744218--3/18/2008--AVANT_IMMUNOTHERAPEUTICS

related topics

{product, candidate, development}

{acquisition, growth, future}

{gas, price, oil}

{property, intellectual, protect}

{stock, price, share}

{product, liability, claim}

{personnel, key, retain}

{cost, operation, labor}

{cost, contract, operation}

{cost, regulation, environmental}

{tax, income, asset}

{customer, product, revenue}

{control, financial, internal}

{product, market, service}

{interest, director, officer}

{regulation, change, law}

Risks Related to Our Business Our products and product candidates are subject to extensive regulatory scrutiny. If our products do not pass required tests for safety and effectiveness, we will not be able to derive commercial revenue from them. Product testing is critical to the success of our products but subject to delay or cancellation if we have difficulty enrolling patients. Any delay in obtaining regulatory approval would have an adverse impact on our ability to earn future revenues. Failure to comply with applicable regulatory requirements would adversely impact our operations. We depend greatly on the intellectual capabilities and experience of our key executives and scientists and the loss of any of them could affect our ability to develop our products. We rely on our contract manufacturers. Should the cost, delivery and quality of clinical and commercial grade materials supplied by contract manufacturers vary to our disadvantage, our business operations could suffer significant harm. We rely on third parties to plan, conduct and monitor our clinical tests, and their failure to perform as required would interfere with our product development. We depend greatly on third party collaborators to license, develop and commercialize some of our products, and they may not meet our expectations. We may face delays, difficulties or unanticipated costs in establishing sales, distribution and manufacturing capabilities for our commercially ready products. A decrease in the demand and sales for and profitability of Megan Vac 1 and Megan Egg could adversely affect our revenues. Certain factors could negatively affect the demand for and sales and profitability of Rotarix , which would have a material adverse affect on our revenues. Other factors could affect the demand for and sales and profitability of Megan Vac 1, Megan Egg, Rotarix and any other of our current or future products. We may be unable to manage multiple late stage clinical trials for a variety of product candidates simultaneously. We face the risk of product liability claims, which could exceed our insurance coverage, and produce recalls, each of which could deplete our cash resources. Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them. We may not be able to successfully integrate newly acquired technology with our existing technology or to modify our technologies to create new vaccines. We license technology from other companies to develop products, and those companies could influence research and development or restrict our use of it. We have many competitors in our field and they may develop technologies that make ours obsolete. We rely on patents, patent applications and other intellectual property protections to protect our technology and trade secrets; which are expensive and may not provide sufficient protection. Our business requires us to use hazardous materials, which increases our exposure to dangerous and costly accidents. Health care reform and restrictions on reimbursement may limit our returns on potential products. Risks Related to Our Capital Stock Our history of losses and uncertainty of future profitability make our common stock a highly speculative investment, and the combined company may not be profitable in the future. If we cannot sell capital stock to raise necessary funds, we may forced to limit our research, development and testing programs. Our share price has been and could remain volatile. If selling stockholders choose to sell shares in large volumes, the trading price of our common stock could suffer. Risks Related to the Merger If we are not successful in integrating our companies, we may not be able to operate efficiently after the Merger, which may harm the value of our common stock. Integrating our companies may divert management's attention away from our operations. We expect to incur significant costs integrating AVANT and Celldex into a single business. If we fail to retain key employees, the benefits of the Merger could be diminished. If one or more of the products in the combined company cannot be shown to be safe and effective in clinical trials, is not approvable or not commercially successful, then the benefits of the Merger may not be realized. The costs associated with the Merger are difficult to estimate, may be higher than expected and may harm the financial results of the combined company. Our stockholders have a reduced ownership and voting interest after the Merger and exercise less influence over management of the combined company. The combined company's ability to use the net operating loss carryforwards of Celldex and AVANT will be subject to limitation and, under certain circumstances, may be eliminated. We expect to continue to incur operating losses and the combined company may need to raise additional funds to cover the cost of operation. If the combined company is not able to raise necessary additional funds it may have to reduce or stop operations. Celldex's business could be materially harmed if Celldex is unable to obtain and enforce patent protection for its products.

Full 10-K form ▸

744218--3/18/2008--AVANT_IMMUNOTHERAPEUTICS_INC