Corcept Therapeutics
Annual Report 2010

Plain-text annual report

Table of Contents UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549 FORM 10-K xANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the fiscal year ended December 31, 2010or ¨TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF1934For the transition period from toCommission File Number: 000-50679CORCEPT THERAPEUTICS INCORPORATED(Exact Name of Corporation as Specified in Its Charter) Delaware 77-0487658(State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.)149 Commonwealth DriveMenlo Park, CA 94025(Address of principal executive offices) (zip code) (650) 327-3270(Registrant’s telephone number, including area code) Securities registered pursuant to Section 12 (b) of the Act: Title of Each Class: Name of Each Exchange on which Registered:Common Stock, $0.001 par value The NASDAQ Capital MarketSecurities registered pursuant to Section 12 (g) of the Act:NoneIndicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ¨ No xIndicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 (d) of the Act. Yes ¨ No xIndicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filingrequirements for the past 90 days. Yes x No ¨Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data Filerequired to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorterperiod that the registrant was required to submit and post such files). Yes ¨ No ¨Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to thebest of the Registrant’s knowledge, in definitive proxy or information statements incorporated by reference to Part III of this Form 10-K or any amendment tothis Form 10-K. ¨Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. Seethe definitions of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.Large accelerated filer ¨ Accelerated filer xNon-accelerated filer ¨ (Do not check if a smaller reporting company) Smaller reporting company xIndicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No xThe aggregate market value of voting and non-voting common equity held by non-affiliates of the Registrant was approximately $119,000,000 as ofJune 30, 2010 based upon the closing price on the Nasdaq Capital Market reported for such date. This calculation does not reflect a determination thatcertain persons are affiliates of the Registrant for any other purpose.On March 8, 2011 there were 83,968,540 shares of common stock outstanding at a par value of $0.001 per share.DOCUMENTS INCORPORATED BY REFERENCEPortions of the Registrant’s definitive proxy statement for its 2011 Annual Meeting of Stockholders are incorporated by reference in Items 10, 11, 12, 13and 14 of Part III.EXPLANATORY NOTEThe Registrant meets the “accelerated filer” requirements as of the end of its 2010 fiscal year pursuant to Rule 12b-2 of the Securities Exchange Act of1934, as amended. However, pursuant to Rule 12b-2 and SEC Release No. 33-8876, the Registrant (as a smaller reporting company transitioning to the largerreporting company system based on its public float as of June 30, 2010) is not required to satisfy the larger reporting company requirements until its firstquarterly report on Form 10-Q for the 2011 fiscal year and is thus eligible to check the “Smaller Reporting Company” box on the cover of this Form 10-K. Table of ContentsTABLE OF CONTENTSForm 10-KFor the year ended December 31, 2010 Page PART I ITEM 1. Business 1 ITEM 1A. Risk Factors 23 ITEM 1B. Unresolved Staff Comments 45 ITEM 2. Properties 45 ITEM 3. Legal Proceedings 45 ITEM 4. (Removed and Reserved) 45 PART II ITEM 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 46 ITEM 6. Selected Financial Data 48 ITEM 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 49 ITEM 7A. Quantitative and Qualitative Disclosures About Market Risk 61 ITEM 8. Financial Statements and Supplementary Data 62 ITEM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 62 ITEM 9A. Controls and Procedures 62 ITEM 9B. Other Information 64 PART III ITEM 10. Directors, Executive Officers and Corporate Governance 65 ITEM 11. Executive Compensation 65 ITEM 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 65 ITEM 13. Certain Relationships and Related Transactions, and Director Independence 65 ITEM 14. Principal Accounting Fees and Services 65 PART IV ITEM 15. Exhibits, Financial Statement Schedules 66 Signatures and Power of Attorney 70 Table of ContentsPART IThis Annual Report on Form 10-K (Form 10-K) contains forward-looking statements within the meaning of Section 21E of the Securities ExchangeAct of 1934, as amended (Exchange Act), and Section 27A of the Securities Act of 1933, as amended (Securities Act). All statements contained in this Form10-K, other than statements of historical fact, are forward-looking statements. When used in this report or elsewhere by management from time to time, thewords “believe,” “anticipate,” “intend,” “plan,” “estimate,” “expect,” “may,” “will,” “should,” “seeks” and similar expressions are forward-lookingstatements. Such forward-looking statements are based on current expectations, but the absence of these words does not necessarily mean that a statement isnot forward-looking. Forward-looking statements made in this Form 10-K include, but are not limited to, statements about: • the progress and timing of our research, development and clinical programs and the timing of regulatory activities, including the anticipatedsubmission of the New Drug Application (NDA) for CORLUX for the treatment of Cushing’s Syndrome to the United States Food and DrugAdministration (FDA), the acceptance of that NDA for filing by the FDA and the review and approval of the NDA by the FDA; • our estimates of the dates by which we expect to report results of our clinical trials and the anticipated results of these trials; • the timing of market introduction of CORLUX and future product candidates, including CORT 108297 and CORT 113083; • our ability to market, commercialize and achieve market acceptance for CORLUX or other future product candidates, including CORT 108297 andCORT 113083; • uncertainties associated with obtaining and enforcing patents; • our estimates for future performance; and • our estimates regarding our capital requirements and our needs for, and ability to obtain, additional financing.Forward-looking statements are not guarantees of future performance and involve risks and uncertainties. Actual events or results may differmaterially from those discussed in the forward-looking statements as a result of various factors. For a more detailed discussion of such forward-lookingstatements and the potential risks and uncertainties that may impact upon their accuracy, see the “Risk Factors” section of this Form 10-K and the“Overview” and “Liquidity and Capital Resources” sections of the “Management’s Discussion and Analysis of Financial Condition and Results ofOperations” section of this Form 10-K. These forward-looking statements reflect our view only as of the date of this report. Except as required by law, weundertake no obligations to update any forward-looking statements. Accordingly, you should also carefully consider the factors set forth in other reports ordocuments that we file from time to time with the Securities and Exchange Commission (SEC). ITEM 1.BUSINESSOverviewWe are a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic andpsychiatric disorders. Our focus is on those disorders that are associated with a steroid hormone called cortisol. Elevated levels and abnormal release patternsof cortisol have been implicated in a broad range of human disorders. Since our inception in May 1998, we have been developing our lead product,CORLUX, a potent glucocorticoid receptor II (GR-II) antagonist that blocks the activity of cortisol. We have also discovered three series of novel selectiveGR-II antagonists and have moved CORT 108297, a compound from one of these series, into clinical development. Unless otherwise stated, all references inthis document to “we,” “us,” “our,” “its,” “Corcept,” the “Company” and similar designations refer to Corcept Therapeutics Incorporated. 1®Table of ContentsCushing’s Syndrome. Cushing’s Syndrome is a disorder caused by prolonged exposure of the body’s tissues to high levels of the hormone cortisol.Sometimes called “hypercortisolism,” it is relatively uncommon and most often affects adults aged 20 to 50. An estimated 10 to 15 of every one millionpeople are newly diagnosed with this syndrome each year, resulting in approximately 3,000 new patients and an estimated prevalence of 20,000 patients withCushing’s Syndrome in the United States.The Investigational New Drug application (IND) for the evaluation of CORLUX for the treatment of the signs and symptoms of Cushing’s Syndromewas opened in September 2007. The United States Food and Drug Administration (FDA) indicated that our single 50-patient open-label study may provide areasonable basis for the submission of a New Drug Application (NDA) for this indication. We completed enrollment in this Phase 3 study in June 2010. Thisopen-label Phase 3 study evaluated the response of two patient groups to CORLUX treatment: one included patients who were glucose intolerant, regardlessof blood pressure level, and one included patients who had been diagnosed with hypertension but had normal glucose tolerance. The patients in both of thesegroups were being treated for their symptoms before study entry; CORLUX was added to their existing medications. On December 22, 2010, we announcedthat both groups in this study achieved their primary endpoints. After this announcement, we determined that one patient did not fully adhere to the protocolfor this study and have since then revised our calculation of the percentage of patients in the hypertensive group meeting the primary endpoint. This did notimpact our determination that this group achieved its primary endpoint. On January 11, 2011, we announced positive results for the key secondary endpointof global clinical improvement. For this endpoint all of the patients in the study were included in one group.Statistically significant improvement in the primary endpoint was achieved for each group with 60% responding in the glucose intolerant group and38% responding in the hypertensive group. The patients in the study, whether included in the “glucose intolerant group” or the “hypertensive group” for thepurpose of evaluating the primary endpoints, were evaluated as a single group on the key secondary endpoint of “global clinical improvement”; 87% ofpatients showed significant clinical improvement as evaluated by an independent board of three physicians highly experienced in the treatment of Cushing’sSyndrome. An initial review of safety data indicates that CORLUX had an acceptable risk-benefit profile in this Phase 3 study. Adverse events related totreatment included signs and symptoms of adrenal insufficiency, endometrial thickening, and hypokalemia, all of which were consistent with earlierpublished reports. The majority of the serious adverse events (SAEs) reported in the study were not related to CORLUX treatment, as determined by theclinical investigators. All of the treatment-related SAEs resolved with clinical management. Eighty-eight percent of the patients who completed the Phase 3study opted to enter the long-term extension study. We expect to submit our NDA for the use of CORLUX in Cushing’s Syndrome by the end of the firstquarter of 2011 and plan to present detailed data from the Phase 3 trial at scientific conferences during 2011.In July 2007, we received Orphan Drug Designation from the FDA for CORLUX for the treatment of endogenous Cushing’s Syndrome. Orphan DrugDesignation is a special status granted by the FDA to encourage the development of treatments for diseases or conditions that affect fewer than 200,000patients in the United States. Drugs that receive Orphan Drug Designation obtain seven years of marketing exclusivity from the date of drug approval, as wellas tax credits for clinical trial costs, marketing application filing fee waivers and assistance from the FDA in the drug development process.Psychotic Depression. We are developing CORLUX for the treatment of the psychotic features of psychotic major depression under an exclusivepatent license from Stanford University. Psychotic major depression will hereafter be referred to as psychotic depression. The FDA has granted “fast track”status to evaluate the safety and efficacy of CORLUX for the treatment of the psychotic features of psychotic depression.In March 2008, we began enrollment in Study 14, our ongoing Phase 3 trial in psychotic depression. The protocol for this trial incorporates what wehave learned from our three previously completed Phase 3 trials. It attempts to address the established relationship between increased drug plasma levels andclinical response and attempts to decrease the random variability observed in the results of the psychometric instruments used to 2Table of Contentsmeasure efficacy. In one of the previously completed Phase 3 trials, Study 06, we prospectively tested and confirmed that patients whose plasma levels roseabove a predetermined threshold statistically separated from both those patients whose plasma levels were below the threshold and those patients whoreceived placebo; this threshold was established from data produced in earlier studies.As expected, patients who took 1200 milligrams (mg) of CORLUX in Study 06 developed higher drug plasma levels than patients who received lowerdoses. Further, there was no discernable difference in the incidence of adverse events between patients who received placebo in Study 06 and those whoreceived 300 mg, 600 mg or 1200 mg of CORLUX in that study. Based on this information, we are using a CORLUX dose of 1200 mg once per day for sevendays in Study 14.In addition, we also are utilizing a third party centralized rating service to independently evaluate the patients for entry into the study as well as toevaluate their level of response throughout their participation in the study. We believe the centralization of this process will improve the consistency ofrating across clinical trial sites and reduce the background noise that was experienced in earlier studies and is endemic to psychopharmacologic studies. Webelieve that this change in dose, as well as the other modifications to the protocol, should allow us to demonstrate the efficacy of CORLUX in the treatmentof the psychotic symptoms of psychotic depression. In mid-2009, in order to conserve financial resources, we reduced the number of clinical sites in thisstudy to eight and extended the timeline for its completion.Antipsychotic-induced Weight Gain Mitigation. In 2005, we published the results of studies in rats that demonstrated that CORLUX both reversedthe weight gain associated with the ongoing use of olanzapine and mitigated the weight gain associated with the initiation of treatment with olanzapine (theactive ingredient in Zyprexa). This study was paid for by Eli Lilly and Company (Eli Lilly).During 2007 we announced positive results from our clinical proof-of-concept study in lean healthy male volunteers evaluating the ability ofCORLUX to mitigate weight gain associated with the use of Zyprexa. The results show a statistically significant reduction in weight gain in those subjectswho took Zyprexa plus CORLUX compared to those who took Zyprexa plus placebo. Also, the addition of CORLUX to treatment with Zyprexa had abeneficial impact on secondary metabolic measures such as fasting insulin, triglycerides and abdominal fat, as indicated by waist circumference. Eli Lillyprovided Zyprexa and financial support for this study and its results were published in the journal Advances in Therapy in 2009. In January 2009, weannounced positive results from a similar proof-of-concept study evaluating the ability of CORLUX to mitigate weight gain associated with the use ofJohnson & Johnson’s Risperdal. This study confirmed and extended the earlier results seen with CORLUX and Zyprexa, demonstrating a statisticallysignificant reduction in weight and secondary metabolic endpoints of fasting insulin, triglycerides and abdominal fat, as indicated by waist circumference.The results from the study of CORLUX and Risperdal were presented at several scientific conferences, including the American Diabetes Association meetingin June 2009, and were published in the journal Obesity in 2010.The combination of Zyprexa or Risperdal and CORLUX is not approved for any indication. The purpose of these studies was to explore the hypothesisthat GR-II antagonists, such as CORLUX and our next generation of selective GR-II antagonists, would mitigate weight gain associated with antipsychoticmedications. The group of medications known as second generation antipsychotic medication, including Zyprexa, Risperdal, Clozaril and Seroquel, arewidely used to treat schizophrenia and bipolar disorder. All medications in this group are associated with treatment emergent weight gain of varying degreesand carry a warning in their labels relating to treatment emergent hyperglycemia and diabetes mellitus.Selective GR-II Receptor Antagonists. In 2003, we initiated a discovery research program to identify and patent selective GR-II antagonists todevelop a pipeline of products for proprietary use. Three distinct series of GR-II antagonists were identified. These compounds, like our lead productCORLUX, potently block the cortisol receptor (GR-II) but, unlike CORLUX, they do not appear to block the PR (progesterone), ER (estrogen), AR (androgen)or GR-I (mineralocorticoid) receptors. Both the United States Patent & Trademark Office (USPTO) 3Table of Contentsand the European Patent Office (EPO) have issued to us composition of matter patents on all of the three series. A fourth composition of matter patentapplication is pending. See “Business—Intellectual Property.”CORT 108297 and CORT 113083In 2007, we conducted a human microdosing study of one of our newly identified selective GR-II antagonists, CORT 108297, with Xceleron Limitedutilizing its Accelerator Mass Spectrometry technology. In this microdosing study, we evaluated CORT 108297, a compound which develops particularlyhigh plasma and brain concentrations in an animal model. In May 2008, we announced the results from this study, which demonstrated that CORT 108297was extremely well absorbed, demonstrated good bioavailability and had a half-life that appears compatible with once-a-day oral dosing. In addition, furtherpharmacokinetic testing of CORT 108297 in a rat model indicated that a ten-fold increase in oral dose (5 milligrams per kilogram (mg/kg) to 50 mg/kg) ledto a proportional increase in the amount of compound detected in plasma.In September 2008, we signed a second agreement with Eli Lilly, under which Eli Lilly agreed to provide funding and provide olanzapine for twostudies to test the effectiveness of CORT 108297 in rat models of olanzapine induced weight gain. In January 2009, we announced top-line results from thesestudies of CORT 108297 and olanzapine. The results from the studies of both the prevention and reversal of antipsychotic-induced weight gain were positiveand statistically significant. The results of these studies were presented at the International Society of Psychoneuroendocrinology and the World Congress ofBiological Psychiatry conferences in July 2009.At the American Diabetes Association conference in June 2009 there was also a presentation of preclinical data from another study of CORT 108297conducted at Stanford University. This study demonstrated that CORT 108297 suppresses body weight gain and improves insulin sensitivity in healthy micefed a 60% fat diet and high sucrose liquid.The manufacturing and preclinical development of CORT 108297 began late in 2008 and resulted in the submission of an IND to the FDA inDecember 2009 for the prevention of weight gain induced by antipsychotic medication. Dosing of healthy volunteers in the first Phase 1 study of CORT108297 was completed in July 2010. A Phase 1b/2a study of this drug was initiated during the fourth quarter of 2010, with the first patients being dosed inDecember 2010.During the second quarter of 2010, we selected a second new compound, CORT 113083, to advance toward an IND filing. CORT 113083 hasdemonstrated substantial bioavailability in animal models. During the third quarter of 2010, we commenced various manufacturing development andpreclinical studies supporting an IND filing for this compound.The Role of Cortisol in DiseaseCortisol is a steroid hormone that plays a significant role in the way the body reacts to stressful conditions and is essential for survival. Cortisolsignificantly influences metabolism, exerts a clinically useful anti-inflammatory effect and contributes to emotional stability. Insufficient levels of cortisolmay lead to dehydration, hypotension, shock, fatigue, low resistance to infection, trauma, stress and hypoglycemia. Excessive levels of cortisol may lead toedema, hypertension, fatigue and impaired glucose tolerance.Elevated levels and abnormal release patterns of cortisol have also been linked to a broad range of metabolic and psychiatric conditions, such asweight gain, diabetes, hypertension, mood changes, psychosis and cognitive impairment.While excess release of cortisol may play a role in numerous diseases, Cushing’s Syndrome is the fundamental disease of excess cortisol, as patientshave tumors that produce excess levels of the hormone cortisol 4Table of Contentsor its precursor, adrenocorticotropic hormone (ACTH). Sometimes called “hypercortisolism”, the body’s exposure to high levels of cortisol can result inweight gain, diabetes, hypertension, infections, severe fatigue and psychosis.Many studies have shown that patients with psychotic depression have elevated levels and abnormal release patterns of cortisol. This abnormal cortisolactivity is not usually present in patients with nonpsychotic depression. More than 20 years ago, one of our scientific co-founders postulated that elevatedlevels of cortisol in patients with psychotic depression lead to elevated levels of dopamine, an important chemical substance found in the brain. Elevatedlevels of dopamine have been implicated in both delusional thinking and hallucinations. This hypothesis led to the concept that, by regulating the level andrelease patterns of cortisol, one could normalize dopamine levels in the brain, which may, in turn, ameliorate the symptoms of psychotic depression. Inaddition to cortisol’s effect on dopamine levels, research has shown that prolonged elevated cortisol may also play a direct role in causing the symptoms ofpsychotic depression.The challenge in regulating levels of cortisol, however, is that it is needed for natural processes in the human body. Destroying the ability of the bodyto make cortisol or to drastically reduce its presence would result in serious detrimental effects. To have a viable therapeutic effect, a compound must be ableto selectively modulate cortisol effects.Glucocorticoid Receptor AntagonistsCortisol is produced by the adrenal glands and is carried via the bloodstream throughout the body, including to the brain, where it directly influencesneuronal function. In the brain, cortisol binds to two receptors, Glucocorticoid Receptor I and Glucocorticoid Receptor II, also known as GR-I and GR-II. GR-I is a high-affinity receptor that is involved in the routine functions of cortisol in the brain. It has approximately ten times the affinity of GR-II for cortisol andits binding sites are filled with cortisol nearly all the time. In general, GR-II binding sites do not fill until levels of cortisol become elevated. Short-termactivation of GR-II has benefits, which include helping the individual to be more alert and better able to function under stressful conditions. Long-termactivation of GR-II, however, has been shown to have significant toxicity and appears to be linked to multiple metabolic and psychiatric disease states, suchas Cushing’s Syndrome and psychotic depression. The action of cortisol can be moderated by the use of blockers, or antagonists, that prevent the binding ofthe hormone to its receptors. These antagonists, referred to as glucocorticoid, or cortisol, receptor antagonists, may prevent the undesirable effects of elevatedlevels and abnormal release patterns of cortisol.CORLUX, also known as mifepristone, works by selectively blocking the binding of cortisol to GR-II; CORLUX is neither an antagonist nor agonist ofGR-I. It also blocks the progesterone receptor (PR). Because of its selective affinity, we believe that CORLUX can have a therapeutic benefit by modulatingthe effects of abnormal levels and release patterns of cortisol without compromising the necessary normal functions of cortisol. We have also discovered threeseries of additional compounds that, like CORLUX, potently block the GR-II receptor, but, unlike CORLUX, do not block the progesterone receptor. Wehave selected two compounds from one of these series for further development. CORT 108297 is now in clinical development and we are working on IND-enabling activities with CORT 113083.Overview of Cushing’s SyndromeEndogenous Cushing’s Syndrome is caused by prolonged exposure of the body’s tissues to high levels of the hormone cortisol due to a variety ofpathologic conditions. In endogenous Cushing’s Syndrome, the production of excess cortisol is stimulated or directly produced by pituitary, adrenal orectopic tumors. Cushing’s Syndrome is an orphan indication which most commonly affects adults aged 20 to 50. An estimated 10 to 15 of every one millionpeople are newly diagnosed with this syndrome each year, resulting in over 3,000 new patients in the United States. An estimated 20,000 patients in theUnited States have been diagnosed with Cushing’s Syndrome. Symptoms vary, but most people have one or more of the following manifestations: high bloodsugar, 5Table of Contentsdiabetes, high blood pressure, upper body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles.Irritability, anxiety, cognitive disturbances and depression are also common. Cushing’s Syndrome can affect every organ system in the body and can belethal if not treated effectively. There is no FDA-approved treatment for Cushing’s Syndrome.Current Treatments for Cushing’s SyndromeCurrent treatment depends on the specific cause of excess cortisol and may include surgery, radiation and chemotherapy. Patients sometimes may betreated with drugs that prevent the body from producing cortisol. Approximately 70% of the patients diagnosed with Cushing’s Syndrome are candidates forsurgery. Depending on the type of tumor there are varying rates of success and complications related to removing the tumor. If the tumor is successfullyremoved in its entirety, the patient is essentially cured and will not require additional treatment for Cushing’s Syndrome. However, in approximately half ofthe patients, it is clear that surgery is not successful or, while surgery may appear to be successful initially, the patient later relapses. These patients currentlyhave limited treatment options.CORLUX for Cushing’s SyndromeCORLUX represents a potentially attractive treatment option with the potential for long-term oral dosing. CORLUX is a GR-II antagonist that appearsto mitigate the effects of the elevated levels of cortisol in patients suffering from Cushing’s Syndrome. We intend for CORLUX to be a once-daily chronictreatment in this indication. Mifepristone, the active ingredient in CORLUX, in addition to blocking GR-II, blocks the progesterone receptor and has beenapproved by the FDA for termination of early pregnancy.We believe that CORLUX may significantly reduce a broad range of signs and symptoms typically associated with Cushing’s Syndrome. Thesesymptoms can include weight gain, diabetes, hypertension, poor tissue quality, fatigue, osteoporosis, cataracts, hirsutism, and psychosis. Cushing’sSyndrome has a five-year 50% mortality rate if left untreated.The FDA has granted Orphan Drug Designation for CORLUX for the treatment of endogenous Cushing’s Syndrome. “Orphan” drugs receive sevenyears of marketing exclusivity from the date of approval, as well as tax credits for clinical trial costs, marketing application filing fee waivers and assistancefrom the FDA in the drug development process.CORLUX for Cushing’s Syndrome Clinical ExperienceThere have been reports in the scientific literature of more than 50 Cushing’s Syndrome patients who have been treated with mifepristone, the activeingredient in CORLUX. The clinical benefit supported by these data served as the rationale for our IND for CORLUX and design of our Phase 3 trial. Whilewe are not aware of any formal trials completed prior to the initiation of our Phase 3 trial, the published results of the treatment of Cushing’s Syndromepatients with mifepristone include improvement in glucose tolerance and hemoglobin A1C levels, blood pressure, depression and psychosis, andimprovement in the patient’s general quality of life.CORLUX for Cushing’s Syndrome Phase 3 StudyWe conducted a Phase 3 trial with CORLUX for the treatment of endogenous Cushing’s Syndrome. In June 2010, we completed enrollment in a single50-patient open-label study, in which each patient’s dose was titrated to clinical benefit, and the primary endpoints focused on improvement in glucosetolerance and blood pressure, while the secondary endpoints focused on broader measures of patient outcomes. The FDA has indicated that this trial mayprovide a reasonable basis for the submission of an NDA for this indication.As discussed above, in December 2010 we announced positive top-line results from this study, which evaluated the response of two patient groups toCORLUX treatment: one included patients who were glucose intolerant, regardless of blood pressure level, and one included patients who had beendiagnosed with hypertension but had normal glucose tolerance. The primary endpoints in the trial were either 1) improvement in 6Table of Contentsglucose tolerance (as measured by the area under the curve of an oral glucose tolerance test) at 24 weeks relative to baseline, or 2) if a patient was not glucoseintolerant at baseline, improvement in diastolic blood pressure at 24 weeks relative to baseline. A patient in the glucose intolerant group was considered aresponder if there was a 25% or greater improvement in the area under the curve of a standard oral glucose tolerance test over the 24-week course of the study(or at the early termination visit) compared to baseline. A patient in the hypertension group was considered a responder if there was a 5 millimeter or greaterdrop in diastolic blood pressure at 24 weeks (or at the early termination visit) relative to baseline. If a sufficient number of patients in either group wereresponders, such that the lower limit of the exact one-sided 95% binomial confidence interval for the responder rate was greater than 20%, then the trialwould have met its primary endpoint. The calculation, which was predetermined in the study design, was based on analyzing the response rates in a modifiedintention to treat group (mITT group), which was comprised of those patients who received CORLUX for at least 30 days during their participation in thestudy.Statistically significant improvement in the primary endpoint was achieved for both groups: with 60% responding in the glucose intolerant group and38% in the hypertensive group. • 15 of 25, or 60%, of patients in the glucose intolerant group responded to treatment with CORLUX, significantly higher than the 20% hurdle rate(lower bound of the 95% Confidence Interval (CI) = 41.7) which equates to p<0.0001. • 8 of 21, or 38%, of patients in the hypertensive group responded to treatment with CORLUX, significantly higher than the 20% hurdle rate(lower bound of the 95% CI = 20.6) which equates to p<0.05.After our December 2010 announcement of our top-line primary endpoint results, we determined that one patient had a protocol violation thatprevented an accurate efficacy assessment and subsequently revised our calculations of the percentage of patients in the hypertensive group meeting theprimary endpoint. This revision is reflected in the results shown above. However, this revision did not impact our determination that statistically significantimprovement was achieved for patients in the hypertensive group, as well as the glucose intolerant group.The key secondary endpoint in the trial, global clinical improvement, was designed to capture the broader clinical benefit of CORLUX in this patientpopulation. The patients in the study, whether included in the “glucose intolerant group” or the “hypertensive group” for the purpose of evaluating theprimary endpoints, were evaluated as a single group on the key secondary endpoint of “global clinical improvement”. As discussed above, in January 2011,we announced that 87% of patients in this study showed a positive response to CORLUX based on global clinical improvement (lower bound of the 95% CI= 75.87) which equates to p<0.000001.Global clinical improvement was determined by a Data Review Board (DRB), an independent three-member group of highly experienced academicphysicians, expert in the evaluation and treatment of patients with Cushing’s Syndrome. Each member of the DRB independently assessed all efficacy dataavailable for each patient at each study visit beginning at the sixth week of the each patient’s trial course and determined if the patient’s clinicalmanifestations of Cushing’s Syndrome had worsened, stayed the same, or improved compared to baseline. Data assessed by the DRB in determining globalclinical improvement included changes in diabetes and hypertension medications, hemoglobin A1c (HgbA1c), insulin sensitivity, metabolic function,weight, body composition, Cushingoid appearance, cognitive/psychiatric evaluations, and quality of life, as well as other efficacy data collected over thecourse of the study. With the exception of the baseline visit, DRB members were blinded to visit sequence. At each visit, at least two of the members of theDRB had to determine that a patient had made “clinically significant improvement” for the patient to be deemed a responder. The key secondary endpointwas determined to have been met if the lower bound of the 95% confidence level of the response rate was greater than 30%. In fact, the response rate was87%, giving a lower bound of 75.87% or p<0.000001.An initial review of safety data indicates that CORLUX had an acceptable risk-benefit profile in this Phase 3 study. Although the detailed analysis ofthe safety data from the study has not yet been completed, the tolerability of CORLUX in the treatment of Cushing’s Syndrome in the Phase 3 study met ourexpectations. Adverse events 7Table of Contentsrelated to treatment included symptoms of adrenal insufficiency, endometrial thickening, and hypokalemia, all of which were consistent with earlierpublished reports. The majority of the SAEs reported in the study were not related to CORLUX treatment, as determined by the clinical investigators.Treatment related SAEs were all resolved with clinical management.Eighty-eight percent of the 34 patients who completed the Phase 3 study opted to enter the long-term extension study.Additional Trials and Preclinical StudiesIn support of our planned NDA submission, we are conducting a long-term extension study in patients who completed the Phase 3 trial to assess safetyof chronic dosing. Under the protocol of this extension study, as originally designed, patients who had completed the initial Phase 3 study would continue tobe treated with CORLUX for up to an additional year. In May 2010, in response to investigator requests, we amended the protocol of this study to allowpatients to stay on the drug beyond the end of that one year period. Thirty (30) patients opted to enter the long-term extension study after having been treatedwith CORLUX for six months as part of our Phase 3 study. As of March 1, 2011, four of these patients have been in the extension study for over 18 monthsand thus have over two years of total treatment.We have conducted several small trials to evaluate how the drug acts on the human body, how the human body acts on the drug and the drug’s safety,including drug-drug interaction studies. In addition to our clinical trials, we have completed a standard 12-month toxicology study in dogs, acarcinogenicity study in rats, and a carcinogenicity study in mice. These studies are designed to meet FDA requirements and the guidelines of aninternational regulatory body called the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals forHuman Use.Overview of Psychotic DepressionPsychotic depression is a serious psychiatric disease in which a patient suffers from severe depression accompanied by delusions, hallucinations orboth. These psychotic features typically develop after the onset of a depressed mood, but may develop concurrently as well. Once psychotic symptoms occur,they usually reappear with each subsequent depressive episode. Of particular importance, when the patient’s mood returns to normal the psychosis alsoresolves.Data from the National Institutes of Mental Health published in 2005 indicate that depressive disorders affect an estimated 9.5% of adults in the UnitedStates, or about 19 million people each year. Of these 19 million people, many published studies show that approximately 15-20%, or about three millionpeople, have psychotic depression. Most patients with psychotic depression suffer their first episode of major depression between the ages of 30 and 40 andthe majority will experience more than one episode in their lifetime. People with psychotic depression are approximately 70 times more likely to commitsuicide in their lifetime than the general population and often require lengthy and expensive hospital stays.Current Treatments for Psychotic DepressionThere are two treatment approaches for psychotic depression currently used by psychiatrists: electroconvulsive therapy (ECT) and combination drugtherapy, which is a combination of antidepressant and antipsychotic medication. Neither of these treatments has been approved by the FDA for psychoticdepression and both approaches almost always have a slow onset of action, which may result in lengthy and costly hospitalization. Each of these treatmentscan have debilitating side effects. Of the two treatments, ECT is generally considered to be more effective. • ECT involves passing an electrical current through the brain until the patient has a seizure. At least 100,000 patients receive ECT each year inthe United States, with each patient requiring approximately six to twelve procedures over a period of three to five weeks. 8Table of Contents • Combination drug therapy is an alternative treatment for psychotic depression that involves taking antipsychotic drugs such as olanzapine,haloperidol or chlorpromazine in combination with antidepressant drugs, such as fluoxetine, imipramine or venlafaxine. Patients on combinationdrug therapy often require three weeks or more to show improvement in their symptoms and treatment can take months before the symptoms areresolved entirely. Antipsychotic drugs can cause significant adverse side effects, including weight gain, diabetes, sedation, permanent movementdisorders and sexual dysfunction.CORLUX for the Psychotic Features of Psychotic DepressionWe are also developing CORLUX as an oral medication to treat the psychotic features of psychotic depression. As a GR-II antagonist, CORLUXappears to mitigate the effects of the elevated and abnormal release patterns of cortisol in patients suffering from psychotic depression. We intend CORLUXto be a once-daily treatment given to patients with psychotic depression over seven consecutive days in a controlled setting, such as a hospital or physician’soffice.We believe that CORLUX may significantly reduce psychotic symptoms of psychotic depression in many patients within one week and allow patientsto be more easily maintained on antidepressant therapy alone without the need for ECT or antipsychotic medication. We believe that CORLUX may besuperior to currently available treatments because we believe that CORLUX will enable patients with psychotic depression to improve their quality of lifemore quickly and with fewer side effects than with ECT or combination drug therapy.Completed Clinical Trials of CORLUX for Psychotic DepressionWe have completed seven prior clinical trials evaluating CORLUX in psychotic depression, in addition to our ongoing Phase 3 trial. The trials includethree Phase 3 trials conducted from 2004 through 2007, in addition to four earlier stage clinical trials with CORLUX. These completed trials generatedimportant data confirming the safety profile of CORLUX (alone and in combination with commonly prescribed antipsychotic and antidepressantmedications), demonstrated positive efficacy trends, and provided insights into the design of future clinical trials which might improve the probability ofclinical success.Completed Phase 3 Clinical Trials. In addition to Phase 1 and 2 studies, we have completed three randomized, double-blind, placebo-controlledPhase 3 clinical trials to further assess the safety and efficacy of CORLUX for the treatment of the psychotic features of psychotic depression. Two of thesetrials (Study 06 and Study 07) were conducted primarily in the United States. The third trial (Study 09) was conducted in Eastern Europe.The primary endpoint for Study 06 and Study 07 was the proportion of patients with at least a 50% improvement in the Brief Psychiatric Rating ScalePositive Symptom Subscale (BPRS PSS) at both Day 7 and Day 56. The primary endpoint for Study 09 was the proportion of patients with at least a 50%improvement in the BPRS PSS, at both Day 7 and Day 28, with day 56 as a secondary endpoint. Patients must have had at least mild psychotic symptoms(BPRS PSS 12) to enter the studies and were hospitalized if clinically necessary. • Study 07: The first of these trials, which began in September 2004, enrolled 257 patients randomized one-to-one to either treatment or placebo.Patients in the treatment arm received 600 mg of CORLUX once daily for a period of seven days. Patients did not take any antidepressant orantipsychotic medication for at least one week before beginning the seven day treatment period. After the seven days of CORLUX treatment, allpatients received antidepressant therapy through Day 56. Treatment with antipsychotic medications or ECT was not allowed at any time duringthe study.In this study patients receiving CORLUX did not have a statistically significant difference in response rate at the primary endpoint than did thepatients receiving placebo. A retrospective analysis of the data showed that patients achieving drug plasma levels higher than 1800 nanogramsper milliliter (ng/ml) 9Table of Contentshad a statistically significant greater response rate than placebo. There was also a statistically significant site by treatment effect in this trial.Among the twenty sites who participated from the trial onset, patients who were given CORLUX had a significantly higher response rate thanpatients who received placebo. Among the sites added later in the trial, there was no significant difference in response rate between CORLUXand placebo patients. These findings were published in 2009 by Contemporary Clinical Trials. • Study 09: This study, which commenced in May 2005, was a randomized, double-blind, placebo-controlled study in which 247 patients wereenrolled at sites in Eastern Europe. The primary endpoint was the proportion of patients with at least a 50% improvement in the BPRS PSS scoreat both Day 7 and Day 28. The study did not demonstrate a significant difference in response between patients receiving CORLUX and patientsreceiving placebo as measured by the primary endpoint. The results at the two key secondary endpoints of Study 09 also were not statisticallysignificant. Study 09 had an extremely high placebo response rate. • Study 06: This trial began in October 2004, and enrolled 443 patients. These patients were randomly assigned to three active dose groups (300mg, 600 mg and 1200 mg) or a placebo group, with patients receiving once daily dosing for a period of seven days. The three dosing levelsresponded to the FDA’s request to supplement data on a range of doses to augment the data provided by our open label dose ranging studycompleted in 2001.The study did not achieve statistical significance with respect to the primary endpoint. However, there was a statistically significant correlationbetween plasma levels and clinical outcome achieved during treatment. Response rates for patients whose plasma levels rose above apredetermined threshold of 1661 ng/mL were statistically different than those patients whose plasma levels were below the threshold and thosepatients who received placebo. Further, the incidence of serious adverse events did not differ between placebo and any of the three CORLUXdose groups.Ongoing Phase 3 trial – Study 14: We believe that the confirmation of a correlation between drug concentration and clinical response, as well asother observations from Study 06 and our two other completed Phase 3 clinical trials, served as a strong basis for the design of our ongoing Phase 3 study,which commenced in March 2008. The protocol for this trial incorporates information learned from the three completed Phase 3 trials in that it addresses theestablished relationship between increased drug plasma levels and clinical response, and it attempts to decrease the random variability observed in the resultsof the psychometric instruments used to confirm diagnosis and measure efficacy. • Increased Signal: In this trial we are administering a CORLUX dose of 1200 mg once per day for seven days instead of 600 mg once per day forseven days. • Decreased “Noise”: We also are utilizing a third party centralized rating service to independently evaluate the patient’s diagnosis prior to entryinto the study as well as to assess response. We believe the centralization of this process will improve the accuracy of diagnosis and theconsistency of rating across clinical trial sites and reduce the background noise that is endemic to psychopharmacologic studies and clearlyvisible in our earlier studies.We believe that these changes in the protocol should allow us to establish the efficacy of CORLUX in the treatment of the psychotic features ofpsychotic depression. Given the serious nature of psychotic depression, the lack of any approved drugs for the disorder and the data from our first clinicaltrial, the FDA granted a fast track designation for CORLUX for the treatment of the psychotic features of psychotic depression. In addition, the FDA hasindicated that CORLUX will receive a priority review if no other treatment is approved for psychotic depression at the time we submit our NDA.Clinical Trial Agreements. Many of our Phase 3 clinical trials are conducted through the use of clinical research organizations (CROs.) At ourrequest, these organizations oversee clinical trials at various institutions to test the safety and efficacy of our product candidates for the targeted indications.Our ongoing Phase 3 clinical 10Table of Contentstrial, Study 14, evaluating CORLUX for the treatment of the psychotic features of psychotic depression is being conducted under an agreement with ICONClinical Research, LP (ICON). We may terminate this agreement with 60 days notice to ICON, or sooner based on mutual agreement of the parties. Inaddition, we entered into an agreement with MedAvante, Inc., in March 2008, to provide the centralized psychiatric diagnosis and rating services for patientsbeing screened and enrolled in Study 14. We may terminate this agreement with 30 days notice to MedAvante.CORLUX Proof-of-Concept Studies for Other Metabolic DisordersIn April 2005, we announced results from two preclinical studies conducted in a rat model of olanzapine-induced weight gain. These studiesdemonstrated that CORLUX’s GR-II antagonist action has the potential to both reverse the weight gain associated with olanzapine and to prevent the weightgain associated with the initiation of treatment with olanzapine, which led to our studies in humans.In 2007, we announced results of our human clinical proof-of-concept study evaluating the ability of CORLUX to mitigate weight gain associated withthe administration of Eli Lilly’s Zyprexa (olanzapine). The results indicated a statistically significant reduction in weight gain in those subjects who tookZyprexa plus CORLUX compared to those who took Zyprexa plus placebo. Eli Lilly provided Zyprexa and financial support for this study. During 2009, weannounced results from another proof-of-concept study evaluating the ability of CORLUX to mitigate weight gain associated with the administration ofJohnson & Johnson’s Risperdal (risperidone). The results indicated a statistically significant reduction in weight gain in those subjects who took Risperdalplus CORLUX compared to those who took Risperdal plus placebo. Both Zyprexa and Risperdal are indicated for the treatment of schizophrenia and bipolardisorder.In the study of CORLUX and Zyprexa, 57 lean, healthy men (body mass index of 25 or less) were randomized to receive either Zyprexa plus placebo(n=22), Zyprexa plus CORLUX (n=24) or CORLUX plus placebo (n=11). This study took place in an institutional setting where daily weights were recordedand a range of metabolic parameters were measured. In the two week study, subjects in the Zyprexa plus placebo group gained an average of 7.0 pounds andsubjects in the Zyprexa plus CORLUX group gained an average of 4.4 pounds; which is a statistically significant difference (p<.001). Subjects in theCORLUX plus placebo group gained an average of 4.4 pounds. The difference in weight gain trajectory was apparent in the first days of the study, reachingstatistical significance during the first week. The increase in waist circumference, a surrogate for abdominal fat, in subjects who received Zyprexa plusplacebo was also significantly greater than subjects who received Zyprexa plus CORLUX (p<.01). The study was not designed to enroll a sufficient number ofpatients to have statistical power to detect significant effects on metabolic measures; however, the effect of CORLUX in this model was greater than expected.In addition to the finding about waist circumference, notable additional non-statistically significant group differences were observed. Patients takingZyprexa plus placebo experienced greater increases from baseline to end of study in both triglycerides and fasting insulin compared to patients takingZyprexa plus CORLUX. No unexpected study drug related adverse events were observed. These results were published in Advances in Therapy in 2009.In the study of CORLUX and Risperdal, 75 lean, healthy men (body mass index of 23 or less) were randomized to receive either Risperdal plus placebo(n=30), Risperdal plus CORLUX (n=30) or CORLUX plus placebo (n=15). This study also took place in an institutional setting where daily weights wererecorded and a range of metabolic parameters were measured. In this four-week randomized double-blind controlled study, subjects in the Risperdal plusplacebo group gained an average of 9.2 pounds, compared to a gain of 5.1 pounds in the Risperdal plus CORLUX group. This difference was statisticallysignificant (p<0.0001). Additional important metabolic parameters, including fasting insulin, triglycerides and abdominal fat, as reflected by waistcircumference, were also measured. The addition of CORLUX to Risperdal resulted in a statistically significant reduction in fasting insulin levels,triglyceride levels, and abdominal fat (as measured by waist circumference). Consistent with prior studies, CORLUX appeared to be well tolerated. Theseresults were published in Obesity in 2010. 11®Table of ContentsThe combinations of Zyprexa and CORLUX or Risperdal and CORLUX are not approved for any indication. The purpose of these studies was toexplore the hypothesis that GR-II antagonists would mitigate weight gain and other metabolic effects associated with antipsychotic medications. The groupof medications sometimes referred to as “atypical antipsychotics,” including Zyprexa, Risperdal, Clozaril (clozapine) and Seroquel (quetiapine), are widelyused to treat schizophrenia and bipolar disorder. All medications in this group are associated with treatment emergent weight gain of varying degrees andcarry a warning in the label relating to treatment emergent hyperglycemia and diabetes mellitus.CORT 108297 for the Prevention and Reversal of Antipsychotic Induced Weight GainIn January 2009, we announced results from two preclinical studies of our next-generation selective GR-II receptor antagonist, CORT 108297, for theprevention and reversal of weight gain caused by olanzapine, a medication marketed by Eli Lilly as Zyprexa. Using the same experimental rat model usedpreviously with mifepristone, the preclinical studies demonstrated that CORT 108297 1) reversed and 2) prevented the weight gain caused by olanzapine inrats. • In the first of these two studies, seventy-two female rats (n=12 per group) were allowed to eat a normal diet for 56 days. During an “induction”phase of weight gain (study days 1-34), 12 rats were administered placebo, whereas 48 were administered olanzapine. Animals receivingolanzapine gained significantly more weight than animals receiving placebo (p<.000001). On Day 35, the 48 animals that had receivedolanzapine during the weight induction phase were randomized (n=12 per group) to receive one of the following regimens: placebo, CORT108297 (20mg/kg), CORT 108297 (60mg/kg), CORT 108297 (120mg/kg) for the subsequent 21 days. There were robust, statistically significant,differences in weight between the olanzapine plus placebo and olanzapine plus CORT 108297 groups: Animals receiving olanzapine andplacebo continued to gain significant body weight from day 35 to 56 (p<.0001) while animals receiving olanzapine plus CORT 108297 (alldoses) exhibited significant weight reduction (p<.00001). At the highest dose tested (120 mg/kg), the animals’ weight returned to levelsobserved prior to initial olanzapine ingestion. The results of this first study suggest that after significant weight gain from olanzapine has alreadyoccurred, CORT 108297 can be introduced while olanzapine is continued and reverse the weight gain caused by olanzapine. • In the second study, rats (n = 96) were dosed with placebo, olanzapine (2.4 mg/kg), or, olanzapine plus CORT 108297 (2, 6, 20, 60, or120 mg/kg) for 21 days. From baseline to day 21, rats administered olanzapine plus CORT 108297 gained significantly less weight than ratsreceiving olanzapine and placebo (p <.00001). Larger doses of CORT 108297 were significantly correlated with greater weight reduction(p<.00001). This second study suggests that when CORT 108297 is administered concomitantly with olanzapine, weight gain associated withthe use of olanzapine can be prevented or at least attenuated.These first two studies used dose levels of 20 mg/kg, 60 mg/kg and 120 mg/kg of CORT 108297. The results of these two experiments replicated thefindings from previous animal studies of mifepristone, and were also consistent with results from randomized trials conducted in humans. These studies wererecently published in the peer-reviewed journal Diabetes Obesity Metabolism in 2010. Eli Lilly provided olanzapine and funded the costs of these twostudies. • A third study in the rat further evaluated the dose response relationship of CORT 108297 in preventing olanzapine induced weight gain withdoses from 2 mg/kg to 20 mg/kg.In summary, these studies in the rat demonstrated a constant dose response relationship from 2 mg/kg to 120 mg/kg.CORT 108297 has also produced statistically significant results in the prevention of weight gain and insulin insensitivity in mice fed a high fat, highsucrose diet. These data were presented at the 2009 Annual Meeting of American Diabetes Association. 12®®Table of ContentsThe manufacturing and preclinical development of CORT 108297 began late in 2008 and resulted in the submission of an IND to the FDA inDecember 2009. Dosing of healthy volunteers in the first Phase 1 study of CORT 108297 was completed in July 2010. This initial study was a single doseescalation study in healthy volunteers. A Phase 1b/2a study of this drug was initiated during the fourth quarter of 2010, with the first healthy volunteersbeing dosed in December 2010. The trial is evaluating CORT 108297 in models of antipsychotic induced weight gain and changes in biomarkers induced byprednisone, a steroid.If CORT 108297 or other GR-II antagonists prove to mitigate the weight gain and metabolic disturbances associated with the use of antipsychoticmedication, they could potentially be of benefit to the millions of people currently taking this important pharmacotherapy.GR-II Antagonist PlatformWe have assembled a patent portfolio covering a broad range of uses, as well as the composition of our new chemical entities. • We have composition of matter claims on three patent families of novel selective glucocorticoid receptor (GR-II) antagonists. Applications for allthree families have been allowed or issued in both the United States and Europe. A fourth composition of matter patent application is pending. • We also have a portfolio of patents describing the use of drugs that block the GR-II receptor for the treatment of metabolic and psychiatricdisorders. In addition to psychotic depression, we own or have exclusively licensed issued patents for the use of GR-II antagonists for treatmentand / or prevention of: • weight gain following treatment with antipsychotic medication; • mild cognitive impairment; • stress disorders; • early dementia, including early Alzheimer’s disease; • delirium; • gastroesophageal reflux disease; • cognitive deterioration in adults with Down’s Syndrome; • psychosis associated with cocaine addiction and • increasing the therapeutic response to ECT.See “Business—Intellectual Property.”Discovery ResearchIn 2003, we initiated a discovery research program to identify and patent selective GR-II antagonists at a contract research organization in the UnitedKingdom. Through the research program, we identified and filed patent applications for three distinct series of GR-II antagonists. These compounds appear tobe as potent as Corcept’s lead product CORLUX in blocking cortisol but, unlike CORLUX, they do not appear to block the progesterone or other steroidreceptors. Currently, we are evaluating several compounds in our research programs, including CORT 108297 and CORT 113083. CORT 108297 hasdemonstrated attractive characteristics, with high plasma and brain concentrations in an animal model and promising results in a human microdosing studyand Phase 1 studies, including good bioavailability and potential for once-daily dosing. CORT 108297 has also demonstrated the ability to prevent andreverse olanzapine induced weight gain in a rat model, as well as to prevent weight gain from a high fat, high sugar diet and increase insulin sensitivity in amouse model. CORT 108297 is being evaluated in a Phase 1b/2a study. We plan to submit an IND for CORT 113083 this year. 13Table of ContentsResearch and DevelopmentWe incurred approximately $18.9 million, $14.4 million and $14.2 million of research and development expenses in the years ended December 31,2010, 2009 and 2008, respectively, which accounted for approximately 69%, 71% and 71% of our total operating expenses in these respective fiscal years.For a further discussion, see Part II, Item 7, Management’s Discussion and Analysis of Financial Conditions and Results of Operations—Results ofOperations.Medical Education and CommercializationWe are planning for the commercialization of CORLUX. To achieve commercial success for any approved product, we must either develop a marketingand sales force or enter into arrangements with others to market and sell our products. We intend to develop our own medical affairs and commercialinfrastructure in the United States for CORLUX because we believe that the initial markets for Cushing’s Syndrome and psychotic depression in the UnitedStates are highly concentrated and accessible. We intend to engage a partner to commercialize CORLUX in territories outside of the United States. • If approved, we expect to hire a small, experienced field sales force, supported by medical affairs and other infrastructure, to sell CORLUX for thetreatment of Cushing’s Syndrome. We intend to focus on patients who are in the care of an endocrinologist and in active treatment for theirdisease. We estimate that there are fewer than 1,000 endocrinologists who would need to be targeted to reach the Cushing’s Syndromepopulation in active treatment. We plan to reach out directly to patients utilizing web-based initiatives and interactions with patient groups. Weplan to execute agreements with specialty pharmacies to distribute CORLUX and provide logistical support.A large portion of the people who suffer from Cushing’s Syndrome remain undiagnosed or inadequately treated. We intend to develop programsto educate the medical community about early diagnosis of this syndrome and to increase awareness regarding the role of GR-II antagonists forthis syndrome. • If approved for the treatment of psychotic depression, we plan to reach patients who are candidates for ECT by marketing to hospitals andpsychiatrists that perform ECT. We estimate that there are approximately 900 hospitals with more than 30 in-patient psychiatric beds. Of these,we estimate that approximately 300 offer ECT. We believe that approximately 1,000 psychiatrists administer most ECT procedures.Subsequently, we also intend to expand our commercialization efforts to address the larger set of patients with psychotic depression currentlyundergoing combination drug therapy, which would require an increase in the size of our initial sales force.As with Cushing’s Syndrome, a large portion of the people who suffer from psychotic depression remain undiagnosed or inadequately treated.We intend to develop programs to educate the medical community about early diagnosis of psychotic depression and increase awarenessregarding the role of GR-II antagonists for this disorder.Manufacturing of CORLUXAs a drug discovery, development and commercialization entity, we intend to continue to utilize our financial resources to complete the developmentand commercialization of CORLUX and advance other product candidates rather than diverting resources to establishing our own manufacturing facilities.We intend to continue to rely on experienced contract manufacturers to produce our product candidates. We have entered into a manufacturingagreement with one contract manufacturer, Produits Chimiques Auxiliaires et de Synthese SA (PCAS), to produce the active pharmaceutical ingredient (API)for CORLUX. We plan to submit a request for approval for commercial use of material produced by PCAS as part of our NDA submission for CORLUX for thetreatment of Cushing’s Syndrome. The agreement with PCAS, which was executed in November 2006, is for an initial period of five years with an automaticextension for one additional year and we 14Table of Contentsintend to pursue discussions for further extensions. There is no guaranteed minimum purchase commitment under this agreement until NDA approval. Afterthe NDA approval, we agree to purchase from PCAS 100% of our requirements for six months after the approval and 75% of our requirements from six monthsthrough 18 months after approval for the initial five year term of the agreement. If PCAS is unable to manufacture the product for a consecutive six-monthperiod, we have the right to terminate the agreement, without penalty. We also have a memorandum of understanding with ScinoPharm Taiwan (ScinoPharm).Pursuant to that memorandum of understanding, ScinoPharm agrees to manufacture API and we agree to purchase at least $1,000,000 of bulk mifepristone peryear following the commercial launch of CORLUX. ScinoPharm is considered to be a potential secondary site for the manufacture of the API. However, noactivities are currently being conducted at this site to develop or qualify the manufacturing processes or facilities and we do not plan to include a request forapproval of material produced by ScinoPharm when we submit our NDA for Cushing’s Syndrome planned for the first quarter of 2011.We have also entered into an agreement with another contract manufacturer, PharmaForm, L.L.C. (PharmaForm), for the production of CORLUX tablets.To date, our need for CORLUX tablets has been limited to the amounts required to support our clinical trials and the registration batches needed to supportour anticipated NDA filing for CORLUX for the treatment of Cushing’s Syndrome. The agreement with PharmaForm was executed in December 2006 and willexpire upon the completion of the development program for CORLUX, but may be extended. There are no minimum purchase amounts under this agreement.CompetitionIf approved for commercial use as a treatment for Cushing’s Syndrome or the psychotic features of psychotic depression, CORLUX will compete withestablished treatments, including other potential compounds under development for Cushing’s Syndrome or, in the case of psychotic depression, with ECTand combination drug therapy.We are aware that Laboratoire HRA Pharma has received an Orphan Drug Designation in the United States and Europe for the use of mifepristone totreat a subtype of Cushing’s Syndrome and has begun a clinical trial in Europe and the United States. If this product is approved for commercialization beforeCORLUX, our potential future revenue could be reduced. We are also aware that Exelgyn Laboratories, which operates as a subsidiary of Medi Challenge(Pty) Ltd., received Orphan Drug Designation for endogenous Cushing’s Syndrome in Europe, but they have stated that they have not yet conducted anyclinical trials. We may also experience competition from Novartis, which is developing a somatostatin analogue, pasireotide, that is in Phase 3 trials forvarious endocrine disorders, including Cushing’s disease, which is a subset of the patients with Cushing’s Syndrome. Novartis completed its Phase 3 trial ofpasireotide in Cushing’s disease and has stated it plans to submit an NDA to the FDA in the first half of 2011. Novartis filed for regulatory approval ofpasireotide in Cushing’s disease in the European Union in October 2010.ECT has been shown to be the most effective treatment for psychotic depression, but it carries the risks of general anesthesia, potential memory lossand other adverse effects as well as the stigma associated with the procedure. Use of CORLUX does not require anesthesia and, in our clinical trials conductedto date, patients treated with CORLUX have not exhibited the adverse effects associated with ECT.Other competitors include companies that market antipsychotic drugs that are used off-label as part of combination drug therapy for psychoticdepression. To reduce the psychotic features of psychotic depression, these drugs generally are taken in combination with antidepressant medication over aperiod of weeks to several months. Unlike the use of CORLUX, this extended course of treatment may put patients at risk of significant adverse side effects,including weight gain, diabetes, sedation, permanent movement disorders and sexual dysfunction. Antipsychotics include Bristol-Myers Squibb’s Abilify,Novartis’ Clozaril, Pfizer’s Geodon and Navane, Ortho-McNeil’s Haldol, Janssen Pharmaceutica’s Risperdal, AstraZeneca’s Seroquel, GlaxoSmithKline’sStelazine and Thorazine, Mylan’s Mellaril, Schering Corporation’s Trilafon and Eli Lilly’s Zyprexa. 15Table of ContentsWe are aware of one clinical trial that has taken place, conducted by the pharmaceutical division of Akzo Nobel, a division of Schering Plough, for anew chemical entity for the treatment of psychotic depression. This medicine is a GR-II antagonist, the commercial use of which would be covered by ourpatent. In 2004, Akzo Nobel filed an observation in our exclusively licensed European patent application with claims directed to psychotic depression, inwhich Akzo Nobel challenged the claims of that patent application. In 2005, we filed a rebuttal to Akzo Nobel’s observation. In February 2006, the EuropeanPatent Office (EPO) allowed our patent application. In July 2006, the patent was issued. We are not aware of any public disclosures by any company, otherthan Akzo Nobel, regarding the development of new medicinal products to treat psychotic depression. However, other companies may be developing newdrug products to treat psychotic depression and the other conditions we are exploring. Our present and potential competitors include major pharmaceuticalcompanies, as well as specialty pharmaceutical firms. Most of our competitors have considerably greater financial, technical and marketing resources than wedo. We expect competition to intensify as technical advances are made.Many colleges, universities and public and private research organizations are also active in the human health care field. While these entities focus oneducation, they may develop or acquire proprietary technology that we may require for the development of our product candidates. We may attempt to obtainlicenses to this proprietary technology.Our ability to compete successfully will be based on our ability to develop proprietary products, attract and retain scientific personnel, obtain patent orother protection for our product candidates, obtain required regulatory approvals and manufacture and successfully market our future products either alone orthrough outside parties.Intellectual PropertyPatents and other proprietary rights are important to our business. It is our policy to seek patent protection for our inventions, and to rely upon tradesecrets, know-how, continuing technological innovations and licensing opportunities to develop and maintain our competitive position.Under an agreement with Stanford University, we have licensed exclusive rights to the following issued U.S. patents and any corresponding foreignpatents: U.S. Patent Number Subject Matter Expiration Date6,150,349 Use of GR-II antagonists in the treatment of psychotic majordepression October 5, 20186,362,173 Use of GR-II antagonists in the treatment of cocaine-inducedpsychosis October 5, 20186,369,046 Use of GR-II antagonists in the treatment of early dementia February 4, 2019The corresponding foreign patents expire in 2018.We are required to make milestone payments and pay royalties to Stanford University on sales of products commercialized under any of the abovepatents. We are currently in compliance with our obligations under the agreement. If Stanford University were to terminate any of our exclusive licenses dueto breach of the license on our part, we would not be able to commercialize CORLUX for the treatment of the psychotic features of psychotic depression,cocaine-induced psychosis or early dementia.We also own issued U.S. patents for the use of GR-II antagonists in the treatment of mild cognitive impairment, for the treatment of weight gainfollowing treatment with antipsychotic medication, for the prevention and treatment of stress disorders, for increasing the therapeutic response to ECT, for thetreatment of delirium, for the treatment of gastroesophageal reflux disease and for inhibiting cognitive deterioration in adults with Down’s Syndrome. Theexpiration dates of these patents and their foreign counterparts range from 2020 to 2025. 16Table of ContentsIn addition, we have seven U.S. method of use patent applications covering certain GR-II antagonists, including the treatment of: • patients suffering from mental disorders by optimizing mifepristone levels in plasma serum; • neurological damage in premature infants; • catatonia; • migraine headaches; • psychosis associated with interferon-alpha therapy; • depression in patients taking Interleukin-2 (IL-2) and • amyotrophic lateral sclerosis (ALS).The expiration dates of these patents and their foreign counterparts range from 2023 to 2029.We have composition of matter claims on three patent families of novel selective GR-II antagonists. Applications for all of the three families have beenallowed in both the United States and Europe. The expiration dates of these U.S. and European patents range from 2025 to 2026. A fourth composition ofmatter patent application is pending.We have also filed, where we deemed appropriate, foreign patent applications corresponding to our U.S. patents and applications.However, we cannot assure you that any of our patent applications will result in the issuance of patents, that any issued patent will include claims ofthe breadth sought in these applications or that competitors will not successfully challenge or circumvent our patents if they are issued.Although three of our patents have claims directed to the composition of compounds, we do not have a patent with claims directed to the compositionof mifepristone. Our rights under our issued patents related to mifepristone cover only the use of that compound in the treatment of specific diseases.The patent covering the product mifepristone has expired. The only FDA-approved use of mifepristone is to terminate pregnancy. The FDA hasimposed significant restrictions on the use of mifepristone to terminate pregnancy and may impose restrictions on CORLUX for the treatment of Cushing’sSyndrome and the psychotic features of psychotic depression. We plan to rely on (1) the scope of our use patent, (2) the restrictions imposed by the FDA onthe use of mifepristone to terminate pregnancy and (3) the different patient populations, administering physicians and treatment settings between the use ofmifepristone to terminate pregnancy and to treat Cushing’s Syndrome and psychotic depression.The patent positions of companies in the pharmaceutical industry are highly uncertain, involve complex legal and factual questions and have been andcontinue to be the subject of much litigation. Our product candidates may give rise to claims that we infringe on the products or proprietary rights of others. Ifit is determined that our drug candidates infringe on others’ patent rights, we may be required to obtain licenses to those rights. If we fail to obtain licenseswhen necessary, we may experience delays in commercializing our product candidates while attempting to design around other patents, or determine that weare unable to commercialize our product candidates at all. If we do become involved in intellectual property litigation, we are likely to incur considerablecosts in defending or prosecuting the litigation. We believe that we do not currently infringe any third party’s patents or other proprietary rights, and we arenot obligated to pay royalties to any third party other than Stanford University.In November 2003, McLean Hospital had alleged that it also had rights to the technology that led to the patent for the use of GR-II antagonists to treatthe psychotic features of psychotic depression. McLean Hospital 17Table of Contentswas a prior employer of one of our founders, Dr. Alan Schatzberg and it alleged that the invention of the technology underlying this patent was conceived byDr. Schatzberg and/or Dr. Anthony Rothschild while the two were employed by McLean Hospital. We contended that the invention was actually conceivedby Dr. Schatzberg and Dr. Joseph Belanoff while they were employed by Stanford University and that the patent was appropriately assigned by them toStanford University. In October 2004, we announced a resolution of this issue in which we retained our exclusive rights under the patent and which requiredus to make no additional payments under the license, regardless of the resolution of the impending inventorship dispute. In January 2005, the inventorshipissue was resolved in favor of Stanford University.As discussed earlier under “Competition,” in 2004 Akzo Nobel filed an observation to the grant of our exclusively licensed European patentapplication with claims directed to psychotic depression. In February 2006, the EPO allowed our patent application. We are not aware of any other disputesrelated to patent issues.License AgreementUnder our exclusive license agreement with Stanford University to patents covering the use of CORLUX to treat the psychotic features of psychoticdepression and for the treatment of early dementia, we are required to pay Stanford $50,000 annually as a nonrefundable royalty payment. This payment iscreditable against future royalties. We are also obligated to pay Stanford a $50,000 milestone upon the filing of the NDA for CORLUX for the treatment ofpsychotic depression and a further $200,000 milestone payment upon FDA approval of CORLUX. The milestone payments are also creditable against futureroyalties. This license agreement expires upon expiration of the related patents or upon notification by us to Stanford. See “Intellectual Property.”Government RegulationPrescription pharmaceutical products are subject to extensive pre- and post-market regulation, including regulations that govern the testing,manufacturing, safety, efficacy, labeling, storage, record keeping, advertising, and promotion of the products under the Federal Food, Drug and Cosmetic Act.All of our product candidates will require regulatory approval by government agencies prior to commercialization. The process required by the FDA before anew drug may be marketed in the United States generally involves the following: completion of preclinical laboratory and animal testing; submission of anIND, which must become effective before clinical trials may begin; performance of adequate and well controlled human clinical trials to establish the safetyand efficacy of the proposed drug or biologic’s intended use; and, in the case of a new drug, approval by the FDA of an NDA. The process of complying withthese and other federal and state statutes and regulations in order to obtain the necessary approvals and subsequently complying with federal and statestatutes and regulations involves significant time and expense.Preclinical studies are generally conducted in laboratory animals to evaluate the potential safety and the efficacy of a product. Drug developers submitthe results of preclinical studies to the FDA as a part of an IND, which must be approved before beginning clinical trials in humans. Typically, human clinicaltrials are conducted in three sequential phases that may overlap. • Phase 1. Clinical trials are conducted with a small number of subjects to determine the early safety profile, maximum tolerated dose andpharmacokinetics of the product candidate in human volunteers. • Phase 2. Clinical trials are conducted with groups of patients afflicted with a specific disease to determine preliminary efficacy, optimaldosages and expanded evidence of safety. • Phase 3. Large-scale, multi-center, comparative trials are conducted with patients afflicted with a target disease to establish the overallrisk/benefit ratio of the drug and to provide enough data to demonstrate with substantial evidence the efficacy and safety of the product, asrequired by the FDA.The FDA and the Institutional Review Boards closely monitor the progress of each of the three phases of clinical trials that are conducted in the UnitedStates and may reevaluate, alter, suspend or terminate the testing at 18Table of Contentsany time for various reasons, including a belief that the subjects are being exposed to an unacceptable health risk. The FDA may also require that additionalstudies be conducted, such as studies demonstrating that the drug being tested does not cause cancer.After Phase 3 trials are completed, drug developers submit the results of preclinical studies, clinical trials, formulation studies and data supportingmanufacturing to the FDA in the form of an NDA for approval to commence commercial sales. The FDA reviews all NDAs submitted before it accepts them forfiling. The FDA may request additional information rather than accept an NDA for filing. If the FDA accepts an NDA for filing, it may grant marketingapproval, request additional information or deny the application if it determines that the application does not meet regulatory approval criteria. FDAapprovals may not be granted on a timely basis, or at all.If the FDA approves an NDA, the subject drug becomes available for physicians to prescribe in the United States. Once approved, the FDA maywithdraw the product approval if compliance with pre- and post-market regulatory standards is not maintained. The drug developer must submit periodicreports to the FDA. Adverse experiences with the product must be reported to the FDA and could result in the imposition of marketing restrictions throughlabeling changes or product removal. Product approvals may be withdrawn if problems with safety or efficacy occur after the product reaches the marketplace.In addition, the FDA may require post- marketing studies, referred to as Phase 4 studies, to monitor the effect of approved products, and may limit furthermarketing of the product based on the results of these post-market studies.Facilities used to manufacture drugs are subject to periodic inspection by the FDA and other authorities where applicable, and must comply withcurrent Good Manufacturing Practices regulations (cGMP). Failure to comply with the statutory and regulatory requirements subjects the manufacturer topossible legal or regulatory action, such as suspension of manufacturing, seizure of product or voluntary recall of a product.With respect to post-market product advertising and promotion, the FDA imposes a number of complex regulations on entities that advertise andpromote pharmaceuticals, which include, among others, standards and regulations for direct-to-consumer advertising, off-label promotion, industry sponsoredscientific and educational activities, and promotional activities involving the Internet. The FDA has very broad enforcement authority under the FederalFood, Drug and Cosmetic Act, and failure to abide by these regulations can result in penalties including the issuance of a warning letter directing a companyto correct deviations from FDA standards, a requirement that future advertising and promotional materials be pre-cleared by the FDA, and state and federalcivil and criminal investigations and prosecutions.In addition to studies requested by the FDA after approval, a drug developer may conduct other trials and studies to explore use of the approvedcompound for treatment of new indications. The purpose of these trials and studies and related publications is to broaden the application and use of the drugand its acceptance in the medical community. Data supporting the use of a drug for these new indications must be submitted to the FDA in a new orsupplemental NDA that must be approved by the FDA before the drug can be marketed for the new indications.Approvals outside the United States. We have not started the regulatory approval process in any jurisdiction other than the United States and we areunable to estimate when, if ever, we will commence the regulatory approval process in any foreign jurisdiction. We or our partners will have to complete anapproval process similar to the U.S. approval process in foreign target markets for our product candidates before we can commercialize our product candidatesin those countries. The approval procedure and the time required for approval vary from country to country and can involve additional testing. Foreignapprovals may not be granted on a timely basis, or at all. Regulatory approval of prices is required in most countries other than the United States. The pricesapproved may be too low to generate an acceptable return to us.Orphan Drug Designation. The FDA has granted us Orphan Drug designation for CORLUX for the treatment of endogenous Cushing’s Syndrome.The designation provides special status to a product to treat a rare 19Table of Contentsdisease or condition providing that the product meets certain criteria. Orphan designation qualifies the sponsor of the product for the tax credit and marketingincentives of the Orphan Drug Act, including seven years of exclusive marketing rights for the specific drug for the orphan indication. A marketingapplication for a prescription drug product that has been designated as a drug for a rare disease or condition is not subject to a prescription drug user feeunless the application includes an indication for other than a rare disease or condition.Fast Track Designation. The FDA sometimes grants “fast track” status under the Food and Drug Administration Modernization Act of 1997. The fasttrack mechanism was created to facilitate the development and approval of new drugs intended for the treatment of life-threatening conditions for which thereare no effective treatments and which demonstrate the potential to address unmet medical needs for the condition. The fast track process includes schedulingof meetings to seek FDA input into development plans, the option of submitting an NDA serially in sections rather than submitting all componentssimultaneously, the option to request evaluation of studies using surrogate endpoints, and the potential for a priority review.We have been granted fast track status for CORLUX for the treatment of the psychotic features of psychotic depression. However, the fast trackdesignation may be withdrawn by the FDA at any time. The fast track designation does not guarantee that we will qualify for or be able to take advantage ofthe expedited review procedures and does not increase the likelihood that CORLUX will receive regulatory approval.Priority Review. We plan to request a priority review for the NDA for Cushing’s Syndrome when it is submitted. The FDA has indicated to us that itwill grant us a priority review of our NDA of CORLUX for the treatment of the psychotic features of psychotic depression if no other medications have beenapproved for this indication at the time of our submission.Executive OfficersThe following table sets forth, as of December 31, 2010, information about our executive officers: Name Age PositionJoseph K. Belanoff, M.D. 53 Chief Executive Officer and DirectorRobert L. Roe, M.D. 70 President and SecretaryCaroline M. Loewy 44 Chief Financial OfficerSteven Lo 43 Vice President of Commercial OperationsAnne M. LeDoux 63 Vice President, Controller and Chief Accounting OfficerJoseph K. Belanoff, M.D. is a co-founder and has served as a member of the Board and as our Chief Executive Officer since 1999. Dr. Belanoff iscurrently a clinical faculty member and has held various positions in the Department of Psychiatry and Behavioral Sciences at Stanford University since1992. From 1997 to 2001, he served as the Director of Psychopharmacology at the outpatient division of the Palo Alto Veterans Affairs Hospital. Dr. Belanoffreceived his B.A. from Amherst College and his M.D. from Columbia University’s College of Physicians & Surgeons. As our Chief Executive Officer,Dr. Belanoff brings expertise and knowledge regarding our business and operations to our Board of Directors. Dr. Belanoff also has expertise in clinicalmedicine and psychopharmacology.Robert L. Roe, M.D. joined us as President in October 2001. Dr. Roe has spent more than 30 years in the pharmaceutical and biotechnology industries.From 1999 to 2001, he served as President and Chief Executive Officer of Allergenics, Inc. From 1996 to 1999, he was Executive Vice President, ChiefOperating Officer and a director of Cytel Corporation. From 1995 to 1996, he was Executive Vice President, Chief Operating Officer and a director of ChugaiBiopharmaceuticals, Inc. From 1992 to 1995, Dr. Roe served as President of the Development Research Division and Senior Vice President of SyntexCorporation. Dr. Roe received his B.A. from Stanford University and his M.D. from the University of California, San Francisco. 20Table of ContentsCaroline M. Loewy joined us as Chief Financial Officer in November 2008. From 2006 to 2008, Ms. Loewy served as Chief Financial Officer of PoniardPharmaceuticals, a publicly traded biopharmaceutical company. From 2004 to 2006 she acted as an independent consultant to a variety of biopharmaceuticalcompanies advising on corporate strategy, business development, and financing. Ms. Loewy spent 14 years in equity research and corporate finance. From2000 to 2004 she was an Executive Director in biotechnology equity research at Morgan Stanley, providing fundamental analysis and recommendations toinvestors, as well as strategic advisory services to corporate clients. She was also a Managing Director in biotechnology equity research at PrudentialSecurities and held positions in corporate finance at BankAmerica. Ms. Loewy received her B.A. degree from the University of California, Berkeley, and herMBA/MS degree from Carnegie Mellon University.Steven Lo joined us as Vice President of Commercial Operations in September 2010. Mr. Lo brings 15 years of commercial experience in thepharmaceutical and biotechnology industry. From 1997 to 2010, Mr. Lo held various positions in marketing, sales and managed markets at Genentech, Inc., abiotechnology company that became a member of the Roche Group in March in 2009, most recently as Franchise Head, leading that company’sendocrinology marketing and sales organization. Mr. Lo received his B.S. degree from the University of California, Davis and his Master of HealthAdministration from the University of Southern California.Anne M. LeDoux joined the company as Controller in 2004 and was promoted to the position of Vice President, Controller and Chief AccountingOfficer in April 2007. Ms. LeDoux has 20 years of financial and accounting management experience with public pharmaceutical and biotechnologycompanies. Prior to joining Corcept in 2004, Ms. LeDoux served in various financial positions at Aviron, Roche Biosciences and Syntex Corporation. Shewas also Vice President and Chief Financial Officer at the Northern California Health Center and Vice President, Finance for the Children’s Hospital of SanFrancisco. Ms. LeDoux is a Certified Public Accountant and has over 13 years of experience in public accounting, primarily at Coopers and Lybrand.Ms. LeDoux received her B.A. degree in Business from the University of Massachusetts and her law degree from Western New England College, School ofLaw.EmployeesWe are managed by a core group of experienced pharmaceutical executives with a track record of bringing new drugs to market. To facilitateadvancement of development programs, we also enlist the expertise of associates and advisors with extensive pharmaceutical development experience.As of December 31, 2010, we had 19 full-time employees, four part-time employees and 12 long-term contract staff. Four of our employees and two ofour contractors have M.D.s. We consider our employee relations to be good. None of our employees is covered by a collective bargaining agreement.GeneralWe were incorporated in the State of Delaware on May 13, 1998. Our registered trademarks include Corcept and CORLUX. Other service marks,trademarks and trade names referred to in this document are the property of their respective owners.Available InformationWe are subject to the information requirements of the Securities Exchange Act of 1934, as amended, and we therefore file periodic reports, proxystatements and other information with the SEC relating to our business, financial statements and other matters. The reports, proxy statements and otherinformation we file may be inspected and copied at prescribed rates at the SEC’s Public Reference Room, 100 F Street, N.E., Washington, D.C. 20549, onofficial business days during the hours of 10:00 A.M. to 3:00 P.M. You may obtain information on the operation of the SEC’s Public Reference Room bycalling the SEC at 1-800-SEC-0330. The SEC also maintains an Internet site that contains reports, proxy statements and other information regarding issuerslike us 21®®Table of Contentsthat file electronically with the SEC. The address of the SEC’s Internet site is www.sec.gov. For more information about us, please visit our website atwww.corcept.com. You may also obtain a free copy of our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K andamendments to those reports on the day the reports or amendments are filed with or furnished to the SEC by visiting our website at www.corcept.com. Theinformation found on, or otherwise accessible through, our website, is not incorporated information, and does not form a part of, this Form 10-K. 22Table of ContentsITEM 1A.RISK FACTORSAn investment in our common stock involves significant risks. You should carefully consider the risks described below and the other information inthis Form 10-K, including our financial statements and related notes, before you decide to invest in our common stock. If any of the following risks oruncertainties actually occurs, our business, results of operations or financial condition could be materially harmed, the trading price of our common stockcould decline and you could lose all or part of your investment. The risks and uncertainties described below are those that we currently believe maymaterially affect us; however, they may not be the only ones that we face. Additional risks and uncertainties of which we are unaware or currently deemimmaterial may also become important factors that may harm our business. Except as required by law, we undertake no obligations to update any riskfactors.Risks Related to Our BusinessWe depend heavily on the success of our lead product candidate, CORLUX, currently being developed for the treatment of Cushing’s Syndrome and forthe treatment of the psychotic features of psychotic depression. If we are unable to commercialize CORLUX for Cushing’s Syndrome or for psychoticdepression, or experience significant delays in doing so, we may be unable to generate revenues and our stock price will likely decline.We have invested a significant portion of our time and financial resources since our inception in the development of CORLUX for the treatment ofCushing’s Syndrome and the psychotic features of psychotic depression. We currently do not have any commercial products and we anticipate that for theforeseeable future our ability to generate meaningful revenues and achieve profitability will be solely dependent on the successful development, approvaland commercialization of CORLUX for the treatment of Cushing’s Syndrome or for the psychotic features of psychotic depression. We have completedpatient treatment in our Phase 3 trial in Cushing’s Syndrome and are preparing an NDA in that indication for submission to the FDA. We are also conductinga Phase 3 clinical trial in psychotic depression. We have previously completed three Phase 3 clinical trials evaluating CORLUX for psychotic depression, allof which failed to achieve statistically significant results with regard to the primary or key secondary endpoints. Many factors could harm our efforts todevelop and commercialize CORLUX, including: • insufficient funding; • negative, inconclusive or otherwise unfavorable results from our preclinical or clinical development programs; • side effects that may be identified in the course of our clinical trials; • changes or delays in our clinical development program; • rapid technological change making CORLUX obsolete; • competition from companies with greater financial, technical and marketing resources than ours; • increases in the costs of our clinical trials; • a delay in the submission of our NDA for CORLUX for the treatment of Cushing’s Syndrome; • a delay in the FDA’s acceptance of our NDA submission for the treatment of Cushing’s Syndrome for filing; • an inability to obtain, or delay in obtaining, regulatory approval for the commercialization of CORLUX for the treatment of Cushing’s Syndromeor for the treatment of the psychotic features of psychotic depression; • an inability to manufacture CORLUX or the active ingredient in CORLUX in commercial quantities and at an acceptable cost; and • political concerns relating to other uses of mifepristone, or RU-486, that could limit the market acceptance of CORLUX. 23Table of ContentsOur clinical trials may not demonstrate that CORLUX is safe and effective. If our clinical program for CORLUX for the treatment of Cushing’sSyndrome, for the treatment of the psychotic features of psychotic depression or for any other indications does not demonstrate safety and efficacy, ourbusiness will be harmed.To gain regulatory approval from the FDA to market CORLUX, our Phase 3 clinical trials must demonstrate the safety and efficacy of CORLUX for theparticular indication. The FDA has indicated that our single 50-patient open-label study may provide a reasonable basis for the submission of an NDA for thisindication. However, the FDA may determine that the results of our Phase 3 trial in Cushing’s Syndrome, while meeting its primary and key secondayendpoints, do not sufficiently demonstrate safety and/or efficacy. The ongoing Phase 3 clinical trial of CORLUX for the treatment of the psychotic features ofpsychotic depression, may not demonstrate safety or efficacy results sufficient for approval, and we may need to conduct other studies in support of apotential NDA in that indication. Clinical development is a long, expensive and uncertain process and is subject to delays, and data obtained from clinicaltrials and supportive studies are susceptible to varying interpretations, which could delay, limit or prevent regulatory approval.The development plan for CORLUX, or any other compound, is not certain. If we decide to, or if the FDA or other regulatory agencies require us topursue additional clinical trials or other studies, there may be a delay in the development of our compounds, which may have a negative impact on ourbusiness.During the development of CORLUX, we have been engaged in dialogue with the FDA to determine an acceptable development plan which wouldenable the FDA to complete its review in a satisfactory manner. We anticipate continued dialogue with the FDA to define any additional data needed tocomplete an NDA.We may decide, or the FDA or other regulatory authorities may require us, to pursue additional clinical, preclinical or manufacturing studies tosatisfactorily complete our NDA for either Cushing’s Syndrome or psychotic depression. Additional trials or studies will require additional funding which isnot assured. Also, it is possible that additional trials or studies that we decide are necessary or desirable will delay or prevent the completion of thedevelopment of CORLUX for treating Cushing’s Syndrome or the psychotic features of psychotic depression.Many other factors could delay or result in termination of our clinical trials, including, but not limited to: • availability of funding; • negative or inconclusive results; • slow patient enrollment; • patient noncompliance with the protocol; • adverse medical events or side effects among patients during the clinical trials; • negative or problematic FDA inspections of our clinical operations or our manufacturing operations; and • real or perceived lack of effectiveness or safety of CORLUX.Even after we conduct all of the clinical trials and supportive studies that we consider appropriate for an optimal NDA, we may not receive regulatoryapproval to market CORLUX.We will need additional capital in order to complete the development and commercialization of CORLUX and our other proprietary, selective GR-IIantagonists, including CORT 108297 and CORT 113083. Additional capital may not be available to us at all or on favorable terms, which couldadversely affect our business.We may have to perform additional clinical trials prior to the approval of an NDA for CORLUX for the treatment of Cushing’s Syndrome and for thetreatment of the psychotic features of psychotic depression. We 24Table of Contentsmay need to raise additional funds to complete the development of CORLUX for the treatment of Cushing’s Syndrome or for the treatment of psychoticdepression. In addition, we will need to raise additional funds for the commercialization of CORLUX for either of these indications, to develop a product forweight gain management associated with antipsychotic medications, and to continue and expand the development of our proprietary, selective GR-IIantagonists, including CORT 108297 and CORT 113083 in various indications.We anticipate that our existing capital resources will be sufficient to fund our current operating plan into the third quarter of 2012. However, ourexpectations are based on our currently planned clinical development and research programs for CORLUX and for certain of our proprietary, selective GR-IIantagonists, including CORT 108297 and CORT 113083, which may change as a result of many factors, including: • the costs, timing of site selection and enrollment of our clinical trials; • the results of our research efforts and clinical trials; • the need to perform additional clinical trials and other supportive studies; • the need to establish a second source for CORLUX tableting; • the timing of the submission of an NDA to the FDA, the acceptance of the filing and approval of an NDA by the FDA to market CORLUX for thetreatment of Cushing’s Syndrome or for the treatment of the psychotic features of psychotic depression; • developments or disputes concerning patents or proprietary rights, including announcements of claims of infringement, interference or litigationagainst us or our licensors; • actual or anticipated fluctuations in our operating results; • changes in our growth rates; • changes in our research development plans for our proprietary, selective GR-II antagonists, including CORT 108297 and CORT 113083; • the timing of commercialization of CORLUX and future product candidates; and • changes in the reimbursement policies of third-party insurance companies or government agencies.Consequently, we may need additional funding sooner than anticipated. In addition, we may choose to raise additional capital due to marketconditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans.We cannot be certain that additional funding will be available on acceptable terms or at all. Even though we have raised funds several times over thepast twelve months, market and economic conditions may make it difficult for us to raise any or sufficient additional capital. The sales of common stock andwarrants during 2010 and through January 2011 have been dilutive to stockholders and any exercise of outstanding warrants and additional equity financingwill cause further dilution to stockholders. Debt financing, if available, may involve restrictive covenants. If we obtain funds through collaborations withothers, these arrangements may be on unfavorable terms or may require us to relinquish certain rights to our technologies or product candidates, includingour lead product candidate, which we would otherwise seek to develop on our own. If adequate funds are not available, we may be required to delay, reducethe scope of or eliminate one or more of our research or development programs or we may be required to discontinue operations.We have incurred losses since inception and anticipate that we will incur continued losses for at least the next few years.We are a development stage company with no current source of product revenue. We have a limited history of operations and have focused primarilyon clinical trials, and if the outcome of our clinical trials supports it, we plan to seek FDA regulatory clearance to market CORLUX for the treatment ofCushing’s Syndrome and for the 25Table of Contentstreatment of the psychotic features of psychotic depression. Historically, we have funded our operations primarily from the sale of our equity securities. Wehave incurred losses in each year since our inception in 1998. As of December 31, 2010, we had an accumulated deficit of $176.2 million. We do not knowwhen or if we will generate product revenue. Subject to our ability to raise additional funds, we expect our research and development expenses to increase inconnection with the clinical trials and other development activities for CORLUX and for other product candidates. We expect to incur significant expensesrelated to the preparation for commercializing CORLUX and for the product’s launch, if the FDA approves our NDA. As a result, we expect that our losses willincrease at least until CORLUX is launched and commercially available to patients. We are unable to predict the extent of any future losses or whether orwhen we will become profitable.The committed equity financing facility (CEFF) that we entered into with Kingsbridge in March 2008 may not be available to us at certain times, maygenerate a lower level of funding than we anticipate, may require us to make additional “blackout” or other payments to Kingsbridge, and will result indilution to our stockholders.Kingsbridge will not be obligated to purchase shares under the CEFF unless certain conditions are met, which include a minimum price for ourcommon stock, currently set at $1.50 per share and the effectiveness and continued effectiveness of the resale registration statements. The actual amount offunds that can be raised under this agreement will be dependent on the number of shares actually sold under the agreement and the market value of our stockduring the pricing periods of each sale.In June 2008, the SEC declared effective our registration statement with the SEC covering the resale of approximately 3.6 million of the shares issuableunder the CEFF and the shares issuable upon the exercise of the warrant issued to Kingsbridge. This registration statement covers approximately 37% of the9.6 million shares of our common stock issuable pursuant to the CEFF and all of the 330,000 shares of our common stock issuable upon exercise of thewarrant issued to Kingsbridge. We intend to file an additional registration statement covering the resale of the remaining shares of our common stock issuablepursuant to the CEFF 60 days after Kingsbridge and its affiliates have resold substantially all of the securities covered by this initial registration statement;therefore, the timing of the submission of this subsequent registration statement is uncertain. This subsequent registration statement may be subject to reviewand comment by the Staff of the SEC, and will require the consent of our independent registered public accounting firm. We cannot assure you that theseregistration statements will be declared effective or, if declared effective, that they will remain continuously effective thereafter.In addition, Kingsbridge is permitted to terminate the CEFF if it determines that a material and adverse event has occurred affecting our business,operations, properties or financial condition and if such condition continues for a period of 10 days from the date Kingsbridge provides us notice of suchmaterial and adverse event. If we are unable to access funds through the CEFF, or if the CEFF is terminated by Kingsbridge, we may be unable to accessalternative capital on favorable terms or at all.We are entitled in certain circumstances, to deliver a blackout notice to Kingsbridge to suspend the use of the resale registration statement and prohibitKingsbridge from selling shares thereunder. If we deliver a blackout notice in the 15 trading days following the settlement of a draw down, or if the resaleregistration statement is not effective in circumstances not permitted by our agreement with Kingsbridge, then we may be required to make a payment toKingsbridge, or issue Kingsbridge additional shares in lieu of the payment. If the trading price of our common stock declines during a suspension of theresale registration statement, the blackout or other payment could be significant.Any shares that we may issue to Kingsbridge under the CEFF will have a dilutive effect on the holdings of our current stockholders, and may result indownward pressure on the price of our common stock. For each draw down under the CEFF, we will issue shares to Kingsbridge at a discount of up to 10%from the volume weighted average price of our common stock during the eight-day trading period following the issuance of the draw down 26Table of Contentsnotice. If we draw down amounts under the CEFF when our share price is decreasing, we will need to issue more shares to raise the same amount than if ourstock price was higher. Issuances in the face of a declining share price will have an even greater dilutive effect than if our share price were stable orincreasing, and may further decrease our share price.We may not be able to pursue all of our product research and development opportunities if we are unable to secure adequate funding for theseprograms.The costs required to start or continue many of the programs that our intellectual property allow us to consider for further development are collectivelygreater than the funds currently available to us. For example, we have successfully discovered three series of compounds that are specific GR-II antagonistsbut, unlike CORLUX, do not appear to block the progesterone receptor. Further development of these proprietary compounds, including CORT 108297 andCORT 113083, or any further development stemming from our method of use patents may be delayed or cancelled if we determine that such developmentmay jeopardize our ability to complete activities necessary for the submission of our NDA for CORLUX for the treatment of Cushing’s Syndrome, the supportof this NDA through its successful approval, the commercialization of this product for this indication or to complete the clinical development of CORLUXfor the treatment of psychotic depression.Global economic conditions could adversely affect our liquidity and financial condition.Global economic and market conditions have been volatile since the fall of 2008, with significantly tighter credit conditions. As a result of theseconditions, the cost and availability of capital have been and may continue to be adversely affected. Concern about the stability of the markets generally,and the strength of counterparties specifically, has led many lenders and institutional investors to reduce, and in some cases, cease, to provide credit tobusinesses. Continued turbulence in the global markets and economies may adversely affect our liquidity and financial condition.In addition, our access to funds under our CEFF or any credit facility into which we may enter depends on the ability of the counterparties to suchfacilities to meet their funding commitments to us. We cannot assure you that recent disruptions in the global economy and tighter credit conditions will nothave an adverse effect on such counterparties.If we do not have sufficient cash flow to continue operating our business and are unable to borrow funds, access our CEFF or raise equity capital, wemay need to find alternative ways to increase our liquidity. Such alternatives may include, without limitation, curtailing clinical or drug developmentactivity, or limiting our commercial efforts, product manufacturing or sales and marketing support, which would have an adverse affect on our business andresults of operations.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 performrelated data collection and analysis, and, as a result, we may face costs and delays outside of our control.We rely on clinical investigators and clinical sites to enroll patients and other third parties to manage our trials and to perform related data collectionand analysis. However, we may not be able to control the timing of identification and selection of appropriate sites for our planned trials and the amount andtiming of resources that the clinical sites that conduct the clinical testing may devote to our clinical trials. If our clinical investigators and clinical sites fail toenroll a sufficient number of patients in our clinical trials or fail to enroll them on our planned schedules, we will be unable to complete our trials or tocomplete them as planned, which could delay or prevent us from completing the clinical development of CORLUX or other development programs.We have a contract research organization, Octagon Research Solutions, Inc., that is managing our data and statistical analysis for our Phase 3 trial ofCORLUX for the treatment of Cushing’s Syndrome. They may be 27Table of Contentsunable to collect, process or analyze the trial data in a timely manner or may fail to process the data appropriately, which could delay or prevent us fromproducing data which may be submitted to the FDA as part of our NDA.We have an agreement with a clinical research organization (CRO) that is conducting our ongoing Phase 3 trial evaluating CORLUX for the treatmentof the psychotic features of psychotic depression, Study 14, to supervise and monitor clinical site performance and to perform investigator supervision, datacollection and analysis for this trial. We may not be able to maintain relationships with this or other CROs or with the clinical investigators and the clinicalsites through the completion of all trial activities without delays in anticipated timing of trial activities or excessive expenditures. Our agreements placesubstantial responsibilities on these parties, which could result in excessive expenditures for our clinical trials if these parties fail to perform as expected. Forexample, if any of our clinical trial sites fail to comply with FDA-approved good clinical practices, we may be unable to use the data gathered at those sites. Ifthese CROs, clinical investigators, clinical sites or other third parties do not carry out their contractual duties or obligations or fail to meet expecteddeadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to their failure to adhere to our clinical protocols or for otherreasons, we may be unable to obtain regulatory approval for, or successfully commercialize, CORLUX.The conduct of any future clinical trials will likely also be conducted through the use of CROs and clinical research sites. The conduct, timing and costof these trials will be subject to the same kinds of risks as discussed above.Our use of MedAvante to provide centralized psychiatric rating services in Study 14, our ongoing clinical trial evaluating CORLUX for the psychoticfeatures of psychotic depression, may not result in any improvement in the accuracy and consistency of the psychiatric assessments and may continue toslow the pace of enrollment in Study 14.In connection with our ongoing Phase 3 trial evaluating CORLUX for the psychotic features of psychotic depression, Study 14, we engagedMedAvante to provide centralized psychiatric rating services. MedAvante is providing centralized psychometric assessments via high resolution video-conferencing. The use of MedAvante’s centralized rating services is expected to increase the accuracy and consistency of the psychiatric assessments.MedAvante has provided similar centralized rating services to companies conducting clinical studies in various psychiatric disorders. However, theyhave not previously provided centralized rating services to any study in patients with psychotic depression. Although Corcept and MedAvante conducted asmall pilot evaluation in patients with psychotic depression to assess patient receptivity, we cannot be certain that centralized rating will be successful in thepatients enrolled in our study.If patients are uncomfortable or unwilling to participate in the centralized rating process or if MedAvante is unable to provide services in a satisfactorymanner over the course of the trial, we may not see any improvement in the accuracy or reliability of the psychiatric assessments. Such a result mightdiminish the likelihood of a successful trial or a definitive demonstration of the efficacy of CORLUX in treating the psychotic features of psychoticdepression.During screening for Study 14, we have seen a higher than anticipated incidence of potential patients who do not meet appropriate criteria for entranceinto the trial for diagnostic and other clinical reasons. Although we believe that this is the result of improved accuracy in the screening process resulting fromthe use of the MedAvante centralized rating services as an additional step in the selection of patients appropriate for inclusion in the study, MedAvante’sdiagnostic screening has resulted in slower patient enrollment and may not actually improve trial performance. In addition, in mid-2009, in order to lowerexpenses and to conserve financial resources, we scaled back our planned rate of spending on this trial and extended the timeline for its completion. We arecurrently using a reduced total of eight clinical sites in order to conserve capital. This strategy may result in increased total study costs over the longer term. 28Table of ContentsIf we are unable to obtain or maintain regulatory approval, we will be limited in our ability to commercialize our product candidates, includingCORLUX, and our business will be harmed.The research, testing, manufacturing, selling and marketing of product candidates are subject to extensive regulation by the FDA and other regulatoryauthorities in the United States and other countries, in which regulations differ from country to country. Obtaining and maintaining regulatory approvaltypically is an uncertain process, is costly and takes many years. In addition, failure to comply with the FDA and other applicable foreign and U.S. regulatoryrequirements may subject us to administrative or judicially imposed sanctions. These include warning letters, civil and criminal penalties, injunctions,product seizure or detention, product recalls, total or partial suspension of production, and refusal to approve pending NDAs, or supplements to approvedNDAs.The Food and Drug Administration Amendments Act of 2007 gave the FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS)from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks. A REMS program may include a medication guide, a patientpackage insert, a plan for communicating risks to health care providers or other elements that the FDA deems necessary to assure the safe use of the drug. Weare working with a vendor to assist in development of our REMS program, a plan for which will be submitted to the FDA as part of our NDA for CORLUX forthe treatment of Cushing’s Syndrome.Regulatory approval of an NDA or NDA supplement is never guaranteed. Despite the time, resources and effort expended, failure can occur at anystage. The FDA has substantial discretion in the approval process for human medicines. The FDA can deny, delay or limit approval of a product candidate formany reasons including: • the FDA may not find that the candidate is safe; • the FDA may not find data from the clinical or preclinical testing to be sufficient; • the FDA may not approve our or our third party manufacturers’ processes or facilities; or • the FDA may not find that our REMS program is adequate to address the risks associated with our product candidate.Future governmental action or changes in FDA policy or personnel may also result in delays or rejection of an NDA in the United States. In addition,because the only currently FDA-approved use of mifepristone is the termination of pregnancy, we expect that the label for CORLUX will include somelimitations, including a warning that it should not be used by pregnant women or women seeking to become pregnant.If we receive regulatory approval for our product candidates, including CORLUX, we will also be subject to ongoing FDA obligations and continuedregulatory oversight and review, such as continued safety reporting requirements; and we may also be subject to additional FDA post-marketing obligations.If we are not able to maintain regulatory compliance, we may not be permitted to market our product candidates and/or may be subject to product recalls orseizures.Any regulatory approvals that we receive for our product candidates may also be subject to limitations on the indicated uses for which the medicinemay be marketed or contain requirements for potentially costly post-marketing follow-up studies. In addition, if the FDA approves any of our productcandidates, the labeling, packaging, adverse event reporting, storage, advertising, promotion and record-keeping for the medicine will be subject to extensiveregulatory requirements. The subsequent discovery of previously unknown problems with the medicine, including adverse events of unanticipated severityor frequency, may result in restrictions on the marketing of the medicine, and could include withdrawal of the medicine from the market. 29Table of ContentsFailure to obtain regulatory approval in foreign jurisdictions will prevent us from commercializing our product candidates abroad.We intend to commercialize our product candidates in international markets with the help of one or more partners. Outside the United States, we cancommercialize a product only if we receive a marketing authorization and, in some cases, pricing approval, from the appropriate regulatory authorities, whoseapproval processes includes all of the risks associated with the FDA approval process, and, in some cases, additional risks. The approval procedure variesamong countries and can involve additional testing, and the time required to obtain approval may differ from that required to obtain FDA approval. We havenot taken any actions to obtain foreign approvals. We may not develop our product candidates in the clinic in order to obtain foreign regulatory approvals ona timely basis, if at all.Approval by the FDA does not ensure approval by regulatory authorities in other countries, and approval by one foreign regulatory authority does notensure approval by regulatory authorities in other foreign countries or by the FDA. We may not be able to file for regulatory approvals and may not receivenecessary approvals to commercialize our product candidates in any market.The Orphan Drug Designation for CORLUX for the treatment of endogenous Cushing’s Syndrome may not provide protection from competition andother benefits as anticipated.In July 2007, we received Orphan Drug Designation from the FDA for CORLUX for the treatment of endogenous Cushing’s Syndrome. Drugs thatreceive Orphan Drug Designation obtain seven years of marketing exclusivity from the date of drug approval, as well as tax credits for clinical trial costs,marketing application filing fee waivers and assistance from the FDA in the drug development process. Although we have received Orphan Drug Designationfrom the FDA, we cannot be assured that we will recognize the potential benefits of this designation.For example, we are aware that Laboratoire HRA Pharma has received an Orphan Drug Designation in the United States and Europe for the use ofmifepristone to treat a subtype of Cushing’s Syndrome and has begun a Phase 2 clinical trial in Europe and the United States for this indication. We are alsoaware that Exelgyn Laboratories, which operates as a subsidiary of Medi Challenge (Pty) Ltd., received Orphan Drug Designation for Cushing’s Syndrome inEurope, but they have stated that they have not yet conducted any clinical trials.If another drug with the same active ingredient is approved for this indication before CORLUX, we will not garner the seven years of marketingexclusivity from the date of drug approval in the U.S. and other benefits that we anticipate. If CORLUX is the first drug approved by the FDA for thisindication, any delay in our commercialization of the product, may have a negative impact on the revenue that we might be able to realize from theexclusivity provided during those seven years.The “fast track” designation for the development program of CORLUX for the treatment of the psychotic features of psychotic depression may not leadto a faster development or regulatory review or approval process.If a human medicine is intended for the treatment of a serious or life-threatening condition and the medicine demonstrates the potential to addressunmet medical needs for this condition, the sponsor of an IND may apply for FDA “fast track” designation for a particular indication. Marketing applicationssubmitted by sponsors of product candidates in fast track development may qualify for expedited FDA review under the policies and procedures offered bythe FDA, but the fast track designation does not assure any such qualification. Although we have obtained a fast track designation from the FDA forCORLUX for the treatment of the psychotic features of psychotic depression, we may not experience a faster development process, review or approvalcompared to applications considered for approval under conventional FDA procedures. In addition, the FDA may withdraw our fast track designation at anytime. If we lose our fast track designation, the approval process may be delayed. 30Table of ContentsIn addition, our fast track designation does not guarantee that we will qualify for or be able to take advantage of the expedited review procedures and doesnot increase the likelihood that CORLUX will receive regulatory approval for the treatment of the psychotic features of psychotic depression.Even if we receive approval for the marketing and sale of CORLUX for the treatment of Cushing’s Syndrome and / or psychotic depression, CORLUXmay never be accepted as a treatment for the approved indications, which would adversely affect our financial results.Many factors may affect the market acceptance and commercial success of CORLUX for the treatment of Cushing’s Syndrome and / or the psychoticfeatures of psychotic depression or for any other approved indication.Even if the FDA approves CORLUX for the treatment of Cushing’s Syndrome, for the treatment of the psychotic features of psychotic depression, or forany other indication, physicians may not adopt CORLUX. Physicians will recommend the use of CORLUX only if they determine, based on experience,clinical data, side effect profiles and other factors, that it is preferable to other products or treatments then in use. Acceptance of CORLUX among influentialpractitioners may be essential for market acceptance of CORLUX.Other factors that may affect the market acceptance and commercial success of CORLUX include: • the effectiveness of CORLUX, including any side effects, as compared to alternative treatment methods; • the product labeling or product insert required by the FDA for CORLUX; • the cost-effectiveness of CORLUX and the availability of third-party insurance coverage and reimbursement, in particular from governmentpayors such as Medicare and Medicaid, for patients using CORLUX; • the timing of market entry of CORLUX relative to competitive products; • the intentional restriction of distribution of CORLUX to physicians treating the target patient population; • the extent and success of our efforts to manufacture, commercialize, market, distribute and sell CORLUX; • the rate of adoption of CORLUX by physicians and by target patient populations; and • negative publicity concerning CORLUX, RU-486 or mifepristone.The failure of CORLUX to achieve market acceptance would prevent us from generating meaningful product revenue.Public perception of the active ingredient in CORLUX, mifepristone or RU-486, may limit our ability to market and sell CORLUX.The active ingredient in CORLUX, mifepristone (RU-486) is used to terminate pregnancy. As a result, mifepristone has been and continues to be thesubject of considerable ethical and political debate in the United States and elsewhere. Public perception of mifepristone may limit our ability to engagealternative manufacturers and may limit the commercial acceptance of CORLUX by patients and physicians. Even though we intend to create measures tominimize the likelihood of the prescribing of CORLUX to a pregnant woman, physicians may choose not to prescribe CORLUX to a woman simply to avoidaltogether any risk of unintentionally terminating a pregnancy. We intend to create measures for controlling the distribution of CORLUX to reduce thepotential for diversion. Controlled distribution may negatively impact sales of CORLUX. 31Table of ContentsWe have no manufacturing capabilities and we currently depend on third parties to manufacture the active ingredient and the tablets for CORLUX. Ourtablet manufacturer is a single source supplier. If these suppliers are unable to continue manufacturing CORLUX and we are unable to contract quicklywith alternative sources, our business will be harmed.We currently have no experience in, and we do not own facilities for, nor do we plan to develop facilities for, manufacturing any products. We have anagreement with one manufacturer of the active pharmaceutical ingredient (API) of mifepristone which we expect to include in our initial NDA submission.We have a memorandum of understanding with a second API manufacturer. However, there are no activities currently being conducted at this site to developor qualify the manufacturing processes or facilities and we do not plan to include a request for approval of material produced by this second manufacturerwhen we submit our NDA for Cushing’s Syndrome.We have an agreement with a tablet manufacturer to be included in our initial NDA submission. The tablet manufacturer is a single source supplier tous. If this single source supplier were to cease manufacturing tablets for us or fail to manufacture tables on a timely basis, we might be required to qualify analternate supplier and we would likely experience a lengthy delay in our manufacturing processes. We cannot assure you that our single source supplier willbe able or willing to meet our future demands.Our current arrangements with these manufacturers are terminable by such manufacturers. We anticipate engaging some or all of the suppliers toproduce commercial quantities of CORLUX, however we cannot guarantee that we will enter into an agreement with them on terms acceptable to us. If we areunable, for whatever reason, to obtain the active pharmaceutical ingredient or CORLUX tablets from our contract manufacturers, we may not be able tomanufacture our required quantities or identify alternate manufacturers of mifepristone or CORLUX tablets in a timely manner or on reasonable terms, if atall.If our third-party manufacturers of CORLUX fail to comply with FDA regulations or otherwise fail to meet our requirements, our product developmentand commercialization efforts may be delayed.We depend on third party manufacturers to supply the active pharmaceutical ingredient in CORLUX and to manufacture CORLUX tablets. Thesesuppliers and manufacturers must comply with the FDA’s current Good Manufacturing Practices (cGMP) regulations and guidelines. Our suppliers andmanufacturers may encounter difficulties in achieving quality control and quality assurance and may experience shortages of qualified personnel. Theirfailure to follow cGMP or other regulatory requirements and to document their compliance with cGMP may lead to significant delays in the availability ofproducts for commercial use or clinical study or the termination or hold on a clinical study, or may delay or prevent filing or approval of marketingapplications for CORLUX.If we, or our third party suppliers and manufacturers fail to comply with applicable regulations, sanctions could be imposed on us, including fines,injunctions, civil penalties, failure of regulatory authorities to grant marketing approval of our product candidates, delays, suspension or withdrawal ofapprovals, license revocation, seizures or recalls of products, operating restrictions and criminal prosecutions, any of which could harm our business. If theoperations of any current or future supplier or manufacturer were to become unavailable for any reason, commercialization of CORLUX could be delayed andfuture revenue from product sales could be reduced.We may use a different third-party manufacturer to produce commercial quantities of CORLUX than we are using in our clinical trials. The FDA mayrequire us to conduct a study to demonstrate that the tablets used in our clinical trials are equivalent to the final commercial product, which could result inincreased costs and a delay in the commercial launch of CORLUX. If we are unable to establish that the tablets are equivalent or if the FDA disagrees with theresults of our study, a commercial launch of CORLUX could be delayed and we may incur additional costs. 32Table of ContentsIf 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 togenerate revenues.If we or others identify side effects after any of our product candidates are on the market: • regulatory authorities may withdraw their approvals; • we may be required to reformulate our future products, conduct additional clinical trials, make changes in labeling of such products orimplement changes to or obtain re-approvals of our manufacturing facilities; • we may experience a significant drop in the sales of the affected products; • our reputation in the marketplace may suffer; and • we may become the target of lawsuits, including class action lawsuits.Any of these events could harm or prevent sales of the affected products or could increase the costs and expenses of commercializing and marketingthese product candidates.If CORLUX or future product candidates conflict with the patents of others or if we become involved in other intellectual property disputes, we mayhave to engage in costly litigation or obtain a license and we may be unable to commercialize our product candidates.Our success depends in part on our ability to obtain and maintain adequate patent protection for the use of CORLUX for the treatment of Cushing’sSyndrome or the psychotic features of psychotic depression and other potential uses of GR-II antagonists. If we do not adequately protect our intellectualproperty, competitors may be able to use our intellectual property and erode our competitive advantage.To date, we own seven issued U.S. method of use patents and have exclusively licensed three issued U.S. method of use patents. We have seven U.S.method of use patent applications for GR-II antagonists. We own three composition of matter patents and have one composition of matter patent applicationpending. We have applied, and will continue to apply, for patents covering our product candidates as we deem appropriate. We have also filed, where wedeemed appropriate, foreign patent applications corresponding to our U.S. patents and applications.We have exclusively licensed three issued U.S. patents from Stanford University for the use of GR-II antagonists in the treatment of psychotic majordepression, which is commonly referred to as psychotic depression, cocaine-induced psychosis and early dementia, including early Alzheimer’s disease. Webear the costs of protecting and defending the rights to these patents. In order to maintain the exclusive license to these patents until their expiration, we areobligated to make milestone and royalty payments to Stanford University. We are currently in compliance with our obligations under this agreement. If webecome noncompliant, we may lose the right to commercialize CORLUX for the treatment of psychotic depression, cocaine-induced psychosis and earlydementia and our business would be materially harmed. In addition, if Stanford University were to terminate our CORLUX license due to breach of thelicense on our part, we would not be able to commercialize CORLUX for the treatment of the psychotic features of psychotic depression, cocaine-inducedpsychosis or early dementia.Our patent applications and patents licensed or issued to us may be challenged by third parties and our patent applications may not result in issuedpatents. For example, in 2004, Akzo Nobel, which was subsequently acquired by Schering Plough which was then subsequently acquired by Merck & Co.,filed an observation challenging the claims of our exclusively licensed European patent application with claims directed to psychotic depression. In thisinstance, the patent later issued and, in 2007, we received notice that there will be no opposition proceedings in Europe in regard to this patent. 33Table of ContentsOur presently pending and future patent applications may not issue as patents, and any patent issued to us may be challenged, invalidated, heldunenforceable or circumvented. For example, the arguments presented by Akzo Nobel could be raised in the United States either before the U.S. Patent andTrademark Office or in a court of law. Furthermore, the claims in patents which have been issued to us, or which may be issued to us in the future, may not besufficiently broad to prevent third parties from producing competing products. In addition, the laws of various foreign countries in which we compete maynot protect our intellectual property to the same extent as do the laws of the United States. If we fail to obtain adequate patent protection for our proprietarytechnology, our competitors may produce competing products based on our technology, which would impair our ability to compete.If a third party were successful in asserting an infringement claim against us, we could be forced to pay damages and prevented from developing,manufacturing or marketing our potential products. We do not have liability insurance for patent infringements. A third party could require us to obtain alicense to continue to use their intellectual property, and we may not be able to do so on commercially acceptable terms, or at all. We believe that significantlitigation will continue in our industry regarding patent and other intellectual property rights. If we become involved in litigation, it could consume asubstantial portion of our resources. Regardless of the merit of any particular claim, defending a lawsuit takes significant time, is expensive and divertsmanagement’s attention from other business.If we are unable to protect our trade secrets and proprietary information, our ability to compete in the market could be diminished.In addition to patents, we rely on a combination of confidentiality, nondisclosure and other contractual provisions, laws protecting trade secrets andsecurity measures to protect our trade secrets and proprietary information. Nevertheless, these measures may not adequately protect our trade secrets or otherproprietary information. If they do not adequately protect our rights, third parties could use our proprietary information, which could diminish our ability tocompete in the market. In addition, employees, consultants and others who participate in the development of our product candidates may breach theiragreements with us regarding our trade secrets and other proprietary information, and we may not have adequate remedies for the breach. We also realize thatour trade secrets may become known through means not currently foreseen. Notwithstanding our efforts to protect our trade secrets and proprietaryinformation, our competitors may independently develop similar or alternative products that are equal or superior to our product candidates withoutinfringing on any of our proprietary information or trade secrets.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 Cushing’s Syndrome or psychoticdepression rather than CORLUX or patients may acquire mifepristone from other sources, such as the internet or black market.We have an exclusive license from Stanford University to a patent covering the use of GR-II antagonists, including mifepristone, for the treatment ofpsychotic depression. A method of use patent covers only a specified use of a particular compound, not a particular composition of matter. Because none ofour issued patents covers the composition of mifepristone, we cannot prevent others from commercializing mifepristone in indications not covered by ourmethod of use patents. If others receive approval to manufacture and market mifepristone or any other GR-II antagonist, physicians could prescribemifepristone or any other GR-II antagonist for patients with psychotic depression instead of CORLUX. Although any such “off-label” use would violate ourlicensed patent, effectively monitoring compliance with our licensed patent may be difficult and costly. In addition, if others develop a treatment forpsychotic depression that works through a mechanism which does not involve the GR-II receptor, physicians could prescribe that treatment instead ofCORLUX.In addition, we cannot be assured that patients will not obtain mifepristone from other sources. As with other pharmaceutical products, patients may beable to purchase mifepristone through the internet or black 34Table of Contentsmarket. Mifepristone is also sold in the United States by Danco Laboratories for the termination of early pregnancy. While distribution is limited to a singledose provided in the physician’s office and covered by other restrictions, we cannot be certain that Cushing’s Syndrome patients may not be able to obtainmifepristone from this source.Our efforts to discover, develop and commercialize new product candidates beyond CORLUX are at a very early stage. If we fail to identify anddevelop additional uses for GR-II antagonists, we may be unable to market additional products.To develop additional potential sources of revenue, we believe that we must identify and develop additional product candidates. We own or haveexclusively licensed issued U.S. patents covering the use of GR-II antagonists to treat psychotic depression, mild cognitive impairment, weight gain due totreatment with antipsychotic medication, stress disorders, early dementia, delirium, gastroesophageal reflux disease, Down’s Syndrome and psychosisassociated with cocaine addiction, and to increase the therapeutic response to electroconvulsive therapy (ECT). In addition, we have seven U.S. method ofuse patent applications covering GR-II antagonists for the treatment of a number of other metabolic and psychiatric disorders, three U.S. composition ofmatter patents covering specific GR-II antagonists, and a fourth U.S. composition of matter patent is pending. We have also filed patent applications in all ofthe major international markets.We may not develop or continue to develop product candidates for any of the indications or compounds covered by our patents and patentapplications. Typically, there is a high rate of attrition for product candidates in preclinical and clinical trials, so our product development efforts may notlead to commercially viable products. The use of GR-II antagonists may not be effective to treat these conditions or any other indications. In addition, wecould discover that the use of GR-II antagonists in these patient populations has unacceptable side effects or is otherwise not safe.We may elect to enter into collaboration arrangements with respect to one or more of our product candidates. If we do enter into such an arrangement,we would be dependent on a collaborative partner for the success of the product candidates developed under the arrangement. Any future collaborativepartner may fail to successfully develop or commercialize a product candidate under a collaborative arrangement.We only have significant clinical experience with CORLUX and we may determine that CORLUX is not desirable for uses other than for the treatmentof Cushing’s Syndrome or the treatment of the psychotic features of psychotic depression. For example, we do not intend to develop CORLUX for mitigationof the weight gain associated with the use of Zyprexa, Risperdal or other atypical antipsychotics, even though we have reported positive results in the proofof concept studies described elsewhere in this Annual Report on Form 10-K. We are pursuing other GR-II antagonists for this use. The compounds developedpursuant to our early clinical, preclinical and discovery research programs, including CORT 108297 and CORT 113083, may fail to generate commerciallyviable product candidates in spite of the resources we may dedicate to the program. Even if product candidates are identified, we may abandon furtherdevelopment efforts before we reach clinical trials or after expending significant expense and time conducting clinical trials due to financial constraints,concerns over safety, efficacy of the product candidates or for other reasons. Moreover, governmental authorities may enact new legislation or regulationsthat could limit or restrict our development efforts. If we are unable to successfully discover and commercialize new uses for GR-II antagonists, we may beunable to generate sufficient revenue to support our operations.We may have substantial exposure to product liability claims and may not have adequate insurance to cover those claims.We may be subject to product liability or other claims based on allegations that the use of our products has resulted in adverse effects or that ourproduct candidates are not effective, whether by participants in our clinical trials for CORLUX or other product candidates, or by patients using our futureproducts. A product liability 35Table of Contentsclaim may damage our reputation by raising questions about our product candidates’ safety or efficacy and could limit our ability to sell a product bypreventing or interfering with product commercialization. In some cases, less common adverse effects of a pharmaceutical product are not known until longafter the FDA approves the product for marketing. The active ingredient in CORLUX is used to terminate pregnancy. Therefore, clinicians using the medicinein our clinical trials and, if approved by the FDA, physicians prescribing the medicine to women with childbearing potential, must take necessary and strictprecautions to insure that the medicine is not administered to pregnant women. The failure to observe these precautions could result in significant productclaims.We have only limited product liability insurance coverage, with limits that we believe to be customary for a development stage company. We intend toexpand our product liability insurance coverage to any product candidates for which we obtain marketing approval. However, this insurance may beprohibitively expensive or may not fully cover our potential liabilities. Our inability to obtain adequate insurance coverage at an acceptable cost couldprevent or inhibit the commercialization of our product candidates. Defending a lawsuit could be costly and significantly divert management’s attentionfrom conducting our business. If a third party successfully sues us for any injury caused by our product candidates, our liability could exceed our total assets.If CORLUX is approved and we are unable to obtain acceptable prices or adequate coverage and reimbursement for it from third-party payors, we willbe unable to generate significant revenues.There is significant uncertainty related to the availability of third-party insurance coverage and reimbursement for newly approved medications. Thecommercial success of our potential medications in both domestic and international markets is dependent on whether third-party coverage andreimbursement is available for them. Government payors, including Medicare and Medicaid, health maintenance organizations and other third-party payorsare increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement of new medicines, and, as a result, they maynot cover or provide adequate payment for our medications. The continuing efforts of government and other third-party payors to contain or reduce the costsof health care and recent healthcare legislation may limit our future revenues. Our near-term dependence on the commercial success of CORLUX makes usparticularly susceptible to any such cost containment or reduction efforts. Accordingly, even if CORLUX or future product candidates are approved forcommercial sale, unless government and other third-party payors provide adequate coverage and reimbursement for our future products, physicians may notprescribe them. In addition, we may need to obtain approvals from hospital formularies to receive wide-spread third-party coverage and reimbursement forthose situations where our products may be needed during in-patient treatment. If we fail to obtain such approvals, this will reduce the level of revenues thatwe are able to attain.In some foreign markets, pricing and profitability of prescription pharmaceuticals are subject to government control. In the United States, we expectthat there will continue to be federal and state proposals for similar controls. Also, the trends toward managed health care in the United States and recent lawsand legislation intended to reduce the cost of government insurance programs could significantly influence the purchase of health care services and productsand may result in lower prices for our future products or the exclusion of such products from reimbursement programs.In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act,collectively referred to as the PPACA, was passed. The PPACA includes, among other things, the following measures: • Annual, non-deductible fees on any entity that manufactures or imports certain prescription drugs and biologics; • Increases in Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program for both branded and generic drugs; • A new Patient-Centered Outcomes Research Institute to oversee, identify priorities in and conduct comparative clinical research; 36Table of Contents • New requirements for manufacturers to discount drug prices to eligible patients by 50 percent at the pharmacy level and for mail order services inorder for their outpatient drugs to be covered under Medicare Part D; • An increase in the number of entities eligible for discounts under the Public Health Service pharmaceutical pricing program; and • Establishment of a licensure framework for follow-on biologic products.The PPACA provisions on comparative clinical effectiveness research extend the initiatives of the American Recovery and Reinvestment Act of 2009,also known as the stimulus package, which included $1.1 billion in funding to study the comparative effectiveness of health care treatments. This stimulusfunding was designated for, among other things, conducting, supporting or synthesizing research that compares and evaluates the risks and benefits, clinicaloutcomes, effectiveness and appropriateness of products. The PPACA also appropriates additional funding to comparative clinical effectiveness research.Although Congress has indicated that this funding is intended to improve the quality of health care, it remains unclear how the research will impact currentMedicare coverage and reimbursement or how new information will influence other third-party payor policies. We expect that the PPACA and regulationsand policies implementing this legislation, as well as other healthcare reform measures that may be adopted in the future, may have a material adverse effecton our industry generally and on our ability to successfully develop and commercialize our products.If we market products in a manner that violates health care fraud and abuse laws, we may be subject to civil or criminal penalties.In the United States, we will be subject to health care fraud and abuse regulation and enforcement by both the federal government and the states inwhich we conduct our business once we commercialize. The laws that may affect our ability to operate include: • the federal health care programs’ Anti-Kickback Law, which prohibits, among other things, persons from knowingly and willfully soliciting,receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or thepurchase, order or recommendation of, any good or service for which payment may be made under federal health care programs such as theMedicare and Medicaid programs; • federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented,claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent; • the federal Health Insurance Portability and Accountability Act of 1996, (HIPAA), which created federal criminal laws that prohibit executing ascheme to defraud any health care benefit program or making false statements relating to health care matters; • federal “sunshine” laws that require transparency regarding financial arrangements with health care providers, such as the reporting anddisclosure requirements imposed by PPACA on drug manufacturers regarding any “transfer of value” made or distributed to prescribers and otherhealth care providers; and • state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or servicesreimbursed by any third-party payor, including commercial insurers.Some states, such as California, Massachusetts and Vermont, mandate implementation of commercial compliance programs to ensure compliance withthese laws.The risk of our being found in violation of these laws is increased by the fact that many of them have not been fully interpreted by the regulatoryauthorities or the courts, and their provisions are open to a variety of interpretations. Moreover, recent health care reform legislation has strengthened theselaws. For example, the 37Table of Contentsrecently enacted PPACA, among other things, amends the intent requirement of the federal anti-kickback and criminal health care fraud statutes; a person orentity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, PPACA provides that the government may assertthat a claim including items or services resulting from a violation of the federal anti-kickback statute constitutes a false or fraudulent claim for purposes ofthe false claims statutes. If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply tous, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from governmental health care programs, and thecurtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results.We may face competition from other companies who attempt to develop mifepristone or other compounds 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 negativeimpact on future revenues from the commercialization of CORLUX for any indication.As discussed above in the risk related to Orphan Drug Designation, we are aware that Laboratoire HRA Pharma has begun a Phase II clinical trial inEurope and the United States evaluating the use of mifepristone to treat a subtype of Cushing’s Syndrome. We are also aware that Novartis is developing asomatostatin analogue and has reported results from a Phase 3 trial for Cushing’s disease, which is a subset of the patients with Cushing’s Syndrome. If aproduct for treatment of Cushing’s Syndrome is approved for commercialization before CORLUX, our potential future revenue could be reduced.We face competition from companies with substantial financial, technical and marketing resources, which could limit our future revenues from thecommercialization of CORLUX for the treatment of psychotic depression or for other indications.If approved for commercial use, CORLUX as a treatment for psychotic depression will compete with established treatments, including ECT andcombination medicinal therapy.Combination medicinal therapy consists of the use of antipsychotic and antidepressant medicines, not currently approved for the treatment ofpsychotic depression. The antipsychotics are prescribed for off-label use by physicians to treat the psychotic features of psychotic depression, which is theclinical target of CORLUX. Antipsychotics include Bristol-Myers Squibb’s Abilify, Novartis’ Clozaril, Pfizer’s Geodon and Navane, Ortho-McNeil’s Haldol,Janssen Pharmaceutica’s Risperdal, AstraZeneca’s Seroquel, GlaxoSmithKline’s Stelazine and Thorazine, Mylan’s Mellaril and Eli Lilly’s Zyprexa. CORLUXmay not compete effectively with these established treatments. We are aware of one clinical trial conducted by Organon, for a new chemical entity for thetreatment of psychotic depression. Organon was the pharmaceutical division of Akzo Nobel, which was purchased by Schering Plough which was thensubsequently acquired by Merck & Co. Organon’s new chemical entity is a GR-II antagonist; we believe that its commercial use would be covered by ourpatent. As of the time of filing of this report, we are not aware of any other public disclosures by any company, regarding the development of new products totreat psychotic depression.Our present and potential competitors include major pharmaceutical companies, as well as specialized pharmaceutical firms, universities and publicand private research institutions. Moreover, we expect competition to intensify as technical advances are made. These competitors, either alone or withcollaborative parties, may succeed with the development and commercialization of medicinal products that are superior to and more cost-effective thanCORLUX. Many of our competitors and related private and public research and academic institutions have greater experience, more financial resources andlarger research and development staffs than we do. In addition, many of these competitors, either alone or together with their collaborative partners, havesignificantly greater experience than we do in developing human medicines, obtaining regulatory approvals, manufacturing and commercializing products. 38Table of ContentsAccordingly, CORLUX may not be an effective competitor against established treatments and our present or potential competitors may succeed indeveloping medicinal products that are superior to CORLUX or render CORLUX obsolete or non-competitive. If we are unable to establish CORLUX as asuperior and cost-effective treatment for psychotic depression, or any future use, we may be unable to generate the revenues necessary to support ourbusiness.Rapid technological change could make our product candidates obsolete.Pharmaceutical technologies have undergone rapid and significant change and we expect that they will continue to do so. Our future will depend inlarge part on our ability to maintain a competitive position with respect to these technologies. Any products and processes that we develop may becomeobsolete or uneconomical before we recover any or all expenses incurred in connection with their development. Rapid technological change could make ourproduct candidates obsolete or uneconomical, which could materially adversely affect our business, financial condition and results of operations.We will need to develop sales and marketing capabilities to successfully commercialize CORLUX and any future uses of GR-II antagonists.A limited number of our employees have experience in marketing or selling pharmaceutical products. To achieve commercial success for any approvedproduct, we must either develop a sales and marketing force or enter into arrangements with others to market and sell our future products. We currently planto establish small, specialty sales forces to market and sell CORLUX in the United States for the treatment of Cushing’s Syndrome and for the treatment of thepsychotic features of psychotic depression, as each indication is approved for marketing by the FDA. However, our sales and marketing efforts may not besuccessful or cost-effective. If our efforts to develop a sales and marketing force are not successful, cost-effective and timely, we may not achieve profitability.We may need to increase the size of our organization, and we may experience difficulties in managing growth.As we expand our research and development efforts and develop a sales and marketing organization, we expect to experience growth, which may strainour operations, product development and other managerial and operating resources. Future growth will impose significant added responsibilities on membersof management, including the need to identify, recruit, maintain and integrate additional employees. To date, we have relied on a small management team,including a number of part-time contributors. Our future financial performance and our ability to compete effectively will depend, in part, on our ability tomanage any future growth effectively.To that end, we must be able to: • manage our research and development efforts effectively; • manage our clinical trials effectively; • integrate additional management, clinical development, administrative and sales and marketing personnel; • expand the size and composition of our management team; • develop our administrative, accounting and management information systems and controls; and • hire and train additional qualified personnel.We may not be able to accomplish these tasks, and our failure to accomplish any of them could harm our business. 39Table of ContentsIf we lose our key personnel or are unable to attract and retain additional skilled personnel, we may be unable to pursue our product development andcommercialization efforts.We depend substantially on the principal members of our management and scientific staff, including Joseph K. Belanoff, M.D., our Chief ExecutiveOfficer, and Robert L. Roe, M.D., our President. We do not have agreements with any of our executive officers that provide for their continued employmentwith us or employment insurance covering any of our key personnel. Any officer or employee can terminate his or her relationship with us at any time andwork for one of our competitors. The loss of these key individuals could result in competitive harm because we could experience delays in our productresearch, development and commercialization efforts without their expertise.Our ability to operate successfully and manage our potential future growth depends significantly upon retaining key research, technical, sales,marketing, managerial and financial personnel, and attracting and retaining additional highly qualified personnel in these areas. We face intense competitionfor such personnel from numerous companies, as well as universities and nonprofit research organizations in the highly competitive northern Californiabusiness area. Although we believe that we have been successful in attracting and retaining qualified personnel to date, we may not be able to attract andretain sufficient qualified personnel in the future. The inability to attract and retain these personnel could result in delays in the research, development andcommercialization of our potential products.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 anticipatedbenefits of the acquisition.If appropriate opportunities become available, we may attempt to acquire other GR-II antagonists, particularly GR-II antagonists that do not terminatepregnancy. We may also be able to acquire other technologies or potential products that are complementary to our operating plan. We currently have nocommitments, agreements or plans for any acquisitions. The process of acquiring rights to another GR-II antagonist or any other potential product ortechnology may result in unforeseen difficulties and expenditures and may absorb significant management attention that would otherwise be available forongoing development of our business. In addition, we may fail to realize the anticipated benefits of any acquired potential product or technology. Futureacquisitions could dilute our stockholders’ ownership interest in us and could cause us to incur debt, expose us to future liabilities and result in amortizationor other expenses related to goodwill and other intangible assets.The occurrence of a catastrophic disaster or other similar events could cause damage to our or our manufacturers’ facilities and equipment, whichcould require us to cease or curtail operations.Because our executive offices are located in the San Francisco Bay Area and some of our current manufacturers are located in earthquake-prone areas,our business is vulnerable to damage from various types of disasters or other similarly disruptive events, including earthquake, fire, flood, power loss andcommunications failures. In addition, political considerations relating to mifepristone may put us and our manufacturers at increased risk for terrorist attacks,protests or other disruptive events. If any disaster or other similar event were to occur, we may not be able to operate our business and our manufacturers maynot be able to produce our product candidates. Our insurance may not be adequate to cover, and our insurance policies may exclude coverage for, our lossesresulting from disasters or other business interruptions. 40Table of ContentsRisks Related to Our StockThe market price of our common stock has been and is likely to continue to be highly volatile due to the limited number of shares of our common stockheld by non-affiliates of the Company or factors influencing the stock market and opportunities for sale at any given time may be limited.We cannot assure you that an active trading market for our common stock will exist at any time. Holders of our common stock may not be able to sellshares quickly or at the market price if trading in our common stock is not active. During the 52-week period ended March 8, 2011, our average daily tradingvolume has been approximately 180,000 shares and the intra-day sales prices per share of our common stock on the NASDAQ Capital Market has ranged from$2.52 to $4.70. As of March 8, 2011, our officers, directors and principal stockholders control approximately 40% of our common stock. The trading price ofour common stock has been and is likely to continue to be highly volatile and could be subject to wide fluctuations in price in response to various factors,many of which are beyond our control, including: • our cash and short-term investment position; • actual or anticipated timing and results of our clinical trials; • actual or anticipated regulatory approvals of our product candidates or of competing products; • changes in laws or regulations applicable to our product candidates or our competitors’ products; • changes in the expected or actual timing of our development programs or our competitors’ potential development programs; • actual or anticipated variations in quarterly operating results; • announcements of technological innovations by us, our collaborators or our competitors; • new products or services introduced or announced by us or our competitors; • general market and economic conditions, including those seen as a result of the recent worldwide financial credit crisis; • changes in financial estimates or recommendations by securities analysts; • conditions or trends in the biotechnology and pharmaceutical industries; • changes in the market valuations of similar companies; • announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments; • additions or departures of key personnel; • disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection forour technologies; • developments concerning collaborations; • trading volume of our common stock; • limited number of shares of our common stock held by our non-affiliates; • maintaining compliance with the listing requirements of the stock exchange on which we are listed; • announcement of, or expectation of, additional financing efforts; and • sales of our common stock by us or our stockholders.In addition, the stock market in general, the Nasdaq Capital Market and the market for biotechnology and life sciences companies in particular haveexperienced extreme price and volume fluctuations that have often 41Table of Contentsbeen unrelated or disproportionate to the operating performance of those companies. These broad market and industry factors may seriously harm the marketprice of our common stock, regardless of our operating performance. In the past, following periods of volatility in the market, securities class-action litigationhas often been instituted against companies. Such litigation, if instituted against us, could result in substantial costs and diversion of management’s attentionand resources.If we fail to continue to meet all applicable Nasdaq Capital Market requirements, our stock could be delisted by the Nasdaq Capital Market. If delistingoccurs, it would adversely affect the market liquidity of our common stock and harm our business.If we are unable to meet any of the Nasdaq listing requirements in the future, including, for example, if the closing bid price for our common stock isbelow $1 per share for 30 consecutive trading days, the Nasdaq Capital Market staff could determine to delist our common stock, the delisting couldadversely affect the market liquidity of our common stock and the market price of our common stock could decrease. Such delisting could also adverselyaffect our ability to obtain financing for the continuation of our operations and could result in the loss of confidence by investors, suppliers and employees.Securities analysts may not continue to provide or initiate coverage of our common stock or may issue negative reports, and this may have a negativeimpact on our common stock’s market price.Securities analysts currently covering our common stock may discontinue research coverage. Additional securities analysts may elect not to provideresearch coverage of our common stock. A lack of research coverage may adversely affect our common stock’s market price. The trading market for ourcommon stock may be affected in part by the research and reports that industry or financial analysts publish about us or our business. If one or more of theanalysts who elects to cover us downgrades our stock, our stock price would likely decline rapidly and significantly. If one or more of these analysts ceasescoverage of our company, we could lose visibility in the market, which in turn could cause our stock price to decline. In addition, rules mandated by theSarbanes-Oxley Act of 2002, and a global settlement reached in 2003 between the SEC, other regulatory analysts and a number of investment banks have ledto a number of fundamental changes in how analysts are reviewed and compensated. In particular, many investment banking firms are required to contractwith independent financial analysts for their stock research. It may be difficult for companies such as ours with smaller market capitalizations to attractindependent financial analysts that will cover our common stock. This could have a negative effect on our market price.A sale of a substantial number of shares of our common stock may cause the price of our common stock to decline.Sales of a substantial number of shares of our common stock in the public market could harm the market price of our common stock. As additionalshares of our common stock become available for resale in the public market, the supply of our common stock will increase, which could decrease the price.Substantially all of the shares of our common stock are eligible for sale, subject to applicable volume and other resale restrictions.We may be required to pay significant amounts if we are not able to meet our obligations under our outstanding registration rights agreements.The registration rights agreement covering the approximately 8.9 million shares of our common stock issued in a private offering in March 2008 andan additional approximately 4.5 million shares of common stock underlying warrants issued in connection with the offering provided that if we failed to fileor cause to be declared effective the registration statement covering the resale of these shares prior to specified deadlines, or failed to maintain theeffectiveness of such registration statement (subject to limited permissible suspension periods), we would be required to pay the holders of such shares andwarrants liquidated damages at the rate of 1% of the purchase price of these shares and warrants per month, up to a total of 10%. The registration statement 42Table of Contentscovering the resale of the shares and shares underlying the warrants sold in this transaction was declared effective by the SEC in November 2008. Since thisregistration statement was not declared effective within the time frame specified in the registration rights agreement, we became obligated to pay liquidateddamages of approximately $1.3 million in 2008 to the investors in this financing. As noted above, if we fail to maintain the effectiveness of this registrationstatement, we may be obligated to pay additional liquidated damage amounts in the future.See the discussion above under “Risks Related to our Business” regarding risks associated with the CEFF, including the risks regarding registrationrights under that agreement.If we are required to pay significant amounts under these or future registration rights agreements, it could have a material adverse effect on our financialcondition and ability to finance our operations.Our officers, directors and principal stockholders acting as a group, will be able to significantly influence corporate actions.As of March 8, 2011, our officers, directors and principal stockholders control approximately 40% of our common stock. As a result, thesestockholders, acting together, will be able to significantly influence all matters requiring approval by our stockholders, including the election of directorsand the approval of mergers or other business combination transactions. The interests of this group of stockholders may not always coincide with our interestsor the interests of other stockholders and may prevent or delay a change in control. This significant concentration of share ownership may adversely affect thetrading price of our common stock because investors often perceive disadvantages to owning stock in companies with controlling stockholders.Changes in laws and regulations may result in increased costs to us, which may harm our financial results.New laws and regulations, as well as changes to existing laws and regulations, affecting public companies, including the provisions of the Sarbanes-Oxley Act of 2002 and rules adopted by the SEC and by The Nasdaq Capital Market, have and will likely continue to result in increased costs to us as werespond to their requirements. We are investing resources to comply with evolving laws and regulations, and this investment may result in increased generaland administrative expenses and a diversion of management’s time and attention from revenue-generating activities to compliance activities.In addition, new rules and regulations could make it more difficult or costly for us to obtain certain types of insurance, including director and officerliability insurance, and we may be forced to accept reduced policy limits and coverage or incur higher costs to obtain the same or similar coverage. Theimpact of these events could also make it more difficult for us to attract and retain qualified persons to serve on our Board of Directors, or our boardcommittees, or as executive officers. At present, we cannot predict or estimate the amount of the additional costs related to new rules and regulations or thetiming of such costs.Compliance with public company obligations, including the securities laws and regulations, is costly and requires significant management resources,and we may fail to comply.We are a small company with limited resources.The federal securities laws and regulations, including the corporate governance and other requirements of the Sarbanes-Oxley Act of 2002, imposecomplex and continually changing regulatory requirements on our operations and reporting. These requirements impose comprehensive reporting anddisclosure requirements, set stricter independence and financial expertise standards for audit committee members, and impose civil and criminal penalties forcompanies, their chief executive officers, principal financial officers and directors for securities law violations. These requirements have increased and willcontinue to increase our legal compliance costs, increase the difficulty and expense in obtaining director and officer liability insurance, and make it harder 43Table of Contentsfor us to attract and retain qualified members of our Board of Directors and/or qualified executive officers. Such developments could harm our results ofoperations and divert management’s attention from business operations.In addition, as directed by Section 404 of the Sarbanes-Oxley Act of 2002, the SEC adopted rules requiring public companies to include a report ofmanagement on the company’s internal control over financial reporting in their annual reports on Form 10-K. This requirement first applied to our annualreport on Form 10-K for the year ended December 31, 2007. This same legislation also requires that the independent registered public accounting firmauditing our financial statements must attest to and report on the effectiveness of our internal controls over financial reporting. The SEC postponed the initialcompliance date for this requirement for smaller reporting companies such that the requirement for the auditor’s attestation and report first applies to thisannual report on Form 10-K for our fiscal year ended December 31, 2010. Uncertainty exists regarding our ability to comply with these requirements byapplicable deadlines and to maintain compliance in future years. If we are unable to complete the required assessment as to the adequacy of our internalcontrol over financial reporting in future years or if our independent registered public accounting firm is unable to provide us with an unqualified report as tothe effectiveness of our internal control over financial reporting as of future year ends, investors could lose confidence in the reliability of our financialreporting.Changes in or interpretations of accounting rules and regulations could result in unfavorable accounting charges or require us to change ouraccounting policies or operating practices.Accounting methods and policies for business and marketing practices of pharmaceutical companies are subject to continual review, interpretation andguidance from relevant accounting authorities, including the SEC. For example, in December 2004, the Financial Accounting Standards Board adopted arevised standard related to stock-based compensation. This standard, which we adopted in 2006, requires the recording of expense for stock options grantedusing fair-value-based measurements. As a result, our operating expenses have increased and are likely to continue to increase. We rely heavily on stockoptions to compensate existing employees and attract new employees. Because we are now required to expense stock options using fair-value-basedmeasurements, we may choose to reduce our reliance on stock options as a compensation tool. If we reduce our use of stock options, it may be more difficultfor us to attract and retain qualified employees. Although we believe that our accounting practices are consistent with current accounting pronouncements,changes to or interpretations of accounting methods or policies in the future may require us to reclassify, restate or otherwise change or revise our financialstatements. Any such changes could result in corresponding changes to the amounts of assets, liabilities, revenues, expenses and income. Any such changescould have a material adverse effect on our business, financial position and results of operations and could cause the market value of our common stock todecline.Anti-takeover provisions in our charter and bylaws and under Delaware law may make an acquisition of us or a change in our management moredifficult, even if an acquisition or a management change would be beneficial to our stockholders.Provisions in our charter and bylaws may delay or prevent an acquisition of us or a change in our management. Some of these provisions divide ourboard into three classes with only a portion of our directors subject to election at each annual meeting, allow us to issue preferred stock without any vote orfurther action by the stockholders, require advance notification of stockholder proposals and nominations of candidates for election as directors and prohibitstockholders from acting by written consent. In addition, a supermajority vote of stockholders is required to amend our bylaws. Our bylaws provide thatspecial meetings of the stockholders may be called only by our Chairman, President or the Board of Directors and that the authorized number of directors maybe changed only by resolution of the Board of Directors. These provisions may prevent or delay a change in our Board of Directors or our management, whichis appointed by our Board of Directors. In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of theDelaware General Corporation Law. Section 203 may prohibit large stockholders, in particular those owning 15% or more of our outstanding voting stock,from merging or combining with us. These provisions in our charter, bylaws and under Delaware law could reduce the price that investors might be willing topay for shares of our common stock in the future and result in the market price being lower than it would be without these provisions. 44Table of ContentsITEM 1B.UNRESOLVED STAFF COMMENTSNone. ITEM 2.PROPERTIESWe lease approximately 7,700 square feet of office space in Menlo Park, California for our corporate facilities. On August 12, 2010, we renewed ourlease for office space for a one-year term commencing on January 1, 2011. We expect that these facilities will accommodate our operations for the next year. ITEM 3.LEGAL PROCEEDINGSWe are not currently involved in any material legal proceedings. ITEM 4.(Removed and Reserved) 45Table of ContentsPART II ITEM 5.MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OFEQUITY SECURITIESMarket InformationOur common stock is traded on The Nasdaq Capital Market under the symbol “CORT”. The following table sets forth the high and low intra-day saleprices per share of our common stock on The Nasdaq Capital Market for the periods indicated. These prices represent quotations among dealers withoutadjustments for retail mark-ups, markdowns or commissions, and may not represent prices of actual transactions. High Low 2010 First Quarter $3.22 $2.50 Second Quarter $3.93 $2.56 Third Quarter $4.33 $2.76 Fourth Quarter $4.70 $3.34 High Low 2009 First Quarter $1.46 $0.75 Second Quarter $1.29 $0.73 Third Quarter $1.65 $0.75 Fourth Quarter $3.10 $1.36 Stockholders of Record and DividendsAs of March 8, 2011, we had 83,968,540 shares of common stock outstanding held by 133 stockholders of record. We have never declared or paid cashdividends on our capital stock. We currently intend to retain any future earnings to finance the growth and development of our business and therefore, do notanticipate paying any cash dividends in the foreseeable future.Sale of Unregistered SecuritiesAll sales of unregistered securities during the year ended December 31, 2010 have previously been disclosed in filings with the SEC. We have used, orwill use, the net proceeds from these transactions to fund our research and development activities including clinical trials, commercialization andadministrative activities, as well as for general corporate purposes, including working capital.Repurchases of SecuritiesNone.Market Performance GraphThe graph and the accompanying text below is not “soliciting material,” is not deemed filed with the SEC and is not to be incorporated by referencein any filings by us under the Securities Act or the Exchange Act, whether made before or after the date hereof and irrespective of any generalincorporation language in such filing.The rules of the SEC require that we include a line-graph comparing cumulative stockholder returns on our common stock with the NASDAQComposite Index (which tracks the aggregate price performance of equity securities of companies traded on NASDAQ) and either a published industry orline-of-business standard index 46Table of Contentsor an index of peer companies selected by us. We have elected to use the NASDAQ Biotechnology Index (consisting of a group of approximately 130companies in the biotechnology sector, including us) for purposes of the performance comparison that appears below.The graph shows the cumulative total stockholder return assuming the investment of $100.00 and the reinvestment of dividends and is based on thereturns of the component companies weighted according to their market capitalizations as of the end of the period for which returns are indicated. Nodividends have been declared on our common stock.The stockholder return shown on the graph below is not necessarily indicative of future performance, and we do not make or endorse any predictions asto future stockholder returns.COMPARISON OF 5 YEAR CUMULATIVE TOTAL RETURN* AMONGCORCEPT THERAPEUTICS, THE NASDAQ CAPITAL MARKET (U.S.) INDEXAND THE NASDAQ BIOTECHNOLOGY INDEX *$100 invested on December 31, 2005 including reinvestment of dividends. Fiscal year ended December 31.Securities Authorized for Issuance under Equity Compensation PlansThe information required by this Item concerning our equity compensation plans will be included in the section captioned “Equity CompensationPlans” contained in our Definitive Proxy Statement to be filed related to the 2011 Annual Meeting of Stockholders and is incorporated herein by reference. 47Table of ContentsITEM 6.SELECTED FINANCIAL DATASELECTED FINANCIAL DATA(in thousands, except per share data)The selected financial data set forth below are derived from our financial statements. The statement of operations data for the years ended December 31,2010, 2009 and 2008 and for the period from inception (May 13, 1998) to December 31, 2010 and the balance sheet data as of December 31, 2010 and 2009are derived from our audited financial statements included in this Annual Report on Form 10-K (Form 10-K). The statements of operations data for the yearsended December 31, 2007 and 2006, and the balance sheet data as of December 31, 2008, 2007 and 2006 have been derived from our audited financialstatements, which are not included in this Form 10-K. The selected financial data set forth below should be read in conjunction with our financial statements,the related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included elsewhere in this Form 10-K. Year Ended December 31, Period frominception(May 13, 1998) toDecember 31,2010 2010 2009 2008 2007 2006 (In thousands, except per share data) Statement of Operations Data: Collaboration revenue $— $29 $209 $482 $294 $1,014 Operating expenses: Research and development* 18,949 14,402 14,152 7,860 20,834 133,161 General and administrative* 8,488 5,877 5,746 4,867 5,042 49,249 Total operating expenses 27,437 20,279 19,898 12,727 25,876 182,410 Loss from operations (27,437) (20,250) (19,689) (12,245) (25,582) (181,396) Non-operating income (expense), net 1,471 84 (372) 672 709 5,191 Net loss $(25,966) $(20,166) $(20,061) $(11,573) $(24,873) $(176,205) Net loss per share: Basic and diluted $(0.38) $(0.38) $(0.43) $(0.34) $(1.09) Weighted average shares—basic and diluted 68,336 52,443 46,721 34,251 22,841 * Includes non-cash stock-based compensation, net of recoveries, of the following: Research and development $219 $263 $268 $213 $535 $5,495 General and administrative 1,896 1,552 1,360 846 1,013 11,458 Total non-cash stock-based compensation $2,115 $1,815 $1,628 $1,059 $1,548 $16,953 As of December 31, 2010 2009 2008 2007 2006 (In thousands) Balance Sheet Data: Cash, cash equivalents and investments $24,578 $23,867 $18,309 $17,366 $9,456 Working capital 21,136 22,001 16,717 14,662 6,286 Total assets 25,104 24,511 19,775 17,744 9,902 Long-term liabilities — — 6 16 29 Total stockholders’ equity 21,244 22,092 16,907 14,734 6,360 See our financial statements and related notes for a description of the calculation of the net loss per share and the weighted-average number of sharesused in computing the per share amounts. 48Table of ContentsITEM 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSForward-Looking StatementsThis Management’s Discussion and Analysis of Financial Condition and Results of Operations contains forward-looking statements within themeaning of Section 21E of the Exchange Act and Section 27A of the Securities Act and should be read in conjunction with the “Risk Factors” section ofPart I of this Form 10-K. All statements contained in this Form 10-K other than statements of historical fact are forward-looking statements. When used inthis report or elsewhere by management from time to time, the words “believe,” “anticipate,” “intend,” “plan,” “estimate,” “expect,” “may,” “will,”“should,” “seeks” and similar expressions are forward-looking statements. Such forward-looking statements are based on current expectations, but theabsence of these words does not necessarily mean that a statement is not forward-looking. Forward-looking statements may include, but are not limited to,statements about: • the progress and timing of our research, development and clinical programs and the timing of regulatory activities, including the anticipatedsubmission of the New Drug Application (NDA) for CORLUX for the treatment of Cushing’s Syndrome to the United States Food and DrugAdministration (FDA), the acceptance of that NDA for filing by the FDA and the review and approval of the NDA by the FDA; • our estimates of the dates by which we expect to report results of our clinical trials and the anticipated results of these trials; • the timing of the market introduction of CORLUX and future product candidates, including CORT 108297 and CORT 113083; • our ability to market, commercialize and achieve market acceptance for CORLUX or other future product candidates, including CORT 108297 andCORT 113083; • uncertainties associated with obtaining and enforcing patents; • our estimates for future performance; and • our estimates regarding our capital requirements and our needs for, and ability to obtain, additional financing.Forward-looking statements are not guarantees of future performance and involve risks and uncertainties. Actual events or results may differmaterially from those discussed in the forward-looking statements as a result of various factors. For a more detailed discussion of such forward-lookingstatements and the potential risks and uncertainties that may impact upon their accuracy, see “Risk Factors” included in Part I of this Form 10-K and the“Overview” and “Liquidity and Capital Resources” sections of this Management’s Discussion and Analysis of Financial Condition and Results ofOperations. These forward-looking statements reflect our view only as of the date of this report. Except as required by law, we undertake no obligations toupdate any forward-looking statements. Accordingly, you should also carefully consider the factors set forth in other reports or documents that we file fromtime to time with the SEC.OverviewWe are a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic andpsychiatric disorders. Our focus is on those disorders that are associated with a steroid hormone called cortisol. Elevated levels and abnormal release patternsof cortisol have been implicated in a broad range of human disorders. Since our inception in May 1998, we have been developing our lead product,CORLUX, a potent glucocorticoid receptor II (GR-II) antagonist that blocks the activity of cortisol. We have also discovered three series of novel selectiveGR-II antagonists and have moved CORT 108297, a compound from one of these series, into clinical development. Unless otherwise stated, all references inthis document to “we,” “us,” “our,” “its,” “Corcept,” the “Company” and similar designations refer to Corcept Therapeutics Incorporated. 49®Table of ContentsCushing’s Syndrome. Cushing’s Syndrome is a disorder caused by prolonged exposure of the body’s tissues to high levels of the hormone cortisol.Sometimes called “hypercortisolism,” it is relatively uncommon and most often affects adults aged 20 to 50. An estimated 10 to 15 of every one millionpeople are newly diagnosed with this syndrome each year, resulting in approximately 3,000 new patients and an estimated prevalence of 20,000 patients withCushing’s Syndrome in the United States.The Investigational New Drug application (IND) for the evaluation of CORLUX for the treatment of the signs and symptoms of Cushing’s Syndromewas opened in September 2007. The United States Food and Drug Administration (FDA) indicated that our single 50-patient open-label study may provide areasonable basis for the submission of a New Drug Application (NDA) for this indication. We completed enrollment in this Phase 3 study in June 2010. Thisopen-label Phase 3 study evaluated the response of two patient groups to CORLUX treatment: one included patients who were glucose intolerant, regardlessof blood pressure level, and one included patients who had been diagnosed with hypertension but had normal glucose tolerance. The patients in both of thesegroups were being treated for their symptoms before study entry; CORLUX was added to their existing medications. On December 22, 2010, we announcedthat both groups in this study achieved their primary endpoints. After this announcement, we determined that one patient did not fully adhere to the protocolfor this study and have since then revised our calculation of the percentage of patients in the hypertensive group meeting the primary endpoint. This did notimpact our determination that this group achieved its primary endpoint. On January 11, 2011, we announced positive results for the key secondary endpointof global clinical improvement. For this endpoint all of the patients in the study were included in one group.Statistically significant improvement in the primary endpoint was achieved for each group with 60% responding in the glucose intolerant group and38% responding in the hypertensive group. The patients in the study, whether included in the “glucose intolerant group” or the “hypertensive group” for thepurpose of evaluating the primary endpoints, were evaluated as a single group on the key secondary endpoint of “global clinical improvement”; 87% ofpatients showed significant clinical improvement as evaluated by an independent board of three physicians highly experienced in the treatment of Cushing’sSyndrome. An initial review of safety data indicates that CORLUX had an acceptable risk-benefit profile in this Phase 3 study. Adverse events related totreatment included signs and symptoms of adrenal insufficiency, endometrial thickening, and hypokalemia, all of which were consistent with earlierpublished reports. The majority of the serious adverse events (SAEs) reported in the study were not related to CORLUX treatment, as determined by theclinical investigators. All of the treatment-related SAEs resolved with clinical management. Eighty-eight percent of the patients who completed the Phase 3study opted to enter the long-term extension study. We expect to submit our NDA for the use of CORLUX in Cushing’s Syndrome by the end of the firstquarter of 2011 and plan to present detailed data from the Phase 3 trial at scientific conferences during 2011.In July 2007, we received Orphan Drug Designation from the FDA for CORLUX for the treatment of endogenous Cushing’s Syndrome. Orphan DrugDesignation is a special status granted by the FDA to encourage the development of treatments for diseases or conditions that affect fewer than 200,000patients in the United States. Drugs that receive Orphan Drug Designation obtain seven years of marketing exclusivity from the date of drug approval, as wellas tax credits for clinical trial costs, marketing application filing fee waivers and assistance from the FDA in the drug development process.Psychotic Depression. We are developing CORLUX for the treatment of the psychotic features of psychotic major depression under an exclusivepatent license from Stanford University. Psychotic major depression will hereafter be referred to as psychotic depression. The FDA has granted “fast track”status to evaluate the safety and efficacy of CORLUX for the treatment of the psychotic features of psychotic depression.In March 2008, we began enrollment in Study 14, our ongoing Phase 3 trial in psychotic depression. The protocol for this trial incorporates what wehave learned from our three previously completed Phase 3 trials. It attempts to address the established relationship between increased drug plasma levels andclinical response and attempts to decrease the random variability observed in the results of the psychometric instruments used to measure efficacy. In one ofthe previously completed Phase 3 trials, Study 06, we prospectively tested and 50Table of Contentsconfirmed that patients whose plasma levels rose above a predetermined threshold statistically separated from both those patients whose plasma levels werebelow the threshold and those patients who received placebo; this threshold was established from data produced in earlier studies.As expected, patients who took 1200 milligrams (mg) of CORLUX in Study 06 developed higher drug plasma levels than patients who received lowerdoses. Further, there was no discernable difference in the incidence of adverse events between patients who received placebo in Study 06 and those whoreceived 300 mg, 600 mg or 1200 mg of CORLUX in that study. Based on this information, we are using a CORLUX dose of 1200 mg once per day for sevendays in Study 14.In addition, we also are utilizing a third party centralized rating service to independently evaluate the patients for entry into the study as well as toevaluate their level of response throughout their participation in the study. We believe the centralization of this process will improve the consistency ofrating across clinical trial sites and reduce the background noise that was experienced in earlier studies and is endemic to psychopharmacologic studies. Webelieve that this change in dose, as well as the other modifications to the protocol, should allow us to demonstrate the efficacy of CORLUX in the treatmentof the psychotic symptoms of psychotic depression. In mid-2009, in order to conserve financial resources, we reduced the number of clinical sites in thisstudy to eight and extended the timeline for its completion.Antipsychotic-induced Weight Gain Mitigation. In 2005, we published the results of studies in rats that demonstrated that CORLUX both reversedthe weight gain associated with the ongoing use of olanzapine and mitigated the weight gain associated with the initiation of treatment with olanzapine (theactive ingredient in Zyprexa). This study was paid for by Eli Lilly and Company (Eli Lilly).During 2007 we announced positive results from our clinical proof-of-concept study in lean healthy male volunteers evaluating the ability ofCORLUX to mitigate weight gain associated with the use of Zyprexa. The results show a statistically significant reduction in weight gain in those subjectswho took Zyprexa plus CORLUX compared to those who took Zyprexa plus placebo. Also, the addition of CORLUX to treatment with Zyprexa had abeneficial impact on secondary metabolic measures such as fasting insulin, triglycerides and abdominal fat, as indicated by waist circumference. Eli Lillyprovided Zyprexa and financial support for this study and its results were published in the journal Advances in Therapy in 2009. In January 2009, weannounced positive results from a similar proof-of-concept study evaluating the ability of CORLUX to mitigate weight gain associated with the use ofJohnson & Johnson’s Risperdal. This study confirmed and extended the earlier results seen with CORLUX and Zyprexa, demonstrating a statisticallysignificant reduction in weight and secondary metabolic endpoints of fasting insulin, triglycerides and abdominal fat, as indicated by waist circumference.The results from the study of CORLUX and Risperdal were presented at several scientific conferences, including the American Diabetes Association meetingin June 2009, and were published in the journal Obesity in 2010.The combination of Zyprexa or Risperdal and CORLUX is not approved for any indication. The purpose of these studies was to explore the hypothesisthat GR-II antagonists, such as CORLUX and our next generation of selective GR-II antagonists, would mitigate weight gain associated with antipsychoticmedications. The group of medications known as second generation antipsychotic medication, including Zyprexa, Risperdal, Clozaril and Seroquel, arewidely used to treat schizophrenia and bipolar disorder. All medications in this group are associated with treatment emergent weight gain of varying degreesand carry a warning in their labels relating to treatment emergent hyperglycemia and diabetes mellitus.Selective GR-II Receptor Antagonists. In 2003, we initiated a discovery research program to identify and patent selective GR-II antagonists todevelop a pipeline of products for proprietary use. Three distinct series of GR-II antagonists were identified. These compounds, like our lead productCORLUX, potently block the cortisol receptor (GR-II) but, unlike CORLUX, they do not appear to block the PR (progesterone), ER (estrogen), AR (androgen)or GR-I (mineralocorticoid) receptors. Both the United States Patent & Trademark Office (USPTO) and the European Patent Office (EPO) have issued to uscomposition of matter patents on all of the three series. A fourth composition of matter patent application is pending. See “Business—Intellectual Property.” 51Table of ContentsCORT 108297 and CORT 113083In 2007, we conducted a human microdosing study of one of our newly identified selective GR-II antagonists, CORT 108297, with Xceleron Limitedutilizing its Accelerator Mass Spectrometry technology. In this microdosing study, we evaluated CORT 108297, a compound which develops particularlyhigh plasma and brain concentrations in an animal model. In May 2008, we announced the results from this study, which demonstrated that CORT 108297was extremely well absorbed, demonstrated good bioavailability and had a half-life that appears compatible with once-a-day oral dosing. In addition, furtherpharmacokinetic testing of CORT 108297 in a rat model indicated that a ten-fold increase in oral dose (5 milligrams per kilogram (mg/kg) to 50 mg/kg) ledto a proportional increase in the amount of compound detected in plasma.In September 2008, we signed a second agreement with Eli Lilly, under which Eli Lilly agreed to provide funding and provide olanzapine for twostudies to test the effectiveness of CORT 108297 in rat models of olanzapine induced weight gain. In January 2009, we announced top-line results from thesestudies of CORT 108297 and olanzapine. The results from the studies of both the prevention and reversal of antipsychotic-induced weight gain were positiveand statistically significant. The results of these studies were presented at the International Society of Psychoneuroendocrinology and the World Congress ofBiological Psychiatry conferences in July 2009.At the American Diabetes Association conference in June 2009 there was also a presentation of preclinical data from another study of CORT 108297conducted at Stanford University. This study demonstrated that CORT 108297 suppresses body weight gain and improves insulin sensitivity in healthy micefed a 60% fat diet and high sucrose liquid.The manufacturing and preclinical development of CORT 108297 began late in 2008 and resulted in the submission of an IND to the FDA inDecember 2009 for the prevention of weight gain induced by antipsychotic medication. Dosing of healthy volunteers in the first Phase 1 study of CORT108297 was completed in July 2010. A Phase 1b/2a study of this drug was initiated during the fourth quarter of 2010, with the first patients being dosed inDecember 2010.During the second quarter of 2010, we selected a second new compound, CORT 113083, to advance toward an IND filing. CORT 113083 hasdemonstrated substantial bioavailability in animal models. During the third quarter of 2010, we commenced various manufacturing development andpreclinical studies supporting an IND filing for this compound.GeneralOur activities to date have included: • product development; • designing, funding and overseeing clinical trials; • regulatory affairs; and • intellectual property prosecution and expansion.Historically, we have financed our operations and internal growth primarily through private placements of our preferred and common stock and thepublic sale of common stock rather than through collaborative or partnership agreements. Therefore, we have no research funding or collaborative paymentspayable to us, except for the limited revenue that has been collected under the agreements with Eli Lilly discussed above.We are in the development stage and have incurred significant losses since our inception. We have not generated any revenue other than the revenueunder the agreements with Eli Lilly, and do not expect to generate significant revenue until CORLUX has been approved by the FDA for marketing in theUnited States, if at all. As 52Table of Contentsof December 31, 2010, we had an accumulated deficit of $176.2 million. Our historical operating losses have resulted principally from our research anddevelopment activities, including clinical trial activities for CORLUX and CORT 108297, discovery research, non-clinical activities such as toxicology andcarcinogenicity studies, manufacturing process development and regulatory activities, as well as general and administrative expenses. We expect to continueto incur net losses over at least the next few years as we continue our CORLUX and CORT 108297 clinical development programs, apply for regulatoryapprovals, initiate development of CORT 113083 or other newly identified GR-II antagonists for various indications, continue our discovery researchprogram, acquire and develop treatments in other therapeutic areas, establish sales and marketing capabilities and expand our operations.Our business is subject to significant risks, including the risks inherent in our research and development efforts, the results of our CORLUX and CORT108297 clinical trials, uncertainties associated with securing financing, uncertainties associated with obtaining and enforcing patents, our investment inmanufacturing set-up, the lengthy and expensive regulatory approval process and competition from other products. Our ability to successfully generaterevenues in the foreseeable future is dependent upon our ability, alone or with others, to finance our operations and develop, obtain regulatory approval for,manufacture and market our lead product.Results of OperationsCollaboration revenue—Collaboration revenue relates to services rendered in connection with our agreements with Eli Lilly discussed above underthe caption “Overview-Antipsychotic-Induced Weight Gain Mitigation.” Under these agreements, Eli Lilly agreed to supply the Zyprexa and olanzapine andpay for the costs of the studies. We were required to perform development activities as specified in the agreements and we were reimbursed based on the costsassociated with the conduct of the trial and the preparation and packaging of clinical trial materials. Revenue was recognized as the services were rendered inaccordance with the agreements.During the years ended December 31, 2009 and 2008, we recognized approximately $29,000 and $209,000, respectively, under these agreements. Wedid not recognize any revenue under the agreements during the year ended December 31, 2010 and none will be recognized in the future as all of theactivities relating to these agreements were completed by mid-2009.Research and development expenses—Research and development expenses include the personnel costs related to our development activities,including facilities costs and non-cash stock-based compensation, as well as the costs of discovery research, pre-clinical studies, clinical trial preparations,enrollment and monitoring expenses, regulatory costs, the costs of manufacturing development and the costs of manufacture and / or acquisition of clinicaltrial materials.Research and development expenses increased 32% to $18.9 million for the year ended December 31, 2010 from $14.4 million for the year endedDecember 31, 2009. Clinical trial cost increases during 2010, as compared to 2009, included approximately $405,000 related to the clinical trials withCORLUX for the treatment of Cushing’s Syndrome, $3.4 million related to other NDA-supportive studies with CORLUX and approximately $1.8 millionrelated to the Phase 1a study with CORT 108297. These increases were partially offset by decreases of approximately $1.8 million related to scaling back ourPhase 3 study with CORLUX for the treatment of psychotic depression, and approximately $420,000 related to the study for the mitigation of weight gaincaused by Risperdal, which was completed in 2009.During 2010, as compared to 2009, there were also increases of approximately $1.0 million in research work with our proprietary, selective new GR-IIantagonists, including CORT 113083, and approximately $665,000 in CORLUX manufacturing costs related to the acquisition of active pharmaceuticalingredient and the manufacture of clinical trial materials and registration batches to be used for the NDA. There was also an increase of approximately$800,000 related to the start of manufacturing of clinical trial material for use in the Phase 1b/2a study with CORT 108297. During 2010, we recorded anaggregate amount of approximately $340,000, related to 53Table of Contentsbonuses awarded to employees working in research and development functions in recognition of significant company accomplishments during 2010. Bonusamounts during 2009 were negligible. In addition, consultancy and staffing costs increased approximately $920,000 during 2010 as compared to 2009, dueto the additional resources necessary to assist in the management of the research and development activities, and to commence activities toward a submissionof an NDA for CORLUX for the treatment of Cushing’s Syndrome by the end of the first quarter of 2011. During 2010 as compared to 2009, there was also adecrease of approximately $2.7 million, related to the preclinical and IND-enabling work on CORT 108297, which entered a Phase 1a study in February2010.Research and development expenses increased 2% to $14.4 million for the year ended December 31, 2009, from $14.2 million for the year endedDecember 31, 2008. During 2009, as compared to 2008, there were increases of approximately $1.9 million in costs related to research, manufacturing andIND-enabling work with our selective GR-II antagonist, CORT 108297, $830,000 related to the Phase 3 trial and the long-term extension study in Cushing’sSyndrome, $242,000 related to the conduct of other NDA-supportive studies, $260,000 in staffing costs, $130,000 of consulting expenses and $90,000related to the cost of a carcogenicity study. Offsetting these increases were decreases of approximately $1.5 million in manufacturing expenses related toCORLUX due to the acquisition and manufacture during 2008 of the initial supply of materials for the CORLUX clinical trials and completion of certainmanufacturing process development activities related to CORLUX, $840,000 related to the scaling back of our Phase 3 trial of CORLUX in psychoticdepression that was announced in March 2009, $610,000 in basic research on our selective GR-II antagonists as CORT 108297 moved into the IND-enablingphase and $210,000 related to our clinical trial of CORLUX for the mitigation of weight gain caused by Risperdal that was completed early in 2009.Research and development expenses discussed above included stock based compensation charges related to option grants to individuals performingthese functions of approximately $220,000, $263,000 and $268,000, respectively, for the years ended December 31, 2010, 2009 and 2008. The decrease inexpense between years was primarily the result of the completion of vesting of earlier grants to employees in these functions with higher exercise prices andfair values not being fully offset by the costs related to more recent option grants to existing and new employees in these functions.Below is a summary of our research and development expenses by major project: Year EndedDecember 31, Project 2010 2009 2008 (in thousands) CORLUX Cushing’s Syndrome $5,075 $2,952 $2,316 Psychotic Depression 2,567 5,030 5,948 Weight Gain Mitigation 11 565 1,588 Selective GR-II antagonists 5,089 3,940 2,186 Unallocated activities, including NDA supportive studies and manufacturing, regulatory and pre-clinical activities 5,987 1,652 1,846 Stock-based compensation 220 263 268 Total research and development expense $18,949 $14,402 $14,152 We expect that research and development expenditures will increase during 2011 as compared to 2010 due to the preparation and support of our NDAfiling for CORLUX for the treatment of Cushing’s Syndrome, increased manufacturing activities for pre-validation and validation batches of CORLUX,continuation of our long-term extension study in Cushing’s Syndrome, continuation of our Phase 3 study of CORLUX for the treatment of psychoticdepression, and the continued development of CORT 108297, CORT 113083 and our 54Table of Contentsother proprietary selective GR-II antagonists, which costs will be only partially offset by decreases in the costs related to the completion of our Phase 3 studyin Cushing’s Syndrome. Research and development expenses in 2012 and future years will be largely dependent on the availability of additional funds tofinance clinical development plans. See also, “Liquidity and Capital Resources”.Many factors can affect the cost and timing of our trials including inconclusive results requiring additional clinical trials, slow patient enrollment,adverse side effects in study patients, insufficient supplies for our clinical trials and real or perceived lack of effectiveness or safety of the drug in our trials.The cost and timing of development of our selective GR-II antagonists will be dependent on our success in the effort and any difficulties that may beencountered. In addition, the development of all of our product candidates will be subject to extensive governmental regulation. These factors make itdifficult for us to predict the timing and costs of the further development and approval of our product candidates.General and administrative expenses—General and administrative expenses consist primarily of the costs of administrative personnel and relatedfacility costs along with legal, accounting and other professional fees.For the year ended December 31, 2010, general and administrative expenses increased 44% to $8.5 million from $5.9 million for the year endedDecember 31, 2009. During 2010, we recorded an aggregate amount of $1.3 million related to bonuses awarded to our officers and employees working ingeneral and administrative functions in recognition of significant company accomplishments during 2010. We did not award bonuses for 2009 performanceto any officer or employee in these functions. In addition, during 2010, as compared to 2009, staffing and consultancy costs increased approximately$885,000 due primarily to additional resources necessary to engage in planning for the potential commercialization of CORLUX for Cushing’s Syndrome,approximately $345,000 of which represented increases in noncash stock-based compensation costs related to stock options granted to employees, directorsand consultants. There was also an increase in legal costs related to patents and other corporate matters during 2010, as compared to 2009, of approximately$150,000.For the year ended December 31, 2009, general and administrative expenses increased 2% to $5.9 million from $5.7 million for the year endedDecember 31, 2008. This increase reflected higher staffing costs of approximately $445,000, due primarily to the recruitment of our new chief financialofficer during the fourth quarter of 2008, which included a net increase in stock-based compensation of $180,000 that reflected the expense related to stockoptions granted to our new chief financial officer, other employees and directors late in 2008 and during 2009. During this period, there were also increases inprofessional fees and consultancy costs of approximately $195,000, primarily related to the costs associated with periodic filings with the SEC and thepreparations for the initial year of auditor attestation under SOX section 404, which requirement was deferred until 2010 by the SEC in a ruling announced inOctober 2009. These increases were partially offset by a decrease of approximately $575,000 in legal expenses due primarily to the reduction in patentrelated legal costs in 2009 as compared to the prior year.General and administrative expenses included stock-based compensation expense related to option grants to individuals performing these functions ofapproximately $1.9 million, $1.5 million and $1.4 million for the years ended December 31, 2010, 2009 and 2008, respectively.We expect that general and administrative expenses will increase in 2011 as compared to 2010 in regard to activities directly associated withpreparations for potential product commercialization and the need to increase our administrative infrastructure to support these activities. The amount ofgeneral and administrative expenses in 2012 and future years will be largely dependent on our assessment of the staff necessary to support expected productcommercialization and our continued clinical development activities and the availability of additional funds. See also, “Liquidity and Capital Resources”.Interest and other income, net—Interest and other income, net of investment management fees, was approximately $1.5 million for the year endedDecember 31, 2010 as compared to $101,000 for the same period in 2009 and $945,000 in 2008. Other income in 2010 included $750,000 in connectionwith the favorable 55Table of Contentssettlement of a lawsuit brought on our behalf against an individual for defamation and harassment and approximately $733,438 in grants from the UnitedStates Treasury’s Therapeutic Discovery Project Grant program. Interest income in 2009 and 2008 included approximately $60,000 and $410,000,respectively, related to the note receivable in connection with our March 2008 financing, which was collected in February 2009. In 2009, there were alsodecreases in yields and balances of invested funds as compared to 2008.Other expense—Other expense for the year ended December 31, 2010 was approximately $25,000 as compared to $17,000 in 2009 and $1.3 million in2008. The other expense for 2008 was primarily related to the cost of liquidated damages due to the delay in the effectiveness of the registration statement ofthe securities sold in our March 2008 financing. Other expense includes interest expense on capitalized leases and state tax on capital, which is based on ourcapital and asset positions as of each year-end.Liquidity and Capital ResourcesWe have incurred operating losses since inception, and at December 31, 2010, we had a deficit accumulated during the development stage of $176.2million. Since our inception, we have relied primarily on the proceeds from public and private sales of our equity securities to fund our operations.At December 31, 2010, we had cash and cash equivalents of $24.6 million, compared to $23.9 million at December 31, 2009. Net cash used inoperating activities for the years ended December 31, 2010, 2009 and 2008 was $22.3 million, $18.0 million and $18.4 million, respectively. The use of cashin each period was primarily a result of our research and development activities and amounts incurred to develop our administrative infrastructure.During 2010, we issued common stock upon the exercise of warrants that had been issued in a private placement transaction in October 2009 and soldnew warrants to the same investors, generating gross proceeds of approximately $7.7 million and sold common stock in an underwritten public offering,generating gross proceeds of approximately $15.0 million. We also sold common stock to Kingsbridge Capital Limited (Kingsbridge), a private investmentgroup, under a Committed Equity Financing Facility (CEFF) generating gross proceeds of approximately $1.6 million. Issuance costs for these transactionscollectively totaled approximately $1.4 million. The net proceeds of all these transactions have been, or will be, used for general corporate purposes.In January 2011, we sold 11.5 million shares of our common stock in an underwritten public offering at a price to the public of $3.90 per share foraggregate gross proceeds of approximately $44.9 million, which resulted in net proceeds of approximately $41.9 million after deducting the underwriter’sdiscount and commissions and other expenses related to this offering.We expect cash used in operating activities to increase during 2011 as compared to spending levels in 2010 due to the preparation and support of ourNDA filing for CORLUX for the treatment of Cushing’s Syndrome, increased manufacturing activities for pre-validation and validation batches of CORLUX,commercialization planning activities, continuation of the long-term extension study of CORLUX for Cushing’s Syndrome and the continued developmentof our selective GR-II antagonists, including CORT 108297 and CORT 113083. We expect our funding requirements for operating activities may increaseduring later years as costs associated with the continuation and expansion of our development programs for Cushing’s Syndrome, psychotic depression andour selective GR-II antagonists, research activities, commercialization activities and general and administrative expenses may be only partially offset byrevenues from sales of CORLUX once approval for marketing has been received from the FDA.We believe that we have sufficient capital resources to maintain our operations into the third quarter of 2012, including the planned continuation ofour long-term extension study of CORLUX for the treatment of Cushing’s Syndrome, the planned submission of an NDA and commercialization activities forCORLUX, the Company’s lead product, for this indication, the continuation of enrollment in our Phase 3 psychotic depression 56Table of Contentstrial, the completion of a Phase 1b/2a multi-dose safety and proof of concept clinical study for CORT 108297, one of our proprietary, selective GR-IIantagonists, and research and pre-clinical activities related to additional selective GR-II antagonists, including the submission of an Investigational NewDrug (IND) application for CORT 113083.We will need to raise additional funds to support the potential commercialization of CORLUX for the treatment of Cushing’s Syndrome, continue thedevelopment of CORLUX for the treatment of the psychotic features of psychotic depression and continue and expand the development of our proprietaryselective GR-II antagonists beyond mid-2012.We cannot be certain that additional funding will be available on acceptable terms or at all. Further, any additional equity financing may be dilutive tostockholders, and any debt financing, if available, may involve restrictive covenants. If we obtain funds through collaborations with others, thesearrangements may be on unfavorable terms or may require us to relinquish certain rights to our technologies or product candidates, including potentially ourlead product candidate that we would otherwise seek to develop on our own. If adequate funds are not available, we may be required to delay, reduce thescope of or eliminate one or more of our research or development programs or we may be required to discontinue operations.In March 2008, we entered into a CEFF with Kingsbridge. Under the terms of the agreement, Kingsbridge committed to provide up to $60 million ofcapital in exchange for newly-issued shares of our common stock for a period of up to three years after the SEC declares effective the registration statementsfiled by us covering the resale of the shares of common stock issuable in connection with the CEFF and the shares of common stock underlying the warrantissued to Kingsbridge. In June 2008, the SEC declared effective our registration statement with the SEC covering the resale of approximately 3.6 million ofthe shares issuable under the CEFF and the shares issuable upon the exercise of the warrant issued to Kingsbridge. This registration statement coversapproximately 37% of the 9.6 million shares of our common stock issuable pursuant to the CEFF and all of the 330,000 shares of our common stock issuableupon exercise of the warrant issued to Kingsbridge. As of the filing of this report, approximately 2.6 million shares remain available for sale under the initialregistration statement. We intend to file an additional registration statement covering the resale of the remaining 6.0 million shares of our common stockissuable pursuant to the CEFF approximately 60 days after Kingsbridge and its affiliates have resold substantially all of the securities registered for sale underthis initial registration statement.Under the terms of the agreement, the determination of the exact timing and amount of any CEFF financings will be made solely by us, subject tocertain conditions. The agreement currently requires a minimum stock price of $1.50 per share to allow us to issue shares to Kingsbridge under the CEFF.Through December 31, 2010, we have raised a total of approximately $2.6 million from the sales of stock under the CEFF. Based on the volume weightedaverage price on the NASDAQ Capital Market for our common stock for the period from March 25, 2008, the date of the signing of the Kingsbridge CEFF,through March 8, 2011, the maximum amount of additional funds that could be raised under the CEFF is approximately $26 million. The actual amount offunds that can be raised under this agreement will be dependent on the number of shares actually sold under the agreement and the market value of our stockduring the pricing periods of each sale.While we monitor the cash balance in our checking account and transfer the funds in only as needed, these cash balances and our money market fundcould be impacted if the underlying financial institution were to fail or could be subject to other adverse conditions in the financial markets. To date, wehave experienced no loss or lack of access to cash in our checking accounts or money market fund.As a result of volatile market conditions, the cost and availability of capital has been and may continue to be adversely affected by illiquid capitalmarkets. Concern about the stability of the markets generally and the strength of counterparties specifically has led many lenders and institutional investorsto reduce, and in some cases, cease to provide credit to businesses and consumers. Continued turbulence in the U.S. and international markets and economiesand prolonged declines in business consumer spending may adversely affect our liquidity and financial condition, including our ability to access the capitalmarkets to meet liquidity needs. 57Table of ContentsContractual Obligations and Commercial CommitmentsThe following table presents our estimates of obligations under contractual agreements as of December 31, 2010: Contractual Obligations Less than1 Year 1-3Years 3-5Years More than5 Years (in thousands) Research and development studies $5,358 $6,058 $— $— Commercialization planning activities 1,100 — — — Operating lease 231 — — — Minimum royalty payments 50 100 100 50 per year Total $6,739 $6,158 $100 $50 per year Amounts reflected for research and development studies exclude amounts included in accounts payable and accrued clinical costs reflected on the balance sheet as of December 31, 2010.During 2008, we entered into agreements for services in connection with our ongoing Phase 3 trial to confirm the utility of CORLUX for the treatment of the psychotic features of psychotic depression.The total commitment under these original agreements was approximately $21.1 million. In June 2009, we amended these agreements to reduce the amounts of commitments with these organizations byapproximately $5.0 million in accordance with the reduction in the near-term scope of activities under this trial. However, we view the reduction in these commitments as a temporary measure as it is ourintent to continue the conduct of this trial to its conclusion, when sufficient capital is available for this purpose. Approximately $8.0 million of these costs were expensed through December 31, 2010, withthe remainder to be incurred over the course of the trial. Under the master services agreements with these vendors, the project contracts may be terminated upon thirty to sixty day’s notice. If terminatedearly, we would be responsible for the costs incurred by the vendors through the effective date of termination plus cancellation charges as stipulated in the agreements.During 2010, we entered into agreements for the conduct of the initial clinical trials using CORT 108297. The total commitment under these agreements is approximately $2.3 million. Approximately$1.3 million of costs under these agreements have been incurred as of December 31, 2010, with the remainder expected to be incurred during 2011.In June 2010, we entered into agreements with the vendor that provides manufacturing services for materials to be used in development work for CORT 108297 and CORT 113083 in the aggregate amountof $1.6 million. Approximately $1.2 million has been incurred under these agreements through December 31, 2010, with the remainder to be incurred during 2011.During the period from September to December 2010, we entered into purchase orders for the acquisition of mifepristone, the active pharmaceutical ingredient (API) in CORLUX, to be delivered during2011 for aggregate commitments of approximately $1.8 million.In August 2010, we entered into an agreement with United Biosource Corporation (UBC) to assist us in developing our Risk Evaluation and Mitigation Strategy (REMS), a plan for which will besubmitted to the FDA as part of our NDA for CORLUX for the treatment of Cushing’s Syndrome. The financial commitment under the initial set-up phase of this agreement is approximately $1.2 million;approximately $105,000 of which cost was incurred during 2010 with the remainder expected to be incurred during 2011. See discussion below regarding potential contingent future obligations under thisagreement after approval of CORLUX by the FDA for marketing.In August 2010, we renewed the operating lease agreement for our office facility for a one-year term commencing on January 1, 2011.Under our cancellable license agreement with Stanford University, we are obligated to make nonrefundable minimum royalty payments of $50,000 annually for as long as we maintain our licenses withStanford; however, these payments are creditable against future royalties.We also have other contractual payment obligations and purchase commitments, the timing of which are contingent on future events. Under our license agreement with Stanford University related to the patent covering the use of GR-II antagonists to treat the psychosis associated withpsychotic depression and early dementia, we are obligated to make milestone payments to Stanford of $50,000 upon filing of an NDA covering thelicensed product and $200,000 upon FDA approval of the licensed product. The milestone payments payable to Stanford under these licenses arecreditable against future royalties. Under the agreement with our contract research company we may be obligated to make milestone payments upon the occurrence of certain events,including: (i) patent filings in connection with the project; (ii) entries into Phase 1 clinical trials; and (iii) national regulatory approval of each productarising from work performed under the agreement, provided that sales of the product by the Company or any future licensees reach $5,000,000. Theseobligations remain in force after the conclusion of work under the agreement. There are no royalty obligations associated with this contract. 58(1) through (5)(6)(7)(8)(1)(2)(3)(4)(5)(6)(7)(8)(a)(b)Table of ContentsPursuant to our memorandum of understanding with ScinoPharm, ScinoPharm agrees to manufacture API for CORLUX and we agree to purchase atleast $1,000,000 bulk mifepristone per year following the commercial launch of CORLUX. ScinoPharm is considered to be a potential secondary sitefor the manufacture of the API. However, no activities are currently being conducted at this site to develop or qualify the manufacturing processes orfacilities and we do not plan to include a request for approval of material produced by ScinoPharm when we submit our NDA for Cushing’s Syndrome. In November 2006, we entered into an agreement with PCAS for the manufacture of mifepristone, the API in CORLUX, for our development andcommercial needs for an initial period of five years. The agreement provides for an automatic extension for one additional year. We intend to pursuediscussions for further extensions. There is no guaranteed minimum purchase commitment under this agreement until NDA approval. After NDAapproval, we agree to purchase from PCAS 100% of our requirements for six months after the approval and 75% of our requirements from six monthsthrough 18 months after the approval for the initial five year term of the agreement. If PCAS is unable to manufacture the product for a consecutive six-month period, we have the right to terminate the agreement without penalty. See discussion in footnote 6 above regarding the agreement with UBC for development of the REMS system which would require future obligations foruse of the system following the FDA approval of our NDA for CORLUX for the treatment of Cushing’s Syndrome. The majority of such costs arevariable and dependent on patient utilization of our drug.In February 2011, we amended our agreement with Argenta Discovery 2009 Limited (Argenta) for the continuation of research services regarding newproprietary selective GR-II antagonists through September 30, 2011 for an additional commitment of approximately $840,000.Net Operating Loss CarryforwardsAt December 31, 2010 we had net operating loss carryforwards available to offset any future taxable income that we may generate for federal incometax purposes of approximately $94.0 million, which expire in the years 2019 through 2030, and California net operating loss carryforwards of approximately$94.6 million, which expire in the years 2012 through 2030. We also had federal and California research and development tax credits of approximately $10.2million and $1.5 million, respectively. The federal research credits will expire in the years 2019 through 2030 and the California research credits have noexpiration date. Our deferred tax assets have been offset by a full valuation allowance as the realization of such assets is uncertain. Utilization of our netoperating losses and tax credit carryforwards may be subject to substantial annual limitation due to the ownership change limitations provided by theInternal Revenue Code and similar state provisions. Such limitations could result in the expiration of the net operating losses and tax credit carryforwardsbefore utilization.Off-Balance Sheet ArrangementsNone.Critical Accounting Policies and EstimatesOur financial statements have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financialstatements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses. We base our estimates onhistorical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis formaking judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from theseestimates under different assumptions or conditions.Accruals of Research and Development Costs—We recorded accruals for estimated costs of research, pre-clinical and clinical studies, andmanufacturing development of approximately $815,000 and $710,000 as of 59(c)(d)(e)Table of ContentsDecember 31, 2010 and 2009, respectively. These costs are a significant component of our research and development expenses. We make significantjudgments and estimates in determining the accrual balance in each reporting period. Accrued clinical trial costs are based on estimates of the workcompleted under the service agreements, milestones achieved, patient enrollment and past experience with similar contracts and service providers. Ourestimate of the work completed, and associated costs to be accrued, includes our assessment of the information received from our third-party contract researchorganizations and the overall status of our clinical trial activities. In the past, we have not experienced any material deviations between accrued clinical trialexpenses and actual clinical trial expenses. However, actual services performed, number of patients enrolled and the rate of patient enrollment may vary fromour estimates, resulting in adjustments to clinical trial expense in future periods.Stock-based compensation—Stock-based compensation arises from the granting of stock options to employees and directors, as well as to non-employees.Employees and directorsOur accounting practices and the estimates and judgments that are considered in determining fair value in regard to stock option grants to employeesand directors are as follows: • Options granted subsequent to January 1, 2006: The grant date fair value for all new grants issued after January 1, 2006 is being amortized to expense using the straight-line method over thevesting period of the options. For service-based awards, expense is recognized over the requisite service period. For options with performance-based vesting criteria,expense will be recognized at such time as there is a high degree of probability (i.e., greater than 70%) of achieving the required vestingcriteria. The expected term used in determining the fair value for options is based on the ”simplified” method prescribed by the SEC that considers theweighted average of the vesting period and contractual life of the options. There has been no adjustment made to the expected term to adjustfor employees’ expected exercise and expected post-vesting termination behavior because we have a limited employee base and do not havesufficient historical information to determine such an adjustment. The expected volatility of our common stock used in determining the fair value of option grants is based on a weighted-average combinationof the volatility of our own stock price and that of a group of peer companies since we do not have sufficient historical data from which tobase an appropriate volatility assumption. • Options granted prior to January 1, 2006: For options granted prior to our initial public offering (IPO) in 2004, we have continued to account for the portion of these grants that werenon-vested as of January 1, 2006 based on the intrinsic value of these grants. For the options granted after the IPO, we began, as of January 1, 2006, to record non-cash stock-based compensation expense in the financialstatements in amounts that represent the remaining fair value of the non-vested portion of these grants. For all options granted prior to January 1, 2006, we continued to utilize the graded-vesting attribution method for amortization of the relevantcompensation amounts until these grants were fully vested in 2010. • Since we have a limited employee base and have experienced minimal turnover, we do not have sufficient historical information to determine areasonable forfeiture rate for options that might not vest because of employee terminations and, therefore, do not apply a forfeiture rate. When anemployee terminates, we will record a change in accounting estimate that represents the difference between the expense recorded in the financialstatements and the expense that would have been recorded based upon the rights to options that vested during the individual’s service as anemployee. 60¡¡¡¡¡¡¡Table of ContentsAs of December 31, 2010, we had approximately $4.0 million of unrecognized compensation expense for employee and director options outstandingas of that date. Approximately $3.3 million of the unrecognized compensation relates to option grants with service-based vesting criteria, which had aremaining weighted-average vesting period of 2.4 years. Approximately $637,000 of the unrecognized compensation relates to option grants withperformance-based vesting criteria; as this amount will be expensed based on the high probability of success of the performance criteria, it is not possible toestimate the timing of recognition of this expense.Non-employeesAll stock option grants to consultants vest solely based upon continuing service, with the exception of a performance-based award granted during2010, in the amount of 50,000 shares. Stock-based compensation related to service-based option grants to non-employees is charged to expense on a straightline basis over the vesting period of the options, which approximates the period over which the related services are rendered, based on the fair value of theoptions using the Black-Scholes option pricing model. The assumptions used in these calculations are similar to those used for the determination of fair valuefor options granted to employees, with the exception that, for non-employee options, we are required to use the remaining contractual term as the life of theoption and the fair value related to unvested non-employee options is re-measured quarterly, based on the then current stock price as reflected on the NasdaqCapital Market. The grant with performance-based vesting criteria awarded in 2010 will vest in its entirety upon the filing by the FDA of the Company’sNDA for CORLUX for the treatment of Cushing’s Syndrome. The fair value of the grant as of the date of vesting, as determined using the Black-Scholesoption pricing model, will be charged to expense at that time.Recently Adopted Accounting StandardsOn March 31, 2010, the Financial Accounting Standards Board ratified the conclusions reached by its Emerging Issues Task Force that the milestonemethod of revenue recognition is a valid application of the proportional performance model when applied to research or development arrangements.Accordingly, the guidance states that an entity can make an accounting policy election to recognize a payment that is contingent upon the achievement of asubstantive milestone in its entirety in the period in which the milestone is achieved. The milestone method is not required and is not the only acceptablemethod of revenue recognition for milestone payments.This guidance also indicates that, in order to recognize the revenue, certain criteria must be met, including the requirement that the activities leadingup to the achievement of the milestone must be conducted by the entity. A milestone is defined in the guidance as an event: (a) that can only be achievedbased in whole or in part on either (1) the entity’s performance or (2) on the occurrence of a specific outcome resulting from the entity’s performance, (b) forwhich there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (c) that would result in additionalpayments being due to the entity. Therefore, a milestone does not include events for which the occurrence is contingent solely on the passage of time orsolely on a customer’s performance.The new guidance was effective for fiscal years that began on or after June 15, 2010 and interim periods within those years. The adoption of the newstandard on January 1, 2011 did not have any effect on our financial statements as we do not currently have any arrangements to which the standard wouldapply. ITEM 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKQuantitative and Qualitative Disclosures About Market RiskMarket RiskThe primary objective of our investment activities is to preserve principal while at the same time maximizing the income we receive from ourinvestments without significantly increasing risk of loss. As of December 31, 2010, our cash and cash equivalents consisted primarily of money market fundsmaintained at 61Table of Contentsmajor U.S. financial institutions. To minimize our exposure to interest rate risk, we have limited the maturities of our investments to less than two years withan average maturity not to exceed one year. Due to the short-term nature of these instruments, a 1% increase or decrease in market interest rates would nothave a material impact on the total value of our portfolio as of December 31, 2010. ITEM 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATAThe financial statements required by this item are set forth beginning at page F-1 of this report and are incorporated herein by reference. ITEM 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURENone. ITEM 9A. CONTROLSAND PROCEDURES (a)Evaluation of Disclosure Controls and Procedures.We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our periodic and current reportsthat we file with the SEC is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that suchinformation is accumulated and discussed with our management, including our Chief Executive Officer, Chief Financial Officer and Chief AccountingOfficer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures,management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable and not absoluteassurance of achieving the desired control objectives. In reaching a reasonable level of assurance, management necessarily was required to apply its judgmentin evaluating the cost-benefit relationship of possible controls and procedures. In addition, the design of any system of controls also is based in part uponcertain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under allpotential future conditions; over time, control may become inadequate because of changes in conditions, or the degree of compliance with policies orprocedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not bedetected.As of December 31, 2010, our Chief Executive Officer, Chief Financial Officer and Chief Accounting Officer have evaluated our disclosure controlsand procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act) which were designed to ensure that the information required to bedisclosed by us in this Annual Report on Form 10-K was recorded, processed, summarized and reported within the time periods specified in the SEC’s rulesand Form 10-K. Our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance that the objectives of our disclosurecontrol system are met. Based on the evaluation, our Chief Executive Officer, Chief Financial Officer and Chief Accounting Officer have concluded that ourdisclosure controls and procedures are effective.There were no changes in our internal controls over financial reporting during the quarter ended December 31, 2010 that have materially affected, orare reasonably likely to materially affect, our internal control over financial reporting. (b)Management’s Report on Internal Control Over Financial ReportingOur management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined inExchange Act Rule 13a-15(f). Our internal control system is designed to provide reasonable assurance regarding the preparation and fair presentation offinancial statements for external 62Table of Contentspurposes in accordance with generally accepted accounting principles. All internal control systems, no matter how well designed, have inherent limitationsand can provide only reasonable assurance that the objectives of the internal control system are met.Our management, including our Chief Executive Officer, Chief Financial Officer and Chief Accounting Officer, conducted an evaluation of theeffectiveness of our internal control over financial reporting, based on criteria established in Internal Control—Integrated Framework issued by theCommittee of Sponsoring Organizations of the Treadway Commission (COSO). Based on this evaluation, our management concluded that our internalcontrol over financial reporting was effective as of December 31, 2010.Our independent registered public accounting firm has issued an attestation report on our internal control over financial reporting as included below. (c)Report of Independent Registered Public Accounting FirmThe Board of Directors and Stockholders of Corcept Therapeutics IncorporatedWe have audited Corcept Therapeutics Incorporated’s internal control over financial reporting as of December 31, 2010, based on criteria establishedin Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (the COSO criteria). CorceptTherapeutics Incorporated’s management is responsible for maintaining effective internal control over financial reporting, and for its assessment of theeffectiveness of internal control over financial reporting included in the accompanying Management’s Report on Internal Control Over Financial Reporting.Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards requirethat we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in allmaterial respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weaknessexists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures aswe considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financialreporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’sinternal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail,accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded asnecessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of thecompany are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assuranceregarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on thefinancial statements.Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of anyevaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degreeof compliance with the policies or procedures may deteriorate.In our opinion, Corcept Therapeutics Incorporated maintained, in all material respects, effective internal control over financial reporting as ofDecember 31, 2010, based on the COSO criteria. 63Table of ContentsWe also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the balance sheets ofCorcept Therapeutics Incorporated (a development stage company) as of December 31, 2010 and 2009, and the related statements of operations, convertiblepreferred stock and stockholders’ equity (net capital deficiency), and cash flows for each of the three years in the period ended December 31, 2010, and forthe period from inception (May 13, 1998) to December 31, 2010 of Corcept Therapeutics Incorporated (a development stage company), and our report datedMarch 15, 2011 expressed an unqualified opinion thereon./s/ Ernst & Young LLPPalo Alto, CaliforniaMarch 15, 2011 ITEM 9B. OTHERINFORMATIONNone. 64Table of ContentsPART IIICertain information required by Part III is omitted from this Annual Report on Form 10-K because we expect to file with the U.S. Securities andExchange Commission, not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K, a definitive proxy statement (theProxy Statement), pursuant to Regulation 14A in connection with the solicitation of proxies for our 2011 Annual Meeting of Stockholders, and certaininformation included therein is incorporated herein by reference. ITEM 10.DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCEExcept as disclosed below, the information required by this Item will be included in the Proxy Statement and is incorporated herein by reference.Executive OfficersThe information required by this Item concerning our executive officers is set forth in Part I of this Annual Report on Form 10-K.Code of EthicsWe have adopted a Code of Ethics that applies to all officers and employees, including our principal executive officer, principal financial officer andcontroller. The Code of Ethics is publicly available on our website at www.corcept.com. We will also deliver a copy of our Code of Ethics to any stockholder,without charge, upon written request to Corcept Therapeutics, 149 Commonwealth Drive, Menlo Park, California 94025, Attention: Secretary, or upon oralrequest by calling (650) 327-3270. We intend to satisfy the disclosure requirement under Item 5.05 of Form 8-K regarding an amendment to, or waiver from, aprovision of our Code of Ethics by posting such information on our website, at the address and location specified above and, to the extent required by thelisting standards of The NASDAQ Stock Market, by filing a Current Report on Form 8-K with the SEC, disclosing such information. ITEM 11.EXECUTIVE COMPENSATIONThe information required by this Item will be included in the Proxy Statement and is incorporated herein by reference. ITEM 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDERMATTERSThe information required by this Item will be included in the Proxy Statement and is incorporated herein by reference. ITEM 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCEThe information required by this Item will be included in the Proxy Statement and is incorporated herein by reference. ITEM 14.PRINCIPAL ACCOUNTING FEES AND SERVICESThe information required by this Item will be included in the Proxy Statement and is incorporated herein by reference. 65Table of ContentsPART IV ITEM 15.EXHIBITS, FINANCIAL STATEMENT SCHEDULESThe following documents are filed as part of this Form 10-K(1) Financial Statements: Page Report of Independent Registered Public Accounting Firm F-2 Audited Financial Statements Balance Sheets F-3 Statements of Operations F-4 Statement of Convertible Preferred Stock and Stockholders’ Equity (Net Capital Deficiency) F-5 Statements of Cash Flows F-12 Notes to Financial Statements F-13 (2) Financial Statement Schedules:All schedules have been omitted because the information required to be set forth therein is not applicable or is shown in the financial statements ornotes thereto.(3) Exhibits:Item 601 of Regulation S-K requires the exhibits listed below. Each management contract or compensatory plan or arrangement required to be filed asan exhibit to this Form 10-K has been identified.(A) EXHIBITS ExhibitNumber Description of Document 3.1 Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the registrant’s Registration Statementon Form S-1/A (File No. 333-112676) filed on March 19, 2004). 3.2 Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to the registrant’s Current Report on Form 8-K filed onSeptember 27, 2007). 4.1 Specimen Common Stock Certificate (incorporated by reference to Exhibit 4.1 to the registrant’s Registration Statement on Form S-1(Registration No. 333-112676) filed on February 10, 2004). 4.2 Amended and Restated Information and Registration Rights Agreement by and among Corcept Therapeutics Incorporated and certainholders of preferred stock, dated as of May 8, 2001 (incorporated by reference to Exhibit 4.2 to the registrant’s Registration Statementon Form S-1 (Registration No. 333-112676) filed on February 10, 2004). 4.3 Amendment No. 1 to Amended and Restated Information and Registration Rights Agreement by and among Corcept TherapeuticsIncorporated and certain holders of preferred stock, dated as of March 16, 2004 (incorporated by reference to Exhibit 4.3 to theregistrant’s Registration Statement on Form S-1/A (File No. 333-112676) filed on March 19, 2004). 4.4 Registration Rights Agreement by and among Corcept Therapeutics Incorporated and the investors signatory thereto, dated March 14,2008 (incorporated by reference to Exhibit 10.25 to the registrant’s Annual Report on Form 10-K filed on March 31, 2008). 66Table of ContentsExhibitNumber Description of Document 4.5 Registration Rights Agreement by and between Corcept Therapeutics Incorporated and Kingsbridge Capital Limited, dated as of March25, 2008 (incorporated by reference to Exhibit 10.27 to the registrant’s Annual Report on Form 10-K filed on March 31, 2008). 4.6 Amendment to Registration Rights Agreement by and among Corcept Therapeutics Incorporated and the investors signatory thereto,dated November 11, 2008 (incorporated by reference to Exhibit 10.30 to the registrant’s Annual Report on Form 10-K filed on March 31,2009). 4.7 Registration Rights Agreement by and among Corcept Therapeutics Incorporated and the investors signatory thereto, dated October 12,2009 (incorporated by reference to Exhibit 4.2 to the registrant’s Quarterly Report on Form 10-Q filed on November 12, 2009). 4.8 Registration Rights Agreement dated as of April 21, 2010 by and among Corcept Therapeutics Incorporated and the investors signatorythereto (incorporated by reference to Exhibit 4.2 to the registrant’s Current Report on Form 8-K filed on April 23, 2010).10.1* 2000 Stock Option Plan (incorporated by reference to Exhibit 10.1 to the registrant’s Registration Statement on Form S-1 (RegistrationNo. 333-112676) filed on February 10, 2004).10.2* Promissory Note and Pledge Agreement by and between Corcept Therapeutics Incorporated and Robert L. Roe, M.D., dated as of October22, 2001 (incorporated by reference to Exhibit 10.4 to the registrant’s Registration Statement on Form S-1 (Registration No. 333-112676)filed on February 10, 2004).10.3# License Agreement by and between The Board of Trustees of the Leland Stanford Junior University and Corcept TherapeuticsIncorporated, dated as of July 1, 1999 (incorporated by reference to Exhibit 10.6 to the registrant’s Registration Statement on Form S-1(Registration No. 333-112676) filed on February 10, 2004).10.4# Memorandum of Understanding, Supply and Services Agreement, by and between Corcept Therapeutics Incorporated and ScinoPharmTaiwan, dated as of June 12, 2000 (incorporated by reference to Exhibit 10.9 to the registrant’s Registration Statement on Form S-1/A(File No. 333-112676) filed on March 19, 2004).10.5 Master Services Agreement by and between Corcept Therapeutics Incorporated and PPD Development, LP, dated as of January 17, 2003(incorporated by reference to Exhibit 10.12 to the registrant’s Registration Statement on Form S-1/A (File No. 333-112676) filed onMarch 19, 2004).10.6## Manufacturing Agreement with Produits Chimiques Auxiliaires et de Synthese SA, dated November 8, 2006 (incorporated by reference toExhibit 10.15 to the registrant’s Annual Report on Form 10-K filed on April 2, 2007).10.7 Common Stock Purchase Agreement by and among Corcept Therapeutics Incorporated and each of the Purchasers listed on Exhibit Athereto, dated November 14, 2006 (incorporated by reference to Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed onNovember 16, 2006).10.8 Common Stock Purchase Agreement by and among Corcept Therapeutics Incorporated and each of those persons and entities listed on theSchedule of Purchasers thereto, dated as of March 30, 2007 (incorporated by reference to Exhibit 10.1 to the registrant’s Current Report onForm 8-K filed on April 3, 2007).10.9 Common Stock Purchase Agreement by and among Corcept Therapeutics Incorporated and each of those persons and entities listed on theSchedule of Purchasers thereto, dated as of August 16, 2007 (incorporated by reference to Exhibit 10.1 to the registrants Current Report onForm 8-K filed on August 21, 2007). 67Table of ContentsExhibitNumber Description of Document10.10* Form of Indemnification Agreement for directors and officers approved by the Board of Directors on September 24, 2007 (incorporated byreference to Exhibit 10.7 to the registrant’s Quarterly Report on Form 10-Q filed on November 14, 2007).10.11 Securities Purchase Agreement by and among Corcept Therapeutics Incorporated and the purchasers named therein, dated March 14, 2008(incorporated by reference to Exhibit 10.24 to the registrant’s Annual Report on Form 10-K filed on March 31, 2008).10.12 Form of Warrant issued in connection with the Securities Purchase Agreement by and among Corcept Therapeutics Incorporated and thepurchasers named therein, dated March 14, 2008 (incorporated by reference to Exhibit 4.4 to the registrant’s Annual Report on Form 10-Kfiled on March 31, 2008).10.13 Common Stock Purchase Agreement by and between Kingsbridge Capital Limited and Corcept Therapeutics Incorporated dated as ofMarch 25, 2008 (incorporated by reference to Exhibit 10.26 to the registrant’s Annual Report on Form 10-K filed on March 31, 2008).10.14 Warrant, dated March 25, 2008 issued to Kingsbridge Capital Limited (incorporated by reference to Exhibit 4.5 to the registrant’s AnnualReport on Form 10-K filed on March 31, 2008).10.15# Master Service Agreement by and among Corcept Therapeutics Incorporated and ICON Clinical Research, L.P., signed on June 4, 2008(incorporated by reference to Exhibit 10.5 to the registrant’s Quarterly Report on Form 10-Q filed on August 14, 2008).10.16* Amended and Restated Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and Joseph K.Belanoff, M. D., dated September 19, 2008 (incorporated by reference to Exhibit 10.25 to the registrant’s Annual Report on Form 10-Kfiled on March 31, 2009).10.17* Amended and Restated Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and Robert L.Roe, M. D., dated September 19, 2008 (incorporated by reference to Exhibit 10.26 to the registrant’s Annual Report on Form 10-K filed onMarch 31, 2009).10.18* Amended and Restated Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and Anne M.LeDoux, dated September 19, 2008 (incorporated by reference to Exhibit 10.27 to the registrant’s Annual Report on Form 10-K filed onMarch 31, 2009).10.19* Amended and Restated Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and James N.Wilson, dated September 19, 2008 (incorporated by reference to Exhibit 10.28 to the registrant’s Annual Report on Form 10-K filed onMarch 31, 2009).10.20* Employment offer letter to Caroline M. Loewy, dated October 21, 2008 (incorporated by reference to Exhibit 10.29 to the registrant’sAnnual Report on Form 10-K filed on March 31, 2009).10.21* Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and Caroline M. Loewy, datedNovember 28, 2008 (incorporated by reference to Exhibit 10.31 to the registrant’s Annual Report on Form 10-K filed on March 31, 2009).10.22 Form of Warrant issued in connection with the Securities Purchase Agreement by and among Corcept Therapeutics Incorporated and thepurchasers named therein, dated October 12, 2009 (incorporated by reference to Exhibit 4.1 to the registrant’s Quarterly Report on Form10-Q filed on November 12, 2009). 68Table of ContentsExhibitNumber Description of Document10.23 Securities Purchase Agreement by and among Corcept Therapeutics Incorporated and the purchasers named therein, dated October 12,2009 (incorporated by reference to Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q filed on November 12, 2009).10.24* Amended and Restated 2004 Equity Incentive Plan (incorporated by reference to the registrant’s Proxy Statement on Schedule 14A filedon May 7, 2009).10.25* Form of Option Agreement10.26 Warrant Purchase Agreement dated as of April 21, 2010 by and among Corcept Therapeutics Incorporated and the purchasers namedtherein (incorporated by reference to Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on April 23, 2010).10.27 Form of Warrant issued in connection with the Warrant Purchase Agreement dated as of April 21, 2010 by and among CorceptTherapeutics Incorporated and the purchasers named therein (incorporated by reference to Exhibit 4.1 to the registrant’s Current Report onForm 8-K filed on April 23, 2010).10.28 Development Agreement by and between Corcept Therapeutics Incorporated and Formulation Technologies L.L.C. d/b/a PharmaForm,dated as of December 14, 2006.10.29 Master Services Agreement by and between Corcept Therapeutics Incorporated and United BioSource Corporation, dated as of June 29,2010.10.30* Employment offer letter to Steven Lo, dated August 9, 2010 (incorporated by reference to Exhibit 10.1 to the registrant’s Quarterly Reporton Form 10-Q filed on November 12, 2010).10.31* Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and Steven Lo, dated September 15,2010 (incorporated by reference to Exhibit 10.2 to the registrant’s Quarterly Report on Form 10-Q filed on November 12, 2010).14.1 Code of Ethics (incorporated by reference to Exhibit 99.1 to the registrant’s Registration Statement on Form S-1/A (File No. 333-112676)filed on March 19, 2004).23.1 Consent of Independent Registered Public Accounting Firm24.1 Power of Attorney (See signature page)31.1 Certification pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 of Joseph K. Belanoff, M.D.31.2 Certification pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 of Caroline M. Loewy32.1 Certification pursuant to 18 U.S.C. Section 1350 of Joseph K. Belanoff, M.D.32.2 Certification pursuant to 18 U.S.C. Section 1350 of Caroline M. Loewy #Confidential treatment granted##Confidential treatment requested*Management contract or compensatory plan or arrangement 69####Table of ContentsSIGNATURESPursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on itsbehalf by the undersigned thereunto duly authorized. CORCEPT THERAPEUTICS INCORPORATEDBy: /s/ JOSEPH K. BELANOFF Joseph K. Belanoff, M.D.,Chief Executive OfficerDate: March 15, 2011POWER OF ATTORNEYKNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below hereby constitutes and appoints Joseph K. Belanoffand Caroline M. Loewy, and each of them acting individually, as his or her true and lawful attorneys-in-fact and agents, each with full power of substitution,for him or her in any and all capacities, to sign any and all amendments to this report on Form 10-K and to file the same, with exhibits thereto and otherdocuments in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, with full power of each toact alone, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully for allintents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or his or theirsubstitute or substitutes, may lawfully do or cause to be done by virtue hereof.Pursuant to the requirements of the Exchange Act, this Annual Report on Form 10-K has been signed by the following persons on behalf of theregistrant and in the capacities and on the dates indicated: Signature Title Date/S/ JOSEPH K. BELANOFF Joseph K. Belanoff, M.D. Chief Executive Officer and Director (Principal ExecutiveOfficer) March 15, 2011/S/ CAROLINE M. LOEWY Caroline M. Loewy Chief Financial Officer (Principal Financial Officer) March 15, 2011/S/ ANNE M. LEDOUX Anne M. LeDoux Vice President and Controller (Principal Accounting Officer) March 15, 2011/S/ JAMES N. WILSON James N. Wilson Director and Chairman of the Board of Directors March 15, 2011/S/ G. LEONARD BAKER, JR. G. Leonard Baker, Jr. Director March 15, 2011/S/ JOSEPH C. COOK, JR. Joseph C. Cook, Jr. Director March 15, 2011/S/ PATRICK G. ENRIGHT Patrick G. Enright Director March 15, 2011 70Table of ContentsSignature Title Date/S/ JAMES A. HARPER James A. Harper Director March 15, 2011/S/ DAVID L. MAHONEY David L. Mahoney Director March 15, 2011/s/ JOSEPH L. TURNER Joseph L. Turner Director March 15, 2011 71Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)INDEX TO FINANCIAL STATEMENTS Page Report of Independent Registered Public Accounting Firm F-2 Audited Financial Statements Balance Sheets F-3 Statements of Operations F-4 Statement of Convertible Preferred Stock and Stockholders’ Equity (Net Capital Deficiency) F-5 Statements of Cash Flows F-12 Notes to Financial Statements F-13 F-1Table of ContentsREPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMThe Board of Directors and Stockholders of Corcept Therapeutics IncorporatedWe have audited the accompanying balance sheets of Corcept Therapeutics Incorporated (a development stage company) as of December 31, 2010 and2009, and the related statements of operations, convertible preferred stock and stockholders’ equity (net capital deficiency), and cash flows for each of thethree years in the period ended December 31, 2010, and for the period from inception (May 13, 1998) to December 31, 2010. These financial statements arethe responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States.) Those standardsrequire that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An auditincludes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing theaccounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe thatour audits provide a reasonable basis for our opinion.In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Corcept TherapeuticsIncorporated (a development stage company) at December 31, 2010 and 2009, and the results of its operations and its cash flows for each of the three years inthe period ended December 31, 2010 and for the period from inception (May 13, 1998) to December 31, 2010, in conformity with U.S. generally acceptedaccounting principles.We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), Corcept TherapeuticsIncorporated’s internal control over financial reporting as of December 31, 2010, based on criteria established in Internal Control—Integrated Frameworkissued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated March 15, 2011 expressed an unqualified opinionthereon./s/ Ernst & Young LLPPalo Alto, CaliforniaMarch 15, 2011 F-2Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)BALANCE SHEETS(in thousands, except per share amounts) December 31, 2010 2009 Assets Current assets: Cash and cash equivalents $24,578 $23,867 Prepaid expenses and other current assets 418 553 Total current assets 24,996 24,420 Property and equipment, net of accumulated depreciation 4 10 Other assets 104 81 Total assets $25,104 $24,511 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $817 $1,270 Accrued clinical expenses 815 709 Accrued compensation 1,806 210 Obligations under capital lease — 6 Other liabilities 422 224 Total current liabilities 3,860 2,419 Commitments Stockholders’ equity: Preferred stock, $0.001 par value, 10,000 shares authorized and no shares outstanding at December 31, 2010 or2009 — — Common stock, $0.001 par value, 140,000 shares authorized and 72,404 and 62,475 shares issued andoutstanding at December 31, 2010 and 2009, respectively 72 62 Additional paid-in capital 197,473 172,369 Notes receivable from stockholders (97) (101) Deficit accumulated during the development stage (176,204) (150,238) Total stockholders’ equity 21,244 22,092 Total liabilities and stockholders’ equity $25,104 $24,511 See accompanying notes. F-3Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)STATEMENTS OF OPERATIONS(in thousands, except per share amounts) Year Ended December 31, Period FromInception(May 13, 1998)to December 31,2010 2010 2009 2008 Collaboration revenue $— $29 $209 $1,014 Operating expenses: Research and development* 18,949 14,402 14,152 133,161 General and administrative* 8,488 5,877 5,746 49,249 Total operating expenses 27,437 20,279 19,898 182,410 Loss from operations (27,437) (20,250) (19,689) (181,396) Interest and other income, net 1,496 101 944 6,822 Other expense (25) (17) (1,316) (1,630) Net loss $(25,966) $(20,166) $(20,061) $(176,204) Basic and diluted net loss per share $(0.38) $(0.38) $(0.43) Shares used in computing basic and diluted net loss per share 68,336 52,443 46,721 * Includes non-cash stock-based compensation of the following: Research and development $220 $263 $268 $5,495 General and administrative 1,896 1,552 1,360 11,458 Total non-cash stock-based compensation $2,116 $1,815 $1,628 $16,953 See accompanying notes. F-4Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)STATEMENT OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (NET CAPITAL DEFICIENCY)(in thousands, except per share amounts) ConvertiblePreferred Stock Common Stock AdditionalPaid-inCapital NotesReceivablefromStockholders DeferredCompensation DeficitAccumulatedDuring theDevelopmentStage AccumulatedOtherComprehensiveIncome (Loss) TotalStockholders’Equity (NetCapitalDeficiency) Shares Amount Shares Amount Balance at inception (May 13, 1998) — $— — $— $— $— $— $— $— $— Issuance of common stock to directors forcash in June and July 1998 — — 7,500 8 (5) — — — — 3 Issuance of common stock to a director forcash in May 1999 — — 1,771 2 63 — — — — 65 Issuance of common stock to Stanford anddirectors in conjunction with a licenseagreement in October 1999 — — 30 — 1 — — — — 1 Issuance of Series A convertible preferredstock to institutional and individualinvestors at $1.08 per share for cash andconversion of notes payable, net ofissuance costs of $34 in May 1999 608 623 — — — — — — — — Common stock issued to attorneys andconsultants in exchange for services inMay 1999 — — 49 — 2 — — — — 2 Issuance of common stock upon optionexercise — — 60 — — — — — — — Repurchase of common stock held bydirector in March 1999 — — (750) (1) — — — — — (1) Deferred compensation related to optionsgranted to non-employees — — — — 65 — (65) — — — Amortization of deferred compensation — — — — — — 7 — — 7 Net loss from inception to December 31,1999 — — — — — — — (321) — (321) Balance at December 31, 1999 608 623 8,660 9 126 — (58) (321) — (244) Issuance of Series B convertible preferredstock to institutional and individualinvestors at $3.00 per share for cash,net of issuance costs of $19 in January2000 400 1,180 — — — — — — — — Deferred compensation related to optionsgranted to an employee and non-employees — — — — 248 — (248) — — — Amortization of deferred compensation — — — — — — 91 — — 91 Net loss — — — — — — — (1,846) — (1,846) Balance at December 31, 2000 1,008 1,803 8,660 9 374 — (215) (2,167) — (1,999) Issuance of Series B convertible preferredstock to consultants in exchange forservices in January and April 2001 12 205 — — — — — — — — Issuance of Series BB convertible preferredstock to institutional and individualinvestors at $4.033 per share uponconversion of promissory notes in May2001 268 1,081 — — — — — — — — Issuance of Series C convertible preferredstock to institutional and individualinvestors at $7.066 per share for cash,net of issuance costs of approximately$95 in May and June 2001 3,807 26,805 — — — — — — — — Issuance of Series C convertible preferredstock to consultants in exchange forservices in October 2001 1 20 — — — — — — — — Issuance of common stock to a consultantfor cash below fair value in April 2001 — — 50 — 50 — — — 50 Issuance of common stock upon optionexercises — — 768 — 438 (438) — — — — Issuance of common stock in conjunctionwith a license agreement — — 1 — 15 — — — — 15 Deferred compensation related to optionsgranted to employees and non-employees — — — — 10,226 — (10,226) — — — Amortization of deferred compensation — — — — — — 1,849 — — 1,849 Net loss — — — — — — — (7,454) — (7,454) Balance at December 31, 2001 (carried forward) 5,096 29,914 9,479 9 11,103 (438) (8,592) (9,621) — (7,539) F-5Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)STATEMENT OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (NET CAPITAL DEFICIENCY), (Continued)(in thousands, except per share amounts) ConvertiblePreferred Stock Common Stock AdditionalPaid-inCapital NotesReceivablefromStockholders DeferredCompensation DeficitAccumulatedDuring theDevelopmentStage AccumulatedOtherComprehensiveIncome (Loss) TotalStockholders’Equity (NetCapitalDeficiency) Shares Amount Shares Amount Balance at December 31, 2001 (brought forward) 5,096 $29,914 9,479 $9 $11,103 $(438) $(8,592) $(9,621) $— $(7,539) Issuance of Series C convertible preferredstock to institutional and individualinvestors at $7.066 per share for cash, netof issuance costs of approximately $19 inDecember 2002 1,673 11,802 — — — — — — — — Issuance of common stock upon optionexercises — — 62 — — — — — — — Amortization of deferred compensation — — — — — — 4,085 — — 4,085 Reduction of deferred compensation relatedto the unamortized portion of deferredstock compensation related to aterminated employee — — — — (239) — 239 — — — Reversal of previously expensed deferredcompensation related to a terminatedemployee based on the straight linemethod — — — — (50) — — — — (50) Stock-based compensation related to lapsingrepurchase right of stock held by a non-employee — — — — 68 — — — — 68 Net loss — — — — — — — (18,504) — (18,504) Balance at December 31, 2002 6,769 41,716 9,541 9 10,882 (438) (4,268) (28,125) — (21,940) Deferred compensation related to optionsgranted to employees and non-employees — — — — 1,159 — (1,159) — — — Amortization of deferred compensation — — — — — — 1,559 — — 1,559 Reduction of deferred compensation relatedto the unamortized portion of deferredstock compensation related to terminatedemployees — — — — (1,588) — 1,588 — — — Reversal of previously expensed deferredcompensation related to terminatedemployees — — — — (1,384) — — — — (1,384) Repurchase of common stock and reductionof note payable upon termination ofemployees — — (206) — (155) 155 — — — — Repayment of note receivable fromstockholder — — — — — 37 — — — 37 Stock-based compensation related to lapsingrepurchase right of stock held by a non-employee — — — — 68 — — — — 68 Net loss — — — — — — — (9,812) — (9,812) Unrealized loss on short-term investments — — — — — — — — (1) (1) Total comprehensive loss (9,813) Balance at December 31, 2003 (carried forward) 6,769 41,716 9,335 9 8,982 (246) (2,280) (37,937) (1) (31,473) F-6Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)STATEMENT OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (NET CAPITAL DEFICIENCY), (Continued)(in thousands, except per share amounts) ConvertiblePreferred Stock Common Stock AdditionalPaid-inCapital NotesReceivablefromStockholders DeferredCompensation DeficitAccumulatedDuring theDevelopmentStage AccumulatedOtherComprehensiveIncome (Loss) TotalStockholders’Equity (NetCapitalDeficiency) Shares Amount Shares Amount Balance at December 31, 2003 (brought forward) 6,769 $41,716 9,335 $9 $8,982 $(246) $(2,280) $(37,937) $(1) $(31,473) Sale of Shares in IPO at $12.00 per share for cash, netof issuance costs of approximately $4,974 — — 4,500 5 49,020 — — — — 49,025 Conversion of preferred shares in IPO (6,769) (41,716) 8,807 9 41,707 — — — — 41,716 Conversion of note payable — — 45 — 534 — — — — 534 Issuance of common stock upon option exercises — — 7 — 1 — — — — 1 Deferred compensation related to options granted toemployees and non-employees — — — — 1,447 — (1,447) — — — Amortization of deferred compensation — — — — — — 1,854 — — 1,854 Reduction of deferred compensation related to theunamortized portion of deferred stockcompensation related to terminated employees andconsultants — — — — (155) — 155 — — — Reversal of previously expensed deferredcompensation related to employees terminated orconverted to consultant — — — — (243) — — — — (243) Repayment of note receivable from stockholder — — — — — 62 — — — 62 Stock-based compensation related to lapsingrepurchase right of stock held by a non-employee — — — — 68 — — — — 68 Net loss — — — — — — — (15,535) — (15,535) Change in unrealized loss on investments — — — — — — — — (61) (61) Total comprehensive loss (15,596) Balance at December 31, 2004 — — 22,694 23 101,361 (184) (1,718) (53,472) (62) 45,948 Issuance of common stock upon option exercise forcash in June 2005 at a price of $0.10 per share — — 9 — 1 — — — — 1 Deferred compensation related to options granted toemployees and non-employees — — — — (94) — 94 — — — Amortization of deferred compensation — — — — 35 — 912 — — 947 Reduction of deferred compensation related to theunamortized portion of deferred stockcompensation related to unvested shares attermination of employees — — — — (109) — 109 — — — Reversal of previously expensed deferredcompensation related to employees terminated orconverted to consultant — — — — (250) — — — — (250) Repayment of note receivable from stockholder — — — — — 16 — — — 16 Stock-based compensation related to lapsingrepurchase right of stock held by a non-employee — — — — 68 — — — — 68 Issuance of common stock for services — — 1 — 2 — — — — 2 Net loss — — — — — — — (20,093) — (20,093) Change in unrealized loss on investments — — — — — — — — (46) (46) Total comprehensive loss (20,139) Balance at December 31, 2005 (carried forward) — — 22,704 23 101,014 (168) (603) (73,565) (108) 26,593 F-7Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)STATEMENT OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (NET CAPITAL DEFICIENCY), (Continued)(in thousands, except per share amounts) ConvertiblePreferred Stock Common Stock AdditionalPaid-inCapital NotesReceivablefromStockholders DeferredCompensation DeficitAccumulatedDuring theDevelopmentStage AccumulatedOtherComprehensiveIncome (Loss) TotalStockholders’Equity (NetCapitalDeficiency) Shares Amount Shares Amount Balance at December 31, 2005 (brought forward) — $— 22,704 $23 $101,014 $(168) $(603) $(73,565) $(108) $26,593 Sale of common stock in December 2006 at$1.00 per share for cash, net of issuancecosts of approximately $83 — — 3,000 3 2,914 — — — — 2,917 Issuance of common stock upon optionexercises at various times for cash atweighted-average exercise price of $0.73per share — — 26 — 19 — — — — 19 Issuance of common stock at various times forservices in lieu of cash compensation at anaverage value of $4.93 per share — — 2 — 12 — — — — 12 Amortization of deferred compensation relatedto options granted to employees prior tothe IPO — — — — — — 375 — — 375 Stock-based compensation related to employeeand director options granted after the IPO — — — — 1,118 — — — — 1,118 Stock-based compensation related to optionsto consultants — — — — 75 — — — — 75 Reversal of previously expensed compensationrelated to employees terminated orconverted to consultant — — — — (50) — — — — (50) Repayments of notes receivable fromstockholders in October and December of2006 — — — — — 43 — — — 43 Stock-based compensation related to lapsingrepurchase right of stock held by a non-employee — — — — 23 — — — — 23 Net loss — — — — — — — (24,873) — (24,873) Change in unrealized loss on investments — — — — — — — — 108 108 Total comprehensive loss (24,765) Balance at December 31, 2006 (carried forward) — — 25,732 26 105,125 (125) (228) (98,438) — 6,360 F-8Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)STATEMENT OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (NET CAPITAL DEFICIENCY), (Continued)(in thousands, except per share amounts) ConvertiblePreferred Stock Common Stock AdditionalPaid-inCapital NotesReceivablefromStockholders DeferredCompensation DeficitAccumulatedDuring theDevelopmentStage AccumulatedOtherComprehensiveIncome (Loss) TotalStockholders’Equity (NetCapitalDeficiency) Shares Amount Shares Amount Balance at December 31, 2006 (brought forward) — $— 25,732 $26 $105,125 $(125) $(228) $(98,438) $— $6,360 Sale of common stock in March 2007 at$1.00 per share for cash, net of issuancecosts of approximately $151 — — 9,000 9 8,840 — — — — 8,849 Sale of common stock in August &September 2007 at $2.10 per share forcash, net of issuance costs ofapproximately $64 — — 4,790 5 9,991 — — — — 9,996 Issuance of common stock upon optionexercises at various times for cash atweighted-average exercise price of $0.79per share — — 26 — 21 — — — — 21 Amortization of deferred compensation relatedto options granted to employees prior tothe IPO — — — — — — 96 — — 96 Stock-based compensation related to employeeand director options granted after the IPO — — — — 1,334 — — — — 1,334 Stock-based compensation related to optionsto consultants — — — — 48 — — — — 48 Reduction of deferred compensation related tothe unamortized portion of deferred stockcompensation related to unvested shares attermination of employees — — — — (119) — 119 — — — Reversal of previously expensed compensationrelated to employees terminated — — — — (418) — — — — (418) Repayments of notes receivable fromstockholders in March and October 2007 — — — — — 18 — — — 18 Net loss — — — — — — — (11,573) — (11,573) Change in unrealized gain on investments — — — — — — — — 3 3 Net comprehensive loss (11,570) Balance at December 31, 2007 (carried forward) — — 39,548 40 124,822 (107) (13) (110,011) 3 14,734 F-9Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)STATEMENT OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (NET CAPITAL DEFICIENCY), (Continued)(in thousands, except per share amounts) ConvertiblePreferred Stock Common Stock AdditionalPaid-inCapital NotesReceivablefromStockholders DeferredCompensation DeficitAccumulatedDuring theDevelopmentStage AccumulatedOtherComprehensiveIncome (Loss) TotalStockholders’Equity (NetCapitalDeficiency) Shares Amount Shares Amount Balance at December 31, 2007 (brought forward) — $— 39,548 $40 $124,822 $(107) $(13) $(110,011) $3 $14,734 Sale of common stock and issuance ofwarrants in March 2008 at $2.83 per unitfor cash and note receivable, net ofissuance costs of approximately $382 — — 8,924 9 24,783 (6,000) — — — 18,792 Sales of common stock in August andSeptember 2008 under Committed EquityFinancing Facility (CEFF), at an averagediscounted price of $1.85 per share, net ofcosts associated with the registration ofshares under the CEFF of $216 — — 405 — 533 — — — — 533 Issuance of common stock in November 2008in settlement of liquidated damages, netof issuance costs of $5 — — 883 1 1,274 — — — — 1,275 Issuance of common stock upon optionexercise in September 2008 for cash atexercise price of $1.50 per share — — 2 — 4 — — — — 4 Issuance of common stock in February forservices in lieu of cash compensation at avalue of $2.73 per share — — 1 — 4 — — — — 4 Amortization of deferred compensation relatedto options granted to employees prior tothe IPO — — — — — — 13 — — 13 Stock-based compensation related to employeeand director options granted after the IPO — — — — 1,580 — — — — 1,580 Stock-based compensation related to optionsto consultants — — — — 31 — — — — 31 Repayment of note receivable fromstockholder in May 2008 — — — — — 6 — — — 6 Net loss — — — — — — — (20,061) — (20,061) Change in unrealized loss on investments — — — — — — — — (4) (4) Total comprehensive loss (20,065) Balance at December 31, 2008 — — 49,763 50 153,031 (6,101) — (130,072) (1) 16,907 Sale of common stock and issuance ofwarrants in October 2009 at $1.43 per unitfor cash, net of issuance costs ofapproximately $720 — — 12,597 12 17,280 — — — — 17,292 Sales of common stock in October 2009 underCEFF, at an average discounted price of$2.45 per share, net of issuance costs ofapproximately $7 — — 102 — 243 — — — — 243 Issuance of common stock in August –October 2009 for services in lieu of cashcompensation at an average value of $1.22per share — — 13 — 16 — — — — 16 Stock-based compensation related to employeeand director options — — — — 1,789 — — — — 1,789 Stock-based compensation related to optionsto consultants — — — — 10 — — — — 10 Repayment of note receivable fromstockholder in February 2009 — — — — — 6,000 — — — 6,000 Net loss — — — — — — — (20,166) — (20,166) Change in unrealized loss on investments — — — — — — — — 1 1 Total comprehensive loss (20,165) Balance at December 31, 2009 (carried forward) — — 62,475 62 172,369 (101) — (150,238) — 22,092 F-10Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)STATEMENT OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (NET CAPITAL DEFICIENCY), (Continued)(in thousands, except per share amounts) ConvertiblePreferred Stock Common Stock AdditionalPaid-inCapital NotesReceivablefromStockholders DeferredCompensation DeficitAccumulatedDuring theDevelopmentStage AccumulatedOtherComprehensiveIncome (Loss) TotalStockholders’Equity (NetCapitalDeficiency) Shares Amount Shares Amount Balance at December 31, 2009 (brought forward) — $— 62,475 $62 $172,369 $(101) $— $(150,238) $— $22,092 Sales of common stock in January andOctober 2010 under CEFF, at an averagediscounted price of $3.13 per share, net ofissuance costs of approximately $15 — — 519 1 1,609 — — — — 1,610 Issuance in April 2010 of common stock uponexercise of warrants at $1.66 per share andissuance of new warrants at $0.125 pershare for cash, net of issuance costs ofapproximately $168 — — 4,286 4 7,480 — — — — 7,484 Sale of common stock in June 2010 at $3.00per unit for cash, net of issuance costs ofapproximately $1,247 — — 5,000 5 13,748 — — — — 13,753 Issuance of common stock upon optionexercise for cash at exercise prices rangingfrom $0.10 to $2.23 per share — — 124 — 151 — — — — 151 Stock-based compensation related to employeeand director options — — — — 1,947 — — — — 1,947 Stock-based compensation related to an optionto a consultant — — — — 169 — — — — 169 Repayment of note receivable fromstockholder in January 2010 — — — — — 4 — — — 4 Net loss and comprehensive loss (25,966) (25,966) Balance at December 31, 2010 — $— 72,404 $72 $197,473 $(97) $— $(176,204) $— $21,244 See accompanying notes. F-11Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)STATEMENTS OF CASH FLOWS(in thousands) Year ended December 31, Period frominception(May 13,1998) toDecember 31,2010 2010 2009 2008 Operating activities Net loss $(25,966) $(20,166) $(20,061) $(176,204) Adjustments to reconcile net loss to net cash used in operations: Depreciation and amortization of property and equipment 6 10 12 116 Stock-based compensation, net of recoveries 2,116 1,799 1,624 16,579 Expense related to stock issued for services — 16 4 64 Settlement of liquidated damages in stock — — 1,281 1,281 Expense related to stock issued in conjunction with license agreement — — — 31 Expense related to stock issued below fair value — — — 522 Interest accrued on convertible promissory notes — — — 104 Changes in operating assets and liabilities: Prepaid expenses and other current assets 135 717 (980) (418) Other assets (23) 95 (113) (104) Accounts payable (453) (34) 189 817 Accrued clinical expenses 106 (280) 110 815 Accrued compensation and other liabilities 1,794 (125) (428) 2,228 Net cash used in operating activities (22,285) (17,968) (18,362) (154,169) Investing activities Purchases of property and equipment — — (7) (61) Purchases of short-term and long-term investments — — (3,594) (118,320) Maturities of short-term investments — 3,594 5,930 118,320 Net cash provided by (used in) investing activities — 3,594 2,329 (61) Financing activities Proceeds from issuance of common stock and warrants, including collection ofstockholder notes receivable, net of cash paid for issuance costs 23,002 23,535 19,329 136,946 Proceeds from issuance of convertible notes — — — 1,543 Principal payments of obligations under capital leases (6) (10) (13) (59) Proceeds from issuance of convertible preferred stock, net of cash paid for issuancecosts — — — 40,378 Net cash provided by financing activities 22,996 23,525 19,316 178,808 Net increase in cash and cash equivalents 711 9,151 3,283 24,578 Cash and cash equivalents at beginning of period 23,867 14,716 11,433 — Cash and cash equivalents at end of period $24,578 $23,867 $14,716 $24,578 Supplemental disclosure of cash flow information Interest paid $— $1 $5 $16 Supplemental disclosure of non-cash financing activities Conversion of convertible promissory notes and accrued interest —to convertible preferred stock $— $— $— $1,111 —to common stock $— $— $— $534 Issuance of warrant in connection with financing agreement $— $— $653 $653 Issuance of common stock in settlement of liquidated damages $— $— $1,281 $1,281 Purchase of equipment under capital leases $— $— $— $59 See accompanying notes. F-12Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)NOTES TO FINANCIAL STATEMENTS1. Basis of Presentation and Summary of Significant Accounting PoliciesDescription of BusinessCorcept Therapeutics Incorporated was incorporated in the state of Delaware on May 13, 1998, and its facilities are located in Menlo Park, California.Corcept is a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic andpsychiatric diseases. Our most advanced program is for the use of CORLUX, our lead product, for the treatment of the signs and symptoms of endogenousCushing’s Syndrome, for which we have completed treatment and reported top-line results of our Phase 3 trial and are preparing for the submission of a NewDrug Application (NDA) to the United States Food and Drug Administration (FDA) late in the first quarter of 2011. We have another clinical program for theuse of CORLUX for the treatment of psychotic depression, where we are engaged currently in a Phase 3 study. Unless otherwise stated, all references in thesefinancial statements to “we,” “us,” “our,” “its,” “Corcept,” the “Company” and similar designations refer to Corcept Therapeutics Incorporated.Our activities since incorporation have been establishing our offices, recruiting personnel, conducting research and development, performing businessand financial planning, raising capital, overseeing clinical trials, and preparing for potential commercialization. Accordingly, we are considered to be in thedevelopment stage.Management Plans Regarding LiquidityIn the course of our development activities, we have sustained operating losses and expect such losses could continue into the future. We plan tocontinue to finance our operations through the sale of our equity and/or debt securities or by engaging in strategic relationships with potential partners. Ourability to continue our operations through the complete development and commercialization of our products is dependent upon the successful execution ofour financing and/or any partnership strategies.As reflected in the accompanying financial statements as of December 31, 2010, we had cash and cash equivalents of $24.6 million, working capital of$21.1 million and an accumulated deficit of $176.2 million. In January 2011, we sold additional shares of our common stock for net proceeds ofapproximately $41.9 million. (See Note 14 – Subsequent Events.) We believe that we have sufficient funds to maintain our operations into the third quarterof 2012.Use of EstimatesThe preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates andassumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ materially from those estimates.Any changes in estimates are recorded in the period of the change.Cost accruals for clinical trials are based upon estimates of work completed under service agreements, milestones achieved, patient enrollment and pastexperience with similar contracts. Our estimates of work completed and associated cost accruals include our assessments of information received from third-party contract research organizations and the overall status of clinical trial activities. The estimates are updated on a recurring basis as new informationbecomes available.Cash and Cash EquivalentsWe invest our excess cash in bank deposits, money market accounts, corporate debt securities, and obligations of the U.S. government and U.S.government sponsored entities. We consider all highly liquid F-13Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)NOTES TO FINANCIAL STATEMENTS, Continued investments purchased with maturities of three months or less from the date of purchase to be cash equivalents. Cash equivalents are carried at fair value,which approximates cost and, as of December 31, 2010 and 2009, consist of money market funds maintained at major U.S. financial institutions. As ofDecember 31, 2010 and 2009, all of our funds were invested in cash and cash equivalents.Credit Risks and ConcentrationsOur concentration of credit risk relate to our cash and cash equivalents. We are exposed to credit risk in the event of default by the financialinstitutions holding these funds to the extent of the amount recorded on the balance sheet. This risk is mitigated by investing in securities with high creditratings from the major rating services and by limiting the amount of investment in any one issuer. As of December 31, 2010 and 2009, we had no investmentsin mortgage-backed securities or auction rate securities. For the years ended December 31, 2010, 2009 and 2008, we experienced no loss or lack of access tocash and cash equivalents in our operating or investment accounts.We also have a concentration of risk in regard to the manufacture of our product. As of December 31, 2010, we had one pre-existing supplier for ourtablet manufacture and had negotiated a contract with a second tablet manufacturer with whom we have not yet completed process transfer or testmanufacture. If we are not able to qualify our second tablet manufacturer or if our pre-existing supplier is unable to prepare the CORLUX tablets in thequantities and time frame required, we may not be able to manufacture our product in a timely manner.Fair Value MeasurementsFinancial instruments are categorized in a fair value hierarchy that prioritizes the information used to develop assumptions for measuring fair value.The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets or liabilities (Level 1 input), then to quoted prices (innon-active markets or in active markets for similar assets or liabilities), inputs other than quoted prices that are observable for the asset or liability, and inputsthat are not directly observable, but that are corroborated by observable market data for the asset or liability (Level 2 input), then the lowest priority tounobservable inputs, for example, our own data about the assumptions that market participants would use in pricing an asset or liability (Level 3 input). Fairvalue is a market-based measurement, not an entity-specific measurement, and a fair value measurement should therefore be based on the assumptions thatmarket participants would use in pricing the asset or liability.No assets or liabilities in our financial statements are required to be measured at fair value other than the Company’s investment portfolio.Revenue RecognitionCollaboration revenue relates to services rendered in connection with agreements signed with Eli Lilly and Company (Eli Lilly), in which Eli Lillyagreed to support certain of our pre-clinical and clinical proof-of-concept studies evaluating the ability of our product candidates to mitigate or preventweight gain associated with the use of Zyprexa (olanzapine), an atypical antipsychotic medication. Under the agreements, Eli Lilly agreed to supply theZyprexa and olanzapine and pay for the studies. We were required to perform development activities as specified in these agreements and were reimbursedbased on the costs associated with the conduct of the trial and the preparation and packaging of clinical trial materials. Revenue was recognized as serviceswere rendered in accordance with the agreements. F-14Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)NOTES TO FINANCIAL STATEMENTS, Continued Research and DevelopmentResearch and development expenses consist of costs incurred for Company-sponsored research and development activities. These costs include directexpenses (including nonrefundable payments to third parties) and research and development-related overhead expenses, as well as the cost of fundingclinical trials, pre-clinical studies, manufacturing development and the development of second-generation compounds, and are expensed as incurred. Costs toacquire technologies and materials that are utilized in research and development and that have no alternative future use are expensed when incurred (see Note2).Segment ReportingOperating segments are determined based on the way we organize our business for making operating decisions and assessing performance. We haveonly one operating segment, which is involved in the development of pharmaceutical products.Property and EquipmentProperty and equipment are stated at cost less accumulated depreciation and amortization. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets, ranging from three to five years. Assets acquired under capital leases were amortized over the term oftheir useful lives or the lease period, whichever is shorter.Stock-Based CompensationStock-based compensation for employee and director optionsSince January 1, 2006, we have accounted for stock-based compensation related to option grants to employees and directors under the fair valuemethod, based on the fair value-based measurement of the award at the grant date except that, for option awards granted prior to our initial public offering(IPO), we calculated stock-based compensation expense based on the intrinsic value method. For service awards, expense is recognized over the requisiteservice period. For options with performance-based vesting criteria, expense will be recognized at such time as there is a high degree of probability (i.e.,greater than 70%) of achieving the vesting criteria.Stock-based compensation expense related to non-employeesExpense is recognized for options granted to non-employees based on the fair-value based measurement of the option grants at the time of vesting. Forservice-based awards, expense is recognized over the requisite service period. For options with performance-based vesting criteria, expense is recognizedbased on the minimum number of shares that will vest over time as the criteria are met based on the Black-Scholes valuation of the vested shares.See Note 9 for a detailed discussion of stock-based compensation expense.Income TaxesDeferred tax assets and liabilities are determined based on the differences between the financial reporting and tax bases of assets and liabilities and aremeasured using the enacted tax rates that will be in effect when the differences are expected to reverse. A valuation allowance is recorded when it is morelikely than not that the deferred tax asset will not be realized. F-15Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)NOTES TO FINANCIAL STATEMENTS, Continued No amounts have been recognized as interest or penalties on income tax related matters. The determination of an accounting policy as to theclassification of such costs has been deferred until such time as any such costs are incurred.Recently Adopted Accounting StandardsMilestone Method of Revenue RecognitionOn March 31, 2010, the Financial Accounting Standards Board ratified the conclusions reached by its Emerging Issues Task Force that the milestonemethod of revenue recognition is a valid application of the proportional performance model when applied to research or development arrangements.Accordingly, the guidance states that an entity can make an accounting policy election to recognize a payment that is contingent upon the achievement of asubstantive milestone in its entirety in the period in which the milestone is achieved. The milestone method is not required and is not the only acceptablemethod of revenue recognition for milestone payments.This guidance also indicates that, in order to recognize the revenue, certain criteria must be met, including the requirement that the activities leadingup to the achievement of the milestone must be conducted by the entity. A milestone is defined in the guidance as an event: (a) that can only be achievedbased in whole or in part on either (1) the entity’s performance or (2) on the occurrence of a specific outcome resulting from the entity’s performance, (b) forwhich there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (c) that would result in additionalpayments being due to the entity. Therefore, a milestone does not include events for which the occurrence is contingent solely on the passage of time orsolely on a customer’s performance.The new guidance was effective for fiscal years that began on or after June 15, 2010 and interim periods within those years and allowed prospective orretrospective adoption. The adoption of the new standard on January 1, 2011 on a prospective basis did not have any effect on our financial statements as wedo not currently have any arrangements to which the standard would apply.2. Significant AgreementsStanford License AgreementsIn October 1998, we entered into an agreement with The Board of Trustees of Leland Stanford Junior University (Stanford) in which Stanford grantedus an exclusive option to acquire an exclusive license for inventions and patents related to “Mifepristone for Psychotic Major Depression” and “Mifepristoneand Alzheimer’s Disease” owned by Stanford.In October 1999, we exercised our option to acquire an exclusive license to patents covering the use of glucocorticoid receptor antagonists for thetreatment of psychotic major depression, early dementia, and cocaine-induced psychosis, as specified in the license agreement. This license agreementexpires upon the expiration of the related patents or upon notification by us to Stanford. In exchange for the license, we paid Stanford $47,000 andimmediately issued 30,000 shares of our common stock to Stanford. We are further required to pay Stanford $50,000 per year as a nonrefundable royaltypayment. The annual royalty payments are creditable against future royalties. We are also obligated to pay a $50,000 milestone upon filing of the first NDAby FDA for CORLUX in one of the indications covered by the license and a $200,000 milestone upon FDA approval of the related drug. The milestonepayments are also creditable against future royalties. We have expensed the $47,000 payment made up front, the $50,000 annual nonrefundable royaltypayments and the value of the common stock issued to Stanford as research and development costs. F-16Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)NOTES TO FINANCIAL STATEMENTS, Continued Manufacturing AgreementsOn November 8, 2006, we signed an agreement with Produits Chimiques Auxiliaires et de Synthese SA (PCAS) for the manufacture of the activepharmaceutical ingredient (API) in CORLUX, for our development and commercial needs for an initial period of five years. The agreement provides for anautomatic extension for one additional year and we intend to pursue discussions for further extensions. If PCAS is unable to manufacture the product for aconsecutive six-month period, we have the right to terminate the agreement, without penalty. During the period from September through December 2010, wesigned purchase orders for the acquisition of API to be delivered during 2011 for aggregate commitments of approximately $1.8 million. There is noguaranteed minimum purchase commitment under this agreement until after approval of the NDA.We also have a memorandum of understanding with ScinoPharm Taiwan (ScinoPharm). Pursuant to that memorandum of understanding, ScinoPharmagrees to manufacture API and we agree to purchase at least $1,000,000 of bulk mifepristone per year following the commercial launch of CORLUX.ScinoPharm is considered to be a potential secondary site for the manufacture of the API. However, no activities are currently being performed at this site todevelop or qualify the manufacturing processes or facilities and we do not plan to include a request for approval of material produced by ScinoPharm whenwe submit our NDA for Cushing’s Syndrome planned for the first quarter of 2011.We have also entered into an agreement with another contract manufacturer, PharmaForm, L.L.C. (PharmaForm), for the production of CORLUX tablets.To date, our need for CORLUX tablets has been limited to the amounts required to support our clinical trials and the registration batches needed to supportour anticipated NDA filing for CORLUX for the treatment of Cushing’s Syndrome. The agreement with PharmaForm was executed in December 2006 and willexpire upon the completion of the development program for CORLUX, but may be extended. There are no minimum purchase amounts under this agreement.The agreement with PharmaForm may be terminated by either party upon 180 days written notice; we may terminate projects initiated under this agreementwith 30 days written notice.In June 2010, we signed agreements with a vendor that provides manufacturing services for materials to be used in development work for CORT108297 and CORT 113083 in the aggregate amount of $1.6 million. Approximately $1.2 million has been incurred under these agreements throughDecember 31, 2010, with the remainder to be incurred in 2011.Research and Development AgreementsIn 2003, we entered into a contract research agreement with Argenta Discovery Limited (Argenta) in which Argenta agreed to conduct research towardidentifying a novel small molecule glucocorticoid receptor antagonist for the treatment of psychotic depression, Alzheimer’s disease, and other metabolicand psychiatric disorders. The project was expected to last at least two years, during which time we would make payments to Argenta based upon the numberof FTEs (full-time equivalents) that we have working on our projects. By December 31, 2008, work under the initial agreement with Argenta and majorsubsequent amendments had been concluded. We continue our relationship with Argenta, requesting them to conduct research projects on a regular basis.Under the agreements with Argenta, we may be obligated to make milestone payments upon the occurrence of certain events, including: (i) patent filings inconnection with the project; (ii) entries into Phase 1 clinical trials; and (iii) national regulatory approval of each product arising from work performed underthe agreement, provided that sales of the product by us or any future licensees reach $5,000,000. These obligations remain in force after the conclusion ofwork under the agreement. During 2010, we expensed a $100,000 payment to Argenta upon the initiation of the Phase 1 clinical trial with CORT 108297 as aresearch and development expense. See footnote 14 regarding the signing of an amendment under this agreement. F-17Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)NOTES TO FINANCIAL STATEMENTS, Continued In 2008, we executed a Master Service Agreement (MSA) and a Project Contract (Contract), with ICON Clinical Research, L.P. (ICON) to assist us invarious clinical trial activities, including the selection of clinical sites, supervision and monitoring of clinical site performance, data collection and analysisin connection with Study 14, our current Phase 3 trial to confirm the utility of CORLUX for the treatment of the psychotic features of psychotic depression. InJune 2009, we amended our agreements with this vendor to reduce the amounts of commitments under these agreements in accordance with the reduction inthe near-term scope of activities in this trial. However, we view the reduction in these commitments as a temporary measure as it is our intent to continue theconduct of this trial to its conclusion, assuming the availability of sufficient capital for this purpose. The total commitment under this agreement, includingamendments executed through 2010 is estimated to be approximately $12.3 million over the course of the trial. Approximately $5.3 million of costs underthis agreement have been expensed through December 31, 2010. The actual amount and timing of expense recognition and payments will depend uponvarious factors, including the timing of site initiation, the pace of patient enrollment, the fees negotiated with site investigators, the timing of other trialactivities and the timing of payments of pass-through costs, such as grants to investigators and laboratory services. The Contract may be terminated by us atany time upon sixty days’ written notice, or sooner based on mutual agreement of the parties. Upon termination, we would be obligated to pay ICON forservices performed and pass-through costs incurred to the date of termination plus a cancellation fee to compensate the CRO for staff reallocation costs.We entered into an agreement with MedAvante, Inc. (MedAvante), effective March 17, 2008, under which MedAvante will provide centralizedpsychiatric rating services of patients to be screened and enrolled in Study 14. In June 2009, we amended our agreements with this vendor to reduce theamounts of commitments under these agreements in accordance with the reduction in the near-term scope of activities in this trial. However, we view thereduction in these commitments as a temporary measure as it is our intent to continue the conduct of this trial to its conclusion, assuming the availability ofsufficient capital for this purpose. The total commitment under this agreement, including amendments executed through 2010, is approximately $4.0 million.Approximately $2.7 million of costs under this agreement have been expensed through December 31, 2010, with the remainder of any actual costs to beincurred over the remainder of the course of the trial. We may terminate this agreement with 30 days notice to MedAvante. In the event of termination, we areobligated to pay certain costs including costs incurred to date, costs associated with any non-cancellable commitments for video service connectivity andcosts of staff assigned to the project for a period of three months or until such time as they can be assigned to other projects, whichever is less.During 2010, we signed agreements for the conduct of the initial clinical trials using CORT 108297. The total commitment under these agreements isapproximately $2.3 million. Approximately $1.3 million of costs under these agreements have been incurred as of December 31, 2010, with the remainderexpected to be incurred during 2011.See footnote 14 – Subsequent Events for discussion of agreements signed during the first quarter of 2011.Other AgreementsIn August 2010, we entered into an agreement with United Biosource Corporation (UBC) to assist us in developing our Risk Evaluation andMitigation Strategy (REMS), a plan for which will be submitted to the FDA as part of our NDA for CORLUX for the treatment of Cushing’s Syndrome. Thefinancial commitment under the initial set-up phase of this agreement is approximately $1.2 million; approximately $105,000 of which cost was incurredduring 2010 with the remainder expected to be incurred during 2011. Commitments for any future phases of the agreement will not be effective until after theFDA approval of our NDA; the majority of such costs will be variable and dependent on patient utilization of our drug. We may terminate this agreement at F-18Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)NOTES TO FINANCIAL STATEMENTS, Continued any time upon 30 days written notice. The agreement may be terminated by UBC for any reason upon 120 days written notice. In the event of termination, weare obligated to compensate UBC for any actual costs and any uncancellable obligations incurred prior to the date of termination.3. Fair ValueAs of December 31, 2010 and 2009, our financial assets were invested in a money market fund, which can be converted to cash at par on demand. Thesefunds, which totaled $23.9 and $23.0 million, respectively, were measured at fair value as of December 31, 2010 and 2009 and were classified as Level 1assets in the fair value hierarchy for financial assets.All cash equivalents and short-term investments held as of December 31, 2010 and 2009 and 2008 were in active markets and valued based upon theirquoted prices.4. Financial InstrumentsThe following tables present a summary of cash and cash equivalents. All amounts are in thousands. Cost UnrealizedGain UnrealizedLoss Fair Value December 31, 2010 Cash $662 $— $— $662 Money market fund 23,916 — — 23,916 $24,578 $— $— $24,578 Reported as: Cash and cash equivalents $24,578 $— $— $24,578 Cost UnrealizedGain UnrealizedLoss Fair Value December 31, 2009 Cash $887 $— $— $887 Money market fund 22,980 — — 22,980 $23,867 $— $— $23,867 Reported as: Cash and cash equivalents $23,867 $— $— $23,867 As of December 31, 2010 and 2009, all cash and cash equivalents were classified as available-for-sale securities. There were no mortgage-backedsecurities and no auction rate securities in the portfolio at any time during 2010 or 2009.The net realized loss on sales of available-for-sale investments was not material for any period presented. F-19Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)NOTES TO FINANCIAL STATEMENTS, Continued 5. Property and EquipmentProperty and equipment, including assets purchased under capitalized leases, consists of the following: December 31, 2010 2009 (in thousands) Furniture and equipment $51 $51 Less: accumulated depreciation and amortization (47) (41) $4 $10 Amortization expense related to assets under capital lease was approximately $4,000, $9,000 $12,000 and $59,000 for the years ended December 31,2010, 2009 and 2008 and the period from inception (May 13, 1998) to December 31, 2010, respectively. During 2009, we returned to the lessor a piece ofequipment that had been financed under one of the capital leases and wrote-off both the $15,000 capitalized value of the asset and the accumulatedamortization. During 2010, we acquired title to furniture with a capitalized asset value of approximately $44,000 that had been acquired under the remainingcapital lease.6. Other LiabilitiesOther liabilities consisted of the following: December 31, 2010 2009 (in thousands) Accrued professional fees $224 $186 Accrued legal fees 135 — Other 63 38 $422 $224 7. Lease ObligationsOn August 12, 2010, we renewed our lease for office space for a one-year term commencing on January 1, 2011 at a monthly cost of approximately$19,000 plus operating expenses. At December 31, 2010, the remaining minimum rental payments under this operating lease were approximately $230,000.Rent expense amounted to approximately $250,000, $240,000, $265,000 and $2.2 million for the years ended December 31, 2010, 2009 and 2008,and the period from inception (May 13, 1998) to December 31, 2010, respectively.8. Related Party TransactionsSee discussion below in Note 9, Preferred Stock and Stockholders’ Equity, Stockholder Notes Receivable, regarding and, in Common Stock,regarding the sale of securities in April 2010 to various investors, including members of the Board of Directors, and a Note Receivable from an officer of thecompany. F-20Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)NOTES TO FINANCIAL STATEMENTS, Continued See discussion under Note 14, Subsequent Events, regarding the participation of an entity affiliated with one of the members of our Board of Directorsin a financing transaction in January 2011.9. Preferred Stock and Stockholders’ EquityPreferred StockThe board of directors is authorized, subject to any limitations prescribed by law, without stockholder approval, to issue up to an aggregate of10,000,000 shares of preferred stock at $0.001 par value in one or more series and to fix the rights, preferences, privileges and restrictions granted to orimposed upon the preferred stock, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences. The rightsof the holders of common stock will be subject to the rights of holders of any preferred stock that may be issued in the future.As of December 31, 2010 and 2009, we had no outstanding shares of preferred stock.Common StockOur authorized capital stock includes 140,000,000 shares of common stock at $0.001 par value. Holders of common stock are entitled to one vote pershare on all matters to be voted upon by our stockholders.On April 21, 2010, we issued approximately 4.3 million shares of our common stock upon the exercise of warrants that had been issued in a privateplacement transaction in October 2009 at their exercise price of $1.66 per share and sold new warrants to the same investors to purchase a total ofapproximately 4.3 million shares of our common stock, which we refer to as the April 2010 Warrant Exchange. The new warrants are exercisable throughApril 21, 2013 at an exercise price of $2.96 per share. The total net proceeds generated in this transaction were approximately $7.5 million, after thededuction of issuance costs. Approximately 40% of the securities sold in this transaction were purchased by venture capital funds, trusts and other entitiesaffiliated with members of our Board of Directors, with the remainder being purchased by other qualified investors.On June 30, 2010, we sold 5.0 million shares of our common stock in an underwritten public offering at a price to the public of $3.00 per share foraggregate net proceeds of approximately $13.8 million after deducting the underwriter’s discount and commissions and other expenses of the offering. Seethe discussion in Note 14, Subsequent Events, regarding an additional public offering in January 2011.During 2010, we also sold an aggregate of 518,639 shares of common stock to Kingsbridge under the Committed Equity Financing Facility (CEFF) atan average price of $3.13 per share, for net proceeds of approximately $1.6 million. There were no underwriting discounts or commissions paid in connectionwith the CEFF sales and the transaction costs were immaterial.Under the terms of the CEFF, which was executed in March 2008, Kingsbridge has committed to provide up to $60 million of capital in exchange fornewly-issued shares of Corcept’s common stock for a period of up to three years after the SEC declares effective the registration statement covering the resaleof the shares of common stock issuable in connection with the CEFF and the shares of common stock underlying the warrant discussed below. The maximumnumber of shares that we can sell to Kingsbridge under this agreement is approximately 9.6 million shares. Through December 31, 2010, approximately1.0 million shares of common stock had been sold to Kingsbridge under this CEFF, for aggregate gross proceeds of approximately $2.6 million. Based on thevolume weighted average price on the NASDAQ Capital Market for our common stock for the F-21Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)NOTES TO FINANCIAL STATEMENTS, Continued period from March 25, 2008, the date of the signing of the Kingsbridge CEFF, through March 8, 2011, the maximum amount of additional funds that couldbe raised under the CEFF is projected to be approximately $26 million. Under the terms of the agreement, the determination of the exact timing and amountof any CEFF financings will be made solely by us, subject to certain conditions. The actual amount of funds that can be raised under this agreement will bedependent on the number of shares actually sold under the agreement and the market value of our common stock during the pricing periods of each sale.Certain details of the CEFF are as follows: • We can access capital under the CEFF in tranches of up to 1.25% of our market capitalization at the time of the initiation of the draw downperiod, or, at our option, the lesser of (a) 2.5% of our market capitalization at the time of the initiation of the draw down period, and (b) analternative draw down amount as defined in the agreement; provided, however, that in no event may the maximum draw down amount exceed$10 million per tranche, subject to certain conditions. • Each tranche will be issued and priced over an eight-day pricing period. Kingsbridge will purchase shares of common stock pursuant to the CEFFat discounts ranging from 6% to 10%, depending on the volume weighted average price of our common stock during the eight-day pricingperiod, provided that the minimum acceptable purchase price for any shares to be issued to Kingsbridge during the eight-day period isdetermined by the higher of $1.50 or 90% of our common stock closing price the day before the commencement of each draw down. • Throughout the term of the agreement, Kingsbridge has agreed it will not, and will not cause any other person to, enter into or execute a shortsale of any of our securities. • We are not obligated to utilize any of the $60 million initially available under the CEFF and there are no minimum commitments or minimumuse penalties. The CEFF agreement does not contain any restrictions on our operating activities, automatic pricing resets or minimum marketvolume restrictions. • The agreement does not prohibit us from conducting additional debt or equity financings, other than financings similar to the CEFF and otherfuture priced securities. • In connection with the CEFF, we issued a warrant to Kingsbridge to purchase up to 330,000 shares of common stock at an exercise price of$3.525 per share, which represents 125% of the average of the closing bid prices of our common stock during the 5 trading days preceding thesigning of the agreement. The warrant became exercisable on September 25, 2008 and will remain exercisable, subject to certain exceptions,until five years after that date. The warrant was valued at approximately $653,000 using the Black-Scholes pricing model using the followingassumptions: a contractual term of five and one-half years, risk-free interest rate of 2.71%, volatility of 89%, and the closing price of our stockprice on the Nasdaq Capital Market on the date of signing the commitment, March 25, 2008, of $2.84 per share. The warrant value was recordedin Additional Paid In Capital with an offsetting amount recorded as issuance cost in Additional Paid In Capital.At the time of the signing of the CEFF agreements, the warrant issued to Kingsbridge and the shares of common stock issuable under the CEFF, and theshares issuable upon the exercise of the warrant, were not registered under the Securities Act, or state securities laws, and could not be offered or sold in theUnited States without being registered with the SEC or through an applicable exemption from SEC registration requirements. On June 10, 2008, the SECdeclared effective our initial registration statement covering the resale of approximately 3.9 million shares, which includes approximately 3.6 million of theshares issuable under the CEFF and the shares issuable upon the exercise of the warrant. This registration statement covers approximately F-22Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)NOTES TO FINANCIAL STATEMENTS, Continued 37% of the 9.6 million shares of our common stock issuable pursuant to the CEFF and all of the 330,000 shares of our common stock issuable upon exerciseof the warrant issued to Kingsbridge. We intend to file an additional registration statement covering the resale of the remaining 6.0 million shares of ourcommon stock issuable pursuant to the CEFF approximately 60 days after Kingsbridge and its affiliates have resold substantially all of the securitiesregistered for sale under the initial registration statement.In March 2008, we sold approximately 8.9 million shares of our common stock and warrants to purchase approximately 4.5 million shares of ourcommon stock in a private placement (the March 2008 Financing). The registration rights agreement covering securities issued in the March 2008 Financingprovides that if we failed to file or cause to be declared effective the registration statement or registration statements covering the resale of these shares priorto specified deadlines, or fail to maintain the effectiveness of such registration statements (subject to limited permissible suspension periods), we may berequired to pay the holders of such shares and warrants liquidated damages at the rate of 1% per month of the purchase price of these shares and warrants, upto a total of 10%. We filed the registration statement covering the resale of the shares sold and shares underlying the warrants sold in this transaction with theSecurities and Exchange Commission (SEC) on April 11, 2008, within the time period required by the agreement. However, this registration statement wasnot declared effective by the SEC until November 10, 2008. During 2008, we recorded approximately $1.3 million in liquidated damages to other non-operating expense because of the delay in the effectiveness of the registration statement, which represented approximately 5% of the purchase price.No dividends have been declared or paid by us.Shares of common stock reserved for future issuance as of December 31, 2010 are as follows: (in thousands) Common stock: Exercise of outstanding options 7,961 Exercise of warrants 9,200 Shares available for grant under stock option plans 1,949 19,110 In November 2010, our Board of Directors authorized an increase in the shares available under the 2004 Equity Incentive Plan (the 2004 Plan) to beeffective on January 1, 2011, equivalent to 4% of the shares of our common stock outstanding as of December 31, 2010, pursuant to the terms of the 2004Plan. Accordingly, the shares available under the 2004 Plan have been increased by a total of 2,896,155 shares as of January 1, 2011.Stock Option PlansIn October 2000, we adopted the 2000 Stock Option Plan (the 2000 Plan), which was amended in May 2001 to provide for the issuance of optiongrants for up to 2,000,000 shares of our common stock to eligible participants. Under the 2000 Plan, options to purchase common stock could be granted atno less than 100% of fair value on the date of grant for incentive stock options and 85% of fair value on the date of grant for nonqualified options, asdetermined by the board of directors. Options became exercisable at such times and under such conditions as determined by the board of directors. As ofDecember 31, 2010, all option grants under this plan were fully vested, with grants covering approximately 317,000 shares remaining outstanding withcontractual lives expiring in 2011 through 2014. Vested shares under this plan that are not exercised within the remaining contractual life will expire on thatdate and not be added to the pool of shares available for future grant. F-23Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)NOTES TO FINANCIAL STATEMENTS, Continued In 2004, our board of directors and stockholders approved the 2004 Plan, which became effective upon the completion of our IPO, after which time, noadditional options have been or will be issued under the 2000 Plan. Under the 2004 Plan, options, stock purchase and stock appreciation rights and restrictedstock awards can be issued to our employees, officers, directors and consultants. The 2004 Plan provides that the exercise price for incentive stock optionswill be no less than 100% of the fair value of the Company’s common stock, as of the date of grant. Options granted under the 2004 Plan vest over periodsranging from one to five years. The vesting period of the options is generally equivalent to the requisite service period.Upon exercise, new shares are issued.In December 2009, the Board of Directors authorized an increase of 2,498,987 shares in the shares available under the 2004 Plan to be effective onJanuary 1, 2010, which amount was based on 4% of the shares of our common stock outstanding as of December 31, 2009, pursuant to the terms of the 2004Plan. As of December 31, 2010, the total number of shares authorized for issuance under the 2004 Plan was 9,707,805, of which 1,948,907 shares remainedavailable for future grants. See discussion above under Common Stock regarding an additional increase to the shares available for grant under the 2004 Planthat was authorized by the Board of Directors in November 2010 and effective as of January 1, 2011. F-24Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)NOTES TO FINANCIAL STATEMENTS, Continued Option activity during 2008, 2009 and 2010The following table summarizes all stock plan activity: Outstanding Options SharesAvailableFor FutureGrants SharesSubject toOptionsOutstanding Weighted-AverageExercisePrice WeightedAverageRemainingContractualLife AggregateIntrinsicValue (in thousands) (in thousands) (in years) (in thousands) Balance at December 31, 2007 887 3,891 $3.10 $3,819 Increase in shares authorized under 2004Plan 791 — — Shares granted (1,273) 1,273 $1.48 Shares exercised — (2) $1.50 Shares issued for services (1) — $2.73 Shares cancelled and forfeited under 2004Plan 30 (30) $2.70 Balance at December 31, 2008 434 5,132 $2.70 $31 Increase in shares authorized under 2004Plan 1,995 — — Shares granted (2,300) 2,300 $1.36 Shares issued for services (13) — $1.17 Shares cancelled and forfeited under 2004Plan 85 (85) $2.62 Balance at December 31, 2009 201 7,347 $2.28 $7,933 Increase in shares authorized under 2004Plan 2,499 — — Shares granted (838) 838 $3.40 Shares exercised — (124) $1.22 Shares cancelled and forfeited under 2000Plan — (13) $15.00 Shares cancelled and forfeited under 2004Plan 87 (87) $2.26 Balance at December 31, 2010 1,949 7,961 $2.40 7.1 $14,306 Options exercisable at December 31, 2010 5,020 $2.70 6.3 $8,478 Options fully vested and expected to vest atDecember 31, 2010 7,211 $2.51 7.0 $12,389 All stock option grants vest solely based upon continuing service, with the exception of an award with performance-based vesting criteria that wasgranted during 2010 to a consultant in the amount of 50,000 shares that will vest in its entirety on the filing by the FDA of our NDA for CORLUX for thetreatment of Cushing’s Syndrome, and awards with performance-based vesting criteria that were granted during 2009 to Joseph K. Belanoff, our ChiefExecutive Officer, and Robert L. Roe, our President, in the amounts of 500,000 shares and F-25Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)NOTES TO FINANCIAL STATEMENTS, Continued 200,000 shares, respectively, that will vest in their entirety upon the approval of the NDA for the Company’s first product by the FDA.The total intrinsic value of options exercised during the years ended December 31, 2010 and 2008 was approximately $250,000 and $1,000,respectively, based on the difference between the closing price of our common stock on the date of exercise of the options and the exercise price. There wereno exercises of options during the year ended December 31, 2009.The following table presents the total fair value of options to employees and directors that vested during the years ended December 31, 2010, 2009 and2008. All amounts are in thousands. Year ended December 31, 2010 2009 2008 Pre-IPO options, using minimum value method $— $— $197 Options granted after IPO through 2005, using fair value 34 318 475 Options granted after January 1, 2006, using fair values 1,858 1,849 1,330 Total $1,892 $2,167 $2,002 As of December 31, 2010, we had approximately $4.0 million of unrecognized compensation expense for employee and director options outstandingas of that date. Approximately $3.3 million of the unrecognized compensation relates to option grants with service-based vesting criteria, which had aremaining weighted-average vesting period of 2.4 years. Approximately $637,000 of the unrecognized compensation relates to option grants withperformance-based vesting criteria; as this amount will be expensed based on the high probability of success of the performance criteria, it is not possible toestimate the timing of recognition of this expense.The following is a summary of options outstanding and options exercisable at December 31, 2010. Options Outstanding Options Exercisable NumberofShares WeightedAverageRemainingContractualLife WeightedAverageExercisePrice AggregateIntrinsicValue OptionsExercisable WeightedAverageExercisePrice AggregateIntrinsicValue (in thousands) (in years) (in thousands) (in thousands) (in thousands) $ 0.10 - $ 1.19 2,660 8.1 $1.12 $7,281 1,022 $1.08 $2,844 $ 1.50 - $ 3.47 3,479 7.1 $1.89 6,852 2,672 $1.75 5,634 $ 3.51 - $ 5.00 1,295 6.9 $4.07 173 799 $4.41 — $ 5.70 - $ 14.50 527 3.0 $8.06 — 527 $8.06 — 7,961 7.1 $2.40 $14,306 5,020 $2.70 $8,478 The aggregate intrinsic value in the table above represents the total pre-tax intrinsic value that option holders would have received had all optionholders exercised their options on December 31, 2010. The aggregate intrinsic value is the difference between our closing stock price on December 31, 2010and the exercise price, multiplied by the number of in-the-money options. F-26Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)NOTES TO FINANCIAL STATEMENTS, Continued Stock-Based Compensation related to Employee and Director OptionsAccounting PracticesFor options granted prior to our initial public offering (IPO) in 2004, we accounted for options granted to employees and directors based on theintrinsic value of these grants. This treatment was followed even after the change in accounting pronouncements affecting stock-based compensation inJanuary 2006 because we had used the “minimum” value method for these options for purposes of pro-forma disclosure under the previous guidance. Duringthe period from inception (May 13, 1998) to September 30, 2008, we recorded $10.1 million in deferred compensation for employee stock options topurchase common stock granted at exercise prices deemed to be below the fair value of common stock at the date of grant. We amortized the deferred stock-based compensation to expense utilizing the graded-vesting method over the vesting periods of the applicable stock options, generally five years. As ofSeptember 30, 2008, the deferred compensation related to these options was fully amortized.For options granted after the IPO, we began, as of January 1, 2006, to account for stock-based compensation related to option grants to employees anddirectors under the fair value method. Following is a synopsis of our accounting practices in regard to these stock option grants: • Options granted after the IPO but prior to January 1, 2006: Prior to January 1, 2006, we had accounted for employee options under the intrinsic value method, which did not require the recognition of anycompensation expense as the grants had been issued at the market value on the date of grant. We began, as of January 1, 2006, to record non-cash stock-based compensation expense related to these grants in the financial statements basedon the remaining fair value, as of January 1, 2006, of the non-vested portion of these grants, utilizing the assumptions and fair value per shareinformation as of the original grant date that we had been using for pro forma disclosure purposes. We continued to utilize the graded-vestingattribution method for amortization of the relevant compensation amounts, which were fully expensed early in 2010. • Options granted on or after January 1, 2006: Compensation expense is being recorded in the financial statements based on the fair value on the date of grant. For service based awards, the grant date fair value being amortized to expense using the straight-line attribution method over the vesting periodof the options, which is commensurate with the service period. For awards with performance-based vesting criteria, expense will be recognized at such time as there is a high degree of probability (i.e., greaterthan 70%) of achieving the vesting criteria. F-27¡¡¡¡¡Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)NOTES TO FINANCIAL STATEMENTS, Continued Assumptions used in determining fair value for options granted to employees and directorsThe following table summarizes the weighted-average assumptions and resultant fair value for options granted to employees and directors. Year Ended December 31, 2010 2009 2008 Weighted average assumptions for stock options granted: Risk-free interest rate 1.83% 2.24% 2.63% Expected term 5.9 years 6.0 years 6.0 years Expected volatility of stock price 96.3% 94.2% 90.6% Dividend rate 0% 0% 0% Weighted average grant date fair value $2.68 $1.05 $1.12 The expected term for options granted since January 1, 2006 is based on the “simplified” method prescribed by the SEC, and considers the weightedaverage of the vesting period and contractual life of the options. There has been no adjustment made to the expected term to adjust for employees’ expectedexercise and expected post-vesting termination behavior because we have a limited employee base and do not have sufficient historical information todetermine such an adjustment.The expected volatility of our stock used in determining the fair value of option grants to employees and directors prior to April 2010 has been basedon a weighted-average combination of the volatility of our own stock price and that of a group of peer companies since we do not have sufficient historicaldata from which to base an appropriate valuation assumption for a period of time equivalent to the expected term of the option. For stock options granted toemployees and directors after April 2010, the volatility is based on historical data of the price for our common stock since the date of our IPO as the expectedterm of these option grants has been covered by this period.Since we have a limited employee base and have experienced minimal turnover, we do not have sufficient historical information to determine areasonable forfeiture rate for options that might not vest because of employee terminations and does not, therefore, apply a forfeiture rate. When an employeeterminates, we will record a change in accounting estimate that represents the difference between the expense recorded in the financial statements and theexpense that would have been recorded based upon the rights to options that vested during the individual’s service as an employee.Summary of compensation expense related to employee and director optionsCompensation expense of approximately $1.9 million, $1.8 million, $1.6 million and $15.5 million was recognized for employee and director optionsduring the years ended December 31, 2010, 2009 and 2008 and for the period from inception (May 13, 1998) to December 31, 2010, respectively, net ofrecoveries.Stock Options to ConsultantsStock-based compensation related to option grants to non-employees is charged to expense on a straight line basis over the vesting period of theoptions, which approximates the period over which the related services are rendered, based on the fair value of the options using the Black-Scholes optionpricing model. The assumptions used in these calculations are similar to those used for the determination of fair value for options granted to F-28Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)NOTES TO FINANCIAL STATEMENTS, Continued employees and directors, with the exception that, for non-employee options, the remaining contractual term is utilized as the expected term of the option andthe fair value related to unvested non-employee options is re-measured quarterly, based on the then current stock price as reflected on the Nasdaq CapitalMarket.All stock option grants to consultants vest solely based upon continuing service, with the exception of an award with performance-based vestingcriteria that was granted during 2010, in the amount of 50,000 shares. This performance-based grant will vest in its entirety upon the filing by the FDA of theCompany’s NDA for CORLUX for the treatment of Cushing’s Syndrome. The fair value of the grant as of the date of vesting, as determined using the Black-Scholes option pricing model, will be charged to expense at that time.The Company recorded charges in the statement of operations for stock options granted to consultants using the straight-line vesting method ofapproximately $169,000, $11,000, $30,000 and $1.1 million for the years ended December 31, 2010, 2009 and 2008 and for the period from inception (May13, 1998) to December 31, 2010, respectively. The straight-line method is commensurate with the services being provided by such consultants.As of December 31, 2010, all options that had been granted to consultants were fully vested, with the exception of the performance-based grantdiscussed above.Stockholder Notes ReceivableIn 2001, we recorded notes receivable from stockholders in the aggregate amount of $438,165 in connection with the exercise of options issued underthe 2000 Plan to purchase 585,000 shares of common stock. The notes are secured by the related shares of common stock and are full recourse notes, withinterest compounded annually at the rate of 6.5% per year. The notes mature ten years from the date of issuance. As of December 31, 2010, the amountsoutstanding under these notes included principal in the amount of approximately $97,000 and interest in the amount of approximately $70,000.WarrantsOn April 21, 2010, we sold warrants to purchase approximately 4.3 million shares of our common stock in the April 2010 Warrant Exchange. Seediscussion above under the caption Common Stock.Outstanding warrants at December 31, 2010 were as follows: Number of shares Exercise Price Expiration Date March 2008 Financing 4,461,599 $2.77 3/25/15 Kingsbridge CEFF 330,000 $3.525 9/25/13 October 2009 Financing 122,378 $1.66 10/16/12 April 2010 Warrant Exchange 4,286,395 $2.96 4/21/13 10. Other IncomeIn June 2010, we received a payment of $750,000 in connection with the favorable settlement of a lawsuit brought on our behalf against an individualfor defamation and harassment. This is the full amount due to us in settlement of this claim. F-29Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)NOTES TO FINANCIAL STATEMENTS, Continued In November 2010, we received grants totaling $733,438 from the United States Treasury’s Therapeutic Discovery Project Grant program. Thisincluded the maximum available grant of $244,479 for each of our three clinical programs—CORLUX for the treatment of Cushing’s Syndrome, CORLUXfor the treatment of psychotic depression, and CORT 108297 for the treatment of antipsychotic induced weight gain.11. Net Loss Per ShareBasic and diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding during theperiod less outstanding shares subject to repurchase. The computation of net loss per share for each period, including the number of weighted-average sharesoutstanding, is shown on the face of the statements of operations.We have excluded the impact of common stock equivalents from the calculation of diluted net loss per common share because all such securities areantidilutive for all periods presented. In addition, for all periods presented, we excluded additional shares that might have been issued under stock optiongrants.The following table presents information on securities outstanding as of the end of each period that could potentially dilute the per share data in thefuture. December 31, 2010 2009 2008 (in thousands) Stock options outstanding 7,961 7,347 5,132 Warrants outstanding 9,200 9,200 4,792 Total 17,161 16,547 9,924 12. Income TaxesDeferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reportingpurposes and the amounts used for income tax purposes. Significant components of our deferred tax assets are as follows: December 31, 2010 2009 (in thousands) Deferred tax assets: Federal and state net operating losses $37,466 $30,463 Capitalized research and patent costs 23,397 22,734 Stock-based compensation costs 2,195 1,756 Research credits 11,149 5,743 Total deferred tax assets 74,207 60,696 Valuation allowance (74,207) (60,696) Net deferred tax assets $— $— F-30Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)NOTES TO FINANCIAL STATEMENTS, Continued Realization of deferred tax assets is dependent upon future earnings, if any, the timing and amount of which are uncertain. Accordingly, the netdeferred tax assets have been fully offset by a valuation allowance. The valuation allowance increased by $13.5 million, $8.4 million and $8.9 million for theyears ended December 31, 2010, 2009 and 2008, respectively.At December 31, 2010 we had net operating loss carryforwards available to offset any future taxable income that we may generate for federal incometax purposes of approximately $94.0 million, which expire in the years 2019 through 2030, and California net operating loss carryforwards of approximately$94.6 million, which expire in the years 2012 through 2030. We also had federal and California research and development tax credits of approximately $10.2million and $1.5 million, respectively. The federal research credits will expire in the years 2019 through 2030 and the California research credits have noexpiration date. Our deferred tax assets have been offset by a full valuation allowance as the realization of such assets is uncertain. Utilization of our netoperating losses and tax credit carryforwards may be subject to substantial annual limitation due to the ownership change limitations provided by theInternal Revenue Code and similar state provisions. Such limitations could result in the expiration of the net operating losses and tax credit carryforwardsbefore utilization.All tax years from inception remain open to examination by the Internal Revenue Service and the California Franchise Tax Board until such time as thenet operating losses and research credits are either fully utilized or expire.A reconciliation from the statutory federal income tax rate to the effective rate is as follows: Year ended December 31, 2010 2009 2008 (in thousands) U.S. federal taxes (benefit) at statutory rate $(8,828) $(6,856) $(6,821) State tax — — — Unutilized, net operating loss 7,208 5,955 6,294 Non-deductible offset of Orphan Drug Credit 1,671 694 303 Non-deductible stock based compensation 189 207 168 Research & Development grants under Section 48D (249) — — Other 9 — 56 Total $— $— $— 13. CommitmentsWe have entered into a number of agreements to conduct clinical trials and pre-clinical studies for further development of our lead product, CORLUX,and our proprietary, selective GT-II antagonists. See the discussion in Note 2—Significant Agreements for further discussion regarding the commitmentsunder these agreements.In the ordinary course of our business, we make certain indemnities, commitments and guarantees under which we may be required to make paymentsin relation to certain transactions. These include indemnities of clinical investigators and contract research organizations involved in the development of ourclinical stage product candidates, indemnities of contract manufacturers and indemnities to our directors and officers to the maximum extent permitted underthe laws of the State of Delaware. The duration of these indemnities, commitments and guarantees varies, and in certain cases, is indefinite. The majority ofthese indemnities, commitments and guarantees do not provide for any limitation of the maximum potential future payments that we F-31Table of ContentsCORCEPT THERAPEUTICS INCORPORATED(A DEVELOPMENT STAGE COMPANY)NOTES TO FINANCIAL STATEMENTS, Continued could be obligated to make. We have not recorded any liability for these indemnities, commitments and guarantees in the accompanying balance sheets.However, we would accrue for losses for any known contingent liability, including those that may arise from indemnification provisions, when futurepayment is probable. No such losses have been recorded to date.14. Subsequent EventsOn January 26, 2011, we sold 11.5 million shares of our common stock in an underwritten public offering at a price to the public of $3.90 per share foraggregate net proceeds of approximately $41.9 million after deducting the underwriter’s discount and commissions and other expenses of the offering.Longitude Venture Partners, LP purchased approximately 750,000 (approximately 6.5%) of the shares sold in this transaction. Patrick Enright, who is amember of our board of directors, is a managing member of Longitude Capital Partners, LLC, the general partner of Longitude Venture Partners, LP.In February 2011, we amended our agreement with Argenta Discovery 2009 Limited (Argenta) for the continuation of research services regarding newproprietary selective GR-II antagonists through September 30, 2011 for an additional commitment of approximately $840,000.15. Quarterly Financial Data (Unaudited)The following table is in thousands, except per share amounts: Quarter Ended March 31 June 30 September 30 December 31 2010 Net revenue $— $— $— $— Net loss $(6,073) $(5,695) $(7,104) $(7,094) Basic and diluted net loss per share $(0.10) $(0.09) $(0.10) $(0.10) 2009 Net revenue $24 $5 $— $— Net loss $(5,450) $(4,877) $(4,668) $(5,170) Basic and diluted net loss per share $(0.11) $(0.10) $(0.09) $(0.09) F-32Table of ContentsExhibit Index ExhibitNumber Description of Document 3.1 Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the registrant’s Registration Statement onForm S-1/A (File No. 333-112676) filed on March 19, 2004). 3.2 Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to the registrant’s Current Report on Form 8-K filed on September27, 2007). 4.1 Specimen Common Stock Certificate (incorporated by reference to Exhibit 4.1 to the registrant’s Registration Statement on Form S-1(Registration No. 333-112676) filed on February 10, 2004). 4.2 Amended and Restated Information and Registration Rights Agreement by and among Corcept Therapeutics Incorporated and certain holdersof preferred stock, dated as of May 8, 2001 (incorporated by reference to Exhibit 4.2 to the registrant’s Registration Statement on Form S-1(Registration No. 333-112676) filed on February 10, 2004). 4.3 Amendment No. 1 to Amended and Restated Information and Registration Rights Agreement by and among Corcept TherapeuticsIncorporated and certain holders of preferred stock, dated as of March 16, 2004 (incorporated by reference to Exhibit 4.3 to the registrant’sRegistration Statement on Form S-1/A (File No. 333-112676) filed on March 19, 2004). 4.4 Registration Rights Agreement by and among Corcept Therapeutics Incorporated and the investors signatory thereto, dated March 14, 2008(incorporated by reference to Exhibit 10.25 to the registrant’s Annual Report on Form 10-K filed on March 31, 2008). 4.5 Registration Rights Agreement by and between Corcept Therapeutics Incorporated and Kingsbridge Capital Limited, dated as of March 25,2008 (incorporated by reference to Exhibit 10.27 to the registrant’s Annual Report on Form 10-K filed on March 31, 2008). 4.6 Amendment to Registration Rights Agreement by and among Corcept Therapeutics Incorporated and the investors signatory thereto, datedNovember 11, 2008 (incorporated by reference to Exhibit 10.30 to the registrant’s Annual Report on Form 10-K filed on March 31, 2009). 4.7 Registration Rights Agreement by and among Corcept Therapeutics Incorporated and the investors signatory thereto, dated October 12, 2009(incorporated by reference to Exhibit 4.2 to the registrant’s Quarterly Report on Form 10-Q filed on November 12, 2009). 4.8 Registration Rights Agreement dated as of April 21, 2010 by and among Corcept Therapeutics Incorporated and the investors signatorythereto (incorporated by reference to Exhibit 4.2 to the registrant’s Current Report on Form 8-K filed on April 23, 2010).10.1* 2000 Stock Option Plan (incorporated by reference to Exhibit 10.1 to the registrant’s Registration Statement on Form S-1 (Registration No.333-112676) filed on February 10, 2004).10.2* Promissory Note and Pledge Agreement by and between Corcept Therapeutics Incorporated and Robert L. Roe, M.D., dated as of October 22,2001 (incorporated by reference to Exhibit 10.4 to the registrant’s Registration Statement on Form S-1 (Registration No. 333-112676) filedon February 10, 2004).10.3# License Agreement by and between The Board of Trustees of the Leland Stanford Junior University and Corcept Therapeutics Incorporated,dated as of July 1, 1999 (incorporated by reference to Exhibit 10.6 to the registrant’s Registration Statement on Form S-1 (Registration No.333-112676) filed on February 10, 2004).10.4# Memorandum of Understanding, Supply and Services Agreement, by and between Corcept Therapeutics Incorporated and ScinoPharmTaiwan, dated as of June 12, 2000 (incorporated by reference to Exhibit 10.9 to the registrant’s Registration Statement on Form S-1/A (FileNo. 333-112676) filed on March 19, 2004).Table of ContentsExhibitNumber Description of Document10.5 Master Services Agreement by and between Corcept Therapeutics Incorporated and PPD Development, LP, dated as of January 17, 2003(incorporated by reference to Exhibit 10.12 to the registrant’s Registration Statement on Form S-1/A (File No. 333-112676) filed on March19, 2004).10.6## Manufacturing Agreement with Produits Chimiques Auxiliaires et de Synthese SA, dated November 8, 2006 (incorporated by reference toExhibit 10.15 to the registrant’s Annual Report on Form 10-K filed on April 2, 2007).10.7 Common Stock Purchase Agreement by and among Corcept Therapeutics Incorporated and each of the Purchasers listed on Exhibit A thereto,dated November 14, 2006 (incorporated by reference to Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on November 16,2006).10.8 Common Stock Purchase Agreement by and among Corcept Therapeutics Incorporated and each of those persons and entities listed on theSchedule of Purchasers thereto, dated as of March 30, 2007 (incorporated by reference to Exhibit 10.1 to the registrant’s Current Report onForm 8-K filed on April 3, 2007).10.9 Common Stock Purchase Agreement by and among Corcept Therapeutics Incorporated and each of those persons and entities listed on theSchedule of Purchasers thereto, dated as of August 16, 2007 (incorporated by reference to Exhibit 10.1 to the registrants Current Report onForm 8-K filed on August 21, 2007).10.10* Form of Indemnification Agreement for directors and officers approved by the Board of Directors on September 24, 2007 (incorporated byreference to Exhibit 10.7 to the registrant’s Quarterly Report on Form 10-Q filed on November 14, 2007).10.11 Securities Purchase Agreement by and among Corcept Therapeutics Incorporated and the purchasers named therein, dated March 14, 2008(incorporated by reference to Exhibit 10.24 to the registrant’s Annual Report on Form 10-K filed on March 31, 2008).10.12 Form of Warrant issued in connection with the Securities Purchase Agreement by and among Corcept Therapeutics Incorporated and thepurchasers named therein, dated March 14, 2008 (incorporated by reference to Exhibit 4.4 to the registrant’s Annual Report on Form 10-Kfiled on March 31, 2008).10.13 Common Stock Purchase Agreement by and between Kingsbridge Capital Limited and Corcept Therapeutics Incorporated dated as of March25, 2008 (incorporated by reference to Exhibit 10.26 to the registrant’s Annual Report on Form 10-K filed on March 31, 2008).10.14 Warrant, dated March 25, 2008 issued to Kingsbridge Capital Limited (incorporated by reference to Exhibit 4.5 to the registrant’s AnnualReport on Form 10-K filed on March 31, 2008).10.15# Master Service Agreement by and among Corcept Therapeutics Incorporated and ICON Clinical Research, L.P., signed on June 4, 2008(incorporated by reference to Exhibit 10.5 to the registrant’s Quarterly Report on Form 10-Q filed on August 14, 2008).10.16* Amended and Restated Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and Joseph K.Belanoff, M. D., dated September 19, 2008 (incorporated by reference to Exhibit 10.25 to the registrant’s Annual Report on Form 10-K filedon March 31, 2009).10.17* Amended and Restated Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and Robert L. Roe,M. D., dated September 19, 2008 (incorporated by reference to Exhibit 10.26 to the registrant’s Annual Report on Form 10-K filed on March31, 2009).10.18* Amended and Restated Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and Anne M.LeDoux, dated September 19, 2008 (incorporated by reference to Exhibit 10.27 to the registrant’s Annual Report on Form 10-K filed onMarch 31, 2009).Table of ContentsExhibitNumber Description of Document10.19* Amended and Restated Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and James N.Wilson, dated September 19, 2008 (incorporated by reference to Exhibit 10.28 to the registrant’s Annual Report on Form 10-K filed on March31, 2009).10.20* Employment offer letter to Caroline M. Loewy, dated October 21, 2008 (incorporated by reference to Exhibit 10.29 to the registrant’s AnnualReport on Form 10-K filed on March 31, 2009).10.21* Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and Caroline M. Loewy, dated November28, 2008 (incorporated by reference to Exhibit 10.31 to the registrant’s Annual Report on Form 10-K filed on March 31, 2009).10.22 Form of Warrant issued in connection with the Securities Purchase Agreement by and among Corcept Therapeutics Incorporated and thepurchasers named therein, dated October 12, 2009 (incorporated by reference to Exhibit 4.1 to the registrant’s Quarterly Report on Form 10-Qfiled on November 12, 2009).10.23 Securities Purchase Agreement by and among Corcept Therapeutics Incorporated and the purchasers named therein, dated October 12, 2009(incorporated by reference to Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q filed on November 12, 2009).10.24* Amended and Restated 2004 Equity Incentive Plan (incorporated by reference to the registrant’s Proxy Statement on Schedule 14A filed onMay 7, 2009).10.25* Form of Option Agreement10.26 Warrant Purchase Agreement dated as of April 21, 2010 by and among Corcept Therapeutics Incorporated and the purchasers named therein(incorporated by reference to Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed on April 23, 2010).10.27 Form of Warrant issued in connection with the Warrant Purchase Agreement dated as of April 21, 2010 by and among Corcept TherapeuticsIncorporated and the purchasers named therein (incorporated by reference to Exhibit 4.1 to the registrant’s Current Report on Form 8-K filedon April 23, 2010).10.28 Development Agreement by and between Corcept Therapeutics Incorporated and Formulation Technologies L.L.C. d/b/a PharmaForm, datedas of December 14, 2006.10.29 Master Services Agreement by and between Corcept Therapeutics Incorporated and United BioSource Corporation, dated as of June 29, 2010.10.30* Employment offer letter to Steven Lo, dated August 9, 2010 (incorporated by reference to Exhibit 10.1 to the registrant’s Quarterly Report onForm 10-Q filed on November 12, 2010).10.31* Severance and Change in Control Agreement by and between Corcept Therapeutics Incorporated and Steven Lo, dated September 15, 2010(incorporated by reference to Exhibit 10.2 to the registrant’s Quarterly Report on Form 10-Q filed on November 12, 2010).14.1 Code of Ethics (incorporated by reference to Exhibit 99.1 to the registrant’s Registration Statement on Form S-1/A (File No. 333-112676)filed on March 19, 2004).23.1 Consent of Independent Registered Public Accounting Firm24.1 Power of Attorney (See signature page)31.1 Certification pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 of Joseph K. Belanoff, M.D.31.2 Certification pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 of Caroline M. Loewy####Table of ContentsExhibitNumber Description of Document32.1 Certification pursuant to 18 U.S.C. Section 1350 of Joseph K. Belanoff, M.D.32.2 Certification pursuant to 18 U.S.C. Section 1350 of Caroline M. Loewy #Confidential treatment granted##Confidential treatment requested*Management contract or compensatory plan or arrangementExhibit 10.25Corcept Therapeutics Incorporated2004 Equity Incentive PlanStock Option Grant Notice and Agreement[DATE] Re:Grant of [Incentive or]* Nonqualified Stock Option Option Shares: Grant Date: Price per share: Vesting Base Date: Fully-Vested Date: Expiration Date: Dear :I am pleased to confirm that the Company has granted you an option to purchase shares of our common stock under the Corcept Therapeutics 2004Equity Incentive Plan. To accept your stock option, please sign the original and return it to me. Keep the copy for your files.General termsYour option is intended to be an incentive option to the extent allowed by law. The remainder will be a nonqualified option. The basic terms of youroption grant are identified in the information block at the top of this offer letter, but other important terms and conditions are described in the plan. Weencourage you to carefully review the plan, a copy of which is attached.Vesting Schedule[Varies by grant]Change of Control**The Options shall be subject to the terms and conditions of the option agreement and the Plan, provided that in the event of a Change of Control,100% of the total shares subject to the option shall become immediately vested upon termination without cause, or resignation for “good reason” within 18months following such Change in Control. “Good reason” will permit acceleration only on a resignation following a material reduction in base salary orrelocation of the Company’s headquarters by 35 or more miles.Exercise PeriodIn general, subject to the Plan and to insider trading considerations, your option will be exercisable to the extent the shares are vested at any timeduring your service to the company and until the 3rd monthly anniversary of your termination date, but in no event after the Expiration Date. Sharesunvested at your termination date will be cancelled.[For employees and directors, the period of time to exercise vested options after termination may be extended to the earlier of the 3rd anniversary of thetermination of service or the original expiration date of the option if either: 1.the employee or director is 55 years old or older and has 5 years or more of service with the Company upon voluntary termination of service (e.g.,retirement); or 2.the employee or director is involuntarily terminated (e.g., the director is not re-elected to the Board or the employee is terminated without cause)and has 5 years or more of service with the Company upon termination of service, regardless of age.]**The grant will automatically terminate if not exercised within the time specified.Change of employment statusIn the event of a change in your employment status wherein there is a reduction in the number of your hours per week, there will be a cancellation ofunvested Option Shares in proportion to the percentage drop of your hours. For example, if your status changes from full time to half time, 50% of yourunvested Option shares will be cancelled.Purchase and paymentIf you decide to purchase shares under this option, you will be required to submit a completed exercise agreement on a form approved by the Company,together with payment for the shares. You may pay for the shares (plus any associated withholding taxes) using cash, a check, a wire transfer or any other formof payment listed in section 6.4(c) of the plan and permitted by the Administrator at the time you wish to exercise. Shares available under this option must bepurchased, if at all, no later than the Expiration Date.We value your efforts and look forward to your continued contribution.Sincerely, [Title of Officer]I accept this option and agree to the terms of this offer letter and the plan. Optionee signature Date *- Consultants and non-employee directors are not eligible for Incentive Stock Options.**- These clauses are not applicable to option grants to consultantsExhibit 10.28 DEVELOPMENT AGREEMENTBY AND BETWEENCORCEPT THERAPEUTICSANDFORMULATION TECHNOLOGIES L.L.C.DATED AS OFDecember 14, 2006 11400 Burnet RoadBuilding 4, Suite 4010Austin, Texas 78758 Ph (512) 834-0449Fax (512) 834-2105www.pharmaform.com Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to theconfidentiality request. Omissions are designated as [ *** ]. A complete version of this exhibit has been filed separately with theSecurities and Exchange Commission.DEVELOPMENT AGREEMENTThis DEVELOPMENT AGREEMENT (this “Agreement”) is made and entered into effective this 14th day of December,2006 by and between Corcept Therapeutics Incorporated, a Delaware corporation (“Corcept”), and Formulation Technologies L.L.C.,a Texas limited liability company d/b/a PharmaForm (“PharmaForm”).RECITALSA. Corcept is commercializing an oral immediate release solid dosage form, Corlux®C-1073 (Mifepristone). Corcept has proprietary rights for the therapeutic use of mifepristone and other GR-II antagonistsfor the treatment of psychiatric and neurological disorders.B. PharmaForm is engaged in the business of, and has facilities for, developing, testing and producing drugdosage forms.C. Corcept desires to engage PharmaForm and PharmaForm desires to be engaged to develop, manufacturefor clinical studies, and FDA filing purposes, an immediate release solid dosage form containing mifepristone(“MIFEPRISTONE”) suitable for oral administration pursuant to a Development Program as hereinafter defined.AGREEMENTNOW, THEREFORE, in consideration of the foregoing and the mutual covenants and considerations set forth herein, theparties hereto agree as follows:ARTICLE 1DEFINITIONSThe following terms shall have the meanings set forth in this Article 1.1.1 “Confidential Information” shall mean and include this Agreement and any and all information, including but notlimited to, clinical, analytical and/or scientific data, reports, processes, procedures, methods, formulations, Inventions, and/or tradesecrets relating to Products developed pursuant to this Agreement and any other non-public information disclosed by a party pursuantto this Agreement of any kind, nature or description concerning any matters affecting or relating to the business of PharmaForm orCorcept.1.2 “Development Program” shall collectively refer to the activities to be conducted by Corcept and PharmaForm withrespect to developing one or more products containing MIFEPRISTONE, as reflected by and enumerated in the R&D Plan as setforth in Article 2. 11400 Burnet RoadBuilding 4, Suite 4010Austin, Texas 78758 Ph (512) 834-0449Fax (512) 834-2105www.pharmaform.com 21.3 “R&D Plan” shall collectively refer to the plan(s) and/or proposals describing the scope(s), task(s) and goal(s) of theDevelopment Program, which shall be attached as Exhibits to and made part of this Agreement, as such plan(s) or proposal(s) mayfrom time to time be added, amended or modified by written agreement of the Parties.1.4 “Know-How” shall mean all present and future technical information and practical experience which relates to anyProduct and shall include, without limitation, all biological, chemical, pharmacological, toxicological, clinical, assay, control, andmanufacturing data and any other information relating to any Product and useful for the development and commercialization of anyProduct.1.5 “Invention(s)” shall mean any and all inventions or improvements, discoveries, know-how, trade secrets, processes,compositions, machines or manufactures or other technology (whether patentable or not) conceived or reduced to practice during theterm of this Agreement relating to any Product including any compositions or formulations or any methods or processes of making orusing any Product.1.6 “Product(s)” shall mean any and all pharmaceutical compositions, formulations and dosing units containingMIFEPRISTONE that are developed under this Agreement.ARTICLE 2DEVELOPMENT2.1 Development Program. Corcept and PharmaForm shall pursue a Development Program as described in the R&DPlan attached as Exhibits, which set forth the agreed tasks and goals of the Development Program. PharmaForm agrees to perform thetasks assigned to it in the R&D Plan and to use its best efforts to accomplish the agreed goals, with Corcept’s support and assistance (tothe extent provided in Exhibits). However, nothing therein shall bind PharmaForm to any guarantees of success at any developmentstage nor shall the failure to achieve the goals of the Development Program result in liability to PharmaForm unless otherwise providedin this Agreement.2.2 Technology Transfer. To accomplish the goal of successful formulation and development of Products, Corcept shalluse commercially reasonable efforts to transfer to PharmaForm reasonable amount of Product drug substance, analytical methods fordrug substance and cleaning methods for drug substance as Corcept deems to be necessary, and such information shall be deemedCorcept’s Confidential Information under Article 6. PharmaForm shall disclose to Corcept all Inventions made and all Know-Howgenerated under the Development Program or relating to Products, promptly and on a regular basis, or as requested by Corcept.2.3 Regulatory Filings and Meetings. PharmaForm agrees to use its best efforts to provide information for regulatoryfilings and meetings at the request of Corcept. Any such 11400 Burnet RoadBuilding 4, Suite 4010Austin, Texas 78758 Ph (512) 834-0449Fax (512) 834-2105www.pharmaform.com 3filings shall become properties of Corcept and shall be deemed Corcept’s Confidential Information under Article 6.2.4 Project Management and Schedules. A formalized Product development timeline will be prepared and periodicallyupdated by Corcept based on input from PharmaForm. The project timeline will serve as a project management tool that will contributeto the effectiveness of the collaboration, and will facilitate planning and management of the Development Program. The parties agreeto use commercially reasonable efforts to meet the timeline. PharmaForm agrees to make every effort to expedite procurement anddelivery of materials required to perform the development work, but if the availability of materials necessary to perform thisdevelopment work is beyond the control of PharmaForm, then PharmaForm makes no guarantees regarding availability of materials. IfPharmaForm becomes aware of a delay that may impact the timeline it will immediately and fully communicate information concerningsuch delay to Corcept. PharmaForm shall provide Corcept with written reports of its progress in conducting the Development Programtogether with any data that have been generated under the Development Program on a monthly basis, and such reports and data shallbe the property of Corcept and shall be deemed Corcept’s Confidential Information under Article 6.2.5 Non-Exclusive. The parties agree and acknowledge that PharmaForm is in the business of providing contract researchand development services to the pharmaceutical industry. Accordingly, PharmaForm shall be free to undertake the provision ofservices to any third party and/or conduct research and development on its own behalf so long as it does not otherwise breach theconfidentiality and intellectual property provisions of this Agreement; provided, however, that during the term of this Agreement andduring the two year period following its expiration, without the consent of Corcept PharmaForm shall not provide contract researchand development services relating to any product or product candidate (i) containing MIFEPRISTONE and (ii) with an intended use orapplication in the field of neuropsychiatric disorders.2.6 Commercial Supply Agreement. The parties agree to negotiate in good faith a commercial supply agreement for themanufacturing, packaging and testing of Product for commercial sale and distribution, and shall use their reasonable efforts to enter intosuch a contract on or before the submission of an NDA for CORLUX by Corcept.ARTICLE 3INTELLECTUAL PROPERTY3.1 Objective. The two-fold intellectual property objective is to establish a strong patent position for the Products thatmaximize the commercial opportunity for the Product(s) while respecting valid third party patents. PharmaForm and Corcept agree touse commercially reasonable efforts to develop patentable Product(s). However, nothing herein is, or shall be construed to be, aguarantee by PharmaForm that any Inventions will result from this Agreement. To the extent any Inventions (whether or notpatentable) result from the Development Program under this Agreement, Corcept shall be the sole owner and controller of allInventions and any 11400 Burnet RoadBuilding 4, Suite 4010Austin, Texas 78758 Ph (512) 834-0449Fax (512) 834-2105www.pharmaform.com 4intellectual property rights arising out of this Agreement. PharmaForm agrees to provide technical assistance as reasonably requestedby Corcept’s patent counsel regarding the determination of the freedom to operate in the field of drug compositions, dosage forms,formulations, and delivery systems as they relate to the subject matter of the Development Program. However, it is Corcept’s soleresponsibility to make the determinations in regard to both the freedom to operate and decisions to pursue patent protection ofInventions developed pursuant to the Development Program. Corcept is thus solely responsible for decisions associated with preparingand filing patent applications and prosecuting such applications. Corcept shall have sole responsibility for maintaining any patentprotection acquired and maintaining any actions against infringing third parties of such intellectual property. PharmaForm shall use itsreasonable efforts to avoid potential infringement of third party intellectual property in its performance under this Agreement, and toavoid the unauthorized incorporation of any technology or matter that is claimed or covered by or under any third party patents or otherintellectual property rights. Subject to the foregoing, PharmaForm neither guarantees nor assumes any legal liability in the event that:(a) a court of law finds that Corcept’s drug compositions, dosage forms, formulations, and delivery systems infringe the patents ofothers; or (b) patents issued as a result of work performed in this Agreement are legally challenged by a third party.3.2 Additional Services. As requested by Corcept, PharmaForm agrees to provide the following services: (a) Collaborating in setting and executing a patent strategy directed to obtaining claims relating toMIFEPRISTONE and its forms or formulations, including but not limited to claims to compositions of matter, pharmaceuticalcompositions, formulations, process methodology, dosage forms performance, and methods of treatment. (b) Participating in interpretation of published patents and patent applications to facilitate formulation development,assisting Corcept’s patent counsel in setting a legal strategy by providing technical assistance, aiding in the preparation of patentapplication(s), disclosing inventions developed pursuant to the Development Program, assisting in inventorship determinations,assisting in obtaining inventor signatures required for patent filing and patent prosecution, and seeking reasonable assistancefrom the inventors for patent filing and patent prosecution. (c) Upon reasonable notice, participating in meetings with Governmental Patent office(s) as may be necessary inthe U.S. and abroad to facilitate the issuance or defense of patents disclosing inventions resulting from the DevelopmentProgram.3.3 Know-How. All Know-How and intellectual property of Corcept received by PharmaForm is ConfidentialInformation of Corcept and is the sole and exclusive property of Corcept. All Inventions and Know-How and other data identified,discovered, developed, learned or applied in developing Product(s) or otherwise in performance of services in accordance with thisAgreement, shall be and is deemed assigned to Corcept and is the 11400 Burnet RoadBuilding 4, Suite 4010Austin, Texas 78758 Ph (512) 834-0449Fax (512) 834-2105www.pharmaform.com 5Confidential Information of Corcept, and is the sole and exclusive property of Corcept. All Know-How and intellectual property ofPharmaForm received by Corcept related to PharmaForm’s business and not arising from PharmaForm’s services with regard toProduct(s) hereunder is Confidential Information of PharmaForm and is the sole and exclusive property of PharmaForm.3.4 Intellectual Property Ownership. The parties agree that Corcept is and shall be the sole owner and controller of anyintellectual property rights, including all rights to Inventions, arising out of this Agreement. PharmaForm shall and hereby does assignall rights, title and interest in any Inventions arising out of this Agreement to Corcept. Notwithstanding the foregoing, Corceptacknowledges and agrees that PharmaForm retains all right, title and license in PharmaForm’s technology, knowledge, formulas,software, models, development tools and routines, as well as derivatives and modifications thereof that exist on or prior to the EffectiveDate (the “Developer Stock”), and that Corcept shall have no rights in and to the Developer Stock incorporated into the Product.Without the prior written consent of Corcept, PharmaForm shall not incorporate any Developer Stock into the Products. The partiesagree that: (a) Corcept shall pay to PharmaForm the amounts for applications and patents specified in Section 4.2; (b) Corcept shall be responsible for payment of all fees and costs, including without limitation attorneys’ fees,relating to the filing and prosecution of each patent application hereunder; (c) Each patent application and patent is assigned to Corcept; (d) Corcept shall pay no royalty to PharmaForm or other inventors; (e) Corcept shall pay no amount to PharmaForm for filing of foreign patent applications or issuance of foreignpatents; (f) Fees as specified in Section 4.2 are due for each application or patent with at least one PharmaForm inventor,even if Corcept co-inventors are listed on the application or patent; and (g) Neither party guarantees that a patent or patent application will be filed, issued or maintained.ARTICLE 4PAYMENTS4.1 Development Payment Schedule and Related Costs. The parties hereby agree to the following developmentpayment schedule: 11400 Burnet RoadBuilding 4, Suite 4010Austin, Texas 78758 Ph (512) 834-0449Fax (512) 834-2105www.pharmaform.com 6 (a) Development Payments. Corcept agrees to pay PharmaForm according to the payment schedule set forth inindividual proposals for specific development tasks outlined in Exhibits and additional tasks, as defined in such proposals. Corceptagrees that any amount not paid within 30 days of notice is overdue and will accrue interest at the lesser of [ *** ] per month or themaximum rate allowed by law. In addition, without waiving all other rights or remedies under law, PharmaForm may refuse tocontinue work under this Agreement, terminate this Agreement under Section 8 of this Agreement and/or seek collection from Corcept,including reasonable attorneys’ fees and costs of court. Changes to this payment schedule are to be submitted in writing (i.e., changeorder) for prior written approval by Corcept. (b) Clinical Supplies. If requested by Corcept, production and testing of clinical supplies will be provided underseparate proposals and attached as Exhibits. The acquisition of specific items required for the manufacture of the clinical supplies, suchas analytical columns, analytical reference standards, drug substance, specialty excipients tablet tooling, and packaging supplies, willbe addressed in a separate proposals and attached as Exhibits. (c) Travel. The cost of travel by PharmaForm representatives as requested by Corcept under this Agreement isnot included in this budget and will require preapproval by Corcept and will be invoiced to Corcept in accordance with PharmaForm’sstandard travel billing policies.4.2 Intellectual Property Payment Schedule. In consideration of the assignment of all intellectual property as describedin Article 3 and in addition to the amounts paid pursuant to Section 4.1, Corcept agrees to pay PharmaForm the following amounts, butsubject to the maximum set forth below: U.S. Patent Applications or U.S. Patents. Corcept agrees to pay PharmaForm for each U.S. patent application filed,and each U.S. patent issued that claims any Invention developed pursuant to the Development Program where a PharmaFormemployee is listed as an inventor or co-inventor according to the following fee schedule: Provisional U.S. Patent Application Filed [ *** ]U.S. Patent Issued [ *** ]Corcept agrees to pay PharmaForm an hourly rate of [ *** ]for work related to preparation and prosecution of any patent applicationsor patents described in Section 3.2. 11400 Burnet RoadBuilding 4, Suite 4010Austin, Texas 78758 Ph (512) 834-0449Fax (512) 834-2105www.pharmaform.com 7 [ *** ]Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission.Confidential treatment has been requested with respect to the omitted portions.ARTICLE 5PUBLICATION; PROHIBITION ON PUBLIC DISCLOSURE OF AGREEMENTCorcept acknowledges that PharmaForm may have an interest in publishing certain results of the Development Program, butPharmaForm recognizes that Corcept’s interest in obtaining valid patent protection and protecting Corcept’s business interests takesprecedence over any such publication interest. Consequently, PharmaForm agrees that it shall not publish or disclose any Inventions orKnow-how or data resulting from the Development Program or any other Confidential Information of Corcept without the prior writtenconsent of Corcept.Corcept acknowledges and agrees that due to the nature of mifepristone and certain applications for which it was designed,PharmaForm has an interest in prohibiting and limiting public disclosure of the terms and existence of this Agreement and therelationship between Corcept and PharmaForm evidenced by this Agreement. Accordingly, unless agreed upon in writing betweenPharmaForm and Corcept, neither party shall discuss with third parties or originate any publicity, news release or other public orprivate announcement, written or oral, whether to the public press, stockholders or otherwise, regarding any matters relating to theexistence, content or terms of this Agreement, or any amendment hereto, or the performance by either of the parties hereunder, exceptfor such announcement as in the opinion of legal counsel to the party making such announcement is required under applicable law orstock exchange regulations, in which event such party shall give the other party an opportunity, reasonable under the circumstances, toreview the form and content of the announcement before such legally required disclosure is made. Subject to confidentiality obligationsset forth in this Agreement, either party may discuss the terms of the Agreement with directors, officers, shareholders, legal advisors,consultants, and financial investors.ARTICLE 6CONFIDENTIALITY6.1 Nondisclosure Obligations and Exceptions. All Confidential Information received by one party from the other partyor developed pursuant to this Agreement is to be considered highly confidential. The receiving party shall not use, except as providedfor under this Agreement, or disclose to others (except to those of its directors, officers, employees, consultants or agents who requirethe information for purposes of carrying out the Agreement and who are bound by a nondisclosure agreement not less restrictive thanthe provisions in this Agreement) any such Confidential Information received from or developed by the other without the express priorwritten consent of the other party; provided, however, that the forgoing restrictions on disclosure and use shall not apply to any specificConfidential Information of a party that the receiving party can demonstrate with competent evidence: 11400 Burnet RoadBuilding 4, Suite 4010Austin, Texas 78758 Ph (512) 834-0449Fax (512) 834-2105www.pharmaform.com 8 (a) was already known to the receiving party at the time of disclosure without obligation to keep it confidential, asdemonstrated by written documentation; (b) is generally available at the time of disclosure to the public, or subsequently becomes generally available to thepublic other than by an act or omission on the part of the receiving party charged with the obligations; (c) subsequent to the disclosure is acquired from or made available by a third party having the lawful right todisclose such information; or (d) is developed by the receiving party without use of or reference to the disclosing party’s confidentialinformation.For purposes of this Article 6, PharmaForm shall be deemed to be the “receiving party” for any and all Confidential Information ofCorcept that is initially developed by PharmaForm pursuant to this Agreement and assigned to Corcept as provided in Sections 3.1, 3.3and/or 3.4.6.2 Permitted Disclosures. Notwithstanding the foregoing limits on disclosure of Confidential Information, a receivingparty shall be permitted to disclose Confidential Information of the other party solely to the extent such disclosure: (a) is legally compelled to be disclosed pursuant to government regulation, a subpoena, court order oradministrative order or other legal process; provided, however, that such party shall have first provided prompt written notice tothe other party of such subpoena, court order or administrative order or other legal process so that such party may raise anyobjections on its behalf and on behalf of the other party, which rights are expressly reserved, seek a protective order or otherappropriate remedy, and/or otherwise agree to disclose for purposes of complying with such subpoena, court order oradministrative order or other legal process; and further provided that should disclosure be required, such party shall exercise itscommercially reasonable efforts, at the expense of the disclosing party, to ensure that confidential treatment be accorded suchinformation; (b) is required by law or regulation in connection with seeking approvals, registrations, licenses, authorizations,visas, or permits required by any governmental authority or agency in any country in order to import, offer for sale, sell, market,manufacture, have made or use the Product(s) developed pursuant to this; (c) to a treating physician or health professional in the event that a medical emergency associated with the handlingor exposure to a Product developed pursuant to this Development Agreement by a PharmaForm employee or authorizedrepresentative solely to the extent that the physician or health professional determines that a medical need exists for ConfidentialInformation in order to administer appropriate emergency or first-aid treatment; provided, that Corcept shall promptly be notifiedof any disclosure required under this Section 6.2(c) and the requesting physician or health professional 11400 Burnet RoadBuilding 4, Suite 4010Austin, Texas 78758 Ph (512) 834-0449Fax (512) 834-2105www.pharmaform.com 9shall immediately be referred to the appropriate contact person or representative of Corcept; or (d) if the disclosing party waives the right to restrict disclosure under this Article 6.6.3 Term of Confidentiality. The restrictions on disclosure and use of Confidential Information shall remain in forceuntil [ *** ], the date of the expiration confidentiality obligations set forth in the Mutual Confidentiality and Non-DisclosureAgreement dated [ *** ] by and between PharmaForm and Corcept. In the event of breach or threatened breach of the provisions ofthis Section, either party shall be entitled to an injunction restraining the other party from disclosing, in whole or in part, suchConfidential Information. Nothing herein shall be construed as prohibiting a party from pursuing any other remedies available to it forsuch breach or threatened breach, including recovery of damages from the other party.ARTICLE 7INDEMNIFICATION7.1 Warranties. (a) PharmaForm represents and warrants that: (i) PharmaForm has the legal authority and right to enter into thisAgreement; (ii) it has no obligation to any other party which is in conflict with its obligations under this Agreement; (iii) all activitieshereunder will be completed in a timely fashion, will conform to consistently high standards of workmanship and the specificationsreasonably requested by Corcept, and will be conducted in compliance with all applicable laws, rules, regulations, guidelines andstandards and; (iv) all employees of PharmaForm have and will continue to have the knowledge, experience, and skill to provide, andwill provide, the services hereunder and have executed an invention assignment agreement assigning all Inventions related to thisAgreement to PharmaForm, (v) all Product shall have been manufactured and shipped in conformance with the specifications providedby Corcept and will have been manufactured in accordance with current Good Manufacturing Practices, (vi) Product will not beadulterated or misbranded under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 321 et seq., as amended (“FFDCA”), orunder any other applicable laws, rules, regulations or requirements, and (vii) it will have obtained and maintained such approvals asmay be required under applicable laws, rules, regulations and requirements to operate its manufacturing facility for the purposescontemplated by this Agreement. (b) Corcept represents and warrants that: (i) it has the legal authority and right to enter into this Agreement; (ii) ithas no obligation to any other party which is in conflict with its obligations under this Agreement; and (iii) it will conduct all activitiesunder this Agreement in compliance in all material respects with all applicable local, state and federal laws. (c) EXCEPT AS SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY EXPRESS ORIMPLIED WARRANTIES HEREUNDER AND DISCLAIMS 11400 Burnet RoadBuilding 4, Suite 4010Austin, Texas 78758 Ph (512) 834-0449Fax (512) 834-2105www.pharmaform.com 10 [ *** ]Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission.Confidential treatment has been requested with respect to the omitted portions.ALL WARRANTIES EXCEPT THOSE SET FORTH HEREIN, INCLUDING, WITHOUT LIMITATION, IMPLIEDWARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.7.2 Indemnification by Corcept. Corcept agrees to indemnify and hold PharmaForm and each of its affiliates andrepresentatives harmless from any and all liability, loss, or damage PharmaForm might suffer as a result of claims, demands, costs orjudgments (including reasonable attorneys’ fees and costs of court) against it arising out of this Agreement, including, withoutlimitation, any and all claims to the extent arising out of (a) any use of Product by Corcept or third parties or the formulation of Productby PharmaForm in accordance with the terms of this Agreement (and any amendments, addendums or exhibits to this Agreement),(b) the manufacture, design, handling, use, sale, offer for sale, distribution or other exploitation by Corcept or its licensees of anyProduct or (c) patent infringement that may be brought against PharmaForm related to such formulation, use or exploitation of theProduct as a result of intellectual property not provided by PharmaForm; provided, however, that this indemnity will not cover anyclaims, demands, costs or judgments brought against PharmaForm that are or are alleged to arise solely from the negligence, bad faith,or misconduct of PharmaForm; a material breach of any applicable federal, state or local law by PharmaForm; a material breach of thisAgreement by PharmaForm; or an act of alleged infringement of third party intellectual property based on PharmaForm’s activitiesunder this Agreement or unauthorized incorporation of any technology, matter or intellectual property that is covered under any thirdparty intellectual property.7.3 Indemnification by PharmaForm. PharmaForm agrees to indemnify and hold Corcept and each of its affiliates andrepresentatives harmless from any and all liability, loss or damage Corcept might suffer as a result of claims, demands, costs orjudgments (including reasonable attorneys’ fees and costs of court) to the extent arising out of the (a) the negligence, bad faith ormisconduct on the part of PharmaForm, (b) a material breach of any applicable federal, state or local law by PharmaForm, (c) amaterial breach of this Agreement by PharmaForm, or (d) an act of alleged infringement of third party intellectual property based onPharmaForm’s activities under this Agreement or unauthorized incorporation of any technology, matter or intellectual property that iscovered under any third party intellectual property, other than infringement based on intellectual property provided by Corcept.7.4 Duty to Indemnify. Each party’s agreement to indemnify and hold the other harmless is conditioned on theindemnified party: (a) providing written notice to the indemnifying party of any claim, demand or action arising out of the Indemnifiedactivities as soon as practicable but at least within 15 days after the indemnified party receives written notice of such claim, demand oraction, (b) permitting the indemnifying party to assume full responsibility to investigate, prepare for and defend against any such claim,demand, or action, (c) assisting the indemnifying party at the indemnifying party’s reasonable expense, in the investigation of,preparation for and defense of any such claim, demand or action, and (d) not compromising or settling such claim or demand withoutthe indemnifying party’s prior written consent. 11400 Burnet RoadBuilding 4, Suite 4010Austin, Texas 78758 Ph (512) 834-0449Fax (512) 834-2105www.pharmaform.com 117.5 General Regulatory Compliance. Each party, at its own expense, will comply in all material respects with allapplicable laws, orders and regulations of any governmental authority with jurisdiction over its activities in connection with thisAgreement. Each party will furnish to the other party any information required to enable the other party to comply in all materialrespects with applicable laws and regulations related to the Products.7.6 Limitation of Liability. EXCEPT WITH RESPECT TO LOSSES PAYABLE IN RESPECT OFINDEMNIFICATION OBLIGATIONS HEREUNDER, OR CAUSED BY A BREACH OF CONFIDENTIALITY ORINTELLECTUAL PROPERTY OBLIGATIONS HEREUNDER OR BY THE GROSS NEGLIGENCE, WILLFULMISCONDUCT, FRAUD OR INTENTIONAL OR NEGLIGENT MISREPRESENTATION OF A PARTY, A PARTYHEREUNDER SHALL NOT BE LIABLE TO THE OTHER PARTY FOR (I) ANY INCIDENTAL, INDIRECT, SPECIAL ORCONSEQUENTIAL DAMAGES WHATSOEVER, INCLUDING, BUT NOT LIMITED TO, LOST PROFITS, EVEN IF SUCHPARTY HAS BEEN ADVISED, KNEW OF OR SHOULD HAVE KNOWN OF THE POSSIBILITY THEREOF OR (II) ANYAMOUNT GREATER THAN [ *** ] THE AGGREGATE OF ALL PAYMENTS PAYABLE TO PHARMAFORM BYCORCEPT UNDER THIS AGREEMENT.ARTICLE 8TERM AND TERMINATION8.1 Term. The term of this Agreement (“Term”) shall commence upon the Effective Date and expire upon the completionof the Development Program, unless terminated earlier as provided in Section 8.2 or 8.3 below.8.2 Termination for Cause. Either party may terminate this Agreement, at its option, upon the occurrence of any of thefollowing: (a) Voluntary Liquidation Events. The other party shall (i) seek the liquidation, reorganization, dissolution orwinding up of itself or the composition or readjustment of all or substantially all of its debts, (ii) apply for or consent to theappointment of, or the taking of possession by, a receiver, custodian, trustee or liquidator of itself or of all or any substantialportion of its assets, (iii) make a general assignment for the benefit of its creditors, (iv) commence a voluntary case underapplicable bankruptcy, insolvency, reorganization, winding-up or composition or readjustment of debts or (v) adopt anyresolution of its board of directors or shareholders for the purpose of effecting any of the foregoing. (b) Involuntary Liquidation Events. A proceeding or case shall be commenced without the application or consentof the other party and such proceeding or case shall continue undismissed, or an order, judgment or decree approving orordering any of the following shall be entered and continue unstayed in effect, for a period of 90 days from and after the dateservice of process is effected upon the other party, seeking (a) its liquidation, reorganization, dissolution or winding up, or thecomposition or 11400 Burnet RoadBuilding 4, Suite 4010Austin, Texas 78758 Ph (512) 834-0449Fax (512) 834-2105www.pharmaform.com 12 [ *** ]Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission.Confidential treatment has been requested with respect to the omitted portions.readjustment of all or substantially all of its debts, (b) the appointment of a trustee, receiver, custodian, liquidator or the like ofitself or of all or substantially all of its assets or (c) similar relief under any law relating to bankruptcy, insolvency,reorganization, winding up or readjustment of debts. (c) Material Breach. Upon or after the breach of any material provision of this Agreement, if the breaching partyhas not cured such breach within 45 days after written notice thereof from the other party.8.3 Termination. Corcept shall have the right to terminate this Agreement upon 180 days written notice to PharmaForm.PharmaForm shall have the right to terminate this Agreement upon 180 days written notice to Corcept; provided, however, ifPharmaForm reasonably determines that continuing to perform its obligations under this Agreement will result in a material adverseeffect on PharmaForm’s ongoing business, operations or personnel as a result of negative or adverse publicity or responses from otherclients or potential clients of PharmaForm, PharmaForm and Corcept shall use commercially reasonable efforts to expedite the transferof all manufacturing operations and obligations away from PharmaFrom, after which point PharmaForm shall have the right toterminate this Agreement.8.4 Effect of Termination. Termination of this Agreement shall not relieve the parties of any obligation, including thepayment of money, accruing prior to such expiration or termination. Sections 2.4 and 3.3 and the provisions of Articles 4, 6, 7 and 9shall survive the expiration or termination of this Agreement.ARTICLE 9MISCELLANEOUS9.1 Notice. Any notice given under this Agreement must be in writing and will be effective when delivered to the otherparty at the address set forth for that party below. Notice addresses may only be changed in writing by the parties by following thenotice provisions of this Section 9.1.Formulation Technologies, LLCd/b/a/ PharmaForm11400 Burnet RoadSuite 4010Austin, Texas 78758Attn: John Koleng, Ph.D.Corcept Therapeutics Incorporated149 Commonwealth DriveMenlo Park, California 94025Attn: Robert L. Roe, M.D. 11400 Burnet RoadBuilding 4, Suite 4010Austin, Texas 78758 Ph (512) 834-0449Fax (512) 834-2105www.pharmaform.com 139.2 Entire Agreement. This Agreement contains the entire understanding of the parties with respect to the subject matterhereof. All express or implied agreements and understandings, either oral or written, heretofore made are expressly superseded by thisAgreement. This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by both partieshereto. No prior drafts of this Agreement may be used in the construction or interpretation of this Agreement.9.3 Waiver. The waiver by either party hereto of any right hereunder or the failure to perform or of a breach by the otherparty shall not be deemed a waiver of any other right hereunder or of any other breach or failure by said other party whether of asimilar nature or otherwise.9.4 Headings. The captions to the several Articles and Sections hereof are not a part of this Agreement, but are merelyguides or labels to assist in locating and reading the several Articles and Sections hereof.9.5 Drafting. This Agreement was, and shall be deemed for all purposes to have been, drafted by both parties.9.6 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State ofDelaware, without regard to the conflicts of laws principles thereof.9.7 Assignment. This Agreement may not be assigned or otherwise transferred, nor, except as expressly providedhereunder, may any right or obligations hereunder be assigned or transferred by either party without the prior written consent of theother party. Notwithstanding the foregoing, this Agreement may be assigned or transferred by a party without such prior consent to anysuccessor entity by merger, sale, transfer, or consolidation or the transferee of all or substantially all of the assets of the business unit towhich this Agreement relates. Any permitted assignee shall assume all obligations of its assignor under this Agreement.9.8 Force Majeure. Neither party shall be held liable or responsible to the other party nor be deemed to have defaultedunder or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement (except for the failure topay money) when such failure or delay is caused by or results from causes beyond the reasonable control of the affected party,including, but not limited to, fire, floods, embargoes, war, acts of war (whether war be declared or not), insurrections, riots, civilcommotions, strikes, lockouts or other labor disturbances, acts of God or acts, omissions or delays in acting by any governmentalauthority or the other party. The delayed party’s time for performance will be excused for the duration of the force majeure, but if theforce majeure events lasts longer than 60 days, the other party may immediately terminate this Agreement by giving written notice tothe delayed party.9.9 Dispute Resolution. Except as otherwise specifically provided herein, any disputes or disagreements arising underthe Agreement will be referred to the chief executive officers of PharmaForm and Corcept for good faith discussions, for a period notto exceed 60 11400 Burnet RoadBuilding 4, Suite 4010Austin, Texas 78758 Ph (512) 834-0449Fax (512) 834-2105www.pharmaform.com 14days. During such 60 days, both parties may in good faith explore resolution of the dispute using alternative dispute resolutiontechniques before pursuing other remedies. If such dispute is not resolved by the end of such 60-day period, the parties shall be free topursue any legal or equitable remedy available to them.9.10 Independent Contractors. Corcept and PharmaForm each acknowledge that they shall be independent contractorsand that the relationship between the two parties shall not constitute a partnership, joint venture or agency. Neither Corcept norPharmaForm shall have the authority to make any statements, representations or commitments of any kind, or to take any action, whichshall be binding on the other party, without the prior consent of the other party to do so.9.11 Severability. Should one or more provisions of this Agreement be or become invalid, the parties hereto shallsubstitute, by mutual consent, valid provisions for such invalid provisions which valid provisions in their economic effect aresufficiently similar to the invalid provisions that it can be reasonably assumed that the parties would have entered into this Agreementwith such provisions. In case such provisions cannot be agreed upon, the invalidity of one or several provisions of this Agreement shallnot affect the validity of this Agreement as a whole, unless the invalid provisions are of such essential importance to this Agreementthat it is to be reasonably assumed that the parties would not have entered into this Agreement without the invalid provisions.9.12 Product Labeling. Corcept covenants and agrees to use its commercially reasonable efforts to ensure that theproduct labeling and packaging on any NDA Product batches or commercial Product batches does not include any information relatingto or identifying PharmaForm or associating PharmaForm with the Product, including, without limitation, petitioning the FDA toprevent the inclusion of any information identifying PharmaFrom on the product labeling.[Signature Page Follows] 11400 Burnet RoadBuilding 4, Suite 4010Austin, Texas 78758 Ph (512) 834-0449Fax (512) 834-2105www.pharmaform.com 15 FORMULATION TECHNOLOGIES L.L.C. d/b/a PHARMAFORM By: /s/ John Koleng, Ph.D. John Koleng, Ph.D. Chief Operating Officer CORCEPT THERAPEUTICS By: /s/ Robert L. Roe, M.D. Robert L. Roe, M.D. President Exhibit A – Development Program Tasks • Transfer tablet manufacturing process to PharmaForm; conduct process improvement trials as required to achieve areliable tablet production and coating process. • Develop and validate analytical methods required for testing the drug product and drug substance. Specific methodsrequired for testing will be based on published regulatory guidance, specific regulatory feedback from the FDA and otherregulatory agencies and experience with the product. • Produce registration stability batches that will be used to establish the stability of the product in the NDA or otherregulatory submission. Conduct stability studies (thermal and photostability) according to regulatory guidance to generatestability data for regulatory submissions. • Perform product scale-up trials to scale the product from the registration stability batch size to commercial size andestablish criteria for process and product validation. • Prepare a process and product validation protocol and produce validation batches according to the protocol. Performstability testing on the validation batches. • Conduct additional product development activities as needed to address specific development issues as they arise.Exhibit 10.29MASTER SERVICES AGREEMENTTHIS MASTER SERVICES AGREEMENT (“Agreement”) is made as of 29 June 2010 (“Effective Date”), between United BioSource Corporation with aplace of business at 3822 Summit, Kansas City, Missouri 64111 (“UBC”) and Corcept Therapeutics Incorporated with its office located at 149Commonwealth Drive, Menlo Park, CA 94025 (“Client”), with each of UBC and Client being referred to herein individually as a “Party” or collectively asthe “Parties”.WHEREAS, UBC is engaged in the business of providing its clients with specialized pharmaceutical services in connection with the design, managementand conduct of clinical trials and registries of pharmaceuticals and biologics, and employs personnel knowledgeable about and experienced in clinicalresearch, statistics, computer programming, contracting, data processing and management, project management, and drug development regulations (UnitedStates and international) (the “Services”); andWHEREAS, Client wishes to retain UBC on an as-needed basis to provide Risk Evaluation and Mitigation Services (REMS) services (“Projects”).NOW, THEREFORE, In consideration of the premises and of the mutual promises of each Party to the other herein contained, it is hereby mutually agreed asfollows:1. Services1.1 The Services to be performed hereunder and accompanying timelines, budget and payment terms shall be specified in separate Statements of Work(“SOWs”), which upon signature and execution by both Parties, shall be deemed incorporated herein. Each SOW shall constitute a separate agreement andshall stand alone with respect to any other SOW entered into under this Agreement. In the event of a conflict between this Agreement and any SOW, theprovisions of this Agreement will control, unless the SOW specifically acknowledges the conflict and expressly states that the conflicting SOW controls.1.2 Any changes to the Services shall be subject to mutual agreement by the Parties and the details of such changes (e.g. budget impact, scope of serviceschanges, etc.) shall be agreed upon and memorialized via an amendment to the applicable SOW.1.3 UBC shall not subcontract or assign any Services to a non-affiliate without the prior written consent of Client provided, however, that UBC’s use ofsubcontractors is deemed approved when UBC’s proposal for Services explicitly details the usage of subcontractors or affiliate and such proposal has beenaccepted by Client. Should any subcontract or assignment of the Services occur, UBC shall be solely responsible for ensuring that any subcontractors orassignees are in compliance with the terms of this Agreement.2. Compensation2.1 Compensation for the Services rendered pursuant to this Agreement shall be in accordance with the applicable SOW. All payments (excluding DisputedAmounts as defined below) are due within thirty (30) days after receipt of invoice. As used herein, “Disputed Amounts” mean invoice amounts that aresubject to a bona fide dispute raised by Client within [ *** ] days of Client’s receipt of said invoice, which claim of Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request.Omissions are designated as [ *** ]. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.dispute may concern not only the accuracy of the charge itself, but also any claim of [ *** ] that relates to the specific charges in the invoice. A DisputedAmount raised by Client in writing within such [ *** ] day period may be withheld from the specific invoice to which it relates. All Disputed Amounts thatClient subsequently agrees in writing to pay or that are required to be paid pursuant to a proper court order or award shall be paid within [ *** ] days from thedate of such agreement or determination.2.2 Unless otherwise indicated in the respective SOW, all budgets, invoices and payments, and SOWs under this Agreement will be in United States Dollars(“US$”).2.3 All payments to UBC under this Agreement shall be made either via electronic transfer to:United BioSource CorporationC/o [ *** ][ *** ][ *** ][ *** ]or via check to:United BioSource CorporationLockbox [ *** ]PO Box [ *** ]Baltimore, MD 212752.4 In the event delay, postponement or suspension in the Services is requested by Client, and such delay, postponement or suspension has been continuingfor [ *** ] days, Client shall pay UBC for all Services rendered through the date of such delay, postponement or suspension plus reasonable costs directlyarising out of such delay, postponement or suspension, if any. Upon notice of delay, postponement or suspension of the Services, UBC agrees to use itscommercially reasonable efforts to immediately curtail its efforts and make no subsequent commitments for expenditures under this Agreement. In the eventof resumption of the Project, Client shall notify UBC, at which time UBC will resume Services under the terms of this Agreement.2.5 In the event the Services being performed under any SOW are terminated pursuant to Section 7 below, unless such termination is due to UBC’s breach ofany term or obligation hereunder, or other termination for cause, UBC shall be (a) compensated within [ *** ] days of termination for all fees and actualdocumented permitted costs incurred by UBC due as of the date of termination but not yet paid pursuant to the applicable SOW and (b) reimbursed any andall reasonable uncancellable obligations regarding third parties that were incurred as of the date of termination in compliance with the applicable SOW. Anyfunds held by UBC which shall be shown by Client to be unearned at the date of termination shall be returned to Client within [ *** ] days of termination ofthis Agreement.3. Confidential Information3.1 Both Parties shall treat any business strategies, plans and procedures, proprietary information, scientific, medical and technical data and trade secrets, andother confidential information and materials of the other Party, whether written, electronic, visual or verbal, tangible or intangible, made available, disclosed,or otherwise made known to it (“Confidential Information”) as the confidential and exclusive property of the other Party and shall not divulge or disclose thesame to third parties except with the prior written consent of the other Party. Further, each Party agrees that it will use the Confidential Information of [ *** ] Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment hasbeen requested with respect to the omitted portions.the other Party only for purposes of performing its obligations under this Agreement, and neither Party will use such Confidential Information for any otherpurpose without the prior written consent of the other Party. The provisions of this Section shall not apply to information which: a) is in, or later comes into,the public domain other than by breach of this Agreement or other fault of receiving Party; b) the receiving Party can demonstrate was in its possession priorto receipt of the Confidential Information as evidenced by its written business records; c) is independently received by receiving Party from a third-party withthe legal right to disclose it on a non-confidential basis; d) is independently developed by receiving Party without reliance on or use of the ConfidentialInformation of the disclosing Party, as evidenced by receiving Party’s written business records; or e) is required to be disclosed by a court of competentjurisdiction, by any governmental agency having supervisory authority over the business of the disclosing Party, or by any administrative body or legislativebody (including a committee thereof) with jurisdiction to order receiving Party to divulge, disclose or make accessible such information; provided that, in theevent that receiving Party is ordered by a court or other government agency to disclose any Confidential Information, receiving Party shall (i) promptlynotify disclosing Party of such order, (ii) at the written request of disclosing Party, diligently contest such order at the sole expense of disclosing Party asexpenses occur, and (iii) at the written request of disclosing Party, seek to obtain at the sole expense of disclosing Party such confidential treatment as may beavailable under applicable laws for any information disclosed under such order.3.2 The obligations of receiving Party as to disclosure and confidentiality shall come into effect as of the Effective Date of this Agreement and shall continuein force and survive the termination or expiration of this Agreement or the termination of the underlying SOW.3.3 Confidential Information of disclosing Party will only be provided by the receiving Party to the receiving Party’s employees, agents and consultants whohave a need to know such information for purposes of this Agreement, provided that such employees, agents and consultants shall be bound byconfidentiality obligations at least as restrictive as those set forth herein.3.4 Each Party agrees that, upon termination or expiration of this Agreement or any underlying SOW, or, at the disclosing Party’s earlier request, the receivingParty will return to the disclosing Party or destroy, as directed by disclosing Party, (i) all Confidential Information provided by or on behalf of the disclosingParty in tangible form, (ii) all Confidential Information of the disclosing Party received in soft-copy form (i.e., that was received by email or computer disk),and (iii) all copies, summaries, notes or derivatives thereof made by or at the direction of the receiving Party. The foregoing notwithstanding, each Party mayretain one (1) archival copy of the Confidential Information provided by the other Party in a limited access file for purposes of monitoring its ongoingobligations hereunder and to comply with any applicable regulatory requirements (including, but not limited to, those set forth in ICH Guideline E6GCP §4.9.5 and 21 CFR Section 312.57).3.5 Each Party agrees that a breach of this Agreement by the receiving Party may result in irreparable harm to disclosing Party for which money damageswould be inadequate. Consequently, in the event of a breach or threatened breach by receiving Party of this Agreement, disclosing Party shall be entitled,without the requirement of posting a bond or other security, to equitable relief, including injunctive relief and specific performance.4. Representations and Warranties4.1 Each Party represents and warrants that it is a corporation or limited liability company duly organized, validly existing and in good standing under thelaws of the state of its incorporation or formation.4.2 Each Party represents and warrants that it has the power and authority and legal right to enter into this Agreement and to perform the obligationshereunder, including under each SOW, and that it has taken all necessary corporate action to authorize execution of this Agreement.4.3 Each Party represents and warrants that all necessary consents, approvals and authorizations of governmental authorities and other persons required to beobtained related to the performance of this Agreement have been obtained.4.4 Each Party represents and warrants that the execution and delivery of this Agreement will not conflict with or violate any requirement of any applicablelaws or regulations, and do not conflict with or constitute a default under any contractual obligation enforceable against it.4.5 UBC represents and warrants that it shall perform the Services in a professional manner, in accordance with the standards of care and diligence practicedby recognized organizations in performing services of a similar nature at the time the Services are performed, and in accordance with all applicable laws,rules, regulations and guidelines.4.6 UBC represents and warrants that it has the right to provide the Services herein and in the provision of such Services, it will not infringe a valid patent,trade secret, copyright, or other intellectual property rights of a third-party.4.7 Client represents and warrants that it has the full legal right to provide all materials, biological or chemical specimens, and all associated intellectualproperty rights necessary for UBC to perform the Services pursuant to this Agreement or any SOW, (“Materials”) and that the Materials do not infringe uponany patent, trademark, copyright or any trade secret or any other proprietary right of any third party or person.4.8 Each Party certifies that neither it nor any of its officers, directors, employees or agents is currently subject to debarment action and none have beendebarred or convicted of a crime, which could lead to debarment, under the Generic Drug Enforcement Act of 1992. In the event that UBC or any of itsdirectors, officers, employees, agents, subcontractors, consultants, affiliates or advisors under contract to perform services under a SOW with UBC becomesdebarred or receives notice of action or threat of action with respect to its debarment, UBC shall notify Client immediately.4.9 UBC represents and warrants that entering into and performing Services under this Agreement will not interfere with or violate the terms of any otheragreement, arrangement or understanding to which it is or was a Party, and that there exist no restrictions or obligations to any third parties which will restrictits performance of Services under this Agreement.4.10 During the term of this Agreement, UBC shall maintain all materials and all other data obtained or generated by UBC in the course of providing theServices hereunder, including all computerized records and files. UBC shall cooperate with any reasonable request for internal review or audit by Client andmake available to Client for examination and duplication, during normal business hours and at mutually agreeable times, all documentation, data andinformation relating to a SOW or Project.5. Ownership and Use5.1 All right, title and interest in and to any data, materials, results, deliverables or other work arising, directly or indirectly, from the Services hereunder,whether prepared or performed by UBC, alone or in conjunction with others (“Work Product”) shall be considered “work for hire” and shall be owned solelyand exclusively by Client without any further payment owed. UBC hereby assigns to Client all rights UBC or its agents may have in any invention,technology, know-how or other intellectual property relating to such Work Product.5.2 Client acknowledges that as of the Effective Date of this Agreement, UBC possesses certain inventions, processes, know-how, improvements, otherintellectual properties and other assets, including butnot limited to, project management methods, procedures and techniques, procedure manuals, personnel data, financial information, site listings, SOP’s, andcomputer technical expertise and technology, which have been independently developed by UBC without the benefit of any information provided by Clientand which relate to UBC’s business or operations (collectively “UBC’s Property”). Client and UBC agree that any UBC Property or improvements theretowhich are used, improved, modified or developed by UBC under or during the term of this Agreement are the sole and exclusive property of UBC.6. Indemnification and Limitation of Liability6.1 Client shall indemnify UBC, its directors, officers, employees, agents, representatives, subcontractors, affiliates and advisors, for any and all damages,costs, expenses and other liabilities, including reasonable attorney’s fees and court costs, incurred in connection with any third-party claim, action orproceeding arising from (a) UBC’s connection to its obligations under this Agreement or any protocol related thereto, (b) any harmful or otherwise unsafeeffect of any Client drug product, (c) any breach by Client of this Agreement, or (d) any negligence, gross negligence or intentional misconduct of Client;provided however, that Client shall have no obligation hereunder with respect to any claim, action or proceeding to the extent shown by a court of competentjurisdiction to have arisen from the negligence, gross negligence or intentional misconduct on the part of UBC or any of its directors, officers, employees,agents, representatives, subcontractors, affiliates or advisors, or breach by UBC of any of its obligations under this Agreement.6.2 UBC shall indemnify Client, its directors, officers, and employees for any and all damages, costs, expenses and other liabilities, including reasonableattorney’s fees and court costs, incurred in connection with any third-party claim, action or proceeding to the extent shown by a court of competentjurisdiction to have arisen from the negligence or intentional misconduct of UBC or any of its directors, officers, employees, agents, affiliates orrepresentatives, or breach of UBC of any of its obligations under this Agreement.6.3 Neither Party, together with their affiliates and any of their respective directors, officers, employees, subcontractors, consultants or agents, shall have anyliability of any type (including, but not limited to, contract, negligence, and tort liability), for any special, incidental, indirect or consequential damages,including, but not limited to the loss of opportunity, loss of use, or loss of revenue or profit, in connection with or arising out of this Agreement, except asmay otherwise arise under applicable law.6.4 THE COLLECTIVE, AGGREGATE LIABILITY (INCLUDING, BUT NOT LIMITED TO, CONTRACT, NEGLIGENCE AND TORT LIABILITY) OF UBC,TOGETHER WITH ITS DIRECTORS, OFFICERS, EMPLOYEES AND AGENTS, UNDER THIS AGREEMENT SHALL NOT EXCEED [ *** ] FROM CLIENTPURSUANT TO THE SOW FOR THE SERVICES FROM WHICH SUCH LIABILITY AROSE. SUCH LIMITATION SHALL NOT LIMIT EITHER PARTY’SINDEMNIFICATION OBLIGATIONS UNDER SECTIONS 6.1 AND 6.2 AND SHALL NOT APPLY IN THE CASES OF (A) A PARTY’S BREACH OF ITSCONFIDENTIALITY OBLIGATIONS UNDER SECTION 3 OR (B) THE WILLFUL MISCONDUCT OF EITHER PARTY.6.5 Any Party liable to provide indemnification hereunder shall be entitled, at its option, to control the defense and settlement of any claim on which it isliable, provided that the indemnifying Party shall act reasonably and in good faith with respect to all matters relating to the settlement or disposition of theclaim as the disposition or settlement relates to the Party being indemnified. The indemnified Party shall reasonably cooperate in the investigation, defenseand settlement of any claim for which indemnification is sought hereunder and shall provide prompt notice of any such claim or reasonably expected claimto the [ *** ] Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment hasbeen requested with respect to the omitted portions.indemnifying Party. An indemnified Party shall have the right to retain its own separate legal counsel at its own expense.6.6 No settlement or compromise of a claim subject to the indemnification provision will be binding on either Party without prior written consent. Suchconsent of settlement or compromise will not be unreasonably withheld. Neither Party will admit fault on behalf of the other Party with out the writtenapproval of that Party.7. Term and Termination7.1 This Agreement shall be effective as of the Effective Date set forth above and shall terminate on the later of (a) the fourth (4) anniversary date from theEffective Date and (b) the completion of the Services being performed pursuant to a SOW that is in effect on the foregoing described third anniversary date.The early termination of this Agreement for any reason shall automatically terminate any and all SOWs, unless the Parties otherwise agree in writing. In anyevent, each SOW is and shall remain subject to the terms and conditions of this Agreement.7.2 Either Party may terminate this Agreement (in which case all then outstanding SOWs will terminate) and/or any specific SOW, for material breach by theother Party, upon [ *** ] days’ prior written notice if such breach is not cured within the notice period. Additionally, Client may terminate this Agreementand/or any SOW, in whole or in part, without cause at any time during the term of the Agreement upon [ *** ] days’ prior written notice to UBC, and UBCmay terminate this Agreement and/or any SOW, in whole or in part, without cause at any time during the term of the Agreement upon [ *** ] days’ writtennotice to Client, and help Client facilitate an orderly transition7.3 Upon the termination or expiration of this Agreement and/or any SOW, UBC shall promptly deliver to Client all data and materials provided by Client toUBC for the conduct of the Services and any other documentation and/or Work Product produced as the result of Services performed by UBC pursuant hereto.Further, UBC and Client shall cooperate with each other to provide for an orderly cessation of the Services provided by UBC hereunder and in accordancewith all applicable laws, rules and regulations, including those of the FDA. UBC may retain one (1) copy of the materials for archival purposes.7.4 The rights and obligations of UBC and Client, which by intent or meaning have validity beyond such termination or expiration shall survive thetermination or expiration of this Agreement.8. PublicityNeither Party shall use the other’s name in marketing materials and/or publicly release information pertaining to the details of the relationship,including but not limited to a press release, without the other Party’s prior written approval.9. Successors and AssignsUBC may not assign or otherwise transfer, without prior written consent of Client, which shall not be unreasonably withheld, its rights, duties orobligations under this Agreement, in whole or in part, to any person or entity other than an affiliate of UBC. Any such attempted assignment or transfer byUBC without the written consent of Client shall be void. Subject to the foregoing restrictions on assignment, this Agreement shall be binding upon UBC,assigns, and successors and shall inure to the benefit of Client, its successors and assigns. Upon written notice to UBC, Client may assign this Agreementand/or any SOW. [ *** ] Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment hasbeen requested with respect to the omitted portions.The rights and obligations of Client under this Agreement shall inure to the benefit of and shall be binding upon the successors and assign of Client.10. NoticeAny notice, demand or communication required or permitted to be given by any provision of this Agreement shall be in writing, in the Englishlanguage and shall be deemed to have been sufficiently given or served for all purposes if (a) delivered personally; (b) deposited with a pre-paid messenger,express or air courier or similar courier; or (c) transmitted by facsimile. Notices shall be addressed to a Party at the Party’s address or facsimile number set forthbelow. Notices shall be deemed to have been received (i) upon receipt in the case of personal delivery; (ii) three (3) days after being deposited in the case ofmessenger, express or air courier or similar courier; and (iii) the day of receipt as evidenced by a machine generated confirmation statement in the case oftransmittal by facsimile. If to UBC: United BioSource Corporation 920 Harvest Drive, Suite 200 Blue Bell, PA 19422 Attn: Contracts Management Fax: 215.591.2890With a copy to: United BioSource Corporation 7501 Wisconsin Avenue, Suite 705 Bethesda, MD 20814 Attn: General Counsel Fax: 240.644.0421If to Client: Corcept Therapeutics Incorporated 149 Commonwealth Drive Menlo Park, CA 94025 Attn: President Fax: 650.327.3218Either Party may change the individual designated above or its contact information or both by written notice in accordance with this Section.11. General Provisions11.1 If any provision of this Agreement is found by any court of competent jurisdiction to be invalid or unenforceable, the invalidity of such provision shallnot affect the other provisions of this Agreement, and all provisions not affected by such invalidity shall remain in full force and effect.11.2 No waiver of any term, condition or obligation of this Agreement shall be valid unless made in writing and signed by the Party or Parties to which suchperformance is due. No waiver of any one or several of the terms, conditions or obligations of this Agreement, and no partial waiver thereof, shall beconstrued as a waiver of any of the other terms, conditions or obligations of this Agreement. No failure or delay by either Party at any time to enforce one ormore of the terms, conditions or obligations of this Agreement shall constitute waiver of such terms, conditions or obligations or shall preclude such Partyfrom requiring performance by the other Party at any later time.11.3 This Agreement, including SOWs (and all exhibits hereto and thereto), constitute the entire agreement between the Parties with respect to the subjectmatter hereof and supersedes all prior agreements between the Parties, whether written or oral, relating to the same subject matter. No modifications,amendments or supplements to this Agreement shall be effective for any purpose unless set forth in writing and signed by both Parties. Any purchase order orother document issued by UBC or Client is for administrative convenience only. In the event of any conflict between the provisions of this Agreement andany purchase order, as well as the introduction of new terms on any such purchase order, the provisions of this Agreement shall prevail and govern.11.4 The Parties hereto are independent contractors and nothing contained in this Agreement shall be construed to place them in the relationship of partners,principal and agent, employer/employee or joint venturer. Both Parties agree that they shall neither have the power nor right to bind or obligate the other, norshall either hold itself out as having such authority. Neither Party’s employees, agents nor representatives are employees or agents of the other Party, norentitled to any of the other Party’s benefits. Neither Party will be responsible for payment of the other Party’s workers’ compensation, disability benefits orunemployment insurance, nor will it be responsible for withholding or paying employment related taxes for the other Party or its employees.11.5 In the event either Party shall be delayed or hindered in or prevented from the performance of any act required hereunder by reasons of strike, lockouts,restrictive government or judicial orders or decrees, riots, insurrection, war, Acts of God, inclement weather or other similar reason or a cause beyond suchParty’s control, then performance of such act shall be excused for the period of such delay. Any timelines affected by such force majeure shall be extended fora period equal to that of the delay and any affected SOW shall be adjusted to reflect costs resulting from force majeure, provided that, should any delaycontinue for more than [ *** ] days, either Party may terminate this Agreement immediately upon written notice and shall not be responsible for anytermination expenses or increased costs. Notice of the start and stop of any such force majeure shall be provided to the other Party.11.6 This Agreement is governed by and will be construed in accordance with the laws of the State of New York and the laws of the United States of Americaapplicable therein.11.7 Any dispute under this Agreement involving its interpretation or the obligations of a Party hereto shall be resolved by binding arbitration [ *** ].Arbitration shall be by a panel of three (3) arbitrators. All arbitrators are to be selected by mutual agreement of the Parties from a panel provided by the [ ***]. The chairman shall be an attorney at law knowledgeable in clinical research law, and the other arbitrators shall have a background or training in eitherpharmaceutical or clinical research law, clinical science, or pharmaceutical product liability law. In the event the Parties cannot agree on the selection of anymembers of the arbitration panel, the [ *** ] shall have the power to appoint any and all such arbitrators. The arbitrators shall have the authority to permitdiscovery, to the extent deemed appropriate by the arbitrators, upon request of a Party. The arbitrators shall have no power or authority to add to or detractfrom the agreements of the Parties. The arbitrators shall have the authority to grant injunctive relief in a form substantially similar to that which wouldotherwise be granted by a court of law. The resulting arbitration award may be enforced in a court of competent jurisdiction.11.8 Each Party agrees that in the event of any dispute hereunder, such Party will reimburse the other Party for the reasonable attorneys’ fees, costs andexpenses incurred by such other Party in investigating, preparing and defending against claims made in such arbitration to the extent such other Partyprevails on the merits with respect to all such claims. The tribunal which hears such claims may determine which is the prevailing Party and the amount ofsuch fees, costs and expenses to which such other Party is entitled.11.9 This Agreement may be executed in two counterparts, each of which shall be an original but all of which together shall constitute one and the sameinstrument. [ *** ] Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment hasbeen requested with respect to the omitted portions.IN WITNESS THEREOF, this Agreement has been executed by the Parties hereto through their duly authorized officers as of the Effective Date setforth above. Duly authorized on behalf ofUnited BioSource Corporation Duly authorized on behalf ofCorcept Therapeutics Incorporated Signed: /s/ Patrick Lindsay Signed: /s/ Joseph K. Belanoff, M.D.Name: Patrick Lindsay Name: Joseph K. Belanoff, M.D.Title: Executive Vice President Title: Chief Executive OfficerDate: 29 June 2010 Date: July 6, 2010Exhibit 23.1Consent of Independent Registered Public Accounting FirmWe consent to the incorporation by reference in the following Registration Statements:(1) Registration Statement (Form S-8 No. 333-116127) pertaining to the 2000 Stock Option Plan and the 2004 Equity Incentive Plan of Corcept TherapeuticsIncorporated,(2) Registration Statements (Form S-8 Nos. 333-150199, 333-158406 and 333-164531) pertaining to the 2004 Equity Incentive Plan of Corcept TherapeuticsIncorporated, and(3) Registration Statements (Form S-3 Nos. 333-149087, 333-150204, 333-163140, 333-167211, 333-168928, 333-141881, 333-150232 and 333-150259) ofCorcept Therapeutics Incorporated and in the related Prospectuses;of our reports dated March 15, 2011, with respect to the financial statements of Corcept Therapeutics Incorporated (a development stage company) and theeffectiveness of internal control over financial reporting of Corcept Therapeutics Incorporated included in this Annual Report (Form 10-K) of CorceptTherapeutics Incorporated for the year ended December 31, 2010./s/ Ernst & Young LLPPalo Alto, CaliforniaMarch 15, 2011Exhibit 31.1CERTIFICATIONI, Joseph K. Belanoff, M.D., certify that: 1.I have reviewed this Annual Report on Form 10-K for the period ended December 31, 2010 of Corcept Therapeutics Incorporated; 2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport; 3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4.The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a-15(e) and 15d-15(e) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f))for the registrant and have: (a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, toensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within thoseentities, particularly during the period in which this report is being prepared; (b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under oursupervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements forexternal purposes in accordance with generally accepted accounting principles; (c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and (d)Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recentfiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materiallyaffect, the registrant’s internal control over financial reporting; and 5.The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to theregistrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): (a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonablylikely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and (b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controlover financial reporting. /s/ JOSEPH K. BELANOFFJoseph K. Belanoff, M.D.Chief Executive OfficerMarch 15, 2011Exhibit 31.2CERTIFICATIONI, Caroline M. Loewy, certify that: 1.I have reviewed this Annual Report on Form 10-K for the period ended December 31, 2010 of Corcept Therapeutics Incorporated; 2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport; 3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4.The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a-15(e) and 15d-15(e) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f))for the registrant and have: (a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, toensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within thoseentities, particularly during the period in which this report is being prepared; (b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under oursupervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements forexternal purposes in accordance with generally accepted accounting principles; (c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and (d)Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recentfiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materiallyaffect, the registrant’s internal control over financial reporting; and 5.The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to theregistrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): (a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonablylikely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and (b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controlsover financial reporting. /s/ CAROLINE M. LOEWYCaroline M. LoewyChief Financial OfficerMarch 15, 2011Exhibit 32.1Corcept Therapeutics IncorporatedCERTIFICATION PURSUANT TO18 U.S.C. SECTION 1350,AS ADOPTED PURSUANT TOSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002In connection with the Annual Report of Corcept Therapeutics Incorporated (the “Company”) on Form 10-K for the period ended December 31, 2010,as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Joseph K. Belanoff, M.D., Chief Executive Officer of theCompany, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that: (1)The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and (2)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of theCompany. /s/ JOSEPH K. BELANOFFJoseph K. Belanoff, M.D.Chief Executive OfficerMarch 15, 2011Exhibit 32.2Corcept Therapeutics IncorporatedCERTIFICATION PURSUANT TO18 U.S.C. SECTION 1350,AS ADOPTED PURSUANT TOSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002In connection with the Annual Report of Corcept Therapeutics Incorporated (the “Company”) on Form 10-K for the period ended December 31, 2010,as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Caroline M. Loewy, Chief Financial Officer of the Company,certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that: (1)The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and (2)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of theCompany. /s/ CAROLINE M. LOEWYCaroline M. LoewyChief Financial OfficerMarch 15, 2011

Continue reading text version or see original annual report in PDF format above