If health care reform measures are enacted, our operating results and our ability to commercialize products could be adversely
In recent years, there have been numerous proposals to change the health care system in the U.S. and in other jurisdictions.
Some ofthese proposals have included measures that would change the nature of and regulatory requirements relating to drug discovery, clinical testingand regulatory approvals, limit or eliminate payments for medical procedures and treatments, or subject the pricing of pharmaceuticals togovernment control. Outside the U.S., and particularly in the E.U., the pricing of prescription pharmaceuticals is subject to governmentalcontrol. In addition, as a result of the trend towards managed health care in the U.S., as well as legislative proposals to reduce governmentnsurance programs, third-party payors are increasingly attempting to contain health care costs by limiting both coverage and the level ofreimbursement of new drug products, including relatively expensive products which may be perceived to provide relatively limited benefits topatients with potentially terminal conditions. Consequently, significant uncertainty exists as to the reimbursement status of newly approvedhealth care products.
If we or any of our collaborators succeed in bringing one or more of our product candidates to market, third party payors may establish and maintain price levels insufficient for us to realize an appropriate return on our investment in product development. Significant changes in the health care system in the U.S. or elsewhere, including changes resulting from adverse trends in third-party reimbursement programs, couldhave a material adverse effect on our operating results and our ability to raise capital and commercialize products.
A substantial portion of our past funding has come from federal government grants and research contracts. We cannot rely on these grants or contracts as a continuing source of funds.
A portion of our revenues to date has been derived from federal government grants and research contracts. During the last three years,we generated revenues from awards made to us by the NIH to partially fund some of our programs. Most of these resources have been directedtoward candidates which we have discontinued work on or are now seeking to out-license. In any event, we cannot rely on grants or additionalcontracts as a continuing source of funds, as funds available under these grants and/or contracts must be applied toward the research anddevelopment programs specified by the government rather than for all our programs generally, and are subject to adjustment based on theresults of periodic audits. The government’s obligation to make payments under these grants and/or contracts is subject to appropriation by theU.S. Congress for funding in each year, which is subject to being scaled back due to budgetary constraints. We have a history of operating losses.
Progenics has incurred substantial losses since its founding. A large portion of our revenues has historically consisted of upfront andmilestone payments from licensing transactions. While we reported a profit in 2011 as a result of the upfront payment we received from Salix,the timing and amount of such transactions is highly unpredictable and uncertain. We have derived no significant revenues from product salesand have only in the last several years derived revenue from royalties. We may not achieve significant product sales or royalty revenue for anumber of years, if ever. We expect to incur operating losses in the future, which could increase significantly if we expand our clinical trialprograms and other product development efforts. Our ability to achieve and sustain profitability is dependent in part on obtaining regulatoryapproval for and then commercializing our products, either alone or with others. We may not be able to develop and commercialize productsbeyond subcutaneous RELISTOR. Our operations may not be profitable even if any of our other products under development arecommercialized.Our stock price has a history of volatility and may be affected by selling pressure. You should consider an investment in our stock as
risky and invest only if you can withstand a significant loss.
Our stock price has a history of significant volatility. At times, our stock price has been volatile even in the absence of significant news or developments. The stock prices of biotechnology companies and securities markets generally have been subject to dramatic priceswings in recent years, and financial and market conditions during that period have resulted in widespread pressures on securities of issuersthroughout the world economy. Factors that may have a significant impact on the market price of our common stock include the results ofclinical trials and pre-clinical studies undertaken by us or others; delays, terminations or other changes in development programs; developmentsin marketing approval efforts; developments in collaborator or other business relationships, particularly regarding RELISTOR, PSMA ADC orother significant products or programs; technological innovation or product announcements by us, our collaborators or our competitors; patentor other proprietary rights developments; governmental regulation; changes in reimbursement policies or health care legislation; safety andefficacy concerns about products developed by us, our collaborators or our competitors;our ability to fund ongoing operations;fluctuations inour operating results; purchases we may make under our 2008 share repurchase program, or discontinuation of any such purchases; and general market conditions.