874255--3/15/2006--MEDAREX

related topics

{product, candidate, development}

{product, liability, claim}

{stock, price, share}

{cost, regulation, environmental}

{property, intellectual, protect}

{stock, price, operating}

{debt, indebtedness, cash}

{investment, property, distribution}

{product, market, service}

{provision, law, control}

{interest, director, officer}

{control, financial, internal}

{personnel, key, retain}

{financial, litigation, operation}

{acquisition, growth, future}

Successful development of our products is uncertain. Our revenue and profit potential are unproven. No revenues have been generated from the commercial sale of our products and our products may not generate revenues in the future. We have incurred large operating losses and we anticipate that these losses will continue. Our operating results may vary significantly from period-to-period, which may result in a decrease in the price of our securities. We are at risk of securities class action litigation. We may need substantial additional funding. We may not be able to obtain sufficient funds to grow our business or continue our operations. We have a significant amount of debt and may have insufficient cash to satisfy our debt service obligations. In addition, the amount of our debt could impede our operations and flexibility. Clinical trials required for our product candidates are expensive and time-consuming, and their outcome is uncertain. Success in early clinical trials may not be indicative of results obtained in later trials. Product candidates employing our antibody technology may fail to gain market acceptance. The successful commercialization of our antibody products will depend on obtaining coverage and reimbursement for use of these products from third-party payors. Our manufacturing facilities may not continue to meet regulatory requirements and have limited capacity. The development of commercialization of our lead product candidate, ipilimumab, is, in large part, dependent on the actions of BMS, which are outside of our control. We are, in part, dependent on our partners willingness and/or ability to devote resources to the development of product candidates or otherwise support our business as contemplated in our partnership agreements. Our existing partnerships may be terminated, and we may not be able to establish additional partnerships. Due to the size of our equity interest in Celldex, we must consolidate the results of its operations in our financial statements. Our strategic equity investments in our partners expose us to equity price risk and, in addition, investments in our partners may be deemed impaired, which would affect our results of operations. We are dependent on our key personnel. We depend on patents and proprietary rights. Third parties may allege our products infringe their patents or may challenge the validity of our patents and other intellectual property rights, resulting in litigation or other time-consuming and expensive proceedings which could deprive us of valuable products and/or rights. We have had and may continue to face product liability claims related to the use or misuse of products developed by us or our partners. We face intense competition and rapid technological change. We are subject to extensive and costly government regulation. We do not have, and may never obtain, the regulatory approvals we need to market our product candidates. If we or our manufacturing partners do not comply with current good manufacturing practices requirements, we will not be able to commercialize our product candidates. Even if approved, our products will be subject to extensive post-approval regulation. If we are able to obtain approvals for our products, the law or FDA policy could change and expose us to competition from generic or follow-on versions of our products. Our operations involve hazardous materials and are subject to environmental, health and safety controls and regulations. Our stock price may be volatile. We have obligations to issue shares of our common stock in the future, which may have a dilutive effect on the shares of our common stock currently outstanding. Future sales of our common stock or other securities could cause the market price of our common stock to decline. Upon the occurrence of certain change of control events of our company, we are required to offer to repurchase all of our debt, which may adversely affect our business and the price of our common stock. Our restated certificate of incorporation, amended and restated by-laws, shareholder rights plan and New Jersey law contain provisions that could delay or prevent an acquisition of our company even if the acquisition would be beneficial to our shareholders, and as a result, our management may become entrenched and hard to replace. We do not intend to pay cash dividends on our common stock in the foreseeable future.

Full 10-K form ▸

874255--3/15/2006--MEDAREX_INC