CORCEPT THERAPEUTICS INC Q3 FY2025 earnings call

Hypercortisolism Business - Robust growth in Q3 2025 with 42.5% more tablets shipped than prior year, driven by record prescriptions for Korlym. - Transitioning pharmacy vendor due to insufficient capacity of previous vendor, planning to add second and third specialty pharmacies. - Expanding base of prescribers over the last 2 years. ### Oncology Development - NDA for relacorilant for hypercortisolism has a PDUFA date of December 30, 2025; NDA for relacorilant in platinum-resistant ovarian cancer has a PDUFA date of July 11, 2026. - Upcoming study results: MOMENTUM trial on resistant hypertension in early 2026, ROSELLA trial in platinum-resistant ovarian cancer and BELLA trial in advanced ovarian cancer, MONARCH trial in MASH by end of 2026. - Planning Phase III trial of dazucorilant in ALS by mid-2026. - Expanding oncology portfolio with new studies in platinum-sensitive ovarian cancer, endometrial cancer, cervical cancer, pancreatic cancer, etc. ### Other Programs - CATALYST trial found 1 in 4 patients with resistant diabetes has hypercortisolism. - MOMENTUM trial on resistant hypertension expected in early 2026. - Miricorilant in MASH showed rapid reduction in liver fat and improved liver health markers in Phase Ib study. - Dazucorilant in ALS showed 84% reduction in risk of death at 1-year mark in Phase II trial, planning Phase III trial in 2026.

In the third quarter of 2025, Corcept's revenue was $207.6 million. The hypercortisolism business had robust growth, with shipments 42.5% higher than the prior year quarter, driven by record prescriptions for Korlym. The hypercortisolism segment contributed significantly to the overall revenue, with its underlying strength continuing to build.

• Modified 2025 revenue guidance to $800 million to $850 million. - Expect FDA approval of relacorilant for hypercortisolism in December 2025. - Anticipate relacorilant's first oncology approval in platinum-resistant ovarian cancer by mid-2026. - Plan to start Phase III trial of dazucorilant in ALS by mid-2026.

• Patent litigation with Teva Pharmaceuticals: Appeal to Federal Circuit Court of Appeals, decision could come at any time; outcome uncertain, with potential loss of FDA approval for Teva's product until 2037 if Corcept prevails.

Q: I wanted to ask, I know sometimes you give the numbers. I just want to get an idea of how many patients at the end of the quarter that you had on drug? And then also, can you give us some idea of -- I know you're going to be bringing on a second new distributor at the beginning of the year, as you mentioned. But just wanted to have an idea of based upon what historically your previous distributor, what additional capacity or what magnitude of capacity does this new distributor that sort of come on in October have over your old distributor?

A: Thanks, Edward. I think we understand both of those questions. And I'm going to pass you over to Sean Maduck, who is the President of our Endocrinology division. Sean Maduck: Thanks, Ed. I appreciate the question. Your first question was around about how many patients do we have on medicine at the end of the quarter. We had around 3,250 paying patients at the end of the third quarter. So in terms of the pharmacy that was just onboarded on October 1, it's a great pharmacy and we think we're going to -- they're going to do just a fantastic job supporting patients. And they've got about 25 years of experience, which is in serving orphan and orphan disease products, which is great. In terms of the specific question around capacity, they have the ability to continually expand with our business. They also have multiple locations around the country to distribute, which is something that was very appealing to us as we continue through the rest of the year with Korlym and then get ready for the relacorilant launch in 2026.

Q: Just a couple of quick ones. One, can you just remind us what the -- what net pricing looks like relative to brand pricing, just given that more and more of the business is going through the AG? How much of your business is coming from the AG? And then also, as you look to the PDUFA in ovarian, were you surprised you didn't get a priority review? And then lastly, can you talk about R&D and SG&A directionally for 2026 given the launches and given all the clinical studies?

A: Thanks, David. And I think we'll give your questions to the person who could each answer them best. Sean, why don't you begin? Sean Maduck: Yes. Thanks, David. In terms of our authorized generic in the second quarter, we were -- about 2/3 of our business were on the authorized generic. In the third quarter, it ended in the low 70s. And our expectation is by the end of the year, it might creep up a little bit, maybe ending at around 75%. And then in terms of the net, it's about a 30% discount to Korlym's list price. Joseph K. Belanoff: Charlie, answer about the ovarian cancer NDA. Gary Robb: Yes. So we requested priority review. We didn't receive it. And to say, we weren't surprised to not receive it. We wouldn't have been surprised to receive it. Just based on the strength of the application, we were confident that we met the sort of stated criteria about substantial benefit in terms of safety or efficacy over available treatments. But the FDA has many priorities, many other things going on and their decisions are theirs and are sometimes opaque to us. So no, not surprised. Always hopeful, not surprised. And that's just, I think, the way dealing with the FDA on this kind of question has to be. Joseph K. Belanoff: And Atabak? Atabak Mokari: Sure. So regarding your question on R&D spend and SG&A, so we've talked a lot about the huge opportunity that we see ahead of us on multiple fronts across all of our businesses. And so we're going to invest to capture that. So on the R&D side, while we -- Bill walked you through many new studies that we're planning, there are many studies that we've been running throughout this year that are completing and winding down. So I would expect our R&D expenditures next year to be about the same as we are in 2025. And then on the SG&A side, we see huge opportunities on both hypercortisolism and ovarian cancer. And so we've been investing to prepare for launches of relacorilant in both of those indications, and we'll continue to invest to capture the large market opportunity. So I would expect those SG&A expenses to continue to increase.

Q: Congrats on the quarter. This is Asim Rana on for Joe. Just a couple from us. So you said previously that the second pharmacy would have more meaningful contribution in the fourth quarter. Now that the first pharmacies out of the picture seems to be, how confident are you that Curant can handle the increase in volume over, say, fourth quarter and the quarters going forward? Is Curant fully online as of the fourth quarter? And then just as a follow-up, on the upcoming PDUFA for relacorilant, have you had a late cycle review for relacorilant? And if so, what can you share?

A: Sure. Thank you very much for those questions. I think I understand all of them. The first one, we will send to Sean. Sean Maduck: Yes. So I'll answer your second question first. Curant is fully online. They started taking new patients on October 1. Almost all new enrollments are going to Curant. And over the course of the quarter, we will be transitioning the remainder of the business. So we're very confident in their ability to handle the capacity and meet the demands of the fourth quarter. Joseph K. Belanoff: And Charlie? Gary Robb: So just can you repeat the question for me because I want to make sure I answer it really correctly. What you say? Asim Rana: Yes. Just on the upcoming PDUFA for relacorilant, have you had a late cycle review for rela? And if so, what can you share? Gary Robb: Sure. So just a little background for people who don't -- are not as familiar with NDAs as you are. When the FDA agrees to review your new drug application, they give you a letter that sets out sort of the key milestones that are going to happen during the review process. And one of them is the mid-cycle review meeting with -- between the sponsor and the FDA. And the second is, as you know, another one is this late cycle review meeting. I can tell you that we've had both. I cannot tell you sort of what transpired or the nature of our back and forth with the FDA because we just can't comment on that. But we held them both exactly on the schedule the FDA set out in additional -- in its original letter to us. Things have moved per schedule, very ordinary course, and we are very confident as a result that the FDA will meet its target date of December 30. Asim Rana: And if I could just have a quick follow-up. Is Optime still selling Korlym? And if so, like how long would they have to? Joseph K. Belanoff: Yes. Sean, please take that. Sean Maduck: So Optime is still servicing patients just as they were before as they're obligated by the contract.

Q: A couple of questions. So first question being on the guidance. If I take the midpoint of your current guidance, the fourth quarter sales should come around $265 million or so, which is -- which means it requires a 28% growth from the third quarter number. With only one pharmacy in operation per se, how comfortable are you in thinking about that sort of growth, especially with holidays and less number of sales days? And the second question...

A: Go ahead, please. Swayampakula Ramakanth: Sorry. And the second question is on the new molecule that I see on the pipeline, nenocorilant. -- how different is that from rela? And do you plan to release any preclinical data from that molecule as we start thinking about the study in solid tumors as a combination therapy with the PD-1 inhibitors? Joseph K. Belanoff: Okay. I think we have both of those questions. The first one is Sean. Please go ahead, Sean. Sean Maduck: Yes. So RK, just to be clear, you said in your question that we only have one pharmacy. That's incorrect. We actually have 2 pharmacies. Optime Care is continuing to service the active patient base and all new prescriptions are going to Curant. So over time, a greater percentage of our business is going to transfer over there. We expect combined to see some efficiencies, and we expect to have a strong Q4. Joseph K. Belanoff: And Bill, any comments you'd like to make about nenocorilant? William Guyer: Yes. Thank you. So related to nenocorilant in our oncology portfolio, when we look at relacorilant, as you heard, all the studies we're doing with relacorilant. Relacorilant is a great molecule and it's shown its benefit not only in oncology, but also endocrinology, but we're always looking at and evaluating new molecules preclinically to help us broaden our reach in every therapeutic area and especially oncology. And as we looked at the opportunity with combinations with PD-1 inhibitors, we felt that a drug like nenocorilant had unique properties that allowed us to dose it on a regular basis to help us look at other solid tumors. And we really felt it was the best partner for PD-1 inhibitors compared to that of relacorilant. And so when it comes to publishing our preclinical data, yes, we always publish our data, and I would expect us to have that data in the public domain next year.