Corcept Therapeutics - Earnings Call - Q1 2025

Executive Summary

• Q1 2025 revenue was $157.2M, up 7.1% YoY but down 13.6% sequentially; EPS diluted was $0.17 vs $0.25 YoY, with operating income margin compressing to ~2.2% as SG&A and R&D rose and pharmacy capacity constraints limited shipments early in the quarter. Versus consensus, EPS beat (+$0.03), while revenue missed (−$20.7M), driven by January–February fulfillment constraints and a higher mix of authorized generics lowering net price per tablet by 13% YoY; March–April set records for tablets dispensed, pointing to stabilization and acceleration ahead.
• 2025 revenue guidance was maintained at $900–$950M; management expects growth to accelerate through the year and into 2026 as pharmacy operations normalize, sales capacity expands, and awareness from CATALYST and MOMENTUM increases screening and treatment.
• Strategic catalysts: FDA filed the relacorilant NDA in hypercortisolism (PDUFA Dec 30, 2025); ROSELLA Phase 3 (ovarian) met primary PFS endpoint (HR=0.70) with OS benefit (HR=0.69); ovarian NDA expected Q3 2025; ASCO late-breaker in June; ADA CATALYST treatment results presentation June 23.
• Litigation: Appeal vs Teva generic Korlym pending at Federal Circuit; oral argument earliest plausible July with decision 3–4 months later—a potential stock-moving legal catalyst.

What Went Well and What Went Wrong

What Went Well

• “Record number of prescriptions from new and existing prescribers” and record tablets dispensed in March and April as pharmacy operations improved; guidance reiterated. Quote: “Pharmacy operations improved substantially in March and April, with each month setting a record for tablets dispensed”.
• ROSELLA Phase 3 in platinum-resistant ovarian cancer achieved PFS (HR=0.70; p=0.008) and showed interim OS benefit (HR=0.69; p=0.012) with comparable safety, supporting Q3 NDA/MAA submissions and ASCO late-breaker visibility.
• FDA filed relacorilant NDA for hypercortisolism (PDUFA Dec 30, 2025), backed by GRACE/GRADIENT and long-term extension data demonstrating efficacy and favorable safety without hypokalemia, progesterone-related AEs, adrenal insufficiency, or QT prolongation.

What Went Wrong

• Revenue missed consensus due to early-quarter specialty pharmacy capacity constraints, delaying fills; net price per tablet declined 13% YoY as mix shifted toward authorized generic, compressing revenue despite robust prescription growth.
• Profitability compressed: total operating expenses rose to $153.8M from $117.3M YoY; income from operations fell to $3.4M (EBIT margin ~2.2%), reflecting higher SG&A and R&D and price mix headwinds.
• ALS Phase 2 (dazucorilant) did not meet primary ALSFRS-R endpoint; while exploratory analysis suggested OS benefit at 300mg, next steps require regulatory input, implying uncertainty and timing risk.

Transcript

Operator (participant)

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. To ask a question during the session, you will need to press star one one on your telephone. To remove yourself from the queue, you may press star one one again. I would now like to hand the call over to Atabak Mokari, CFO. Please go ahead.

Atabak Mokari (CFO)

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 the 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 the 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 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-$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 on 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.

Sean Maduck (President of Endocrinology Division)

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 has supported the identification and the treatment across a broader spectrum of disease. Screening for hypercortisolism has increased and 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 very powerful. The study unequivocally shows that one in four patients with difficult-to-control diabetes have hypercortisolism, and that treatment with a cortisol modulator dramatically improves their hyperglycemia, even while all the current medications, including Ozempic and Mounjaro, have not. Our Q1 financial results do not reflect the tremendous patient growth our business is experiencing or what we expect for the rest of this year. Our first quarter results, specifically in January and February, were affected by insufficient capacity at our pharmacy vendor.

As I said on our last call, the rapid growth in our business in the second half of 2024 overwhelmed the pharmacy's operational capabilities, and these challenges persisted into this year. That said, we have seen a substantial improvement in pharmacy operations in March and April. This has translated to a record number of tablets dispensed in March and April. Our first quarter results were also affected by a greater portion of our business transitioning from branded Korlym to our authorized generic, which has a lower net price. As a result, our average price per tablet decreased by 13% relative to the prior year. We expect that the transition to authorized generic tablets will continue to grow this year, but that this decrement in price will be overwhelmed by an increase in the number of tablets shipped.

Please let me emphasize that all factors, including pharmacy operations and pricing impact from our authorized generic, are factored into our 2025 revenue guidance. I will end where I began. I have never been more confident in both our current and future commercial growth, and most important, our potential to help many more patients. Korlym is a great medication, but relacorilant is even better. It will be a great option for both prescribers and patients, and I expect that our patient numbers will accelerate when it emerges. I believe that in the next three to five years, relacorilant will generate $3 billion-$5 billion in annual revenue in hypercortisolism alone. I will now turn the call over to Charlie Robb, our Chief Business Officer. Charlie.

Charlie Robb (Chief Business Officer)

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 argument. The earliest plausible date for which is now July, with a decision issuing three 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?

Joe Belanoff (CEO)

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 in hypercortisolism is based on positive results from our pivotal phase III GRACE trial and is supported by the results from our GRADIENT, long-term extension, and Phase II 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 one or more of them. As we advance relacorilant, we continue to work at increasing physician awareness and understanding of hypercortisolism. Our CATALYST study was the largest and most rigorous trial ever conducted to assess the prevalence and treatment of hypercortisolism in patients with difficult-to-control type 2 diabetes. The prevalence phase of the study found that one in four patients with difficult-to-control type 2 diabetes has hypercortisolism, a far higher rate than was assumed. These results were published last month in Diabetes Care, a peer-reviewed journal of the American Diabetes Association. The results from the treatment phase of the CATALYST study were equally striking.

Patients who received relacorilant exhibited a large reduction, 1.47%, in hemoglobin A1c, a key measure of glucose control, compared to a 0.15% decrease in patients who received placebo, a p-value of less than 0.0001. The magnitude of reduction seen in the treatment arm is especially striking, given that these patients were already receiving multiple glucose-lowering therapies, including the most potent GLP-1 agonist. Results from the treatment phase of CATALYST will be presented at a keynote session at the American Diabetes Association's annual scientific sessions next month. A rapidly increasing number of physicians now know that hypercortisolism is much more prevalent than was previously assumed. They are screening and treating many more patients than ever before. The findings from CATALYST, once they are more broadly known, will undoubtedly stimulate even more doctors to screen for hypercortisolism. Many more patients with hypercortisolism than are currently identified will be found.

Corcept is well positioned to help them. As Sean said earlier, we are confident that our Cushing's syndrome business will continue to grow for years. Since the founding of Corcept, our research and development efforts have been built on the hypothesis that cortisol modulation is a powerful therapeutic mechanism in many serious disorders. The success of our pivotal ROSELLA trial in platinum-resistant ovarian cancer is tangible proof of the therapeutic value of cortisol modulation and highlights the potential of this mechanism of action to be broadly useful. In ROSELLA, 381 women with platinum-resistant ovarian cancer were randomized one-to-one to receive either nab-paclitaxel, probably the most effective chemotherapy currently prescribed to women with platinum-resistant disease, or nab-paclitaxel plus relacorilant. For these patients, nab-paclitaxel or any chemotherapy had become much less useful than earlier in their course of treatment.

We expected that relacorilant would resensitize ovarian tumors to the effects of nab-paclitaxel by blunting the anti-apoptotic effect of cortisol activity. The ROSELLA trial met its primary endpoint of improved progression-free survival as assessed by Blinded Independent Central Review. Patients treated with relacorilant, in addition to nab-paclitaxel chemotherapy, experienced a 30% reduction in risk of disease progression compared to patients treated with nab-paclitaxel alone, with a hazard ratio of 0.70 and a p-value of 0.008. In the interim evaluation of overall survival, patients treated with relacorilant plus nab-paclitaxel showed a large improvement, with a median overall survival of 16 months compared to 11.5 months in patients receiving nab-paclitaxel alone. Hazard ratio was 0.69, with a p-value of 0.01. Safety and tolerability were comparable in the two groups. ROSELLA clearly confirmed the positive efficacy and safety results that we saw in our Phase II study.

The full results of the ROSELLA study will be presented at an oral late-breaker session at the American Society of Clinical Oncology's annual meeting next month. We expect to submit relacorilant's NDA in platinum-resistant ovarian cancer next quarter and a marketing authorization application in Europe shortly thereafter. In anticipation of a successful regulatory outcome, we have been building a standalone oncology division. We are fully prepared to move swiftly to bring relacorilant plus nab-paclitaxel to the women who can benefit from it once it is approved. We expect to expand the findings from ROSELLA with our recently initiated BELLA study, which will examine whether relacorilant with two medications, nab-paclitaxel and bevacizumab, will offer patients with platinum-resistant ovarian cancer an additional effective treatment regimen. We will then explore relacorilant's use to help treat earlier stages of ovarian cancer and other solid tumors that express the glucocorticoid receptor.

In addition to exploring cortisol modulation's potential to resensitize tumors to chemotherapy, we are evaluating its potential use in combination with androgen deprivation therapy in prostate cancer. Cortisol stimulation is a major reason why patients with prostate cancer treated with the widely prescribed androgen receptor antagonist, enzalutamide, eventually experience resurgent disease. Deprived of androgen stimulation, their tumors switch to cortisol activity to stimulate growth. Leading academic researchers and clinicians hypothesize that cortisol modulation can block this tumor escape route. Our collaborators at the University of Chicago are currently enrolling a randomized placebo-controlled phase II trial of relacorilant plus enzalutamide in patients with early-stage prostate cancer before these patients have had an initial prostatectomy. Another possible role of cortisol modulation is in combination with immunotherapy. Because cortisol suppresses the immune system, it may blunt the effectiveness of cancer therapies intended to stimulate an immune response.

Adding a cortisol modulator to immunotherapies, such as checkpoint inhibitors, may enhance their effectiveness. Following our phase IB trial in advanced adrenal cancer, we are deciding how best to investigate the utility of our compounds in combination with immunotherapies in other tumor types and earlier stages of cancer. One of our proprietary compounds, dazucorilant, readily crosses the blood-brain barrier and is a candidate for the treatment of neurologic disorders. Based on compelling data showing improved motor performance and reduced neuroinflammation and muscular atrophy in a commonly used mouse model of ALS, we conducted a 249-patient randomized double-blind placebo-controlled phase II trial of dazucorilant in that dire disease. Unfortunately, patients who received dazucorilant did not show improvement in the ALS Functional Rating Scale-Revised, the study's primary endpoint. However, an improvement in overall survival, first seen at the six-month mark, was also observed at year one of the study.

An exploratory analysis showed that patients who were randomized to 300 milligrams of dazucorilant at the start of the study lived significantly longer than patients who were randomized to placebo and then did not switch to dazucorilant in the long-term extension study, with a hazard ratio of 0.16, a p-value of 0.0009. We will immediately seek input from U.S. and European regulatory authorities on the next steps for this program. MASH, metabolic dysfunction associated with steatohepatitis, is a serious liver disorder that afflicts millions of patients in the United States and many millions outside of the United States. Cortisol activity plays a role in both the initial development and progression of the disease, and cortisol modulation may serve as a treatment. One of our proprietary molecules, miricorilant, has very potent activity in the liver.

Our phase IB dose-finding study of miricorilant found that patients who received 100 milligrams orally, just twice a week for 12 weeks, experienced a 30% reduction in liver fat and improvement in liver enzymes, markers of fibrosis, and key metabolic and lipid measures, such as insulin-resistant serum triglycerides and LDL. Miricorilant was also very well tolerated, with none of the GI side effects which commonly arise in patients being treated for MASH. Our randomized double-blind placebo-controlled phase IIB Monarch study aims to expand on our encouraging phase IB results. Monarch is enrolling two cohorts. In the first, patients with biopsy-confirmed MASH are randomized two-to-one to receive either 100 milligrams of miricorilant twice weekly or placebo for 48 weeks. The primary endpoint for this cohort is reduction in liver fat with biopsy-confirmed MASH resolution and fibrosis improvement as key secondary endpoints. The second cohort is enrolling patients with presumed MASH.

Patients in this cohort will be randomized two-to-one to receive either 100 milligrams of miricorilant twice weekly for six weeks, followed by 200 milligrams of miricorilant twice weekly for 18 weeks, or placebo for the whole 24 weeks. In this cohort, the primary endpoint is also reduction in liver fat. As I said earlier, this is a truly exciting time at Corcept. We have made substantial progress throughout the company and have established two potent drivers of long-term growth in entirely different areas of medicine: endocrinology and oncology. Awareness of hypercortisolism's true prevalence continues to grow rapidly. More patients are being identified and treated than ever before. The results of the CATALYST study will undoubtedly stimulate more physicians to screen for hypercortisolism and treat the patients that they identified. Our new drug application for relacorilant in hypercortisolism is progressing towards approval by the end of this year.

Relacorilant's strong efficacy and safety profile gives it the potential to become the new standard of care for patients with hypercortisolism. We expect our Cushing's syndrome business to continue growing for years to come. The positive results of our ROSELLA study open Corcept's oncology portfolio. The efficacy benefits observed in the context of no increased side effect burden support a successful new drug application for platinum-resistant ovarian cancer and create, with further study, the potential to treat earlier stages of ovarian cancer and other tumors that express the glucocorticoid receptor. In addition, we continue to explore the potential of cortisol modulation to treat a broad range of diseases, including neurologic diseases like ALS and hepatic diseases. We continue to develop and discover proprietary selective cortisol modulators with potentially very distinct clinical attributes.

We are comprehensively evaluating these attributes in their therapeutic applications and will advance the most promising compounds to the clinic. The problems caused by excess cortisol activity often have profoundly negative effects on patients. We are dedicated to finding new, more effective, and safer treatments to help them. Operator, let's proceed now to questions.

Operator (participant)

Thank you. As a reminder, to ask a question, you will need to press star one one on your telephone. To remove yourself from the queue, you may press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Edward Nash of Canaccord. Your line is open, Edward.

Edward Nash (Managing Director)

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 does that in any way push Elahere forward or back within the treatment paradigm? Also, could you just give us any clarity or any granularity you have on the feedback you've been getting from oncologists based on the RESELLA data?

Joe Belanoff (CEO)

Yeah. Hey, Edward, thank you. That is 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.

Roberto Vieira (President of Oncology Division)

Thank you, Joe. Now several questions into one there.

As far as our view for relacorilant, relacorilant plays another impact that excels for us 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. Most patients have limited options and suffer with very poor outcomes. We feel confident relacorilant plays another impact that excels such as 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.

Edward Nash (Managing Director)

Great. That's very helpful. Thank you. I just had one additional question. That was just on the revenue.

Given that it sounds like March and April, things really picked up significantly after the correction was made, just wanted to understand how that's going to affect 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? Just wanted to better understand how to model for that.

Joe Belanoff (CEO)

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

Sean Maduck (President of Endocrinology Division)

Yeah. Thanks, Ed. I'll just start by saying, 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. We do expect that through the rest of the year.

We had a record number of prescribers, prescriptions, and patients on Korlym to end the quarter. 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. 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 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. 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-$950 million.

Joe Belanoff (CEO)

Edward, to answer your question directly, yeah, we're not expecting an instant bolus.

We just think the growth will accelerate through the entire year and then into the next year.

Edward Nash (Managing Director)

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

Joe Belanoff (CEO)

Thanks, Edward. Thanks very much for the questions.

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

David Amsellem (Managing Director)

Hey, thanks. 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? I guess, is it fair to say that irrespective of that mix between the AG and the brand, this acceleration in volume growth and this expansion of the market that we're seeing ultimately is what gets you to that $900 million-$950 million? That's my first question.

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? 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.

Joe Belanoff (CEO)

Thank you, David. Yes, you've given us an opportunity for several people to respond to your various questions. Sean, why don't you take the first question about relacorilant?

Sean Maduck (President of Endocrinology Division)

Yeah. Thanks for the question. Your last statement and the first part of the question on relacorilant is exactly it. We expect that future volume growth will overwhelm any price change that we see given the mix of products.

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.

Joe Belanoff (CEO)

Charlie?

Charlie Robb (Chief Business Officer)

Yes. We do not expect to have an advisory committee. Didn't have one for Korlym. The most recently approved drugs in hypercortisolism didn't have them either, and we're not anticipating one here. Okay. Bill, could you please answer the last question about the other tumors? For future studies. It's really been on our mind for quite some time to look at relacorilant in combination with any therapy in solid tumors.

It is based upon our phase one, phase two, and now with the phase three results, we have taken something from a concept to a reality, and we are now going to be hopefully rapidly expanding into that. Our goal is to really establish relacorilant as the foundational drug to be used in combination with any agent in solid tumors. BELLA is that first foray into that next study in the earlier lines of therapy in combination now with nab-paclitaxel and bevacizumab. You will shortly see later this year, and as you had indicated, we are going to go to earlier lines of ovarian cancer and then also expand into other gynecological oncology cancers. Soon after that, we will go longer term into other solid tumors.

You're going to see many new studies coming, but again, all geared around relacorilant as that core molecule in combination with any agent. Next question, please.

Joe Belanoff (CEO)

Sure. Thank you.

Operator (participant)

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

Joon Lee (Managing Director)

Hey, 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-$950 million? I have a follow-up question.

Joe Belanoff (CEO)

All right. Oh, thanks, Joon. I'll give you back to Sean to answer your question.

Sean Maduck (President of Endocrinology Division)

Thanks for the question.

In case anybody did not get a chance to listen to the opening remarks, the issue that is 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. In general, there were some—I will not go into all the specifics—but there were some staffing issues associated with enough individuals to pull through all the appropriate volume. Because of that, patients' prescriptions were not filled on time. That has been remedied. It has been staffed up. I will just point to, again, having the strongest March—two of the strongest months—the two strongest months we have ever had in our history in March and April. We expect that the pharmacy will continue to scale up with our growth going forward.

Joon Lee (Managing Director)

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

Sean Maduck (President of Endocrinology Division)

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. 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. We do expect that the market is potentially much larger. There is the potential for a broader distribution network for that product, and that's something that we're actively exploring now.

Joon Lee (Managing Director)

Great. 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 potentially transformative drug out there? Thank you.

Joe Belanoff (CEO)

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

Charlie Robb (Chief Business Officer)

The question is, with data like this, we've confronted the exact same questions. 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.

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. Once we've settled things, we'll let folks know.

Joon Lee (Managing Director)

Thank you.

Joe Belanoff (CEO)

Thank you, Joon.

Operator (participant)

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

Thank you. Good afternoon, Joe. A couple of quick questions on Korlym from me too. Yeah. Please. In the opening remarks, you said there was a significant increase in scripts that you saw got 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 January and February?

When you say that 50% of your patients are moving towards authorized generics, I am just trying to understand what is the price differential between the Korlym and authorized generic? I am trying to triangulate between that and the increase in scripts to get to your stated 30-some percent increase in revenue year over year. Yeah. I really do think we understand your question, RK.

Joe Belanoff (CEO)

Thank you. I am going to give you back to Sean to give you kind of a broad answer to that question.

Sean Maduck (President of Endocrinology Division)

Yeah. Thanks for the question. 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. We have seen that continue on. A lot of growth is driven by more screening. We are starting to see the impact of the CATALYST results.

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. That is 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 any list price. Net price varies by payer. 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. All of that is included in our range.

Joe Belanoff (CEO)

RK, did you have a follow-up question? 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 sort of speaking at this juncture. I have to admit that in the many years that I've run Corcept, I've considered lots of problems. I must admit to you that I did not anticipate that our Korlym business would overwhelm our pharmacy vendor. Obviously, this set of problems had a short-term impact on our revenues, but more important, it delayed drug shipments to patients, which is inexcusable. I guess to some degree, for whatever it's worth, I apologize to any patients who were terribly inconvenienced by this. As Sean stated, the problem appears resolved. March and April were very strong months. I have to now tell you, of course, as a result, we're intensely vigilant that this problem does not arise again.

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. 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 glucocorticoid receptor antagonism, cortisol modulation in this way, was Korlym, mifepristone.

We can unequivocally say that we have follow-on molecules which are more specific, starting with relacorilant, more selective, have a much better side effect profile, and give us an opportunity to really look at more places where they can be useful clinically. That really dovetails with the third point I want to make. ROSELLA unequivocally shows that cortisol modulation has utility outside of your basic Cushing's syndrome patients. It clearly worked in a very difficult group of patients with platinum-resistant ovarian cancer. I think it gives you good reason to think that it's going to work in a much wider range of cancers, both earlier in ovarian cancer and in other tumors where the glucocorticoid receptor is represented. I really want you to start to think about Corcept Therapeutics as a company with a very broad medicinal platform. Tumors—sorry—hormones go everywhere.

All of you are familiar with the broad amount of work which is being done with another hormone, GLP-1. My own opinion is that when the field is fully mined for the benefits of hypercortisolism, you will see that kind of reach and breadth. Thank you for all listening today, and I will see you next quarter. Thank you. Bye-bye.

Operator (participant)

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