cept Therapeutics rporated(CORT) - 2025 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company's revenue for 2025 was $761 million, an increase from $675 million in the previous year, with a revenue guidance for 2026 set at $900 million to $1 billion [3][4] - Net income for 2025 was $99.7 million, down from $141.2 million in the prior year [3] Business Line Data and Key Metrics Changes - The Cushing's syndrome business saw a 37% increase in tablet deliveries compared to 2024, with a record number of new prescriptions and first-time prescribers [11][12] - Despite a 61% increase in new prescriptions, the gap between new prescriptions and tablets sold indicates capacity issues with the pharmacy vendor [11] Market Data and Key Metrics Changes - The company transitioned to a new specialty pharmacy in October 2025 to address capacity issues, which has shown promising signs of improved performance [12][56] - The Cushing's syndrome business is expected to grow to at least $2 billion in annual revenue by the end of the decade, driven by increased recognition of hypercortisolism [14][26] Company Strategy and Development Direction - The company plans to appeal the recent court ruling against its patent for Korlym and is focused on making relacorilant available to patients as quickly as possible [4][10] - The company is optimistic about the potential of relacorilant in treating various solid tumors and is exploring its use in combination with other anticancer therapies [21][22] Management's Comments on Operating Environment and Future Outlook - Management expressed surprise at the FDA's decision not to approve relacorilant, citing strong clinical trial data and a history of collaboration with the FDA [5][10] - The company is confident in its future growth, particularly in the Cushing's syndrome market, and anticipates significant demand as findings from recent studies are recognized by physicians [26][28] Other Important Information - The company reported cash and investments of $532 million as of December 31, 2025, reflecting a stock repurchase program [4] - The ROSELLA trial demonstrated a 35% reduction in the risk of death for patients receiving relacorilant in combination with nab-paclitaxel, with a median overall survival increase of 4.1 months [19][20] Q&A Session Questions and Answers Question: Thoughts on the CRL and future trials for relacorilant - Management believes the FDA may have shifted its expectations and plans to clarify this in an upcoming meeting [30][34] - The company is considering running a randomized trial for relacorilant in type 2 diabetes and hypertensive patients, but no definitive path has been established yet [41] Question: Guidance assumptions for Korlym - The net price for Korlym through the AG is about a 30% discount, with expectations for 2026 indicating a stabilization in pricing pressures [31][40] Question: Supply chain issues and safety data - The transition to a new pharmacy partner has improved metrics, and management is confident in their ability to meet future demand [55][56] - Safety data from the ROSELLA trial shows no significant increases in ALT levels compared to nab-paclitaxel alone, indicating a favorable safety profile [60][62] Question: Impact of KEYTRUDA on the market - Management noted that KEYTRUDA's approval is limited to specific biomarker expressions, and there is interest in maintaining treatment options for patients [64]