1088856--3/31/2009--CORCEPT_THERAPEUTICS_INC

related topics
{product, liability, claim}
{product, candidate, development}
{stock, price, operating}
{stock, price, share}
{regulation, change, law}
{financial, litigation, operation}
{cost, operation, labor}
{property, intellectual, protect}
{provision, law, control}
{control, financial, internal}
{operation, natural, condition}
{personnel, key, retain}
{product, market, service}
{system, service, information}
{acquisition, growth, future}
{debt, indebtedness, cash}
Risks Related to Our Business We will depend heavily on the success of our lead product candidate, CORLUX, in development for the treatment of the psychotic features of psychotic depression and for the treatment of Cushing s Syndrome. Our first three Phase 3 trials in psychotic depression did not meet their primary and key secondary endpoints. If we are unable to commercialize CORLUX for the psychotic depression indication or for Cushing s Syndrome, or experience significant delays in doing so, we may be unable to generate revenues and our stock price may decline. Our clinical trials may not demonstrate that CORLUX is safe and effective. If our clinical program for CORLUX for the treatment of the psychotic features of psychotic depression, for Cushing s Syndrome or for any other indications does not demonstrate safety and efficacy, our business will be harmed. The development plan for CORLUX is not certain, and will require additional, expensive clinical and preclinical trials. We may not be able to finance the development programs. We will need additional capital in order to complete the development and commercialization of CORLUX and our other proprietary, selective GR-II antagonists. Additional capital may not be available to us at all or on favorable terms. The Committed Equity Financing Facility (CEFF) that we entered into with Kingsbridge on March 25, 2008 may not be available to us at certain times, may generate a lower level of funding than we anticipate, may require us to make additional blackout or other payments to Kingsbridge, and will result in dilution to our stockholders. We may not be able to pursue all of our product research and development opportunities if we are unable to secure adequate funding for these programs. Although our pivotal Phase 3 clinical trial in Cushing s Syndrome only requires 50 patients, both site selection and enrollment could be an extended process. Delays in selection and initiation of clinical trial sites and/or patient enrollment could extend the time and cost for completion or inhibit our ability to complete the trial at all. We have incurred losses since inception and anticipate that we will incur continued losses for the foreseeable future. We depend on clinical investigators and clinical sites to enroll patients in our clinical trials and other third parties to manage the trials and to perform related data collection and analysis, and, as a result, we may face costs and delays outside of our control. In Study 14, our ongoing clinical trial evaluating CORLUX for the psychotic features of psychotic depression, we have engaged MedAvante to provide centralized psychiatric rating services. If patients are uncomfortable or unwilling to participate in the centralized rating process or if MedAvante is unable to provide services in a satisfactory manner over the course of the trial, we may not see any improvement in the accuracy and consistency of the psychiatric assessments. The use of psychiatric rating services provided by a third-party, MedAvante, as an additional screening element may continue to slow the pace of enrollment in Study 14. If we are unable to obtain or maintain regulatory approval, we will be limited in our ability to commercialize our product candidates, including CORLUX, and our business will be harmed. Failure to obtain regulatory approval in foreign jurisdictions will prevent us from commercializing our product candidates abroad. The fast track designation for the development program of CORLUX for the treatment of the psychotic features of psychotic depression may not lead to a faster development or regulatory review or approval process. Even if we receive approval for the marketing and sale of CORLUX for the treatment of the psychotic features of psychotic depression, or endogenous Cushing s Syndrome, CORLUX may never be accepted as a treatment for the approved indications. Public perception of the active ingredient in CORLUX, mifepristone or RU-486, may limit our ability to market and sell CORLUX. We have no manufacturing capabilities and we currently depend on third parties to manufacture the active ingredient and the tablets for CORLUX. The tablet manufacturer is a single source supplier. If these suppliers are unable to continue manufacturing CORLUX and we are unable to contract quickly with alternative sources, our business will be harmed. If our third-party manufacturers of CORLUX fail to comply with FDA regulations or otherwise fail to meet our requirements, our product development and commercialization efforts may be delayed. If we or others identify side effects after our product candidates are on the market, we may be required to perform lengthy additional clinical trials, change the labeling of our future products or withdraw our future products from the market, any of which would hinder or preclude our ability to generate revenues. If CORLUX or future product candidates conflict with the patents of others or if we become involved in other intellectual property disputes, we could have to engage in costly litigation or obtain a license and we may be unable to commercialize our product candidates. If we are unable to protect our trade secrets and proprietary information, our ability to compete in the market could be diminished. Our licensed patent covering the use of mifepristone to treat psychotic depression is a method of use patent rather than a composition of matter patent, which increases the risk that physicians will prescribe another manufacturer s mifepristone for the treatment of psychotic depression rather than CORLUX. The composition of matter patents on our families of novel selective glucocorticoid antagonists may not be issued and we would not be able to prevent competition from others. We may be subject to fines, penalties or injunctions if we are determined to be promoting the use of our products for unapproved or off-label uses, resulting in damage to our reputation and business. Our efforts to discover, develop and commercialize new product candidates beyond CORLUX are at a very early stage. If we fail to identify and develop additional uses for GR-II antagonists, we may be unable to market additional products. We may have substantial exposure to product liability claims and may not have adequate insurance to cover those claims. If CORLUX is approved and we are unable to obtain acceptable prices or adequate coverage and reimbursement for it from third-party payors, we will be unable to generate significant revenues. We face competition from companies with substantial financial, technical and marketing resources, which could limit our future revenues from the commercialization of CORLUX for the treatment of the psychotic features of psychotic depression or for other indications. We may face competition from other companies who attempt to develop mifepristone for the treatment of Cushing s Syndrome, which could limit our future revenues from the commercialization of CORLUX for the treatment of that disorder and which could have a negative impact on future revenues from the commercialization of CORLUX for any indication. Rapid technological change could make our product candidates obsolete. We have no sales staff and limited marketing activities and will need to develop sales and marketing capabilities to successfully commercialize CORLUX and any future uses of GR-II antagonists. We may need to increase the size of our organization, and we may experience difficulties in managing growth. If we lose our key personnel or are unable to attract and retain additional skilled personnel, we may be unable to pursue our product development and commercialization efforts. If we acquire other GR-II antagonists or other technologies or potential products, we will incur a variety of costs and may never realize the anticipated benefits of the acquisition. The occurrence of a catastrophic disaster or other similar events could cause damage to our or our manufacturers facilities and equipment, which could require us to cease or curtail operations. Risks Related to Our Stock The market price of our common stock may be highly volatile due to the limited number of shares of our common stock held by non-affiliates of the Company or factors influencing the stock market and opportunities for sale at any given time may be limited. If we fail to continue to meet all applicable Nasdaq Capital Market requirements, our stock could be delisted by the Nasdaq Capital Market. If delisting occurs, it would adversely affect the market liquidity of our common stock and harm our business. Securities analysts may not continue to provide or initiate coverage of our common stock or may issue negative reports, and this may have a negative impact on our common stock s market price. A sale of a substantial number of shares of our common stock may cause the price of our common stock to decline. We may be required to pay significant amounts if we are not able to meet our obligations under our outstanding registration rights agreements. Our officers, directors and principal stockholders acting as a group, will be able to significantly influence corporate actions. We may incur increased costs as a result of recently enacted and proposed changes in laws and regulations. Compliance with public company obligations, including the securities laws and regulations, is costly and requires significant management resources, and we may fail to comply. Changes in or interpretations of accounting rules and regulations, such as expensing of stock options, could result in unfavorable accounting charges or require us to change our compensation policies. Anti-takeover provisions in our charter and bylaws and under Delaware law may make an acquisition of us or a change in our management more difficult, even if an acquisition or a management change would be beneficial to our stockholders.

Full 10-K form ▸

related documents
1088856--3/26/2010--CORCEPT_THERAPEUTICS_INC
1008848--2/26/2010--ACORDA_THERAPEUTICS_INC
1411861--3/10/2010--MAKO_Surgical_Corp.
1161924--3/26/2007--ADVANCIS_PHARMACEUTICAL_CORP
1113481--2/29/2008--MEDICINES_CO_/DE
1411861--3/31/2008--MAKO_Surgical_Corp.
1354217--3/17/2008--Volcano_CORP
946840--3/2/2009--VIROPHARMA_INC
1113481--3/16/2010--MEDICINES_CO_/DE
1088856--3/31/2008--CORCEPT_THERAPEUTICS_INC
1088856--4/2/2007--CORCEPT_THERAPEUTICS_INC
1113481--3/1/2007--MEDICINES_CO_/DE
927829--3/8/2007--NITROMED_INC
927829--3/2/2006--NITROMED_INC
1048477--2/28/2007--BIOMARIN_PHARMACEUTICAL_INC
1048477--3/7/2006--BIOMARIN_PHARMACEUTICAL_INC
1113481--3/2/2009--MEDICINES_CO_/DE
1354217--3/23/2007--Volcano_CORP
1411861--3/12/2009--MAKO_Surgical_Corp.
907562--3/12/2010--DYAX_CORP
1051514--3/2/2009--ELECTRO_OPTICAL_SCIENCES_INC_/NY
1276591--2/28/2008--HANSEN_MEDICAL_INC
1180145--9/29/2009--Cardiovascular_Systems_Inc
1100962--3/1/2007--ENDO_PHARMACEUTICALS_HOLDINGS_INC
1051514--3/4/2010--ELECTRO_OPTICAL_SCIENCES_INC_/NY
1100962--2/26/2008--ENDO_PHARMACEUTICALS_HOLDINGS_INC
722104--3/1/2010--SAVIENT_PHARMACEUTICALS_INC
899866--2/23/2010--ALEXION_PHARMACEUTICALS_INC
1235010--3/12/2010--MOMENTA_PHARMACEUTICALS_INC
874255--3/2/2009--MEDAREX_INC