907562--3/12/2010--DYAX_CORP

related topics
{product, liability, claim}
{product, candidate, development}
{acquisition, growth, future}
{property, intellectual, protect}
{stock, price, share}
{stock, price, operating}
{provision, law, control}
{control, financial, internal}
{regulation, government, change}
{regulation, change, law}
{debt, indebtedness, cash}
{operation, international, foreign}
{personnel, key, retain}
{product, market, service}
{cost, regulation, environmental}
Risks Related To Our Business We have a history of net losses, expect to incur significant additional net losses and may never achieve or sustain profitability. We will need substantial additional capital in the future and may be unable to raise the capital that we will need to sustain our operations. Our revenues and operating results have fluctuated significantly in the past, and we expect this to continue in the future. We depend heavily on the success of our lead product, KALBITOR, which was approved in the United States for treatment of acute attacks of HAE in patients 16 years and older. Because the target patient population of KALBITOR for treatment of HAE is small and has not been definitively determined, we must be able to successfully identify HAE patients and achieve a significant market share in order to achieve or maintain profitability. If HAE patients are unable to obtain and maintain reimbursement for KALBITOR from government health administration authorities, private health insurers and other organizations, KALBITOR may be too costly for regular use and our ability to generate product sales would be harmed. We may not be able to gain or maintain market acceptance among the medical community or patients for KALBITOR which would prevent us from achieving or maintaining profitability in the future. If we fail to comply with continuing regulations, we could lose our approvals to market KALBITOR, and our business would be adversely affected. If the use of KALBITOR harms people, or is perceived to harm patients even when such harm is unrelated to KALBITOR, our regulatory approvals could be revoked or otherwise negatively impacted and we could be subject to costly and damaging product liability claims. Although we obtained regulatory approval of KALBITOR for treatment of acute attacks of HAE in patients 16 years and older in the United States, we may be unable to obtain regulatory approval for KALBITOR in any other territory. If we are unable to establish and maintain effective sales, marketing and distribution capabilities, or to enter into agreements with third parties to do so, we will be unable to successfully commercialize KALBITOR. If we market KALBITOR in a manner that violates health care fraud and abuse laws, we may be subject to civil or criminal penalties. The FDA is requiring us to implement a Risk Evaluation and Mitigation Strategy (REMS) for KALBITOR. Additionally, the FDA or similar agencies in other jurisdictions may require us to restrict the distribution or use of KALBITOR or other future products or take other potentially limiting or costly actions if we or others identify side effects after the product is on the market. We rely on third-party manufacturers to produce our preclinical and clinical drug supplies and we intend to rely on third parties to produce commercial supplies of KALBITOR and any future approved product candidates. Any failure by a third-party manufacturer to produce supplies for us may delay or impair our ability to develop, obtain regulatory approval for or commercialize our product candidates. We are dependent on a single contract manufacturer to produce drug substance for DX-88, which may adversely affect our ability to commercialize KALBITOR and other potential DX-88 products. Our biopharmaceutical product candidates must undergo rigorous clinical trials which could substantially delay or prevent their development or marketing. We lack experience in and/or capacity for conducting clinical trials and handling regulatory processes. This lack of experience and/or capacity may adversely affect our ability to commercialize any biopharmaceuticals that we may develop. Government regulation of drug development is costly, time consuming and fraught with uncertainty, and our products in development cannot be sold if we do not gain regulatory approval. Product liability and other claims arising in connection with the testing our product candidates in human clinical trials may reduce demand for our products or result in substantial damages. Competition and technological change may make our potential products and technologies less attractive or obsolete. If we fail to establish and maintain strategic license, research and collaborative relationships, or if our collaborators are not able to successfully develop and commercialize product candidates, our ability to generate revenues could be adversely affected. Our success depends significantly upon our ability to obtain and maintain intellectual property protection for our products and technologies and upon third parties not having or obtaining patents that would prevent us from commercializing any of our products. Proceedings to obtain, enforce or defend patents and to defend against charges of infringement are time consuming and expensive activities. Unfavorable outcomes in these proceedings could limit our patent rights and our activities, which could materially affect our business. Failure to meet our Cowen Healthcare debt service obligations could adversely affect our financial condition and our loan agreement obligations could impair our operating flexibility. If we lose or are unable to hire and retain qualified personnel, then we may not be able to develop our products or processes. We use and generate hazardous materials in our business, and any claims relating to the improper handling, storage, release or disposal of these materials could be time-consuming and expensive. Our business is subject to risks associated with international contractors and exchange rate risk. Compliance with changing regulations relating to corporate governance and public disclosure may result in additional expenses. We may not succeed in acquiring technology and integrating complementary businesses. Risks Related To Our Common Stock Our common stock may continue to have a volatile public trading price and low trading volume. Anti-takeover provisions in our governing documents and under Delaware law and our shareholder rights plan may make an acquisition of us more difficult.

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