874663--5/21/2010--ALKERMES

related topics

{product, candidate, development}

{product, liability, claim}

{stock, price, share}

{regulation, government, change}

{property, intellectual, protect}

{cost, regulation, environmental}

{customer, product, revenue}

{stock, price, operating}

{personnel, key, retain}

{acquisition, growth, future}

{operation, international, foreign}

{condition, economic, financial}

{control, financial, internal}

{provision, law, control}

{competitive, industry, competition}

We are substantially dependent on revenues from our principal product. We are subject to risks related to the manufacture of our products. VIVITROL may not be successfully marketed and sold by Alkermes and may not generate significant revenues. Revenues generated by sales of our products depend on the availability of reimbursement from third party payors and a reduction in payment rate or reimbursement or an increase in our financial obligation to governmental payors could result in decreased sales of our products and revenue. Our customer base that purchase VIVITROL directly from us is highly concentrated. We rely on third parties to provide services in connection with the manufacture and distribution of our products. If we fail to meet the stringent requirements of governmental regulation in the manufacture of our products, we could incur substantial remedial costs and a reduction in sales. Our business involves environmental risks. We rely heavily on collaborative partners. We have very little sales and marketing experience and limited sales capabilities, which may make commercializing our products difficult. Our product platforms or product development efforts may not produce safe, efficacious or commercially viable products. Clinical trials for our product candidates are expensive and their outcome is uncertain. We often depend on third parties in the conduct of our clinical trials and any failure of those parties to fulfill their obligations could adversely affect our development and commercialization plans. We may not become profitable on a sustained basis. We may require additional funds to complete our programs and such funding may not be available on commercially favorable terms and may cause dilution to our existing shareholders. The FDA or foreign regulatory agencies may not approve our product candidates or may impose limitations upon any product approval. Changes in laws affecting the health care industry could adversely affect our revenues and profitability. If we fail to comply with the extensive legal and regulatory requirements affecting the health care industry, we could face increased costs, penalties and a loss of business. Patent protection for our products is important and uncertain. Uncertainty over intellectual property in the biotechnology industry has been the source of litigation, which is inherently costly and unpredictable. The commercial use of our products may cause unintended side effects or adverse reactions or incidence of misuse may occur. We may be exposed to product liability claims and recalls. We may not be successful in the development of products for our own account. If we are not able to develop new products, our business may suffer. Foreign currency exchange rates may affect revenue. We face competition in the biotechnology and pharmaceutical industries, and others. We may not be able to retain our key personnel. Future transactions may harm our business or the market price of our stock. If we issue additional common stock, shareholders will suffer dilution of their investment and the stock price may decline. The current credit and financial market conditions may exacerbate certain risks affecting our business. Our common stock price is highly volatile. Anti-takeover provisions may not benefit shareholders. Our business could be negatively affected as a result of the actions of activist shareholders.

Full 10-K form ▸

874663--5/21/2010--ALKERMES_INC