357097--3/14/2006--ISOLAGEN

related topics

{product, candidate, development}

{product, liability, claim}

{stock, price, share}

{product, market, service}

{acquisition, growth, future}

{property, intellectual, protect}

{operation, international, foreign}

{personnel, key, retain}

{control, financial, internal}

{stock, price, operating}

{regulation, change, law}

{cost, operation, labor}

{financial, litigation, operation}

{interest, director, officer}

{provision, law, control}

{operation, natural, condition}

{debt, indebtedness, cash}

{cost, regulation, environmental}

We may be unable to successfully commercialize our Isolagen Process or any of our product candidates currently under development. We have not generated significant revenue from commercial sales of our products to date, and we do not know whether we will ever generate significant revenue. Obtaining FDA and other regulatory approvals is complex, time consuming and expensive, and the outcomes are uncertain. Our ability to effectively commercialize our dermal product and our product candidates depends on our ability to improve our manufacturing process and to satisfactorily validate the cellular expansion and harvesting process. Our inability to comply with regulatory requirements in the United Kingdom will limit or delay our ability to attain profitability. Our dermal product and our product candidates are all derived from our Isolagen Process. If our Isolagen Process is found to be unsafe or ineffective, our business would be materially harmed. Our ability to expand our operations to support the full-scale commercialization of our Isolagen Process is dependent on our ability to establish new manufacturing facilities. Our recent issuance of notes or of other indebtedness in the future may impact our financial condition and results of operations. We may need to raise substantial additional capital to fund our operations in the future, and we do not have any future commitments for capital. As a result of our limited operating history, we may not be able to correctly estimate our future operating expenses, which could lead to cash shortfalls. Clinical trials may fail to demonstrate the safety and efficacy of our product candidates, which could prevent or significantly delay regulatory approval. Our operating results may fluctuate significantly in the future, which may cause our results to fall below the expectations of securities analysts, stockholders and investors. Losses may continue to increase from current levels and we will continue to experience negative cash flow as we expand our operations, which may limit or delay our ability to become profitable. We are party to securities and derivative litigation that distracts our management, is expensive to conduct and seeks a damage award against us. Our failure to comply with extensive governmental regulation may significantly affect our operating results. Legislative or regulatory reform of the healthcare system may affect our ability to sell our future products profitably. We conduct business in foreign markets, and we are subject to a variety of regulations in those foreign markets that could have a material adverse effect on our business in a particular market or in general. Our foreign operations are exposed to risks associated with exchange rate fluctuations, trade restrictions and political, economic and social instability. Any future products that we develop may not be commercially successful. Our competitors in the pharmaceutical, medical device and biotechnology industries may have superior products, manufacturing capabilities, financial resources or marketing position. Difficulties managing growth could adversely affect our business, operating results and financial condition. We are dependent on our key scientific and other management personnel, and the loss of any of these individuals could harm our business. We will need to attract, train and retain additional highly qualified senior executives and technical and managerial personnel in the future. If we are unable to effectively promote our brand and establish a leading position in the marketplace, our business may fail. Our ability to achieve commercial success will depend in part on obtaining and maintaining patent protection and trade secret protection of our technology and future products, as well as successfully defending these patents against third party challenges. If we are unable to obtain and maintain protection for our intellectual property and proprietary technology, the value of our technology and future products will be adversely affected, and we will not be able to protect our technology from unauthorized use by third parties. We have obtained some of our rights from third parties. If our agreements with these parties do not appear as we anticipate our business may be adversely affected. Our business may be harmed, and we may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights. We may not be successful in our efforts to develop commercial-scale manufacturing technology and methods. We may be liable for product liability claims not covered by insurance. If we are unable to keep up with rapid technological changes, our future products may become obsolete or unmarketable. Our acquisitions of companies or technologies may result in disruptions in business and diversion of management attention. Our business, which depends on a small number of facilities, is vulnerable to natural disasters, telecommunication and information systems failures, terrorism and similar problems, and we are not fully insured for losses caused by all of these incidents. Our stock price has been volatile and could experience substantial declines. We have not declared any dividends on our common stock to date, and we have no intention of declaring dividends in the foreseeable future. Provisions in our charter documents could prevent or delay stockholders attempts to replace or remove current management. Provisions in our bylaws provide for indemnification of officers and directors, which could require us to direct funds away from our business and future products. Future sales of our common stock may depress our stock price. There is a limited public trading market for our common stock. As a public company, our business is subject to numerous reporting requirements that are currently and continuously evolving and could substantially increase our operating expenses and divert management s attention from the operation of our business. Lack of effectiveness of internal controls over financial reporting could adversely affect the value of our securities.

Full 10-K form ▸

357097--3/14/2006--ISOLAGEN_INC