Corcept Therapeutics Announces First Quarter Financial Results and Provides Corporate Update
Corcept Therapeutics Announces First Quarter Financial Results and Provides Corporate Update
May 3, 2023 at 4:05 PM EDT
Financial Results
- Revenue of
$105.7 million , compared to$93.7 million in first quarter 2022 - Raised 2023 revenue guidance to
$435 -$455 million , from$430 -$450 million - Net income per common share of
$0.14 (diluted), compared to$0.20 in first quarter 2022 - Cash and investments of
$465.1 million as ofMarch 31, 2023 - Purchase of 6.6 million shares of Corcept common stock for
$145.4 million inApril 2023
Corcept’s first quarter 2023 revenue was
Cash and investments were
“Korlym is an excellent treatment for patients with Cushing’s syndrome and there are many eligible patients who have yet to receive it. We are making substantial investments to improve the ability of physicians to identify and treat patients with hypercortisolism, most notably our recently established CATALYST study, and are optimistic about the growth of our Cushing’s syndrome business. We are raising our 2023 revenue guidance to
Clinical Development
“In the next twelve months we expect data from our GRACE, GRADIENT and NASH Phase 1b studies, submission of the NDA for relacorilant in Cushing’s syndrome, completion of enrollment of our CATALYST, ROSELLA and DAZALS studies and initiation of a Phase 2b trial of miricorilant in patients with NASH,” added
Cushing’s Syndrome
- Phase 3 GRACE trial of relacorilant as a treatment for patients with all etiologies of Cushing’s syndrome – new drug application (NDA) submission expected in the first half of 2024
- Enrollment continues in Phase 3 GRADIENT trial of relacorilant as a treatment for patients with Cushing’s syndrome caused by adrenal adenomas
- Enrollment continues in CATALYST – 1,000-patient Phase 4 trial examining the prevalence of hypercortisolism in patients with difficult to control type 2 diabetes; patients with hypercortisolism may enter a randomized, double-blind, placebo-controlled study of Korlym
Our GRACE trial will serve as the basis for relacorilant’s NDA in Cushing’s syndrome, which we plan to submit in the first half of 2024. We are pleased to share that we have identified all the patients necessary to complete this study and expect to complete enrollment in the coming weeks. Our Phase 3 GRADIENT trial will produce valuable data about an etiology of Cushing’s syndrome that affects many patients but has not been rigorously examined in a controlled study.
“Independent studies conducted over the last fifteen years have found that the prevalence of hypercortisolism in patients with type 2 diabetes is substantially higher than in the general population. The most prominent diabetologists in
Oncology
- Enrollment continues in ROSELLA – 360-patient pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in patients with recurrent, platinum-resistant ovarian cancer
- Enrollment continues in open-label, Phase 1b trial of relacorilant plus pembrolizumab in patients with adrenal cancer with cortisol excess
- Randomized, placebo-controlled Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer expected to begin by mid-year in collaboration with the
University of Chicago
“We and our investigators are excited to advance relacorilant in platinum-resistant ovarian cancer. Relacorilant plus nab-paclitaxel has the potential to become a new standard of care for the treatment of patients with this dire disease. We are on track to complete enrollment in ROSELLA by the end of this year,” said
Amyotrophic Lateral Sclerosis (ALS)
- Enrollment continues in DAZALS – 198-patient, randomized, double-blind, placebo-controlled Phase 2 trial of dazucorilant in patients with ALS
“ALS, commonly known as Lou Gehrig’s disease, is a devastating illness with an urgent need for better treatment. We are conducting our DAZALS study in collaboration with TRICALS, the leading ALS academic consortium in
Non-alcoholic Steatohepatitis (NASH)
- Enrollment completed in Phase 1b dose-finding trial of miricorilant in patients with presumed NASH – data expected by mid-year; Phase 2b trial to begin in the fourth quarter
“Miricorilant, a potent, oral, selective cortisol modulator with targeted activity in the liver, continues to demonstrate great promise as a treatment for NASH. Our Phase 1b study has identified a range of doses, all substantially lower than our originally tested doses, that significantly reduce liver fat without causing excessive liver irritation,” said
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 has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol and owns extensive
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 such statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business, conduct our clinical trials and achieve our other goals during the COVID-19 pandemic and generate sufficient revenue to fund our activities; the availability of competing treatments for hypercortisolism, including generic versions of Korlym; our ability to obtain acceptable prices and adequate insurance coverage and reimbursement for Korlym; risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates, oversight and other requirements; the timing, cost and outcome of legal disputes and investigations; and the scope and protective power of our intellectual property. These and other risks are set forth in our
In this press release, forward-looking statements include, among others: our continued revenue growth and 2023 revenue guidance; the number of eligible patients who have yet to receive Korlym; cortisol modulation’s potential to treat many serious diseases; development of relacorilant as a treatment for Cushing’s syndrome and ovarian, adrenal and prostate cancer, including relacorilant’s clinical attributes, regulatory approvals, mandates, oversight and other requirements; expectations regarding the GRACE trial as the basis for relacorilant’s NDA in Cushing’s syndrome; the design, timing and expectations regarding our CATALYST trial; the timing and expectations of our ROSELLA trial of relacorilant plus nab-paclitaxel in patients with recurrent platinum-resistant ovarian cancer and the potential for relacorilant plus nab-paclitaxel to become a standard of care for these patients; the timing and expectations of our DAZALS trial of dazucorilant in patients with ALS; the timing and substance of our Phase 1b trial and planned Phase 2 trial in patients with NASH; our other pre-clinical and clinical development programs, including the pace of enrollment, study design and timelines, and the accrual and attributes of clinical data; and the timing of regulatory submissions. We disclaim any intention or duty to update forward-looking statements made in this press release.
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| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||
| (In thousands) | ||||||
2023 |
2022(1) |
|||||
| (Unaudited) | ||||||
| Assets | ||||||
| Cash and investments | $ | 465,057 | $ | 436,619 | ||
| Trade receivables, net of allowances | 32,557 | 31,057 | ||||
| Insurance recovery receivable related to Melucci litigation | 14,000 | 14,000 | ||||
| Inventory | 16,565 | 17,031 | ||||
| Operating lease right-of-use asset | 575 | 1,143 | ||||
| Deferred tax assets, net | 67,999 | 61,465 | ||||
| Other assets | 21,095 | 22,115 | ||||
| Total assets | $ | 617,848 | $ | 583,430 | ||
| Liabilities and Stockholders’ Equity | ||||||
| Accounts payable | $ | 11,216 | $ | 11,976 | ||
| Accrued settlement related to Melucci litigation | 14,000 | 14,000 | ||||
| Operating lease liabilities | 575 | 1,143 | ||||
| Other liabilities | 62,473 | 54,469 | ||||
| Stockholders’ equity | 529,584 | 501,842 | ||||
| Total liabilities and stockholders’ equity | $ | 617,848 | $ | 583,430 | ||
| (1) Derived from audited financial statements at that date | ||||||
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| CONDENSED CONSOLIDATED STATEMENTS OF INCOME | ||||||||
| (In thousands, except per share data) | ||||||||
| Three Months Ended | ||||||||
| 2023 | 2022 | |||||||
| Revenues | ||||||||
| Product revenue, net | $ | 105,654 | $ | 93,688 | ||||
| Operating expenses | ||||||||
| Cost of sales | 1,386 | 1,250 | ||||||
| Research and development | 40,851 | 28,120 | ||||||
| Selling, general and administrative | 48,564 | 37,549 | ||||||
| Total operating expenses | 90,801 | 66,919 | ||||||
| Income from operations | 14,853 | 26,769 | ||||||
| Interest and other income | 3,581 | 80 | ||||||
| Income before income taxes | 18,434 | 26,849 | ||||||
| Income tax expense | (2,555 | ) | (4,052 | ) | ||||
| Net income | $ | 15,879 | $ | 22,797 | ||||
| Net income attributable to common stockholders | $ | 15,807 | $ | 22,797 | ||||
| Basic net income per common share | $ | 0.15 | $ | 0.22 | ||||
| Diluted net income per common share | $ | 0.14 | $ | 0.20 | ||||
| Weighted-average shares outstanding used in computing net income per common share | ||||||||
| Basic | 107,885 | 106,012 | ||||||
| Diluted | 115,425 | 115,037 | ||||||
CONTACT:
Investor Relations
ir@corcept.com
www.corcept.com
Source: Corcept Therapeutics Incorporated