Cortisol Modulation
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cept Therapeutics rporated(CORT) - 2025 Q3 - Earnings Call Transcript
2025-11-04 23:00
Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $207.6 million, up from $182.5 million in the same period last year, reflecting a year-over-year increase of approximately 13% [3] - Net income decreased to $19.7 million from $47.2 million in Q3 2024 [3] - Cash and investments as of September 30, 2025, totaled $524 million, which includes a $50 million stock repurchase [3] Business Line Data and Key Metrics Changes - The hypercortisolism business experienced a 42.5% increase in tablet shipments compared to Q3 2024, driven by record prescriptions for Korlym [7] - The company is transitioning to a new pharmacy vendor due to capacity constraints with the previous vendor, which may affect growth in the short term [7][8] Market Data and Key Metrics Changes - The company reported around 3,250 paying patients at the end of Q3 2025, with expectations for significant market capacity growth as relacorilant is launched [34][35] - The authorized generic accounted for approximately 70% of the business in Q3 2025, with expectations to reach around 75% by year-end [42] Company Strategy and Development Direction - The company is preparing for the launch of relacorilant, with PDUFA dates set for December 30, 2025, for hypercortisolism and July 11, 2026, for ovarian cancer [12] - The oncology program is expanding significantly, with plans for new studies in various solid tumors and a focus on combining treatments with existing therapies [20][21] - The company aims to triple the potential patient base for gynecological cancers from 20,000 to 60,000 annually in the U.S. [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of relacorilant, anticipating it could generate $3-$5 billion in annual revenue in hypercortisolism alone within three to five years [11] - The company is optimistic about the upcoming FDA approvals and the potential impact of its clinical studies on treatment paradigms [28][29] Other Important Information - The company is finalizing a phase 3 trial design for dazcorilant in ALS, expected to start by mid-2026 [14][27] - The CATALYST study revealed that one in four patients with resistant diabetes has hypercortisolism, indicating a significant opportunity for treatment [24] Q&A Session Summary Question: How many patients were on drug at the end of the quarter? - Approximately 3,250 paying patients were reported at the end of Q3 2025 [34] Question: What is the capacity of the new pharmacy compared to the old one? - The new pharmacy has the ability to continually expand and has multiple locations, which is expected to support the business effectively [34] Question: Are there any downward pressures on margins? - No downward pressure on margins has been observed, and the company does not expect any [36] Question: What is the net pricing relative to brand pricing? - The net pricing is about a 30% discount to Korlym's list price, with the authorized generic making up a significant portion of the business [42] Question: Was the lack of priority review for the ovarian cancer NDA surprising? - Management was not surprised by the lack of priority review, acknowledging the FDA's many priorities [44] Question: What are the expectations for R&D and SG&A in 2026? - R&D expenditures are expected to remain stable, while SG&A expenses are anticipated to increase due to preparations for product launches [46]
cept Therapeutics rporated(CORT) - 2025 Q1 - Earnings Call Presentation
2025-06-16 17:12
Financial Performance and Guidance - Corcept achieved significant revenue growth, increasing from $3 million in 2012 to $482 million in 2024 [13] - The company's 2025 revenue guidance is between $900 million and $950 million [13] - As of March 31, 2025, Corcept had $570.8 million in cash [13] Clinical Trial Results and Drug Development - The GRACE trial showed that 63% of patients with hypertension met the study's response criteria, with a mean improvement of 12.6 mm Hg in SBP and 8.3 mm Hg in DBP [29] - In the GRACE trial, 50% of patients with hyperglycemia met the study's response criteria, showing a mean improvement of 0.7% in HbA1c, 25.2 mg/dL in fasting glucose, and 85.0 mg/dL in 2-hour oGTT [33] - The ROSELLA trial in platinum-resistant ovarian cancer met its primary endpoint, with relacorilant + nab-paclitaxel reducing disease progression risk by 30% (HR=0.70; p=0.008) and mortality risk by 31% (HR=0.69; p=0.01) [62] - In the CATALYST trial, 23.8% of 1,057 patients with difficult-to-control type 2 diabetes were found to have hypercortisolism [21] - Patients who received Korlym in the CATALYST trial experienced a 1.47% reduction in HbA1c compared to a 0.15% reduction in patients who received placebo (p<0.0001) [21] Regulatory and Intellectual Property - Relacorilant's NDA has a PDUFA target date of December 30, 2025 [15, 24] - Corcept holds method of use patents for Korlym extending to 2038 [24] - Corcept holds composition of matter patents for Relacorilant extending to 2038 and method of use, formulation and manufacturing patents extending to 2040 [25]