GlobeNewswire Inc | Nov 3, 2020 04:05PM EST

November 03, 2020

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 September30, 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 companys 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 Cushings syndrome, antipsychotic-induced weight gain and solid tumors, and on the formulation and manufacture the companys proprietary selective cortisol modulators.

Cash and investments were $444.2 million at September 30, 2020, an increase of $34.7 million fromJune 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, Corcepts 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 Cushings syndrome, four different types of solid tumors, antipsychotic-induced weight gain (APIWG) and starting this month nonalcoholic steatohepatitis (NASH). The pandemics 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.

Cushings Syndrome

-- Phase 3 GRACE trial of relacorilant in patients with any etiology of Cushings 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 Cushings 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 Cushings syndrome in two double-blind, placebo-controlled Phase 3 trials, said Andreas Grauer, MD, Corcepts Chief Medical Officer. GRACE has a planned enrollment of 130 patients with any type of Cushings syndrome. GRADIENT has a planned enrollment of 130 patients with Cushings 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 infirst 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 cortisols 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 Corcepts Stock Repurchase Program

Our Board of Directors has approved a program authorizing the repurchase of up to $200 million of the companys 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 Cushings 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 SECs 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 December 30, 31, 2020 2019 ^(1) (Unaudited) Assets Cash and investments $ 444,218 $ 315,314Trade receivables, net of allowances 21,957 19,928Inventory 16,892 17,405Operating lease right-of-use asset 2,993 3,446Deferred tax assets, net 33,818 45,677Other assets 14,247 10,542Total assets $ 534,125 $ 412,312Liabilities and Stockholders? Equity Accounts payable $ 6,510 $ 7,537Operating lease liabilities 3,031 3,461Other liabilities 34,904 30,132Stockholders' equity 489,680 371,182Total 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 Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Revenues Product revenue, $ 86,327 $ 81,505 $ 268,139 $ 218,591 net Operating expenses Cost of sales 1,216 1,451 4,328 4,068 Research and 33,869 22,805 86,489 64,705 developmentSelling, general 26,523 24,245 79,630 73,228 and administrativeTotal operating $ 61,608 $ 48,501 $ 170,447 $ 142,001 expensesIncome from 24,719 33,004 97,692 76,590 operationsInterest and other 622 1,348 3,103 3,626 incomeIncome before 25,341 34,352 100,795 80,216 income taxesIncome tax expense (3,716 ) (8,012 ) (20,778 ) (15,416 )Net income $ 21,625 $ 26,340 $ 80,017 $ 64,800 Othercomprehensive income (loss):Net unrealizedgain onavailable-for-saleinvestments, net (347 ) (2 ) 259 389 of tax impact of$109, $1, $(81)and $(123),respectivelyForeign currencytranslation loss, 84 (5 ) 57 (5 )net of taxTotalcomprehensive $ 21,362 $ 26,333 $ 80,333 $ 65,184 income Basic net income $ 0.19 $ 0.23 $ 0.70 $ 0.57 per share Diluted net income $ 0.17 $ 0.22 $ 0.65 $ 0.53 per share Shares used incomputing basic 115,734 113,875 115,107 114,349 net income percommon shareShares used incomputing diluted 124,464 121,762 123,337 122,478 net income percommon share

CORCEPT THERAPEUTICS INCORPORATED

RECONCILIATION OF GAAP TO NON-GAAP NET INCOME(In thousands, except per share data)

Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 GAAP net $ 21,625 $ 26,340 $ 80,017 $ 64,800 income Non-cashexpenses (benefits)Stock-based compensationCost of sales 13 22 51 105 Research and 2,958 2,350 8,357 6,834 developmentSelling,general and 5,731 4,899 16,701 14,764 administrativeTotalstock-based 8,702 7,271 25,109 21,703 compensationDeferred 1,761 5,897 11,778 11,731 income taxesIncome taxeffect ofnon-GAAP (2,088 ) (1,745 ) (6,026 ) (5,209 )adjustments ^(1)Non-GAAP netincome,adjusted for $ 30,000 $ 37,763 $ 110,878 $ 93,025 non-cashexpenses GAAP basic netincome $ 0.19 $ 0.23 $ 0.70 $ 0.57 per share GAAP dilutednet income $ 0.17 $ 0.22 $ 0.65 $ 0.53 per share Non-GAAP basicnet income pershare,adjusted for $ 0.26 $ 0.33 $ 0.96 $ 0.81 non-cashexpenses pershare Non-GAAPdiluted netincome pershare, $ 0.24 $ 0.31 $ 0.90 $ 0.76 adjusted fornon-cashexpenses pershare Shares used incomputingbasic net 115,734 113,875 115,107 114,349 income percommon shareShares used incomputingdiluted net 124,464 121,762 123,337 122,478 income percommon share ^(1) Calculated by applying the statutory tax rate to the pre-tax,non-discrete, non-GAAP adjustments.

CONTACT:Christopher S. James, MDDirector, Investor RelationsCorcept Therapeutics650-684-8725cjames@corcept.comwww.corcept.com