1097264--3/1/2010--ALLOS_THERAPEUTICS

related topics

{product, candidate, development}

{product, liability, claim}

{stock, price, share}

{stock, price, operating}

{provision, law, control}

{control, financial, internal}

{acquisition, growth, future}

{regulation, government, change}

{condition, economic, financial}

{system, service, information}

{personnel, key, retain}

{property, intellectual, protect}

{customer, product, revenue}

{regulation, change, law}

We have a history of net losses and an accumulated deficit, and we may never generate sufficient revenue to achieve or maintain profitability in the future. Our near-term prospects are dependent on FOLOTYN. If we are unable to successfully commercialize FOLOTYN for the treatment of patients with relapsed or refractory PTCL, our ability to generate significant revenue or achieve profitability will be adversely affected. Our operating results are unpredictable and may fluctuate. If our operating results are below the expectations of securities analysts or investors, the trading price of our stock could decline. If we are unable to maintain adequate sales, marketing or distribution capabilities or enter into agreements with third parties to perform some of these functions, we will not be able to commercialize FOLOTYN effectively. Even though we have obtained accelerated approval to market FOLOTYN for the treatment of patients with relapsed or refractory PTCL, we are subject to ongoing regulatory obligations and review, including post-approval requirements. The status of coverage and reimbursement from third-party payers for newly approved health care drugs is uncertain and failure to obtain adequate coverage and reimbursement could limit our ability to generate revenue. We are dependent upon a small number of customers for a significant portion of our revenue, and the loss of, or significant reduction or cancellation in sales to, any one of these customers could adversely affect our operations and financial condition. If the distributors that we rely upon to sell FOLOTYN fail to perform, our business may be adversely affected. If we fail to comply with healthcare fraud and abuse laws, we could face substantial penalties and our business, operations and financial condition could be adversely affected. If our competitors develop and market products that are more effective than FOLOTYN, our commercial opportunity will be reduced or eliminated. We cannot predict when or if we will obtain regulatory approval to market FOLOTYN in the United States for any additional indications or in any other countries. Reports of adverse events or safety concerns involving FOLOTYN or in related technology fields or other companies' clinical trials of similar small molecule chemotherapeutic agents could delay or prevent us from obtaining or maintaining regulatory approval or negatively impact public perception of FOLOTYN. If FOLOTYN fails to meet safety or efficacy endpoints in clinical trials for additional indications, it will not receive regulatory approval and we will be unable to market FOLOTYN for those indications studied. Even if FOLOTYN meets safety and efficacy endpoints in clinical trials for additional indications, regulatory authorities may not approve FOLOTYN, or we may face post-approval problems that require withdrawal of FOLOTYN from the market. We may experience delays in our clinical trials that could adversely affect our financial position and our commercial prospects. We may be required to suspend, repeat or terminate our clinical trials if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive or the trials are not well designed. Due to our reliance on contract research organizations and other third parties to conduct our clinical trials, we are unable to directly control the timing, conduct and expense of our clinical trials. We may need to raise additional capital to support our future operations. If we fail to obtain the capital necessary to fund our operations, we will be unable to successfully develop or commercialize FOLOTYN. Budget constraints may force us to delay our efforts to develop FOLOTYN for additional indications while we complete the post-approval clinical studies required by the FDA, which may prevent us from commercializing FOLOTYN for all desired indications as quickly as possible. We do not have manufacturing facilities or capabilities and are dependent on third parties to fulfill our manufacturing needs, which could result in the delay of clinical trials, regulatory approvals, product introductions and commercial sales. If we are unable to effectively protect our intellectual property, we will be unable to prevent third parties from using our technology, which would impair our competitiveness and ability to commercialize FOLOTYN. In addition, enforcing our proprietary rights may be expensive and result in increased losses. We may explore strategic partnerships that may never materialize or may fail. If we enter into one or more strategic partnerships, we may be required to relinquish important rights to and control over the development of FOLOTYN or otherwise be subject to unfavorable terms. Health care reform measures could adversely affect our business. We may not obtain orphan drug exclusivity or we may not receive the full benefit of orphan drug exclusivity even if we obtain such exclusivity. If product liability lawsuits are successfully brought against us, we may incur substantial liabilities and may be required to limit commercialization of FOLOTYN. Our success depends on the retention of our President and Chief Executive Officer and other key personnel. We cannot guarantee that we will be in compliance with all potentially applicable regulations. If our internal controls over financial reporting are not considered effective, our business and stock price could be adversely affected. Our revenue recognition model under the sell-through method is complex and depends upon the accuracy and consistency of third party data as well as dependence upon key finance and accounting personnel to maintain and implement the surrounding controls. If we do not progress in our programs as anticipated, our stock price could decrease. Warburg Pincus Private Equity VIII, L.P. controls a substantial percentage of the voting power of our outstanding common stock. Anti-takeover provisions in our charter documents and under Delaware law could discourage, delay or prevent an acquisition of us, even if an acquisition would be beneficial to our stockholders, and may prevent attempts by our stockholders to replace or remove our current management. We have adopted a stockholder rights plan that may discourage, delay or prevent a merger or acquisition that is beneficial to our stockholders. Unstable market conditions may have serious adverse consequences on our business. The market price for our common stock has been and may continue to be highly volatile, and an active trading market for our common stock may never exist. Substantial sales of shares may impact the market price of our common stock.

Full 10-K form ▸

1097264--3/1/2010--ALLOS_THERAPEUTICS_INC