cept Therapeutics rporated(CORT) - 2024 Q3 - Quarterly Results

Corcept Therapeutics Third Quarter 2024 Results Corcept Therapeutics reported strong financial performance in Q3 2024 and provided significant updates on its clinical development pipeline Financial Highlights and Corporate Update Corcept Therapeutics reported strong Q3 2024 results with a 48% year-over-year revenue increase to $182.5 million and raised its full-year 2024 revenue guidance to $675–$700 million. Diluted net income per share grew to $0.41. The company also announced Positive results from its Phase 3 GRADIENT trial, which will support the New Drug Application (NDA) for relacorilant, planned for submission this quarter | Metric | Q3 2024 | Q3 2023 | % Change | | :--- | :--- | :--- | :--- | | Revenue | $182.5 million | $123.6 million | +48% | | Diluted EPS | $0.41 | $0.28 | +46% | | Cash & Investments (as of Sep 30, 2024) | $547.6 million | N/A | N/A | - The company increased its 2024 revenue guidance from $640–$670 million to $675–$700 million[1][3] - Positive results from the Phase 3 GRADIENT trial will support the New Drug Application (NDA) for relacorilant, which is scheduled for submission this quarter[1] Financial Results In Q3 2024, revenue growth was driven by a record number of Korlym® prescribers and patients. Operating expenses rose to $135.9 million from $92.4 million in Q3 2023. The company's cash and investments balance increased to $547.6 million, even after repurchasing $23.4 million of its common stock during the quarter - Revenue growth was attributed to an increase in Korlym® prescribers and patients, with physicians becoming more aware of hypercortisolism's prevalence[2] | Financial Item | Q3 2024 | Q3 2023 | | :--- | :--- | :--- | | Revenue | $182.5 million | $123.6 million | | Operating Expenses | $135.9 million | $92.4 million | | Net Income | $47.2 million | $31.4 million | - Cash and investments grew to $547.6 million at September 30, 2024, from $492.5 million at June 30, 2024. This was after acquiring $23.4 million of common stock (870,000 shares) through the company's repurchase program[3] Clinical Development Corcept is poised for significant clinical milestones in Q4 2024, including the NDA submission for relacorilant for Cushing's syndrome. The company also expects to release pivotal data from its ROSELLA trial in ovarian cancer, the CATALYST study in Cushing's syndrome, and the DAZALS study in ALS by year-end - Key data readouts expected by year-end include: - CATALYST study (Cushing's syndrome) - ROSELLA pivotal study (platinum-resistant ovarian cancer) - DAZALS study (amyotrophic lateral sclerosis - ALS)[4] Cushing's Syndrome The NDA for relacorilant is on track for submission this quarter, supported by positive data from the pivotal Phase 3 GRACE trial and the supportive Phase 3 GRADIENT trial. Both studies demonstrated that relacorilant provided clinically meaningful improvements in hypercortisolism symptoms with a favorable safety profile, notably lacking side effects like hypokalemia. The GRADIENT trial showed statistically significant improvements in hyperglycemia, weight, and body composition compared to placebo - The pivotal Phase 3 GRACE trial met its primary endpoint, demonstrating that relacorilant maintained improvements in hypertension and hyperglycemia[5][6] - The supportive Phase 3 GRADIENT trial confirmed relacorilant's efficacy, showing statistically significant improvements versus placebo in glucose metabolism, body weight, and visceral adipose fat[7][9][10] - Relacorilant was well-tolerated in both GRACE and GRADIENT trials, with no induced instances of hypokalemia, endometrial hypertrophy, adrenal insufficiency, or QT prolongation[5][6][11] - Results from the CATALYST study, the largest study of hypercortisolism in patients with difficult-to-control diabetes, are expected by year-end[6][13] Oncology Enrollment is complete in the pivotal Phase 3 ROSELLA trial, which evaluates relacorilant plus nab-paclitaxel in 381 patients with platinum-resistant ovarian cancer. Data on the primary endpoint, progression-free survival, is expected this quarter and could form the basis for relacorilant's next NDA. A Phase 2 trial in early-stage prostate cancer is also ongoing - The pivotal Phase 3 ROSELLA trial in 381 patients with platinum-resistant ovarian cancer has completed enrollment[14] - Progression-free survival data, the primary endpoint for ROSELLA, is expected by the end of the current quarter[14] Amyotrophic Lateral Sclerosis (ALS) The Phase 2 DAZALS trial of dazucorilant in 249 patients with ALS has completed enrollment. Following promising results in animal models, data on the trial's primary endpoint—improvement in the ALS Functional Rating Scale-Revised (ALSFRS-R) score—is expected by the end of the year - Enrollment is complete for the Phase 2 DAZALS trial of dazucorilant in 249 patients with ALS[15] - Data for the primary endpoint (ALSFRS-R score) is expected by year-end[15] Metabolic Dysfunction-Associated Steatohepatitis (MASH) Enrollment is ongoing for the Phase 2b MONARCH trial of miricorilant in patients with MASH. This study builds on promising Phase 1b results where miricorilant rapidly reduced liver fat and improved key metabolic measures - The Phase 2b MONARCH trial of miricorilant in patients with MASH is currently enrolling[16] - Previous Phase 1b results showed miricorilant rapidly reduced liver fat, improved liver health, and was well-tolerated[16] Financial Statements This section provides a detailed overview of Corcept's financial position and performance through its condensed consolidated balance sheets and income statements Condensed Consolidated Balance Sheets As of September 30, 2024, Corcept's total assets increased to $784.3 million from $621.5 million at the end of 2023. This growth was primarily driven by a rise in cash and investments to $547.6 million. Stockholders' equity also saw substantial growth, reaching $638.8 million | (In thousands) | Sep 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash and investments | $547,646 | $425,397 | | Total assets | $784,257 | $621,517 | | Total liabilities | $145,422 | $114,812 | | Stockholders' equity | $638,835 | $506,705 | Condensed Consolidated Statements of Income For the third quarter of 2024, Corcept generated net product revenue of $182.5 million, a significant increase from $123.6 million in the same period last year. Net income for the quarter rose to $47.2 million ($0.41 per diluted share) from $31.4 million ($0.28 per diluted share) in Q3 2023. Operating expenses increased, driven by higher R&D and SG&A costs Three Months Ended September 30 (in thousands, except per share data) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Product revenue, net | $182,546 | $123,601 | | Total operating expenses | $135,948 | $92,424 | | Income from operations | $46,598 | $31,177 | | Net income | $47,213 | $31,378 | | Diluted net income per common share | $0.41 | $0.28 | Nine Months Ended September 30 (in thousands) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Product revenue, net | $493,150 | $346,970 | | Total operating expenses | $381,461 | $271,357 | | Net income | $110,463 | $74,785 | Corporate Information and Forward-Looking Statements This section outlines Corcept's long-standing focus on cortisol modulation and provides cautionary statements regarding future projections and clinical outcomes About Corcept Therapeutics Corcept Therapeutics has focused on cortisol modulation for over 25 years, discovering over 1,000 proprietary selective cortisol modulators. The company commercialized Korlym for Cushing's syndrome in 2012 and is advancing clinical trials in hypercortisolism, solid tumors, ALS, and liver disease - The company's focus on cortisol modulation has led to the discovery of over 1,000 proprietary selective cortisol modulators[18] - Corcept introduced Korlym, its first FDA-approved medication for Cushing's syndrome, in February 2012[18] Forward-Looking Statements This section cautions that statements in the press release regarding future events are subject to risks and uncertainties. Key forward-looking statements include the 2024 revenue guidance, the timing and outcome of the relacorilant NDA submission, and the expected data releases and potential approvals for its clinical programs, including CATALYST, ROSELLA, and DAZALS - Forward-looking statements cover topics such as 2024 revenue guidance, clinical development timelines for relacorilant, dazucorilant, and miricorilant, and the timing of regulatory submissions and data readouts[20]