regulatory approval held by our collaborators and licensees. We also use third-party suppliers to provide bulk active drugs used in its products and the testing of those products. Because our customers and suppliers will continue to be subject to FDA regulation, our continued development and manufacturing of these products will continue to depend not only on our own compliance with FDA requirements but also on the compliance of customers and suppliers over whom we have no control.
Our competitors may develop products that are less expensive, safer or more effective than, and may diminish or prevent the commercial success of, any product candidates that we may bring to market.
We face intense competition from pharmaceutical and biotechnology companies, including other drug formulation companies, contract research organizations, academic institutions and government agencies. Some of these competitors are also its collaboration partners.
Our competitors may be able to use alternative technologies that do not infringe upon its patents to formulate the active materials in its products. If successful, products derived from alternative technologies will compete against our products and product candidates. Examples of competing technologies include the multiple particle systems of Watson, Biovail and Elan; the controlled-release tablet technologies of Elan and SkyePharma; and the solubility-enhancement technologies of Elan, SkyePharma and Soliqs, a division of Solvay/Abbott. The products derived from these technologies may be safer or more efficacious than some of our products and product candidates.
Potential products being tested in the United States and Europe of which we are not currently aware may also compete with product candidates using its drug formulation systems. Our collaboration partners could choose a competing drug formulation system to use with their drugs instead of our. In addition, our collaboration partners themselves face competition with other major pharmaceutical companies on products using our drug formulation technologies, which could adversely impact the potential for our technologies and co-development products, as well as our royalty revenues and business and financial condition.
Many of our competitors have greater capital resources, manufacturing and marketing experience, research and development resources and production facilities than we have. In addition, their success in obtaining patents may make it difficult or impossible for us to compete with them.
Major technological changes can happen quickly in the drug formulation and pharmaceutical industries. Our development of technologically improved or different products may make its technologies and product candidates obsolete or noncompetitive.
In addition, with respect to products that we develop and manufactures for our collaborators, we face the risk that such products or our collaborators’ other products may compete with our proprietary products. Some of these products may target the same diseases and conditions that are the focus of our drug development programs.
The failure to maintain our existing co-development relationships on acceptable terms, or the failure to develop and maintain new co-development relationships using our formulation technologies, could adversely affect our ability to develop and commercialize our product candidates and impair our future growth prospects.
Co-development agreements utilized to create relationships for the purpose of exploring development opportunities with collaboration partners will continue to be important for the business of the combined companies. By way of example, in 2010, we entered into four co-development agreements with various collaborators and we expect to continue to negotiate additional co-development agreements. In general, co-development agreements involve feasibility studies and early-stage development activities whereby an hourly service fee is paid for research and development and, in some instances, additional milestone payments may be made based on the achievement of certain development goals within specified timeframes. Accordingly, our receipt of revenue in a given period during the development phase is dictated in part by the speed at which development goals are met and the time and resources that a collaboration partner wishes to dedicate to development in such period. In some instances, we and our collaboration partner decide to negotiate and include provisions in a co-development agreement that will govern their relationship from development through commercialization. In other instances, we and our collaboration partner elect to define their relationship for the development phases and, if development is promising, may elect to enter into a subsequent agreement that further defines their relationship for subsequent periods of a product’s or product candidate’s life. The likelihood of completing development or progressing past development is highly uncertain notwithstanding the inclusion of provisions that govern the relationship through commercialization. Thus, the existence of such provisions, which could provide for the payment of royalties and sales milestones based on the success of the product, is not indicative of the likelihood that we will receive such payments. We believe that we will not be substantially dependent on any co-development agreements individually; however, the maintenance of such relationships will be important to our growth prospects because of the potential that a co-development relationship could evolve into a licensing and supply relationship that could generate significant revenue from licensing fees, product sales, sales milestone payments and/or royalties.
Our obligations under our co-development agreements can include performance of development activities, such as feasibility studies, formulation optimization, stability testing and scale-up of the manufacturing process, supply of the product to the collaborator for clinical testing, assistance in the preparation of regulatory filings by our collaborator and supply of the product for sale by our collaborator. If we fail to meet certain of these obligations, we may lose our rights to certain development fees and future royalty and milestone payments, and our collaboration partners may have the right to terminate the agreement. In addition, many of our agreements allow for the collaboration partner to terminate the agreement with limited notice and without penalty or in the event the collaborator reasonably determines that the product does not justify continued development or commercialization. We have completed work under some of these agreements without developing a commercial product and, based on past experience, it is likely that a number of these agreements will not progress to the stage where the product is actually commercialized. In addition, even if our collaborators choose not to terminate an agreement, the risk still remains that the collaborator could decide not to launch a particular product. The loss of a collaboration partner, as a result of either our failure to meet our obligations or early termination by the collaboration partner could affect our results of operations and future growth prospects.
Furthermore, our success is in part based upon a reputation that we are an attractive collaborator for leading pharmaceutical companies seeking to enhance existing products or to develop new products. For example, one of our co-development products, EUR-1000, is being developed in collaboration with GlaxoSmithKline, or GSK (acquired Reliant Pharmaceuticals in December 2007), and AMRIX is being commercialized in the United States by Cephalon, Inc. (acquired rights to AMRIX from ECR Pharmaceuticals in August 2007). If we fail to meet our obligations under these and other existing co-development agreements, we may diminish our reputation and decrease our potential future co-development opportunities.
Finally, the process of establishing new co-development relationships is difficult, time-consuming and involves significant uncertainty. We face, and will continue to face, significant competition in seeking appropriate collaboration partners. Moreover, if we do establish co-development relationships, our collaborators may fail to fulfill their responsibilities or may seek to renegotiate or terminate their relationships with us due to unsatisfactory clinical results, a change in business strategy, a change of control or other reasons. In many cases, our collaborators may terminate their relationships with us with limited notice and without penalty or in the event the collaborator reasonably determines that the product does not justify continued development or commercialization. If we are unable to establish and maintain co-development arrangements on acceptable terms, we may have to delay or discontinue further development of one or more of our product candidates, seek regulatory approval or undertake commercialization activities at our own expense or find alternative sources of funding, and our growth prospects will be materially harmed.
RISKS RELATED TO REGULATORY MATTERS
If our products fail in clinical studies or if we fail, or encounter difficulties, in obtaining regulatory approval for our new products or new indications of existing products or relaunching our PEPs, we will have expended significant resources for no return.
If our products are not successful in clinical trials or if we do not obtain such regulatory approvals, we will have expended significant resources for no return. Our ongoing clinical studies might be delayed or halted or additional studies might be required, for various reasons, including the following:
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Our products are shown not to be effective.
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We are unable to demonstrate that a product candidate’s benefits outweigh its risks.
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We are unable to demonstrate that a product candidate presents an advantage over existing products.
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We do not comply with requirements concerning the investigational NDAs, biologic license applications (BLAs) or new drug submissions (NDSs), for the protection of the rights and welfare of human subjects.
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The FDA, the EMA or other applicable regulatory authorities may require additional or expanded trials or may disagree with the manner in which the results from preclinical studies or clinical trials are interpreted.
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We may experience delays in obtaining, or the inability to obtain or maintain, required approvals from institutional review boards, or IRBs, or other reviewing entities at clinical sites selected for participation in our clinical trials.
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Patients experience unacceptable side effects or die during clinical trials.
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Patients do not enroll in the studies at the rate we expect.
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A drug is modified during testing.
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Product supplies are delayed or are not sufficient to treat the patients participating in the studies.
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Failure by our manufacturers or suppliers to comply with any of the FDA’s or other relevant foreign counterparts continuing regulations.
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A change in the approval policies or regulations of the FDA, EMA or other applicable regulatory authorities, or a change in the laws governing the approval process.
If we cannot obtain regulatory approvals for the products we are developing or may seek to develop in the future, our sales and competitive position will suffer. This risk is most acute for products that are currently in the development of the final formulation. There is no guarantee that we would obtain regulatory approval, even if our clinical trials are successful. With respect to ULTRASE MT and VIOKASE, for which we need to comply with the FDA’s requirements in order to return to market, we face the risk of not being able to obtain the FDA’s approval on a timely basis or at all. In addition, we are currently in discussions with the EMA with respect to the regulatory process and filing requirements relating to ZENPEP in the EU. There can be no assurance that the regulatory approval of ZENPEP by the EMA will be obtained on a timely basis or at all.
Approval might entail ongoing requirements for post-marketing studies. Even if regulatory approval is obtained, labeling and promotional activities are subject to continual scrutiny by the regulatory agencies, in particular the FDA, and, in some circumstances, the Federal Trade Commission. FDA enforcement policy prohibits the marketing of approved products for unapproved, or off-label, uses. These regulations and the FDA’s interpretation of them might impair our ability to effectively market our products.
We, our third-party manufacturers and certain of our suppliers are also required to comply with the applicable FDA cGMP regulations, which include requirements relating to quality control and quality assurance, as well as the corresponding maintenance of records and documentation. Furthermore, manufacturing facilities must be approved by regulatory authorities before they can be used to manufacture our products and certain raw materials used therein, and they are subject to additional inspections. If we or any of our manufacturers or suppliers fails to comply with any of the FDA’s or other relevant foreign counterparts continuing regulations, we could be subject to sanctions, including:
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delays, warning letters and fines;
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product recalls or seizures and injunctions on sales;
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refusal to review pending applications;
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total or partial suspension of production;
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withdrawals of previously approved marketing applications; and
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civil penalties and criminal prosecutions.
In addition, identification of side effects after a drug is on the market or the occurrence of manufacturing problems could cause subsequent withdrawal of the product from the market, reformulation of the drug, additional testing or changes in labeling of the product.
Sales of our products outside the United States and any of our product candidates that are commercialized are subject to the regulatory requirements of each country in which the products are sold. Accordingly, the introduction of our products and product candidates in markets outside the United States will be subject to regulatory clearances in those jurisdictions. Approval and other regulatory requirements vary by jurisdiction and may differ from the United States requirements. We may be required to perform additional preclinical or clinical studies even if FDA approval has been obtained. In addition, failures in European preclinical or clinical studies could impact our filings in the United States. Many countries also impose product standards, packaging and labeling requirements and import restrictions on our products. The approval by government authorities outside of the United States is unpredictable and uncertain and can be expensive. Our ability to market our approved products could be substantially limited due to delays in receipt of, or failure to receive, the necessary approvals or clearances.
We may find it difficult to achieve market acceptance of our products in our product pipeline.
The commercial success of any of our product candidates for which we obtain marketing approval from the FDA, Health Canada’s Therapeutic Products Directorate, or TPD, the European medicines Agency, or EMA, or other regulatory authorities will depend upon the acceptance of these products by the medical community, including physicians, patients and health-care payors. The degree of market acceptance of any of our approved products will depend on a number of factors, including
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demonstration of clinical safety and efficacy compared to other products;
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the relative convenience and ease of administration;
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the prevalence and severity of any adverse side effects;
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limitations or warnings contained in a product’s FDA, TPD or EMA approved labeling;
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availability of alternative treatments for the indications we target;
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pricing and cost effectiveness compared to competing products, particularly generic products;
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the effectiveness of our or any future collaborators’ sales and marketing strategies;
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the effectiveness of our manufacturing and distribution plans;
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our ability to obtain sufficient third-party coverage or reimbursement; and
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the willingness of patients to pay out-of-pocket in the absence of third-party coverage.
If any of our product candidates are approved but do not achieve an adequate level of acceptance by physicians, health-care payors and patients, we may not generate sufficient revenue from these products for such products to become or remain profitable. In addition, our efforts to educate the medical community and third-party payors on the benefits of our product candidates may require significant resources and may never be successful.
Our business is subject to limitations imposed by government regulations.
Governmental agencies in the countries in which we conduct business regulate pharmaceutical products intended for human use. These regulations normally require extensive clinical trials and other testing in addition to governmental review and final approval before products can be marketed. Governmental authorities in such countries also regulate the research and development, manufacture, distribution, promotion, testing and safety of products, and therefore, the cost of complying with governmental regulations can be substantial.
Requirements for approval can vary widely from country to country. A product must normally be approved by regulatory authorities in each country in which we intend to market it, prior to the commencement of marketing in that country. There can be long delays in obtaining required clearances from regulatory authorities in many countries after applications are filed. Therefore, there can be no assurance that we will obtain regulatory approvals in such countries or that we will not incur significant costs in obtaining or maintaining such regulatory approvals. Moreover, the regulations applicable to our existing and future products may change.
Government regulations require the detailed inspection and control of research and laboratory procedures, clinical studies, manufacturing procedures and marketing and distribution methods, all of which significantly increase the level of difficulty and the costs involved in obtaining and maintaining the regulatory approval for marketing new and existing products. Moreover, regulatory measures adopted by governments provide for the possible withdrawal of products from the market and, in certain cases, suspension or revocation of the required approvals for their production and sale.
Failure to obtain necessary regulatory approvals; the restriction, suspension or revocation of existing approvals; or any other failure to comply with regulatory requirements would restrict or impair our ability to market our products and carry on our business.
Regulatory approval for our currently marketed products is limited by the regulatory authorities to those specific indications and conditions for which clinical safety and efficacy have been demonstrated.
Any regulatory approval is limited to those specific diseases and indications for which our products are deemed to be safe and effective by the FDA, the TPD, the EMA, or other regulatory authorities. In addition to approval required for new formulations, any new indication for an approved product also requires regulatory approval. If we are not able to obtain regulatory approval for any desired future indications for our products, our ability to effectively market and sell or products may be reduced and our business may be adversely affected.
Our ability to promote the product is limited to those indications that are specifically approved by regulatory authorities. Regulatory authorities further restrict communications by pharmaceutical companies on the subject of off-label use. If our promotional activities fail to comply with these regulations or guidelines, we may be subject to warnings from, or enforcement action by, these authorities. In addition, our failure to follow rules and guidelines relating to promotion and advertising may cause regulatory authorities to delay approval or refuse to approve a product, the suspension or withdrawal of an approved product from the market, recalls, fines, disgorgement of money, operating restrictions, injunctions or criminal prosecution, any of which could harm our business.
Our approved products and pipeline products remain subject to ongoing regulatory requirements. If we fail to comply with these requirements, we could lose these approvals, and the sales of any such approved commercial products could be suspended.
After receipt of initial regulatory approval, each product remains subject to extensive regulatory requirements, including requirements relating to manufacturing, labeling, packaging, adverse event reporting, storage, advertising, promotion, distribution and recordkeeping. Furthermore, even if we receive regulatory approval to market a particular product, such a product will remain subject to the same extensive regulatory requirements. Even if regulatory approval of a product is granted, the approval may be subject to limitations on the uses for which the product may be marketed or the conditions of approval, or contain requirements for costly post-marketing testing and surveillance to monitor product safety or efficacy, which could reduce our revenues, increase our expenses and render the approved product not commercially viable. In addition, as clinical experience with a drug expands after approval because it is typically used by a greater number and more diverse group of patients after approval than during clinical trials, side effects and other problems may be observed after approval that were not seen or anticipated during pre-approval clinical trials or other studies.
Our approved products and pipeline products remain subject to ongoing regulatory requirements.
Following receipt of regulatory approval, any products that we market continue to be subject to extensive regulation. These regulations affect many aspects of our operations, including the manufacture, labeling, packaging, adverse-event reporting, storage, distribution, advertising, promotion and record keeping related to the products. The FDA also frequently requires post-marketing testing and surveillance to monitor the effects of approved products or place conditions on any approvals that could restrict the commercial applications of these products. We must also comply with the Prescription Drug Marketing Act, or PDMA, which governs the distribution of prescription drug samples to healthcare practitioners since, as part of our commercialization efforts, we provide physicians with samples. Among other things, the PDMA prohibits the sale, purchase or trade of prescription drug samples. It also sets out record keeping and other requirements for distributing samples to licensed healthcare providers. In addition, we must comply with the Medicaid Rebate Program, the Veterans’ Health Care Act of 1992 and the Deficit Reduction Act of 2005. These laws governs product pricing for government reimbursement and sets forth detailed formulas for how we must calculate and report the pricing of our products so as to ensure that the federally funded programs will get the best price. Further, the subsequent discovery of previously unknown problems with the product may result in restrictions on the product, including withdrawal of the product from the market. If we fail to comply with applicable regulatory requirements, we may be subject to fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, significant disbursements, operating restrictions and criminal prosecution.
In addition to FDA restrictions on marketing of pharmaceutical products, several other types of state and federal laws have been applied to restrict certain marketing practices in the pharmaceutical industry in recent years. These laws include anti-kickback statutes and false claims statutes. The federal health-care program anti-kickback statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration to induce or in return for purchasing, leasing, ordering or arranging for the purchase, lease or order of any health-care item or service reimbursable under Medicare, Medicaid or other federally financed health-care programs. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers on the other. Violations of the anti-kickback statute are punishable by imprisonment, criminal fines, civil monetary penalties and exclusion from participation in federal health-care programs. Although there are a number of statutory exemptions and regulatory safe harbors protecting certain common activities from prosecution or other regulatory sanctions, the exemptions and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exemption or safe harbor. Our practices may not in all cases meet all of the criteria for safe harbor protection from anti-kickback liability.
Federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government, or knowingly making, or causing to be made, a false statement to have a false claim paid. Several pharmaceutical and other health-care companies have been prosecuted under these laws for allegedly inflating drug prices they report to pricing services, which in turn are used by the government to set Medicare and Medicaid reimbursement rates, and for allegedly providing free products to customers with the expectation that the customers would bill federal programs for those products. In addition, certain marketing practices, including off-label promotion, may also violate false claims laws. The majority of states also have statutes or regulations similar to the federal anti-kickback law and false claims laws, which apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor. Sanctions under these federal and state laws may include civil monetary penalties, exclusion of a manufacturer’s products from reimbursement under government programs, criminal fines and imprisonment.
Because of the breadth of these laws and the narrowness of the safe harbors, it is possible that some of our business activities could be subject to challenge under one or more of such laws. Such a challenge could have a material adverse effect on our business, financial condition and results of operations.
In addition, as part of the sales and marketing process, pharmaceutical companies frequently provide samples of approved drugs to physicians. This practice is regulated by the FDA and other governmental authorities, including, in particular, requirements concerning record keeping and control procedures. Any failure to comply with the regulations may result in significant criminal and civil penalties as well as damage to our credibility in the marketplace.
RISKS RELATED TO OUR INDUSTRY
The pharmaceutical industry is highly competitive and is subject to rapid and significant change, which could render our products obsolete or uncompetitive.
Competition in our business is intense and characterized by extensive research efforts and rapid technological progress. Technological developments by competitors, regulatory approval for marketing competitive products, including potential generic or over-the-counter products, or competitors’ superior marketing resources could adversely affect the commercial potential of our products and could have a material adverse effect on our revenue and results of operations. We believe that there are numerous pharmaceutical and biotechnology companies, including large well-known pharmaceutical companies, as well as academic research groups throughout the world, engaged in research and development efforts with respect to pharmaceutical products targeted at gastrointestinal diseases and conditions addressed by our current and potential products. In particular, we are aware of products in research or development by competitors that address the diseases targeted by our products. Developments by others might render our current and potential products obsolete or noncompetitive. Competitors might be able to complete the development and regulatory approval process sooner and, therefore, market their products earlier than we can. They may succeed in developing products that are more effective or less expensive to use than any that we may develop or license. These developments could render our products obsolete or uncompetitive, which would have a material adverse effect on our business and financial results.
Many of our competitors have greater financial resources and selling and marketing capabilities, have greater experience in clinical testing and human clinical trials of pharmaceutical products, and have greater experience in obtaining approvals from the FDA, the TPD or other applicable regulatory approvals.
Development of pharmaceutical products is expensive, time-consuming and subject to uncertainties, and we may not realize a return on our investment in product development for a significant period of time, if at all.
Developing pharmaceutical products is expensive, and there is typically a significant amount of time prior to realizing a return on an investment in product development, if a return is realized at all. To obtain regulatory approval for the sale of any product candidates, extensive clinical trials must demonstrate that our products are safe and effective for use in humans. Clinical trial costs are included in our research and development expenses and may take years to complete. We cannot be sure that we or our collaboration partners will complete clinical testing within the time we anticipate or that we or they will be able to do so without requiring significant resources or expertise in excess of what we anticipate. Completion of clinical trials depends on various factors, including the indication and size of the patient population and its proximity to clinical sites, the nature of the clinical protocol, the eligibility of the criteria for trial, competition for trial patients, availability of sufficient quantities of a product candidate, the assistance of third parties, regulatory compliance and adequate financial resources.
Our future plans include significant investments in research and development, including clinical trials, and related product opportunities. We believe that we must continue to dedicate a significant amount of financial and operational resources to our research and development efforts to grow our business and maintain our competitive position. However, we do not expect to receive significant revenues from these investments for several years, if at all.
Pricing pressures from, and other measures taken by, third-party payors, including managed care organizations, government sponsored health-care systems and regulations relating to Medicare and Medicaid, Health Care and Education Reconciliation Act of 2011, pharmaceutical reimbursements and pricing in general could decrease our revenues.
Our ability to successfully commercialize our products and product candidates-even if FDA, TPD or EMA approval is obtained-depends, in part, on whether appropriate reimbursement levels for the cost of the products and related treatments are obtained from government authorities and private health insurers and other organizations, such as health maintenance organizations, or HMOs, managed-care organizations, or MCOs, and provincial formularies.
Third-party payors are increasingly challenging the pricing of pharmaceutical products. In addition, the trend toward managed health-care in the U.S., the growth of organizations such as HMOs and MCOs, and the recently enacted Health Care and Education Reconciliation Act of 2011, could significantly influence the purchase of pharmaceutical products, resulting in lower prices and a reduction in product demand. One way in which MCOs and government sponsored health-care systems seek to control their costs is by developing formularies to encourage plan beneficiaries to use preferred products for which the plans have negotiated favorable terms. Exclusion of a product from a formulary, or placement of a product on a disfavored formulary tier, can lead to sharply reduced usage in the patient population covered by the applicable MCO or government-sponsored health-care system. If our products are not included in an adequate number of formularies or if adequate reimbursement levels are not provided, or if reimbursement policies increasingly favor generic products, our market share and business could be negatively affected.
Recent reforms to Medicare added an out-patient prescription drug reimbursement for all Medicare beneficiaries beginning in 2006. The U.S. federal government and private plans contracting with the government to deliver the benefit, through their purchasing power under these programs, are demanding discounts from pharmaceutical companies that may implicitly create price controls on prescription drugs. These reforms may decrease our future revenues from product lines covered by the Medicare drug benefit, thereby adversely affecting our results or operations and cash flows.
Uncertainty also exists regarding the reimbursement status of certain newly-approved pharmaceutical products and reimbursement may not be available for some of our products. Any reimbursements granted may not be maintained or limits on reimbursements available from third-party payors may reduce the demand for, or negatively affect the price of, these products. If our products do not qualify for reimbursement, if reimbursement levels diminish, or if reimbursement is denied, our sales and profitability would be adversely affected.
In some countries, particularly those of the European Economic Area, the pricing of prescription pharmaceuticals can be subject to government control, often resulting in lower pricing or reimbursement rates than in the U.S. market. In these countries, pricing negotiations with governmental authorities can take considerable time and delay the placing of a product on the market. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares cost-effectiveness of our product candidate with other available products. If reimbursement of our product is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be adversely affected.
The Patient Protection and Affordable Care Act of 2011 and the Health Care and Education Reconciliation Act of 2011, known together as the Affordable Care Act, enacted in the U.S in March 2011 contain several provisions that could impact our business.
Although many provisions of the new legislation do not take effect immediately, several provisions became effective during fiscal year 2011. These include (1) an increase in the minimum Medicaid rebate to States participating in the Medicaid program on our branded prescription drugs; (2) the extension of the Medicaid rebate to Managed Care Organizations that dispense drugs to Medicaid beneficiaries; and. (3) the expansion of the 340B Public Health Service Act drug pricing program, which provides outpatient drugs at reduced rates, to include certain children’s hospitals, free standing cancer hospitals, critical access hospitals, and rural referral centers.
In addition, beginning in 2011, the new law requires drug manufacturers to provide a 50% discount to Medicare beneficiaries for any covered prescription drugs purchased during a Medicare Part D coverage gap (i.e. the “donut hole”). Also, beginning in 2011, new fees will be assessed on all branded prescription drug manufacturers and importers. This fee will be calculated based upon each organization’s percentage share of total branded prescription drug sales to U.S. government programs (such as Medicare Parts B and D, Medicaid, Department of Veterans Affairs and Department of Defense programs and TRICARE retail pharmacy program) made
during the previous year. The aggregated industry wide fee is expected to total $28 billion through 2019, ranging from $2.5 billion to $4.1 billion annually. The IRS has issued guidance for calculating preliminary fees, but there is still uncertainty as to final implementation, since the IRS has requested public comment and may make changes in response. The new law also imposes a 2.3% excise tax on sales of certain taxable medical devices that are made after December 31, 2012, including our FLUTTER mucus clearance device. Further, effective March 31, 2013, the law requires pharmaceutical, medical device, biological, and medical supply manufacturers to begin reporting to the federal government the payments they make to physicians and teaching hospitals, and physician ownership interests in those entities. The law also provides for the creation of an abbreviated regulatory pathway for FDA approval of biosimilars and interchangeable biosimilar products. While creation of the biosimilars program is authorized as of passage of the legislation in 2010, the process of creating the regulatory pathway for approval of biosimilars will likely be lengthy, and the FDA is in the process of soliciting public input.
The impact in terms of additional reserves recorded has been $4.5 million for the fiscal year ended September 30, 2011 compared to $0.5 million for the corresponding period of the preceding fiscal year.
Uncertainties regarding the Affordable Care Act and third-party reimbursement may impair our ability to continue to sell our products or form collaborations.
The continuing efforts of governmental and third-party payers to contain or reduce the costs of health-care through various means may harm our business. For example, in some foreign markets, the pricing or profitability of health-care products is subject to government control. In the United States, there have been, and we expect there will continue to be, a number of federal and state proposals to implement similar government control. The implementation or even the announcement of any of these legislative or regulatory proposals or reforms could harm our business by reducing the prices we are able to charge for our products, or impeding our ability to continue to achieve profitability or form collaborations. In addition, the availability of reimbursement from third-party payers determines, in large part, the demand for health-care products in the United States and elsewhere. Examples of such third-party payers are government and private insurance plans. Significant uncertainty exists as to the reimbursement status of newly approved health-care products and third-party payers are increasingly challenging the prices charged for medical products and services. Reimbursement from third-party payers may not be available or may not be sufficient to allow us to continue to sell our products on a competitive or profitable basis.
Our relationships with customers and payors are subject to applicable fraud and abuse and other health-care laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, and diminished profits and future earnings.
Health-care providers, physicians and others play a primary role in the recommendation and prescription of our products. Our arrangements with third-party payors and customers may expose us to broadly applicable fraud and abuse and other health-care laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute our products. Applicable U.S. federal and state health-care laws and regulations, include, but are not limited to, the following:
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The federal health-care anti-kickback statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal health-care programs such as Medicare and Medicaid.
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The federal False Claims Act imposes criminal and civil penalties, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease, or conceal an obligation to pay money to the federal government.
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The federal false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for health-care benefits, items or services.
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Analogous state laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving health-care items or services reimbursed by non-governmental third-party payors, including private insurers, and some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government.
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There are similar laws in countries outside the U.S.
Efforts to ensure that our business arrangements with third parties comply with applicable health-care laws and regulations could be costly. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other health-care laws and regulations. If our past or present operations, including activities conducted by our sales team or agents, are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, exclusion from third-party payor programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations. If any of the physicians or other providers or entities with whom we do business are found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded health-care programs.
Many aspects of these laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of subjective interpretations, which increases the risk of potential violations. In addition, these laws and their interpretations are subject to change. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses, divert our management’s attention from the operation of our business and damage our reputation.
Private civil litigation may be instituted against us in connection with alleged violation of the federal or state laws and regulations discussed above, under a number of different theories. Such litigation can result in significant expense and management distraction, as well as potential monetary damages or equitable relief.
Changes in laws and regulations could affect our results of operations, financial position or cash flows.
Our future operating results, financial position or cash flows could be adversely affected by changes in laws and regulations such as (i) changes in the FDA, TPD or EMA (or their foreign equivalents) approval processes that may cause delays in, or prevent the approval of, new products; (ii) new laws, regulations and judicial decisions affecting product development, marketing, promotion or the healthcare field generally; (iii) new laws or judicial decisions affecting intellectual property rights and (iv) changes in the application of tax principles, including tax rates, new tax laws, or revised interpretations of existing tax laws and precedents, which result in a shift of taxable earnings between tax jurisdictions.
We may be subject to investigations or other inquiries concerning our compliance with reporting obligations under federal healthcare program pharmaceutical pricing requirements.
Under federal healthcare programs, some state governments and private payors investigate and have filed civil actions against numerous pharmaceutical companies alleging that the reporting of prices for pharmaceutical products has resulted in false and overstated average wholesale price, or AWP, which in turn may be alleged to have improperly inflated the reimbursements paid by Medicare, private insurers, state Medicaid programs, medical plans and others to healthcare providers who prescribed and administered those products or pharmacies that dispensed those products. These same payors may allege that companies do not properly report their “best prices” to the state under the Medicaid program. Suppliers of outpatient pharmaceuticals to the Medicaid program are also subject to price rebate agreements. Failure to comply with these price rebate agreements may lead to federal or state investigations, criminal or civil liability, exclusion from federal healthcare programs, contractual damages, and otherwise harm our reputation, business and prospects.
Future litigation and the outcome of current litigation may harm our business.
In general, and subject to the terms of each specific agreement, we have agreed to indemnify our licensors, distributors and certain of our contract manufacturers for product liability claims and there is a risk that we will be subject to product liability claims and
claims for indemnification under these agreements. A substantial portion of our revenues are derived and will continue to be derived from activities in the United States, where pharmaceutical companies are exposed to a higher risk of litigation than in other jurisdictions. For example, under the Drug Price Competition and Patent Restoration Act of 1984, when a drug developer files an ANDA for a generic drug, it must certify to the FDA that it believes its product will not infringe on any unexpired patent that a patent holder has listed with the FDA as covering that brand-name product, or that any such patent is invalid or unenforceable. The drug developer must also provide such certification to the patent holder, who may challenge the developer’s certification of non-infringement, invalidity or unenforceability by filing a suit for patent infringement. Such a patent challenge within the first 45 days of notice of the ANDA certification can result in a 30-month stay of approval by FDA of the ANDA. Certain of our collaboration partners may have or develop generic versions of existing or then existing drugs. Our development of any such generic versions of drugs will be subject to this process. Should a patent holder commence a lawsuit against us with respect to alleged patent infringement, the uncertainties inherent in patent litigation make the outcome of such litigation difficult to predict. Litigation over patents could result in delays in obtaining FDA approval to market our product candidates and diversion of management resources and the costs resulting therefrom. Similar risks of the delay in obtaining approvals in other applicable jurisdictions could result from patent related litigation.
Currently, we maintain claims-based product liability insurance coverage in respect of all our products marketed in the United States and international markets. We cannot be certain that existing or future insurance coverage available to us will be adequate to satisfy any or all future product liability claims and defense costs in the United States.
One of our subsidiaries, Axcan Scandipharm (now Aptalis Pharma US, Inc.), has been a party to several legal proceedings related to the product line it previously sold under the trademark ULTRASE and, in particular, with respect to certain dosage strengths. Axcan Scandipharm’s insurance carriers have defended the lawsuits to date and we expect them to continue to defend Axcan Scandipharm (to the extent of its product liability insurance) should other lawsuits be filed in the future.
Exposure relating to product liability claims may harm our business.
We face an inherent business risk of exposure to product liability and other claims in the event that the use of our products results, or is alleged to have resulted, in adverse effects. While we have taken, and will continue to take, what we believe are appropriate precautions, there can be no assurance that we will avoid significant product liability claims. Although we currently carry product liability insurance that we believe is appropriate for the risks that we face, there can be no assurance that we have sufficient coverage, or can in the future obtain sufficient coverage at a reasonable cost. An inability to obtain product liability insurance at an acceptable cost or to otherwise protect against potential product liability claims could prevent or inhibit the growth of our business or the number of products we can successfully market. Our obligation to pay indemnities, the withdrawal of a product following complaints, or a product-liability claim could have a material adverse effect on our business, results of operations, cash flows and financial condition. For details regarding certain litigation matters in which we are currently involved, see “Business-Legal Proceedings.”
We deal with hazardous materials and must comply with environmental, health and safety laws and regulations, which can be expensive, restrict how we do business and/or give rise to significant liabilities.
We are subject to various environmental, health and safety laws and regulations, including those governing air emissions, including greenhouse gases, water and wastewater discharges, noise emissions, the use, management and disposal of hazardous, radioactive and biological materials and wastes, and the cleanup of contaminated sites. The cost of compliance with these laws and regulations could be significant. In the event of a violation of these laws and regulations, including from accidental contamination or injury, we could be held liable for damages exceeding our available financial resources. We could be subject to monetary fines, penalties or third-party damage claims as a result of violations of such laws and regulations or noncompliance with environmental permits required at our facilities. As an owner and operator of real property and a generator of hazardous materials and wastes, we also could be subject to environmental cleanup liability, in some cases without regard to fault or whether we were aware of the conditions giving rise to such liability. In addition, we may be subject to liability and may be required to comply with new or existing environmental laws regulating pharmaceuticals in the environment. Environmental laws or regulations (or their interpretation) may become more stringent in the future. If any such future changes to environmental laws and regulations require significant changes in our operations, or if we engage in the development and manufacturing of new products or otherwise expand our operations requiring new or different environmental controls, we will have to dedicate additional management resources and incur additional expenses to comply with such laws and regulations.
In the event of an accident, applicable authorities may curtail our use of hazardous materials and interrupt our business operations. In addition, with respect to our manufacturing facilities, we may incur substantial costs to comply with environmental laws and regulations and may become subject to the risk of accidental contamination or injury from the use of hazardous materials in our manufacturing process.
We maintain limited insurance coverage for the foregoing types of risks. In the event of environmental discharge, contamination or accident, we may be held liable for any resulting damages, and any liability could exceed our resources.
RISKS RELATED TO INTELLECTUAL PROPERTY
The four categories of products on which we have depended in the past two fiscal years for the majority of our revenues are not covered by any issued patents.
Other than limited patent protection relating to ZENPEP, we have no issued patents covering our PEPs (ULTRASE, VIOKASE and PANZYTRAT), ursodiol products (URSO, URSO 250, URSO DS, URSO FORTE and DELURSAN), mesalmine products (CANASA and SALOFALK) or sucralfate products (CARAFATE and SULCRATE). These four categories of products accounted collectively for a substantial portion of our revenues in fiscal years 2010 and 2011. While we believe that these product lines benefit from a variety of regulatory, clinical, sourcing and manufacturing hurdles to competitive entry, our current patents do not present any such hurdle, and there can be no assurance that any future patent that may issue to us would provide any meaningful protection.
We rely on the intellectual property of others, and we may not be able to protect our own intellectual property.
Our continued success will depend, in part, on our ability to obtain, protect and maintain intellectual property rights and licensing arrangements for our products. Some of the proprietary rights in some of our products are held by third parties, which require us to obtain licenses for the use of such products. Despite these licenses, there can be no guarantees that the rights or patents used by us will not be challenged by third parties. Furthermore, an adverse outcome could lead to an infringement or other legal action being brought against us directly which regardless of its merit could be costly and time-consuming. Moreover, third party licensors may breach their license agreements with us or may otherwise fail to perform their obligations thereunder. We have filed and/or licensed patent applications related to certain of our products, but such applications may fail to be granted, or, even if granted, may be challenged or invalidated or may fail to provide us with any competitive advantages.
To protect our intellectual property, we have historically relied on patents, trademarks and trade secrets, know-how and other proprietary information, as well as requiring our employees and vendors, suppliers and collaboration partners to sign confidentiality agreements prohibiting them from taking proprietary information and technology or from using or disclosing proprietary information to third parties except in specified circumstances. However, confidentiality agreements may be breached despite all precautions taken, and we may not have adequate remedies for any breach. Third parties may gain access to our proprietary information or may independently develop substantially equivalent proprietary information. Furthermore, the strength of patents and other intellectual property rights in the pharmaceutical industry involves complex legal and scientific questions and can be uncertain. We have filed and/or licensed patent applications related to certain of our products (including with respect to certain co-development products and product candidates), but such applications may fail to be granted, or, even if granted, may be challenged or invalidated or may fail to provide us with any competitive advantages. Additionally, patent applications in the United States and most other countries are confidential for a period of time until they are published, and publication of discoveries in scientific or patent literature typically lags actual discoveries by several months or more. As a result, we cannot be certain that we were the first to conceive inventions covered by our patents and pending patent applications or that we were the first to file patent applications for such inventions. Our inability to protect and maintain intellectual property rights in our products may impair our competitive position and adversely affect our sales and growth.
Litigation or third-party claims of intellectual property infringement could require substantial time and money to resolve. Unfavorable outcomes to these proceedings could limit our intellectual property rights and our activities.
Our commercial success depends upon our ability to develop and market products without infringing the proprietary rights of third parties. As the pharmaceutical industry expands and more patents are issued, the risk increases that our products or product candidates may give rise to claims of infringement of the patent rights of others. Third-party patents (now or in the future) may cover
the materials or methods of treatment related to our products, and third parties may make allegations of infringement, regardless of merit. Because patent applications can take many years to issue, there may be currently pending applications which may later result in issued patents that our products may infringe. We cannot provide any assurances that our products or activities, or those of our licensors, will not infringe patents or other intellectual property owned by third parties. We have been (and from time to time we may be) notified that third parties consider their patents or other intellectual property infringed by, or otherwise relevant to, our products.
In addition, we may from time to time have access to confidential or proprietary information of third parties that could bring a claim against us asserting that we have misappropriated their technology (which, although not patented, may be protected by trade secrets) and that we have improperly incorporated that technology into our products. Some of our employees may have been employed by other pharmaceutical or biotechnology companies that may allege violations of their trade secrets by these individuals, irrespective of the steps that we may take to prevent such violations.
If a lawsuit is commenced with respect to any alleged intellectual property infringement by us, the uncertainties inherent in such litigation make the outcome difficult to predict, and the costs that we may incur as a result may have an adverse effect on our profitability. Such litigation would involve significant expense and would be a substantial diversion of the efforts of our scientific and our management teams. During the course of any intellectual property litigation, there may be public announcements regarding claims and defenses, and regarding the results of hearings, motions and other interim proceedings or developments in the litigation. If securities analysts or investors perceive these announcements as negative, the market price of the secured notes or any other securities that we may issue from time to time may decline.
Any such lawsuit that culminates in an adverse determination may result in the award of monetary damages to the intellectual property holder and payment by us of any such damages, and/or an injunction prohibiting all of our business activities that infringe the intellectual property, or may require us to obtain licenses from third parties on terms that may not be commercially acceptable to us, which would in each case adversely affect our profitability and our business. If so, we may attempt to redesign our processes, products or technologies so that they do not infringe, but that might not be possible. If we cannot obtain a necessary or desirable license, can obtain such a license only on terms that we consider to be unattractive or unacceptable, or cannot redesign our products or processes to avoid potential patent or other intellectual property infringement, then we or our collaborators may be restricted or prevented from developing and commercializing our products and our business will be harmed.
In October 2008, Eurand and Cephalon received Paragraph IV certification letters relating to ANDAs submitted to the FDA by Mylan Pharmaceuticals, Inc. (“Mylan”) and Barr Laboratories, Inc. (“Barr”), each requesting approval to market and sell a generic version of the 15 mg and 30 mg strengths of AMRIX. In November 2008, Eurand received a similar certification letter from Impax Laboratories, Inc. (“Impax”). In May 2009, Eurand received a similar certification letter from Anchen Pharmaceuticals, Inc. (“Anchen”) Mylan, Impax, and Anchen alleged that U.S. Patent Number 7,387,793 (the “‘793 Patent”), entitled “Modified Release Dosage Forms of Skeletal Muscle Relaxants,” issued to Eurand, will not be infringed by the manufacture, use or sale of the product described in the applicable ANDA and reserved the right to challenge the validity and/or enforceability of the ‘793 Patent. Barr alleged that the ‘793 Patent is invalid, unenforceable and/or will not be infringed by its manufacture, use or sale of the product described in its ANDA. In late November 2008, Eurand filed a lawsuit with Cephalon, in the U.S. District Court in Delaware against Mylan (and its parent) and Barr (and its parent) for infringement of the ‘793 Patent. In January 2009, Eurand filed a lawsuit with Cephalon in the U.S. District Court in Delaware against Impax for infringement of the ‘793 Patent. In July 2009, Eurand filed a lawsuit with Cephalon in the U.S. District Court in Delaware against Anchen (and its parent) for infringement of the ‘793 Patent. Subsequently, in response to additional Paragraph IV certification letters regarding U.S. Patent Number 7,544,372, (the “‘372 Patent”) entitled “Modified Release Dosage Forms of Skeletal Muscle Relaxants” Eurand and Cephalon also filed lawsuits against Mylan, Barr, and Anchen for the infringement of the ‘372 Patent. All cases were consolidated in one action in the U.S. District Court in Delaware, and were tried in a bench trial in September-October, 2010. In May 2011, the U.S. District Court in Delaware rendered a decision against Eurand and Cephalon. An expedited appeal of the decision was filed in the Court of Appeals for the Federal Circuit and the appeal was held in September 2011. There is currently an injunction in place against the sale of generic Amrix by Mylan, and Anchen has agreed to be preliminarily enjoined from launching a generic form of Amrix while awaiting the ruling from the Federal Circuit. A ruling is expected in Spring 2012. Under the provisions of the Hatch-Waxman Act, the filing of these lawsuits stays FDA approval of each ANDA until the earlier of a district court judgment in favor of the ANDA holder or 30 months from the date of the plaintiff’s receipt of the respective Paragraph IV certification letter.
On October 7, 2010, both Eurand and Anesta AG (“Anesta”), an indirect wholly owned subsidiary of Cephalon, reached an agreement to settle the pending patent infringement litigation over AMRIX with Impax. Under terms of the settlement, both Eurand and Anesta will grant to Impax a non-exclusive, royalty-bearing license to market and sell a generic version of AMRIX in the United States beginning one year prior to expiration of the ‘793 Patent, which is expected to expire in February 2025, or earlier under certain circumstances. The settlement does not affect the status of the patent litigation with the other defendants set forth above. Cephalon is bearing the bulk of the expenses associated with the litigation. We intend to continue to work with Cephalon and Anesta to defend the AMRIX intellectual property rights, but there can be no assurance that these efforts will be successful.
Based on information available to us, GSK received a Paragraph IV certification letter from a generic drug manufacturer regarding an ANDA for a generic version of LAMICTAL ODT and claiming that the U.S. Patent No. 7,815,937 (the “‘937 Patent”) does not bar such a generic. The ‘937 Patent is not owned by us, and we believe that the patent does not cover the LAMICTAL product developed by us. We are not involved with any patent infringement lawsuit regarding GSK’s LAMICTAL ODT product and do not have any opinion on the validity or strength of the ‘937 Patent. However, if a generic version of LAMICTAL ODT is approved, it could have a material adverse effect on the revenue we derive from GSK based on the LAMICTAL product.
Our intellectual property rights might not afford us with meaningful protection.
The intellectual property rights protecting our products might not afford us with meaningful protection from generic and other competition. The laws of certain foreign countries do not protect intellectual property rights to the same extent as the United States, which may render our protection and enforcement of such rights difficult or impossible in such foreign jurisdictions. In addition, because our strategy is to in-license or acquire pharmaceutical products that typically have been discovered and initially researched by others, future products might have limited or no remaining patent protection due to the time elapsed since their discovery. Competitors could also design around any of our intellectual property or otherwise design competitive products that do not infringe our intellectual property.
We also rely on trade secrets, proprietary know-how and technological advances, which we seek to protect, in part, through confidentiality agreements with collaborative partners, employees and consultants. These agreements might be breached and we might not have adequate remedies for any such breach. In addition, our trade secrets and proprietary know-how might otherwise become known or be independently developed by others. Any litigation that we become involved in to enforce intellectual property rights could result in substantial cost to us. In addition, claims by others that we infringe their intellectual property rights could be costly. Our patent or other proprietary rights related to our products might conflict with the current or future intellectual property rights of others. Litigation or patent interference proceedings, either of which could result in substantial cost to us, might be necessary to defend any patents to which we have rights and our other proprietary rights or to determine the scope and validity of other parties’ proprietary rights. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during any such litigation. The defense of patent and intellectual property claims is both costly and time consuming, even if the outcome is favorable. Any adverse outcome could subject us to significant liabilities to third parties, result in the narrowing of our intellectual property rights (including a ruling that a patent of ours is not valid or is unenforceable), require disputed rights to be licensed from third parties, or require us to cease selling one or more of our products. We might not be able to obtain a license to any third-party technology that we require to conduct our business, or, if obtainable, that technology might not be available at a reasonable cost.
RISKS RELATED TO GENERAL ECONOMIC AND FINANCIAL CONDITIONS
We are exposed to political, economic and other risks that arise from operating a multinational business.
We have operations in several different countries. For the fiscal years ended September 30, 2009, 2010 and 2011, approximately 24.5%, 27.9% and 30.0% of our revenues, respectively, were derived from sources outside the U.S. We are therefore exposed to risks inherent in international operations. These risks include, but are not limited to
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changes in general economic, social and political conditions;
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adverse tax consequences;
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the difficulty of enforcing agreements and collecting receivables through certain legal systems;
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inadequate protection of intellectual property;
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required compliance with a variety of laws and regulations of jurisdictions outside of the U.S., including labor and tax laws;
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customers outside of the U.S. may have longer payment cycles;
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changes in laws and regulations of jurisdictions outside of the U.S.; and
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terrorist acts and natural disasters.
In addition, we face several risks relating to compliance with international and U.S. laws and regulations that apply to our international operations. These laws and regulations include data privacy requirements, labor relations laws, tax laws, anti-competition regulations, import and trade restrictions, export requirements, U.S. laws such as the Foreign Corrupt Practices Act, and local laws which also prohibit corrupt payments to governmental officials or certain payments or remunerations to customers. Given the high level of complexity of these laws and regulations, however, there is a risk that some provisions may be inadvertently breached, for example through fraudulent or negligent behavior of individual employees or our partners, our failure to comply with certain formal documentation requirements or otherwise. Violations of these laws and regulations could result in fines, criminal sanctions against us, our officers, our partners or our employees, and prohibitions on the conduct of our business. Any such violations could include prohibitions on our ability to offer our products in one or more countries and could materially damage our reputation, our brand, our international expansion efforts, our ability to attract and retain employees, our business and our operating results. Our success depends, in part, on our ability to anticipate these risks and manage these difficulties.
Our business success depends in part on our ability to anticipate and effectively manage these and other regulatory, economic, social and political risks inherent in multinational business. We cannot provide assurances that we will be able to effectively manage these risks or that they will not have a material adverse effect on our multinational business or on our business as a whole.
Currency exchange rate fluctuations may have a negative effect on our financial condition.
We operate internationally, but a majority of our revenue and expense activities, including our debt service obligations, and capital expenditures are denominated in U.S. dollars. The other currencies in which we engage in significant transactions are Canadian dollars and Euros. As a consequence, we are exposed to currency fluctuations from purchases of goods, services and equipment and investments in other countries, and funding denominated in the currencies of other countries. In particular, we are exposed to the fluctuations in the exchange rate between the U.S. dollar, the euro and the Canadian dollar. During fiscal year 2011, approximately 17.8% of our revenues was denominated in Euros, 9.0% of our revenue was denominated in Canadian dollar, while the remainder was denominated in U.S. dollars.
Fluctuations in currency exchange rates may affect the results of our operations and the value of our assets and revenues, and increase our liabilities and costs, which in turn may adversely affect reported earnings and the comparability of period-to-period results of operations. For example, in 2011, we experienced a positive foreign exchange effect on revenues of approximately 0.8%. Changes in currency exchange rates may affect the relative prices at which we and our competitors sell products in the same market. Changes in the value of the relevant currencies also may affect the cost of goods, services and equipment required in our operations.
In addition, due to the constantly changing currency exposures and the potential substantial volatility of currency exchange rates, we cannot predict the effect of exchange rate fluctuations on our future results and, because we do not currently hedge fully against all currency risks and fluctuations between the U.S. dollar and the euro, such fluctuations may result in currency exchange rate losses. Fluctuations in exchange rates could result in our realizing a lower profit margin on sales of our product candidates than we anticipate at the time of entering into commercial agreements. Adverse movements in exchange rates could have a material adverse effect on our financial condition and results of operations.
A 1% change in the value of foreign currencies as compared the U.S. dollar to in which we had sales, income or expense in 2011 would have increased or decreased the translation of foreign sales by $0.9 million and income by $0.1 million.
We might be impacted by unfavorable decisions in proceedings related to future tax assessments.
We operate in a number of jurisdictions and are from time to time subject to audits and reviews by various taxation authorities with respect to income, consumption, payroll and other taxes and remittances, for current as well as past periods. Accordingly, we may become subject to future tax assessments by various authorities. Any amount we might be required to pay in connection with a future tax assessment may have a material adverse effect on our financial position, cash flows or overall results of operations. There is a possibility of a material adverse effect on the results of operations of the period in which the matter is ultimately resolved, if it is resolved unfavorably, or in the period in which an unfavorable outcome becomes probable and reasonably estimable.
We are currently unable to accurately predict what our short-term and long-term effective tax rates will be in the future.
We are subject to taxes in the United States and the various other jurisdictions in which we operate, and will become subject to taxes in additional jurisdictions. Significant judgment is required in determining our worldwide provision for taxes and, in the ordinary course of business, there are many transactions and calculations where the ultimate tax determination is uncertain. Our effective tax rates could be adversely affected by changes in the mix of earnings (losses) in countries with differing statutory tax rates, changes in the valuation of deferred tax assets and liabilities or changes in tax laws, as well as other factors. Our judgments may be subject to audits or reviews by local tax authorities in each of these jurisdictions, which could adversely affect our tax provisions.
RISKS RELATED TO OUR INDEBTEDNESS
We may need additional capital.
We believe that our current cash and cash equivalents, together with cash generated from the sale of our products will be sufficient to fund our operations for fiscal year 2012. Our future capital requirements will depend on many factors, including but not limited to:
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any impact on us of current conditions and uncertainties in the economy;
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patient and physician demand for our products;
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the status of competitive products, including current and potential generics;
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the results, costs and timing of our research and development activities, regulatory approvals and product launches;
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our ability to reduce our costs in the event product demand is less than expected, or regulatory approvals are delayed or more expensive than expected;
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the number of products and/or companies we acquire or in-license;
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the actual amounts of returns we receive compared to our current estimates;
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our ability to maintain our current credit facility;
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the cost of future bank borrowing; and
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our ability to realize and maintain future integration savings.
If we need additional capital, we might seek additional debt to fund our operations or acquisitions. If we incur more debt, we might be restricted in our ability to raise additional capital and be subject to financial and restrictive covenants. We might also enter into additional collaborative arrangements that could provide us with additional funding in the form of equity, debt, licensing, milestone and/or royalty payments. We might not be able to enter into such arrangements or raise any additional funds on terms favorable to us or at all, especially in the current economic environment.
Our substantial level of indebtedness could materially adversely affect our ability to generate sufficient cash to fulfill our obligations under our existing indebtedness, our ability to react to changes in our business and our ability to incur additional indebtedness to fund future needs.
We have a substantial amount of indebtedness. As of September 30, 2011, our total indebtedness was $976.9 million and we had an additional $147.0 million of borrowing capacity available under our senior secured revolving credit facility. The following chart shows our level of indebtedness as of September 30, 2011.
(1) Represents the net proceeds received on our $750.0 million senior secured term loan facility after the unamortized portion of the original issuance discount.
(2) Represents the net proceeds received on $235.0 million aggregate principal amount of senior notes after original issue discount.
In addition, we have significant other commitments, including milestone and royalty payments. See Note 22 in “Notes to Consolidated Financial Statements.” As of September 30, 2011, we had outstanding approximately $750.0 million in aggregate principal amount of indebtedness under our senior secured credit facilities that would bear interest at a floating rate. Although we may enter into interest rate swap agreements, we are exposed to interest rate increases on the floating portion of our senior secured credit facility that is not covered by interest rate swaps. On April 4, 2011, we entered into two separate pay-fixed, receive-floating interest rate swap agreements with an effective date of June 30, 2011, effectively converting a portion of the variable rate debt under our senior secured credit facilities to fixed rate debt. The first swap has a notional amount of $331,000,000 amortizing to $84,000,000 by its maturity in December 2015. The second swap has a notional amount of $219,000,000 and matures in December 2016. These swaps were designated as cash flow hedges of interest rate risk. The interest rate swaps will effectively fix our interest payments on the hedged debt at 2.386% for the first swap and 3.18% for the second swap, respectively, inclusive of a LIBOR floor of 1.5%, plus the appropriate margin on each debt interest period which is currently 4%. As of September 30, 2011, we had two interest rate swaps with a combined notional amount of $550,000,000 that were designated as cash flow hedges of interest rate risk. The weighted average fixed interest rate on these swaps is 2.7%. Absent any such interest rate swap agreements, a change of 1/8% in floating rates would affect our annual interest expense on the senior secured borrowings by approximately $0.9 million. See “Item 7A. Quantitative and Qualitative Disclosures about Market Risk-Interest Rate Risk.”
Our substantial level of indebtedness increases the possibility that we may be unable to generate cash sufficient to pay, when due, the principal of, interest on or other amounts due in respect of our indebtedness. Our substantial indebtedness, combined with our other financial obligations and contractual commitments, could have important consequences for our note holders. For example, it could:
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make it more difficult for us to satisfy our obligations with respect to our indebtedness, including the senior notes, and any failure to comply with the obligations under any of our debt instruments, including restrictive covenants, could result in an event of default under the indenture governing the senior notes and the agreements governing such other indebtedness;
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require us to dedicate a substantial portion of our cash flow from operations to payments on our indebtedness, thereby reducing funds available for working capital, capital expenditures, acquisitions, selling and marketing efforts, research and development and other purposes;
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increase our vulnerability to adverse economic and industry conditions, which could place us at a competitive disadvantage compared to our competitors that have relatively less indebtedness;
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limit our flexibility in planning for, or reacting to, changes in our business and the industries in which we operate;
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limit our ability to borrow additional funds, or to dispose of assets to raise funds, if needed, for working capital, capital expenditures, acquisitions, research and development and other corporate purposes; and
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prevent us from raising the funds necessary to buy back all notes tendered to us upon the occurrence of certain changes of control, which would constitute a default under the indenture governing the senior notes.
We, including our subsidiaries, have the ability to incur substantially more indebtedness, including senior secured indebtedness.
Subject to the restrictions in our senior secured credit facilities and the indenture governing the senior notes, we, including our subsidiaries, may incur significant additional indebtedness. As of September 30, 2011:
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we had $741.1 million of borrowings under our senior secured credit facilities;
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we had $233.4 million of senior unsecured indebtedness under the senior notes; and
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we had approximately $147.0 million available for borrowing under our senior secured revolving credit facilities, which, if borrowed, would be senior secured indebtedness.
Although the terms of our senior secured credit facilities and the indenture governing the senior notes contain restrictions on the incurrence of additional indebtedness, these restrictions are subject to a number of important exceptions, and indebtedness incurred in compliance with these restrictions could be substantial. If we and our restricted subsidiaries incur significant additional indebtedness, the related risks that we face could increase.
Restrictions imposed by the indenture governing the senior notes, our senior secured credit facilities and our other outstanding indebtedness may limit our ability to operate our business and to finance our future operations or capital needs or to engage in other business activities.
The terms of our senior secured credit facilities and the indenture governing the senior notes restrict us and our subsidiaries from engaging in specified types of transactions. These covenants restrict our ability and the ability of our restricted subsidiaries, among other things, to:
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incur or guarantee additional indebtedness;
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pay dividends on our capital stock or redeem, repurchase or retire our capital stock or indebtedness;
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make investments, loans, advances and acquisitions;
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create restrictions on the payment of dividends or other amounts to us from our restricted subsidiaries;
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engage in transactions with our affiliates;
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sell assets, including capital stock of our subsidiaries;
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consolidate or merge; and
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create liens.
In addition, the agreements governing our senior secured credit facilities require us to comply with certain financial ratio maintenance covenants. Our ability to comply with these ratios can be affected by events beyond our control, and we may not be able to satisfy them. A breach of any of these covenants would be an event of default. In the event of a default under any of our senior secured credit facilities, the lenders could elect to declare all amounts outstanding under the agreements governing our senior secured credit facilities to be immediately due and payable or terminate their commitments to lend additional money. If the indebtedness under our senior secured credit facilities accelerates, the indebtedness under the senior notes would also accelerate and our assets may not be sufficient to repay such indebtedness in full. In particular, holders of senior notes will be paid only if we have assets remaining after we pay amounts due on our secured indebtedness, including our senior secured credit facilities. We have pledged a significant portion of our assets as collateral under our senior secured credit facilities.
We may not be able to generate sufficient cash to service all of our indebtedness and may be forced to take other actions to satisfy our obligations under our indebtedness, which may not be successful.
Our ability to make scheduled payments on or to refinance our debt obligations depends on our financial condition and operating performance, which is subject to prevailing economic and competitive conditions and to certain financial, business and other factors beyond our control. We may not be able to maintain a level of cash flows from operating activities sufficient to permit us to pay the principal, premium, if any, and interest on our indebtedness, including the senior notes.
If our cash flows and capital resources are insufficient to fund our debt service obligations, we may be forced to reduce or delay investments and capital expenditures, or to sell assets, seek additional capital or restructure or refinance our indebtedness, including the senior notes. Our ability to restructure or refinance our debt will depend on the condition of the capital markets and our financial condition at such time. Any refinancing of our debt could be at higher interest rates and may require us to comply with more onerous covenants, which could further restrict our business operations. The terms of existing or future debt instruments and the indenture governing the senior notes may restrict us from adopting some of these alternatives. In addition, any failure to make payments of interest and principal on our outstanding indebtedness on a timely basis would likely result in a reduction of our credit rating, which could harm our ability to incur additional indebtedness. In the absence of such operating results and resources, we could face substantial liquidity problems and might be required to dispose of material assets or operations to meet our debt service and other obligations. Our senior secured credit facilities and the indenture governing the senior notes restrict our ability to dispose of assets and use the proceeds from the disposition. We may not be able to consummate those dispositions or to obtain the proceeds that we could realize from them and these proceeds may not be adequate to meet any debt service obligations then due. These alternative measures may not be successful and may not permit us to meet our debt service obligations.
Our note holders’ right to receive payments on the senior notes is effectively junior to the right of lenders who have a security interest in our assets to the extent of the value of those assets.
Our obligations under the senior notes and our guarantors’ obligations under their guarantees of the senior notes are unsecured, but our obligations under our senior secured credit facilities and each guarantor’s obligations under its guarantee of our senior secured credit facilities are secured by a security interest in substantially all of our domestic tangible and intangible assets, including the stock of substantially all of our wholly-owned U.S. subsidiaries and all or a portion of the stock of certain of our non-U.S. subsidiaries. If we are declared bankrupt or insolvent, or if we default under our senior secured credit facilities, the lenders could declare all of the funds borrowed thereunder, together with accrued interest, immediately due and payable. If we were unable to repay such indebtedness, the lenders could foreclose on the pledged assets to the exclusion of holders of the senior notes, even if an event of default exists under the indenture governing the senior notes at such time. Furthermore, if the lenders foreclose and sell the pledged equity interests in any guarantor under the senior notes, then that guarantor will be released from its guarantee of the senior notes automatically and immediately upon such sale. In any such event, because the senior notes will not be secured by any of our assets or the equity interests in the guarantors, it is possible that there would be no assets remaining from which our note holders’ claims could be satisfied or, if any assets remained, they might be insufficient to satisfy our note holders’ claims in full.
As of September 30, 2011, we had secured indebtedness consisting of:
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$741.1 million of senior secured debt under our senior secured credit facilities; and
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an additional $147.0 million of borrowing capacity under our senior secured revolving credit facility, which, if borrowed, would be senior secured indebtedness.
Subject to the limits set forth in the indenture governing the senior notes, we may also incur additional secured debt.
Our ability to repay our debt is affected by the cash flow generated by our subsidiaries.
Our subsidiaries own substantially all of our assets and conduct substantially all of our operations. Accordingly, repayment of our indebtedness is dependent on the generation of cash flow by our subsidiaries and their ability to make such cash available to us, by dividend, debt repayment or otherwise. Unless they are guarantors of the senior notes, our subsidiaries will not have any obligation to pay amounts due on the senior notes or to make funds available for that purpose. Our subsidiaries may not be able to, or may not be permitted to, make distributions to enable us to make payments in respect of our indebtedness, including the senior notes. Each subsidiary is a distinct legal entity and, under certain circumstances, legal and contractual restrictions may limit our ability to obtain cash from our subsidiaries. While the indenture governing the senior notes limit the ability of our subsidiaries to incur consensual restrictions on their ability to pay dividends or make other intercompany payments to us, these limitations are subject to certain qualifications and exceptions. In the event that we do not receive distributions from our subsidiaries, we may be unable to make required principal and interest payments on our indebtedness, including the senior notes.
Claims of note holders will be structurally subordinated to claims of creditors of certain of our subsidiaries that will not guarantee the senior notes.
The senior notes are not guaranteed by certain of our subsidiaries, including all of our significant non-U.S. subsidiaries (other than Aptalis Pharma Canada Inc.). Accordingly, claims of holders of the senior notes will be structurally subordinated to the claims of creditors of these non-guarantor subsidiaries, including trade creditors. All obligations of our non-guarantor subsidiaries will have to be satisfied before any of the assets of such subsidiaries would be available for distribution, upon liquidation or otherwise, to us or a guarantor of the senior notes.
For fiscal year 2011, our non-guarantor subsidiaries accounted for approximately $103.1 million, or 21.9% of our consolidated revenue. As of September 30, 2011, our non-guarantor subsidiaries accounted for approximately $1,529.0 million, or 121.6% of our consolidated total assets and $363.2 million, or 28.3% of our consolidated total liabilities. All amounts are presented after giving effect to intercompany eliminations. The indenture governing the senior notes permit these subsidiaries to incur certain additional debt and do not limit, or will not limit, their ability to incur other liabilities that are not considered indebtedness under the indenture.
The lenders under our senior secured credit facilities have the discretion to release any guarantors under these facilities in a variety of circumstances, which will cause those guarantors to be released from their guarantees of the senior notes.
While any obligations under our senior secured credit facilities remain outstanding, any guarantee of the notes may be released without action by, or consent of, any holder of the notes or the trustee under the indenture governing the senior notes, at the discretion of lenders under our senior secured credit facilities, if the related guarantor is no longer a guarantor of obligations under our senior secured credit facilities or any other indebtedness. The lenders under our senior secured credit facilities have the discretion to release the guarantees under our senior secured credit facilities in a variety of circumstances. Any of our subsidiaries that is released as a guarantor of our senior secured credit facilities will automatically be released as a guarantor of the senior notes. Our note holders will not have a claim as a creditor against any subsidiary that is no longer a guarantor of the senior notes, and the indebtedness and other liabilities, including trade payables, whether secured or unsecured, of those subsidiaries will effectively be senior to claims of note holders.
If we default on our obligations to pay our other indebtedness, we may not be able to make payments on the senior notes.
Any default under the agreements governing our indebtedness, including a default under our senior secured credit facilities, that is not waived by the required lenders, and the remedies sought by the holders of such indebtedness, could prevent us from paying principal, premium, if any, and interest on the senior notes and substantially decrease the market value of the senior notes. If we are
unable to generate sufficient cash flow and are otherwise unable to obtain funds necessary to meet required payments of principal, premium, if any, and interest on our indebtedness, or if we otherwise fail to comply with the various covenants, including financial and operating covenants in the instruments governing our indebtedness (including covenants in our senior secured credit facilities and the indenture governing the senior notes), we could be in default under the terms of the agreements governing such indebtedness, including our senior secured credit facilities and the indenture governing the senior notes. In the event of such default:
•
the holders of such indebtedness could elect to declare all the funds borrowed thereunder to be due and payable, together with accrued and unpaid interest;
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the lenders under our senior secured credit facilities could elect to terminate their commitments thereunder, cease making further loans and institute foreclosure proceedings against our assets; and
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we could be forced into bankruptcy or liquidation.
If our operating performance declines, we may in the future need to obtain waivers from the required lenders under our senior secured credit facilities to avoid being in default. If we breach our covenants under our senior secured credit facilities and seek a waiver, we may not be able to obtain a waiver from the required lenders. If this occurs, we would be in default under our senior secured credit facilities, the lenders could exercise their rights, as described above, and we could be forced into bankruptcy or liquidation.
We may not be able to repurchase the senior notes upon a change of control.
Upon the occurrence of specific kinds of change of control events, we will be required to offer to repurchase all outstanding senior notes at 101% of their principal amount plus accrued and unpaid interest, if any. The source of funds for any such purchase of the senior notes will be our available cash or cash generated from our operations or the operations of our subsidiaries or other sources, including borrowings, sales of assets or sales of equity. We may not be able to repurchase the senior notes upon a change of control because we may not have sufficient financial resources to purchase all of the senior notes that are tendered upon a change of control. Further, under the terms of our senior secured credit facilities, a change of control is an event of default that permits lenders to accelerate the maturity of borrowings and requires us to offer to repay loans thereunder. Any of our future debt agreements may contain similar provisions. Accordingly, we may not be able to satisfy our obligations to purchase the senior notes unless we are able to refinance or obtain waivers under our senior secured credit facilities. Our failure to repurchase the senior notes upon a change of control would cause a default under the indenture governing the senior notes and a cross-default under our senior secured credit facilities.
Insolvency and fraudulent transfer laws and other limitations may preclude the recovery of payment under the senior notes and the guarantees.
Federal bankruptcy and state fraudulent transfer and conveyance statutes may apply to the issuance of the senior notes and the incurrence of any guarantees. In addition, insolvency, fraudulent transfer and conveyance statutes in Canada, the Netherlands and Luxembourg may apply to the incurrence of the guarantees by our subsidiaries organized in these countries. Although laws differ among these jurisdictions, in general, under applicable fraudulent transfer or conveyance laws, the senior notes or guarantees could be voided as a fraudulent transfer or conveyance if (1) we or any of the guarantors, as applicable, issued the senior notes or incurred the guarantees with the intent of hindering, delaying or defrauding creditors; (2) in the case of a guarantee incurred by any of our foreign subsidiaries, such subsidiary issued the guarantee in a situation where a prudent businessperson as a shareholder of such a subsidiary would have contributed equity to such subsidiary; or (3) we or any of the guarantors, as applicable, received less than reasonably equivalent value or fair consideration in return for either issuing the senior notes or incurring the guarantees and, in the case of (3) only, one of the following is also true:
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We or any of the guarantors, as applicable, were insolvent or rendered insolvent by reason of the issuance of the senior notes or the incurrence of the guarantees or subsequently become insolvent for other reasons.
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The issuance of the senior notes or the incurrence of the guarantees left us or any of the guarantors, as applicable, with an unreasonably small amount of capital to carry on the business.
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We or any of the guarantors intended to, or believed that we or such guarantor would, incur debts beyond our or such guarantor’s ability to pay such debts as they mature.
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We or any of the guarantors was a defendant in an action for money damages, or had a judgment for money damages docketed against us or such guarantor if, in either case, after final judgment, the judgment is unsatisfied.
A court could find that we or a guarantor did not receive reasonably equivalent value or fair consideration for the senior notes or such guarantee if we or such guarantor did not substantially benefit directly or indirectly from the issuance of the senior notes or the applicable guarantee. As a general matter, value is given for a transfer or an obligation if, in exchange for the transfer or obligation, property is transferred or an antecedent debt is secured or satisfied. A debtor will generally not be considered to have received value in connection with a debt offering if the debtor uses the proceeds of that offering to make a dividend payment or otherwise retire or redeem equity securities issued by the debtor. In addition, because the debt was incurred for our benefit, and only indirectly for the benefit of the guarantors, a court could conclude that the guarantors did not receive fair value.
Different jurisdictions evaluate insolvency on various criteria. Generally, however, an entity would be considered insolvent if, at the time it incurred indebtedness,
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the sum of its debts, including contingent liabilities, was greater than the fair saleable value of all its assets;
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the present fair saleable value of its assets was less than the amount that would be required to pay its probable liability on its existing debts, including contingent liabilities, as they become absolute and mature; or
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it could not pay its debts as they become due.
We cannot be certain as to the standards a court would use to determine whether or not we or the guarantors were solvent at the relevant time or, regardless of the standard that a court uses, that the issuance of the senior notes and the incurrence of the guarantees would not be held to constitute fraudulent transfers or conveyances on other grounds. If a court were to find that the issuance of the senior notes or the incurrence of the guarantee was a fraudulent transfer or conveyance, the court could void the payment obligations under the senior notes or such guarantee or further subordinate the senior notes or such guarantee to presently existing and future indebtedness of ours or of the related guarantor, or require the holders of the senior notes to repay any amounts received with respect to such guarantee. In the event of a finding that a fraudulent transfer or conveyance occurred, our note holders may not receive any repayment on the senior notes.
Although each guarantee entered into by a guarantor will contain a provision intended to limit that guarantor’s liability to the maximum amount that it could incur without causing the incurrence of obligations under its guarantee to be a fraudulent transfer, this provision may not be effective to protect those guarantees from being voided under fraudulent transfer or conveyance laws, or may reduce that guarantor’s obligation to an amount that effectively makes its guarantee worthless.
In addition, enforcement of any of the guarantees against any guarantor will be subject to certain other defenses available to guarantors generally. These laws and defenses include those that relate to voidable preference, financial assistance, corporate purpose or benefit, preservation of share capital, thin capitalization, and regulations or defenses affecting the rights of creditors generally. If one or more of these laws and defenses are applicable, a guarantor may have no liability or decreased liability under its guarantee.
Enforcing our note holders’ rights under the guarantees entered into by certain of our foreign subsidiaries across multiple jurisdictions may be difficult.
We are a U.S. company incorporated in the state of Delaware. The senior notes are guaranteed by all of our significant U.S. subsidiaries and certain of our foreign subsidiaries in Canada, the Netherlands and Luxembourg. In the event of bankruptcy, insolvency or a similar event, proceedings could be initiated in any of these jurisdictions and in the jurisdiction of organization of any
future guarantor of the senior notes. Our note holders’ rights under the senior notes and the guarantees will thus be subject to the laws of several jurisdictions, and they may not be able to effectively enforce our note holders’ rights in multiple bankruptcies, insolvency and other similar proceedings. Moreover, such multi jurisdictional proceedings are typically complex and costly for creditors and often result in substantial uncertainty and delay in the enforcement of creditors’ rights.
We are indirectly owned and controlled by the Sponsor, and the Sponsor’s interests as equity holders may conflict with the interests of our note holders.
The Sponsor owns approximately 70% of our indirect parent’s equity and, accordingly, has the ability to control our policies and operations. The Sponsor does not have any liability for any obligations under the senior notes, and the interests of the Sponsor may not in all cases be aligned with our note holders’ interests. For example, if we encounter financial difficulties or are unable to pay our debts as they mature, the interests of our equity holders might conflict with our note holders’ interests. In addition, our equity holders may have an interest in pursuing acquisitions, divestitures, financings or other transactions that, in their judgment, could enhance their equity investments, even though such transactions might involve risks to our note holders. Furthermore, the Sponsor may in the future own businesses that directly or indirectly compete with us. The Sponsor also may pursue acquisition opportunities that may be complementary to our business, and as a result, those acquisition opportunities may not be available to us. For information concerning our arrangements with the Sponsor, see “Item 13. Certain Relationships and Related Transactions, and Director Independence.”
ITEM 1B.
ITEM 1B. UNRESOLVED STAFF COMMENTS
Not applicable.
ITEM 2.
ITEM 2. PROPERTIES
We own and lease space for manufacturing, warehousing, research, development, sales, marketing, and administrative purposes. A number of these facilities are inspected on a regular basis by regulatory authorities, and our own internal auditing team ensures compliance on an ongoing basis with such standards.
We own and operate 107,000 square feet of office space, manufacturing facilities and warehousing in Mont-Saint-Hilaire, Quebec (Canada). The building houses administrative and pharmaceutical manufacturing operations as well as our research and development activities. We further own property next to that building, which could be used to expand. The building and real estate we own is subject to security granted in favor of our lenders, pursuant to the credit facilities described under “Management’s Discussion and Analysis of Financial Condition and Results of Operations-Liquidity and Capital Resources.”
We own and operate two facilities near Milan, Italy. The main facility, which houses administrative, research, production and warehouse activities, is approximately 151,000 total square feet in size and was built in 1996. The laboratory and office space were expanded in 2001 and the office space was expanded again in 2008, adding an additional 3,700 square feet. We acquired the second facility in 2000 through the acquisition of Pharmatec International S.r.l. This approximately 60,000 square-foot production facility was completely renovated in 2003.
We own 606,837 square feet of office space and manufacturing facilities in Houdan, France.
We also own a manufacturing facility of approximately 22,000 square feet in Nogent-Oise, France. This facility was constructed in 1977 and was upgraded and renovated a number of times over the years, most recently in 2005, when we renovated certain testing and quality control laboratory areas in the facility. We have ceased operations at this facility.
Our U.S. manufacturing operations are based near Dayton, Ohio, where we own a facility of approximately 101,000 square feet, which houses our administrative, research, production and warehouse operations in the U.S. This facility was built in 1985 and completely renovated and expanded in 2001. In 2008, we completed a construction project which included the renovation of approximately 13,000 square feet of our existing building, as well as a 13,000 square-foot addition. In addition, adjacent to the facility, we lease approximately 5,000 square feet of office space that houses certain administrative personnel.
All our manufacturing facilities are operated in compliance with cGMPs and GLPs and are periodically audited by the relevant authorities and customers. We believe that all of our present facilities are suitable for their intended purposes. We believe our current manufacturing capabilities in our existing facilities are sufficient for our present and future operations, and we currently have no material expansion plans. We believe, however, that we have the ability to expand our manufacturing capacity in our existing facilities, if needed.
We lease approximately 18,233 square feet of office space in Birmingham, Alabama, (U.S.A.) under a lease expiring in December 2013.
We lease approximately 19,715 square feet of office space in Bridgewater, New Jersey, (U.S.A.). On September 12, 2011, we amended the agreement to lease an additional 12,029 square feet of space on the same floor for a total of 31,744 square feet in Bridgewater, New Jersey and extended the term for an additional five (5) years.
We believe that we have sufficient facilities to conduct our operations during fiscal year 2012 and that our facilities are in satisfactory condition and are suitable for their intended use, although investments to improve and expand our manufacturing and other related facilities are contemplated, as our business requires.
ITEM 3.
ITEM 3. LEGAL PROCEEDINGS
From time to time, we are party to various legal proceeding or claims, either asserted or unasserted, which arise in the ordinary course of business. We have reviewed pending legal matters and believe that the resolution of such matters will not have a significant adverse effect on our financial condition or results of operations.
In December 2003 and May 2004, Pharmascience Inc., or PMS, served us two notices of allegation in accordance with section 5 of the Patented Medicines (Notice of Compliance) Regulations in Canada, or the Regulations. The first notice of allegation indicated that PMS was seeking a regulatory approval to market a generic version of URSO 250 in the Canadian market, or the PMS Product, for use in gallstone dissolution, an indication for which URSO 250 was formerly approved and marketed in Canada. The second notice of allegation dealt with the validity of our Canadian PBC use patent. We opposed both these notices of allegation by seeking prohibition orders. In September 2005, with respect to the first notice of allegation, the Federal Court of Canada held that, for purposes of the Regulations, the PMS Product did not infringe the patent that we own for the use of URSO in the treatment of PBC.
In May 2006, the second application seeking a prohibition order was dismissed as our Canadian PBC use patent was held to be invalid for purposes of the Regulations. PMS has since filed a claim against us pursuant to section 8 of the Regulations seeking recovery of alleged damages sustained by reason of the delay to commercialize its product due to our opposition. In 2011, this claim was settled out of court for a non-material amount.
In October 2008, Eurand and Cephalon received Paragraph IV certification letters relating to ANDAs submitted to the FDA by Mylan Pharmaceuticals, Inc. (“Mylan”) and Barr Laboratories, Inc. (“Barr”), each requesting approval to market and sell a generic version of the 15 mg and 30 mg strengths of AMRIX. In November 2008, Eurand received a similar certification letter from Impax Laboratories, Inc. (“Impax”). In May 2009, Eurand received a similar certification letter from Anchen Pharmaceuticals, Inc. (“Anchen”). Mylan, Impax, and Anchen alleged that U.S. Patent Number 7,387,793 (the “‘793 Patent”), entitled “Modified Release Dosage Forms of Skeletal Muscle Relaxants,” issued to Eurand, will not be infringed by the manufacture, use or sale of the product described in the applicable ANDA and reserved the right to challenge the validity and/or enforceability of the ‘793 Patent. Barr alleged that the ‘793 Patent is invalid, unenforceable and/or will not be infringed by its manufacture, use or sale of the product described in its ANDA. In late November 2008, Eurand filed a lawsuit with Cephalon, in the U.S. District Court in Delaware against Mylan (and its parent) and Barr (and its parent) for infringement of the ‘793 Patent. In January 2009, Eurand filed a lawsuit with Cephalon in the U.S. District Court in Delaware against Impax for infringement of the ‘793 Patent. In July 2009, Eurand filed a lawsuit with Cephalon in the U.S. District Court in Delaware against Anchen (and its parent) for infringement of the ‘793 Patent. Subsequently, in response to additional Paragraph IV certification letters regarding U.S. Patent Number 7,544,372, (the “‘372 Patent”) entitled “Modified Release Dosage Forms of Skeletal Muscle Relaxants” Eurand and Cephalon also filed lawsuits against Mylan, Barr, and Anchen for the infringement of the ‘372 Patent. All cases were consolidated in one action in the U.S. District Court in Delaware, and were tried in a bench trial in September-October, 2010. In May 2011, the U.S. District Court in Delaware rendered a
decision against Eurand and Cephalon. An expedited appeal of the decision was filed in the Court of Appeals for the Federal Circuit and the appeal was held in September 2011. There is currently an injunction in place against the sale of generic Amrix by Mylan, and Anchen has agreed to be preliminarily enjoined from launching a generic form of Amrix while awaiting the ruling from the Federal Circuit. A ruling is expected in Spring 2012. Under the provisions of the Hatch-Waxman Act, the filing of these lawsuits stays FDA approval of each ANDA until the earlier of a district court judgment in favor of the ANDA holder or 30 months from the date of the plaintiff’s receipt of the respective Paragraph IV certification letter.
In September 2010, one of our subsidiaries, and our indirect parent, received notice of Sanofi-Aventis U.S. LLC’s (“SA”) complaint filed with the Superior Court of New Jersey, Somerset County, requesting certain remedies in connection with SA’s stated intention to close its Kansas City facility where CARAFATE product is currently manufactured. The supply agreement with SA, as amended, provides that the CARAFATE product’s manufacturing site may not be changed without our subsidiary’s prior written consent. Pursuant to the complaint filed, SA was seeking an order for specific performance compelling the defendants to consent to the transfer of the manufacturing site of CARAFATE product to an alleged SA facility located in Laval, Canada and to execute related documentation, and for a declaration that SA will not be liable, including for lost profits, for any interruption in supply by reason of the current site’s closure or by reason of a site transfer to Laval. Our subsidiary removed the case to the United States District Court for the District of New Jersey; SA had moved to remand the case back to the Superior Court of New Jersey. The defendants believe that SA’s claims lack merit, and that under the supply agreement as amended, our subsidiary is entitled to have CARAFATE product continue to be manufactured at the Kansas City site until the expiry of that agreement as amended which, assuming our subsidiary exercises its option to extend the term as amended, will be in August 2016. Later, SA decided to transfer the manufacturing of CARAFATE to a different site other than the Laval site. On June 13, 2011 SA filed a notice of voluntary dismissal with the Court, which automatically effectuates that dismissal. Subsequently, we were notified that SA will be keeping the Kansas City facility open to manufacture CARAFATE at least through the expiry of the supply agreement, that is through August 2016.
ITEM 4.
ITEM 4. (REMOVED AND RESERVED)
PART II
ITEM 5.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
Market and other information
We are a privately-owned company with no established public trading market for our common stock.
Holders
As of December 16, 2011, Aptalis MidCo Inc. was the sole holder of our common stock, Aptalis Holdings was the sole holder of the common stock of Aptalis MiCo Inc., and there were 55 holders of Aptalis Holdings’ common stock. See “Item 12 - Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters” for additional information about the ownership of Aptalis Holdings’ common stock.
Dividends
We are currently restricted in our ability to pay dividends under various covenants of our debt agreements, including our senior secured credit facilities and the indenture governing our senior notes. Save to the extent required to finance the repurchase by our indirect parent corporation, Aptalis Holdings, of stock issued pursuant to our equity-based compensation programs, in connection with the administration of this program, we do not expect for the foreseeable future to pay dividends on our common stock. Any future determination to pay dividends will depend upon, among other factors, our results of operations, financial condition, capital requirements, any contractual restrictions and any other considerations our Board of Directors deems relevant.
ITEM 6.
ITEM 6. SELECTED FINANCIAL DATA
Financial Information
Financial information for the fiscal year ended September 30, 2008, including product revenue, is presented as the mathematical combination of the relevant financial information of the Predecessor (from October 1, 2007, to February 25, 2008) and the Successor (from February 26, 2008, to September 30, 2008) for the period. The financial information presented for the Predecessor is the financial information for Aptalis Pharma Inc. and its consolidated subsidiaries and the financial information presented for the Successor is the financial information for APTALIS PHARMA INC. and its consolidated subsidiaries.
Our results of operations for the Predecessor Periods and the Successor Periods should not be considered representative of our future results of operations.
(1) Exclusive of depreciation and amortization.
(2) Amounts shown for the five-month period ended February 25, 2008, seven-month period ended September 30, 2008, and for the fiscal year ended September 30, 2009 include expenses related to the February 2008 Transactions. Amount shown for the fiscal year ended September 30, 2011 includes certain reorganization, special projects and due diligence costs.
(3) A portion of our common stock was issued to our parent company, Aptalis MidCo Inc., in the February 2008 Transactions in exchange for a note receivable amounting to $133,154,405. Pursuant to U.S. GAAP, we report the principal amount as a separate balance offset against shareholders’ equity. Furthermore, we do not recognize interest income related to this note receivable due from Aptalis MidCo Inc. in our income statement.
(4) EBITDA and Adjusted EBITDA are both non-U.S. GAAP financial measures and are presented in this report because our management considers them important supplemental measures of our performance and believes that they are frequently used by interested parties in the evaluation of companies in the industry. EBITDA, as we use it, is net income before financial expenses, interest income, income taxes and depreciation and amortization. We believe that the presentation of EBITDA enhances an investor’s understanding of our financial performance. We believe that EBITDA is a useful financial metric to assess our operating performance from period to period by excluding certain items that we believe are not representative of our core business. The term EBITDA is not defined under U.S. GAAP, and EBITDA is not a measure of net income, operating income or any other performance measure derived in accordance with U.S. GAAP, and is subject to important limitations. Adjusted EBITDA, as we use it, is EBITDA adjusted to exclude certain non-cash charges, unusual or non-recurring items and other adjustments set forth below. Adjusted EBITDA is calculated in the same manner as “EBITDA” and “Consolidated EBITDA” as those terms are defined under the indentures governing our notes and Credit Facility further described in the section “Liquidity and Capital Resources-Long-term Debt and New Senior Secured Credit Facility”. We believe that the inclusion of supplementary adjustments applied to EBITDA in presenting Adjusted EBITDA are appropriate to provide additional information to investors about certain material non-cash items and unusual or non-recurring items that we do not expect to continue in the future and to provide additional information with respect to our ability to meet our future debt service and to comply with various covenants in our indentures and Credit Facility. Adjusted EBITDA is not a measure of net income, operating income or any other performance measure derived in accordance with U.S. GAAP, and is subject to important limitations. EBITDA and Adjusted EBITDA have limitations as an analytical tool, and they should not be considered in isolation, or as substitutes for analysis of our results as reported under U.S. GAAP. Some of these limitations are:
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EBITDA and Adjusted EBITDA do not reflect all cash expenditures, future requirements for capital expenditures, or contractual commitments;
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EBITDA and Adjusted EBITDA do not reflect changes in, or cash requirements for, working capital needs;
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EBITDA and Adjusted EBITDA do not reflect the significant interest expense, or the cash requirements necessary to service interest or principal payments, on our debt;
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Although depreciation and amortization are non-cash charges, the assets being depreciated and amortized will often have to be replaced in the future, and EBITDA and Adjusted EBITDA do not reflect any cash requirements for such replacements;
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Adjusted EBITDA reflects additional adjustments as provided in the indentures governing our secured and unsecured notes and new senior secured credit facilities; and
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Other companies in our industry may calculate EBITDA and Adjusted EBITDA differently than we do, limiting its usefulness as a comparative measure.
Because of these limitations, EBITDA and Adjusted EBITDA should not be considered as measures of discretionary cash available to us to invest in our business. Our management compensates for these limitations by relying primarily on the U.S. GAAP results and using EBITDA and Adjusted EBITDA as supplemental information.
a) Represents transaction, integration, restructuring and refinancing costs as well as due diligence costs related to the Eurand Acquisition as well as to certain other business development projects, non-recurring transactions, certain payments to third parties in respect of research and development milestones and other progress payments as defined within our credit agreement.
b) Represents management fees and other charges associated with the Management Services Agreement with TPG.
c) Represents EBITDA generated by MPEX Pharmaceuticals Inc., an unrestricted subsidiary, with the exception of Acquired in-process research charges.
d) Represents stock-based employee compensation expense under the provisions of FASB guidance, excluding the impact of the unapproved PEPs event.
e) Intangible assets and goodwill write-downs related to the unapproved PEPs event.
f) Other Adjustments and other write-downs related to the unapproved PEPs event, including a reduction of $3.1 million to the sales returns reserve during the fiscal year ended September 30, 2011 (additional returns provision of $23.4 million, inventory write-down and accrual for purchases and other materials and supply commitments of $44.9 million and a stock-based compensation recovery of $4.9 million during the fiscal year ended September 30, 2010).
g) Loss resulting from the disposal of the PHOTOFRIN/PHOTOBARR product line.
h) As part of the purchase price allocation for Eurand Acquisition, the book value of inventory acquired was stepped-up to fair value by $18.7 million as at Acquisition Date. The stepped-up value has been recorded as charge to cost of goods sold as acquired inventory was sold, until acquired inventory was sold off.
i) Represents the initial non-contingent payment of $12.0 million, the discounted value of future time-based non-contingent payments payable under the Option agreement of $44.8 million and the payment towards certain pre-agreement incurred development expenses of $8.7 million related to the Aeroquin Transaction as described in Acquired-in-Process Research section below.
j) Partial write-down of intangible assets related to URSO products.
k) EBITDA and Adjusted EBITDA are both non-U.S. GAAP financial measures and are presented in this report because our management considers them important supplemental measures of our performance and believes that they are frequently used by interested parties in the evaluation of companies in the industry. EBITDA, as we use it, is net income before financial expenses, interest income, income taxes and depreciation and amortization. We believe that the presentation of EBITDA enhances an investor’s understanding of our financial performance. We believe that EBITDA is a useful financial metric to assess our operating performance from period to period by excluding certain items that we believe are not representative of our core business. The term EBITDA is not defined under U.S. GAAP, and EBITDA is not a measure of net income, operating income or any other performance measure derived in accordance with U.S. GAAP, and is subject to important limitations. Adjusted EBITDA, as we use it, is EBITDA adjusted to exclude certain non-cash charges, unusual or non-recurring items and other adjustments set forth above. Adjusted EBITDA is calculated in a similar manner as “EBITDA” and “Consolidated EBITDA” as those terms are defined under the indenture governing our senior notes and Credit Facility. further described in the section “Liquidity and Capital Resources-Long-term Debt and New Senior Secured Credit Facility”, except that in calculating Adjusted EBITDA, we do not include certain additional adjustments under the indenture and the Credit Facility that permit us to increase “EBITDA” and “Consolidated EBITDA” by including projected cost savings and synergies calculated on a pro forma basis that we expect to realize in future periods related to actions already taken or expected to be taken within twelve months of the end of the applicable period, including the Eurand Acquisition and related initiatives. We believe that the inclusion of supplementary adjustments applied to EBITDA in presenting Adjusted EBITDA are appropriate to provide additional information to investors about certain material non-cash items and unusual or non-recurring items that we do not expect to continue in the future and to provide additional information with respect to our ability to meet our future debt service and to comply with various covenants in our indenture and Credit Facility. Adjusted EBITDA is not a measure of net income, operating income or any other performance measure derived in accordance with U.S. GAAP, and is subject to important limitations. EBITDA and Adjusted EBITDA have limitations as an analytical tool, and they should not be considered in isolation, or as substitutes for analysis of our results as reported under U.S. GAAP. Some of these limitations are:
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EBITDA and Adjusted EBITDA do not reflect all cash expenditures, future requirements for capital expenditures, or contractual commitments;
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EBITDA and Adjusted EBITDA do not reflect changes in, or cash requirements for, working capital needs;
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EBITDA and Adjusted EBITDA do not reflect the significant interest expense, or the cash requirements necessary to service interest or principal payments, on our debt;
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Although depreciation and amortization are non-cash charges, the assets being depreciated and amortized will often have to be replaced in the future, and EBITDA and Adjusted EBITDA do not reflect any cash requirements for such replacements;
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Adjusted EBITDA reflects additional adjustments as provided in the indenture governing our unsecured notes and new senior secured credit facilities; and
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Other companies in our industry may calculate EBITDA and Adjusted EBITDA differently than we do, limiting its usefulness as a comparative measure.
Because of these limitations, EBITDA and Adjusted EBITDA should not be considered as measures of discretionary cash available to us to invest in our business. Our management compensates for these limitations by relying primarily on the U.S. GAAP results and using EBITDA and Adjusted EBITDA as supplemental information.
ITEM 7.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
On May 4, 2011, Axcan Intermediate Holdings Inc. announced that it has changed its name to Aptalis Pharma Inc.
You should read the following discussion in conjunction with “Item 6. Selected Financial Data” and the historical audited consolidated financial statements and related notes included elsewhere in this Report. The results of operations for the fiscal years ended September 30, 2011, and September 30, 2010, and September 30, 2009, reflect the results of operations for Aptalis Pharma Inc. previously known as Axcan Intermediate Holdings Inc. and its consolidated subsidiaries.
Unless the context otherwise requires, in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations”, the terms “Axcan”, “Eurand”, “Aptalis”, “Company”, “we”, “us” and “our” refer to Aptalis Pharma Inc. and its consolidated subsidiaries.
This discussion contains forward-looking statements and involves numerous risks and uncertainties, including but not limited to those described in “Item 1A Risk Factors and Forward-Looking Statements.” Actual results may differ materially from those contained in any forward-looking statements.
OVERVIEW
Our Business
We are a privately held, leading specialty pharmaceutical company providing innovative, effective therapies for unmet medical needs including cystic fibrosis and gastrointestinal disorders. Aptalis has manufacturing and commercial operations in the United States, the European Union and Canada, and its products include ZENPEP®, CANASA®, CARAFATE®, PYLERA®, LACTEOL®, DELURSAN®, and SALOFALK®. Our vision is to become the reference specialty pharma company providing innovative, effective therapies for unmet medical needs, including cystic fibrosis and gastrointestinal disorders, and we hope to achieve this through our mission: to improve health and quality of care by providing specialty therapies for patients around the world. We will strive to improve patient quality of care thanks to a broad range of products in cystic fibrosis and gastrointestinal disorders, a robust pipeline, technology platform, manufacturing capabilities and a skilled team of professionals with deep understanding of our customers’ needs.
In addition to our marketing activities, we also formulate and clinically develop enhanced pharmaceutical and biopharmaceutical products for itself and others using its proprietary pharmaceutical technology platforms including bioavailability enhancement of poorly soluble drugs, custom release profiles, and taste-masking/orally disintegrating tablet (ODT) formulations.
We intend to enhance our position as the leading specialty pharmaceutical company concentrating in the field of cystic fibrosis and gastroenterology by pursuing the following strategic initiatives: 1) growing sales of existing products; 2) launching new products; 3) selectively acquiring or in-licensing complementary late stage or in-market products from third parties; 4) pursuing growth opportunities through development pipeline and through our pharmaceutical technologies business; and 5) expanding internationally.
Business Environment
While the ultimate end users of our products are the individual patients to whom our products are prescribed by physicians, our direct customers include a number of large pharmaceutical wholesale distributors and large pharmacy chains. The pharmaceutical wholesale distributors that comprise a significant portion of our customer base sell our products primarily to retail pharmacies, which ultimately dispense our products to the end consumers.
Increasingly, in North America, third-party payors, such as private insurance companies and drug plan benefit managers, aim to rationalize the use of pharmaceutical products and medical treatments, in order to ensure that prescribed products are necessary for the patients’ disorders. Moreover, large drug store chains now account for an increasing portion of retail sales of prescription medicines. The pharmacists and managers of such retail outlets are under pressure to reduce the number of items in inventory in order to reduce costs.
We use a “pull-through” marketing approach that is typical of pharmaceutical companies. Under this approach, our sales representatives actively promote our portfolio products by demonstrating the features and benefits of our products to physicians and, in particular, gastroenterologists and cystic fibrosis centers who may prescribe our products for their patients. The patients, in turn, take the prescriptions to pharmacies to be filled. The pharmacies then place orders, directly or through buying groups, with the wholesalers, to whom we sell our products.
Our expenses are comprised primarily of selling and administrative expenses (including marketing expenses), cost of goods sold (including royalty payments to those companies from which we license some of our commercialized products), research and development expenses, financial expenses as well as depreciation and amortization.
In March 2010, the Health Care and Education Reconciliation Act of 2010 was enacted in the U.S. This healthcare reform legislation contains several provisions that impact our business, which include expanding rebate coverage to managed Medicaid and an increase to the rate of rebates for all our drugs dispensed to Medicaid beneficiaries; expanding the 340(B) drug pricing program requiring drug manufacturers to provide discounted product to reduce the Medicare Part D coverage gap; and assessing a new fee on manufacturers and importers of branded prescription drugs paid for pursuant to coverage provided under specified government programs. The impact of these changes is further discussed below under the “Affordable Care Act” subsection.
On April 29, 2010, we announced that we had taken steps to cease the distribution of ULTRASE MT and VIOKASE, effective April 28, 2010, in response to U.S Food and Drug Administration (“FDA”) guidance related to the distribution of unapproved pancreatic enzyme products, or PEPs. The effects of ceasing to distribute these product lines on our financial statements are summarized in the section “Unapproved pancreatic enzyme products (“PEPs”) event” below.
Acquisition of Eurand N.V. (“Eurand Acquisition”)
On February 11, 2011 (or the “Acquisition Date”), Axcan Holdings Inc., which subsequently changed its name to Aptalis Holdings, Inc., our indirect parent (“Aptalis Holdings”), and Axcan Pharma Holding B.V. (“Axcan Acquisition Co”), an indirect subsidiary of ours, pursuant to a Share Purchase Agreement dated November 30, 2010 (as amended) acquired the outstanding equity of Eurand N.V. (“Eurand”) for total consideration of approximately $589.6 million. As a result of the acquisition, Eurand has become an indirect subsidiary of ours.
Prior to the transaction, Eurand was a specialty pharmaceutical company that developed, manufactured and commercialized enhanced pharmaceutical and biopharmaceutical products based on its proprietary pharmaceutical technologies. Eurand has had six products approved by the FDA since 2001 and has a pipeline of product candidates in development for itself and its collaboration partners. Its technology platforms include bioavailability enhancement of poorly soluble drugs, custom release profiles and taste-masking/orally disintegrating tablet (ODT) formulations. Eurand was a global company with facilities in the U.S. and Europe. The acquisition of Eurand enables us to leverage the combination of two leading specialty pharmaceutical players, expand our gastroenterology product portfolio and provide us with a proprietary R&D growth engine and technology platforms supported by an extensive patent portfolio to meaningfully diversify our business and expand our geographic and manufacturing footprint.
Fair value of consideration transferred
The table below details the consideration transferred to acquire Eurand:
(a) Each Eurand stock option, whether or not vested and exercisable on the acquisition date, was canceled for a cash payment equal to the excess of the per share value of the acquisition consideration over the per share exercise price of the Eurand stock option.
The aggregate equity purchase price of $589.6 million plus acquisition costs (including related fees and expenses) were funded by cash equity contributions, made through Aptalis Holdings, amounting to $140.0 million from affiliates of TPG Capital L.P. and certain co-investors, the proceeds from the Senior Secured Term Loan Facility (as defined below) under our amended and restated credit agreement and related security and other agreements and cash on hand from Aptalis and Eurand.
The amended and restated credit agreement and related security and other agreements is composed of (i) a senior secured revolving credit facility in an aggregate principal amount of $147.0 million (the “Senior Secured Revolving Credit Facility”) and (ii) a $750.0 million senior secured term loan facility (the “Senior Secured Term Loan Facility” and, together with the Senior Secured Revolving Credit Facility, collectively, the “Amended and Restated Senior Secured Credit Facilities”). The Senior Secured Revolving Credit Facility is comprised of $115.0 million of existing revolving credit commitments that were extended or issued on February 11, 2011 (the “ Extended Commitments”) and $32.0 million of existing revolving credit commitments that were not extended (the “ Unextended Commitments”) pursuant to the Senior Secured Revolving Credit Facility.
We borrowed $500.0 million of the amount available under the Senior Secured Term Loan Facility at the closing of the acquisition. The Senior Secured Revolving Credit Facility remained undrawn at the closing of the acquisition. A portion of the proceeds of the equity and debt financings, together with cash on hand of Axcan and Eurand, were used to repay the outstanding term loan portion amounting to $125.7 million of our prior senior secured credit facilities and to pay related fees and expenses. The remaining amount of $250.0 million of the Senior Secured Term Loan Facility was used on March 15, 2011 to redeem 100% of our existing 9.25% senior secured notes due 2015.
Basis of presentation
The transaction has been accounted for in accordance with the acquisition method of accounting for business combinations under existing U.S. generally accepted accounting principles (“GAAP”). The acquisition method of accounting requires, among other things, that assets acquired and liabilities assumed be recognized at their fair values as of the acquisition date including acquired in-process research and development assets.
Assets acquired and liabilities assumed
A preliminary purchase price allocation had been made as of the Acquisition Date. We finalized our purchase price allocation during the fourth quarter of fiscal year ended September 30, 2011 resulting in no retrospective adjustments to the provisional amounts recognized at the Acquisition Date.
The following table summarizes the fair values of the assets acquired and liabilities assumed as of the acquisition date.
(a) As of the Acquisition Date, the fair value of accounts receivable acquired approximated book value. The gross contractual amount receivable was $23.2 million, of which $0.5 million was not expected to be collected.
(b) Reflects the adjustment to step-up the carrying value of inventory acquired by $18.7 million to estimated fair value as of February 11, 2011. The stepped-up value is recorded as a charge to cost of goods sold as acquired inventory is sold.
(c) Includes prepaid assets and income tax receivable.
(d) The amounts recorded for the major components of acquired identifiable intangible assets are as follows:
In addition, the estimated aggregate amortization expense for the five succeeding years will be $25.6 million annually.
(e) Includes accounts payable, accrued liabilities and income taxes payable.
(f) Comprises of current deferred tax assets $0.8 million, non-current deferred tax assets $15.7 million and non-current deferred tax liabilities $77.7 million.
(g) The excess of purchase price over the fair value amounts assigned to the assets acquired and liabilities assumed represents the goodwill amount resulting from the acquisition. The goodwill recorded as part of the acquisition is largely attributable to synergies expected to result from combining our operations with Eurand and intangible assets that do not qualify for separate recognition. We do not expect any portion of this goodwill to be deductible for tax purposes.
(h) Prior to the acquisition, we had entered into an exclusive development license and supply agreement with Eurand. No gain or loss was recognized in conjunction with the effective settlement of the contractual relationship between us and Eurand as a result of this acquisition.
Transaction related costs
During the fiscal year ended September 30, 2011, we have expensed $11.9 million (an additional $1.1 million had been expensed in the fiscal year ended September 30, 2010) of costs relating to legal, financial, valuation and accounting advisory services performed in connection with effecting the acquisition of Eurand, which are included in transaction, restructuring and integration costs in the accompanying Consolidated Statements of Operations.
Actual and proforma information
The revenue derived from the Eurand entities for the period from the Acquisition Date to September 30, 2011 were $121.9 million and loss before income taxes was $39.6 million.
The following table presents pro forma consolidated results of operations as if the acquisition of Eurand had occurred as of October 1, 2009:
The pro forma consolidated results of operations were prepared using the acquisition method of accounting and are based on the historical financial information of us and Eurand. The pro forma information does not reflect any synergies and other benefits that the Company may achieve as a result of the acquisition, or the costs necessary to achieve these synergies. In addition, the pro forma information does not reflect the costs to integrate the operations of us and Eurand.
The pro forma information is not necessarily indicative of what our consolidated results of operations actually would have been had the transaction been completed on October 1, 2009. In addition, the pro forma information does not purport to project the future results of our operations. The pro forma information reflects primarily the following pro forma adjustments:
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elimination of product sales and royalties between Eurand and us, an elimination of our cost of sales for Eurand-sourced inventories, and the elimination of certain PEP-related charges stemming from intercompany transactions;
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elimination of Eurand’s historical intangible asset amortization expense;
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additional amortization expense related to the fair value of identifiable intangible assets acquired;
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additional depreciation expense related to the fair value adjustment to property, plant and equipment acquired;
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elimination of interest expense and amortization of deferred financing costs related to the Company’s term loan under the legacy senior secured credit facilities and 9.25% senior secured notes due 2015 that were repaid as part of the acquisition transaction;
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additional interest expense and amortization of deferred financing costs associated with financing obtained under the Amended and Restated Senior Secured Credit Facilities obtained by us in connection with the acquisition transaction;
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reduction of interest income associated with cash and cash equivalents that were used to partially fund the acquisition;
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elimination of acquisition-related costs and acquisition-related restructuring charges;
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elimination of $19.1 million of the acquisition accounting adjustment on Eurand’s inventory that was sold subsequent to the Acquisition Date, which will not have a continuing impact on our operations.
The pro forma effective tax rate differs from the statutory rate due to the relatively large impact of actual permanent differences on relatively small pro forma income before tax, valuation allowances on deferred tax assets in certain jurisdictions, and the expected impact of foreign withholding taxes upon repatriation of foreign earnings.
Agreements with Mpex Pharmaceuticals Inc. for the acquisition and development of Aeroquin™
On April 11, 2011, Aptalis Holdings and Axcan Lone Star Inc. (“Merger Sub”), affiliates of ours, entered into a series of agreements with Mpex Pharmaceuticals Inc. (“Mpex”) for the acquisition and development of Aeroquin™ (the “Aeroquin Transaction”), a proprietary aerosol formulation of levofloxacin, which is currently in Phase 3 clinical trials for the treatment of pulmonary infections in patients with cystic fibrosis (CF). Subsequently on August 31, 2011, under the terms of these agreements, Aptalis Holdings and Merger Sub acquired all of Mpex’s assets related to Aeroquin™ in a merger of Mpex with and into Merger Sub, with Mpex being the surviving corporation and a direct, wholly-owned subsidiary of us. Prior to the merger, Mpex transferred all of its assets that are not related to Aeroquin™ to Rempex Pharmaceuticals, Inc. (“Rempex”), a newly formed company that is owned primarily by the previous Mpex stockholders. As a result of the Aeroquin Transaction, we made an initial non-contingent payment of $12.0 million on April 21, 2011. Additional consideration in relation with the Aeroquin Transaction consists of (i) remaining time-based, non-contingent payments amounting to $33.0 million and an additional $17.5 million of time-based payments will be paid in a number of installments, of which the final installment is due on April 1, 2014, plus, (ii) contingent payments of up to $195.0 million if certain regulatory and commercial milestones are met related to Aeroquin™, and (iii) earn-out payments based on net sales of Aeroquin™. Indemnity obligations of the Mpex security holders will be satisfied by set-off against a portion of the foregoing merger consideration payments.
The further development of Aeroquin™ is being conducted pursuant to the terms of the Development Agreement dated April 11, 2011 among Aptalis Holdings, Merger Sub, and Mpex. Since the completion of the divestiture of assets and liabilities unrelated to Aeroquin™ (the “Divestiture”) to Rempex, Rempex has assumed all of Mpex’s obligations under the Development Agreement. Under the Development Agreement, Rempex is paid for the actual development costs of Aeroquin™ and has primary responsibility for conducting day-to-day development activities. We are required to pay in advance development costs estimated for the next three months based on a rolling three months forecast. Aptalis Holdings and Mpex have input regarding development strategy. Pursuant to the Development Agreement, on April 12, 2011 Mpex was paid $8.7 million for development expenses incurred by Mpex from November 15, 2010, to March 31, 2011, which has been expensed as acquired in-process research and an additional $9.9 million for estimated development costs to be incurred during the first three months of the Development Agreement, of which $8.5 million has been expensed as research and development. All payments under the Development Agreement, Option Agreement and Merger Agreement to Mpex or Mpex security holders, as applicable, were made by or on behalf of Merger Sub prior to the closing of the Aeuroquin Transaction, and are being made on behalf of Mpex since the closing of the Aeroquin Transaction.
During the year ended September 30, 2011, we expensed $15.8 million as research and development and $65.5 million as acquired in-process research and development reflecting the initial non-contingent payment of $12.0 million, the discounted value of future time-based non-contingent payments payable under the Option and Merger agreements of $44.8 million (with a corresponding liability) and the payment for certain pre-agreement incurred development expenses of $8.7 million. As of September 30, 2011, $7.8 million reflecting forecasted development costs for the next three months is included in prepaid expenses and other current assets. As of September 30, 2011, $45.7 million represents the amount accrued for the non-contingent payments payable under the Option and Merger agreements with $32.5 million included in other long term liabilities and the balance included in accounts payable and accrued liabilities.
Equity investment in Aptalis Holdings
Simultaneous with the execution of the Mpex agreements, Aptalis Holdings received the proceeds of a $55.0 million equity investment from funds managed by Investor Growth Capital Limited. Aptalis Holdings contributed the proceeds of the equity investment to its subsidiaries to fund a portion of the cost of the Mpex transactions and a partial repayment on our $133.2 million note receivable from our parent company.
FINANCIAL OVERVIEW FOR THE FISCAL YEAR ENDED SEPTEMBER 30, 2011
This discussion and analysis is based on our audited annual consolidated financial statements and the related notes thereto reported under U.S. GAAP. The results of Eurand’s business have been included in our results of operations, financial condition and cash flows only for the period subsequent to the completion of the Acquisition Date. For a description of our products, see the section entitled “Business Products”.
For the fiscal year ended September 30, 2011, total revenue was $470.4 million ($354.6 million in fiscal year 2010 and $416.9 million in fiscal year 2009), operating loss was $66.4 million (operating loss of $103.6 million in fiscal year 2010 and operating income of $33.6 million in fiscal year 2009) and net loss was $187.9 million ($170.4 million in fiscal year 2010 and $7.9 million in fiscal year 2009).
In the United States, total revenue was $337.7 million (71.8% of total revenue) for the fiscal year ended September 30, 2011, compared to $259.0 million (73.0% of total revenue) in fiscal year 2010 and $319.6 million (76.7% of total revenue) in fiscal year 2009. In the European Union, total revenue was $95.5 million (20.3% of total revenue) for the fiscal year ended September 30, 2011, compared to $63.2 million (17.8% of total revenue) in fiscal year 2010 and $65.8 million (15.8% of total revenue) in fiscal year 2009. In Canada, total revenue was $37.2 million (7.9% of total revenue) for the fiscal year ended September 30, 2011, compared to $32.4 million (9.1% of total revenue) in fiscal year 2010 and 30.9 million (7.4% of total revenue) in fiscal year 2009.
Unapproved pancreatic enzyme products (“PEPs”) event
As previously disclosed, we ceased distributing our ULTRASE MT and VIOKASE product lines in the U.S. effective April 28, 2010. ULTRASE MT and VIOKASE had accounted for approximately 19% of our total net sales in the last three fiscal years.
This action was taken as we did not receive FDA approval for ULTRASE MT or VIOKASE by April 28, 2010, the date mandated by the FDA to obtain approval for pancreatic enzyme products. We also interrupted shipments of product from the United States to Canada and export markets to allow time for the FDA to review our request confirming that applicable export requirements were being met as the FDA does not currently allow any shipment of this product within the U.S. As of September 30, 2011, this interruption of shipments was still in place.
On September 1, 2011 we filed our response to the FDA’s Complete Response letters dated November 28, 2010 for the VIOKASE and ULTRASE NDAs. We have a PDFA date of March 1st, 2012. We continue to work with the manufacturer of the active pharmaceutical ingredient to address any open issues identified by the FDA. However, we do not believe additional clinical studies will be required at this time.
As a result of taking steps to cease distribution of ULTRASE MT and VIOKASE and in accordance with U.S. GAAP, we recorded an additional $23.5 million sales deduction reserve for the fiscal year ended September 30, 2010. This additional reserve was an estimate of our liability for ULTRASE MT and VIOKASE that may be returned by the original purchaser under our DSAs or applicable return policies as well as other incremental sales deductions that may be incurred in addition to those previously recorded for ULTRASE MT and VIOKASE prior to the PEPs event. The cease distribution order issued by the FDA was not considered as a product recall. This reserve was based on management estimates of ULTRASE MT and VIOKASE inventory in the distribution channel, assumptions on related expiration dates of this inventory as well as estimated erosion of ULTRASE MT and VIOKASE demand, based on competition from approved PEPs and the resulting estimated sell-through of ULTRASE MT and VIOKASE, actual return activity and other factors.
The reserves that we have taken as a result of having ceased distribution of our PEPs reflect many subjective estimates that were required to be made by management. These estimates include:
a) The quantity and expiration dates of PEPs inventory in the distribution channel;
b) Short-term prescription demand during the period of time during which the products continued to be available at the pharmacy level;
c) Other factors.
The remaining reserve related to the PEPs event, was $3.1 million at September 30, 2011, ($11.0 million at September 30, 2010). This reserve was affected by a reversal of $3.1 million in the fiscal year ended September 30, 2011 to reflect the sell-through of inventory in the distribution channel as well as the estimated sales value of the remaining inventory in the distribution channel as of September 30, 2011. In future periods, we will continue to monitor and review the assumptions and estimates and will prospectively record changes to the PEPs reserve.
Financial highlights
(a) Including the current portion
(1) A reconciliation of net income to EBITDA (a non-U.S. GAAP measure) and from EBITDA to Adjusted EBITDA (a non-U.S. GAAP measure) for the fiscal year ended September 30, 2011, 2010 and 2009 are as follows:
a) Represents transaction, integration, restructuring and refinancing costs as well as due diligence costs related to the Eurand Acquisition as well as to certain other business development projects, non-recurring transactions, certain payments to third parties in respect of research and development milestones and other progress payments as defined within our credit agreement.
b) Represents management fees and other charges associated with the Management Services Agreement with TPG.
c) Represents EBITDA generated by MPEX Pharmaceuticals Inc., an unrestricted subsidiary, with the exception of Acquired in-process research charges.
d) Represents stock-based employee compensation expense under the provisions of FASB guidance, excluding the impact of the unapproved PEPs event.
e) Intangible assets and goodwill write-downs related to the unapproved PEPs event.
f) Other Adjustments and other write-downs related to the unapproved PEPs event, including a reduction of $3.1 million to the sales returns reserve during the fiscal year ended September 30, 2011 (additional returns provision of $23.4 million, inventory write-down and accrual for purchases and other materials and supply commitments of $44.9 million and a stock-based compensation recovery of $4.9 million during the fiscal year ended September 30, 2010).
g) Loss resulting from the disposal of the PHOTOFRIN/PHOTOBARR product line.
h) As part of the purchase price allocation for Eurand Acquisition, the book value of inventory acquired was stepped-up to fair value by $18.7 million as at Acquisition Date. The stepped-up value has been recorded as charge to cost of goods sold as acquired inventory was sold, until acquired inventory was sold off.
i) Represents the initial non-contingent payment of $12.0 million, the discounted value of future time-based non-contingent payments payable under the Option agreement of $44.8 million and the payment towards certain pre-agreement incurred development expenses of $8.7 million related to the Aeroquin Transaction as described in Acquired-in-Process Research section below.
j) Partial write-down of intangible assets related to URSO products.
k) EBITDA and Adjusted EBITDA are both non-U.S. GAAP financial measures and are presented in this report because our management considers them important supplemental measures of our performance and believes that they are frequently used by interested parties in the evaluation of companies in the industry. EBITDA, as we use it, is net income before financial expenses, interest income, income taxes and depreciation and amortization. We believe that the presentation of EBITDA enhances an investor’s understanding of our financial performance. We believe that EBITDA is a useful financial metric to assess our operating
performance from period to period by excluding certain items that we believe are not representative of our core business. The term EBITDA is not defined under U.S. GAAP, and EBITDA is not a measure of net income, operating income or any other performance measure derived in accordance with U.S. GAAP, and is subject to important limitations. Adjusted EBITDA, as we use it, is EBITDA adjusted to exclude certain non-cash charges, unusual or non-recurring items and other adjustments set forth above. Adjusted EBITDA is calculated in a similar manner as “EBITDA” and “Consolidated EBITDA” as those terms are defined under the indenture governing our senior notes and Credit Facility. further described in the section “Liquidity and Capital Resources-Long-term Debt and New Senior Secured Credit Facility”, except that in calculating Adjusted EBITDA, we do not include certain additional adjustments under the indenture and the Credit Facility that permit us to increase “EBITDA” and “Consolidated EBITDA” by including projected cost savings and synergies calculated on a pro forma basis that we expect to realize in future periods related to actions already taken or expected to be taken within twelve months of the end of the applicable period, including the Eurand Acquisition and related initiatives. We believe that the inclusion of supplementary adjustments applied to EBITDA in presenting Adjusted EBITDA are appropriate to provide additional information to investors about certain material non-cash items and unusual or non-recurring items that we do not expect to continue in the future and to provide additional information with respect to our ability to meet our future debt service and to comply with various covenants in our indenture and Credit Facility. Adjusted EBITDA is not a measure of net income, operating income or any other performance measure derived in accordance with U.S. GAAP, and is subject to important limitations. EBITDA and Adjusted EBITDA have limitations as an analytical tool, and they should not be considered in isolation, or as substitutes for analysis of our results as reported under U.S. GAAP. Some of these limitations are:
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EBITDA and Adjusted EBITDA do not reflect all cash expenditures, future requirements for capital expenditures, or contractual commitments;
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EBITDA and Adjusted EBITDA do not reflect changes in, or cash requirements for, working capital needs;
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EBITDA and Adjusted EBITDA do not reflect the significant interest expense, or the cash requirements necessary to service interest or principal payments, on our debt;
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Although depreciation and amortization are non-cash charges, the assets being depreciated and amortized will often have to be replaced in the future, and EBITDA and Adjusted EBITDA do not reflect any cash requirements for such replacements;
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Adjusted EBITDA reflects additional adjustments as provided in the indenture governing our unsecured notes and new senior secured credit facilities; and
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Other companies in our industry may calculate EBITDA and Adjusted EBITDA differently than we do, limiting its usefulness as a comparative measure.
Because of these limitations, EBITDA and Adjusted EBITDA should not be considered as measures of discretionary cash available to us to invest in our business. Our management compensates for these limitations by relying primarily on the U.S. GAAP results and using EBITDA and Adjusted EBITDA as supplemental information.
Fiscal year ended September 30, 2011, compared to the fiscal year ended September 30, 2010
Overview of results of operations
a) Exclusive of depreciation and amortization
b) Including one time charges related to the unapproved PEPs event
Net product sales
Net product sales in the U.S. increased $71.0 million (27.4%), to $330.0 million for the fiscal year ended September 30, 2011, compared to $259.0 million for the corresponding period of the preceding fiscal year. The increase in sales in U.S. is mainly due to the inclusion of post-acquisition sales of legacy Eurand products amounting to $86.1 million and due to the sales returns provision related to the PEPs event for the fiscal year ended September 30, 2011, compared to the previous year, which amounted to $20.3 million (additional $23.4 million sales deduction reserve in the fiscal year ended September 30, 2010 and reversal of $3.1 million in the fiscal year ended September 30, 2011). The increase in net product sales for the fiscal year ended September 30, 2011 is partially offset by the absence of ULTRASE and VIOKASE product sales which amounted to $49.6 million in the fiscal year ended September 30, 2010. Wholesaler inventory fluctuations have also favourably impacted our U.S. net sales by approximately $8.0 million overall.
Net product sales in the European Union increased $31.3 million (49.5%), to $94.5 million for the the fiscal year ended September 30, 2011, compared to $63.2 million for the corresponding period of the preceding fiscal year. The increase is mostly due to the inclusion of post-acquisition sales of legacy Eurand products amounting to $27.2 million for the fiscal year ended September 30, 2011.
Net product sales in Canada increased $4.5 million (13.9%), to $36.9 million for the the fiscal year ended September 30, 2011, compared to $32.4 million for the corresponding period of the preceding fiscal year. The increase in sales resulted primarily from higher sales volume of SALOFALK combined with the positive impact of currency fluctuations compared to the preceding year, as the value of the Canadian dollar improved against the U.S. dollar by 6.1%.
Net product sales are stated net of deductions for product returns, chargebacks, contract rebates, DSA fees, discounts and other allowances. The following table summarizes our gross-to-net product sales adjustments for each significant category:
Product returns, contract rebates, DSA fees, discounts and other allowances totalled $117.9 million (20.4% of gross product sales) for the fiscal year ended September 30, 2011, compared to $120.0 million (25.3% of gross product sales) for the corresponding period of the preceding fiscal year.
The decrease in total deductions as a percentage of gross product sales was mainly due to taking $23.4 million during the fiscal year ended September 30, 2010 as a result of the PEPS event partially offset by a reversal of the provision amounting to $3.1 million during the fiscal year ended September 30, 2011).
Affordable Care Act
The Patient Protection and Affordable Care Act of 2010 and the Health Care and Education Reconciliation Act of 2010, known together as the Affordable Care Act, enacted in the U.S in March 2010 contain several provisions that could impact our business.
Although many provisions of the new legislation did not take effect immediately, several provisions became effective during the fiscal year ended September 30, 2010. These include (1) an increase in the minimum Medicaid rebate to States participating in the Medicaid program on our branded prescription drugs; (2) the extension of the Medicaid rebate to Managed Care Organizations that dispense drugs to Medicaid beneficiaries; and (3) the expansion of the 340(B) Public Health Service Act drug pricing program, which provides outpatient drugs at reduced rates, to include certain children’s hospitals, free standing cancer hospitals, critical access hospitals, and rural referral centers.
In addition, beginning in 2011, the new law requires drug manufacturers to provide a 50% discount to Medicare beneficiaries for any covered prescription drugs purchased during a Medicare Part D coverage gap (i.e. the “donut hole”). Also, beginning in 2011, new fees are assessed on all branded prescription drug manufacturers and importers. This fee is calculated based upon each organization’s percentage share of total branded prescription drug sales to U.S. government programs (such as Medicare Parts B and D, Medicaid, Department of Veterans Affairs and Department of Defense programs and TRICARE retail pharmacy program) made during the previous fiscal year. The aggregated industry wide fee is expected to total $28 billion through 2019, ranging from $2.5 billion to $4.1 billion annually. The Internal Revenue Service, or “IRS”, has issued guidance for calculating preliminary fees, but there is still uncertainty as to final implementation, since the IRS has requested public comment and may make changes in response. The new law also imposes a 2.3% excise tax on sales of certain taxable medical devices that are made after December 31, 2012, including our FLUTTER mucus clearance device. Further, effective March 31, 2013, the law requires pharmaceutical, medical device, biological, and medical supply manufacturers to begin reporting to the federal government the payments they make to physicians and teaching hospitals, and physician ownership interests in those entities. The law also provides for the creation of an abbreviated regulatory pathway for FDA approval of biosimilars and interchangeable biosimilar products. While creation of the biosimilars program is authorized as of passage of the legislation in 2010, the process of creating the regulatory pathway for approval of biosimilars will likely be lengthy, and the FDA is in the process of soliciting public input.
While certain aspects of the new legislation implemented in 2010 are expected to reduce our revenues in future years, other provisions of this legislation may offset, at some level, any reduction in revenues when these provisions become effective. In future
years, based on our understanding, these other provisions are expected to result in higher revenues due to an increase in the total number of patients covered by health insurance and an expectation that existing insurance coverage will provide more comprehensive consumer protections. This would include a federal subsidy for a portion of a beneficiary’s out-of-pocket cost under Medicare Part D. However, these higher revenues will be negatively impacted by the branded prescription drug manufacturers’ fee.
The impact in terms of additional reserves recorded has been $4.5 million for the fiscal year ended September 30, 2011 compared to $0.5 million for the corresponding period of the preceding fiscal year.
Performance of our main product lines
Variations in sales performance in fiscal year 2011 versus the preceding fiscal year were the result of a combination of changes in sales volume as well as price increases.
Key sales figures for our main product lines for the fiscal year 2011 are as follows:
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Sales of pancreatic enzyme products (ULTRASE, PANZYTRAT, VIOKASE and ZENPEP) increased $13.9 million (20.3%) to $82.2 million from $68.3 million for the preceding fiscal year mainly due to combination of the integration of Zenpep following the acquisition of Eurand, which was partially offset by the continued impact of the PEP event in fiscal year 2011.
•
Sales of ursodiol products (URSO, URSO 250, URSO FORTE, URSO DS and DELURSAN) decreased $0.9 million (2.0%) to $43.7 million from $44.6 million for the preceding fiscal year.
•
Sales of mesalamine products (CANASA and SALOFALK) increased $17.1 million (17.0%) to $117.8 million from $100.7 million for the preceding fiscal year. The increase mainly resulted from increases in net selling price and to a lesser extent, increases in sales volume.
•
Sales of sucralfate products (CARAFATE and SULCRATE) increased $22.1 million (25.6%) to $108.6 million from $86.5 million for the preceding fiscal year. The increase mainly resulted from an increase in sales volume and to a lesser extent, to an increase in net selling price.
•
Sales of other specialty pharmaceutical products increased $5.6 million (10.3%) to $60.1 million from $54.5 million for the preceding fiscal year.
•
Sales of our various pharmaceutical technologies products were $49.0 million in 2011 ($0 in 2010) due to the acquisition of Eurand.
Other Revenue
Other revenue consists of development fees, royalties and other revenue. Development fees amounted to $3.6 million for the fiscal year ended September 30, 2011. These fees resulted from the inclusion of Eurand’s business in the post-acquisition period. Development of a new pharmaceutical formulation generally includes the following stages:
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feasibility and prototype development;
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formulation optimization and preparation of pilot clinical samples;
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scale-up, validation and preparation of clinical samples for regulatory and commercial purposes;
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clinical trials; and
•
preparation of documents and regulatory filings.
We apply our proprietary pharmaceutical technologies in one of two ways - either to develop products on behalf of our collaborators or as internal programs. In both situations, we are involved in all stages of the formulation development process and perform largely
the same types of work although, in general, we only perform clinical trials for the products we develop internally. Clinical trials for co-developed products are typically performed by our collaboration partners. For internal projects, we fund all of the development costs with a view either to out-license the product once it is fully developed and has obtained the applicable regulatory approvals, or to market it directly.
In our typical co-development contract, we generally receive development fees and milestones payments from our collaborators. Most of our current co-development agreements provide for us to perform development activities based on an hourly service fee. Our current co-development agreements also typically include provisions for the receipt of milestone payments upon the achievement of certain development and/or regulatory milestones including, by way of example, successful completion of development phases, successful demonstration of bioequivalence, and acceptance and approval by the applicable regulatory agencies. Milestone payments are usually structured as lump sum payments, which are due if and when we reach certain mutually agreed-upon development milestones as set forth in the agreements. In many cases, achievement of such milestone payments is based on factors that are out of our control, including, among other things, regulatory approval of the product. In addition, in many cases, decisions directly affecting the receipt of these payments are made at the sole discretion of our collaborator. Due to the structure of our co-development agreements and the inherent difficulty in predicting progress on development plans, our development fees may fluctuate significantly from quarter to quarter. In addition, development fees will fluctuate depending on the number of co-development agreements we enter into in a given year or quarter.
Royalties amounted to $5.0 million for the fiscal year ended September 30, 2011, and resulted from the inclusion of legacy Eurand’s business in the post-acquisition period. We earn royalty revenues from its collaborators equal to a percentage of their sales of the products on which we assisted in the development of.
Cost of goods sold
Cost of goods sold consists principally of the cost of raw materials, royalties and manufacturing. For the fiscal year ended September 30, 2011, cost of goods sold increased $4.5 million (3.4 %) to $135.4 million from $130.9 for the corresponding period of the preceding fiscal year. As a percentage of net product sales, cost of goods sold for the fiscal year ended September 30, 2011 decreased compared to the corresponding period of the preceding fiscal year to 29.3% from 36.9% primarily due to the unfavourable impact from the provisions taken as a result of the unapproved PEPs event in the fiscal year ended September 30, 2010 amounting to $44.9 million. The decrease related to the unapproved PEPs event was partially offset by the additional expense associated with the inventory stepped-up to fair value as a result of the Eurand transaction. As part of the purchase price allocation for the Eurand Acquisition, the book value of the inventory acquired was stepped-up to fair value by $18.7 million as at the Acquisition Date. The stepped-up value has been recorded as charge to cost of goods sold as acquired inventory is sold, until the acquired inventory is sold off. The total stepped-up value was expensed during the fiscal year ended September 30, 2011.
Excluding the impact of the unapproved PEPs, the charge related to the inventory stepped-up value and the integration of Eurand business, cost of goods sold as a percentage of net product sales would have been 25.4% compared to 22.8% for the fiscal year ended September 30, 2010.
Selling and administrative expenses
Selling and administrative expenses, on an ongoing basis, consist principally of salaries and other costs associated with our sales force and marketing activities. For the fiscal year ended September 30, 2011, selling and administrative expenses increased $29.3 million (25.7%) to $143.2 million from $113.9 million for the corresponding period of the preceding fiscal year. The increase is resulting from the inclusion of legacy Eurand’s business in the post-acquisition period amounting to $35.6 million for the fiscal year ended September 30, 2011. The increase was partially offset by a reduction of ULTRASE and VIOKASE products marketing expenses and patient programs.
During the fiscal year ended September 30, 2011, we completed the rationalization of its sales force as part of its cost reduction initiatives. Separation costs associated with sales force reductions are reflected in Transaction, restructuring and integration costs as discussed below. The associated synergies will be realized to a greater extent in future reporting periods.
Management fees
Management fees consist of fees and other charges associated with the Management Services Agreement with TPG. For the fiscal year ended September 30, 2011, management fees decreased $0.8 million (18.2%) to $3.6 million from $4.4 million for the corresponding period of the preceding fiscal year.
Research and development expenses
Research and development expenses refer to internal research and development expense and consist principally of fees paid to outside parties that we use to conduct clinical studies and to submit governmental approval applications on our behalf, as well as the salaries and benefits paid to personnel involved in research and development projects. For the fiscal year ended September 30, 2011, research and development expenses increased $26.3 million (83.0 %) to $58.0 million, from $31.7 million for the corresponding period of the preceding fiscal year. The increase in research and development expenses is mainly due to (i) the inclusion of expenses associated with Eurand activities in the post-acquisition period amounting to $15.7 million for the fiscal year ended September 30, 2011 and (ii) expenses of $15.8 million for the fiscal year ended September 30, 2011 incurred under the Mpex Development Agreement as described in the Aeroquin transaction section above. This increase was partially offset by the reduction in expenses related to the development work on PEPs for the fiscal year ended September 30, 2011.
During the fiscal year ended September 30, 2011, we commenced the rationalization of its internal research and development team as part of its cost reduction initiatives. Separation costs associated with headcount reductions are reflected in transaction, restructuring and integration costs as discussed below. The associated synergies will be realized to a greater extent in future reporting periods. We will also continue to incur ongoing development costs of Aeroquin under the Mpex Development Agreement.
On March 14, 2011, we entered into an agreement with a third-party to jointly develop a new combination product including Sucralfate. Under the terms of this agreement, we will pay a series of contingent and non-contingent milestone based payments. Upon commercialization of the new product, we will pay the third party to the arrangement a single digit royalty on net sales of the new product. Additionally, we will pay the third party a single digit royalty on net sales of Carafate, beginning on January 1, 2013, until December 31, 2019.
Acquired in-process research
Acquired in-process research represents incomplete research and development projects acquired in a business combination or an asset acquisition which, at the time of acquisition are determined to have no future alternative use. The fair value of in-process research acquired in a business combination is capitalized as indefinite-lived intangible asset subject to impairment testing until completion or abandonment of the project. The fair value of in-process research acquired as part of an asset acquisition is expensed on acquisition.
On April 11, 2011, Aptalis Holdings and Axcan Lone Star Inc. (“Merger Sub”), affiliates of ours, entered into a series of agreements with Mpex Pharmaceuticals Inc. (“Mpex”) for the acquisition and development of Aeroquin™ (the “Aeroquin Transaction”), a proprietary aerosol formulation of levofloxacin, which is currently in Phase 3 clinical trials for the treatment of pulmonary infections in patients with cystic fibrosis (CF). Subsequently on August 31, 2011, under the terms of these agreements, Aptalis Holdings and Merger Sub acquired all of Mpex’s assets related to Aeroquin™ in a merger of Mpex with and into Merger Sub, with Mpex being the surviving corporation and a direct, wholly-owned subsidiary of us. Prior to the merger, Mpex transferred all of its assets that are not related to Aeroquin™ to Rempex Pharmaceuticals, Inc. (“Rempex”), a newly formed company that is owned primarily by the previous Mpex stockholders. As a result of the Aeroquin Transaction, we made an initial non-contingent payment of $12.0 million on April 21, 2011.
The further development of Aeroquin™ is being conducted pursuant to the terms of the Development Agreement dated April 11, 2011 among Aptalis Holdings, Merger Sub, and Mpex. Pursuant to the Development Agreement, on April 12, 2011 Mpex was paid $8.7 million for development expenses incurred by Mpex since November 15, 2010 and $9.9 million for estimated development costs to be incurred during the first three months of the Development Agreement.
During the year ended September 30, 2011, we expensed $15.8 million as research and development, $65.5 million as acquired in-process research and development reflecting the initial non-contingent payment of $12.0 million, the discounted value of future time-based non-contingent payments payable under the Option and Merger agreements of $44.8 million (with a corresponding liability) and the payment for certain pre-agreement incurred development expenses of $8.7 million. As of September 30, 2011, $7.8 million reflecting forecasted development costs for the next three months is included in prepaid expenses and other current assets. As of September 30, 2011, $45.7 million represents the amount accrued for the non-contingent payments payable under the Option and Merger agreements with $32.5 million included in other long term liabilities and the balance included in accounts payable and accrued liabilities.
During the fiscal year ended September 30, 2010, we entered into an asset purchase and license agreement to acquire rights in and to the intellectual property, assigned contracts, permits and inventories related to a compound to be used in the development of an undisclosed product in the field of gastroenterology. Certain other rights were licensed under the agreement. Pursuant to the agreement, we made an upfront payment of $8.0 million on closing and additional payments of up to $86.0 million based on the achievement of certain development, regulatory and commercialization milestones. In addition, we will pay royalties on the basis of net sales. We completed the asset acquisition in April 2010 and recorded an expense of $8.0 million for the payment of acquired in-process research in the third quarter of fiscal year 2010.
Loss on disposal of product line
On March 28, 2011, we entered into a definitive agreement with Pinnacle Biologics, Inc., which acquired all global assets and rights related to PHOTOFRIN/PHOTOBARR, including inventory, for $4.2 million. In addition to the non-contingent payments, additional payments will be made to us after the achievement of certain milestones events. In addition, we will be paid royalties on annual net sales of PHOTOFRIN/PHOTOBARR.
During the fiscal year ended September 30, 2011, we recorded a loss of $7.4 million as a result of the disposal of the PHOTOFRIN/PHOTOBARR product line. Consideration for additional contingent payments to be made to us shall be recorded as a gain in the period in which they are received.
Depreciation and amortization
Depreciation and amortization consists principally of the amortization of intangible assets with a finite life. Intangible assets include trademarks, trademark licenses and manufacturing rights. For the fiscal year ended September 30, 2011, depreciation and amortization increased $11.8 million (19.3%) to $72.8 million from $61.0 million for the corresponding period of the preceding fiscal year. This increase is mainly due to additional depreciation and amortization of intangible assets recognized on the acquisition of Eurand.
Transaction, restructuring and integration costs
During the fiscal year ended September 30, 2011, we have expensed $11.9 million ($1.1 million was expensed in the fiscal year ended September 30, 2010) of costs relating to legal, financial, valuation and accounting advisory services performed in connection with effecting the transaction with Eurand, which are included in Transaction, restructuring and integration costs in the accompanying Consolidated Statements of Operations.
We have initiated restructuring measures in conjunction with the integration of the operations of Eurand. These measures are intended to capture synergies and generate cost savings across the Company.
Restructuring actions taken thus far include workforce reductions across the Company and other organizational changes. These reductions primarily come from the elimination of redundancies and consolidation of staff in the sales and marketing, manufacturing, research and development, and general and administrative functions, as well as from the planned closure of Eurand’s manufacturing facility in Nogent-Oise, France.
During the fiscal year ended September 30, 2011, we recorded a restructuring expense of $16.0 million related to plan employee termination costs. Employee termination costs are generally recorded when the actions are probable and estimable and include accrued severance benefits and health insurance continuation, many of which may be paid out during periods after termination.
We estimate we will incur additional restructuring costs of between $0.9 million and $1.5 million, primarily consisting of severance costs. The restructuring actions taken thus far are expected to be substantially completed by the end of fiscal 2012.
Through the fiscal year ended September 30, 2011, we have incurred integration costs of $23.0 million representing certain external, incremental costs directly related to integrating the Eurand business and primarily include expenditures for consulting and systems integration.
Impairment of intangible assets and goodwill
The value of goodwill and intangible assets with an indefinite life are subject to an annual impairment test unless events or changes in circumstances indicate that the carrying amounts of these assets may not be recoverable. The intangible assets with a finite life and property, plant and equipment are subject to an impairment test whenever events or changes in circumstances indicate that the carrying amounts of these assets may not be recoverable. As a result of the unapproved PEPs event, we compared the carrying value of the intangible assets with a finite life affected by the unapproved PEPs event to estimated future undiscounted cash flows. The change in circumstances associated with the unapproved PEPs event also caused us to review the carrying value of our long lived intangible assets including goodwill. Based on this review, an impairment charge of $107.2 million was recorded during the fiscal year ended September 30, 2010, reflecting charges of $91.4 million for the goodwill allocated to our U.S. reporting unit and of $15.8 million related to finite life intangible assets.
Financial expenses
Financial expenses consist principally of interest and fees paid in connection with funds borrowed primarily for the Eurand acquisition and for our acquisition by TPG Capital in February 2008. For the fiscal year ended September 30, 2011, financial expenses increased $24.5 million (37.7%) to $89.5 million from $65.0 million for the corresponding period of the preceding fiscal year. For the fiscal year ended September 30, 2011, financial expenses included certain one-time fees related to bridge financing and the renegotiation of our credit agreement. On February 11, 2011, we entered into an amended and restated credit agreement and related security and other agreements in connection with the Eurand Acquisition as described in the Long-term Debt and Credit Facility section below.
Loss on extinguishment of debt
In conjunction with the Eurand Acquisition, the proceeds of the debt and equity financing were used to repay the outstanding term loan amounting to $125.7 million of our then existing senior secured credit facilities. Subsequent to the Eurand Acquisition, we redeemed our existing 9.25% senior secured notes of $228.0 million due 2015 at a price equal to 106.938% of the outstanding principal amount of the notes. The difference between the net carrying value and the repayment price of the outstanding term loan and 9.25% senior secured notes was recognized as a loss on extinguishment of debt. For the fiscal year ended September 30, 2011, loss on extinguishment of debt amounted to $28.3 million and comprised of the write-off of the unamortized deferred financing fees, the original issuance discount and the redemption premium.
Interest income
For the fiscal year ended September 30, 2011, total interest income decreased to $0.4 million from $0.7 million for the corresponding period of the preceding fiscal year.
Other income
In June 2007, we initiated a lawsuit under the U.S. Lanham Act against a number of defendants alleging they falsely advertised their products to be similar or equivalent to ULTRASE® MT. During the fiscal year ended September 30, 2010, an amount of $9.7 million was paid to us pursuant to settlement arrangements entered into with the defendants in these matters.
Income taxes
For the fiscal year ended September 30, 2011, income tax expense amounted to $4.0 million compared to income tax expense of $11.0 million for the preceding fiscal year. The effective tax rate was minus 2.2% for the fiscal year ended September 30, 2011, compared to minus 6.9% for the preceding fiscal year. The effective tax rate for the fiscal year ended September 30, 2011 is affected by a number of elements, the most important being the non-deductibility of certain expenses and the establishment of a valuation allowance of $54.3 million during the fiscal year ended September 30, 2011 mainly against our net deferred tax assets generated in the U.S. and France. If, in future periods, the deferred tax assets are determined by management to be more likely than not to be realized, the tax benefits relating to the reversal of the valuation allowance will be recorded.
The difference between our effective tax rate and the statutory income tax rate is summarized as follows:
Net income
For the fiscal year ended September 30, 2011, net loss increased $17.5 million (10.3%) to $187.9 million from net loss of $170.4 million for the corresponding period of the preceding fiscal year. For the fiscal year ended September 30, 2011, the net loss is mainly due to the acquired-in process research charge amounting to $65.5 million and the development expenses amounting to $15.8 million related to the Aeroquin Transaction combined with the transaction, integration and restructuring costs amounting to $50.9 million and the loss on extinguishment of debt amounting to $28.3 million. For the fiscal year ended September 30, 2010, the net loss is mainly due to the additional charges related to the unapproved PEPs event amounting to $196.7 million.
Balance sheets as of September 30, 2011, and September 30, 2010
The following table summarizes balance sheet information as of September 30, 2011, compared to September 30, 2010.
Working capital decreased by $20.7 million (17.9%) to $94.7 million as of September 30, 2011, from $115.4 million as of September 30, 2010.
Total assets increased $544.7million (76.1%) to $1,257.9 million as of September 30, 2011, from $713.2 million as of September 30, 2010. This increase was mainly due to the total assets acquired with the Eurand Acquisition amounting to $606.7 million.
Long-term debt increased $387.1 million (66.6%) to $968.4 million as of September 30, 2011, from $581.3 million as at September 30, 2010. On February 11, 2011, we entered into an amended and restated credit agreement and related security and other agreements in connection with the Eurand Acquisition as described in the Long-term debt and Credit Facility section below.
Fiscal year ended September 30, 2010, compared to fiscal year ended September 30, 2009
Overview of results of operations
a) Exclusive of depreciation and amortization
b) 2010 includes charges related to the unapproved PEPs event
Net product sales
For the fiscal year ended September 30, 2010, net product sales were $354.6 million compared to $409.8 million for the preceding fiscal year, a decrease of 13.5%.
This decrease was primarily derived from lower sales in the U.S., which amounted to $259.0 million for the fiscal year ended September 30, 2010, compared to $319.6 million for the preceding fiscal year, a decrease of 19.0%. The decrease in sales in the U.S. is mainly due to the effects of the unapproved PEPs event and the continued decrease in sales of certain of our URSO branded products. This decrease in URSO sales resulted from the entry on the U.S. market of generic versions of URSO 250 and URSO FORTE following their approval by the Office of Generic Drugs on May 13, 2009, combined with increases in sales deductions discussed hereafter in the gross-to-net product sales analysis.
Net product sales in the European Union increased 7.7%, to $63.2 million for the fiscal year ended September 30, 2010, from $58.7 million for the preceding fiscal year. The increase in sales resulted primarily from higher sales volume of DELURSAN and the introduction of a new product, FLEET PHOSPHO-SODA in our distribution channel.
Net product sales in Canada increased 4.9%, to $32.4 million for the fiscal year ended September 30, 2010, from $30.9 million for the preceding fiscal year. The increase in sales resulted primarily from the positive impact of currency fluctuations compared to the preceding fiscal year, as the value of the Canadian dollar improved against the U.S. dollar by 10.9%. This increase was partially offset by the decrease in sales of certain products.
Net product sales are stated net of deductions for product returns, chargebacks, contract rebates, DSA fees, discounts and other allowances. The following table summarizes our gross-to-net product sales adjustments for each significant category:
Product returns, contract rebates, DSA fees, discounts and other allowances totalled $120.0 million (25.3% of gross product sales) for the fiscal year ended September 30, 2010, compared to $93.3 million (18.5% of gross product sales) for the preceding fiscal year. The increase in total deductions as a percentage of gross product sales was mainly due to the additional provision of $23.4 million for the fiscal year ended September 30, 2010, related to the unapproved PEPs event and to an increase of 1.2% in chargebacks. The increase in chargebacks is primarily due to Medicaid and the Affordable Care Act.
In May 2009, we entered into an agreement with the Department of Defense, or DOD, to remain eligible for inclusion on the DOD’s formulary and pursuant to which we agreed to pay rebates under the TRICARE retail pharmacy program. We began accounting for these rebates in the third quarter of fiscal year 2009. Under its contracting process, the DOD is further seeking rebates from pharmaceutical manufacturers on all prescriptions of covered prescription drugs filled under TRICARE from January 28, 2008, forward, unless DOD agrees to a waiver or compromise of amounts due. On November 30, 2009, in litigations initiated by third parties seeking to have the DOD’s ability to seek retroactive rebates invalidated, the Court affirmed DOD’s position that it is entitled to retroactive refunds on prescriptions filled on or after January 28, 2008. In October 2010, the DOD affirmed its former rulemaking which was the subject of litigation and its intention to seek to collect rebates for periods prior to the contract date. We have estimated that our exposure to the retroactive rebates claimed by the DOD would not be material and have recorded an accrual in fiscal year 2010.
Deductions also increased due to increases in DSA fees resulting from new DSA agreements signed with two additional U.S. wholesalers during the previous year.
Affordable Care Act
The Patient Protection and Affordable Care Act of 2010 and the Health Care and Education Reconciliation Act of 2010, known together as the Affordable Care Act, enacted in the U.S in March 2010 contain several provisions that could impact our business. A summary of the Affordable Care Act and recent developments is provided above.
The impact in terms of additional reserves recorded in contract rebates has been $1.8 million for the fiscal year ended September 30, 2010. However, we continue to assess the full extent of this legislation’s longer-term impact on our business. While certain aspects of the new legislation implemented in 2010 are expected to reduce our revenues in future years, other provisions of this legislation may offset, at some level, any reduction in revenues when these provisions become effective. In future years, based on our understanding, these other provisions are expected to result in higher revenues due to an increase in the total number of patients covered by health insurance and an expectation that existing insurance coverage will provide more comprehensive consumer protections. This would include a federal subsidy for a portion of a beneficiary’s out-of-pocket cost under Medicare Part D. However, these higher revenues will be negatively impacted by the branded prescription drug manufacturers’ fee.
Performance of our main product lines
Variations in sales performance in fiscal year 2010 versus the preceding fiscal year were the result of a combination of changes in sales volume as well as price increases.
Key sales figures for our main product lines for the fiscal year 2010 are as follows:
•
Sales of pancreatic enzyme products (ULTRASE, PANZYTRAT and VIOKASE) decreased $44.5 million (39.5%) to $68.3 million from $112.8 million for the preceding fiscal year mainly due to decreases in sales volume as a result of the unapproved PEPs event.
•
Sales of ursodiol products (URSO, URSO 250, URSO FORTE, URSO DS and DELURSAN) decreased $29.3 million (39.6%) to $44.6 million from $73.9 million for the preceding fiscal year. This decrease resulted mainly in sales volume from the entry of generic versions of URSO 250 and URSO FORTE on the U.S. market, approved by the Office of Generic Drugs on May 13, 2009.
•
Sales of mesalamine products (CANASA and SALOFALK) decreased $3.0 million (2.9%) to $100.7 million from $103.7 million for the preceding fiscal year.
•
Sales of sucralfate products (CARAFATE and SULCRATE) increased $18.0 million (26.3%) to $86.5 million from $68.5 million for the preceding fiscal year. The increase mainly resulted from price increases announced during the preceding fiscal year and, to a lesser extent, from an increase in prescription volumes.
•
Sales of other products increased $3.6 million (7.1%) to $54.5 million from $50.9 million for the preceding fiscal year.
Other revenue
In April 2009, we entered into a license agreement with a leading multi-national company (the “Licensee”) whereby we granted the Licensee the right to use the active ingredient contained in one of our commercialized products, LACTEOL, to develop and commercialize new food products that will contain this active ingredient. Under the terms of the agreement, the Licensee will have exclusive rights to commercialize these new products. We will continue to own all other rights related to the active ingredient, including the right to use the active ingredient and develop, manufacture and commercialize non-food products containing the active ingredient, including pharmaceutical products. For the fiscal year ended September 30, 2009, we recorded as revenue milestones that we are entitled to receive under the agreements in the amount of $7.1 million.
Cost of goods sold
Cost of goods sold consists principally of the costs of raw materials, royalties and manufacturing. We outsource most of our manufacturing requirements. For the fiscal year ended September 30, 2010, cost of goods sold increased $27.9 million (27.1%) to $130.9 million from $103.0 million for the preceding fiscal year. As a percentage of net product sales, cost of goods sold for the fiscal year ended September 30, 2010, increased compared to the preceding fiscal year from 25.1% to 36.9%. The increase in cost of goods sold is mostly due to adjustments to reduce certain inventory to net realizable value and purchase commitments reserves related to the unapproved PEPs event that amounted to $44.9 million (12.7% of net product sales) for the fiscal year ended September 30, 2010. Excluding the impact related to the unapproved PEPs event, cost of goods sold as a percentage of net product sales would have been 22.8% for the fiscal year ended September 30, 2010.
Selling and administrative expenses
Selling and administrative expenses, on an ongoing basis, consist principally of salaries and other costs associated with our sales force and marketing activities. For the fiscal year ended September 30, 2010, selling and administrative expenses decreased $7.9 million (6.4%) to $115.0 million from $122.9 million for the preceding fiscal year. This decrease in selling and administrative expenses is mainly due to a reduction of PEPs marketing expenses combined with the adjustment of $6.5 million for stock-based compensation further to changes in assumptions affecting our valuation of these expenses primarily due to the impact of the unapproved PEPs event on our business amounting to $4.9 million. This decrease was partially offset by an increase in non-recurring professional fees.
Management fees
Management fees consist of fees and other charges associated with the Management Services Agreement with TPG. For the fiscal year ended September 30, 2010, management fees decreased $1.0 million (18.5%) to $4.4 million from $5.4 million for the preceding fiscal year. The variance was due to the fact that historically, these fees were previously not allocated to the subsidiaries of Aptalis Holdings, the indirect parent company of Aptalis Pharma Inc. In the fiscal year ended September 30, 2009, they were allocated to the subsidiaries based on revenue.
Research and development expenses
Research and development expenses consist principally of fees paid to outside parties that we use to conduct clinical studies and to submit governmental approval applications on our behalf, as well as the salaries and benefits paid to personnel involved in research and development projects. For the fiscal year ended September 30, 2010, research and development expenses decreased $4.3 million (11.9%) to $31.7 million, from $36.0 million for the preceding fiscal year. The research and development expenses include a reduction in expenses related to the development work on PEPs and European clinical trial costs for PYLERA as compared to the previous fiscal year. This decrease was offset by the effect of foreign currencies on some of our expenses denominated in Canadian dollars and in Euros.
Acquired in-process research
During the fiscal year ended September 30, 2010, we entered into an asset purchase and license agreement to acquire rights in and to the intellectual property, assigned contracts, permits and inventories related to a compound to be used in the development of an undisclosed product in the field of gastroenterology. Certain other rights were licensed under the agreement. Pursuant to the agreement, we made an upfront payment of $8.0 million on closing and will make additional payments of up to $86.0 million may be required based on the achievement of certain development, regulatory and commercialization milestones. In addition, we will pay royalties on the basis of net sales. We completed the asset acquisition in April 2010 and recorded an expense of $8.0 million for the payment of acquired in-process research in the third quarter of fiscal year 2010.
Depreciation and amortization
Depreciation and amortization consists principally of the amortization of intangible assets with a finite life. Intangible assets include trademarks, trademark licenses and manufacturing rights. For the fiscal year ended September 30, 2010, depreciation and amortization increased $0.7 million (1.2%) to $61.0 million from $60.3 million for the preceding fiscal year.
Impairment of intangible assets and goodwill
The value of goodwill and intangible assets with an indefinite life are subject to an annual impairment test unless events or changes in circumstances indicate that the carrying amounts of these assets may not be recoverable. The intangible assets with a finite life and property, plant and equipment are subject to an impairment test whenever events or changes in circumstances indicate that the carrying amounts of these assets may not be recoverable. As a result of the unapproved PEPs event, we compared the carrying value of the intangible assets with a finite life affected by the unapproved PEPs event to estimated future undiscounted cash flows. The change in circumstances associated with the unapproved PEPs event also caused us to review the carrying value of our long lived intangible assets including goodwill. Based on this review, an impairment charge of $107.2 million was recorded during the fiscal year ended September 30, 2010, reflecting charges of $91.4 million for the goodwill allocated to our U.S. reporting unit and of $15.8 million related to finite life intangible assets.
As a result of certain factors related to the ongoing marketing of certain of our products including the approval of a generic formulation of URSO 250 and URSO FORTE, during the fiscal year ended September 30, 2009, we reviewed the carrying amount of our intangible assets specifically related to these products. Based on a discounted cash-flow analysis and market prices, we concluded that a $55.7 million reduction to the carrying value of the related intangible assets totalling $83.7 million prior to the write-down was required in that year.
Financial expenses
Financial expenses consist principally of interest and fees paid in connection with funds borrowed for acquisitions. For the fiscal year ended September 30, 2010, financial expenses decreased $4.8 million (6.9%) to $65.0 million from $69.8 million for the preceding fiscal year. The decrease in financial expenses is mainly due to the reduction of interest on long-term debt of $3.2 million as a result of the decrease in interest rates combined with lower capital outstanding and the change in the fair value of derivatives of $1.2 million. We also had two interest rate swaps with a combined notional amount of $63.0 million that were designated as cash-flow hedges of interest rate risk. These swaps matured during the three-month period ended March 31, 2010, and were not renewed.
Interest income
For the fiscal year ended September 30, 2010, total interest income increased $0.3 million (75.0%) to $0.7 million from $0.4 million for the preceding fiscal year. This increase is mainly due to the increase in our cash and cash equivalent investments.
Other income
We initiated claims in damages under the U.S. Lanham Act against a number of defendants alleging they falsely advertised their products to be similar or equivalent to ULTRASE. During the fiscal year ended September 30, 2009, a settlement arrangement with respect to these claims was entered into with certain of these defendants and in the second quarter of fiscal 2010, another settlement agreement was entered into with the remaining defendants. Pursuant to each of the agreements, the settling defendants agreed to pay a
confidential global amount in one or several installments; all of which have now been paid. Additionally, in the fourth quarter of fiscal year 2010, pursuant to the settlement of another matter in which we were a defendant, we received compensation for legal fees incurred by reason of having to defend against unfounded claims made by the plaintiff. A total amount of $9.7 million was paid to us during the fiscal year ended September 30, 2010, ($3.5 million during the fiscal year ended September 30, 2009) in respect of these settlement agreements. These amounts were recorded as Other income in the Consolidated Statements of Operations.
Income taxes
For the fiscal year ended September 30, 2010, income tax expense amounted to $11.0 million compared to an income tax benefit of $24.1 million for the preceding fiscal year. The effective tax rate was minus 6.9% for the fiscal year ended September 30, 2010, compared to 75.3% for the preceding fiscal year. The effective tax rate for the fiscal year ended September 30, 2010, is affected by a number of elements, the most important being the non-deductible provisions related to the unapproved PEPs event and the valuation allowance taken against deferred tax assets attributable to the U.S. reporting unit. During the fiscal year ended September 30, 2010, we recorded a valuation allowance of $57.5 million against our net deferred tax assets mostly attributable to the U.S. reporting unit. If, in future periods, the deferred tax assets are determined by management to be more likely than not to be realized, the recognized tax benefits relating to the reversal of the valuation allowance will be recorded.
The difference between our effective tax rate and the statutory income tax rate is summarized as follows:
Net loss
For the fiscal year ended September 30, 2010, net loss increased $162.5 million to $170.4 million from $7.9 million for the preceding fiscal year. The increase in net loss for is mainly due to the impacts of the unapproved PEPs event amounting to $196.7 million for the fiscal year ended September 30, 2010. This increase in net loss was partially offset by the partial write-down of intangible assets related to our URSO products amounting to $55.7 million which was recorded during the fiscal year ended September 30, 2009.
Balance sheets as of September 30, 2010, and September 30, 2009
The following table summarizes balance sheet information as of September 30, 2010, compared to September 30, 2009.
Working capital decreased by $14.3 million (11.0%) to $115.4 million as of September 30, 2010, from $129.7 million as of September 30, 2009. This decrease was mainly due to net working capital adjustments of $59.6 million related to the unapproved PEPs event. This decrease was partially offset by an increase in cash and cash equivalents of $35.1 million from operating activities and the reduction in installments on long-term debt. Pursuant to our credit agreement we are required to annually prepay amounts equal to a portion of our annual excess cash flow, as defined under our credit agreement. For fiscal year 2010, we will be required to offer to prepay $13.2 million of outstanding term loans in the first quarter of fiscal year 2011 ($17.6 million for the fiscal year ended September 30, 2009, was paid in the first quarter of fiscal year 2010). As allowed by the credit agreement, the prepayment is applied to the remaining scheduled installments of principal in direct order of maturity and the current portion of long-term debt was reduced accordingly.
Total assets decreased $201.4 million (22.0%) to $713.2 million as of September 30, 2010, from $914.6 million as of September 30, 2009. This decrease was mainly due to the adjustments related to the unapproved PEPs event amounting to $165.9 million. Long-term debt decreased $1.3 million (0.2%) to $581.3 million as of September 30, 2010, from $582.6 million as of September 30, 2009.
Selected quarterly financial data
The following tables present selected quarterly financial data for the fiscal years ended September 30, 2011, and 2010 and should be read in conjunction with our historical audited consolidated financial statements and related notes contained elsewhere in this Annual Report. Our operating results for any quarter are not necessarily indicative of results for any future quarter or for a full fiscal year.
a) Exclusive of depreciation and amortization
b) Including one time charges related to the unapproved PEPs event
c) A reconciliation of net income to EBITDA (a-non U.S. GAAP measure) and from EBITDA to Adjusted EBITDA (a-non U.S. GAAP measure) for each of the quarters ended in 2011 and 2010 is as follows:
a) Represents transaction, integration, restructuring and refinancing costs as well as due diligence costs related to the Eurand Acquisition as well as to certain other business development projects, non-recurring transactions, payments to third parties in respect of research and development milestones and other progress payments as defined within our credit agreement.
b) Represents management fees and other charges associated with the Management Services Agreement with TPG.
c) Represents stock-based employee compensation expense under the provisions of FASB guidance, excluding the impact of the unapproved PEPs event.
d) Intangible assets and goodwill write-downs related to the unapproved PEPs event.
e) Other Adjustments and other write-downs related to the unapproved PEPs event, including a reduction of $3.1 million to the sales returns reserve during the fiscal year ended September 30, 2011 (additional returns provision of $23.4 million, inventory write- down and accrual for purchases and other materials and supply commitments of $44.9 million and a stock-based compensation recovery of $4.9 million during the fiscal year ended September 30, 2010).
f) Loss resulting from the disposal of the PHOTOFRIN/PHOTOBARR product line.
g) As part of the purchase price allocation for Eurand Acquisition, the book value of inventory acquired was stepped-up to fair value by $18.7 million as at Acquisition Date. The stepped-up value has been recorded as charge to cost of goods sold as acquired inventory was sold, until acquired inventory was sold off.
h) Represents the initial non-contingent payment of $12.0 million, the discounted value of future time-based non-contingent payments payable under the Option agreement of $44.8 million and the payment towards certain pre-agreement incurred development expenses of $8.7 million related to the Aeroquin Transaction during the fiscal year ended September 30, 2011 as described in Acquired-in-Process Research section above.
i) EBITDA and Adjusted EBITDA are both non-U.S. GAAP financial measures and are presented in this report because our management considers them important supplemental measures of our performance and believes that they are frequently used by interested parties in the evaluation of companies in the industry. EBITDA, as we use it, is net income before financial expenses, interest income, income taxes and depreciation and amortization. We believe that the presentation of EBITDA enhances an investor’s understanding of our financial performance. We believe that EBITDA is a useful financial metric to assess our operating performance from period to period by excluding certain items that we believe are not representative of our core business. The term EBITDA is not defined under U.S. GAAP, and EBITDA is not a measure of net income, operating income or any other performance measure derived in accordance with U.S. GAAP, and is subject to important limitations. Adjusted EBITDA, as we use it, is EBITDA adjusted to exclude certain non-cash charges, unusual or non-recurring items and other adjustments set forth above. Adjusted EBITDA is calculated in the same manner as “EBITDA” and “Consolidated EBITDA” as those terms are defined under the indenture governing our senior notes and Credit Facility further described in the section “Liquidity and Capital Resources-Long-term Debt and New Senior Secured Credit Facility”, except that in calculating Adjusted EBITDA, we do not include certain additional adjustments under the indenture and the Credit Facility that permit us to increase “EBITDA” and “Consolidated EBITDA” by including projected cost savings and synergies calculated on a pro forma basis that we expect to realize in future periods related to actions already taken or expected to be taken within twelve months of the end of the applicable period, including the Eurand Acquisition and related initiatives. We believe that the inclusion of supplementary adjustments applied to EBITDA in presenting Adjusted EBITDA are appropriate to provide additional information to investors about certain material non-cash items and unusual or non-recurring items that we do not expect to continue in the future and to provide additional information with respect to our ability to meet our future debt service and to comply with various covenants in our indenture and Credit Facility. Adjusted EBITDA is not a measure of net income, operating income or any other performance measure derived in accordance with U.S. GAAP, and is subject to important limitations. EBITDA and Adjusted EBITDA have limitations as an analytical tool, and they should not be considered in isolation, or as substitutes for analysis of our results as reported under U.S. GAAP. Some of these limitations are:
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EBITDA and Adjusted EBITDA do not reflect all cash expenditures, future requirements for capital expenditures, or contractual commitments;
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EBITDA and Adjusted EBITDA do not reflect changes in, or cash requirements for, working capital needs;
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EBITDA and Adjusted EBITDA do not reflect the significant interest expense, or the cash requirements necessary to service interest or principal payments, on our debt;
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Although depreciation and amortization are non-cash charges, the assets being depreciated and amortized will often have to be replaced in the future, and EBITDA and Adjusted EBITDA do not reflect any cash requirements for such replacements;
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Adjusted EBITDA reflects additional adjustments as provided in the indenture governing our unsecured notes and new senior secured credit facilities; and
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Other companies in our industry may calculate EBITDA and Adjusted EBITDA differently than we do, limiting its usefulness as a comparative measure.
Because of these limitations, EBITDA and Adjusted EBITDA should not be considered as measures of discretionary cash available to us to invest in our business. Our management compensates for these limitations by relying primarily on the U.S. GAAP results and using EBITDA and Adjusted EBITDA as supplemental information.
Liquidity and Capital Resources
Cash requirements
As of September 30, 2011, working capital was approximately $94.7 million and $115.4 million as of September 30, 2010. Cash generated from operations, is used to fund working capital, capital expenditures, milestone payments, debt service and business development activities. We regularly review product and other acquisition opportunities and may therefore require additional debt or equity financing. We cannot be certain that such additional financing, if required, will be available on acceptable terms, or at all.
The aggregate equity purchase price of $589.6 million plus acquisition costs (including related fees and expenses) for the Eurand Acquisition were funded by cash equity contributions amounting to $140.0 million from affiliates of TPG Capital L.P. and certain co-investors, the proceeds from the Senior Secured Term Loan Facility (as defined below) under our amended and restated credit agreement and related security and other agreements and cash on hand from Axcan and Eurand. The amended and restated credit agreement and related security and other agreements is composed of (i) a senior secured revolving credit facility in an aggregate principal amount of $147.0 million (the “Senior Secured Revolving Credit Facility”) and (ii) a $750.0 million senior secured term loan facility (the “Senior Secured Term Loan Facility” and, together with the Senior Secured Revolving Credit Facility, the “Amended and Restated Senior Secured Credit Facilities”). We borrowed $500.0 million of the amount available under the Senior Secured Term Loan Facility at the closing of the acquisition. The Senior Secured Revolving Credit Facility remained undrawn at the closing of the acquisition.
A portion of the proceeds of the equity and debt financings, together with cash on hand of Aptalis and Eurand, were also used to repay the outstanding term loan portion amounting to $125.7 million of our existing senior secured credit facilities and to pay related fees and expenses. The remaining amount of $250.0 million of the Senior Secured Term Loan Facility was used on March 15, 2011 to redeem 100% of our existing 9.25% senior secured notes due 2015.
There are currently two rating agencies (Moody’s and Standard & Poor’s) rating our debt. These ratings are revised from time to time.
Contractual obligations and other commitments
The following table summarizes our significant contractual obligations as of September 30, 2011, and the effect such obligations are expected to have on our liquidity and cash flows in future years.
Purchase orders for raw materials, finished goods and other goods and services are not included in the above table. Management is not able to accurately determine the aggregate amount of such purchase orders that represent contractual obligations, as purchase orders may represent authorizations to purchase rather than binding agreements. For the purpose of this table, contractual obligations for the purchase of goods or services are only included in other commitments where there exist agreements that are legally binding and enforceable on us and that specify all significant terms, including: fixed or minimum quantities to be purchased; fixed, minimum
or variable price provisions; and the approximate timing of the transaction. Our purchase orders are based on current needs and are fulfilled by our vendors within relatively short timetables. We do not have significant agreements for the purchase of raw materials or finished goods specifying minimum quantities or set prices that exceed our short-term expected requirements. We also enter into contracts for outsourced services; however, the obligations under these contracts are not significant and the contracts generally contain clauses allowing for cancellation without significant penalty. As milestone payments are primarily contingent upon successfully achieving clinical milestones or on receiving regulatory approval for products under development, they do not have defined maturities and therefore are not included in the above table.
The expected timing of payment of the obligations discussed above is estimated based on current information. The timing of payments and actual amounts paid may differ depending on the timing of receipt of goods or services, or, for some obligations, changes to agreed-upon amounts.
As of September 30, 2011, we had unrecognized tax benefits of $14.8 million ($11.5 million as of September 30, 2010). Due to the nature and timing of the ultimate outcome of these uncertain tax positions, we cannot make a reasonably reliable estimate of the amount and period of related future payments. Therefore, our unrecognized tax benefits with respect to our uncertain tax positions has been excluded from the above contractual obligations table.
Long-term debt and Credit Facility
On February 11, 2011, we entered into an amended and restated credit agreement and related security and other agreements in connection with the Eurand Acquisition.
The amended and restated credit agreement and related security and other agreements is composed of (i) a senior secured revolving credit facility in an aggregate principal amount of $147.0 million (the “Senior Secured Revolving Credit Facility”) and (ii) a $750.0 million senior secured term loan facility (the “Senior Secured Term Loan Facility” and, together with the Senior Secured Revolving Credit Facility, the “Amended and Restated Senior Secured Credit Facilities”).
We borrowed $500.0 million of the amount available under the Senior Secured Term Loan Facility at the closing of the acquisition. The Senior Secured Revolving Credit Facility remained undrawn at the closing of the acquisition. A portion of the proceeds of the equity and debt financings, together with cash on hand of Aptalis and Eurand, were used to repay the outstanding term loan portion amounting to $125.7 million of our existing senior secured credit facilities and to pay related fees and expenses. Following the repayment, all unamortized deferred financing fees of $2.7 million and original issuance discount of $3.2 million related to the term loan were written off and are included in Loss on extinguishment of debt in the accompanying Consolidated Statements of Operations. The remaining amount of $250.0 million of the Senior Secured Term Loan Facility was drawn on March 15, 2011 to redeem our existing 9.25% senior secured notes due 2015.
On February 25, 2008, we issued $228.0 million aggregate principal amount of its 9.25% senior secured notes (the “Senior Secured Notes”) due March 1, 2015. The Senior Secured Notes were priced at $0.98737 with a 10% yield to March 1, 2015. On March 15, 2011, $250.0 million of the Senior Secured Term Loan Facility was used to redeem 100% of our Senior Secured Notes at a redemption price of 106.938%. The aggregate redemption amount consisted of $228.0 million in aggregate principal amount, $0.8 million accrued interest and $15.8 million of redemption premium which is included in Loss on extinguishment of debt in the accompanying Consolidated Statements of Operations. Following the redemption all unamortized deferred financing fees of $5.0 million and original issuance discount of $1.7 million related to these notes were written off and are included in Loss on extinguishment of debt in the accompanying Consolidated Statements of Operations.
Our Amended and Restated Senior Secured Credit Facilities totaling $897.0 million is composed of a Senior Secured Term Loan Facility amounting to $750.0 million and a Senior Secured Revolving Credit Facility totaling $147.0 million. The Senior Secured Revolving Credit Facility is comprised of $115.0 million of existing revolving credit commitments that were extended or issued on February 11, 2011 (the “ Extended Commitments”) and $32.0 million of existing revolving credit commitments that were not extended (the “ Unextended Commitments”) pursuant to the Senior Secured Revolving Credit Facility. The Amended and Restated Senior Secured Credit Facilities bear interest at a variable rate composed of either (i) the highest of the federal funds rate plus 0.5%, Bank of America, N.A.’s “prime rate”, or the one month British Banker Association LIBOR rate plus 1.00%, or (ii) the British
Banker Association LIBOR rate (subject to a floor of 1.50% with respect to borrowings under the Senior Secured Term Loan Facility) at our option, plus an applicable rate established by the credit agreement governing the Amended and Restated Senior Secured Credit Facilities (including, with respect to borrowings under the Senior Secured Revolving Credit Facility, step-downs based on our consolidated total leverage ratio). The principal amount of the Senior Secured Term Loan Facility amortizes in equal quarterly installments in aggregate annual amounts equal to 1% of the original principal amount with payments beginning in March 2011. The principal amount outstanding of the loans under the Senior Secured Term Loan Facility will be due and payable on February 11, 2017. The principal amount of outstanding loans under the Senior Secured Revolving Facility will be due and payable on February 11, 2016 with respect to Extended Commitments and on February 25, 2014 with respect to Unextended Commitments.
As of September 30, 2011, $750.0 million of term loans had been issued and no amounts are currently drawn against the Senior Secured Revolving Credit Facility. The term loans were priced at $0.995 with a yield to maturity of 5.6% before the effect of the interest rate swaps. We use interest rate swaps as part of our interest rate risk management strategy to add stability to interest expense and to manage our exposure to interest rate movements. On April 4, 2011, we entered into two separate pay-fixed, receive-floating interest rate swap agreements with an effective date of June 30, 2011 effectively converting a portion of the variable rate debt under our Amended and Restated Senior Secured Credit Facilities to fixed rate debt. The first swap has a notional amount of $331 million amortizing to $84 million by its maturity in December 2015. The second swap has a notional amount of $219 million and matures in December 2016. These swaps were designated as cash flow hedges of interest rate risk. The interest rate swaps will effectively fix our interest payments on the hedged debt at 2.386% for the first swap and 3.18% for the second swap, respectively, inclusive of a LIBOR floor of 1.5%, plus the appropriate margin on each debt interest period, which is currently 4%. As of September 30, 2011, we had two interest rate swaps with a combined notional amount of $550 million that were designated as cash flow hedges of interest rate risk. The weighted average fixed interest rate on these swaps is 2.7%. We have agreements with each of our derivative counterparties that contain a provision where we could be declared in default on our derivative obligations if repayment of the underlying indebtedness is accelerated by the lender due to our default on the indebtedness. If we had breached this provision, we could have been required to settle our obligations under the agreements at their termination value. As of September 30, 2011, the termination value of derivatives in a net liability position including accrued interest and excluding any adjustment for nonperformance risk, related to these agreements was $18.9 million and we have not posted any collateral related to these agreements.
The credit agreement governing the Amended and Restated Senior Secured Credit Facilities requires us to meet certain financial covenants, beginning the third quarter of the fiscal year ending September 30, 2011. The maintenance of these financial covenants is solely with respect to the Senior Secured Revolving Credit Facility. These covenants were met as of September 30, 2011. The credit agreement governing the Amended and Restated Senior Secured Credit Facility requires us to prepay outstanding term loans contingent upon the occurrence of events, subject to certain exceptions, with: (1) 100% of the net cash proceeds of any incurrence of debt other than debt permitted under the credit agreement governing the Amended and Restated Senior Secured Credit Facilities, (2) commencing with the fiscal year ended September 30, 2012, 50% (which percentage will be reduced if the senior secured leverage ratio is less than a specified ratio) of the annual excess cash flow (as defined in the credit agreement governing the Senior Secured Term Loan Facility) and (3) 100% of the net cash proceeds of all non-ordinary course asset sales or other dispositions of property (including casualty events) by us or by our subsidiaries, subject to reinvestments rights and certain other exceptions.
Pursuant to the annual excess cash flow requirements of our credit agreement in effect prior to the Amended and Restated Senior Secured Credit Facilities, we were required to prepay $13.2 million of outstanding term loans in the first quarter of fiscal year 2011.
On May 6, 2008, we issued $235.0 million of 12.75% senior unsecured notes due March 1, 2016, (the “Senior Unsecured Notes”). The Senior Unsecured Notes were priced at $0.9884 with a yield to maturity of 13.16%. The Senior Unsecured Notes are subordinated to the Amended and Restated Senior Secured Credit Facilities.
We may redeem some or all of the Senior Unsecured Notes prior to March 1, 2012, at a redemption price equal to 100% of the principal amount of the Senior Unsecured Notes redeemed plus a “make-whole” premium and accrued and unpaid interest. On or after March 1, 2012, we may redeem some or all of the Senior Unsecured Notes at the redemption prices (expressed as percentages of principal amount of the Senior Unsecured Notes to be redeemed) set forth below:
Certain of our subsidiaries have been designated as guarantors with respect to the Amended and Restated Senior Secured Credit Facilities and the Senior Unsecured Notes. Our obligations under, and each of the guarantors’ obligations under its guarantee of, the Amended and Restated Senior Secured Credit Facilities are secured by a first priority security interest in our assets and of such guarantor subsidiaries, respectively.
Operating leases
We have various long-term operating lease agreements for office space, automotive equipment and other equipment. The latest expiry date for these agreements is in 2017.
Other commitments
Other operating commitments consist primarily of amounts relating to administrative services, clinical studies and other research and development services.
Related party transactions
At September 30, 2011, we had a note receivable from its parent company amounting to $78.2 million ($133.2 million at September 30, 2010). During the year ended September 30, 2011, the parent company made a partial repayment of $55,0 million on the note receivable from the contributions made by Aptalis Holdings of proceeds received from an equity investment made by Investor Growth Capital Limited managed funds. We earned interest income on the note of $6.3 million (net of taxes of $3.4 million) during the year ended September 30, 2011. We earned interest income on the note of $7.8 million (net of taxes of $4.2 million) during the years ended September 30, 2010 and 2009 respectively. The related interest receivable from the parent company amounting to $36.8 million at September 30, 2011, ($27.1 million at September 30, 2010) has been recorded in the shareholder’s equity section of the consolidated balance sheet. This amount was subject to a full provision which was also recorded in the statement of shareholder’s equity. At September 30, 2011, we also have an account receivable from the parent company amounting to $0.7 million ($0.5 million at September 30, 2010).
We recorded charges pursuant to the terms of a management fee arrangement with a controlling shareholding company of $3.6 million during the year ended September 30, 2011 ($4.4 million and $5.4 million for the years ended September 30, 2010 and 2009 respectively). Also, during the year ended September 30, 2011, we recorded fees from a controlling shareholding company amounting to $5.0 million of which $1.5 million was accounted for as deferred debt issue costs, $2.5 million as selling and administrative expense and $1.0 million as financing fees. At September 30, 2011, we accrued fees payable to a controlling shareholding company amounting to $1.4 million ($1.6 million at September 30, 2010).
We paid a dividend to our parent company of $0.4 million during the year ended September 30, 2011 ($0.1 million and $0.5 million for 2010 and 2009 respectively) to allow for the payment of certain group expenses.
Balance sheet arrangements
We do not have any transactions, arrangements and other relationships with unconsolidated entities that are likely to affect our operating results, our liquidity or capital resources. We have no special purpose or limited purpose entities that provide off-balance sheet financing, liquidity or market or credit risk support, and do not engage in leasing, hedging, research and development services, or other relationships that expose us to liability that is not reflected on the face of the consolidated financial statements.
Cash flows
Our cash flows from operating, investing and financing activities For the fiscal year ended September 30, 2011, and September 30, 2010 as reflected in the Consolidated Statements of Cash Flows, are summarized in the following table:
Cash flows provided by operating activities decreased $112.1 million to $49.0 million of cash used in operating activities from $63.1 million of cash provided by operating activities for the fiscal years ended September 30, 2011 and 2010 respectively. The decrease in net cash provided by operating activities is mainly due to the payments to Mpex related to the Aeroquin Transaction combined with the payment of transaction and restructuring costs, and financing fees related to the Eurand Acquisition.
Cash flows used in investing activities increased $523.9 million to $530.0 million from $6.1 million for the fiscal years ended September 30, 2011 and 2010 respectively. The increase in cash flows used in investing activities is mainly due to the Eurand Acquisition.
Cash flows provided by financing activities increased $564.3 million to $543.0 million of cash provided in the fiscal year ended September 30, 2011, from $21.3 of cash used in the fiscal year ended September 30, 2010. On February 11, 2011, we entered into an amended and restated credit agreement and related security and other agreements in connection with the Eurand Acquisition as described in the Long-term debt and Credit Facility section above. Simultaneous with the execution of the Mpex agreements, Aptalis Holdings received the proceeds of a $55.0 million equity investment from funds managed by Investor Growth Capital Limited. Aptalis Holdings contributed the entire proceeds to our parent to make a partial repayment on the $133.2 million note receivable from parent company.
Significant accounting policies
Our consolidated financial statements are prepared in accordance with U.S. GAAP, applied on a consistent basis. Some of our critical accounting policies require the use of judgment in their application or require estimates of inherently uncertain matters. Therefore, a change in the facts and circumstances of an underlying transaction could significantly change the application of our accounting policies to that transaction, which could have an effect on our financial statements. The policies that management believes are critical and require the use of complex judgment in their application are discussed below.
Use of estimates
The preparation of financial statements in accordance with generally accepted accounting principles requires management to make estimates and assumptions that affect the recorded amounts of assets and liabilities and the disclosure of contingent assets and liabilities as at the date of the financial statements and also affect the recognized amounts of revenues and expenses during the fiscal year. Estimates are used when accounting for amounts recorded in connection with acquisitions, including fair value determinations of assets and liabilities. Other significant estimates and assumptions made by management include those related to the charges to be recorded in conjunction with ceasing of distributing ULTRASE MT and VIOKASE, allowances for accounts receivable, inventories,
reserves for product returns, rebates, chargebacks and DSA fees, the classification of intangible assets between finite life and indefinite life, the useful lives of long-lived assets, the expected cash flows used in evaluating long-lived assets, goodwill and investments for impairment, stock based compensation costs, pending legal settlements and the establishment of provisions for income taxes including the realizability of deferred tax assets. The estimates are made using the historical information and various other relevant factors available to management. We review all significant estimates affecting the financial statements on a recurring basis and record the effect of any adjustments when necessary. Actual results could differ from those estimates based upon future events, which could include, among other risks, changes in regulations governing the manner in which we sell our products, changes in the healthcare environment, foreign exchange and managed care consumption patterns.
The charges that we have recorded as a result of having ceased distribution of ULTRASE MT and VIOKASE also reflect many subjective estimates that were required to be made by management. These estimates include:
a) The quantity and expiration dates of ULTRASE MT and VIOKASE inventory in the distribution channel;
b) Assumptions regarding market share growth after an eventual re-launch of our ULTRASE MT and VIOKASE; and
c) Other factors.
In future periods, management will monitor and review the assumptions and estimates and will prospectively record changes to provisions reflected in the current fiscal year.
Revenue recognition
Revenue is recognized when the product is delivered to our customers, provided we have not retained any significant risks of ownership or future obligations with respect to the product delivered. Provisions for sales discounts and estimates for chargebacks, managed care and Medicaid rebates, product returns and DSA fees are established as a reduction of product sales revenues at the time such revenues are recognized. These revenue reductions are established by us at the time of sale, based on historical experience adjusted to reflect known changes in the factors that impact such reserves. In certain circumstances, product returns are allowed under our policy and provisions are maintained accordingly. These revenue reductions are generally reflected as an addition to accrued liabilities. Amounts received from customers as prepayments for products to be delivered in the future are reported as deferred revenue.
The following table summarizes the activity in the accounts related to revenue reductions:
Product returns
We do not provide any form of price protection to our wholesale customers and we generally permit product returns only if the product is returned in the six months prior to and twelve months following its expiration date. Under our policy, credit for returns is issued to the original purchaser at current wholesale acquisition cost less 10%.
We estimate the proportion of recorded revenue that will result in a return by considering relevant factors, including:
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past product returns activity;
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the duration of time taken for products to be returned;
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the estimated level of inventory in the distribution channel;
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product recalls and discontinuances;
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the shelf life of products;
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the launch of new drugs or new formulations; and
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the loss of patent protection or new competition.
Our estimate of the level of inventory in the distribution channel is based on inventory data provided by wholesalers, third-party prescription data and, for some product return provisions, estimated retail pharmacy information.
Returns for new products are more difficult to estimate than for established products. For shipments made to support the commercial launch of a new product under standard terms, our estimate of sales return accruals are primarily based on the historical sales returns experience of similar products. Once sufficient historical data on actual returns of the product are available, the returns provision is based on this data and any other relevant factors as noted above.
The accrual estimation process for product returns involves in each case a number of interrelating assumptions, which vary for each combination of product and customer. Accordingly, it would not be meaningful to quantify the sensitivity to change for any individual assumption or uncertainty. However, we do not believe that the effect of uncertainties, as a whole, significantly impacts our financial condition or results of operations.
The accrued liabilities include reserves of $20.6 million as of September 30, 2011, ($13.4 million as of September 30, 2010) for estimated product returns, excluding the additional provision related to the unapproved PEPs event. The increase is due to the integration of legacy Eurand products ($17.9 million).
As of September 30, 2011, the product returns reserve related to the unapproved PEPs event amounted to $3.1 million which represents primarily management’s current estimate of the balance of ULTRASE MT and VIOKASE inventory in the distribution channel. Due to the subjectivity of this estimate, we prepared various sensitivity analyses to ensure our final estimate is within a reasonable range. A change in assumptions that resulted in a 10% change in the quantity of ULTRASE MT and VIOKASE inventory in the distribution channel would have resulted in a change in the return reserve of approximately $0.3 million.
Rebates, chargebacks and other sales deduction
In the U.S., we establish and maintain reserves for amounts payable to managed care organizations, state Medicaid and other government programs for the reimbursement of portions of the retail price of prescriptions filled that are covered by these programs.
We also establish and maintain reserves for amounts payable to wholesale distributors for the difference between their regular sale price and the contract price for the products sold to our contract customers.
The amounts are recognized as revenue reductions at the time of sale based on our best estimate of the product’s utilization by these managed care and state Medicaid patients and sales to our contract customers, using historical experience, the timing of payments, the level of reimbursement claims, changes in prices (both normal selling prices and statutory or negotiated prices), changes in prescription demand patterns, and the levels of inventory in the distribution channel.
Amounts payable to managed care organizations and state Medicaid programs are based on statutory or negotiated discounts to the selling price. Medicaid rebates generally increase as a percentage of the selling price over the life of the product. As it can take up to six months for information to reach us on actual usage of our products in managed care and Medicaid programs and on the total discounts to be reimbursed, we maintain reserves for amounts payable under these programs relating to sold products. We estimate the level of inventory in the distribution channels based on inventory data provided by wholesalers and third-party prescription data.
Revisions or clarification of guidelines related to state Medicaid and other government program reimbursement practices which are meant to apply to prior periods, or retrospectively, can result in changes to management’s estimates of the rebates reported in prior periods. However, since the prices of our products are fixed at the time of sale and the quantum of rebates is therefore reasonably determinable at the outset of each transaction; these factors would not impact the recording of revenues in accordance with generally accepted accounting principles.
The accrual estimation process for managed care organizations, state Medicaid and other government programs rebates involves in each case a number of interrelating assumptions, which vary for each combination of products and programs. Accordingly, it would not be meaningful to quantify the sensitivity to change for any individual assumption or uncertainty. However, we do not believe that the effect of uncertainties, as a whole, significantly impacts our financial condition or results of operations.
Accrued liabilities include reserves of $26.4 million and $14.0 million as of September 30, 2011, ($6.1 million and $8.1 million as of September 30, 2010) for estimated contract rebates and chargebacks. The increase is mainly due to the integration of legacy Eurand products ($17.9 million) and additional reserves related to the Affordable Care Act ($4.5 million).
If the levels of chargebacks, fees pursuant to DSAs, managed care, Medicaid and other government rebates, product returns and discounts fluctuate significantly and/or if our estimates do not adequately reserve for these reductions of net product revenues, our reported revenue could be negatively affected.
Intangible assets and goodwill
Intangible assets with a finite life are amortized over their estimated useful lives according to the straight-line method over periods varying from 5 to 20 years. The straight-line method of amortization is used because it reflects, in the opinion of management, the pattern in which the intangible assets with a finite life are used. In determining the useful life of intangible assets, we consider many factors including the intention of management to support the asset on a long-term basis by maintaining the level of expenditure necessary to support the asset, the use of the asset, the existence and expiration date of a patent, the existence of a generic version of, or competitor to, the product and any legal or regulatory provisions that could limit the use of the asset.
The following table summarizes the changes to the carrying value of the intangible assets and goodwill from September 30, 2010, to September 30, 2011:
Research and development expenses
Research and development expenses are charged to operations in the period they are incurred. The costs of intangibles that are purchased from others for a particular research and development project that have no alternative future use are expensed at the time of acquisition.
Income taxes
Income taxes are calculated using the asset and liability method. Under this method, deferred income tax assets and liabilities are recognized to account for the estimated taxes that will result from the recovery or settlement of assets and liabilities recorded at their financial statement carrying amounts. Deferred income tax assets and liabilities are measured based on enacted tax rates and laws at the date of the financial statements for the fiscal years in which the temporary differences are expected to reverse. A valuation allowance is provided for the portion of deferred tax assets that is more likely than not to remain unrealized. Adjustments to the deferred income tax asset and liability balances are recognized in net income as they occur.
We conduct business in various countries throughout the world and are subject to tax in numerous jurisdictions. As a result of our business activities, we file a significant number of tax returns that are subject to examination by various federal, state, and local tax authorities. Tax examinations are often complex as tax authorities may disagree with the treatment of items reported by us and this may require several years to resolve.
Changes in accounting standards
See Note 3 to our Consolidated Financial Statements in Item 8
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
TO THE BOARD OF DIRECTORS AND SHAREHOLDER OF APTALIS PHARMA INC.
We have audited the accompanying consolidated balance sheets of Aptalis Pharma Inc. (formerly known as Axcan Intermediate Holdings Inc.) and subsidiaries as of September 30, 2011, and 2010 and the consolidated statements of operations, shareholder’s equity (deficiency) and comprehensive income (loss) and cash flows for the three years ended September 30, 2011, 2010, and 2009. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform an audit of its internal control over financial reporting. An audit includes consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Aptalis Pharma Inc. and subsidiaries as of September 30, 2011, and 2010 and the results of their operations and their cash flows for the three years ended September 30, 2011, 2010, and 2009, in conformity with accounting principles generally accepted in the United States of America.
/s/ Raymond Chabot Grant Thornton LLP1
Chartered Accountants
Montreal, Quebec, Canada
November 30, 2011
Chartered Accountant Auditor permit No. 10019
APTALIS PHARMA INC.
Consolidated Balance Sheets
The accompanying notes are an integral part of the consolidated financial statements.
APTALIS PHARMA INC.
Consolidated Statements of Operations
(a) Excluding depreciation and amortization
The accompanying notes are an integral part of the consolidated financial statements.
APTALIS PHARMA INC.
Consolidated Shareholder’s Equity (Deficiency) and Comprehensive Income (Loss)
The accompanying notes are an integral part of the consolidated financial statements.
APTALIS PHARMA INC.
Consolidated Shareholder’s Equity (Deficiency) and Comprehensive Income (Loss)
The accompanying notes are an integral part of the consolidated financial statements.
APTALIS PHARMA INC.
Consolidated Cash Flows
The accompanying notes are an integral part of the consolidated financial statements and Note 16 provides other information on cash flows.
APTALIS PHARMA INC.
1. Governing Statutes, Description of Business and Basis of Presentation
On May 4, 2011, Axcan Intermediate Holdings Inc. announced that it has changed its name to Aptalis Pharma Inc. The entity is a corporation incorporated on November 28, 2007, under the General Corporation Law of the State of Delaware. The corporation and its subsidiaries (together the “Company”), commenced active operations with the purchase, through a wholly-owned indirect subsidiary on February 25, 2008, of all of the outstanding common shares of Axcan Pharma Inc., a company incorporated under the Canada Business Corporation Act. The Company provides innovative, effective therapies for unmet medical needs including cystic fibrosis and gastrointestinal disorders. The Company has manufacturing and commercial operations in the United States, the European Union and Canada. The Company also formulates and clinically develops enhanced pharmaceutical and biopharmaceutical products for itself and others using its proprietary technology platforms including bioavailability enhancement of poorly soluble drugs, custom release profiles, and taste-masking/orally disintegration tablet (ODT) formulations.
On February 11, 2011, the Company completed the acquisition of Eurand N.V. (“Eurand”) through a wholly owned indirect subsidiary pursuant to a Share Purchase Agreement dated November 30, 2010 (as amended) resulting in Eurand becoming an indirect subsidiary of the Company. Eurand was a specialty pharmaceutical company that was engaged in the development, manufacturing and commercialization of enhanced pharmaceutical and biopharmaceutical products based on its proprietary pharmaceutical technologies.
As described in Note 4, the Eurand transaction has been accounted for in accordance with the acquisition method of accounting for business combinations. Accordingly, the Company’s consolidated financial statements reflect the assets, liabilities and results of operations of Eurand from the date of acquisition.
These consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) and are presented in U.S. dollars, the reporting currency. The financial statements reflect all adjustments (including those that are normal and recurring) that are necessary for a fair presentation of the results of operations for the periods shown. Certain prior period amounts have been reclassified to conform to the current period presentation.
2. Significant Accounting Policies
Use of estimates
The preparation of financial statements in accordance with generally accepted accounting principle requires management to make estimates and assumptions that affect the recorded amounts of assets and liabilities and the disclosure of contingent assets and liabilities as at the date of the financial statements, and also affect the recognized amounts of revenues and expenses during the year. Significant estimates and assumptions made by management include those related to the allocation of the purchase price of acquired assets and businesses, the changes to be recorded in conjunction with ceasing of distributing pancreatic enzyme products, allowances for accounts receivable, inventories, reserves for product returns, rebates, chargebacks and distribution service agreement fees, the classification of intangible assets between finite life and indefinite life, the useful lives of long-lived assets, the expected cash flows used in evaluating long-lived assets, goodwill and investments for impairment, reporting unit fair values in testing goodwill for impairment, stock-based compensation costs, pending legal settlements, the establishment of provisions for income taxes including the realizability of deferred tax assets and restructuring costs. The estimates are made using the historical information and various other relevant factors available to management. The Company reviews all significant estimates affecting the financial statements on a recurring basis and records the effect of any adjustments when necessary. Actual results could differ from those estimates based upon future events, which could include, among other risks, changes in regulations governing the manner in which the Company sells its products, changes in the health care environment and regulations, foreign exchange and managed care consumption patterns.
Principles of consolidation
These financial statements include the accounts of Aptalis Pharma Inc. and its wholly-owned subsidiaries, the most significant being Aptalis Pharma Canada Inc., Aptalis Pharma U.S. Inc., Aptalis Pharmatech Inc., Aptalis Pharma Srl, Aptalis Pharma Ltd. and Aptalis Pharma S.A. Intercompany balances and transactions have been eliminated on consolidation.
Business and asset acquisitions
The consolidated financial statements include the operations of an acquired business after the completion of the acquisition. Acquired businesses are accounted for using the acquisition method of accounting, which requires that assets acquired and liabilities assumed be recorded at the date of acquisition at their fair values. Any excess of the purchase price over the fair value of the net assets acquired is recorded as goodwill. If the acquired net assets do not constitute a business, the transaction is accounted for as an asset acquisition and no goodwill is recognized.
Revenue recognition
Revenue from product sales is recognized when title and substantially all the risks and rewards of ownership have transferred to the customer, generally when the product has been delivered to the customer. Provisions for sales discounts and estimates for chargebacks, managed care and Medicaid rebates, product returns and distribution service agreement fees are recorded as a reduction of product sales revenues at the time such revenues are recognized. These revenue reductions are established by the Company at the time of sale, based on historical experience adjusted to reflect known changes in the factors that impact such reserves. In certain circumstances, returns of products are allowed under the Company’s policy and provisions are maintained accordingly. These revenue reductions are generally reflected as an addition to accrued liabilities. Amounts received from customers as prepayments for products to be shipped in the future are reported as deferred revenue.
The Company presents, on a net basis, taxes collected from customers and remitted to governmental authorities; that is, they are excluded from revenues.
ULTRASE and VIOKASE, the Company’s pancreatic enzyme products (“PEPs”) had historically accounted for approximately 19% of the Company’s net sales in the three years ended September 30, 2009. Prior to April 28, 2010, products that were marketed in the U.S. to treat exocrine pancreatic insufficiency had been available before the passage of the Federal Food, Drug, and Cosmetic Act, or FDCA, in 1938 and, consequently, there were marketed PEPs that had not been approved under the New Drug Application (“NDA”) process by the Food and Drug Administration (“FDA”). Subsequently, the FDA has required all manufacturers to file an NDA to obtain marketing approval for exocrine pancreatic insufficiency drug products and to cease distribution of products without approved NDAs after April 28, 2010, until such time that an NDA approval is granted. After this date, the unapproved products remained available on pharmacy shelves until stock depletion. ULTRASE MT and VIOKASE did not receive NDA approval by the April 28, 2010 deadline, and the Company has ceased distributing the two products after that date, in compliance with the FDA guideline. The Company recorded an additional $23,452,000 sales deductions reserve in the fiscal year ended September 30, 2010 for product returns and other sales deductions as an estimate of Company’s liability for ULTRASE MT and VIOKASE that may be returned by the original purchaser under the Company DSAs or applicable return policies. The cease distribution order issued by the FDA was not considered as a product recall. At September 30, 2011, the remaining reserve was $3,100,000 and was based on management estimates of ULTRASE MT and VIOKASE inventory in the distribution channel, assumptions on related expiration dates of this inventory as well as estimated erosion of ULTRASE MT and VIOKASE demand, based on competition from approved PEPs and the resulting estimated sell-through of ULTRASE MT and VIOKASE, actual return activity and other factors.
Other revenue, which includes revenue from collaborative agreements, consists primarily of payments for research and development services, up-front fees, milestone payments and royalty payments. The Company enters into arrangements for the license, research and development, manufacture and/or commercialization/supply of products and product candidates utilizing the Company’s technology platforms. Non-refundable up-front license fees where continuing involvement is required of the Company are deferred and recognized in revenue over the related performance period. The Company estimates its performance period based on the specific terms of each agreement, and adjusts the performance periods, if appropriate, based on the applicable facts and circumstances. Periodic payments are recognized as revenue on a percentage of completion basis over the period that the related activities are performed under the terms of the agreements. The Company immediately recognizes the full amount of developmental milestone payments due to us upon the achievement of the milestone event if the event is substantive, objectively determinable, and represents an important point in the development life cycle of the product. Payments for achieving milestones which are not considered substantive are deferred and recognized in revenue over the related performance period.
Royalty revenue from licensees are based on third party sales of licensed products, and recognized as earned in accordance with the contract terms when third party sales can be reliably measured and collection is reasonably assured.
Amounts recognized under collaborative arrangements consisted of the following:
Cash and cash equivalents
Cash and cash equivalents consist of U.S. Treasury backed securities, bank deposits, time deposits and money market funds. Cash equivalents are primarily highly liquid short-term investments with original maturities of three months or less at the time of purchase and are recorded at cost, which approximates fair value.
Accounts receivable
The majority of the Company’s accounts receivable is due from companies in the pharmaceutical industry including major US wholesalers of pharmaceutical products. Credit is extended based on an evaluation of a customer’s financial condition and, generally, collateral is not required. Accounts receivable are generally due within 30 to 60 days and are stated at amounts due from customers net of an allowance for doubtful accounts. Accounts outstanding longer than the contractual payment terms are considered past due. The Company determines its allowance by considering a number of factors, including the length of time trade accounts receivable are past due, the Company’s previous loss history, the customer’s current ability to pay its obligation to the Company and the condition of the general economy and the industry as a whole. The Company writes off accounts receivable when they become uncollectible and payments subsequently received on such receivables are credited to bad debt expense.
Inventory valuation
Inventories of raw materials and packaging material are valued at the lower of cost and replacement cost. Inventories of work in progress and finished goods are valued at the lower of cost and net realizable value. Cost is determined by the first-in, first-out method. Cost for work in progress and finished goods include raw materials, direct labor, subcontracts and an allocation for overhead. Allowances are maintained for slow-moving inventories based on the remaining shelf life of products and estimated time required to sell such inventories. Obsolete inventory and rejected products are written-off to cost of goods sold.
Inventory costs associated with products that have not yet received regulatory approval are capitalized if the Company believes there is probable future commercial use and future economic benefit. If future commercial use and future economic benefit are not considered probable, then costs associated with pre-launch inventory that has not yet received regulatory approval are expensed as research and development expense during the period the costs are incurred. The Company could be required to expense previously capitalized costs related to pre-approval inventory if the probability of future commercial use and future economic benefit changes due to denial or delay of regulatory approval, a delay in commercialization, or other factors.
The Company recorded a charge of $44,883,000 during the year ended September 30, 2010, to cost of goods sold to reduce inventories to their net realizable value and for estimated loss for purchase and other materials and supply commitments related to ULTRASE® MT and VIOKASE® products.
Research and development
Research and development expenses are expensed as incurred. These expenses include the costs of our proprietary R&D efforts, as well as costs incurred in connection with certain co-development contracts. Upfront and milestone payments made to third parties in
connection with agreements with third parties (or research and development collaborations) are expensed as incurred up to the point of regulatory approval, in the absence of an alternative future uses. Payments made to third parties subsequent to regulatory approval are capitalized and amortized over the remaining useful life of the related product. Amounts capitalized for such payments are included in intangible assets.
In-process research and development
In-process research and development (“IPR&D”) represents the fair value assigned to incomplete research and development projects acquired in a business combination or asset acquisition which, at the time of acquisition, are determined to have no alternative future use. For business combinations that closed prior to October 1, 2009, the fair value of such project was expensed upon acquisition. For business combinations that closed after October 1, 2009, the fair value of such acquired IPR&D projects are capitalized as indefinite lived intangible assets, subject to impairment testing until completion or abandonment of the projects. Alternatively, the fair value of IPR&D projects acquired as part of an asset acquisition is expensed on acquisition.
Depreciation and amortization
Property, plant and equipment and intangible assets with a finite life are reported at acquisition cost, less accumulated depreciation and amortization, and are depreciated or amortized over their estimated useful lives according to the straight-line method over the following periods:
Impairment of long lived-assets and goodwill
The value of goodwill and intangible assets with an indefinite life are subject to an annual impairment test unless events or changes in circumstances indicate that the carrying amounts of these assets may not be recoverable.
The intangible assets with a finite life and property, plant and equipment are subject to an impairment test whenever events or changes in circumstances indicate that the carrying amounts of these assets may not be recoverable. The Company compares the carrying value of the unamortized portion of property, plant and equipment and intangible assets with a finite life to estimated future undiscounted cash flows. If the carrying value exceeds estimated discounted future cash flows, an impairment loss equal to the excess is recorded in earnings and the cost basis is adjusted.
During the fourth quarter of fiscal 2011, the Company early adopted the recently issued guidance on annual testing of goodwill for impairment which gives entities the option of to first assess qualitative factors to determine whether it is necessary to perform the two-step quantitative goodwill impairment test. The Company tests goodwill for impairment at a reporting unit level by first assessing a range of qualitative factors, including but not limited to macroeconomic conditions, industry conditions, the competitive environment, changes in the market for the Company’s products, regulatory and political developments, entity specific factors such as strategy and changes in key personnel, and overall financial performance. If after completing this assessment, it is determined that it is more likely than not that the fair value of a reporting unit is less than its carrying value, the Company proceeds to a two-step impairment testing process. Step one consists of a comparison of the fair value of a reporting unit with its carrying amount, including the goodwill allocated to the reporting unit. Measurement of the fair value of a reporting unit may be based on one or more fair value
measures including present value technique of estimated future cash flows and estimated amounts at which the unit as a whole could be bought or sold in a current transaction between willing parties. If the carrying amount of the reporting unit exceeds the fair value, step two requires the fair value of the reporting unit to be allocated to the underlying tangible and intangible assets and liabilities of that reporting unit, resulting in an implied fair value of goodwill. If the carrying amount of the goodwill of the reporting unit exceeds the implied fair value of that goodwill, an impairment loss equal to the excess is recorded in earnings.
Using the new guidance previously described, the Company determined that the two-step impairment testing of goodwill was not required in the fourth quarter of fiscal 2011. An impairment charge of $107,158,000 was recorded during the year ended September 30, 2010 (Note 12) as the Company’s pancreatic enzyme products did not receive NDA approval from the FDA by the April 28, 2010 deadline. This was a change in circumstance that caused the Company to review the carrying value of its associated long-lived assets including goodwill.
Income taxes
Income taxes are calculated using the asset and liability method. Under this method, deferred income tax assets and liabilities are recognized to account for the estimated taxes that will result from the recovery or settlement of assets and liabilities recorded at their financial statement carrying amounts. Deferred income tax assets and liabilities are measured based on enacted tax rates and laws at the date of the financial statements for the years in which the temporary differences are expected to reverse. A valuation allowance is provided for the portion of deferred tax assets that is more likely than not to remain unrealized. Adjustments to the deferred income tax asset and liability balances are recognized in net income as they occur.
The Company conducts business in various countries throughout the world and is subject to tax in numerous jurisdictions. As a result of its business activities, the Company files a significant number of tax returns that are subject to examination by various federal, state and local tax authorities. Tax examinations are often complex as tax authorities may disagree with the treatment of items reported by the Company and this may require several years to resolve.
Selling and administrative expenses
Selling and administrative expenses include shipping and handling expenses, other than distribution service agreement fees, costs of marketing, advertising, information technology and the associated employee compensation. Distribution service agreement fees are deducted from revenue. Advertising costs are expensed as incurred.
Restructuring costs
The Company incurs restructuring charges in connection with acquisitions when it implements plans to restructure and integrate the acquired operations or in connection with cost-reduction initiatives that are initiated from time to time. Termination costs are a significant component of restructuring costs and are generally recorded when the actions are probable and estimable. Costs for one-time termination benefits in which the employee is required to render service until termination in order to receive the benefits are recognized ratably over the future service period.
Foreign currency translation
The Company has operations in the United States of America, Canada and some European Union countries, the most significant of which are France, Italy and Ireland. For foreign subsidiaries where the local currencies have been determined to be the functional currency, the net assets of these subsidiaries are translated into U.S. dollars for consolidation purposes using the current rate method. Assets and liabilities are translated at the rate of exchange prevailing on the balance sheet date and revenues and expenses are translated using the average exchange rate for the period. The resulting gains and losses arising from the translation of the financial statements of subsidiaries are deferred in a cumulative foreign currency translation adjustments account reported as a component of Accumulated other comprehensive income in Shareholder’s Equity (Deficiency).
Monetary foreign currency assets and liabilities for subsidiaries operating in a currency other than the functional currency are translated at exchange rate in effect at the balance sheet whereas non-monetary assets and liabilities are translated at exchange rates in
effect at the transaction dates. Revenue and operating expense are translated at the average rates in effect during the year, except for the depreciation and amortization, translated at historical rates. Foreign currency exchange gains and losses on transactions occurring included in net income.
Deferred debt issue expenses
Financing costs incurred in connection with the issuance of debt are deferred and included in deferred debt issue expenses on the Consolidated Balance Sheets. These financing costs are being expensed over the terms of the respective debt using the effective interest method and included in interest expense.
Derivative instruments and hedging activities
The Company records all derivatives on the balance sheets at fair value. The accounting for changes in the fair value of derivatives depends on the intended use of the derivatives, whether the consolidated Company has elected to designate a derivative in a hedging relationship and apply hedge accounting and whether the hedging relationship has satisfied the criteria necessary to apply hedge accounting. Derivatives designated and qualifying as a hedge of the exposure to changes in the fair value of an asset, liability, or firm commitment attributable to a particular risk, such as interest rate risk, are considered fair value hedges. Derivatives designated and qualifying as a hedge of the exposure to variability in expected future cash flows, or other types of forecasted transactions, are considered cash flow hedges. Hedge accounting generally provides for the matching of the timing of gain or loss recognition on the hedging instrument with the recognition of the changes in the fair value of the hedged asset or liability that are attributable to the hedged risk in a fair value hedge or the earnings effect of the hedged forecasted transactions in a cash flow hedge. The Company may enter into derivative contracts that are intended to economically hedge certain of its risk, even though hedge accounting does not apply or the Company elects not to apply hedge accounting.
The Company has designated its interest rate swaps as cash flow hedges of interest rate risk (Note 19). On an ongoing basis, the Company assesses whether each derivative continues to be highly effective in offsetting changes in the cash flows of hedged items. Hedge ineffectiveness, if any, is immediately recognized in earnings.
Stock incentive plans
The Company recognizes the fair value of stock-based awards granted pursuant to its stock incentive plans as expense over the requisite service period, which generally equals the vesting period. All stock-based awards are approved by the Board of Directors prior to the grant.
3. Recently Issued Accounting Standards
In September 2011, the Financial Accounting Standards Board (“FASB”) amended the existing guidance on the annual testing of goodwill for impairment. The amended guidance gives an entity the option to first assess qualitative factors to determine whether it is necessary to perform the two-step quantitative goodwill impairment test. An entity no longer will be required to calculate the fair value of a reporting unit unless the entity determines, based on a qualitative assessment, that it is more likely than not that its fair value is less than its carrying amount. This new guidance is effective for annual and interim goodwill impairment tests performed for fiscal years beginning after December 15, 2011 with early adoption permitted. The Company has early adopted this new guidance in connection with the performance of its annual goodwill impairment test for fiscal year ended September 30, 2011.
In June 2011, the FASB issued new guidance on the presentation of comprehensive income. The new guidance allows an entity two options to present the components of net income and other comprehensive income; (1) in a single continuous financial statement, statement of comprehensive income or (2) in two separate but consecutive financial statements, consisting of an income statement followed by a separate statement of other comprehensive income. The new guidance eliminates the current option to report other comprehensive income and its components in the statement of changes in equity. Additionally, items that are reclassified from other comprehensive income to net income must be presented on the face of the financial statements. This new guidance requires retrospective application and is effective for fiscal years, and interim periods within those years, beginning after December 15, 2011. Early adoption is permitted. The adoption of this guidance will change how the Company presents other comprehensive income (loss) which has been historically presented as part of the Consolidated Statement of Shareholder’s equity.
In May 2011, the FASB issued new guidance to achieve common fair value measurement and disclosure requirements between GAAP and International Financial Reporting Standards. Additional disclosure requirements include: (1) for Level 3 fair value measurements, quantitative information about unobservable inputs used, a description of the valuation processes used by the entity, and a qualitative discussion about the sensitivity of the measurements to changes in the unobservable inputs; (2) for an entity’s use of a nonfinancial asset that is different from the asset’s highest and best use, the reason for the difference; (3) for financial instruments not measured at fair value but for which disclosure of fair value is required, the fair value hierarchy level in which the fair value measurements were determined; and (4) the disclosure of all transfers between Level 1 and Level 2 of the fair value hierarchy. This new guidance is effective for annual and interim periods beginning after December 15, 2011. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements.
In December 2010, the FASB issued guidance that modifies the Step 1 of the goodwill impairment test for reporting units with zero or negative carrying amounts. For those reporting units, an entity is required to perform Step 2 of the goodwill impairment test if qualitative factors indicate that it is more likely than not that a goodwill impairment exists. This guidance is effective for fiscal years and interim periods within those years, beginning after December 15, 2010. Early adoption is not permitted. The Company is currently evaluating the impact of the adoption of this guidance on its consolidated financial statements.
In December 2010, the FASB issued guidance that clarified the recognition and classification of annual fees mandated by the Patient Protection and Affordable Care Act as amended by the Health Care and Education Reconciliation Act in the income statements of pharmaceutical manufacturers. The guidance requires that the liability for the fee should be estimated and recorded in full upon the first qualifying sale with a corresponding deferred cost that is amortized to expense using a straight-line method of allocation unless another method better allocates the fee over the calendar year that it is payable. The annual fee shall be presented as an operating expense. This guidance is effective for calendar years beginning after December 31, 2010, when the fee initially becomes effective. The adoption of this guidance did not have a material impact on the Company’s consolidated financial statements.
In March 2010, the FASB issued guidance related to revenue recognition that applies to arrangements with milestones relating to research or development deliverables. This guidance provides criteria that must be met to recognize consideration that is contingent upon achievement of a substantive milestone in its entirety in the period in which the milestone is achieved. The guidance provides a definition of substantive milestone and should be applied regardless of whether the arrangement includes single or multiple deliverables or units of accounting. This guidance is effective prospectively to milestones achieved in fiscal years, and interim periods within those years, after June 15, 2010, with early adoption permitted. The adoption of this guidance did not have a material impact on the Company’s consolidated financial statements.
In March 2010, the FASB amended the existing guidance on stock compensation to clarify that an employee share-based payment award with an exercise price denominated in the currency of a market in which a substantial portion of the entity’s equity securities trades should not be considered to contain a condition that is not a market, performance, or service condition. Therefore, such an award should not be classified as a liability if it otherwise qualifies as equity. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning on or after December 15, 2010.The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements.
In October 2009, the FASB amended the existing guidance on revenue recognition related to accounting for multiple-element arrangements. This amendment addresses how to determine whether an arrangement involving multiple deliverables contains more than one unit of accounting, and how the arrangement consideration should be allocated among the separate units of accounting. This guidance is effective prospectively for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010, and early adoption is permitted. The adoption of this guidance did not have a material impact on the Company’s consolidated financial statements.
4. Acquisition of Eurand N.V. (“Eurand”)
Description of the transaction
On February 11, 2011 (or the “Acquisition Date”), the Company’s indirect parent (“Aptalis Holdings”) and Axcan Pharma Holding B.V. (“Axcan AcquisitionCo”), an indirect subsidiary of the Company, pursuant to a Share Purchase Agreement dated November 30, 2010 (as amended), acquired the outstanding equity of Eurand N.V. (“Eurand”) for total cash consideration of approximately $589,555,000. As a result of the acquisition, Eurand has become an indirect subsidiary of the Company.
Prior to the transaction, Eurand was a specialty pharmaceutical company that developed, manufactured and commercialized enhanced pharmaceutical and biopharmaceutical products based on its proprietary pharmaceutical technologies. Its technology platforms include bioavailability enhancement of poorly soluble drugs, custom release profiles and taste-masking/orally disintegrating tablet (ODT) formulations. Eurand was a global company with facilities in the U.S. and Europe. The acquisition of Eurand enables the Company to leverage the combination of two leading specialty pharmaceutical players, expand its gastroenterology product portfolio and provide the Company with a proprietary R&D growth engine and technology platforms supported by an extensive patent portfolio to meaningfully diversify its business and expand its geographic and manufacturing footprint.
Fair value of consideration transferred
The table below details the consideration transferred to acquire Eurand:
(b) Each Eurand stock option, whether or not vested and exercisable on the acquisition date, was canceled for a cash payment equal to the excess of the per share value of the acquisition consideration over the per share exercise price of the Eurand stock option.
The aggregate equity purchase price of $589,555,000 plus acquisition costs (including related fees and expenses) were funded by cash equity contributions amounting to $140,000,000 from affiliates of TPG Capital L.P. and certain co-investors made through Aptalis Holdings, the proceeds from the Senior Secured Term Loan Facility (as defined below) under the Company’s amended and restated credit agreement and related security and other agreements and cash on hand from the Company and Eurand.
The amended and restated credit agreement and related security and other agreements is composed of (i) a senior secured revolving credit facility in an aggregate principal amount of $147,000,000 (the “Senior Secured Revolving Credit Facility”) and (ii) a $750,000,000 senior secured term loan facility (the “Senior Secured Term Loan Facility” and, together with the Senior Secured Revolving Credit Facility, collectively, the “Amended and Restated Senior Secured Credit Facilities”). The Senior Secured Revolving Credit Facility is comprised of $115,000,000 of existing revolving credit commitments that were extended or issued on February 11, 2011, (the “ Extended Commitments “) and $32,000,000 of existing revolving credit commitments that were not extended (the “ Unextended Commitments”) pursuant to the Senior Secured Revolving Credit Facility.
The Company borrowed $500,000,000 of the amount available under the Senior Secured Term Loan Facility at the closing of the acquisition. The Senior Secured Revolving Credit Facility remained undrawn at the closing of the acquisition. A portion of the proceeds of the equity and debt financings, together with cash on hand of the Company and Eurand, were also used to repay the outstanding term loan portion amounting to $125,660,000 of the Company’s prior senior secured credit facilities and to pay related fees and expenses. The remaining amount of $250,000,000 of the Senior Secured Term Loan Facility was used on March 15, 2011 to redeem 100% of the Company’s existing 9.25% senior secured notes due 2015.
Basis of presentation
The transaction has been accounted for in accordance with the acquisition method of accounting for business combinations under existing U.S. GAAP. The acquisition method of accounting requires, among other things, that assets acquired and liabilities assumed be recognized at their fair values as of the acquisition date including acquired in-process research and development assets.
Assets acquired and liabilities assumed
A preliminary purchase price allocation had been made as of the Acquisition Date. The Company finalized its purchase price allocation during the fourth quarter of the fiscal year ended September 30, 2011 resulting in no retrospective adjustments to the provisional amounts recognized at the Acquisition Date.
The following table summarizes the fair values of the assets acquired and liabilities assumed as of the acquisition date.
(a) As of the Acquisition Date, the fair value of accounts receivable acquired approximated book value. The gross contractual amount receivable was $23,118,000 of which $456,000 was not expected to be collected.
(b) Reflects the adjustment to step-up the carrying value of inventory acquired by $18,727,000 to estimated fair value as of February 11, 2011. The stepped-up value is recorded as a charge to cost of goods sold as acquired inventory is sold.
(c) Includes prepaid assets and income tax receivable.
(d) Identifiable intangible assets comprise trademarks, trademark licenses, manufacturing rights and other intangible assets with a finite life with weighted average useful lives of 17.04 years. The estimated aggregate amortization expense for the five succeeding years will be $25,599,000 annually.
(e) Includes accounts payable, accrued liabilities and income taxes payable.
(f) Comprises of current deferred tax assets $823,000, non current deferred tax assets $15,703,000, current deferred tax liabilities $3,000 and non current deferred tax liabilities $77,772,000.
(g) The excess of purchase price over the fair value amounts assigned to the assets acquired and liabilities assumed represents the goodwill amount resulting from the acquisition. The goodwill recorded as part of the acquisition is largely attributable to synergies expected to result from combining the operations of Eurand and the Company and intangible assets that do not qualify for separate recognition. The Company does not expect any portion of this goodwill to be deductible for tax purposes.
(h) Prior to the acquisition, the Company had entered into an exclusive development license and supply agreement with Eurand. No gain or loss was recognized in conjunction with the effective settlement of the contractual relationship between the Company and Eurand as a result of this acquisition.
Transaction related costs
For the fiscal year ended September 30, 2011, the Company expensed $11,874,000 (an additional $1,070,000 had been expensed in the fiscal year ended September 30, 2010) of costs relating to legal, financial, valuation and accounting advisory services performed in connection with effecting the transaction with Eurand, which are included in transaction, restructuring and integration costs in the accompanying Consolidated Statements of Operations.
Actual and pro forma information
The revenue derived from the Eurand entities for the period from the Acquisition Date to September 30, 2011 were $121,943,000 and loss before income taxes was $39,647,000.
The following table presents unaudited pro forma consolidated results of operations as if the acquisition of Eurand had occurred as of October 1, 2009:
The pro forma consolidated results of operations were prepared using the acquisition method of accounting and are based on the historical financial information of the Company and Eurand. The pro forma information does not reflect any synergies and other benefits that the Company may achieve as a result of the acquisition, or the costs necessary to achieve these synergies. In addition, the pro forma information does not reflect the costs to integrate the operations of the Company and Eurand.
The pro forma information is not necessarily indicative of what the Company’s consolidated results of operations actually would have been had the transaction been completed on October 1, 2009. In addition, the pro forma information does not purport to project the future results of operations of the Company. The pro forma information reflects primarily the following pro forma adjustments:
•
elimination of product sales and royalties between Eurand and the Company, an elimination of the Company’s cost of sales for Eurand-sourced inventories, and the elimination of certain PEP-related charges stemming from intercompany transactions;
•
elimination of Eurand’s historical intangible asset amortization expense;
•
additional amortization expense related to the fair value of identifiable intangible assets acquired;
•
additional depreciation expense related to the fair value adjustment to property, plant and equipment acquired;
•
elimination of interest expense and amortization of deferred financing costs related to the Company’s term loan under the legacy senior secured credit facilities and 9.25% senior secured notes due 2015 that were repaid as part of the acquisition transaction;
•
additional interest expense and amortization of deferred financing costs associated with financing obtained under the Amended and Restated Senior Secured Credit Facilities obtained by the Company in connection with the acquisition transaction;
•
reduction of interest income associated with cash and cash equivalents that were used to partially fund the acquisition;
•
elimination of acquisition-related costs and acquisition-related restructuring charges;
•
elimination of $19,062,000 of the acquisition accounting adjustment on Eurand’s inventory that was sold subsequent to the Acquisition Date, which will not have a continuing impact on the Company’s operations.
The pro forma effective tax rate differs from the statutory rate due to the relatively large impact of actual permanent differences on relatively small pro forma income before tax, valuation allowances on deferred tax assets in certain jurisdictions, and the expected impact of foreign withholding taxes upon repatriation of foreign earnings.
5. Restructuring and Integration
Acquisition related cost-rationalization and integration initiatives
The Company has initiated restructuring measures in conjunction with the integration of the operations of Eurand. These measures are intended to capture synergies and generate cost savings across the Company.
Restructuring actions taken thus far include workforce reductions across the Company and other organizational changes. These reductions primarily come from the elimination of redundancies and consolidation of staff in the sales and marketing, manufacturing, research and development, and general and administrative functions, as well as from the planned closure of Eurand’s manufacturing facility in Nogent-Oise, France.
The Company recorded a restructuring expense in the amount of $16,051,000 during the fiscal year ended September 30, 2011 related to planned employee termination costs included in transaction, restructuring and integration on the Consolidated Statements of Operations. Employee termination costs are generally recorded when the actions are probable and estimable and include accrued severance benefits and health insurance continuation, many of which may be paid out during periods after termination.
The following table summarizes restructuring liability activity related to the Eurand acquisition through September 30, 2011:
The Company estimates to incur additional restructuring costs of between $900,000 and $1,500,000 primarily consisting of severance costs. The restructuring actions taken thus far are expected to be substantially completed by the end of fiscal 2012.
Through September 30, 2011, the Company has incurred integration costs of $22,987,000 representing certain external, incremental costs directly related to integrating the Eurand business and primarily include expenditures for consulting and systems integration. Restructuring and integration costs are included in transaction, restructuring and integration costs in the accompanying Consolidated Statements of Operations.
6. Acquisitions, Research Collaborations and License Agreements
Agreements with Mpex Pharmaceuticals Inc. for the acquisition and development of Aeroquin™
On April 11, 2011, Aptalis Holdings and Axcan Lone Star Inc. (“Merger Sub”), affiliates of the Company, entered into a series of agreements with Mpex Pharmaceuticals Inc. (“Mpex”) for the acquisition and development of Aeroquin™ (the “Aeroquin Transaction”), a proprietary aerosol formulation of levofloxacin, which is currently in Phase 3 clinical trials for the treatment of pulmonary infections in patients with cystic fibrosis (CF). Subsequently on August 31, 2011, under the terms of these agreements, Aptalis Holdings and Merger Sub acquired all of Mpex’s assets related to Aeroquin™ in a merger of Mpex with and into Merger Sub, with Mpex being the surviving corporation and a direct, wholly-owned subsidiary of us. Prior to the merger, Mpex transferred all of its assets that are not related to Aeroquin™ to Rempex Pharmaceuticals, Inc. (“Rempex”), a newly formed company that is owned
primarily by the previous Mpex stockholders. As a result of the Aeroquin Transaction, the Company made an initial payment of $12,000,000 on April 21, 2011. Additional consideration in relation with the Aeroquin Transaction consists of (i) remaining time-based, non-contingent payments amounting to $33,000,000 and an additional $17,500,000 of time-based payments will be paid in a number of installments, of which the final installment is due on April 1, 2014, plus, (ii) contingent payments of up to $195,000,000 if certain regulatory and commercial milestones are met related to Aeroquin™, and (iii) earn-out payments based on net sales of Aeroquin™. Indemnity obligations of the Mpex security holders will be satisfied by set-off against a portion of the foregoing merger consideration payments.
The further development of Aeroquin™ is being conducted pursuant to the terms of the Development Agreement dated April 11, 2011 among Aptalis Holdings, Merger Sub, and Mpex. Since the completion of the divestiture of assets and liabilities unrelated to Aeroquin™ (the “Divestiture”) to Rempex, Rempex has assumed all of Mpex’s obligations under the Development Agreement. Under the Development Agreement, Mpex (and after the Divestiture, Rempex) is paid for the actual development costs of Aeroquin™ and has primary responsibility for conducting day-to-day development activities. The Company is required to pay in advance development costs estimated for the next three months based on a rolling three months forecast. The Company and Merger Sub have input regarding development strategy. Pursuant to the Development Agreement, on April 12, 2011 Mpex was paid $8,731,000 for development expenses incurred by Mpex from November 15, 2010, to March 31, 2011, which has been expensed as acquired in-process research and an additional $9,913,000 for estimated development costs to be incurred during the first three months of the Development Agreement, of which $8,514,000 has been expensed as research and development. All payments under the Development Agreement, Option Agreement and Merger Agreement to Mpex or Mpex security holders, as applicable, will be made by or on behalf of Merger Sub prior to the closing of the Aeroquin Transaction, and are being made on behalf of Mpex since the closing of the Aeroquin Transaction.
During the year ended September 30, 2011, the Company expensed $15,842,000 as research and development $65,540,000 as acquired in-process research and development reflecting the initial non-contingent payment of $12,000,000, the discounted value of future time-based non-contingent payments payable under the Option and Merger agreements of $44,809,000 (with a corresponding liability) and the payment for certain pre-agreement incurred development expenses of $8,731,000. As of September 30, 2011, $7,807,000 reflecting forecasted development costs for the next three months is included in prepaid expenses and other current assets. As of September 30, 2011, $45,710,000 represents the amount accrued for the non-contingent payments payable under the Option and Merger agreements with $32,487,000 included in other long term liabilities and the balance included in accounts payable and accrued liabilities.
Equity investment in Axcan Holdings
Simultaneous with the execution of the Mpex agreements, Aptalis Holdings received the proceeds of a $55,000,000 equity investment from funds managed by Investor Growth Capital Limited. Aptalis Holdings contributed the proceeds of the equity investment to its subsidiaries to fund a portion of the cost of the Mpex transactions and a partial repayment on the Company’s $133,154,000 note receivable from its parent company.
Other product acquisitions
During the twelve-month period ended September 30, 2010, the Company entered into an asset purchase and license agreement to acquire rights in and to the intellectual property, assigned contracts, permits and inventories related to a compound to be used in the development of an undisclosed product in the field of gastroenterology. Certain other rights were licensed under the agreement. Pursuant to the agreement, the Company made an upfront payment of $8,000,000 on closing and additional payments of up to $86,000,000 may be required based on the achievement of certain development, regulatory and commercialization milestones. In addition, the Company will pay royalties on the basis of net sales. The Company completed the asset acquisition in April 2010 and recorded an expense of $7,948,000 and $52,000 in property, plant and equipment for the payment of acquired in-process research and development in the third quarter of fiscal year 2010.
7. Disposal of the PHOTOFRIN/PHOTOBARR Product Line
On March 28, 2011, The Company entered into a definitive agreement with Pinnacle Biologics, Inc., which acquired all global assets and rights related to PHOTOFRIN/PHOTOBARR, including inventory, for non-contingent payments amounting to $4,252,000. In addition to the non-contingent payments, additional payments shall be made to the Company after the achievement of certain milestones events. In addition, the Company will be paid royalties on annual net sales of PHOTOFRIN/PHOTOBARR.
During the year ended September 30, 2011 the Company recorded a loss of $7,365,000 as a result of the disposal of the PHOTOFRIN/PHOTOBARR product line. Consideration for additional contingent payments to be made to the Company, for which there is significant uncertainty, shall be recorded as a gain in the period in which they are received.
8. Accounts Receivable
The Company believes that there is no unusual exposure associated with the collection of these accounts receivable.
a) At September 30, 2011, the accounts receivable include amounts receivable from three major customers which represent approximately 50% (42% at September 30, 2010) of the Company’s total trade accounts receivable (Note 17).
9. Inventories
As disclosed in Note 2, the Company’s PEPs did not obtain regulatory approval by the April 28, 2010 deadline established by the FDA. As a result, a charge of $44,883,000 was recorded during the fiscal year ended September 30, 2010, to cost of goods sold to reduce inventories to their net realizable value and for estimated losses on purchase and other materials and supply commitments related to ULTRASE MT and VIOKASE products.
10. Income Taxes
Income taxes included in the Consolidated Statements of Operations are as follows:
The Company’s effective income tax rate differs from the U.S. statutory federal income tax rate of 35.00%. This difference arises from the following:
As of September 30, 2011, the Company has approximately $ 221,236,000 of unremitted earnings of its international subsidiaries, these earnings are intended to be permanently reinvested; as such, no deferred tax liability on these permanently reinvested earnings is recorded.
The deferred income tax assets and liabilities result from differences between the tax value and book value of the following items:
Recorded as:
Current and non-current deferred income tax assets and liabilities within the same jurisdiction are generally offset for presentation in the Consolidated Balance sheets.
As of September 30, 2011, the Company had tax benefit carryovers of $124,957,000 ($42,046,000 as of September 30, 2010) relating to operating losses and capital losses and $12,720,000 ($3,032,000 as of September 30, 2010) relating to tax credits which are available to reduce future U.S. federal and state, as well as international, income taxes payable with either an indefinite life or expiring at various times between 2016 and 2031. Certain of our U.S. net operating losses are subject to limitations under Internal Revenue Code Section 382.
A valuation allowance against deferred tax assets is established when it is not more likely than not that the deferred tax assets will be realized. Based on all available evidence, both positive and negative, the Company determined that it is more likely than not that the deferred tax assets related to substantially all of the U.S. and France jurisdictions cumulative gross net operating loss carry forwards, and certain other deferred assets, will not be realized. Accordingly, the Company recorded a valuation allowance of $60,044,000 for the year ended September 30, 2011 ($57,242,000 in 2010), mainly against the following net deferred tax assets: $ 52,370,000 for unused losses, $ 5,738,000 for interest rate swaps and $ 1,936,000 for other net deferred tax assets. As at September 30, 2011, the Company had a total valuation allowance of $165,994,000 mainly against the following net deferred tax assets: $ 121,228,000 for unused losses, $ 5,738,000 for interest rate swaps and $ 16,178,000 for accounts payable and accrued liabilities, $12,539,000 for tax credits, $ 3,510,000 for stock-based compensation. The jurisdictions in which the Company recorded valuation allowances are the United States for $151,053,000, France for $14,010,000 and Canada for $ 931,000.
In future periods, if the deferred tax assets are determined by management to be more likely than not to be realized, the recognized tax benefits relating to the reversal of the valuation allowance will be recorded in the Consolidated Statements of Operations.
The accounting for uncertainty in income taxes prescribe a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities. The adoption of the provisions of this guidance did not have a material impact on the Company’s consolidated financial position and results of operations and a cumulative effect adjustment to the opening balance of retained earnings was not necessary. If recognized, the total amount of unrecognized tax benefits of $14,769,000 as at September 30, 2011, ($11,485,000 as at September 30, 2010) would affect the Company’s effective tax rate.
The following table presents a summary of the changes to unrecognized tax benefits:
The Company has historically recognized interest relating to income tax matters as a component of financial expenses and penalties related to income tax matters as a component of income tax expense. As of September 30, 2011, the Company had accrued $2,410,000 ($1,075,000 as of September 30, 2010) for interest relating to income tax matters. There were no amounts recorded for penalties as of September 30, 2011, and 2010.
The Company and its subsidiaries file tax returns in the U.S. federal jurisdiction and various states, local and foreign jurisdictions including Canada and France. In many cases, the Company’s uncertain tax positions are related to tax years that remain subject to examination by relevant tax authorities. The Company is subject to federal and state income tax examination by U.S. tax authorities for fiscal years 2006 through 2011. The Company is subject to Canadian and provincial income tax examination for fiscal years 2009 through 2011 and for international transactions for fiscal years 2005 through 2011. There are numerous other income jurisdictions for which tax returns are not yet settled, none of which is individually significant.
As a result of the completion by the Canada Revenue Agency domestic audit for taxation years 2005 to 2008 in October 2011, the Company has re-classified an amount of $ 9,241,000 as Current Tax Payable; which was earlier classified as other long-term liability. This reclassification relates to uncertain tax positions that were under audit and for which a payment was expected within the next twelve months. Effective settlement occurred after September 30, 2011 and as a result, the Company will record a favorable tax benefit of approximately $1,800,000 in the statement of operations in the first quarter of 2012.
The Company has approximately $118,000,000 of unrecognized suspended capital loss in Canada that can be carried forward indefinitely.
The Company and its U.S. subsidiaries file as members of a U.S. Federal income tax return, of which Aptalis Holdings Inc. is the parent. The consolidated income tax liability is allocated among the members of the group in accordance with a tax allocation agreement. The tax allocation agreement provides that each member of the group is allocated its share of the consolidated tax provision determined generally on a separate income tax return method.
11. Property, Plant and Equipment
Acquisitions of property, plant and equipment amount to $7,408,000 for the year ended September 30, 2011, ($5,577,000 and $11,023,000 for the years ended September 30, 2010 and 2009 respectively).
The cost and accumulated depreciation of equipment under capital leases amount to $1,386,000 and $1,227,000 respectively ($1,401,000 and $1,077,000 in 2010).
12. Goodwill and Intangible Assets
The following table reflects the changes in carrying amount of goodwill:
As disclosed in Note 4, the Company has finalized its allocation of the fair value assigned to the assets acquired and liabilities assumed resulting in no changes to the amount recorded as goodwill for the acquisition of Eurand.
Using the new guidance previously described, the Company determined that the two-step impairment testing of goodwill was not required.
Goodwill impairment in fiscal 2010
The Company recorded a goodwill impairment charge of $91,400,000 during the year ended September 30, 2010. The FDA mandated that all manufacturers of exocrine pancreatic insufficiency drug products file an NDA and receive approval for their products by April 28, 2010. On April 28, 2010, neither of the Company’s two pancreatic insufficiency drug products, ULTRASE®MT and VIOKASE®, had obtained FDA approval. The Company plans to continue to seek to obtain an NDA approval for these products. The Company is currently not distributing these products and expects that the future cash flows that would be generated from these products will be negatively impacted by market share erosion that will occur between April 28, 2010 and the date of eventual re-launch of the products on the market, and management cannot provide any assurances that the Company will be able to re-launch the products. The Company had considered the FDA April 28, 2010 approval deadline to be a triggering event which caused the Company to assess whether any portion of its recorded goodwill balance was impaired. As a result, an estimate of the impact of these developments was reflected in certain valuation assumptions of the Company’s interim goodwill impairment test performed as at March 31, 2010.
Prior to adoption of the recently issued guidance in the fourth quarter of fiscal 2011, the goodwill impairment test was a mandatory quantitative two step process. Step one of the impairment analysis consisted of a comparison of the fair value of the U.S. reporting unit with its net carrying value, including the goodwill. The Company performed extensive valuation analyses, utilizing both income and market-based approaches, in its goodwill assessment process. The following describes the valuation methodologies used to derive the estimated fair value of the reporting unit. To determine the fair value, the Company discounted the expected future cash flows of the U.S. reporting unit, using a discount rate, which reflected the overall level of inherent risk and the rate of return an outside investor would have expected to earn. To estimate cash flows beyond the final year of its model, the Company used a terminal value approach. Under this approach, the Company used estimated operating income before interest, taxes, depreciation and amortization in the final year of its model, adjusted to estimate a normalized cash flow, applied a perpetuity growth assumption, and discounted by a perpetuity discount factor to determine the terminal value. The Company incorporated the present value of the resulting terminal value into its estimate of the fair value.
Based on the “step one” analysis that was performed for the U.S. reporting unit, the Company determined that the carrying amount of the net assets of the reporting unit was in excess of its estimated fair value. As such, the Company was required to perform the “step two” analysis for its U.S. reporting unit, in order to determine the amount of any goodwill impairment. The “step two” analysis consisted of comparing the implied fair value of the goodwill with the carrying amount of the goodwill, with an impairment charge resulting from any excess of the carrying value of the goodwill over the implied fair value of the goodwill, based on a hypothetical allocation of the estimated fair value to the net assets. Based on the preliminary step two analysis, the Company determined that the goodwill allocated to the U.S. reporting unit, in the amount of $91,400,000 was impaired. As a result, the Company recorded a preliminary goodwill impairment charge of $91,400,000 during the three-month period ended March 31, 2010, which represented the Company’s best estimate as of March 31, 2010. The hypothetical allocation of the fair value of the reporting unit to individual assets and liabilities within the reporting unit also required the Company to make significant estimates and assumptions. The hypothetical allocation required several analyses to determine the estimate of the fair value of assets and liabilities of the reporting unit. During the three-month period ended June 30, 2010, the Company finalized its step two analysis. The finalization of this analysis did not result in any adjustment to the previously recorded impairment.
The determination of the fair value of the reporting unit required the Company to make significant estimates and assumptions that affected the reporting unit’s expected future cash flows. These estimates and assumptions primarily included, but were not limited to,
the discount rate, terminal growth rates, operating income before depreciation and amortization, and capital expenditure forecasts. Additionally, the Company made assumptions relating to the expected amount of time required to eventually obtain FDA approval for the Company’s pancreatic enzyme products and the eventual market share of these products. Due to the inherent uncertainty involved in making these estimates, actual results could differ significantly from those estimates.
Trademarks, trademark licenses, manufacturing rights and other intangible assets with a finite life
In conjunction with the goodwill impairment identified during the year ended September 30, 2010, the Company completed its review of the impairment test for intangible assets with a finite life related to PEPs within the U.S. reporting unit for recoverability and recorded a non-cash charge for impairment of intangible assets other than goodwill of $15,758,000. The Company used a discounted cash flow based approach to value these assets.
During the twelve-month period ended September 30, 2009, as a result of certain factors related to the ongoing marketing of certain of the Company’s products including the approval of a generic formulation of URSO 250® and URSO FORTE®, the Company reviewed the carrying amount of the intangible assets specifically related to these products. Based on a discounted cash flow analysis and market prices, the Company concluded that a $55,665,000 reduction to the carrying value of the related intangible assets totalling $83,709,000 prior to the write-down was required. In addition, the estimated remaining amortizable life of these intangible assets was reduced to periods ranging from 6 months to 14 years.
The following table reflects the changes in the carrying amount of intangible assets:
As of September 30, 2011, the intangible assets with a finite life have a weighted average remaining amortization period of approximately 14 years (11 years as of September 30, 2010).
The annual amortization expenses, without taking into account any future acquisitions expected for the years 2012 through 2016, are as follows:
13. Accounts payable and accrued liabilities
14. Long-term Debt
On February 11, 2011, the Company entered into an amended and restated credit agreement and related security and other agreements in connection with the Eurand Acquisition. The amended and restated credit agreement and related security and other agreements is composed of (i) a senior secured revolving credit facility in an aggregate principal amount of $147,000,000 (the “Senior Secured Revolving Credit Facility”) and (ii) a $750,000,000 senior secured term loan facility (the “Senior Secured Term Loan Facility” and, together with the Senior Secured Revolving Credit Facility, collectively, the “Amended and Restated Senior Secured Credit Facilities”).
The Company borrowed $500,000,000 of the amount available under the Senior Secured Term Loan Facility at the closing of the acquisition of Eurand. The Senior Secured Revolving Credit Facility remained undrawn at the closing of the acquisition. A portion of the proceeds of the equity and debt financings, together with cash on hand of the Company and Eurand, were used to repay the outstanding term loan portion amounting to $125,660,000 of the Company’s existing senior secured credit facilities. Following the repayment, all unamortized deferred financing fees of $2,653,000 and original issuance discount of $3,188,000 related to the term loan were written off and are included in Loss on extinguishment of debt in the accompanying Consolidated Statements of Operations.
On February 25, 2008, the Company had issued $228,000,000 aggregate principal amount of its 9.25% senior secured notes (the “Senior Secured Notes”) due March 1, 2015. The Senior Secured Notes were priced at $0.98737 with a 10% yield to March 1, 2015. On March 15, 2011, $250,000,000 of the Senior Secured Term Loan Facility was drawn to redeem the Company’s Senior Secured Notes at a redemption price of 106.938%. The aggregate redemption amount consisted of $228,000,000 in aggregate principal amount, and $15,819,000 of redemption premium which is included in Loss on extinguishment of debt in the accompanying Consolidated Statements of Operations. Following the redemption all unamortized deferred financing fees of $4,992,000 and original issuance discount of $1,659,000 related to these notes were written off and are included in Loss on extinguishment of debt in the accompanying Consolidated Statements of Operations.
The Company’s Amended and Restated Senior Secured Credit Facilities totaling $897,000,000 is composed of a Senior Secured Term Loan Facility amounting to $750,000,000 and a Senior Secured Revolving Credit Facility totaling $147,000,000. The Senior Secured Revolving Credit Facility is comprised of $115,000,000 of existing revolving credit commitments that were extended or issued (the “ Extended Commitments”) and $32,000,000 of existing revolving credit commitments that were not extended (the “ Unextended Commitments”) pursuant to the Senior Secured Revolving Credit Facility. The Amended and Restated Senior Secured Credit Facilities bear interest at a variable rate available composed of either the Federal Funds Rate or the British Banker Association LIBOR rate, at the option of the Company, plus the applicable rate based on the consolidated total leverage ratio of the Company and certain of its subsidiaries for the preceding twelve months. The principal amount of the Senior Secured Term Loan Facility amortizes in equal quarterly installments in aggregate annual amounts equal to 1% of the original principal amount with payments beginning in fiscal year 2011. The principal amount outstanding of the loans under the Senior Secured Term Loan Facility will be due and payable on February 11, 2017. The principal amount of outstanding loans under the Senior Secured Revolving Facility will be due and payable on February 11, 2016 with respect to Extended Commitments and on February 25, 2014 with respect to Unextended Commitments.
At September 30, 2011, $750,000,000 of term loans had been issued and no amounts had been drawn during the year against the revolving credit facility. The term loans were priced at $0.995, with a yield to maturity of 5.6%, before the effect of interest rate swaps as disclosed in Note 19. The Amended and Restated Senior Secured Credit Facility requires the Company to meet certain financial covenants, beginning in the quarter ended June 30, 2011. The maintenance of these financial covenants is solely with respect to the Senior Secured Revolving Credit Facility. These covenants were met as of September 30, 2011. The credit agreement governing the Amended and Restated Senior Secured Credit Facility requires the Company to prepay outstanding term loans contingent upon the occurrence of events, subject to certain exceptions, with: (1) 100% of the net cash proceeds of any incurrence of debt other than debt permitted under the Amended and Restated Senior Secured Credit Facility, (2) commencing with the fiscal year ending September 30, 2012, 50% (which percentage will be reduced if the senior secured leverage ratio is less than a specified ratio) of the annual excess cash flow (as defined in the credit agreement governing the Senior Secured Term Loan Facility) and (3) 100% of the net cash proceeds of all non-ordinary course asset sales or other dispositions of property (including casualty events) by the Company or by its subsidiaries, subject to reinvestment rights and certain other exceptions.
Pursuant to the annual excess cash flow requirements defined in the preceding credit agreement, the Company was required to prepay $13,163,000 of outstanding term loans in the first quarter of fiscal year 2011 ($17,583,000 for the fiscal year 2009 which was paid in the first quarter of fiscal year 2010).
On May 6, 2008, the Company had issued $235,000,000 of 12.75% senior unsecured notes due March 1, 2016, (the “Senior Unsecured Notes”). The Senior Unsecured Notes were priced at $0.9884 with a yield to maturity of 13.16%. The Senior Unsecured Notes are subordinated to the Credit Facility and Senior Secured Notes.
The Company may redeem some or all of the Senior Unsecured Notes prior to March 1, 2012, at a redemption price equal to 100% of the principal amount of the Senior Unsecured Notes redeemed plus a “make-whole” premium and accrued and unpaid interest. On or after March 1, 2012, the Company may redeem some or all of the Senior Unsecured Notes at the redemption prices (expressed as percentages of principal amount of the Senior Unsecured Notes to be redeemed) set forth below:
Payments required in each of the next five fiscal years to meet the retirement provisions of the long-term debt are as follows:
15. Stock Incentive Plans
Management equity incentive plan
In April 2008, the Company’s indirect parent company adopted a Management Equity Incentive Plan (the “MEIP Plan”), pursuant to which the indirect parent company grants options to selected employees and directors of the Company. The MEIP Plan provides that a maximum of 3,833,307 shares of common stock of the indirect parent company are issuable pursuant to the exercise of options. The per share purchase price cannot be less than the fair value of the share of common stock of the indirect parent company at the grant date and the option expires no later than ten years from the date of grant. Vesting of these stock options is split into 3 categories: 1) time-based options: 50% of option grants generally vest ratably over 5 years and feature a fixed exercise price equal to the fair value of common stock of the indirect parent company on grant date; 2) premium options: 25% of stock option grants with an exercise price initially equal to the fair value of common stock on grant date that will increase by 10% each year and generally vesting ratably over 5 years; and 3) performance-based options: 25% of stock option grants with a fixed exercise price equal to the fair value of common stock on grant date which vest upon the occurrence of a liquidity event (as defined under the terms of the MEIP Plan) based on the achievement of return targets calculated based on the return received by majority shareholders from the liquidity event. While the time-based options and the premium options are expensed over the requisite service period, the performance-based options will not be expensed until the occurrence of the liquidity event. The MEIP Plan was amended and restated effective February 11, 2011 primarily to reflect an increase to a maximum of 5,033,507 shares of common stock of the indirect parent company issuable pursuant to the exercise of options and to change the required return targets that need to be achieved for vesting performance based options for options issued under the amended and restated plan.
In May 2011, the Company’s indirect parent approved a one-time voluntary stock option exchange program (the “Program”) under which eligible employees (which included executive officers and directors) were given the opportunity to surrender all of their outstanding options with an exercise price of $10.00 per share or higher and granted on or prior to February 10, 2011 for cancellation in exchange for the grant of an equal number of replacement options with an exercise price per share equal to the fair market value on the exchange date ($10 at the “regrant date”) and with different vesting terms for premium and performance-based options. The terms of the time-based options remain unchanged. The terms of the premium and performance-based options were modified in the replacement options as follows:
•
Premium options - option grants with an exercise price initially equal to the fair value of common stock on the regrant date that will increase by 10% each year. 20% of options vested immediately on the regrant date and the remaining 80% will vest ratably over 4 years from the regrant date.
•
Performance based options - options grants with a fixed exercise price equal to the fair value of common stock on the regrant date which vest upon the occurrence of a liquidity event based on the achievement of return targets calculated based on the return received by majority shareholders from the liquidity event and defined under the terms of the MEIP plan amended and restated effective February 11, 2011.
The goal of the exchange offer was to help reinforce the intended purpose of the equity incentive plan, which is to retain and motivate key employees and ultimately help build shareholder value. The Program commenced on July 21, 2011 and expired on September 16, 2011. On September 22, 2011, the Company’s indirect parent accepted for cancellation eligible options to purchase 785,000 shares of its common stock and 785,000 replacement options were granted with an exercise price of $10 which represented fair market value on the regrant date. The replacement options have a contractual term of 10 years. The impact of the cancellations and grants of new options under the option exchange program is reflected in the 2011 fiscal year end tables below. The exchange was treated as a modification and the incremental expense associated with the exchange was immaterial.
The following table presents the changes to the number of stock options outstanding under the MEIP:
Stock options outstanding as at September 30, 2011, are as follows:
Stock options outstanding as at September 30, 2010, are as follows:
The changes to the number of non-vested stock options for the years ended September 30, 2011, and September 30, 2010, are as follows:
The weighted average grant date fair value of stock options granted under the MEIP was $3.00 for the year ended September 30, 2011, ($5.18 and $5.12 for the years ended September 30, 2010 and 2009 respectively). The weighted average fair value of shares vested under the MEIP was $3.45 for the year ended September 30, 2011 ($3.59 and $3.45 for the years ended September 30, 2010 and 2009).
The fair value of each option award is estimated on the date of grant using the Black-Scholes valuation model for the service-based options and the Monte Carlo simulation model for the performance-based options. The expected life of options is based on the weighted contractual life based on the probability of change in control or a liquidity event. The expected volatility is based on historical volatility of peer companies. The risk free interest rate is based on the average rate of return on U.S. Government Strips with a remaining term equal to the expected term of the option. The dividend yield reflects that the indirect parent Company has not paid any cash dividends since inception and does not intend to pay any cash dividends in the foreseeable future.
The fair value estimates are based on the following weighted average assumptions for options granted:
Special equity grant
In April 2008, Aptalis Holdings approved the Restricted Stock Unit grant agreement and the penny option grant agreement (collectively “Equity Grant Agreements”) pursuant to which a one-time grant of equity-based awards of either restricted stock units (“RSUs”) or options to purchase shares of common stock of the indirect parent company for a penny (“Penny Options”) was made to certain employees of the Company. A maximum of 1,343,348 shares of common stock of the indirect parent company are issuable with respect to the special grants. As a result of the option to allow the recipients to elect to have an amount withheld that is in excess of the required minimum withholding under the current tax law, the special grants will be accounted for as liability awards. As a liability award, the fair value on which the expense is based is remeasured each period based on the estimated fair value and the final expense will be based on the fair value of the shares on the date the award is settled. The RSUs and Penny Options expire no later than four years and ten years respectively from the date of grant. One third of the granted RSUs and Penny Options vested immediately on date of grant; one third vested on August 25, 2009, and the remainder vested on August 25, 2010.
The carrying value of an RSU or Penny Option is always equal to the estimated fair value of one common share of the indirect parent company. The RSUs and Penny Options entitle the holders to receive common shares of the indirect parent company at the end of a vesting period. The total number of RSUs and Penny Options granted were 1,343,348 with an initial fair value of $10, equal to the share price at the date of grant. At September 30, 2011, there were 889,336 outstanding RSUs and Penny Options (1,172,396 at September 30, 2010) of which 886,002 (1,167,396 at September 30, 2010) were vested.
The Company recorded share-based compensation expense of $ 7,873,000 relative to the MEIP and the Special Equity Grant for the year ended September 30, 2011, net recovery of $378,000 for the year ended September 30, 2010, and expense of $6,172,000 for the year ended September 30, 2009 with related income tax benefits of $1,409,000, $300,000 and $1,098,000 respectively. The amount of expense has been reduced to take into account estimated forfeitures. As of September 30, 2011, there were $5,685,000 ($5,404,000 as of September 30, 2010) of total unrecognized compensation costs related to MEIP and the Special Equity Grant based on the recorded fair value. These costs are expected to be recognized over a weighted average period of 5 years. At September 30, 2011, there was $3,319,000 ($3,108,000 as at September 30, 2010) of compensation expense related to the performance based options that will be recognized upon the occurrence of a liquidity event.
Annual grant
In June 2008, the Company’s indirect parent company adopted a Long Term Incentive Plan (the “LTIP”), pursuant to which the indirect parent company is expected to grant annual awards to certain employees of the Company (the “participants”). The value of an award is initially based on the participant’s pay grade and base salary and is subsequently adjusted based on the outcome of certain performance conditions relating to the fiscal year. Each award that vests is ultimately settleable, at the option of the participant, in cash or in parent company common stock of equivalent value. The awards vest (i) upon the occurrence of a liquidity event (as defined under the terms of the LTIP) and (ii) in varying percentages based on the level of return realized by majority shareholders as a result of the liquidity event.
The awards granted under this LTIP are eventually to be classified as liabilities in accordance with the FASB issued guidance on distinguishing liabilities from equity, since the award is for a fixed amount of value that can be settled, at the option of the participant, in (i) cash, or (ii) a variable number of parent company common stock of equivalent value.
The Company will not recognize any compensation expense until such time as the occurrence of a liquidity event generating sufficient return to the majority shareholders (in order for the award to vest) is probable. If such an event was probable as of September 30, 2011, the value of the awards to be expensed by the Company would range between $4,730,000 and $5,680,000 depending on the level of return expected to be realized by the majority shareholders.
16. Information Included in the Consolidated Operations and Cash Flows
a) Financial expenses
b) Other information
c) Cash flows relating to interest and income taxes of operating activities
17. Segment Information
Prior to the acquisition of Eurand, the Company operated in one operating segment, pharmaceutical products. Following the acquisition of Eurand, the Management of the Company reassessed the internal reporting structure and composition of its business operations and concluded, based on the level of detail contained in the financial information package used by the Company’s chief operating decision maker to drive operational decision making, that it continues to operate in one operating segment, pharmaceutical products.
Three major customers in the U.S. market for which the sales represent 61.8% of revenue for the year ended September 30, 2011, (70.2% and 79.5% of revenue for the years ended September 30, 2010 and 2009 respectively) are detailed as follows:
Purchases from one supplier represent approximately 12% of the cost of goods sold for the year ended September 30, 2011, (one supplier for 32% for the year ended September 30, 2010, two suppliers for 51% for the year ended September 30, 2009).
The Company purchases the majority of its inventory from third party manufacturers, many of whom are the sole source of products for the Company. The failure of such manufacturers to provide an uninterrupted supply of products could adversely impact the Company’s ability to sell such products.
The Company operates in the following geographic areas:
Revenue is attributed to geographic areas based on the country of origin of the sales.
18. Financial Instruments
Interest rate risk
The Company is exposed to interest rate risk on its variable interest bearing term loans. The term loans bear interest based on British Banker Association LIBOR. As further disclosed in Note 19, the Company may enter into derivative financial instruments to manage its exposure to interest rate changes and reduce its overall cost of borrowing.
Currency risk
The Company is exposed to financial risk arising from fluctuations in foreign exchange rates and the degree of volatility of the rates. The Company has used derivative instruments historically to reduce its exposure to foreign currencies risk. At September 30, 2011, no foreign exchange contracts were outstanding. At September 30, 2011, the financial assets totaling $202,309,000 ($194,005,000 at September 30, 2010) include cash and cash equivalents and accounts receivable for CAN$3,681,000, 22,777,000 Euros and 1,391,000 Swiss francs respectively (CAN$4,073,000, 18,658,000 Euros and 1,820,000 Swiss francs at September 30, 2010). At September 30, 2011, the financial liabilities totaling $1,136,295,000 ($689,148,000 at September 30, 2010) include accounts payable and accrued liabilities and long-term debt of CAN$10,128,000 and 22,839,000 Euros respectively (CAN$10,234,000 and 8,158,000 Euros at September 30, 2010).
Credit risk
Generally, the carrying amount of the Company’s financial assets exposed to credit risk, net of applicable provisions for losses, represents the maximum amount of exposure to credit risk. At September 30, 2011 and 2010, the Company’s financial assets exposed to credit risk are primarily composed of cash and cash equivalents and amounts receivable. The Company is not exposed to any substantial risk as a result of a particular customer or a third party. The concentration of the credit risk associated with accounts receivable is presented in Note 8.
The Company has approximately 83% of its cash and cash equivalents as of September 30, 2011 with two financial institutions. At times, such deposits may exceed the amount insured by the Federal Deposit Insurance Corporation.
Fair value of the financial instruments on the balance sheet
The estimated fair value of the financial instruments is as follows:
The following methods and assumptions were used to calculate the estimated fair value of the financial instruments on the balance sheet.
a) Financial instruments for which fair value is deemed equivalent to carrying amount
The estimated fair value of certain financial instruments shown on the consolidated balance sheet is equivalent to their carrying amount. These financial instruments include cash and cash equivalents, accounts receivable, net, accounts receivable from the parent company, accounts payable and accrued liabilities.
b) Long-term debt
The fair value of the long-term debt bearing interest at fixed rates has been established according to market prices obtained from a large U.S. financial institution. The fair value of the variable interest bearing term loan has been established based on broker-dealer quotes.
19. Derivates and Hedging Activities
Risk management objective of using derivatives
The Company is exposed to certain risks arising from both its business operations and economic conditions. The Company principally manages its exposures to a wide variety of business and operational risks through management of its core business activities. The Company manages economic risks, including interest rate, liquidity and credit risk primarily by managing the amount, sources, conditions and duration of its debt funding and the use of derivative financial instruments. Specifically, the Company enters into derivative financial instruments to manage exposures that arise from business activities that result in the payment of future known and uncertain cash amounts, the value of which are determined by interest rates. The Company’s derivative financial instruments, if any, are used to manage differences in the amount, timing and duration of the Company’s known or expected cash payments principally related to the Company’s borrowings.
Cash flow hedges of interest rate risk
The Company’s objectives in using interest rate derivatives are to add stability to interest expense and to manage its exposure to interest rate movements. To accomplish this objective, the Company primarily uses interest rate swaps as part of its interest rate risk management strategy. Interest rate swaps designated as cash flow hedges involve the receipt of variable-rate amounts from a counterparty in exchange for the Company making fixed-rate payments over the life of the agreements without exchange of the underlying notional amount. During the year ended September 30, 2011, such derivatives were used to hedge the variable cash flows associated with a portion of the existing variable-rate debt.
The effective portion of changes in the fair value of derivatives designated and that qualify as cash flow hedges is recorded in Accumulated Other Comprehensive Income and is subsequently reclassified into earnings in the period that the hedged forecasted transaction affects earnings. The ineffective portion of the change in fair value of the derivatives is recognized directly in earnings.
On April 4, 2011, the Company entered into two separate pay-fixed, receive-floating interest rate swap agreements with an effective date of June 30, 2011 effectively converting a portion of the variable rate debt under its Amended and Restated Senior Secured Credit Facilities to fixed rate debt. The first swap has a notional amount of $331,000,000 amortizing to $84,000,000 by its maturity in December 2015. The second swap has a notional amount of $219,000,000 and matures in December 2016. These swaps were designated as cash flow hedges of interest rate risk. The interest rate swaps will effectively fix the Company’s interest payments on
the hedged debt at 2.386% for the first swap and 3.18% for the second swap, respectively, inclusive of a LIBOR floor of 1.5%, plus the appropriate margin on each debt interest period which is currently 4%. As of September 30, 2011, the Company had two interest rate swaps with a combined notional amount of $550,000,000 that were designated as cash flow hedges of interest rate risk. The weighted average fixed interest rate on these swaps is 2.7%.
In March 2009, the Company had entered into a pay-fixed, receive-floating interest rate swap of a notional amount of $52,000,000 amortizing to $13,000,000 through February 2010. In March 2008, the Company had entered into two pay-fixed, receive-floating interest rate swap agreements of a combined notional amount of $115,000,000. The Company’s $65,000,000 notional interest rate swap matured in February 2009. The Company’s remaining two interest rate swaps with a combined notional amount of $63,000,000 that were designated as cash flow hedges of interest rate risk matured during the quarter ended March 31, 2010.
Amounts reported in Accumulated Other Comprehensive Income related to derivatives will be reclassified to interest expense as interest payments are made on the Company’s variable-rate debt. The Company estimates that $6,532,000 presently classified in Accumulated Other Comprehensive Income will be reclassed as an increase to interest expense during the next year.
The table below presents the fair value of the Company’s derivative financial instruments as well as their classification on the Consolidated Balance Sheet as of September 30, 2011.
Tabular disclosure of fair values of derivative instruments
The tables below present the effect of the Company’s derivative financial instruments on the consolidated operations for the years ended September 30, 2011, 2010 and 2009.
Tabular disclosure of the effect of derivative instruments for the years ended September 30, 2011, and 2010:
The Company has agreements with each of its derivative counterparties that contain a provision where the Company could be declared in default on its derivative obligations if repayment of the underlying indebtedness is accelerated by the lender due to the Company’s default on the indebtedness. If the Company had breached this provision, it could have been required to settle its obligations under the agreements at their termination value, including accrued interest and excluding any adjustment for nonperformance risk, related to these agreements of $18,858,000. The Company has not posted any collateral related to these agreements.
20. Fair Value Measurements
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The guidance also establishes a fair value hierarchy which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The guidance describes three levels of inputs that may be used to measure fair value:
Level 1 - Quoted prices in active markets for identical assets or liabilities.
Level 2 - Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3 - Inputs that are unobservable and significant to the overall fair value measurement.
If the inputs used to measure the financial assets and liabilities fall within the different levels described above, the categorization is based on the lowest level input that is significant to the fair value measurement of the instrument.
Financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2011 and September 30, 2010 are summarized below:
Derivative financial instruments represent interest rate swap agreements as more fully described in Note 19 and are measured at fair value based on market observable interest rate curves as of the measurement date. There are no other financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2011.
During the year ended September 30, 2010, the Company recorded a goodwill impairment charge of $91,400,000 and an intangible assets impairment charge of $15,758,000 related to the PEPs event. The fair value measurement method used in the Company’s impairment analysis utilized a discounted cash flow model and market approach that incorporates significant unobservable inputs or Level 3 assumptions. These assumptions include, among others, projections of the Company’s future operating results, the implied fair value using an income approach by preparing a discounted cash flow analysis and other subjective assumptions.
21. Related Party Transactions
At September 30, 2011, the Company had a note receivable from its parent company amounting to $78,154,000 ($133,154,000 at September 30, 2010). During the year ended September 30, 2011, the parent company made a partial repayment of $55,000,000 on the note receivable from the contributions made by Aptalis Holdings of proceeds received from an equity investment made by Investor Growth Capital Limited managed funds. The Company earned interest income on the note of $6,307,000 (net of taxes of $3,397,000) during the year ended September 30, 2011. The Company earned interest income on the note of $7,833,000 (net of taxes of $4,217,000) during the years ended September 30, 2010 and 2009 respectively. The related interest receivable from the parent company amounting to $36,835,000 at September 30, 2011, ($27,130,000 at September 30, 2010) has been recorded in the shareholder’s equity section of the consolidated balance sheet. This amount was subject to a full provision which was also recorded in the statement of shareholder’s equity. At September 30, 2011, the Company has also an account receivable from the parent company amounting to $676,000 ($487,000 at September 30, 2010).
The Company recorded charges pursuant to the terms of a management fee arrangement with a controlling shareholding company of $3,607,000 during the year ended September 30, 2011 ($4,412,000 and $5,351,000 for the years ended September 30, 2010 and 2009 respectively). Also, during the year ended September 30, 2011, the Company recorded fees from a controlling shareholding company amounting to $5,028,000 of which $1,508,000 was accounted for as deferred debt issue costs, $2,514,000 as selling and administrative expense and $1,006,000 as financing fees. At September 30, 2011, the Company accrued fees payable to a controlling shareholding company amounting to $1,354,000 ($1,574,000 at September 30, 2010).
The Company paid a dividend to its parent company of $440,000 during the year ended September 30, 2011 ($128,000 and $500,000 for the years ended 2010 and 2009 respectively) to allow for the payment of certain group expenses.
22. Commitments and Contingencies
a) Commitments
The Company has entered into non-cancellable operating leases and service agreements with fixed minimum payment obligations expiring on different dates for the rental of office space, automotive equipment and other equipment and for administrative, research and development and other services.
Minimum future payments under these commitments for the next years are as follows:
b) Licensing agreements
In March 2010, the Company entered into an asset purchase and license agreement to acquire rights in and to the intellectual property, assigned contracts, permits and inventories related to a compound to be used in the development of an undisclosed product in the field of gastroenterology. Certain other rights were licensed under the agreement. Pursuant to the agreement, the Company made an upfront payment of $8,000,000 on closing and additional payments of up to $86,000,000 based on the achievement of certain development, regulatory and commercialization milestones. In addition, the Company will pay royalties on the basis of net sales of an approved product.
c) Royalties
The Company pays royalties on the sales of certain of its marketed products to unrelated third parties under license and similar agreements.
During the year ended September 30, 2011, the Company charged to cost of goods sold a total of $368,000 ($2,404,000 and $5,330,000 for the years ended September 30, 2010 and 2009 respectively) in royalties in connection with the sales of certain of its products, the most significant of which are URSO®, ULTRASE®, VIOKASE®, and PYLERA®.
d) Contingencies
The Company and its subsidiaries are involved in litigation matters arising in the ordinary course and conduct of its business.
In May 2009, the Company entered into an agreement with the U.S. Department of Defense, or DOD, to remain eligible for inclusion on the DOD’s formulary and pursuant to which the Company agreed to pay rebates under the TRICARE retail pharmacy program. The Company began accounting for these rebates in the third quarter of fiscal year 2009. Under its contracting process, the DOD is further seeking rebates from pharmaceutical manufacturers on all prescriptions of covered prescription drugs filled under TRICARE from January 28, 2008, forward, unless DOD agrees to a waiver or compromise of amounts due. On November 30, 2009, in litigation initiated by third parties seeking to have the DOD’s ability to seek retroactive rebates invalidated, the Court affirmed DOD’s position that it is entitled to retroactive refunds on prescriptions filled on or after January 28, 2008. In October 2010, the DOD affirmed its former rulemaking which was the subject of litigation and its intention to seek to collect rebates for periods prior to the contract date.
The Company has estimated that its exposure to the retroactive rebates claimed by the DOD would not be material and has recorded an accrual in fiscal year 2010.
e) Litigation settlement
The Company initiated claims in damages under the U.S. Lanham Act against a number of defendants alleging they falsely advertised their products to be similar or equivalent to ULTRASE®. During the fiscal year ended September 30, 2009, a settlement arrangement with respect to these claims was entered into with certain of these defendants and in the second quarter of fiscal year 2010, another settlement agreement was entered into with the remaining defendants. Pursuant to each of the agreements, the settling defendants agreed to pay a confidential global amount in one or several installments; all of which have now been paid. Additionally, in the fourth quarter of fiscal year 2010, pursuant to the settlement of another matter in which the Company was a defendant, the Company received compensation for legal fees incurred by reason of having to defend against unfounded claims made by the plaintiff. A total amount of $9,704,000 was paid to the Company during the year ended September 30, 2010, ($3,500,000 during the year ended September 30, 2009) in respect of these settlement agreements. These amounts were recorded as other income in the statement of operations.
23. Condensed Consolidated Financial Information
As of September 30, 2011, the Company had an aggregate principal amount of $744,375,000 of Senior Secured Term loan Facility Outstanding. The Senior Secured Term Loan Facility is fully and unconditionally guaranteed, jointly and severally by certain of the Company’s wholly-owned subsidiaries.
The following supplemental tables present condensed consolidated balance sheets of the Company and its subsidiary guarantors and non-guarantors at September 30, 2011, and September 30, 2010 and the condensed consolidated statements of operations and cash flows for the years ended September 30, 2011, 2010 and 2009.
Condensed consolidated balance sheet as of September 30, 2011
Condensed consolidated operations for the year ended September 30, 2010
Condensed consolidated operations for the year ended September 30, 2009
Condensed consolidated cash flows cash flows for the year ended September 30, 2010
Condensed consolidated cash flows cash flows for the year ended September 30, 2009
ITEM 9.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
Not applicable.
ITEM 9A.
ITEM 9A. CONTROLS AND PROCEDURES
(a) Evaluation of disclosure controls and procedures.
We conducted an evaluation under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act), as of September 30, 2011, the end of the period covered by this Annual Report on Form 10-K. Based upon this evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures are effective.
(b) Changes in internal control over financial reporting.
We conducted an evaluation under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the internal control over financial reporting, as required by Rule 13a-15(d) under the Exchange Act, to determine whether any changes occurred during the fourth fiscal quarter covered by this annual report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. Based on that evaluation, there has been no such change during the fourth fiscal quarter covered by this annual report.
(c) Management’s report on internal control over financial reporting.
Management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act). Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP. Internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, and that receipts and expenditures of the company are being made only in accordance with authorizations of
management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the interim or annual consolidated financial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Our management conducted an assessment of the effectiveness of our internal control over financial reporting as of September 30, 2011. In making this assessment, management used the criteria established in the report entitled “Internal Control-Integrated Framework” issued by the Committee of Sponsoring Organizations of the Treadway Commission (the “COSO Report”). Management concluded that we did maintain effective internal control over financial reporting as of September 30, 2011, based on the criteria established in the COSO Report.
This annual report does not include an attestation report of the company’s independent registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by the company’s independent registered public accounting firm pursuant to rules of the Securities and Exchange Commission that permit the company to provide only management’s report in this annual report.
ITEM 9B.
ITEM 9B. OTHER INFORMATION
Not applicable.
PART III
ITEM 10.
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Directors and Executive Officers
Below is a list of the names, ages and positions, and a brief account of the business experience, of (1) the individuals who serve as our executive officers and as members of our Board of Directors, or the Board, and (2) the individuals who serve as the executive officers and members of the Board of Directors of our indirect parent Aptalis Holdings. We include director and management information for both us and Aptalis Holdings, an entity controlled by the Sponsor and the Co-Investors, and certain decisions relating to our business are made by the Board of Directors of Aptalis Holdings, or the Aptalis Holdings Board, in their capacity as our indirect parent. See “Item 11.
ITEM 11. EXECUTIVE COMPENSATION
Introduction
In this section, unless otherwise noted, for purposes of presenting in U.S. dollars the cash compensation paid to named executive officers and directors in non-U.S. currency, we have used the following exchange rates: 0.9860 Canadian dollars to 1 U.S. dollar and 0.7147 Euros to 1 U.S. dollar. These exchange rates are the average of the monthly average exchange rates for each respective currency conversion during fiscal year 2011 as reported by The Bank of Canada. Unless otherwise specified, the source of all exchange rates mentioned in this section is The Bank of Canada.
Compensation Discussion and Analysis
Overview
This section includes information regarding, among other things, the overall objectives of our compensation programs and each element of compensation that we provided in fiscal year 2011. The goal of this section is to provide a summary of our executive compensation practices and the decisions that we made during this period concerning the compensation package payable to our executive officers, including the five executives listed in the summary compensation table below. Each of the executives listed in the summary compensation table is referred to herein as a “named executive officer.” Our “named executive officers” for fiscal year 2011 were:
Dr. Frank Verwiel, President and Chief Executive Officer;
Steve Gannon, Senior Vice President, Chief Financial Officer and Treasurer;
John Fraher, President, Pharmaceutical Technologies;
Theresa Stevens, Senior Vice President, Chief Corporate Development Officer; and
Jean-Louis Anspach, President, International Specialty Pharmaceuticals.
This section should be read in conjunction with the detailed tables and narrative descriptions under “Executive Compensation Tables” below.
It is generally the responsibility of the Compensation Committee of Holdings, or the Holdings Compensation Committee, to review and recommend to the Board of Directors of Holdings, or Holdings Board, for its approval at the beginning of the fiscal year (1) the corporate goals and objectives that are relevant to the determinations regarding the compensation of our executive officers for the upcoming fiscal year and (2) the level and form of compensation to be offered to our President and Chief Executive Officer and other named executive officers. After the conclusion of each fiscal year, the Holdings Compensation Committee evaluates the performance of its executive officers against these predetermined goals and objectives along with the effectiveness of the respective executive officer’s leadership and makes recommendations to the Holdings Board with respect to the incentive compensation that should be paid to such executive officers, including the named executive officers. Dr. Verwiel is excluded from participating in his own performance evaluation and compensation determination.
The most significant development in our executive compensation philosophy following the consummation of the February 2008 Transaction has been a greater emphasis on the correlation between compensation and long-term equity growth. In this regard, the Holdings Board has provided to certain employees significant equity investment opportunities in Holdings tied to our financial objectives by (1) offering such employees a one-time opportunity to purchase shares of Holdings common stock and (2) granting to such employees options to purchase shares of Holdings common stock.
Executive Compensation Philosophy and Objectives
Our executive compensation philosophy is to provide and maintain a total compensation program that is internally equitable in relation to the value of each job and externally competitive in relation to the total compensation levels and practices at other companies with similar revenue levels in the pharmaceutical industry and geographic areas, and that also recognizes the Company’s performance. A cornerstone of the executive compensation philosophy is that equity incentives in the form of stock options are an excellent motivation for employees, including executive officers, and serve to align the interests of employees, management and investors.
We believe our success depends upon the continued contributions of our named executive officers. Our executive compensation program, or the Program, is designed to attract and retain experienced and talented individuals and motivate them to achieve overall business results and individual performance that contribute to our long-term success. The Program has been developed and administered in a manner to reward superior operating performance while maximizing shareholder value; and rewards have been linked to the accomplishment of specific business goals and outstanding individual performance.
The Holdings Board and Holdings Compensation Committee, when making compensation decisions in fiscal year 2011, followed these four principles:
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Performance-based: Executive compensation levels were intended to reflect both company and individual results based on specific quantitative and qualitative objectives established at the start of each fiscal year in keeping with our short-term, mid-term and long-term strategic objectives.
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Aligned with shareholder interests: We sought to align the interests of the executive officers with the interests of its investors by evaluating executive performance on the basis of key financial measurements which were believed to be closely correlated to long-term shareholder value. Key elements of the Program that were meant to align the interests of our executive officers with shareholders include:
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Performance-based annual cash incentives, which use adjusted EBITDA and net sales as measures of corporate performance; and
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The Aptalis Holdings Inc. Management Equity Incentive Plan, or the Management Equity Incentive Plan, which provides for the grant of options to executives with the intention of encouraging them to increase shareholder value.
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Market competitive: Our total direct compensation for executives was designed to be competitive with total direct compensation of executives of comparable peer companies and to consider company and business operations results relative to the results of peers. See “Compensation Methodology-Benchmarking Practices” below.
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Individual considerations: Our compensation levels were also designed to reflect individual factors such as scope of responsibility, experience and performance against individual objectives.
Compensation Methodology
The Program consists of the following three basic components: (1) base salary that is internally equitable and externally competitive; (2) annual performance-based cash incentives linked to our performance and the performance of its individual executive officers; and (3) long-term equity incentives comprised of equity-based compensation. Each compensation component has a different function. Base salary is the cornerstone of the compensation package and is defined as fixed compensation paid to employees for performing specific job responsibilities. The purpose of our annual performance-based cash incentives is to maximize corporate and individual performance by establishing specific, aggressive yearly operational and financial goals and providing financial incentives to employees based on their level of achievement of these goals. Our long-term equity incentives are designed to retain talent and align employee interests with those of shareholders. All compensation elements are intended to work in concert to maximize corporate and individual performance by establishing specific, aggressive operational and financial goals and by providing financial incentives to employees based on their level of achievement of these goals.
Benchmarking Practices
In fiscal year 2011, we engaged Mercer to conduct a compensation analysis for our top executive positions. In conducting its analysis, the comparator peer group included 35 specialty pharmaceutical and biotechnology companies similar in size with revenues within .5x and 2.5x of ours and included both public and private companies.
Results of the assessment show that executive compensation was generally in line with market. However, as discussed below, the base salaries of the President and Chief Executive Officer, Senior Vice President, Chief Financial Officer and Treasurer, and Senior Vice President and Chief Corporate Development Officer were adjusted to be better positioned within the salary range reflected in the peer group. We believe that each component of our Program in fiscal year 2011 was aligned with competitive market practices and levels of compensation for executives from competitor organizations of comparable revenue and market capitalization size, and from other pharmaceutical companies with whom we compete for talent.
Compensation Elements
During fiscal year 2011, the principal elements of compensation for our named executive officers were (1) base salary; (2) performance-based annual cash incentives; (3) long-term equity incentives; and (4) other benefits and perquisites.
Base Salary
We believe that competitive base salary is required in order to provide our named executive officers with a stable income stream that is commensurate with their responsibilities and market conditions. The base salaries for our named executive officers in fiscal year 2011 were established with consideration to the criteria discussed above in “Executive Compensation Philosophy and Objectives” and “Compensation Methodology.” Base salary adjustments for our named executive officers in fiscal year 2011 were established by the Holdings Compensation Committee. As set forth in the table below, for fiscal year 2011, base salary adjustments for our named executive officers ranged from 0% to 6% based on the named executive officer’s individual performance and position within the relevant salary range.
Dr. Verwiel’s base salary was increased by 2.50%, from $645,000 to $661,125, effective October 1, 2010, Mr. Gannon’s base salary was increased by 3.50%, from CDN $383,578 to CDN $397,018, on October 1, 2010 and Ms. Stevens’ base salary was increased by 3.70% on October 1, 2010 and by 5.50% on March 21, 2011, for a cumulative increase from $320,000 to $343,042. In each case, these adjustments were made to bring his or her compensation into a more competitive market position. Payments of base salaries were made in the currency of the named executive officer’s country of residence. The base salaries for our other named executive officers during fiscal year 2011 are set forth below in “Executive Compensation Tables-Summary Compensation Table”. Please note that the base salary figures for Mr. Gannon disclosed in the Summary Compensation Table are reflected in U.S., rather than Canadian, dollars.
Performance-Based Cash Incentives
During fiscal year 2011, our named executive officers received performance-based incentive compensation in accordance with the Company’s annual cash incentive program, or Incentive Program which is designed to maximize corporate and individual performance by establishing specific, ambitious operational and financial goals at the beginning of the fiscal year and providing financial incentives to employees based on the level of achievement of these goals. Cash incentives granted to the named executive officers under the Incentive Plan require the approval of both the Holdings Compensation Committee and Holdings Board and are based upon an assessment of corporate and individual performance, respectively described as:
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Corporate performance, a measure of adjusted EBITDA and corporate net sales; and
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Individual performance, determined by means of an evaluation under our formal performance management program and general discharge of duties.
The weighting of corporate performance measures varies for each named executive officer, and is described in more detail below.
Under the Incentive Program, incentive compensation awards are not paid to our named executive officers, including the President and Chief Executive Officer, if minimum corporate and individual performance objectives are not met. We have established annual incentive targets to provide median total cash compensation when performance objectives are achieved. The annual incentive target for each of our named executive officers is set forth in his or her respective employment agreement or employment letter agreement, as applicable.
The following table sets forth the annual incentive targets for each named executive officer, as well as the weighting of corporate performance measures for each named executive officer. In accordance with the Incentive Program, corporate weighting varies depending on the specific responsibilities and span of control of the respective named executive officer.
(1) Does not include Match Payment related to supplemental retirement plan replacement as described below.
In addition, we determine the potential for incentive compensation in excess of each named executive officer’s annual incentive target when performance objectives are exceeded, and the limitations on incentive compensation (as a percentage of each named executive officer’s t annual incentive target) when performance objectives are not met. The tables below generally illustrates the potential incentive compensation payouts under the Incentive Program based on both corporate and individual performance measures, which are calculated separately. The table below does not illustrate the full incremental range of potential annual incentive compensation payouts.
Upon our achievement of 80% of its corporate goal attainment, 50% of the named executive officer’s annual incentive target would be earned and for approximately every 5% of the corporate goal attainment achieved above the 80% level, the named executive officer’s annual incentive target would increase by 12.5%. For example, if we achieved between 105.0% and 109.9999% of its corporate goal attainment, 112.5% of the named executive officer’s annual incentive target would be earned.
The named executive officer’s annual incentive target amount is multiplied by the Corporate Performance Factor which is then multiplied by such named executive officer’s individual performance factor to determine the amount of the performance-based cash incentive compensation to which an individual is entitled for a given fiscal year. If either corporate performance or individual performance did not meet a certain threshold, then, generally, no incentive award would be granted to the named executive officer. Regardless of corporate and/or individual performance, no non-equity incentive awards are guaranteed and all such awards are subject to the discretion of our Board.
As mentioned above, corporate objectives, or corporate goal attainment, for fiscal year 2011 were based on aggressive adjusted EBITDA and revenue goals.
Each fiscal year, with the exception of our President and Chief Executive Officer, each named executive officer’s individual performance is measured in part by the evaluation of his direct supervisor, who gives his recommended evaluation of the named executive officer to the Holdings Compensation Committee for review and consideration. The Holdings Compensation Committee ultimately makes a recommendation to the Holdings Board for the individual performance evaluation of such named executive officer. The individual performance of Holding’s President and Chief Executive Officer, Dr. Frank Verwiel, is evaluated by the Holdings Compensation Committee and the Holdings Board. In addition, if in any year Dr. Verwiel receives an annual cash incentive as described above, he also receives a Match Payment equal to one-half (1/2) the annual incentive payable with respect to such year, in accordance with his employment agreement with us dated May 16, 2008. The Match Payment is intended to replace the supplemental retirement plan listed in Dr. Verwiel’s employment agreement with Aptalis Pharma dated May 19, 2005. For additional information regarding the Match Payment, please see “Employment Agreements and Potential Payments upon Certain Terminations - Employment Agreement with Dr. Frank Verwiel” below.
For additional information regarding the fiscal year 2011 incentive awards for our named executive officers, please see the “Summary Compensation Table” below.
Long-Term Equity Incentives
Our compensation philosophy places a strong emphasis on long-term equity incentives. As discussed in greater detail below, the Holdings Compensation Committee has provided equity investment opportunities tied to financial objectives.
We do not anticipate that annual grants of long-term equity incentive awards will be made to our named executive officers. Currently, there is one plan under which our named executive officers receive long-term equity incentive awards, the Aptalis Holdings Inc. Management Equity Incentive Plan, or the Management Equity Incentive Plan, which provides for the grant of options to purchase Holdings common stock, or Holdings Options, to our own and our affiliates’ key employees, directors, service providers and consultants. In the past, however, we have also granted to certain of our named executive officers restricted share units and penny options, each as described below in “Equity Grants of Restricted Share Units (RSUs) and Penny Options.”
The Management Equity Incentive Plan was originally adopted on April 15, 2008, and was amended and restated effective February 11, 2011. Under the Management Equity Incentive Plan, each of our named executive officers received equity incentive awards between fiscal years 2008 and 2011. The Management Equity Incentive Plan is discussed in more detail below. As of September 30, 2011, there were 4,144,750 Holdings Options outstanding under the Management Equity Incentive Plan. Of the Holdings Options currently outstanding, Holding Options representing the option to purchase 1,675,000 shares of Holdings common stock were granted to our named executive officers between fiscal years 2008 and 2011. Dr. Verwiel was granted 640,000 Holdings Options in fiscal year 2008, Mr. Gannon has been granted 335,000 Holdings Options in fiscal year 2008, Mr. Fraher was granted 300,000 Holdings Options in fiscal year 2011, and Mr. Anspach was granted 200,000 Holding Options in fiscal year 2011. Ms. Stevens was granted 160,000 Holdings Options in fiscal year 2009 and 40,000 Holdings Options in fiscal year 2011. Ms. Stevens participated in the 2011 option exchange program and exchanged the 160,000 Holdings Options granted in fiscal year 2009 for the same number of Replacement Holdings Options. For additional information regarding the 2011 option exchange program, please see “2011 Option Exchange Program” discussed below. As of September 30, 2011, all of the Holdings Options granted to our named executive officers remained outstanding.
Aptalis Holdings Inc. Management Equity Incentive Plan
The following summary describes what we consider to be the material terms of the Management Equity Incentive Plan. This summary is not a complete description of all provisions of the Management Equity Incentive Plan. You are encouraged to read the full text of the Management Equity Incentive Plan which has been filed as an exhibit to the Form 10-K. All capitalized terms used herein shall have the meaning set forth in the Management Equity Incentive Plan, as amended and restated effective February 11, 2011.
Plan Administration. The Management Equity Incentive Plan is administered by the Holdings Board or a committee appointed by the Holdings Board.
Authorized Shares. Currently, under the Management Equity Incentive Plan, 5,033,307 shares of Holdings common stock have been reserved for issuance. The number of shares was increased by 1,200,000 in February 2011.
Eligibility. The Holdings Board, after consultation with the chief executive officer of Holdings, will select participants from among our affiliates’ key employees, directors, service providers and consultants of Holdings and its affiliates who, in the judgment of the Holdings Board, should be eligible to participate in the Management Equity Incentive Plan due to the services they perform on our behalf.
Types of Awards; Vesting. The Management Equity incentive Plan provides for grants of non-qualified stock options. For each grant made under the Management Equity Incentive Plan, 50% of the Holdings Options vest based solely on continued employment (“time-based options”), 25% of the Holdings Options vest based on continued employment and have an annual accreting exercise price (“premium options”), and 25% of the Holdings Options vest based on continued employment, upon the occurrence of a Liquidity Event and the achievement of specified performance targets (“performance-based options”).
In general, for each grant made under the Management Equity Incentive Plan: (a) the time-based options and premium options shall vest and become exercisable, if at all, on each of the first through fifth anniversaries of the grant date, subject to continued employment of the option holder through the vesting date; and (b) the performance-based options shall vest and become exercisable, if
at all, following the occurrence of a Liquidity Event, upon the realization of certain profits by the Majority Stockholder as a result of such event(s), subject to continued employment of the option holder through the vesting date. For grants of Holdings Options prior to the effective date of the 2011 amendment and restatement of the Management Equity Incentive Plan, such profits were calculated on the basis of receipt by the Majority Stockholder of a certain required return on investment taking into account only the initial Sponsor Price. For grants of Holdings Options on or after the effective date of the 2011 amendment and restatement of the Management Equity Incentive Plan, such profits are calculated on the basis of receipt by the Majority Stockholder of a lower required return on investment, but taking into account both the initial Sponsor Price and the aggregate purchase price of, and all related transaction expenses paid by the Majority Stockholder in connection with the acquisition of, any Subsequent Majority Stockholder Shares.
Termination of Employment. Upon termination of a participant’s employment, the Management Equity Incentive Plan provides that, subject to the terms of any participant’s stock option grant agreement, any unvested portion of a participant’s Holdings Options will be forfeited, and that the vested portion of his or her Holdings Options will expire on the earlier of (1) the date the participant’s employment is terminated for cause, (2) 90 days after the date the participant’s employment is terminated for any reason other than cause, death or disability, (3) one year after the date the participant’s employment is terminated by reason of death or disability, or (4) the tenth anniversary of the grant date of the Holdings Options. However, if a participant’s employment is terminated by us without Cause or by the participant for Good Reason during the two-year period following a Change in Control, all time-based and premium options will immediately vest and become exercisable as of the date of such termination.
Adjustment. In the event of certain changes in our capital structure, the Holdings Board shall make appropriate adjustments to the maximum number of shares that may be delivered under the Management Equity Incentive Plan, and shall also make appropriate adjustments to the number and kinds of shares or stock or securities subject to the awards, the exercise prices of such awards and nay other terms of the awards affected by such change in our capital structure. The Holdings Board may also make the types of adjustments described above to take into account events other than those listed above if it determines that such adjustments are appropriate to avoid distortion and preserve the value of such awards.
Management Stockholders’ Agreement. Prior to receiving shares of Holdings common stock (whether pursuant to the exercise of Holdings Options or otherwise), participants must execute a Management Stockholders’ Agreement, which provides that the shares are subject to certain transfer restrictions, put and call rights, and tag-along and drag-along rights.
French Sub-Plan. For our employees who are residents of France, the Management Equity Incentive Plan includes a French sub-plan, which amends certain guidelines set forth in the Management Equity Incentive Plan, including certain provisions regarding termination of employment, in order to allow our French employees to benefit from, as it relates to the Holdings Options, a favorable tax and social regime under French law.
2011 Option Exchange Program
During fiscal year 2011, we offered option holders the opportunity to participate in an option exchange program, whereby eligible option holders could choose whether to keep their outstanding eligible Holdings Options granted under the Management Equity Incentive Plan, as in effect prior to February 11, 2011, or to exchange such Holdings Options for an equal amount of replacement options granted under the Management Equity Incentive Plan, as amended and restated effective February 11, 2011, with an exercise price and vesting terms that were different than the original Holdings Options (“Replacement Holdings Options”).
The option exchange program began on July 21, 2011 and ended at midnight on September 16, 2011. Replacement Holdings Options were granted effective September 22, 2011. Under the option exchange program, Holdings Options representing options to purchase an aggregate of 785,000 shares of Holdings common stock were cancelled in exchange for Replacement Holdings Options. Nineteen option holders, including Ms. Stevens, participated in the option exchange program. Ms. Stevens exchanged Holdings Options to acquire 160,000 shares of Holdings common stock for Replacement Holdings Options to acquire the same. No other named executive officers participated in the option exchange program.
Option holders that participated in the option exchange program received Replacement Holdings Options under the Management Equity Incentive Plan, as amended and restated effective February 11, 2011, that had substantially the same terms and conditions as their tendered Holdings Options so tendered, except that:
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The exercise price of each share underlying the Replacement Holdings Options was reduced to the fair market value of a share of Holdings common stock as of the grant date of the Replacement Holdings Options;
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The portion of the Replacement Holdings Options that were time-based options retained the same vesting schedule as the original Holdings Options, measured from the original grant date of each tendered Holdings Options;
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The portion of the Replacement Holdings Options that were premium options contained the following vesting schedule: (a) 20% of the shares underlying the premium option vested immediately on the grant date of the Replacement Holdings Options; and (b) 20% of the shares underlying the premium options will vest on each of the first, second, third and fourth anniversary of the grant date of the Replacement Holdings Options. In addition, the portion of the Replacement Holdings Options that were premium options had an accreting exercise price whose initial value was reset to the fair market value at the grant date of the Replacement Options and that increased on each anniversary of that date, rather than the original grant date of the tendered Holdings Options.
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The portion of the Replacement Holdings Options that were performance-based options will be eligible for vesting on the basis of receipt by the Sponsor and its affiliates of a return on investment, taking into account the initial Sponsor Price, plus the aggregate purchase price of, and all related transaction expenses paid by the Majority Stockholder in connection with the acquisition of, any Subsequent Majority Stockholder Shares as of July 21, 2011, subject to the participant’s continued employment through the applicable vesting date. The required return on the investment of the Replacement Holdings Options was reduced from the return on investment applicable to the original Holdings Options.
Equity Grants of Restricted Share Units (RSUs) and Penny Options
Dr. Verwiel, in consideration of his continued employment with us, received nonrecurring equity grants of 77,834 Restricted Stock Units (RSUs) on April 15, 2008, which vested immediately upon grant and settled April 15, 2011; 29,631shares were withheld to pay withholding taxes. Dr Verwiel received an additional grant of 155,666 RSUs on August 25, 2009, one-half of which vested immediately upon grant and one-half of which vested on August 25, 2011. Outstanding RSUs shall be settled into shares of Holdings common stock, with certain exceptions, on the earlier of: (1) three years from the date of grant, or April 15, 2012; (2) the termination of the officer’s employment; (3) a Liquidity Event (as defined in the Management Equity Incentive Plan); and (4) a Change in Control (as defined in the Management Equity Incentive Plan).
Mr. Gannon, in consideration of his continued employment with us, received a one-time equity grant on April 15, 2008 in the form of penny options, or options to purchase shares of common stock of Holdings for $0.01. Mr. Gannon received 96,436 penny options pursuant to the terms of a Penny Option Grant Agreement which each officer granted penny options entered into with Holdings on April 15, 2008. Approximately one-third of these penny options vested on April 15, 2008, one-third vested on August 25, 2009 and the remainder of the penny options vested on August 25, 2010.
Other Benefits and Perquisites
Benefits
Our benefit programs are targeted to be competitive with other pharmaceutical companies, and include participation in competitive health, welfare and retirement plans. The benefit programs provided to our named executive officers are generally the same benefits provided to all of our eligible employees. Although the types of benefits offered to our named executive officers were similar, the cost paid by us to secure such benefits varied depending on the country of residence of the named executive officer.
Perquisites
As disclosed in the “All Other Compensation” column of the “Summary Compensation Table” below in “Executive Compensation Tables”, we provided our named executive officers with additional compensation in the form of perquisites during fiscal year 2011. This compensation was targeted to be competitive with other pharmaceutical companies and included, in the case of each named executive officer, a car allowance or a company-provided vehicle.
Retirement Plans
During fiscal year 2011, we maintained a group registered retirement savings plan (RRSP/DPSP), for all of our Canadian employees and a tax-qualified defined contribution plan in the form of a 401(k) Plan for all of our U.S. employees, including in each case our named executive officers residing in each location. Additionally, we maintain a non-registered Employee Profit Sharing Plan for Canadian executives designed to allow salaried employees above a certain salary level to contribute to and benefit from matching employer contributions up to a certain threshold, as described below, because the amount of contributions under the RRSP/DPSP is capped under relevant Canadian regulations. An employee was eligible to participate in the Employee Profit Sharing Plan during fiscal year 2011 if he or she (1) was a regular employee working in Canada with a base salary of $224,500 during fiscal year 2011 and (2) was a participant in the RRSP/DPSP during fiscal year 2011 and his or her total contribution reached the maximum allowed by the Canadian government ($22,450 in fiscal year 2011). If the employee met the criteria set forth above, he or she could then make after income tax contributions into the Employee Profit Sharing Plan and receive matching employer contributions up to 5% of his or her base salary. Employer contributions are made before income tax and employee pays taxes at the end of the calendar year on his/her income tax return. Mr. Gannon participated in this program in fiscal years 2009, 2010 and 2011.
We did not maintain a supplemental retirement plan, pension plan or any other retirement benefits for any executive, including our named executive officers, or employee groups other than those described above.
Compensation Committee Report
The following report of the Holdings Compensation Committee is included in accordance with the rules and regulations of the Securities and Exchange Commission.
The Holdings Compensation Committee has reviewed and discussed the Compensation Discussion and Analysis, or CD&A, with management. Based upon the review and discussions, the Holdings Compensation Committee recommended to the Board of Directors of Aptalis Pharma Inc., and such board approved, that the CD&A be included in the Form 10-K for the year ended September 30, 2011.
Respectfully submitted on December 1, 2011 by the members of the Compensation Committee of the Board of Directors of Aptalis Holdings Inc.:
Todd Sisitsky
Fred Cohen
Frank Verwiel
Executive Compensation Tables
In fiscal years 2011, 2010 and 2009, certain of our named executive officers were compensated in either U.S. or non-U.S. currency, depending on the named executive officer’s country of residence. For conversions of Canadian dollars to U.S. dollars in fiscal year 2011, this rate was equal to 0.9860 and for conversions of Euros to U.S. dollars, this rate was equal to 0.7147. For conversions of Canadian dollars to U.S. dollars in fiscal year 2010, this rate was equal to 1.0498 and for conversions of Euros to U.S. dollars, this rate was equal to 0.7376. For conversions of Canadian dollars to U.S. dollars in fiscal year 2009, this rate was equal to 1.1778 and for conversions of Euros to U.S. Dollars, this rate was equal to 0.7419. As designated by footnotes, figures related to equity compensation in the tables below may have been converted using a different exchange rate in order to accurately reflect values related to such equity compensation at a particular time, such as the date of grant.
Summary Compensation Table
The information set forth below reflects the compensation awarded to, earned by, or paid to our named executive officers in fiscal years 2011, 2010 and 2009 for their services rendered in all capacities to us and our subsidiaries.
(1) Through June 30, 2009, Dr. Verwiel was compensated in Canadian dollars. In fiscal year 2009, Dr. Verwiel was paid $490,807 in Canadian dollars, $161,250 in U.S. dollars and a currency exchange adjustment of $99,018.29 in Canadian dollars.
(2) Amounts set forth in the Restricted Stock Awards column represents the aggregate grant date fair value of restricted stock and certain other equity awards granted to our named executive officers during the fiscal years ended September 30, 2011, 2010 and 2009 and calculated in accordance with the guidance issued by the FASB on stock compensation. For a discussion of the assumptions used in calculating award values for fiscal years 2011, 2010 and 2009, see Note 12 to our audited consolidated financial statements for the fiscal year ended September 30, 2011, contained in this report. The value set forth in this column for Dr. Verwiel represents aggregate grant date fair value of our grant of Restricted Stock Awards calculated in accordance with the guidance issued by the FASB on stock compensation.
(3) Amounts set forth in the Option Awards column represent the aggregate grant date fair value of awards granted to the named executive officers during the fiscal years ended September 30, 2011, 2010 and 2009 and calculated in accordance with the guidance issued by the FASB on stock compensation. The fair value of the service based options was calculated using a Black-Scholes option-pricing model. Values for awards subject to performance conditions are calculated based upon the probable outcome of the performance condition as of the grant date using a Monte Carlo simulation model. The amounts also include the incremental fair value of any repriced options. For a discussion of the assumptions used in calculating award values for fiscal years 2011, 2010 and 2009, see Note 12 to our audited consolidated financial statements for the fiscal year ended September 30, 2011, contained in this report.
(4) The values in this column represent, in U.S. dollars, incentive awards under the Incentive Program earned by the named executive officers in fiscal years 2011, 2010 and 2009, but paid in fiscal years 2012, 2011 and 2010. The non-equity incentive awards for Mr. Fraher and Mr. Anspach have been prorated based on the amount of time served in their respective positions. Since the incentive award granted to Mr. Gannon was paid in Canadian dollars, the value for such award has been converted to U.S. Dollars. For fiscal year 2010, an exchange rate of 1.0498 Canadian dollars to one U.S. dollar and 0.7376 Euros to one U.S. dollars was used for the conversion. For fiscal year 2009, an exchange rate of 1.0574 Canadian dollars to one U.S. dollar and 0.6670 Euros to one U.S. dollars was used for the conversion.
(5) Amounts set forth in the Base Salary column represent, in U.S. dollars, the salaries earned by our named executive officers during the fiscal years ended September 30, 2011, 2010 and 2009. The salary paid to Mr. Gannon was paid in Canadian dollars. Mr. Fraher and Mr. Anspach’s salary amounts represent the amount paid by Aptalis during their employment periods with the Company (February through October 2011).
(6) During fiscal year 2011, Ms. Stevens participated in the option exchange program. Under the option exchange program, Ms. Stevens exchanged Holdings Options to acquire 160,000 shares of Holdings common stock, which she had originally acquired during fiscal year 2009, for Replacement Holdings Options to acquire 160,000 shares of Holdings common stock, with exercise price and vesting terms that were slightly different than the tendered Holdings Options. In addition, in fiscal year 2011, Ms. Stevens received another grant of 40,000 Holding Options. For additional information regarding the 2011 option exchange program, please see “2011 Option Exchange Program” discussed above.
(7) All other compensation for fiscal year 2011 includes the compensation set forth in the table below:
(a) Company contributions to defined contribution plans include contributions to RRSP/DPSP matching funds and 401(k) during fiscal year 2011.
(b) The Insurance Premiums column includes payments for life and disability insurance, as well as medical and dental benefits. In addition, $3,656 in fiscal year 2011 in additional life insurance and long-term disability premiums was paid on behalf of Dr.Verwiel.
(c) Pursuant to the terms of Dr. Verwiel’s employment agreement, he received a Match Payment of $247,922, a payment equal to one-half of his non-equity incentive award for fiscal year 2011. In addition, pursuant to the terms of Dr. Verwiel’s employment agreement, we paid $14,224 in fiscal year 2011 for preparation of his annual tax returns and financial planning services.
Pursuant to the terms of Mr. Fraher’s employment agreement, we paid $16,475 in legal fees for the preparation of such agreement. In addition, in August 2011, the third tranche of a Retention Plan payment was made to Mr. Fraher and Mr. Anspach in the amounts of $262,500 and $159,250, respectively.
Grants of Plan-Based Awards
The named executive officers currently do not receive annual grants of long-term equity incentive awards.
(1) This column shows the potential non-equity incentive awards that are possible under the Incentive Program, at the target and maximum levels of performance in fiscal year 2011. The target payments are based on achieving the 100% target level of performance for both corporate financial measures and individual performance measures. See “Compensation Discussion and Analysis- Performance-Based Cash Incentives”, for additional information.
Outstanding Equity Awards at Fiscal Year-End
The following table shows the outstanding equity awards as of the end of fiscal year 2011 for each of our named executive officers:
(1) These amounts reflect the number vested and unvested time-based options granted to our named executive officers under the Management Equity Incentive Plan. Time-based options vest ratably on each of the first through fifth anniversaries of the date of grant, subject to the named executive officer’s continued employment with us through each anniversary. Dr. Verwiel and Mr. Gannon’s time-based options will become fully vested on April 15, 2013. Mr. Fraher and Mr. Anspach’s time-based options will become fully vested on February 11, 2016. Ms. Stevens 20,000 time-based options granted on May 13, 2011 will become fully vested on May 13, 2016. For information regarding Ms. Stevens’ time-based options, please see note 5 below. For additional information regarding the terms of the Management Equity Incentive Program, please see “Aptalis Holdings Inc. Management Equity Incentive Plan,” discussed above.
(2) These amounts reflect the number of vested and unvested premium options granted to our named executive officers under the Management Equity Incentive Plan. Premium options vest ratably on each of the first through fifth anniversaries of the date of grant, subject to the named executive officer’s continued employment with us through each anniversary. Dr. Verwiel and Mr. Gannon’s premium options become fully vested on April 15, 2013. Mr. Fraher and Mr. Anspach’s premium options will become fully vested on February 11, 2016. Ms. Stevens’ 10,000 premium options granted on May 13, 2011 will become fully vested on May 13, 2016. For additional information regarding Ms. Stevens’ premium options , please see note 5 below.
For the premium options of Dr. Verwiel, Mr. Gannon, Mr. Fraher and Mr. Anspach, the exercise price of these options increases at a 10.00% compound rate on each anniversary of the date of grant of such options until, with certain exceptions, the earlier of: (a) the exercise of such option; (b) the fifth anniversary of the grant date of such option; (c) a Liquidity Event (as defined in the
Management Equity Incentive Plan) or (d) the occurrence of a Change in Control (as defined in the Management Equity Incentive Plan) of Aptalis Holdings Inc. Ms. Stevens’ 10,000 premium options granted on May 13, 2011 have the same exercise price provisions as that which is described in the immediately preceding sentence. For information regarding the exercise provision of Ms. Stevens’ premium Replacement Holdings Options, please see note 5 below. For additional information regarding the terms of the Management Equity Incentive Program, please see “Aptalis Holdings Inc. Management Equity Incentive Plan,” discussed above.
(3) This amount reflects the number of “penny options”, or options to purchase common stock of Holdings for $0.01, granted to Mr. Gannon, who resides and works in Canada, pursuant to his penny option grant agreement. Approximately one-third of the penny options immediately vested upon grant on April 15, 2008, one-third vested on August 25, 2009, and the remainder of the penny options vested on August 25, 2010.
(4) These amounts reflect the number of performance-based options granted to our named executive officers under the Management Equity Incentive Plan. The vesting of performance-based options depends upon the occurrence of a Liquidity Event and the realization of certain profits by the Majority Stockholders (as defined in the Management Equity Incentive Plan) as a result of such event(s), subject to the named executive officer’s continued employment with us through such Liquidity Event. For Dr. Verwiel and Mr. Gannon, whose option grants are subject to the Management Equity Incentive Plan, as in effect prior to February 11, 2011, such profits are calculated on the basis of receipt by the Majority Stockholders of a return on investment taking into account only the initial Sponsor Price (as defined in the Management Equity Incentive Plan). For Mr. Fraher’s, Ms. Stevens’ and Mr. Anspach’s performance-based options, which are subject to the Management Equity Incentive Plan, as in effect February 11, 2011, such profits are calculated on the basis of receipt by the Majority Stockholder of a return on investment taking into account both the initial Sponsor Price and the aggregate purchase price of, and all related transaction expenses paid by the Majority Stockholder in connection with the acquisition of, any Subsequent Majority Stockholder Shares (as defined in the Management Equity Incentive Plan). For additional information regarding certain of Ms. Stevens’ performance based options, please see note 5 below. For additional information regarding the terms of the Management Equity Incentive Program, please see “Aptalis Holdings Inc. Management Equity Incentive Plan,” discussed above.
(5) During fiscal year 2011, Ms. Stevens participated in the option exchange program. Under the option exchange program, Ms. Stevens exchanged Holdings Options to acquire 160,000 shares of Holdings common stock for Replacement Holdings Options to acquire 160,000 shares of Holdings common stock, with exercise price and vesting terms that were slightly different than the tendered Holdings Options. Of the tendered Holdings Options and Replacement Holdings Options, 80,000 were time-based options, 40,000 were premium options and 40,000 were performance-based options.
The portion of Ms. Stevens’ Replacement Holdings Options that are time-based options retained the same vesting schedule as the tendered Holdings Options that were time-based options. Of the portion of Ms. Stevens’ Replacement Holdings Options that are premium options, (a) 20% vested immediately upon the grant date of the Replacement Holdings Options, and 20% will vest on each of the first, second, third and fourth anniversary of the grant date of the Replacement Holdings Options, and (b) have an accreting exercise price that increases on each anniversary of September 22, 2011, rather than the original grant date of the tendered Holdings Options. Lastly, the portion of Ms. Stevens’ Replacement Holdings Options that are performance-based options vest upon the realization of certain profits by the Majority Stockholders as a result of a Liquidity Event. Such profits are calculated on the basis of receipt by the Majority Stockholder of a return on investment that is lower than the required return on investment applicable to the original Holdings Options, but taking into account both the initial Sponsor Price and the aggregate purchase price of, and all related transaction expenses paid by the Majority Stockholder in connection with the acquisition of, any Subsequent Majority Stockholder Shares (as defined in the Management Equity Incentive Plan). In each case, vesting of the Replacement Holdings Options is subject to Ms. Stevens’ continued employment on the vesting date of such options.
For additional information regarding the 2011 option exchange program, please see “2011 Option Exchange Program” discussed above.
Options Exercised and Stock Vested
In the fiscal year 2011, there were no options exercised by our named executive officers and no shares acquired upon vesting of options held by our named executive officers.
Employment Arrangements and Potential Payments upon Certain Terminations
The following are descriptions of our employment agreements with our named executive officers in effect as of the end of fiscal year 2011. We have employment agreements with Dr. Verwiel, Mr. Gannon and Mr. Fraher, and employment letters with Ms. Stevens, and Mr. Anspach. The benefits that our named executive officers are entitled to receive upon a termination of employment are set forth in their respective employment agreements or employment letter agreements.
Employment Agreement with Dr. Frank Verwiel
On May 16, 2008, we entered into an amended and restated employment agreement with Dr. Verwiel to continue his service as our President and Chief Executive Officer, and to serve as President and Chief Executive Officer of Holdings and as an officer of certain other subsidiaries of Holdings, including Aptalis Pharma Inc. The agreement has an initial five-year term beginning on February 25, 2008, and provides for automatic twelve-month extensions beginning on February 25, 2013, unless either the Company or Dr. Verwiel gives 60 days’ prior notice of termination.
Dr. Verwiel receives a base salary at a rate no less than USD$661,125 per year, which may be adjusted at the Company’s discretion. Although no annual bonus is guaranteed to Dr. Verwiel, he has the opportunity to earn an annual cash bonus of 60% of his base salary for on-target performance, or Target Annual Bonus, with the possibility of achieving 120% of base salary for high achievement. In addition, if in any year Dr. Verwiel receives an annual cash bonus as described above, he is also entitled to receive a Match Payment equal to one-half (1/2) the annual bonus payable with respect to such year.
In addition, Dr. Verwiel received a one-time nonrecurring grant of 640,000 options to purchase shares of Holdings under the Management Equity Incentive Plan. These Holdings Options vest in accordance with our Management Equity Incentive Plan (described above) and have an initial exercise price of $10.00 per share.
Dr. Verwiel also received a grant of a total of 233,500 restricted stock units. 77,834 of these RSUs were granted as fully vested on April 15, 2008 and settled April 15, 2011; and an additional 155,666 RSUs were granted to Dr. Verwiel on August 25, 2009, half of which vested immediately upon grant and half vested on August 25, 2010. Outstanding RSUs will be settled into Holdings common stock, with certain exceptions, upon the earlier of: (1) third anniversary of the grant date; (2) the termination of the officer’s employment; (3) a Liquidity Event (as defined in the Management Equity Incentive Plan); and (4) a Change in Control (as defined in the Management Equity Incentive Plan).
In addition, Dr. Verwiel purchased 75,000 shares of Holdings common stock for an aggregate investment of USD$750,000 pursuant to a subscription agreement and a Management Stockholders’ Agreement. For more details on these agreements, see “Item 13. Certain Relationships and Related Transactions, and Director Independence” in this Annual Report on Form 10-K.
Dr. Verwiel’s agreement also provides tax planning and filing, financial planning and accounting expenses, not to exceed $50,000 in the aggregate on an annual basis.
The agreement further provides that Dr. Verwiel could be entitled to certain severance benefits following a termination of employment. If we terminate him without Cause or if Dr. Verwiel terminates his employment for Good Reason (each as defined in the agreement), all outstanding Holdings Options granted to Dr. Verwiel by us pursuant to the Management Equity Incentive Plan will expire pursuant to the terms of that plan as described above in “-The Aptalis Holdings Inc. Management Equity Incentive Plan” except that, with certain exceptions, any performance-based Holdings Options that have not vested as of the date of termination shall remain outstanding for a 12-month period following termination and if a Liquidity Event (as defined under the Management Equity Incentive Plan) occurs within such period, all, none or one-half of the unvested performance-based options will become vested and exercisable in accordance with the Management Equity Incentive Plan. In addition, Dr. Verwiel would be entitled to the following:
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An amount equal to accrued but unused vacation and base salary through the date of termination, or collectively, the Accrued Benefits, payable within thirty (30) days following the date of termination.
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An amount equal to (a) two times his base salary in effect at the date of termination, plus (b) two times his Target Annual Bonus (which is 60% of Dr. Verwiel’s base salary). This amount is payable in equal, ratable installments in accordance with our regular payroll policies over the course of 24 months.
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Medical benefits which are substantially similar to the benefits provided to our executive officers for 24 months after the date of termination. However, if Dr. Verwiel becomes re-employed with another employer and is eligible to receive comparable benefits, we shall cease to provide continued medical benefits.
If Dr. Verwiel is terminated without Cause or terminates his employment for Good Reason within twelve (12) months following a Change of Control (as defined in the agreement), Dr. Verwiel is entitled to the benefits described above, except that he shall receive an amount equal to two times his base salary and two times his Target Annual Bonus immediately, rather than over a 24-month period.
If Dr. Verwiel is terminated due to Dr. Verwiel’s death, Disability or is terminated with Cause or without Good Reason, we will pay Dr. Verwiel Accrued Benefits (as defined in the agreement).
Employment Agreement with Steve Gannon
On July 3, 2008, we entered into an employment agreement with Mr. Gannon to continue his service to us as our Senior Vice President and Chief Financial Officer, and to serve as Senior Vice President and Chief Financial Officer of Holdings as well as an officer of certain other subsidiaries of Holdings, including as Senior Vice President, Chief Financial Officer and Treasurer of Aptalis Pharma Inc. The agreement has an initial five-year term beginning on February 25, 2008, and provides for automatic twelve-month extensions beginning on February 25, 2013, unless either we or Mr. Gannon give 60 days’ prior notice of termination.
Mr. Gannon receives a base salary at a rate no less than CDN $397,018 per year, which may be adjusted at the Company’s discretion. Although no annual bonus is guaranteed to Mr. Gannon, he has the opportunity to earn an annual cash bonus of at least 45% (in fiscal year 2009, this bonus opportunity was increased from 45% to 50%) of his base salary for on-target performance with the possibility of achieving 90% of base salary for high achievement.
In addition, Mr. Gannon received a one-time nonrecurring grant of 335,000 options to purchase shares of Holdings under the Management Equity Incentive Plan. These Holdings Options vest in accordance with our Management Equity Incentive Plan, as in effect prior to February 11, 2011 (as described above), and have an initial exercise price of $10.00 per share.
Mr. Gannon also received a grant of 96,436 “penny options”, which are options to purchase a share of Holdings common stock for USD $0.01. Subject to Mr. Gannon’s continued employment with us, these penny options vested in three approximately equal installments on April 15, 2008, August 25, 2009 and August 25, 2010.
In addition, Mr. Gannon purchased 20,640 shares of Holdings common stock for an aggregate investment of USD $206,400 pursuant to a subscription agreement and a Management Stockholders’ Agreement. For more details on these agreements, see “Item 13. Certain Relationships and Related Transactions, and Director Independence” in this Annual Report on Form 10-K.
The agreement further provides that Mr. Gannon could be entitled to certain severance benefits following a termination of employment. If we terminate him without Cause or if Mr. Gannon terminates his employment for Good Reason (each as defined in the agreement), all outstanding options granted to Mr. Gannon by us pursuant to the Management Equity Incentive Plan will expire pursuant to the terms of that plan as described above in “-The Aptalis Holdings Inc. Management Equity Incentive Plan” except that, with certain exceptions, any performance-based Holdings Options that have not vested as of the date of termination shall remain outstanding for a 12-month period following termination and if a Liquidity Event (as defined under the Management Equity Incentive Plan) occurs within such period, all, none or one-half of the unvested performance-based options will become vested and exercisable in accordance with the Management Equity Incentive Plan. In addition, Mr. Gannon would be entitled to the following:
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An amount equal to Mr. Gannon’s Accrued Benefits within thirty (30) days following the Date of Termination.
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An amount equal to one-and-a-half times (1.5x) his base salary in effect at the date of termination. This amount is payable in equal, ratable installments in accordance with our regular payroll policies over the course of 18 months.
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Medical benefits which are substantially similar to the benefits provided to our executive officers for 18 months after the date of termination. However, if Mr. Gannon becomes re-employed with another employer and is eligible to receive comparable benefits, we shall cease to provide continued medical benefits.
If Mr. Gannon is terminated without Cause or terminates his employment for Good Reason within twelve (12) months following a Change of Control (as defined in the agreement), Mr. Gannon shall be entitled to the benefits described above, except that he shall receive one-and-a-half times (1.5x) base salary and Target Annual Bonus immediately, rather than over an 18-month period.
If Mr. Gannon is terminated due to Mr. Gannon’s death, Disability, or is terminated with Cause or without Good Reason, we will pay Mr. Gannon Accrued Benefits (as defined in the agreement).
Employment Agreement with John Fraher
On February 27, 2011, we entered into an employment agreement with Mr. Fraher to serve as President of Axcan Pharma (now known as Aptalis Pharma). The agreement has an initial five-year term beginning on February 16, 2011, and provides for automatic twelve-month extensions beginning on February 16, 2016, unless either we or Mr. Fraher give 60 days’ prior notice of termination.
Mr. Fraher participated in a Eurand Retention Plan Agreement dated September 20, 2010, and the Amendment to the Retention Plan Agreement dated November 28, 2010. Pursuant to Mr. Fraher’s employee agreement with the Company, the third tranche of the Retention Payment in the amount of USD$262,500 was made August 2011 following the six-month anniversary of the closing date.
Mr. Fraher receives a base salary at a rate no less than USD$410,000 per year, which may be adjusted at the Company’s discretion. Although no annual bonus is guaranteed to Mr. Fraher, he has the opportunity to earn an annual cash bonus of at least 50% of his base salary for on-target performance, or Target Annual Bonus.
In addition, Mr. Fraher received a one-time nonrecurring grant of 300,000 options to purchase shares of Holdings under the Management Equity Incentive Plan. These Holdings Options will vest in accordance with our Management Equity Incentive Plan, as in effect on February 11, 2011 (as described above), and have an initial exercise price of $10.00 per share.
In addition, Mr. Fraher purchased 13,000 shares of Holdings common stock for an aggregate investment of USD$130,000 pursuant to a subscription agreement and a Management Stockholders’ Agreement. For more details on these agreements, see “Item 13. Certain Relationships and Related Transactions, and Director Independence” in this Annual Report on Form 10-K.
In addition, Mr. Fraher would be entitled to the following if termination is without Cause or the Executive terminates for Good Reason:
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An amount equal to Mr. Fraher’s Accrued Benefits, payable within thirty (30) days following the Date of Termination.
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An amount equal to (a) one-and-a-half times (1.5x) his base salary in effect at the date of termination, plus (b) his Target Annual Bonus (which is 50% of Mr. Fraher’s base salary). This amount is payable in equal, ratable installments in accordance with our regular payroll policies over the course of 18 months.
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Medical benefits which are substantially similar to the benefits provided to our executive officers for 12 months after the date of termination. However, if Mr. Fraher becomes re-employed with another employer and is eligible to receive comparable benefits, we shall cease to provide continued medical benefits.
If Mr. Fraher is terminated without Cause or terminates his employment for Good Reason within twelve (12) months following a Change of Control (as defined in the agreement), Mr. Fraher is entitled to the benefits described above, except that he shall receive an amount equal to one-and-a-half times his base salary and his Target Annual Bonus immediately, rather than over a 18-month period.
If Mr. Fraher is terminated due to Mr. Fraher’s death, Disability, or is terminated with Cause or without Good Reason we will pay Mr. Fraher Accrued Benefits (as defined in the agreement).
In addition, Eurand N.V. and Mr. Fraher were parties to a Retention Plan Agreement dated September 20, 2010, and Amendment to the Retention Plan Agreement dated November 28, 2010, under which he was entitled to receive certain payments provided he remained employed by Eurand (or its successor) over a specified period. Under such agreements, Aptalis made the final payment to Mr. Fraher following the six-month anniversary of the closing of the Eurand acquisition in the amount of USD$262,500. No further payments are due to Mr. Fraher under the agreements.
Employment Letter with Theresa Stevens
On May 18, 2009, Ms. Stevens joined Axcan Pharma US, Inc. (now Aptalis Pharma US, Inc.) as Senior Vice President, Business Development.
Ms. Stevens receives a base salary at a rate no less than USD$350,000 per year, which may be adjusted at our discretion. Although no annual bonus is guaranteed to Ms. Stevens, she has the opportunity to earn an annual cash bonus of at least 45% of her base salary for on-target performance, or Target Annual Bonus.
In addition, Ms. Stevens received a grant of 160,000 options to purchase shares of Holdings under the Management Equity Incentive Plan. These options were tendered as part of the 2011 option exchange program (as described above), and Ms. Stevens was granted replacement options effective September 22, 2011. During fiscal year 2011, Ms. Stevens received an additional grant of 40,000 options, which will vest in accordance with our Management Equity Incentive Plan, as amended February 11, 2011 (as described above), and have an initial exercise price of $10.00 per share.
In addition, if the Company terminates Ms. Stevens or she resigns within ninety (90) days after having her job responsibilities or base compensation materially reduced following a Change in Control (as defined in the agreement), subject to certain notice and cure provisions set forth in Ms. Stevens’ agreement, Ms. Stevens shall receive, in return for execution of a general release, a lump sum severance payment equivalent to 12 months of base salary and Target Annual Bonus.
Employment Letter with Jean-Louis Anspach
Effective February 21, 2011, Mr. Anspach joined Axcan Intermediate Holdings, Inc. (now Aptalis Holdings, Inc.) as President, International Specialty Pharmaceuticals.
Mr. Anspach receives a base salary at a rate no less than $341,250 per year, which may be adjusted at our discretion. Although no annual bonus is guaranteed to Mr. Anspach, he has the opportunity to earn an annual cash bonus of at least 45% of his base salary for on-target performance, or Target Annual Bonus.
In addition, Mr. Anspach received a one-time grant of 200,000 options to purchase shares of Holdings under the Management Equity Incentive Plan. These Holdings Options vest in accordance with our Management Equity Incentive Plan, as in effect on February 11, 2011 (as described above), and have an initial exercise price of $10.00 per share.
In addition, Mr. Anspach purchased 3,000 shares of Holdings common stock for an aggregate investment of USD$30,000 pursuant to a subscription agreement and a Management Stockholders’ Agreement. For more details on these agreements, see “Item 13. Certain Relationships and Related Transactions, and Director Independence” in this Annual Report on Form 10-K.
Mr. Anspach is expected to relocate to our European office by August 31, 2012. We will provide a full relocation package to assist Mr. Anspach’s move per Exhibit A of his employment letter.
In addition, if we terminate Mr. Anspach’s employment by reason of a Change of Control (as such term is defined in the Management Equity Incentive Plan) within twelve (12) months following the Change of Control and does not offer Mr. Anspach a comparable position, or if he resigns for Good Reason (as such term is defined in the Management Equity Incentive Plan), Mr. Anspach shall receive, in return for his execution of a general release, a lump sum severance payment equivalent to twelve (12) months of his base salary and target annual bonus, as of the date of termination.
In addition, Eurand N.V. and Mr. Anspach were parties to a Retention Plan Agreement dated September 20, 2010, and Amendment to the Retention Plan Agreement dated November 28, 2010, under which he was entitled to receive certain payments provided he remained employed by Eurand (or its successor) over a specified period. Under such agreements, Aptalis made the final payment to Mr. Anspach following the six-month anniversary of the closing of the Eurand acquisition in the amount of USD$159,200. No further payments are due to Mr. Anspach under the agreements.
Potential Payments upon Certain Terminations or a Change in Control
The following table shows the potential compensation that we would have had to pay to each of our named executive officers in the event of a termination of such named executive officer’s employment under certain scenarios. The table values are based solely on each named executive officer’s respective employment contract or employment letter agreements. The amounts shown below assume that termination of employment was effective September 30, 2011. Although the calculations are intended to provide reasonable estimates of the potential benefits, they are based on numerous assumptions and do not represent the actual amount, if any, an executive would receive if an eligible termination event were to occur. Actual amounts to be paid can only be determined at the time of separation.
The following table provides information regarding the potential value of our severance arrangements for our named executive officers under the following termination of service scenarios: (1) upon termination by us with cause or by the executive officer without good reason, including a retirement; (2) upon termination by us without cause or by the executive officer for good reason; (3) upon termination of the executive due to his death or disability or (4) our change-in-control.
(1) The severance payments set forth in this column would have been paid to Dr. Verwiel in equal installments over a period of 24 months in accordance with our standard payroll procedures and any benefits would be provided over a period of 24 months. For Mr. Gannon and Mr. Fraher, the severance payments set forth in this column would have been paid to them in equal installments over a period of 18 months in accordance with our standard payroll procedures and any benefits would be provided over a period of 18 months.
(2) All severance payments set forth in this column would have been paid immediately as a lump sum.
(3) In general, upon the termination of employment of a named executive officer, any unvested Holdings Options are forfeited. However, if such termination of employment is without Cause or by the participant for Good Reason and occurred during the two-year period following a Change of Control (each as defined in the Management Equity Incentive Plan), such unvested Holdings Options that are time-based and premium options immediately vest and become exercisable as of the date of such termination. In the event either Dr. Verwiel or Mr. Gannon is terminated without cause or for good reason, any Holdings Options that are performance-based options that had not vested as of the date of termination would remain outstanding for a 12-month period following termination, and if a Liquidity Event (as defined in the Management Equity Incentive Plan) were to occur within such period, such unvested performance-based options would become vested and exercisable in accordance with the Management Equity Incentive Plan.
Director Compensation
The following table sets forth information concerning the compensation earned by our directors during fiscal year 2011. Directors who are employees of the Company or certain of our parents and subsidiaries do not receive any fees for their services as directors. Dr. Frank Verwiel’s compensation is included above with that of our named executive officers.
(a) Dr. Kessler and Mr. Labrum were appointed as Directors of the Company on May 13, 2011.
(b) This figure reflects payments earned by Dr. Kessler in fiscal year 2011 for his services as an outside director and his services as a consultant to us. During fiscal year 2011, Dr. Kessler earned $21,270 for his services as an outside director. Pursuant to a Consulting Services Agreement, dated November 3, 2008, by and between Dr. Kessler, Axcan Holdings Inc. and Axcan Pharma Inc. (the “Consulting Agreement”) Dr. Kessler earned $75,000 for his services as a consultant during fiscal year 2011.
(c) This figure reflects quarterly payments earned by Mr. Labrum in fiscal year 2011 for his services as an outside director.
(d) This figure reflects the grant date fair value of the Holdings Stock Options awarded to Dr. Kessler. Pursuant his appointment as a director of the Company, Dr. Kessler received a grant of 25,000 Holdings Stock Options on May 13, 2011, under the Management Equity Incentive Plan, as amended and restated effective February 11, 2011. In addition, for his services as a consultant to the Company, Dr. Kessler received a grant of 5,000 Holdings Stock Options on June 1, 2011, under the Management Equity Incentive Plan, as amended and restated effective February 11, 2011.
In addition, during fiscal year 2011, Dr. Kessler participated in the option exchange program. Under the option exchange program, Dr. Kessler exchanged Holdings Options to acquire 5,000 shares of Holdings common stock, which he had previously been granted on July 16, 2009, for Replacement Holdings Options to acquire 5,000 shares of Holdings common stock, with exercise price and vesting terms that were slightly different than the tendered Holdings Options. Of the tendered Holdings Options and Replacement Holdings Options, 2,500 were time-based options, 1,250 were premium options and 1,250 were performance-based options.
The portion of Dr. Kessler’s Replacement Holdings Options that are time-based options retained the same vesting schedule as the tendered Holdings Options that were time-based options. Of the portion of Dr. Kessler’s Replacement Holdings Options that are premium options, (a) 20% vested immediately upon the grant date of the Replacement Holdings Options, and 20% will vest on each of the first, second, third and fourth anniversary of the grant date of the Replacement Holdings Options, and (b) have an accreting exercise price that increases on each anniversary of September 22, 2011, rather than the original grant date of the tendered Holdings Options. Lastly, the portion of Dr. Kessler’s Replacement Holdings Options that are performance-based options vest upon the realization of certain profits by the Majority Stockholders as a result of a Liquidity Event. Such profits are calculated on the basis of receipt by the Majority Stockholder of a return on investment that is lower than the required return on investment applicable to the original Holdings Options, but taking into account both the initial Sponsor Price and the aggregate purchase price of, and all related transaction expenses paid by the Majority Stockholder in connection with the acquisition of, any Subsequent Majority Stockholder Shares (as defined in the Management Equity Incentive Plan). In each case, vesting of the Replacement Holdings Options is subject to Dr. Kessler’s continued service on the vesting date of such options.
For additional information regarding the 2011 option exchange program, please see “2011 Option Exchange Program” discussed above.
(e) This figure reflects the grant date fair value of the Holdings Stock Options awarded to Mr. Labrum. Pursuant the his appointment as a director of the Company, Mr. Labrum received a one-time grant of 25,000 Holdings Stock Options under the Management Equity Incentive Plan, as amended and restated effective February 11, 2011.
ITEM 12.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
Beneficial Ownership
Aptalis MidCo Inc., or MidCo, directly owns all our issued and outstanding stock. All of MidCo’s issued and outstanding stock is directly owned by Aptalis Holdings Inc., or Holdings. All equity interests in Holdings are owned, directly or indirectly, by the Sponsor Funds, the Co-investors and certain of our employees, including certain of our named executive officers and directors.
The following table sets forth information with respect to the ownership as of September 30, 2011 for (a) each person known by us to own beneficially more than a 5% equity interest in Holdings, (b) each member of our Board of Directors, (c) each member of Holdings’ board of directors, (d) each of our named executive officers (who are also the named executive officers of Holdings), and (e) all of our and Holdings’ executive officers and directors as a group. We have 100 shares of common stock outstanding, all of which are owned indirectly by Holdings. The beneficial ownership percentages reflected in the table below are based on 67,610,227 shares of Holdings’ common stock outstanding as of September 30, 2011.
The amounts and percentages of shares beneficially owned are reported on the basis of SEC regulations governing the determination of beneficial ownership of securities. Under SEC rules, a person is deemed to be a “beneficial owner” of a security if that person has or shares voting power or investment power, which includes the power to dispose of or to direct the disposition of such security. A person is also deemed to be a beneficial owner of any securities of which that person has a right to acquire beneficial ownership within 60 days. Securities that can be so acquired are deemed to be outstanding for purposes of computing such person’s ownership percentage, but not for purposes of computing any other person’s percentage. Under these rules, more than one person may be deemed to be a beneficial owner of the same securities and a person may be deemed to be a beneficial owner of securities with respect to which such person has no economic interest.
Except as otherwise indicated in the footnotes below, each of the beneficial owners has, to our knowledge, sole voting and investment power with respect to the indicated shares. Unless otherwise noted, the address of each beneficial owner is c/o APTALIS PHARMA INC., Chief Corporate Development Officer, 100 Somerset Corporate Boulevard, Bridgewater, New Jersey USA 08807.
* Represents less than one percent.
(1) APTALIS HOLDINGS INC. shares shown as beneficially owned by TPG Funds (as defined below) reflect an aggregate of the following record ownership: (i) 39,948,067.90 shares of Holdings held by TPG Partners V, L.P., a Delaware limited partnership (“TPG Partners V”), (ii) 104,504.70shares of Holdings held by TPG FOF V-A, L.P., a Delaware limited partnership (“TPG FOF V-A”), (iii) 84,269.50 shares of Holdings held by TPG FOF V-B, L.P., a Delaware limited partnership (“TPG FOF V-B”) and (iv) 3,236,842.10 shares of Holdings held by TPG Biotechnology Partners II, LP., a Delaware limited partnership (“Biotech II” and together with TPG Partners V, TPG FOF V-A, TPG FOF V-B and Biotech II, the “TPG Funds”). The general partner of each of the TPG Partners V, TPG FOF-VA and TPG FOF-VB is TPG GenPar VI, L.P., A Delaware limited partnership, whose general partner is TPG GenPar V Advisors, LLC, a Delaware limited liability company, whose sole member is TPG Holdings I, L.P., a Delaware limited partnership (“Holdings I”), whose general partner is TPG Holdings I-A, LLC, a Delaware limited liability company, whose sole member is TPG Group Holdings (SBS), L.P., a Delaware limited partnership, whose general partner is TPG Group Holdings (SBS) Advisors, Inc., a Delaware corporation (“Group Advisors”). The general partner of Biotech II is TPG Biotechnology GenPar II, L.P., a Delaware limited partnership, whose general partner is TPG Biotechnology GenPar II Advisors, LLC, a Delaware limited liability company, whose sole member is Holdings I. Messrs. Bonderman and Coulter are directors, officers and sole shareholders of Group Advisors and may therefore be deemed to beneficially own the shares held by the TPG Funds. Messrs. Bonderman and Coulter disclaim beneficial ownership of the shares held by the TPG Funds except to the extent of their pecuniary interest therein. The address of the TPG Funds is 301 Commerce Street, Suite 3300, Fort Worth, TX 76102.
(2) APTALIS HOLDINGS INC. shares shown as beneficially owned by Banc of America Capital Investors V, L.P. through its investment in TPG Aptalis Co-Invest II, LLC reflect the following record ownership: 5,178,947.40 shares of Holdings held by Banc of America Capital Investors V, L.P. Banc of America Capital Investors V, L.P. is an investment fund controlled by Ridgemont Equity Partners in which Bank of America Corporation has an indirect pecuniary interest. The address of Banc of America Capital Investors V, L.P. is 100 North Tryon Street, 25th floor, Attention: Scott R. Poole, Charlotte, NC 28255.
(3) APTALIS HOLDINGS INC. shares shown as beneficially owned by Société Générale de Financement du Quebec through its investment in TPG Aptalis Co-Invest, LLC reflect the following record ownership: 4,473,684.20 shares of Holdings held by SGF Bio-Pharma Capital Inc. The address of Société Générale de Financement du Québec is 600 de la Gauichetière West, Suite 1500, Montreal, Quebec, Canada, H3B 4L8.
(4) Includes vested options to purchase 288,000 shares of common stock of Aptalis Holdings Inc.
(5) Includes vested options to purchase 184,500 shares of common stock of Aptalis Holdings Inc.
(6) Includes vested options to purchase 247,186 shares of common stock of Aptalis Holdings Inc.
(7) Neither Dr. Cohen, Dr. Preston or Mr. Sisitsky has voting power over and disclaims beneficial ownership of the shares held by the TPG Funds. The address of each of Dr. Cohen, Dr. Preston and Mr. Sisitsky is c/o TPG Capital, 301 Commerce Street, Suite 3300, Fort Worth, TX 76102.
(8) Includes vested options to purchase 719,686 shares of common stock of Aptalis Holdings Inc.
Securities Authorized for Issuance Under Equity Compensation Plans
The following table provides information about the shares of Holdings common stock that may be issued upon the exercise of options and rights (including restricted stock units) under all of our existing equity compensation plans as of September 30, 2011, including the Management Equity Incentive Plan and certain individual arrangements between us and our employees. The table below does not include shares of Holdings common stock that may be issued to certain of our employees as incentive awards correlated to our performance under the Aptalis Holdings Inc. Employee Long Term Incentive Plan, since we cannot predict the value, if any, of such awards or whether any of our employees will elect to receive shares of Holdings common stock in lieu of cash awards under such plan. All of our shares are owned by Aptalis Midholdings, Inc. and we do not have any equity compensation plans under which shares of our common stock are granted.
(1) Since our indirect parent Holdings is owned primarily by the Sponsor and the majority of members of the Holdings Board are affiliated with the Sponsor, the Holdings Board, and not the Holdings stockholders, have approved all decisions related to equity-based compensation, including the approval of the Management Equity Incentive Plan and individual compensation arrangements with our executive officers.
(2) This amount includes 4,144,750 shares of Holdings common stock issuable under the Management Equity Incentive Plan, 595,117 shares of Holdings common stock issuable upon the settlement of Restricted Stock Unit (RSUs) awards granted to certain of our employees and 294,219 shares of Holdings common stock issuable upon the exercise of penny options, or options to purchase Holdings Common Stock for $0.01, granted to certain of our employees.
(3) The weighted-average exercise price reflects the exercise price of all options to purchase Holdings common stock issued under the Management Equity Incentive Plan and does not reflect the exercise price of the RSUs awards or penny option awards, which have exercise prices of $0 and $0.01, respectively.
ITEM 13.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
Review, Approval or Ratification of Transactions with Related Persons
We have not adopted any formal policies or procedures for the review, approval or ratification of certain related-party transactions that may be required to be reported under the SEC disclosure rules. Such transactions, if and when they are proposed or have occurred, have traditionally been (and will continue to be) reviewed by our Board of Directors (other than the board members involved, if any) on a case-by-case basis.
Stockholders Agreement
We have entered into a stockholders agreement with Holdings and the stockholders of Holdings, including investment funds associated with our Sponsors and certain members of our management. Future stockholders may also be required to become parties to the agreement. The stockholders agreement contains agreements among the parties with respect to the election of our directors and the directors of Holdings, restrictions on the issuance of shares (including certain participation rights), restrictions on the transfer of shares (including tag-along rights, drag-along rights and a right of first offer) and other special corporate governance provisions (including the right of our Sponsor and its affiliates to approve various corporate actions).
Registration Rights Agreement
We have entered into a registration rights agreement with Holdings and the stockholders of Holdings, including investment funds associated with our Sponsors and certain members of our management. The registration rights agreement contains customary demand and piggyback registration rights. The agreement also requires Holdings and us to indemnify each holder of registrable securities and certain of their affiliates against liability arising from any violation of the securities laws by Holdings or us or any material misstatements or omissions made by Holdings or us in connection with a public offering.
Management Agreement
We have entered into a management agreement with Holdings and our Sponsors, pursuant to which our Sponsors will provide management and other advisory services to us. In consideration for ongoing management and other advisory services, the management agreement requires us to pay our Sponsors an annual management fee of $750,000 and to reimburse our Sponsors for out-of-pocket expenses incurred in connection with its services. The management agreement also provides that our Sponsors will receive transaction fees in connection with certain subsequent financings and acquisition transactions. The management agreement includes customary indemnification provisions in favor of our Sponsors and its affiliates.
In addition, on December 16, 2009 and April 12, 2011, we entered into an agreement with our Sponsors to clarify our indemnification obligations with respect to the Sponsors and its affiliates. The agreement clarifies that we have the primary obligation to indemnify the Sponsors and its affiliates for expenses and indemnification obligations that we provide to our officers and directors and those of Holdings.
Director Independence
We are a privately held corporation. As discussed in Item 10 above, no current director of our Board is deemed to be “independent” under our previously adopted independence standards. See “Item 10. Directors, Executive Officers and Corporate Governance.”
ITEM 14.
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
During the periods indicated, Raymond Chabot Grant Thornton LLP, and its affiliates, the Company’s independent registered public accounting firm and principal accountant, billed the fees set forth below.
(1) Audit Fees billed during the periods indicated represented fees for the following services: audit of the Company’s annual financial statements, reviews of the Company’s quarterly financial statements, audit of the financial statements of certain subsidiaries and other services normally provided in connection with statutory and regulatory filings.
(2) Audit-Related Fees billed during the periods indicated represented fees for the following services: issue of consent and comfort letters and other services provided in conjunction with financing transactions and consultations on accounting matters.
(3) Tax Fees billed during the periods indicated represented fees for the following services: compliance, transfer-pricing studies and other tax consultation.
We do not have an audit committee and as such, the audit committee of Aptalis Holdings Inc., our indirect parent, performs the duties of an audit committee, including the review and pre-approval of fees paid to and services performed by Raymond Chabot Grant Thornton LLP.
PART IV
ITEM 15.
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a) Financial Statements The financial statements are filed as part of this Annual Report on Form 10-K under “Item 8 - Financial Statements and Supplementary Data.”
(b) Financial Statement Schedules Financial statement schedules have been omitted because they are either not required, not applicable, or the information is presented in the consolidated financial statements and the notes thereto in Item 8 above.
(c) Exhibits
Refer to the Index to Exhibits immediately following the signature page of this report.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized in the City of Birmingham, Sate of Alabama, United States of America, on December 19, 2011.
APTALIS PHARMA INC.
By:
/s/ Steve Gannon
Name:
Steve Gannon
Title:
Senior Vice President and
Chief Financial Officer and Treasurer
Pursuant to the requirements of Section 13 or Section 15(d) of the Securities Exchange Act of 1934, this report has been signed by the following persons in the capacities and on the date indicated below.
EXHIBIT INDEX
* Exhibits marked with an asterisk (*) are filed herewith.
+ This Exhibit was filed separately with the Commission pursuant to an application for confidential treatment. The confidential portions of the Exhibit have been omitted and have been marked by the following symbol: [ ** ].
 Denotes management contract or compensatory plan or arrangement