1052837--3/15/2006--ABGENIX

related topics

{product, candidate, development}

{product, liability, claim}

{acquisition, growth, future}

{property, intellectual, protect}

{stock, price, share}

{debt, indebtedness, cash}

{customer, product, revenue}

{control, financial, internal}

{product, market, service}

{personnel, key, retain}

{provision, law, control}

{cost, regulation, environmental}

{system, service, information}

{cost, contract, operation}

We are an early stage company without commercial therapeutic products, and we cannot assure you that we will develop sufficient revenues in the future to sustain our business. We have a history of losses and we expect to continue to incur losses for the foreseeable future. We are currently unprofitable and may never be profitable, and our future revenues could fluctuate significantly. We may require additional financing, and an inability to raise the necessary capital or to do so on acceptable terms would threaten the continued success of our business. Our indebtedness may harm our financial condition and results of operations. Failure to complete our proposed acquisition by Amgen could adversely affect our stock price and future business and operations. The restrictive covenants of the merger agreement have placed, and will continue to place, significant restrictions on our business operations until the completion of the merger with Amgen. Our XenoMouse and XenoMax technologies may not produce safe, efficacious or commercially viable products, which will be critical to our ability to generate revenues from our products. If we do not successfully develop our products, or if they do not achieve commercial success, our business will be materially harmed. Before we commercialize and sell any of our product candidates, we must conduct clinical trials, which are expensive and have uncertain outcomes. Success in early clinical trials may not be indicative of results obtained in subsequent trials. Our own ability to manufacture is uncertain, which may make it more difficult for us to develop and sell our products. We may rely on third party manufacturers, and we may have difficulty conducting clinical trials or commercializing product candidates if a manufacturer does not perform in accordance with our expectations. The successful growth of revenues from our manufacturing services may depend on our ability to find third parties who agree to use our services and our ability to provide those services successfully. The successful growth of our business depends in part on our ability to find third party collaborators to assist or share in the costs of product development. We are subject to extensive government regulation, which will require us to spend significant amounts of money, and we may not be able to obtain regulatory approvals, which are required for us to conduct clinical testing and commercialize our products. If we are unable to manufacture our product candidates in compliance with current good manufacturing practices requirements and applicable regulations, we will not be able to commercialize our product candidates. If our products do not gain market acceptance among the medical community, our revenues would greatly decline and might not be sufficient to support our operations. We do not have marketing and sales experience, which may require us to rely on others to market and sell our products and may make it more challenging for us to commercialize our product candidates. Our ability to protect our intellectual property rights will be critically important to the success of our business, and we may not be able to protect these rights in the United States or abroad. We may face challenges from third parties regarding the validity of our patents and proprietary rights, or from third parties asserting that we are infringing their patents or proprietary rights, which could result in litigation that would be costly to defend and could deprive us of valuable rights. We face intense competition and rapid technological change, and if we fail to develop products that keep pace with new technologies and that gain market acceptance, our product candidates or technologies could become obsolete. We face uncertainty over reimbursement and healthcare reform, which, if determined adversely to us, could seriously hinder the market acceptance of our products. We may experience pressure to lower the prices of any prescription pharmaceutical products we are able to obtain approval for because of new and/or proposed federal legislation. The future growth and success of our business will depend on our ability to continue to attract and retain our employees and consultants. We may experience difficulty in the integration of any future acquisition with the operations of our business. We have implemented a stockholder rights plan and are subject to other anti-takeover provisions, which could deter a party from effecting a takeover of us at a premium to our then-current stock price. We face product liability risks and may not be able to obtain adequate insurance, and if we are held liable for an uninsured claim or a claim in excess of our insurance limits, our business, financial condition and results of operations may be harmed. Our operations involve hazardous materials, and we could be held responsible for any damages caused by such materials. We do not intend to pay cash dividends on our common stock. Our stock price is highly volatile, and you may not be able to sell your shares of our common stock at a price greater than or equal to the price you paid for them.

Full 10-K form ▸

1052837--3/15/2006--ABGENIX_INC