Thank you for standing by. And welcome to Corcept Therapeutics First Quarter 2025 Earnings Conference Call. At this time all participants are in a listen-only mode. After the speaker presentation there will be a question-and-answer session. [Operator Instructions] I would now like to hand the call over to Atabak Mokari, CFO. Please go ahead.

Hello, everyone. Good afternoon and thank you for joining us. Today we issued a press release announcing our financial results for the first quarter and providing a corporate update. A copy is available at corcept.com. Our complete financial results will be available when we file our form 10-Q with SEC. Today’s call is being recorded. A replay will be available at Investors Past Events tab of our website. Statements during this call other than statements of historical fact are forward-looking statements based on our plans and expectations that are subject to risks and uncertainties which might cause actual results to be materially different than those such statements express or imply. The risks and uncertainties that may affect our forward-looking statements are described in our annual report on Form 10-K and our quarterly reports on Form 10-Q, all of which are available at the SEC’s website. Please refer to those documents for additional information. We disclaim any intention or duty to update forward-looking statements. Our revenue in the first quarter of 2025 was $157.2 million, compared to $146.8 million in the first quarter of last year. We are reiterating our 2025 revenue guidance of $900 million to $950 million. Net income was $20.5 million in the first quarter of 2025, compared to $27.8 million in the first quarter of last year. Our cash and investments at March 31st were $570.8 million. We acquired $43 million of our common stock in the first quarter of 2025 pursuant to our stock repurchase program, the net exercise of stock options by Corcept employees and the net vesting of restricted stock. I will now turn the call over to Sean Maduck, President of our Endocrinology division. Sean?

Thank you, Atabak. We are on the cusp of a new diagnosis and treatment paradigm for patients with hypercortisolism. For many years, most physicians reserved both screening and treatment for the most physically obvious cases of hypercortisolism. Over the last 15 years, published data supported the identification and the treatment across a broader spectrum of disease. Screening for hypercortisolism has increased and it is driving rapid patient growth in our business. I’m certain that this increase in screening is just beginning. I’ve never been more confident in both our current and future growth prospects, and most important, our potential to help many, many patients for years to come. We now know that patients with hypercortisolism exist in every medical practice. More and more physicians are starting to recognize that, too. To put this in perspective, our new prescriber base has grown at a record rate for five straight quarters, and the number of Korlym prescriptions in the first quarter of this year was almost double what we saw in the same period last year. Both our prescriber base and our patient base are growing rapidly, and we expect growth to accelerate. In 2023 and 2024, we amplified our efforts to educate physicians about hypercortisolism and Korlym. We also increased the size of our sales force and we will continue to grow that team to reach and serve all our potential customers. We currently have 125 clinical specialists, up from 60 at the beginning of 2024, and our plan is to have 175 in place before year end in preparation for relacorilant’s launch. In 2024, we also introduced our first direct-to-patient disease awareness education campaign in an effort to arm patients with the knowledge that they need to discuss hypercortisolism with their physician. Finally, the results of our CATALYST study are…

Thanks, Sean. As was true last quarter, there’s not much to report regarding our patent litigation with Teva. In December of 2023, the trial court ruled against us in our lawsuit to stop Teva from marketing a generic version of Korlym in violation of our patents. We’ve appealed that decision to the Federal Circuit Court of Appeals. Briefing is complete. For anyone interested, the documents are available at the government’s PACER website. The Federal Circuit has still not scheduled oral arguments, the earliest plausible date for which is now July, the decision issued three months or four months after that. As I’ve said before, we’re eager to advance this appeal. We strongly believe our position is correct and that the Federal Circuit will agree with us. If we prevail, Teva will lose FDA approval of its product until 2037 when the patents we have asserted against Teva in this lawsuit expire. I will now turn the call over to Joe Belanoff, our Chief Executive Officer. Joe?

Thank you, Charlie, and thank you, everyone, for joining us this afternoon. This is a very exciting time at Corcept. Our development programs have generated two profound medical findings in hypercortisolism and oncology, and two potential avenues of substantial revenue growth. Let’s focus on hypercortisolism first. Our new drug application for relacorilant and hypercortisolism is based on positive results from our pivotal Phase 3 GRACE trial and is supported by the results from our GRADIENT, Long-Term Extension and Phase 2 trials. It is currently under review with an FDA action date of December 30, 2025. Patients treated with relacorilant in these studies experienced clinically meaningful and statistically significant improvements across all of the signs and symptoms of hypercortisolism in hypertension, hyperglycemia, weight, lean muscle mass, waist circumference, cognition, Cushing’s quality of life score and other important clinical measures. There was a high level of consistency and durability of therapeutic benefit across our studies. In each of them, patients exhibited rapid improvements at the start of relacorilant therapy and these improvements were maintained or continued to improve throughout the course of treatment, including in a Long-Term Extension study where some patients have received relacorilant for more than six years. Just as important as relacorilant’s efficacy is its safety. Relacorilant has been well tolerated in all of its studies. The most common adverse events are consistent with the cortisol withdrawal that patients with hypercortisolism experience following a rapid reduction in their cortisol activity, whether due to surgery or at the start of medical therapy. As expected, there have been no relacorilant-induced instances of hypokalemia, endometrial hypertrophy or drug-induced vaginal bleeding, no cases of adrenal insufficiency, and no instances of QT prolongation. These adverse events can have serious health consequences. Each of the currently available medications for patients with Cushing’s syndrome can cause…

Thank you. [Operator Instructions] Our first question comes from the line of Edward Nash of Canaccord. Your line is open, Edward.

Hi. Thanks, guys, for taking my question. I wanted to ask specifically on the oncology program. You have ROSELLA under your belt now and now you’ve started BELLA. I just wanted to understand from the treatment paradigm side of things, exactly where would the physicians start to employ and start to use relacorilant versus, say, Elahere? How would that -- how does that in any way push Elahere forward or back within the treatment paradigm? Then also, could you just give us any clarity or any some -- any granularity you have on the feedback you’ve been getting from oncologists based on the ROSELLA data?

Yeah. Hey, Edward. Thank you. And that’s a great opening question because it gives me a chance to introduce, for the first time on this call, Roberto Vieira, who is the President of our Oncology division. I think he has the answers for both of those questions. Please go ahead, Roberto.

Thank you, Joe. So, Ed, several questions into one there. So, as far as our view for relacorilant. Relacorilant plays a double-packed excel. It’s poised to become a new standard-of-care in platinum-resistant ovarian cancer. When you look at the treatment patterns, you see a very fragmented landscape. So, most patients have limited options and suffer with very poor outcomes. So, we feel confident relacorilant plays a nab-paclitaxel sets the foundation for a new standard-of-care. Now, concerning your question about Elahere and positioning, the results from the ROSELLA trial support relacorilant as an option in multiple lines of therapy, including before or after a biomarker-driven agent such as Elahere.

Great. That’s very helpful. Thank you. And then, I just had one additional question, and that was just on the revenue. Given that it sounds like March and April, you really -- things really picked up significantly after the correction was made, just wanted to understand how that’s going to affect the third -- the second, third and fourth quarters. Are we going to expect to see a huge bolus in second quarter in revenue, and then things kind of get back down to a normal level or just wanted to better understand how to model for that?

Yeah. I think we understand the question, and I’m going to, Edward, reintroduce you to Sean Maduck, who is the President of our Endocrinology division.

Yeah. Thanks. Thanks, Ed. So, I’ll start by saying that, as I sort of ended my opening remarks on, that the fundamentals of our business are extremely strong and really strengthened in the fourth quarter of last year into Q1 and we do expect that through the rest of the year. And we had a record number of prescribers, prescriptions and patients on Korlym to end the quarter. And as you’ve seen, our first quarter financial results did not match the strength of the business, due to everything I mentioned on the call. But to your question, I mean, we expect the growth to continue through the second quarter and the rest of the year, and actually accelerate in the half of the -- second half of the year, given all the initiatives we have on the commercial side, as well as the publication of the full CATALYST data results. So, very excited about it, and more confident than ever that the market is, A, bigger than we once thought, and that we’re on track for a range of $900 million to $950 million.

But Edward, to answer your question directly, yeah, we’re not expecting an instant bolus. We just think that growth will accelerate through the entire year and then into the next year.

Got it. Okay. That makes sense. Thanks so much for taking our questions and also congratulations on that DAZALS overall survival data.

Thanks. Thanks, Edward. Thanks very much for the questions.

Thank you. Our next question comes from the line of David Amsellem of Piper Sandler. Please go ahead, David.

Hey. Thanks. So got a Korlym question and then a couple of relacorilant questions. On Korlym, can you talk about the mix between brand and authorized generic business for Korlym as the year progresses? And I guess, is it fair to say that irrespective of that mix between the AG and the brand, this acceleration and volume growth and this expansion of the market that we’ve seen ultimately is what gets you to that $900 million to $950 million? So that’s my first question. And then on relacorilant, just two quick ones. Just remind us if you are expecting an ADCOM going into the December PDUFA and are you preparing for one? And then when are we going to hear more about additional solid tumor studies for relacorilant? Presumably, you’re going to look at potentially earlier lines of therapy in ovarian, other solid tumors. When are we going to get more details on your overall solid tumor strategy? Thank you.

Hey. Thank you, David. And yes, you’ve given us an opportunity for several people to respond to your various questions. So, Sean, why don’t you take the first question about Korlym?

Yeah. Thanks for the question. So, your last statement and the first part of the question on Korlym is exactly it. And that’s that we expect that future volume growth will overwhelm any price change that we see, given the mix of products. So, to the first part of the question, what’s the mix of Korlym and our authorized generic? A little over half right now of our product, our patients are on our authorized generic. We expect that that percentage will continue to increase over the course of the year and we factor that into our guides.

Charlie?

Yes. We do not expect to have an advisory committee. We didn’t have one for Korlym. The most recently approved drugs in the hypercorazolism didn’t have them either and we’re not anticipating one here.

Okay. And Bill, could you please answer the last question about the other tumors?

For a future study. So, it’s really been on our mind for quite some time to look at relacorilant in combination with any therapy in solid tumors. And it’s based upon our Phase 1, Phase 2 and now with the Phase 3 results, we have taken something from a concept to a reality and we’re now going to be hopefully rapidly expanding into that. And so, our goal is to really establish relacorilant as the foundational drug to be used in combination with any agent in solid tumors. And so, BELLA is that first foray into that next study in the earlier lines of therapy in combination now with nab-pac and bevacizumab. You’ll shortly see later this year, and as you had indicated, we’re going to go to earlier lines of ovarian cancer, and then also expand into other gynecological oncology cancers. And then soon after that, go into longer term into other solid tumors. So, you’re going to see many new studies coming, but again, all geared around relacorilant as that core molecule in combination with any agent.

Thank you.

Okay. Next question, please. Sure. Thank you.

Thank you. Our next question comes from the line of Joon Lee of Truist Securities. Please go ahead, Joon.

Yeah. Thanks for the updates and for taking our questions. Can you help us understand the nature of the corrective measures the pharmacy vendor took to improve operations in March and April? And what, if anything more needs to be done for them to be able to meet the demand so you can hit the guidance of $900 million to $950 million? And I have a follow-up question.

Thanks, Joon. And I’ll give you back to Sean to answer your question.

Thanks for the question. And again, in case anybody didn’t get a chance to listen to the opening remarks, the issue that’s being referenced at the pharmacy is really through the fourth quarter of last year through February of this year, there was really a massive prescription volume increase that sort of overwhelmed the pharmacy. So, in general, there were some, I won’t go into all the specifics, but there were some staffing issues associated with enough individuals to pull-through all the appropriate volume. And because of that, patients’ prescriptions weren’t filled on time. That has been remedied. It’s been staffed up. And I’ll just point to, again, having the strongest March, two of the strongest months, the two strongest months we’ve ever had in our history in March and April. And we expect that the pharmacy will continue to scale up with our growth going forward.

And then, with the measures that they’re taking to staff up, I mean, would you -- would they be able to meet the demand of relacorilant which we think could be a much bigger product and have a follow-up last question after that?

Yeah. No. That’s a great question and something we’re exploring. I mean, I’ll remind you that the reason we have such a narrow distribution network for Korlym is because the active ingredient in Korlym is mifepristone. And it was originally set up to make sure there was no product diversion for termination of pregnancy or other uses. Now, relacorilant obviously doesn’t have that same issue. And we do expect that the market is potentially much larger. So, there is the potential for a broader distribution network for that product and that’s something that we’re actively exploring now.

Great. And last question, regarding the ALS, is it your expectation that the existing data may be adequate for some sort of conditional approval or are you anticipating some sort of additional study to get this especially transformative drug out there? Thank you.

Hey, Joon. Thank you for the question. I’m going to give that to Charlie, who runs our regulatory area.

So, the question is with data like this, we’ve confronted the exact same questions and that’s why we’re going immediately to both the U.S. and European regulators to sort of present them with plans for further study and see what they think the appropriate next step is in terms of moving the drug forward, whether that’s an accelerated approval or rapid completion of another study or something else. So, I don’t want to speak to what the regulators are going to say, but we think these data are obviously promising and worth that discussion, and once we’ve settled things, we’ll let folks know.

Thank you.

Hey. Thank you, Joon.

Thank you. Our next question comes from the line of RK of H. C. Wainwright. Please go ahead.

Thank you. Good afternoon, Joe. A couple of quick questions on Korlym from me, too.

Okay. Please.

So, in the opening remarks, you said there was a significant increase in scripts that you saw were filled in March and April. I know you won’t be able to tell me the exact numbers, but, in general, what is that percentage increase as compared to, like, January and February? And then when you say that, 50% of your patients are moving towards authorized generics. So, I’m just trying to understand, like, what’s the price differential between the Korlym and authorized generics? And the -- I’m trying to triangulate between that and the increase in scripts…

Yes.

… to get to your stated 30%-some increase in revenue year-over-year?

Yeah. I really do think we understand your question, RK. Thank you. And I’m going to give you back to Sean to give you kind of a broad answer to that question.

Yeah. Thanks for the question. So, the first question was just around volume and volume increase. I mean, our first quarter enrollments were almost double what they were in the first quarter of last year and we’ve seen that continue on. So, a lot of growth driven by more screening. We’re starting to see the impact of the CATALYST results, and we expect, with the publication of the CATALYST treatment results in the second half of the year, again, we expect to see that growth to accelerate. So, that’s the first question. The second question around the authorized generic. As a reminder, we priced our authorized generic at a 12% discount from Korlym, but recognize that payers negotiate from there, as they do with sort of any list price. So, net price varies by payer. And again, the increased erosion that we expect to see over time, as well as that price, we expect to be overwhelmed by volume through the course of 2025 and all of that is included in our range.

RK, did you have a follow-up question? Okay. It sounds like we have had our last question, but I would just like to take a minute. I don’t do this often, but I think it’s just important speaking at this juncture. I have to admit that in the many years that I’ve run Corcept, I’ve considered lots of problems, and must admit to you that I did not anticipate that our Korlym business would overwhelm our pharmacy vendor. Obviously, this problem, set of problems, had a short-term impact on our revenues, but more important, it delayed drug shipments to patients, which is inexcusable, and I guess, to some degree, for whatever it’s worth, I apologize to any patients who were really terribly inconvenienced by this. As Sean stated, the problem appears resolved. March and April were very strong months, and I have to now tell you, of course, as a result, we’re intensely vigilant that this problem does not arise again. But I really want to focus you on three things, which I think are real shifts in what’s going on at Corcept. It’s now certain that there are many more patients with hypercortisolism than have been assumed for, in some sense, all of its study. We weren’t the first people to look at this, but the CATALYST study definitively said that there just are many more patients who have the potential to be screened and then found and treated. And I really actually suggest to you that you read the paper in Diabetes Care. It’s very accessible, plainly written and will really describe in all the detail you need why the fact that hypercortisolism was underrepresented before is not going to be true for much longer. The second thing is that, for many years, the only molecule to approach…

This concludes today’s conference call. Thank you for participating. You may now disconnect.