1140028--3/16/2006--Hana_Biosciences

related topics

{product, candidate, development}

{product, liability, claim}

{stock, price, share}

{personnel, key, retain}

{product, market, service}

{property, intellectual, protect}

{acquisition, growth, future}

{investment, property, distribution}

{control, financial, internal}

Risks Related to Our Business We currently have no product revenues and will need to raise additional capital to operate our business. We are not currently profitable and may never become profitable. We have a limited operating history upon which to base an investment decision. If we do not obtain the necessary U.S. or worldwide regulatory approvals to commercialize our product candidates, we will not be able to market and sell our product candidates. Some of product candidates are in early stages of clinical trials, which are very expensive, time-consuming and difficult to design. We cannot predict with any certainty that we will ever receive regulatory approval to sell our product candidates. If the results of our clinical trials do not support our product candidate claims, the completion of development of such product candidates may be significantly delayed or we may be forced to abandon development altogether, which will significantly impair our ability to generate product revenues. If physicians and patients do not accept and use our drugs, our ability to generate revenue from sales of our products will be materially impaired. 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 intention to rely exclusively 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. We have no experience selling, marketing or distributing products and no internal capability to do so. 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. 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. If we infringe the rights of third parties we could be prevented from selling products, forced to pay damages, and defend against litigation. Our license agreements relating to our product candidates may be terminated in the event we commit a material breach, the result of which would significantly harm our business prospects. Our ability to generate product revenues will be diminished if our drugs sell for inadequate prices or patients are unable to obtain adequate levels of reimbursement. 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 our company. 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. Risks Related to Our Securities Our stock price is, and we expect it to remain, volatile, which could limit investors ability to sell stock at a profit. 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--3/16/2006--Hana_Biosciences_Inc