912183--2/27/2009--CUBIST_PHARMACEUTICALS

related topics

{product, candidate, development}

{stock, price, operating}

{product, liability, claim}

{acquisition, growth, future}

{tax, income, asset}

{regulation, change, law}

{provision, law, control}

{product, market, service}

{interest, director, officer}

{cost, regulation, environmental}

{personnel, key, retain}

{property, intellectual, protect}

{control, financial, internal}

{operation, international, foreign}

{regulation, government, change}

{loss, insurance, financial}

Risks Related to Our Business We depend heavily on the success of CUBICIN, which may not continue to be widely accepted in the U.S. by physicians, patients, third-party payors, or the medical community in general or may not become as widely accepted in other countries around the world where CUBICIN is being commercialized or may be commercialized in the future. We may not be able to obtain, maintain or protect certain proprietary rights necessary for the development and commercialization of CUBICIN or our internally-developed drug candidates and research technologies. In addition, third parties from which we license proprietary rights or obtain other types of rights to develop and/or commercialize marketed products, drug candidates or research technologies may not be able to obtain, maintain or protect such proprietary rights. We are completely dependent on third parties to manufacture CUBICIN and MERREM I.V. As a result, our commercialization of CUBICIN could be stopped, delayed, or made less profitable if those third parties fail to provide us with sufficient quantities of CUBICIN or fail to do so at acceptable prices, and our revenues from the promotion of MERREM I.V. could be stopped, delayed or impeded if AstraZeneca fails to supply to the market sufficient quantities of MERREM I.V. We face significant competition from other biotechnology and pharmaceutical companies and may face additional competition in the future, particularly with respect to CUBICIN, including from Teva, who is seeking to market a generic version of CUBICIN, and our operating results will suffer if we fail to compete effectively. If we are unable to maintain satisfactory sales and marketing capabilities, we may not continue to succeed in commercializing CUBICIN or succeed in our promotion activities with respect to MERREM I.V. Our business may suffer if we fail to manage our growth and increased breadth of our activities effectively. If pre-clinical or clinical trials for our drug candidates are unsuccessful or delayed, we will be unable to meet our anticipated development and commercialization timelines, which could harm our business. If we are unable to discover, in-license, or acquire drug candidates, we will not be able to implement our current business strategy. We, and/or our partners, will need to obtain regulatory approvals for CUBICIN in international jurisdictions in which CUBICIN has not yet received approvals, our existing drug candidates and any other drug candidates in order to commercialize them as products, and our ability to generate revenues from the commercialization and sale of products resulting from our development efforts is contingent upon obtaining and maintaining these approvals. The FDA may change its approval requirements or policies for antibiotics, or apply interpretations to its requirements or policies, in a manner that could delay or prevent commercialization of any new antibiotic product candidates or any additional indications for CUBICIN that we may seek in the U.S. If we are unable to generate the revenues we expect from MERREM I.V. or from any of our other drug candidates, our ability to create long-term shareholder value may be limited. We have collaborative and other similar types of relationships that expose us to a number of risks. A variety of risks associated with our international business relationships could materially adversely affect our business. We depend on third parties in the conduct of our clinical trials for CUBICIN and our drug candidates and expect to do so with respect to other drug candidates, and any failure of those parties to fulfill their obligations could adversely affect our development and commercialization plans. We have undertaken and may in the future undertake strategic acquisitions, and we may not realize the benefits of such acquisitions. The investment of our cash is subject to risks which could result in losses. We have incurred substantial losses in the past and may incur additional losses. We may require additional funds and we do not know if additional funds would be available to us at all, or on terms that we find acceptable, particularly given the distress in the financial and credit markets. If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy. Risks Related to Our Industry Patent litigation or other intellectual property proceedings relating to our products or processes could result in liability for damage or stop our development and commercialization efforts. Revenues generated by products we currently market or that we successfully develop and for which we obtain regulatory approval depend on reimbursement from third-party payors such that if reimbursement for our products is reduced or is insufficient, there could be a negative impact on the utilization of the products that we market. Our industry is highly regulated and our products are subject to ongoing regulatory review. Competitors may develop drug products that make our drug products obsolete, less cost effective or otherwise less attractive to use. The way that we account for our operational and business activities is based on estimates and assumptions that may differ from actual results, and new accounting pronouncements or guidance may require us to change the way in which we account for our operational or business activities. We may incur liabilities to tax authorities in excess of amounts that have been accrued Our corporate compliance program cannot ensure that we are in compliance with all applicable "fraud and abuse" laws and regulations and other applicable laws and regulations in the jurisdictions in which we sell CUBICIN and promote MERREM I.V., and a failure by us or AstraZeneca to comply with such regulations or prevail in litigation related to noncompliance could harm our business. We could incur substantial costs resulting from product liability claims relating to our pharmaceutical products. Our use of hazardous materials, chemicals, microorganisms and radioactive compounds exposes us to potential liabilities. If we are unable to adequately protect our confidential, electronically stored, transmitted and communicated information, it could significantly harm our business. Risks Related to Ownership of Our Common Stock Our stock price may be volatile, and the value of our stock could decline. If our officers, directors and certain stockholders choose to act together, they would be able to influence our management and operations, acting in their best interests and not necessarily those of other stockholders. Several aspects of our corporate governance may discourage a third party from attempting to acquire us. Our business could be negatively affected as a result of the actions of activist shareholders.

Full 10-K form ▸

912183--2/27/2009--CUBIST_PHARMACEUTICALS_INC