Corcept Therapeutics Announces Second Quarter Financial Results and Provides Corporate Update
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Revenue of
$194.4 million , compared to$163.8 million in second quarter 2024 -
Modified 2025 revenue guidance of
$850 –$900 million -
Net income of
$35.1 million , compared to$35.5 million in second quarter 2024 -
Cash and investments of
$515.0 million atJune 30, 2025 -
Acquired
$115.4 million of Corcept common stock in second quarter 2025
Financial Results
“The second quarter marked another period of robust growth in our hypercortisolism business. Once again, we had a record number of new prescribers and a record number of new patients receiving treatment. Physicians increasingly recognize hypercortisolism’s true prevalence and the necessity of appropriate treatment, which has led to increased screening and diagnosis. Our financial results don’t fully reflect this surge in demand, which outpaced our specialty pharmacy vendor’s capacity. We expect improved performance by our current vendor, as well as contribution from a second pharmacy that is coming online soon, in the coming quarters and have modified our 2025 revenue guidance to
Corcept’s second quarter 2025 revenue was
Cash and investments were
Clinical Development
“We achieved many important clinical development milestones in the second quarter. Results of Part 1 and Part 2 of our CATALYST study were published in Diabetes Care in April and June. Our ROSELLA study’s results were published in
Hypercortisolism (Cushing’s Syndrome)
-
Relacorilant for patients with hypercortisolism – FDA review of NDA continues, with Prescription Drug User Fee Act (PDUFA) date of
December 30, 2025 -
CATALYST Part 1 – Prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes – Results published in Diabetes Care (Buse et al,
April 2025 ) -
CATALYST Part 2 – Randomized, double-blind, placebo-controlled study of Korlym® in 136 patients with hypercortisolism and difficult-to-control type 2 diabetes – Results presented at the American Diabetes Association’s 85th Scientific Sessions; published in Diabetes Care (DeFronzo et al,
June 2025 ) - MOMENTUM – Enrollment continues in 1,000-patient trial examining the prevalence of hypercortisolism in patients with resistant hypertension – Results expected by year-end
“CATALYST is a landmark study in hypercortisolism, a serious and deadly disease that too often goes undetected,” said
“We continue to work toward relacorilant’s approval. In our studies, patients who received relacorilant exhibited clinically and statistically significant improvements in a wide array of hypercortisolism’s signs and symptoms, without the off-target effects and toxicities that accompany currently available treatments,” added
Oncology
-
NDA submitted in
July 2025 for relacorilant to treat patients with platinum-resistant ovarian cancer – Submission of European Marketing Authorization Application (MAA) expected this quarter -
ROSELLA – Primary endpoint met in pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in 381 patients with platinum-resistant ovarian cancer – Results presented at the
American Society of Clinical Oncology (ASCO) 2025 annual meeting and published inThe Lancet (Olawaiye et al,June 2025 ) - BELLA – Enrollment continues briskly in Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab in 90 patients with platinum-resistant ovarian cancer
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Early-stage prostate cancer – Enrollment continues in randomized, placebo-controlled, Phase 2 trial of relacorilant plus enzalutamide in patients with early-stage prostate cancer, conducted in collaboration with the
University of Chicago
“Our NDA for relacorilant to treat patients with platinum-resistant ovarian cancer is based on the results of our pivotal ROSELLA study, which confirmed the positive results of our Phase 2 study. The progression-free and overall survival improvements in patients who received relacorilant, with no increase in safety burden and without the requirement of biomarker screening, are groundbreaking,” said
“The BELLA study builds on ROSELLA’s findings, assessing the safety and efficacy of combining relacorilant with two medications – nab-paclitaxel and bevacizumab – to treat patients with platinum-resistant ovarian cancer. Separately, we expect that relacorilant can help treat earlier stages of ovarian cancer and other solid tumors and will soon initiate additional clinical trials.”
Amyotrophic Lateral Sclerosis (ALS)
- DAZALS – Exploratory analysis showed that patients receiving dazucorilant 300 mg exhibited an 84 percent reduction in risk of death during the study’s first year compared to patients receiving placebo (hazard ratio: 0.16, p-value: 0.0009)
-
DAZALS – Results presented at European Network to Cure ALS (ENCALS) annual meeting in
June 2025
“ALS is a devastating disease. In DAZALS, dazucorilant did not meet its primary endpoint of improvement in the ALS Functional Rating Scale-Revised (ALSFRS-R). However, patients who received dazucorilant 300 mg daily had an 84 percent lower chance of dying during the study’s first year compared to patients who received placebo (hazard ratio: 0.16, p-value: 0.0009),” said
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- MONARCH – Enrollment nearly complete in randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant in patients with biopsy-confirmed or presumed MASH
“In our Phase 1b study, miricorilant reduced liver fat very rapidly, improved liver health and key metabolic and lipid measures and was well-tolerated. We look forward to building on these promising results in our Phase 2b MONARCH study. Enrollment will complete in the coming weeks with first results expected by the end of next year,” said
Conference Call
We will hold a conference call on
About
For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders and has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In
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 expressed or implied by such statements. These risks and uncertainties include, but are not limited to, those related to our ability to: operate our business; study and develop Korlym, relacorilant, miricorilant, dazucorilant and our other product candidates; those molecules’ clinical attributes, regulatory approvals, mandates, oversight and other requirements; 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 those concerning: trends in medical practice, including trends regarding the identification and treatment of patients with hypercortisolism; our 2025 revenue guidance and factors that may affect our revenue and revenue growth, such as increased uptake or price reductions in competing medications, including generic versions of Korlym; relacorilant as a treatment for patients with hypercortisolism and ovarian and other cancers; dazucorilant as a treatment for patients with ALS; miricorilant as a treatment for patients with MASH; the timing and outcome of relacorilant’s NDAs and planned MAA in hypercortisolism and ovarian cancer; the timing and outcome of our CATALYST, MOMENTUM, ROSELLA, BELLA, DAZALS and MONARCH trials and their impact on patient care and Corcept’s commercial prospects; and the accrual and attributes of our clinical data. We disclaim any intention or duty to update forward-looking statements made in this press release.
CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) |
|||||
|
|
|
|
||
|
(Unaudited) |
|
|
||
Assets |
|
|
|
||
Cash and investments |
$ |
515,001 |
|
$ |
603,165 |
Trade receivables, net of allowances |
|
64,567 |
|
|
53,976 |
Inventory |
|
20,267 |
|
|
15,995 |
Operating lease right-of-use asset |
|
4,964 |
|
|
5,324 |
Deferred tax assets, net |
|
162,229 |
|
|
130,914 |
Other assets |
|
34,694 |
|
|
31,179 |
Total assets |
$ |
801,722 |
|
$ |
840,553 |
Liabilities and Stockholders’ Equity |
|
|
|
||
Accounts payable |
$ |
23,525 |
|
$ |
15,376 |
Operating lease liabilities |
|
6,605 |
|
|
6,936 |
Other liabilities |
|
135,799 |
|
|
138,652 |
Stockholders’ equity |
|
635,793 |
|
|
679,589 |
Total liabilities and stockholders’ equity |
$ |
801,722 |
|
$ |
840,553 |
|
|
|
|
||
(1) Derived from audited financial statements at that date |
CONDENSED CONSOLIDATED STATEMENTS OF INCOME (In thousands, except per share data) |
|||||||||||||
|
Three Months Ended |
|
Six Months Ended |
||||||||||
|
|
|
|
||||||||||
|
2025 |
|
2024 |
|
2025 |
|
2024 |
||||||
Revenues |
|
|
|
|
|
|
|
||||||
Product revenue, net |
$ |
194,430 |
|
$ |
163,796 |
|
|
$ |
351,644 |
|
$ |
310,604 |
|
|
|
|
|
|
|
|
|
||||||
Operating expenses |
|
|
|
|
|
|
|
||||||
Cost of sales |
|
3,433 |
|
|
2,524 |
|
|
|
5,836 |
|
|
5,059 |
|
Research and development |
|
60,471 |
|
|
58,745 |
|
|
|
121,206 |
|
|
117,251 |
|
Selling, general and administrative |
|
103,851 |
|
|
66,935 |
|
|
|
194,511 |
|
|
123,203 |
|
Total operating expenses |
|
167,755 |
|
|
128,204 |
|
|
|
321,553 |
|
|
245,513 |
|
Income from operations |
|
26,675 |
|
|
35,592 |
|
|
|
30,091 |
|
|
65,091 |
|
Interest and other income |
|
5,017 |
|
|
6,004 |
|
|
|
11,219 |
|
|
11,498 |
|
Income before income taxes |
|
31,692 |
|
|
41,596 |
|
|
|
41,310 |
|
|
76,589 |
|
Income tax benefit (expense) |
|
3,457 |
|
|
(6,108 |
) |
|
|
14,386 |
|
|
(13,339 |
) |
Net income |
$ |
35,149 |
|
$ |
35,488 |
|
|
$ |
55,696 |
|
$ |
63,250 |
|
|
|
|
|
|
|
|
|
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Net income attributable to common stockholders |
$ |
34,611 |
|
$ |
35,120 |
|
|
$ |
54,918 |
|
$ |
62,640 |
|
|
|
|
|
|
|
|
|
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Basic net income per common share |
$ |
0.33 |
|
$ |
0.34 |
|
|
$ |
0.53 |
|
$ |
0.61 |
|
|
|
|
|
|
|
|
|
||||||
Diluted net income per common share |
$ |
0.29 |
|
$ |
0.32 |
|
|
$ |
0.46 |
|
$ |
0.57 |
|
|
|
|
|
|
|
|
|
||||||
Weighted-average shares outstanding used in computing net income per common share |
|||||||||||||
Basic |
|
104,111 |
|
|
103,118 |
|
|
|
104,108 |
|
|
102,954 |
|
Diluted |
|
120,485 |
|
|
111,244 |
|
|
|
120,227 |
|
|
110,550 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20250731305676/en/
Investor inquiries:
ir@corcept.com
Media inquiries:
communications@corcept.com
www.corcept.com
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