1140028--4/2/2007--Hana_Biosciences

related topics

{product, candidate, development}

{property, intellectual, protect}

{acquisition, growth, future}

{product, liability, claim}

{stock, price, operating}

{personnel, key, retain}

{product, market, service}

{stock, price, share}

{financial, litigation, operation}

Risks Related to Our Business We are a development stage company with a limited operating history and may not be able to commercialize any products, generate significant revenues or attain profitability. We may need to raise additional capital to fund our operations. If we are unable to raise additional capital when needed, we may have to discontinue our product development programs or relinquish our rights to some or all of our product candidates. The manner in which we raise any additional funds may affect the value of your investment in our common stock. If we are unable to successfully reformulate Zensana, we may not be able to obtain FDA approval and commercialize this product candidate. If we fail to acquire and develop other product candidates we may be unable to grow our business. If we are unable to successfully manage our growth, our business may be harmed. We rely on key executive officers and their experience and knowledge of our business would be difficult to replace in the event any of them left Hana. If we are unable to hire additional qualified personnel, our ability to grow our business may be harmed. We may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability lawsuits. We may experience difficulty integrating our newly acquired product candidates into our business. Risks Related to the Clinical Testing, Regulatory Approval and Manufacturing of Our Product Candidates If we are unable to obtain regulatory approval to sell our lead product candidate, Marqibo, or any of our other product candidates, our business will suffer. Many of our product candidates are in early stages of clinical trials, which are very expensive and time-consuming. Any failure or delay in completing clinical trials for our product candidates could harm our business. If we do not obtain the necessary U.S. or foreign regulatory approvals to commercialize our product candidates, we will not be able to market and sell our product candidates. Our competitive position may be harmed if a competitor obtains orphan drug designation and approval for the treatment of ALL for a clinically superior drug. Even if we obtain regulatory approvals for our products, the terms of approvals and ongoing monitoring and regulation of our products may limit how we manufacture and market our products, which could materially impair our ability to generate revenue. Because we are dependent on clinical research institutions and other contractors for clinical testing and for research and development activities, the results of our clinical trials and such research activities are, to a certain extent, beyond our control. Our reliance on third parties to formulate and manufacture our product candidates exposes us to a number of risks that may delay the development, regulatory approval and commercialization of our products or result in higher product costs. Risks Related to Our Ability to Commercialize Our Product Candidates Our success depends substantially on Marqibo, which is still under development and requires further regulatory approvals. If we are unable to commercialize Marqibo, or experience significant delays in doing so, our ability to generate product revenue and our likelihood of success will be diminished. If we are unable either to create sales, marketing and distribution capabilities or enter into agreements with third parties to perform these functions, we will be unable to commercialize our product candidates successfully. The terms of our license agreements relating to intellectual property ownership rights may make it more difficult for us to establish collaborations for the development and commercialization of our product candidates. If physicians and patients do not accept and use our product candidates, our ability to generate revenue from sales of our products will be materially impaired. Adequate coverage and reimbursement may not be available for our product candidates, which could diminish our sales or affect our ability to sell our products profitably. If we cannot compete successfully for market share against other drug companies, we may not achieve sufficient product revenues and our business will suffer. Developments by competitors may render our products or technologies obsolete or non-competitive. Risks Related to Our Intellectual Property If we fail to adequately protect or enforce our intellectual property rights or secure rights to patents of others, the value of our intellectual property rights would diminish. Our license agreements relating to our product candidates may be terminated in the event we commit a material breach, the result of which would harm our business and future prospects. Third party claims of intellectual property infringement would require us to spend significant time and money and could prevent us from developing or commercializing our products. Risks Related to Our Securities Our stock price has, and we expect it to continue to, fluctuate significantly, and the value of your investment may decline. If our results do not meet analysts forecasts and expectations, our stock price could decline. We are at risk of securities class action litigation. Because we do not expect to pay dividends, you will not realize any income from an investment in our common stock unless and until you sell your shares at profit.

Full 10-K form ▸

1140028--4/2/2007--Hana_Biosciences_Inc