UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-K
x | ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| |
| For the fiscal year ended December 31, 2008 |
o | TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number 001-33426
NEURO-HITECH, INC.
(Exact name of Registrant as Specified in its Charter)
Delaware | | 20-4121393 |
(State or Other Jurisdiction of | | (I.R.S. Employer |
Incorporation or Organization) | | Identification No.) |
16255 Aviation Loop Drive, Brooksville, FL 34604
(Address of Principal Executive Offices)
(352) 754-8587
(Registrant’s Telephone Number, Including Area Code)
Securities registered under Section 12(b) of the Exchange Act: None
Securities registered under Section 12(g) of the Exchange Act:
Title of each class
Common Stock, $0.001 par value per share
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes o No x
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.Yes o No x
Indicate by check mark whether the issuer: (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.Yes x No o
Indicate by check mark if disclosure of delinquent filers in response to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of Form 10-K or any amendment to this Form 10-K. o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large Accelerated Filer ¨ | Accelerated Filer ¨ |
Non-Accelerated Filer ¨ | Smaller reporting company x |
(Do not check if a smaller reporting company)
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). o Yes x No
The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant as of June 30, 2008, the last business day of the registrant’s most recently completed second fiscal quarter, was approximately $8,995,340.
The number of shares outstanding of each of the registrant’s common stock, as of March 18, 2009 is:
DOCUMENTS INCORPORATED BY REFERENCE
(1) Portions of the registrant’s Proxy Statement relating to its 2009 Annual Stockholders’ Meeting, to be filed subsequently—Part III
NEURO-HITECH, INC.
FORM 10-K
FOR THE FISCAL YEAR ENDED DECEMBER 31, 2008
| | Page |
PART I | | |
Item 1. Business | | 1 |
Item 2. Properties | | 14 |
Item 3. Legal Proceedings | | 14 |
Item 4. Submission of Matters to a Vote of Security Holders | | 14 |
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PART II | | |
| | |
Item 5. Market for Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | | 15 |
Item 6. Selected Financial Data | | 15 |
Item 7. Management’s Discussion and Analysis or Plan of Operations | | 16 |
Item 8. Financial Statements | | 21 |
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosures | | 21 |
Item 9A(T). Controls and Procedures | | 22 |
| | |
PART III | | |
| | |
Item 10. Directors, Executive Officers and Corporate Governance | | 24 |
Item 11. Executive Compensation | | 24 |
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | | 24 |
Item 13. Certain Relationships and Related Transactions, and Director Independence | | 24 |
Item 14. Principal Accountant Fees and Services | | 24 |
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PART III | | |
| | |
Item 15. Exhibits | | |
PART I
Item 1. Description of Business
Description of the Company
Neuro-Hitech, Inc. (the “Company” or “Neuro-Hitech”) is a specialty pharmaceutical company focused on developing, marketing and distributing branded and generic pharmaceutical products primarily in the cough and cold markets. The Company’s principal business is operated through two subsidiaries, one of which focuses on branded pharmaceuticals and the other which focuses on the generic pharmaceutical equivalents of the Company’s branded pharmaceuticals products. The Company sells its products domestically through U.S. based distributors.
The Company’s subsidiary MCR American Pharmaceuticals (“MCR”) is focused on the acquisition, development, marketing and distribution of cough and cold, prenatal and pain management pharmaceutical products that provide quick and low-cost market entry through the ANDA, and OTC monograph regulatory approval pathways. Typically, these products are referred to as “branded generics”.
MCR believes it has established a strong niche in marketing and distributing effective and conveniently dosed branded generics. MCR’s marketing of its pharmaceutical products is focused within targeted niche pharmaceutical markets. The pharmaceutical products the Company markets typically have low representative selling activity relative to large market blockbuster drugs and low brand loyalty among physicians for these products. MCR’s strategy is to market its products aggressively through it sales force by building brand loyalty among high-prescribing physicians.
MCR markets its products primarily to general practice, family practice, internal medicine, pediatric and ENT physicians. MCR currently has a national sales platform with 25 full-time sales representatives and regional sales managers covering high-prescribing physicians in key markets. MCR believes that it has attained strong prescription volume and strong repeat prescription volume for its product introductions over the past several years, because of its strategic market focus.
MCR believes it provides physicians with a comprehensive offering of products within the cough, cold, allergy, mild pain management and pre-natal health areas. MCR believes its product portfolio provides significant value to physicians as these products provide prescription treatment options for physicians with patients that might otherwise revert to Over-The-Counter (“OTC”) treatment options.
AMBI Pharmaceuticals, Inc. (“AMBI”) is focused on the distribution of generic equivalent pharmaceutical products to pharmaceutical wholesalers, distributors and chain pharmacies. AMBI currently has an account manager serving its customer base of distributors, wholesalers and retailers. Given the highly consolidated nature of the generic pharmaceutical distribution / wholesaler industry, the success of smaller generic distributors, such as AMBI, depends on the strength of the relationships that a company has with these large wholesalers, distributors and national chain pharmacies.
The Company believes it has very strong relationships, both in the branded and generic divisions, with large distributors and wholesalers and a significant opportunity to gain distribution for additional products through these channels. Typically, it is extremely difficult for new manufacturers and distributors to gain access to large national wholesaler and distribution networks without an existing business relationship. MCR has developed significant relationships with the top three pharmaceutical wholesalers and many other significant distributors and wholesalers in the U.S. because of AMBI sales of generic versions of MCR’s “Branded Generics” in the cough and cold area. Additionally, as MCR and AMBI grow and introduce additional products, including ANDA products, AMBI believes it will be able to leverage its current distribution agreements to introduce additional products.
Products – Branded Pharmaceuticals
MCR’s branded pharmaceutical products include:
| · | Maxiphen – Phenylephrine and guaifenesin-based DESI regulated prescription decongestant / expectorant tablet product line for cough and cold offering five products with varying dosage strengths and ingredient combinations. Several formulations contain dextromethorphan and chlorpheniramine. |
| · | Maxifed – Pseudoephedrine and guaifenesin-based DESI regulated prescription decongestant / expectorant tablet product line for cough and cold offering four products with varying dosage strengths and ingredient combinations. Several formulations contain dextromethorphan. |
| · | Maxi-Tuss – Hydrocodone-based DESI regulated prescription antitussive product line offering three products with varying dosage strengths and active ingredients. Certain formulations contain guaifenesin, phenylephrine and chlorpheniramine. |
| · | Allfen – Guaifenesin-based DESI regulated prescription expectorant product line offering three products with varying dosage strengths and active ingredients. Certain formulations contain dextromethorphan and carbetapentane. |
| · | Promacet – FDA approved prescription tablet containing butalbital and acetaminophen for the relief of moderate to moderately severe pain. |
| · | Maxinate – DESI regulated and patented prescription pre-natal vitamin containing DHA and choline. |
| · | Time-Hist – Pseudoephedrine-based DESI regulated prescription decongestant / antihistamine / antispasmodic tablet with pseudoephedrine, chlorpheniramine and methscopolamine. |
| · | Ambifed – Pseudoephedrine and guaifenesin-based DESI regulated prescription decongestant / expectorant tablet product line for cough and cold treatment. This product line offers two products with varying dosage strengths and ingredient combinations. |
Licenses & Permits
The pharmaceutical business is subject to various regulations. MCR holds the required federal and state licenses to distribute prescription pharmaceuticals within the U.S. The Company’s licenses are all currently valid and in good standing.
The Company’s licenses include:
| · | Drug Enforcement Administration: Controlled Substance Registration Certificate |
| · | Drug Enforcement Administration: Domestic Chemical Diversion Control Registration Certificate |
| · | State of Florida Department of Health – Drugs, Devices, and Cosmetics |
Its permits include:
| · | Complimentary Drug Distributor and Prescription Drug Wholesaler |
Manufacturing & Logistics
MCR outsources manufacturing of its products to one third party contract manufacturer, TG United Pharmaceuticals, Inc. (“TG United”), an entity that is wholly-owned by David Ambrose, the Company’s Chief Executive Officer and President, and beneficial owner of the greatest number of shares of the Company’s capital stock. TG United is responsible for receipt and storage of raw materials and the production, packaging and labeling of finished goods.
TG United and the Company are parties to a Manufacturing and Distribution Agreement dated June 6, 2008, as amended on November 18, 2008 (the “Supply Agreement”). The initial term of the Supply Agreement is through June 6, 2013, and permits additional one-year renewals based upon the parties’ written agreement. Under the terms of the Supply Agreement, TG United will manufacture specified products for the Company, including branded products acquired on June 6, 2008 that will be manufactured exclusively for the Company. On November 18, 2008, the Company was provided an inventory credit of $1.26 million. The Company is required to make minimum monthly payments of $100,000 to TG United with respect to inventory purchases, subject to a quarterly reconciliation against amounts due. The $1.26 million inventory credit may be applied by MCR and AMBI against invoices issued by TG United at a rate of up to $100,000 per month, after any required minimum monthly cash payments are made. Approximately $1.025 million and $0.9 million of the inventory credit remained available to the Company as of December 31, 2008 and March 31, 2009, respectively.
The Company manages the storage and distribution of its products to its customers from its 2,000 square foot warehouse facility in Brooksville, FL. This air-conditioned facility is equipped with a DEA controlled substance cage for the Scheduled products within the MCR and AMBI portfolio. This facility is licensed by the appropriate state and federal governments and agencies for the storage and distribution of prescription pharmaceuticals.
Nationwide Distribution Outlets
Virtually all pharmaceutical products in the United States are distributed through an established network of wholesale distributors. Similar to its peers MCR generates prescriptions at the physician level which are filled at local pharmacies. Local pharmacies purchase prescription pharmaceuticals from the established drug wholesaler network. In addition to the drug wholesale networks, MCR sells its pharmaceutical products to specialty retailers and distributors, including large chain drug stores, hospitals, clinics, government agencies and managed healthcare providers such as health maintenance organizations and other institutions.
Largest Customers | |
| MCR | AMBI |
Cardinal Health, Inc. | 32% | 78% |
McKesson Corporation | 52% | * |
AmeriSourceBergen Corp. | 7% | * |
North Carolina Mutual | * | 8% |
History of the Company
The Company was initially formed in February 2005.
Marco Hi-Tech JV Ltd.
In January 2006, the Company acquired Marco Hi-Tech JV Ltd. (“Marco”), a company focused primarily on licensing proprietary Huperzine A technology from independent third-party developers and investigators, and conducting analytical work and clinical trials of Huperzine A. In addition, from time to time, Marco imported and sold inventories of natural Huperzine and other dietary supplement ingredients to vitamin and supplement suppliers to generate revenues. After our acquisition of Marco, the Company undertook studies for the development and commercialization of Huperzine A, including securing rights to third-party transdermal patch technology.
Q-RNA, LLC
In November 2006, the Company acquired Q-RNA, Inc., a New York-based biotechnology company focused on diseases such as Alzheimer’s, epilepsy and Parkinson’s disease. The acquisition of Q-RNA provided the Company with a pipeline of compounds, many of which have been discovered and developed internally. Among the compounds that Q-RNA believed were ready to move to optimization and pre-clinical development were NHT0012, which is one of a number of second generation disease modifying drugs for Alzheimer’s disease that inhibit A-beta and Tau oligomerization and NHT1107, which is one of a large pharmaceutical library of drugs designed for the treatment of epilepsy that offer both anti-ictogenci (ability to treat epilepsy) and anti-epileptogenic (ability to prevent epilepsy) properties.
MCR American Pharmaceuticals, Inc.
In June 2008, the Company acquired MCR, which was founded in 1991. MCR’s operations are located in the Company’s Brooksville, Florida offices. MCR is focused on the acquisition, development, marketing and distribution of cough and cold, prenatal and pain management pharmaceutical products that provide quick and low-cost market entry through the ANDA, and OTC monograph regulatory approval pathways. These products are referred to as “Branded Generics.”
AMBI Pharmaceuticals, Inc.
In June 2008, the Company acquired AMBI. AMBI is focused on the distribution of generic equivalent pharmaceutical products to pharmaceutical wholesalers, distributors and chain pharmacies. AMBI’s operations are located in the Company’s Brooksville, Florida offices
Other Information
The Company was originally formed on February 1, 2005, as Northern Way Resources, Inc., a Nevada corporation, for the purpose of acquiring exploration and early stage natural resource properties. The Company’s name was changed in January 2006 to Neuro-Hitech Pharmaceuticals, Inc. The Company subsequently changed its name to Neuro-Hitech, Inc. in August 2006.
Prior to its acquisition of MCR and AMBI, the Company had been focused primarily on technologies that address investigational compounds that have the potential to show clinical improvements versus current treatments for Alzheimer’s disease, Epilepsy and other central nervous system applications. The Company’s most advanced product candidate targeting these needs is Huperzine A which completed a Phase II clinical trial in the U.S. earlier this year for efficacy and safety in the treatment of mild to moderate Alzheimer’s disease. In addition to Huperzine A, the Company has worked on two pre-clinical development programs: one for second generation anti-amyloid compounds or disease modifying drugs for Alzheimer’s disease and, secondly, development of a series of compounds targeted to treat and prevent epilepsy.
In view of the results of the Phase II clinical trial, the cost associated with additional trials, and the acquisition of MCR and AMBI, the Company is principally focusing on the development, marketing and distribution of branded and generic pharmaceutical products targeted to the cough and cold markets. The Company continues to explore the potential development of collaborative, joint and strategic alliances and licensing arrangements with one or more pharmaceutical companies for the further development of Huperzine A and its pipeline of other compounds.
Employees
As of March 10, 2009, the Company had 30 full-time employees, including 25 sales representatives and sales managers. MCR and AMBI operations are housed within the same buildings, which include a 3,000 square foot office building and a 2,000 square foot distribution facility, both in Brooksville, Florida.
Corporate Information
The Company’s corporate headquarters are located at 16255 Aviation Loop Drive, Brooksville, FL 34604. The Company’s telephone number is (352) 754-8587, and its fax number is (352) 754-8507.
Executive Officers and Significant Employees of the Registrant
The following sets forth certain information with regard to the executive officers of the Company as of March 13, 2009 (ages are as of December 31, 2008):
Name | | Age | | Position |
David Ambrose | | 42 | | President, Chief Executive Officer and Director |
David Barrett | | 33 | | Chief Financial Officer |
Gary Dutton | | 35 | | Chief Operating Officer and Director |
David Ambrose has been serving as Chief Executive Officer of the Company since January 2009 and a Director of the Company since November 2008. During the past five years, Mr. Ambrose has been the Chief Executive Officer of TG United Pharmaceuticals, Inc. (“TG United”) and during that time, until June 6, 2008, he was also serving as the President and Chief Executive Officer of MCR and AMBI.
David Barrett has been serving as Chief Financial Officer since April 2006. Between January 2005 and April 2006, Mr. Barrett had been serving as Chief Financial Officer of Overture Financial Services, LLC, a company specializing in construction and management of investment platforms for financial intermediaries. Between September 2003 and January 2005, Mr. Barrett served in a variety of capacities, most recently as Chief Financial Officer of Overture Asset Managers, LLC, an asset management holding company that partners, acquires and manages investment managers with complementary investment products. Between June 1999 and September 2003, Mr. Barrett was employed by Deloitte & Touche where he served in a variety of capacities, most recently as Senior Consultant in merger and acquisition services.
Gary Dutton has been serving as Chief Operations Officer since January 2009 and as a Director since November 2008. During the past five years, Mr. Dutton has served as Chief Operations Officer of TG United. From 1999 to January 2008 Mr. Dutton served a variety of roles with MCR American and AMBI Pharmaceuticals, Inc., most recently as a Sales representative, Director of Sales and Vice-President of Sales.
The Company is committed to legal and ethical conduct in fulfilling its responsibilities. The Board expects all directors, as well as officers and employees, to act ethically at all times. Additionally, the Board expects the Chief Executive Officer, the Chief Financial Officer, and all senior financial and accounting officials to adhere to the Company’s Code of Ethics which was adopted on February 23, 2006. The Code of Ethics incorporates the Company’s expectations of its executive officers that enable the Company to provide accurate and timely disclosure in its filings with the SEC and other public communications. In addition, they incorporate the Company’s guidelines pertaining to topics such as complying with applicable laws, rules, and regulations; reporting of code violations; and maintaining accountability for adherence to the code.
The full text of the Code of Ethics is published on the investor relations portion of our website at www.neurohitech.com. The Company intends to disclose any amendments to provisions of its Code of Ethics, or waivers of such provisions granted to executive officers and directors, on this website within four business days following the date of any such amendment or waiver.
Risk Factors
Investing in the Company’s common stock involves a high degree of risk. Prospective investors should carefully consider the risks described below, together with all of the other information included or referred to in this Annual Report on Form 10-K, before purchasing shares of the Company’s common stock. There are numerous and varied risks, known and unknown, that may prevent the Company from achieving its goals. The risks described below are not the only ones the Company will face. If any of these risks actually occur, the Company’s business, financial condition or results of operation may be materially adversely affected. In such case, the trading price of the Company’s common stock could decline and investors in the Company’s common stock could lose all or part of their investment.
Risks Related to the Company and the Company’s Business
The Company has limited cash available, and it may not have sufficient cash to continue its business operations.
As of December 31, 2008 the Company had $397,147 available in cash and cash equivalents. The Company may continue to incur losses in future months as the Company engages in further expenditures as it pursues its business plan.
The Company has relied almost entirely on external financing to fund its operations to date. Such financing has historically come from the sale of common stock to third parties. The Company may need to raise additional capital in the future to fund its operations and there is no guarantee that financing from external sources will be available if needed or on favorable terms. The sale of the Company’s common stock to raise capital may cause dilution to its existing stockholders. If additional financing is not available when required or is not available on acceptable terms, the Company may be unable to fund its operations and expansion, successfully develop its products, take advantage of business opportunities or respond to competitive market pressures, any of which could make it more difficult for the Company to continue operations. Any financing on unfavorable terms or a reduction in the Company’s operations may result in a lower stock price.
Presently, the Company expects that its available cash, cash equivalents and interest income earned may not be sufficient to meet its operating expenses and capital requirements for the next 12 months. If the Company fails to raise additional capital it may not have sufficient cash to meet future operating expenses and capital requirements during this period or in future periods. Even with additional capital, the Company may not be able to execute its current business plan nor fund its operations long enough to achieve positive cash flow. Furthermore, the Company may be forced to implement more significant reductions of its expenses and cash expenditures, which would impair the Company’s ability to execute its business operations.
A small number of customers account for a large portion of the Company’s sales and the loss of one of them, or changes in their purchasing patterns, could hurt the Company’s business.
While the Company markets its products to a large number of doctors and pharmacists, the Company sells its products to a small number of wholesale drug distributors and a limited number of pharmacies. In 2008, McKesson HBOC, Inc. and Cardinal Health, Inc. represented approximately 52% and 32% of MCR’s sales, respectively, and 78% of AMBI’s sales, respectively. The loss of either of these distributors could have an adverse effect on the Company’s business, financial condition and results of operations. A change in purchasing patterns or a reduction in inventory carrying levels by either of these distributors could have a material adverse impact on the Company’s results of operations. Additionally, the distribution network for pharmaceutical products has been subject to increasing consolidation. As a result, a few large wholesale distributors control a large share of the market. Further consolidation or financial difficulties of these distributors could result in the combination or elimination of warehouses that could increase product returns or delay product purchases to reduce inventory levels at the distributor.
The Company may require significant additional funding and may have difficulty raising needed capital in the future.
The Company has not historically generated significant revenue and may not generate sufficient revenue from its operations to meet its future capital requirements. The Company has expended and may continue to expend substantial funds in the operation of its business. The Company will require additional funds to provide for the marketing and distribution of its products. The Company may also require additional funds if it elects to engage in any acquisitions. Additional funds may not be available on acceptable terms, if at all. If adequate funds are unavailable, the Company may have to delay, reduce the scope of or eliminate some of its product development or marketing efforts or forego acquisition opportunities which may materially harm the Company’s business, financial condition and results of operations. The Company’s long term capital requirements are expected to depend on many factors, including:
· | the number of potential products in development; |
· | costs of developing sales, marketing and distribution channels and the Company’s ability to sell its drugs; |
· | competing technological and market developments; |
· | market acceptance of the Company’s products; and |
· | costs for recruiting and retaining management, employees and consultants. |
The Company may consume available resources more rapidly than currently anticipated, resulting in the need for additional funding. The Company may seek to raise any necessary additional funds through the issuance of equity securities or debt financings, collaborative arrangements with corporate partners or other sources, which may be dilutive to existing stockholders or otherwise have a material effect on the Company’s current or future business prospects. In addition, in the event that additional funds are obtained through arrangements with collaborative partners or other sources, the Company may have to relinquish economic and/or proprietary rights to some of the Company’s technologies or products under development that the Company would otherwise seek to develop or commercialize by itself. If adequate funds are not available, the Company may be required to significantly reduce or refocus its development efforts.
Product returns, product liability claims and product recalls could hurt our profits.
The Company permits customers to return pharmaceutical products under certain conditions and the amount of product returns may be material. Although the Company has experienced product returns in the past, it is difficult to estimate what level of product returns it will experience in the future. The Company believes product returns may represent 10% of the revenue of comparable companies. If the Company fails to properly estimate the amount of product returns or experience a material increase in product returns the Company’s results could be adversely affected.
The Company also faces the risk of exposure to product liability claims. Although the Company carries product liability insurance; this insurance may not be sufficient to cover potential claims. This insurance may not be available to the Company in the future at an acceptable cost.
Even after the Company receives regulatory approval for a product and markets it, identification of side effects or manufacturing problems could result in withdrawal of marketing approval or recall of the product or some other corrective action by the FDA or other government agencies that could require:
| · | reformulation of the product; |
| · | changes in the labeling or marketing of the product. |
In addition, the Company may have to issue market withdrawals or take other corrective actions. In May 2007, the FDA announced that companies must stop manufacturing and distributing unapproved time-release dosage forms containing guaifenesin. In anticipation of this announcement, MCR withdrew its products including guaifenesin and reformulated all affected products. If a product recall or withdrawal occurs, it could affect the Company’s profits, financial condition and results of operations.
If third-party payors do not reimburse patients for the Company’s products, the Company’s sales and profits could decline.
Third-party payors, such as the government, private healthcare insurers and managed care organizations, continuously challenge the pricing of medical products and services through their reimbursement policies. If reimbursement for the Company’s products is low or non-existent, patients and pharmacies may not continue to choose them. Competition among pharmaceutical companies to place their products on the list of products approved for third-party reimbursement creates downward pricing pressure in the industry. In the past several years there have been federal and state government initiatives or reforms affecting the payment for healthcare services and products, including proposals that would limit reimbursement under the Medicare and Medicaid programs. The Company anticipates that federal and state governments will continue to review and assess healthcare delivery systems and payment methods especially in light of the anticipated increase in healthcare costs caused by the aging of the population. Reforms may include:
| · | controls on healthcare spending through limitations on the growth of private health insurance premiums and Medicare and Medicaid spending; |
| · | the increased use of managed care contractors by government payors; and |
| · | price controls on pharmaceutical products. |
Any of these reforms could adversely affect the Company’s revenues and ability to achieve profitability.
Because the Company currently has no commercial manufacturing capabilities of its own, the Company is and will continue to be dependent upon TG United to manufacture products for it.
The Company has no commercial manufacturing experience and currently outsources all of its product manufacturing to one third−party contract manufacturer, TG United. Although the Company has received sufficient material from TG United to meet its current needs, it does not have any contracts with any other third parties. The termination of its agreement with or any loss of services under that agreement would be difficult for the Company to replace. The Company expects to continue to rely on TG United to produce materials required for the commercial production of the Company’s products.
There are a limited number of third−party manufacturers that operate under the FDA’s current Good Manufacturing Practices (“GMP”), regulations and that have the necessary expertise and capacity to manufacture the Company’s products. Additionally, the Company’s current manufacturing needs may not be a large enough volume to appeal to many potential manufacturers. As a result, it may be difficult for the Company to locate manufacturers for the Company’s anticipated future needs. If the Company is unable to arrange for third−party manufacturing of its products, or to do so on commercially reasonable terms, the Company may not be able market and sell its products.
Reliance on third−party manufacturers entails risks to which the Company would not be subject if it manufactured its own products, including reliance on the third party for regulatory compliance and quality assurance, the possibility of breach of the manufacturing agreement by the third party, and the possibility of termination or non−renewal of the agreement by the third party. Dependence upon third parties for the manufacture of the Company’s products may reduce the Company’s profit margins, or the sale of the Company’s products, and may limit the Company’s ability to develop and deliver products on a timely and competitive basis.
The Company is dependent upon TG United as its sole source of operating credit.
On November 18, 2008, TG United provided the Company a $1.26 million inventory credit. The Company is required to make minimum monthly payments of $100,000 to TG United with respect to inventory purchases, subject to a quarterly reconciliation against amounts due. The $1.26 million inventory credit may be applied by MCR and AMBI against invoices issued by TG United at a rate of up to $100,000 per month, after any required minimum monthly cash payments are made. Approximately $1.025 million and $0.9 million of the inventory credit remained available to the Company as of December 31, 2008 and March 31, 2009, respectively.
If the Company’s third−party manufacturer does not operate in accordance with current Good Manufacturing Practices, the Company could be subject to FDA enforcement actions, including the seizure of the Company’s products and the halting of production.
The third−party manufacturer that the Company currently relies on or any third-party manufacturers the Company will rely on in the future must continuously adhere to the GMPs set forth in the FDA’s regulations. In complying with GMPs, the Company and its third−party manufacturer must expend significant time, money and effort in development, testing, production, record keeping and quality control to assure that the Company’s products meet applicable specifications and other regulatory requirements. The failure to comply with these specifications and other requirements could result in an FDA enforcement action, including the seizure of products and shutting down of production. If the Company’s third−party manufacturer is unable to comply with GMPs, the Company’s ability to develop, produce and sell its products would be impaired.
The Company is dependent on its manufacturer party for the development of the Company’s products.
The Company currently relies on its manufacturer for the development of the Company’s products. The Company’s ability to commercialize the products that it develops and generate revenues from product sales depends on its partner’s ability to assist the Company in establishing the safety and efficacy of the Company’s product candidates, obtaining and maintaining regulatory approvals and achieving market acceptance of the products once commercialized. If the Company’s partner fails to perform as expected, the Company’s potential for revenue from products developed through its strategic relationship could be dramatically reduced.
If the Company utilizes other partners for the development of its products, those partners may elect to delay or terminate development of one or more product candidates, independently develop products that could compete with the Company’s products or fail to commit sufficient resources to the distribution of products developed through their strategic relationships with the Company.
The Company may engage in strategic transactions or acquisitions that fail to enhance stockholder value.
From time to time, the Company may consider possible strategic transactions, including the potential acquisition or licensing of products or technologies or acquisition of companies.
Strategic transactions involve numerous risks, including the following:
• | Difficulties in integrating the operations, technologies, products and personnel of the acquired companies; |
• | Diversion of management’s attention from normal daily operations of the business; |
• | Difficulties in entering markets in which the Company has no or limited direct prior experience and where competitors in such markets have stronger market positions; |
• | Initial dependence on unfamiliar partners; |
• | Insufficient revenues to offset increased expenses associated with acquisitions; and |
• | The potential loss of key employees of the acquired companies. |
Acquisitions may also cause the Company to:
• | Issue common stock that would dilute the Company’s current shareholders’ percentage ownership; |
• | Record goodwill and non-amortizable intangible assets that will be subject to impairment testing on a regular basis and potential periodic impairment charges; |
• | Incur amortization expenses related to certain intangible assets; |
• | Incur large and immediate write-offs, and restructuring and other related expenses; or |
• | Become subject to litigation. |
Mergers and acquisitions of pharmaceutical companies are inherently risky, and no assurance can be given that the Company’s previous or future acquisitions will be successful and will not materially adversely affect its business, operating results or financial condition. Failure to manage and successfully integrate acquisitions the Company makes could harm its business and operating results in a material way.
The loss of key executives and failure to attract qualified management could limit the Company’s growth and negatively impact its results of operations.
The Company depends highly upon its senior management team, primarily David Ambrose, its Chief Executive Officer and President, and David Barrett, its Chief Financial Officer. The Company will continue to depend on management personnel with pharmaceutical industry experience. At this time, the Company does not know of the availability of such experienced management personnel or how much it may cost to attract and retain such personnel. The loss of the services of any member of senior management or the inability to hire experienced management personnel could have a material adverse effect on the Company’s financial condition and results of operations.
Because none of the Company’s products have been approved by the FDA or subject of FDA-approved new drug applications, the Company could be subject to FDA enforcement actions.
New drugs must be the subject of a U.S. Food and Drug Administration (“FDA”) approved New Drug Application (“NDA”) or Abbreviated New Drug Application (“ANDA”) demonstrating safety and effectiveness before they may be marketed in the United States. Some prescription and other drugs marketed by pharmaceutical companies have not been the subject of an FDA-approved marketing application because NDAs or ANDAs requiring demonstration of safety and effectiveness were not required at the time that these active ingredients were initially marketed. While the FDA reviewed classes of these products in the 1960s and 1970s as part of its Drug Efficacy Study Implementation (“DESI”) program, there are several types of drugs, including some cold and cough drugs, that the FDA has not yet evaluated and remain on the market without FDA approval.
The Company’s products are marketed in the United States without an FDA-approved marketing application because they have been considered by the Company to be identical, related or similar to products that have existed in the market without an NDA or ANDA. These products are marketed subject to the FDA’s regulatory discretion and/or enforcement policies. The FDA has adopted a risk-based enforcement policy concerning unapproved drugs. The agency has articulated that, in enforcing the NDA requirements, it prioritizes drugs that pose potential safety risks, lack evidence of effectiveness and prevent patients from seeking effective therapies, and those that are marketed fraudulently. In addition, the FDA has indicated that approval of an NDA for one drug within a class of drugs marketed without FDA approval may also trigger agency enforcement of the other drugs in that class. Once the FDA issues an approved NDA for one of the drug products at issue or completes the efficacy review for that drug product, it may require the Company to also file an NDA or ANDA for other drugs in the same class of drugs in order to continue marketing them in the United States. While the FDA generally allows a one-year grace period, it is not statutorily required to do so. In addition, although the Company may be given time to submit a marketing application for a product before the FDA would take enforcement action, the time it takes us to complete the necessary clinical studies and submit an application to the FDA may exceed the one-year grace period, resulting in an interruption of marketing and sales. It is also possible that the FDA could disagree with our determination that some or all of these products are identical, related or similar to products that have existed in the marketplace without an NDA or ANDA. In the event the FDA disagrees with our determination that these products are identical, the FDA may file an enforcement action which could result in these products being pulled off the market. If this were to occur it would have a substantial, negative impact on the Company’s business.
The regulatory status of some of the Company’s products makes these products subject to increased competition and other regulatory risks, which could result in reduced sales or enforcement actions against the Company.
The regulatory status of the Company’s products may allow third parties to more easily introduce competitive products. Several of the Company’s lines of products are marketed in the United States without an FDA-approved marketing application because they have been considered by the Company to be identical, related or similar to products that have existed in the market without an NDA or ANDA. On several occasions, the FDA has considered changing the classification of certain single entity and combination product types of drugs from prescription to over-the-counter use, and permitting sponsors to utilize foreign over-the-counter experience data to establish a product as safe and effective for over-the-counter use in the United States. If the FDA changes such classification, the Company may have to reformulate certain of its products or submit safety and efficacy data on such products, which would be costly, or the Company may have to discontinue selling certain products if the FDA does not approve any marketing application for such products.
In addition, the FDA considers certain products to be new drugs, but has indicated its intent to exercise enforcement discretion and not pursue regulatory action unless certain conditions occur. If these conditions were to materialize, or the FDA disagreed with the Company’s conclusions about the regulatory status of such products, the Company might be required to submit an NDA and/or cease marketing until the FDA grants approval to do so. The FDA could also, at any time, promulgate new regulations or policies to require the submission of an NDA for each of these products.
The Company’s business is heavily regulated by governmental authorities, and failure to comply with such regulation or changes in such regulations could negatively impact the Company’s financial results.
The Company’s business is regulated by many government authorities, including, among others, the FDA, the U.S. Drug Enforcement Agency (“DEA”), the Consumer Product Safety Commission, the Department of Health and Human Services (“HHS”) and the Centers for Medicare and Medicaid Services. The Company may incur significant expenses to comply with regulations imposed by these authorities. Also, the Company’s future results of operations could be negatively impacted by changes in governmental regulation over the pharmaceutical industry, including regulation of Medicare, Medicaid and similar programs, by reducing the Company’s revenue and profits and/or increasing its costs and expenses in order to comply with such regulations. In addition, the Company’s third-party manufacturer and other partners are subject to inspection by the FDA and, in appropriate cases, the DEA and other regulators. If the Company’s third-party manufacturer and other partners do not comply with FDA or DEA regulations in the future, they may not deliver products to the Company or deliver samples to the Company’s representatives, or the Company may have to recall products. Even if deficiencies observed by the FDA or DEA do not relate to the Company’s products, its third-party manufacturer and other partners may be delayed in manufacturing and in supplying the Company’s products to it in a timely manner until they address their compliance issues with the FDA and/or DEA.
Any regulatory approvals that the Company or its partners receive for its product candidates may also be subject to limitations on the indicated uses for which the drug may be marketed or contain requirements for potentially costly post-marketing follow-up studies. The subsequent discovery of previously unknown problems with the drug, including adverse effects of unanticipated severity or frequency, may result in restrictions on the marketing of the drug, and could include withdrawal of the drug from the market.
Period−to−period comparisons of the Company’s operating results are not meaningful due to its acquisition of MCR American Pharmaceuticals, Inc. and AMBI Pharmaceuticals, Inc.
The Company completed its acquisition of MCR American Pharmaceuticals, Inc. and AMBI Pharmaceuticals, Inc. in June 2008, which makes it difficult to analyze its pre−acquisition and post−acquisition results of operations and to compare them from period to period. Period−to−period comparisons of the Company’s results of operations may not be meaningful due to these acquisitions and are not indications of the Company’s future performance. Any future acquisitions will also make the Company’s future results difficult to compare from period to period.
The Company’s financial results may fluctuate due to factors outside its control, which fluctuations may have an adverse affect on the Company’s stock price.
The Company’s quarterly results of operations will be highly dependent upon the results of its subsidiaries MCR American Pharmaceuticals, Inc. and AMBI Pharmaceuticals, Inc. The results of operations for these subsidiaries have fluctuated in the past with the majority of their sales recorded in the first and fourth quarters. The Company’s results are likely to continue to fluctuate significantly in the future. The factors that contribute to these fluctuations are largely out of the Company’s control, and include:
| · | seasonality of sales of cough, cold and allergy products; |
| · | demand for and market acceptance of the Company’s products; |
| · | insufficient demand in the marketplace causing the Company’s distributors to return product; |
| · | the development of new competitive products by others; |
| · | changes in treatment practices of physicians who currently prescribe the Company’s products; |
| · | the timing, release and competitiveness of the Company’s products; |
| · | the mix of products that the Company sells during any time period; |
| · | increased price competition; |
| · | increased expenses, whether related to marketing, product development, administration or otherwise; and |
| · | adverse changes in the level of economic activity in the United States and other major regions in which the Company does business. |
Due to the factors summarized above, the Company does not believe that period−to−period comparisons of its results of operations are necessarily meaningful and should not necessarily be relied upon to predict future results of operations. It is also possible that in future periods the Company’s results of operations will not meet the expectations of investors.
The Company’s limited operating history makes evaluating its common stock more difficult, and therefore, investors have limited information upon which to rely.
An investor can only evaluate the Company’s business based on a limited operating history. The Company’s operations have changed dramatically since its inception and may continue to change. This limited history may not be adequate to enable an investor to fully assess the Company’s ability to execute its business plan, and achieve market acceptance of the Company’s products and respond to competition, or conduct such affairs as are presently contemplated.
Some of the Company’s products contain controlled substances, which are subject to extensive regulation by the Drug Enforcement Agency and other regulatory agencies.
Some of the Company’s products contain codeine as an active ingredient. Codeine is a controlled substance and is subject to extensive regulation by the Drug Enforcement Agency and other agencies. These regulations apply to the manufacture, shipment, sale and use of products containing controlled substances. These regulations are also imposed on prescribing physicians and other third parties, and could make the storage, transport and use of such products relatively complicated and expensive. The DEA is also involved in the review of labeling, promotion and risk management plans with the FDA for certain controlled substances. With the increased concern for safety by the FDA and the DEA with respect to products containing controlled substances, it is possible that these regulatory agencies could impose additional restrictions on marketing or even withdraw regulatory approval for such products.
In addition, adverse publicity may result in rejection of the product by the medical community. If the DEA, FDA or any other regulatory authority withdrew the approval of, or placed additional significant restrictions on these products, the Company’s product sales could be adversely affected. In addition, there can be no assurance that the DEA will not, in the future, seek to regulate other ingredients in the Company’s products as controlled substances.
If physicians and patients do not accept the Company’s current or future products, the Company may be unable to generate significant additional revenue, if any.
The Company’s future financial performance will depend upon the acceptance of the Company’s products by physicians, patients, third-party payors and the broader medical community. The degree of market acceptance will depend upon a number of factors, including:
| · | timing of market introduction of competitive drugs; |
| · | lower demonstrated clinical safety and efficacy compared to other drugs; |
| · | lack of cost-effectiveness; |
| · | pricing and reimbursement policies of government and third party payors such as insurance companies, health maintenance organizations and other health plan administrators; |
| · | lack of convenience or ease of administration; |
| · | prevalence and severity of adverse side effects; |
| · | other potential advantages of alternative treatment methods; and |
| · | ineffective marketing and distribution support. |
If the Company’s products fail to achieve market acceptance, the Company would not be able to generate significant revenue.
The market for products and services in the pharmaceuticals industry is highly competitive, and the Company may not be able to compete successfully.
The market for products and services in the pharmaceuticals industry is highly competitive. Most of the Company’s competitors in the industry have longer operating histories and significantly greater financial, technical, marketing and other resources than the Company, and may be able to respond more quickly than the Company can to new or changing opportunities and customer requirements. Also, many competitors have greater name recognition and more extensive customer bases that they can leverage to gain market share. Such competitors are able to undertake more extensive promotional activities, adopt more aggressive pricing policies and offer more attractive terms to purchasers than the Company can.
Recent federal legislation may increase the pressure to reduce prices of pharmaceutical products paid for by Medicare, which may adversely affect the Company’s revenues, if any.
The Medicare Prescription Drug Improvement and Modernization Act of 2003 (“MMA”) changed the way that Medicare covers and pays for pharmaceutical products. The legislation expanded Medicare coverage for drug purchases by the elderly and will eventually introduce a new reimbursement methodology based on average sales prices for drugs. In addition, this legislation provides authority for limiting the number of drugs that will be covered in any therapeutic class. As a result of this legislation and the expansion of federal coverage of drug products, the Company expects that there will be additional pressure to contain and reduce costs. These cost reduction initiatives and other provisions of this legislation could decrease the coverage and price that the Company receives for any approved products and could seriously harm its business. While the MMA applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates, and any reduction in reimbursement that results from the MMA may result in a similar reduction in payments from private payors.
The Company’s compliance with the reporting requirements of federal securities laws and SEC rules concerning internal controls may be time consuming, difficult and expensive.
The Company is a public reporting company and, accordingly, subject to the information and reporting requirements of the Exchange Act and other federal securities laws, including compliance with the Sarbanes-Oxley Act. It may be time consuming, difficult and costly for the Company to develop and implement the internal controls and reporting procedures required by the Sarbanes-Oxley Act. The costs of preparing and filing annual and quarterly reports, proxy statements and other information with the SEC and furnishing audited reports to stockholders will cause the Company’s expenses to be higher than they would be if the Company had remained privately-held. The Company may need to hire additional financial reporting, internal controls and other finance personnel in order to develop and implement appropriate internal controls and reporting procedures. If the Company is unable to comply with the internal controls requirements of the Sarbanes-Oxley Act, the Company may not be able to obtain the independent accountant certifications required by the Sarbanes-Oxley Act.
If the Company is unable to hire and retain additional qualified personnel, the Company’s business may be harmed.
The Company is small and if unable to continue to attract, retain and motivate highly qualified management and sales personnel, may not be able to achieve its objectives. Competition for management and sales personnel is intense.
The Company competes for qualified individuals with numerous pharmaceutical companies and other emerging entrepreneurial companies. Competition for such individuals is intense and the Company cannot be certain that the Company’s search for such personnel will be successful. Attracting and retaining qualified personnel will be critical to the Company’s success. Skilled employees in the Company’s industry are in great demand. The Company is competing for employees against companies that are larger, more established than the Company is and companies that have the ability to pay more compensation than the Company. If the Company is unable to hire and retain needed personnel, operating results and future prospects could be materially adversely affected.
Risks Relating to the Market and the Company’s Common Stock
The market price of the Company’s common stock has been, and is likely to continue to be, highly volatile and subject to wide fluctuations.
The market price of the Company’s common stock has been, and is likely to continue to be, highly volatile and could be subject to wide fluctuations in response to a number of factors, some of which are beyond the Company’s control, including:
· | announcements or developments related to the products of the Company’s competitors; |
· | quarterly variations in the Company’s operating expenses; |
· | issuances or sales of capital stock by the Company; and |
· | sales of the common stock by the Company’s founders or other selling stockholders. |
Applicable SEC rules governing the trading of “penny stocks” may limit the trading and liquidity of the Company’s common stock in the future, which could affect its trading price.
The Company’s common stock is currently traded on the OTC Bulletin Board market under the symbol “NHPI.”
The Company’s common stock may be considered a “penny stock” and subject to SEC rules and regulations which impose limitations upon the manner in which such shares may be publicly traded. These regulations require the delivery, prior to any transaction involving a penny stock, of a disclosure schedule explaining the penny stock market and the associated risks. Under these regulations, certain brokers who recommend such securities to persons other than established customers or certain accredited investors must make a special written suitability determination regarding such a purchaser and receive such purchaser’s written agreement to a transaction prior to sale. These regulations have the effect of limiting the trading activity of the common stock and reducing the liquidity of an investment in the common stock.
There is currently very little liquidity in the trading market for the Company’s common stock and the Company cannot ensure that a liquid trading market will ever develop or be sustained.
To date there has been a very limited trading market for the Company’s common stock. The Company cannot predict how liquid the market for its common stock might become. The Company’s common stock is currently trading on the OTC Bulletin Board. In addition, the price at which the Company’s common stock may be sold is hard to predict because of the limited liquidity of its common stock. Because the Company’s common stock is so thinly traded, a large block of shares traded can lead to dramatic fluctuations in the share price.
The Company has not paid dividends in the past and does not expect to pay dividends in the future. Any return on investment may be limited to the value of the Company’s common stock.
The Company currently intends to retain any future earnings to support the development and expansion of its business and does not anticipate paying cash dividends in the foreseeable future. Any payment of future dividends will be at the discretion of the board of directors after taking into account various factors, including but not limited to the Company’s financial condition, operating results, cash needs, growth plans and the terms of any credit agreements that the Company may be a party to at the time. If the Company does not pay dividends, its common stock may be less valuable because a return on your investment will only occur if the Company’s stock price appreciates.
Item 2. | Description of Property. |
The Company leases office and warehouse space from an affiliate of David Ambrose, at 16255 Aviation Loop Drive, Brooksville, FL 34604. Each of those leases is subject to a month-to-month lease.
Item 3. | Legal Proceedings. |
On January 7, 2009, the Company terminated the employment of its former chief executive officer, Matthew Colpoys. In terminating his employment, the Company asserted, pursuant to Section 5(d) of his employment agreement, that the termination was for “cause” as defined in the agreement. On January 26, 2009, Mr. Colpoys filed suit in Supreme Court in Erie County, New York, asserting that prior to his termination his salary had been reduced in violation of the agreement and that his termination was without “without cause” under his employment agreement. He is seeking the payment of the amount of the salary reduction ($55,000), two year’s salary and benefits pursuant to the provision of the agreement pertaining to termination without “cause” ($664,000) and indemnification for his legal fees. The Company believes that Mr. Colpoys’ suit is without merit and intends to vigorously defend it. The Company has answered the complaint denying the claims and has asserted counterclaims for breach of fiduciary duty based upon various acts of misconduct prior to his termination.
On November 20, 2008, the Company terminated the employment of its former officers, David Benharris, Patrick Sullivan and Brendan Carney as part of a reorganization and down-sizing of its executive staff. Messrs. Benharris, Sullivan and Carney have asserted various claims for allegedly unpaid vacation benefits and unreimbursed business expenses. In addition, they have asserted that they were terminated following a “change in control” as that term is defined in the change in control agreement entered in connection with their employment and have asserted claims for two year’s salary and benefits pursuant to the termination provisions of those agreements (approximately $550,000 in the aggregate). Messrs. Benharris, Sullivan and Carney submitted a demand for arbitration on March 4, 2009. The Company believes that their claims are without merit and intends to vigorously defend them.
Item 4. | Submission of Matters to a Vote of Security Holders. |
The Company did not submit any matter to a vote of security holders through the solicitation of proxies or otherwise during the fourth quarter of the fiscal year ended December 31, 2008.
PART II
Item 5. | Market for Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities |
The Company’s common stock is currently traded on the OTC Bulletin Board market under the symbol “NHPI.”
The Company’s common stock was first traded on the OTCBB market on February 2, 2006 until the common stock began trading on the NASDAQ Capital Market on April 24, 2007. The Company’s common stock was delisted from the NASDAQ Capital Market on April 2, 2008. The following table sets forth the high and low sales prices for the period during which the common stock has been traded on the NASDAQ Capital Market and the range of the high and low bid prices for the period during which the common stock was traded on the OTCBB market. The information provided for trading on the OTCBB market, as reported by the National Quotation Bureau, represents interdealer quotations, without retail markup, markdown or commission and may not be reflective of actual transactions.
| | Bid Price Per Share | |
| | High | | | Low | |
January 2007 - March 2007 | | $ | 7.25 | | | $ | 4.75 | |
April 2007 – June 2007 | | $ | 8.15 | | | $ | 5.82 | |
July 2007 – September 2007 | | $ | 6.47 | | | $ | 4.25 | |
October 2007 – December 2007 | | $ | 5.50 | | | $ | 3.01 | |
January 2008 – March 2008 | | $ | 4.40 | | | $ | 0.40 | |
April 2008 – June 2008 | | $ | 0.51 | | | $ | 0.22 | |
July 2008 – September 2008 | | $ | 0.45 | | | $ | 0.20 | |
October 2008 – December 2008 | | $ | 0.20 | | | $ | 0.04 | |
Stockholders
As of March 2, 2009, the Company believes there were approximately 126 holders of record of its common stock. The Company believes that a greater number of holders of its common stock are “street name” or beneficial holders, whose shares are held of record by banks, brokers and other financial institutions.
Dividends
The Company has never declared or paid any cash dividends on its common stock. The Company currently intends to retain all available funds and any future earnings to fund the development and growth of its business and does not anticipate declaring or paying any cash dividends on its common stock in the foreseeable future.
Recent Sales of Unregistered Securities
The Company did not sell any unregistered equity securities during the year ended December 31, 2008 that were not previously reported on a Quarterly Report on Form 10-Q or a Current Report on Form 8-K.
Item 6. | Selected Financial Data |
Not applicable.
Item 7. | Management’s Discussion and Analysis or Plan of Operation |
FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking statements (as defined in Section 27A of the Securities Act and Section 21E of the Exchange Act). To the extent that any statements made in this Report contain information that is not historical, these statements are essentially forward-looking. Forward-looking statements can be identified by the use of words such as “expects,” “plans” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” “projects” and other words of similar meaning. These statements are subject to risks and uncertainties that cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include those outlined in “Risk Factors” found within our Annual Report on Form 10-K and include, without limitation, the Company’s limited history, limited revenues, limited cash and ability to raise capital to finance the growth of the Company’s operations, the ability of the Company to develop its products and obtain necessary governmental approvals, the Company’s ability to protect its proprietary information, the Company’s ability to attract or retain qualified personnel, including scientific and technical personnel and other risks detailed from time to time in the Company’s filings with the SEC, or otherwise.
THE FOLLOWING DISCUSSION SHOULD BE READ TOGETHER WITH THE INFORMATION CONTAINED IN THE FINANCIAL STATEMENTS AND RELATED NOTES INCLUDED ELSEWHERE IN THIS ANNUAL REPORT ON FORM 10-K.
Neuro-Hitech, Inc. (the “Company” or “Neuro-Hitech”) is a specialty pharmaceutical company focused on developing, marketing and distributing branded and generic pharmaceutical products primarily in the cough and cold markets. The Company sells its products domestically through U.S. based distributors.
Prior to June 6, 2008, the Company had been focused primarily on technologies that address investigational compounds that have the potential to show clinical improvements versus current treatments for Alzheimer’s disease, epilepsy and other central nervous system applications.
As a result of the acquisition of MCR and AMBI, the Company is now a specialty pharmaceutical company principally focused on developing, marketing and distributing branded and generic pharmaceutical products primarily in the cough and cold markets. The Company sells its products domestically through U.S. based distributors.
Until its acquisition of MCR and AMBI, the Company’s revenue was a result of the importation and sale of inventories of natural Huperzine to vitamin and supplement suppliers. The majority of the Company’s operations to date have been funded through the Company’s private placement of equity securities.
In view of the results of the Phase II clinical trial, the cost associated with additional trials, and the acquisition of MCR and AMBI, the Company is principally focusing on the development, marketing and distribution of branded and generic pharmaceutical products primarily in the cough and cold markets. The Company continues to explore the potential development of collaborative, joint and strategic alliances and licensing arrangements with one or more pharmaceutical companies for the further development of Huperzine A and its pipeline of other compounds. The Company continually evaluates merger and/or acquisition opportunities.
Results of Operations
The following discussion provides a comparison of the Company’s results of operations for the year ended December 31, 2008 to the year ended December 31, 2007. The Company’s results of operations reported herein reflect the acquisition of MCR and AMBI since June 5, 2008. Accordingly, the results of operations for the periods prior to the acquisition of MCR and AMBI are not comparable to periods after the acquisition of MCR and AMBI.
| | For the twelve-month | | | | | | | |
| | period ended | | | | | | | |
| | December 31 | | | 2008 vs 2007 | | | 2008 vs 2007 | |
| | 2008 | | | 2007 | | | ($) | | | (%) | |
| | | | | | | | | | | | |
Revenues | | $ | 4,129,612 | | | $ | 458,870 | | | $ | 3,670,742 | | | | 800 | % |
| | | | | | | | | | | | | | | | |
Cost of goods sold | | | 1,827,160 | | | | 215,854 | | | | 1,611,306 | | | | 746 | % |
| | | | | | | | | | | | | | | | |
Gross Profit | | | 2,302,452 | | | | 243,016 | | | | 2,059,436 | | | | 847 | % |
| | | | | | | | | | | | | | | | |
Operating expenses: | | | | | | | | | | | | | | | | |
Selling, general & administrative expenses | | | 5,788,983 | | | | 2,561,402 | | | | 3,227,581 | | | | 126 | % |
Research & development costs | | | 1,549,879 | | | | 3,523,954 | | | | (1,974,075 | ) | | | -56 | % |
Share Based Compenssation | | | 5,331,308 | | | | 2,427,904 | | | | 2,903,404 | | | | 120 | % |
Amortization of Deferred comp | | | 589,874 | | | | 242,447 | | | | 347,427 | | | | 143 | % |
| | | | | | | | | | | | | | | | |
Registration Rights payments | | | 0 | | | | 490,550 | | | | (490,550 | ) | | | -100 | % |
| | | | | | | | | | | | | | | | |
Total operating expenses | | | 13,260,044 | | | | 9,246,257 | | | | 4,013,787 | | | | 43 | % |
| | | | | | | | | | | | | | | | |
Operating loss | | | (10,957,592 | ) | | | (9,003,241 | ) | | | (1,954,351 | ) | | | 22 | % |
| | | | | | | | | | | | | | | | |
Other income (expense): | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | |
Interest income (expense) | | | (143,616 | ) | | | 206,804 | | | | (350,420 | ) | | | -169 | % |
Forgiveness of debt | | | 375,338 | | | | 0 | | | | 375,338 | | | NM | |
| | | | | | | | | | | | | | | | |
Net loss | | | (10,725,870 | ) | | | (8,796,437 | ) | | | (1,929,433 | ) | | | 22 | % |
Revenues
Revenues consist of sales of pharmaceutical products adjusted for any allowance for product returns and sales of natural Huperzine to vitamin and supplement suppliers.
The Company had revenues from operations of $4,129,612 for the year ended December 31, 2008, a 800% increase from the $458,870 in revenue achieved for the year ended December 31, 2007. The increase in revenue was attributable to revenues generated by MCR and AMBI following the Company’s acquisition of those companies.
Cost of Goods Sold
Cost of goods sold as a percentage of the Company’s revenue was 44.2% for the year ended December 31, 2008, compared with 47% for the year ended December 31, 2007. The change in the cost of goods sold as a percentage of the Company’s revenue was attributable to the higher margins associated with the sales of the Company’s pharmaceutical products following its acquisition of MCR and AMBI compared to the margins associated with the sales of Huperzine A in the prior period. A comparison to the prior period is not meaningful in light of the change in the composition of the Company’s business.
Selling, general and administrative expenses
Selling, general and administrative expenses generally consist of share-based and cash compensation to our employees and consultants who support our operations as well as professional fees, insurance costs and investor relations.
The Company’s total selling, general and administrative expenses increased from $2,561,402 for the year ended December 31, 2007 to $5,788,983 for the year ended December 31, 2008. The increase in these expenses was attrituable to increases in salaries and employee benefit expenses following the acquisition of MCR and AMBI.
Share based compensation for the year ended December 31, 2008 was $5,331,308, an increase from the $2,427,904 for the year ended December 31, 2007. The increase in share based compensation expense was attrituable to share-based payments of approximately $3.1 million associated with the forefeiture of options granted to officers, employees and consultants in prior years, and the grant of options and stock appreciation rights.
Research and development costs
The Company’s research and development costs decreased from $3,523,954 for the year ended December 31, 2007 to $1,549,879 for the year ended December 31, 2008. The decrease in research and development expenses is attributable to the conclusion of the Company’s clinical development programs following the announcement of its Phase II results for Huperzine A.
Georgetown
In December 2003, the Company entered into a clinical research agreement, which was amended in November 2005 and October 2007, with Georgetown pursuant to which Georgetown provided the Company with Phase II research on Huperzine A. The costs associated with this agreement totaled $5,336,842 and were partially funded by the National Institutes of Health. The Company’s portion of the total cost was $4,036,842 and payable in installments upon the achievement of certain milestones. For the years ended December 31, 2008 and 2007, the payments made by the Company to Georgetown under the terms of the clinical research agreement were approximately $785,305 and $1,183,167, respectively, and the total payments made by the Company to Georgetown since inception of the agreement were approximately $3,895,972. These costs are reflected in the Research and Development caption of the Statement of Operations. The Company expects to make final payments in 2009 to Georgetown in the amount of $80,000.
XEL Herbaceuticals, Inc.
On March 15, 2006, the Company entered into a development agreement with XEL for the development of the Huperzine A Transdermal Delivery System (“Product”). For the years ended December 31, 2008 and 2007, the payments made by the Company to XEL were approximately $92,500 and $1,111,250, respectively, and are reflected in the Research and Development caption of the Statement of Operations. The Company does not expect to make any additional payments in 2009.
Dalhousie License Agreements (PARTEQ)
As part of the acquisition of Q-RNA, the Company assumed exclusive license agreements with PARTEQ Research and Development Innovations (“PARTEQ”), the technology licensing arm of Queens University, Kingston, Ontario, Canada.
Under the terms of the exclusive PARTEQ Licensing Agreement with PARTEQ, which was amended in early 2007, the Company was obligated to pay fixed annual fees of C$283,000. Under the terms of the Exclusive Patent License Option Agreement with PARTEQ which was amended in early 2007, the Company was obligated to pay fixed annual fees of C$151,000. For the years ended December 31, 2008 and December 31, 2007 the payments made by the Company to PARTEQ under these agreements have been approximately $122,000 and $457,115, respectively. The Company expects to make final payments in 2009 to PARTEQ in the amount of C$60,000.
Interest income (expense)
The Company invests any cash and cash equivalents not used for working capital in short-term, interest-bearing, investment-grade securities or accounts. For the year ended December 31, 2008, the Company incurred an expense of $143,616 related to interest accrued on notes payable to David Ambrose issued in connection with the Company’s acquisition of MCR and AMBI in June 2008, compared to $206,804 in interest income generated in the year ended December 31, 2007. The decrease is attributable to a decrease in the balance of the Company’s cash and cash equivalents during the 2008 fiscal year and a decrease in the rate of interest paid on the Company’s cash and cash equivalents.
Liquidity and Capital Resources
Presently, the Company expects that its available cash, cash equivalents and interest income earned may not be sufficient to meet its operating expenses and capital requirements for the next 12 months, although its financial condition has been improved since November 2008. In November 2008, the Company and David Ambrose and an affiliate of Mr. Ambrose modified certain terms of the agreement pursuant to which the Company purchased MCR and AMBI, pursuant to a Modification Agreement and Release (“Modification Agreement”). Pursuant to the Modification Agreement the Company issued 1,500,000 shares of the Company’s Series A Preferred Stock and 1,397,463 shares of the Company’s Series B Preferred Stock (i) to satisfy its obligations to Mr. Ambrose under a Convertible Note and a Subordinated Note aggregating approximately $6.1 million and payables aggregating approximately $1 million and (ii) to receive products from an affiliate of Mr. Ambrose valued at up to $1,257,717. Each share of the Series A and B Preferred Stock is convertible in 10 shares of the Company’s common stock. Additionally, the features of the Series A Preferred Stock include, among other things, a non-participating liquidation preference of $4,500,000.
The Company is dependent upon TG United as its sole source of operating credit. As part of the Modification Agreement, the Company was provided a $1.26 million inventory credit by TG United. The Company is required to make minimum monthly payments of $100,000 to TG United with respect to inventory purchases, subject to a quarterly reconciliation against amounts due. The $1.26 million inventory credit may be applied by MCR and AMBI against invoices issued by TG United at a rate of up to $100,000 per month, after any required minimum monthly cash payments are made. Approximately $1.025 million and $0.9 million of the inventory credit remained available to the Company as of December 31, 2008 and March 31, 2009, respectively.
Prior to the Company’s acquisition of MCR and AMBI, the Company generated limited revenue from operations. The Company expects that it will generate most of its revenue from the sale of its pharmaceutical products and limited operating revenue from the sale of natural Huperzine. If the sale of its pharmaceutical products is not sufficient to meet its working capital needs, the Company may need to raise capital through the sale of its securities or debt offerings. The Company also intends to expand its business operations in several respects, but it will need additional capital to pursue these opportunities. If the Company fails to generate sufficient cash flow or raise additional capital it may not have sufficient cash to pursue its business expansion plans and meet capital requirements during this period or in future periods.
Historically, the principal uses of the Company’s cash and cash equivalents have been conducting the Phase II clinical trials, developing alternative delivery technologies, improving on the synthetic processes, and continuing to fund pre-clinical compounds associated with the agreements with PARTEQ. The Company expects that the principal use of its cash and cash equivalents now, following its acquisition of MCR and AMBI, will be related to the sale of its pharmaceutical products to the cough and cold markets, and the expansion of its business. Although the Company has developed plans related to its operations, management continues to retain significant flexibility for the uses of Company funds. In addition to meeting its working capital needs, the Company may also use its cash and cash equivalents to acquire additional products, technologies or businesses.
During the year ended December 31, 2008 the Company used approximately $4.3 million in its operating activities. The cash used in operating activities consisted primarily of the following:
| · | Net loss of approximately $10.7 million, adjusted for share-based payments aggregating $5.3 million and the amortization of intangible assets acquired pursuant to the MCR and AMBI acquisition amounting to approximately $0.6 million; |
| · | An increase in accounts receivable of approximately $1.25 million which is primarily due to sales of products sold in late November and early December 2008 ; |
| · | A decrease in accounts payable of approximately $0.3 million; and |
| · | An increase in inventory of approximately $0.1 million |
During the year ended December 31, 2008, the net cash consideration paid for MCR and AMBI amounted to approximately $5 million.
During the year ended December 31, 2008, the Company issued 13,172,000 shares of its Common Stock in private placements of the Company’s securities, raising gross proceeds of $3,279,828.
The Company expects to incur additional expenses in 2009 payable to Georgetown of $80,000 related to the open label extension of the Phase II Clinical Trial and $60,000 payable to Dalhouise related to the preclinical licensing agreement.
The Company may also incur additional expenses in connection with its agreement with Numoda Corporation (“Numoda”). Following Numoda’s delivery of its analysis of the Phase II clinical trials, the Company paid Numoda $100,000.
To fund the implementation of its business plan, the Company has historically engaged in equity financing through existing investors and potential new investors. If the Company does not enter into a transaction that provides it additional liquidity, or the sales of its pharmaceutical products are not sufficient to provide it needed liquidity, it may engage in additional financing efforts. Additional funds may not be available or not available on acceptable terms, if at all. Given the anticipated cash expenditures, the potential cash requirements and the lack of sufficient cash to fully fund those expenses, the Company is continually analyzing alternative ways in which it can preserve its cash and cash equivalents. If the Company is unable to raise additional financing and is forced to take such measures, they may materially harm the Company’s prospects, financial condition and future operations.
Critical Accounting Policies
Our financial statements are prepared in accordance with accounting principles generally accepted in the United States of America. Preparing financial statements in accordance with generally accepted accounting principles requires management to make estimates and assumptions which affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the balance sheet dates, and the recognition of revenues and expenses for the reporting periods. These estimates and assumptions are affected by management’s application of accounting policies.
Revenue Recognition
Revenue is recognized when it is earned. The Company’s revenue recognition policies are in compliance with the Securities and Exchange Commission’s (“SEC”) Staff Accounting Bulletin (“SAB”) No. 104 “Revenue Recognition”. The Company recognizes revenues from the sale of pharmaceutical products, including shipping fees, if any, upon shipment, provided that a purchase order has been received or a contract has been executed, there are no uncertainties regarding customer acceptance, the sales price is fixed or determinable and collection is deemed probable. If uncertainties regarding customer acceptance exist, the Company recognizes revenue when those uncertainties are resolved and title has been transferred to the customer, which is generally upon delivery to the destination point.
Revenue from sales of the Company’s products are recorded, net of returns and other sales allowances. Other sales allowances include cash discounts, rebates, trade promotions, and sales incentives. According to the terms of a sales contract, and consistent with industry practices, a customer may return products up to a maximum amount and under certain conditions. Allowances are calculated based upon current economic conditions, the underlying contractual terms with both direct and indirect customers, the remaining time to expiration of the products and an evaluation of the levels of inventories held by the Company’s distributors. The excess of allowance for returns over the gross amount of receivables is recorded as accrued sales allowance.
Research and Development Costs
All research and development costs are expensed as incurred and include costs paid to sponsored third parties to perform research and conduct clinical trials.
Share-Based Compensation
Effective January 1, 2006, the Company adopted Statement of Financial Accounting Standards No. 123(R), (“SFAS No. 123(R)”), “Share-Based Payment,” which requires the Company to record as an expense in its financial statements the fair value of all stock-based compensation awards. The Company currently utilizes the Black-Scholes option pricing model to measure the fair value of stock options granted to employees using the “modified prospective” method. Under the “modified prospective” method, compensation cost is recognized in the financial statements beginning with the effective date, based on the requirements of SFAS No. 123(R) for all share-based payments granted after that date, and based on the requirements of SFAS No. 123(R) for all unvested awards granted prior to the effective date of SFAS No. 123(R).
Deferred Compensation
In accordance with EITF Abstract No. 96-18, “Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services,” the Company initially measures the fair value of any equity granted to consultants on the date of grant and subsequently remeasures such grants in accordance with promulgated accounting principles using the Black-Scholes pricing model. Amounts are initially recorded as Deferred Compensation in the Stockholders’ Equity section of the balance sheet and are subsequently charged to the appropriate expense over the period to which the service relates.
Item 8. | Financial Statements |
The Company’s Consolidated Financial Statements and the Report of the Independent Registered Public Accounting Firm appears at the end of this annual report and are incorporated herein by reference.
Item 9. | Changes in and Disagreements With Accountants on Accounting and Financial Disclosure |
None
Item 9A. | Controls and Procedures |
Evaluation of Disclosure Controls and Procedures
Based on management’s evaluation (with the participation of our Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”)), as of the end of the period covered by this report, the Company’s CEO and CFO have concluded that the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)), are effective to provide reasonable assurance that information required to be disclosed by the Company in reports that it files or submits under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and is accumulated and communicated to management, including the Company’s principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting
There were no changes to our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the period covered by this report that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
Management Report on Internal Control Over Financial Reporting
The Company’s management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) to provide reasonable assurance regarding the reliability of its financial reporting and the preparation of financial statements for external purposes in accordance with U.S. generally accepted accounting principles.
Management assessed the Company’s internal control over financial reporting as of December 31, 2008, the end of the Company’s fiscal year. Management based its assessment on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. Management’s assessment included evaluation of elements such as the design and operating effectiveness of key financial reporting controls, process documentation, accounting policies, and the Company’s overall control environment.
Based on the Company’s assessment, management has concluded that the Company’s internal control over financial reporting was effective as of the end of the fiscal year to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external reporting purposes in accordance with U.S. generally accepted accounting principles. The Company reviewed the results of management’s assessment with the Audit Committee of the Company’s Board of Directors.
This report does not include an attestation report of the Company’s registered public accounting firm regarding the Company’s internal controls over financial reporting. The disclosure contained under this Item 9A 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 the disclosure under this Item 9A in this Report.
Inherent Limitations on Effectiveness of Controls
The Company’s management, including its CEO and CFO, does not expect that the Company’s disclosure controls or its internal control over financial reporting will prevent or detect all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. The design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Further, because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Projections of any evaluation of controls effectiveness to future periods are subject to risks. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures.
Item 9B. | Other Information |
None.
PART III
Item 10. | Directors, Executive Officers and Corporate Governance |
The information required by this Item is hereby incorporated herein by reference to the Proxy Statement. The information under the heading “Executive Officers of the Registrant” in Part I, Item 1 of this Form 10-K is also incorporated by reference in this section.
Item 11. | Executive Compensation |
The information required by this Item is hereby incorporated herein by reference to the Proxy Statement.
Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters |
The information required by this Item is hereby incorporated herein by reference to the Proxy Statement.
Item 13. | Certain Relationships and Related Transactions, and Director Independence |
The information required by this Item is hereby incorporated herein by reference to the Proxy Statement.
Item 14. | Principal Accountant Fees and Services |
The information required by this Item is hereby incorporated herein by reference to the Proxy Statement.
PART IV
Exhibit | | | | Incorporated by Reference | | Filed |
Number | | Exhibit Description | | Form | | Exhibit | | Filing Date | | Herewith |
2.1 | | Agreement and Plan of Merger, dated January 17, 2006, between Northern Way Resources, Inc., a Nevada corporation and Northern Way Resources, Inc., a Delaware corporation | | 8-K | | 2.1 | | 1/23/06 | | |
| | | | | | | | | | |
2.2 | | Certificate of Ownership and Merger merging Northern Way Resources, Inc., a Nevada corporation into Northern Way Resources, Inc., a Delaware corporation | | 8-K | | 2.2 | | 1/23/06 | | |
| | | | | | | | | | |
2.3 | | Articles of Merger merging Northern Way Resources, Inc., a Nevada corporation into Northern Way Resources, Inc., a Delaware corporation | | 8-K | | 2.3 | | 1/23/06 | | |
| | | | | | | | | | |
2.4 | | Agreement of Merger and Plan of Reorganization, dated as of January 24, 2006, by and among Neurotech Pharmaceuticals, Inc., Marco Hi-Tech JV Ltd., and Marco Acquisition I, Inc. | | 8-K | | 2.1 | | 1/30/06 | | |
| | | | | | | | | | |
2.5 | | Agreement and Plan of Merger, dated as of November 16, 2006, by and among Neuro-Hitech, Inc., QA Acquisition Corp., QA Merger LLC, Q-RNA, Inc., and Dr. David Dantzker, as the Representative of the Q-RNA, Inc. security holders. | | 8-K | | 2.1 | | 12/5/06 | | |
| | | | | | | | | | |
2.6 | | Agreement and Plan of Merger, dated as of June 5, 2008, by and among Neuro-Hitech, Inc., GKI Acquisition Sub, Inc., GKI Acquisition Corporation and Timothy J. Ryan, Matthew Colpoys, Jr. and Philip J. Young. | | 8-K | | 2.1 | | 6/11/08 | | |
| | | | | | | | | | |
2.7 | | Amended and Restated Stock Purchase Agreement, dated as of June 6, 2008, by and among, Neuro-Hitech, Inc., GKI Acquisition Corporation, and David Ambrose. | | 8-K | | 2.2 | | 6/11/08 | | |
| | | | | | | | | | |
2.8 | | Modification Agreement and Release by and among the Company, TG United Pharmaceuticals, Inc. and David Ambrose | | 10-Q | | 2.1 | | 11/19/08 | | |
| | | | | | | | | | |
3.1 | | Certificate of Incorporation of Neurotech Pharmaceuticals, Inc. | | 8-K | | 3.1 | | 1/23/06 | | |
| | | | | | | | | | |
3.2 | | Certificate of Merger of Marco Acquisition I, Inc. with and into Marco Hi-Tech JV Ltd. | | 8-K | | 3.5 | | 1/30/06 | | |
3.3 | | Certificate of Merger of Marco Acquisition I, Inc. with and into Marco Hi-Tech JV Ltd. | | 8-K | | 3.6 | | 1/30/06 | | |
| | | | | | | | | | |
3.4 | | Certificate of Amendment of Certificate of Incorporation of Neurotech Pharmaceuticals, Inc., changing name to Neuro-Hitech Pharmaceuticals, Inc. | | 8-K | | 3.7 | | 1/30/06 | | |
| | | | | | | | | | |
3.5 | | Certificate of Ownership and Merger effective August 11, 2006 | | 8-K | | 3.1 | | 8/11/06 | | |
| | | | | | | | | | |
3.6 | | By-laws of the Company | | 8-K | | 3.2 | | 1/23/06 | | |
| | | | | | | | | | |
3.7 | | Certificate of Designation of Series A Preferred Stock | | 10-Q | | 3.1 | | 11/19/08 | | |
| | | | | | | | | | |
3.8 | | Certificate of Designation of Series B Preferred Stock | | 10-Q | | 3.2 | | 11/19/08 | | |
| | | | | | | | | | |
4.1 | | Form of Common Stock Purchase Warrant Certificate | | 8-K | | 4.1 | | 1/30/06 | | |
| | | | | | | | | | |
4.2 | | Form of Marco Hi-Tech JV Ltd. Registration Rights Agreement | | 8-K | | 10.4 | | 1/30/06 | | |
| | | | | | | | | | |
4.3 | | Registration Rights Agreement, dated as of November 29, 2006, by and among Neuro-Hitech, Inc. and David Dantzker as the Representative of the Q-RNA, Inc. security holders | | 8-K | | 4.1 | | 12/5/06 | | |
| | | | | | | | | | |
4.4 | | Registration Rights Agreement, dated as of November 29, 2006, by and among Neuro-Hitech, Inc. and individuals and entities that are parties to the Securities Purchase Agreement dated as of November 16, 2006 | | 8-K | | 4.2 | | 12/5/06 | | |
| | | | | | | | | | |
4.5 | | Form of $13 Warrant issued pursuant to the Merger. | | 8-K | | 4.3 | | 12/5/06 | | |
| | | | | | | | | | |
4.6 | | Form of $18 Warrant issued pursuant to the Merger. | | 8-K | | 4.4 | | 12/5/06 | | |
| | | | | | | | | | |
4.7 | | Form of Warrant issued in connection with private offering | | 8-K | | 4.5 | | 12/5/06 | | |
| | | | | | | | | | |
4.8 | | Stock and Warrant Purchase Agreement, dated as of November 29, 2007, by and among Neuro-Hitech, Inc. and the investors identified therein | | 8-K | | 4.1 | | 12/19/07 | | |
| | | | | | | | | | |
4.9 | | Registration Rights Agreement, dated as of November 29, 2007, by and among Neuro-Hitech, Inc. and the investors identified therein | | 8-K | | 4.2 | | 12/19/07 | | |
4.10 | | Form of Warrant issued in connection with private offering | | 8-K | | 4.3 | | 12/19/07 | | |
| | | | | | | | | | |
4.11 | | Registration Rights Agreement, dated as of November 18, 2008, by and between Neuro-Hitech, Inc. and David Ambrose | | 10-Q | | 4.1 | | 11/19/08 | | |
| | | | | | | | | | |
10.1 | | Neurotech Pharmaceuticals, Inc. 2006 Incentive Stock Plan | | 8-K | | 10.1 | | 1/30/06 | | |
| | | | | | | | | | |
10.2 | | Neurotech Pharmaceuticals, Inc. 2006 Non-Employee Directors Stock Option Plan | | 8-K | | 10.2 | | 1/30/06 | | |
| | | | | | | | | | |
10.3 | | Form of Private Placement Subscription Agreement | | 8-K | | 10.3 | | 1/30/06 | | |
| | | | | | | | | | |
10.4 | | Securities Purchase Agreement, dated January 5, 2006, by and between Marco Hi-Tech JV Ltd. and the investors signatory thereto | | 8-K | | 10.5 | | 1/30/06 | | |
| | | | | | | | | | |
10.5 | | Director and Officer Indemnification Agreement dated January 24, 2006, between Neurotech Pharmaceuticals, Inc. and Reuben Seltzer | | 8-K | | 10.6 | | 1/30/06 | | |
| | | | | | | | | | |
10.6 | | Director and Officer Indemnification Agreement dated January 24, 2006, between Neurotech Pharmaceuticals, Inc. and John Abernathy | | 8-K | | 10.8 | | 1/30/06 | | |
| | | | | | | | | | |
10.7 | | Director and Officer Indemnification Agreement dated January 24, 2006, between Neurotech Pharmaceuticals, Inc. and Mark Auerbach | | 8-K | | 10.9 | | 1/30/06 | | |
| | | | | | | | | | |
10.8 | | Technology License Contract, dated as of June 1, 1997, by and between Mayo Foundation for Medical Education and Research and Marco Hi-Tech JV Ltd. | | 8-K | | 10.12 | | 1/30/06 | | |
| | | | | | | | | | |
10.9 | | Clinical Research Agreement, dated March 1, 2002, by and between Georgetown University and Marco Hi-Tech JV Ltd. | | 8-K | | 10.13 | | 1/30/06 | | |
| | | | | | | | | | |
10.10 | | Offer Letter, dated January 6, 2006, to John Abernathy from Marco Hi-Tech JV Ltd. | | 8-K | | 10.14 | | 1/30/06 | | |
| | | | | | | | | | |
10.11 | | Offer Letter, dated January 5, 2006, to Mark Auerbach from Marco Hi-Tech JV Ltd. | | 8-K | | 10.15 | | 1/30/06 | | |
10.12 | | Development Agreement dated February 1, 2006, between the Company and Org Syn Laboratory, Inc | | 10-QSB | | 10.1 | | 5/15/06 | | |
| | | | | | | | | | |
10.13 | | Development Agreement dated March 15, 2006, between the Company and Xel Herbaceuticals, Inc | | 10-QSB | | 10.2 | | 5/15/06 | | |
| | | | | | | | | | |
10.14 | | Securities Purchase Agreement, dated as of November 16, 2006, by and among Neuro-Hitech, Inc. and the investors identified therein. | | 8-K | | 2.2 | | 12/5/06 | | |
| | | | | | | | | | |
10.15 | | Amendment No. 1 to 2006 Incentive Stock Plan | | 8-K | | 4.6 | | 12/5/06 | | |
| | | | | | | | | | |
10.16 | | Amendment No. 2 to 2006 Incentive Stock Plan | | 8-K | | 4.7 | | 12/5/06 | | |
| | | | | | | | | | |
10.17 | | Consultant Agreement, dated as of November 29, 2006, by and between Neuro-Hitech, Inc., and D.F. Weaver Medical, Inc., Donald F. Weaver, Principal Consultant. | | 8-K | | 10.1 | | 12/5/06 | | |
| | | | | | | | | | |
10.18 | | 2002 Q-RNA, Inc. Stock Incentive Plan | | S-8 | | 10.1 | | 12/13/06 | | |
| | | | | | | | | | |
10.19 | | 2006 Stock Incentive Plan | | DEF 14A | | | | 6/05/07 | | |
| | | | | | | | | | |
10.20 | | Non-Management Directors Deferral Program | | 10-QSB | | 10.2 | | 8/08/07 | | |
| | | | | | | | | | |
10.21 | | Officers Deferral Program | | 10-QSB | | 10.3 | | 8/08/07 | | |
| | | | | | | | | | |
10.22 | | Employment Agreement, dated August 22, 2007, between Neuro-Hitech, Inc. and Gary Shearman | | 8-K | | 10.1 | | 8/29/07 | | |
| | | | | | | | | | |
10.23 | | Employment Agreement, dated December 7, 2007, between Neuro-Hitech, Inc. and David Barrett | | 8-K | | 10.1 | | 12/11/07 | | |
| | | | | | | | | | |
10.24 | | Securities Purchase Agreement, dated as of June 6, 2008, by and among Neuro-Hitech, Inc. and each of the investors identified therein. | | 8-K | | 10.1 | | 6/11/08 | | |
| | | | | | | | | | |
10.25 | | Consulting Agreement, dated as of June 6, 2008, by and among Neuro-Hitech, Inc. and David Ambrose. | | 8-K | | 10.2 | | 6/11/08 | | |
| | | | | | | | | | |
10.26 | | Resignation Agreement and Mutual Release, dated as of June 5, 2008, by and among Neuro-Hitech, Inc. and Gary T. Shearman. | | 8-K | | 10.3 | | 6/11/08 | | |
10.27 | | Employment Agreement between NHI and Matthew E. Colpoys, dated June 6, 2008. | | 8-K | | 10.4 | | 6/11/08 | | |
| | | | | | | | | | |
10.28 | | Manufacturing and Distribution Agreement, effective June 6, 2008, between TG United Pharmaceuticals, Inc. and Neuro-Hitech, Inc.* | | 10-Q | | 10.5 | | 8/12/08 | | |
| | | | | | | | | | |
14.1 | | Code of Ethics | | 10-KSB | | 14.1 | | 3/31/06 | | |
| | | | | | | | | | |
16.1 | | Letter of MSPC, Certified Public Accountants and Advisors, a Professional Corporation, dated July 11, 2008, regarding change in independent registered public accounting firm. | | 8-K | | 16.1 | | 7/11/08 | | |
| | | | | | | | | | |
21.1 | | Subsidiaries | | | | | | | | X |
| | | | | | | | | | |
23.01 | | Consent of Independent Registered Public Accounting Firm – Sherb & Co., LLP | | | | | | | | X |
| | | | | | | | | | |
31.1 | | Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | | | | | | | | X |
| | | | | | | | | | |
31.2 | | Certification of the Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | | | | | | | | X |
| | | | | | | | | | |
32.1 | | Certification of the Chief Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C. 1350, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | | | | | | | | X |
* Confidential treatment requested for certain information.
NEURO-HITECH, INC. AND SUBSIDIARIES
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
| | Page |
Report of Independent Registered Public Accounting Firm | | F-1 |
| | |
Consolidated Balance Sheets as of December 31, 2008 and 2007 | | F-3 |
| | |
Consolidated Statements of Operations for the Years Ended December 31, 2008 and 2007 | | F-4 |
| | |
Consolidated Statements of Changes in Stockholders’ Equity for the Years Ended December 31, 2008 and 2007 | | F-5 |
| | |
Consolidated Statements of Cash Flows for the Years Ended December 31, 2008 and 2007 | | F-6 |
| | |
Notes to the Consolidated Financial Statements | | F-7 |
| 1900 NW Corporate Blvd., East Suite 210 Boca Raton, Florida 33431 Tel. 561-886-4200 Fax. 561-886-3330 e-mail:info@sherbcpa.com Offices in New York and Florida |
Certified Public Accountants
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Audit Committee
Neuro-Hitech, Inc.
Brooksville, Florida
We have audited the accompanying consolidated balance sheet of Neuro-Hitech, Inc. as of December 31, 2008 and the related consolidated statements of operations, changes in stockholders’ equity and cash flows for the year then ended. These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audit.
We conducted our audit 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 consolidated 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 audit 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 purposes 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 consolidated financial statements, 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 audit provides a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Neuro-Hitech, Inc. as of December 31, 2008, and the results of their operations and their cash flows for the year then ended in conformity with accounting principles generally accepted in the United States of America.
The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. The Company has experienced losses from operations in 2008 and 2007. These matters raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regards to these matters are discussed in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
| | /s/ Sherb & Co., LLP |
| | Certified Public Accountants |
March 24, 2009 | | |
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders
Neuro-Hitech, Inc.
New York, New York
We have audited the accompanying consolidated balance sheet of Neuro-Hitech, Inc. and Subsidiaries as of December 31, 2007 and the related consolidated statements of operations, changes in stockholders’ equity, and cash flows for the year ended December 31, 2007, of Neuro-Hitech, Inc. and subsidiaries. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audit.
We conducted our audit in accordance with 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. An audit 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 financial statement presentation. We believe that our audit provides 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 Neuro-Hitech, Inc. and subsidiaries as of December 31, 2007, and the consolidated results of their operations and their cash flows for the year ended December 31, 2007, in conformity with U.S. generally accepted accounting principles.
| /s/ MSPC |
| Certified Public Accountants and Advisors, |
| A Professional Corporation |
New York, New York
March 28, 2008
Neuro-Hitech, Inc. and Subsidiaries
Consolidated Balance Sheets
| | December 31, 2008 | | | December 31, 2007 | |
| | | | | | |
ASSETS: | | | | | | |
Current Assets: | | | | | | |
Cash and Cash Equivalents | | $ | 397,147 | | | $ | 6,137,592 | |
Accounts Receivable | | | 1,310,852 | | | | 63,300 | |
Inventory | | | 326,946 | | | | 33,821 | |
Prepaid Inventory | | | 1,025,059 | | | | | |
Prepaid Expenses | | | 38,054 | | | | 11,861 | |
Total Current Assets | | | 3,098,058 | | | | 6,246,574 | |
| | | | | | | | |
Property and Equipment, net | | | 9,472 | | | | 4,248 | |
| | | | | | | | |
Other Assets: | | | | | | | | |
Security Deposit | | | - | | | | 13,226 | |
Intangible Asset, net | | | 6,021,751 | | | | - | |
| | | | | | | | |
Total assets | | $ | 9,129,281 | | | $ | 6,264,048 | |
| | | | | | | | |
LIABILITIES AND STOCKHOLDERS' EQUITY: | | | | | | | | |
| | | | | | | | |
Current Liabilities: | | | | | | | | |
Accounts payable and accrued expenses | | $ | 830,588 | | | $ | 1,000,399 | |
Accrued Returns and Chargebacks | | | 408,307 | | | | | |
Total current liabilities | | | 1,238,895 | | | | 1,000,399 | |
| | | | | | | | |
| | | | | | | | |
Stockholders' Equity: | | | | | | | | |
Preferred stock, $.001 par value, 5,000,000 shares authorized: | | | | | | | | |
Series A Preferred Stock,1,500,000 issued and outstanding at December 31, 2008 | | | 1,500 | | | | - | |
Series B Preferred Stock,1,397,463 issued and outstanding at December 31, 2008 | | | 1,397 | | | | - | |
Common stock, $.001 par value, 44,999,990 shares authorized, 31,520,186 and 14,004,853 issued and outstanding at December 31, 2008 and December 31, 2007, respectively | | | 31,520 | | | | 14,005 | |
Subscriptions receivable | | | (15,000 | ) | | | - | |
Deferred Compensation | | | (15,936 | ) | | | (1,190,654 | ) |
Additional paid-in capital | | | 51,443,428 | | | | 39,270,951 | |
Accumulated deficit | | | (43,556,523 | ) | | | (32,830,653 | ) |
| | | | | | | | |
Total stockholders' equity | | | 7,890,386 | | | | 5,263,649 | |
| | | | | | | | |
Total liabilities and stockholders' equity | | $ | 9,129,281 | | | $ | 6,264,048 | |
The accompanying notes are an integral part of these consolidated financial statements
Neuro-Hitech, Inc. and Subsidiaries
Consolidated Statements of Operations
| | Years Ended December 31, | |
| | 2008 | | | 2007 | |
| | | | | | |
Sales | | $ | 4,129,612 | | | $ | 458,870 | |
Cost of Goods Sold | | | 1,827,160 | | | | 215,854 | |
Gross Profit | | | 2,302,452 | | | | 243,016 | |
| | | | | | | | |
Operating Expenses: | | | | | | | | |
Selling, General and Administrative Expenses | | | 5,788,983 | | | | 2,561,402 | |
Research and Development Costs | | | 1,549,879 | | | | 3,523,954 | |
Share-Based Compensation | | | 5,331,308 | | | | 2,427,904 | |
Amortization of Intangibles | | | 589,874 | | | | 242,447 | |
Registration Payment Arrangement | | | - | | | | 490,550 | |
Total Operating Expenses | | | 13,260,044 | | | | 9,246,257 | |
| | | | | | | | |
(Loss) from Operations | | | (10,957,592 | ) | | | (9,003,241 | ) |
| | | | | | | | |
Other Income: | | | | | | | | |
Forgiveness of Debt | | | 375,338 | | | | - | |
Interest and Dividend Income | | | 21,150 | | | | 206,804 | |
Interest Expense | | | (164,766 | ) | | | - | |
Total Other Income | | | 231,722 | | | | 206,804 | |
| | | | | | | | |
(Loss) Before Provision for IncomeTaxes | | | (10,725,870 | ) | | | (8,796,437 | ) |
| | | | | | | | |
Provision for Income Taxes | | | - | | | | - | |
| | | | | | | | |
Net (Loss) | | $ | (10,725,870 | ) | | $ | (8,796,437 | ) |
| | | | | | | | |
Basic and Diluted (Loss) per Weighted Average Common Shares Outstanding | | $ | (0.34 | ) | | $ | (0.71 | ) |
| | | | | | | | |
Weighted Average - Common Shares Outstanding | | | 31,520,186 | | | | 12,351,746 | |
The accompanying notes are an integral part of these consolidated financial statements
Neuro-Hitech, Inc. and Subsidiaries
Consolidated Statement of Changes in Stockholders' Equity
| | Class A - Common Stock | | | | | | Preffered Stock | | | Common Stock | | | Additional Paid- In Capital | | | Subscription Receivable | | | Deferred Compensation | | | Accumulated Deficit | | | | |
| | Shares | | | Amount | | | Class A | | | Class B | | | Shares | | | Amount | | | | | | | | | (Deficit) | | | (Deficit) | | | Totals | |
Balance as of December 31, 2006 | | | 100 | | | $ | - | | | | | | | | | | 11,855,135 | | | $ | 11,855 | | | $ | 28,891,967 | | | | | | $ | (1,178,147 | ) | | $ | (24,034,216 | ) | | $ | 3,691,459 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Private Placement of Common Stock, net of issuance costs of $376,548 | | | | | | | | | | | | | | | | | 2,016,930 | | | | 2,017 | | | | 7,000,440 | | | | | | | | | | | | | | | 7,002,457 | |
Repurchase of Class A Common Stock | | | (100 | ) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Exercise of Stock Options | | | | | | | | | | | | | | | | | 12,059 | | | | 12 | | | | 45,812 | | | | | | | | | | | | | | | 45,824 | |
Share-Based Compensation Expense | | | | | | | | | | | | | | | | | | | | | | | | | 2,427,904 | | | | | | | | | | | | | | | 2,427,904 | |
Recognition of Common Stock or Warrants in connection with services to be rendered | | | | | | | | | | | | | | | | | 20,000 | | | | 20 | | | | 375,934 | | | | | | | (254,954 | ) | | | | | | | 121,000 | |
Remeasurement of Common Stock or Warrants in connection with services rendered | | | | | | | | | | | | | | | | | | | | | | | | | 38,445 | | | | | | | | | | | | | | | 38,445 | |
Amortization of Deferred Compensation | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 242,447 | | | | | | | | 242,447 | |
Penalty shares issued in connection with Registration Rights Agreement | | | | | | | | | | | | | | | | | 100,729 | | | | 101 | | | | 490,449 | | | | | | | | | | | | | | | 490,550 | |
Net (Loss) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | (8,796,437 | ) | | | (8,796,437 | ) |
Balance as of December 31, 2007 | | | - | | | | - | | | | | | | | | | 14,004,853 | | | | 14,005 | | | | 39,270,951 | | | | | | | (1,190,654 | ) | | | (32,830,653 | ) | | | 5,263,649 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Private Placement of Common Stock | | | | | | | | | | | | | | | | | 13,172,000 | | | | 13,172 | | | | 3,279,828 | | | | (15,000 | ) | | | | | | | | | | | 3,278,000 | |
Share-Based Compensation, net of Deferred Compensation and Stock Grants | | | | | | | | | | | | | | | | | | | | | - | | | | 4,215,976 | | | | | | | | | | | | | | | | 4,215,976 | |
Common Stock & Warrants Issued in connection with mergers | | | | | | | | | | | | | | | | | 3,333,333 | | | | 3,333 | | | | 1,360,717 | | | | | | | | | | | | | | | | 1,364,050 | |
Preffered Shares Issued in connection with mergers | | | | | | | | | | | 1,500 | | | | 1,397 | | | | | | | | | | | | 2,894,566 | | | | | | | | | | | | | | | | 2,897,463 | |
Stock Grants Issued on June 26, 2008 | | | | | | | | | | | | | | | | | | | 1,010,000 | | | | 1,010 | | | | 421,390 | | | | | | | | | | | | | | | | 422,400 | |
Amortization of Deferred Compensation | | | | | | | | | | | | | | | | | | | | | | | | | | | - | | | | | | | | 1,174,718 | | | | | | | | 1,174,718 | |
Net (Loss) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | (10,725,870 | ) | | | (10,725,870 | ) |
Balance as of December 31, 2008 | | | - | | | | - | | | $ | 1,500 | | | $ | 1,397 | | | | 31,520,186 | | | $ | 31,520 | | | $ | 51,443,428 | | | $ | (15,000 | ) | | $ | (15,936 | ) | | $ | (43,556,523 | ) | | $ | 7,890,386 | |
Neuro-Hitech, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
| | For The Years Ended | |
| | December 31, | |
| | 2008 | | | 2007 | |
| | | | | | |
Cash flows used in operating activities: | | | | | | |
Net (Loss) | | $ | (10,725,870 | ) | | $ | (8,796,437 | ) |
| | | | | | | | |
Adjustments to Reconcile Net (Loss) to Net Cash (Used In) Operating Activities: | | | | | | | | |
Fair Value of Options, Warrants, and Stock Appreciation Rights | | | 4,215,976 | | | | 2,427,904 | |
Fair Value of Shares Issued for Service | | | 421,390 | | | | | |
Amortization of Deferred Compensation | | | 1,174,718 | | | | 242,447 | |
Amortization of Intangibles | | | 589,874 | | | | - | |
Gain on Sale of Net Assets | | | 2,765 | | | | - | |
Registration Payment Arrangement | | | - | | | | 490,550 | |
Depreciation Expense | | | 3,021 | | | | 2,998 | |
Other Share-Based Selling, General and Administrative Expenses | | | - | | | | 225,808 | |
| | | | | | | | |
Change in operating assets and liabilities: | | | | | | | | |
(Increase) Decrease in Assets: | | | | | | | | |
Accounts Receivable | | | (1,247,552 | ) | | | (37,500 | ) |
Inventory | | | (80,253 | ) | | | (2,530 | ) |
Prepaid Expenses | | | 206,465 | | | | (1,166 | ) |
Deferred Charges | | | - | | | | 93,750 | |
Security Deposits | | | 13,226 | | | | - | |
Increase (Decrease) in Liabilities: | | | | | | | | |
Accounts Payable and Accrued Expenses | | | (269,813 | ) | | | (261,707 | ) |
Deferred revenue | | | 1,393,805 | | | | - | |
Net cash (used in) Operating activities | | | (4,302,248 | ) | | | (5,615,883 | ) |
| | | | | | | | |
Cash flows from investing activities: | | | | | | | | |
Business Acquisition and Related Costs | | | | | | | | |
Investment in Property and Equipment | | | (11,000 | ) | | | - | |
Cash Used in Acquistion,net | | | (4,703,581 | ) | | | - | |
Net cash (used in) Investing activities | | | (4,714,581 | ) | | | - | |
| | | | | | | | |
Cash flows from financing activities: | | | | | | | | |
Net Proceeds from Private Placement Offering of Common Stock | | | 3,279,828 | | | | 7,002,456 | |
Net Payments to Related Party | | | (3,444 | ) | | | | |
Proceeds from the Sale of Stock | | | - | | | | 45,824 | |
Net cash provided by Financing activities | | | 3,276,384 | | | | 7,048,280 | |
| | | | | | | | |
Net (decrease) increase in cash and cash equivalents | | | (5,740,445 | ) | | | 1,432,397 | |
| | | - | | | | | |
Cash and cash equivalents, beginning of year | | | 6,137,592 | | | | 4,705,195 | |
| | | | | | | | |
Cash and cash equivalents, end of year | | $ | 397,147 | | | $ | 6,137,592 | |
| | | | | | | | |
Cash Paid For: | | | | | | | | |
Income Taxes | | $ | - | | | $ | - | |
Interest | | $ | - | | | $ | - | |
Supplemental Disclosure of Non-Cash Investing and Financing Activities:
During the twelve months ended December 31, 2008, options held by the Company's executive officers and board of directors vested as to 2,449,653 shares of the Company's common stock. The Company recognized an aggregate compensation cost of approximatly $4,216,000 for the vesting of the aforementioned options for the twelve months ended December 31, 2008.
During the third quarter of 2008, 960,000 shares of common stock were issued to directors and employees. The Company recognized an aggregate compensation cost of approximatly $422,000 for the aforemetioned shares
In connection with the Q-RNA merger, the Company entered into a consulting agreement and issued 500,000 non-qualified stock options valued at their grant date fair value as of the date of the merger closing. During 2008, the Company recognized approximately $1,178,000 of expense for the amortization of Deferred Compensation.
The Company entered into a service agreement and issued 100,000 warrants measured at fair value as of February 14, 2007, the date the service agreement was ratified by the Company's board of directors. During 2008, the Company ratably recognized approximately $128,000 of expenses for the amortization of Deferred Compensation in accordance with the service term.
In connection with the MCR merger, the Company determined the future value of purchased property and allocated a portion to an intangible asset. Approximately $590,000 amortization of purchased intanbile assets was expensed during 2008.
The accompanying notes are an integral part of these consolidated financial statements
NEURO-HITECH, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
[1] Nature of Operations
Neuro-Hitech, Inc. (the “Company” or “Neuro-Hitech”) is a specialty pharmaceutical company focused on developing, marketing and distributing branded and generic pharmaceutical products primarily in the cough and cold markets. The Company sells its products domestically through U.S. based distributors.
On June 6, 2008, the Company acquired the capital stock of MCR American Pharmaceuticals, Inc., a Florida corporation (“MCR”) and AMBI Pharmaceuticals, Inc., a Florida corporation (“AMBI”) pursuant to an Amended and Restated Stock Purchase Agreement (the “Purchase Agreement”), by and among the Company, GKI Acquisition Corporation, the Company’s wholly-owned subsidiary (“GKI”), and David Ambrose (“Seller”), the sole stockholder of MCR and AMBI.
Prior to June 6, 2008, the Company had been focused primarily on technologies that address investigational compounds that have the potential to show clinical improvements versus current treatments for Alzheimer’s disease, Epilepsy and other central nervous system applications. The Company’s most advanced product candidate targeting these needs is Huperzine A which completed a Phase II clinical trial in the U.S. earlier this year for efficacy and safety in the treatment of mild to moderate Alzheimer’s disease. In addition to Huperzine A, the Company has worked on two pre-clinical development programs: one for second generation anti-amyloid compounds or disease modifying drugs for Alzheimer’s disease and, secondly, development of a series of compounds targeted to treat and prevent Epilepsy.
In view of the results of the Phase II clinical trial, the cost associated with additional trials, and the acquisition of MCR and AMBI, the Company is principally focusing on the development, marketing and distribution of branded and generic pharmaceutical products targeted to the cough and cold markets. The Company continues to explore the potential development of collaborative, joint and strategic alliances and licensing arrangements with one or more pharmaceutical companies for the further development of Huperzine A and its pipeline of other compounds.
Liquidity
The accompanying consolidated financial statements have been prepared on a going-concern basis, which contemplates the continuation of operations, realization of assets, and liquidation of liabilities in the ordinary course of business. For the twelve-month period ended December 31, 2008 the Company generated a net loss of approximately $10 million. Until its acquisition of MCR and AMBI, the Company’s revenue was a result of the importation and sale of inventories of natural Huperzine to vitamin and supplement suppliers. The majority of the Company’s working capital requirements to date have been funded through the Company’s private placement of equity securities to founders and to institutional and individual investors. Management intends to fund future operations through the sale of its products as well as additional equity or debt offerings.
There can be no assurance that the Company will be successful in obtaining additional funds at the level needed for long-term operations or on terms acceptable to the Company. In addition, there can be no assurance, assuming the Company is successful in distributing its products, realizing revenues and obtaining new equity or debt offerings that the Company will achieve profitability or positive operating cash flow. The Company is incurring significant losses, which give rise to questions about its ability to continue as a going concern. The accompanying consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
[2] Summary of Significant Accounting Policies
Cash and Cash Equivalents
The Company considers all highly liquid temporary cash investments with an original maturity of three months or less when purchased, to be cash equivalents.
NEURO-HITECH, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
Intangible Assets
Intangible assets, net consists of the aquired customer relationships, vendor relationships and product formulations. The Company capitalizes and amortizes the cost of aquired intangible assets over their useful lives on a straight-line basis. The estimated useful lives of the Company’s intangible assets are 5 years.
Accounts receivable
Accounts receivable are recorded based on our revenue recognition policy. Our allowance for doubtful accounts
provides for specific doubtful receivables, as well as general counterparty credit risk evaluated using observable market information and internal assessments.
Largest Customers | | | |
| | 2008 | |
McKesson Corporation | | | 39 | % |
Cardinal Health, Inc. | | | 53 | % |
Concentration of Credit Risks
The Company is subject to concentrations of credit risk primarily from cash and cash equivalents and accounts receivable.
The Company’s cash and cash equivalents accounts are held at financial institutions and are insured by the Federal Deposit Insurance Corporation (“FDIC”) up to $100,000. During the twelve-month period ended December 31, 2008, the Company had bank balances exceeding the FDIC insurance limit. Effective October 3, 2008 through December 31, 2009, federally insured limits have been increased from $100,000 to $250,000 per account. While the Company periodically evaluates the credit quality of the financial institutions in which it has deposits, it cannot eliminate the risk associated with the sudden possible failure of such financial institutions.
Product Concentration
Most of the Company’s revenues were derived from the sale of its products in the United States to the following customers:
Largest Customers | |
| MCR | AMBI |
Cardinal Health, Inc. | 32% | 78% |
McKesson Corporation | 52% | * |
AmeriSourceBergen Corp. | 7% | * |
North Carolina Mutual | * | 8% |
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All inter-company balances and transactions have been eliminated.
Fair Value of Financial Instruments
The carrying value of cash and cash equivalents, accounts receivable, accounts payable and accrued expenses, approximate their fair value due to their short-term maturities.
NEURO-HITECH, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
Income Taxes
Income taxes are accounted for in accordance with SFAS No. 109, “Accounting for Income Taxes”. SFAS No. 109 requires the recognition of deferred tax assets and liabilities to reflect the future tax consequences of events that have been recognized in the Company’s financial statements or tax returns. Measurement of the deferred items is based on enacted tax laws. In the event the future consequences of differences between financial reporting bases and tax bases of the Company’s assets and liabilities result in a deferred tax asset, SFAS No. 109 requires an evaluation of the probability of being able to realize the future benefits indicated by such assets. A valuation allowance related to a deferred tax asset is recorded when it is more likely than not that some or all deferred tax assets will not be realized. Penalties and interest on underpayment of taxes are reflected in the Company’s effective tax rate.
Use of Estimates
The preparation of financial statements in accordance with accounting principles generally accepted in the United States requires management to make estimates and assumptions that 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 periods. Significant estimates made by management include, but are not limited to, the realization of receivables, the valuation of share-based payments, the impairment valuation of intangible assets, the allocation of the purchase price of the acquisition among various types of intangible assets and accrued sales allowance. Actual results will differ from these estimates.
Revenue Recognition
Revenue is recognized when it is earned. The Company’s revenue recognition policies are in compliance with the Securities and Exchange Commission’s (“SEC”) Staff Accounting Bulletin (“SAB”) No. 104 “Revenue Recognition”. The Company recognizes revenues from the sale of pharmaceutical products, including shipping fees, if any, upon shipment, provided that a purchase order has been received or a contract has been executed, there are no uncertainties regarding customer acceptance, the sales price is fixed or determinable and collection is deemed probable. If uncertainties regarding customer acceptance exist, the Company recognizes revenue when those uncertainties are resolved and title has been transferred to the customer, which is generally upon delivery to the destination point.
Revenue from sales of the Company’s products are recorded, net of returns and other sales allowances. Other sales allowances include cash discounts, rebates, trade promotions, and sales incentives. According to the terms of a sales contract, and consistent with industry practices, a customer may return products up to a maximum amount and under certain conditions. Allowances are calculated based upon current economic conditions, the underlying contractual terms with both direct and indirect customers, the remaining time to expiration of the products and an evaluation of the levels of inventories held by the Company’s distributors. The Company continually monitors its assumptions, giving considerations to pricing trends, seasonality of its product lines and estimated trade inventory levels and makes adjustments to these estimates when it believes that its actual sales returns and sales allowances in the future will differ from its estimate.
Inventories and Cost of Goods Sold
The Company maintains an inventory of pharmaceutical products and samples. Inventories are stated at the lower of cost or market. Cost has been determined using the first-in, first-out method. Sample costs are charged to cost of goods sold.
During the year end, the Company recognized cost of goods sold of $1,827,160 for products by MCR and AMBI. Substantially all of our cost of goods sold relate to the cost of the pharmaceutical products, fees paid to our contract manufacturers and samples provided to our sales representatives.
NEURO-HITECH, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
Basic and Diluted Earnings Per Share
Basic earnings per share are calculated by dividing income available to stockholders by the weighted-average number of common shares outstanding during each period. Diluted earnings per share are computed using the weighted average number of common shares and dilutive common share equivalents outstanding during the period. Dilutive common share equivalents consist of shares issuable upon the exercise of stock options and warrants (calculated using the modified-treasury stock method). The options and warrants outstanding at December 31, 2008 and 2007 have been excluded from the computation of diluted earnings per share due to their antidilutive effect.
Common share equivalent are as follows:
| | December 31, 2008 | | | December 31, 2007 | |
Options | | | 5,312,043 | | | | 2,775,319 | |
Warrants | | | 3,255,357 | | | | 3,255,357 | |
Preferred Stock (if converted) | | | 28,974,630 | | | | - | |
| | | 37,542,030 | | | | 6,030,676 | |
Share-Based Payments
In December 2004, the Financial Accounting Standards Board (“FASB”) issued SFAS No. 123(R), “Share-Based Payment,” which replaces SFAS No. 123 and supersedes APB Opinion No. 25. Under SFAS No. 123(R), companies are required to measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and recognize the costs in the financial statements over the period during which employees are required to provide services. Share-based compensation arrangements include stock options, restricted shares, performance-based awards, share appreciation rights and employee share purchase plans. In March 2005, the SEC issued SAB 107. SAB 107 expresses views of the staff regarding the interaction between SFAS No. 123(R) and certain SEC rules and regulations and provides the staff’s views regarding the valuation of share-based payment arrangements for public companies. SFAS No. 123(R) permits public companies to adopt its requirements using one of two methods. On April 14, 2005, the SEC adopted a new rule amending the compliance dates for SFAS 123(R). Companies may elect to apply this statement either prospectively, or on a modified version of retrospective application under which financial statements for prior periods are adjusted on a basis consistent with the pro forma disclosures required for those periods under SFAS 123. Effective January 1, 2006, the Company has fully adopted the provisions of SFAS No. 123(R) and related interpretations as provided by SAB 107 prospectively. As such, compensation cost is measured on the date of grant as its fair value. The Company currently utilizes the Black-Scholes option pricing model to measure the fair value of equity awards, including stock options and stock appreciation rights granted to employees using the “modified prospective” method. Such compensation amounts, if any, are amortized over the respective vesting periods of the option grant. The Company applies this statement prospectively.
Research and Development Costs
All research and development costs are expensed as incurred and include costs paid to sponsored third parties to perform research and conduct clinical trials.
Impairment of Long-Lived Assets
The Company reviews long-lived assets for impairment whenever circumstances and situations change such that there is an indication that the carrying amounts may not be recovered. In such circumstances, the Company will estimate the future cash flows expected to result from the use of the asset and its eventual disposition. Future cash flows are the future cash inflows expected to be generated by an asset less the future outflows expected to be necessary to obtain those inflows. If the sum of the expected future cash flows (undiscounted and without interest charges) is less than the carrying amount of the asset, the Company will recognize an impairment loss to adjust to the fair value of the asset.
NEURO-HITECH, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
Deferred Compensation
In accordance with EITF Abstract No. 96-18, “Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services,” the Company uses the Black-Scholes pricing model to value options granted in connection with services rendered, which are recorded as Deferred Compensation in the Stockholders’ Equity section of the balance sheet and are subsequently remeasured and charged to the appropriate expense for which the service relates.
[3] Property and Equipment
Property and equipment is stated at cost, net of accumulated depreciation. Depreciation is provided using the straight-line method over the estimated useful lives of the related assets. The estimated useful lives are 3 years.
| | December 31, 2008 | |
Office Equipment | | $ | 11,000 | |
Less: Accumulated depreciation | | | 1,528 | |
Net Office Equipment | | $ | 9,472 | |
[4] Operating Lease
The Company leases office and warehouse space at 16255 Aviation Loop Drive, Brooksville, FL 34604. Each of those leases is subject to a month-to-month lease.
[5] Business Combinations and Intangible Assets and Private Placement Offerings
On June 5, 2008, the Company acquired GKI pursuant to the Merger Agreement. The Merger Agreement provided for, among other things, the issuance of an aggregate of 1,700,000 shares of the Company’s common stock to three individuals, one of whom became our chief executive officer and another who became a director immediately following the merger. Pursuant to the Merger Agreement, the Company acquired rights to acquire MCR and AMBI. The shares issued to these three stockholders are subject to a lock-up agreement which restricts, for each of them, the sale of 25% of the issued shares until September 5, 2009, an additional 25% of the issued shares until February 5, 2010, an additional 25% of the issued shares until July 5, 2010 and the remaining 25% of the issued shares until December 5, 2010. Subsequently, one of the three stockholders has been released from the lock-up agreement.
On June 6, 2008, the Company acquired all of the capital stock of MCR and AMBI pursuant to the Purchase Agreement. The consideration paid to Seller pursuant to the Purchase Agreement consisted of: (i) $4,410,000 in cash, (ii) 1,333,333 shares of the Company’s common stock, (iii) a Convertible Note in the principal amount of $3,000,000 (the “Convertible Note”) and (iv) a Subordinated Note in the amount of $3,000,000 (the “Subordinated Note”). The shares issued to the Seller are subject to a lock-up agreement which restricts the Seller from selling the shares prior to June 6, 2009. Subsequently, this date was shortened to March 31, 2009.
Concurrent with the completion of the aforementioned transactions, the Company issued 300,000 shares of its common stock to an individual in lieu of payment for services rendered in connection with the transactions.
The acquisition of the operations of MCR and AMBI was accounted for pursuant to the Financial Accounting Standard (“FAS”) No. 141R, Business Combinations, which provides that the assets and liabilities acquired and the equity interest issued are initially recognized at the date of acquisition and measured at the fair value of the net assets acquired and consideration exchanged. Additionally, FAS No. 141R provides that the results of operations of the acquired entity after the effective date of acquisition be consolidated in the results of operations of the acquirer.
NEURO-HITECH, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
The total aggregate purchase price, including professional fees of $492,624 incurred in connection with the acquisition, amounts to $7,953,934. The aggregate purchase price consists of the following:
| | Pre-Modification | | | Adjustments | | | Post-Modification | |
Cash | | $ | 4,492,624 | | | | 400,000 | | | | 4,892,624 | |
Notes | | | 6,000,000 | | | | (6,000,000 | ) | | | - | |
Fair value of shares | | | 1,366,666 | | | | 2,897,463 | | | | 4,264,130 | |
Assumption of liabilities | | | 1,518,161 | | | | (2,403,660 | ) | | | (885,499 | ) |
| | $ | 13,377,451 | | | | (5,106,196 | ) | | | 8,271,255 | |
The purchase price has initially been allocated as follows:
| | Pre-Modification | | | Adjustments | | | Post-Modification | |
Cash | | $ | 189,042 | | | | - | | | | 189,042 | |
Inventory | | | 212,872 | | | | 1,257,717 | | | | 1,470,589 | |
Intangible assets | | | 12,975,537 | | | | (6,363,912 | ) | | | 6,611,625 | |
| | $ | 13,377,451 | | | | (5,106,196 | ) | | | 8,271,255 | |
The fair value of the shares issued pursuant to this transaction was based on the quoted closing price per share of the Company’s common stock on the acquisition date.
The intangible assets resulting from this transaction are primarily attributable to the customer contracts and related relationships, noncontractual customer relationships, royalty agreements, supply contracts, drug formulas, brand names, distribution networks, and governmental registrations.
During November 2008, the Company and the Seller and an affiliate of the Seller agreed to modify certain terms of the Purchase Agreement pursuant to a Modification Agreement and Release (“Modification Agreement”). Pursuant thereto the Company issued 1,500,000 shares of the Company’s Series A Preferred Stock and 1,397,463 shares of the Company’s Series B Preferred Stock (i) to satisfy its obligations under the Convertible Note and the Subordinated Note aggregating approximately $6.1 million, including interest, and accounts payable aggregating approximately $1 million and (ii) to receive products from an affiliate of Seller valued at up to $1,257,717. Each shares of the Series A and B Preferred Stock is convertible into 10 shares of the Company’s common stock. Additionally, the features of the Series A Preferred Stock include, among other things, a non-participating liquidation preference of $4,500,000. The fair value of the consideration issued to the Seller pursuant to the Modification Agreement amounted to approximately $2.8 million. The excess of the carrying value of the satisfied obligations and the right to receive future products from an affiliate of the Seller over the consideration issued to the Seller, which amounts to approximately $4.5 million will be recorded as a reduction of the intangible assets.
NEURO-HITECH, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
Had these acquisitions occurred on January 1, 2007, the results would be as follows:
| | For the Year Ended December 31, | | | For the Year Ended December 31, | |
| | 2008 | | | 2007 | |
| | | | | | |
Total Revenue | | $ | 8,084,170 | | | $ | 6,288,450 | |
| | | | | | | | |
Net [Loss] | | $ | (9,842,433 | ) | | $ | (9,308,275 | ) |
| | | | | | | | |
Basic & Diluted [Loss] Per Common Share | | $ | (0.31 | ) | | $ | (0.75 | ) |
Intangible Assets
Intangible assets consisted of the following:
| | Useful Life (Years) Weighted Average | | | At December 31, 2008 | | | At December 31, 2007 | |
MCR and AMBI Pharmaceuticals | | | 4.87 | | | $ | 6,611,625 | | | $ | 0 | |
| | | | | | | | | | | | |
| | | | | | $ | 6,611,625 | | | $ | 0 | |
Less: accumulated amortization | | | | | | $ | (589,874 | ) | | | | |
| | | | | | $ | 6,021,751 | | | $ | 0 | |
For the years ended December 31 2008 and 2007, amortization expense was $589,875 and $0 respectively.
Amortization expense subsequent to the period ended December 31, 2008 is as follows:
2009 | | $ | 1,322,325 | |
2010 | | $ | 1,322,325 | |
2011 | | $ | 1,322,325 | |
2012 | | $ | 1,322,325 | |
2013 | | $ | 732,451 | |
| | $ | 6,021,751 | |
Private Placement Offerings
During the twelve-month period ended December 31, 2008, the Company issued 13,172,000 shares of its common stock pursuant to two private placements, which generated proceeds of $3,278,000, net of subscription receivable of $15,000.
During the twelve-month period ended December 31, 2007, the Company issued 464,196 shares of its common stock and warrants to purchase 232,098 shares pursuant to a private placement, which generated gross proceeds of $2,220,805. The warrants issued in this private placement are exercisable at a price of $7 per share and expire on November 29, 2011.
Between January 2007 and March 2007, the Company received total gross proceeds of $2,379,005 from the private placement with accredited investors of an aggregate of 464,196 shares of the Company’s common stock and warrants to purchase 232,098 shares of the Company’s common stock. The common stock was sold in the offering at $5.125 per share and the exercise price of the warrants was $7.00 per share. The warrants expire on November 29, 2011.
NEURO-HITECH, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
In December 2007, the Company received total gross proceeds of $5,000,000 from the private placement with accredited investors receiving an aggregate of 1,250,000 shares of the Company’s common stock and warrants to purchase 625,000 shares of the Company’s common stock. The common stock was sold in the offering at $4.00 per share and the exercise price of the warrants was $7.00 per share. The warrants expire on December 14, 2012.
In connection with these private placement offerings, placement agent, legal, accounting, printing and other costs in the aggregate amount of $376,548 and $353,127, were charged to Additional Paid-In Capital in the year ended December 31, 2007 and December 31, 2006, respectively.
Registration Rights Payment Arrangement
During 2007, 100,729 shares of common stock were issued to investors that purchased common stock and warrants from the Company in the private offerings that the Company conducted in 2006 and 2007. The shares were issued in accordance with the provisions of a Registration Rights Agreement dated as of January 5, 2006 between the Company and the purchasers of securities in the 2006 Private Offering and a Registration Rights Agreement dated November 29, 2006 between the Company and the purchasers of securities in the 2007 Private Offering. The aforementioned registration rights agreements, required the Company to pay an amount equal to 1% payable in the Company’s common stock, up to a maximum 6%, of the aggregate dollar amount of securities purchased by such investors if the Company did not file a resale registration statement or have such registration statement declared effective by the dates set forth in each agreement. The shares of common stock issued to these investors had an aggregate value of approximately $491,000 and were expensed as a Registration Payment Arrangement which is reflected in the Selling, General and Administrative Expense caption of the 2007 Statement of Operations. The Company issued the maximum 6% of shares and is under no obligation to issue any additional shares pursuant to the terms of the registration rights agreements previously described.
Option Exercises
In addition to the aforementioned private placements, the Company received approximately $46,000 from the exercise of options to purchase 12,059 during 2007.
Class A Common Stock
On April 24, 2007, immediately prior to listing of the Company’s Common Stock on the NASDAQ Capital Market, the Chief Executive Officer and Executive Vice President of the Company surrendered all of the Class A Common Stock they owned. The shares were repurchased for $2 and as of December 31, 2007, no Class A Common Stock remains outstanding.
[6] Research and License Agreements
Georgetown University
In December 2003, the Company entered into a clinical research agreement, which was amended in November 2005 and October 2007, with Georgetown pursuant to which Georgetown provided the Company with Phase II research on Huperzine A. The costs associated with this agreement totaled $5,336,842 and were partially funded by the National Institutes of Health. The Company’s portion of the total cost was $4,036,842 payable in installments upon the achievement of certain milestones. For the years ended December 31, 2008 and 2007, the payments made or accrued by the Company to Georgetown under the terms of the clinical research agreement were approximately $785,305 and $1,183,167, respectively, and the total payments made by the Company to Georgetown since inception of the agreement were approximately $3,895,972. These costs are reflected in the Research and Development caption of the Statement of Operations. The Company expects to make an additional payments in 2009 to Georgetown in the amount of $80,000.
NEURO-HITECH, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
Xel Herbaceuticals, Inc.
On March 15, 2006, the Company entered into a development agreement with XEL for the development of the Huperzine A Transdermal Delivery System (“Product”). For the years ended December 31, 2008 and 2007, the payments made to XEL under this agreement were approximately $92,500 and $1,111,250, respectively, and are reflected in the Research and Development caption of the Statement of Operations. The Company does not expect to make any additional payments in 2009.
Dalhousie License Agreements (PARTEQ)
As part of the acquisition of Q-RNA, the Company assumed exclusive License Agreements with PARTEQ Research and Development Innovations (“PARTEQ”), the technology licensing arm of Queens University, Kingston, Ontario, Canada.
Under the terms of the Exclusive Patent License Agreement with PARTEQ which was amended in early 2007, the Company was obligated to pay fixed annual fees of C$282,944. Under the terms of the Exclusive Patent License Option Agreement with PARTEQ which was amended in early 2007, the Company was obligated to pay fixed annual fees of C$150,800. For the years ended December 31, 2008 and 2007, the payments made or accrued by the Company to PARTEQ under these agreements have been approximately $122,000 and $475,115, respectively, and are reflected in the Research and Development caption of the Statement of Operations. The Company expects to make additional payments in 2009 to PARTEQ in the amount of C$60,000.
Numoda Corporation
On March 3, 2008, the Company entered into an agreement with Numoda corporation (“Numoda”) pursuant to which Numoda reviewed the results of the Company’s recently completed Phase II clinical trial of Huperzine A. Following Numoda’s delivery of its analysis of the Phase II clinical trials, the Company paid Numoda $100,000.
The Company does not expect to incur any fixed annual research and development costs for the foreseeable future.
[7] Employee, Director and Third Party Stock-Based Compensation
As of December 31, 2008 the Company had two stock-based compensation plans, which are described below. Effective January 1, 2006, the Company adopted the fair value method of recording stock-based compensation in accordance with the modified prospective method of SFAS No. 123(R), “Share-Based Payment.”
The Company’s Incentive Plan provides for the issuance of options and other equity-based awards for the Company’s common stock. Shares issued upon exercise of equity-based awards are shares held in treasury that have been reserved for issuance under the plan. The Company’s Incentive Plan is administered by the Company’s board of directors, or a committee appointed by the Board, which determines recipients and types of awards to be granted, including the number of shares subject to the awards, the exercise price and the vesting schedule. Options generally have an exercise price equal to the fair market value of the Company’s common stock as of the grant date.
Non-Employee Directors Stock Option Plan
On January 24, 2006, Neuro-Hitech’s shareholders approved the Company’s 2006 Non-Employee Directors Stock Option Plan (the “Directors Plan”). Key features of this Plan include:
| · | Non-employee directors of the Company and its subsidiaries are eligible to participate in the Directors Plan. The term of the Directors Plan is ten years. 400,000 shares of common stock have been reserved for issuance under the Directors Plan. |
| · | Options may only be issued as non-qualified stock options. |
| · | Stockholder approval is required in order to replace or reprice options. |
NEURO-HITECH, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
| · | The Directors Plan is administered by a committee designated by the board. |
| · | Options shall be granted within ten years from the effective date. |
| · | Upon a “change in control” any unvested options shall vest and become immediately exercisable. |
The fair value used in calculating the stock option expense has been estimated using Black-Scholes pricing model which takes into account as of the grant date, the exercise price, expected life of the option, contractual term, current price of the underlying stock, expected volatility, expected dividends on the stock and the risk-free interest rate based on expected term of the option. The risk-free rate is estimated based on U.S. Treasury security rates for the applicable terms.
The following is the average of the data used for the aforementioned assumptions:
Year Ended December 31, | | Risk-Free Interest Rate | | Expected Term | | Expected Volatility | | Expected Dividends |
2008 | | | 3.20 | % | | | 5 | | 121.0 | % | None |
2007 | | | 3.45 | % | | | 5 | | 55.16 | % | None |
A summary of the stock option activity under the Company’s Non-Employee Directors Stock Option Plan during the year ended December 31, 2008 is presented below:
| | Options Outstanding as of 12/31/2008 | | | Options Exercisable | |
Exercise Price Range | | Number of Shares Outstanding | | | Remaining Contractual Life | | | Weighted Average Exercise PricePer Share | | | As of 12/31/2008 | | | Exercise Price Per Share | | | Aggregate Intrinsic Value | |
$0 to $2.50 per share | | | 350,000 | | | | 1.00 | | | $ | 2.50 | | | | 350,000 | | | $ | 2.50 | | | $ | 0 | |
| | Number of Options | | | Weighted Average Exercise Price Per Share | | | Aggregate Intrinsic Value | |
Outstanding at December 31, 2006 | | | 350,000 | | | | 2.50 | | | $ | 0 | |
Granted | | | - | | | | - | | | | - | |
Exercised | | | - | | | | - | | | | - | |
Expired | | | - | | | | - | | | | - | |
Outstanding at December 31, 2007 | | | 350,000 | | | | 2.50 | | | $ | - | |
Granted | | | - | | | | - | | | | - | |
Exercised | | | - | | | | - | | | | - | |
Expired | | | - | | | | - | | | | - | |
Outstanding at December 31, 2008 | | | 350,000 | | | $ | 2.50 | | | $ | 0 | |
Incentive Stock Plan
The Company’s 2006 Incentive Stock Plan was initially approved by the Company’s stockholders on January 24, 2006. Amendments to the 2006 Incentive Stock Plan (as amended, the “Incentive Plan”) were approved by the Company’s stockholders at a meeting of the Company’s stockholders on June 26, 2007. Key features of the Incentive Plan include:
NEURO-HITECH, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
| · | Company’s officers, directors, key employees and consultants of the Company and its subsidiaries are eligible to participate in the Incentive Plan. The term of the Incentive Plan is ten years. 4,575,000 shares of common stock are reserved for issuance under the Incentive Plan. |
| · | Both incentive and nonqualified stock options may be granted under the Incentive Plan, as well as Stock Appreciation Rights, Restricted Stock, Restricted Stock Units and Unrestricted Stock. |
| · | The Incentive Plan terminates on January 23, 2016. |
| · | The Incentive Plan is administered by a committee designated by the board. |
On June 24, 2008, Kevin Esval and Philip J. Young, were each granted a stock appreciation right to purchase 365,000 shares of the Company’s common stock, at an exercise price of $.44 per share. The fair value of the stock appreciation rights was approximately $127,000 and was calculated using the Black-Scholes option pricing model.
On June 24, 2008, the Company granted 1,010,000 shares of the Company’s common stock to 3 members of the Board and 1 employee in consideration of services for the year. The fair value of the stock grants was approximately $422,000 and was calculated using the Black-Scholes option pricing model.
During 2008, compensation costs on vested awards totaled approximately $4,089,000, and are reflected in Share-Based Compensation caption of the Statement of Operations. Total compensation cost related to non-vested awards not yet recognized is approximately $1,127,000 and the weighted period of recognition is approximately 1.4 years.
In connection with the Q-RNA merger, the Company entered into a consulting agreement with Dr. Donald Weaver and issued 500,000 non-qualified stock options valued at their grant date fair value as of the date of the merger closing. The total fair value of these options approximated $1,309,000 and was recognized as Deferred Compensation in the Stockholders' Equity section of the Balance Sheet. During 2008, the Company parted ways with Dr. Weaver and recognized approximately $1,175,000 of expense for the amortization of Deferred Compensation.
| | Options Outstanding as of 12/31/2008 | | | Options Exercisable | |
Exercise Price Range | | Number of Shares Under Option | | | Contractual Life | | | Weighted Average Exercise Price Per Share | | | As of 12/31/2007 | | | Exercise Price Per Share | | | Aggregate Intrinsic Value | |
$0 to $2.50 per share | | | 585,000 | | | | 8.06 | | | $ | 1.21 | | | | 280,833 | | | $ | 2.05 | | | $ | 0 | |
$2.51 to $4.25 per share | | | 51,940 | | | | 8.95 | | | $ | 4.05 | | | | 35,967 | | | $ | 4.12 | | | | - | |
$4.26 to $6.25 per share | | | 325,104 | | | | 6.02 | | | $ | 5.97 | | | | 289,680 | | | $ | 5.96 | | | | - | |
| | | 962,043 | | | | | | | | | | | | 606,480 | | | | | | | | 0 | |
NEURO-HITECH, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
| | Number of Options | | Weighted Average Exercise Price Per Share | | Aggregate Intrinsic Value |
Outstanding at December 31, 2006 | | 1,240,000 | | $ | 5.07 | | |
Granted | | 1,185,319 | | $ | 5.46 | | |
Exercised | | - | | | - | | |
Expired | | - | | | - | | |
Outstanding at December 31, 2007 | | 2,425,319 | | $ | 5.26 | | - |
Granted | | 365,000 | | $ | .44 | | - |
Exercised | | - | | | - | | - |
Expired | | 1,828,276 | | | 5.50 | | - |
Outstanding at December 31, 2008 | | 962,043 | | $ | 2.98 | | - |
Non-Plan Grants
As part of the acquisition of MCR and AMBI, the Company granted the following options:
| | Options Outstanding as of 12/31/2008 | | Options Exercisable |
Exercise Price Range | | Number of Option | | Remaining Contractual Life | | Weighted Average Exercise PricePer Share | | As of 12/31/2008 | | Exercise Price Per Share | | Aggregate Intrinsic Value |
$0 to $2.00 per share | | | 4,000,000 | | 9.50 | | | 2.00 | | 1,583,333 | | | 2.00 | | 0 |
| | | 4,000,000 | | | | | 2.00 | | 1,583,333 | | | 2.00 | | |
Warrants to Non-Employees
There were no warrants issued in 2008.
| | Options Outstanding as of 12/31/2008 | | | Options Exercisable | |
| | Number of | | | | | | Weighted Average | | | | | | | |
| | Shares Under | | | Remaining | | | Exercise Price | | | As of | | | Exercise Price | |
Exercise Price Range | | Option | | | Contractual Life | | | Per Share | | | 12/31/2007 | | | Per Share | |
$0.00 to $2.50 per share | | | 100,000 | | | | 1.00 | | | $ | 2.50 | | | | 100,000 | | | $ | 2.50 | |
$2.51 to $5.00 per share | | | 437,500 | | | | 2.10 | | | $ | 5.00 | | | | 437,500 | | | $ | 5.00 | |
$5.01 to $7.00 per share | | | 1,517,145 | | | | 3.35 | | | $ | 7.05 | | | | 1,517,145 | | | $ | 7.05 | |
*$7.01 to $13.00 per share | | | 600,356 | | | | 7.92 | | | $ | 13.00 | | | | 600,356 | | | $ | 13.00 | |
*$13.01 to $18.00 per share | | | 600,356 | | | | 7.92 | | | $ | 18.00 | | | | 600,356 | | | $ | 18.00 | |
| | | 3,255,357 | | | | | | | | | | | | 3,255,357 | | | | | |
| | Year Ended December 31, 2007 | |
| | | | | Weighted | |
| | Number of | | | Average Exercise | |
| | Warrants | | | Price Per Share | |
Beginning of year | | | 3,255,357 | | | $ | 9.75 | |
Granted | | | 0 | | | $ | 0 | |
Exercised | | | - | | | | - | |
Expired | | | 0 | | | $ | 0 | |
Outstanding at end of year | | | 3,255,357 | | | $ | 9.75 | |
NEURO-HITECH, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
*On November 29, 2006, the Company completed an acquisition by merger of Q-RNA, Inc. a privately held New York-based biotechnology company. In connection with the acquisition, the Company issued (i) 1,800,000 shares of the Company’s common stock, (ii) warrants to purchase 600,356 shares of the Company’s common stock at an exercise price of $13 per share, and (iii) warrants to purchase 600,356 shares of the Company’s common stock at an exercise price of $18 per share.
[8] Related Party Transaction
In November 2008, pursuant to the terms of the Modification Agreement, the Company issued 1,500,000 shares of the Company’s Series A Preferred Stock and 1,397,463 shares of the Company’s Series B Preferred Stock to the Seller (i) to satisfy its obligations under the Convertible Note and the Subordinated Note aggregating approximately $6.1 million, including interest, and accounts payable aggregating approximately $1 million and (ii) to receive products from an affiliate of Seller valued at up to $1,257,717. Each share of the Series A and B Preferred Stock is convertible into 10 shares of the Company’s common stock. Additionally, the features of the Series A Preferred Stock include, among other things, a non-participating liquidation preference of $4,500,000. The fair value of the consideration issued to the Seller pursuant to the Modification Agreement amounted to approximately $2.8 million. The excess of the carrying value of the satisfied obligations and the right to receive future products from an affiliate of the Seller over the consideration issued to the Seller, which amounts to approximately $4.5 million will be recorded as a reduction of the intangible assets.
Since June 6, 2008, the Company has been a party to a Manufacturing and Distribution Agreement with TG United Pharmaceuticals, Inc. (“TG United”), a corporation wholly-owned by the Company’s CEO. Since the execution of that agreement, the Company has been completely dependent upon TG United as the sole supplier of the Company’s products.
The Company leases office and warehouse space at 16255 Aviation Loop Drive, Brooksville, FL 34604 from TG United. Each of those leases is subject to a month-to-month lease.
[9] Income Taxes
For 2008 and 2007, the Company had no current or deferred income tax provision. Deferred taxes are based upon differences between the financial statement and tax basis of assets and liabilities and available net operating loss carryforwards summarized as follows:
| | December 31, | |
| | 2008 | | | 2007 | |
Deferred Tax Asset - Non-Current: | | | | | | |
Net Operating Loss Carryforwards | | $ | 1,246,000 | | | $ | 3,613,600 | |
Valuation Allowance | | | (1,246,000 | ) | | | (3,613,600 | ) |
| | $ | - | | | $ | - | |
A full valuation allowance has been established due to the uncertainty about the realization of the deferred tax asset. The net change during 2008 and 2007 in the total valuation allowance was approximately ($2,367,000) and $1,138,000, respectively.
As of December 31, 2008, the Company’s cumulative net operating losses are subject to an annual limitation pursuant to IRC Section 382 whereby the maximum amount of taxable income in any give year that can be offset by net operating losses is approximately $155,700. Such amount can be utilized in tax years 2009 through 2028. The total of such carryforwards available is $3,114,000 at December 31, 2008.
The following table reconciles the Company’s expected tax rate to its effective income tax rate (actual):
NEURO-HITECH, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
For the Years Ended December 31, | | 2008 | | | 2007 | |
Federal statutory tax rate | | | -35.0 | % | | | -35.0 | % |
Changes to valuation allowance | | | 12.0 | % | | | 12.9 | % |
Effective state tax rate, net of federal benefits | | | 5.0 | % | | | 0.1 | % |
Permanent differences | | | 18.0 | % | | | 22.0 | % |
Effective Income tax rate | | | 0.00 | % | | | 0.00 | % |
[10] Supply Concentrations
On June 6, 2008, the Company entered into a Manufacturing and Distribution Agreement with TG United. Since the execution of that agreement, the Company has been completely dependent upon TG United as the sole supplier of the Company’s products.
[11] Recent Accounting Pronouncements
In February 2007, the Financial Accounting Standards Board (FASB) issued SFAS No. 159, “The Fair Value Option for Financial Assets and Financial Liabilities - Including an Amendment of FASB Statement No. 115”. This statement permits entities to choose to measure many financial instruments and certain other items at fair value. Most of the provisions of SFAS No. 159 apply only to entities that elect the fair value option. However, the amendment to SFAS No. 115 “Accounting for Certain Investments in Debt and Equity Securities” applies to all entities with available-for-sale and trading securities. SFAS No. 159 is effective as of the beginning of an entity’s first fiscal year that begins after November 15, 2007. Early adoption is permitted as of the beginning of a fiscal year that begins on or before November 15, 2007, provided the entity also elects to apply the provision of SFAS No. 157, “Fair Value Measurements”. The adoption of this statement is not expected to have a material effect on the Company’s financial statements.
In December 2007, the Financial Accounting Standards Board (FASB) issued SFAS No. 141 (revised 2007), "Business Combinations" (SFAS 141(R)), which replaces SFAS No. 141, "Business Combinations." SFAS 141(R) retains the underlying concepts of SFAS 141 in that all business combinations are still required to be accounted for at fair value under the acquisition method of accounting but SFAS 141(R) changed the method of applying the acquisition method in a number of significant aspects. Acquisition costs will generally be expensed as incurred; noncontrolling interests will be valued at fair value at the acquisition date; in-process research and development will be recorded at fair value as an indefinite-lived intangible asset at the acquisition date; restructuring costs associated with a business combination will generally be expensed subsequent to the acquisition date; and changes in deferred tax asset valuation allowances and income tax uncertainties after the acquisition date generally will affect income tax expense. SFAS 141(R) is effective on a prospective basis for all business combinations for which the acquisition date is on or after the beginning of the first annual period subsequent to December 15, 2008, with the exception of the accounting for valuation allowances on deferred taxes and acquired tax contingencies. SFAS 141(R) amends SFAS 109 such that adjustments made to valuation allowances on deferred taxes and acquired tax contingencies associated with acquisitions that closed prior to the effective date of SFAS 141(R) would also apply the provisions of SFAS 141(R). Early adoption is not permitted. We are currently evaluating the effects, if any, that SFAS 141(R) may have on our financial statements and believe it could have a significant impact if business combinations are consummated. However, the effect is indeterminable as of December 31, 2007.
In December 2007, the Financial Accounting Standards Board (FASB) issued Financial Accounting Standards No. 160, "Noncontrolling Interests in Consolidated Financial Statements—an amendment of ARB No. 51." This statement is effective for fiscal years, and interim periods within those fiscal years, beginning on or after December 15, 2008, with earlier adoption prohibited. This statement requires the recognition of a noncontrolling interest (minority interest) as equity in the consolidated financial statements and separate from the parent's equity. The amount of net income attributable to the noncontrolling interest will be included in consolidated net income on the face of the income statement. It also amends certain of ARB No. 51's consolidation procedures for consistency with the requirements of SFAS 141(R). This statement also includes expanded disclosure requirements regarding the interests of the parent and its noncontrolling interest. We are currently evaluating this new statement and anticipate that the statement will not have a significant impact on the reporting of our results of operations.
NEURO-HITECH, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
In March 2008, the Financial Accounting Standards Board (FASB) issued FASB Statement No. 161, Disclosures about Derivative Instruments and Hedging Activities. The new standard is intended to improve financial reporting about derivative instruments and hedging activities by requiring enhanced disclosures to enable investors to better understand their effects on an entity’s financial position, financial performance, and cash flows. It is effective for financial statements issued for fiscal years and interim periods beginning after November 15, 2008, with early application encouraged. The Company is currently evaluating the impact of adopting SFAS. No. 161 on its financial statements.SIGNATURES
In accordance with Section 13 or 15(d) of the Exchange Act, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized..
| | NEURO-HITECH, INC. (Registrant) |
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Date: March 30, 2009 | | |
| | /s/ David J. Barrett |
| | David J. Barrett Chief Financial Officer and Principal Accounting Officer |
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.
SIGNATURE | | TITLE | | DATE |
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/s/ David Ambrose | | President, Chief Executive Officer, | | March 30, 2009 |
David Ambrose | | Principal Executive Officer and Director | | |
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/s/ David J. Barrett | | Chief Financial Officer and | | March 30, 2009 |
David Barrett | | Principal Accounting Officer | | |
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/s/ John Abernathy | | Director | | March 30, 2009 |
John Abernathy | | | | |
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/s/ Mark Auerbach | | Director | | March 30, 2009 |
Mark Auerbach | | | | |
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/s/ David Dantzker | | Director | | March 30, 2009 |
David Dantzker | | | | |
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/s/ Gary Dutton | | Director | | March 30, 2009 |
Gary Dutton | | | | |
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/s/ Kevin Esval | | Director | | March 30, 2009 |
Kevin Esval | | | | |
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| | Director | | March __, 2009 |
Reuben Seltzer | | | | |