Financial Data and Key Metrics Changes - The company's revenue for 2024 was $675 million, representing a 40% increase compared to the previous year [4] - Net income for 2024 was $141 million, an increase of 33% year-over-year [5] - Cash and investments at the end of 2024 were $603 million, up from $425 million at the end of the previous year [5] - The company provided revenue guidance for 2025 of $900 million to $950 million [5] Business Line Data and Key Metrics Changes - The number of new Korlym prescribers and patients receiving Korlym reached record levels throughout 2024 [10] - The CATALYST study indicated that hypercortisolism is more prevalent than previously assumed, with 1 in 4 patients with difficult-to-control type 2 diabetes affected [20] - In the CATALYST treatment phase, patients receiving Korlym showed a significant reduction in hemoglobin A1c by 1.47% compared to a 0.15% decrease in the placebo group [21] Market Data and Key Metrics Changes - The company noted that the prevalence of hypercortisolism is higher than historical estimates, with the FDA agreeing on the increased patient population [80] - The company anticipates that the market for hypercortisolism treatments could grow from $3 billion to $5 billion in annual revenues within 3 to 5 years [81] Company Strategy and Development Direction - The company is focused on increasing physician awareness of hypercortisolism and expanding its treatment offerings, including relacorilant [20][40] - A new drug application for relacorilant was submitted, based on positive results from clinical studies [12][41] - The company is also exploring relacorilant's potential in oncology, particularly in ovarian cancer and prostate cancer [24][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued revenue growth and the effectiveness of their treatments for hypercortisolism [5][39] - The operational challenges faced by their pharmacy partner were acknowledged, but management is optimistic about resolving these issues [78] - The company expects to see a significant impact from the CATALYST study data in the second half of the year and beyond [68] Other Important Information - The company is conducting multiple studies, including the ROSELLA study for ovarian cancer and the MOMENTUM study for resistant hypertension [27][23] - The safety profile of relacorilant was highlighted, with no serious adverse events reported [19] Q&A Session Summary Question: When should the company expect NDA acceptance for relacorilant? - The NDA was submitted on December 30, and the FDA has 60 days to review it for acceptance, with routine correspondence ongoing [49][50] Question: What is the status of the ROSELLA trial and the change in endpoints? - The change to dual primary endpoints was made in collaboration with the FDA, allowing for two chances for a positive outcome [74] Question: How is the CATALYST study impacting patient screening and treatment? - Initial impacts are being observed, with expectations for more significant changes in medical practice as more data is published [68]