821616--3/17/2008--BENTLEY_PHARMACEUTICALS_INC

related topics
{product, candidate, development}
{acquisition, growth, future}
{product, liability, claim}
{stock, price, operating}
{operation, international, foreign}
{regulation, government, change}
{cost, contract, operation}
{system, service, information}
{product, market, service}
{provision, law, control}
{regulation, change, law}
{personnel, key, retain}
{property, intellectual, protect}
{customer, product, revenue}
{stock, price, share}
If medical doctors do not prescribe our products or the medical profession does not accept our products, our ability to grow our revenues will be limited. We will rely on strategic partners to conduct clinical trials and commercialize products that use our drug delivery technologies. If we are unable to meet our responsibilities under any of our agreements, we may lose potential business and be subject to penalties and other damages. A significant portion of our revenues are generated by the sale of products formulated from one active ingredient. An interruption in the sourcing and availability of the active ingredient used in our CPE-215 technology could cause our drug delivery technology product development and commercialization to slow or stop. If any of our product candidates for which we receive regulatory approval do not achieve broad market acceptance, the revenues that we generate from their sales will be limited. Pharmaceutical pricing, changes in third-party reimbursement and governmental mandates are uncertain and may adversely affect us. If our clinical trials fail, we will be unable to market products. We rely on third parties to conduct clinical trials for our product candidates and plan to rely on third parties to conduct future clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be unable to obtain regulatory approval for or commercialize our current and future product candidates. Our patent positions and intended proprietary or similar protections are uncertain. Regulatory approvals must be obtained and maintained for products incorporating our technologies and, if approvals are delayed or withdrawn, we will be unable to commercialize these products. Our business will suffer if we fail to continue to comply with federal regulations and rules of the Securities and Exchange Commission and New York Stock Exchange relating to corporate governance reform. Sustained compliance with the requirements of the Sarbanes-Oxley Act of 2002 may require a reallocation of resources that would otherwise be dedicated to operating our business. Implementation of new information systems could cause business interruptions and negatively affect our profitability and cash flows. If we are unable to obtain marketing approvals to sell our products in countries other than Spain, we may not be able to obtain additional revenues from sales in those countries. We must comply with Good Manufacturing Practices in the production of pharmaceutical products. We are dependent on only one manufacturing facility that can be used to manufacture our pharmaceutical products and only one manufacturing facility that can be used to manufacture active pharmaceutical ingredients. We operate a significant portion of our business in, and plan to expand further into, markets outside the United States, which subjects us to additional business risks. Currency fluctuations could have a material adverse impact on our business. If we cannot keep pace with rapid technological change and meet the intense competition in our industry, we may not succeed. We may be unable to meet increasing expenses and demands on our resources from future growth, if any, or to effectively pursue additional business opportunities. Our operations could be adversely affected if we are unable to raise or obtain needed funding. If we undertake an acquisition, we will incur a variety of costs, and we may never realize the anticipated benefits of the acquisition. If we do not successfully manage our growth, our business goals may not be achieved. If we cannot attract and retain key personnel, we may not be able to execute our business plan as anticipated. We may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability claims. The discovery of any new side effects or negative efficacy findings for our products could significantly harm our business. Our revenues, operating results and cash flows may fluctuate in future periods and we may fail to meet investor expectations, which may cause the price of our common stock to decline. Your percentage of ownership and voting power and the price of our common stock may decrease as a result of events that increase the number of our outstanding shares. Our stock price is volatile. Delaware law and provisions in our certificate of incorporation, bylaws and stockholder rights plan may prevent or discourage third parties or stockholders from attempting to replace the management of the Company.

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