
Press Releases
Corcept Therapeutics Announces Third Quarter 2020 Financial Results and Provides Corporate Update
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 atJune 30, 2020 - Announcement of
$200 million stock repurchase program - 2020 revenue guidance narrowed to
$355 – 365 million
Revenue was
Corcept narrowed its 2020 revenue guidance range to
Third quarter operating expenses were
Cash and investments were
The company announced a program to repurchase up to
“While pandemic-related public health restrictions and related changes in physician and patient practices dampened our third quarter commercial results,” said
“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
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 andIsrael ; 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 andIsrael
“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
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
“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
“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
Conference Call
We will hold a conference call on
(passcode 9018217).
About Corcept’s Stock Repurchase Program
Our Board of Directors has approved a program authorizing the repurchase of up to
About
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
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
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data)
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 | |||||
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(In thousands, except per share data)
Three Months Ended |
Nine Months Ended |
||||||||||||||
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 |
(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 | |||||||||||
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME
(In thousands, except per share data)
Three Months Ended |
Nine Months Ended |
||||||||||||||
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:
Director, Investor Relations
650-684-8725
cjames@corcept.com
www.corcept.com
Source: Corcept Therapeutics Incorporated