cept Therapeutics rporated(CORT) - 2023 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company's revenue for Q3 2023 was $123.6 million, representing a 22% increase compared to the same quarter last year [47] - Net income for the quarter was $31.4 million, or $0.28 per share [47] - Cash and investments as of September 30th totaled $414.8 million, an increase of $51.5 million during the quarter [47] - The revenue guidance for 2023 has been raised to a range of $470 million to $480 million, up from the previous range of $455 million to $470 million [52] Business Line Data and Key Metrics Changes - The growth in revenue was driven by a 12% increase in volume and a 9% increase in price for Korlym [79] - The company is experiencing a mix of new prescribers and repeat prescriptions from existing physicians, contributing to the growth in Korlym sales [82] Market Data and Key Metrics Changes - There is an increasing recognition among physicians that hypercortisolism is more common than previously assumed, leading to more screenings and diagnoses [80] - The CATALYST study is expected to provide further evidence supporting the prevalence of hypercortisolism, which could enhance the treatment landscape for Cushing's syndrome [51] Company Strategy and Development Direction - The company is focused on expanding its sales force and improving the effectiveness of its team, with a target of increasing the sales force from mid-60s to about 75 [18] - The company is advancing multiple clinical development programs, including GRACE, GRADIENT, CATALYST, ROSELLA, and DAZALS studies, with significant milestones expected in 2024 [35][43] - The company is optimistic about the growth potential of its Cushing's syndrome business and the broader applications of cortisol modulation in various diseases [73] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of their case against Teva Pharmaceuticals regarding patent infringement, which is expected to be resolved by mid-2025 [32] - The management anticipates continued growth in the Cushing's syndrome market as more physicians become aware of the condition and its treatment options [51] Other Important Information - The company has robust intellectual property protections for both Korlym and relacorilant, with protections extending through 2037 and beyond 2040, respectively [25][26] - The company introduced a new executive team member, Monica Toledo, who will focus on emerging markets such as ALS and NASH [74] Q&A Session Summary Question: Can you provide specifics on the year-over-year volume growth for Korlym? - The company reported a 22% growth, with 12% driven by volume and 9% by price [79] Question: What does the increase in screening for hypercortisolism mean for future growth? - The recognition that hypercortisolism is more common is expected to sustain growth as more patients are diagnosed and treated [80] Question: Can you elaborate on the GRACE study and its primary endpoint? - The GRACE trial is evaluating dosing escalation and aims to show significant improvement in patients with Cushing's syndrome [85]