• Revenue: $675 million for 2024, a 40% increase compared to the prior year.
• 2025 Revenue Guidance: $900 million to $950 million.
• Net Income: $141 million for 2024, a 33% increase compared to the prior year.
• Cash and Investments: $603 million as of December 31, 2024, compared to $425 million at the end of the prior year.
• Stock Repurchase: $38 million of common stock acquired in 2024.

• Warning! GuruFocus has detected 3 Warning Signs with CORT.

Release Date: February 26, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Corcept Therapeutics Inc (NASDAQ:CORT) reported a 40% increase in revenue for 2024, reaching $675 million, with expectations for continued growth in 2025.
• The company successfully submitted a new drug application for relacorilant, a proprietary selective cortisol modulator, based on positive results from multiple studies.
• The GRACE Phase 3 study demonstrated significant improvements in patients with hypercortisolism, including better blood pressure control and other clinical measures.
• Corcept's CATALYST study revealed that hypercortisolism is more prevalent than previously assumed, particularly in patients with difficult-to-control type 2 diabetes.
• The company is advancing its oncology division, with the ROSELLA study in ovarian cancer showing promise for relacorilant in combination with chemotherapy.

Negative Points

• Corcept Therapeutics Inc (NASDAQ:CORT) is facing legal challenges, as it has appealed a court decision against its patent lawsuit with Teva.
• The company experienced operational challenges with its pharmacy partner, impacting Q4 revenues despite record patient and prescriber numbers.
• The ALS trial for dazucorilant did not meet its primary endpoint, although it showed a statistically significant improvement in patient survival.
• There is a delay between data generation and changes in medical practice, which may slow the impact of the CATALYST study findings.
• The company is not expecting an advisory committee meeting for relacorilant's NDA, but it remains a possibility, which could affect the approval timeline.

Q & A Highlights

Q: Can you discuss the timeline for the NDA acceptance of relacorilant and the potential for an advisory committee (ad com) meeting? A: Gary Robb, Chief Business Officer, explained that the NDA for relacorilant was submitted on December 30, and the FDA has 60 days to review it for acceptance. The process has been routine, and they expect a response soon. They do not anticipate an ad com meeting, as previous Cushing's syndrome medications were approved without one, and relacorilant's efficacy and safety do not suggest the need for one.

Q: Regarding the ROSELLA trial, why was overall survival elevated to a dual primary endpoint, and what are the statistical implications? A: William Guyer, Chief Development Officer, stated that the change to dual primary endpoints was made in collaboration with regulators to provide two chances for a positive study outcome. The p-value for progression-free survival (PFS) is now 0.04, and for overall survival (OS) is 0.01. Meeting either endpoint will define the study as positive, and if PFS is met, the alpha can be recycled to elevate the OS p-value to 0.05.

Q: What happens if the ROSELLA trial misses the PFS endpoint, and how does the CATALYST study impact patient screening and treatment? A: William Guyer noted that if the PFS endpoint is missed, they have a second chance with the OS endpoint, expected in about a year. Sean Maduck, President of Corcept Endocrinology, mentioned that the CATALYST study has started to impact patient screening and treatment, with more data expected to be released, influencing medical practice changes in the future.

Q: Was there a specific reason for changing the ROSELLA trial's endpoint, and did the FDA agree with it? A: William Guyer explained that the change was prompted by collaborative discussions with the FDA and EMA, leading to an agreement to elevate OS as a dual primary endpoint, providing two chances for a positive trial outcome.

Q: What factors are included in the 2025 revenue guidance, and why was revenue flat quarter-to-quarter? A: Sean Maduck addressed that the flat revenue was due to operational challenges faced by their pharmacy partner, which delayed patient starts on Korlym. The guidance considers the increasing recognition of hypercortisolism's prevalence and the potential market growth, with expectations to grow the hypercortisolism business significantly in the coming years.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.