1118361--3/15/2007--RENOVIS

related topics

{product, candidate, development}

{stock, price, share}

{product, liability, claim}

{control, financial, internal}

{property, intellectual, protect}

{stock, price, operating}

{provision, law, control}

{competitive, industry, competition}

{product, market, service}

{cost, regulation, environmental}

{personnel, key, retain}

Risks Related to Our Company We are an early stage biopharmaceutical company without commercial products, and we cannot assure you that we will successfully develop and commercialize potential products. We depend on the efforts of our strategic partners and licensees to develop and commercialize many of our product candidates. Clinical trials have in the past and may in the future fail to demonstrate the safety and efficacy of our product candidates, which could prevent or significantly delay their regulatory approval and may adversely affect our business and stock price. Failure to enroll patients for clinical trials may cause delays in developing our product candidates. The contract research organizations and independent clinical investigators that we and our strategic partners or licensees rely upon to conduct preclinical studies and clinical trials may not be diligent, careful or timely, and may make mistakes in the conduct of these studies. If we or our strategic partners or licensees fail to obtain U.S. regulatory approvals for product candidates under development, we will not be able to generate revenue in the U.S. market from the commercialization of product candidates. If we or our strategic partners or licensees fail to obtain regulatory approvals in other countries for product candidates under development, we will not be able to generate revenue in such countries from the commercialization of product candidates. Even if our product candidates are approved and commercialized, competitive products may impede market acceptance of our products. We have no experience selling, marketing or distributing products and no internal capability to do so. If our partners, licensees or contract manufacturers of our products fail to devote sufficient time and resources to our concerns, or if their performance is substandard, our clinical trials and product introductions may be delayed and our costs may rise. We or our strategic partners or licensees may not be able to manufacture our product candidates in commercial quantities, which would prevent us from commercializing our product candidates. If we are unable to retain and recruit qualified scientists or if any of our key executives, key employees or key consultants discontinues his or her employment or consulting relationship with us, it may delay our development efforts or otherwise harm our business. We have a history of losses and we may never achieve sustained profitability. If we cannot raise additional capital on acceptable terms, we may be unable to complete clinical trials, obtain regulatory approvals or commercialize our product candidates. Risks Related to Our Industry Claims that we infringe a third party s intellectual property may give rise to burdensome litigation, result in potential liability for damages or stop our development and commercialization efforts. We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of their former employers. If we are unable to protect our intellectual property rights, our competitors may develop and market products with similar features that may reduce demand for our potential products. Governmental and third-party payors may impose sales and pharmaceutical pricing restrictions or controls on our potential products that could limit our future product revenues and adversely affect profitability. Competition in the biotechnology and pharmaceutical industries is intense, and if we fail to compete effectively our financial results will suffer. Rapid technological change could make our products obsolete. We face potential product liability exposure far in excess of our limited insurance coverage. Our activities involve hazardous materials and we may be liable for any resulting contamination or injuries. If we are unable to complete our assessment as to the adequacy of our internal control over financial reporting within the required time periods as required by Section 404 of the Sarbanes-Oxley Act of 2002, or in the course of such assessments identify and report material weaknesses in our controls, our investors could lose confidence in the reliability of our financial statements, which could result in a decrease in the value of our common stock. Risks Related to Our Common Stock Our stock price has fluctuated significantly and we expect that it may continue to do so. Future sales of common stock by our existing stockholders may cause our stock price to fall. Our directors and management exercise significant control over our company. Provisions of Delaware law or our charter documents and stockholder rights plan could delay or prevent an acquisition of our company, even if the acquisition would be beneficial to our stockholders, and could make it more difficult for stockholders to change management. We have never paid dividends on our capital stock, and we do not anticipate paying any cash dividends in the foreseeable future.

Full 10-K form ▸

1118361--3/15/2007--RENOVIS_INC