730272--6/10/2010--REPLIGEN

related topics

{product, candidate, development}

{property, intellectual, protect}

{customer, product, revenue}

{control, financial, internal}

{personnel, key, retain}

{provision, law, control}

{regulation, government, change}

{stock, price, operating}

{product, market, service}

We are dependent on others to develop, conduct clinical trials for, manufacture, market and sell our principal products. We depend on, and expect to continue to depend on, a limited number of customers for a high percentage of our revenues. Royalty revenue from Bristol-Myers Squibb Company for sales of Orencia could fail to materialize. Our research activities may not identify a clinical candidate with appropriate efficacy, safety and pharmacology to support clinical trials in humans. Our clinical trials may not be successful and we may not be able to develop and commercialize related products. We may not obtain regulatory approvals; the approval process is costly and lengthy. Even if we obtain marketing approval, our therapeutic products will be subject to ongoing regulatory review, which may be expensive and may affect our ability to successfully commercialize our products. If we are unable to obtain, maintain and enforce patents or regulatory exclusivity (orphan drug or new chemical entity exclusivity) for our products, we may not be able to succeed commercially. Since some of our U.S. patents covering recombinant Protein A have expired, we may face increased competition which could harm our results of operations, financial condition, cash flow and future prospects. Our freedom to develop our product candidates may be challenged by others and we may have to engage in litigation to determine the scope and validity of competitors patents and proprietary rights, which, if we do not prevail, could harm our business, results of operations, financial condition, cash flow and future prospects. We may become involved in litigation or other proceedings with collaborative partners, which may be time consuming, costly and could result in delays in our development and commercialization efforts. We have limited sales and marketing experience and capabilities. We have limited pharmaceutical manufacturing capabilities and will be dependent on third party manufacturers. If we are unable to continue to hire and retain skilled personnel, then we will have trouble developing and marketing our products. The market may not be receptive to our products upon their introduction. Healthcare reform measures could adversely affect our business. We compete with pharmaceutical and biotechnology companies who are capable of developing new approaches that could make our products and technology obsolete. We have incurred substantial losses, we may continue to incur operating losses and we will not be successful until we reverse this trend. We may need to obtain additional capital resources for our drug development programs, or we may be unable to develop or discover new drugs. Our stock price could be volatile, which could cause you to lose part or all of your investment. Provisions in our certificate of incorporation and by-laws and of Delaware law may prevent or delay an acquisition of our Company, which could decrease the trading price of our common stock.

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730272--6/10/2010--REPLIGEN_CORP