cept Therapeutics rporated(CORT) - 2022 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Revenue in Q4 2022 was $103.1 million, up from $98.8 million in Q4 2021, with 2023 revenue guidance of $430 million to $450 million compared to 2022 revenue of $401.9 million [3][28] - Net income for Q4 2022 was $16.6 million, totaling $101.4 million for the full year 2022 [23] Business Line Data and Key Metrics Changes - The Cushing's syndrome business is expected to grow significantly, with substantial investments being made to improve screening and treatment [28] - Clinical development programs for proprietary selective cortisol modulators, including relacorilant, dazucorilant, and miricorilant, are advancing, with multiple trials ongoing [8][10] Market Data and Key Metrics Changes - In-person clinical interactions have returned to about 80% to 90% of pre-COVID levels, which is expected to be the new baseline [80] Company Strategy and Development Direction - The company is focused on expanding its Cushing's syndrome business and enhancing disease awareness among physicians [28][48] - The CATALYST study aims to understand the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes and evaluate the efficacy of Korlym [12][73] Management's Comments on Operating Environment and Future Outlook - Management is optimistic about the growth potential of the Cushing's syndrome business and believes there are more patients to be diagnosed and treated than previously thought [28] - The company remains confident in its legal position regarding ongoing litigation and believes recent settlements will positively influence future cases [5][92] Other Important Information - The company has successfully settled two lawsuits, including a securities class action and a patent infringement case with Hikma Pharmaceuticals [5][6] - The company is conducting a Phase 1b trial for miricorilant in NASH, with promising results expected to be shared by midyear [63] Q&A Session Summary Question: What endpoints are being looked for in the ALS study? - The primary endpoint is a 24-week evaluation using the ALS functional rating scale, which is a validated FDA endpoint [41] Question: What would increase confidence in the NASH program as it enters Phase 2? - The goal is to find the right dosing regimen that achieves progressive fat loss over time without ALT rises, with plans to move to Phase 2 in Q4 [42] Question: What drives the revenue range for 2023? - The revenue range is driven by the number of patients added to the active patient base, with stable pricing and retention rates [47] Question: How are in-person clinical interactions progressing? - In-person interactions are at about 80% to 90% of pre-COVID levels, which is expected to be the new baseline [80] Question: Will the CATALYST study impact new starts on Korlym? - The study is expected to increase awareness among physicians who are currently not treating or diagnosing hypercortisolism, thus not negatively impacting new starts on Korlym [88]