1159036--3/12/2010--HALOZYME_THERAPEUTICS

related topics

{product, candidate, development}

{product, liability, claim}

{stock, price, share}

{property, intellectual, protect}

{operation, natural, condition}

{personnel, key, retain}

{interest, director, officer}

{acquisition, growth, future}

{competitive, industry, competition}

{stock, price, operating}

If our contract manufacturers are unable to manufacture significant amounts of the API used in our products and product candidates, our product development and commercialization efforts could be delayed or stopped and our collaborative partnerships could be damaged. Our key partners are responsible for providing certain proprietary materials that are essential components of our partnered product candidates, and any failure to supply these materials could delay the development and commercialization efforts for these partnered product candidates and/or damage our collaborative partnerships. If any party to a key collaboration agreement, including us, fails to perform material obligations under such agreement, or if a key collaboration agreement is terminated for any reason, our business would significantly suffer. We may wish to raise funds in the next twelve months, and there can be no assurance that such funds will be available. If we are unable to sufficiently develop our sales, marketing and distribution capabilities or enter into successful agreements with third parties to perform these functions, we will not be able to fully commercialize our products. If we have problems with third parties that either distribute API on our behalf or prepare, fill, finish and package our products and product candidates for distribution, our commercialization and development efforts for our products and product candidates could be delayed or stopped. Most of our current proprietary and partnered products and product candidates rely on the rHuPH20 enzyme. If our proprietary and partnered product candidates do not receive and maintain regulatory approvals, they will not be commercialized, and this failure would substantially impair our ability to generate revenues. Our proprietary and partnered product candidates may not receive regulatory approvals for a variety of reasons, including unsuccessful clinical trials. If we or our partners fail to comply with regulatory requirements, regulatory agencies may take action against us or them, which could significantly harm our business. If proprietary or partnered product candidates are approved by regulatory bodies such as the FDA but do not gain market acceptance, our business may suffer and we may not be able to fund future operations. 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 could negatively affect our business. Our operations might be interrupted by the occurrence of a natural disaster or other catastrophic event. If we or our partners do not achieve projected development goals in the timeframes we publicly announce or otherwise expect, the commercialization of our products and the development of our product candidates may be delayed and, as a result, our stock price may decline. Future acquisitions could disrupt our business and harm our financial condition. Risks Related To Ownership of Our Common Stock Our stock price is subject to significant volatility. Future sales of shares of our common stock pursuant to our universal shelf registration statement may negatively affect our stock price. 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. 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. 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. Patent protection for protein-based therapeutic products and other biotechnology inventions is subject to a great deal of uncertainty, and if patent laws or the interpretation of patent laws change, our competitors may be able to develop and commercialize products based on our discoveries. 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.

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1159036--3/12/2010--HALOZYME_THERAPEUTICS_INC