Corcept Therapeutics Announces Second Quarter 2019 Financial Results and Provides Corporate Update
Financial Highlights
- Revenue of
$72.3 million , a 16 percent increase from second quarter 2018 - GAAP net income of
$0.17 per share, compared to$0.14 per share in second quarter 2018 - Non-GAAP net income of
$0.25 per share, compared to$0.20 per share in second quarter 2018 - Cash and investments of
$225.7 million , compared to$215.7 million atMarch 31, 2019 - Reaffirmed 2019 revenue guidance of
$285 –$315 million
Corcept reported quarterly revenue of
The company reaffirmed its 2019 revenue guidance of $285 – $315 million.
Second quarter operating expenses were
Cash and investments were
“Our Cushing’s franchise had a strong quarter,” said
Clinical Highlights
“It is gratifying to work on development programs that may benefit so many patients,” said
Cushing’s Syndrome
- Dosing continues in Phase 3 trial (“GRACE”) of relacorilant in patients with Cushing’s syndrome
- Placebo-controlled trial of relacorilant to treat patients with less severe Cushing’s syndrome
to begin late this year
GRACE seeks to confirm relacorilant’s positive Phase 2 results and to provide the basis for its approval in
In the fourth quarter, Corcept plans to start a double-blind, placebo-controlled trial of relacorilant in patients whose Cushing’s syndrome is caused by an adrenal adenoma – an etiology where the effect of medical treatment has not been extensively studied. A controlled study is possible in these patients because their symptoms, while serious, are usually less severe than those experienced by patients with other etiologies of the disorder. The trial will enroll approximately the same number of patients as the GRACE trial at sites in
Metabolic Disease
- Phase 1b trial underway in reduction of antipsychotic-induced weight gain; results expected late this year
- Phase 2 trial in reversal of recent antipsychotic-induced weight gain planned to start late this year
Corcept’s Phase 1b trial in the reduction of weight-gain caused by antipsychotic medication is on track to produce results late this year. Approximately 60 healthy subjects will receive olanzapine (Eli Lily’s Zyprexa®) and either miricorilant or placebo for two weeks, with the primary endpoint being change in weight. “We modeled this trial on the successful placebo-controlled studies3 we conducted with Korlym,” said Dr. Grauer. “Unfortunately, Korlym’s off-target effects preclude its development for such a common disorder. Miricorilant is a better potential medication because it does not bind to the progesterone receptor. Activity at the progesterone receptor is what causes Korlym’s off-target effects. We look forward to completing this trial and starting one double-blind, placebo-controlled Phase 2 trial in patients later this year and another in 2020.”
Corcept is also advancing miricorilant as a treatment for NASH, a serious and widespread liver disorder, and plans to start a double-blind, placebo-controlled Phase 2 trial in 2020.
Solid Tumors
- Phase 3 trial of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer planned
to start late this year - European Medicines Agency Committee for Orphan Medicinal Products (COMP) recommends orphan drug designation for relacorilant to treat metastatic pancreatic cancer
“At the
“We hope to confirm these findings in larger, more definitive studies. Our 180-patient, placebo-controlled Phase 2 trial in ovarian cancer is enrolling patients. We plan to start a Phase 3 trial in metastatic pancreatic cancer later this year and are seeking
On
The European Commission is expected to adopt the COMP’s recommendation later this year. The
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 treatment 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, 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
Zyprexa® is a registered trademark of
Abraxane® is a registered trademark of
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1 For more about GRACE, go to cushingresearch.com.
2 For more data, see our poster from the 2019
3 Gross et al, Advances in Therapy (2009); Gross et al, Obesity (2010).
4 For more data, see our
CORCEPT THERAPEUTICS INCORPORATED | ||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||
(in thousands) | ||||||
June 30, | December 31, | |||||
2019 | 2018(1) | |||||
(Unaudited) | ||||||
ASSETS | ||||||
Cash and investments | $ | 225,702 | $ | 206,760 | ||
Trade receivables, net of allowances | 19,774 | 17,588 | ||||
Inventory | 17,868 | 16,242 | ||||
Operating right-of-use asset | 1,106 | — | ||||
Deferred tax assets | 56,700 | 62,659 | ||||
Other assets | 7,529 | 8,445 | ||||
Total assets | $ | 328,679 | $ | 311,694 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
Accounts payable | $ | 7,026 | $ | 8,266 | ||
Operating lease liability | 1,148 | — | ||||
Other liabilities | 22,452 | 27,546 | ||||
Stockholders’ equity | 298,053 | 275,882 | ||||
Total liabilities and stockholders’ equity | $ | 328,679 | $ | 311,694 | ||
(1) Derived from audited financial statements at that date | ||||||
CORCEPT THERAPEUTICS INCORPORATED | ||||||||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||||||||||||||
(in thousands, except per share amounts) | ||||||||||||||||||||||
(Unaudited) | ||||||||||||||||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||||||||
2019 |
2018 | 2019 |
2018 |
|||||||||||||||||||
Revenues: | ||||||||||||||||||||||
Product sales, net | $ | 72,257 | $ | 62,312 | $ | 137,086 | $ | 119,971 | ||||||||||||||
Operating expenses: | ||||||||||||||||||||||
Cost of sales | 1,377 | 1,154 | 2,617 | 2,328 | ||||||||||||||||||
Research and development | 21,656 | 20,543 | 41,900 | 37,593 | ||||||||||||||||||
Selling, general and administrative | 24,591 | 19,981 | 48,980 | 38,421 | ||||||||||||||||||
Total operating expenses | $ | 47,624 | $ | 41,678 | $ | 93,497 | $ | 78,342 | ||||||||||||||
Income from operations | 24,633 | 20,634 | 43,589 | 41,629 | ||||||||||||||||||
Interest and other income | 1,178 | 562 | 2,275 | 856 | ||||||||||||||||||
Income before income taxes | 25,811 | 21,196 | 45,864 | 42,485 | ||||||||||||||||||
Income tax expense | (5,625 | ) | (3,000 | ) | (7,404 | ) | (6,830 | ) | ||||||||||||||
Net income | $ | 20,186 | $ | 18,196 | $ | 38,460 | $ | 35,655 | ||||||||||||||
Other comprehensive income: | ||||||||||||||||||||||
Net unrealized gain (loss) on available-for-sale securities, net of tax impact of $(73), $(7), $(124) and $41, respectively |
227 | 25 | 391 | (127 | ) | |||||||||||||||||
Total comprehensive income | $ | 20,413 | $ | 18,221 | $ | 38,851 | $ | 35,528 | ||||||||||||||
Basic net income per common share | $ | 0.18 | $ | 0.16 | $ | 0.34 | $ | 0.31 | ||||||||||||||
Diluted net income per common share | $ | 0.17 | $ | 0.14 | $ | 0.31 | $ | 0.28 | ||||||||||||||
Shares used to compute basic net income per share | 114,340 | 115,492 | 114,590 | 115,189 | ||||||||||||||||||
Shares used to compute diluted net income per share | 121,783 | 127,515 | 122,831 | 127,610 | ||||||||||||||||||
CORCEPT THERAPEUTICS INCORPORATED | |||||||||||||||||
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME | |||||||||||||||||
(in thousands, except per share amounts) | |||||||||||||||||
(Unaudited) | |||||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||||
June 30, | June 30, | ||||||||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||||||||
GAAP net income | $ | 20,186 | $ | 18,196 | $ | 38,460 | $ | 35,655 | |||||||||
Non-cash expenses (benefits): | |||||||||||||||||
Stock-based compensation | |||||||||||||||||
Cost of Sales | 55 | — | 83 | — | |||||||||||||
Research and development | 2,505 | 1,963 | 4,484 | 3,427 | |||||||||||||
Selling, general and administrative | 5,176 | 4,054 | 9,865 | 7,544 | |||||||||||||
Total stock-based compensation | 7,736 | 6,017 | 14,432 | 10,971 | |||||||||||||
Deferred tax assets | 4,908 | 2,474 | 5,834 | 5,643 | |||||||||||||
Income tax effect of non-GAAP adjustments(1) | (1,857 | ) | (1,264 | ) | (3,464 | ) | (2,304 | ) | |||||||||
Non-GAAP net income, as adjusted for non-cash expenses |
$ | 30,973 | $ | 25,423 | $ | 55,262 | $ | 49,965 | |||||||||
GAAP basic net income per share | $ | 0.18 | $ | 0.16 | $ | 0.34 | $ | 0.31 | |||||||||
GAAP diluted net income per share | $ | 0.17 | $ | 0.14 | $ | 0.31 | $ | 0.28 | |||||||||
Non-GAAP basic net income per share, as adjusted for non-cash expenses |
$ | 0.27 | $ | 0.22 | $ | 0.48 | $ | 0.43 | |||||||||
Non-GAAP diluted net income per share, as adjusted for non-cash expenses |
$ | 0.25 | $ | 0.20 | $ | 0.45 | $ | 0.39 | |||||||||
Shares used to compute basic net income per share | 114,340 | 115,492 | 114,590 | 115,189 | |||||||||||||
Shares used to compute diluted net income per share | 121,783 | 127,515 | 122,831 | 127,610 | |||||||||||||
(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