cept Therapeutics rporated(US:CORT)2026-02-24 23:00Financial 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 between $900 million and $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 record number of new prescriptions and a 37% increase in tablets delivered compared to 2024, despite a 61% increase in new prescriptions indicating capacity issues with the pharmacy vendor [11][12] - The transition to a new specialty pharmacy began in October 2025, which is expected to resolve previous capacity issues and improve performance [12] Market Data and Key Metrics Changes - The company anticipates its Cushing's syndrome business to grow to at least $2 billion in annual revenue by the end of the decade, driven by increased recognition of hypercortisolism and the approval of relacorilant [14][25] Company Strategy and Development Direction - The company is focused on cortisol modulation to treat serious diseases, with ongoing research in oncology and metabolic conditions [15][16] - The ROSELLA trial demonstrated significant benefits for patients with platinum-resistant ovarian cancer, leading to expectations of relacorilant becoming a new standard of care [19][20] - The company is exploring the use of glucocorticoid receptor antagonism in combination with other therapies, including immunotherapy and androgen deprivation therapy [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 data and alignment with FDA guidelines during the development process [10][33] - The company plans to meet with the FDA to understand the reasoning behind the decision and explore options for moving forward [10][37] Other Important Information - The company has completed the MOMENTUM trial, which examines hypercortisolism in patients with resistant hypertension, with results expected to be announced soon [17] - The company is also advancing its proprietary compounds for various conditions, including metabolic dysfunction-associated steatohepatitis (MASH) and amyotrophic lateral sclerosis (ALS) [22][24] Q&A Session Summary Question: Thoughts on the CRL and potential randomized trials for relacorilant - Management believes the FDA may have shifted its criteria for approval, expressing confidence in the data supporting relacorilant [33][36] - The likelihood of running a randomized trial for relacorilant in type 2 diabetes or hypertensive patients is uncertain, but management emphasizes the importance of identifying and treating hypercortisolism [40][41] Question: Guidance assumptions regarding Korlym and pricing - The net price for Korlym through the AG is approximately a 30% discount, with expectations for pricing pressures in 2026 [39] Question: Supply chain issues and confidence in new pharmacy partner - Management is confident in the new pharmacy's capabilities, citing their expertise and ability to scale operations effectively [54][55] Question: Safety profile of relacorilant and comparison with nab-paclitaxel - The safety profile of relacorilant in the ROSELLA trial is consistent with previous analyses, showing no significant added toxicity compared to nab-paclitaxel [60][61] Question: Impact of KEYTRUDA on treatment options - Management notes that KEYTRUDA's approval is limited to specific patient populations, and there is interest among oncologists in maintaining treatment options that include relacorilant [63]