1203944--10/30/2008--RAPTOR_PHARMACEUTICALS

related topics

{product, candidate, development}

{stock, price, share}

{product, liability, claim}

{property, intellectual, protect}

{personnel, key, retain}

{acquisition, growth, future}

{provision, law, control}

{interest, director, officer}

{regulation, change, law}

{operation, natural, condition}

{capital, credit, financial}

Even if we are able to develop our drug product candidates, we may not be able to receive regulatory approval, or if approved, we may not be able to generate significant revenues or successfully commercialize our products, which would adversely affect our financial results and financial condition and we would have to delay or terminate some or all of our research product development programs. If we are limited in our ability to utilize acquired or licensed technologies, we may be unable to develop, out-license, market and sell our product candidates, which could cause delayed new product introductions, and/or adversely affect our reputation, any of which could have a material adverse effect on our business, prospects, financial condition, and operating results. If the purchase or licensing agreements we entered into are terminated, we will lose the right to use or exploit our owned and licensed technologies, in which case we will have to delay or terminate some or all of our research and development programs, our financial condition and operating results will be adversely affected and we may have to cease our operations. If we fail to compete successfully with respect to acquisitions, joint venture and other collaboration opportunities, we may be limited in our ability to develop our drug product candidates. If we do not achieve our projected development goals in the time frames we announce and expect, the credibility of our management and our technology may be adversely affected and, as a result, our financial condition may suffer. Our product development programs will require substantial additional future funding which could impact our operational and financial condition. If we fail to demonstrate efficacy in our preclinical studies and clinical trials our future business prospects, financial condition and operating results will be materially adversely affected. If we do not obtain the support of new, and maintain the support of existing, key scientific collaborators, it may be difficult to establish products using our technologies as a standard of care for various indications, which may limit our revenue growth and profitability and could have a material adverse effect on our business, prospects, financial condition and operating results. If we fail to obtain or maintain orphan drug exclusivity for some of our drug product candidates, our competitors may sell products to treat the same conditions and our revenues will be reduced. The fast-track designation for our drug product candidates, if obtained, may not actually lead to a faster review process and a delay in the review process or in the approval of our products will delay revenue from the sale of the products and will increase the capital necessary to fund these product development programs. Because the target patient populations for some of our products are small, we must achieve significant market share and obtain high per-patient prices for our products to achieve profitability. We may not be able to market or generate sales of our products to the extent anticipated. There are many difficult challenges associated with developing proteins that can be used to transport therapeutics across the blood-brain barrier. If our competitors succeed in developing products and technologies that are more effective than our own, or if scientific developments change our understanding of the potential scope and utility of our drug product candidates, then our technologies and future drug product candidates may be rendered less competitive. Our reliance on third parties, such as university laboratories, contract manufacturing organizations and contract or clinical research organizations, may result in delays in completing, or a failure to complete, preclinical testing or clinical trials if they fail to perform under our agreements with them. The use of any of our drug product candidates in clinical trials may expose us to liability claims. If we are unable to protect our proprietary technology, we may not be able to compete as effectively. The patent positions of biopharmaceutical products are complex and uncertain. The current disruptions in the financial markets could affect our ability to obtain debt financing on favorable terms (or at all). Our future success depends, in part, on the continued service of our management team. Our success depends on our ability to manage our growth. Our executive offices and laboratory facility is located near known earthquake fault zones, and the occurrence of an earthquake or other catastrophic disaster could cause damage to our facility and equipment, or that of our third-party manufacturers or single-source suppliers, which could materially impair our ability to continue our product development programs. We will incur increased costs as a result of recently enacted and proposed changes in laws and regulations. RISKS RELATED TO OUR COMMON STOCK We are obligated to issue additional common stock based on our contractual obligations, if we meet certain triggering events, if at all. When we issue such additional common stock, this will result in dilution to common stockholders at the time such additional common stock is issued. There is no active trading market for our common stock and if a market for our common stock does not develop, our investors will be unable to sell their shares. Because we do not intend to pay any cash dividends on our common stock, investors seeking dividend income or liquidity should not purchase shares of our common stock. Our stock is a penny stock. Trading of our stock may be restricted by the SEC s penny stock regulations and the FINRA s sales practice requirements, which may limit a stockholder s ability to buy and sell our stock. Our stock price may be volatile, and an investment in our stock could suffer a decline in value. Anti-takeover provisions under Delaware law may make an acquisition of us, which may be beneficial to our stockholders, more difficult. You are advised to read carefully the section titled Risk Factors beginning on page 19 of this Annual Report.

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1203944--10/30/2008--RAPTOR_PHARMACEUTICALS_CORP.