Item 1. BUSINESS
OVERVIEW
We are currently engaged in two industry segments, the delivery of home healthcare services (sometimes referred to as the “home healthcare business”) and, since our acquisition of BioBalance in a merger transaction in January 2003 (treated for accounting purposes as a reverse acquisition of us by BioBalance), the development of proprietary biotherapeutic agents for the treatment of various gastrointestinal (“GI”) disorders. BioBalance is a wholly-owned subsidiary of the Company. For accounting purposes, BioBalance is considered to be the “accounting acquirer” in the transaction.
We believe that the PROBACTRIX® offers a platform technology that could ultimately achieve regulatory approval for a wide range of GI indications. The product is thought to work by restoring the microbial balance within the GI tract by selective displacement of pathogenic bacteria and prevention of their re-colonization. Clinical studies independently conducted by Dr. Mark Pimentel in 2002 at Cedars-Sinai Medical Center in California have confirmed the direct link of pathogenic bacterial overgrowth with GI symptoms such as Irritable Bowel Syndrome (IBS). The Company believes that these studies support the rationale for the Company’s lead product to address a potential root cause of GI disease resulting in relief of symptoms with no significant side effects.
The Company is a New York corporation incorporated in 1983. The Company’s principal executive office is 1850 McDonald Avenue, Brooklyn, New York 11223, telephone 718-375-6700.
For more information as to the financial performance of our home healthcare and BioBalance business segments, see Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and Note 13 of Notes to Consolidated Financial Statements included elsewhere in this report.
HISTORY, DEVELOPMENT AND OVERVIEW
The Company was initially organized to act as a licensed home healthcare agency engaged primarily in supplying the services of paraprofessionals who provide a broad range of healthcare support services to patients in their homes.
The home healthcare business operates in all five boroughs of New York City and the counties of Nassau, Westchester, Rockland, Orange, Dutchess, Ulster, Putnam and Sullivan, in the State of New York. Services are supplied principally pursuant to contracts with healthcare institutions and governmental agencies, such as various county departments of social services, the New York City Human Resources Administration, Beth Abraham Long-Term Home Health Services, and Kingsbridge Medical Center.
BioBalance is a development stage biopharmaceutical company incorporated in Delaware in May 2001. BioBalance is focused on the development of innovative treatments for various gastrointestinal (GI) disorders with significant unmet needs. BioBalance has not generated any revenues to date.
CORPORATE STRATEGY
We intend to pursue BioBalance’s business plan of developing PROBACTRIX® as a prescription drug for treating various gastrointestinal disorders, subject to the availability of funding. The Company intends to finance a portion of the continuing development of the BioBalance business, including its prescription drug development efforts, from existing cash and cash flow from the home healthcare business. Funding from outside sources will be needed for BioBalance’s remaining capital requirements. Potential outside sources include the sale of BioBalance equity, debt or convertible securities, third party financing and strategic partnering.
BIOBALANCE BUSINESS
Overview
BioBalance is a development stage biopharmaceutical company focused on the identification, licensing and development of novel treatments for GI disorders that we believe are poorly addressed by current therapies. These include pouchitis, irritable bowel syndrome (“ IBS”), Crohn’s disease, ulcerative colitis, celiac disease, and C. difficile infections. We believe that our lead product candidate, PROBACTRIX® , a probiotic, can reduce symptoms of pouchitis, IBS and other GI disorders.
Our current efforts consist of identifying, licensing and developing products for GI diseases where current therapies are inadequate or may have significant side effects. Unlike conventional treatments, we believe that our lead product technology restores the microbial balance in the GI tract by displacing pathogenic bacteria and preventing their re-establishment. For example, clinical trials conducted independently at the Cedars-Sinai Medical Center in California have confirmed the direct link of pathogenic bacterial overgrowth with IBS symptoms. Therefore, we believe that our products may address an underlying root cause of many GI disorders in addition to providing symptom relief with no significant side effects.
Our lead development product, PROBACTRIX® , is a proprietary strain of E.coli M-17 bacteria, which we plan to develop as a prescription drug treatment for pouchitis, IBS and other GI disorders.
BioBalance is pursuing an accelerated regulatory approval for the use of PROBACTRIX® in the U.S. by having filed an Investigational New Drug (“IND ”) application with the FDA for treating patients with chronic pouchitis for the purpose of preventing relapse of their symptoms. . Pouchitis is a non-specific inflammation of the ileal reservoir, which can be a long-term problem for some patients. This usually occurs during the first two years after bowel reconstruction due to ulcerative colitis. Most pouchitis sufferers experience symptoms including steadily increasing stool frequency that may be accompanied by incontinence, bleeding, fever and/or a feeling of urgency. There are no drugs currently approved in the U.S. for pouchitis. We believe that current treatments being used “off-label” (including antibiotics) are often ineffective in relieving symptoms.
BioBalance originally submitted the IND application for the pouchitis indication which was received by the FDA on January 2, 2005. On March 24, 2006, the FDA gave us clearance to proceed with the Phase I/II clinical trial. This study is currently on hold, pending the availability of third party funding, as described above under “Recent Developments”.
We plan to seek orphan drug designation for treatment of pouchitis. “Orphan drug” refers to a product that treats a rare disease affecting less than a specified number of persons (200,000 in the U.S.). FDA approval of an IND permits the sponsor to conduct clinical trials in humans in the United States.
The patented formulation used for PROBACTRIX® consists of a proprietary strain of non-pathogenic E.coli M-17, derived from an organism that was originally isolated from the intestinal mircoflora of healthy volunteers. The technology and the processes comprise conditions that preserve E.coli M-17, in the biologically active form. Patent applications have been filed by BioBalance for various formulations designed to extend the product’s shelf-life in a liquid form.
In addition, we received approval of the registration of PROBACTRIX® as a registered trademark in the U.S. on March 1, 2005. Our intellectual property portfolio also includes rights to a combination of two patented Bacillus strains, B. subtilis and B. licheniformis .
We have contracted for the manufacture of PROBACTRIX® with Benchmark Biolabs Inc. to satisfy our clinical trial needs in a state-of-the-art facility located in Lincoln, Nebraska. At the present time, no product is being manufactured at this or any other facility.
Regulatory Strategy
Our current regulatory strategy involves pursuing accelerated approval for PROBACTRIX® under the auspices of an active IND, for treating patients with chronic pouchitis for the purpose of preventing relapse of their symptoms. There are currently no approved treatments for pouchitis. Additional clinical studies can subsequently be conducted to determine whether there is support for broader usage.
BioBalance originally planned to pursue marketing of PROBACTRIX® as a medical food for IBS, given limited resources and the significant time required for prescription drug development. Industry studies indicate that it takes approximately eight to 10 years for the average prescription drug to progress from the IND filing to market introduction. However, following discussions with regulatory consultants and potential pharmaceutical licensees, it was determined that a shorter pathway to drug development through filing an IND for an orphan drug indication would be the most economically attractive course. This involved addressing pouchitis, a narrowly focused indication with unmet therapeutic needs, rather than IBS. Pouchitis also offered the potential for orphan drug designation and expedited FDA approval. We believe that we can achieve FDA approval for PROBACTRIX® as a prescription drug to treat pouchitis in approximately four to five years from the date on which we are able to commence the Phase I/II clinical trials, dependent on our obtaining necessary funding. However, there is no assurance that we will be able to commence the clinical trials, that such trials will yield desired results, or that FDA approval will be granted in any event.
Upon receipt of funding, we plan to conduct double blind, placebo controlled studies now that we have obtained FDA approval of our IND for the pouchitis indication. The first step would involve a Phase I/II study in pouchitis patients. This study would likely be followed with a pivotal Phase III trial in approximately 50-75 pouchitis patients. A dose-ranging study may also be required. No assurance can be given as to if or when approval can be obtained.
A prescription drug can be assigned orphan drug status by the FDA and European regulatory authorities if the indication addresses a target population of less than 200,000 sufferers in the U.S. or less than 5 sufferers per 10,000 persons in Europe. There is a separate Office of Orphan Drug Product Development at the FDA designed to help facilitate rapid approval of orphan drug applications. Once approved, orphan drugs are given seven year exclusivity in the U.S. and ten years of exclusivity in Europe. Additional benefits of receiving orphan drug status in the U.S. include study design assistance, a 50% reduction in the filing cost of the NDA/BLA (new drug application/biological licensing application) and may also include partial funding of clinical costs by the FDA. The NDA/BLA requests permission from FDA to market a drug in the U.S. In Europe, a drug product is filed with the European Medicines Agency (EMEA) for marketing throughout the European Commission area. The EMEA has a Committee for Orphan Medicinal Products (COMP) whereby drugs are designated "orphan drug" status for the European Union.
Longer term, we are currently considering expanding the label indication of PROBACTRIX® to include a number of additional GI indications, including the treatment of C. difficile infections.
We also plan to explore licensing opportunities for a veterinary formulation of PROBACTRIX® as an animal feed additive. We believe that a veterinary formulation of PROBACTRIX® could be a potential replacement for antibiotics and/or animal growth hormones. This issue has generated significant worldwide attention as governments and consumer groups have called for the reduction or elimination of unnecessary antibiotics and growth hormones in farm animals. Based on studies conducted in Israel beginning in 1996 with a number of animal species, we believe that PROBACTRIX® has a beneficial safety and efficacy profile as an animal feed additive. A veterinary formulation of PROBACTRIX® was approved in Israel in 1998 as a veterinary feed additive. However, we can not assure you that we will ever license a veterinary formulation of PROBACTRIX® as an animal feed product.
In September 2007, BioBalance completed an international, multi-center, randomized, double-blind, placebo-controlled, clinical trial in 129 patients with irritable bowel syndrome. PROBACTRIX® was well tolerated. However, due to an unusually high placebo response rate (53.1%), there was no statistical difference in the primary endpoint (relief of abdominal pain and discomfort) when PROBACTRIX® - and placebo-treated patients were compared. There were more placebo-treated patients who experienced at least one adverse event and who experienced at least one adverse event related to study product (46 and 15, respectively) than did PROBACTRIX® -treated patients (39 and 10, respectively). This study demonstrated the safety of PROBACTRIX® when given for long periods of time and is consistent with other studies that BioBalance has conducted to assess product safety. Despite the unexpected high placebo response rate and its negative impact on the study's primary endpoint, BioBalance remains encouraged by the strong improvements in stool consistency, pain and discomfort, bloating, and stool frequency compared to baseline. BioBalance is investigating the use of higher concentrations of the probiotic and plans to review the data derived from the irritable bowel syndrome study as a knowledge base for new studies in order to target indications which the company believes on-going research supports.
PRODUCTS
PROBACTRIX®
Our initial product opportunity, PROBACTRIX® , is a non-pathogenic probiotic, which we believe addresses a root cause of many GI disorders, including pouchitis, IBS, IBD and diarrhea, by inhibiting and replacing the growth of pathogenic bacteria and preventing their re-colonization. Studies conducted overseas in over 14,000 patients have documented the safety and efficacy profile of this ingredient.
A predecessor product was approved as a biological agent for the treatment of a broad range of GI disorders and diarrheas in Russia in May 1998, as a food supplement for human use by the Ministry of Health of Israel in May 1998 and for use as animal food by the Ministry of Agriculture of Israel in September 1998. In August 2000, Tetra-Pharm, an Israeli pharmaceutical company, agreed to cease manufacture and sale of the product in conjunction with its agreement to sell all rights relating to the product to BioBalance. Since then, production of the formula has been limited to supplying hospitals and universities where BioBalance is conducting further research.
The basic active component in PROBACTRIX® is a selective strain of non-pathogenic E.coli bacteria, which is contained in a liquid suspension. This bacterium is a commonly represented species in the healthy microflora of humans and animals. It has been used for the preparation of Colibacterin, Bificon and other medicines and food supplements outside the U.S.
The research on PROBACTRIX® originated in Russia from studies by Dr. Nellie Kelner-Padalka, a pediatrician and our scientific founder. These studies found liquid food supplements containing E.coli M-17 to be useful in treating intestinal infections of various origins. However, shelf life was short and the product had a strong odor that made it difficult for some patients to ingest. Dr. Kelner-Padalka later brought her studies to Israel where several technologies were used to expand the shelf life and improve the smell and taste.
As part of the regulatory approval process of E. coli M-17 in Russia, a scientific panel determined the product’s mechanism of action included the following:
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Rapid suppression of pathogenic microorganisms and their repulsion.
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Restoration of the normalization of the body’s immune system due to increased synthesis of immunoglobulin, interferon and activation of macrophages.
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Stimulation of the enzyme complex (protease, amylase, lipase and cellulase), which helps to improve digestion.
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Binding, neutralizing and withdrawing toxic substances (including heavy metals) from the body.
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Improvement of the absorption of selected micronutrients including B-complex vitamins and essential amino acids.
The patented formulation used for PROBACTRIX® consists of a proprietary strain of non-pathogenic E.coli, derived from an organism that was originally isolated from the intestinal microflora of healthy volunteers, which is preserved in a liquid extract formulation. The technology and the processes comprise conditions that preserve M-17 E. coli in the biologically active form. Additional patent applications have been filed by BioBalance for technology that could extend the product’s shelf life for two years or longer at room temperature.
Bacillus Product
We have acquired the rights to a combination of two Bacillus strains that has exhibited anti-inflammatory, anti-bacterial and anti-viral properties, which may be effective in treating a variety of GI diseases. We believe our Bacillus strains are therapeutically effective against rotavirus and campylobacter pathogens, which are the leading causes of infectious diarrhea. We believe this technology could also be effective in treating ulcerative colitis. There was a predecessor product (called Biosporin) based on the Bacillus strains acquired, which was approved in Russia. The study conducted by us to date was inconclusive regarding the usefulness or effectiveness of the strains in treating GI diseases. Therefore, we have elected not to pursue this project further at this time.
Prior Clinical Studies
The active ingredient in PROBACTRIX® has undergone testing by more than 14,000 patients in controlled trials as well as case study reports and has demonstrated safety and efficacy in adults and children as young as six months old. The product has demonstrated effectiveness in a broad range of GI diseases and conditions including IBS, IBD, pouchitis, Crohn’s disease, ulcerative colitis and diarrhea caused by antibiotics, chemotherapy and travel.
Two clinical studies conducted independently at Cedars-Sinai Medical Center showed the link between IBS symptoms and pathogenic bacteria and support the rationale for the use of PROBACTRIX® as an effective treatment for IBS.
Clinical studies conducted in Israel indicate that PROBACTRIX® is effective at addressing various GI symptoms in both male and female patients with no significant side effects. Patients typically reported a marked reduction in abdominal symptoms. Two pilot studies have been completed in Israel with the current formulation. The first was an open label study conducted on 63 patients with IBS, who were unresponsive to other therapies, and 20 patients with Crohn’s disease. After four to six weeks of therapy, 52% of the IBS patients had an excellent response, 35% and 30% of the Crohn’s disease patients had an excellent and partial response, respectively, and no adverse events were observed.
An open-label trial, examining the impact of PROBACTRIX® on patients with Crohn’s disease, reported that three of the eight patients experienced a marked reduction in abdominal symptoms, two dropped out, two experienced no improvement and one experienced a worsening of symptoms.
A randomized, double blind pilot study conducted by Tiomny, et. al. in 2003 reported that PROBACTRIX® relieved major symptoms of IBS with no significant side effects. This study involved patients, who were experiencing severe symptoms of diarrhea and constipation with a mean duration of eight years. Eight of the ten patients in the placebo group withdrew from the study due to lack of response. All ten patients in the treatment group completed the study. The treatment group experienced significant improvement in IBS symptom relief with no significant side effects.
We have completed a randomized, multi-center double blind, placebo-controlled, clinical trial in IBS patients to study the effectiveness of PROBACTRIX® as a medical food. Sites for this study include Cornell Medical Center in New York City, St. Michael’s Hospital in Toronto, Canada, Bikur Cholim Hospital in Jerusalem, Israel, and Sourasky Medical Center in Tel Aviv, Israel. This data is currently undergoing statistical analysis.
In September 2007, BioBalance completed an international, multi-center, randomized, double-blind, placebo-controlled, clinical trial in 129 patients with irritable bowel syndrome. PROBACTRIX® was well tolerated. There were more placebo-treated patients who experienced at least one adverse event and who experienced at least one adverse event related to study product (46 and 15, respectively) than did PROBACTRIX® -treated patients (39 and 10, respectively). This study demonstrated the safety of PROBACTRIX® when given for long periods of time and is consistent with other studies that BioBalance has conducted to assess product safety. Despite the unexpected high placebo response rate and its negative impact on the study's primary endpoint, BioBalance remains encouraged by the strong improvements in stool consistency, pain and discomfort, bloating, and stool frequency compared to baseline. BioBalance is investigating the use of higher concentrations of the probiotic and plans to review the data derived from the irritable bowel syndrome study as a knowledge base for new studies in order to target indications which the company believes on-going research supports.
Veterinary Application
Numerous clinical studies have been conducted in farm animals to support the use of PROBACTRIX® as a veterinary feed additive to replace antibiotics and/or animal growth hormones. BioBalance believes that enough safety and efficacy data accumulated presents an attractive opportunity for licensing to leading animal health companies. BioBalance has directed its efforts toward human clinical studies and has not pursued licensing to animal health companies up to this point. Veterinary experts believe that repeated applications of antibiotics often leave animals weak and growth retarded. BioBalance believes that PROBACTRIX® has a particularly high safety and efficacy profile in many different animal species. There are already probiotic products used today in the veterinary market but lack well-designed scientific studies. Significantly, PROBACTRIX® has been studied for its use in preventing bacterial diarrhea in piglets and as a replacement for gentamycin and Advocin, which are most often used to treat diarrhea in these animals. We cannot provide any assurance that we will ever license a veterinary formulation of PROBACTRIX® as a veterinary feed additive.
MANUFACTURING
During 2005, BioBalance transferred the manufacturing process of PROBACTRIX® to Benchmark Biolabs, Inc. for pilot-lab production of clinical trial materials in a state-of-the-art facility located in Lincoln, Nebraska. BioBalance has not yet committed for commercial production of PROBACTRIX® , since it will likely rely on a marketing/licensing partner for production. The process for growing E. coli and formulating the bacteria into a probiotic agent requires specialized fermentation facilities maintained and operated under FDA laboratory and good manufacturing procedure (“GMP”) requirements as a prescription drug product.
INTELLECTUAL PROPERTY
BioBalance uses a combination of patents, trademarks and trade secrets to protect its core technology. We have 14 patents issued in the U.S. and two patent applications filed and pending. The patent expiration dates range from 2020 to 2023. It has also filed patent applications covering application of its core technology in Japan, European, Canada, Australia, Mexico, Brazil, Poland, Russia and New Zealand. BioBalance is also pursuing additional patent applications relating to its core technology. On March 1, 2005, it received notification that PROBACTRIX® was approved as a registered U.S. trademark.
At December 31, 2007, management determined that the value of the PROBACTRIX® intellectual property was partially impaired due to the unusually high placebo response rate in the clinical trial related to the irritable bowel syndrome ("IBS") indication. While management believes that further testing may prove the efficacy of PROBACTRIX® for that indication, further clinical trials would require substantial additional funding which is currently unavailable. Accordingly, management recorded an impairment loss of $729,792 against the intellectual property. The remaining carrying value after recording the impairment loss was $628,056 , representing the net carrying amount of the patents and trademarks.
BioBalance also previously acquired the global patent rights to a combination of two patented Bacillus strains (B. subtilis and B. licheniformis ) (”NexGen Product Platform”) for $3,850,000 which included a one-time cash payment of $250,000 and one million shares of Common Stock of the Company valued at $3,600,000. See “Bacillus Product” above. At December 31, 2004 it was determined that the investment in the NexGen Product Platform was impaired and as a result of the impairment analysis, a total of $1,740,326 was expensed during the fourth quarter of 2004. The impairment was determined by an independent valuation firm using a discounted cash flow model. At the time, the impairment was felt necessary due to a number of factors including the acceleration of the Company’s efforts to obtain regulatory approval and take other action necessary to market PROBACTRIX® as a prescription product, overall limited funding available to the Company to develop the Bacillus product and available management time.
At December 31, 2006, management determined that the value of the NexGen Product Platform was impaired in its entirety due to inconclusive testing results. While management believes that further testing may prove the safety and efficacy of the NexGen Product Platform, a decision was made to devote all efforts and funds towards the development and clinical trials of PROBACTRIX® , if, as and when further funding is received or a strategic partner joins the Company. Accordingly, management recorded an impairment loss of $926,322 (intellectual property $334,787; patents and trademarks $341,285 and; non-compete agreement $250,250) representing the entire unamortized balance of the NexGen Product Platform and has discontinued any further testing or development of the NexGen product platform.
BIOBALANCE EMPLOYEES
The only employees of BioBalance are the Company's two part-time executive officers, Murry Englard, CEO and Stewart W. Robinson, CFO, who divide their time between BioBalance and the home health care business as needed. BioBalance outsources most of its clinical and regulatory needs through the use of part-time or consultants. While BioBalance has no definitive plans with respect to the ultimate size of its workforce or persons who will fill specific positions, BioBalance plans to evaluate its staffing needs relative to research and development, product manufacturing and marketing and finance and administration and will seek to retain personnel as employees or consultants based on that evaluation.
HOME HEALTH CARE BUSINESS
Overview
We provide a broad range of home health and personal care support services in capacities ranging from companions to live-ins, including assistance with personal hygiene, dressing and feeding, meal preparation, light housekeeping and shopping and, to a limited extent, physical therapy and standard skilled nursing services such as the changing of dressings, injections and administration of medications.
Our services are provided principally by our staff of professionals and paraprofessionals (some are bilingual), who provide personal care to patients, and, to a lesser extent, by our staff of skilled nurses. Approximately 99% of our home health revenues in 2007 were attributable to services by our paraprofessional staff.
We are approved by New York State Department of Health for the training and certification of Home Health Aides and Personal Care Aides. In order to provide a qualified and reliable staff, we continuously recruit, train, provide continuing education for, and offer benefits and other programs to encourage retention of, our staff. Recruiting is conducted primarily through advertising, direct contact with community groups, employment programs, and the use of benefits programs designed to encourage new employee referrals by existing employees.
Organization and Operations
We operate 24 hours a day, seven days a week, to receive referrals and coordinate services with physicians, case managers, patients and their families. Services are provided through one principal office, five branch offices and one recruitment and training office. Each office is typically staffed with an administrator/branch manager, director of nursing, nursing supervisor, home care coordinators, clerical staff and nursing services staff.
Our principal office retains functions necessary to ensure quality of patient care and to maximize financial efficiency. Services performed at the principal office include billing and collection, quality assurance, financial and accounting functions, policy and procedure development, system design and development, corporate development and marketing. We use financial reporting systems through which we monitor data for each branch office, including collections, revenues and staffing. Our systems also provide monthly, financial comparisons to prior periods and comparisons among our branch offices.
Referral Sources
We obtain patients primarily through contracts, referrals from hospitals, community-based healthcare institutions and social service agencies, case management and insurance companies. Referrals from these sources accounted for substantially all of our net revenues in 2007. We generally conduct business with most of our institutional referral sources under one-year contracts that fix the rates and terms of all referrals but do not require that any referrals be made. Under these contracts, the referral sources refer patients to us and we bill the referral sources for services provided to patients. Approximately 60 such contracts were in effect and active as of December 31, 2007.
One or more referring institutions have accounted for more than 5% of our net revenues during our last fiscal year, as set forth in the following table:
Overall, our 10 largest referring institutions accounted for approximately 88.5% of net revenues for 2007.
Days Sales Outstanding (“DSO”) is a measure of the average number of days required for the Company to collect accounts receivable, calculated from the date services are billed. For the year ended December 31, 2007 the Company's DSO were 68.
Reimbursement
We are reimbursed for services, primarily by referring institutions, such as healthcare institutions and social service agencies, which in turn receive their reimbursement from Medicaid, Medicare and, to a much lesser extent, through direct payments by insurance companies and private payers. New York State Medicaid programs constitute our largest reimbursement sources, when including both direct Medicaid reimbursement and indirect Medicaid payments through many of our referring institutions. For 2007, payments from referring institutions that receive direct payments from Medicare and Medicaid, together with direct reimbursement to us from Medicaid, accounted for approximately 99% of net revenues. Direct reimbursements from private insurers, prepaid health plans, patients and other private sources accounted for approximately 1% of net revenue for 2007.
The New York State Department of Health, in conjunction with local Departments of Social Services, sets annual reimbursement rates for patients covered by Medicaid. These rates are generally established on a county-by-county basis, using a complex reimbursement formula applied to cost reports filed by providers.
Third party payers, including Medicaid, Medicare and private insurers, have taken extensive steps to contain or reduce the costs of healthcare. These steps include reduced reimbursement rates, increased utilization review of services and negotiated prospective or discounted pricing and adoption of a competitive bid approach to service contracts. Home-based healthcare, which is generally less costly to third party payers than hospital-based care, has benefited from many of these cost containment measures.
We negotiate contracts on the basis of services to be provided, in connection with contracts either currently in effect with us or with other agencies. Prevailing market conditions are such that, despite escalating operating expenses, third party payers are negotiating at the same or reduced contract rates are regularly negotiated as a result of internal budget restraints and reductions mandated by managed care contracts between our clients and HMO's and other third party administrators. While we anticipate that this trend is likely to continue for the foreseeable future, we do not expect the impact on the Company to be significant, since we believe our rates are competitive. Accordingly, we expect to be subject to only minor rate reductions. However, as expenditures in the home healthcare market continue to grow, initiatives aimed at reducing the costs of healthcare delivery at non-hospital sites are increasing. A significant change in coverage or a reduction in payment rates by third party payers, particularly by New York State Medicaid, would have a material adverse effect upon our home healthcare business.
Performance Improvement
We believe that our reputation for quality patient care has been and will continue to be a significant factor in our success. To this end, we have established a performance improvement management program, including a performance improvement program to ensure that our service standards are implemented and that the objectives of those standards are met.
We believe that we have developed and implemented service standards that comply with or exceed the service standards required by the Joint Commission on Accreditation of Healthcare Organizations (“JCAHO”). In May 2006, the New York offices of the Company received full accreditation from the Joint Commission; this accreditation expires in September 2009.
Sales and Marketing
Each administrator/branch manager is responsible for sales activities in the branch office's local market area. We attempt to cultivate strong, long-term relationships with referral sources through high quality service and education of local healthcare personnel about the appropriate role of home healthcare in the clinical management of patients.
Government Regulation
The federal government and the State of New York where we operate, regulate various aspects of our business. Changes in the law or new interpretations of existing laws can have a material adverse effect on permissible activities of the Company, the relative costs associated with doing business and the amount of reimbursement by government and other third-party payers.
We are licensed by New York State as a home care services agency. New York State law requires prior approval by the New York State Public Health Council ("Council") of any transfer of 10% or more of the stock or voting rights of a corporation or any transfer which results in ownership of 10% or more of the stock or voting rights of a corporation, or any other change in "the controlling person" of an operator of a licensed home care services agency ("LHCSA"). Control of an entity is presumed to exist if any person owns, controls or holds the power to vote 10% or more of the voting securities of the LHCSA. A person seeking approval as a controlling person of a LHCSA, or of an entity that is the operator of a LHCSA, must, in most cases, file an application and receive Council approval prior to becoming a controlling person.
We are subject to federal and state laws prohibiting payments for patient referrals and regulating reimbursement procedures and practices under Medicare, Medicaid and other health care benefit programs. The federal Medicare and Medicaid legislation contains anti-kickback provisions, which prohibit any remuneration in return for the referral of Medicare and Medicaid patients or for purchasing or leasing equipment or services that are paid for in whole or in part by Medicare or Medicaid. Courts have, to date, interpreted these anti-kickbacks laws to apply to a broad range of financial relationships. Violations of these provisions may result in civil and criminal penalties, including fines of up to $15,000 for each separate service billed to Medicare or Medicaid in violation of the anti-kickback provisions, exclusion from participation in the Medicare and state health programs such as Medicaid and imprisonment for up to five years.
The Medicare and Medicaid anti-kickback provisions of the Social Security Act are broadly worded and often vague, and the future interpretation of these provisions and their applicability to our operations cannot be fully predicted with certainty. Any non-compliance or violation could have a material adverse effect on our home healthcare business.
Federal laws to which we are subject also include the broadly worded fraud and abuse provisions of the Social Security Act that are applicable to the Medicare and Medicaid programs, which prohibit various transactions involving Medicare or Medicaid covered patients or services and the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which is applicable to both public and private health care programs. Among other things, these provisions restrict referrals by physicians for certain designated health services, including home health care, to entities with which the physician or the physician's immediate family member has a "financial relationship" and the receipt of remuneration by anyone in return for, or to induce, the referral of a patient for treatment or purchasing or leasing equipment or services that are paid for, in whole or in part, by Medicare or Medicaid. They also prohibit false statements, false billings and fraudulent conduct. Violations of these provisions may result in civil or criminal penalties for individuals or entities and/or exclusion from participation in the Medicare and Medicaid programs. The future interpretation of these provisions and their applicability to our operations cannot be predicted.
New York also has statutes and regulations prohibiting payments for patient referrals and other types of financial arrangements with healthcare providers that, while similar in many respects to the federal legislation, are often vague and have infrequently been interpreted by courts or regulatory agencies. Sanctions for violation of these state restrictions may include loss of licensure and civil and criminal penalties.
We believe that our operations, in general, comply in all material respects with applicable federal and state anti-kickback laws, and that we will be able to arrange our future business relationships so as to comply with the fraud and abuse provisions.
Management believes that the trend of federal and state legislation is to subject the home healthcare and nursing services industry to greater regulation and enforcement activity, particularly in connection with third-party reimbursement and arrangements designed to induce or encourage the referral of patients to a particular provider of medical services. We attempt to be responsive to such regulatory climate. However, we are unable to accurately predict the effect, if any, of such increased regulatory or enforcement activities on our future results of operations.
In addition, we are subject to laws and regulations which relate to business corporations in general, including antitrust laws, occupational health and safety laws, and environmental laws (which relate, among other things, to the disposal, transportation and handling of hazardous and infectious wastes). To date, none of these laws and regulations has had a material adverse effect on our home healthcare business or the competitive position of such business or required any material expenditure by us. We cannot assure that we will not be adversely affected by such laws and regulations in the future.
We cannot accurately predict what additional legislation, if any, may be enacted in the future relating to our business or the healthcare industry, including third-party reimbursement, or what affect any such legislation may have on us.
We have never been denied any home healthcare license we have sought to obtain. We believe that our home healthcare operations are in material compliance with all applicable state and federal regulations and licensing requirements.
Competition
The home healthcare market is highly fragmented and significant competitors are often localized in particular geographical markets. Our largest competitors include Premiere Health Services, National Home Health Care Corp., Patient Care, Inc., and Personal Touch Home Care Services, Inc. The home healthcare business is marked by low entry costs so that, given the increasing level of demand for nursing services, significant additional competition can be expected to develop in the future. Some of the companies with which we presently compete in home healthcare have substantially greater financial and human resources than we do. We also compete with many other small temporary medical staffing agencies.
We believe that the principal competitive factors in our industry are quality of care, including responsiveness of services and quality of professional personnel; breadth of therapies and nursing services offered; successful referrals from referring Government agencies, hospitals and health maintenance organizations; general reputation with physicians, other referral sources and potential patients; and price. We believe that our competitive strengths have been the quality, responsiveness, flexibility and breadth of services and staff we offer, and to some extent our competitive pricing, as well as our reputation with referral sources and patients.
The United States healthcare industry generally faces a shortage of qualified personnel. Accordingly, we experience intense competition from other companies in recruiting healthcare personnel for our home healthcare operations. Our success to date has depended, to a significant degree, on our ability to recruit and retain qualified healthcare personnel. Most of the registered and licensed nurses and healthcare paraprofessionals who we employ are also registered with, and may accept placements from time to time through, our competitors. We believe we are able to compete for nursing and paraprofessional personnel by recruitment through newspaper advertisements, work fairs/job fairs, flexible work schedules and competitive compensation arrangements. We cannot assure you, however, that we will be able to continue to attract and retain sufficient qualified personnel. The inability to either attract or retain such qualified personnel would have a material adverse effect on our business.
HOME HEALTH CARE EMPLOYEES
At March 9, 2008, our home healthcare business had 1,460 employees, of whom sixty four are salaried, including one division officer, a controller, a vice president of operations, a human resources administrator, an IT specialist, seven administrators/branch managers, nine nurses, three accounting staff, eighteen clerical staff, and twenty two field staff supervisors. The remaining 1,396 employees are paid on an hourly basis and consist of professional and paraprofessional staff.
None of our home healthcare or BioBalance employees are compensated on an independent contractor basis or represented by a labor union. A local labor union has been attempting to organize the Company's home care health aides. The local union recently withdrew its request from the labor board to initiate a vote. Management believes that the Company has good relations with its employees.
Item 1A.
Item 1A. RISK FACTORS
THE COMPANY OPERATES IN A CHANGING ENVIRONMENT THAT INVOLVES NUMEROUS KNOWN AND UNKNOWN RISKS AND UNCERTAINTIES THAT COULD MATERIALLY AND ADVERSELY AFFECT ITS OPERATIONS. THE FOLLOWING HIGHLIGHTS SOME OF THE FACTORS THAT HAVE AFFECTED, AND/OR IN THE FUTURE COULD AFFECT, ITS OPERATIONS.
Risks Relating to the BioBalance Business
BIOBALANCE IS A DEVELOPMENT STAGE COMPANY, HAS GENERATED NO REVENUES TO DATE AND HAS A LIMITED OPERATING HISTORY UPON WHICH IT MAY BE EVALUATED.
BioBalance was incorporated in May 2001, has generated no revenues from operations, and has no meaningful assets other than its intellectual property rights and $38,000 in available cash at December 31, 2007. BioBalance faces all of the risks inherent in a new business and those risks specifically inherent in the business of developing, testing, obtaining regulatory approvals for, manufacturing, commercializing and selling a new prescription drug product, with all of the unforeseen costs, expenses, problems, and difficulties to which such ventures are subject. We cannot assure you that BioBalance will be able to generate revenues or profits from operation of its business or that BioBalance will be able to generate or sustain profitability in the future.
FAILURE TO SECURE ADDITIONAL FINANCING WOULD RESULT IN IMPAIRED GROWTH AND INABILITY TO OPERATE.
BioBalance will be required to expend substantial amounts of working capital in order to develop, test, obtain the requisite regulatory approvals, manufacture and market its proposed product and establish the necessary relationships to implement its business plan. At December 31, 2007, BioBalance had available cash in the amount of $38,000. For the year ended December 31, 2007, BioBalance’s operations were funded entirely by capital from the Company’s health care operations. BioBalance is entirely dependent on existing cash, working capital from the health care operations, and its ability to attract and receive additional funding from either the sale of securities or outside sources such as private investment or a strategic partner. See “Recent Developments”. If BioBalance fails to obtain additional financing, BioBalance's clinical and regulatory programs will need to be further scaled back, suspended or cancelled. BioBalance has no firm agreements or arrangements with respect to any such financing and we cannot assure you that any needed funds will be available to BioBalance on acceptable terms or at all. The inability to obtain sufficient funding of BioBalance’s operations in the immediate future could cause BioBalance to curtail or cease its operations.
THE LOSS OF KEY EXECUTIVES OR CONSULTANTS OR THE FAILURE TO HIRE QUALIFIED EMPLOYEES WOULD DAMAGE OUR BUSINESS
Because of the highly technical nature of our BioBalance business, we depend greatly on attracting and retaining experienced management and highly qualified and trained scientific personnel.
As previously reported by the Company in its Form 8-K filed with the Securities and Exchange Commission on September 12, 2006, Mr. Dennis O'Donnell, the Company's President and Chief Executive Officer, acting Principal Financial Officer and a director, resigned from all of his positions with the Company effective September 8, 2006. Although the Board has not selected a permanent replacement for Mr. O'Donnell, Mr. Murry Englard is presently serving in the capacity of Chief Executive Officer and Mr. Stewart Robinson as Principal Financial Officer. The Board believes that the part-time participation of these executive officers is sufficient for the Company at its present size and form. Should the Board determine at a later date that these executive positions should be filled by full-time employees, there can be no assurance that the Company will be able to obtain the services of a qualified Chief Executive Officer or Chief Financial Officer in the near term, particularly in light of BioBalance's current financial situation, as discussed above under the risk factor “Failure to Secure Additional Financing Would Result in Impaired Growth and Inability to Operate.”
We compete with other companies intensely for qualified and well trained professionals in our industry. If we cannot hire or retain, and effectively integrate, a sufficient number of qualified scientists and experienced professionals, this will have a material adverse effect on our capacity to sustain and grow our business and develop our products through the clinical trial process and otherwise.
THE UNILATERAL RESCISSION OF THE EMERALD SETTLEMENT AGREEMENT MAY RESULT IN FUTURE LITIGATION
The Company reported in the Company's Form 8-K filed on August 21, 2006 that the Company had unilaterally rescinded the settlement between the Company and Emerald Asset and Yitz Grossman. The settlement agreement was originally entered into as reported in the Company's Form 8-K filed on March 6, 2006, and the related liability was recorded on the books of the Company at December 31, 2005, in the amount of $1,545,000. The rescission of the settlement by the Company was done without the consent of Emerald Asset and Yitz Grossman. Accordingly there may be future litigation brought against the Company by Emerald Asset and Yitz Grossman to seek enforcement of the agreement. The Company continues to retain the accrual for the settlement agreement on its books in its entirety. If there is litigation brought by Emerald Asset and Yitz Grossman to enforce the settlement agreement, there can be no assurance that at a future time the accrual that was recorded would be sufficient to offset amounts resulting from the future litigation.
BIOBALANCE’S PRODUCTS ARE IN DEVELOPMENT AND MAY NOT SATISFY REGULATORY REQUIREMENTS OR BECOME COMMERCIALLY VIABLE.
The products that we are currently developing will require additional development, testing, and investment in order to market them as prescription drugs. We cannot be sure that our product research and development efforts will be successful, that candidates will enter clinical studies as anticipated, that we will satisfy Good Laboratory Procedures (“GLP”), medical food or prescription drug requirements or that any required regulatory approvals will be expeditiously applied for or obtained, or that any products, if introduced, will be commercially successful. We have conducted anecdotal and pre-clinical trials and are conducting an IBS medical food clinical trial for our initial product and have established GRAS (Generally Recognized As Safe) status to date. The results of these pre-clinical and anecdotal trials on products under development are not necessarily predictive of results that will be obtained from large scale clinical testing. We cannot be sure that clinical trials of the products under development will demonstrate the safety and efficacy of such products or will result in a marketable product. In addition, the administration alone or in combination with drugs of any product developed by BioBalance may produce undesirable side effects in humans. The failure to demonstrate adequately the safety and efficacy of a therapeutic drug product under development could delay or prevent regulatory approval, where required, and delay or prevent commercial sale of the product, any of which could have a material adverse effect on BioBalance. We may encounter difficulties in manufacturing, process development and formulation activities that could result in delays in clinical trials, regulatory submissions, regulatory approvals and commercialization of our product, or cause negative financial and competitive consequences. We cannot assure you that PROBACTRIX® or any other product will be successfully developed, be developed on a timely basis or prove to be more effective than competing products based on existing or newly developed technologies. The inability to successfully complete development, or a determination by us, for financial or other reasons, not to undertake to complete development of PROBACTRIX® or any other product, particularly in instances in which we have made significant capital expenditures, could have a material adverse effect on us.
POTENTIAL FAILURE OF PLANNED CLINICAL TRIALS TO PRODUCE STATISTICALLY SIGNIFICANT DATA COULD IMPAIR OUR ABILITY TO OBTAIN REGULATORY APPROVAL AND DEVELOP, MANUFACTURE AND SUCCESSFULLY MARKET OUR PRODUCTS.
There still is substantial risk that the studies that we are planning will not yield sufficient statistically significant data to make strong marketing claims. This could impede our ability to obtain FDA approval for our products and, even if approval is obtained, would adversely affect marketing efforts to the medical community, which is traditionally resistant to new treatments unless supported by statistically significant data before recommending it to patients.
WE ARE DEPENDENT ON NEW PRODUCTS AND CONTINUED INNOVATION.
The pharmaceutical industry in general, including the market for GI treatments, is characterized by rapid innovation and advances. These advances result in frequent product introductions and short product life cycles, requiring a high level of expenditures for research and development and the timely introduction of new products. We believe our ability to grow and succeed is partially dependent upon our ability to introduce new and innovative products into such markets. We cannot assure you that we will be successful in our plans to introduce additional products to the market or expand our current label indications.
INTELLECTUAL PROPERTY RIGHTS MAY NOT PROTECT OUR BUSINESS.
We use a combination of patents, trademarks and trade secrets to protect our proprietary position on PROBACTRIX® . We cannot assure you that our pending or future patent and trademark registration applications will result in issued patents and registered trademarks, or that, if issued, our applications will be upheld if challenged. Further, even if granted, we cannot assure you that these patents and trademarks will provide us with any protection from competitors or, that if they do provide any meaningful level of protection, that we will have the financial resources necessary to enforce our patent and trademark rights. In addition, we cannot assure you that others will not independently develop technologies similar to those covered by our pending patents and trade secrets, or design around the pending patents. If others are able to design around our patents, our results of operations could be materially adversely affected. Further, we will have very limited, if any, protection of our proprietary rights in those jurisdictions where we have not affected any filings or where we fail to obtain protection through our filings. We cannot assure you that third parties will not assert intellectual property infringement claims against us in the future with respect to current or future products. We are responsible for defending against charges of infringement of third party intellectual property rights by our actions and products and such assertion may require us to refrain from the sale of our products, enter into royalty arrangements or undertake costly litigation. Further, challenges may be instituted by third parties as to the validity, enforceability and infringement of our patents. Our adherence to industry standards with respect to our product may limit our opportunities to provide proprietary features which may be protected. In addition, the laws of various countries in which our product may be sold may not protect our product and intellectual property rights to the same extent as the laws of the United States.
THE VALIDITY OF PATENTS COVERING PHARMACEUTICAL AND BIOTECHNOLOGICAL INVENTIONS AND THE SCOPE OF INTELLECTUAL PROPERTY CLAIMS MADE UNDER SUCH PATENTS IS UNCERTAIN; FAILURE TO SECURE NECESSARY PATENTS COULD IMPAIR OUR ABILITY TO PRODUCE AND MARKET OUR PRODUCTS .
There is no consistent policy regarding the breadth of intellectual property claims permitted in specialty pharmaceutical and biotechnology patents. In addition, patents may have been granted, or may be granted, to others covering products or processes that we need, or may need, for testing and developing our products. If our products or processes infringe upon patents held by third parties, or otherwise impermissibly utilize the intellectual property of others, we might be unable to develop, manufacture, or sell our products. In such event, we may be required to obtain licenses to from third parties to use such intellectual property. We cannot be sure that we will be able to obtain such licenses on acceptable terms, or at all.
FAILURE TO DEVELOP, OR CONTRACT FOR, AN ADEQUATE SALES AND MARKETING ORGANIZATION, OR PARTNER WITH A LARGER PHARMACEUTICAL COMPANY WOULD RESULT IN THE INABILITY TO MARKET AND SELL OUR PRODUCT.
To market any of our products directly, we would have to develop a substantial marketing and sales force. Alternatively, we may, for certain products, attempt to obtain the assistance of larger pharmaceutical companies with established distributions systems and direct sales forces. We do not know if we will be able to enter into agreements with other companies to assist in the marketing and sales of our products. If we are not able to sustain such marketing efforts, we may license marketing rights to a third party. However, we cannot be sure that we would be able to locate a qualified marketer or distributor or enter into any such agreement on reasonable terms or at all.
WE OWN NO MANUFACTURING FACILITIES AND WILL BE DEPENDENT ON THIRD PARTIES TO MAKE OUR PRODUCT .
We own no manufacturing facilities or equipment, and employ no manufacturing personnel. We expect to use third parties to manufacture certain of our products on a contract basis. We may not be able to obtain contract-manufacturing services on reasonable terms or at all. If we are not able to contract manufacturing services, we will not be able to make our products.
WE WILL BE REQUIRED TO COMPLY WITH GOOD MANUFACTURING PRACTICES.
The manufacture of our proposed products will be subject to current Good Manufacturing Practices ("GMP") prescribed by the FDA in the United States. We cannot give assurance that we or any entity manufacturing products on our behalf will be able to comply with GMP or satisfy certain regulatory inspections in connection with the manufacture of our proposed products. Failure or delay by any manufacturer of our products to comply with GMP or similar regulations or satisfy regulatory inspections would have a material adverse effect on us.
POTENTIAL SIDE EFFECTS OF OUR PRODUCT COULD IMPAIR OUR ABILITY TO CONTINUE CLINICAL TRIALS, OBTAIN REGULATORY APPROVAL, OR SUCCESSFULLY MARKET OUR PRODUCTS .
Although no significant side effects of our products have been demonstrated, it is possible that, any time during clinical trials or patient usage, side effects may be encountered. If they are common enough or significant enough, this could result in the termination of our clinical trials, denial of FDA approval, the inability to market and sell our products, our products being withdrawn from the market, or liability claims being asserted against us.
OUR PRODUCTS MAY NOT BE ACCEPTED BY PHYSICIANS, PATIENTS OR THIRD PARTY PAYERS.
Patients, doctors and third-party payers must accept our products as medically useful and cost-effective for us to be successful. Doctors and patients are very important constituents because they directly make all medical decisions. Third party payers are also very important because they pay for a major portion of all medical care expenses. Third party payers consist of health maintenance organizations (“HMOs”), health insurers, managed care providers, Medicare and Medicaid, and their equivalent organizations in jurisdictions outside the U.S. In order to achieve our sales targets in the jurisdictions in which we intend to sell our products, we must educate patients, doctors and third-party payers on the benefits of our products. We cannot assure you that patients, doctors or third-party payers will accept our products, even if approved for marketing, on a timely basis.
GOVERNMENT AND PRIVATE INSURANCE PLANS MAY NOT PAY FOR OUR PRODUCTS.
The success of our products in the United States and other significant markets will depend, in part, upon the extent to which a consumer will be able to obtain reimbursement for the cost of such product from governmental authorities, third-party payers and other organizations. We cannot determine in advance the reimbursement status of newly approved therapeutic products. Even if a product is approved for marketing, we cannot be sure that adequate reimbursement will be available. Also, future legislation or regulation, or related announcements or developments, concerning the healthcare industry, or third party or governmental coverage and reimbursement, may adversely affect our business. In particular, legislation or regulation limiting consumers' reimbursement rights could have a material adverse effect on our business and revenues.
WE MAY LOSE ANY TECHNOLOGICAL ADVANTAGE BECAUSE PHARMACEUTICAL RESEARCH TECHNOLOGIES CHANGE RAPIDLY .
The pharmaceutical research field is characterized by rapid technological progress and intense competition. As a result, our business strategy may not be successful and our products may not reach the marketplace or be saleable Businesses, academic institutions, governmental agencies, and other public and private research organizations, are conducting research to develop technologies that may compete with those of BioBalance. It is possible that competitors could acquire or develop technologies that would render our technology obsolete or noncompetitive. We cannot be certain that we will be able to access the same technologies at an acceptable price, or at all.
WE MAY NOT BE ABLE TO PROCURE REQUIRED INSURANCE COVERAGE.
We will need to procure liability insurance coverage required by clinical investigators, patients and other third parties with respect to future clinical studies. There can be no assurance that such coverage will be available to the Company or that, even if available, the Company will be able to bear the expense of such insurance coverage. Absent such coverage, the Company will not be able to perform required clinical studies.
WE MAY BE SUBJECT TO PRODUCT LIABILITY CLAIMS WHICH COULD RESULT IN SIGNIFICANT LOSSES AND ADVERSE PRODUCT PUBLICITY .
BioBalance, like any other manufacturer of products that are designed to be ingested, faces an inherent risk of exposure to product liability claims and negative publicity in the event that the use of its product results in injury. We face the risk that materials used in the manufacture of the final product may be contaminated with substances that may cause sickness or injury to persons who have used the products, or that sickness or injury to persons may occur if the product distributed by us is ingested in dosages that exceed the dosage recommended on the product label. In the event that insurance coverage or contractual indemnification is not adequate, product liability claims could have a material adverse effect on our business. The successful assertion or settlement of any uninsured claim, a significant number of insured claims, or a claim exceeding any future insurance coverage, could have a material adverse effect on our business. Additionally, we are highly dependent upon consumers' perception of the safety and quality of our product as well as similar products distributed by other companies. Thus, the mere publication of reports and negative publicity asserting that our products, or similar products of others, may be harmful could have a material adverse effect on our business, regardless of whether such reports are scientifically supported, regardless of whether the harmful effects would be present at the dosages recommended for such products, and regardless of whether such adverse effects resulted from failure to consume the product as directed.
INTENSE COMPETITION MAY RESULT IN OUR INABILITY TO GENERATE SUFFICIENT REVENUES TO OPERATE PROFITABLY.
The pharmaceutical industry is highly competitive. Numerous companies, many of which are significantly larger than us, and which have greater financial, personnel, distribution and other resources than us and may be better able to withstand volatile market conditions, will compete with us in the development, manufacture and marketing of probiotics for the treatment of IBS or other GI disorders. There can be no assurance that national or international companies will not seek to enter or increase their presence in the industry. In addition, large nationally known companies (such as Novartis and GlaxoSmithKline) are in competition with us in this segment, and they have already spent millions of dollars to develop treatments for IBS or other GI disorders. Current or increased competition could have a material adverse effect on our business, as many of our competitors have far greater financial and other resources and possess extensive manufacturing, distribution and marketing capabilities far greater than ours.
RISKS RELATING TO THE HOME HEALTHCARE BUSINESS
RECENT RULING REGARDING COMPANIONSHIP SERVICES EXEMPTION MAY IMPACT OUR ABILITY TO PROVIDE HEALTHCARE SERVICES.
On July 22, 2004, the federal Second Circuit Court of Appeals issued a ruling on the applicability to paraprofessional field staff in New York of the Fair Labor Standards Act “companionship services” exemption from minimum wage and overtime requirements. Home care providers have long relied on this exemption to provide compensation to home care aides and personal care workers with the expectation that there is no obligation under federal laws for overtime pay. In September 2004, a request for a rehearing was submitted en banc for the full Court. On January 13, 2005, the Court rejected the request for a rehearing on the issue.
The issue was submitted to the Supreme Court and, on January 23, 2006, the Supreme Court granted a writ of certiorari, vacated the judgment and remanded the case to the Second Circuit Court of Appeals to reconsider its decision in light of a memorandum issued by the U.S. Department of Labor on December 1, 2005. In that memo, the DOL stated that it considers its regulations allowing the companionship exemption to be used by third party employers to be “authoritative and legally binding”. The Second Circuit Court of Appeals reconsidered and, on August 31, 2006, reaffirmed its decision. The Supreme Court again granted a writ of certiorari on January 5, 2007. In June 2007, the U.S. Supreme Court issued its decision which upheld the "companionship exemption" as applying to employment by "third party employers", e.g. home care agencies, such as New York Health Care. Based on this decision, federal law does not require payment of premium wages for overtime, but New York State continues to require payment of one and one-half times the State minimum wage for overtime worked by employees falling within the companionship exemption. Federal legislation has been introduced that would limit the use of the companionship exemption to persons employed “casually” as companions, i.e. to those who do not work full-time and do not work for third-party employers such as New York Health Care. If this legislation is enacted, challenges for the home care industry will be affording higher overtime wages, ensuring patient continuity of care if agencies can no longer afford to authorize overtime, and retention of workers who cannot secure the number of hours of work they desire. All of these factors may cause a higher cost per hour serviced thereby adversely affecting profitability.
WE ARE INDIRECTLY DEPENDENT UPON REIMBURSEMENT BY THIRD-PARTY PAYERS; HEALTHCARE REFORM COULD REDUCE REVENUES.
More than 45% of our revenues are paid by Certified Home Health Agencies and Long-Term Home Health Care Programs, as well as other clients who receive their payments from "third-party payers," such as private insurance companies, self-insured employers and HMOs. Our revenues and profitability, like those of other home healthcare companies, are affected by the continuing efforts of third-party payers to contain or reduce the costs of healthcare by lowering reimbursement or payment rates, increasing case management review of services, and negotiating reduced contract pricing. Because home care is generally less costly than hospital-based care, home nursing and home care providers have benefited from cost containment initiatives aimed at reducing the costs of medical care. However, as expenditures in the home healthcare market continue to grow, cost containment initiatives aimed at reducing the costs of delivering services at non-hospital sites are likely to increase. A significant reduction in coverage or payment rates of public or private third-party payers would reduce the Company’s revenues and profit margins. While we are not aware of any substantive changes in the Medicare or Medicaid reimbursement systems for home healthcare which are about to be implemented, revised budget plans of New York State or the federal government could result in limitation or reduction in the reimbursement of home care costs and in the imposition of limitations on the provision of services which will be reimbursed. Moreover, third party payers, particularly private insurance companies, may negotiate fee discounts and reimbursement caps for services we provide. These circumstances would have a material adverse impact on our business.
SLOW PAYMENTS AND POSSIBLE BAD DEBTS MAY CAUSE WORKING CAPITAL SHORTAGES AND OPERATING LOSSES.
We generally collect payments from our customers within one to three months after services are rendered, but pay our obligations on a current basis. This timing delay may cause working capital shortages from time to time. We have a secured revolving credit facility. Such facility may be available to cover these periodic shortages. However, borrowings or other methods of financing may not be available when needed or, if available, may not be on terms acceptable to us. Although we have established a bad debt reserve for uncollectible accounts, any significant increase in bad debts would damage our revenues and profitability.
PROFESSIONAL LIABILITY INSURANCE MAY BECOME INADEQUATE, UNAVAILABLE OR TOO COSTLY.
The administration of home care and the provision of nursing services entail certain liability risks. We maintain professional liability insurance coverage with limits of $1,000,000 per claim and $3,000,000 annual aggregate, with an umbrella policy providing an additional $5,000,000 of coverage. Although we believe that the insurance we maintain is sufficient for present operations, professional liability insurance is increasingly expensive and sometimes difficult to obtain. A successful claim against us in excess of, or not covered by, our insurance could adversely affect our business and financial condition. Claims against us, regardless of their merit or eventual outcome, could also adversely affect our reputation and home healthcare business.
CHANGES IN FEDERAL AND STATE REGULATION COULD INCREASE COSTS AND REDUCE REVENUES.
Our home healthcare business is subject to substantial regulation at the state level and also under the federal Medicare and Medicaid laws. In particular, we are subject to state laws regulating home care, nursing services, health planning and professional ethics, as well as state and federal laws regarding fraud and abuse in government funded health programs. Changes in the law, or new interpretations of existing laws, can increase the relative costs of doing business and reduce the amount of reimbursement by government and private third-party payers. Although we have not experienced any difficulties to date complying with applicable laws, rules or regulations, our failure to obtain, renew or maintain any required regulatory approvals or licenses could have a material adverse effect on us and could prevent us from offering our existing services to patients or from further expansion. Pending federal or State legislation could substantially impact the conduct of our home healthcare business and potentially adversely affect the cost of operations and available reimbursement. Under the pending legislation in New York, certain reporting requirements, as well as caps on permissible administrative expenses, would be imposed. If the pending legislation becomes law in its current form, costs of operations of our home healthcare business in New York are likely to increase. Under the pending federal legislation, the federal companionship exemption would be eliminated for home care agencies, resulting in increased costs of operations.
INTENSE COMPETITION COULD RESULT IN LOSS OF CLIENTS, LOSS OF PERSONNEL, REDUCED REVENUES AND INABILITY TO OPERATE PROFITABLY.
The home healthcare industry is marked by low entry costs and is highly fragmented and competitive. We compete for personnel with hospitals and nursing homes, and we also compete for both personnel and business with other companies that provide home healthcare services, most of which are large established companies with significantly greater resources, access to capital and greater name recognition than we have. Our principal business competitors include Premiere Health Services, National Home Health Care Corp., Patient Care, Inc., and Personal Touch Home Care Services, Inc. We also compete with many other small temporary medical staffing agencies. Competition for qualified paraprofessional personnel in the New York Metropolitan area is intense. We believe that, given the increasing level of demand for nursing services, significant additional competition can be expected to develop in the future and there are no assurances that we will be able to remain competitive or profitable.
DEPENDENCE ON MAJOR CUSTOMERS AND REFERRAL SOURCES MAY RESULT IN SUBSTANTIAL DECLINES IN REVENUES IF SUCH CUSTOMERS ARE LOST.
The development and growth of our home care and nursing businesses depends, to a significant extent, on our ability to establish close working relationships with hospitals, clinics, nursing homes, physician groups, HMO's, governmental healthcare agencies and other healthcare providers. Many of our contractual arrangements with customers are renewable annually. Existing relationships may not be successfully maintained and additional relationships may not be successfully developed and maintained in existing and future markets. Our 10 largest customers accounted for approximately 88.5% of gross revenues during the year ended December 31, 2007. One referral source, New York City Medicaid, was responsible for approximately 56.1% of our gross revenues for the year ended December 31, 2007. The loss of, or a significant reduction in, referrals by these sources, as well as certain other key sources, would have a material adverse effect on results of operations of our home healthcare business.
RISKS RELATING TO OUR COMMON STOCK
POSSIBLE VOLATILITY OF COMMON STOCK MAY RESULT IN LOSSES TO SHAREHOLDERS.
The trading price of our Common Stock has been subject to significant fluctuations, and there is a limited market for our Common Stock. For the fiscal year 2007, the price of our Common Stock has ranged from a high of $0.260 to a low of $0.035. The price of our Common Stock is likely to continue to be affected by various factors, including, but not limited to, the results of our development efforts of PROBACTRIX® and other products, variations in quarterly results of operations, announcements of new contracts or services, or acquisitions by us or our competitors, governmental regulatory action, general trends in the industry, and other factors, such as extreme price and volume fluctuations which have been generally experienced by the securities markets from time to time in recent years.
OUR DELISTING FROM NASDAQ DUE TO OUR FAILURE TO SATISFY NASDAQ LISTING STANDARDS AND OUR STOCK BEING SUBJECT TO THE “PENNY STOCK” RULES HAS RESULTED IN REDUCED LIQUIDITY AND LOWER STOCK PRICE .
Our Common Stock was delisted from the NASDAQ SmallCap market in April 2004 and was listed for trading in the OTC "pink sheets.” As of September 22, 2005, our Common Stock has been listed for trading on the NASDAQ Bulletin Board which provides significantly less liquidity than a securities exchange (such as the American or New York Stock Exchange) or an automated quotation system (such as the NASDAQ National or Capital Market ) . As a result, the liquidity of our Common Stock is impaired, not only in the number of shares which can be bought and sold, but also through delays in the timing of transactions, reduction in security analysts' and news media's coverage, and lower prices for our Common Stock than might otherwise be attained. There is currently a very limited market and low volume of trading in our Common Stock, and on many days there is no trading activity at all in our Common Stock. Moreover, because of the limited market and low volume of trading, our Common Stock is more likely to be affected by and fluctuate from broad market fluctuations, general market conditions, fluctuations in our operating results, future securities offering by us, changes in the market’s perception of our business, announcements made by us or our competitors, and general industry conditions. Our Common Stock may not be accepted for a listing on an automated quotation system or securities exchange.
In addition, our Common Stock is subject to the low-priced security or so-called "penny stock" rules that impose additional sales practice requirements on broker-dealers who sell such securities. For any transaction involving a penny stock, the rules require, among other things, the delivery, prior to the transaction, of a disclosure schedule required by the SEC relating to the penny stock market. The broker-dealer also must disclose the commissions payable to both the broker-dealer and the registered representative and current quotations for the securities. Finally, monthly statements must be sent disclosing recent price information for the penny stocks held in the customer's account. The regulations relating to penny stocks could limit the ability of broker dealers to sell our Common Stock and thus, the ability of shareholders to sell their shares in the market.
FUTURE ISSUANCES OR SALES OF OUR COMMON STOCK COULD ADVERSELY AFFECT THE MARKET PRICE OF OUR COMMON STOCK AND OUR ABILITY TO RAISE ADDITIONAL CAPITAL.
We have previously issued a substantial number of shares of Common Stock, which are eligible for resale under Rule 144 of the Securities Act, and which may become freely tradable. We have registered, or agreed to register, a substantial number of shares of Common Stock that are issuable upon the exercise of options and warrants, or that were previously issued in private transactions. If holders of options or warrants choose to exercise their purchase rights and sell shares of Common Stock in the public market, or if holders of currently restricted shares choose to sell such shares in the public market under Rule 144 or otherwise, the prevailing market price for the Common Stock may decline. Future public sales of shares of Common Stock may adversely affect the market price of our Common Stock or our future ability to raise capital by offering equity securities.
ISSUANCE OF PREFERRED STOCK COULD REDUCE THE VALUE OF COMMON STOCK AND COULD HAVE ANTI-TAKEOVER EFFECTS.
We are authorized by our certificate of incorporation to issue up to 5,000,000 shares of preferred stock, on terms which may be fixed by our board of directors without further shareholder action. There are now no shares of preferred stock issued and outstanding. The terms of any new series of preferred stock, which may include priority claims to assets and dividends and special voting rights, could adversely affect the rights of holders of the Common Stock. The issuance of an additional series of preferred stock, depending upon the rights and preferences of such series, could make the possible takeover of our company, or the removal of our management, more difficult, discourage hostile bids for control of our company in which shareholders may receive premiums for their shares of Common Stock, or otherwise dilute the rights of holders of Common Stock and the market price of the Common Stock.
WE HAVE NEVER PAID ANY DIVIDENDS ON OUR COMMON STOCK.
We have never paid any dividends on our Common Stock and do not anticipate paying cash dividends in the foreseeable future. We currently intend to retain all earnings. The declaration and payment of future dividends, if any, will be at the sole discretion of our board of directors and will depend upon our profitability, financial condition, cash requirements, future prospects, the rights of any other classes of preferred stock, and other factors deemed relevant by the board of directors.
SHARES OF OUR COMMON STOCK ISSUED IN CONNECTION WITH OUR ACQUISITION OF BIOBALANCE MAY HAVE BEEN ISSUED WITHOUT COMPLYING WITH CERTAIN STATE SECURITIES LAWS.
During October 2003, it was determined that certain of the shares of common stock that we issued to holders of BioBalance stock in connection with our January 2003 acquisition of BioBalance may not have been exempt from the registration or qualification requirements of the state securities laws of certain of the states where the holders of BioBalance stock then resided, although they were registered under the Securities Act of 1933, as amended. Although we are unable to quantify the actual number of shares involved that are still owned by the original recipients of our shares in the acquisition, the per share purchase price paid by the BioBalance holders for the shares they exchanged in the acquisition ranged from $.03 to $3.00 per share, and we currently believe that the purchase price paid by such persons who might have certain statutory rescission rights does not exceed approximately $345,000, exclusive of any penalties or interest, although no assurance can be given that any such claims will not exceed this amount. We cannot determine the effect, if any, on our operations or financial condition that may occur from the failure to register or qualify these shares under applicable state securities laws. If it is determined that we offered securities without properly registering or qualifying them under state laws, or securing exemption from registration, regulators could impose on us significant monetary fines or other sanctions. We are unable to estimate the amount of monetary fines, if any, or the nature or scope of any sanctions at this time.
Item 1B.
Item 1B. UNRESOLVED STAFF COMMENTS
None.
Item 2.
Item 2. DESCRIPTION OF PROPERTIES
All of our executive and branch offices are located in facilities leased from unaffiliated persons.
Our corporate headquarters is located in a building containing approximately 6,000 square feet located in Brooklyn, New York under a lease expiring in 2010, at a monthly rental of approximately $10,000, subject to annual increases and rent escalations based on increases in real estate taxes. Our home healthcare business is administered from our corporate headquarters and 7 branch and recruitment offices located in New York under month to month tenancies and term leases expiring from March 2008 through June 2011 at annual rentals ranging from approximately $23,000 to $129,000, and additional rent based upon increases in real estate taxes and other cost escalations.
BioBalance's executive office was located at 345 Seventh Avenue, New York, New York under a five year lease that commenced in April 2006 at a monthly rental of approximately $15,200. BioBalance surrendered this office space to the landlord in March 2007 in exchange for lease cancellation, incurring exit costs and asset disposal/impairment losses of approximately $74,000 .
Item 3.
Item 3. LEGAL PROCEEDINGS
We are subject to various legal proceedings and claims, either asserted or unasserted, which arise in the ordinary course of business. While the outcome of these claims cannot be predicted with certainty, management does not believe that the outcome of any of these legal matters will have a material adverse effect on our results of operations or financial position, except as follows:
On March 30, 2006, the Company was served with a shareholder derivative complaint captioned Jay Glatzer v. Yitz Grossman, Emerald Asset Management, Murry Englard, Michael Nafash, Stuart Ehrlich, and Dennis O'Donnell and New York Health Care, Inc., (Supreme Court of State of New York County of Nassau, (Index No. 5125/06). The lawsuit alleged that the directors breached their fiduciary duty by approving the Emerald Settlement Agreement disclosed in the Company's Form 8-K (Date of Report March 6, 2006) filed with the Securities Exchange Commission on March 10, 2006. The lawsuit claimed that such breach was a product of their respective relationships with Mr. Grossman. The lawsuit also alleged that Mr. Grossman and Emerald Asset Management injured the Company by engaging in the actions underlying the November 2004 criminal conviction of Mr. Grossman. The lawsuit was dismissed in September 2006. A notice of appeal was filed by the plaintiff in October 2006 and the plaintiff filed its appeal brief in April 2007. On January 15, 2008, the court dismissed the appeal.
The Company reported in the Company's Form 8-K filed on August 21, 2006 that the Company had unilaterally rescinded the settlement between the Company and Emerald Asset and Yitz Grossman. The settlement agreement was originally entered into as reported in the Company's Form 8-K filed on March 6, 2006, and the related liability was recorded on the books of the Company at December 31, 2005, in the amount of $1,545,000. The rescission of the settlement by the Company was done without the consent of Emerald Asset and Yitz Grossman. Accordingly there may be future litigation brought against the Company by Emerald Asset and Yitz Grossman to seek enforcement of the agreement. The Company continues to retain the accrual for the settlement agreement on its books in its entirety. If there is litigation brought by Emerald Asset and Yitz Grossman to enforce the settlement agreement, there can be no assurance that at a future time the accrual that was recorded would be sufficient to offset amounts resulting from the future litigation.
Item 4.
Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Not applicable.
PART II
Item 5.
Item 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
Our Common Stock traded on the National Association of Securities Dealers Automated Quotation System (“NASDAQ”) Capital Market (formerly known as the SmallCap Market) Market until April 6, 2004. From April 6, 2004 until September 22, 2005, our Common Stock was traded over-the-counter on the Pink Sheets. On September 22, 2005, our Common Stock was listed for trading on the Bulletin Board. Our Common Stock was also listed on the Boston Stock Exchange (“BSE”) until March 5, 2005, when our voluntary delisting application was granted, although no trades of our Common Stock had been executed on the BSE for at least two years prior to our making the voluntary application to delist from the BSE. The following table sets forth, for the quarters indicated, the high and low sales prices for our Common Stock on the NASDAQ Capital Market or the Pink Sheets or the Bulletin Board as applicable.
Holders
At March 13, 2008, we had 212 holders of record and approximately 1,400 beneficial holders of our Common Stock.
Dividends
The Company has not paid any cash dividends since its inception and presently anticipates that all earnings, if any, will be retained for development of the Company’s business and that no dividends on the shares of Common Stock will be declared in the foreseeable future. Any future dividends will be subject to the discretion of the Company’s Board of Directors and will depend upon, among other things, future earnings, the operating and financial condition of the Company, its capital requirements, general business conditions and other facts and circumstances as assessed by the Board of Directors in its reasonable judgment. There can be no assurance that any dividends on the Common Stock will be paid in the future.
Securities Authorized for Issuance under Equity Compensation Plans
For information on securities authorized for issuance and issued under the Company’s equity compensation plans, see Part III, Item 11 of this report, “Executive Compensation - Savings and Equity Compensation Plans.”
Item 6.
Item 6. SELECTED FINANCIAL DATA
Not applicable.
Item 7.
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Forward Looking Statements
Certain information contained in this report is forward-looking in nature. All statements in this report, including those made by the Company and its subsidiaries (“we”, “our”, or the “Company”), other than statements of historical fact, are forward-looking statements. Examples of forward-looking statements include statements regarding the Company's future financial condition, operating results, business and regulatory strategies, projected costs, services, research and development, competitive positions and plans and objectives of management for future operations. These forward-looking statements are based on management's estimates, projections and assumptions as of the date hereof and include the assumptions that underlie such statements. Forward-looking statements may contain words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” or the negative of these terms or other comparable terminology. Any expectations based on these forward-looking statements are subject to risks and uncertainties and other important factors, including those discussed in Item 1A. - Risk Factors. Other risks and uncertainties are disclosed in the Company's prior SEC filings. These and many other factors could affect the Company's future financial operating results, and could cause actual results to differ materially from expectations based on forward-looking statements made in this report or elsewhere by the Company or on its behalf. The Company assumes no obligation to update such statements.
Overview
We are currently engaged in two industry segments, the delivery of home healthcare services (sometimes referred to as the “home healthcare business”) and the development of proprietary biotherapeutic agents for the treatment of various gastrointestinal (“GI”) disorders, through our acquisition BioBalance.
The Company is a New York corporation incorporated in 1983. The Company's principal executive office is 1850 McDonald Avenue, Brooklyn, New York 11223, telephone 718-375-6700.
Critical Accounting Policies
The Company's critical accounting policies are those it believes are the most important in determining its financial condition and results of operations, and require significant subjective judgment by management as a result of inherent uncertainties. A summary of the Company’s significant accounting policies is set out in the notes to the consolidated financial statements. Such policies are discussed below.
The preparation of financial statements and related disclosures in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the Consolidated Financial Statements and accompanying notes. Estimates are used for, but not limited to, the accounting for allowance for doubtful accounts and potential impairment of goodwill and other intangibles. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable the circumstances. Actual results could differ from these estimates under different assumptions or conditions.
Long-Lived Assets and Other Intangible Assets
We evaluate long-lived assets, such as intangible assets other than goodwill, equipment and leasehold improvements, for impairment when events or changes in circumstances indicate that the carrying amounts of the assets may not be recoverable through estimated undiscounted cash flows from the use of these assets. When impairment exists, the related assets are written down to fair value.
Accounting for Income Taxes and Valuation Allowances
We currently have significant deferred tax assets, resulting from net operating loss carry forwards and differences between financial reporting and tax treatment of intangible assets amortization and impairment losses. These deferred tax assets may reduce taxable income in future periods. Based on the Company’s losses and its accumulated deficit, the Company has provided a full valuation allowance against the net deferred tax asset. A valuation allowance is required when it is more likely than not that all or a portion of a deferred tax asset will not be realized. Cumulative losses weigh heavily in the overall assessment of valuation allowances.
We expect to continue to maintain a full valuation allowance on future tax benefits until an appropriate level of profitability is sustained, or we are able to develop tax strategies that would enable us to conclude that it is more likely than not that a portion of our deferred tax assets would be realizable.
Classification of Amounts Due to HRA
Historically, management has maintained a liability account to show amounts paid to the Company under the contract with the City of New York Human Resources Administration (“HRA”) which were required to be used for certain employee benefits purposes and were to be paid to or on behalf of the home health aid employees. In 2006, management determined that approximately $904,000 could no longer be used for the employee benefit and could not be paid to the employees but could be expected to be required to be repaid to HRA. Accordingly, this amount was reclassified from general accrued expenses to the caption “Due to HRA”.
Recently Issued Accounting Pronouncements
In December 2007, the FASB issued SFAS No. 141 (revised 2007), "Business Combinations." SFAS 141(R) broadens the guidance of SFAS 141, extending its applicability to all transactions and other events in which one entity obtains control over one or more other businesses. It broadens the fair value measurement and recognition of assets acquired, liabilities assumed, and interests transferred as a result of business combinations. SFAS 141(R) expands on required disclosures to improve the statement users' abilities to evaluate the nature and financial effects of business combinations. SFAS 141(R) is effective for our fiscal year beginning January 1, 2009. The adoption of SFAS 141(R) is not expected to have a material impact on the Company's financial position, results of operations or cash flows.
In December 2007, the FASB issued SFAS No. 160, "Noncontrolling Interests in Consolidated Financial Statements-an amendment of ARB No. 51." SFAS 160 requires that a noncontrolling interest in a subsidiary be reported as equity and the amount of consolidated net income specifically attributable to the noncontrolling interest be identified in the consolidated financial statements. It also calls for consistency in the manner of reporting changes in the parent's ownership interest and requires fair value measurement of any noncontrolling equity investment retained in a deconsolidation. SFAS 160 is effective for our fiscal year beginning January 1, 2009. We have not yet determined the impact of adopting SFAS 160 on the Company's financial position, results of operations or cash flows.
In February, 2007, FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and Financial Liabilities including an amendment of FAS 115, or FAS 159. This statement provides companies with an option to report selected financial assets and liabilities at fair value. This statement is effective for fiscal years beginning after November 15, 2007 with early adoption permitted. Management does not believe that adoption of this statement will have a material impact on the financial position of the Company.
In September 2006, the FASB issued SFAS No. 158 Employers' Accounting for Defined Benefit Pension and Other Postretirement Plans - an Amendment of FASB Statements No. 87, 88, 106, and 132(R). This statement requires a company to recognize the funded status of a benefit plan as an asset or a liability in its statement of financial position. In addition, a company is required to measure plan assets and benefit obligations as of the date of its fiscal year-end statement of financial position. The recognition provision of this statement, along with additional disclosure requirements, is effective for fiscal years ending after December 15, 2006, while the measurement date provision is effective for fiscal years ending after December 15, 2008. Management does not believe that adoption of this statement will have a material impact on the financial position of the Company.
In September 2006, the FASB issued SFAS No. 157, "Fair Value Measurements" which defines fair value, establishes guidelines for measuring fair value and expands disclosures regarding fair value measurements. SFAS 157 does not require any new fair value measurements but rather eliminates inconsistencies in guidance found in various prior accounting pronouncements. SFAS 157 is effective for fiscal years beginning after November 15, 2007. However, on February 12, 2008, the FASB issued proposed FASB Staff Position ("FSP") SFAS No. 157-2, "Effective Date of FASB Statement No. 157," which defers the effective date for adoption of fair value measurements for nonfinancial assets and liabilities to fiscal years beginning after November 15, 2008. The Company will adopt SFAS 157 during 2008, except as it applies to those non-financial assets and non-financial liabilities as noted in proposed FSP 157-2. The partial adoption of SFAS 157 is not expected to have a material impact on the Company's financial position, results of operations or cash flows.
In June, 2006, the FASB issued Interpretation No. 48, Accounting for Uncertainty in Income Taxes, an Interpretation of FASB Statement No. 109, Accounting for Income Taxes (FIN48), to create a single model to address accounting for uncertainty in tax positions. FIN 48 clarifies the accounting for income taxes by prescribing a minimum recognition threshold a tax position is required to meet before being recognized in the financial statements. FIN 48 also provides guidance on derecognition, measurement, classification, interest, and penalties, accounting in interim periods, disclosure and transition. The Company adopted FIN 48 as of January 1, 2007. Based on our evaluation, we have concluded that there are no significant uncertain tax positions requiring recognition in our financial statements. Our evaluation was performed for the tax years which remain subject to examination by major tax jurisdictions as of December 31, 2007. We may from time to time be assessed interest or penalties by major tax jurisdictions, although any such assessments historically have been minimal and immaterial to our financial results. In the event we have received an assessment for interest and/or penalties, it has been classified in the financial statements as selling, general and administrative expense. The Company is currently subject to a three year statue of limitations by major tax jurisdictions. The Company and its subsidiaries file income tax returns in the U.S. federal jurisdiction, New York State, New York City and New Jersey.
Results of Operations
The following table reflects the results of operations for the years ended December 31, 2007 and 2006 for each business segment.
BioBalance Segment
During the years 2007 and 2006, the BioBalance segment had no revenues and no cost of sales.
Selling, general and administrative expenses ("SG&A") for the year ended December 31, 2007 decreased ($1,986,024) (48.64%) to $2,096,976 from $4,083,000 for the year ended December 31, 2006. The decrease is attributable largely to management's cost cutting efforts with reductions in rents, salaries and benefits, share based compensation, public relations and professional fees. The SG&A expenses for BioBalance include charges for impairment of intangible assets of $729,792 in and $926,322 in 2006.
Product development costs for the BioBalance segment for the year ended December 31, 2007 were $648,759 compared to $1,637,558 for 2006, a decrease of ($988,799) or 60.38%. The decrease was a result of scaling back operations because of a lack of available funding to continue clinical trials.
For the year ended December 31, 2007, the operations of the BioBalance segment showed loss from continuing operations of ($2,745,153) compared to a loss of ($5,492,072) in 2006, an improvement of $2,746,919 or 50.02%. The improvement was a result of the cost cutting efforts described above as well as the scaling back of clinical operations.
Home Healthcare Segment
Revenues the year ended December 31, 2007 decreased by ($1,159,028) or 2.54% to $44,399,303 from $45,558,331 in 2006. The 2006 revenue in the home health care segment includes a reversal of debt from HRA in the amount of approximately $704,000, which relates to funds that HRA agreed not collect for their fiscal year 2002. The Company had previously accrued this amount as due to HRA.
Cost of professional care of patients decreased ($120,994) or 0.33% in 2007 to $36,626,372 from $36,747,366 in 2006.
Selling, general and administrative expenses (SG&A) decreased by ($626,973) (9.12%) to $6,247,562 in as compared to $6,874,535 in 2006. This decrease is due to the reduction in personnel costs, and reductions of general operating costs at the home health care operations, particularly in the area of professional fees and executive compensation..
For the year ended December 31, 2007, the net income from the home health care segment was $1,692,802 as compared to $1,736,399 for the year ended December 31, 2006 a decrease of ($43,597) or -2.51%.
Liquidity and Capital Resources
For the year ended December 31, 2007, cash used for operating activities on a consolidated basis was $88,614 compared to $2,717,201 in 2006, an improvement of.$2,628,587 . The change resulted from a decrease in the net loss for 2007 as compared to 2006 of $2,703,322 , offset by and a decrease in cash from changes in non-cash expenses of ($917,347) and an increase in cash provided by changes in components of operating assets and liabilities of $842,612 .
Net cash used in investing activities for the year ended December 31, 2007 totaled $134,934 and consisted principally of the acquisition of intangible assets.
Home Healthcare Segment
At December 31, 2007, the Company had no long-term debt.
Operating leases for premises also generally contain provisions allowing rental obligations to be accelerated upon default in the payment of rent or the performance of other lease obligations. These leases generally contain provisions for additional rent based upon increases in real estate taxes and other cost escalations. The lease for the office space for BioBalance is included in the above amounts.
The Company has no off-balance sheet arrangements and has not entered into any transactions involving unconsolidated, limited purpose entities or commodity contracts.
On September 20, 2007, New York Health Care entered into a Loan and Security agreement with CIT Healthcare LLC, as lender (“Lender”). The term of the Loan and Security Agreement is three years. The Loan and Security Agreement provides for a revolving line of credit facility under which the Company may borrow, repay and re-borrow an amount not exceeding the lesser of $5,000,000 or the borrowing base, which is an amount that may not exceed 85% of the estimated net value of the Company's Eligible Accounts, as defined in the agreement. As of December 31, 2007, approximately $3,600,000 of the line was available for borrowing by the Company. Interest is payable on the outstanding principal balance of the credit facility at an annual rate equal to 30-day LIBOR plus three and one-half percent (3.50%), adjusted monthly in accordance with changes in 30-day LIBOR. The Company's obligations to Lender under the Loan and Security Agreement are secured by a first priority lien on all of the Company's accounts receivable, general intangibles, instruments and documents, and the proceeds thereof. However, no collateral consists of any assets or property of BioBalance.
New York Health Care is prohibited from making dividend, distributions or other withdrawals during the term of the credit facility. However, New York Health Care is permitted to make loans, advances or contributions to its subsidiary, BioBalance, provided that certain liquidity requirements are met. New York Health Care is further restricted from mergers and acquisitions, as well as asset sales or dispositions outside the ordinary course of business, provided that such sale restrictions are not applicable to the capital stock or assets of BioBalance.
Days Sales Outstanding ("DSO") is a measure of the average number of days taken by the Company to collect its account receivable, calculated from the date services are billed. For the year ended December 31, 2007, the DSO of the home care segment of the Company was 68, compared to 58 days for the year ended December 31, 2006. The increase in DSO was primarily caused by delays in collection from one of the Company's contracts. Management has adequately reserved for potential losses from this contract.
BioBalance Segment
As of December 31, 2007, BioBalance has generated no revenues and has no accounts receivable. The assets of BioBalance consist mainly of intangibles related to the patents it holds on its lead product PROBACTRIX®.
As of December 31, 2007, BioBalance had cash on hand of approximately $38,000, all of which was available to fund operations. BioBalance management estimates that its capital requirements for an entire year of operations are approximately $5,000,000. This amount includes the cost of the initial up front payment for the Phase I/II clinical trial, in the amount of $3,000,000, for the Company's lead product PROBACTRIX® that is not expected to be started in 2008. It will be necessary for the Company to secure additional funding in order for BioBalance to begin the Phase I/II clinical trial, which was approved by FDA on March 24, 2006. The Company has not been able to obtain additional funding up to the present time and the BioBalance subsidiary has been operating solely by utilizing funds from the health care operations, which are insufficient for BioBalance's needs. The Company is in continuing discussions with potential funding sources but no agreements with any such funding sources have been entered into. Accordingly, since additional funding from outside sources has not been obtained, the Company began scaling back the operations of BioBalance at the end of November 2006, and BioBalance began operating on a substantially reduced budget in 2007. BioBalance management has taken steps to secure the data from clinical trials and has begun the production of a duplicate of the biological strain of PROBACTRIX® . Additionally, BioBalance surrendered its office space to the landlord in March 2007 in exchange for lease cancellation, incurring exit costs through the time the space was fully vacated of approximately $38,000 and asset disposal/impairment losses of approximately $36,000 . Management has instituted temporary cutbacks in consultant compensation until such time as additional funds or a strategic partner can be found. There can be no assurances that the Company will be able to raise additional capital in the near term to allow BioBalance to continue its normal level of operations.
Off-Balance Sheet Arrangements
The Company has not entered into any transactions with unconsolidated entities whereby the Company has financial guarantees, subordinated retained interests, derivative instruments or other contingent arrangements that expose the Company to material continuing risks, contingent liabilities, or any other obligation under a variable interest in an unconsolidated entity that provides financing, liquidity, market risk or credit risk support to the Company.
Item 7A.
Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable.
Item 8.
Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The consolidated financial statements of the Company, together with the Independent Registered Public Accounting Firms’ report thereon of Holtz Rubenstein Reminick LLP, for the years ended December 31, 2007 and 2006. See Index to “Financial Statements.”
Item 9.
Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
During the fiscal years ended December 31, 2007 and 2006, there were no disagreements with Holtz Rubenstein Reminick LLP ("Holtz") on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure, which disagreements, if not resolved to the satisfaction of Holtz, would have caused them to make reference in connection with their report to the subject matter of the disagreement, and Holtz has not advised the Company of any reportable events as defined in Item 304(a)(1)(v) of Regulation S-K.
Item 9A
Item 9A (T). Controls and Procedures.
(a) Evaluation of Disclosure Controls and Procedures.
As of the end of the period covered by this annual report, we carried out 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 the Exchange Act Rules 13a-15(e) and 15d-15(e)). Based upon the foregoing evaluation, our principal executive officer and principal financial officer have concluded that our disclosure controls and procedures are not effective, for the reasons discussed below, to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC.
(b) Management’s Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting and for the assessment of the effectiveness of internal control over financial reporting, as defined in Rule 13a-15(f) under the Exchange Act. Internal control over financial reporting is a process designed by, or under the supervision of our principal executive officer and principal financial officer and effected by our Board of Directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of the financial statements in accordance with U.S. generally accepted accounting principles.
Our 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 our transactions and dispositions of our assets; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of the financial statements in accordance with U.S. generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the 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.
In connection with the preparation of our annual financial statements, management has undertaken an assessment of the effectiveness of our internal control over financial reporting as of December 31, 2007, based on criteria established in Internal Control - Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission, or the COSO Framework. Management’s assessment included an evaluation of the design of our internal control over financial reporting and testing of the operational effectiveness of those controls. Due to the inherent issue of segregation of duties in a small company, we have relied heavily on entity or management review controls to lessen the issue of segregation of duties.
Based on this evaluation, management has concluded that our internal control over financial reporting was not effective as of December 31, 2007. Our principal executive officer and principal financial officer have concluded that we have a material weakness in our internal control over financial reporting.
A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely basis. Management identified the following material weaknesses as of December 31, 2007:
Supervision: The controller is responsible for making all journal entries relating the home health care segment. The journal entries made by the controller are not reviewed by another person in the organization with sufficient accounting knowledge and authority. This weakness also has an affect on our period end closing process whereby the lack of supervision of the controller results in a substantial number of journal entries made during the closing process. We believe that if this weakness did not exist, there would be far fewer journal entries required during the closing process. One of our main goals in remediating this weakness is to substantially reduce the number of entries made during the closing process, to be fully implemented by the third quarter of 2008. We are remediating this weakness by implementing a rearrangement of the work flow so that other members of the accounting staff will be responsible for preparing and entering certain journal entries that the controller will review. Entries made directly by the controller will be reviewed periodically by the Chief Financial Officer. Additionally, we are developing a review checklist that will be utilized by the Chief Financial Officer to periodically review the work of the controller at least quarterly, with some aspects being reviewed on a monthly basis.
Information Technology: Management did not perform tests of information technology controls before the year end so we cannot assert that the controls functioned as designed as of December 31, 2007. However, we were able to ascertain that the controls were in place through certain documentation available relating to bills received from our outside computer consultants.
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 temporary rules of the SEC that permit the Company to provide only management’s report on internal control in this annual report.
Changes in Internal Controls
There have been no changes in our internal control over financial reporting during our most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B.
Item 9B. OTHER INFORMATION:
Not applicable.
PART III
Item 10.
Item 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The persons who currently serve as executive officers and directors of the Company, and who served in such capacities during the 2007 fiscal year, are as follows:
Murry Englard was designated by the Board as Chief Executive Officer effective August 1, 2007. Murry Englard has been a director of the Company since September 2005 and acting Chief Executive Officer since November 20, 2006. Mr. Englard is a partner of the accounting firm Harlib, Grossman & Englard, CPA's since January 1996. He was managing partner of Englard & Company, CPA, P.C. from January 1992 until December 1995 and a partner at Englard & Company CPA from January 1985 until December 1991. Mr. Englard is a certified public accountant. He received a B.A. in Accounting from Queens College in 1980 and attended Bernard Baruch Graduate School of Business concentrating in finance.
Effective February 5, 2007, Stewart W. Robinson was appointed to serve as the Company’s Chief Financial Officer on a part-time basis. Since November 1998, Mr. Robinson has been a partner-in-charge of SEC practice and quality control in the accounting firm of KBL, LLP and its predecessor. KBL, LLP is a Public Accounting Company Oversight Board (“PCAOB”) registered auditing and consulting firm concentrating in audits of small public companies and small to medium size private companies. Mr. Robinson was previously partner in-charge of litigation services and SEC auditing at several New York area accounting firms from 1984 through 1997. Mr. Robinson, received a B.A. in Accounting from Queens College in 1977, attended Pace University Graduate School of Business for taxation and completed business valuation training at both the American Society of Appraisers and the National Association of Certified Valuation Analysts. He is a member of the American Institute of Certified Public Accountants and the New York State Society of Certified Public Accountants. Mr. Robinson is also registered with the PCAOB under the name Stewart W. Robinson, CPA.
Dr. Howard Berg, a partner in Specialists in Otolaryngology, LLC since November and a partner in Short Hills Surgical Center since February 2005, is a practicing physician in Otolaryngology and Head and Neck Surgery. Dr. Berg has served as an attending surgeon at New York Downtown Hospital in New York City since July 1986 and as an attending surgeon at St. Barnabas Medical Center in Livingston, New Jersey since July 1996. Dr. Berg has been an Assistant Professor of Otolaryngology at New York University Medical Center since June 1985 and participates in the Otolaryngology Surgical Resident Training Program at Mount Sinai Medical Center.”
Since January 2008, Yoram Hacohen is a partner in Hacohen Wolf, a law firm in Jerusalem, Israel. From January 2007 through December 2007, Yoram Hacohen was a partner with the firm Jaffe, Fund & Co, Advocates, in Jerusalem, Israel, specializing in corporate, commercial and civil law in the fields of international trade, tax and real estate. For the preceding five years, Mr. Hacohen was an independent practitioner in those fields of law. Mr. Hacohen earned his law degree from London Guildhall University, London, England in July 1995.
Michael Nafash served as a director of the Company since August 31, 2005. He resigned as a director of the Company on April 3, 2007. Mr. Nafash is a Certified Public Accountant and held various corporate finance positions throughout his career.
Directors hold office until the next annual meeting of the stockholders and/or until their successors have been duly elected and qualified, or until death, resignation or removal. Executive officers are elected by the Board of Directors on an annual basis and serve at the discretion of the Board. There is no family relationship between any of the Company’s directors or its executive officers.
Audit Committee
The Audit Committee of the Board of Directors previously consisted of Murry Englard and Michael Nafash. Upon Michael Nafash’s resignation, on April 3, 2007, the Audit Committee was effectively terminated.
Section 16(a) Beneficial Ownership Reporting and Compliance
Section 16(a) of the Exchange Act requires the Company’s directors and executive officers and holders of more than 10% of the Company's common stock to file reports with the SEC about their ownership of common stock and other securities of the Company. These persons are required by SEC rules to furnish the Company with copies of all Section 16(a) forms they file. The Company is required to identify anyone who filed a required report late during 2007.
Based solely on our review of forms we received and written representations from reporting persons stating that they were not required to file these forms, the Company believes, that during 2007, all Section 16(a) filing requirements were satisfied on a timely basis.
Code of Ethics
The Company has adopted a Code of Ethics for Senior Financial Officers which applies to the Company’s Chief Executive Officer and Chief Financial and Principal Accounting Officer. A copy of this Code was filed with the Securities and Exchange Commission as an exhibit to the Company’s Form 10-K for the fiscal year ended December 31, 2003.
Item 11.
Item 11. EXECUTIVE COMPENSATION
The following table sets forth, for the fiscal years ended December 31, 2007 and 2006, the cash compensation paid by the Company, as well as certain other compensation paid with respect to those fiscal years, to the Company’s Chief Executive Officer and to each of the three other most highly compensated executive officers of the Company and its BioBalance subsidiary, whose total salary and bonuses for the fiscal year 2007, in all capacities in which served, was $100,000 or more (collectively, the “Named Executive Officers”):
(1)
Murry Englard has been a director of the Company since September 2005. Mr. Englard was paid director's fees of $1,000 per month from September through August 2006, increasing to $2,500 per month staring in September 2006. The total director's fees paid to Mr. Englard were $35,200 in 2007 and $18,000 in 2006. Other compensation for Mr. Englard also includes $11,026 in expense reimbursements. Effective August 1, 2007, the Board appointed Mr. Englard as Chief Executive Officer to serve on a part-time basis at annual compensation of $100,000.
(2)
Stewart W. Robinson was appointed effective February 5, 2007 to serve as the Company’s Chief Financial Officer on a part-time basis with annual compensation of $65,000 for between 36 and 45 days. By May 3, 2007, Mr. Robinson had already worked 45 days and was paid up to the contract amount. From May 4, 2007 through December 31, 2007, Mr. Robinson worked for the Company for 44 more days and was paid at the per-diem rate agreed to in the contract. Other compensation for Mr. Robinson includes: payment for bookkeeping and clerical services ($4,825) provided by persons employed by him or KBL, LLP; reimbursement for office related expenses incurred of $877; reimbursement for software and related training costs of $2,340 and; continuing education and related travel costs specifically related to his position with the company of $2,251.
(3)
Dennis O'Donnell became President of BioBalance on November 26, 2003 and the Company's Chief Executive Officer on February 24, 2005. On September 9, 2006, Mr. O'Donnell resigned from all of his positions with the Company. Other Compensation includes $24,444 of medical insurance premiums paid on behalf of Mr. O'Donnell in 2006.
Option/SAR Grants in 2007
275,000 stock options were granted to the Named Executive Officers and Directors in 2007.
Outstanding Equity Awards at Fiscal Year End
The following table sets forth, for the Named Executive Officers, unexercised options; stock that has not vested; and equity incentive plan awards as of December 31, 2007.
OUTSTANDING EQUITY AWARDS AT FISCAL YEAR-END
Stock Option Exercises and Year End Values
The following table sets forth, for the Named Executive Officers, the number of shares covered by stock options as of December 31, 2007, and the value of “in-the-money” stock options, which represents the positive spread between the exercise price of a stock option and the market price of the shares subject to such option on December 31, 2007. No options were exercised by the Named Officers in 2007.
Compensation of Directors
The directors of the Company receive monthly compensation as follows: Murry Englard, who has taken on additional responsibilities since September 2006 while serving as a director in the absence of full-time executive management, receives director’s fees of $2,500 per month. Prior to September 2006, Mr. Englard received director compensation of $1,000 per month plus $700 for attendance at committee meetings. Michael Nafash served as director from August 31, 2005 through April 3, 2007 and received director compensation of $1,000 per month plus $700 for attendance at committee meetings through September 2006 and $2,500 per month commencing October 2006 through his resignation on April 3, 2007. Stuart Ehrlich served as director from August 31, 2005 through September 22, 2006 and received director compensation of $1,000 per month plus $700 for attendance at committee meetings. Yoram Hacohen and Howard Berg, who have served as directors since February 2007, are entitled to directors’ fees of $1,000 per month. Howard Berg receives an additional $2,000 per month as compensation for his position with the Company as non-executive Chairman of Product Development. No other amounts are payable to the directors, except for reimbursement for expenses of attending Board meetings. Except for Mr. Englard, none of the present directors of the Company is an employee of the Company or its BioBalance subsidiary.
The Company also issues common stock options or warrants to non-employee directors from time to time in recognition of their services. In January 2006, 15,000 common stock options, and, in September 2006, 150,000 common stock options, were issued to each of Murry Englard, Stuart Ehrlich and Michael Nafash. When Mr. Ehrlich resigned as a director on September 22, 2006, he relinquished all of those options to the Company. When Mr. Nafash resigned as a director on April 3, 2007, he relinquished 75,000 of those options to the Company.
In 2007, the Company issued an aggregate of 275,000 options to directors as follows:
When Mr. Hacohen and Dr. Berg were appointed directors in February 2007, they each received a grant of 25,000 options in consideration for their services.
When Mr. Englard was appointed Chief Executive Officer in August 2007, he received 150,000 options.
In August 2007, Dr. Berg received 75,000 options in recognition of his appointment non-executive Chairman of Product Development.
Employment Agreements of the Named Executive Officers; Change in Control Arrangements
Stewart W. Robinson was appointed effective February 5, 2007 to serve as the Company’s Chief Financial Officer on a part-time basis with annual compensation of $65,000 for between 36 and 45 days. By May 3, 2007, Mr. Robinson had already worked days and was paid up to the contract amount.
Mr. Robinson's responsibilities and duties in connection with the operations of BioBalance and New York Health Care have increased wherein he worked a total of 89 days in 2007 and was paid additional compensation above the contract cap at the per-diem rate in the contract.
From May 4, 2007 through December 31, 2007, Mr. Robinson worked for the Company for approximately 44 more days and was paid at the per-diem rate agreed to in the contract. All other compensation for Mr. Robinson includes: payment for bookkeeping and clerical services ($4,825) provided by persons employed by him or KBL, LLP; reimbursement for office related expenses incurred of $877; reimbursement for software and related training costs of $2,340 and; continuing education and related travel costs specifically related to his position with the company of $2,251.
Savings and Equity Compensation Plans
401(k) Plan
The Company maintains an Internal Revenue Code Section 401(k) salary deferral savings plan (the "Plan") for all of its eligible New York home healthcare division employees who have been employed for at least one year and are at least 21 years old (effective July 1, 1996, field staff employees at the Company's Orange County branch office in Newburgh, New York ceased being eligible to participate in the Plan). Subject to certain limitations, the Plan allows participants to voluntarily contribute up to 15% of their pay on a pre-tax basis. Under the Plan, the Company may make matching contributions on behalf of the pre-tax contributions made by participants.
Profit Sharing Plan:
The Company maintains a qualified profit sharing plan under Internal Revenue Code Section 401 whereby it may contribute up to 15% of employee compensation. Specified employees are generally eligible for plan participation upon their employment commencement date with immediate vesting on the employee’s plan entrance date. All contributions to the plan are at the discretion of Company management.
Equity Compensation Plans
The following table summarizes with respect to options and warrants under the Company’s equity compensation plans at December 31, 2007:
Item 12.
Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREHOLDER MATTERS
The following table sets forth certain information regarding shares of the Common Stock beneficially owned as of March 12, 2008 by (i) each person, known to the Company, who beneficially owns more than 5% of the Common Stock, (ii) each Named Executive Officer, (iii) each of the Company’s directors and (iv) all officers and directors as a group:
(1)
The shares of Common Stock owned by each person or by the group, and the shares included in the total number of shares of Common Stock outstanding, have been adjusted in accordance with Rule 13d-3 under the Securities Exchange Act of 1934, as amended, to reflect the ownership of shares issuable upon exercise of outstanding options, warrants or other common stock equivalents which are exercisable within 60 days. As provided in such Rule, such shares issuable to any holder are deemed outstanding for the purpose of calculating such holder's beneficial ownership but not any other holder's beneficial ownership. Unless otherwise indicated, the address of each shareholder is c/o the Company.
(2)
Includes a total of 350,000 shares issuable upon the exercise of stock options granted to Mr. Englard and also 20,161 shares issuable upon the exercise of warrants.
(3)
Includes a total of 25,000 shares issuable upon the exercise of stock options granted to Mr. Hacohen.
(6)
All shares are owned of record by KPT Partners, of which Mr. Korolnick holds sole voting and investment power.
(7)
All shares are owned of record by Nekavim Investors, of which Ms. Rose holds sole voting and investment power.
Item 13.
Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE.
Not applicable.
Item 14.
Item 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The following table presents fees for professional audit services rendered by Holtz Rubenstein Reminick LLP, our principal accountants for the audit of the Company’s annual financial statements for the years ended December 31, 2007 and 2006:
(1)
Audit Fees consist of fees billed for professional services rendered for the audit of the Company’s consolidated annual financial statements and review of the interim consolidated financial statements included in quarterly reports and services that are normally provided in connection with statutory and regulatory filings or engagements.
(2)
Audit-Related Fees consist of fees billed for assurance and related services that are reasonably related to the performance of the audit or review of the Company’s consolidated financial statements and are not reported under “Audit Fees.”
(3)
Tax Service Fees consist of fees billed for professional services rendered for tax compliance, tax advisory and tax planning. These services include assistance regarding federal, state and local tax compliance and tax planning.
(4)
The line for all other fees for 2007 and 2006 represents the audit of cost reports and employee benefit plans performed by Holtz Rubenstein Reminick, LLP.
Policy on Audit Committee Pre-Approval of Audit and Permissible Non-Audit Services of Independent Auditor.
The Board of Directors as a whole functions as the Audit Committee. The Audit Committee had not adopted a formal pre-approval policy for audit and non-audit services. However, the Audit Committee had pre-approved all audit, audit-related, tax and other services provided by Holtz Rubenstein Reminick, LLP prior to the engagement the firm to provide these services.
PART IV
Item 15.
Item 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a)
The following documents are filed as a part of this report:
(1)
Consolidated Financial Statements: See Index to Financial Statements on page of this report for financial statements and supplementary data filed as part of this report.
(2)
Financial Statement Schedules
Schedule II - Valuation and Qualifying Accounts for each of the years ended December 31, 2007 and 2006.
(3)
Exhibits:
The exhibits listed in the accompanying Index to Exhibits are filed or incorporated by reference as part of this report.
NEW YORK HEALTH CARE, INC.
AND SUBSIDIARIES
CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED
DECEMBER 31, 2007 AND 2006
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors
New York Health Care, Inc.
We have audited the accompanying consolidated balance sheets of New York Health Care, Inc. and Subsidiaries (the "Company") as of December 31, 2007 and 2006 and the related consolidated statements of operations, shareholders' deficiency and cash flows for the two years then ended. Our audits also included the consolidated financial statement Schedule II for the years ended December 31, 2007 and 2006. These financial statements and schedule are the responsibility of the Company's management. Our responsibility is to express an opinion on these consolidated financial statements and schedule 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. Our audits included 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. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall consolidated 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 consolidated financial position of New York Health Care, Inc. and Subsidiaries as of December 31, 2007 and 2006 and the consolidated results of their operations and their cash flows for the two years then ended in conformity with accounting principles generally accepted in the United States of America. Also, in our opinion, the related financial statement schedule, when considered in relation to the basic financial statements taken as a whole, presents fairly in all material respects the information set forth therein.
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company’s losses and negative working capital raises substantial doubt about its ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
/s/ Holtz Rubenstein Reminick LLP
Holtz Rubenstein Reminick LLP
New York, NY
April 10,
NEW YORK HEALTH CARE, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
The accompanying notes are an integral part of these consolidated financial statements.
NEW YORK HEALTH CARE, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
The accompanying notes are an integral part of these consolidated financial statements.
NEW YORK HEALTH CARE, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY
FOR THE YEARS ENDED DECEMBER 31, 2007, and 2006
The accompanying notes are an integral part of these consolidated financial statements.
NEW YORK HEALTH CARE, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
The accompanying notes are an integral part of these consolidated financial statements.
NEW YORK HEALTH CARE, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2007 and 2006
NOTE 1 - ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Organization and Basis of Consolidation and Presentation:
New York Health Care, Inc. (“New York Health Care”) was organized under the laws of the State of New York in 1983. New York Health Care provides services of registered nurses and paraprofessionals to patients throughout New York. The BioBalance Corp. (“BioBalance”), a Delaware corporation, was formed in May 2001. BioBalance is a biopharmaceutical company focused on the development of treatments for gastrointestinal diseases that are poorly addressed by current therapies. BioBalance is currently pursuing prescription drug development of its lead product, PROBACTRIX® for the prevention of pouchitis. On March 24, 2006, the Company received approval from the FDA to start Phase II clinical trials. There can be no assurance that BioBalance will be successful in obtaining regulatory approval or in marketing any such products. The consolidated entity, collectively referred to, unless the context otherwise requires, as the “Company”, “we”, “our” or similar pronouns, includes New York Health Care and its wholly-owned subsidiaries, BioBalance and NYHC Newco Paxxon, Inc. D/B/A Helping Hands Healthcare (“Helping Hands”).
On January 2, 2003, BioBalance consummated a business combination with New York Health Care, Inc., a public company. As a result of the merger BioBalance shareholders exchanged all their BioBalance shares for 2,475,154 shares of common stock and 590,375 shares of preferred stock of New York Health Care. Because the former BioBalance shareholders own a majority of the common stock (89.7%) of the merged company, BioBalance is considered to be the accounting acquirer in the transaction.
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. The Company’s recurring losses and negative working capital raises substantial doubt about its ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Management’s plans in connection with this matter include drawing down the line of credit as necessary and continuing the search for a strategic partner for the BioBalance operations.
As of December 31, 2007, BioBalance had cash on hand of approximately $38,000, all of which was available to fund operations. BioBalance management estimates that its capital requirements for an entire year of operations is approximately $5,000,000. This amount includes the cost of the initial up front payment for the Phase I/II clinical trial, in the amount of $3,000,000, for the Company's lead product PROBACTRIX® that is not expected to be started in 2008. It will be necessary for the Company to secure additional funding in order for BioBalance to begin the Phase I/II clinical trial, which was approved by FDA on March 24, 2006. The Company has not been able to obtain additional funding up to the present time and the BioBalance subsidiary has been operating solely by utilizing funds from the health care operations, which are insufficient for BioBalance's needs. Management is continuing to search for potential funding sources but none have been found thus far. Accordingly, since additional funding from outside sources has not been obtained, the Company began scaling back the operations of BioBalance at the end of November 2006, and BioBalance began operating on a substantially reduced budget in 2007. BioBalance management has taken steps to secure the data from clinical trials and has begun the production of a duplicate of the biological strain of PROBACTRIX®. Additionally, BioBalance surrendered its office space to the landlord in March 2007 in exchange for lease cancellation, incurring exit costs through the time the space was fully vacated of $38,998 and asset disposal losses of approximately $36,000 . Management has instituted temporary cutbacks in consultant compensation until such time as additional funds or a strategic partner can be found. There can be no assurances that the Company will be able to raise additional capital in the near term to allow BioBalance to continue its normal level of operations.
BioBalance has also commenced preliminary studies regarding the use of PROBACTRIX® in the treatment of Celiac disease (a dietary gluten intolerance). This study was conducted as a small scale pilot study which, while not providing data that is clinically or statistically useful in demonstrating efficacy, produced encouraging preliminary results. The Company is contemplating various options including funding costs relating to clinical research and statistical analysis for a follow up study.
Summary of Significant Accounting Policies
Estimates:
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that could affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
Accounts Receivable:
Accounts receivable consists of trade receivables recorded at original invoice amount, less an estimated allowance for uncollectible accounts. Trade credit is generally extended on a short-term basis; thus trade receivables do not bear interest, although a finance charge may be applied to receivables that are past due. Trade receivables are periodically evaluated for collectiblity based on past credit history with customers and their current financial condition. Changes in the estimated collectiblity of trade receivables are recorded in the results of operations for the period in which the estimate is revised. Trade receivables that are deemed uncollectible are offset against the allowance for uncollectible accounts. The Company generally does not require collateral for trade receivables.
Revenue Recognition:
The Company recognizes patient service revenue on the date services are rendered. Unbilled services represent amounts due for services rendered that had not been billed at the end of each period because written authorization had not been received from the referral source.
Property and Equipment:
Property and equipment is carried at cost and is depreciated under the straight-line method over the following estimated useful lives of the assets. Leasehold improvements are amortized over the estimated useful lives of the improvements or the life of the lease, whichever is shorter.
Machinery and equipment
3-5 years
Furniture and fixtures
5-7 years
Goodwill and Other Intangible Assets:
Statement of Financial Accounting Standards (SFAS No. 142) "Goodwill and Other Intangible Assets" requires that goodwill and intangible assets having indefinite lives not be amortized, but instead be tested for impairment at least annually. Intangible assets determined to have definite lives are amortized over their remaining useful lives.
Income Taxes:
The Company used the asset and liability method to calculate deferred tax assets and liabilities. Deferred taxes are recognized based on the differences between financial reporting and income tax bases of assets and liabilities using enacted income tax rates. Deferred tax assets and liabilities are measured using enacted tax rates in effect for the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.
Long-Lived Assets:
Long-lived assets, such as intangible assets other than goodwill, furniture, equipment and leasehold improvements, are evaluated for impairment when events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable through estimated undiscounted future cash flows from the use of these assets. When any such impairment exists, the related assets will be written down to fair value.
Cash Equivalents:
The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents.
Stock Based Compensation:
On January 1, 2006 the Company adopted Statement of Financial Accounting Standards (SFAS) No. 123 (revised 2004), “Share-Based Payment,” (“SFAS 123(R)”). SFAS 123(R) requires the Company to recognize expense related to the fair value of employee stock option awards and to measure the cost of employee services received in exchange for an award of equity instruments based on the grant date fair value of the award. This eliminated the exception to account for such awards using the intrinsic method previously allowable under Accounting Principles Board Opinion No. 25, “Accounting for Stock issued to Employees” (“APB 25”). Prior to January 1, 2006, we accounted for the stock based compensation plans under the recognition and measurement provisions of APB 25, as permitted by SFAS No. 123, “Accounting for Stock-Based Compensation.”
Effective January 1, 2006, the Company adopted the fair value recognition provisions of SFAS 123(R), using the modified-prospective-transition method. Under that transition method, compensation cost recognized in 2006 and beyond includes: (a) compensation cost for all share-based payments granted prior to, but not yet vested as of January 1, 2006, based on the grant date fair value estimated in accordance with the original provisions of SFAS No. 123, and (b) compensation cost for all stock-based payments granted subsequent to January 1, 2006, based on the grant-date fair value estimated in accordance with the provisions of SFAS 123(R).
Loss Per Share:
Basic (loss) per share excludes dilution and is computed by dividing net (loss) available to common shareholders by the weighted average number of shares of Common Stock outstanding for the period.
Diluted earnings per share is computed by dividing income available to common shareholders by the weighted average number of common shares outstanding for the period, adjusted to reflect potentially dilutive securities. Due to losses from continuing operations for the years ended December 31, 2007 and 2006, potential common stock attributable to options, warrants and preferred stock outstanding of 8,862,046 for and 8,996,212 for were not included in the computation of diluted earnings per share, because to do so would be antidilutive. During the years ended December 31, 2007 and 2006 potential dilutive securities also include common stock and options to be issued of 1,500,000.
Classification of Amounts Due to HRA:
Historically, management has maintained a liability account to show amounts paid to the Company under the contract with the City of New York Human Resources Administration (“HRA”) which were required to be used for certain employee benefits purposes and were to be paid to or on behalf of the home health aid employees. In 2006, management determined that approximately $904,000 could no longer be used for the employee benefit and could not be paid to the employees but could be expected to be required to be repaid to HRA. Accordingly, this amount was reclassified from general accrued expenses to the caption “Due to HRA”.
Recently Issued Accounting Pronouncements:
In December 2007, the FASB issued SFAS No. 141 (revised 2007), "Business Combinations." SFAS 141(R) broadens the guidance of SFAS 141, extending its applicability to all transactions and other events in which one entity obtains control over one or more other businesses. It broadens the fair value measurement and recognition of assets acquired, liabilities assumed, and interests transferred as a result of business combinations. SFAS 141(R) expands on required disclosures to improve the statement users' abilities to evaluate the nature and financial effects of business combinations. SFAS 141(R) is effective for our fiscal year beginning January 1, 2009. The adoption of SFAS 141(R) is not expected to have a material impact on the Company's financial position, results of operations or cash flows.
In December 2007, the FASB issued SFAS No. 160, "Noncontrolling Interests in Consolidated Financial Statements-an amendment of ARB No. 51." SFAS 160 requires that a noncontrolling interest in a subsidiary be reported as equity and the amount of consolidated net income specifically attributable to the noncontrolling interest be identified in the consolidated financial statements. It also calls for consistency in the manner of reporting changes in the parent's ownership interest and requires fair value measurement of any noncontrolling equity investment retained in a deconsolidation. SFAS 160 is effective for our fiscal year beginning January 1, 2009. We have not yet determined the impact of adopting SFAS 160 on the Company's financial position, results of operations or cash flows.
In February, 2007, FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and Financial Liabilities including an amendment of FAS 115, or FAS 159. This statement provides companies with an option to report selected financial assets and liabilities at fair value. This statement is effective for fiscal years beginning after November 15, 2007 with early adoption permitted. We believe that adoption of FAS No. 159 will not have a material affect on our results of operations or financial position.
In September 2006, the FASB issued SFAS No. 158 Employers' Accounting for Defined Benefit Pension and Other Postretirement Plans - an Amendment of FASB Statements No. 87, 88, 106, and 132(R). This statement requires a company to recognize the funded status of a benefit plan as an asset or a liability in its statement of financial position. In addition, a company is required to measure plan assets and benefit obligations as of the date of its fiscal year-end statement of financial position. The recognition provision of this statement, along with additional disclosure requirements, is effective for fiscal years ending after December 15, 2006, while the measurement date provision is effective for fiscal years ending after December 15, 2008. Management does not believe that adoption of this statement will have a material impact on the financial position of the Company.
In September 2006, the FASB issued SFAS No. 157, "Fair Value Measurements" which defines fair value, establishes guidelines for measuring fair value and expands disclosures regarding fair value measurements. SFAS 157 and eliminates inconsistencies in guidance found in various prior accounting pronouncements. SFAS 157 is effective for fiscal years beginning after November 15, 2007. However, on February 12, 2008, the FASB issued proposed FASB Staff Position ("FSP") SFAS No. 157-2, "Effective Date of FASB Statement No. 157," which defers the effective date for adoption of fair value measurements for nonfinancial assets and liabilities to fiscal years beginning after November 15, 2008. The Company will adopt SFAS 157 during 2008, except as it applies to those non-financial assets and non-financial liabilities as noted in proposed FSP 157-2. The partial adoption of SFAS 157 is not expected to have a material impact on the Company's financial position, results of operations or cash flows.
In June, 2006, the FASB issued Interpretation No. 48, Accounting for Uncertainty in Income Taxes, an Interpretation of FASB Statement No. 109, Accounting for Income Taxes (FIN48), to create a single model to address accounting for uncertainty in tax positions. FIN 48 clarifies the accounting for income taxes by prescribing a minimum recognition threshold a tax position is required to meet before being recognized in the financial statements. FIN 48 also provides guidance on derecognition, measurement, classification, interest, and penalties, accounting in interim periods, disclosure and transition. The Company adopted FIN 48 as of January 1, 2007. Based on our evaluation, we have concluded that there are no significant uncertain tax positions requiring recognition in our financial statements. Our evaluation was performed for the tax years which remain subject to examination by major tax jurisdictions as of December 31, 2007. We may from time to time be assessed interest or penalties by major tax jurisdictions, although any such assessments historically have been minimal and immaterial to our financial results. In the event we have received an assessment for interest and/or penalties, it has been classified in the financial statements as selling, general and administrative expense. The Company is currently subject to a three year statue of limitations by major tax jurisdictions. The Company and its subsidiaries file income tax returns in the U.S. federal jurisdiction, New York State, New York City and New Jersey.
NOTE 2 - PROPERTY AND EQUIPMENT
Property and equipment, at cost consist of the following at December 31:
Depreciation expense for the years ended December 31, 2007 and 2006 was approximately $40,000 and $52,000 respectively.
NOTE 3 - GOODWILL AND INTANGIBLE ASSETS:
The annual changes in the carrying amount of goodwill relating entirely to the home healthcare business since 2006 were as follows:
The major classifications of intangible assets and their respective estimated useful lives are as follows:
On August 20, 2003, the Company purchased from NexGen Bacterium Inc. ("NexGen") certain proprietary technology and intellectual property assets that did not constitute a business.
At December 31, 2006, management determined that the remaining value of the NexGen Platform was impaired in its entirety due to inconclusive testing results. While management believes that further testing may prove the safety and efficacy of the NexGen Platform, a decision was made to devote all efforts and funds towards the development and clinical trials of PROBACTRIX® , if, as and when further funding is received or a strategic partner joins the Company. Accordingly, during the year ended December 31, 2006, management recorded an impairment loss of $926,322 (intellectual property $334,787; patents and trademarks $341,285 and; non-compete agreement $250,250), representing the entire unamortized balance of the NexGen Platform and has discontinued any further testing or development of the Platform at this time.
At December 31, 2007, management determined that the value of the PROBACTRIX® intellectual property was partially impaired due to the results of clinical studies related to the Irritable Bowel Syndrome ("IBS") indication (unusually high placebo response rate). Accordingly, during the year ended December 31, 2007, management recorded an impairment loss of $729,792. As of December 31, 2007, the net carrying value of $628,056 of intangible assets representing the cost of patents net of accumulated amortization, were attributable to BioBalance. BioBalance is a research and development company and has had significant losses since inception. In November 2006, as described in Note 1, a decision was made to scale back the operations of BioBalance by surrendering its office space in March 2007 and continuing to operate on a substantially reduced budget.
Amortization expense for intangible assets amounted to $340,509 and $620,061, for the years ended December 31, 2007 and 2006, respectively. Amortization of deferred loan costs in 2007 was $12,073.
Future amortization of existing intangible assets for their remaining useful lives:
NOTE 4 - ACCOUNTS PAYABLE AND ACCRUED EXPENSES:
Accounts payable and accrued expenses consist of the following at December 31:
(a) Accrued employee benefits include a component of amounts collected by the Company from HRA that is required to be used for employee recruitment and retention. In the even that the Company does not use these funds for the specified purposes, it may be required to return those funds to HRA.
NOTE 5 - LINE OF CREDIT:
On September 20, 2007 (amended on December 13, 2007), New York Health Care entered into a Loan and Security Agreement with CIT Healthcare LLC, as lender (“ Lender”). The term of the Loan and Security Agreement is three years. The Loan and Security Agreement provides for a revolving line of credit facility under which New York Health Care may borrow, repay and re-borrow an amount not exceeding the lesser of $5,000,000 or the borrowing base, which is an amount that may not exceed 85.00% of the estimated net value of New York Health Care's Eligible Accounts, as defined in the agreement. As of December 31, 2007, approximately $3,600,000 of the line was available for borrowing by the Company.
Interest is payable on the outstanding principal balance of the credit facility at an annual rate equal to 30-day LIBOR plus three and one-half percent (3.50%), adjusted monthly in accordance with changes in 30-day LIBOR. At December 31, 2007, the interest rate on this facility was 8.1%. Additionally, the Company is required to pay an Unused Line Fee and a Collateral Management Fee, the total of which represent 0.50% per annum of the line amount.
New York Health Care's obligations to Lender under the Loan and Security Agreement are secured by a first priority lien on all of New York Health Care's accounts receivable, general intangibles, instruments and documents, and the proceeds thereof. However, no collateral will consist of any assets or property of BioBalance.
Beginning with the quarter ended September 30, 2007, the Company is subject to meeting periodic financial covenants contained in the Loan and Security Agreement. As of December 31, 2007, the Company was in compliance with all of the specified financial covenants.
The Company is prohibited from making dividends, distributions and other withdrawals during the term of the credit facility. However, New York Health Care is permitted to make loans, advances or contributions to its subsidiary, BioBalance provided that certain liquidity requirements are met. The Company is further restricted from mergers and acquisitions, as well as asset sales or dispositions outside the ordinary course of business, provided that such sale restrictions are not applicable to the sale of the stock or assets of BioBalance.
As of December 31, 2007, there was no balance due on this line of credit. For the year ended December 31, 2007, the company incurred interest expense of $11,492 on this line of credit.
New York Health Care previously had an agreement with G.E. Capital Health Care Financial Services ("G.E. Capital") that expired on March 30, 2007 providing for a $4,000,000 line of credit and lockbox collection services. The lender did not allow any borrowing on this line in 2007 and 2006. At December 31, 2006, there was an amount due from G.E. Capital of $274,934 . This resulted from collections deposited with G.E. Capital through a lockbox and then transferred to the Company's bank account.
NOTE 6 - INCOME TAXES:
Deferred tax attributes resulting from differences between financial accounting amounts and tax bases of assets and liabilities at December 31, 2007 and 2006 follows (rounded to the nearest thousand).
As of December 31, 2007, the Company had net operating loss carry forwards of approximately $17,000,000 which expire between 2022 through 2027.
The provision (benefit) for income taxes, consist of the following:
The provision (benefit) for income taxes is comprised of the following:
The statutory Federal income tax rate and the effective rate is reconciled as follows:
NOTE 7 - FAIR VALUE OF FINANCIAL INSTRUMENTS:
As of December 31, 2007 and 2006, the carrying amount of cash and cash equivalents, accounts receivable, accounts payable and accrued expenses, accrued payroll and due to HRA, approximates fair value due to their short-term nature.
NOTE 8 - SHAREHOLDERS' EQUITY:
On March 6, 2006, the Company agreed to issue 400,000 shares of common stock (valued at $312,000) and 1,100,000 options (valued at $462,220) to settle with Emerald Asset, who provided services as a consultant to the Company, as part of a final settlement with the Emerald Asset. These amounts were recorded as common stock and options to be issued at December 31, 2005.
On March 9, 2006, the Company agreed to issue 300,000 shares of Common Stock (valued at $216,000) to a former consultant of the Company as part of a final settlement with the consultant. At December 31, 2005, these shares were recorded as common stock and options to be issued. These shares were subsequently issued in October 2006. Warrants that were previously granted to the consultant expired while held in suspension by the Company. The consultant has asserted that these warrants were wrongfully held in suspension and had expired prior to being released by the Board of Directors.
In July 2006, the Company issued 250,000 shares to a public relations consultant. All of the shares were unconditionally returned to the Company in March 2007.
NOTE 9 - STOCK OPTION/WARRANTS:
For the years ended December 31, 2007 and 2006, no consultant warrants were issued and no expense was recognized.
The shareholders approved an option plan on August 31, 2005, that allows for the issuance of warrants and options to consultants.
Performance Incentive Plan:
On August 31, 2005, the shareholders approved the Company's 2004 Incentive Plan, (the "Incentive Plan"). Under the terms of the Incentive Plan, up to 5,000,000 shares of common stock may be granted. The Incentive Plan is administered by the Compensation Committee which is appointed by the Board of Directors. The Committee determines which key employee, officer or director on the regular payroll of the Company, or outside consultants shall receive stock options. Granted options are exercisable after the date of grant in accordance with the terms of the grant up to ten years after the date of the grant. The exercise price of any incentive stock option or nonqualified option granted under the Incentive Plan may not be less than 100% of the fair market value of the shares of common stock of the Company at the time of the grant.
On March 26, 1996, the Company's Board of Directors adopted the Performance Incentive Plan, (the "Option Plan"). The Option plan has substantially the same terms as the Incentive Plan above.
Options/Warrants:
The following options and warrants were issued to employees and non-employee Board of Directors and consultants in accordance with the Company's Performance Incentive Plan. However, they may not be outstanding at each year end.
At December 31, 2007, the Company has shares of common stock reserved for issuance of these options/warrants and for options/warrants granted previously.
Valuation assumptions for these options are as follows:
Activity in stock options and warrants, including those outside the Performance Incentive Plan, for each of the three years ended December 31, is summarized as follows:
*Includes the performance based warrants discussed above.
All of the options listed in the above table have no intrinsic value as their exercise prices are all in excess of the market value of the Company’s common stock as of December 31, 2007.
During the years ended December 31, 2007 and 2006, the Company incurred $24,500 and $ 269,404 of stock compensation expense, respectively.
On November 26, 2003, the Company suspended the 100,000 options granted on March 7, 2003, to Paul Stark, the former President of BioBalance. The options are considered outstanding but can not be exercised until the Company gives notice that they may be exercised. The options have been recorded under the intrinsic value method.
The following table summarizes information about options and warrants outstanding and exercisable at December 31, 2007:
(A) - Expired on January 1, 2008
NOTE 10 - COMMITMENTS AND CONTINGENCIES:
Compliance with State Securities Laws
During October 2004, it was determined that certain of the shares of Common Stock that the Company issued to holders of BioBalance stock in connection with the Company's January 2003 acquisition of BioBalance may not have been exempt from the registration or qualification requirements of the state securities laws of certain of the states where the holders of BioBalance stock then resided although they were registered under the Securities Act of 1933, as amended. Although the Company is unable to quantify the actual number of shares involved that are still owned by the original recipients of the Company's Common Stock received in the BioBalance acquisition, the per share purchase price paid by the BioBalance holders for the BioBalance shares they exchanged in the acquisition ranged from $.03 to $3.00 per share and the Company currently believes that the purchase price paid by such persons who might have certain statutory rescission rights does not exceed approximately $345,000, exclusive of any penalties or interest, although no assurance can be given that any such claims will not exceed this amount. The Company cannot determine the effect, if any, on its operations or financial condition that may occur from the failure to register or qualify these shares under applicable state securities laws. If it is determined that the Company offered Common Stock in connection with the BioBalance acquisition without properly registering or qualifying the shares under state laws, or securing exemption from registration, regulators could impose on the Company monetary fines or other sanctions as provided under these laws. The Company is unable to estimate the amount of monetary fines, if any, or the nature or scope of any sanctions at this time and is continuing its investigation of this matter.
Risk Factors Associated with Fair Labor Standards Act:
On July 22, 2004, the federal Second Circuit Court of Appeals issued a ruling on the applicability to paraprofessional field staff in New York of the Fair Labor Standards Act “companionship services” exemption from minimum wage and overtime requirements. Home care providers have long relied on this exemption to provide compensation to home care aides and personal care workers with the expectation that there is no obligation under federal laws for overtime pay. In September 2004, a request for a rehearing was submitted en banc for the full Court. On January 13, 2005, the Court rejected the request for a rehearing on the issue.
The issue was submitted to the Supreme Court and, on January 23, 2006, the Supreme Court granted a writ of certiorari, vacated the judgment and remanded the case to the Second Circuit Court of Appeals to reconsider its decision in light of the memorandum issued by the U.S. Department of Labor on December 1, 2005. In that memo, the DOL stated that it considers its regulations allowing the companionship exemption to be used by third party employers to be “authoritative and legally binding”. The Second Circuit Court of Appeals reconsidered and, on August 31, 2006, reaffirmed its decision. The Supreme Court again granted a writ of certiorari on January 5, 2007. In June 2007, the U.S. Supreme Court issued its decision which upheld the "companionship exemption" as applying to employment by "third party employers", e.g. home care agencies, such as New York Health Care.
Lease Commitments
The Company leases office space under non-cancelable operating leases which expire between June 2008 and June 2011.
At December 31, 2007, future minimum lease payments due under operating leases approximate:
Rent expense for Company facilities charged to operations, including real estate taxes, was approximately $355,000 and $461,000 for the years ended December 31, 2007 and 2006.
In April 2006, the Company entered into a five year non-cancelable operating lease for office space in New York, New York at an average annual rental of approximately $182,000 for its BioBalance subsidiary. In March 2007, the Company entered into an agreement with the landlord whereby it was released from its obligation under the lease going forward from the date of the agreement. Pursuant to the agreement, the Company surrendered the premises. The Company incurred a loss of approximately $101,000 in connection with terminating the lease of which $27,000 was charged to property impairment in 2006 and approximately $74,000 was charged to operations during 2007. Rent expense incurred by the Company relating to this lease for the years ended December 31, 2007 and 2006 was approximately $26,000 and $118,000, respectively. This lease has been eliminated from the table above due to its termination in 2007.
Employment Agreements:
In June 2004, the Company entered into an employment agreement with Dennis O'Donnell the president and CEO of the Company that expired on May 5, 2006 at an annual compensation of $200,000. The board approved an increase of $25,000 upon the closing of the Offering of securities that took place on February 24, 2005. On May 6, 2005, the board of directors approved a bonus of $90,000 and granted him 100,000 options to acquire common stock. In 2006, the Board approved a bonus of $112,500. On September 6, 2006, Mr. O’Donnell resigned his positions as President, Chief Executive Officer and a Director of New York Health Care Inc. and its subsidiary BioBalance Corporation.
Effective February 5, 2007, Stewart W. Robinson was appointed to serve as the Company’s Chief Financial Officer on a part-time basis. The Company has agreed to pay Mr. Robinson on a per diem basis, with total compensation for the 2007 calendar year capped at $65,000 for days up to a maximum of 45 days per calendar year. Due to increased responsibilities not originally contemplated, Mr. Robinson worked approximately 44 additional days and received additional compensation of $79,531 for a total salary of $144,531 in 2007. Other compensation for Mr. Robinson includes: payment for bookkeeping and clerical services ($4,825) provided by persons employed by him or KBL, LLP; reimbursement for office related expenses incurred of $877; reimbursement for software and related training costs of $2,340 and; continuing education and related travel costs specifically related to his position with the company of $2,251.
Effective August 20, 2007, the Board of Directors appointed Murry Englard Chief Executive Officer of the Company. Prior to such appointment, Mr. Englard was serving as Acting Chief Executive Officer and a Director. Mr. Englard will continue to serve as a Director of the Company. Mr. Englard will receive a monthly salary of $8,333 for his services as Chief Executive Officer. The term for Mr. Englard’s service as Chief Executive Officer will be one year, renewable monthly, and the Company will continue its search for a full-time Chief Executive Officer. In 2007, Mr. Englard received salaries of $44,231 , a bonus of $15,000 , director's fees of $35,200 and, expense reimbursements of $11,026. In 2006, Mr. Englard received director's fees of $18,000 .
401(k) Plan:
The Home Healthcare segment maintains an Internal Revenue Code Section 401(k) salary deferred savings plan (the "Plan") for eligible employees who have been employed for at least one year and are at least 21 years old. Subject to certain limitations, the Plan allows participants to voluntarily contribute up to 15% of their pay on a pretax basis. The Company currently contributes 50% of each dollar contributed to the Plan by participants up to a maximum of 3% of the participant's salary. The Plan also provides for certain discretionary contributions by the Company as determined by the Board of Directors. The Company's contributions offset by unvested, forfeited matching funds amounted to approximately $45,000 and $46,000 for the years ended December 31, 2007 and 2006, respectively.
Profit Sharing Plan:
The Company maintains a qualified profit sharing plan under Internal Revenue Code Section 401 whereby it may contribute up to 15% of employee compensation. Specified employees are generally eligible for plan participation upon their employment commencement date with immediate vesting on the employee’s plan entrance date. All contributions to the plan are at the discretion of Company management. The Company made contributions to the plan of $162,583 and $169,739 for the years ended December 31, 2007, and 2006 respectively.
Bonus Plan:
The Home Healthcare segment of the Company has established a bonus plan pursuant to which 10% of the Company's pre-tax net income is contributed to a bonus pool which is available for distribution to all employees as decided by the Company's Compensation Committee. All allocated amounts were paid before year end and no bonus was accrued for 2007 and 2006..
Concentrations of Credit Risk:
Financial instruments that potentially subject the Company to concentrations of credit risk consist of temporary cash investments, which from time-to-time exceed the Federal depository insurance coverage and commercial accounts receivable. The Company has cash investment policies that restrict placement of these investments to financial institutions evaluated as highly creditworthy. Cash and cash equivalents held in one bank exceed federally insured limits by approximately $2,038,000 at December 31, 2007. The Company does not require collateral on commercial accounts receivable as the customer base generally consists of large, well-established institutions.
Major Customers:
One major customer accounted for approximately 56% and 55% of net patient service revenue for the years ended December 31, 2007 and 2006. In addition, three customers represented approximately 41% and 38% of accounts receivable at December 31, 2007 and 2006, respectively.
Business Risks:
The Company's primary business, offering home healthcare services, is heavily regulated at both the federal and state levels. While the Company is unable to predict what regulatory changes may occur or the impact on the Company of any particular change, the Company's operations and financial results could be negatively affected.
Further, the Company operates in a highly competitive industry, which may limit the Company's ability to price its services at levels that the Company believes appropriate. These competitive factors may adversely affect the Company's financial results.
Cautionary Statement
BioBalance operates in a competitive environment that involves a number of risks, some of which are beyond its control. Although we believe the expectations for BioBalance are based on reasonable assumptions, we can give no assurance that our expectations will be attained. Factors that could cause actual events or results to differ materially from expected results involve both known and unknown risks. Key factors include, among others: our need to secure additional financing and at acceptable terms; the high cost and uncertainty of clinical trials and other development activities involving pharmaceutical products; the dependence on third parties to manufacture its products; the unpredictability of the duration and results of regulatory approval for our products; our dependence on our lead biotherapeutic agent, PROBACTRIX® and the uncertainty of its market acceptance; the possible impairment of, or inability to enforce, intellectual property rights and the subsequent costs of defending these rights; and the loss of key executives or consultants.
Litigation
We are subject to various legal proceedings and claims, either asserted or unasserted, which arise in the ordinary course of business. While the outcome of these claims cannot be predicted with certainty, management does not believe that the outcome of any of these legal matters will have a material adverse effect on our results of operations or financial position, except as follows:
On March 30, 2006, the Company was served with a shareholder derivative complaint captioned Jay Glatzer v. Yitz Grossman, Emerald Asset Management, Murry Englard, Michael Nafash, Stuart Ehrlich, and Dennis O'Donnell and New York Health Care, Inc., (Supreme Court of State of New York County of Nassau, (Index No. 5125/06). The lawsuit alleged that the directors breached their fiduciary duty by approving the Emerald Settlement Agreement disclosed in the Company's Form 8-K (Date of Report March 6, 2006) filed with the Securities Exchange Commission on March 10, 2006. The lawsuit claimed that such breach was a product of their respective relationships with Mr. Grossman. The lawsuit also alleged that Mr. Grossman and Emerald Asset Management injured the Company by engaging in the actions underlying the November 2004 criminal conviction of Mr. Grossman. The lawsuit was dismissed in September 2006. A notice of appeal was filed by the plaintiff in October 2006 and the plaintiff filed its appeal brief in April 2007. On January 15, 2008, the court dismissed the appeal.
On March 9, 2006, the Company entered into a final settlement agreement (the "Corval Settlement Agreement") with Mark Olshenitsky related to the resolution of disputes under a consulting agreement dated April 14, 2003 (the "Corval Consulting Agreement") between the Company and Corval International, Inc. ("Corval"). Pursuant to the Corval Consulting Agreement, Corval was issued warrants to purchase 500,000 shares of the Company's Common Stock for $2.50 per share until April 21, 2004 (the "Warrants"). Mark Olshenitsky ("Olshenitsky") is the sole owner of Corval and is the assignee/successor to Corval.
In November 2003, the Company suspended the Warrants in response to the indictment of one of its directors and officer of BioBalance and a consultant to BioBalance as reported in the Company's Form 10-K for the year ended December 31, 2003.
Both Corval and Olshenitsky have continually denied any involvement in the events leading up to the indictments and have threatened litigation alleging breach of contract and related compensatory damages as a result of the suspension of the Warrants. Neither Corval nor Olshenitsky was indicted.
Pursuant to the Corval Settlement Agreements and in order avoid the cost and uncertainty of litigation, the Company agreed to issue 300,000 (valued at $216,000) shares of common stock to Olshenitsky in return for a general release of all claims Corval and Olshenitsky may have against the Company. The common stock are "restricted shares" and may only be resold after registration of such shares or the availability of an exemption from registration, including under Rule 144 of the Securities Act of 1933 as amended (the "Securities Act").
On March 6, 2006, the Company entered into a settlement agreement (the "Emerald Settlement Agreement") with Emerald Asset Management, Inc. ("Emerald") and Yitz Grossman ("Grossman") related to the resolution of disputes under a consulting agreement dated June 1, 2001 (the "Emerald Consulting Agreement") between the Company and Emerald. Grossman is the sole owner of Emerald. Pursuant to the Emerald Consulting Agreement, Emerald was entitled to $250,000 per year through 2011, additional payments equal to bonuses paid to the Chief Executive Officer of the Company and reimbursement for expenses.
In November 2003, the Company terminated the Emerald Consulting Agreement in response to the indictment of one of its directors and officer of BioBalance, and a consultant as reported in the Company's Form 10-K for the year ended December 31, 2003. As of September 2004, BioBalance notified the consultant in writing that the consulting agreement was terminated for cause. At December 31, 2004, the Company had accrued had approximately $359,000 relating to this consulting agreement as reported in the 2004 10-K.
Emerald and Grossman have threatened litigation alleging breach of contract and related compensatory damages as a result of the termination of the Emerald Consulting Agreement. Emerald asserts that the Emerald Consulting Agreement was terminated "without cause" as defined in the agreement entitling Emerald to certain payments that Emerald estimates at approximately $2,225,000.
Pursuant to the Emerald Settlement Agreement and in order avoid the cost and uncertainty of uncertainty of litigation, the Company agreed to (i) the immediate payment of $700,000 to Emerald, (ii) payment of $22,000 per month for eighteen months beginning January 1, 2006, (iii) the issuance of 400,000 shares of common stock, (iv) options to purchase 1,100,000 shares of common stock at $0.78 per share until March 1, 2010 and (v) health insurance for Grossman and his family for the eighteen month period ending June 30, 2008 amounting to approximately $35,100. In return, Emerald and Grossman have executed a general release of all claims they may have against the Company. The common stock to be issued and the common stock issuable pursuant to the options are "restricted shares" and may only be resold after registration of such shares or the availability of an exemption from registration, including under Rule 144 of the Securities Act. The Company has granted Emerald a one-time demand registration right and unlimited piggy back registrant rights. The Company has not paid any of this liability and has expensed $1,545,931 for the above settlement during the year ended December 31, 2005. As of December 31, 2005, the Company has recorded a liability of $1,131,100 and common stock and options to be issued valued at $774,220 as of March 6, 2006. On April 17, 2006, Emerald Asset and Grossman have agreed not to demand the cash portion of the settlement agreement until such time as New York Health Care receives any additional monies from any source.
On August 21, 2006, the Company unilaterally rescinded the settlement between the Company and Emerald Asset and Yitz Grossman. The rescission of the settlement by the Company was done without the consent of Emerald Asset and Yitz Grossman. Accordingly there may be future litigation brought against the Company by Emerald Asset and Yitz Grossman to seek enforcement of the agreement. The Company continues to retain the accrual for the settlement agreement on its books in its entirety. If there is litigation brought by Emerald Asset and Yitz Grossman to enforce the settlement agreement, there can be no assurance that at a future time the accrual that was recorded would be sufficient to offset amounts resulting from the future litigation.
NOTE 11 - THIRD-PARTY RATE ADJUSTMENTS AND REVENUE AND CERTAIN CONTRACTS RELATED TO OPERATIONS:
Approximately 4% of net patient service revenue was derived under New York State Medicaid reimbursement programs during each of the years ended December 31, 2007 and 2006. These revenues are based, in part, on cost reimbursement principles and are subject to audit and retroactive adjustment. Differences between current rates and subsequent revisions are reflected in the year that the revisions are determined.
The Company has an agreement with the City of New York acting through the Department of Social Services of The Human Resources Administration ("HRA") to provide personal care services to certain qualified individuals as determined by HRA. The agreement with HRA sets a fixed direct labor cost in the reimbursement rate. Should the Company incur direct costs of home attendant services below this fixed rate, the Company must repay the difference to HRA, subject to final audit by the City of New York. As of December 31, 2007 and 2006, the amount included in due to HRA relating to direct labor costs amounted to $618,589 and $1,461,063, respectively. In addition, the City's reimbursement methodology for general and administrative expenses is based on a fixed amount per client based on the number of cases. The Company is reimbursed at an hourly rate. Any amount over this fixed rate must be repaid to HRA. As of December 31, 2007 and 2006, this amount was $8,135,819 and $6,481,694, respectively, subject to final audit by the City of New York. The aggregate amount due to HRA was $8,754,408 and $7,942,757 at December 31, 2007 and 2006, respectively. HRA has completed their field work relating to the audit for the fiscal year ended June 30, 2004.
In January 2003, the New York State Department of Health ("DOH") approved additional funding to home healthcare agencies in a form of a rate increase. The additional funding is to be used exclusively for the recruitment and retention of home healthcare employees. Any unspent money relating to recruitment and retention is recorded as an accrued liability until such time as it is spent. As of December 31, 2007 and 2006, the Company accrued approximately $1,484,000 and $1,699,000, respectively, related to recruitment and retention funds not yet expended and is included in accrued employee benefits.
NOTE 12- SUPPLEMENTAL CASH FLOW DISCLOSURES:
NOTE 13 - SEGMENT REPORTING:
The Company has two reportable business segments: New York Health Care, a home health care agency that provides a broad range of health care support services to patients in their homes, and BioBalance, a company that is developing a patented biotherapeutic agent for the treatment of gastrointestinal disorders. BioBalance has not generated any revenue as of December 31, 2007.
SCHEDULE II - VALUATION AND QUALIFYING ACCOUNTS
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) 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.
Pursuant to the requirements of the Securities Exchange Act of 1934, this Report been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.
SIGNATURE
TITLE
DATE
/s/ Murry Englard
Director, Chief Executive Officer
April 14, 2008
Murry Englard
/s/ Stewart W. Robinson
Chief Financial Officer
April 14, 2008
Stewart W. Robinson
/s/ Howard Berg
Director
April 14, 2008
Howard Berg
/s/ Yoram Hacohen
Director
April 14, 2008
Yoram Hacohen
INDEX TO EXHIBITS
These Exhibits are numbered in accordance with Exhibit Table of Item 601 of Regulation S-K.
Exhibit
Number
Description of Exhibit
2.1
Stock for Stock Exchange Agreement between the Company and BioBalance dated October 11, 2001, as amended by Amendment No. 1 dated February 13, 2002, Amendment No. 2 dated July 10, 2002, Amendment No. 3 dated August 13, 2002 and Amendment No. 4 dated October 25, 2002 (Incorporated by reference to Exhibits No. 2.1-2.4, inclusive, to the Company's Registration Statement on Form S-4, SEC File No. 333-85054).
2.2
Asset Purchase Agreement dated as of April 11, 2005 by and among Accredited Health Services, Inc., the Company and NYHC Newco Paxxon Inc. Incorporated by reference to Exhibit 2.1 to the Company's Form 8-K filed (on May 26, 2005).
3.1
Restated Certificate of Incorporation filed on March 26, 1996. (Incorporated by reference to Exhibit 3.2 to the Company's Registration Statement on Form SB-2, SEC File No. 333-08152, declared effective on December 20, 1996).
3.2
Certificate of Correction of Restated Certificate of Incorporation filed on March 26, 1996. Incorporated by reference to Exhibit 3.3 to the Company's Registration Statement on Form SB-2, SEC File No. 333-08152, declared effective on December 20, 1996).
3.3
Amendment to the Certificate of Incorporation filed October 17, 1996. (Incorporated by reference to Exhibit 3.4 to the Company's Registration Statement on Form SB-2, SEC File No. 333-08152, declared effective on December 20, 1996).
3.4
Amendment to the Certificate of Incorporation filed December 4, 2006. (Incorporated by reference to Exhibit 3.6 to the Company's Registration Statement on Form SB-2, SEC File No. 333-08152, declared effective on December 20, 1996).
3.5
Amendment to the Certificate of Incorporation filed February 5, 2001. (Incorporated by reference to Exhibit 3.5 to the Company's Form 10-K filed on April 17, 2006).
3.6
Amendment to the Certificate of Incorporation filed January 7, 2002. (Incorporated by reference to Exhibit 3.6 to the Company's Form 10-K filed on April 17, 2006).
3.7
Certificate of Amendment to the Restated Certificate of Incorporation filed on September 10, 2004 (Incorporated by reference to Exhibit 3.1 to the Company's 8-K filed on September 15, 2004).
3.8
Amended and Restated Bylaws (Incorporated by reference to Appendix B to the Company's Definitive Proxy Statement on Schedule 14A filed on August 5, 2005 with respect to the Company's Annual Meeting of Stockholders held on August 31, 2005).
4.1
Form of certificate evidencing shares of Common Stock. (Incorporated by reference to Exhibit 4.1 to the Company's Registration Statement on Form SB-2, SEC File No. 333-08152, declared effective on December 20, 1996).
++10.1
Employment Agreement for Dennis O'Donnell. (Incorporated by reference to Exhibit 10.1 to the Company's Form 10-Q filed on August 16, 2004 for the quarter ended June 30, 2004).
++10.3
Option Agreement dated September 14, 2004 between the Company and Dennis O'Donnell. (Incorporated by reference to Exhibit 10.1 to the Company's Form 10-Q filed on November 22, 2004 for the quarter ended September 30, 2004).
++10.4
Option Agreement between the Company and Dennis O'Donnell dated May 6, 2005. (Incorporated by reference to Exhibit 10.2 to the Company's Form 10-Q filed on August 17, 2005 for the quarter ended June 30, 2005).
++10.5
Employment Agreement between the Company and A. James Forbes, Jr. dated June 1, 2005. (Incorporated by reference to Exhibit 10.1 to the Company's Form 10-Q filed on August 17, 2005 for the quarter ended June 30, 2005).
++10.6
Amended Performance Incentive Plan (Stock Option Plan). (Incorporated by reference to Exhibit 10.50 to the Company's Form 10-K filed on March 17, 2003 for the year ended December 31, 2003).
++10.7
Stock Incentive Plan (incorporated by reference to Appendix A to the Company's Definitive Proxy Statement on Schedule 14A filed on August 9, 2005 with respect to the Company's Annual Meeting of Stockholders held on August 31, 2005).
10.8
Loan Security Agreement among the Company, NYHC Newco Paxxon, Inc. and Heller Healthcare Finance, Inc. dated November 28, 2000. (Incorporated by reference to Exhibit 10.45 to the Company's Form 8-K filed on December 8, 2000).
10.9
Amendment No. 1 to Loan and Security Agreement and Consent and Waiver with Heller Healthcare Finance, Inc. dated November 27, 2002. (Incorporated by reference to Exhibit 10.49 to the Company's Form 8-K filed on December 4, 2002).
10.10
Amendment No. 2 to Loan and Security Agreement among GE HFS Holding, Inc., the Company and Newco Paxxon, Inc. dated March 29, 2004. (Incorporated by reference to Exhibit 10.2 to the Company's Form 10-Q filed on May 17, 2004 for the quarter ended March 31, 2004).
10.11
Amendment No. 3 to Loan and Security Agreement among GE HFS Holdings, Inc., the Company and Newco Paxxon, Inc. dated November 29, 2004 (Incorporated by reference to Exhibit 10.1 the Company's Form 8-K filed on December 2, 2004).
10.12
Amendment No. 4 to Loan and Security Agreement among the Company, NYHC Newco Paxxon, Inc. and GE HFS Holdings, Inc. dated January 13, 2005. (Incorporated by reference to Exhibit 10.1 to the Company's Form 8-K filed on January 19, 2005).
10.13
Amendment No. 5 to Loan and Security Agreement among the Company, NYHC Newco Paxxon, Inc. and GE HFS Holdings, Inc. dated August 12, 2005. (Incorporated by reference to Exhibit 10.3 to the Company's Form 10-Q filed on August 17, 2005 for the quarter ended June 30, 2005).
10.14
Amendment No. 6 to Loan and Security Agreement among the Company, NYHC Newco Paxxon, Inc. and GE HFS Holdings, Inc. dated November 29, 2005.
10.15
Engagement Letter Agreement between the Company and Sterling Financial Investment Group, Inc. dated May 6, 2004. (Incorporated by reference to Exhibit 10.1 to the Company's Form 10-Q filed on May 17, 2004 for the quarter ended March 31, 2004).
10.16
Placement Agreement between the Company and Sterling Financial Investment Corp., Inc. dated November 19, 2004. (Incorporated by reference to Exhibit 10.1 to the Company's Form 8-K filed on November 23, 2004).
10.18
Amendment dated February 7, 2005 to the Placement Agreement between the Company and Sterling Financial Group, Inc. dated November 19, 2004. (Incorporated by reference to Exhibit 10.2 to the Company's Form 10-Q filed on May 23, 2005 for the quarter ended March 31, 2005).
10.19
Amendment dated February 18, 2005 to the Placement Agreement between the Company and Sterling Financial Group, Inc. dated November 19, 2004. (Incorporated by reference to Exhibit 10.3 to the Company's Form 10-Q filed on May 23, 2005 for the quarter ended March 31, 2005).
10.19
State of New York Department of Health Office of Health Systems Management Home Care Service Agency License for the Company doing business in Rockland, Westchester and Bronx Counties dated May 8, 1995. (Incorporated by reference to Exhibit 10.8 to the Company's Registration Statement on Form S-4, SEC File No. 333-85054).
10.20
State of New York Department of Health Office of Health Systems Management Home Care Service Agency License for the Company doing business in Dutchess, Orange, Putnam, Sullivan and Ulster Counties dated May 8, 1995. (Incorporated by reference to Exhibit 10.9 to the Company's Registration Statement on Form S-4, SEC File No. 333-85054).
10.21
State of New York Department of Health Office of Health Systems Management Home Care Service Agency License for the Company doing business in Nassau, Suffolk and Queens Counties dated May 8, 1995. (Incorporated by reference to Exhibit 10.10 to the Company's Registration Statement on Form S-4, SEC File No. 333-85054).
10.22
State of New York Department of Health Office of Health Systems Management Home Care Service Agency License for the Company doing business in Orange and Rockland Counties dated July 1, 1995. (Incorporated by reference to Exhibit 10.11 to the Company's Registration Statement on Form S-4, SEC File No. 333-85054).
10.23
Personal Care Aide Agreement by and between the Company and Nassau County Department of Social Services dated October 18, 1995. (Incorporated by reference to Exhibit 10.15 to the Company's Registration Statement on Form S-4, SEC File No. 333-85054).
10.24
State of New York Department of Health Offices of Health Systems Management Home Care Service Agency License for the Company doing business in Bronx, Kings, New York, Queens and Richmond Counties dated December 29, 1995. (Incorporated by reference to Exhibit 10.17 to the Company's Registration Statement on Form S-4, SEC File No. 333-85054).
10.25
Homemaker and Personal Care Agreements by and between the Company and the County of Rockland Department of Social Services dated January 1, 1996. (Incorporated by reference to Exhibit 10.19 to the Company's Registration Statement on Form S-4, SEC File No. 333-85054).
10.26
Termination Agreement and Release among the Company, NYHC Newco Paxxon, Inc., New York Health Care, LLC, Jerry Braun and Jacob Rosenberg dated July 27, 2005. (Incorporated by reference to Exhibit 10.1 to the Company's Form 8-K filed on August 10, 2005).
10.27
Settlement Agreement among Corval International, Inc., Mark Olshenitsky and the Company dated March 9, 2006. (Incorporated by reference to Exhibit 10.2 to the Company's Form 8-K filed on March 10, 2006).
10.28
Settlement Agreement among Emerald Asset Management, Inc., Yitz Grossman and the Company dated March 1, 2006. (Incorporated by reference to Exhibit 10.4 to the Company's Form 8-K filed on March 10, 2006).
10.29
Engagement Letter of Corval International Inc. (“Corval”) and BioBalance dated April 21, 2003 with warrant agreement in favor of Corval attached (Incorporated by reference to Exhibit 10.1 filed as part of the Company's Form 8-K on March 10, 2006).
10.30
Consulting Agreement dated June 1, 2001 between The Zig Zag Corp., Emerald Asset Management, Inc. (“Emerald”), and Yitz Grossman (Incorporated by reference to Exhibit 10.3 filed as part of the Company's Form 8-K on March 10, 2006).
10.31
Revival Press Release dated January 17, 2006 (Incorporated by reference to Exhibit 10.5 filed as part of the Company's Form 8-K on March 10, 2006)
10.32
Amendment to Emerald Settlement Agreement dated April 17, 2006 between the Company, Emerald and Yitz Grossman (Incorporated by reference to Exhibit 10.1 filed as part of the Company's Form 8-K on April 19, 2006).
10.33
Engagement Agreement between Stewart Robinson and the Company dated February 5, 2007 (Incorporated by reference to Exhibit 10.1 filed as part of the Company's Form 8-K on February 8, 2007).
10.34
Non-Qualified Stock Option Agreement dated September 20, 2006 between the Company and Michael Nafash. 2007 (Incorporated by reference to Exhibit 10.34 filed as part of the Company's Form 10-K on April 19, 2007).
10.35
Non-Qualified Stock Option Agreement dated February 28, 2007 between the Company and Howard Berg. (Incorporated by reference to Exhibit 10.35 filed as part of the Company's Form 10-K on April 19, 2007).
10.36
Non-Qualified Stock Option Agreement dated February 28, 2007 between the Company and Yoram Hacohen. (Incorporated by reference to Exhibit 10.36 filed as part of the Company's Form 10-K on April 19, 2007).
10.37
Surrender Agreement dated March 8, 2007 between the Company and 345 Seventh Avenue LLC. (Incorporated by reference to Exhibit 10.37 filed as part of the Company's Form 10-K on April 19, 2007).
10.38
Loan and Security Agreement, dated September 20, 2007, between New York Health Care, Inc. and CIT
Healthcare LLC. (Incorporated by reference to Exhibit 10.1 filed as part of the Company's Form 8-K on September 24, 2007).
10.39
Revolving Credit Note, dated September 20, 2007, delivered by New York Health Care, Inc. to CIT Healthcare
LLC. (Incorporated by reference to Exhibit 10.2 filed as part of the Company's Form 8-K on September 24, 2007).
14.1
Code of Ethics for Senior Financial Officers. (Incorporated by reference to Exhibit 14.1 of the Company's Form 10-K filed on March 31, 2004 for the fiscal year ended December 31, 2003.
23.1*
Consent of Holtz Rubenstein Reminick, LLP.
31.1 and 31.2*
Certification of Chief Executive Officer and Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1 and 32.2*
Certification of Chief Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
* Filed herewith.
++ Compensation plan.