Corcept Therapeutics Announces Second Quarter 2020 Financial Results and Provides Corporate Update
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 atMarch 31, 2020 - Reaffirmed 2020 revenue guidance of
$355 – 375 million
Revenue was
We reaffirm our 2020 revenue guidance of
Second quarter GAAP net income was
Second quarter operating expenses were
Cash and investments were
“Patients with Cushing’s syndrome are at elevated risk of infection with the novel coronavirus,” said
“The pandemic’s impact on Corcept has been varied,”
“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
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 andIsrael ; 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
“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
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
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
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
“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
“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
Conference Call
We will hold a conference call on
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 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) |
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2020 |
December 31, 2019 (1) |
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(Unaudited) | |||||||||
Assets | |||||||||
Cash and investments | $ | 409,558 | $ | 315,314 | |||||
Trade receivables, net of allowances | 22,725 | 19,928 | |||||||
Inventory | 16,120 | 17,405 | |||||||
Operating lease right-of-use asset | 3,472 | 3,446 | |||||||
Deferred tax assets, net | 35,470 | 45,677 | |||||||
Other assets | 10,478 | 10,542 | |||||||
Total assets | $ | 497,823 | $ | 412,312 | |||||
Liabilities and Stockholders’ Equity | |||||||||
Accounts payable | $ | 6,304 | $ | 7,537 | |||||
Operating lease liabilities | 3,505 | 3,461 | |||||||
Other liabilities | 34,316 | 30,132 | |||||||
Stockholders' equity | 453,698 | 371,182 | |||||||
Total liabilities and stockholders’ equity | $ | 497,823 | $ | 412,312 | |||||
(1) Derived from audited financial statements at that date |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (In thousands, except per share data) |
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Three Months Ended |
Six Months Ended |
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2020 | 2019 | 2020 | 2019 | ||||||||||||||||
Revenues | |||||||||||||||||||
Product revenue, net | $ | 88,565 | $ | 72,257 | $ | 181,812 | $ | 137,086 | |||||||||||
Operating expenses | |||||||||||||||||||
Cost of sales | 1,234 | 1,377 | 3,112 | 2,617 | |||||||||||||||
Research and development | 26,497 | 21,656 | 52,620 | 41,900 | |||||||||||||||
Selling, general and administrative | 25,572 | 24,591 | 53,107 | 48,980 | |||||||||||||||
Total operating expenses | $ | 53,303 | $ | 47,624 | $ | 108,839 | $ | 93,497 | |||||||||||
Income from operations | 35,262 | 24,633 | 72,973 | 43,589 | |||||||||||||||
Interest and other income | 1,010 | 1,178 | 2,481 | 2,275 | |||||||||||||||
Income before income taxes | 36,272 | 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 |
545 | 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 share | 115,006 | 114,340 | 114,790 | 114,590 | |||||||||||||||
Shares used in computing diluted net income per common share | 123,234 | 121,783 | 122,756 | 122,831 | |||||||||||||||
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME (In thousands, except per share data) |
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Three Months Ended |
Six Months Ended |
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2020 | 2019 | 2020 | 2019 | ||||||||||||||||
GAAP net income | $ | 28,327 | $ | 20,186 | $ | 58,392 | $ | 38,460 | |||||||||||
Non-cash expenses (benefits) | |||||||||||||||||||
Stock-based compensation | |||||||||||||||||||
Cost of sales | 15 | 55 | 38 | 83 | |||||||||||||||
Research and development | 2,794 | 2,505 | 5,399 | 4,484 | |||||||||||||||
Selling, general and administrative | 5,680 | 5,176 | 10,970 | 9,865 | |||||||||||||||
Total stock-based compensation | 8,489 | 7,736 | 16,407 | 14,432 | |||||||||||||||
Deferred income taxes | 4,922 | 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 share | 123,234 | 121,783 | 122,756 | 122,831 | |||||||||||||||
(1) Calculated by applying the statutory tax rate to the pre-tax, non-discrete, non-GAAP adjustments. |
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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:
Director, Investor Relations
650-684-8725
cjames@corcept.com
www.corcept.com
Source: Corcept Therapeutics Incorporated