920465--3/13/2006--LA_JOLLA_PHARMACEUTICAL

related topics

{product, candidate, development}

{stock, price, share}

{control, financial, internal}

{personnel, key, retain}

{acquisition, growth, future}

{customer, product, revenue}

{product, liability, claim}

{product, market, service}

{property, intellectual, protect}

{interest, director, officer}

{regulation, government, change}

{cost, regulation, environmental}

{operation, natural, condition}

{stock, price, operating}

In order to complete our ongoing clinical trial of Riquent, we will need to enroll a sufficient number of patients who meet the trial criteria. If we are unable to successfully complete the trial, our business will be adversely affected and it may be difficult or impossible for us to continue to operate. Current and future clinical trials may be delayed or halted. We may be required to design and conduct additional trials. The technology underlying our products is uncertain and unproven. We may experience shortages of Riquent for use in our clinical studies. If we encounter delays or difficulties in establishing or maintaining relationships with manufacturing or distribution contractors, our ability to timely complete necessary clinical trials and potentially deliver commercial products may be negatively affected. Our limited manufacturing capabilities and experience could result in shortages of drugs for future sale, and our revenues and profit margin could be negatively affected. Our suppliers may not be able to provide us with sufficient quantities of materials that we may need to manufacture our products. An interruption in the operation of our sole manufacturing facility could disrupt our operations. If we are to obtain regulatory approval of Riquent, we must validate our manufacturing facilities and processes. We are currently devoting nearly all of our resources to the development and approval of Riquent. Accordingly, our efforts with respect to other drug candidates have significantly diminished. Our operations depend on key employees. Losing these employees would have a negative effect on our product development and operations. Retaining our current personnel and recruiting additional personnel will be critical to our success. Our efforts to obtain approval to market Riquent in Europe may be delayed or unsuccessful. We may not have sufficient financial resources to complete the ongoing Phase 3 clinical benefit trial of Riquent. We will need additional funds to support our operations. We may need to sell stock or assets, enter into collaborative agreements, significantly reduce our operations, or merge with another entity to continue operations. Our freedom to operate our business or profit fully from sales of our products may be limited if we enter into collaborative agreements. Our blood test to measure the binding affinity for Riquent has not been validated by independent laboratories and is likely to require regulatory review as part of the Riquent approval process. Any regulatory approvals that we may obtain for our product candidates may be limited and subsequent issues regarding safety or efficacy could cause us to remove products from the market. Even if we receive regulatory approval for our product candidates, we will be subject to ongoing regulatory obligations and review. The size of the market for our potential products is uncertain. Our drugs may not achieve market acceptance. We lack experience in marketing products for commercial sale. We may not earn as much income as we hope due to possible changes in healthcare reimbursement policies. We have a history of losses and may not become profitable. Our success in developing and marketing our drug candidates depends significantly on our ability to obtain patent protection for Riquent and any other developed products. In addition, we will need to successfully preserve our trade secrets and operate without infringing on the rights of others. Because a number of companies compete with us, many of which have greater resources than we do, and because we face rapid changes in technology in our industry, we cannot be certain that our products will be accepted in the marketplace or capture market share. We may not be able to take advantage of the orphan drug designation for Riquent. The use of Riquent or other potential products in clinical trials, as well as the sale of any approved products, may expose us to lawsuits resulting from the use of these products. We face environmental liabilities related to certain hazardous materials used in our operations. II. RISK FACTORS RELATED SPECIFICALLY TO OUR STOCK. Our stock may be removed from listing on the Nasdaq quotation system and may not qualify for listing on any stock exchange, in which case it may be difficult to maintain a market in our stock. The ownership of our common stock is concentrated. Our common stock price is volatile and may decline even if our business is doing well. Future sales of our stock by our stockholders could negatively affect the market price of our stock. Failure to achieve and maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act could have a material adverse effect on our business and stock price.

Full 10-K form ▸

920465--3/13/2006--LA_JOLLA_PHARMACEUTICAL_CO