CORCEPT THERAPEUTICS INC Q3 FY2024 earnings call

• Revenue in Q3 2024 was $182.5M, up 48% y/y; 2024 revenue guidance raised to $675M - $700M.
• Net income in Q3 was $47.2M vs $31.4M prior year; cash/investments at Sept 30 were $547.6M.
• Lawsuit vs Teva: Appeal to Federal Circuit Court of Appeals, briefing complete, oral argument possible Jan next year; if prevail, Teva loses FDA approval of generic Korlym until 2037.
• GRACE and GRADIENT Phase 3 studies for relacorilant: GRACE met primary endpoint for blood pressure control; GRADIENT showed improvements in hypertension, hyperglycemia, weight; both support NDA submission by year end.
• CATALYST Phase 4 study in diabetes: Found higher prevalence of hypercortisolism; 1 in 4 of first 1,055 patients had hypercortisolism.
• ROSELLA study in ovarian cancer: Enrollment complete, expecting data by end of year; DAZALS study in ALS ongoing, expecting data by end of year; MONARCH study in MASH ongoing.

In the third quarter of 2024, Corcept Therapeutics' revenue was $182.5 million, representing a 48% increase compared to the third quarter of the prior year. Revenue contribution details by product segment were not explicitly provided in the transcript. The company's cash and investments at September 30th were $547.6 million, up from $492.5 million at June 30th. Net income in the third quarter was $47.2 million, an increase from $31.4 million in the prior year's third quarter.

• Increased 2024 revenue guidance to $675M to $700M.
• Anticipates results from ROSELLA, CATALYST, and DAZALS studies by end of 2024.

• Uncertainty regarding the outcome of the appeal against Teva Pharmaceuticals; if not prevailing, Teva could market a generic version of Korlym, potentially impacting revenue until 2037.

Q: On GRADIENT data interpretation and NDA confidence.

A: Bill Guyer stated the totality of evidence from multiple studies including GRACE, GRADIENT, and Study 452 supports the NDA, with consistent improvements across Cushing's syndrome symptoms and no new safety signals.

Q: Impact of CATALYST results on Korlym screenings.

A: Sean Maduck noted increased screening due to higher prevalence of hypercortisolism revealed by CATALYST, expecting full effect later into 2025 and beyond.

Q: ROSELLA study timeline.

A: Bill Guyer said the study is on track to have enough events by end of year for analysis, with results to be released once analyses are complete.

Q: FDA view on GRADIENT as supportive.

A: Charlie Robb confirmed the FDA sees GRACE as the pivotal study with GRADIENT as supportive, and consistent data across studies strengthens the NDA path.

Q: Last FDA interaction and hyperglycemia endpoint.

A: Joe Belanoff and Bill Guyer discussed no specific comment on recent FDA interactions, and hyperglycemia endpoints in GRADIENT were statistically significant favoring relacorilant.