CORCEPT THERAPEUTICS INC Q4 FY2024 earnings call

Key Points - 2024 was a strong year with record new Korlym prescribers and patients. - In December 2024, Corcept submitted a new drug application for relacorilant based on GRACE GRADIENT and Phase II study results. - Relacorilant showed clinically meaningful improvements in various measures in GRACE studies and was well tolerated. - CATALYST study showed hypercortisolism is more prevalent than assumed, with Korlym showing significant improvements in hemoglobin A1c. - ROSELLA study in ovarian cancer is complete, with progression-free survival results expected by end of Q1 2024. - Dazucorilant is being studied for neurologic disorders, miricorilant for MASH. - The company is advancing research on relacorilant in combination with other therapies for cancer and other conditions.

In 2024, Corcept's revenue was $675 million, a 40% increase compared to the prior year. Net income was $141 million, up 33% from the prior year. Cash and investments at December 31, 2024, were $603 million. The company acquired $38 million of common stock through stock repurchase, option exercises, and restricted stock grants. The main revenue driver is related to Korlym and the development of relacorilant, but no specific segment revenue contribution percentages are provided.

Forward-Looking Statements - 2025 revenue guidance is $900 million to $950 million. - In Q4 2024, pharmacy operational challenges temporarily impacted revenue, but issues are being resolved and expected to handle future growth. - The market for hypercortisolism treatment is expected to expand, with confidence in growing the hypercortisols business from $3 billion to $5 billion in annual revenues in 3-5 years.

Legal Risk - Corcept sued Teva in 2018 to stop marketing a version of Korlym. The trial court ruled against Corcept in December 2023, and the appeal to the Federal Circuit Court of Appeals is ongoing. The outcome of the appeal could impact Teva's FDA approval and market withdrawal until 2037 if Corcept prevails.

Q: Can you talk to when we should hear about NDA acceptance for relacorilant and thoughts on an ADCOM?

A: Corcept submitted the NDA on December 30, and the FDA has 60 days to review for acceptance. They expect to receive a response soon. They do not expect an AdCom as past medications for Cushing's syndrome were approved without it.

Q: On ROSELLA trial changing endpoints to dual primary (PFS and OS), how does that work? And if PFS is negative, what happens?

A: They plan to hit the PFS endpoint and not need to wait for OS. If they miss PFS, they have the second chance with OS, which would be available approximately 1 year from now.

Q: On 2025 revenue guidance and Q4 flat quarter, what's baked into guidance?

A: Q4 flat quarter was due to pharmacy operational challenges temporarily overwhelming capabilities, but issues are being resolved. Guidance includes expectation of continued growth as the market for hypercortisolism treatment expands, with confidence in unlocking the full potential of the market.