1159036--3/9/2007--HALOZYME_THERAPEUTICS

related topics

{product, liability, claim}

{product, candidate, development}

{stock, price, share}

{product, market, service}

{personnel, key, retain}

{property, intellectual, protect}

{acquisition, growth, future}

If we do not receive and maintain regulatory approvals for our product candidates, we will not be able to commercialize our products, which would substantially impair our ability to generate revenues. We may not receive regulatory approvals for our product candidates for a variety of reasons, including unsuccessful clinical trials. If we fail to comply with regulatory requirements, regulatory agencies may take action against us, which could significantly harm our business. If our product candidates are approved by the FDA but do not gain market acceptance, our business will suffer because we may not be able to fund future operations. If we are unable to sufficiently develop our sales, marketing and distribution capabilities or enter into agreements with third parties to perform these functions, we will not be able to commercialize products. If our sole contract manufacturer is unable to manufacture our products, our product development and commercialization efforts could be delayed or stopped. If we have problems with the third parties that prepare, fill, finish, and package our product candidates for distribution, our product development and commercialization efforts for these candidates could be delayed or stopped. Developing and marketing pharmaceutical products for human use involves product liability risks, for which we currently have limited insurance coverage. Our inability to attract, hire and retain key management and scientific personnel, and to recruit qualified independent directors, could negatively affect our business. Risks Related To Our Stock Future sales of shares of our common stock upon the exercise of currently outstanding securities or pursuant to our universal shelf registration statement may negatively affect our stock price. Our stock price is subject to significant volatility. Trading in our stock has historically been limited, so investors may not be able to sell as much stock as they want to at prevailing market prices. Our decision to redeem outstanding warrants may drive down the market price of our stock. Risks Related To Our Industry Compliance with the extensive government regulations to which we are subject is expensive and time consuming, and may result in the delay or cancellation of product sales, introductions or modifications. Our suppliers and sole manufacturer are subject to regulation by the FDA and other agencies, and if they do not meet their commitments, we would have to find substitute suppliers or manufacturers, which could delay the supply of our products to market. We may be required to initiate or defend against legal proceedings related to intellectual property rights, which may result in substantial expense, delay and/or cessation of the development and commercialization of our products. Future acquisitions could disrupt our business and harm our financial condition. If third-party reimbursement and customer contracts are not available, our products may not be accepted in the market. The rising cost of healthcare and related pharmaceutical product pricing has led to cost-containment pressures that could cause us to sell our products at lower prices, resulting in less revenue to us. We face intense competition and rapid technological change that could result in the development of products by others that are superior to the products we are developing. We are exposed to product liability claims, and insurance against these claims may not be available to us on reasonable terms or at all.

Full 10-K form ▸

1159036--3/9/2007--HALOZYME_THERAPEUTICS_INC