Corcept Therapeutics Announces First Quarter 2019 Financial Results and Provides Corporate Update
Financial Highlights
- Revenue of
$64.8 million , a 12 percent increase from first quarter 2018 - Fully-diluted GAAP net income of
$0.15 per share, compared to$0.14 per share in first quarter 2018 - Fully-diluted non-GAAP net income of
$0.20 per share, compared to$0.19 per share in first quarter 2018 - Cash and investments of
$215.7 million , a$9.0 million increase from year-end 2018 - Reaffirmed 2019 revenue guidance of
$285 –$315 million
Corcept reported quarterly revenue of
First quarter operating expenses were
Cash and investments were
The company reaffirmed 2019 revenue guidance of
“As in prior years, our first quarter revenue was reduced as payors forced patients to secure reauthorization of their insurance,” said
“Awareness of Cushing’s syndrome and the importance of screening more widely for the disorder is increasing,” Dr. Belanoff added. “Our goal is to educate physicians about the benefits of cortisol modulation with Korlym and, should it continue to generate positive clinical data and we secure
Clinical Highlights
- Dosing continues in Phase 3 trial of relacorilant in patients with Cushing’s syndrome (“GRACE”)
European Medicines Agency (“EMA”) recommends orphan designation for relacorilant to treat patients with Cushing’s syndrome- Dosing initiated in double-blind, placebo-controlled, Phase 1b trial of CORT118335 for prevention of antipsychotic-induced weight gain; Phase 2 trials in reversal of antipsychotic-induced weight gain planned in second half of 2019
- Placebo-controlled, Phase 2 trial of CORT118335 to treat non-alcoholic steatohepatitis (“NASH”) planned in second half of 2019
- Data from Phase 1/2 trial of relacorilant plus Abraxane in solid tumors to be presented at 2019 ASCO Meeting,
May 31 –June 4 - Dosing continues in controlled, Phase 2 trial of relacorilant plus Abraxane® in metastatic ovarian cancer
- Dosing continues in Phase 1/2 trial of CORT125281 plus Xtandi® in castration-resistant prostate cancer
“It is an exciting time to join Corcept,” said
“Relacorilant’s GRACE trial continues to dose patients with Cushing’s syndrome and has begun opening sites in
Corcept presented data from relacorilant’s Phase 2 trial at the 2019 annual meeting of the
“Our oncology program is also progressing,” said Dr. Grauer. “Enrollment has begun in our 180-patient, controlled, Phase 2 trial of relacorilant plus Abraxane® in patients with metastatic ovarian cancer. At the
“Finally, our most promising compound for metabolic disorders, CORT118335, has entered the clinic. We are dosing healthy subjects in a placebo-controlled Phase 1b trial in the prevention of antipsychotic-induced weight gain and plan to start two placebo-controlled, Phase 2 trials in patients later this year, as well as a placebo-controlled, Phase 2 trial in patients with NASH – a precursor of cirrhosis. These disorders afflict millions of patients and there are no good treatment options.”
Conference Call
We will hold a conference call on
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
About
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 stress hormone cortisol. Corcept’s approved product, Korlym®, was the first
Non-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 better evaluate our past financial performance and potential future results. Our non-GAAP measures should not be considered in isolation or as a substitute for comparable GAAP measures. Investors should read our non-GAAP presentation in conjunction with our financial statements prepared in accordance with GAAP. The non-GAAP measures we use may be different from, and not directly comparable to, similarly titled measures used by other companies.
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
Abraxane® is a registered trademark of
Xtandi® is a registered trademark of
CORCEPT THERAPEUTICS INCORPORATED |
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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(in thousands) | ||||||||
March 31, | December 31, | |||||||
2019 | 2018(1) | |||||||
ASSETS | ||||||||
Cash and investments | $ | 215,747 | $ | 206,760 | ||||
Trade receivables, net of allowances | 19,218 | 17,588 | ||||||
Inventory | 15,360 | 16,242 | ||||||
Operating right-of-use asset | 1,465 | — | ||||||
Deferred tax assets | 61,681 | 62,659 | ||||||
Other assets | 6,741 | 8,445 | ||||||
Total assets | $ | 320,212 | $ | 311,694 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Accounts payable | $ | 9,330 | $ | 8,266 | ||||
Operating lease liability | 1,521 | — | ||||||
Other liabilities | 23,606 | 27,546 | ||||||
Stockholders’ equity | 285,755 | 275,882 | ||||||
Total liabilities and stockholders’ equity | $ | 320,212 | $ | 311,694 | ||||
CORCEPT THERAPEUTICS INCORPORATED | ||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
(in thousands, except per share amounts) | ||||||||
Three Months Ended March 31, |
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2019 | 2018 | |||||||
Revenues: | ||||||||
Product revenue, net | $ | 64,829 | $ | 57,659 | ||||
Operating expenses: | ||||||||
Cost of sales | 1,240 | 1,174 | ||||||
Research and development | 20,244 | 17,050 | ||||||
Selling, general and administrative | 24,389 | 18,440 | ||||||
Total operating expenses | $ | 45,873 | $ | 36,664 | ||||
Income from operations | 18,956 | 20,995 | ||||||
Interest and other income | 1,097 | 294 | ||||||
Income before income taxes | 20,053 | 21,289 | ||||||
Income tax expense | (1,779 | ) | (3,830 | ) | ||||
Net income | $ | 18,274 | $ | 17,459 | ||||
Other comprehensive income: | ||||||||
Net unrealized income (loss) on available-for-sale investments, net of tax impact of $(52) and $48, respectively | 164 | (152 | ) | |||||
Total comprehensive income | $ | 18,438 | $ | 17,307 | ||||
Basic net income per common share | $ | 0.16 | $ | 0.15 | ||||
Diluted net income per common share | $ | 0.15 | $ | 0.14 | ||||
Shares used to compute basic net income per share | 114,844 | 114,882 | ||||||
Shares used to compute diluted net income per share | 123,895 | 127,733 | ||||||
CORCEPT THERAPEUTICS INCORPORATED | ||||||||
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME | ||||||||
(in thousands, except per share amounts) | ||||||||
Three Months Ended |
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March 31, |
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2019 | 2018 | |||||||
GAAP net income | $ | 18,274 | $ | 17,459 | ||||
Non-cash expenses/(benefits): | ||||||||
Stock-based compensation | ||||||||
Cost of Sales | 28 | — | ||||||
Research and development | 1,979 | 1,464 | ||||||
Selling, general and administrative | 4,689 | 3,490 | ||||||
Total stock-based compensation | 6,696 | 4,954 | ||||||
Deferred tax assets | 926 | 3,169 | ||||||
Income tax effect of non-GAAP adjustments(1) | (1,607 | ) | (1,040 | ) | ||||
Non-GAAP net income, as adjusted for non-cash expenses | $ | 24,289 | $ | 24,542 | ||||
GAAP basic net income per share | $ | 0.16 | $ | 0.15 | ||||
GAAP diluted net income per share | $ | 0.15 | $ | 0.14 | ||||
Non-GAAP basic net income per share, as adjusted for non-cash expenses | $ | 0.21 | $ | 0.21 | ||||
Non-GAAP diluted net income per share, as adjusted for non-cash expenses | $ | 0.20 | $ | 0.19 | ||||
Shares used to compute basic net income per share | 114,844 | 114,882 | ||||||
Shares used to compute diluted net income per share | 123,895 | 127,733 | ||||||
(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