cept Therapeutics rporated(CORT) - 2023 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Revenue for the second quarter of 2023 was $117.7 million, a 14% increase compared to the same period last year [8] - Net income was $27.5 million or $0.25 per share, compared to $27.4 million or $0.24 per share in the same period last year [8] - Cash and investments totaled $363.3 million as of June 30, reflecting the purchase of 6.6 million shares for $145.4 million during the quarter [8] - The company raised its 2023 revenue guidance to a range of $455 million to $470 million, up from $435 million to $455 million [8] Business Line Data and Key Metrics Changes - The Cushing's Syndrome business is experiencing growth, with more patients receiving Korlym and an increase in the number of prescribing physicians [120] - The CATALYST study is expected to provide further evidence of the prevalence of hypercortisolism in patients with type 2 diabetes, which may lead to increased treatment rates [122] Market Data and Key Metrics Changes - The prevalence of hypercortisolism in patients with type 2 diabetes is estimated to be significantly higher than in the general population, with studies indicating rates of 10% to 20% [129] - The updated European Society of Endocrinology guidelines encourage physicians to look harder for hypercortisolism, which is expected to increase screening and diagnosis [131] Company Strategy and Development Direction - The company is focused on cortisol modulation as a therapeutic mechanism for various serious disorders, with proprietary compounds being developed for conditions like Cushing's Syndrome, NASH, and various cancers [124] - The company plans to submit an NDA for relacorilant in Cushing's Syndrome in the second quarter of 2024 and is advancing multiple clinical trials [10][12][124] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of the Cushing's Syndrome business and the impact of ongoing clinical development programs [22][124] - The company anticipates continued growth in revenue and patient treatment rates, driven by increased disease awareness and improved field execution [126] Other Important Information - The CATALYST study is a landmark study evaluating the prevalence of hypercortisolism in difficult-to-treat type 2 diabetes patients, with enrollment expected to complete ahead of schedule [122][129] - The company is also conducting a Phase 1b trial of miricorilant for NASH, with promising results from previous studies [11][124] Q&A Session Summary Question: What drove the revenues in the second quarter and confidence in increasing guidance? - Management attributed revenue growth to improved access and field execution, with more patients and prescribers for Korlym [126] Question: What are the implications of the updated European Society of Endocrinology guidelines? - The guidelines encourage increased screening for hypercortisolism, which is expected to enhance diagnosis and treatment rates [131] Question: What are the dynamics of miricorilant in terms of efficacy and safety? - Management highlighted the rapid reduction in liver fat and improvements in liver enzymes observed in previous studies, supporting the advancement to Phase IIb [88]