1099414--3/16/2007--TANOX

related topics

{product, candidate, development}

{cost, regulation, environmental}

{stock, price, share}

{product, liability, claim}

{property, intellectual, protect}

{regulation, change, law}

{control, financial, internal}

{product, market, service}

{interest, director, officer}

{regulation, government, change}

{stock, price, operating}

We are subject to business uncertainties and contractual restrictions in connection with the proposed acquisition by Genentech that could adversely affect our stock price and future business and operations. Our ability to become a profitable fully integrated biopharmaceutical company will depend on the continued commercial success of Xolair and on the success of our products in clinical development or our success in securing, developing and commercializing new clinical candidates. Failure to secure future collaboration partners for our products or failure by those partners to develop, manufacture, market or distribute those products, or pay the royalties and other payments we expect, may delay or significantly impair our ability to generate revenues or profit. We face intense competition and rapid technological change that could result in products superior to the products we are developing. We may be subject to product liability and other claims, and our insurance coverage may not be adequate to cover these claims. We deal with hazardous materials and must comply with environmental laws and regulations, which can be expensive and restrict how we do business. We could be liable for damages, penalties or other forms of censure if we are involved in a hazardous waste spill or other accident. Developing therapeutic monoclonal antibodies is expensive and highly uncertain. We may be unable to enroll sufficient patients in a timely manner in order to complete our clinical trials. If we do not receive and maintain regulatory approvals, we will not be able to market our products. We are subject to the uncertainty related to reimbursement policies and healthcare reform measures. New accounting pronouncements or regulatory rulings may impact our future financial position or results of operations Our revenues are dependent on the continued market acceptance and successful commercialization of Xolair. We have limited experience in manufacturing, and manufacturing problems or delays could result in delayed clinical trials. Our own ability to manufacture products on a commercial scale is uncertain. Manufacturing changes may result in delays in obtaining regulatory approval or marketing for our products. We lack sales and marketing experience, and we depend on third parties for their expertise in this area. We have a history of net losses; we expect to continue to incur net losses and we may never achieve or maintain profitability. The market price of our common stock has been volatile. Failure by Novartis or Genentech to develop, manufacture, market or distribute Xolair would impair our ability to generate revenues. We may need additional financing, but our access to capital funding is uncertain, and issuance of additional common stock could dilute existing stockholders. The patentability, validity, enforceability and commercial value of our patents are highly uncertain. If our intellectual property positions are challenged, invalidated or circumvented and we fail to prevail in resulting intellectual property litigation, our business could be adversely affected. If we fail to obtain any required patent license from third parties, our product development efforts could be limited.

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1099414--3/16/2007--TANOX_INC