Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $207.6 million, up from $182.5 million in the same period last year, reflecting a year-over-year increase of approximately 13% [3] - Net income decreased to $19.7 million from $47.2 million in Q3 2024 [3] - Cash and investments as of September 30, 2025, totaled $524 million, which includes a $50 million stock repurchase [3] Business Line Data and Key Metrics Changes - The hypercortisolism business experienced a 42.5% increase in tablet shipments compared to Q3 2024, driven by record prescriptions for Korlym [7] - The company is transitioning to a new pharmacy vendor due to capacity constraints with the previous vendor, which may affect growth in the short term [7][8] Market Data and Key Metrics Changes - The company reported around 3,250 paying patients at the end of Q3 2025, with expectations for significant market capacity growth as relacorilant is launched [34][35] - The authorized generic accounted for approximately 70% of the business in Q3 2025, with expectations to reach around 75% by year-end [42] Company Strategy and Development Direction - The company is preparing for the launch of relacorilant, with PDUFA dates set for December 30, 2025, for hypercortisolism and July 11, 2026, for ovarian cancer [12] - The oncology program is expanding significantly, with plans for new studies in various solid tumors and a focus on combining treatments with existing therapies [20][21] - The company aims to triple the potential patient base for gynecological cancers from 20,000 to 60,000 annually in the U.S. [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of relacorilant, anticipating it could generate $3-$5 billion in annual revenue in hypercortisolism alone within three to five years [11] - The company is optimistic about the upcoming FDA approvals and the potential impact of its clinical studies on treatment paradigms [28][29] Other Important Information - The company is finalizing a phase 3 trial design for dazcorilant in ALS, expected to start by mid-2026 [14][27] - The CATALYST study revealed that one in four patients with resistant diabetes has hypercortisolism, indicating a significant opportunity for treatment [24] Q&A Session Summary Question: How many patients were on drug at the end of the quarter? - Approximately 3,250 paying patients were reported at the end of Q3 2025 [34] Question: What is the capacity of the new pharmacy compared to the old one? - The new pharmacy has the ability to continually expand and has multiple locations, which is expected to support the business effectively [34] Question: Are there any downward pressures on margins? - No downward pressure on margins has been observed, and the company does not expect any [36] Question: What is the net pricing relative to brand pricing? - The net pricing is about a 30% discount to Korlym's list price, with the authorized generic making up a significant portion of the business [42] Question: Was the lack of priority review for the ovarian cancer NDA surprising? - Management was not surprised by the lack of priority review, acknowledging the FDA's many priorities [44] Question: What are the expectations for R&D and SG&A in 2026? - R&D expenditures are expected to remain stable, while SG&A expenses are anticipated to increase due to preparations for product launches [46]

Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $194.4 million, up from $163.8 million in the same period last year, reflecting a significant increase [5][6] - Net income was $35.1 million compared to $35.5 million in Q2 2024, indicating a slight decrease [5] - Cash and investments as of June 30, 2025, totaled $515 million, which includes $115 million spent on stock repurchase [5] Business Line Data and Key Metrics Changes - The Endocrinology Division reported a record number of new prescribers and prescriptions, with a 49% increase in tablets shipped compared to Q2 2024 [6][7] - Despite substantial quarterly revenue growth, fulfillment issues limited the potential revenue increase, with a $37 million increase over Q1 2025 [7][8] Market Data and Key Metrics Changes - The CATALYST study revealed that one in four patients with difficult-to-control diabetes has hypercortisolism, leading to increased screening and treatment [9][19] - The company is expanding its sales force significantly, increasing from 60 to 145 clinical specialists, with plans to reach 175 by year-end [10] Company Strategy and Development Direction - The company is focused on expanding its product offerings in hypercortisolism and oncology, with two new drug applications in progress [16][22] - Relacorilant is expected to become a new standard of care for hypercortisolism, with projected annual revenues of $3 billion to $5 billion in the next three to five years [10][19] - The company is also exploring the use of cortisol receptor antagonism in various cancers and neurological disorders [29][37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of relacorilant and the overall business, anticipating significant market expansion due to increased physician awareness [10][19] - The company acknowledged challenges with pharmacy capacity but expects improvements in the second half of the year [7][53] Other Important Information - The company is involved in ongoing patent litigation with Teva regarding Korlym, with a decision expected in the next two to three months [12][15] - The company is preparing to launch a second pharmacy to support its growth and improve fulfillment capabilities [7][53] Q&A Session Summary Question: What portion of your business came from the authorized generic during the quarter relative to Q1? - Approximately two-thirds of the business has transitioned to the authorized generic, with an average discount of about 30% to Korlym's list price [43][44] Question: Can you talk about the disconnect between prescriptions written and filled? - The pharmacy did not meet expectations, impacting Q2 results by approximately $15 million, but improvements are expected in Q3 and Q4 [52][53] Question: How much of the $3 billion to $5 billion peak sales opportunity for hypercortisolism comes from Korlym? - Relacorilant is expected to replace Korlym, and the market for hypercortisolism is larger than previously estimated [56][62] Question: When will the second pharmacy come online? - The second pharmacy is expected to contribute in Q4 2025, with plans to expand the distribution network for relacorilant [63][64] Question: What is the timeline for the BELLA study? - Enrollment for the BELLA trial is progressing rapidly, with results expected about a year after enrollment completion [80][81] Question: What is the strategy regarding ALS discussions with the FDA? - A meeting with the FDA is scheduled for later in August to discuss the path forward, including the possibility of approval based on existing data [82][84]