Corcept Therapeutics Announces Third Quarter 2018 Financial Results and Provides Corporate Update
Financial Highlights
- Revenue of
$64.4 million , a 51 percent increase from third quarter 2017 - GAAP net income of
$0.14 per share, compared to$0.11 per share in third quarter 2017 - Non-GAAP net income of
$0.22 per share, compared to$0.14 per share in third quarter 2017 - Cash and investments of
$196.7 million , a$36.8 million increase from second quarter 2018 - Reaffirmed 2018 revenue guidance of
$250-270 million
Corcept reported revenue of
Operating expenses for the third quarter were
Cash and investments were
Relacorilant to Treat Patients with Cushing’s Syndrome
- Enrollment open in relacorilant’s 130-patient Phase 3 trial
- Relacorilant designated orphan drug for treatment of Cushing’s syndrome
The Phase 3 trial of Corcept’s proprietary, selective cortisol modulator, relacorilant, is expected to enroll 130 patients at sites in
For more information about the trial, go to clinicaltrials.gov.
Because the
“We’re excited to have started relacorilant’s Phase 3 trial,” said
Oncologic & Metabolic Disorders
- Selective cortisol modulator CORT118335 safe and well-tolerated in Phase 1; Phase 2 trials in antipsychotic-induced weight gain and non-alcoholic steatohepatitis (NASH) planned to start in first quarter 2019
- Further results expected by year-end in Phase 1/2 trial of relacorilant plus Abraxane® (nab-paclitaxel) to treat metastatic pancreatic cancer;
FDA grants relacorilant orphan drug status for that indication - Controlled Phase 2 trial of relacorilant plus Abraxane to treat metastatic ovarian cancer planned to start by year-end
- Dosing continues in Phase 1/2 trial of CORT125281 plus Xtandi® (enzalutamide) in patients with metastatic castration-resistant prostate cancer
“Our clinical programs continue to make significant progress,” said
“We are also excited to advance relacorilant as a treatment for solid tumors,” said Dr. Fishman. “Our Phase 1/2 trial of relacorilant plus Abraxane® has produced encouraging data. At ASCO earlier this year we reported that four of nine patients with metastatic pancreatic cancer who received the minimum therapeutic dose exhibited durable disease control, as did four of seven patients with metastatic ovarian cancer – notable results in patients with such dire disease, all of whom had progressed on prior taxane-based therapies. By year-end, we plan to open a controlled Phase 2 trial in patients with metastatic ovarian cancer and to have collected sufficient data in patients with metastatic pancreatic cancer to determine if a pivotal trial is warranted.”
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 stress hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In
About
Corcept is a pharmaceutical company engaged in the discovery, development and commercialization of drugs that treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol. Korlym® is the company’s first
Non-GAAP Measures of Net Income
To supplement our financial results presented on a GAAP basis, we use a non-GAAP measure of net income including the following non-cash items – stock-based compensation, use of deferred tax assets, accreted interest on our retired royalty financing obligation and related income tax effects. We believe this non-GAAP measure helps investors better evaluate our past financial performance and potential future results. Our non-GAAP measure should not be considered in isolation or as a substitute for comparable GAAP accounting. Investors should read our non-GAAP presentation in conjunction with our financial statements prepared in accordance with GAAP. The non-GAAP measure 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 protections afforded by Korlym’s Orphan Drug designation and our intellectual property; 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 | ||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||
(in thousands) | ||||||
September 30, | December 31, | |||||
2018 | 2017* | |||||
(Unaudited) | ||||||
ASSETS | ||||||
Cash and investments | $ | 196,675 | $ | 104,025 | ||
Trade receivables, net of allowances | 19,360 | 15,300 | ||||
Inventory | 12,722 | 8,376 | ||||
Other receivable | — | 12,896 | ||||
Deferred tax assets | 66,126 | 76,703 | ||||
Other assets | 4,868 | 3,237 | ||||
Total assets | $ | 299,751 | $ | 220,537 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
Accounts payable | $ | 13,922 | $ | 8,579 | ||
Other liabilities | 26,284 | 20,990 | ||||
Stockholders’ equity | 259,545 | 190,968 | ||||
Total liabilities and stockholders’ equity | $ | 299,751 | $ | 220,537 | ||
*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 September 30, |
Nine Months Ended September 30, |
||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||
Revenues: | |||||||||||||||
Product sales, net | $ | 64,445 | 42,763 | $ | 184,416 | 105,921 | |||||||||
Operating expenses: | |||||||||||||||
Cost of sales | 1,308 | 976 | 3,636 | 2,397 | |||||||||||
Research and development | 18,860 | 11,693 | 56,453 | 26,745 | |||||||||||
Selling, general and administrative | 21,308 | 16,471 | 59,729 | 45,621 | |||||||||||
Total operating expenses | $ | 41,476 | $ | 29,140 | $ | 119,818 | $ | 74,763 | |||||||
Income from operations | 22,969 | 13,623 | 64,598 | 31,158 | |||||||||||
Interest and other income (expense) | 759 | 86 | 1,615 | (237 | ) | ||||||||||
Income before income taxes | 23,728 | 13,709 | 66,213 | 30,921 | |||||||||||
Income tax (expense) benefit | (5,981 | ) | 48 | (12,811 | ) | (129 | ) | ||||||||
Net income | $ | 17,747 | $ | 13,757 | $ | 53,402 | $ | 30,792 | |||||||
Other comprehensive income (loss): | |||||||||||||||
Net unrealized gain (loss) on available-for-sale securities, net of tax impact of ($16), $0, $25 and $0, respectively | 50 | 3 | (77 | ) | (14 | ) | |||||||||
Total comprehensive income | $ | 17,797 | $ | 13,760 | $ | 53,325 | $ | 30,778 | |||||||
Basic net income per common share | $ | 0.15 | $ | 0.12 | $ | 0.46 | $ | 0.27 | |||||||
Diluted net income per common share | $ | 0.14 | $ | 0.11 | $ | 0.42 | $ | 0.25 | |||||||
Shares used to compute basic net income per share | 115,798 | 113,603 | 115,394 | 113,242 | |||||||||||
Shares used to compute diluted net income per share | 126,159 | 125,651 | 127,167 | 123,417 | |||||||||||
CORCEPT THERAPEUTICS INCORPORATED | |||||||||||||||
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME | |||||||||||||||
(in thousands, except per share amounts) | |||||||||||||||
(Unaudited) | |||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||
September 30, | September 30, | ||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||
GAAP net income | $ | 17,747 | $ | 13,757 | $ | 53,402 | $ | 30,792 | |||||||
Non-cash expenses (benefits): | |||||||||||||||
Stock-based compensation | |||||||||||||||
Research and development | 1,961 | 1,049 | 5,388 | 2,552 | |||||||||||
Selling, general and administrative | 4,549 | 2,574 | 12,093 | 6,977 | |||||||||||
Total stock-based compensation | 6,510 | 3,623 | 17,481 | 9,529 | |||||||||||
Accretion of interest expense related to debt obligation | — | 37 | — | 456 | |||||||||||
Deferred tax assets | 4,960 | — | 10,603 | — | |||||||||||
Income tax effect of non-GAAP adjustments(1) | (1,367 | ) | — | (3,671 | ) | — | |||||||||
Non-GAAP net income, as adjusted for non-cash expenses | $ | 27,850 | $ | 17,417 | $ | 77,815 | $ | 40,777 | |||||||
GAAP basic net income per share | $ | 0.15 | $ | 0.12 | $ | 0.46 | $ | 0.27 | |||||||
GAAP diluted net income per share | $ | 0.14 | $ | 0.11 | $ | 0.42 | $ | 0.25 | |||||||
Non-GAAP basic net income per share, as adjusted for non-cash expenses | $ | 0.24 | $ | 0.15 | $ | 0.67 | $ | 0.36 | |||||||
Non-GAAP diluted net income per share, as adjusted for non-cash expenses | $ | 0.22 | $ | 0.14 | $ | 0.61 | $ | 0.33 | |||||||
Shares used to compute basic net income per share | 115,798 | 113,603 | 115,394 | 113,242 | |||||||||||
Shares used to compute diluted net income per share | 126,159 | 125,651 | 127,167 | 123,417 | |||||||||||
(1)Calculated by applying the statutory tax rate to the pre-tax, non-discrete, non-GAAP adjustments.
CONTACT:
Chief Financial Officer
650-688-8783
crobb@corcept.com
www.corcept.com
Source: Corcept Therapeutics Incorporated