cept Therapeutics rporated(CORT) - 2025 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $157.2 million, an increase from $146.8 million in Q1 2024, with a revenue guidance for 2025 set between $900 million and $950 million [5] - Net income decreased to $20.5 million in Q1 2025 from $27.8 million in Q1 2024 [5] - Cash and investments as of March 31, 2025, totaled $570.8 million [5] Business Line Data and Key Metrics Changes - The prescriber base and patient base for hypercortisolism treatments are growing rapidly, with new prescriber growth at a record rate for five consecutive quarters [7] - The number of prescriptions for Korlym in Q1 2025 was nearly double that of the same period last year [7] - The average price per tablet decreased by 13% due to a transition from branded Korlym to an authorized generic [11] Market Data and Key Metrics Changes - The increase in screening for hypercortisolism is driving rapid patient growth, with expectations for continued acceleration [8] - The transition to authorized generic tablets is expected to grow, but the decrease in price will be offset by an increase in the number of tablets shipped [12] Company Strategy and Development Direction - The company is focused on increasing physician awareness of hypercortisolism and expanding its sales force to support growth [8] - The new drug application for relacorilant in hypercortisolism is under FDA review, with an action date set for December 30, 2025 [16] - The company is exploring the use of cortisol modulation in various cancers, including ovarian and prostate cancers, and is preparing for potential regulatory submissions [22][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth prospects for hypercortisolism treatments, citing the CATALYST study's findings as a catalyst for increased screening and treatment [21] - The company anticipates that the operational improvements at the pharmacy vendor will support continued growth throughout 2025 [61] - Management emphasized the potential for relacorilant to become the new standard of care for hypercortisolism patients [33] Other Important Information - The company has made substantial progress in its oncology portfolio, with positive results from the ROSELA trial indicating potential for broader applications of cortisol modulation [22][33] - The company is actively exploring the potential of proprietary compounds for treating neurologic and hepatic diseases [28][30] Q&A Session Summary Question: Clarification on oncology program and treatment paradigm - Management indicated that relacorilant plus nab-paclitaxel is poised to become a new standard of care in platinum-resistant ovarian cancer, with potential positioning before or after biomarker-driven agents [40][41] Question: Revenue expectations for upcoming quarters - Management expects growth to continue through the second quarter and accelerate in the second half of the year, driven by strong fundamentals and the publication of full CATALYST data [45][46] Question: Mix between brand and authorized generic for Korlym - Currently, a little over half of patients are on the authorized generic, which is expected to increase, but volume growth is anticipated to outweigh any price changes [51][75] Question: Nature of corrective measures taken by pharmacy vendor - The pharmacy vendor has improved staffing and operations to meet increased demand, with March and April showing record dispensing numbers [60][61] Question: Expectations for ALS data and potential approval - Management plans to discuss further studies with regulatory authorities to determine the next steps for the ALS program [66]