Corcept Therapeutics (CORT) Q4 FY25 earnings call: guidance and Q&A

Analyst asked for more detailed thoughts on the FDA's CRL for relacorilant in Cushing's syndrome, suggesting the agency 'moved the goalpost' and seeking clarification on the gap between the company's and FDA's views.

Management stated they believe the FDA 'missed the mark' as their data met approval hurdles and compared favorably to other approved drugs. They acknowledged a 'daylight' between their position and the FDA's, particularly regarding an analysis performed by the agency that the company couldn't replicate. They plan to meet with the FDA in April to understand their decision.

“I mean I think the -- again, I think that without sort of parsing the CRL line by line, there are things in it that are sort of curious and hard to follow. For example, leading with -- the acknowledge is right out of the gate that our pivotal trial met its primary endpoint for instance.”

asked by David Amsellem · answered by Gary Robb

Analyst inquired about the assumptions in the guidance regarding Korlym, specifically erosion of net price, percentage of business going through the AG, and net price discounts off the list price for 2026.

Management stated that the AG's net price is about a 30% discount on Korlym's WAC, consistent since launch. The AG share ended 2025 at about 75% and is currently around 78%, expected to stabilize. They have built in potential pricing pressures and discounting for the remainder of 2026.

“So in terms of the AG, the AG's net price is about a 30% discount on Korlym's WAC. And that's been consistent really since we launched the AG -- now over the course of 2025, more volume shifted from Korlym prescriptions, obviously, to AG prescriptions. And we ended the year at about 75% and that really was what the pricing impact was in our 2025 revenues. Now in terms of 2026. We're at about 78% AG. We expect it's going to maybe move a tick or so more, but it's essentially stabilized. But we have built in potential pricing pressures and discounting in through the remainder of 2026.”

asked by David Amsellem · answered by Sean Maduck

Analyst asked about the likelihood and timeline of running a conventional randomized trial for relacorilant in type 2 diabetes or hypertensive patients, similar to CATALYST/MOMENTUM.

Management emphasized that their medicines treat hypercortisolism, which is more prevalent than previously thought and underlies many resistant disease states. They highlighted CATALYST's success in resistant diabetes and MOMENTUM's upcoming results for resistant hypertension. They did not commit to a specific trial design or timeline for relacorilant in these indications, focusing on the mechanistic understanding.

“So where it leads us to do in terms of clinical development. I'm not -- I can't tell you with certainty at this point, but really understand that mechanistically what's going on is the identification of patients with hypercortisolism and then their treatment.”

asked by David Amsellem · answered by Joseph K. Belanoff

Analyst asked what to expect from the full ROSELLA data set at SGO, including subgroup/safety analysis, and how it will support early adoption.

Management expects to show the full Kaplan-Meier curve and full safety data sets at SGO, noting that the safety profile is very similar to prior analyses and shows no added toxicity, even a reduction in ALT rises compared to nab-paclitaxel alone. They anticipate very early and broad adoption due to the 35% reduction in risk of death, 4.1-month OS extension, favorable safety, and convenient oral administration.

“So overall, very tolerable regimen. It's also an oral therapy that actually doesn't add to the burden of treatment altogether. So when you look into efficacy in the all-comer population, the safety and the conveniency of this regimen, our expectation for adoption is really a very early adoption lines of therapy and very broad adoption, establishing what we consider to be a potential new standard of care in the category.”

asked by Jing Deng · answered by Roberto Vieira

Analyst asked if the full safety picture of relacorilant from the ROSELLA trial would be presented, given FDA's concerns in Cushing's syndrome, and how the safety profiles compare.

Management confirmed that the ROSELLA safety profile is very similar to previous analyses, with no significant ALT elevations. They clarified that in the endocrinology program, there were no cases of drug-induced liver injury. In ROSELLA, the combination arm actually showed half the amount of ALT rises compared to nab-paclitaxel monotherapy, indicating no added toxicity and even a reduction.

“We actually see half the amount of ALT rises in the combination arm compared to that of the nab-paclitaxel alone arm. So we're not seeing any added toxicity. We're actually seeing a reduction in that of ALT rises.”

asked by Swayampakula Ramakanth · answered by William Guyer

Analyst asked how management views KEYTRUDA's entry into the ovarian cancer picture and how they plan to message relacorilant's position.

Management noted KEYTRUDA's approval is limited to CPS >1 or PD-L1 expression >1, covering 50-60% of the total population, and it's already used in later lines of therapy in other regimens. They believe oncologists will maintain options, using ROSELLA's regimen in earlier lines due to its all-comer efficacy (HR 0.65) and safety, while reserving KEYTRUDA for later lines.

“So overall, when you compare a regimen that came with a safety button that you can see in their data, hazard ratio of 0.76. There is a clear signal here that there's a utilization of our ROSELLA regimen in other lines and maintaining optionality for KEYTRUDA in later lines of therapy.”

asked by Swayampakula Ramakanth · answered by Roberto Vieira