881464--2/27/2009--AMYLIN_PHARMACEUTICALS_INC

related topics
{product, liability, claim}
{product, candidate, development}
{property, intellectual, protect}
{stock, price, operating}
{debt, indebtedness, cash}
{control, financial, internal}
{regulation, change, law}
{stock, price, share}
{provision, law, control}
{investment, property, distribution}
{personnel, key, retain}
{product, market, service}
{loan, real, estate}
{cost, regulation, environmental}
{acquisition, growth, future}
{financial, litigation, operation}
CAUTIONARY FACTORS THAT MAY AFFECT FUTURE RESULTS We have a history of operating losses, anticipate future losses and may never become profitable. We began selling, marketing and distributing our first products, BYETTA and SYMLIN, in 2005 and we will depend heavily on the success of those products in the marketplace. If we encounter safety issues with BYETTA or SYMLIN or any other drugs we market or fail to comply with extensive continuing regulations enforced by domestic and foreign regulatory authorities, it could cause us to discontinue marketing those drugs, reduce our revenues and harm our ability to generate future revenues, which would negatively impact our financial position. We currently do not manufacture our own drug products or some of our drug candidates and may not be able to obtain adequate supplies, which could cause delays, subject us to product shortages, or reduce product sales. Our ability to generate revenues will be diminished if we fail to obtain acceptable prices or an adequate level of reimbursement for our products from third-party payers. Competition in the biotechnology and pharmaceutical industries may result in competing products, superior marketing of other products and lower revenues or profits for us. Delays in the conduct or completion of our clinical trials, the analysis of the data from our clinical trials or our manufacturing scale-up activities may result in delays in our planned filings for regulatory approvals, and may adversely affect our ability to enter into new collaborative arrangements. We are substantially dependent on our collaboration with Lilly for the development and commercialization of BYETTA and dependent on Lilly and Alkermes for the development of exenatide once weekly. If our patents are determined to be unenforceable or if we are unable to obtain new patents based on current patent applications or for future inventions, we may not be able to prevent others from using our intellectual property. If we are unable to obtain licenses to third party patent rights for required technologies, we could be adversely affected. We may be unable to obtain regulatory clearance to market our drug candidates in the United States or foreign countries on a timely basis, or at all. Litigation regarding patents and other proprietary rights may be expensive, cause delays in bringing products to market and harm our ability to operate. We are subject to "fraud and abuse" and similar laws and regulations, and a failure to comply with such regulations or prevail in any litigation related to noncompliance could harm our business. Our financial results will fluctuate, and these fluctuations may cause our stock price to fall. We may require additional financing in the future, which may not be available to us on favorable terms, or at all. Our investments in marketable debt securities are subject to credit and market risks that may adversely affect their fair value. Our business has a substantial risk of product liability claims, and insurance may not be adequate to cover these claims. Our ability to enter into and maintain third-party relationships is important to our successful development and commercialization of BYETTA, SYMLIN and our other drug candidates and to our potential profitability. We have a significant amount of indebtedness. We may not be able to make payments on our indebtedness, and we may incur additional indebtedness in the future, which could adversely affect our operations. We may be required to redeem our convertible senior notes upon a designated event or repay the Term Loan upon an event of default. If our research and development programs fail to result in additional drug candidates, the growth of our business could be impaired. Our future success depends on our chief executive officer, and other key executives and our ability to attract, retain and motivate qualified personnel. We may be unable to adequately prevent disclosure of trade secrets and other proprietary information. Our research and development activities and planned manufacturing activities involve the use of hazardous materials, which subject us to regulation, related costs and delays and potential liabilities. We are exposed to potential risks from legislation requiring companies to evaluate internal control over financial reporting. We have implemented anti-takeover provisions that could discourage or prevent an acquisition of our company, even if the acquisition would be beneficial to our stockholders, and as a result our management may become entrenched and hard to replace. Our executive officers, directors and major stockholders control approximately 66% of our common stock. We could be negatively affected as a result of a threatened proxy fight and other actions of activist shareholders Substantial future sales of our common stock by us or our existing stockholders or the conversion of our convertible senior notes to common stock could cause the trading price of our common stock to fall. Significant volatility in the market price for our common stock could expose us to litigation risk.

Full 10-K form ▸

related documents
881464--3/7/2006--AMYLIN_PHARMACEUTICALS_INC
881464--2/26/2007--AMYLIN_PHARMACEUTICALS_INC
881464--2/26/2010--AMYLIN_PHARMACEUTICALS_INC
1009356--3/10/2010--SALIX_PHARMACEUTICALS_LTD
883975--3/16/2006--STEMCELLS_INC
896778--3/14/2008--CONCEPTUS_INC
1009356--3/14/2008--SALIX_PHARMACEUTICALS_LTD
883975--3/15/2007--STEMCELLS_INC
896778--3/16/2006--CONCEPTUS_INC
1009356--3/11/2009--SALIX_PHARMACEUTICALS_LTD
1116463--3/16/2007--ORASURE_TECHNOLOGIES_INC
1131907--3/16/2006--CANCERVAX_CORP
34956--7/28/2006--SYNTHETIC_BLOOD_INTERNATIONAL_INC
34956--8/14/2007--SYNTHETIC_BLOOD_INTERNATIONAL_INC
896778--3/13/2009--CONCEPTUS_INC
883975--3/11/2010--STEMCELLS_INC
863680--3/31/2009--CARDIOGENESIS_CORP_/CA
827809--3/10/2010--QLT_INC/BC
1047188--3/16/2007--PENWEST_PHARMACEUTICALS_CO
849778--2/22/2006--CYTYC_CORP
884629--3/1/2007--WATSON_PHARMACEUTICALS_INC
789132--3/17/2008--SPECTRANETICS_CORP
1040666--3/16/2009--VNUS_MEDICAL_TECHNOLOGIES_INC
896778--3/15/2007--CONCEPTUS_INC
1105184--3/11/2010--NANOSPHERE_INC
1114529--3/31/2006--VIACELL_INC
749660--3/31/2006--ICAD_INC
850693--2/28/2008--ALLERGAN_INC
789132--3/16/2007--SPECTRANETICS_CORP
1012140--2/23/2010--ONYX_PHARMACEUTICALS_INC