815508--1/29/2008--BIOPURE

related topics

{product, candidate, development}

{stock, price, share}

{property, intellectual, protect}

{product, liability, claim}

{regulation, government, change}

{control, financial, internal}

{customer, product, revenue}

{cost, operation, labor}

{competitive, industry, competition}

{personnel, key, retain}

{provision, law, control}

{cost, regulation, environmental}

We could fail to remain a going concern. We could fail in financing efforts if we fail to receive stockholder approval when needed. Failure to raise sufficient additional funds will significantly impair or possibly cause us to cease the development, manufacture and sale of our products and our ability to operate. If we fail to obtain FDA approval to market Hemopure, we will be highly adversely affected. If we fail to obtain regulatory approvals in foreign jurisdictions, we will not be able to market Hemopure abroad. Clinical trials are extremely costly and subject to numerous risks and uncertainties. If we do not have the financial resources to fund trials required to develop Hemopure for multiple potential indications, our success will be adversely affected. If the Navy were to abandon its attempt to develop Hemopure for a trauma indication, it would have a serious adverse effect on our prospects. If we cannot retain the personnel we need or if we cannot hire or retain highly qualified people, our operations will suffer. If we cannot generate adequate, profitable sales of Hemopure, we will not be successful. If we cannot find appropriate marketing partners, we may not be able to market and distribute Hemopure effectively. If we cannot obtain market acceptance of Hemopure, we will not be able to generate adequate, profitable sales. If we fail to comply with good manufacturing practices, we may not be able to sell our products. The manufacturing process for Hemopure is complicated and time-consuming, and we may experience problems that would limit our ability to manufacture and sell Hemopure. If we were unable to use our manufacturing facilities in Massachusetts or Pennsylvania, we would not be able to manufacture for an extended period of time. If Hemopure receives regulatory approval in a major market, we will be required to expand our manufacturing capacity to develop our business, which will require substantial third-party financing. Failure to increase our manufacturing capacity and to lower our manufacturing cost per unit may impair market acceptance of Hemopure and prevent us from achieving profitability. Our lack of operating history makes evaluating our business difficult. If we are not able to protect our intellectual property, competition could force us to lower our prices, which might reduce profitability. Failure to avoid infringement of others intellectual property rights could impair our ability to manufacture and market our products. Our operating results will be adversely affected if we incur product liability claims in excess of our insurance coverage. Replacing our sole- source suppliers for key materials could result in unexpected delays and expenses. Changes in the securities laws and regulations are likely to increase our costs. Provisions of our restated certificate of incorporation and by-laws could impair or delay stockholders ability to replace or remove our management and could discourage takeover transactions that a stockholder might consider to be in its best interest. Intense competition could harm our financial performance. Stringent, ongoing government regulation and inspection of our facilities could lead to delays in the manufacture, marketing and sale of our products. Health care reform and controls on health care spending may limit the price we can charge for Hemopure and the amount we can sell. Uncertainty of third-party reimbursement could affect our profitability. The Nasdaq Capital Market may cease to list our Class A common stock which may cause the value of an investment in our Company to substantially decrease. As we sell additional shares, our stock price may decline as a result of the dilution which will occur to existing stockholders. Shares eligible for future sale may cause the market price for our common stock to drop significantly, even if our business is doing well. Our stock price has been and may continue to be highly volatile, which may adversely affect holders of our stock and our ability to raise capital.

Full 10-K form ▸

815508--1/29/2008--BIOPURE_CORP