Corcept Therapeutics Inc Q1 FY2025 Earnings Call

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.

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 importantly, our potential to help 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 though 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 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 to $5 billion in annual revenue in hypercortisolism alone.

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 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.

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 significant medical discoveries in hypercortisolism and oncology, paving the way for substantial revenue growth. Let’s first discuss hypercortisolism. Our new drug application for relacorilant in treating hypercortisolism is supported by positive outcomes from our pivotal Phase 3 GRACE trial, along with results from our GRADIENT, Long-Term Extension, and Phase 2 trials. It is currently under FDA review with an action date set for December 30, 2025. Patients treated with relacorilant in these studies showed meaningful clinical improvements across various symptoms of hypercortisolism, including hypertension, hyperglycemia, weight changes, lean muscle mass, waist circumference, cognition, quality of life scores related to Cushing’s, and other clinical measures. There was a consistent and durable therapeutic benefit observed across all studies. Patients experienced rapid improvements at the beginning of relacorilant therapy, which were sustained or further improved throughout the treatment duration, including in a Long-Term Extension study where some patients remained on relacorilant for over six years. Equally important is the safety profile of relacorilant. It has been well tolerated in all studies, with the most common adverse events aligning with the cortisol withdrawal symptoms typical in hypercortisolism patients upon significant reduction of cortisol activity, whether due to surgery or the commencement of medical therapy. As expected, there were no instances of hypokalemia, endometrial hypertrophy, drug-induced vaginal bleeding, adrenal insufficiency, or QT prolongation linked to relacorilant. These adverse events can pose serious health risks, and existing treatments for Cushing’s syndrome often result in one or more of these issues. As we advance relacorilant, we are actively working to enhance physician awareness and understanding of hypercortisolism. Our CATALYST study, the largest and most rigorous trial conducted to examine the prevalence and management of hypercortisolism in patients with difficult-to-control type 2 diabetes, found that one in four of these patients has hypercortisolism, a significantly higher prevalence than previously thought. These results were published last month in Diabetes Care, a peer-reviewed journal from the American Diabetes Association. The treatment phase results of the CATALYST study were also striking, showing patients who received Korlym achieved a notable reduction of 1.47% in hemoglobin A1c, a critical glucose control measure, while those on placebo only saw a 0.15% decrease, with a p-value of less than 0.0001. The significant reduction in the treatment group is particularly remarkable considering these patients were already on multiple glucose-lowering therapies, including the most potent GLP-1 agonists. We will present the treatment phase findings at a keynote session during the American Diabetes Association’s Annual Scientific Sessions next month. An increasing number of physicians are now recognizing that hypercortisolism is more widespread than previously believed, leading to more screenings and treatments than ever before. The findings from CATALYST, once widely disseminated, will encourage even more doctors to investigate hypercortisolism, identifying a greater number of undiagnosed patients. Corcept is well positioned to assist these patients. As Sean mentioned earlier, we are confident that our Cushing’s syndrome business will continue to thrive in the years ahead. Since Corcept's inception, our research and development efforts have focused on the hypothesis that cortisol modulation can be a powerful therapeutic approach in many serious conditions. The success of our pivotal ROSELLA trial in platinum-resistant ovarian cancer is tangible evidence of the therapeutic promise of cortisol modulation and underscores the potential of this mechanism across various applications. In ROSELLA, 381 women with platinum-resistant ovarian cancer were randomized to receive either nab-paclitaxel, the most effective chemotherapy prescribed for this condition, or nab-paclitaxel plus relacorilant. For these patients, nab-paclitaxel or any chemotherapy had significantly reduced effectiveness compared to earlier in their treatment journey. We hypothesized that relacorilant would resensitize ovarian tumors to nab-paclitaxel by mitigating the anti-apoptotic influence of cortisol. The ROSELLA trial met its primary endpoint of improving progression-free survival as determined by blinded independent central review. Patients receiving relacorilant alongside nab-paclitaxel saw a 30% reduction in disease progression risk compared to those treated with nab-paclitaxel alone, achieving a hazard ratio of 0.70 and a p-value of 0.008. In interim evaluations of overall survival, those treated with relacorilant plus nab-paclitaxel had significantly better outcomes, with a median overall survival of 16 months versus 11.5 months for those receiving nab-paclitaxel alone. The hazard ratio was 0.69, with a p-value of 0.01. Safety and tolerability were comparable between both treatment groups. ROSELLA has confirmed the positive efficacy and safety results observed in our Phase 2 study. We will present the full ROSELLA results at an oral late-breaker session during the upcoming American Society of Clinical Oncology’s Annual Meeting. We expect to submit relacorilant’s NDA for platinum-resistant ovarian cancer next quarter, followed by a marketing authorization application in Europe soon after. In anticipation of a favorable regulatory outcome, we’ve been developing a standalone oncology division and are fully prepared to act quickly to provide relacorilant in combination with nab-paclitaxel to patients as soon as we receive approval. We plan to extend the findings from ROSELLA with a newly initiated BELLA study, which will investigate the effectiveness of relacorilant alongside nab-paclitaxel and bevacizumab in treating platinum-resistant ovarian cancer. We will also explore relacorilant’s use in treating earlier stages of ovarian cancer and other solid tumors expressing the glucocorticoid receptor. Additionally, we are assessing cortisol modulation’s potential to enhance treatments using androgen deprivation therapy for prostate cancer. Cortisol stimulation often leads to the resurgence of disease in prostate cancer patients treated with the popular androgen receptor antagonist enzalutamide. Without androgen stimulation, tumors may revert to using cortisol for growth. Leading researchers theorize that cortisol modulation could block this escape mechanism in tumors. Our collaborators at the University of Chicago are currently recruiting participants for a randomized placebo-controlled Phase 2 trial of relacorilant combined with enzalutamide in early-stage prostate cancer patients prior to their initial prostatectomy. Furthermore, cortisol modulation may have a role in immunotherapy combinations. Since cortisol can suppress immune function, it might inhibit the effectiveness of cancer therapies designed to elicit immune responses. Combining a cortisol modulator with immunotherapies, such as checkpoint inhibitors, could potentially enhance their efficacy. Following our Phase 1b trial in advanced adrenal cancer, we are determining the best approach to investigate the use of our compounds alongside immunotherapies for other tumor types and earlier cancer stages. One of our proprietary compounds, dazucorilant, effectively crosses the blood-brain barrier and is being considered for treating neurologic disorders. Based on promising data indicating improved motor performance and reduced neuroinflammation and muscular atrophy in a commonly used ALS mouse model, we conducted a 249-patient randomized double-blind placebo-controlled Phase 2 trial of dazucorilant in ALS. Unfortunately, patients treated with dazucorilant did not show improvement in the primary endpoint of the ALS functional rating scale revised. However, we observed a longer overall survival in patients receiving 300 milligrams of dazucorilant at the start of the study compared to those randomized to placebo who did not switch to dazucorilant in the Long-Term Extension study, with a hazard ratio of 0.16 and a p-value of 0.0009. We will promptly seek feedback from U.S. and European regulatory authorities about next steps for this program. MASH, or metabolic dysfunction associated steatohepatitis, is a serious liver disorder affecting millions in the U.S. and around the globe. Cortisol activity is involved in the disease’s initial development and progression, with cortisol modulation potentially offering a treatment pathway. Our proprietary molecule, miricorilant, demonstrates strong activity in the liver. In our Phase 1b dose-finding study, patients given 100 milligrams orally, just twice a week for 12 weeks, achieved a 30% reduction in liver fat, alongside improvements in liver enzymes, fibrosis markers, and key metabolic and lipid measures such as insulin resistance, serum triglycerides, and LDL. Miricorilant also showed excellent tolerability with no gastrointestinal side effects commonly seen with MASH treatments. Our randomized double-blind placebo-controlled Phase 2b MONARCH study aims to build on our encouraging Phase 1b findings. MONARCH will enroll two cohorts: the first will involve patients with biopsy-confirmed MASH randomized 2:1 to receive either 100 milligrams of miricorilant twice weekly or a placebo for 48 weeks, with the primary endpoint being a reduction in liver fat and secondary endpoints including biopsy-confirmed MASH resolution and fibrosis improvement. The second cohort will include patients with presumed MASH, randomized 2:1 to receive either 100 milligrams of miricorilant twice weekly for six weeks, followed by 200 milligrams twice weekly for 18 weeks, or a placebo for the entire 24 weeks, with the primary endpoint again being a reduction in liver fat. As I previously mentioned, this is an especially exciting time for Corcept. We have made significant progress and established two strong growth drivers in distinct areas of medicine, endocrinology and oncology. Awareness of hypercortisolism’s true prevalence is rapidly growing, leading to more patients being diagnosed and treated than ever before. The CATALYST study findings will undoubtedly encourage more physicians to screen for and address hypercortisolism. Our new drug application for relacorilant in hypercortisolism is moving forward towards approval by year-end. The strong efficacy and safety profile of relacorilant position it to potentially become the new standard of care for patients with hypercortisolism. We anticipate continued growth in our Cushing’s syndrome business. The positive outcomes from the ROSELLA study expand Corcept’s oncology portfolio. The efficacy benefits observed without increasing side effects support a strong new drug application for platinum-resistant ovarian cancer and suggest, with further investigation, the possibility of treating earlier stages of ovarian cancer and other tumors that express the glucocorticoid receptor. Moreover, we continue to explore cortisol modulation’s potential for treating a wide range of diseases, including neurological and hepatic disorders. We remain committed to developing proprietary selective cortisol modulators with distinct clinical attributes, carefully evaluating their therapeutic applications, and advancing our most promising compounds into the clinic. The challenges posed by excess cortisol activity can have profoundly negative impacts on patients, and we are dedicated to discovering new, safer, and more effective treatments to support them.

Hi, thank you for taking my question. I wanted to ask specifically about the oncology program. You now have ROSELLA and have begun BELLA. I’d like to know where physicians would typically use relacorilant compared to Elahere. How does this impact Elahere's position within the treatment framework? Additionally, could you provide any insights or detailed feedback from oncologists regarding the ROSELLA data?

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.

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.

Thank you, Ed. I'll begin by stating that the fundamentals of our business are very strong and have actually improved from the fourth quarter of last year into the first quarter. We anticipate this strength to continue throughout the year. We ended the quarter with a record number of prescribers, prescriptions, and patients using Korlym. Although our first quarter financial results did not reflect the strength of the business, as I previously mentioned, we expect growth to carry on into the second quarter and throughout the year, with acceleration in the second half. This is due to our various commercial initiatives and the release of the complete CATALYST data results. We are very excited and more confident than ever that the market potential is larger than we initially realized, and we are aiming 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.

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.

Yes. We do not expect to have an advisory committee. We didn’t have one for Korlym. The most recently approved drugs in the hypercortisolism 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.

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 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.

With the staffing measures they've implemented, will they be able to meet the demand for relacorilant, which we believe could be a significantly larger product? I have a follow-up 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. Good afternoon, Joe. A couple of quick questions on Korlym from me, too.

Okay. Please.

In your opening remarks, you mentioned a notable increase in filled prescriptions during March and April. While I understand you can't provide exact figures, could you give a general idea of the percentage increase compared to January and February? Additionally, you noted that 50% of your patients are transitioning to authorized generics. I'm trying to grasp the price difference between Korlym and the authorized generics and how that relates to the increase in prescriptions to understand your reported year-over-year revenue growth of over 30%.

Yes.

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 glucocorticoid receptor antagonism, cortisol modulation in this way, was Korlym, mifepristone. And now 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. And 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, and 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. And so I really want you to start to think about Corcept as a company with a very broad medicinal platform. Tumors, sorry, hormones go everywhere and all of you are familiar with the broad amount of work which are 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 breath. So thank you for all listening today and I will see you next quarter. Thank you. Bye-bye.

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