881524--3/13/2006--VIVUS

related topics

{product, candidate, development}

{product, liability, claim}

{stock, price, operating}

{customer, product, revenue}

{property, intellectual, protect}

{stock, price, share}

{operation, natural, condition}

{regulation, change, law}

{operation, international, foreign}

{cost, regulation, environmental}

{acquisition, growth, future}

{personnel, key, retain}

{competitive, industry, competition}

{system, service, information}

{control, financial, internal}

{provision, law, control}

Risks Relating to our Product Development Efforts We face significant risks in our product development efforts. If the results of future clinical testing indicate that our proposed products are not safe or effective for human use, our business will suffer. We are exposed to risks related to collaborative arrangements or strategic alliances. We face significant governmental regulation during our product development activities. Our applications for regulatory approval could be delayed or denied due to problems with studies conducted before we licensed some of our product candidates from third parties. Following regulatory approval of any drug candidates, we would be subject to ongoing regulatory obligations and restrictions, which may result in significant expense and limit our ability to commercialize our potential drugs. We rely on third parties to conduct clinical trials for our product candidates in development and those third parties may not perform satisfactorily. We rely on third parties to manufacture sufficient quantities of compounds for use in our pre-clinical and clinical trials and an interruption to this service may harm our business. Risks Relating to our Operations If we, or our suppliers, fail to comply with FDA and other government regulations relating to our manufacturing operations, we may be prevented from manufacturing our products or may be required to undertake significant expenditures to become compliant with regulations. Our marketing activities for our products are subject to continued governmental regulation. We must continue to monitor the use of our approved drugs and may be required to complete post-approval studies mandated by the FDA. We depend exclusively on third-party distributors outside of the United States and we have very limited control over their activities. Sales of our current and any future products are subject to continued governmental regulation, our ability to accurately forecast demand and our ability to produce sufficient quantities to meet demand. We have limited sales and marketing capabilities in the United States. We have little or no control over our wholesalers buying patterns, which may impact future revenues, returns and excess inventory. The markets in which we operate are highly competitive and we may be unable to compete successfully against new entrants or established companies. If our raw material suppliers fail to supply us with alprostadil, for which availability is limited, we may experience delays in our product development and commercialization. We outsource several key parts of our operations, and any interruption in the services provided by third parties could harm our business. We currently depend on a single source for the supply of plastic applicator components for MUSE, and an interruption to this supply source could harm our business. All of our manufacturing operations are currently conducted at a single location, and a prolonged interruption to our manufacturing operations could harm our business. We are dependent upon a single approved therapeutic approach to treat erectile dysfunction. If we fail to retain our key personnel and hire, train and retain qualified employees, we may not be able to compete effectively, which could result in reduced revenues. We are subject to additional risks associated with our international operations. Any adverse changes in reimbursement procedures by government and other third-party payors may limit our ability to market and sell our products or limit our product revenues and delay profitability. Defending against claims relating to improper handling, storage or disposal of hazardous materials could be time consuming and expensive. Natural disasters or resource shortages could disrupt our operations and adversely affect results. Risks Relating to our Intellectual Property We may be sued for infringing the intellectual property rights of others. u r inability to adequately protect our proprietary technologies could harm our competitive position and have a material adverse effect on our business. We may be subject to claims that we or our employees have wrongfully used or disclosed alleged trade secrets of their former employers. We require additional capital for our future operating plans, and we may not be able to secure the requisite additional funding on acceptable terms, or at all. We have an accumulated deficit of $147.0 million as of December 31, 2005 and expect to continue to incur substantial operating losses for the foreseeable future. If we become subject to product liability claims, we may be required to pay damages that exceed our insurance coverage. Risks Relating to an Investment in our Common Stock Our stock price has been and may continue to be volatile. Volatility in the stock prices of other companies may contribute to volatility in our stock price. Our share ownership is concentrated, and our officers, directors and principal stockholders can exert significant control over matters requiring stockholder approval. Our operating results may fluctuate from quarter to quarter and this fluctuation may cause our stock price to decline. There may not be an active, liquid trading market for our common stock. Our charter documents and Delaware law could make an acquisition of our company difficult, even if an acquisition may benefit our stockholders. Changes in accounting standards regarding stock option plans could limit the desirability of granting stock options, which could harm our ability to attract and retain employees, and could also reduce our profitability. Compliance with changing regulation of corporate governance and public disclosure may result in additional expenses.

Full 10-K form ▸

881524--3/13/2006--VIVUS_INC