Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $157.2 million, an increase from $146.8 million in Q1 2024, representing a year-over-year growth of approximately 9% [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] - The company reiterated its 2025 revenue guidance of $900 million to $950 million [5] Business Line Data and Key Metrics Changes - The prescriber base for hypercortisolism treatments has grown at a record rate for five consecutive quarters, with the number of prescriptions nearly doubling compared to 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, which has a lower net price [10] Market Data and Key Metrics Changes - The company has seen a substantial improvement in pharmacy operations in March and April 2025, leading to a record number of tablets dispensed [10] - The transition to authorized generic tablets is expected to continue, but the decrease in price will be offset by an increase in the number of tablets shipped [11] Company Strategy and Development Direction - The company is focused on increasing physician awareness and understanding of hypercortisolism, with plans to expand its sales force from 125 to 175 clinical specialists by year-end [8] - The new drug application for relacorilant in hypercortisolism is under FDA review, with an action date set for December 30, 2025 [15] - The company is also exploring the use of relacorilant in combination with other therapies for various cancers, including ovarian and prostate cancers [25][26] 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 that one in four patients with difficult-to-control diabetes has hypercortisolism [18] - The company anticipates that the publication of full CATALYST treatment results will stimulate further growth in the second half of the year [43] - Management emphasized the potential for relacorilant to become the new standard of care for hypercortisolism patients [33] Other Important Information - The company is actively pursuing regulatory discussions regarding the next steps for its ALS treatment program following mixed results in a Phase II trial [27][66] - The company is preparing to submit relacorilant's NDA for platinum-resistant ovarian cancer in the next quarter [24] Q&A Session Summary Question: How does relacorilant fit into the treatment paradigm compared to Elaher? - Management indicated that relacorilant plus nab-paclitaxel is poised to become a new standard of care in platinum-resistant ovarian cancer, with potential use in multiple lines of therapy [40] Question: What is the expected revenue impact from the recent pharmacy operational improvements? - Management expects growth to continue through the second quarter and accelerate in the second half of the year, driven by strong fundamentals and initiatives [43][44] Question: Can you clarify the 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 [50][74] Question: Will there be an advisory committee for the December PDUFA? - Management does not expect an advisory committee for relacorilant, similar to previous approvals in hypercortisolism [51] Question: What are the next steps for relacorilant in solid tumors? - The company plans to rapidly expand studies for relacorilant in combination with other therapies in solid tumors, with a focus on earlier lines of therapy [53]

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]

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]