• Data from Corcept's 178-patient, randomized, controlled, Phase 2 trial featured in a proffered paper oral presentation at ESMO 2021
    • Results show statistically significant and clinically relevant benefit experienced by women with recurrent platinum-resistant ovarian cancer who were treated with nab-paclitaxel plus Corcept's proprietary selective cortisol modulator, relacorilant

    MENLO PARK, Calif., Sept. 17, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced that results from its 178-patient, randomized, controlled, Phase 2 trial…

    • Data from Corcept's 178-patient, randomized, controlled, Phase 2 trial featured in a proffered paper oral presentation at ESMO 2021

    • Results show statistically significant and clinically relevant benefit experienced by women with recurrent platinum-resistant ovarian cancer who were treated with nab-paclitaxel plus Corcept's proprietary selective cortisol modulator, relacorilant

    MENLO PARK, Calif., Sept. 17, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced that results from its 178-patient, randomized, controlled, Phase 2 trial of relacorilant plus nab-paclitaxel in patients with recurrent platinum-resistant ovarian cancer were featured in a proffered paper oral presentation at the European Society for Medical Oncology (ESMO) Congress 2021.

    "Women with recurrent platinum-resistant ovarian cancer have few therapeutic options," said William Guyer, PharmD, Corcept's Chief Development Officer. "The results presented at ESMO today clearly demonstrate the benefit experienced by the women who received relacorilant – delayed disease progression without increased side effect burden. We and our investigators are excited to begin a pivotal Phase 3 trial in the first quarter of next year to confirm these results."

    Women who entered the trial were randomized 1:1:1 to receive either (i) nab-paclitaxel plus 150 mg of relacorilant given the day before, the day of, and the day after each weekly nab-paclitaxel infusion ("Intermittent" arm) (ii) nab-paclitaxel plus 100 mg relacorilant given daily ("Continuous" arm), or (iii) nab-paclitaxel alone ("Comparator" arm). While women in both relacorilant treatment arms experienced an improvement in progression free survival relative to the Comparator arm, the improvement in the Intermittent arm was statistically significant. Safety and tolerability of relacorilant plus nab-paclitaxel was comparable to nab-paclitaxel monotherapy.

    Intermittent Arm versus Comparator Arm:

    Women who received the higher dose of relacorilant intermittently exhibited a statistically significant improvement in median progression free survival (PFS) compared to those who received nab-paclitaxel alone (median PFS: 5.6 months versus 3.8 months, hazard ratio: 0.66; p-value: <0.05). The women in the Intermittent arm also experienced a statistically significant improvement in the duration of response (DoR) relative to those in the Comparator arm (median DoR: 5.6 months versus 3.7 months, hazard ratio: 0.36; p-value: 0.006). While the overall survival (OS) data was only 63% mature at the time of the database cut-off (March 2021), the women in the Intermittent arm exhibited a median OS of 12.9 months versus 10.4 months in the Comparator arm (see Table 1). 

     

     IntermittentComparatorIntermittent vs Comparator
    Median PFS 

    (95% CI)
    5.6 months3.8 monthsHazard Ratio: 0.66 (0.44, 0.98)



    p-value: <0.05
    Median DoR

    (95% CI)
    5.6 months3.7 monthsHazard Ratio: 0.36 (0.16, 0.77)



    p-value: 0.006
    Median OS

    (63% maturity)
    12.9 months10.4 monthsHazard Ratio: 0.63 (0.35, 1.14)



    p-value: 0.12
    Table 1: Summary of results of Intermittent and Comparator arms. PFS: progression free survival; ORR: objective response rate; DoR: duration of response; OS: overall survival.



    The presentation at ESMO is available at www.corcept.com/research-pipeline/publications. Additional information about the study (NCT03776812) can be obtained at www.ClinicalTrials.gov.

    About Relacorilant

    Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor that does not bind to the body's other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including ovarian, adrenal and castration-resistant prostate cancer and Cushing's syndrome. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents. It has received orphan drug designation in the United States for the treatment of Cushing's syndrome and pancreatic cancer.

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    Forward Looking Statements

    Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties concern, but are not limited to, the design and results of our clinical trials; our ability to achieve our goals during the COVID-19 pandemic; the development of relacorilant as a treatment for ovarian cancer, including its clinical attributes, regulatory approvals, mandates and oversight, and other requirements; and the scope and protective power of our intellectual property. In this press release, forward-looking statements, include those concerning the clinical attributes of relacorilant and its potential benefits in patients with ovarian cancer, results of our Phase 2 trial and our planning for a Phase 3 pivotal trial. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. We disclaim any intention or duty to update forward-looking statements made in this press release.

    CONTACT:

    Corcept Therapeutics

    Investor Relations

    ir@corcept.com

    www.corcept.com



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    • Data from Corcept's 178-patient, randomized, controlled, Phase 2 trial to be featured in a proffered paper oral presentation at the upcoming ESMO conference on September 17, 2021
    • Results show benefit experienced by women with recurrent platinum-resistant ovarian cancer who were treated with nab-paclitaxel plus Corcept's proprietary selective cortisol modulator, relacorilant

    MENLO PARK, Calif., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced that results from its 178-patient, randomized, controlled, Phase 2 trial of…

    • Data from Corcept's 178-patient, randomized, controlled, Phase 2 trial to be featured in a proffered paper oral presentation at the upcoming ESMO conference on September 17, 2021

    • Results show benefit experienced by women with recurrent platinum-resistant ovarian cancer who were treated with nab-paclitaxel plus Corcept's proprietary selective cortisol modulator, relacorilant

    MENLO PARK, Calif., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced that results from its 178-patient, randomized, controlled, Phase 2 trial of relacorilant plus nab-paclitaxel in patients with recurrent platinum-resistant ovarian cancer will be featured in a proffered paper oral presentation at the European Society for Medical Oncology (ESMO) Congress 2021. The congress will take place from September 16 – 21, 2021.

    "We are extremely excited by the potential of relacorilant to treat women with recurrent platinum-resistant ovarian cancer," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer.   "As we announced when we released our preliminary results, delaying disease progression without increasing side effect burden was a tremendous benefit to the women in this trial. In the first quarter of next year, we plan to initiate a pivotal Phase 3 trial to confirm these positive results."  

    Presentation Title: Relacorilant, a selective glucocorticoid receptor modulator, in combination with nab-paclitaxel improves progression-free survival in patients with recurrent platinum-resistant ovarian cancer: A 3-arm, randomized, open-label, phase II study

    Speaker: Dr. Domenica Lorusso, Gynecologic Oncology Unit Fondazione Policlinico Universitario Gemelli IRCCS

    Presentation Number: 721O

    Session: Gynecological Cancers Proffered Paper Session

    Presentation Date/Time: Friday, September 17, 2021 at 13:40 – 13:50 CEST | Channel 3

    About Relacorilant

    Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor that does not bind to the body's other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including ovarian, adrenal and castration-resistant prostate cancer and Cushing's syndrome. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents. It has received orphan drug designation in the United States for the treatment of Cushing's syndrome and pancreatic cancer.

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    Forward Looking Statements

    Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties concern, but are not limited to, the design and results of our clinical trials; our ability to achieve our goals during the COVID-19 pandemic; the development of relacorilant as a treatment for ovarian cancer, including its clinical attributes, regulatory approvals, mandates and oversight, and other requirements; and the scope and protective power of our intellectual property. In this press release, forward-looking statements, include those concerning the clinical attributes of relacorilant and its potential benefits in patients with ovarian cancer, results of our Phase 2 trial and our planning for a Phase 3 pivotal trial. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. We disclaim any intention or duty to update forward-looking statements made in this press release.

    CONTACT:

    Corcept Therapeutics

    Investor Relations

    ir@corcept.com

    www.corcept.com



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  1. MENLO PARK, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol, today announced the appointment, effective August 16, 2021, of William Guyer, PharmD, as the company's Chief Development Officer.

    Dr. Guyer comes to Corcept from Gilead Sciences, Inc., where he most recently served as Senior Vice President and Global Head of Medical Affairs. He will report to Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. Andreas Grauer, MD, previously Corcept's Chief Medical Officer, has become a senior medical advisor to…

    MENLO PARK, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol, today announced the appointment, effective August 16, 2021, of William Guyer, PharmD, as the company's Chief Development Officer.

    Dr. Guyer comes to Corcept from Gilead Sciences, Inc., where he most recently served as Senior Vice President and Global Head of Medical Affairs. He will report to Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. Andreas Grauer, MD, previously Corcept's Chief Medical Officer, has become a senior medical advisor to the company.

    "I am delighted to welcome Bill to Corcept," said Dr. Belanoff. "His decades of experience developing medications to treat complex diseases, including in areas where no effective treatments had previously existed, his commitment to putting patients first, and his proven ability to build and lead teams will make him an exceptional addition to our management team."

    Dr. Guyer brings approximately 30 years of medical and clinical experience to his role at Corcept, including nearly 20 years in positions of increasing seniority at Gilead Sciences. Since 2015 he has served as Senior Vice President of Gilead's global Medical Affairs team, with responsibility for developing strategies to advance compounds from research to commercialization – including designing and supporting company and investigator-sponsored studies and health outcomes research, as well as scientific communications and medical education for Gilead's entire portfolio of medications. Dr. Guyer has been involved in numerous successful drug launches in his career, helping to develop and bring to market medicines for very complex diseases. He has led innovative drug development, medical and scientific programs and partnerships, including collaborative studies, cooperative group engagement and real-world data generation across a broad portfolio in infectious diseases, liver diseases, oncology and inflammation. He holds a PharmD from the University of Southern California.

    "I am thrilled to join Corcept at such a promising time in its development," said Dr. Guyer. "Cortisol modulation's potential to treat such a wide array of serious diseases and to help patients with critical unmet medical needs is incredibly exciting. I look forward to helping my colleagues design, implement and advance our clinical programs as broadly and rapidly as possible."

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    Forward-Looking Statements

    Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business and achieve our goals and conduct our clinical trials during the COVID-19 pandemic and to generate sufficient revenue to fund our commercial operations and development programs; the availability of competing treatments, including generic versions of Korlym; our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym; risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates and oversight, and other requirements; and the scope and protective power of our intellectual property. These and other risks are set forth in our Securities and Exchange Commission ("SEC") filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include those concerning the start of Dr. Guyer's employment and Dr. Grauer's continued service as an advisor to the Company. We disclaim any intention or duty to update forward-looking statements.

    CONTACT:

    Investor Relations

    ir@corcept.com

    www.corcept.com



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  2. MENLO PARK, Calif., July 29, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and neuropsychiatric disorders by modulating the effects of the hormone cortisol, today reported its results for the quarter ended June 30, 2021.

    Financial Results

    • Revenue of $91.6 million, compared to $88.6 million in second quarter 2020
    • GAAP diluted net income of $0.21 per share, compared to $0.23 per share in second quarter 2020
    • Non-GAAP diluted net income of $0.30 per share, compared to $0.32 per share in second quarter 2020
    • Cash and investments of $471.6 million, compared to $454.8 million at March 31, 2021
    • Reiterated 2021

    MENLO PARK, Calif., July 29, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and neuropsychiatric disorders by modulating the effects of the hormone cortisol, today reported its results for the quarter ended June 30, 2021.

    Financial Results

    • Revenue of $91.6 million, compared to $88.6 million in second quarter 2020
    • GAAP diluted net income of $0.21 per share, compared to $0.23 per share in second quarter 2020
    • Non-GAAP diluted net income of $0.30 per share, compared to $0.32 per share in second quarter 2020
    • Cash and investments of $471.6 million, compared to $454.8 million at March 31, 2021
    • Reiterated 2021 revenue guidance of $355$385 million

    Second quarter 2021 revenue was $91.6 million, compared to $88.6 million in the second quarter of 2020. First quarter 2021 revenue was $79.4 million. Second quarter 2021 GAAP net income was $26.5 million, compared to $28.3 million in the second quarter of 2020. Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets, together with related income tax effects, non-GAAP net income in the second quarter was $38.2 million, compared to $39.7 million in the second quarter of 2020. A reconciliation of GAAP to non-GAAP net income is included below.

    Second quarter operating expenses were $59.6 million, compared to $53.3 million in the second quarter of 2020, due to increased employee compensation expenses, commercial spending, spending on clinical trials in Cushing's syndrome and pre-clinical activities.

    Cash and investments were $471.6 million at June 30, 2021, compared to $454.8 million at March 31, 2021. The balance at June 30, 2021 reflects the acquisition of $30.8 million of common stock in the second quarter – 1.4 million shares pursuant to the company's stock repurchase program and 0.1 million shares in connection with the net exercise of stock options. Under the repurchase program's current terms, $127.6 million remains available for the purchase of shares.

    The company reiterated its 2021 revenue guidance of $355 – $385 million.

    "Diminishing COVID-19 public health restrictions and the availability of safe and effective vaccines have allowed our commercial business to resume growing," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "Our second quarter results reflect the fact that physicians are seeing their patients more frequently, which allows them to diagnose and optimally treat those who have Cushing's syndrome. Provided COVID-19 restrictions continue to abate – as we believe they will – we expect growth to continue. Korlym is an excellent treatment for hypercortisolism and there are many eligible patients who have yet to receive it. Our planned successor to Korlym, relacorilant, which is currently in its pivotal trial, promises to be an even better medication."

    Clinical Development

    "We are enthusiastic about the potential of cortisol modulation to help treat many diseases, not just Cushing's syndrome," added Dr. Belanoff. "Our programs in solid tumors, non-alcoholic steatohepatitis (NASH) and antipsychotic-induced weight gain (AIWG) continue to make progress. We are especially excited about our advancing platinum-resistant ovarian cancer program. Based on the statistically significant and clinically meaningful results of our 178-patient, controlled Phase 2 trial, we plan to initiate a pivotal trial in the first quarter of next year."

    Solid Tumors

    • Phase 3 pivotal trial in patients with platinum-resistant ovarian cancer to start in the first quarter of 2022
    • Selection of the optimum dose of exicorilant plus enzalutamide in patients with castration-resistant prostate cancer (CRPC) expected later this year
    • Enrollment continues in 20-patient, open-label, Phase 1b trial of relacorilant plus PD-1 checkpoint inhibitor pembrolizumab in patients with adrenal cancer with cortisol excess

    "We look forward to starting a Phase 3 pivotal trial in women with platinum-resistant ovarian cancer," said Andreas Grauer, MD, Corcept's Chief Medical Officer. "Our Phase 2 results illustrated that women who received relacorilant with nab-paclitaxel experienced improved progression free survival (PFS) without experiencing additional side effects, a welcome finding for women with few good treatment options. We will present detailed results of our Phase 2 trial at the European Society for Medical Oncology (ESMO) meeting in September in a proffered paper oral presentation, with overall survival data expected later in the year. And we continue to evaluate relacorilant as a possible treatment for patients with other glucocorticoid receptor-expressing tumors."

    Metabolic Diseases

    • Phase 1b dose-finding trial in patients with presumed NASH to start in the fourth quarter of 2021
    • Enrollment continues in GRATITUDE, a 100-patient double-blind, placebo-controlled, Phase 2 trial of miricorilant to reverse recent AIWG
    • Enrollment continues in GRATITUDE II, a 150-patient, double-blind, placebo-controlled Phase 2 trial of miricorilant to reverse long-standing AIWG

    "We plan to begin a Phase 1b, dose-finding trial of miricorilant in patients with presumed NASH in the fourth quarter of this year," said Dr. Grauer. "Patients who received miricorilant in our previous trial experienced exceptionally large and rapid reductions in liver fat accompanied by substantial, but transient, elevations of the liver enzymes ALT and AST. Our hypothesis is that the rapidity and magnitude of miricorilant's fat reducing effect irritated the liver. The objective of our planned study is to identify a dosing regimen that can produce significant reductions in fat without causing liver irritation."

    "Meanwhile, our Phase 2 trials evaluating miricorilant as a treatment for patients with AIWG – GRATITUDE and GRATITUDE II – continue to advance," added Dr. Grauer. "We expect to complete enrollment in GRATITUDE II by year-end and in GRATITUDE by mid-2022."

    Cushing's Syndrome

    • Enrollment continues in Phase 3 GRACE trial of relacorilant as a treatment for patients with all etiologies of Cushing's syndrome; NDA submission expected in the second quarter of 2023
    • Enrollment continues in Phase 3 GRADIENT trial of relacorilant as a treatment for patients with Cushing's syndrome caused by adrenal adenomas

    "We advanced relacorilant to Phase 3 based on its extremely promising Phase 2 efficacy and safety data, which we recently published in Frontiers in Endocrinology (Pivonello 2021)," said Dr. Grauer. "We expect our GRACE trial, which is accruing patients and generating data, to serve as the basis for relacorilant's NDA in Cushing's syndrome. We expect to submit this relacorilant NDA in the second quarter of 2023. The Phase 3 GRADIENT trial will produce valuable data about an etiology of Cushing's syndrome that affects many patients, but has not been subject to rigorous, controlled study."

    Conference Call

    We will hold a conference call on July 29, 2021, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, Click this link (listen-only mode) or dial 1-833-693-0540 from the United States or 1-661-407-1581 internationally approximately 15 minutes before the start of the call. The passcode will be 1482035. A replay will be available on the Investors / Past Events tab of our website.

    Hypercortisolism

    Hypercortisolism, often referred to as Cushing's syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing's syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing's syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, 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. Hypercortisolism can affect every organ system and can be lethal if not treated effectively. Corcept holds patents covering the composition of relacorilant and the use of cortisol modulators, including Korlym, in the treatment of patients with hypercortisolism.

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Korlym was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    GAAP Measures of Net Income

    To supplement our financial results presented on a GAAP basis, we use non-GAAP measures of net income, basic net income per share and diluted net income per share that exclude the following non-cash expenses – (i) stock-based compensation, (ii) our use of deferred tax assets to offset current tax expense and (iii) related income tax effects. We believe these non-GAAP measures help investors evaluate our financial performance and potential future results. Our non-GAAP measures may be different from, and not directly comparable to, those used by other companies. They are not a substitute for comparable GAAP measures and should not be considered in isolation. Investors should read our non-GAAP presentation in conjunction with our financial statements prepared in accordance with GAAP.

    Forward-Looking Statements

    Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business and achieve our goals and conduct our clinical trials during the COVID-19 pandemic and to generate sufficient revenue to fund our commercial operations and development programs; the availability of competing treatments, including generic versions of Korlym; our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym; risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates and oversight, and other requirements; and the scope and protective power of our intellectual property. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include those concerning the clinical attributes of relacorilant and its effects in patients with ovarian cancer, plans to initiate a phase 3 trial in women with platinum-resistant ovarian cancer and continued evaluation of relacorilant as a possible treatment for patients with other glucocorticoid receptor-expressing tumors; the clinical attributes of miricorilant and its effects in patients with NASH and plans to initiate a Phase 1b trial in NASH; 2021 revenue guidance; our expectations regarding growth of our business; our clinical development programs; the progress, enrollment, timing, design and results of our clinical trials, including the timing of enrollment, data and dosing selection; the timing of regulatory submissions; the course of the COVID-19 pandemic and its impact on patients, physicians, medical practice, clinical research activities and our business; and the clinical and commercial attributes of Korlym, relacorilant, exicorilant and miricorilant. We disclaim any intention or duty to update forward-looking statements made in this press release.



    CORCEPT THERAPEUTICS INCORPORATED

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands, except per share data)

     June 30, December 31,
     2021 2020
     (Unaudited) (See Note 1)
    Assets   
    Cash and investments$471,639  $476,892 
    Trade receivables, net of allowances27,620  26,198 
    Inventory19,403  21,157 
    Operating lease right-of-use asset1,524  2,509 
    Deferred tax assets, net33,741  31,603 
    Other assets14,553  13,372 
    Total assets$568,480  $571,731 
    Liabilities and Stockholders' Equity   
    Accounts payable$9,216  $10,554 
    Operating lease liabilities1,559  2,551 
    Other liabilities35,030  35,288 
    Stockholders' equity522,675  523,338 
    Total liabilities and stockholders' equity$568,480  $571,731 
        
    (1) Derived from audited financial statements at that date   



    CORCEPT THERAPEUTICS INCORPORATED

    CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

    (Unaudited)

    (In thousands, except per share data)

     Three Months Ended Six Months Ended
     June 30, June 30,
     2021 2020 2021 2020
    Revenues       
    Product revenue, net$91,588  $88,565  $171,025  $181,812 
            
    Operating expenses       
    Cost of sales1,384  1,234  2,652  3,112 
    Research and development28,232  26,497  57,254  52,620 
    Selling, general and administrative30,029  25,572  59,538  53,107 
    Total operating expenses$59,645  $53,303  $119,444  $108,839 
    Income from operations31,943  35,262  51,581  72,973 
    Interest and other income110  1,010  385  2,481 
    Income before income taxes32,053  36,272  51,966  75,454 
    Income tax expense(5,530) (7,945) (1,978) (17,062)
    Net income$26,523  $28,327  $49,988  $58,392 
    Other comprehensive income:       
    Net unrealized (loss) gain on available-for-sale investments, net of tax impact of $16, $(170), 77 and (190), respectively(50) 545  (242) 606 
    Foreign currency translation gain (loss), net of tax16  (15) 42  (27)
    Total comprehensive income$26,489  $28,857  $49,788  $58,971 
            
    Basic net income per share$0.23  $0.25  $0.43  $0.51 
            
    Diluted net income per share$0.21  $0.23  $0.39  $0.48 
            
    Shares used in computing basic net income per common share116,294  115,006  116,555  114,790 
    Shares used in computing diluted net income per common share126,680  123,234  128,204  122,756 



    CORCEPT THERAPEUTICS INCORPORATED

    RECONCILIATION OF GAAP TO NON-GAAP NET INCOME

    (Unaudited)

    (In thousands, except per share data)

     Three Months Ended Six Months Ended
     June 30, June 30,
     2021 2020 2021 2020
    GAAP net income$26,523  $28,327  $49,988  $58,392 
            
    Non-cash expenses (benefits)       
    Stock-based compensation       
    Cost of sales16  15  26  38 
    Research and development3,825  2,794  7,330  5,399 
    Selling, general and administrative7,227  5,680  13,813  10,970 
    Total stock-based compensation11,068  8,489  21,169  16,407 
    Deferred income taxes3,299  4,922  (2,061) 10,017 
    Income tax effect of non-GAAP adjustments (1)(2,656) (2,037) (5,081) (3,938)
    Non-GAAP net income, adjusted for non-cash expenses$38,234  $39,701  $64,015  $80,878 
            
    GAAP basic net income per share$0.23  $0.25  $0.43  $0.51 
            
    GAAP diluted net income per share$0.21  $0.23  $0.39  $0.48 
            
    Non-GAAP basic net income per share, adjusted for non-cash expenses per share$0.33  $0.35  $0.55  $0.70 
            
    Non-GAAP diluted net income per share, adjusted for non-cash expenses per share$0.30  $0.32  $0.50  $0.66 
            
    Shares used in computing basic net income per common share116,294  115,006  116,555  114,790 
    Shares used in computing diluted net income per common share126,680  123,234  128,204  122,756 
            
    (1) Calculated by applying the statutory tax rate to the pre-tax, non-discrete, non-GAAP adjustments.



    CONTACT:


    Corcept Therapeutics

    Investor Relations

    ir@corcept.com

    www.corcept.com



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  3. MENLO PARK, Calif., July 22, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT) today announced it will report second quarter financial results and provide a corporate update on July 29, 2021. The company will also host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

    Conference Call Information
    To participate, click the link below and enter your information. The link will become active 15 minutes prior to the scheduled start time.

    Click to Join Meeting

    Alternatively, you may dial 1-833-693-0540 from the United States or 1-661-407-1581 internationally approximately 15 minutes before the start of the call. The passcode will be 1482035.

    A replay will be available through August 12, 2021…

    MENLO PARK, Calif., July 22, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT) today announced it will report second quarter financial results and provide a corporate update on July 29, 2021. The company will also host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

    Conference Call Information

    To participate, click the link below and enter your information. The link will become active 15 minutes prior to the scheduled start time.

    Click to Join Meeting

    Alternatively, you may dial 1-833-693-0540 from the United States or 1-661-407-1581 internationally approximately 15 minutes before the start of the call. The passcode will be 1482035.

    A replay will be available through August 12, 2021 at 1-855-859-2056 from the United States and 1-404-537-3406 internationally. The passcode will be 1482035.

    About Corcept Therapeutics Incorporated

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    CONTACT:

    Corcept Therapeutics

    Investor Relations

    ir@corcept.com

    www.corcept.com



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  4. MENLO PARK, Calif., July 12, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol, today announced that Amy Flood has joined the company as Chief Human Resources and Communications Officer.

    "I'm very pleased to welcome Amy to our executive team," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "She played a key role in building the talented teams that enabled Gilead Sciences' great success. Her proven communications skills and her ability to attract, engage and retain talented employees will help us meet the challenges…

    MENLO PARK, Calif., July 12, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol, today announced that Amy Flood has joined the company as Chief Human Resources and Communications Officer.

    "I'm very pleased to welcome Amy to our executive team," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "She played a key role in building the talented teams that enabled Gilead Sciences' great success. Her proven communications skills and her ability to attract, engage and retain talented employees will help us meet the challenges Corcept faces as we expand our commercial business and develop our growing portfolio of selective cortisol modulators."

    Ms. Flood has nearly 25 years of experience in team development and communications in the biotech industry. She previously spent 21 years at Gilead Sciences, most recently as Senior Vice President, Public Affairs, where she led a global team responsible for corporate brand, employee communications, product public relations, advocacy and philanthropy. While at Gilead she also led company-wide efforts to expand professional development opportunities for women, a targeted team mentoring and development initiative, and multiple programs focused on diversity, equity and inclusion. Prior to joining Gilead, Amy worked in healthcare public relations in New York, before relocating to San Francisco in 1998 to help establish her firm's west coast operations. 

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    CONTACT:

    Investor Relations

    ir@corcept.com

    www.corcept.com



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    • Enrollment stopped in RELIANT trial
    • Antitumor activity observed in heavily pretreated patients with metastatic pancreatic cancer, including those previously treated with nab-paclitaxel; addition of relacorilant to nab-paclitaxel therapy was well-tolerated
    • Phase 3 pivotal trial in patients with platinum-resistant ovarian cancer upcoming
    • Treatment of patients with earlier line pancreatic cancer as well as patients with other solid tumors will be evaluated

    MENLO PARK, Calif., June 22, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced…

    • Enrollment stopped in RELIANT trial
    • Antitumor activity observed in heavily pretreated patients with metastatic pancreatic cancer, including those previously treated with nab-paclitaxel; addition of relacorilant to nab-paclitaxel therapy was well-tolerated
    • Phase 3 pivotal trial in patients with platinum-resistant ovarian cancer upcoming
    • Treatment of patients with earlier line pancreatic cancer as well as patients with other solid tumors will be evaluated

    MENLO PARK, Calif., June 22, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced preliminary results from its Phase 3 RELIANT trial of relacorilant combined with nab-paclitaxel in patients with metastatic pancreatic cancer.

    "RELIANT evaluated relacorilant plus nab-paclitaxel in pancreatic cancer patients who had relapsed following at least two prior lines of therapy, including treatment with nab-paclitaxel in almost all cases," said Andreas Grauer, MD, Corcept's Chief Medical Officer. "Two of 31 evaluable patients exhibited tumor shrinkage designated as a partial response, a response rate of six percent, while 15 patients achieved stable disease for at least 12 weeks. The combination was well-tolerated. These data are similar to those of our Phase 1 study.

    "Metastatic pancreatic cancer is a dire disease and patients who have relapsed following multiple lines of therapy have no effective treatment options. While our interim analysis suggests that the combination of relacorilant and nab-paclitaxel is active in these patients, the apparent level of benefit does not justify its further study as a treatment for end-stage pancreatic cancer."

    "All of the cancers we are studying are aggressively lethal and we will not pursue an approval unless we believe our candidate therapy offers a substantial benefit," added Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "Our development program in solid tumors continues to advance. Based on the positive results of our controlled Phase 2 trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer, we are very excited to initiate a pivotal trial for that indication in the first quarter of 2022. Our trials of relacorilant plus pembrolizumab in patients with adrenal cancer and of exicorilant plus enzalutamide in patients with castration-resistant prostate cancer continue to enroll. Based on the promising clinical trial results we have observed across our oncology programs, we are evaluating relacorilant as a potential treatment for patients with earlier stages of pancreatic cancer and with other glucocorticoid receptor-expressing tumors."

    Trial Design and Preliminary Results

    RELIANT is a single-arm, multicenter, open-label, Phase 3 trial of relacorilant combined with nab-paclitaxel in patients with metastatic pancreatic cancer, with a planned enrollment of 80 patients and a planned interim analysis of outcomes in the first 40 patients.   Patients received 100 mg of relacorilant every day and 80 mg/m2 nab-paclitaxel on Days 1, 8 and 15 of each 28-day cycle. RELIANT's primary endpoint is objective response rate.

    At the planned interim analysis, the study had enrolled 43 patients with metastatic pancreatic cancer who had received 2-4 prior lines of therapy (median prior lines of therapy: three), including 40 patients who were previously treated with nab-paclitaxel.   As of the database cutoff date of April 15, 2021, there were 31 efficacy-evaluable patients. Two of these patients (six percent) had a partial response (best response based on RECIST v1.1); and 15 patients (48 percent) had stable disease, with two patients (six percent) with stable disease greater than 18 weeks.   Safety was consistent with known profiles for relacorilant and nab-paclitaxel.   

    About Relacorilant

    Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor that does not bind to other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including ovarian, pancreatic and castration-resistant prostate cancer, as well as Cushing's syndrome. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents. It has received orphan drug designation in the United States for the treatment of Cushing's syndrome and pancreatic cancer.

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    Forward Looking Statements

    Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties concern, but are not limited to, the design and results of our clinical trials; our ability to achieve our goals during the COVID-19 pandemic; the development of relacorilant as a treatment for pancreatic cancer, including its clinical attributes, regulatory approvals, mandates and oversight, and other requirements; and the scope and protective power of our intellectual property. In this press release, forward-looking statements, include those concerning the clinical attributes of relacorilant and its potential benefits in patients with pancreatic cancer patients and metastatic ovarian cancer, as well as the progress, timing and results of our trials of relacorilant in ovarian cancer, adrenal cancer and of exicorilant in castration-resistant prostate cancer. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. We disclaim any intention or duty to update forward-looking statements made in this press release.

    CONTACT:

    Corcept Therapeutics

    Investor Relations

    ir@corcept.com

    www.corcept.com



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  5. MENLO PARK, Calif., June 15, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced that it has entered into an agreement with Sun Pharmaceutical Industries Limited and related entities ("Sun") resolving patent litigation related to Korlym®, Corcept's medication for the treatment of patients with Cushing's syndrome. The litigation has been pending in the United States District Court for the District of New Jersey since 2019, shortly after Sun notified Corcept that it had submitted an Abbreviated New Drug Application (ANDA) to the United…

    MENLO PARK, Calif., June 15, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced that it has entered into an agreement with Sun Pharmaceutical Industries Limited and related entities ("Sun") resolving patent litigation related to Korlym®, Corcept's medication for the treatment of patients with Cushing's syndrome. The litigation has been pending in the United States District Court for the District of New Jersey since 2019, shortly after Sun notified Corcept that it had submitted an Abbreviated New Drug Application (ANDA) to the United States Food and Drug Administration (FDA) seeking approval to market a generic version of Korlym.

    In connection with the settlement, Corcept has granted Sun the right to sell a generic version of Korlym in the United States beginning October 1, 2034 or earlier under circumstances customary for settlement agreements of this type.

    "It is gratifying to put this lawsuit behind us," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "Litigation is a costly, time-consuming diversion from our efforts to grow our Korlym business and continue the development of our increasingly mature pipeline of selective cortisol modulators – including relacorilant, our planned successor to Korlym for the treatment of patients with Cushing's syndrome."

    The settlement agreement is subject to entry by the Court of a stipulation and order of dismissal related to the litigation. As required by law, Corcept and Sun will submit the agreement to the United States Federal Trade Commission (FTC) and the United States Department of Justice (DOJ) for review. Similar patent litigation brought by Corcept against two other companies that have filed ANDAs seeking approval to market generic Korlym remains pending.

    About Korlym®

    Korlym modulates the effect of cortisol at the glucocorticoid receptor, one of the two receptors to which cortisol binds, thereby inhibiting the effects of excess cortisol in patients with Cushing's syndrome. Since 2012, Corcept has made Korlym available as a once-daily oral treatment of hyperglycemia secondary to endogenous Cushing's syndrome in adult patients with glucose intolerance or diabetes mellitus type 2 who have failed surgery or are not candidates for surgery. Korlym was the first FDA-approved treatment for that illness.

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol. Korlym was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    Forward Looking Statements

    Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties concern, but are not limited to, our patents being determined to be invalid or unenforceable or a third party marketing a generic version of Korlym before the conclusion of applicable patent litigation, and the Court, the FTC or the DOJ requiring changes to the settlement agreement. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include statements regarding review of the settlement agreement by the Court, the FTC and the DOJ as well as our ability to grow our Korlym business and advance the development of our selective cortisol modulators, including relacorilant as a potential successor to Korlym. We disclaim any intention or duty to update forward-looking statements made in this press release.

    CONTACT:

    Corcept Therapeutics

    Investor Relations

    ir@corcept.com

    www.corcept.com



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  6. MENLO PARK, Calif., June 10, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, announced today that Joshua M. Murray has joined the company's Board of Directors.

    Mr. Murray is currently Senior Vice President, Finance, Strategy and Investor Relations at Orca Bio, a privately held biotechnology company developing allogeneic cell therapies in blood, immune, and genetic diseases. Prior to joining Orca, Mr. Murray spent 15 years at Goldman Sachs, most recently as a Managing Director in the Investment Banking Division, where he…

    MENLO PARK, Calif., June 10, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, announced today that Joshua M. Murray has joined the company's Board of Directors.

    Mr. Murray is currently Senior Vice President, Finance, Strategy and Investor Relations at Orca Bio, a privately held biotechnology company developing allogeneic cell therapies in blood, immune, and genetic diseases. Prior to joining Orca, Mr. Murray spent 15 years at Goldman Sachs, most recently as a Managing Director in the Investment Banking Division, where he advised a wide array of biotechnology and life sciences companies. He received an AB in History and Economics from Harvard College.

    "I am very pleased to welcome Josh to our board," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "His extensive experience counseling healthcare companies confronting the challenges and opportunities of growth will help us as we bring Korlym® to more patients and advance our pipeline of proprietary, selective cortisol modulators."

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Korlym was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. The company owns extensive intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    Forward-Looking Statements

    Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business and achieve our goals and conduct our clinical trials during the Covid-19 pandemic and to generate sufficient revenue to fund our commercial operations and development programs; the availability of competing treatments, including generic versions of Korlym; our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym; and risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates and oversight, and other requirements. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include statements regarding our commercial growth and the advancement of our clinical development programs. We disclaim any intention or duty to update forward-looking statements made in this press release.

    CONTACT:

    Corcept Therapeutics

    Investor Relations

    ir@corcept.com

    www.corcept.com



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    • In a 178-patient, controlled, Phase 2 trial, women with platinum-resistant ovarian cancer who received relacorilant plus nab-paclitaxel experienced improved progression free survival (PFS) compared to women who received nab-paclitaxel alone, with comparable safety and tolerability; planning underway for Phase 3 pivotal trial
    • In Phase 2 trial, patients with presumed nonalcoholic steatohepatitis (NASH) administered miricorilant experienced large, rapid reductions in liver fat
    • Revenue of $79.4 million, compared to $93.2 million in first quarter 2020
    • GAAP diluted net income of $0.18 per share, compared to $0.25 per share in first quarter 2020
    • Non-GAAP diluted net income of $0.20 per share, compared to $0.34 per share in first quarter 2020
    • Cash and investments
    • In a 178-patient, controlled, Phase 2 trial, women with platinum-resistant ovarian cancer who received relacorilant plus nab-paclitaxel experienced improved progression free survival (PFS) compared to women who received nab-paclitaxel alone, with comparable safety and tolerability; planning underway for Phase 3 pivotal trial

    • In Phase 2 trial, patients with presumed nonalcoholic steatohepatitis (NASH) administered miricorilant experienced large, rapid reductions in liver fat
    • Revenue of $79.4 million, compared to $93.2 million in first quarter 2020
    • GAAP diluted net income of $0.18 per share, compared to $0.25 per share in first quarter 2020
    • Non-GAAP diluted net income of $0.20 per share, compared to $0.34 per share in first quarter 2020
    • Cash and investments of $454.8 million, compared to $476.9 million at December 31, 2020
    • Modified 2021 revenue guidance of $355 to $385 million

    MENLO PARK, Calif., May 06, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and neuropsychiatric disorders by modulating the effects of the stress hormone cortisol, today reported its results for the quarter ended March 31, 2021.

    First quarter 2021 revenue was $79.4 million, compared to $93.2 million in the first quarter of 2020. The decrease in revenue in the first quarter was primarily due to the effects of the COVID-19 pandemic on our business.

    First quarter operating expenses were $59.8 million, compared to $55.5 million in the first quarter of 2020, due to increased spending on clinical trials in Cushing's syndrome and metabolic diseases and the formulation and manufacture of the company's proprietary selective cortisol modulators.

    First quarter 2021 GAAP net income was $23.5 million, compared to $30.1 million in the first quarter of 2020. Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets, together with related income tax effects, non-GAAP net income in the first quarter was $25.8 million, compared to $41.2 million in the first quarter of 2020. A reconciliation of GAAP to non-GAAP net income is included below.

    Cash and investments were $454.8 million at March 31, 2021, compared to $476.9 million at December 31, 2020. The company repurchased 2.1 million shares of its common stock in the first quarter – 1.3 million shares for $33.5 million pursuant to the company's stock repurchase program and 0.8 million shares for $16.4 million in connection with the net exercise of stock options – at a total cost of $50.0 million.   Under the stock repurchase program's currently authorized terms, $156.8 million remains available for the purchase of shares.

    Corcept modified its 2021 revenue guidance to $355 – $385 million. Corcept anticipates positive cash flow for the foreseeable future.

    "The lingering effects of the spike in COVID-19 in the fourth quarter of last year extended further into the first quarter than we anticipated, coloring our commercial results," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "Many physicians are still not able to see their patients often enough to optimally diagnose and treat a complex disease such as Cushing's syndrome. Further, many patients introduced to Korlym during the pandemic have so far not reached their ideal dose, as many physicians are seeing their patients less frequently, particularly in person, and testing them less frequently, slowing optimal titration.

    "We expect these effects to diminish as COVID restrictions and fears diminish. The best treatment for Cushing's syndrome involves substantial and frequent engagement between patients and physicians," said Dr. Belanoff. "Our modified 2021 revenue guidance assumes that pandemic-related obstacles will ease substantially in the third quarter – about two quarters later than we had originally thought.   Leading physicians increasingly believe that the number of patients with hypercortisolism is substantially greater than once assumed. Korlym is an excellent treatment for hypercortisolism.   Relacorilant, if approved, will be even better.   We expect significant revenue growth and profits in the years ahead."

    Clinical Development Highlights

    "Despite having to contend with pandemic-related headwinds," said Dr. Belanoff, "our clinical development efforts, particularly in the United States, gained momentum in the first quarter. Today we announced positive data related to two of our proprietary, selective cortisol modulators as possible treatments for platinum-resistant ovarian cancer and NASH. These are important advances for the potential treatment of these diseases, which have a high unmet need. In addition, we are encouraged that these results provide further clinical validation of our cortisol modulation platform as a treatment for a broad range of diseases. In contrast to the past when sometimes a year would pass between releases of clinical results, we now expect important information to emerge every quarter."

    Solid Tumors

    • In a 178-patient, controlled, Phase 2 trial, women with platinum-resistant ovarian cancer who received relacorilant plus nab-paclitaxel experienced improved progression free survival (PFS) compared to women who received nab-paclitaxel alone, with comparable safety and tolerability *
    • Planning underway for a Phase 3 pivotal trial in ovarian cancer
    • Preliminary results in the first 40 patients enrolled in open-label Phase 3 RELIANT trial of relacorilant

      plus nab-paclitaxel in patients with metastatic pancreatic cancer expected this quarter
    • Selection of the optimum dose of exicorilant plus enzalutamide in patients with castration-resistant prostate cancer ("CRPC") expected by third quarter 2021
    • Enrollment continues in a 20-patient, open-label, Phase 1b trial of relacorilant plus PD-1 checkpoint inhibitor pembrolizumab in patients with adrenal cancer with cortisol excess

    "We are extremely pleased with the results of our trial of relacorilant as a possible treatment for platinum-resistant ovarian cancer," said Andreas Grauer, MD, Corcept's Chief Medical Officer. "Delaying disease progression in these women, without causing additional side effects, is heartening. We are planning a Phase 3 pivotal trial which we hope will replicate these positive data."

    Participants in the trial were randomized 1:1:1 to receive either (i) nab-paclitaxel plus a daily dose of relacorilant (100 mg), (ii) nab-paclitaxel plus relacorilant (150mg) given "intermittently" (i.e., the day before, the day after, and the day of each weekly nab-paclitaxel infusion) or (iii) nab-paclitaxel alone.

    Women who received the higher dose of relacorilant intermittently exhibited a statistically significant improvement in median progression free survival compared to those who received nab-paclitaxel alone (median PFS: 5.6 months versus 3.8 months, hazard ratio: 0.66; p-value: 0.038). Women who received the lower, daily, dose of relacorilant experienced longer progression free survival, but the improvement did not reach statistical significance (5.3 months versus 3.8 months, hazard ratio: 0.83). Full results of the trial, including overall survival, will be available later this year.

    "Our trials in other solid tumors continue to progress," added Dr. Grauer. "We expect to have interim data from our RELIANT trial of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer at the end of this quarter. Our trial of relacorilant plus pembrolizumab in patients with adrenal cancer with cortisol excess continues to enroll patients. And by the end of the third quarter, we expect to select an optimal dose of our selective cortisol modulator exicorilant combined with enzalutamide in patients with castration-resistant prostate cancer."

    Metabolic Diseases

    • In Phase 2 trial, patients with presumed NASH administered miricorilant experienced large, rapid reductions in liver fat *
    • Enrollment continues in GRATITUDE, a 100-patient double-blind, placebo-controlled, Phase 2 trial of miricorilant to reverse recent anti-psychotic-induced weight gain ("AIWG")
    • Enrollment continues in GRATITUDE II, a 150-patient, double-blind, placebo-controlled Phase 2 trial of miricorilant to reverse long-standing AIWG

    "Four of the first five patients who received miricorilant for four weeks in our Phase 2 trial of patients with presumed NASH experienced sharply elevated levels of the liver enzymes ALT and AST, which resolved after miricorilant was withdrawn" said Dr. Grauer. "They also exhibited large reductions in liver fat (see Table 1).

    PatientMiricorilant

    (per day)
    Days

    on Drug
    % Liver Fat

    at Baseline
    % Liver Fat

    at Follow up
    Days Between

    Last Dose

    and Follow-up
    Relative

    Reduction in

    % Liver Fat
    Patient 1900 mg3017.66.119-65.3%
    Patient 2900 mg3127.817.164-38.5%
    Patient 3900 mg4428.315.016-47.0%
    Patient 4600 mg3412.63.321-73.8%
    Table 1: Reduction in liver fat content measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF)

    "The improvement in liver fat in these patients was greater and occurred much more rapidly than we had expected. We powered our trial with a planned enrollment of 120 patients to detect a 30 percent reduction in liver fat after twelve weeks' dosing," said Dr. Grauer. "These results are especially notable given that they were measured many days after miricorilant was stopped. We are gathering more information, consulting with experts in liver disease and formulating our plans to advance miricorilant in NASH."

    "In the meantime, our Phase 2 trials evaluating miricorilant as treatment for patients with AIWG – GRATITUDE and GRATITUDE II – continue to add patients," added Dr. Grauer. "We expect to complete enrollment in GRATITUDE II by year-end and GRATITUDE in mid-2022."

    Cushing's Syndrome

    • Enrollment continues in Phase 3 GRACE trial of relacorilant as a treatment for patients with any etiology of Cushing's syndrome at sites in the United States, Canada, Europe and Israel; NDA submission expected by second quarter 2023



    • Enrollment continues in Phase 3 GRADIENT trial of relacorilant as a treatment for patients with Cushing's syndrome of adrenal origin at sites in the United States, Europe and Israel

    "Relacorilant's Phase 2 efficacy and safety data were extremely promising. We expect GRACE to serve as the basis for our NDA in Cushing's syndrome. GRACE is accruing patients and generating data and we have observed an improved enrollment rate at our sites in the United States over the last few months. While the pandemic continues to suppress enrollment in GRACE and GRADIENT, particularly in Europe, where the pace of recovery from COVID has lagged, we remain on track for NDA submission by the second quarter of 2023," said Dr. Grauer. "GRADIENT will produce valuable data about the role of cortisol modulation in an etiology of Cushing's syndrome that has not previously been subject to a rigorous, controlled study."

    Conference Call

    We will hold a conference call on May 6, 2021, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, Click this link (listen-only mode) or dial 1-888-204-4368 from the United States or 1-313-209-4906 internationally approximately 15 minutes before the start of the call. The passcode will be 8720277. A replay will be available on the Investors / Past Events tab of our website.

    Hypercortisolism

    Hypercortisolism, often referred to as Cushing's syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing's syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing's syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, 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. Hypercortisolism can affect every organ system in the body and can be lethal if not treated effectively. Corcept holds patents covering the composition of relacorilant and the use of cortisol modulators, including Korlym, in the treatment of patients with hypercortisolism.

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Korlym was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    GAAP Measures of Net Income

    To supplement our financial results presented on a GAAP basis, we use non-GAAP measures of net income, basic net income per share and diluted net income per share that exclude the following non-cash expenses – (i) stock-based compensation, (ii) our use of deferred tax assets to offset current tax expense and (iii) related income tax effects. We believe these non-GAAP measures help investors evaluate our financial performance and potential future results. Our non-GAAP measures may be different from, and not directly comparable to, those used by other companies. They are not a substitute for comparable GAAP measures and should not be considered in isolation. Investors should read our non-GAAP presentation in conjunction with our financial statements prepared in accordance with GAAP.

    Forward-Looking Statements

    Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business and achieve our goals and conduct our clinical trials during the COVID-19 pandemic and to generate sufficient revenue to fund our commercial operations and development programs; the availability of competing treatments, including generic versions of Korlym; our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym; risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates and oversight, and other requirements; and the scope and protective power of our intellectual property. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include those concerning the clinical attributes of relacorilant and its effects in patients with ovarian cancer, plans to initiate a phase 3 trial and potential to treat other solid tumors; the clinical attributes of miricorilant and its effects in patients with NASH and the requirements to resume the Phase 2 trial in NASH; 2021 revenue guidance; our clinical development programs; the progress, enrollment, timing, design and results of our clinical trials, including the timing of enrollment, data and dosing selection; the timing of regulatory submissions; the course of the COVID-19 pandemic and its impact on patients, physicians, medical practice, clinical research activities and our business; and the clinical and commercial attributes of Korlym, relacorilant, exicorilant and miricorilant. We disclaim any intention or duty to update forward-looking statements made in this press release.

    CONTACT:

    Corcept Therapeutics

    Investor Relations

    ir@corcept.com

    www.corcept.com

    CORCEPT THERAPEUTICS INCORPORATED

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands, except per share data)

     March 31,

    2021
     December 31,

    2020
     (Unaudited) (See Note 1)
    Assets   
    Cash and investments$454,793  $476,892 
    Trade receivables, net of allowances22,200  26,198 
    Inventory20,332  21,157 
    Operating lease right-of-use asset2,020  2,509 
    Deferred tax assets, net37,025  31,603 
    Other assets16,028  13,372 
    Total assets$552,398  $571,731 
    Liabilities and Stockholders' Equity   
    Accounts payable$6,969  $10,554 
    Operating lease liabilities2,067  2,551 
    Other liabilities32,560  35,288 
    Stockholders' equity510,802  523,338 
    Total liabilities and stockholders' equity$552,398  $571,731 
        
    (1) Derived from audited financial statements at that date   



    CORCEPT THERAPEUTICS INCORPORATED

    CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

    (Unaudited)

    (In thousands, except per share data)

     Three Months Ended
     March 31,
     2021 2020
    Revenues   
    Product revenue, net$79,437  $93,247 
        
    Operating expenses   
    Cost of sales1,268  1,878 
    Research and development29,022  26,123 
    Selling, general and administrative29,509  27,535 
    Total operating expenses$59,799  $55,536 
    Income from operations19,638  37,711 
    Interest and other income275  1,471 
    Income before income taxes19,913  39,182 
    Income tax benefit (expense)3,552  (9,117)
    Net income$23,465  $30,065 
    Other comprehensive income:   
    Net unrealized (loss) gain on available-for-sale investments, net of tax impact of $61, $(20), respectively(192) 61 
    Foreign currency translation gain (loss), net of tax26  (12)
    Total comprehensive income$23,299  $30,114 
        
    Basic net income per share$0.20  $0.26 
        
    Diluted net income per share$0.18  $0.25 
        
    Shares used in computing basic net income per common share116,818  114,575 
    Shares used in computing diluted net income per common share129,668  122,226 
          



    CORCEPT THERAPEUTICS INCORPORATED

    RECONCILIATION OF GAAP TO NON-GAAP NET INCOME

    (Unaudited)

    (In thousands, except per share data)

     Three Months Ended
     March 31,
     2021  2020 
    GAAP net income$23,465  $30,065 
        
    Non-cash expenses (benefits)   
    Stock-based compensation   
    Cost of sales10  23 
    Research and development3,505  2,605 
    Selling, general and administrative6,586  5,290 
    Total stock-based compensation10,101  7,918 
    Deferred income taxes(5,360) 5,095 
    Income tax effect of non-GAAP adjustments (1)(2,424) (1,900)
    Non-GAAP net income, adjusted for non-cash expenses$25,782  $41,178 
        
    GAAP basic net income per share$0.20  $0.26 
        
    GAAP diluted net income per share$0.18  $0.25 
        
    Non-GAAP basic net income per share, adjusted for non-cash expenses per share$0.22  $0.36 
        
    Non-GAAP diluted net income per share, adjusted for non-cash expenses per share$0.20  $0.34 
        
    Shares used in computing basic net income per common share116,818  114,575 
    Shares used in computing diluted net income per common share129,668  122,226 
        
    (1) Calculated by applying the statutory tax rate to the pre-tax, non-discrete, non-GAAP adjustments.




    * For more information, see the Investors / Press Releases tab at www.corcept.com.



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  7. MENLO PARK, Calif., May 06, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced interim findings from the Phase 2 trial of its selective cortisol modulator miricorilant in patients with presumed NASH.

    "This was our first trial to evaluate miricorilant as a treatment for patients with liver disease. When we observed elevated ALT and AST levels in four of the first five patients who received miricorilant for four weeks, we suspended the study," said Andreas Grauer, MD, Corcept's Chief Medical Officer. "Our investigation has made…

    MENLO PARK, Calif., May 06, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced interim findings from the Phase 2 trial of its selective cortisol modulator miricorilant in patients with presumed NASH.

    "This was our first trial to evaluate miricorilant as a treatment for patients with liver disease. When we observed elevated ALT and AST levels in four of the first five patients who received miricorilant for four weeks, we suspended the study," said Andreas Grauer, MD, Corcept's Chief Medical Officer. "Our investigation has made two notable findings. First, the elevations in ALT and AST resolved after miricorilant was withdrawn." (See Figures 1 and 2)

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/00d4659c-26e2-4ecf-aa44-10cefb13a5d3

    "Second, the patients with elevated liver enzymes exhibited large reductions in liver fat rapidly." (See Table 1)  

    PatientMiricorilant

    (per day)
    Days

    on Drug
    % Liver Fat

    at Baseline
    % Liver Fat

    at Follow up
    Days Between

    Last Dose and

    Follow-up
    Relative

    Reduction in

    % Liver Fat
    Patient 1900 mg3017.66.119-65.3%
    Patient 2900 mg3127.817.164-38.5%
    Patient 3900 mg4428.315.016-47.0%
    Patient 4600 mg3412.63.321-73.8%
    Table 1: Reduction in liver fat content measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF)

    "We had planned to enroll 120 patients in this study, which we thought would be sufficient to detect a 30 percent reduction in liver fat after 12 weeks," continued Dr. Grauer. "These patients exhibited much larger reductions after receiving miricorilant for 4-6 weeks. These findings are particularly striking because their follow-up liver MRI was some distance from their final dose."

    "Liver fat reductions achieved this quickly and of this magnitude are rarely seen ," said Dr. Stephen A. Harrison, M.D., Medical Director for Pinnacle Clinical Research, San Antonio, Texas, Visiting Professor of Hepatology, Oxford University and principal investigator in Corcept's Phase 2 trial. "Fatty liver disease and NASH afflict many millions of people and there are no approved treatments. Further study is warranted to evaluate if miricorilant can produce such significant reductions in liver fat safely and that the reduction results in a meaningful improvement in NASH."   

    About the Phase 2 Trial

    This double-blind, placebo-controlled Phase 2 study is designed to enroll 120 patients with presumed NASH at 15 clinical sites in the United States. Patients are randomized 1:1:1 to receive a daily dose of 600 mg of miricorilant, 900 mg of miricorilant or placebo. The trial's primary endpoint is reduction in liver fat at week 12 as assessed by MRI-PDFF, with a secondary endpoint being the proportion of patients who exhibit liver fat reduction of at least 30 percent at week 12. Additional information about the study (NCT03823703) is at www.ClinicalTrials.gov.

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds, including miricorilant, that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    Forward Looking Statements

    Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those statements express or imply. These risks and uncertainties include, but are not limited to, the progress, enrollment, timing, design and results of our clinical trials; our ability to operate our business and achieve our goals and conduct our clinical trials during the COVID-19 pandemic; the availability of competing treatments; risks related to the development of miricorilant as a product candidate for NASH, including its clinical attributes, regulatory approvals, mandates and oversight, and other requirements; and the scope and protective power of our intellectual property. In this press release, forward-looking statements include those concerning the clinical attributes of miricorilant and its effects in patients with NASH and the requirements to resume its development as a treatment for fatty liver disease and NASH. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. We disclaim any intention or duty to update forward-looking statements made in this press release.

    CONTACT:

    Corcept Therapeutics

    Investor Relations

    ir@corcept.com

    www.corcept.com



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    • Women with platinum resistant ovarian cancer experienced longer progression free survival with relacorilant plus nab-paclitaxel than with nab-paclitaxel alone
    • Women who received a higher dose of relacorilant given "intermittently" together with nab-paclitaxel exhibited a statistically significant improvement in their progression free survival compared to those who received nab-paclitaxel alone (median PFS: 5.6 months versus 3.8 months, hazard ratio: 0.66; p-value: 0.038)
    • When a lower dose of relacorilant was given daily with nab-paclitaxel, median PFS was 1.5 months longer compared to patients who received nab-paclitaxel alone (5.3 months versus 3.8 months, hazard ratio: 0.83; p-value: NS)
    • Safety and tolerability of relacorilant plus nab-paclitaxel
    • Women with platinum resistant ovarian cancer experienced longer progression free survival with relacorilant plus nab-paclitaxel than with nab-paclitaxel alone

    • Women who received a higher dose of relacorilant given "intermittently" together with nab-paclitaxel exhibited a statistically significant improvement in their progression free survival compared to those who received nab-paclitaxel alone (median PFS: 5.6 months versus 3.8 months, hazard ratio: 0.66; p-value: 0.038)
    • When a lower dose of relacorilant was given daily with nab-paclitaxel, median PFS was 1.5 months longer compared to patients who received nab-paclitaxel alone (5.3 months versus 3.8 months, hazard ratio: 0.83; p-value: NS)
    • Safety and tolerability of relacorilant plus nab-paclitaxel comparable to nab-paclitaxel monotherapy
    • Planning underway for Phase 3 pivotal trial

    MENLO PARK, Calif., May 06, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced positive results from its 178-patient, controlled, Phase 2 trial of relacorilant plus nab-paclitaxel in patients with recurrent platinum-resistant ovarian cancer.

    Women with platinum resistant ovarian cancer (n=60) who received 150 mg of relacorilant the day before, the day of and the day after their weekly nab-paclitaxel infusion exhibited a statistically significant improvement in progression free survival (hazard ratio 0.66, p-value 0.038) compared to women (n=60) who received nab-paclitaxel monotherapy; their median progression free survival was 1.8 months longer (5.6 vs 3.8 months). Safety data and tolerability data for the two groups were comparable. (See Figure 1)

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/04ae9096-0e8c-4248-9473-22c4d4450cb5

    A third cohort of patients (n=58) received a daily dose of relacorilant (100 mg per day, with titration to 150 mg per day at the investigator's discretion) in addition to nab-paclitaxel. These patients' median progression-free survival increased 1.5 months compared to the control arm, to 5.3 months, but this improvement did not reach statistical significance (hazard ratio 0.83).

    "It's impressive how this therapy extends the benefits of taxanes," said Professor Pamela Munster, MD, Director of the University of California San Francisco's Early Phase Clinical Trials Unit and Co-leader of its Center for BRCA Research. "Patients with platinum-resistant ovarian cancer have few good treatment options. A therapy that significantly extends time to tumor progression without additional side effect burden would be an important advance."

    Corcept has begun planning a pivotal Phase 3 trial.

    About the Trial

    This controlled, multi-center, Phase 2 trial enrolled 178 patients with platinum-resistant ovarian cancer in one of three study arms. Sixty patients received 150 mg relacorilant the day before, the day of and the day after their infusion of nab-paclitaxel. Fifty-eight patients received 100 mg relacorilant every day, with titration up to 150 mg permitted at the investigator's discretion. The sixty patients in the control arm received nab-paclitaxel alone. All patients received nab-paclitaxel on Days 1, 8 and 15 of each 28-day cycle. Patients in the control arm received 100 mg/m2 of nab-paclitaxel. Because relacorilant increases nab-paclitaxel plasma levels, the nab-paclitaxel dose in patients receiving relacorilant was 80 mg/m2. The trial's primary endpoint was progression free survival. Secondary endpoints include overall survival, objective response rate and duration of response. The trial is being conducted at 28 sites in the United States and Europe. Additional information about the study (NCT03776812) can be obtained at www.ClinicalTrials.gov.

    About Relacorilant

    Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor that does not bind to the body's other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including ovarian, pancreatic and castration-resistant prostate cancer and Cushing's syndrome. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents. It has received orphan drug designation in the United States for the treatment of Cushing's syndrome and pancreatic cancer.

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    Forward Looking Statements

    Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties concern, but are not limited to, the design and results of our clinical trials; our ability to achieve our goals during the COVID-19 pandemic; the development of relacorilant as a treatment for ovarian cancer, including its clinical attributes, regulatory approvals, mandates and oversight, and other requirements; and the scope and protective power of our intellectual property. In this press release, forward-looking statements, include those concerning the clinical attributes of relacorilant and its potential benefits in patients with ovarian cancer, results of our Phase 2 trial and our planning for a Phase 3 pivotal trial. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. We disclaim any intention or duty to update forward-looking statements made in this press release.

    CONTACT:

    Corcept Therapeutics

    Investor Relations

    ir@corcept.com

    www.corcept.com

     



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  8. MENLO PARK, Calif., April 29, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT) today announced it will report first quarter financial results and provide a corporate update on May 6, 2021. The company will also host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

    Conference Call Information
    To participate, click the link below and enter your information. The link will become active 15 minutes prior to the scheduled start time.

    Click to Join Meeting

    Alternatively, you may dial 1-888-204-4368 from the United States or 1-313-209-4906 internationally approximately 15 minutes before the start of the call. The passcode will be 8720277.

    A replay will be available through May 20, 2021 at…

    MENLO PARK, Calif., April 29, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT) today announced it will report first quarter financial results and provide a corporate update on May 6, 2021. The company will also host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

    Conference Call Information

    To participate, click the link below and enter your information. The link will become active 15 minutes prior to the scheduled start time.

    Click to Join Meeting

    Alternatively, you may dial 1-888-204-4368 from the United States or 1-313-209-4906 internationally approximately 15 minutes before the start of the call. The passcode will be 8720277.

    A replay will be available through May 20, 2021 at 1-888-203-1112 from the United States and 1-719-457-0820 internationally. The passcode will be 8720277.

    About Corcept Therapeutics Incorporated

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    CONTACT:

    Corcept Therapeutics

    Investor Relations

    ir@corcept.com

    www.corcept.com



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  9. MENLO PARK, Calif., March 15, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced enrollment of the first patient in the Phase 1b trial of relacorilant in combination with the PD-1 checkpoint inhibitor pembrolizumab (Merck's medication, Keytruda®) in patients with adrenal cancer with cortisol excess.

    "Cortisol activity blunts the cancer-killing attributes of immunotherapeutic agents such as checkpoint inhibitors," said Andreas Grauer, MD, Corcept's Chief Medical Officer, "which may be why pembrolizumab is rarely effective as…

    MENLO PARK, Calif., March 15, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced enrollment of the first patient in the Phase 1b trial of relacorilant in combination with the PD-1 checkpoint inhibitor pembrolizumab (Merck's medication, Keytruda®) in patients with adrenal cancer with cortisol excess.

    "Cortisol activity blunts the cancer-killing attributes of immunotherapeutic agents such as checkpoint inhibitors," said Andreas Grauer, MD, Corcept's Chief Medical Officer, "which may be why pembrolizumab is rarely effective as monotherapy in patients with adrenal cancer with cortisol excess. Our trial will examine whether adding relacorilant to pembrolizumab therapy will reduce cortisol-activated immune suppression sufficiently to help pembrolizumab achieve its intended tumor-killing effect, while relacorilant treats the Cushing's syndrome caused by excess cortisol activity."

    The open-label, Phase 1b trial has a planned enrollment of 20 patients with metastatic or unresectable adrenal cancer with cortisol excess at five sites in the United States.

    About Relacorilant

    Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor that does not bind to the body's other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including Cushing's syndrome and adrenal, ovarian and pancreatic cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents. Relacorilant has received orphan drug designation in the United States for the treatment of Cushing's syndrome and pancreatic cancer.

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    Forward Looking Statements

    Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those statements express or imply. These risks and uncertainties include, but are not limited to, the progress, enrollment, timing, design and results of our clinical trials; our ability to operate our business and achieve our goals and conduct our clinical trials during the COVID-19 pandemic; the availability of competing treatments; risks related to the development of relacorilant as a product candidate for adrenal cancer with cortisol excess, including its clinical attributes, regulatory approvals, mandates and oversight, and other requirements; and the scope and protective power of our intellectual property. In this press release, forward-looking statements include those concerning the clinical attributes of relacorilant and its effects in patients with adrenal cancer. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. We disclaim any intention or duty to update forward-looking statements made in this press release.

    Keytruda® is a registered trademark of Merck & Co, Inc.

    CONTACT:

    Christopher S. James, MD

    Director, Investor Relations

    Corcept Therapeutics

    650-684-8725

    cjames@corcept.com

    www.corcept.com



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  10. MENLO PARK, Calif., March 01, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol, today announced that Atabak Mokari has joined the company as Chief Financial Officer. Charles Robb, who has been Corcept's CFO since September 2011, has assumed the role of Chief Business Officer.

    "Atabak's talent and broad experience make him a welcome addition to our executive team," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "Further, his arrival will allow Charlie to focus on the significant administrative and operational tasks…

    MENLO PARK, Calif., March 01, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol, today announced that Atabak Mokari has joined the company as Chief Financial Officer. Charles Robb, who has been Corcept's CFO since September 2011, has assumed the role of Chief Business Officer.

    "Atabak's talent and broad experience make him a welcome addition to our executive team," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "Further, his arrival will allow Charlie to focus on the significant administrative and operational tasks we will face in 2021 and beyond."

    Atabak Mokari has nearly 20 years leadership experience in life sciences and healthcare finance. From 2018 to 2020, he was Chief Financial Officer and Vice President of Corporate Development at Bellicum Pharmaceuticals, Inc. He served in the same capacity from 2016 to 2018 at medical device manufacturer IRIDEX. Mr. Mokari was a director at Wells Fargo Securities LLC's healthcare investment banking group from 2013 to 2016, at UBS's healthcare investment banking group from 2009 to 2013 and at Credit Suisse's healthcare investment banking group from 2005 to 2009. Prior to that, he was a member of the business development team at Forest Laboratories, a pharmaceutical company, and an analyst at the private equity firm Olympus Partners and the investment banking firm Bowles Hollowell Conner & Co. Mr. Mokari earned an MBA from The Tuck School of Business at Dartmouth and a B.S. in Chemistry and Biology from Duke University.

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    CONTACT:

    Christopher S. James, MD

    Director, Investor Relations

    Corcept Therapeutics

    650-684-8725

    cjames@corcept.com

    www.corcept.com



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    • 2020 revenue of $353.9 million, compared to $306.5 million in 2019
    • Fourth quarter revenue of $85.7 million, compared to $87.9 million in 2019
    • 2020 GAAP net income of $106.0 million, compared to $94.2 million in 2019
    • Fourth quarter GAAP net income of $26.0 million, compared to $29.4 million in fourth quarter 2019
    • Cash and investments of $476.9 million at year-end, compared to $315.3 million at year-end 2019
    • Acquisition of 458,769 shares pursuant to the company's stock repurchase program
    • Reiterated 2021 revenue guidance of $375 – 405 million

    MENLO PARK, Calif., Feb. 23, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic…

    • 2020 revenue of $353.9 million, compared to $306.5 million in 2019
    • Fourth quarter revenue of $85.7 million, compared to $87.9 million in 2019
    • 2020 GAAP net income of $106.0 million, compared to $94.2 million in 2019
    • Fourth quarter GAAP net income of $26.0 million, compared to $29.4 million in fourth quarter 2019
    • Cash and investments of $476.9 million at year-end, compared to $315.3 million at year-end 2019
    • Acquisition of 458,769 shares pursuant to the company's stock repurchase program
    • Reiterated 2021 revenue guidance of $375 – 405 million

    MENLO PARK, Calif., Feb. 23, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol, today reported its results for the quarter- and year-ended December 31, 2020.

    Corcept's 2020 revenue was $353.9 million, compared to $306.5 million in 2019. Fourth quarter revenue was $85.7 million, compared to $87.9 million in the fourth quarter of 2019. The company reiterated its 2021 revenue guidance of $375 – 405 million.

    GAAP net income was $106.0 million for the year and $26.0 million in the fourth quarter of 2020, compared to $94.2 million for the year and $29.4 million in the fourth quarter of 2019. 

    Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets, together with related income tax effects, non-GAAP net income was $34.7 million in the fourth quarter, compared to $40.3 million in the fourth quarter of 2019. For the full-year, non-GAAP net income was $145.6 million, compared to $133.3 million in 2019. A reconciliation of GAAP to non-GAAP net income is included below.

    Cash and investments increased by $32.7 million in the fourth quarter, to $476.9 million at December 31, 2020. At December 31, 2019, the balance of cash and investments was 315.3 million.

    The company spent $9.7 million in the fourth quarter repurchasing 458,769 shares of common stock pursuant to its stock repurchase program. Under the currently authorized terms of that program, $190.3 million remains available for the repurchase of shares.

    "Corcept's financial and clinical accomplishments in 2020 lay the foundation for significant progress this year," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "As the COVID-19 pandemic is brought under control, the easing of public health restrictions and greater willingness of patients to visit their doctors will allow more physicians to diagnose and optimally treat patients with Cushing's syndrome. We expect revenue next year of $375 – 405 million.

    "Improving conditions should also permit more rapid progress in our clinical development programs, many of which have been significantly slowed by the pandemic," he added. We are currently evaluating our proprietary, selective cortisol modulators as potential treatments for patients with metastatic ovarian and pancreatic cancer, castration-resistant prostate cancer, adrenal cancer, Cushing's syndrome, antipsychotic-induced weight gain and non-alcoholic steatohepatitis. We will have topline data from our ovarian and pancreatic cancer trials in the second quarter. In the fourth quarter, we plan to initiate a Phase 2 trial in patients with amyotrophic lateral sclerosis (ALS)."

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    GAAP Measures of Net Income

    To supplement our financial results presented on a GAAP basis, we use non-GAAP measures of net income, basic net income per share and diluted net income per share that exclude the following non-cash expenses – (i) stock-based compensation, (ii) our use of deferred tax assets to offset current tax expense and (iii) related income tax effects. We believe these non-GAAP measures help investors evaluate our financial performance and potential future results. Our non-GAAP measures may be different from, and not directly comparable to, those used by other companies. They are not a substitute for comparable GAAP measures and should not be considered in isolation. Investors should read our non-GAAP presentation in conjunction with our financial statements prepared in accordance with GAAP.

    Forward-Looking Statements

    Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those statements express or imply. These risks and uncertainties include, but are not limited to, the completion of our financial closing procedures and any adjustments that may result from the completion of the annual independent audit of our consolidated financial statements; our ability to operate our business and achieve our goals and conduct our clinical trials during the COVID-19 pandemic and to generate sufficient revenue to fund our commercial operations and development programs; the availability of competing treatments, including generic versions of Korlym; our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym; risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates and oversight, and other requirements; and the scope and protective power of our intellectual property. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include those concerning our 2021 revenue guidance and our stock repurchase program; the progress, enrollment, timing, design and results of our clinical trials; the course of the COVID-19 pandemic and its impact on patients, physicians, medical practice and clinical research activities; and the clinical and commercial attributes of Korlym, relacorilant, exicorilant and miricorilant and other proprietary, selective cortisol modulators. We disclaim any intention or duty to update forward-looking statements made in this press release.

    CORCEPT THERAPEUTICS INCORPORATED

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands, except per share data)

     December 31, 2020 (1) December 31, 2019 (1)
        
    Assets   
    Cash and investments$476,892  $315,314 
    Trade receivables, net of allowances26,198  19,928 
    Inventory21,157  17,405 
    Operating lease right-of-use asset2,509  3,446 
    Deferred tax assets, net31,603  45,677 
    Other assets13,372  10,542 
    Total assets$571,731  $412,312 
    Liabilities and Stockholders' Equity   
    Accounts payable$10,554  $7,537 
    Operating lease liabilities2,551  3,461 
    Other liabilities35,288  30,132 
    Stockholders' equity523,338  371,182 
    Total liabilities and stockholders' equity$571,731  $412,312 
        
    (1) Derived from audited financial statements at that date   
        

    CORCEPT THERAPEUTICS INCORPORATED

    CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

    (In thousands, except per share data)

     Three Months Ended Year Ended
     December 31, December 31,
     2020 2019 2020 2019
    Revenues       
    Product revenue, net$85,735  $87,895  $353,874  $306,486 
            
    Operating expenses       
    Cost of sales1,254  1,436  5,582  5,504 
    Research and development28,275  24,312  114,764  89,017 
    Selling, general and administrative25,696  27,131  105,326  100,359 
    Total operating expenses$55,225  $52,879  $225,672  $194,880 
    Income from operations30,510  35,016  128,202  111,606 
    Interest and other income297  1,444  3,400  5,070 
    Income before income taxes30,807  36,460  131,602  116,676 
    Income tax expense(4,813) (7,079) (25,591) (22,495)
    Net income$25,994  $29,381  $106,011  $94,181 
    Other comprehensive income (loss):       
    Net unrealized gain on available-for-sale investments, net of tax impact of $96, $20, $15 and $(104), respectively(309) (62) (50) 327 
    Foreign currency translation loss, net of tax147  9  204  4 
    Total comprehensive income$25,832  $29,328  $106,165  $94,512 
            
    Basic net income per share$0.22  $0.26  $0.92  $0.82 
            
    Diluted net income per share$0.20  $0.24  $0.85  $0.77 
            
    Shares used in computing basic net income per common share116,320  114,347  115,412  114,349 
    Shares used in computing diluted net income per common share127,423  122,688  124,194  122,566 
                

    CORCEPT THERAPEUTICS INCORPORATED

    RECONCILIATION OF GAAP TO NON-GAAP NET INCOME

    (In thousands, except per share data)

     Three Months Ended Year Ended
     December 31, December 31,
     2020 2019 2020 2019
    GAAP net income$25,994  $29,381  $106,011  $94,181 
            
    Non-cash expenses (benefits)       
    Stock-based compensation       
    Cost of sales15  39  66  144 
    Research and development2,865  2,707  11,222  9,541 
    Selling, general and administrative5,550  4,864  22,251  19,628 
    Total stock-based compensation8,430  7,610  33,539  29,313 
    Deferred income taxes2,311  5,146  14,089  16,877 
    Income tax effect of non-GAAP adjustments (1)(2,023) (1,826) (8,049) (7,035)
    Non-GAAP net income, adjusted for non-cash expenses$34,712  $40,311  $145,590  $133,336 
            
    GAAP basic net income per share$0.22  $0.26  $0.92  $0.82 
            
    GAAP diluted net income per share$0.20  $0.24  $0.85  $0.77 
            
    Non-GAAP basic net income per share, adjusted for non-cash expenses per share$0.30  $0.35  $1.26  $1.17 
            
    Non-GAAP diluted net income per share, adjusted for non-cash expenses per share$0.27  $0.33  $1.17  $1.09 
            
    Shares used in computing basic net income per common share116,320  114,347  115,412  114,349 
    Shares used in computing diluted net income per common share127,423  122,688  124,194  122,566 
            
    (1) Calculated by applying the statutory tax rate to the pre-tax, non-discrete, non-GAAP adjustments.
     

    CONTACT:

    Christopher S. James, MD

    Director, Investor Relations

    Corcept Therapeutics

    650-684-8725

    cjames@corcept.com

    www.corcept.com



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  11. Financial Highlights, 2021 Revenue Guidance and Legal Update

    • Preliminary 2020 revenue $353.9 million, compared to $306.5 million in 2019
    • Preliminary fourth quarter revenue $85.7 million, compared to $87.9 million in fourth quarter 2019
    • 2021 revenue guidance $375 - 405 million
    • Preliminary 2020 fully diluted GAAP net income $0.85 per share, compared to $0.77 per share in 2019
    • Preliminary fourth quarter fully diluted GAAP net income $0.20 per share, compared to $0.24 per share in fourth quarter 2019
    • Preliminary cash and investments at December 31, 2020 of $476.9 million, an increase
      of $161.6 million from December 31, 2019
    • Patent Trial and Appeals Board affirms validity of all claims in Corcept's U.S. Patent No.10,195,214 (patent term: 2037)

    MENLO PARK…

    Financial Highlights, 2021 Revenue Guidance and Legal Update

    • Preliminary 2020 revenue $353.9 million, compared to $306.5 million in 2019
    • Preliminary fourth quarter revenue $85.7 million, compared to $87.9 million in fourth quarter 2019
    • 2021 revenue guidance $375 - 405 million
    • Preliminary 2020 fully diluted GAAP net income $0.85 per share, compared to $0.77 per share in 2019
    • Preliminary fourth quarter fully diluted GAAP net income $0.20 per share, compared to $0.24 per share in fourth quarter 2019
    • Preliminary cash and investments at December 31, 2020 of $476.9 million, an increase

      of $161.6 million from December 31, 2019
    • Patent Trial and Appeals Board affirms validity of all claims in Corcept's U.S. Patent No.10,195,214 (patent term: 2037)

    MENLO PARK, Calif. , Feb. 08, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and neuropsychiatric disorders by modulating the effects of the stress hormone cortisol, today reported preliminary fourth quarter revenue of $85.7 million, compared to $87.9 million in the fourth quarter of 2019. Preliminary 2020 revenue was $353.9 million compared to $306.5 million in 2019. The company expects 2021 revenue of $375 – 405 million.

    Cash and investments increased by $32.7 million in the fourth quarter to $476.9 million. At December 31, 2019 cash and investments totaled $315.3 million. The company spent $9.7 million in the fourth quarter repurchasing 458,769 shares of common stock pursuant to its stock repurchase program.  Under the currently authorized terms of that program, $190.3 million remains available for the repurchase of shares.

    These results are prior to completion of the company's annual independent audit and are subject to adjustment.

    "Corcept's performance during the COVID-19 pandemic demonstrates the durability of our business," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "Confronted with unprecedented obstacles, we generated significantly more revenue, more income and more cash than we did in 2019. Having won an important legal victory in our dispute with Teva Pharmaceuticals, we look with confidence to the future. As the pandemic is contained, we expect our commercial growth to resume and have provided 2021 revenue guidance of $375 – 405 million.

    "The pandemic's impact on our clinical activities has been variable. Trials in acutely life-threatening indications, such as advanced ovarian and pancreatic cancer, recruited briskly. Studies of illnesses with a slower course of disease, such as Cushing's syndrome, castration-resistant prostate cancer ("CRPC"), anti-psychotic-induced weight gain ("AIWG") and non-alcoholic steatohepatitus ("NASH") have proceeded more slowly.

    "Despite these challenges, our development team made important advances. They maintained our existing trials, although the pandemic significantly slowed enrollment in many of them. They also started new trials that greatly broadened the scope of our clinical program. In 2020, we initiated trials in Cushing's syndrome of adrenal origin, metastatic pancreatic cancer, advanced adrenocortical cancer, AIWG and NASH. We also laid the groundwork for further expansion by advancing promising compounds from our portfolio of selective cortisol modulators towards the clinic."

    Cushing's Syndrome

    • Phase 3 GRACE trial of relacorilant as a treatment for patients with any etiology of

      Cushing's syndrome continues at sites in the United States, Canada, Europe and Israel;

      pandemic conditions delay expected timing of NDA submission
    • Enrollment continues in Phase 3 GRADIENT trial of relacorilant as a treatment for patients with Cushing's syndrome of adrenal origin, with sites planned in the United States, Europe and Israel

    "While our Phase 3 GRACE and GRADIENT trials in patients with Cushing's syndrome continue to accrue patients and generate valuable data, pandemic-related public health measures, which in many places became even more restrictive in the fourth quarter, continue to slow the pace of enrollment," said Andreas Grauer, MD, Corcept's Chief Medical Officer. "As vaccination campaigns falter – especially in Europe, where many of our most productive clinical sites are located – the retarding effects of the pandemic remain in place. Ultimately, relacorilant's NDA submission date will depend on the duration and severity of pandemic-related restrictions, which cannot be known with certainty. The delay may be as long as one year, to the second quarter of 2023.  

    "These delays are especially frustrating because relacorilant's Phase 2 data were extremely promising. Our team of clinical investigators are enthusiastic. We are confident enrollments will accelerate once conditions improve."

    Solid Tumors

    • Preliminary results in 178-patient, controlled, Phase 2 trial of relacorilant plus nab-paclitaxel

      in patients with metastatic ovarian cancer expected in first half 2021
    • Preliminary results in first 40 patients enrolled in open-label Phase 3 RELIANT trial

      of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer expected

      in first half 2021
    • Selection of optimum dose of exicorilant plus enzalutamide in patients with castration-resistant prostate cancer ("CRPC") expected by third quarter 2021
    • Patient selection underway in 20-patient, open-label, Phase 1b trial of relacorilant plus PD-1 checkpoint inhibitor pembrolizumab in patients with adrenal cancer with cortisol excess

    "Our trials in patients with metastatic ovarian and pancreatic cancer are on track to generate preliminary data in the first half of 2021, as planned," said Dr. Grauer. "These trials are evaluating whether relacorilant can enhance the efficacy of nab-paclitaxel by reducing cortisol's suppression of apoptosis in patients with advanced disease, many of whom have experienced progression on prior rounds of taxane-based therapies. It would be wonderful to be able to offer a therapy that benefits them.

    "The dose-finding trial of our selective cortisol modulator exicorilant with enzalutamide as a treatment for CRPC continues to enroll patients," said Dr. Grauer, "although the pandemic has slowed its pace, pushing selection of an optimum dose to the second or third quarter of this year, depending on how quickly pandemic conditions improve. Our hypothesis, which is well-supported by pre-clinical data, is that combining an androgen receptor antagonist like enzalutamide with a cortisol modulator will block an important tumor escape route.

    "Last year, we initiated a Phase 1b trial in patients with adrenal cancer with cortisol excess," said Dr. Grauer. "This study will evaluate whether adding relacorilant to pembrolizumab therapy will reduce cortisol-activated immune suppression sufficiently to help pembrolizumab achieve its intended tumor-killing effect, while relacorilant treats the Cushing's syndrome caused by excess cortisol activity."

    Metabolic Diseases

    • Enrollment underway in double-blind, placebo-controlled Phase 2 trial of miricorilant

      in patients with NASH
    • Enrollment continues in GRATITUDE, a double-blind, placebo-controlled, Phase 2 trial

      of miricorilant to reverse recent AIWG
    • Enrollment continues in GRATITUDE II, a 150-patient, double-blind, placebo-controlled

      Phase 2 trial of miricorilant to reverse long-standing AIWG

    "In the fourth quarter, we initiated a double-blind, placebo-controlled Phase 2 trial of miricorilant as a potential treatment for NASH, a serious liver disorder that affects millions of people," said Dr. Grauer. "We plan to enroll 120 patients, who will receive either 900 mg miricorilant, 600 mg miricorilant or placebo for twelve weeks. The primary endpoint will be reduction in liver fat content, as measured by MRI. Our pre-clinical data suggest miricorilant may be a potent treatment for NASH. We hope to demonstrate similarly encouraging results in patients.

    "Our Phase 2 trials in AIWG – GRATITUDE and GRATITUDE II – continue to enroll patients, although the pandemic has slowed the pace," added Dr. Grauer. "AIWG reduces the quality of life and shortens the life expectancy of millions of patients. Results from the Phase 1b trial we completed last year suggest that miricorilant may benefit them. In that study, healthy volunteers given miricorilant plus olanzapine gained less weight and had lower triglycerides and less sharply elevated liver enzymes than those who received olanzapine plus placebo after only two weeks of dosing. These results build on those we achieved in similar trials using mifepristone (see Gross et al, Advances in Therapy (2009); Gross et al, Obesity (2010). Miricorilant, like mifepristone, modulates cortisol activity. Unlike mifepristone, miricorilant does not affect progesterone activity."

    Conference Call

    We will hold a conference call on February 8, 2021, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, click this link (listen-only mode) or dial 1-833-693-0540 (United States) or 1-661-407-1581 (international) approximately ten minutes before the start of the call. The conference ID number is 9289307.   A replay will be available on the Investors / Past Events tab of our website.

    Hypercortisolism

    Hypercortisolism, often referred to as Cushing's syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing's syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing's syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, 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. Hypercortisolism can affect every organ system in the body and can be lethal if not treated effectively.

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety

    of serious disorders.

    Forward-Looking Statements

    Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those statements express or imply. These risks and uncertainties include, but are not limited to, the completion of our financial closing procedures and any adjustments that may result from the completion of the annual independent audit of our consolidated financial statements; our ability to operate our business and achieve our goals and conduct our clinical trials during the COVID-19 pandemic and to generate sufficient revenue to fund our commercial operations and development programs; the availability of competing treatments, including generic versions of Korlym; our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym; risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates and oversight, and other requirements; and the scope and protective power of our intellectual property. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include those concerning our preliminary fourth quarter and full year 2020 financial results; 2021 revenue guidance; our clinical development programs; the progress, enrollment, timing, design and results of our clinical trials; the course of the COVID-19 pandemic and its impact on patients, physicians, medical practice and clinical research activities; and the clinical and commercial attributes of Korlym, relacorilant, exicorilant and miricorilant. We disclaim any intention or duty to update forward-looking statements made in this press release.

    CONTACT:

    Christopher S. James, MD

    Director, Investor Relations

    Corcept Therapeutics

    650-684-8725

    cjames@corcept.com 

    www.corcept.com 



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  12. MENLO PARK, Calif., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT) today announced it will report its preliminary 2020 fourth quarter and full-year financial results and provide a corporate update on February 8, 2021. The company will host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

    Conference Call Information

    To participate, dial 1-833-693-0540 (United States) or 1-661-407-1581 (internationally) approximately 15 minutes before the start of the call. The conference ID number is 9289307.

    For access to the call in "listen-only" mode, click this link and provide the requested information. The link will be active 15 minutes prior to the call's scheduled start time.

    About

    MENLO PARK, Calif., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT) today announced it will report its preliminary 2020 fourth quarter and full-year financial results and provide a corporate update on February 8, 2021. The company will host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

    Conference Call Information

    To participate, dial 1-833-693-0540 (United States) or 1-661-407-1581 (internationally) approximately 15 minutes before the start of the call. The conference ID number is 9289307.

    For access to the call in "listen-only" mode, click this link and provide the requested information. The link will be active 15 minutes prior to the call's scheduled start time.

    About Corcept Therapeutics Incorporated

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    CONTACT:

    Christopher S. James, MD

    Director, Investor Relations

    Corcept Therapeutics

    650-684-8725

    cjames@corcept.com

    www.corcept.com



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  13. MENLO PARK, Calif., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, announced today that Gillian M. Cannon, PhD, has joined the company's Board of Directors.

    Dr. Cannon brings to Corcept more than 30 years experience in the pharmaceutical industry, where she has served in leadership roles at Merck and Co. Inc., UCB Inc. and Otsuka Pharmaceuticals. In her 27-year career at Merck, Dr. Cannon held a variety of senior positions, including Global Vice President for Commercial Operations at Merck's start-up biosimilar…

    MENLO PARK, Calif., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, announced today that Gillian M. Cannon, PhD, has joined the company's Board of Directors.

    Dr. Cannon brings to Corcept more than 30 years experience in the pharmaceutical industry, where she has served in leadership roles at Merck and Co. Inc., UCB Inc. and Otsuka Pharmaceuticals. In her 27-year career at Merck, Dr. Cannon held a variety of senior positions, including Global Vice President for Commercial Operations at Merck's start-up biosimilar business, Merck BioVentures; Business Unit Head for Merck's specialty products franchise; and Global Commercial Head of its neuroscience franchise. She is currently President of Alyvant and Executive in Residence for Roivant Sciences.

    "I am very pleased to welcome Gillian to our board," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "Her extensive experience in pharmaceutical commercial operations, marketing and sales and her track record of devising and gaining acceptance for innovative solutions will help us advance our pipeline of proprietary, selective cortisol modulators."

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    Forward-Looking Statements

    Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business and achieve our goals and conduct our clinical trials during the Covid-19 pandemic and to generate sufficient revenue to fund our commercial operations and development programs; the availability of competing treatments, including generic versions of Korlym®; our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym; and risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates and oversight, and other requirements. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include statements regarding advancement of our pipeline of proprietary, selective cortisol modulators. We disclaim any intention or duty to update forward-looking statements made in this press release.

    CONTACT:

    Christopher S. James, MD

    Director, Investor Relations

    Corcept Therapeutics

    650-684-8725

    cjames@corcept.com

    www.corcept.com



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  14. MENLO PARK, Calif., Nov. 18, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, announced today that the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office has issued a decision upholding the validity of all claims of U.S. Patent No. 10,195,214, "Concomitant Administration of Glucocorticoid Receptor Modulators and CYP3A Inhibitors" (the "‘214 patent"). The ‘214 patent expires in 2037.

    "We are gratified by the PTAB's decision," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "The…

    MENLO PARK, Calif., Nov. 18, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, announced today that the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office has issued a decision upholding the validity of all claims of U.S. Patent No. 10,195,214, "Concomitant Administration of Glucocorticoid Receptor Modulators and CYP3A Inhibitors" (the "‘214 patent"). The ‘214 patent expires in 2037.

    "We are gratified by the PTAB's decision," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "The ‘214 patent is directed to an important medical discovery – that, with dose-adjustment as set forth in its FDA-approved label, Korlym® can be safely co-administered with medications known as strong CYP3A inhibitors, including commonly-prescribed antiviral, antibiotic, antifungal and antidepressant medications. Patients with Cushing's syndrome often experience significant co-morbidities. We are glad that our research has increased the array of medications available to the physicians who treat them."

    Hypercortisolism

    Hypercortisolism, often referred to as Cushing's syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing's syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing's syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, 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. Hypercortisolism can affect every organ system in the body and can be lethal if not treated effectively.

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    Forward-Looking Statements

    Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business and achieve our goals and conduct our clinical trials during the Covid-19 pandemic and to generate sufficient revenue to fund our commercial operations and development programs; the availability of competing treatments, including generic versions of Korlym; our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym; and risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates and oversight, and other requirements. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include statements regarding the scope of the company's intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release.

    CONTACT:

    Christopher S. James, MD

    Director, Investor Relations

    Corcept Therapeutics

    650-684-8725

    cjames@corcept.com

    www.corcept.com



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  15. MENLO PARK, Calif., Nov. 03, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, today reported its results for the quarter ended September 30, 2020.

    Financial Highlights

    • Revenue of $86.3 million, a 6 percent increase from third quarter 2019
    • GAAP diluted net income of $0.17 per share, compared to $0.22 per share in third quarter 2019
    • Non-GAAP diluted net income of $0.24 per share, compared to $0.31 per share in third quarter 2019
    • Cash and investments of $444.2 million, compared to $409.6 million at June 30, 2020
    • Announcement

    MENLO PARK, Calif., Nov. 03, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, today reported its results for the quarter ended September 30, 2020.

    Financial Highlights

    • Revenue of $86.3 million, a 6 percent increase from third quarter 2019
    • GAAP diluted net income of $0.17 per share, compared to $0.22 per share in third quarter 2019
    • Non-GAAP diluted net income of $0.24 per share, compared to $0.31 per share in third quarter 2019
    • Cash and investments of $444.2 million, compared to $409.6 million at June 30, 2020
    • Announcement of $200 million stock repurchase program
    • 2020 revenue guidance narrowed to $355 – 365 million

    Revenue was $86.3 million in the third quarter, compared to $81.5 million in the third quarter of 2019.  Third quarter GAAP net income was $21.6 million, compared to $26.3 million in the same period last year.  Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets, together with related income tax effects, non-GAAP net income in the third quarter was $30.0 million, compared to $37.8 million in the third quarter of 2019.  A reconciliation of GAAP to non-GAAP net income is included below.

    Corcept narrowed its 2020 revenue guidance range to $355 – 365 million.  The company's initial guidance, announced in January 2020, was $355 – 375 million.

    Third quarter operating expenses were $61.6 million, compared to $48.5 million in the third quarter of 2019, primarily due to increased spending on clinical trials in Cushing's syndrome, antipsychotic-induced weight gain and solid tumors, and on the formulation and manufacture the company's proprietary selective cortisol modulators.

    Cash and investments were $444.2 million at September 30, 2020, an increase of $34.7 million from June 30, 2020.

    The company announced a program to repurchase up to $200 million of its common stock, funded using cash and investments. Details of the program are provided below.

    "While pandemic-related public health restrictions and related changes in physician and patient practices dampened our third quarter commercial results," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer, "we have built a remarkably stable and profitable business.  After Covid-19 is brought under control, we expect our growth to resume.

    "Meanwhile, the breadth of our clinical development program continues to increase.  We are now evaluating our proprietary, selective cortisol modulators in patients with Cushing's syndrome, four different types of solid tumors, antipsychotic-induced weight gain (APIWG) and – starting this month – nonalcoholic steatohepatitis (NASH).  The pandemic's effect on these trials has varied," added Dr. Belanoff.  "Studies of illnesses which are acutely life-threatening, including advanced ovarian and pancreatic cancer have recruited briskly.  Studies of illnesses that are not perceived as immediately dire – such as antipsychotic-induced weight gain – have lagged."

    Cushing's Syndrome

    • Phase 3 GRACE trial of relacorilant in patients with any etiology of Cushing's syndrome continues at sites in the United States, Canada, Europe and Israel; NDA submission planned for second quarter 2022
    • Enrollment begun in Phase 3 GRADIENT trial of relacorilant in patients with Cushing's syndrome of adrenal origin continues, with sites planned in the United States, Europe and Israel

    "We are evaluating our proprietary selective cortisol modulator relacorilant as a treatment for Cushing's syndrome in two double-blind, placebo-controlled Phase 3 trials," said Andreas Grauer, MD, Corcept's Chief Medical Officer.  "GRACE has a planned enrollment of 130 patients with any type of Cushing's syndrome.  GRADIENT has a planned enrollment of 130 patients with Cushing's syndrome caused by adrenal adenomas – an etiology of hypercortisolism where medical treatment has not been rigorously studied. While recruitment in both trials has slowed due to the pandemic, our investigators are enthusiastic.  We plan to submit an NDA based on results from the GRACE trial in the second quarter of 2022."

    Solid Tumors

    • Enrollment complete in 178-patient, controlled, Phase 2 trial of relacorilant plus nab-paclitaxel in patients with metastatic ovarian cancer; results expected in first half 2021
    • Enrollment continues in 80-patient, open-label Phase 3 RELIANT trial of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer; results in first 40 patients expected in first half 2021
    • Selection of optimum dose of exicorilant plus enzalutamide in patients with castration-resistant prostate cancer expected in first quarter 2021
    • Initiation of 20-patient, open-label, Phase 1b trial of relacorilant plus PD-1 checkpoint inhibitor pembrolizumab in patients with adrenal cancer with cortisol excess

    "Our oncology program is evaluating three mechanisms by which cortisol modulators may benefit patients with solid tumors," said Dr. Grauer.  "Our Phase 2 trial in patients with metastatic ovarian cancer and our Phase 3 trial in patients with metastatic pancreatic cancer are evaluating whether relacorilant can enhance the efficacy of nab-paclitaxel by reducing cortisol's suppression of apoptosis – the programmed cell death chemotherapy is meant to promote.  We expect results from both of these trials in the first half of next year. 

    "In the first quarter of 2021, we expect to select a dosing regimen for our selective cortisol modulator exicorilant to advance as a treatment for castration-resistant prostate cancer.  Androgen deprivation therapy is the standard treatment for this disease.  However, with time, many tumors treated with androgen deprivation therapy switch to cortisol stimulation as the pathway to growth. Our hypothesis, which is well-supported in pre-clinical models, is that a regimen that combines an androgen receptor antagonist such as enzalutamide with a cortisol modulator will close off this tumor escape route.

    "Finally, our recently initiated Phase 1b trial of relacorilant combined with pembrolizumab is testing whether co-administrating a cortisol modulator can help immunotherapy achieve its intended effect by reducing cortisol-activated immune suppression." 

    Metabolic Diseases

    • Enrollment begun in GRATITUDE II, a 150-patient, double-blind, placebo-controlled Phase 2 trial of miricorilant to reverse long-standing APIWG
    • Enrollment continues in GRATITUDE, a double-blind, placebo-controlled, Phase 2 trial of miricorilant to reverse recent APIWG
    • Double-blind, placebo-controlled Phase 2 trial of miricorilant in patients with NASH starting this month

    "In the third quarter, we opened GRATITUDE II, the second Phase 2 trial of our selective cortisol modulator miricorilant in patients with antipsychotic-induced weight gain – a life-threatening disorder experienced by many of the millions of patients who take antipsychotic medications," said Dr. Grauer.  "GRATITUDE II is enrolling patients with long-standing weight gain.  Its sister trial, GRATITUDE is enrolling patients with recent weight gain.

    "These trials follow promising pre-clinical and clinical data.  For example, in the Phase 1b trial we completed earlier this year, healthy volunteers given miricorilant plus olanzapine gained less weight and had lower triglycerides and less sharply elevated liver enzymes than those who received olanzapine plus placebo after only two weeks of dosing.

    "Finally, we plan to begin evaluating miricorilant as a potential treatment for liver disease.  Extensive pre-clinical data suggests miricorilant may benefit patients with NASH, a serious liver disorder that affects millions of patients," added Dr. Grauer.  "We are on-track to open a double-blind, placebo-controlled trial of miricorilant in patients with NASH by year-end."

    Conference Call

    We will hold a conference call on November 3, 2020, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).  To participate, click this link 15 minutes prior to the scheduled start time or dial 1-888-204-4368 from the United States or 1-313-209-4906 internationally (passcode 9018217).  A replay will be available through November 17, 2020 at 1-888-203-1112 in the United States and 1-719-457-0820 internationally

    (passcode 9018217).

    About Corcept's Stock Repurchase Program

    Our Board of Directors has approved a program authorizing the repurchase of up to $200 million of the company's common stock through September 30, 2021. Purchases under this program may be made in the open market, in privately negotiated transactions or otherwise. The timing and amount of any repurchases will be determined based on market conditions, stock price and other factors. The program does not require the company to repurchase any specific number of shares of its common stock and may be modified, suspended or discontinued at any time without notice.

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    GAAP Measures of Net Income

    To supplement our financial results presented on a GAAP basis, we use non-GAAP measures of net income, basic net income per share and diluted net income per share that exclude the following non-cash expenses –  (i) stock-based compensation, (ii) our use of deferred tax assets to offset current tax expense and (iii) related income tax effects. We believe these non-GAAP measures help investors evaluate our financial performance and potential future results. Our non-GAAP measures may be different from, and not directly comparable to, those used by other companies. They are not a substitute for comparable GAAP measures and should not be considered in isolation. Investors should read our non-GAAP presentation in conjunction with our financial statements prepared in accordance with GAAP.

    Forward-Looking Statements

    Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business and achieve our goals and conduct our clinical trials during the Covid-19 pandemic and to generate sufficient revenue to fund our commercial operations and development programs; the availability of competing treatments, including generic versions of Korlym; our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym; and risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates and oversight, and other requirements. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include those concerning our 2020 revenue guidance; our stock repurchase program and its intended funding sources; the impact of the Covid-19 pandemic on our operations, financial performance and clinical development programs; expectations regarding our sales levels after Covid-19 is brought under control; the progress, enrollment, timing, design and results of our clinical trials; and the clinical and commercial attributes of relacorilant, exicorilant and miricorilant. We disclaim any intention or duty to update forward-looking statements made in this press release.



    CORCEPT THERAPEUTICS INCORPORATED

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands, except per share data)

     September 30,

    2020
     December 31,

    2019 (1)
     (Unaudited)  
    Assets   
    Cash and investments$444,218 $315,314
    Trade receivables, net of allowances 21,957  19,928
    Inventory 16,892  17,405
    Operating lease right-of-use asset 2,993  3,446
    Deferred tax assets, net 33,818  45,677
    Other assets 14,247  10,542
    Total assets$534,125 $412,312
    Liabilities and Stockholders' Equity   
    Accounts payable$6,510 $7,537
    Operating lease liabilities 3,031  3,461
    Other liabilities 34,904  30,132
    Stockholders' equity 489,680  371,182
    Total liabilities and stockholders' equity$534,125 $412,312
        
    (1) Derived from audited financial statements at that date   
        



    CORCEPT THERAPEUTICS INCORPORATED

    CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

    (In thousands, except per share data)

     Three Months Ended

    September 30,
     Nine Months Ended

    September 30,
      2020   2019   2020   2019 
    Revenues       
    Product revenue, net$86,327  $81,505  $268,139  $218,591 
            
    Operating expenses       
    Cost of sales 1,216   1,451   4,328   4,068 
    Research and development 33,869   22,805   86,489   64,705 
    Selling, general and administrative 26,523   24,245   79,630   73,228 
    Total operating expenses$61,608  $48,501  $170,447  $142,001 
    Income from operations 24,719   33,004   97,692   76,590 
    Interest and other income 622   1,348   3,103   3,626 
    Income before income taxes 25,341   34,352   100,795   80,216 
    Income tax expense (3,716)  (8,012)  (20,778)  (15,416)
    Net income$21,625  $26,340  $80,017  $64,800 
    Other comprehensive

    income (loss):
           
    Net unrealized gain on available-for-sale investments, net of tax impact of $109, $1, $(81) and $(123), respectively (347)  (2)  259   389 
    Foreign currency translation loss, net of tax 84   (5)  57   (5)
    Total comprehensive income$21,362  $26,333  $80,333  $65,184 
            
    Basic net income per share$0.19  $0.23  $0.70  $0.57 
            
    Diluted net income per share$0.17  $0.22  $0.65  $0.53 
            
    Shares used in computing basic net income per common share 115,734   113,875   115,107   114,349 
    Shares used in computing diluted net income per common share 124,464   121,762   123,337   122,478 
                    



    CORCEPT THERAPEUTICS INCORPORATED

    RECONCILIATION OF GAAP TO NON-GAAP NET INCOME

    (In thousands, except per share data)

     Three Months Ended

    September 30,
     Nine Months Ended

    September 30,
      2020   2019   2020   2019 
    GAAP net income$21,625  $26,340  $80,017  $64,800 
            
    Non-cash expenses (benefits)       
    Stock-based compensation       
    Cost of sales 13   22   51   105 
    Research and development 2,958   2,350   8,357   6,834 
    Selling, general and administrative 5,731   4,899   16,701   14,764 
    Total stock-based compensation 8,702   7,271   25,109   21,703 
    Deferred income taxes 1,761   5,897   11,778   11,731 
    Income tax effect of non-GAAP adjustments (1) (2,088)  (1,745)  (6,026)  (5,209)
    Non-GAAP net income, adjusted for non-cash expenses$30,000  $37,763  $110,878  $93,025 
            
    GAAP basic net income

    per share
    $0.19  $0.23  $0.70  $0.57 
            
    GAAP diluted net income

    per share
    $0.17  $0.22  $0.65  $0.53 
            
    Non-GAAP basic net income per share, adjusted for

    non-cash expenses per share
    $0.26  $0.33  $0.96  $0.81 
            
    Non-GAAP diluted net income per share, adjusted for

    non-cash expenses per share
    $0.24  $0.31  $0.90  $0.76 
            
    Shares used in computing basic net income per common share 115,734   113,875   115,107   114,349 
    Shares used in computing diluted net income per common share 124,464   121,762   123,337   122,478 
            
    (1) Calculated by applying the statutory tax rate to the pre-tax, non-discrete, non-GAAP adjustments.
     

    CONTACT:

    Christopher S. James, MD

    Director, Investor Relations

    Corcept Therapeutics

    650-684-8725

    cjames@corcept.com

    www.corcept.com

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  16. MENLO PARK, Calif., Oct. 27, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT) today announced it will report third quarter financial results and provide a corporate update on November 3, 2020. The company will also host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

    Conference Call Information
    To participate, click the link below and enter your information. The link will become active 15 minutes prior to the scheduled start time.

    Click to Join Meeting

    Alternatively, you may dial 1-888-204-4368 from the United States or 1-313-209-4906 internationally approximately 15 minutes before the start of the call. The passcode will be 9018217.

    A replay will be available through November 17…

    MENLO PARK, Calif., Oct. 27, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT) today announced it will report third quarter financial results and provide a corporate update on November 3, 2020. The company will also host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

    Conference Call Information

    To participate, click the link below and enter your information. The link will become active 15 minutes prior to the scheduled start time.

    Click to Join Meeting

    Alternatively, you may dial 1-888-204-4368 from the United States or 1-313-209-4906 internationally approximately 15 minutes before the start of the call. The passcode will be 9018217.

    A replay will be available through November 17, 2020 at 1-888-203-1112 from the United States and 1-719-457-0820 internationally. The passcode will be 9018217.

    About Corcept Therapeutics Incorporated

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    CONTACT:

    Christopher S. James, MD

    Director, Investor Relations

    Corcept Therapeutics

    650-684-8725

    cjames@corcept.com

    www.corcept.com

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  17. MENLO PARK, Calif., Sept. 10, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced enrollment of its first patient in GRATITUDE II, a randomized, double-blind, placebo-controlled, Phase 2 trial of miricorilant in obese patients with schizophrenia and long-standing antipsychotic-induced weight gain (APIWG).

    GRATITUDE II has a planned enrollment of 150 patients, who will continue to receive their established dose of antipsychotic medication, plus either 600 milligrams of miricorilant, 900 milligrams of miricorilant or placebo, for…

    MENLO PARK, Calif., Sept. 10, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced enrollment of its first patient in GRATITUDE II, a randomized, double-blind, placebo-controlled, Phase 2 trial of miricorilant in obese patients with schizophrenia and long-standing antipsychotic-induced weight gain (APIWG).

    GRATITUDE II has a planned enrollment of 150 patients, who will continue to receive their established dose of antipsychotic medication, plus either 600 milligrams of miricorilant, 900 milligrams of miricorilant or placebo, for 26 weeks. The primary endpoint is reduction in bodyweight. GRATITUDE II will be conducted at 35 centers in the United States.

    GRATITUDE I, Corcept's first Phase 2 trial of miricorilant in APIWG, continues to enroll patients with schizophrenia and recent weight gain. Patients in GRATITUDE I receive, in addition to their established antipsychotic regimen, either 600 milligrams of miricorilant or placebo for 12 weeks. The primary endpoint is change in bodyweight.

    "Substantial, sustained weight gain and associated metabolic co-morbidities shorten the lives of many of the millions of patients who take antipsychotic medications and significantly reduce quality of life for many more," said Andreas Grauer, MD, Corcept's Chief Medical Officer. "Miricorilant has demonstrated promise as a potential treatment for this disorder.1 In our double-blind, placebo-controlled, Phase 1b trial, after just two weeks of treatment, healthy subjects given miricorilant in addition to olanzapine gained significantly less weight than subjects who received olanzapine plus placebo. Patients receiving miricorilant also experienced smaller increases in the enzymes AST and ALT, which suggests miricorilant may help protect the liver. We hope to confirm and extend our Phase 1b results in GRATITUDE II, which is using an improved formulation of miricorilant and a longer treatment duration."

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    CONTACT:

    Christopher S. James, MD

    Director, Investor Relations

    Corcept Therapeutics

    650-684-8725

    cjames@corcept.com

    www.corcept.com

    1 For data from our studies in animal models of APIWG, see our 2020 American Psychiatry Association (APA) poster at the Research & Pipeline / Publications tab of our website.

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  18. MENLO PARK, Calif., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, today reported its results for the quarter ended June 30, 2020.

    Financial Highlights

    • Revenue of $88.6 million, a 23 percent increase from second quarter 2019
    • GAAP diluted net income of $0.23 per share, compared to $0.17 per share in second quarter 2019
    • Non-GAAP diluted net income of $0.32 per share, compared to $0.25 per share in second quarter 2019
    • Cash and investments of $409.6 million, compared to $349.0 million at March 31, 2020
    • Reaffirmed 2020

    MENLO PARK, Calif., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, today reported its results for the quarter ended June 30, 2020.

    Financial Highlights

    • Revenue of $88.6 million, a 23 percent increase from second quarter 2019
    • GAAP diluted net income of $0.23 per share, compared to $0.17 per share in second quarter 2019
    • Non-GAAP diluted net income of $0.32 per share, compared to $0.25 per share in second quarter 2019
    • Cash and investments of $409.6 million, compared to $349.0 million at March 31, 2020
    • Reaffirmed 2020 revenue guidance of $355 – 375 million

    Revenue was $88.6 million in the second quarter, compared to $72.3 million in the second quarter of 2019.   Second quarter revenue was $4.7 million lower than in the first quarter, primarily because in March 2020 some patients refilled their prescriptions a few days earlier than usual as a safeguard against pandemic-related delays.  These safety stocks were consumed in the second quarter.   This shift in refill timing increased shipments of Korlym tablets in the first quarter and decreased them by a similar amount in the second quarter.

    We reaffirm our 2020 revenue guidance of $355 – 375 million.

    Second quarter GAAP net income was $28.3 million, compared to $20.2 million in the same period last year.  Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets, together with related income tax effects, non-GAAP net income in the second quarter was $39.7 million, compared to $31.0 million in the second quarter of 2019.  A reconciliation of GAAP to non-GAAP net income is included below.

    Second quarter operating expenses were $53.3 million, compared to $47.6 million in the second quarter of 2019, primarily due to increased spending to conduct clinical trials in Cushing's syndrome, antipsychotic-induced weight gain and solid tumors and to formulate and manufacture the company's proprietary, selective cortisol modulators and to increased employee recruiting and compensation expense.

    Cash and investments were $409.6 million at June 30, 2020, an increase of $60.6 million from March 31, 2020.

    "Patients with Cushing's syndrome are at elevated risk of infection with the novel coronavirus," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer.  "Our clinical specialists, medical science liaisons and patient advocates have done an excellent job helping physicians provide the care these patients need, despite the challenges posed by the Covid-19 pandemic.

    "The pandemic's impact on Corcept has been varied," Dr. Belanoff added.  "As our first and second quarter results showed, pandemic-related changes in patient refill choices can shift revenue from one quarter to another.  More fundamentally, while the heightened vulnerability of patients with Cushing's syndrome to Covid-19 has caused patients to stay on therapy, which tends to increase demand for Korlym, it remains difficult for doctors to arrange the tests and on-going monitoring needed to diagnose new patients and optimize their care.  In addition, many patients are reluctant to leave their homes, even to visit their doctor.  And opportunities for our clinical specialists to meet with physicians in person remain limited, although telephone and video conference contact is becoming more common. 

    "We expect that these countervailing forces will continue in coming quarters, but also expect any changes to be manageable and reiterate our 2020 revenue guidance of $355 – 375 million."

    Cushing's Syndrome

    • Phase 3 trial of relacorilant in patients with all etiologies of Cushing's syndrome (GRACE) continues at 60 sites in the United States, Europe and Israel; NDA submission planned

      in second quarter 2022
    • Enrollment underway in Phase 3 trial of relacorilant in patients with Cushing's syndrome of adrenal origin (GRADIENT)

    "Although the Covid-19 pandemic has slowed patient enrollment and clinical site activation, our Cushing's syndrome program continues to make important progress," said Andreas Grauer, MD, Corcept's Chief Medical Officer.  "We opened five additional clinical sites in GRACE, our pivotal trial of relacorilant to treat patients with all etiologies of Cushing's syndrome, bringing the total to 60.  Enrollment activity has increased, particularly in Europe, where pandemic-related restrictions have eased.  We plan to submit relacorilant's NDA, based on the results of GRACE, in the second quarter of 2022.

    "In addition, enrollment has begun in GRADIENT, our double-blind, placebo-controlled, Phase 3 trial with a planned total of 130 patients whose Cushing's syndrome is caused by an adrenal adenoma or adrenal hyperplasia.1 GRADIENT is the first controlled clinical trial of medical treatment in this etiology of the disease.

    Solid Tumors

    • Completed enrollment in controlled, Phase 2 trial of relacorilant plus nab-paclitaxel in patients with metastatic ovarian cancer; results expected in first half 2021
    • Initiated Phase 3 trial of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer (RELIANT)
    • Selection of optimum dose of exicorilant plus enzalutamide in patients with castration-resistant prostate cancer expected by year-end
    • Phase 1b trial of relacorilant plus PD-1 checkpoint inhibitor pembrolizumab in patients with metastatic or unresectable adrenal cancer expected to start in third quarter 2020

    "Our development of relacorilant as a potential treatment for solid tumors recently achieved two important milestones," said Dr. Grauer.  "We completed enrollment in our controlled, Phase 2 trial of relacorilant combined with nab-paclitaxel to treat patients with metastatic ovarian cancer.  We also initiated RELIANT, our Phase 3 trial of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer.  Data from our open-label, Phase 1/2 trial in patients with these tumors were very encouraging.2  Replicating those results in these larger, more rigorous trials would be an important medical advance."

    Our controlled, Phase 2 trial of relacorilant plus nab-paclitaxel in patients with metastatic, platinum-resistant ovarian cancer has enrolled its goal of 178 patients, at 28 sites in the United States, Canada and Europe.  Participants were randomly assigned to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone.  The trial's primary endpoint is progression free survival, with secondary endpoints including objective response rate and duration of objective response.  Data is expected in the first half of next year.

    RELIANT has a planned enrollment of 80 patients with metastatic pancreatic cancer, with an interim analysis of data from the first 40 patients.  Each patient will receive relacorilant plus nab-paclitaxel.  The primary endpoint is objective response rate, with secondary endpoints including progression-free survival and duration of response.  RELIANT will be conducted at 20 sites in the United States.  We believe sufficiently positive results would support accelerated approval by the FDA.

    "In the third quarter, we plan to initiate an open-label, 20-patient, Phase 1b trial of relacorilant combined with the PD-1 checkpoint inhibitor pembrolizumab in patients with metastatic or unresectable adrenal cancer that produces excess cortisol," said Dr. Grauer.  "These patients respond poorly to pembrolizumab monotherapy and also suffer from Cushing's syndrome.  By modulating the effects of excess cortisol, including cortisol-induced immune suppression, relacorilant may both treat the symptoms of Cushing's syndrome and allow pembrolizumab achieve its full cancer-killing effect."

    Metabolic Diseases

    • Enrollment continues in double-blind, placebo-controlled, Phase 2 trial of miricorilant to reverse recent APIWG (GRATITUDE)
    • Double-blind, placebo-controlled Phase 2 trial (GRATITUDE 2) of miricorilant to reverse long-standing antipsychotic-induced weight gain (APIWG) planned to start in third quarter 2020
    • Double-blind, placebo-controlled Phase 2 trial of miricorilant in patients with non-alcoholic steatohepatitis (NASH) planned to start in fourth quarter 2020

    "Miricorilant has shown great promise as a treatment for APIWG," said Dr. Grauer.  "In our Phase 1b trial, healthy subjects given olanzapine plus miricorilant gained less weight and had lower triglycerides and less sharply elevated liver enzymes than subjects who received olanzapine plus placebo – despite being treated for only two weeks.  We hope to confirm and extend these results in the GRATITUDE trials.

    "Our on-going GRATITUDE trial is testing the ability of miricorilant to reduce recent weight gain caused by antipsychotic medications in 100 patients with schizophrenia," added Dr. Grauer.  "Study participants continue to receive their established dose of antipsychotic medication and either 600 milligrams of miricorilant or placebo for 12 weeks.  Our second trial, GRATITUDE 2 will test the same effect in patients with long-standing APIWG.

    "Completion of formulation work for miricorilant has allowed us to advance by one quarter the start of our second Phase 2 trial in patients with APIWG and our first Phase 2 trial in patients with NASH," said Dr. Grauer.

    Conference Call

    We will hold a conference call on August 4th, 2020, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).  To participate, dial 1-800-353-6461 from the United States or 1-334-323-0501 internationally approximately ten minutes before the start of the call (passcode 6800706).  A replay will be available through August 18, 2020 at 1-888-203-1112 in the United States and 1-719-457-0820 internationally (passcode 6800706).

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. We have discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. We own extensive United States and foreign intellectual property covering the composition of our selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    GAAP Measures of Net Income

    To supplement our financial results presented on a GAAP basis, we use non-GAAP measures of net income, basic net income per share and diluted net income per share that exclude the following non-cash expenses – (i) stock-based compensation, (ii) our use of deferred tax assets to offset current tax expense and (iii) related income tax effects. We believe these non-GAAP measures help investors evaluate our financial performance and potential future results. Our non-GAAP measures may be different from, and not directly comparable to, those used by other companies. They are not a substitute for comparable GAAP measures and should not be considered in isolation. Investors should read our non-GAAP presentation in conjunction with our financial statements prepared in accordance with GAAP.

    Forward-Looking Statements

    Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business and achieve our goals during the Covid-19 pandemic and to generate sufficient revenue to fund our commercial operations and development programs; the availability of competing treatments, including generic versions of Korlym; our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym; and risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates and oversight, and other requirements. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include those concerning our 2020 revenue guidance; the impact of the Covid-19 pandemic on our operations, financial performance and clinical development programs; the progress, enrollment, timing, design and results of our clinical trials; and the clinical and commercial attributes of relacorilant, exicorilant and miricorilant. We disclaim any intention or duty to update forward-looking statements made in this press release.



    CORCEPT THERAPEUTICS INCORPORATED



    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands, except per share data)
     
     June 30,

    2020
     December 31,

    2019 (1)
     
     (Unaudited)   
    Assets    
    Cash and investments$409,558  $315,314 
    Trade receivables, net of allowances22,725   19,928  
    Inventory16,120   17,405  
    Operating lease right-of-use asset3,472   3,446  
    Deferred tax assets, net35,470   45,677  
    Other assets10,478   10,542  
    Total assets$497,823  $412,312 
    Liabilities and Stockholders' Equity    
    Accounts payable$6,304  $7,537 
    Operating lease liabilities3,505   3,461  
    Other liabilities34,316   30,132  
    Stockholders' equity453,698   371,182  
    Total liabilities and stockholders' equity$497,823  $412,312 
         
    (1) Derived from audited financial statements at that date    



    CORCEPT THERAPEUTICS INCORPORATED



    CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

    (In thousands, except per share data)
        
     Three Months Ended June 30, Six Months Ended June 30,
     2020 2019 2020 2019
    Revenues       
    Product revenue, net$88,565   $72,257   $181,812   $137,086  
            
    Operating expenses       
    Cost of sales1,234   1,377   3,112   2,617  
    Research and development26,497   21,656   52,620   41,900  
    Selling, general and administrative25,572   24,591   53,107   48,980  
    Total operating expenses$53,303   $47,624   $108,839   $93,497  
    Income from operations35,262   24,633   72,973   43,589  
    Interest and other income1,010   1,178   2,481   2,275  
    Income before income taxes36,272   25,811   75,454   45,864  
    Income tax expense(7,945)  (5,625)  (17,062)  (7,404) 
    Net income$28,327   $20,186   $58,392   $38,460  
    Other comprehensive income (loss):       
    Net unrealized gain on available-for-sale investments, net of tax impact of $(170), $(73), $(190) and $(124), respectively545   227   606   391  
    Foreign currency translation loss, net of tax(15)     (27)    
    Total comprehensive income$28,857   $20,413   $58,971   $38,851  
            
    Basic net income per share$0.25   $0.18   $0.51   $0.34  
            
    Diluted net income per share$0.23   $0.17   $0.48   $0.31  
            
    Shares used in computing basic net income per common share115,006   114,340   114,790   114,590  
    Shares used in computing diluted net income per common share123,234   121,783   122,756   122,831  
                    



    CORCEPT THERAPEUTICS INCORPORATED



    RECONCILIATION OF GAAP TO NON-GAAP NET INCOME

    (In thousands, except per share data)
        
     Three Months Ended June 30, Six Months Ended June 30,
     2020  2019  2020  2019 
    GAAP net income$28,327  $20,186  $58,392  $38,460 
            
    Non-cash expenses (benefits)       
    Stock-based compensation       
    Cost of sales15  55  38  83 
    Research and development2,794  2,505  5,399  4,484 
    Selling, general and administrative5,680  5,176  10,970  9,865 
    Total stock-based compensation8,489  7,736  16,407  14,432 
    Deferred income taxes4,922  4,908  10,017  5,834 
    Income tax effect of non-GAAP adjustments (1)(2,037) (1,857) (3,938) (3,464)
    Non-GAAP net income, adjusted for non-cash expenses$39,701  $30,973  $80,878  $55,262 
            
    GAAP basic net income per share$0.25  $0.18  $0.51  $0.34 
            
    GAAP diluted net income per share$0.23  $0.17  $0.48  $0.31 
            
    Non-GAAP basic net income

    per share, adjusted for

    non-cash expenses
    $0.35  $0.27  $0.70  $0.48 
            
    Non-GAAP diluted net income

    per share, adjusted for

    non-cash expenses
    $0.32  $0.25  $0.66  $0.45 
            
    Shares used in computing basic

    net income per share
    115,006  114,340  114,790  114,590 
    Shares used in computing diluted net income per share123,234  121,783  122,756  122,831 
            
    (1) Calculated by applying the statutory tax rate to the pre-tax, non-discrete, non-GAAP adjustments.

    ________________________

    1 See our 2020 ENDO poster at the Research & Pipeline / Publications tab of our website.

    2 See our ASCO poster at the Investors / Events tab of our website.

    CONTACT:

    Christopher S. James, MD

    Director, Investor Relations

    Corcept Therapeutics

    650-684-8725

    cjames@corcept.com

    www.corcept.com 

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  19. MENLO PARK, Calif., July 28, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT) today announced it will report second quarter financial results and provide a corporate update on August 4, 2020. The company will also host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

    Conference Call Information
    To participate, dial 1-800-353-6461 from the United States or 1-334-323-0501 internationally approximately ten minutes before the start of the call. The passcode will be 6800706.

    A replay will be available through August 18, 2020 at 1-888-203-1112 from the United States and 1-719-457-0820 internationally. The passcode will be 6800706.

    About Corcept Therapeutics Incorporated

    Corcept is a commercial-stage…

    MENLO PARK, Calif., July 28, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT) today announced it will report second quarter financial results and provide a corporate update on August 4, 2020. The company will also host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

    Conference Call Information

    To participate, dial 1-800-353-6461 from the United States or 1-334-323-0501 internationally approximately ten minutes before the start of the call. The passcode will be 6800706.

    A replay will be available through August 18, 2020 at 1-888-203-1112 from the United States and 1-719-457-0820 internationally. The passcode will be 6800706.

    About Corcept Therapeutics Incorporated

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds, that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    CONTACT:

    Christopher S. James, MD

    Director, Investor Relations

    Corcept Therapeutics

    650-684-8725

    cjames@corcept.com

    www.corcept.com

     

    View Full Article Hide Full Article
  20. MENLO PARK, Calif., July 28, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced enrollment of its first patient in GRADIENT, a double-blind, placebo-controlled, Phase 3 trial of relacorilant in patients with Cushing's syndrome caused by adrenal adenomas or hyperplasia.

    "We are excited to begin enrollment in GRADIENT," said Andreas Grauer, MD, Corcept's Chief Medical Officer.  "Patients with Cushing's syndrome of adrenal origin have poor health outcomes, even if the course of their decline is sometimes less rapid than in Cushing's…

    MENLO PARK, Calif., July 28, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced enrollment of its first patient in GRADIENT, a double-blind, placebo-controlled, Phase 3 trial of relacorilant in patients with Cushing's syndrome caused by adrenal adenomas or hyperplasia.

    "We are excited to begin enrollment in GRADIENT," said Andreas Grauer, MD, Corcept's Chief Medical Officer.  "Patients with Cushing's syndrome of adrenal origin have poor health outcomes, even if the course of their decline is sometimes less rapid than in Cushing's syndrome of other etiologies.  GRADIENT is the first systematic study of the benefits of a medical treatment in these patients. We expect it to contribute meaningfully to physicians' ability to provide optimal care."

    GRADIENT is a double-blind, placebo-controlled Phase 3 trial, with a planned enrollment of 130 patients at sites in the United States and Europe.  Half of the patients will receive relacorilant and the other half placebo for six months.  The trial's primary endpoints are improvement in glucose metabolism and hypertension.1

    GRADIENT is Corcept's second Phase 3 trial of relacorilant in patients with hypercortisolism.  The company's pivotal GRACE trial is enrolling 130 patients with all etiologies of Cushing's syndrome at sites in the United States, Canada, Europe and Israel.  Corcept expects the results of GRACE, if positive, to be the basis for relacorilant's new drug application as a treatment for all etiologies of Cushing's syndrome.

    About Relacorilant

    Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor that does not bind to the body's other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including Cushing's syndrome and adrenal, ovarian and pancreatic cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents. Relacorilant has received orphan drug designation in the United States for the treatment of Cushing's syndrome and pancreatic cancer.

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    1 See our poster at the Research & Pipeline / Publications tab of our website and Clinicaltrials.gov (NCT04308590).

    CONTACT:

    Christopher S. James, MD

    Director, Investor Relations

    Corcept Therapeutics

    650-684-8725

    cjames@corcept.com

    www.corcept.com



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  21. MENLO PARK, Calif., July 23, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced the completion of enrollment in its controlled, Phase 2 trial of relacorilant combined with nab-paclitaxel (Abraxane®) in patients with metastatic, platinum-resistant ovarian cancer.

    "We achieved this milestone thanks in part to the hard work and enthusiasm of our clinical investigators," said Andreas Grauer, MD, Corcept's Chief Medical Officer. "Data from our open-label, Phase 1/2 trial were very promising.1 We expect to have results from this larger…

    MENLO PARK, Calif., July 23, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced the completion of enrollment in its controlled, Phase 2 trial of relacorilant combined with nab-paclitaxel (Abraxane®) in patients with metastatic, platinum-resistant ovarian cancer.

    "We achieved this milestone thanks in part to the hard work and enthusiasm of our clinical investigators," said Andreas Grauer, MD, Corcept's Chief Medical Officer. "Data from our open-label, Phase 1/2 trial were very promising.1 We expect to have results from this larger, controlled trial in the first half of next year."

    The trial has enrolled 177 patients at 28 sites in the United States, Canada and Europe. Participants were randomly assigned to receive either relacorilant in combination with nab-paclitaxel or nab-paclitaxel alone. The trial's primary endpoint is progression free survival, with secondary endpoints including objective response rate and duration of objective response.2

    About Relacorilant

    Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor, the receptor for cortisol which is activated when cortisol levels are high. Relacorilant does not bind to the body's other hormone receptors. Corcept is studying relacorilant as a potential treatment for a variety of serious disorders, including Cushing's syndrome and advanced adrenal, ovarian and pancreatic cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents. Relacorilant has received orphan drug designation in the United States for the treatment of Cushing's syndrome and pancreatic cancer.

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol. Corcept's medication Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    Abraxane® is a registered trademark of Abraxis BioScience, LLC.

    1 For more data, see our ASCO poster at the Investors/Past Events tab of our website.

    2 For additional information, see Clinicaltrials.gov (trial identifier: NCT03776812)

    CONTACT:

    Christopher S. James, MD

    Director, Investor Relations

    Corcept Therapeutics

    650-684-8725

    cjames@corcept.com

    www.corcept.com

    View Full Article Hide Full Article
  22. MENLO PARK, Calif., June 30, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced enrollment of the first patient in RELIANT, an open-label, Phase 3 trial of relacorilant in combination with nab-paclitaxel (Celgene's medication, Abraxane®) in patients with metastatic pancreatic cancer.

    "Metastatic pancreatic cancer is an aggressive disease and there is an urgent need for effective therapies," said Andreas Grauer, MD, Corcept's Chief Medical Officer. "Cortisol activity suppresses apoptosis.  Relacorilant reverses this effect…

    MENLO PARK, Calif., June 30, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced enrollment of the first patient in RELIANT, an open-label, Phase 3 trial of relacorilant in combination with nab-paclitaxel (Celgene's medication, Abraxane®) in patients with metastatic pancreatic cancer.

    "Metastatic pancreatic cancer is an aggressive disease and there is an urgent need for effective therapies," said Andreas Grauer, MD, Corcept's Chief Medical Officer. "Cortisol activity suppresses apoptosis.  Relacorilant reverses this effect and may enable chemotherapeutic agents such as nab-palitaxel to achieve their full, cancer-killing effect.  The results of our open-label, Phase 1/2 study, which we presented at ASCO last year, were very encouraging.1  We are excited to have begun this larger, more definitive trial.  We believe sufficiently positive results would support accelerated approval."

    RELIANT has a planned enrollment of 80 patients with metastatic pancreatic cancer, with an interim analysis of data from the first 40 patients.  Each patient will receive relacorilant plus nab-paclitaxel.  The primary endpoint is objective response rate.  Secondary endpoints include progression-free survival and duration of response.  RELIANT will be conducted at 20 sites in the United States.2

    About Relacorilant

    Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor that does not bind to the body's other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including Cushing's syndrome and adrenal, ovarian and pancreatic cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents. Relacorilant has received orphan drug designation in the United States for the treatment of Cushing's syndrome and pancreatic cancer.

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    Abraxane® is a registered trademark of Abraxis BioScience, LLC.

    CONTACT:

    Christopher S. James, MD

    Director, Investor Relations

    Corcept Therapeutics

    650-684-8725

    cjames@corcept.com

    www.corcept.com

    1 See our ASCO poster at the Investors/Past Events tab of our website.

    2 See Clinicaltrials.gov (trial identifier: NCT04329949)

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  23. MENLO PARK, Calif., June 15, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, will present novel genomic data from patients with adrenocortical carcinoma at the 2020 American Association of Cancer Research (AACR) Annual Meeting. This year's annual meeting will be held in a virtual format starting June 22. Following its presentation, a copy of our poster will be available at the Research & Pipeline / Publications tab of our website.

    "Excessive cortisol in patients with adrenal cancer causes Cushing's syndrome and may also blunt the efficacy…

    MENLO PARK, Calif., June 15, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, will present novel genomic data from patients with adrenocortical carcinoma at the 2020 American Association of Cancer Research (AACR) Annual Meeting. This year's annual meeting will be held in a virtual format starting June 22. Following its presentation, a copy of our poster will be available at the Research & Pipeline / Publications tab of our website.

    "Excessive cortisol in patients with adrenal cancer causes Cushing's syndrome and may also blunt the efficacy of immunotherapeutic agents such as checkpoint inhibitors," said Andreas Grauer, MD, Corcept's Chief Medical Officer. "The data we are presenting informed our Phase 1b trial of our proprietary, selective cortisol modulator relacorilant in combination with the PD-1 checkpoint inhibitor pembrolizumab (Merck's drug, Keytruda®) in patients with metastatic or unresectable adrenocortical cancer.1 Our trial will examine whether relacorilant can, in addition to treating Cushing's syndrome in these patients, also help immunotherapy achieve its maximum effect, by reducing the immunosuppressive effects of excess cortisol activity."

    Suppression of Tumor Immune Activity in Adrenocortical Carcinoma with Excess Glucocorticoid

    • Session Title: Late-Breaking Research: Clinical Research 1 / Endocrinology
    • Session Type: Poster session
    • Poster No: LB-130
    • Location: Virtual meeting
    • Presentation Available Online: Beginning June 22 (meeting registration required)

    About Relacorilant

    Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor, the receptor for cortisol which is activated when cortisol levels are high. Relacorilant does not bind to the body's other hormone receptors, including the progesterone receptor. Corcept is studying relacorilant as a potential treatment for a variety of serious disorders, including Cushing's syndrome and advanced adrenal, ovarian and pancreatic cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents. Relacorilant has received orphan drug designation in the United States for the treatment of Cushing's syndrome and pancreatic cancer.

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    CONTACT:

    Christopher S. James, MD

    Director, Investor Relations

    Corcept Therapeutics

    650-684-8725

    cjames@corcept.com

    www.corcept.com

    _______________

    1 For additional information, see Clinicaltrials.gov (trial identifier: NCT04373265).

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  24. MENLO PARK, Calif., May 14, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, will present novel immuno-oncology data from the selective cortisol receptor modulator relacorilant at the 2020 American Society of Clinical Oncology Annual Meeting. This year's annual meeting will be held in a virtual format from Friday, May 29 through Sunday, May 31, 2020. Following its presentation, a copy of our poster will be available at the Research & Pipeline / Publications tab of our website.

    "Patients with adrenal cancer often have tumors that produce cortisol…

    MENLO PARK, Calif., May 14, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, will present novel immuno-oncology data from the selective cortisol receptor modulator relacorilant at the 2020 American Society of Clinical Oncology Annual Meeting. This year's annual meeting will be held in a virtual format from Friday, May 29 through Sunday, May 31, 2020. Following its presentation, a copy of our poster will be available at the Research & Pipeline / Publications tab of our website.

    "Patients with adrenal cancer often have tumors that produce cortisol, which may limit the efficacy of immune checkpoint inhibitors," said Andreas Grauer, MD, Corcept's Chief Medical Officer. "Our hypothesis is that administering a selective cortisol modulator in combination with an immunotherapeutic agent such as pembrolizumab will treat the symptoms of hypercortisolism and help pembrolizumab achieve its maximum effect.1 The data presented in this abstract have informed the design of our Phase 1b trial in which 20-patients with metastatic or unresectable adrenal tumors that produce cortisol will receive our selective cortisol modulator relacorilant in addition to pembrolizumab."

    Impact of relacorilant, a selective glucocorticoid receptor antagonist,
    on the immunosuppressive effects of endogenous cortisol (abstract no. 3091)

    • Session Title: Developmental Therapeutics – Immunotherapy
    • Session Type: Poster session
    • Location: Virtual meeting
    • Presentation Available Online: May 29 to November 20, 2020 (meeting registration required)

    About Relacorilant

    Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor, the receptor for cortisol which is activated when cortisol levels are high. Relacorilant does not bind to the body's other hormone receptors, including the progesterone receptor. Corcept is studying relacorilant as a potential treatment for a variety of serious disorders, including Cushing's syndrome and advanced adrenal, ovarian and pancreatic cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents through 2037. Relacorilant has received orphan designation in the United States for the treatment of both Cushing's syndrome and pancreatic cancer.

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, exicorilant and miricorilant, that selectively modulate the effects of cortisol but not progesterone. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators, including mifepristone, to treat a variety of serious disorders.

    _____________________________________________
    1
    For additional information, see Clinicaltrials.gov (trial identifier: NCT04373265).

    CONTACT:
    Christopher S. James, MD
    Director, Investor Relations
    Corcept Therapeutics
    650-684-8725
    cjames@corcept.com 
    www.corcept.com 

    View Full Article Hide Full Article
  25. MENLO PARK, Calif. , May 04, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, today reported its results for the quarter ended March 31, 2020.

    Financial Highlights

    • Revenue of $93.2 million, a 44 percent increase from first quarter 2019
    • GAAP diluted net income of $0.25 per share, compared to $0.15 per share in first quarter 2019
    • Non-GAAP diluted net income of $0.34 per share, compared to $0.20 per share in first quarter 2019
    • Cash and investments of $349.0 million, compared to $315.3 million in fourth quarter 2019
    • Reaffirmed

    MENLO PARK, Calif. , May 04, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, today reported its results for the quarter ended March 31, 2020.

    Financial Highlights

    • Revenue of $93.2 million, a 44 percent increase from first quarter 2019
    • GAAP diluted net income of $0.25 per share, compared to $0.15 per share in first quarter 2019
    • Non-GAAP diluted net income of $0.34 per share, compared to $0.20 per share in first quarter 2019
    • Cash and investments of $349.0 million, compared to $315.3 million in fourth quarter 2019
    • Reaffirmed 2020 revenue guidance of $355 – 375 million

    Corcept reported quarterly revenue of $93.2 million in the first quarter, compared to $64.8 million in the first quarter of 2019.  First quarter GAAP net income was $30.1 million, compared to $18.3 million in the same period last year.  Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets, together with related income tax effects, non-GAAP net income in the first quarter was $41.2 million, compared to $24.3 million in the first quarter of 2019.  A reconciliation of GAAP to non-GAAP net income is included below.

    First quarter operating expenses were $55.5 million, compared to $45.9 million in the first quarter of 2019, primarily due to increased employee recruiting and compensation expense, increased spending to conduct clinical trials in Cushing's syndrome and solid tumors and increased spending to formulate and manufacture relacorilant, miricorilant and exicorilant.

    Cash and investments were $349.0 million at March 31, 2020, an increase of $33.7 million from December 31, 2019.  The company reaffirmed its 2020 revenue guidance of $355 – 375 million.

    "Our commercial and medical affairs teams did an excellent job supporting physicians during this difficult time," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer.  "COVID-19 poses especially grave risks to patients with Cushing's syndrome.  Hypercortisolism suppresses the immune system and greatly increases the risk of respiratory infection.  Now, more than ever, it is important that patients with Cushing's syndrome receive optimal treatment.

    "The COVID-19 pandemic's future impact on Corcept is difficult to estimate," said Dr. Belanoff.  "While the heightened vulnerability of patients with Cushing's syndrome and their greater than usual need to adhere to their prescribed regimen tends to increase demand for Korlym, restrictions imposed by public health authorities, hospitals and medical practices make it harder for us to reach physicians and harder for physicians to diagnose and treat new patients.  It is difficult to predict how the balance of these countervailing forces will shift as the year progresses.  That is why, despite an outstanding first quarter, we have not changed our annual revenue guidance.

    "Our clinical development programs continue to advance, although the pandemic has made progress more difficult," Dr. Belanoff continued.  "Some clinical trial sites, particularly those at academic centers, have suspended new patient enrollments.  Some have stopped initiating new trials.  At other sites, patient enrollment and study initiations have continued, but at a slower pace.  The effect of these changes varies from trial-to-trial.  Slowed enrollment will cause our GRACE trial to take longer to complete.  The start of our Phase 3 GRADIENT trial and our planned trials in adrenocortical cancer and non-alcoholic steatohepatitis (NASH) have been delayed one quarter.

    "By contrast, we still expect results from our Phase 2 trial in ovarian cancer in the first half of next year and to complete dose-finding in our trial of exicorilant plus enzalutamide (Xtandi®) to treat castration-resistant prostate cancer this year.  The planned starts of our Phase 3 trial in pancreatic cancer and our additional Phase 2 trial in antipsychotic-induced weight gain have not changed."

    Cushing's Syndrome

    • Phase 3 trial of relacorilant to treat patients with Cushing's syndrome (GRACE) continues at sites in the United States, Europe and Israel; NDA filing planned for second quarter 2022
    • Phase 3 trial of relacorilant to treat patients with Cushing's syndrome caused by adrenal adenomas (GRADIENT) expected to start in second quarter 2020

    "Although the COVID-19 pandemic has greatly slowed new patient screening and enrollment and delayed the opening of our last few clinical trial sites in the GRACE study," said Andreas Grauer, MD, Corcept's Chief Medical Officer, "patients who have already enrolled have continued to participate and we expect the pace of enrollment to increase as public health restrictions ease.  We now plan to submit our relacorilant NDA for Cushing's syndrome in the second quarter of 2022.

    "This quarter, we plan to start our Phase 3 GRADIENT trial of relacorilant in patients with Cushing's syndrome caused by adrenal adenomas," said Dr. Grauer.  GRADIENT is the first randomized, double-blind, placebo-controlled trial in patients with this etiology of Cushing's syndrome, with a planned enrollment of 130 patients at sites in the United States and Europe.  Half of the patients will receive relacorilant and the other half will receive placebo for six months.  The primary endpoints will be improvement in glucose metabolism and hypertension.  Many planned GRADIENT sites are currently participating in GRACE.1

    Solid Tumors

    • Controlled, Phase 2 trial of relacorilant plus nab-paclitaxel (Abraxane®) to treat metastatic ovarian cancer enrolling patients at sites in the United States and Europe; results expected in first half 2021
    • Phase 3 trial of relacorilant plus nab-paclitaxel in metastatic pancreatic cancer (RELIANT)
      to start in second quarter 2020
    • Selection of optimum dose of exicorilant plus enzalutamide in castration-resistant prostate cancer expected by year-end
    • Phase 1b trial of relacorilant plus PD-1 checkpoint inhibitor pembrolizumab (Keytruda®) to treat patients with metastatic or unresectable adrenal cancer to start in third quarter 2020

    "While the COVID-19 pandemic has slowed the pace of enrollment and clinical trial site activation, our oncology program continues to advance," said Dr. Grauer.  "We expect results from our Phase 2 trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant, metastatic ovarian cancer in the first half of 2021.  This quarter, we plan to start our Phase 3 RELIANT trial of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer."

    RELIANT will be an open-label trial in which 80 patients receive relacorilant plus nab-paclitaxel, with the primary endpoint being the objective response rate, assessed by RECIST criteria.  An interim analysis will be performed on data from the first 40 patients.  "RELIANT's design incorporates guidance from the FDA," said Dr. Grauer.  "We believe that sufficiently positive results would support accelerated approval in patients with metastatic pancreatic cancer."

    "Next quarter, we also plan to start a 20-patient, open-label, Phase 1b trial of relacorilant combined with the PD-1 checkpoint inhibitor pembrolizumab in patients with metastatic or unresectable adrenal cancer that produces cortisol.  These patients have a poor response to pembrolizumab monotherapy," Dr. Grauer added. "Patients with adrenal cancer often have Cushing's syndrome as well, because their tumors produce excess cortisol.  We believe relacorilant may treat these patients' Cushing's syndrome and, by countering cortisol's immunosuppressive effect, help pembrolizumab achieve its full effect."

    Metabolic Diseases

    • Results of 900 mg cohort in Phase 1b study confirm miricorilant's activity in reducing antipsychotic-induced weight gain (APIWG)
    • Phase 2 trial of miricorilant to reverse long-standing APIWG to start in fourth quarter
    • Phase 2 trial of miricorilant to treat patients with NASH to start in first quarter 2021

    "Results from the 900 mg cohort in our Phase 1b study of miricorilant to attenuate APIWG confirm the exciting finding from the 600 mg cohort that miricorilant is an active medication," said Dr. Grauer.  Despite being treated for only two weeks and receiving miricorilant at considerably lower exposures than we plan to investigate in future trials, subjects given olanzapine plus miricorilant gained less weight and had lower triglycerides and less sharply elevated liver enzymes than subjects who received olanzapine plus placebo.  No side effects, beyond those seen with olanzapine, were observed. 

    We plan to publish the trial's full results later this year.

    "We hope that our ongoing GRATITUDE trial will confirm our positive Phase 1b results," added Dr. Grauer. GRATITUDE is a multi-site, double-blind, placebo-controlled, Phase 2 trial of miricorilant in 100 patients with schizophrenia and recent APIWG.  Study participants are randomized to receive either miricorilant or placebo in addition to their established antipsychotic medication regimen for 12 weeks.2

    In the fourth quarter, we plan to test a more potent formulation of miricorilant in a double-blind, placebo-controlled, Phase 2 trial in patients with long-standing APIWG.  In the first quarter of 2021, using the same formulation, we plan to start a double-blind, placebo-controlled, Phase 2 trial of miricorilant to treat patients with NASH, a serious liver disorder that afflicts millions of people.

    Conference Call

    We will hold a conference call on May 4, 2020, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, dial 1-800-458-4121 from the United States or 1-323-794-2093 internationally approximately ten minutes before the start of the call (passcode 2827359). A replay will be available through May 18, 2020 at 1-888-203-1112 in the United States and 1-719-457-0820 internationally (passcode 2827359).

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, exicorilant and miricorilant, that selectively modulate the effects of cortisol but not progesterone. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators, including mifepristone, to treat a variety of serious disorders.

    GAAP Measures of Net Income

    To supplement our financial results presented on a GAAP basis, we use non-GAAP measures of net income, non-GAAP basic net income per share and non-GAAP diluted net income per share that exclude the following non-cash expenses – stock-based compensation, our use of deferred tax assets to offset current tax expense, and related income tax effects. We believe these non-GAAP measures help investors evaluate our financial performance and potential future results. Our non-GAAP measures may be different from, and not directly comparable to, those used by other companies. They are not a substitute for comparable GAAP measures and should not be considered in isolation. Investors should read our non-GAAP presentation in conjunction with our financial statements prepared in accordance with GAAP.

    Forward-Looking Statements

    Statements in this press release, other than statements of historical fact, are forward-looking statements, which are based on our current plans and expectations and are subject to risks and uncertainties that might cause actual results to differ materially from those such statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business and achieve our goals during the COVID-19 pandemic, generate sufficient revenue to fund our commercial operations and development programs; the availability of competing treatments, including generic versions of Korlym; our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym; and risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates, oversight and other requirements. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include those concerning our 2020 revenue guidance; impact of the COVID-19 pandemic on our operations, financial performance and clinical development programs; the progress, enrollment, timing, design and results of our clinical trials; and the clinical and commercial attributes of relacorilant, exicorilant and miricorilant. We disclaim any intention or duty to update forward-looking statements made in this press release.

    Xtandi® is a registered trademark of Astellas Pharma Inc.

    Abraxane® is a registered trademark of Abraxis BioScience, LLC.

    Keytruda® is a registered trademark of Merck Sharp & Dohme Corp.

    CORCEPT THERAPEUTICS INCORPORATED
     
    CONDENSED CONSOLIDATED BALANCE SHEETS
    (In thousands, except per share data)
     
      March 31,
    2020
      December 31,
    2019(1)
      (Unaudited)      
    ASSETS      
    Cash and investments $ 349,005     $ 315,314  
    Trade receivables, net of allowances 26,684     19,928  
    Inventory 16,147     17,405  
    Operating lease right-of-use asset 3,082     3,446  
    Deferred tax assets, net 40,562     45,677  
    Other assets 10,014     10,542  
    Total assets $ 445,494     $ 412,312  
    LIABILITIES AND STOCKHOLDERS' EQUITY      
    Accounts payable $ 4,976     $ 7,537  
    Operating lease liabilities 3,112     3,461  
    Other liabilities 27,917     30,132  
    Stockholders' equity 409,489     371,182  
    Total liabilities and stockholders' equity $ 445,494     $ 412,312  
           
    (1)Derived from audited financial statements at that date.      


    CORCEPT THERAPEUTICS INCORPORATED
     
    CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
     
    (In thousands, except per share data)
     
      Three Months Ended
    March 31,
      2020   2019
    Revenues:      
    Product revenue, net $ 93,247     $ 64,829  
           
    Operating expenses:      
    Cost of sales 1,878     1,240  
    Research and development 26,123     20,244  
    Selling, general and administrative 27,535     24,389  
    Total operating expenses 55,536     45,873  
    Income from operations 37,711     18,956  
    Interest and other income 1,471     1,097  
    Income before income taxes 39,182     20,053  
    Income tax expense (9,117   (1,779 )
    Net income $ 30,065     $ 18,274  
    Other comprehensive income (loss):      
    Net unrealized gain on available-for-sale investments,
    net of tax impact of ($20) and ($52) respectively
    61     164  
    Foreign currency translation loss, net of tax   (12 )    
    Total comprehensive income $ 30,114     $ 18,438  
           
    Basic net income per share $ 0.26     $ 0.16  
           
    Diluted net income per share $ 0.25     $ 0.15  
           
    Shares used in computing basic net income
    per common share
    114,575     114,844  
    Shares used in computing diluted net income
    per common share
    122,226     123,895  


    CORCEPT THERAPEUTICS INCORPORATED
     
    RECONCILIATION OF GAAP TO NON-GAAP NET INCOME
     
    (In thousands, except per share data)
     
      Three Months Ended
    March 31,
      2020   2019
    GAAP net income $ 30,065     $ 18,274  
           
    Non-cash expenses (benefits):      
    Stock-based compensation      
    Cost of sales 23     28  
    Research and development 2,605     1,979  
    Selling, general and administrative 5,290     4,689  
      Total stock-based compensation 7,918     6,696  
    Deferred income taxes 5,095     926  
    Income tax effect of non-GAAP adjustments (1,900 )   (1,607 )
    Non-GAAP net income,
    as adjusted for non-cash expenses
    $ 41,178     $ 24,289  
           
    GAAP basic net income per share $ 0.26     $ 0.16  
           
    GAAP diluted net income per share $ 0.25     $ 0.15  
           
    Non-GAAP basic net income per share,
    as adjusted for non-cash expenses
    $ 0.36     $ 0.21  
           
    Non-GAAP diluted net income per share,
    as adjusted for non-cash expenses
    $ 0.34     $ 0.20  
           
    Shares used in computing basic net income per share 114,575     114,844  
    Shares used in computing diluted net income per share 122,226     123,895  
           
    (1)Calculated by applying the statutory tax rate to the pre-tax, non-discrete, non-GAAP adjustments. 

    1 For more information, see our 2020 ENDO poster at the Research & Pipeline / Publications tab of our website.

    2 For more information, see our 2020 APA poster at the Research & Pipeline / Publications tab of our website

    CONTACT:
    Christopher S. James, MD
    Director, Investor Relations
    Corcept Therapeutics
    650-684-8725
    cjames@corcept.com
    www.corcept.com

    View Full Article Hide Full Article
  26. MENLO PARK, Calif., April 27, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT) today announced it will report first quarter financial results and provide a corporate update on May 4, 2020. The company will also host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

    Conference Call Information
    To participate, dial 1-800-458-4121 from the United States or 1-323-794-2093 internationally approximately ten minutes before the start of the call. The passcode will be 2827359.

    A replay will be available through May 18, 2020 at 1-888-203-1112 from the United States and 1-719-457-0820 internationally. The passcode will be 2827359.

    About Corcept Therapeutics Incorporated

    Corcept is a commercial-stage…

    MENLO PARK, Calif., April 27, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT) today announced it will report first quarter financial results and provide a corporate update on May 4, 2020. The company will also host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

    Conference Call Information
    To participate, dial 1-800-458-4121 from the United States or 1-323-794-2093 internationally approximately ten minutes before the start of the call. The passcode will be 2827359.

    A replay will be available through May 18, 2020 at 1-888-203-1112 from the United States and 1-719-457-0820 internationally. The passcode will be 2827359.

    About Corcept Therapeutics Incorporated

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol.  The company's medication Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, exicorilant and miricorilant, that selectively modulate the effects of cortisol but not progesterone. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators, including mifepristone, to treat a variety of serious disorders.

    CONTACT:
    Christopher S. James, MD
    Director, Investor Relations
    Corcept Therapeutics
    650-684-8725
    cjames@corcept.com
    www.corcept.com

    View Full Article Hide Full Article
  27. MENLO PARK, Calif., April 01, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs that treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced the publication of an abstract in the April-May supplemental issue of the Journal of the Endocrine Society (JES). The abstract describes the Phase 3 trial (entitled "GRADIENT") of relacorilant in patients with Cushing's syndrome caused by adrenal adenomas or hyperplasia. Corcept's poster describing the trial had been accepted for presentation at the 2020 Annual Meeting of the Endocrine Society (ENDO), which has been cancelled.

    "We are excited to…

    MENLO PARK, Calif., April 01, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs that treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced the publication of an abstract in the April-May supplemental issue of the Journal of the Endocrine Society (JES). The abstract describes the Phase 3 trial (entitled "GRADIENT") of relacorilant in patients with Cushing's syndrome caused by adrenal adenomas or hyperplasia. Corcept's poster describing the trial had been accepted for presentation at the 2020 Annual Meeting of the Endocrine Society (ENDO), which has been cancelled.

    "We are excited to present the design of a Phase 3 trial of our selective cortisol modulator, relacorilant in patients whose Cushing's syndrome is caused by an adrenal adenoma," said Andreas Grauer, MD, Corcept's Chief Medical Officer. "GRADIENT is the first randomized, double-blind, placebo-controlled trial in patients with this etiology of Cushing's syndrome. These patients experience poor health outcomes despite having a more indolent course of disease."

    GRADIENT (NCT04308590) has a planned enrollment of 130 patients at sites in the United States and Europe. Participants will receive either relacorilant or placebo for six months, with the primary endpoints being improvement in glucose metabolism and hypertension. Many of the investigators for relacorilant's ongoing Phase 3 GRACE trial (NCT03697109) will also participate in GRADIENT. Our poster presentation of GRADIENT's Phase 3 design is available at the Research & Pipeline / Publications tab of our website.

    Journal of the Endocrine Society
    Volume 4, Issue Supplement 1
    April-May 2020

    GRADIENT: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study to Assess the
    Efficacy and Safety of a Selective Glucocorticoid Receptor Modulator, Relacorilant, in Patients With
    Autonomous Cortisol Secretion Due to Cortisol-Secreting Adrenal Adenoma(s)/Hyperplasia


    Richard J. Auchus, MD, PhD; Andreas Grauer, MD; Andreas G. Moraitis, MD

    University of Michigan, Ann Arbor, MI, USA; Corcept Therapeutics, Menlo Park, CA, USA

    About Relacorilant
    Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor, one of the two receptors to which cortisol binds. Relacorilant does not bind to the body's other hormone receptors, including the progesterone receptor. Corcept is studying relacorilant as a potential treatment for a variety of serious disorders, including Cushing's syndrome and advanced ovarian and pancreatic cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents through 2037. Relacorilant has received orphan designation in the United States and Europe for the treatment of both Cushing's syndrome and pancreatic cancer.

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol.  The company's medication Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, exicorilant and miricorilant, that selectively modulate the effects of cortisol but not progesterone. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators, including mifepristone, to treat a variety of serious disorders.

    CONTACT:
    Christopher S. James, MD
    Director, Investor Relations
    Corcept Therapeutics
    650-684-8725
    cjames@corcept.com
    www.corcept.com

    View Full Article Hide Full Article
  28. MENLO PARK, Calif., March 12, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, announced today that former Gilead Sciences executive Gregg Alton has joined Corcept's Board of Directors. Mr. Alton has also been appointed as Chair of the Corporate Governance and Nominating Committee of the Board of Directors.

    Mr. Alton served as Gilead's interim Chief Executive Officer from January 2019 until March 2019. Before that, he was Gilead's Chief Patient Officer, responsible for Gilead's government affairs, public affairs, patient…

    MENLO PARK, Calif., March 12, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, announced today that former Gilead Sciences executive Gregg Alton has joined Corcept's Board of Directors. Mr. Alton has also been appointed as Chair of the Corporate Governance and Nominating Committee of the Board of Directors.

    Mr. Alton served as Gilead's interim Chief Executive Officer from January 2019 until March 2019. Before that, he was Gilead's Chief Patient Officer, responsible for Gilead's government affairs, public affairs, patient outreach and engagement initiatives, as well as efforts to facilitate access to its medicines around the world. Mr. Alton also oversaw Gilead's corporate and medical affairs functions, its digital patient solutions and patient-centered outcomes groups, and commercial operations in certain countries. He had previously served as Gilead's General Counsel.

    "I am excited to welcome Gregg to our Board," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "His twenty years of experience and broad portfolio of responsibilities at Gilead will be invaluable as our commercial operations mature and we advance our proprietary selective cortisol modulators in a wide range of serious disorders. Gregg has devoted his career to helping patients and physicians understand their treatment options and obtain access to life-saving medications."

    "Corcept's FDA-approved medication Korlym® and the drug candidates it is developing have the potential to benefit millions of patients," said Mr. Alton. "I look forward to contributing to the advancement of such a rich commercial and clinical program."

    About Corcept Therapeutics

    We are a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. We have discovered a large portfolio of proprietary compounds, including relacorilant, exicorilant and miricorilant, that selectively modulate the effects of cortisol but not progesterone. We own extensive United States and foreign intellectual property covering the composition of our selective cortisol modulators and the use of cortisol modulators, including mifepristone, to treat a variety of serious disorders.

    Forward-Looking Statements

    Statements in this press release, other than statements of historical fact, are forward-looking statements, which are based on our current plans and expectations and are subject to risks and uncertainties that might cause actual results to differ materially from those such statements express or imply. These risks and uncertainties include, but are not limited to, our ability to generate sufficient revenue to fund our commercial operations and development programs; the availability of competing treatments, including generic versions of Korlym; our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym; and risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates, oversight and other requirements. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include those regarding Corcept's drug candidates and commercial operations, advancement of its proprietary selective cortisol modulators in a wide range of serious disorders and the value that Mr. Alton will bring to Corcept. Corcept disclaims any intention or duty to update forward-looking statements made in this press release.

    CONTACT:
    Christopher S. James, MD
    Director, Investor Relations
    Corcept Therapeutics
    650-684-8725
    cjames@corcept.com
    www.corcept.com

    View Full Article Hide Full Article
  29. MENLO PARK, Calif., Feb. 20, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, today reported its results for the quarter ended December 31, 2019.

    Financial Highlights

    • 2019 revenue of $306.5 million, an increase of 22 percent from 2018
    • Fourth quarter revenue of $87.9 million, an increase of 32 percent from fourth quarter 2018
    • Fully diluted 2019 GAAP net income of $0.77 per share, compared to $0.60 in 2018
    • Fully diluted fourth quarter GAAP net income of $0.24 per share, compared to $0.18 in 2018
    • Year-end cash and investments

    MENLO PARK, Calif., Feb. 20, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, today reported its results for the quarter ended December 31, 2019.

    Financial Highlights

    • 2019 revenue of $306.5 million, an increase of 22 percent from 2018
    • Fourth quarter revenue of $87.9 million, an increase of 32 percent from fourth quarter 2018
    • Fully diluted 2019 GAAP net income of $0.77 per share, compared to $0.60 in 2018
    • Fully diluted fourth quarter GAAP net income of $0.24 per share, compared to $0.18 in 2018
    • Year-end cash and investments of $315.3 million, compared to $206.8 million at year-end 2018
    • Reiterated 2020 revenue guidance of $355 - 375 million

    Financial Results

    Corcept's 2019 revenue was $306.5 million, compared to $251.2 million in 2018. Fourth quarter revenue was $87.9 million, compared to $66.8 million in the fourth quarter of 2018. The company reiterated its 2020 revenue guidance of $355 – 375 million.

    GAAP net income was $94.2 million for the year and $29.4 million in the fourth quarter of 2019, compared to $75.4 million for the year and $22.0 million in the fourth quarter of 2018. 

    Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets, together with related income tax effects, non-GAAP net income was $40.3 million in the fourth quarter, compared to $30.4 million in the fourth quarter of 2018. For the full-year, non-GAAP net income was $133.3 million, compared to $108.2 million in 2018. A reconciliation of GAAP to non-GAAP net income is included below.

    Cash and investments increased by $48.4 million in the fourth quarter, to $315.3 million.

    "Our Cushing's syndrome business had an excellent 2019," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer, "and we expect growth to continue in 2020, as more patients with Cushing's syndrome receive Korlym and the number of first-time and repeat prescribers of the medication continues to increase.

    "Our commercial success has given us the financial resources to advance our portfolio of selective cortisol modulators. By year-end, we plan to be testing three of our proprietary compounds in Phase 2 or Phase 3 trials in Cushing's syndrome, ovarian cancer, pancreatic cancer, adrenal cancer, antipsychotic-induced weight gain (APIWG) and non-alcoholic steatohepatitis (NASH)."

    Cushing's Syndrome

    • Phase 3 trial (GRACE) of relacorilant to treat patients with Cushing's syndrome actively enrolling patients at sites in the United States, Europe and Israel
    • Phase 3 trial (GRADIENT) of relacorilant to treat patients with Cushing's syndrome caused by adrenal adenomas expected to start in first quarter

    "GRACE is open at fifty-four clinical sites," said Andreas Grauer, MD, Corcept's Chief Medical Officer. "Our investigators are enthusiastic. Patients in relacorilant's Phase 2 trial exhibited meaningful improvements in glucose control and hypertension – two of Cushing's syndrome's most pernicious manifestations – as well as in important secondary endpoints, without instances of Korlym®'s significant off-target effects – vaginal bleeding, endometrial thickening and low potassium.1  For these physicians, whose patients have few good treatment options, the prospect of confirming these data in a pivotal trial is exciting. As we have said, we plan to complete GRACE in time to submit our NDA in the fourth quarter of 2021.

    "Our preparations for opening a double-blind, placebo-controlled, Phase 3 trial (GRADIENT) in patients with Cushing's syndrome caused by adrenal adenomas are nearly complete," added Dr. Grauer. Despite having poor health outcomes, patients with this etiology of Cushing's syndrome have not been rigorously studied." GRADIENT is expected to enroll 130 patients at sites in the United States and Europe. Many of the clinical sites participating in GRADIENT are already participating in GRACE.

    Metabolic Disease

    • Phase 2 trial of miricorilant to reverse recent APIWG actively enrolling patients
    • Phase 2 trials of miricorilant to reverse long-standing APIWG and to treat patients with NASH
      planned to start in fourth quarter

    "The exciting recent developments in our program in metabolic disorders build on years of work," said Dr. Grauer. "We know from data with mifepristone that cortisol modulation has the potential to treat APIWG2 and NASH. Both of these serious disorders afflict millions of people. Last year, our Phase 1b trial showed that our selective cortisol modulator miricorilant at 600 mg was active in mitigating weight gain in healthy volunteers administered olanzapine. Next quarter, we will have results from a 900 mg dose cohort. Our double-blind, placebo-controlled Phase 2 trial of miricorilant in patients with schizophrenia and recent APIWG is now actively enrolling. By year-end, we plan to start testing an improved formulation of miricorilant in two double-blind, placebo-controlled Phase 2 trials – one in patients with long-standing APIWG and another in patients with NASH.

    Solid Tumors

    • Controlled, Phase 2 trial of relacorilant plus nab-paclitaxel to treat metastatic ovarian cancer actively enrolling patients at sites in the United States and Europe, on track to produce results in first half of 2021
    • Phase 3 trial of relacorilant plus nab-paclitaxel to treat patients with metastatic pancreatic cancer
      to start in second quarter
    • Phase 1b trial of relacorilant plus the immunotherapeutic agent pembrolizumab (Keytruda®) to treat patients with metastatic or unresectable adrenocortical cancer to start in second quarter

    "Our oncology program continues to mature," said Dr. Grauer. "At the American Society of Clinical Oncologists (ASCO) annual meeting last June, we presented striking results from our open-label, Phase 1/2 trial of relacorilant plus nab-paclitaxel in patients with ovarian and pancreatic cancers.3 We are seeking to confirm those findings. Our controlled, Phase 2 trial of relacorilant plus nab-paclitaxel is actively enrolling patients with metastatic ovarian cancer at 22 sites in the United States and Europe. We expect results in the first half of 2021. Next quarter, we plan to begin a Phase 3 trial of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer. Our trial design reflects guidance we have received from the FDA and may enable accelerated approval.

    "In the second quarter, we plan to start a Phase 1b trial of relacorilant combined with the PD-1 checkpoint inhibitor pembrolizumab to treat metastatic or unresectable adrenal cancer, a disease with a very poor prognosis. Patients with adrenal cancer often suffer from Cushing's syndrome. Our hypothesis is that by modulating the effects of cortisol, relacorilant can alleviate the symptoms of Cushing's syndrome and, by countering the immunosuppressive effect of cortisol activity, help pembrolizumab achieve its full effect.    

    "Finally, we expect to conclude by year-end the dose-finding trial of our proprietary cortisol modulator exicorilant in combination with enzalutamide in castration-resistant prostate cancer."

    Conference Call

    We will hold a conference call on February 20, 2020, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, dial 1-800-367-2403 from the United States or 1-334-777-6978 internationally approximately ten minutes before the start of the call (passcode 7085899). A replay will be available through March 5, 2020 at 1-888-203-1112 in the United States and 1-719-457-0820 internationally (passcode 7085899).

    About Corcept Therapeutics

    We are a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. We have discovered a large portfolio of proprietary compounds, including relacorilant, exicorilant and miricorilant, that selectively modulate the effects of cortisol but not progesterone. We own extensive United States and foreign intellectual property covering the composition of our selective cortisol modulators and the use of cortisol modulators, including mifepristone, to treat a variety of serious disorders.

    GAAP Measures of Net Income

    To supplement our financial results presented on a GAAP basis, we use non-GAAP measures of net income, non-GAAP basic net income per share and non-GAAP diluted net income per share that exclude the following non-cash expenses – stock-based compensation, our use of deferred tax assets to offset current tax expense, and related income tax effects. We believe these non-GAAP measures help investors evaluate our financial performance and potential future results. Our non-GAAP measures may be different from, and not directly comparable to, those used by other companies. They are not a substitute for comparable GAAP measures and should not be considered in isolation. Investors should read our non-GAAP presentation in conjunction with our financial statements prepared in accordance with GAAP.

    Forward-Looking Statements

    Statements in this press release, other than statements of historical fact, are forward-looking statements, which are based on our current plans and expectations and are subject to risks and uncertainties that might cause actual results to differ materially from those such statements express or imply. These risks and uncertainties include, but are not limited to, our ability to generate sufficient revenue to fund our commercial operations and development programs; the availability of competing treatments, including generic versions of Korlym; our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym; and risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates, oversight and other requirements. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include those concerning our 2020 revenue guidance; expected growth in the number of patients receiving Korlym; the financial and managerial resources required to advance our development programs; the progress, enrollment, timing, design and results of our clinical trials; the clinical and commercial attributes of relacorilant, exicorilant and miricorilant; and the scope and protective power of our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release.

    Keytruda® is a registered trademark of Merck Sharp & Dohme Corp.


    CORCEPT THERAPEUTICS INCORPORATED

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

      December
    31, 2019 (1)

      December
    31, 2018 (1)
    ASSETS      
    Cash and investments $ 315,314     $ 206,760  
    Trade receivables, net of allowances 19,928     17,588  
    Inventory 17,405     16,242  
    Right-of-use asset 3,446      
    Deferred tax assets, net 45,677     62,659  
    Other assets 10,542     8,445  
    Total assets $ 412,312     $ 311,694  
    LIABILITIES AND STOCKHOLDERS' EQUITY      
    Accounts payable $ 7,537     $ 8,266  
    Operating lease liability 3,461      
    Other liabilities 30,132     27,546  
    Stockholders' equity 371,182     275,882  
    Total liabilities and stockholders' equity $ 412,312     $ 311,694  
           
    (1) Derived from audited financial statements at that date      


    CORCEPT THERAPEUTICS INCORPORATED

    CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

    (In thousands, except per share data)

      Three Months Ended
    December 31,
      Year Ended
    December 31,
      2019   2018   2019   2018
    Revenues:              
    Product revenue, net $ 87,895     $ 66,831     $ 306,486     $ 251,247  
                   
    Operating expenses:              
    Cost of sales 1,436     1,579     5,504     5,215  
    Research and development 24,312     18,794     89,017     75,247  
    Selling, general and administrative 27,131     21,560     100,359     81,289  
    Total operating expenses 52,879     41,933     194,880     161,751  
    Income from operations 35,016     24,898     111,606     89,496  
    Interest and other income 1,444     1,042     5,070     2,657  
    Income before income taxes 36,460     25,940     116,676     92,153  
    Income tax expense (7,079 )   3,932     (22,495 )   16,743  
    Net income $ 29,381     $ 22,008     $ 94,181     $ 75,410  
    Other comprehensive income (loss):              
    Net unrealized income (loss) on available-for-sale investments, net of tax impact of $20, $(3), ($104)
    and ($22), respectively
    (62 )   7     327     5  
    Foreign currency translation loss, net of tax 9         4      
    Total comprehensive income $ 29,328     $ 22,015     $ 94,512     $ 75,415  
                   
    Basic net income per share $ 0.26     $ 0.19     $ 0.82     $ 0.65  
                   
    Diluted net income per share $ 0.24     $ 0.18     $ 0.77     $ 0.60  
                   
    Shares used in computing basic net income
    per common share
    114,347     115,191     114,349     115,343  
    Shares used in computing diluted net income
    per common share
    122,688     125,152     122,566     126,688  


    CORCEPT THERAPEUTICS INCORPORATED

    RECONCILIATION OF GAAP TO NON-GAAP NET INCOME

    (In thousands, except per share data)

      Three Months Ended
    December 31,
      Year Ended
    December 31,
      2019   2018   2019   2018
    GAAP net income $ 29,381     $ 22,008     $ 94,181     $ 75,410  
                   
    Non-cash expenses (benefits):              
    Stock-based compensation              
    Cost of sales 39     259     144     259  
    Research and development 2,707     1,624     9,541     7,012  
    Selling, general and administrative 4,864     4,383     19,628     16,476  
      Total stock-based compensation 7,610     6,266     29,313     23,747  
    Deferred income taxes 5,146     3,464     16,877     14,067  
    Income tax effect of non-GAAP adjustments (1) (1,826 )   (1,316 )   (7,035 )   (4,987 )
    Non-GAAP net income,
    as adjusted for non-cash expenses
    $ 40,311     $ 30,422     $ 133,336     $ 108,237  
                   
    GAAP basic net income per share $ 0.26     $ 0.19     $ 0.82     $ 0.65  
                   
    GAAP diluted net income per share $ 0.24     $ 0.18     $ 0.77     $ 0.60  
                   
    Non-GAAP basic net income per share,
    as adjusted for non-cash expenses
    $ 0.35     $ 0.26     $ 1.17     $ 0.94  
                   
    Non-GAAP diluted net income per share,
    as adjusted for non-cash expenses
    $ 0.33     $ 0.24     $ 1.09     $ 0.85  
                   
    Shares used in computing basic net income per share 114,347     115,191     114,349     115,343  
    Shares used in computing diluted net income per share 122,688     125,152     122,566     126,688  
                   
    (1) calculated by applying the statutory tax rate to the
    pre-tax, non-discrete, non-GAAP adjustments.

    1 For more data, see our 2019 AACE poster at the Investors/Past Events tab of our website.

    2 Gross et al, Advances in Therapy (2009); Gross et al, Obesity (2010).

    3 Our ASCO poster is available at the Investors/Past Events tab of our website.

    CONTACT:
    Christopher S. James, MD
    Director, Investor Relations
    Corcept Therapeutics
    650-684-8725
    cjames@corcept.com
    www.corcept.com

    View Full Article Hide Full Article
  30. MENLO PARK, Calif., Feb. 13, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT) today announced it will report its audited 2019 fourth quarter and full-year financial results and provide a corporate update on February 20, 2020. The company will host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

    Conference Call Information

    To participate, dial 1-800-367-2403 from the United States or 1-334-777-6978 internationally approximately ten minutes before the start of the call. The passcode will be 7085899.

    A replay will be available through March 5, 2020 at 1-888-203-1112 from the United States and 1-719-457-0820 internationally. The passcode will be 7085899.

    About Corcept Therapeutics Incorporated

    MENLO PARK, Calif., Feb. 13, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT) today announced it will report its audited 2019 fourth quarter and full-year financial results and provide a corporate update on February 20, 2020. The company will host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

    Conference Call Information

    To participate, dial 1-800-367-2403 from the United States or 1-334-777-6978 internationally approximately ten minutes before the start of the call. The passcode will be 7085899.

    A replay will be available through March 5, 2020 at 1-888-203-1112 from the United States and 1-719-457-0820 internationally. The passcode will be 7085899.

    About Corcept Therapeutics Incorporated

    Corcept is a commercial-stage company engaged in the discovery and development of drugs that treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Its product, Korlym®, was the first medication approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, exicorilant and miricorilant, that selectively modulate the effects of cortisol but not progesterone. Corcept owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators, including mifepristone, the active ingredient in Korlym, to treat a variety of serious disorders.

    CONTACT:
    Christopher S. James, MD
    Director, Investor Relations
    Corcept Therapeutics
    650-684-8725
    cjames@corcept.com
    www.corcept.com

    View Full Article Hide Full Article
    • 2019 revenue of $306.5 million, an increase of 22 percent from 2018
    • Fourth quarter revenue of $87.9 million, an increase of 32 percent from fourth quarter 2018
    • Cash and investments at December 31, 2019, of $315.3 million
    • 2020 revenue guidance of $355 - 375 million
    • Advancing development of cortisol modulators to treat patients with Cushing's syndrome, antipsychotic-induced weight gain, non-alcoholic steatohepatitis and solid tumors

    MENLO PARK, Calif., Jan. 30, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and neuropsychiatric disorders by modulating the effects of the stress hormone cortisol, today reported…

    • 2019 revenue of $306.5 million, an increase of 22 percent from 2018
    • Fourth quarter revenue of $87.9 million, an increase of 32 percent from fourth quarter 2018
    • Cash and investments at December 31, 2019, of $315.3 million
    • 2020 revenue guidance of $355 - 375 million
    • Advancing development of cortisol modulators to treat patients with Cushing's syndrome, antipsychotic-induced weight gain, non-alcoholic steatohepatitis and solid tumors

    MENLO PARK, Calif., Jan. 30, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and neuropsychiatric disorders by modulating the effects of the stress hormone cortisol, today reported preliminary fourth quarter revenue of $87.9 million, compared to $66.8 million in the fourth quarter of 2018.  Preliminary 2019 revenue was $306.5 million, an increase of 22 percent from 2018. 

    Cash and investments increased by $48.4 million in the fourth quarter, to $315.3 million.

    These results are prior to completion of the company's annual independent audit and are subject to adjustment.

    Corcept projects 2020 revenue of $355 – 375 million.

    "Our Cushing's syndrome business had an excellent year," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer.  "As awareness of the poor health outcomes associated with hypercortisolism increased and physicians screened more patients for Cushing's syndrome, the number of patients receiving Korlym® grew.  We expect that growth to continue."

    "Korlym's commercial success has given us the resources to develop our proprietary selective cortisol modulators in a wide range of serious disorders," added Dr. Belanoff.  "These compounds represent Corcept's future.  We look forward to an important year."

    "Our program in Cushing's syndrome is the most advanced," said Andreas Grauer, MD, Corcept's Chief Medical Officer.  "The pivotal trial of Korlym's planned successor, relacorilant, is actively enrolling patients at sites in the United States, Europe and Israel. We are also launching a Phase 3 trial in patients whose Cushing's syndrome is caused by adrenal adenomas.

    "Our programs in metabolic and oncologic disorders are poised to advance significantly.  In the second quarter, we will have results from the second part of our Phase 1b trial of miricorilant for the prevention of antipsychotic-induced weight gain (APIWG).  Miricorilant's Phase 2 trial for the reversal of recent APIWG continues to accrue patients.  We plan to start two additional Phase 2 trials – one for the reversal of long-standing APIWG and another for the treatment of patients with non-alcoholic steatohepatitus (NASH) – by year-end.

    "Our Phase 2 trial of relacorilant to treat advanced ovarian cancer continues to enroll patients at sites in the United States and Europe," added Dr. Grauer.  "In the second quarter, we anticipate starting a Phase 3 trial of relacorilant in metastatic pancreatic cancer and a Phase 1b trial of relacorilant combined with an immunotherapeutic agent in adrenal cancer.  By year-end, we expect to conclude the dose-finding trial of our proprietary cortisol modulator exicorilant in combination with enzalutamide in castration-resistant prostate cancer."

    Hypercortisolism

    Hypercortisolism, often referred to as Cushing's syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing's syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing's syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, 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. Hypercortisolism can affect every organ system in the body and can be lethal if not treated effectively.

    About Corcept Therapeutics Incorporated

    Corcept's approved product, Korlym®, was the first medication approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, exicorilant and miricorilant, that selectively modulate the effects of cortisol but not progesterone. Corcept owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators, including mifepristone, to treat a variety of serious disorders.

    Forward-Looking Statements

    Statements in this press release, other than statements of historical fact, are forward-looking statements, which are based on our current plans and expectations and are subject to risks and uncertainties that might cause actual results to differ materially from those such statements express or imply. These risks and uncertainties include, but are not limited to, our ability to generate sufficient revenue to fund our commercial operations and development programs; the availability of competing treatments, including generic versions of Korlym; our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym; and risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates, oversight and other requirements. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include those concerning our final financial results for 2019 and 2020 revenue guidance; increased awareness of the poor health outcomes associated with hypercortisolism and increased screening of patients for Cushing's syndrome; expected growth in the number of patients receiving Korlym; resources to develop our pipeline; the progress, enrollment, timing, design and results of our development programs, including our clinical trials; the clinical and commercial attributes of relacorilant, exicorilant and miricorilant; and the scope and protective power of our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release.

    CONTACT:
    Christopher S. James, MD
    Director, Investor Relations
    Corcept Therapeutics
    650-684-8725
    cjames@corcept.com
    www.corcept.com

    View Full Article Hide Full Article
  31. MENLO PARK, Calif., Nov. 07, 2019 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, today reported its results for the quarter ended September 30, 2019.

    Financial Highlights

    • Revenue of $81.5 million, a 26 percent increase from third quarter 2018
    • GAAP diluted net income of $0.22 per share, compared to $0.14 per share in third quarter 2018
    • Non-GAAP diluted net income of $0.31 per share, compared to $0.22 per share in third quarter 2018
    • Cash and investments of $266.9 million, compared to $225.7 million in second quarter 2019
    • 2019

    MENLO PARK, Calif., Nov. 07, 2019 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, today reported its results for the quarter ended September 30, 2019.

    Financial Highlights

    • Revenue of $81.5 million, a 26 percent increase from third quarter 2018
    • GAAP diluted net income of $0.22 per share, compared to $0.14 per share in third quarter 2018
    • Non-GAAP diluted net income of $0.31 per share, compared to $0.22 per share in third quarter 2018
    • Cash and investments of $266.9 million, compared to $225.7 million in second quarter 2019
    • 2019 revenue guidance narrowed to $300 – $315 million

    Corcept reported quarterly revenue of $81.5 million in the third quarter, compared to $64.4 million in the third quarter of 2018. Third quarter GAAP net income was $26.3 million, compared to $17.7 million in the same period last year. Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets, together with related income tax effects, non-GAAP net income in the third quarter was $37.8 million, compared to $27.9 million in the third quarter of 2018. A reconciliation of GAAP to non-GAAP net income is included below.

    The company narrowed 2019 revenue guidance to $300 – $315 million. Guidance had previously been
    $285 – $315 million.

    Third quarter operating expenses were $48.5 million, compared to $41.5 million in the third quarter of 2018, primarily due to increased spending to recruit and compensate additional personnel and discover and develop new selective cortisol modulators, as well as increased legal expense.  Cash and investments were $266.9 million at September 30, 2019, an increase of $41.2 million from June 30, 2019.

    "Our Cushing's syndrome business had an excellent quarter," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "We expect the number of patients receiving Korlym and physicians prescribing the medication to continue to increase. To reach more doctors, we are expanding our sales force.  We expect the clinical specialists we are hiring now to begin contributing to our results next year.

    "I am also pleased to announce an important advance in our program to treat serious metabolic disorders.  In a double-blind, placebo-controlled trial in healthy subjects, our selective cortisol modulator miricorilant significantly reduced the weight gain caused by the commonly prescribed antipsychotic medication olanzapine (Eli Lily's drug, Zyprexa®).  We have already initiated one of two planned Phase 2 trials to further test miricorilant's activity in this indication."

    Cushing's Syndrome

    • European sites begin dosing patients in Phase 3 trial ("GRACE") of relacorilant to treat patients with Cushing's syndrome
    • Double-blind, placebo-controlled, Phase 3 trial of relacorilant in patients whose Cushing's syndrome is caused by adrenal adenomas to start in the first quarter of next year

    "As of today, 42 of 62 planned sites are recruiting patients for GRACE," said Andreas Grauer, MD, Corcept's Chief Medical Officer. "We expect to open an additional 13 sites by the end of the year.  The activation pace of ex-US sites, which we expect will provide the majority of enrollments, has refined our estimate of the trial's completion date. Our plan is to submit our NDA in the fourth quarter of 2021.

    We spent substantial time in Europe in the past quarter helping clinical site activation and speaking to investigators. Most important, our investigators are highly enthusiastic about GRACE1, because of relacorilant's positive Phase 2 efficacy and side effect profile."

    Patients in relacorilant's Phase 2 trial exhibited meaningful improvements in glucose control and hypertension – two of Cushing's syndrome's most common and pernicious symptoms. The trial also met a wide range of secondary endpoints, including weight loss, liver function, coagulopathy, insulin resistance, cognitive function, mood and quality of life. These results were achieved without relacorilant causing Korlym's significant off-target effects – vaginal bleeding, endometrial thickening and low potassium.2

    In addition to GRACE, Corcept plans to start a Phase 3, double-blind, placebo-controlled trial of relacorilant in patients whose Cushing's syndrome is caused by an adrenal adenoma – a population that has not been rigorously studied. Patients with adrenal Cushing's syndrome typically experience a slower onset of symptoms, but their ultimate health outcomes are poor. Corcept expects to enroll 130 patients at sites in the United States and Europe in the study. Most of the planned investigators and sites are also participating in GRACE.

    Metabolic Disease

    • Positive top-line results from double-blind, placebo-controlled, Phase 1b trial of miricorilant to reduce antipsychotic-induced weight gain
    • Recruiting underway in double-blind, placebo-controlled, Phase 2 trial of miricorilant to reverse recent antipsychotic-induced weight gain

    "Our program to develop miricorilant as a treatment for metabolic disorders is off to an excellent start," said Dr. Grauer. "Antipsychotic medications such as olanzapine are essential to the health of millions of patients, but the weight gain and other metabolic side effects they cause are life-threatening and often lead patients to discontinue treatment. At the first dose level tested in our Phase 1b trial, healthy subjects given olanzapine plus miricorilant gained less weight than subjects receiving olanzapine plus placebo (see Figure 1). In addition, markers of liver damage that often rise temporarily at the start of olanzapine therapy increased less sharply in subjects receiving miricorilant, suggesting that miricorilant may have protective effects in the liver (see Figure 2). Five subjects in the olanzapine alone group were unable to complete the study due to elevated liver enzymes, while one patient in the miricorilant group experienced this problem."

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/008c2ab5-0e41-48f4-af8f-8576b331ffda

    The Phase 1b trial's first part enrolled 66 healthy subjects, each of whom received olanzapine (10 mg) and either miricorilant (600 mg) or placebo daily. The trial's duration was two weeks.  The second part of the trial, which is planned to start in December, will test a higher dose of miricorilant (900 mg) in 30 healthy subjects.  The study's full results will be presented at a scientific meeting in 2020.

    "These preliminary results are especially encouraging given the short duration of treatment and the low dose of miricorilant. They are consistent with the effects we had previously seen in animal studies. Our plan is to confirm these findings and explore the full breadth of miricorilant's activity," said Dr. Grauer.

    In addition to the second part of its Phase 1b trial, Corcept plans to conduct two double-blind, placebo-controlled Phase 2 trials of miricorilant for the treatment of patients with antipsychotic-induced weight gain.  The first trial, which is underway, will test miricorilant's activity in reversing recent weight gain.  It is expected to enroll 100 patients with schizophrenia at 20 sites in the United States.  Patients will continue to receive their established antipsychotic medication and will have either miricorilant or placebo added to their regimen for 12 weeks. A second Phase 2 trial is planned to start next year. It will enroll patients with long-standing weight gain.  A third Phase 2 trial, testing miricorilant's activity in preventing antipsychotic-induced weight gain, is under consideration. 

    Next year, Corcept also plans to start a double-blind, placebo-controlled, Phase 2 trial of miricorilant as a treatment for patients with non-alcoholic steatohepatitis (NASH), a serious liver disorder that afflicts millions of people.

    Solid Tumors

    • European Commission designates relacorilant orphan drug for treatment of pancreatic cancer
    • Phase 3 trial of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer to start upon completion of consultations with the U.S. Food and Drug Administration (FDA)

    "We are pleased the European Commission (EC) has joined the FDA in designating relacorilant an orphan drug for the treatment of pancreatic cancer," said Dr. Grauer. "The EC based its decision on the European Medicines Agency's finding that relacorilant has the potential to significantly benefit patients.

    "We presented the clinical data reviewed by the EMA at last year's ASCO meeting and it was indeed promising," said Dr. Grauer. "Seven of 25 patients with metastatic pancreatic cancer treated with relacorilant plus nab-paclitaxel (Celgene's drug, Abraxane®) achieved durable disease control, meaning their tumors either shrank or ceased growing for 16 weeks or longer. Tumor response in two patients lasted more than 50 weeks.3  All of these patients' tumors had progressed during multiple lines of prior therapy, including treatments with nab-paclitaxel or another taxane.  That any of them responded is remarkable.  We have sought FDA guidance as to the optimum development path in pancreatic cancer and plan to start a Phase 3 trial promptly upon the conclusion of our discussions."

    Corcept's 180-patient, placebo-controlled Phase 2 trial of relacorilant plus nab-paclitaxel in ovarian cancer continues to enroll patients at sites in the United States and the European Union. Dosing also continues in the company's Phase 1/2 study of exicorilant plus enzalutamide in patients with castration-resistant prostate cancer.

    Conference Call

    We will hold a conference call on November 7, 2019, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, dial 1-877-260-1479 from the United States or 1-334-323-0522 internationally approximately ten minutes before the start of the call (passcode 8532239). A replay will be available through November 21, 2019 at 1-888-203-1112 in the United States and 1-719-457-0820 internationally (passcode 8532239).

    Hypercortisolism

    Hypercortisolism, often referred to as Cushing's syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing's syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing's syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, 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. Hypercortisolism can affect every organ system in the body and can be lethal if not treated effectively.

    About Corcept Therapeutics Incorporated

    Corcept's approved product, Korlym®, was the first treatment approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, exicorilant and miricorilant, that selectively modulate the effects of cortisol but not progesterone. Corcept owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators, including mifepristone, to treat a variety of serious disorders.

    GAAP Measures of Net Income

    To supplement our financial results presented on a GAAP basis, we use non-GAAP measures of net income, non-GAAP basic net income per share and non-GAAP diluted net income per share that exclude the following non-cash expenses – stock-based compensation, our use of deferred tax assets to offset current tax expense, and related income tax effects. We believe these non-GAAP measures help investors evaluate our financial performance and potential future results. Our non-GAAP measures may be different from, and not directly comparable to, those used by other companies. They are not a substitute for comparable GAAP measures and should not be considered in isolation. Rather, investors should read our non-GAAP presentation in conjunction with our financial statements prepared in accordance with GAAP.

    Forward-Looking Statements

    Statements in this press release, other than statements of historical fact, are forward-looking statements, which are based on our current plans and expectations and are subject to risks and uncertainties that might cause actual results to differ materially from those such statements express or imply. These risks and uncertainties include, but are not limited to, our ability to generate sufficient revenue to fund our commercial operations and development programs; the availability of competing treatments, including generic versions of Korlym; our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym; and risks related to the development of our product candidates, including regulatory approvals, mandates, oversight and other requirements. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include those concerning our 2019 revenue guidance; expected growth in the number of patients receiving Korlym and physicians writing Korlym prescriptions; the planned expansion of our sales force and the productivity of these newly-hired clinical specialists; the progress, enrollment, timing, design and results of our development programs, including the GRACE trial, our Phase 3 trial in patients with adrenal Cushing's syndrome, and our other clinical trials; discussions with and planned submissions to regulatory authorities; the clinical and commercial attributes of relacorilant, exicorilant and miricorilant; and the scope and protective power of our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release.

    Abraxane® is a registered trademark of Celgene Corporation.

    Zyprexa® is a registered trademark of Eli Lily and Company.


    CORCEPT THERAPEUTICS INCORPORATED

    CONDENSED CONSOLIDATED BALANCE SHEETS
    (In thousands, except per share data)

      September 30, 2019   December 31, 2018(1)
      (Unaudited)    
    ASSETS      
    Cash and investments $ 266,895     $ 206,760  
    Trade receivables, net of allowances 22,405     17,588  
    Inventory 17,001     16,242  
    Operating lease right-of-use asset 742      
    Deferred tax assets, net 50,804     62,659  
    Other assets 9,175     8,445  
    Total assets $ 367,022     $ 311,694  
    LIABILITIES AND STOCKHOLDERS' EQUITY      
    Accounts payable $ 5,937     $ 8,266  
    Operating lease liability 770      
    Other liabilities 25,939     27,546  
    Stockholders' equity 334,376     275,882  
    Total liabilities and stockholders' equity $ 367,022     $ 311,694  
           
    (1) Derived from audited financial statements at that date      


    CORCEPT THERAPEUTICS INCORPORATED

    CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
    (Unaudited)
    (In thousands, except per share data)

      Three Months Ended September 30,   Nine Months Ended September 30,
      2019   2018   2019   2018
    Revenues:              
    Product revenue, net $ 81,505     $ 64,445     $ 218,591     $ 184,416  
                   
    Operating expenses:              
    Cost of sales 1,451