815508--1/17/2006--BIOPURE

related topics

{product, candidate, development}

{stock, price, share}

{product, liability, claim}

{financial, litigation, operation}

{property, intellectual, protect}

{regulation, government, change}

{control, financial, internal}

{cost, operation, labor}

{customer, product, revenue}

{personnel, key, retain}

{provision, law, control}

{competitive, industry, competition}

{cost, contract, operation}

{interest, director, officer}

{cost, regulation, environmental}

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. Our auditors have modified their report for our fiscal year ended October 31, 2005 with respect to our ability to continue as a going concern. This modification may negatively impact our capital raising efforts. If we cannot retain the personnel we need, our costs will rise significantly. If we cannot hire or retain the best people, our operations will suffer. We may fail to obtain FDA approval for Hemopure, in which event we cannot market Hemopure in the United States, which would have negative consequences for the Company. 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 as a company will be adversely affected. The Securities and Exchange Commission has filed a civil injunctive proceeding against us, two of our former officers and one of our current officers. We and several of our former and current officers and directors are subject to consolidated class action lawsuits, and we and several of our former and current directors and officers are subject to consolidated derivative actions. The litigation matters described under Item 3. Legal Proceedings , and any other litigation matters with which we become involved, may harm our business and financial condition if they result in substantial fines, judgments or settlements that exceed the amount of coverage under our insurance policies, or if such fines, judgments or settlements are not covered by our insurance policies. If we cannot find appropriate marketing partners, we may not be able to market and distribute Hemopure effectively. If we cannot generate adequate, profitable sales of Hemopure, we will not be successful. 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, we must expand our manufacturing capacity to develop our business, which will require substantial third party financing. Failure to increase our manufacturing capacity may impair Hemopure s market acceptance and prevent us from achieving profitability. If we are not able to finance additional manufacturing capacity, we will incur a substantial write-off of assets. 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 profitability 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 products 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. We may not continue to qualify for continued listing on the Nasdaq National Market, which may cause the value of your 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--1/17/2006--BIOPURE_CORP