NASDAQ:CORT Corcept Therapeutics Q3 2025 Earnings Report $110.29 -4.57 (-3.98%) Closing price 09/18/2026 04:00 PM EasternExtended Trading$111.28 +0.99 (+0.89%) As of 09/18/2026 07:56 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. ProfileEarnings HistoryForecast Corcept Therapeutics EPS ResultsActual EPS$0.16Consensus EPS $0.18Beat/MissMissed by -$0.02One Year Ago EPS$0.41Corcept Therapeutics Revenue ResultsActual Revenue$207.64 millionExpected Revenue$223.78 millionBeat/MissMissed by -$16.14 millionYoY Revenue Growth+13.80%Corcept Therapeutics Announcement DetailsQuarterQ3 2025Date11/4/2025TimeAfter Market ClosesConference Call DateTuesday, November 4, 2025Conference Call Time5:00PM ETUpcoming EarningsCorcept Therapeutics' Q3 2026 earnings is estimated for Wednesday, November 4, 2026, based on past reporting schedules, with a conference call scheduled on Tuesday, November 3, 2026 at 5:00 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Corcept Therapeutics Q3 2025 Earnings Call TranscriptProvided by QuartrNovember 4, 2025ShareShareShare This ReportLink copied to clipboard.Key Takeaways Positive Sentiment: Q3 revenue was $207.6M (vs. $182.5M year‑ago) and management raised full‑year 2025 revenue guidance to $800–$850M, with cash and investments of $524M after a $50M repurchase. Positive Sentiment: Commercial demand is accelerating — Korlym shipments were up 42.5% YoY, the prescriber base has expanded and the company reported ~3,250 paying patients at quarter end, while transitioning fulfillment to a new primary specialty pharmacy (Curant) and adding two more pharmacies to resolve capacity constraints. Positive Sentiment: Relacorilant regulatory timeline is in place with PDUFA dates of Dec 30, 2025 for hypercortisolism and July 11, 2026 for platinum‑resistant ovarian cancer; the ovarian NDA did not receive priority review but the company expects the FDA to meet the target dates. Positive Sentiment: Oncology momentum — the pivotal ROSELLA results (published in The Lancet) showed improved PFS and OS when adding relacorilant to nab‑paclitaxel, and Corcept is rapidly expanding trials (BELLA additions, pancreatic, cervical, endometrial, prostate programs and PD‑1 combo studies with nenocorilant) to broaden indications. Negative Sentiment: Profitability and legal risk — net income fell to $19.7M from $47.2M YoY, and the patent appeal against Teva remains unresolved (a forthcoming adverse decision could allow generic competition and threaten exclusivity through 2037). AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallCorcept Therapeutics Q3 202500:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Thank you for standing by, and welcome to Corcept Therapeutics' Third 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 MokariCFO at Corcept Therapeutics00:00:34Hello everyone. Good afternoon, and thank you for joining us. Today, we issued a press release announcing our financial results for the third 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 the SEC. Today's call is being recorded. A replay will be available at the Investors Past Events tab of our website. We will also post a presentation regarding our oncology development programs in the same section. Statements during this call, other than statements of historical fact, are forward-looking statements based on our plans and expectations. They are subject to risks and uncertainties which might cause actual results to be materially different from those such statements express or imply. Atabak MokariCFO at Corcept Therapeutics00:01:16The 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 third quarter of 2025 was $207.6 million, compared to $182.5 million in the prior year period. We have modified our 2025 revenue guidance to $800 million-$850 million. Net income was $19.7 million, compared to $47.2 million in the third quarter of last year. Our cash and investments as of September 30th were $524 million, which reflects our acquisition of $50 million of our common stock in the third quarter, pursuant to our stock repurchase program, as well as shares acquired upon the exercise of Corcept stock options and the vesting of restricted stock grants. Atabak MokariCFO at Corcept Therapeutics00:02:16We'll now turn the call over to Charlie Robb, our Chief Business Officer. Charlie. Charlie RobbCBO at Corcept Therapeutics00:02:21Thanks, Atabak. There's nothing new to report regarding our patent litigation with Teva Pharmaceuticals. Recall that in March 2018, we sued Teva to stop it from marketing a generic version of Korlym in violation of our patents. The case went to trial in September 2023, and in December 2023, the trial court ruled against us. We appealed that decision to the Federal Circuit Court of Appeals. The three-judge panel of that court heard oral argument on July 7th of this year. Although it is impossible to say exactly when the court will issue its decision, enough time has passed that it is reasonable to say that the decision could come at any time. If we prevail, Teva will lose FDA approval of its product until the expiration of our patent in 2037. We strongly believe our position is correct and are eager to advance this appeal. Charlie RobbCBO at Corcept Therapeutics00:03:12I'll now turn the call over to Sean Maduck, President of our Endocrinology Division. Sean. Sean MaduckPresident of Endocrinology Division at Corcept Therapeutics00:03:18Thanks, Charlie. Our hypercortisolism business had another quarter of robust growth. In the third quarter, we shipped more tablets to patients than ever before, 42.5% higher than the third quarter of last year, driven by yet another record of prescriptions written for Korlym. Importantly, our base of prescribers has expanded substantially over the last two years. In summary, the underlying strength of our business continues to build. Our financial results don't fully reflect the surge in demand. I discussed on the last few calls the insufficient capacity of our previous pharmacy vendor. While we expected their capacity to improve in the third quarter, it did not, which is why we have begun transitioning our business to a new pharmacy in the fourth quarter. Sean MaduckPresident of Endocrinology Division at Corcept Therapeutics00:03:58While capacity constraints may continue for the next few months as we complete the transition, we are very encouraged by the new pharmacy's abilities and its capacity to meet demand. As welcome as such improvements are, eventually, the growth we anticipate will outstrip the capacity of any single pharmacy, which is why we plan to add a second specialty pharmacy to our network in January and to onboard a third pharmacy shortly thereafter. Our confidence in continued and accelerating growth is based on several factors. The first is growing physician awareness of hypercortisolism. For many years, the prevalence of hypercortisolism and the serious risks it poses for patients were not well understood. As a result, physicians only screened for and treated the most physically obvious cases of the disorder. Sean MaduckPresident of Endocrinology Division at Corcept Therapeutics00:04:41In the last 15 years, many studies have shown that hypercortisolism is much more common and is a serious threat to health in far more than the most extreme cases. Most recently, our CATALYST study confirmed these findings, proving that there are many more patients with hypercortisolism than previously assumed and that treatment with a cortisol modulator is highly effective in improving their condition, even when other medications, including the newest diabetes medications such as Ozempic and Mounjaro, have not. The CATALYST results have been published in Diabetes Care, the field's leading journal, and are now being absorbed by the broader physician community. To translate these insights into patient impact, we continue to expand our physician education efforts, and we have enlarged the size of our sales force to 150 clinical specialists, up from 60 at the beginning of 2024. Sean MaduckPresident of Endocrinology Division at Corcept Therapeutics00:05:28With the awareness of hypercortisolism growing and the effectiveness of cortisol modulation demonstrated in a large placebo-controlled trial published in a leading peer-reviewed journal, I eagerly anticipate Relacorilant's approval. Korlym is a great medication. Relacorilant is even better. It will be a terrific option for both prescribers and patients. I expect that almost all patients who are receiving Korlym will choose to transition to Relacorilant, and our growth will accelerate. I've never been more confident in both our current and future commercial growth, and most important, our potential to help many more patients. In the next three to five years, I believe Relacorilant will generate $3 billion-$5 billion in annual revenue in hypercortisolism alone. I will now turn the call over to Joe Belanoff, our Chief Executive Officer. Joe. Joe BelanoffCEO at Corcept Therapeutics00:06:14Thank you, Sean, and thank you everyone for joining us this afternoon. After many years dedicated to studying the potential of cortisol modulation to help patients suffering from serious diseases, we are on the cusp of a new era at Corcept. We have two new drug applications that are rapidly approaching their FDA target action, or PDUFA dates. Our NDA for Relacorilant as a treatment for patients with hypercortisolism has a PDUFA date of December 30th, 2025. Our NDA for Relacorilant as a treatment for women with platinum-resistant ovarian cancer has a PDUFA date of July 11th, 2026. We believe the FDA will meet both deadlines. We submitted the European analog to our ovarian cancer NDA, known as a Marketing Authorization Application, or MAA, to the European Medicines Agency, or EMA, in October, with a regulatory decision likely by year-end 2026. Joe BelanoffCEO at Corcept Therapeutics00:07:16Some of our most advanced clinical studies will soon produce important data. Our MOMENTUM trial, which is evaluating the prevalence of hypercortisolism in patients with resistant hypertension, will have results early next year. We expect final overall survival results from ROSELLA, our pivotal trial in platinum-resistant ovarian cancer, around the same time. By the end of 2026, we expect results of our BELLA trial, also in patients with advanced ovarian cancer, as well as results from MONARCH, our phase IIB trial in patients with MASH, a life-threatening liver disorder. We are also about to start important new studies. In consultation with regulators, we are finalizing the design of a phase III trial of our proprietary selective cortisol modulator, Dazcorilant, in patients with ALS. Joe BelanoffCEO at Corcept Therapeutics00:08:10We plan to start this trial by the middle of next year with a simple goal of replicating the strong results we saw in DAZALS, our phase II trial. Our oncology program is about to expand significantly beyond platinum-resistant ovarian cancer. The success of ROSELLA provides clear evidence that cortisol-directed therapies have substantial potential in oncology. What comes next in oncology is a unique sequencing challenge because the opportunities are so large. We have spent many months giving careful thought to a long-term development plan in oncology that is both methodical and ambitious, and most important, will best position Corcept to help as many patients as possible. I'm going to ask Bill Guyer, our Chief Development Officer, to describe what he and his team have planned. Bill? Bill GuyerCDO at Corcept Therapeutics00:09:03Thanks, Joe. Now, in order to understand the scope of our opportunity in oncology, I think it helps to recall that our program follows groundbreaking insights made by investigators at the University of Chicago who hypothesized that cortisol activity at the glucocorticoid receptor promotes solid tumor growth in three ways. First, it's anti-apoptotic, so it blunts the effectiveness of chemotherapy. Second, it provides alternative growth pathways for prostate cancer tumors being treated with androgen deprivation medication. And third, it suppresses the immune system, reducing the effectiveness of immunotherapy in the treatment of cancer. Increasing apoptosis by blunting cortisol activity is a very broad platform. It applies to all solid tumors that express the glucocorticoid receptor. Published research has shown that about 60% of solid tumors express the GR, and they do so at every stage of treatment. Bill GuyerCDO at Corcept Therapeutics00:10:01Our oncology program is built on the belief that antagonizing the effects of cortisol at the GR can benefit many, many more patients. And a prime example of that is shown by the women from our phase II and pivotal phase III ROSELLA studies who received Relacorilant in addition to Nab-paclitaxel and experienced extended progression-free survival and lived longer than the women who were treated with just Nab-paclitaxel alone. Now, remember, Nab-paclitaxel is one of the most potent treatments for women with this disease, and adding Relacorilant led to an even better result, and remarkably, without adding to the safety burden of the women who received it. Adverse events with Relacorilant plus Nab-paclitaxel were comparable in type, frequency, and severity to Nab-paclitaxel monotherapy. As I review the data, Relacorilant is a remarkably well-tolerated drug. Bill GuyerCDO at Corcept Therapeutics00:10:54The medical field understands the importance of our results because the data from ROSELLA were presented at high-profile forums this year, including late-breaking oral sessions at both ASCO and ESMO annual meetings, and ROSELLA findings were published in The Lancet, one of the world's most preeminent journals. Our goal now is to undertake studies that will extend this work in three ways. First, in earlier lines of therapy for ovarian cancer. Second, in new types of solid tumors, and third, combining our proprietary GR antagonists with additional regimens. So the first study advancing this goal is a phase II BELLA trial. BELLA's initial objective is to treat and test the additional benefit of Relacorilant may bring when combining it with Nab-paclitaxel as well as bevacizumab, which is a potent drug that is commonly used to treat patients with platinum-resistant ovarian cancer. Bill GuyerCDO at Corcept Therapeutics00:11:51Due to the strong interest in our program by investigators around the world, this study has enrolled patients much faster than we expected. And as Joe mentioned, we will have the results by the end of 2026. But this is just our first step. BELLA's protocol allows us to add more arms to the study that include patients with different types of solid tumors. Currently, we are going to add two new arms. The first will evaluate Relacorilant plus Nab-paclitaxel and Bevacizumab to treat patients with platinum-sensitive ovarian cancer, an earlier stage of the disease. In order to enroll in this arm, patients must have progressed well on a PARP inhibitor, which is the subgroup that experienced profound benefit in ROSELLA, and we just presented that data at the ESMO conference. The second new BELLA arm will evaluate the potential of Relacorilant plus Nab-paclitaxel to treat patients with endometrial cancer. Bill GuyerCDO at Corcept Therapeutics00:12:45Separately, we are also initiating a phase II study of Relacorilant plus Nab-paclitaxel in patients with cervical cancer in collaboration with ARCAGY Research, which is an academic clinical research group specializing in gynecological cancers. These new studies will enable us to triple the potential number of women with gynecological cancers that we can help each year in the United States, from 20,000 patients with platinum-resistant ovarian cancer to 60,000 patients. We are also targeting other tumors with significant unmet medical needs. We are initiating a phase II study in patients with pancreatic cancer by combining Relacorilant with the first-line standard of care regimen of Nab-paclitaxel and gemcitabine. All of these studies will begin enrollment, in the coming weeks and should enroll very quickly, like all of our past studies have done. Their results will be guideline-enabling, with a particular focus on the National Comprehensive Cancer Network, or NCCN, guidelines. Bill GuyerCDO at Corcept Therapeutics00:13:46These studies will also inform our future development decisions. In addition to exploring cortisol receptors antagonism's potential to resensitize tumors to chemotherapy, we are evaluating its use in combination with androgen deprivation therapy. 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 to determine if GR antagonism can block a cortisol-mediated tumor escape route. Another possible role of cortisol receptor antagonism is in combination with immunotherapy. Immunotherapy has emerged as a standard of care cancer treatment, with more than 200,000 patients in the United States receiving this form of therapy each year. Because cortisol suppresses the immune system, it may blunt the effectiveness of cancer therapies intended to stimulate an immune response. Adding a GR antagonist to immunotherapy may enhance their effectiveness. Bill GuyerCDO at Corcept Therapeutics00:14:48Therefore, in the coming weeks, we are initiating a phase Ib dose-finding study of Nenocorilant, our new proprietary selective cortisol receptor antagonist, in combination with nivolumab, a PD-1-directed immunotherapy to treat patients with a broad range of solid tumors. We've embarked on a mission to advance GR antagonism to help many patients with a broad range of solid tumors. Our ROSELLA study produced exciting confirmatory evidence of our hypothesis, and there is much more to come. We look forward to updating you on our progress, and I'll turn the call back over to Joe. Joe BelanoffCEO at Corcept Therapeutics00:15:25Thanks, Phil. Before reporting advances in our MASH and ALS programs, I will briefly describe the research findings that give us confidence in the substantial opportunity before us in our hypercortisolism franchise. The prevalence phase of our CATALYST trial demonstrated that one in four patients with resistant diabetes has hypercortisolism, a far higher rate than was previously assumed. These results are transforming medicine. Patients who were enrolled in the placebo-controlled treatment phase of CATALYST had uncontrolled diabetes, despite treatment with the best current medications administered by the leading diabetologists, and hypercortisolism. In 24 weeks, patients treated with Korlym experienced a 1.47% reduction in hemoglobin A1c, along with significant improvements in body weight and waist circumference. Notably, patients in CATALYST experienced these improvements even as they decreased or entirely discontinued their other glucose-lowering medications, including the most potent GLP-1 agonists. Joe BelanoffCEO at Corcept Therapeutics00:16:38Our MOMENTUM trial builds on the findings from CATALYST by evaluating the prevalence of hypercortisolism in patients with resistant hypertension. Results for MOMENTUM are expected by early next year. The findings from CATALYST and MOMENTUM will substantially accelerate screening for hypercortisolism and its treatment. As physician awareness of hypercortisolism rapidly grows, Relacorilant is approaching its December 30th PDUFA date. Relacorilant's NDA is supported by our pivotal phase III GRACE trial, as well as our open-label long-term extension, and phase II trials. In these studies, patients treated with Relacorilant experienced clinically meaningful improvements in all the measures of hypercortisolism, including hypertension, hyperglycemia, weight, lean muscle mass, waist circumference, cognition, and Cushing's quality of life score. These benefits were observed consistently and durably, with improvements emerging early and continuing or deepening over time. Joe BelanoffCEO at Corcept Therapeutics00:17:43As awareness of hypercortisolism and its ability to be treated grows, many more patients will be identified, and 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. Our proprietary molecule, Miricorilant, has very potent activity in the liver. Metabolic dysfunction-associated steatohepatitis, or MASH, is a serious liver disorder that afflicts millions of patients in the United States and globally. Cortisol activity plays a role in both the initial development and progression of the disease, and cortisol modulation may serve as a treatment. Our phase Ib study showed that Miricorilant rapidly reduced liver fat and improved other important markers of liver health, including fibrosis. Miricorilant was also very well tolerated without the GI side effects commonly seen in patients being treated for MASH. Joe BelanoffCEO at Corcept Therapeutics00:18:44Our randomized double-blind placebo-controlled phase IIb MONARCH study aims to expand on our encouraging phase Ib results. MONARCH enrolled 175 patients in two cohorts. The first cohort of patients has biopsy-confirmed MASH. The second cohort consists of patients with presumed MASH. We expect results from both cohorts late next year. ALS is a devastating disease associated with elevated cortisol activity. Our proprietary compound, Dazcorilant, is an excellent candidate to treat it. In our 249-patient double-blind placebo-controlled phase II DAZALS trial, patients who received 300 milligrams of Dazcorilant exhibited an 84% reduction in the risk of death at the one-year mark compared to patients who only received placebo. The p-value for this finding was 0.0009. This reduction in early death occurs when patients still retain considerable function and quality of life. It does not simply add months to the end of their life when the disease's burden can be enormous. Joe BelanoffCEO at Corcept Therapeutics00:20:00As I mentioned earlier, we plan to start a phase III trial in 2026. Designed with input from the FDA, European regulators, and leading clinicians, it simply aims to replicate the results of DAZALS. We covered a great deal today. Let me reiterate our important developments. Next month, we expect FDA approval of Relacorilant for the treatment of hypercortisolism. This milestone comes as physicians begin to fully absorb the results of the CATALYST study, which demonstrated that hypercortisolism is far more prevalent than previously recognized and that treatment with a cortisol modulator can significantly improve the health of their patients. Our MOMENTUM study will produce results by early next year, building on CATALYST findings. By mid-next year, we anticipate Relacorilant's first oncology approval in platinum-resistant ovarian cancer, a particularly challenging form of ovarian cancer. Joe BelanoffCEO at Corcept Therapeutics00:21:01Results from the ROSELLA trial showing improved progression-free and overall survival without additional safety burden are groundbreaking. The fact that cortisol receptor antagonism demonstrated such compelling results in this extremely difficult-to-treat cancer type gives us confidence in its potential across a broad range of tumors and underpins our decision to expand our oncology development portfolio. We expect first results from our new oncology studies by the end of next year. Beyond hypercortisolism and oncology, we expect results from a large controlled study in patients with MASH by the end of next year and plan to initiate a phase III study in patients with ALS by mid-next year. We continue to discover and develop proprietary selective cortisol modulators with likely very distinctive clinical attributes and are advancing the most promising to the clinic. Cortisol modulation's vast potential to help many patients is just beginning to unfold. Joe BelanoffCEO at Corcept Therapeutics00:22:03It is a very exciting time for Corcept. Operator, let's proceed to questions. Operator00:22:11Thank you. As a reminder, to ask a question, you will need to press Star 11 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 Genuity. Please go ahead, Edward. Edward NashManaging Director at Canaccord Genuity00:22:37Hi. Thanks, guys, for taking my call. Question, sorry. Wanted to ask, I know sometimes you give the numbers, just wanted 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's sort of come on in October have over your old distributor? Joe BelanoffCEO at Corcept Therapeutics00:23:20Thank you, 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 MaduckPresident of Endocrinology Division at Corcept Therapeutics00:23:27Thanks, Ed. 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 1st. It's a great pharmacy, and we think 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 organ 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. Sean MaduckPresident of Endocrinology Division at Corcept Therapeutics00:24:18And Edward, I think you also asked about other pharmacies which are coming on next year. I think a really important thing to realize to tie your two questions together as well, there are now 3,000 or so patients who are taking Korlym. We actually believe that the market capacity is much, much greater than that. And we really do think that as Relacorilant begins to come onto the market, no single pharmacy is going to easily handle all of the business there. And that's why we're gearing up right now to add second, third pharmacies to that. Edward NashManaging Director at Canaccord Genuity00:24:51Great. That's helpful. Thank you. And Ed had one quick model question. On the gross margin line, you guys have historically had really high margins. And given the increase in volume, but also pricing and generic shift, are you seeing any downward pressure on margins that might require modeling adjustments going forward? Joe BelanoffCEO at Corcept Therapeutics00:25:09Yeah. Let me give you back to Atabak for that question. Atabak MokariCFO at Corcept Therapeutics00:25:12Hi, Edward. No. We have not seen that, and we don't expect that. Edward NashManaging Director at Canaccord Genuity00:25:18Great. Thank you, guys. Joe BelanoffCEO at Corcept Therapeutics00:25:21Thank you, Edward. Operator00:25:23Thank you. Our next question comes from the line of David Amsellem of Piper Sandler. Please go ahead, David. David AmsellemManaging Director and Senior Research Analyst at Piper Sandler00:25:32Thanks. Just a couple of quick ones. One, can you just remind us 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 and 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? Thank you. Joe BelanoffCEO at Corcept Therapeutics00:26:09Thanks, David. And I think we'll give your questions to the person who can each answer them best. Sean, why don't you begin? Sean MaduckPresident of Endocrinology Division at Corcept Therapeutics00:26:16Yeah. Thanks, David. In terms of our authorized generic, in the second quarter, we were about two-thirds of our business. We 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. David AmsellemManaging Director and Senior Research Analyst at Piper Sandler00:26:41Charlie, a question about the ovarian cancer NDA. Charlie RobbCBO at Corcept Therapeutics00:26:44Yeah. 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 of a 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. David AmsellemManaging Director and Senior Research Analyst at Piper Sandler00:27:24And Atabak? Atabak MokariCFO at Corcept Therapeutics00:27:25Sure. 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 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. Joe BelanoffCEO at Corcept Therapeutics00:28:28Okay. Next question, please. Operator00:28:30Thank you. Our next question comes from the line of Joon Lee of Truist Securities. Please go ahead, Joon. Analyst at Truist Securities00:28:38Congrats on the quarter, and thanks for taking the questions. This is Austin Ryan on for Joon, 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 pharmacy is out of the picture, it seems to be, how confident are you that Curant can handle the increasing 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? Thank you. Joe BelanoffCEO at Corcept Therapeutics00:29:12Sure. Thank you very much for those questions. I think I understand all of them. The first one we'll send to Sean. Sean MaduckPresident of Endocrinology Division at Corcept Therapeutics00:29:17Yeah. So I'll answer your second question first. Corant is fully online. They started taking new patients on October 1st. Almost all new enrollments are going to Corant. 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. Joe BelanoffCEO at Corcept Therapeutics00:29:40And Charlie? Charlie RobbCBO at Corcept Therapeutics00:29:41Yeah. So. Just could you repeat the question for me? Because I want to make sure I answer it really correctly. What did you say? Analyst at Truist Securities00:29:49Yeah. Just on the upcoming PDUFA for Relacorilant, have you had a late-cycle review for Relacorilant? And if so, what can you share? Charlie RobbCBO at Corcept Therapeutics00:29:56Sure. So just a little background for people who 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 between the sponsor and the FDA. And the second is, as you noted, 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 its original letter to us. Things have moved per schedule, very ordinary course. Charlie RobbCBO at Corcept Therapeutics00:30:41And we are very confident as a result that the FDA will meet its target date of December 30th. Analyst at Truist Securities00:30:48Thank you. And if I could just have a quick follow-up, is Teva still selling Korlym? And if so, how long will they have to? Joe BelanoffCEO at Corcept Therapeutics00:30:57Yes. Sean, please take that. Sean MaduckPresident of Endocrinology Division at Corcept Therapeutics00:31:00Yeah. So Optime is still servicing patients just as they were before, as they're obligated by the contract. Analyst at Truist Securities00:31:07Thank you. Joe BelanoffCEO at Corcept Therapeutics00:31:08Sure. Operator00:31:09Thank you. Our next question comes from the line of RK with H.C. Wainwright. Please go ahead, RK. Joe BelanoffCEO at Corcept Therapeutics00:31:17Hey, RK. Please go ahead. Analyst at H.C. Wainwright & Co Llc00:31:19Thank you. 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 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? Analyst at H.C. Wainwright & Co Llc00:31:58The second question is. Joe BelanoffCEO at Corcept Therapeutics00:31:59Oh, go ahead, please. Analyst at H.C. Wainwright & Co Llc00:32:01Sorry. And the second question is on the new molecule that I see on the pipeline, Nenocorilant. How different is that from Relacorilant? 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? Joe BelanoffCEO at Corcept Therapeutics00:32:26Okay. I think we have both of those questions. The first one is Sean's. Please go ahead, Sean. Sean MaduckPresident of Endocrinology Division at Corcept Therapeutics00:32:30Yeah. So RK, just to be clear, you said in your question that we only have one pharmacy. That's incorrect. We actually have two pharmacies. Optime Care is continuing to service the active patient base, and all new prescriptions are going to Corant. 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. Joe BelanoffCEO at Corcept Therapeutics00:32:55Bill, any comments you'd like to make about Nenocorilant? Bill GuyerCDO at Corcept Therapeutics00:32:58Yeah. Thank you. So related to nenocorilant, then 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 in 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 a best partner for PD-1 inhibitors compared to that of Relacorilant. And so when it comes to publishing our preclinical data, yeah, we always publish our data. Bill GuyerCDO at Corcept Therapeutics00:33:43And I would expect us to have that data in the public domain next year. Joe BelanoffCEO at Corcept Therapeutics00:33:48Let me make just a more general point because I know obviously RK is really the first person who really absorbed our oncology opportunity. You've been following this the longest of anybody. But let me make some points for those who have not. One of the really interesting things is that years ago, when we were only working with mifepristone, which we call Korlym, we were looking for a follow-on compound which wouldn't have progesterone receptor activity. And our terrific chief chemist at that point, now our Chief Scientific Officer, Hazel Hunt, was able to come up with one and then more and then more. What was really interesting about them is that while all of those compounds modulated cortisol activity, and none of them touched the progesterone receptor, so they were really distinct. She had sort of accomplished her mission in separating the activities. Joe BelanoffCEO at Corcept Therapeutics00:34:40As we began to test them preclinically, they simply weren't identical. Some got into the brain, some didn't get into the brain, some were organ-specific, some were general, and some were more potent in various oncology models than others. We're left with not a single follow-on compound, which is frankly what I had anticipated, but with four, five, six, seven compounds each paired with the best treatment opportunity and best disorder for which it could make progress. It's been a very interesting opportunity. I think Nenocorilant is quite interesting. You'll learn more about it next year as we go along. We're very excited to actually begin that study. I think it will really help us learn very much as to what the next thing to do is. Thank you all for your questions. Thank you for listening in. Joe BelanoffCEO at Corcept Therapeutics00:35:29Really an exciting time, and I look forward to talking to you next quarter. Thank you. Bye-bye. Operator00:35:36This concludes today's conference call. Thank you for participating. You may now disconnect.Read moreParticipantsExecutivesAtabak MokariCFOCharlie RobbCBOSean MaduckPresident of Endocrinology DivisionJoe BelanoffCEOBill GuyerCDOAnalystsEdward NashManaging Director at Canaccord GenuityDavid AmsellemManaging Director and Senior Research Analyst at Piper SandlerAnalyst at Truist SecuritiesAnalyst at H.C. Wainwright & Co LlcPowered by Earnings DocumentsEarnings Release(8-K)Quarterly Report(10-Q) Corcept Therapeutics Earnings HeadlinesQ4 EPS Estimate for Corcept Therapeutics Raised by AnalystSeptember 19 at 1:13 AM | americanbankingnews.comMerck, Astra, Roche and Corcept among winners of EU drug recommendations this weekSeptember 18 at 2:43 PM | msn.comALERT: Drop these 5 stocks before the market opens tomorrow!The Wall Street Journal is already raising the alarm about a potential market crash, and Weiss Ratings research points to the first half of 2026 as a particularly rough stretch for certain holdings. Some of America's most popular stocks could take serious damage as a radical market shift plays out. Analysts at Weiss Ratings have identified five names you may want to remove from your portfolio before this unfolds. If any of these are in your portfolio, now is the time to review your positions.September 19 at 1:00 AM | Weiss Ratings (Ad)Corcept Says EU Panel Backs Ovarian Cancer Drug Combination for ApprovalSeptember 18 at 9:43 AM | marketscreener.comMCorcept Therapeutics Incorporated Receives CHMP Recommendation For EU Marketing Authorization For Lifyorli (Relacorilant) Combined With Nab-Paclitaxel For Platinum-Resistant ...September 18 at 9:43 AM | marketscreener.comMCorcept's Lifyorli Gets Positive EU Opinion For Platinum-Resistant Ovarian CancerSeptember 18 at 9:43 AM | rttnews.comSee More Corcept Therapeutics Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Corcept Therapeutics? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Corcept Therapeutics and other key companies, straight to your email. Email Address About Corcept TherapeuticsCorcept Therapeutics (NASDAQ:CORT) is a biopharmaceutical company focused on discovering and developing medicines that modulate the effects of the stress hormone cortisol. The company’s research centers on the glucocorticoid receptor, which regulates cortisol activity and may play a role in metabolic, psychiatric, oncologic and other serious diseases. Corcept’s commercial product is Korlym (mifepristone), an oral glucocorticoid receptor antagonist approved in the United States to control hyperglycemia secondary to endogenous Cushing’s syndrome in adults with type 2 diabetes or glucose intolerance who are not candidates for surgery or have not responded adequately to surgery. The company supports the product through commercial and medical services for healthcare providers and patients. The company is also developing relacorilant, a selective glucocorticoid receptor modulator, for potential use in Cushing’s syndrome and other conditions in which excess cortisol activity may contribute to disease. Corcept was founded in 1998 and is headquartered in Menlo Park, California. Its commercial operations are centered in the United States, while its clinical development programs may involve research sites and participants in multiple regions. Joseph K. Belanoff, M.D., a co-founder of the company, serves as chief executive officer.View Corcept Therapeutics ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Latest Articles J.B. Hunt's Stock Plunges After Market Misprices Profit WarningLennar’s Earnings Miss May Be Sending a Bigger Warning About U.S. HousingLennar's Q3 Miss Hides a Stronger Operating Story Beneath the Housing SlumpAeluma’s Selloff Could Be Setting Up Its Next Big MoveBraze Beat Expectations—Now 2 SaaS Peers Are in FocusPriced for a Pullback or More Gains? These 3 Stocks Are Testing the LimitsCoreWeave’s Vera Rubin Lead Comes Down to Speed, Power, and Scale Upcoming Earnings Cintas (9/23/2026)Costco Wholesale (9/24/2026)Micron Technology (9/30/2026)NIKE (10/1/2026)Accenture (10/1/2026)PepsiCo (10/8/2026)Delta Air Lines (10/8/2026)America Movil (10/13/2026)BlackRock (10/13/2026)Citigroup (10/13/2026) Unlock superior investment research and tools. Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools and reports. Get MarketBeat All Access MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In Email Me a Login Link or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
PresentationSkip to Participants Operator00:00:00Thank you for standing by, and welcome to Corcept Therapeutics' Third 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 MokariCFO at Corcept Therapeutics00:00:34Hello everyone. Good afternoon, and thank you for joining us. Today, we issued a press release announcing our financial results for the third 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 the SEC. Today's call is being recorded. A replay will be available at the Investors Past Events tab of our website. We will also post a presentation regarding our oncology development programs in the same section. Statements during this call, other than statements of historical fact, are forward-looking statements based on our plans and expectations. They are subject to risks and uncertainties which might cause actual results to be materially different from those such statements express or imply. Atabak MokariCFO at Corcept Therapeutics00:01:16The 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 third quarter of 2025 was $207.6 million, compared to $182.5 million in the prior year period. We have modified our 2025 revenue guidance to $800 million-$850 million. Net income was $19.7 million, compared to $47.2 million in the third quarter of last year. Our cash and investments as of September 30th were $524 million, which reflects our acquisition of $50 million of our common stock in the third quarter, pursuant to our stock repurchase program, as well as shares acquired upon the exercise of Corcept stock options and the vesting of restricted stock grants. Atabak MokariCFO at Corcept Therapeutics00:02:16We'll now turn the call over to Charlie Robb, our Chief Business Officer. Charlie. Charlie RobbCBO at Corcept Therapeutics00:02:21Thanks, Atabak. There's nothing new to report regarding our patent litigation with Teva Pharmaceuticals. Recall that in March 2018, we sued Teva to stop it from marketing a generic version of Korlym in violation of our patents. The case went to trial in September 2023, and in December 2023, the trial court ruled against us. We appealed that decision to the Federal Circuit Court of Appeals. The three-judge panel of that court heard oral argument on July 7th of this year. Although it is impossible to say exactly when the court will issue its decision, enough time has passed that it is reasonable to say that the decision could come at any time. If we prevail, Teva will lose FDA approval of its product until the expiration of our patent in 2037. We strongly believe our position is correct and are eager to advance this appeal. Charlie RobbCBO at Corcept Therapeutics00:03:12I'll now turn the call over to Sean Maduck, President of our Endocrinology Division. Sean. Sean MaduckPresident of Endocrinology Division at Corcept Therapeutics00:03:18Thanks, Charlie. Our hypercortisolism business had another quarter of robust growth. In the third quarter, we shipped more tablets to patients than ever before, 42.5% higher than the third quarter of last year, driven by yet another record of prescriptions written for Korlym. Importantly, our base of prescribers has expanded substantially over the last two years. In summary, the underlying strength of our business continues to build. Our financial results don't fully reflect the surge in demand. I discussed on the last few calls the insufficient capacity of our previous pharmacy vendor. While we expected their capacity to improve in the third quarter, it did not, which is why we have begun transitioning our business to a new pharmacy in the fourth quarter. Sean MaduckPresident of Endocrinology Division at Corcept Therapeutics00:03:58While capacity constraints may continue for the next few months as we complete the transition, we are very encouraged by the new pharmacy's abilities and its capacity to meet demand. As welcome as such improvements are, eventually, the growth we anticipate will outstrip the capacity of any single pharmacy, which is why we plan to add a second specialty pharmacy to our network in January and to onboard a third pharmacy shortly thereafter. Our confidence in continued and accelerating growth is based on several factors. The first is growing physician awareness of hypercortisolism. For many years, the prevalence of hypercortisolism and the serious risks it poses for patients were not well understood. As a result, physicians only screened for and treated the most physically obvious cases of the disorder. Sean MaduckPresident of Endocrinology Division at Corcept Therapeutics00:04:41In the last 15 years, many studies have shown that hypercortisolism is much more common and is a serious threat to health in far more than the most extreme cases. Most recently, our CATALYST study confirmed these findings, proving that there are many more patients with hypercortisolism than previously assumed and that treatment with a cortisol modulator is highly effective in improving their condition, even when other medications, including the newest diabetes medications such as Ozempic and Mounjaro, have not. The CATALYST results have been published in Diabetes Care, the field's leading journal, and are now being absorbed by the broader physician community. To translate these insights into patient impact, we continue to expand our physician education efforts, and we have enlarged the size of our sales force to 150 clinical specialists, up from 60 at the beginning of 2024. Sean MaduckPresident of Endocrinology Division at Corcept Therapeutics00:05:28With the awareness of hypercortisolism growing and the effectiveness of cortisol modulation demonstrated in a large placebo-controlled trial published in a leading peer-reviewed journal, I eagerly anticipate Relacorilant's approval. Korlym is a great medication. Relacorilant is even better. It will be a terrific option for both prescribers and patients. I expect that almost all patients who are receiving Korlym will choose to transition to Relacorilant, and our growth will accelerate. I've never been more confident in both our current and future commercial growth, and most important, our potential to help many more patients. In the next three to five years, I believe Relacorilant will generate $3 billion-$5 billion in annual revenue in hypercortisolism alone. I will now turn the call over to Joe Belanoff, our Chief Executive Officer. Joe. Joe BelanoffCEO at Corcept Therapeutics00:06:14Thank you, Sean, and thank you everyone for joining us this afternoon. After many years dedicated to studying the potential of cortisol modulation to help patients suffering from serious diseases, we are on the cusp of a new era at Corcept. We have two new drug applications that are rapidly approaching their FDA target action, or PDUFA dates. Our NDA for Relacorilant as a treatment for patients with hypercortisolism has a PDUFA date of December 30th, 2025. Our NDA for Relacorilant as a treatment for women with platinum-resistant ovarian cancer has a PDUFA date of July 11th, 2026. We believe the FDA will meet both deadlines. We submitted the European analog to our ovarian cancer NDA, known as a Marketing Authorization Application, or MAA, to the European Medicines Agency, or EMA, in October, with a regulatory decision likely by year-end 2026. Joe BelanoffCEO at Corcept Therapeutics00:07:16Some of our most advanced clinical studies will soon produce important data. Our MOMENTUM trial, which is evaluating the prevalence of hypercortisolism in patients with resistant hypertension, will have results early next year. We expect final overall survival results from ROSELLA, our pivotal trial in platinum-resistant ovarian cancer, around the same time. By the end of 2026, we expect results of our BELLA trial, also in patients with advanced ovarian cancer, as well as results from MONARCH, our phase IIB trial in patients with MASH, a life-threatening liver disorder. We are also about to start important new studies. In consultation with regulators, we are finalizing the design of a phase III trial of our proprietary selective cortisol modulator, Dazcorilant, in patients with ALS. Joe BelanoffCEO at Corcept Therapeutics00:08:10We plan to start this trial by the middle of next year with a simple goal of replicating the strong results we saw in DAZALS, our phase II trial. Our oncology program is about to expand significantly beyond platinum-resistant ovarian cancer. The success of ROSELLA provides clear evidence that cortisol-directed therapies have substantial potential in oncology. What comes next in oncology is a unique sequencing challenge because the opportunities are so large. We have spent many months giving careful thought to a long-term development plan in oncology that is both methodical and ambitious, and most important, will best position Corcept to help as many patients as possible. I'm going to ask Bill Guyer, our Chief Development Officer, to describe what he and his team have planned. Bill? Bill GuyerCDO at Corcept Therapeutics00:09:03Thanks, Joe. Now, in order to understand the scope of our opportunity in oncology, I think it helps to recall that our program follows groundbreaking insights made by investigators at the University of Chicago who hypothesized that cortisol activity at the glucocorticoid receptor promotes solid tumor growth in three ways. First, it's anti-apoptotic, so it blunts the effectiveness of chemotherapy. Second, it provides alternative growth pathways for prostate cancer tumors being treated with androgen deprivation medication. And third, it suppresses the immune system, reducing the effectiveness of immunotherapy in the treatment of cancer. Increasing apoptosis by blunting cortisol activity is a very broad platform. It applies to all solid tumors that express the glucocorticoid receptor. Published research has shown that about 60% of solid tumors express the GR, and they do so at every stage of treatment. Bill GuyerCDO at Corcept Therapeutics00:10:01Our oncology program is built on the belief that antagonizing the effects of cortisol at the GR can benefit many, many more patients. And a prime example of that is shown by the women from our phase II and pivotal phase III ROSELLA studies who received Relacorilant in addition to Nab-paclitaxel and experienced extended progression-free survival and lived longer than the women who were treated with just Nab-paclitaxel alone. Now, remember, Nab-paclitaxel is one of the most potent treatments for women with this disease, and adding Relacorilant led to an even better result, and remarkably, without adding to the safety burden of the women who received it. Adverse events with Relacorilant plus Nab-paclitaxel were comparable in type, frequency, and severity to Nab-paclitaxel monotherapy. As I review the data, Relacorilant is a remarkably well-tolerated drug. Bill GuyerCDO at Corcept Therapeutics00:10:54The medical field understands the importance of our results because the data from ROSELLA were presented at high-profile forums this year, including late-breaking oral sessions at both ASCO and ESMO annual meetings, and ROSELLA findings were published in The Lancet, one of the world's most preeminent journals. Our goal now is to undertake studies that will extend this work in three ways. First, in earlier lines of therapy for ovarian cancer. Second, in new types of solid tumors, and third, combining our proprietary GR antagonists with additional regimens. So the first study advancing this goal is a phase II BELLA trial. BELLA's initial objective is to treat and test the additional benefit of Relacorilant may bring when combining it with Nab-paclitaxel as well as bevacizumab, which is a potent drug that is commonly used to treat patients with platinum-resistant ovarian cancer. Bill GuyerCDO at Corcept Therapeutics00:11:51Due to the strong interest in our program by investigators around the world, this study has enrolled patients much faster than we expected. And as Joe mentioned, we will have the results by the end of 2026. But this is just our first step. BELLA's protocol allows us to add more arms to the study that include patients with different types of solid tumors. Currently, we are going to add two new arms. The first will evaluate Relacorilant plus Nab-paclitaxel and Bevacizumab to treat patients with platinum-sensitive ovarian cancer, an earlier stage of the disease. In order to enroll in this arm, patients must have progressed well on a PARP inhibitor, which is the subgroup that experienced profound benefit in ROSELLA, and we just presented that data at the ESMO conference. The second new BELLA arm will evaluate the potential of Relacorilant plus Nab-paclitaxel to treat patients with endometrial cancer. Bill GuyerCDO at Corcept Therapeutics00:12:45Separately, we are also initiating a phase II study of Relacorilant plus Nab-paclitaxel in patients with cervical cancer in collaboration with ARCAGY Research, which is an academic clinical research group specializing in gynecological cancers. These new studies will enable us to triple the potential number of women with gynecological cancers that we can help each year in the United States, from 20,000 patients with platinum-resistant ovarian cancer to 60,000 patients. We are also targeting other tumors with significant unmet medical needs. We are initiating a phase II study in patients with pancreatic cancer by combining Relacorilant with the first-line standard of care regimen of Nab-paclitaxel and gemcitabine. All of these studies will begin enrollment, in the coming weeks and should enroll very quickly, like all of our past studies have done. Their results will be guideline-enabling, with a particular focus on the National Comprehensive Cancer Network, or NCCN, guidelines. Bill GuyerCDO at Corcept Therapeutics00:13:46These studies will also inform our future development decisions. In addition to exploring cortisol receptors antagonism's potential to resensitize tumors to chemotherapy, we are evaluating its use in combination with androgen deprivation therapy. 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 to determine if GR antagonism can block a cortisol-mediated tumor escape route. Another possible role of cortisol receptor antagonism is in combination with immunotherapy. Immunotherapy has emerged as a standard of care cancer treatment, with more than 200,000 patients in the United States receiving this form of therapy each year. Because cortisol suppresses the immune system, it may blunt the effectiveness of cancer therapies intended to stimulate an immune response. Adding a GR antagonist to immunotherapy may enhance their effectiveness. Bill GuyerCDO at Corcept Therapeutics00:14:48Therefore, in the coming weeks, we are initiating a phase Ib dose-finding study of Nenocorilant, our new proprietary selective cortisol receptor antagonist, in combination with nivolumab, a PD-1-directed immunotherapy to treat patients with a broad range of solid tumors. We've embarked on a mission to advance GR antagonism to help many patients with a broad range of solid tumors. Our ROSELLA study produced exciting confirmatory evidence of our hypothesis, and there is much more to come. We look forward to updating you on our progress, and I'll turn the call back over to Joe. Joe BelanoffCEO at Corcept Therapeutics00:15:25Thanks, Phil. Before reporting advances in our MASH and ALS programs, I will briefly describe the research findings that give us confidence in the substantial opportunity before us in our hypercortisolism franchise. The prevalence phase of our CATALYST trial demonstrated that one in four patients with resistant diabetes has hypercortisolism, a far higher rate than was previously assumed. These results are transforming medicine. Patients who were enrolled in the placebo-controlled treatment phase of CATALYST had uncontrolled diabetes, despite treatment with the best current medications administered by the leading diabetologists, and hypercortisolism. In 24 weeks, patients treated with Korlym experienced a 1.47% reduction in hemoglobin A1c, along with significant improvements in body weight and waist circumference. Notably, patients in CATALYST experienced these improvements even as they decreased or entirely discontinued their other glucose-lowering medications, including the most potent GLP-1 agonists. Joe BelanoffCEO at Corcept Therapeutics00:16:38Our MOMENTUM trial builds on the findings from CATALYST by evaluating the prevalence of hypercortisolism in patients with resistant hypertension. Results for MOMENTUM are expected by early next year. The findings from CATALYST and MOMENTUM will substantially accelerate screening for hypercortisolism and its treatment. As physician awareness of hypercortisolism rapidly grows, Relacorilant is approaching its December 30th PDUFA date. Relacorilant's NDA is supported by our pivotal phase III GRACE trial, as well as our open-label long-term extension, and phase II trials. In these studies, patients treated with Relacorilant experienced clinically meaningful improvements in all the measures of hypercortisolism, including hypertension, hyperglycemia, weight, lean muscle mass, waist circumference, cognition, and Cushing's quality of life score. These benefits were observed consistently and durably, with improvements emerging early and continuing or deepening over time. Joe BelanoffCEO at Corcept Therapeutics00:17:43As awareness of hypercortisolism and its ability to be treated grows, many more patients will be identified, and 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. Our proprietary molecule, Miricorilant, has very potent activity in the liver. Metabolic dysfunction-associated steatohepatitis, or MASH, is a serious liver disorder that afflicts millions of patients in the United States and globally. Cortisol activity plays a role in both the initial development and progression of the disease, and cortisol modulation may serve as a treatment. Our phase Ib study showed that Miricorilant rapidly reduced liver fat and improved other important markers of liver health, including fibrosis. Miricorilant was also very well tolerated without the GI side effects commonly seen in patients being treated for MASH. Joe BelanoffCEO at Corcept Therapeutics00:18:44Our randomized double-blind placebo-controlled phase IIb MONARCH study aims to expand on our encouraging phase Ib results. MONARCH enrolled 175 patients in two cohorts. The first cohort of patients has biopsy-confirmed MASH. The second cohort consists of patients with presumed MASH. We expect results from both cohorts late next year. ALS is a devastating disease associated with elevated cortisol activity. Our proprietary compound, Dazcorilant, is an excellent candidate to treat it. In our 249-patient double-blind placebo-controlled phase II DAZALS trial, patients who received 300 milligrams of Dazcorilant exhibited an 84% reduction in the risk of death at the one-year mark compared to patients who only received placebo. The p-value for this finding was 0.0009. This reduction in early death occurs when patients still retain considerable function and quality of life. It does not simply add months to the end of their life when the disease's burden can be enormous. Joe BelanoffCEO at Corcept Therapeutics00:20:00As I mentioned earlier, we plan to start a phase III trial in 2026. Designed with input from the FDA, European regulators, and leading clinicians, it simply aims to replicate the results of DAZALS. We covered a great deal today. Let me reiterate our important developments. Next month, we expect FDA approval of Relacorilant for the treatment of hypercortisolism. This milestone comes as physicians begin to fully absorb the results of the CATALYST study, which demonstrated that hypercortisolism is far more prevalent than previously recognized and that treatment with a cortisol modulator can significantly improve the health of their patients. Our MOMENTUM study will produce results by early next year, building on CATALYST findings. By mid-next year, we anticipate Relacorilant's first oncology approval in platinum-resistant ovarian cancer, a particularly challenging form of ovarian cancer. Joe BelanoffCEO at Corcept Therapeutics00:21:01Results from the ROSELLA trial showing improved progression-free and overall survival without additional safety burden are groundbreaking. The fact that cortisol receptor antagonism demonstrated such compelling results in this extremely difficult-to-treat cancer type gives us confidence in its potential across a broad range of tumors and underpins our decision to expand our oncology development portfolio. We expect first results from our new oncology studies by the end of next year. Beyond hypercortisolism and oncology, we expect results from a large controlled study in patients with MASH by the end of next year and plan to initiate a phase III study in patients with ALS by mid-next year. We continue to discover and develop proprietary selective cortisol modulators with likely very distinctive clinical attributes and are advancing the most promising to the clinic. Cortisol modulation's vast potential to help many patients is just beginning to unfold. Joe BelanoffCEO at Corcept Therapeutics00:22:03It is a very exciting time for Corcept. Operator, let's proceed to questions. Operator00:22:11Thank you. As a reminder, to ask a question, you will need to press Star 11 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 Genuity. Please go ahead, Edward. Edward NashManaging Director at Canaccord Genuity00:22:37Hi. Thanks, guys, for taking my call. Question, sorry. Wanted to ask, I know sometimes you give the numbers, just wanted 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's sort of come on in October have over your old distributor? Joe BelanoffCEO at Corcept Therapeutics00:23:20Thank you, 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 MaduckPresident of Endocrinology Division at Corcept Therapeutics00:23:27Thanks, Ed. 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 1st. It's a great pharmacy, and we think 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 organ 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. Sean MaduckPresident of Endocrinology Division at Corcept Therapeutics00:24:18And Edward, I think you also asked about other pharmacies which are coming on next year. I think a really important thing to realize to tie your two questions together as well, there are now 3,000 or so patients who are taking Korlym. We actually believe that the market capacity is much, much greater than that. And we really do think that as Relacorilant begins to come onto the market, no single pharmacy is going to easily handle all of the business there. And that's why we're gearing up right now to add second, third pharmacies to that. Edward NashManaging Director at Canaccord Genuity00:24:51Great. That's helpful. Thank you. And Ed had one quick model question. On the gross margin line, you guys have historically had really high margins. And given the increase in volume, but also pricing and generic shift, are you seeing any downward pressure on margins that might require modeling adjustments going forward? Joe BelanoffCEO at Corcept Therapeutics00:25:09Yeah. Let me give you back to Atabak for that question. Atabak MokariCFO at Corcept Therapeutics00:25:12Hi, Edward. No. We have not seen that, and we don't expect that. Edward NashManaging Director at Canaccord Genuity00:25:18Great. Thank you, guys. Joe BelanoffCEO at Corcept Therapeutics00:25:21Thank you, Edward. Operator00:25:23Thank you. Our next question comes from the line of David Amsellem of Piper Sandler. Please go ahead, David. David AmsellemManaging Director and Senior Research Analyst at Piper Sandler00:25:32Thanks. Just a couple of quick ones. One, can you just remind us 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 and 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? Thank you. Joe BelanoffCEO at Corcept Therapeutics00:26:09Thanks, David. And I think we'll give your questions to the person who can each answer them best. Sean, why don't you begin? Sean MaduckPresident of Endocrinology Division at Corcept Therapeutics00:26:16Yeah. Thanks, David. In terms of our authorized generic, in the second quarter, we were about two-thirds of our business. We 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. David AmsellemManaging Director and Senior Research Analyst at Piper Sandler00:26:41Charlie, a question about the ovarian cancer NDA. Charlie RobbCBO at Corcept Therapeutics00:26:44Yeah. 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 of a 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. David AmsellemManaging Director and Senior Research Analyst at Piper Sandler00:27:24And Atabak? Atabak MokariCFO at Corcept Therapeutics00:27:25Sure. 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 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. Joe BelanoffCEO at Corcept Therapeutics00:28:28Okay. Next question, please. Operator00:28:30Thank you. Our next question comes from the line of Joon Lee of Truist Securities. Please go ahead, Joon. Analyst at Truist Securities00:28:38Congrats on the quarter, and thanks for taking the questions. This is Austin Ryan on for Joon, 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 pharmacy is out of the picture, it seems to be, how confident are you that Curant can handle the increasing 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? Thank you. Joe BelanoffCEO at Corcept Therapeutics00:29:12Sure. Thank you very much for those questions. I think I understand all of them. The first one we'll send to Sean. Sean MaduckPresident of Endocrinology Division at Corcept Therapeutics00:29:17Yeah. So I'll answer your second question first. Corant is fully online. They started taking new patients on October 1st. Almost all new enrollments are going to Corant. 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. Joe BelanoffCEO at Corcept Therapeutics00:29:40And Charlie? Charlie RobbCBO at Corcept Therapeutics00:29:41Yeah. So. Just could you repeat the question for me? Because I want to make sure I answer it really correctly. What did you say? Analyst at Truist Securities00:29:49Yeah. Just on the upcoming PDUFA for Relacorilant, have you had a late-cycle review for Relacorilant? And if so, what can you share? Charlie RobbCBO at Corcept Therapeutics00:29:56Sure. So just a little background for people who 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 between the sponsor and the FDA. And the second is, as you noted, 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 its original letter to us. Things have moved per schedule, very ordinary course. Charlie RobbCBO at Corcept Therapeutics00:30:41And we are very confident as a result that the FDA will meet its target date of December 30th. Analyst at Truist Securities00:30:48Thank you. And if I could just have a quick follow-up, is Teva still selling Korlym? And if so, how long will they have to? Joe BelanoffCEO at Corcept Therapeutics00:30:57Yes. Sean, please take that. Sean MaduckPresident of Endocrinology Division at Corcept Therapeutics00:31:00Yeah. So Optime is still servicing patients just as they were before, as they're obligated by the contract. Analyst at Truist Securities00:31:07Thank you. Joe BelanoffCEO at Corcept Therapeutics00:31:08Sure. Operator00:31:09Thank you. Our next question comes from the line of RK with H.C. Wainwright. Please go ahead, RK. Joe BelanoffCEO at Corcept Therapeutics00:31:17Hey, RK. Please go ahead. Analyst at H.C. Wainwright & Co Llc00:31:19Thank you. 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 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? Analyst at H.C. Wainwright & Co Llc00:31:58The second question is. Joe BelanoffCEO at Corcept Therapeutics00:31:59Oh, go ahead, please. Analyst at H.C. Wainwright & Co Llc00:32:01Sorry. And the second question is on the new molecule that I see on the pipeline, Nenocorilant. How different is that from Relacorilant? 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? Joe BelanoffCEO at Corcept Therapeutics00:32:26Okay. I think we have both of those questions. The first one is Sean's. Please go ahead, Sean. Sean MaduckPresident of Endocrinology Division at Corcept Therapeutics00:32:30Yeah. So RK, just to be clear, you said in your question that we only have one pharmacy. That's incorrect. We actually have two pharmacies. Optime Care is continuing to service the active patient base, and all new prescriptions are going to Corant. 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. Joe BelanoffCEO at Corcept Therapeutics00:32:55Bill, any comments you'd like to make about Nenocorilant? Bill GuyerCDO at Corcept Therapeutics00:32:58Yeah. Thank you. So related to nenocorilant, then 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 in 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 a best partner for PD-1 inhibitors compared to that of Relacorilant. And so when it comes to publishing our preclinical data, yeah, we always publish our data. Bill GuyerCDO at Corcept Therapeutics00:33:43And I would expect us to have that data in the public domain next year. Joe BelanoffCEO at Corcept Therapeutics00:33:48Let me make just a more general point because I know obviously RK is really the first person who really absorbed our oncology opportunity. You've been following this the longest of anybody. But let me make some points for those who have not. One of the really interesting things is that years ago, when we were only working with mifepristone, which we call Korlym, we were looking for a follow-on compound which wouldn't have progesterone receptor activity. And our terrific chief chemist at that point, now our Chief Scientific Officer, Hazel Hunt, was able to come up with one and then more and then more. What was really interesting about them is that while all of those compounds modulated cortisol activity, and none of them touched the progesterone receptor, so they were really distinct. She had sort of accomplished her mission in separating the activities. Joe BelanoffCEO at Corcept Therapeutics00:34:40As we began to test them preclinically, they simply weren't identical. Some got into the brain, some didn't get into the brain, some were organ-specific, some were general, and some were more potent in various oncology models than others. We're left with not a single follow-on compound, which is frankly what I had anticipated, but with four, five, six, seven compounds each paired with the best treatment opportunity and best disorder for which it could make progress. It's been a very interesting opportunity. I think Nenocorilant is quite interesting. You'll learn more about it next year as we go along. We're very excited to actually begin that study. I think it will really help us learn very much as to what the next thing to do is. Thank you all for your questions. Thank you for listening in. Joe BelanoffCEO at Corcept Therapeutics00:35:29Really an exciting time, and I look forward to talking to you next quarter. Thank you. Bye-bye. Operator00:35:36This concludes today's conference call. Thank you for participating. You may now disconnect.Read moreParticipantsExecutivesAtabak MokariCFOCharlie RobbCBOSean MaduckPresident of Endocrinology DivisionJoe BelanoffCEOBill GuyerCDOAnalystsEdward NashManaging Director at Canaccord GenuityDavid AmsellemManaging Director and Senior Research Analyst at Piper SandlerAnalyst at Truist SecuritiesAnalyst at H.C. Wainwright & Co LlcPowered by