821616--3/16/2006--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}
Our growth depends on identifying drugs suitable for our drug delivery technologies and expanding our generic and branded drug operations. Products using our technologies are in various stages of development and may not achieve commercial success. 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. 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. 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approvals must be obtained and maintained for products incorporating our technologies and, if approvals are delayed or withdrawn, we will be unable to commercialize these products.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 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 have only one manufacturing facility that can be used to manufacture our pharmaceutical products for sale to others. We have only one manufacturing facility that can be used to manufacture active pharmaceutical ingredients for sale to others. 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. 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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