Corcept Therapeutics Incorporated. Aktie

Thank you for standing by, and welcome to the Corcept Therapeutics Second Quarter 2026 Earnings Conference Call. [Operator Instructions] As a reminder, today's program is being recorded.

And now I'd like to introduce your host for today's program, Atabak Mokari, CFO. Please go ahead, sir.

Hello, everyone. Good afternoon, and thank you for joining us. Today, we issued a press release announcing our financial results for the second 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.

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 from those such statements expressed or implied. 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, which are available on the SEC's website. Please refer to those documents for more information. We disclaim any intention or duty to update forward-looking statements.

Our revenue in the second quarter of 2026 was $256.1 million, a 32% increase over the prior-year period. Korlym and authorized generic product revenue was $208.6 million. Lifyorli product revenue was $47.6 million in its first quarter of availability. We expect growth to continue and have increased our 2026 revenue guidance to a range of $1.1 billion to $1.2 billion.

Net income was $43 million in the second quarter of 2026 compared to net income of $35 million in the prior-year period. Please note that our operating expenses in the second quarter were flat to the first quarter of 2026. Our cash and investments at June 30 were $545 million.

I will now turn the call over to Sean Maduck, President of our Endocrinology division. Sean?

Thanks, Atabak. Our Cushing's syndrome business continues to experience strong demand. The second quarter saw a record number of new prescriptions and first-time prescribers. We have never had more patients receiving our medications or more active prescribers.

Our growth is due to physicians increasing awareness that hypercortisolism is a serious disease that is more prevalent than previously understood. Hypercortisolism is underdiagnosed because its signs and symptoms such as difficult-to-treat diabetes or resistant hypertension are the same as those of other more common conditions. Tens of millions of people have diabetes or hypertension or both, but those patients whose conditions are being driven by hypercortisolism have often been missed. That is especially important because hypercortisolism-induced hyperglycemia or hypertension responds poorly, if at all, to conventional pharmacotherapy.

A drug that reduces excess cortisol activity is required to treat these patients. As clinical practice adapts to this critical insight, screening for and treatment of Cushing's syndrome will continue to increase as will the number of patients receiving our medications. Our landmark CATALYST and MOMENTUM trials are driving increased physician awareness of hypercortisolism. CATALYST showed that 24% of patients with difficult-to-treat diabetes had hypercortisolism and that treatment with Korlym led to substantial reductions in hemoglobin A1c, excess body weight and waist circumference.

MOMENTUM screened more than 1,000 patients with high blood pressure that was not controlled despite concurrent use of 3 or more anti-hypertension medications, a condition known as resistant hypertension, and found that 27% of these patients had hypercortisolism. In patients with both resistant diabetes and resistant hypertension, the prevalence of hypercortisolism was even higher, 39.7% in CATALYST and 32.6% in MOMENTUM.

These paradigm-shifting findings will take time to be fully incorporated into medical practice, a process that is only just beginning. CATALYST results were published in the field's leading journal, Diabetes Care, in 2025 and were referenced in the American Association of Clinical Endocrinology, or AACE, guidance documents for the management of diabetes in March of this year.

MOMENTUM's results are also recent. We first presented them at the Annual Conference of the American College of Cardiology or ACC in March, and again at the American Diabetes Association, or ADA, annual scientific sessions in June. The results will be published in a major medical journal later this year.

That being said, the CATALYST and MOMENTUM results are becoming more widely known and doctors are acting upon them. Screening for and treatment of Cushing's syndrome is increasing and with it, the number of patients being treated with our medications. We expect this trend to continue, propelling our current Cushing's syndrome business to at least $2 billion in annual revenue by the end of this decade.

Relacorilant's availability, which should occur shortly after the December 17 PDUFA date assigned to its resubmission, will accelerate this growth. With the addition of relacorilant, we expect that our Cushing's syndrome annual revenue will grow to between $3 billion and $5 billion in 2020 (sic) [ 2030 ].

I will now turn the call over to Roberto Vieira, President of our Oncology division. Roberto?

Thanks, Sean. Lifyorli's launch is one of the strongest ever for an oncology medication. The FDA approved Lifyorli on March 25, nearly 4 months ahead of its PDUFA date. A few days after that, on April 1, we sold our first Lifyorli capsules.

Revenue for the first quarter was $47.6 million. Our success has been driven in large part by Lifyorli's compelling clinical characteristics. Patients with ovarian cancer have few good treatment options. This is especially true for those with platinum-resistant ovarian cancer. They and their physicians are excited to have a new treatment backed by strong efficacy data, a very manageable safety profile, convenient oral administration and no biomarker requirement.

Accordingly, Lifyorli is on its way to becoming a new standard of care. Payer coverage for Lifyorli has been excellent. The National Comprehensive Cancer Network, or NCCN guidelines listed Lifyorli as a preferred regimen just 15 days after approval, an unusually quick action that has supported broad insurance coverage and accelerated physician adoption. As of today, more than 70% of the combined Medicare, Medicaid and commercial lives have formal coverage policies for Lifyorli in place.

More than 1,300 patients have now started treatment with Lifyorli, a number that continues to grow every day. Demand has come from gynecology, medical and hematology oncologists in academic and non-teaching hospitals as well as community oncology clinics across the country. As of today, more than 1,000 doctors have prescribed Lifyorli to at least one patient and an increasing number of physicians have written prescriptions for multiple patients.

While we are extremely pleased with Lifyorli's rapid uptake, we are just getting started. In the near term, we expect to reach more physicians at more oncology practices, large and small. We also expect physicians to prescribe Lifyorli more frequently as they gain experience with the drug. Those efforts alone should grow Lifyorli's annual revenue in the United States to more than $1 billion.

I will now turn the call over to Joe Belanoff, our Chief Executive Officer. Joe?

Thank you, Roberto, and thank you, everyone, for joining us. Since our founding, Corcept has worked to discover...

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Ladies and gentlemen, please stand by, your program will resume momentarily. Once again, please stand by, your program will resume momentarily. Ladies and gentlemen, please stand by, your conference call will resume momentarily. Once again, please stand by, your conference call will resume momentarily.

Okay. We're back. I apologize...

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Yes. I apologize to everyone. We had a drop in the telephone line, but I will start my section again.

Thank you, Roberto, for your oncology update, and thank you, everyone, for joining us. Since our founding, Corcept has worked to discover and develop molecules that harness glucocorticoid receptor, GR, antagonists to treat serious diseases. We have made important progress. It is now established that hypercortisolism is much more prevalent than previously believed and that modulating cortisol's activity can help many patients.

Lifyorli's unprecedented uptake as a treatment for platinum-resistant ovarian cancer is eye-catching and is an important step to proving that GR antagonism can help treat many types of solid tumors, and our plans go well beyond Cushing's syndrome and oncology. Relacorilant's new drug application, NDA, in Cushing's syndrome is based on the positive outcome of our pivotal Phase III GRACE trial with confirmatory evidence from our double-blind, placebo-controlled Phase III GRADIENT trial, our long-term extension study and our earlier-stage development data. Collectively, these results show that patients treated with relacorilant experienced meaningful durable improvements in the signs and symptoms of Cushing's syndrome and without the serious adverse events associated with the currently approved medications, hypokalemia, endometrial hypertrophy, vaginal bleeding, adrenal insufficiency or QT prolongation.

To say that we were disappointed when we received a complete response letter at the end of last year is an understatement. At our meeting with the FDA in April, the agency requested additional analyses of the data in our original NDA submission. We completed those analyses, and based on their results, we resubmitted our NDA on June 17. The FDA accepted our resubmission and has assigned a PDUFA date of December 17, 2026.

It is important to make relacorilant available as soon as possible. As Sean said, the CATALYST and MOMENTUM studies are changing medicine. As screening for hypercortisolism becomes the norm rather than the exception in patients with resistant diabetes and hypertension, many patients whose health has been damaged by previously undiagnosed hypercortisolism will be able to receive more effective targeted care. Better treatments are greatly needed.

The approval of Lifyorli was enormously gratifying. It is wonderful to be able to offer patients with platinum-resistant ovarian cancer, one of the most challenging forms of cancer, a safe and effective treatment option. We presented complete results from Lifyorli's pivotal trial, ROSELLA, in April at the Society of Gynecologic Oncology, SGO's Annual Meeting with their simultaneous publication in the Lancet.

In ROSELLA, Lifyorli met both primary endpoints, significantly delaying disease progression and even more important, significantly extending overall survival. Patients treated with Lifyorli and nab-paclitaxel chemotherapy experienced a 35% reduction in their risk of death, a hazard ratio of 0.65 compared to patients treated with nab-paclitaxel alone. The p-value was 0.0004. Notably, these survival benefits were achieved in all patients with platinum-resistant ovarian cancer, not just those selected based on a specific biomarker.

Lifyorli's approval is just the first step toward advancing GR antagonism's full potential to treat solid tumors. Many tumors exploit GR signaling to drive treatment resistance. Beyond platinum-resistant ovarian cancer, GR antagonism has the potential to treat any solid tumor expressing the GR in combination with any anticancer agent. Our oncology development program aims to provide the evidence needed to realize the potential.

We are evaluating relacorilant combined with chemotherapy in a variety of solid tumors. One of the arms of our BELLA trial is studying the effect of relacorilant plus nab-paclitaxel and bevacizumab in women with platinum-resistant ovarian cancer. This arm will produce results this year. Our BELLA trial has two other arms, one which is studying the treatment of patients with platinum-sensitive ovarian cancer, an earlier stage of the disease, and one which is studying endometrial cancer. Our STELLA trial in cervical cancer and our TRIDENT trial as a first-line treatment for pancreatic cancer are also underway.

These trials will all produce results by the end of next year. We expect data from these studies to be NCCN-guideline enabling and to inform our future development decisions. Successful results would immediately increase the number of patients that relacorilant may help by fivefold. Also very important, GR antagonism may augment the effects of immunotherapy. Cortisol suppresses the immune system, blunting the effectiveness of therapies that stimulated an immune response. A treatment regimen combining an immunotherapy agent with a GR antagonist may stimulate a stronger, more effective immune response.

We have initiated SYNERGY, a Phase Ib study of our proprietary selective GR antagonist, nenocorilant, in combination with nivolumab, a PD-1 directed immunotherapy across a broad range of solid tumors. We expect results from SYNERGY by the end of next year.

Finally, cortisol activity at the GR stimulates the growth of prostate cancer tumors, helping them escape the effects of androgen deprivation therapy. Our collaborators at the University of Chicago are enrolling a randomized placebo-controlled Phase II trial of relacorilant plus the androgen receptor blocker, enzalutamide, in patients with early-stage prostate cancer to see if adding a GR antagonist can block cortisol-mediated tumor escape routes.

Cortisol activities involved in the development and progression of metabolic dysfunction-associated steatohepatitis or MASH. This serious liver disorder afflicts millions of patients worldwide and is a significant and rapidly growing cause of liver and cardiometabolic morbidity and mortality. Our proprietary selective cortisol modulator, miricorilant, is very potent in the liver. In our Phase Ib study, it rapidly reduced liver fat and improved other elements of important markers of liver health, including fibrosis.

Miricorilant was well tolerated without the gastrointestinal side effects commonly seen in patients being treated for NASH. Our 175-patient double-blind, placebo-controlled Phase IIb MONARCH study has completed enrollment and will produce data later this year. Positive results would support advancement to Phase III.

Patients with ALS frequently have elevated cortisol levels, which is why we believe cortisol modulation may help them. Results from DAZALS, the Phase II trial of our proprietary selective cortisol modulator, dazucorilant, have been very encouraging. Patients who received 300 milligrams of dazucorilant exhibited an 84% reduction in risk of death at the 1-year mark compared to patients who received placebo. The p-value for this finding was 0.0009. This survival benefit persisted into the study's second year with an 87% reduction in risk of death with a p-value of less than 0.0001.

There is a common misperception that death from ALS is always coterminous with severe functional decline. It isn't. Many patients die from complications such as pneumonia or cardiovascular events arising well before they have lost significant function and quality of life. Cortisol modulation could prevent such complications or help patients to survive them, it would provide a significant benefit. We are currently conducting a study to see if dose titration can improve dazucorilant's gastrointestinal tolerability. Non-serious GI distress caused most of the discontinuations in DAZALS. The findings from this study will inform the design of the pivotal trial that we plan to start early next year.

To sum up, our Cushing's syndrome business is growing and is poised for accelerated growth driven by increasing awareness of hypercortisolism's true prevalence and the increasing evidence of the importance of treating it. Our landmark CATALYST and MOMENTUM studies are leading to much wider screening for and treatment of Cushing's syndrome. Approval of relacorilant would lead to even faster growth. The launch of Lifyorli in platinum-resistant ovarian cancer is off to a very strong start. We believe that GR antagonism has a broad utility in oncology. We look forward to helping many more patients with cancer in the near future.

Our BELLA, STELLA and TRIDENT studies will produce results by the end of next year and have the potential to increase the number of patients Lifyorli could benefit by a factor of 5. We are also evaluating the treatment of other solid tumors and other treatment combinations to fully realize our potential in oncology. Following up on our positive Phase II DAZALS findings, we are conducting a dose titration study to inform the design of our planned Phase III trial in patients with ALS. By year-end, we will have results from our Phase II MONARCH trial in patients with MASH. If those results are sufficiently positive, we will proceed to Phase III.

The potential of cortisol modulation is immense. Developing that potential into safe and effective medications is important work. We thank the patients who participate in our trials, our employees, our clinical investigators and our academic collaborators who make it possible.

Operator, let's proceed to questions.

[Operator Instructions] Our first question comes from the line of David Amsellem from Piper Sandler.

So just a few for me. First, on the patient-level metrics on Lifyorli. Can you talk to the number of patients on treatment currently or at the end of 2Q? And when you talk about accelerating demand, I'd just want to get a sense of what exactly that means. Does that mean you're adding -- the pace of patient adds continue to increase through June and into July? That kind of color would be helpful.

And then secondly, on the upward revision to the guidance, is it fair to say that most of that is related to the launch of Lifyorli? And if so, can you talk to the dynamics you're seeing surrounding Korlym? Are there any additional bottlenecks or lingering bottlenecks, I should say, regarding the specialty pharmacy and what kind of assumptions are now embedded in the -- in Korlym with this upward revision to your guide?

Okay. Thank you, David. And several questions. I'll try to sort them out. On first question, I think we'll go to Roberto, our President of Oncology.

So thank you, Joe. Thank you, David. So David, we spoke about the 1,300 patients that we have initiated on therapy since we have launched. As you can see from what we discussed in the previous quarter as well, we have really accelerated the adoption of patients there. And we are very happy. We see a very broad range of patients. We see patients very early lines of therapy, but also patients across the entire spectrum, late lines as well.

And we have maintained actually a very strong pace of adding patients every week. We are on our way to become market leaders as well as to realize the potential of $1 billion just for platinum-resistant ovarian cancer in itself. So I think that you can derive from there where we are headed. We are very happy with market access as we discussed. So overall, the story holds together as significant growth is ahead of us.

Now talking about this rate of acceleration of demand. We have, of course, as I said, very strong uptake so far, and we are actually working very hard to educate a much broader group of physicians that expands across new clinics. We think we have meaningful opportunity ahead. So our goal is to really go early and go broad. And when I say go early, we think that Lifyorli is a drug that belongs early in the intervention. We think that the overall survival benefit, especially the fact that the drug has the opportunity to impact the disease, has a disease modification effect. You look at the overall survival curve, you see that those curves separate over time. So there's an increasingly positive benefit to patients.

And all those things together points to this drug really belonging into early lines of platinum-resistant ovarian cancer. So when you put all this together, the profile of the drug, the all-comer opportunity, you should be looking to continuous growth for the brand for the quarters to come.

Very good. Thank you, Roberto. And Sean, why don't you take the next question about where things stand with the pharmacy?

Yes. No, happy to take that. So in terms of just how the quarter ended up, I want to just set the stage. I mean, we had record enrollments. We had a record number of new prescribers, a record number of patients on medicine, which, of course, led to the highest tablets we've seen. The market is growing. And of course, that was evidenced in our business in the second quarter, but we expect that to continue to grow and of course, to continue to benefit our business.

Now in terms of the pharmacy specifically, I mean, we saw a continuous improvement every single day, and we expect that continued improvement to move forward. As I just mentioned, the market is growing. Our business is growing, and we expect them to continue to improve and continue to keep up.

And Atabak, perhaps you can respond to the guidance question.

Sure. Yes. So our new guidance range reflects strength across both of our businesses, across both Endocrinology and Oncology. And so that's -- both of those are reflected in the updated guidance range.

And our next question comes from the line of Swayampakula Ramakanth from H.C. Wainwright.

I have just a couple of questions. One on Lifyorli and one on Korlym. On -- Lifyorli did approximately $48 million in the first quarter with more than 1,300 patients started, as you stated. How much of that reflects dispensed demand versus initial channel build? And how many unique prescribers do you have at this point beyond the 200 that you cited in April? And any commentary on duration of therapy would be helpful as well.

And then on Korlym, we are back to seeing 27% sequential growth. How much of this is clearing up of the backlog from the pharmacy transition versus capacity growth that you currently have gained with a new pharmacy onboard?

Okay. Thank you, RK. I think we got both of those questions. Roberto, would you like to answer the first question on oncology growth?

Yes. So RK, as you said, 1,300 patients initiated therapy and 1,000 unique prescribers since we have launched. So that is, I think, the answer to your question.

You asked about the duration of therapy. It's kind of early for us to assess the duration of therapy. As you can imagine, most of our patients, we have followed them through for a couple of months or weeks. And we think that the ROSELLA data is a very good benchmark for us. So think about our PFS there. That's what we think that we will have that -- reflected in the patient population.

Thank you, Roberto. And Sean...

He had a question on inventory...

Yes. Okay. I'm sorry. Yes. The question was related to inventory. That's for you, Atabak.

I'll take that one. So your question on that, RK, the simple answer is no, there's not much inventory contribution in the quarter results. And so what do I mean by that? So the background is that we sell through both specialty pharmacies and specialty distributors through -- revenues through the specialty pharmacy are direct to patient. So there is no inventory at the channel level. It's all direct to patient and realized when the patient receives the medicine. So through the specialty -- and in our -- and just to be clear, in our Cushing's syndrome business, almost 100% of our business goes through the specialty pharmacy.

And on the oncology side, about 30% goes through the specialty pharmacy and the rest goes through specialty distributors, which do hold inventory to then ultimately provide to hospital pharmacies and so forth. Within that, I mean, ultimately, this is -- given the cost of the medication, the distributors want to hold minimal inventory. So you're talking about -- roughly about a week of demand that they keep on hand. So like I started at the beginning, very little of inventory dynamics in the quarter results.

Thank you. Okay. And Sean, you have a couple of questions here.

Yes. So thanks, RK. So your question, I think, was the $44 million growth we saw from Q2 over Q1 driven by sort of catch-up associated with the pharmacy transition. And the answer to that is no. The transition is behind us. The number was driven by continued servicing of our existing patient base. And as I shared earlier, a record number of new enrollments coming in. So the servicing of new patients coming in. We've had a record number of patients every single month, and we expect that to continue to grow.

Thank you, Sean. Thank you. Well, thank you, everyone. It was a very exciting quarter for us. It's really wonderful to be able to help this new group of patients. We really hope to enlarge that as we go forward and really have great expectations that we will. So we'll talk to you next quarter. Thank you very much, and enjoy the rest of your summer. Bye-bye.

Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.

Thank you for standing by, and welcome to Corcept Therapeutics First Quarter 2026 Earnings Conference Call. [Operator Instructions] I would now like to hand the call over to Atabak Mokari, CFO. Please go ahead.

Hello, everyone. Good afternoon, and thank you for joining us. Today, we issued a press release announcing our financial results for the first quarter and providing a corporate update. A copy is available at corcept.com. Our complete financial results will be available when we file our Form 10-Q with the SEC. Today's call is being recorded. A replay will be available at the Investors Past Events tab of our website.

Statements during this call other than statements of historical fact are forward-looking statements based on our plans and expectations that are subject to risks and uncertainties, which might cause actual results to be materially different from those such statements expressed or implied. 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, which are available at the SEC's website. Please refer to those documents for more information. We disclaim any intention or duty to update forward-looking statements.

Our revenue in the first quarter of 2026 was $164.9 million compared to $157.2 million in the prior year period. We have increased our 2026 revenue guidance to $950 million to $1.05 billion. Net loss was $31.8 million in the first quarter of 2026 compared to net income of $20.5 million in the first quarter of last year. Our cash and investments at March 31 were $515 million.

I will now turn the call over to Sean Maduck, President of our endocrinology division. Sean?

Thanks, Atabak. Demand for our medications continues to increase. We ended the first quarter with a record number of new prescriptions written from a record number of prescribers, which translated to an all-time high for the number of patients receiving our medications. Importantly, we set a record for new patient starts in March and again in April. These figures are outstanding and give me great confidence in the current and future health of our hypercortisolism business. The full impact is not reflected in our revenue for 3 reasons.

First, revenue often dips in the first quarter as it does for many rare disease medications because insurance companies impose onerous reauthorization procedures at the start of each year that interrupt patient coverage for a month or 2. We provide patients with free drug to bridge the gap, but our revenue suffers. Second, new patients, whom we are adding at a rapid clip, provide much less revenue when they start treatment than they will later after payer coverage has been secured and they have titrated to their optimum dose. The full revenue impact of patients added this quarter will grow substantially over the next few quarters.

Finally, our specialty pharmacy vendor has done an excellent job onboarding the thousands of patients transferred from our former vendor and getting them the medicine they've been prescribed. They have also excelled at servicing new prescriptions written for our medications, the new patient starts I just described. The task that remains is grinding through the insurance prior authorization backlog that accumulated as patients transition to the new pharmacy. This is painstaking work, but it yields steady dividends that will be reflected in our revenue over the coming months. Our new pharmacy vendor's ability to handle large numbers of new patients skillfully is important because I expect demand to increase substantially as physicians adapt their practices to the landmark findings of our CATALYST and MOMENTUM trials.

CATALYST showed that 24% of patients with resistant diabetes had hypercortisolism, and that treatment with Korlym led to substantial reductions in hemoglobin A1c, weight and waist circumference compared to placebo. CATALYST results were published in the field's prominent journal, Diabetes Care in December of 2025 and were referenced in the March 2026 American Association of Clinical Endocrinology or AACE, guidance document for the management of diabetes. This is an important step towards increasing the awareness of hypercortisolism by the broader physician community.

The recently reported results of our MOMENTUM study showed that 27% of patients with resistant hypertension had hypercortisolism. MOMENTUM's results were featured in an oral presentation at the annual conference of the American College of Cardiology, or ACC, last month. CATALYST and MOMENTUM will transform the practice of medicine. They provide consistent complementary evidence that hypercortisolism is the underlying cause of many patients' difficult to treat diabetes and hypertension. Physicians have begun responding to these findings, but a change of this magnitude takes some time to be fully absorbed and implemented in clinical practice.

As medical practices adapt, screening for and treatment of Cushing's syndrome will increase and so will the number of patients receiving our medications. We expect our current Cushing's Syndrome business to grow to at least $2 billion in annual revenue by the end of this decade. When relacorilant is available, growth will accelerate further.

I will now turn the call over to Roberto Vieira, President of our Oncology Division. Roberto?

Thank you, Sean. The FDA's approval of Lifyorli for the treatment of patients with platinum-resistant ovarian cancer, 3.5 months ahead of its PDUFA date is wonderful news for patients. On behalf of Corcept, I want to thank the FDA's division of oncology for its rigorous and extremely rapid review of our new drug application, which reflected the determination to make available a safe and effective new medication to women with a very difficult-to-treat disease. Our NDA was supported by compelling clinical data. The Lifyorli's pivotal trial, ROSELLA met both of its primary endpoints, delaying disease progression and even more important, significantly extending patient survival.

Patients treated with Lifyorli and nab-paclitaxel experienced a 35% reduction in risk of death, a hazard ratio of 0.65 comparing to patients treated with nab-paclitaxel monotherapy. The p-value was 0.0004. No biomarker testing was required to identify these patients. We presented ROSELLA's complete results early this month in our oral late-breaker session at the Society of Gynecologic Oncology, SGO, Annual Meeting with simultaneous publication in The Lancet.

As one would expect, oncologists and patients advocacy organizations have responded to this data with great enthusiasm. Lifyorli's efficacy and safety profile make it a powerful treatment option. For those who want to learn more about Lifyorli's clinical characteristics, there is a link to The Lancet article in today's press release. Even though Lifyorli's approval came early, our commercial team was ready to translate our significant prelaunch investments in preparation into execution. Our sales and marketing, medical and market access teams were on board and trained by the time of Lifyorli's approval and its manufacturing and distribution infrastructure was in place.

36 days into our launch, things are going very well. We launched our patient support hub and ensured product availability within 5 days of approval. A wide group of physicians have requested information from our field teams, another indicator of strong interest in Lifyorli. We began seeing enrollments within hours after approval. Prescriptions have already been written by over 200 physicians from all parts of the country, indicating adoption well beyond our study investigators and academic specialists. We are also beginning to see early signs of prescribing breadth with patients coming from multiple physicians in large practices.

Lifyorli's inclusion in the National Comprehensive Cancer Network, or NCCN guidelines as a preferred regimen just 15 days after approval will support strong adoption and payer access. Lifyorli's strong early results do not surprise us, given the drug's excellent efficacy and safety profile, the lack of biomarker test requirements and convenient oral administration. We expect Lifyorli only to exceed $1 billion in annual revenue in the United States by the end of the decade, but it is just the beginning of our journey in oncology.

I will now turn the call over to Joe Belanoff, our Chief Executive Officer. Joe?

Thank you, Roberto, and thank you, everyone, for joining us. Since Corcept's inception, we have explored the potential of cortisol modulation to treat patients with serious diseases. That potential is vast. We have made important advances. It is now established that hypercortisolism is much more prevalent than previously thought and the treatment with a cortisol modulator can benefit many patients. Lifyorli's FDA approval in platinum-resistant ovarian cancer indicates that reducing cortisol activity at the glucocorticoid receptor, GR, may be beneficial in treating a wide variety of solid tumors.

And you should know our plans go well beyond hypercortisolism and oncology. In April, we met with the FDA regarding relacorilant's new drug application, its NDA in Cushing's syndrome. Our NDA was based on the positive outcome of our pivotal Phase III GRACE trial with confirmatory evidence from our double-blind, placebo-controlled Phase III GRADIENT trial, our long-term extension study and our earlier-stage development data. Collectively, these results show that patients treated with relacorilant experienced meaningful durable improvements in the signs and symptoms of Cushing's syndrome without some of the serious adverse events associated with the currently approved medications, hypokalemia, endometrial hypertrophy, vaginal bleeding, adrenal insufficiency or QT prolongation.

We will provide an update on relacorilant's regulatory path in the near future. I also want to underscore Sean's remarks regarding the importance of the CATALYST and MOMENTUM studies. Their findings are changing medicine. As physicians expand screening for hypercortisolism in patients with difficult to control type 2 diabetes and in those with resistant hypertension, patients whose health has been damaged by previously undiagnosed hypercortisolism will receive more targeted and better care. Increased demand for medications that treat Cushing's syndrome will propel our endocrinology business for years to come.

The approval of Lifyorli is an important first step towards realizing the full potential of glucocorticoid receptor antagonism in oncology. Lifyorli works in ovarian cancer by suppressing cortisol's anti-apoptopic effect so that nab-paclitaxel can achieve its full effect. We believe this mechanism has the potential to work with any solid tumor that expresses the glucocorticoid receptor and with any companion anticancer agent. We are currently evaluating relacorilant combined with other anticancer therapies and in a wide variety of solid tumors. The first arm of the BELLA trial is studying the effect of relacorilant plus nab-paclitaxel and bevacizumab in women with platinum-resistant ovarian cancer.

Other studies are enrolling patients with endometrial, cervical, pancreatic and platinum-sensitive ovarian cancers. Data from these studies will be NCCN guideline enabling and will inform our future development decisions. The first arm of BELLA will produce results by the end of this year. Our other ongoing oncology trials will produce results by the end of next year. Successful results in these studies would immediately increase the number of patients that relacorilant might potentially help by fivefold. GR antagonism may also augment the effects of immunotherapy. Cortisol suppresses the immune system, blunting the effectiveness of therapies that stimulate an immune response. A treatment regimen combining an immunotherapy agent with a GR antagonist may stimulate a stronger, more effective immune response. We are conducting a Phase Ib study of our proprietary selective GR antagonist, nenocorilant, in combination with nivolumab, a PD-1 directed immunotherapy to treat patients with a broad range of solid tumors.

Finally, cortisol activity at the GR stimulates the growth of prostate cancer tumors helping them escape the effects of androgen deprivation therapy. Our collaborators at the University of Chicago are enrolling a randomized placebo-controlled Phase II trial of relacorilant plus the androgen receptor blocker enzalutamide in patients with early-stage prostate cancer to see if adding a GR antagonist can block cortisol-mediated tumor escape routes.

Cortisol activity plays a role in the initial development and progression of a serious liver disorder known as metabolic dysfunction-associated steatohepatitis or MASH, which afflicts millions of patients worldwide and is a significant and rapidly growing cause of liver and cardiometabolic morbidity and mortality. Our proprietary selective cortisol modulator, miricorilant, is very potent in the liver. In a Phase Ib study, it rapidly reduced liver fat and improved other important markers of liver health, including fibrosis. The drug was quite well tolerated without the gastrointestinal side effects commonly seen in patients being treated for MASH.

Our 175-patient double-blind, placebo-controlled Phase IIb MONARCH study is fully enrolled and will produce results by year-end. Positive results would support advancement to Phase III. Patients with ALS have dysregulated cortisol levels, which is why we believe our proprietary selective cortisol modulator, dazucorilant, may provide a treatment. Results from our 249-patient double-blind, placebo-controlled DAZALS trial of dazucorilant in patients with ALS have been very encouraging. In DAZALS, patients who received 300 milligrams of dazucorilant exhibited an 84% reduction in the risk of death at the 1-year mark compared to patients who received placebo. The p-value for this finding was 0.0009. This benefit persisted into the study's second year with an 87% reduction in risk of death at the 2-year mark. The p-value for this finding less than 0.0001.

I want to take a minute to be clear about the benefit dazucorilant appears to offer because it's different from the way most medications targeting ALS are intended to work. Dazucorilant does not appear to prevent functional decline. It prevents early death. There is a common misperception that death resulting from ALS is always coterminous with severe functional decline. That is not the case. Many patients die from complications such as pneumonia and cardiovascular events early in the course of the disease when they still retain significant function and good quality of life.

Preventing death during this period, giving back to these patients a good time would be a great benefit. We are currently conducting a small study to see if dose titration can improve dazucorilant's gastrointestinal tolerability. Nonserious GI distress caused most of the discontinuations in DAZALS, an outcome that we think can be avoided. We will incorporate what we learned from our dose titration study into the design of the pivotal trial that we plan to start later this year.

To sum up, our Cushing's syndrome business remains on a strong growth trajectory, driven by increasing understanding of hypercortisolism's true prevalence and the need for treatment. Our landmark CATALYST and MOMENTUM studies are causing expanded screening for Cushing's syndrome, more accurate diagnosis and improved care, trends that will drive substantial revenue growth for our existing medications and even faster growth for relacorilant once it is approved. We are proud to have secured our first oncology approval for Lifyorli in platinum-resistant ovarian cancer and have made great progress in a very short time, bringing it to patients. We are confident relacorilant can help patients with earlier stages of ovarian cancer and with other types of solid tumors and in combination with other anticancer therapies.

We expect results from our Phase II trial of relacorilant combined with nab-paclitaxel and bevacizumab in patients with platinum-resistant ovarian cancer by the end of this year and from our recently initiated portfolio of oncology studies by the end of next year. Following up on our positive Phase II DAZALS findings, we expect to begin a Phase III trial in patients with ALS later this year. By year-end, we will know the outcome of our Phase II MONARCH trial in patients with MASH and we'll proceed to Phase III if that outcome is positive.

The potential of cortisol modulation to benefit patients is immense. We remain deeply committed to converting this potential into meaningful patient outcomes. We thank the patients who participate in our trials, our employees, our clinical investigators and our academic collaborators for being part of this important work.

Operator, let's proceed to questions.

[Operator Instructions] Our first question comes from the line of David Amsellem of Piper Sandler.

So just a few. With the updated guidance, should we assume that it's mostly relacorilant contribution? Have any assumptions changed on Korlym. So can you help us just go through that. And then secondly, can you talk to positioning versus KEYTRUDA in practice and how we should think about that? And then lastly, just give us a little bit of color on how nenocorilant differs from rela. And what you see in that molecule that is driving your development decisions there.

Thank you, David. Thank you. I think I got all of your questions. Atabak, why don't you take the first question about range?

Okay. Great. So David, so at this point, our endocrine business represents the bulk of our guidance range just given where we are with oncology. But in terms of where we -- the updates that we had since last quarter in oncology is obviously, now we have approval. We've published the final ROSELLA results in The Lancet and inclusion in the NCCN guidelines. And as Roberto mentioned, we're really happy with what we're seeing thus far. And to layer on top of that, where Sean talked about, we're really happy with what we're seeing on the Cushing's syndrome side of our business and the strong fundamentals that we're seeing there, we expect to translate to revenue soon. So ultimately, given the strength on both sides, we are confidently raising our guidance range.

Thank you, Atabak. And I think the second question is really Roberto's.

Yes. So thank you for the question there. I think the first thing for us to think about when thinking about KEYTRUDA and Lifyorli is just to take into account that we only compete in a subset of the market. Lifyorli is approved for an all-comer and KEYTRUDA is approved for a PD-L1 population. When you factor in testing rates, we are talking about something 35% to 40% of patients there.

Now when you actually look at the data from our ROSELLA trial, you see the strength of our overall survival data, you see the safety, tolerability of that regimen as well as the convenience. So what we are hearing from physicians is that there is a preference even within that population to actually look into the ROSELLA regimen as being a preferred regimen. Perhaps that is also reflected in the treatment guidelines today, as you see, we have a preferred status. So we feel very confident that our regimen brings benefits to patients.

Thank you, Roberto. And let me introduce a person who hasn't spoken yet, Bill Guyer, who runs all of our -- our Chief Development Officer, who runs all of our development activities to make a comment or 2 about nenocorilant.

Great. Thank you, David. I mean one thing we've seen related to nenocorilant is that every selective glucocorticoid receptor antagonist that we've studied has unique properties and have shown specific benefits. But we've seen those as they progress through our development program. So continuing our research in new molecules like nenocorilant is definitely worth investigating.

We believe nenocorilant has unique properties that will allow us to test even more hypotheses for solid tumors that express the glucocorticoid receptor. In particular, nenocorilant has shown strong activity in animal models in combination with immunotherapy. And so based upon that, we felt that nenocorilant could be a good partner with immunotherapy like nivolumab. But we're going to learn a lot from this Phase I study that will help guide us to rapidly move forward into a Phase II study. And from that study, we'll be able to even better elucidate what those specific attributes are.

Our next question comes from the line of RK with H.C. Wainwright.

Congratulations on the launch of Lifyorli. So the 3 questions that I have, 2 on pipeline -- I mean, 2 on outside of Cushing's syndrome. On the Lifyorli business, what proportion of platinum-resistant ovarian cancer prescribers do you expect to convert to Lifyorli, especially now that you have the NCCN preferred designation. And in general, what does steady-state share of script look like in that.

And the second question is on DAZALS. If you think about a Phase III design, what -- should we think about like the 300-milligram dose. And in terms of endpoints and timing of the initiation of that study is question two. And the third question is on the Korlym business itself, glad to note that the pharmacy, the specialty pharma is able to handle all the increased scripts. Are you also looking to add one more specialty pharma so that we don't face the same situation which we faced last year, especially with the momentum that you're getting from MOMENTUM and on CATALYST.

Okay. I think I got all of those questions, very good. I think the first one is best answered by Roberto.

Yes. So RK, let me -- your question about conversion of prescribers. Let me just go up to the top. We are targeting 5,000 physicians in the U.S. that actually respond to almost 90% of all the volume here. So our expectation is that the very large majority of those will become prescribers that's supported by our market research as we have tested, but also by the very strong uptake. We have been able to capture more than 200 of those within the first month. And we are seeing this coming from community oncology, from gynecology, from academic setting. So from a -- in a very broad and diverse group of physicians from every part of the country.

So we have every expectation that these physicians will adopt the therapy. We think that the profile, as we discussed, is very favorable to that because it's very easy to adapt the clinical practice to utilize this drug given the safety profile we have. You asked about the share at steady state. I think that the most important consideration here is that we do have an expectation of becoming market leader in a relatively short time frame. We expect that the drug will be utilized by the majority of patients in different lines of therapy. But really, it's a very attractive proposition for pretty much every patient there given our indication.

Thank you, Roberto. I think the second question is Bill's.

Yes. Thank you, RK. So related to DAZALS, the 2-year overall survival benefit is highly encouraging and shows consistency of the 300 milligrams. And I think that's the focus, whether it's the 24-week blinded data showed significant benefit of survival to 300 milligrams over placebo. The 1-year data showed survival benefit of the 300 milligrams as did the 2-year data showed benefit for the 300 milligrams. So that's going to be our focus in Phase III. And we've designed a Phase III study that works off the success of the DAZALS trial to replicate those results and confirm that dazucorilant can reduce early death and improve survival.

So again, the endpoint would be survival and the focus would be 300 milligrams and would likely be a placebo-controlled trial. And we're working with the top ALS researchers around the world to help guide that study, and they've already commented on our study design. And we've also collaborated with the FDA and EMA and are incorporating their comments into that study, and that will allow us to start this trial this year and enroll patients by the end of this year.

Thank you, Bill. And the Korlym questions go to Sean.

RK, thanks for the question. So I'll start just by saying we're very happy with what we've seen with Curant. They've done a very nice job transitioning our active patient base from our previous vendor and then handling all the new prescriptions that have come in. And again, they've been at an all-time high. So they've been working sort of in 2 places at once as they've been supporting these patients and have done a very nice job.

They've scaled as our business have grown, and we know that they can continue to scale with that. That being said, we know that eventually, our business is going to get to a place from a volume standpoint that it's going to be far too much for one pharmacy to be able to handle. So our plan is down the road to expand our network. When we expand and by how many we expand will be driven by what we're seeing from a volume growth standpoint. But as it stands today, I mean, our plan is to bring in some additional support in the fourth quarter this year into the network.

Okay. I'm sorry, RK, did you have something question there?

No, no. Actually, I appreciate all the color.

Thank you very much. Well, this concludes our call. Thank you very much for listening for the questions. I think it's a very, very exciting time for the company. We're really pleased with what we're seeing both in the endocrinology and on the oncology side. Please look at our press release for all of the things which are going on in development. It really is wonderful to be able to see us really bring forward towards the potential of cortisol modulation as a treatment for very many serious diseases. So thank you. Good evening, and we'll talk to you next quarter.

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

Thank you for standing by, and welcome to Corcept Therapeutics' Fourth Quarter 2025 Earnings Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions]

I would now like to hand the call over to Atabak Mokari, CFO. Please go ahead.

Hello, everyone. Good afternoon, and thank you for joining us. Today, we issued a press release announcing our financial results for the full year 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-K with the SEC.

Today's call is being recorded. A replay will be available at the Investors Past Events tab of our website. Statements during this call, other than statements of historical fact are forward-looking statements based on our plans and expectations that are subject to risks and uncertainties, which might cause actual results to be materially different from those such statements expressed or implied.

The risk 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, which are available on the SEC's website. Please refer to those documents for more information. We disclaim any intention or duty to update forward-looking statements.

Our 2025 revenue was $761 million compared to $675 million in the prior year. We expect our revenue growth to continue and are providing full year 2026 revenue guidance of $900 million to $1 billion. Net income was $99.7 million for the full year 2025 compared to $141.2 million in the prior year.

Cash and investments at December 31, 2025, were $532 million, which reflects our acquisition in 2025 of $245 million worth of our common stock pursuant to our stock repurchase program as well as shares acquired upon the exercise of Corcept stock options and the vesting of restricted stock rates.

I will now turn the call over to Charlie Robb, our Chief Business Officer. Charlie?

Thanks, Atabak. As many of you know, last Thursday, the Federal Circuit Court of Appeals ruled against us in our lawsuit to stop Teva Pharmaceuticals from marketing a generic version of Korlym in violation of our patents. We believe the court made a mistake, patents we have asserted as included in Korlym's label and Teva's Copy of Korlym's label instruct physicians how to administer Korlym safely with drugs in many patients with Cushing's syndrome require for optimal health.

Such as widely prescribed antifungal and antiviral medications. We know there are physicians to follow these instructions. The expensive, risky research we undertook to make this important medical advance available is exactly what the patent system is meant to encourage we plan to appeal.

I'll now turn to the FDA's failure to approve relacorilant as a treatment for patients with Cushing's syndrome. We were surprised by the FDA's decision. Why? Because relacorilant benefits patients with Cushing's syndrome, and we strongly believe the data we submitted with our NDA shows that. There are many reasons we were so optimistic about relacorilant's prospects.

Most importantly, as the FDA has acknowledged our pivotal GRACE trial met its primary endpoint with a p value of 0.02. The primary evidence we submitted to confirm this positive result came from patients in our double-blind, placebo-controlled gradient trial whom the FDA had identified prior to data unblinding as being of particular importance to its review.

Further, GRACE's primary end point, improvement in hypertension, secondary to Cushing's syndrome addresses a serious unmet medical need. It was also agreed to by the FDA and for good reason, cardiometabolic complications are the leading cause of death in patients with Cushing's syndrome. Existing hypertension medications are often partially or wholly ineffective in treating this condition.

76% of the patients with hypertension who enrolled in Grace, for example, we're already taking 1 or more blood pressure-lowering medications. Of these patients, 39% were taking 3 or more -- these patients needed a blood pressure of treatment that work for them. Relacorilant's demonstrated benefit addressing an unmet need in patients with a serious condition by itself would be ample reason to expect its approval. But we had additional causes for optimism throughout relacorilant development program, patients exhibited meaningful improvements in other signs and symptoms of Cushing's syndrome, not just hypertension.

For example, in the open-label phase of GRACE, patients had a robust and consistent response to treatment. They lost weight without losing muscle mass, their waste are comfort and shrink and their glucose control improved. All without a worsening in their other signs and symptoms. Patients with Cushing's syndrome do not improve without treatment. They get worse.

Another important quality of relacorilant is the gave cost for optimism is that relacorilant confers its benefit without giving rise to serious adverse events and off-target effects associated with the currently approved treatments, including QT interval prolongation, adrenaline sufficiency, hypokalemia endometrial thickening, irregular vaginal bleeding and termination of pregnancy.

Relacorilant would provide a treatment option for patients who find 1 or more of these risks disqualify. The liver enzyme elevations cited in the FDA's complete response letter can be managed as the complete response letter implies through appropriate label instructions and post-marketing surveillance and did not give us reason to adopt.

In addition to the efficacy and safety benefits I just described, there was still another reason for us to expect relacorilant approval. Our clinical development program, it large, by which I mean the design of our trials, the number of patients studied and the amount of data included in our NDA compared favorably to the development programs that led to the approval of other Cushing's syndrome medications.

For example, our pivotal GRACE trial employs the same design as the trials that led to the approval of history and record led the 2 most recently approved Cushing's syndrome medications. Our primary source of confirmatory evidence for Grace's positive result was drawn from patients in a placebo-controlled double-blind study, making it more compelling in our view than the open-label evidence that supported other approvals.

Then the number of patients we studied in GRACE, their trial completion rate and the amount of data they contributed to our NDA exceeded that of the most recently improved medication. In sum, our review of FDA precedent, just as much as our scientific evaluation of relacorilant's clinical data give us ample reason for optimism. I'll close with the final reason. We worked with the FDA for years to bring relacorilant to the point of NDA submission.

During that time, the FDA made recommendations regarding various aspects of our program. As is the case with all development programs, and we accommodated those recommendations. By the time we submitted our NDA, we have tailored our development program to the FDA's guidance in all material respects. The FDA tells sponsors, when it does nothing they submit NDA. They did not tell us that nor did the FDA tell us we would face significant review issues or a possible refusal to file letter if we did submit.

Following the filing with NDA, FDA's internal guidance calls for the agency to inform drug sponsors as quickly as possible to our deficiencies in the form receptance of the NDA package that would preclude approval. We heard nothing of the sort to the very end of the process at neither the mid and our late cycle meetings that are part of every NDA review was the word deficiency is used.

To reiterate my original point, we were surprised and for good reason that relacorilant was not approved. Where do we go from here? Our priority is to make relacorilant available to patients as quickly as possible. We will meet with the FDA in April to better understand it's thinking. Outcomes from that meeting range from resubmission of our NDA, perhaps including additional analyses from our NDAs rich data set to a filing of a formal appeal with the FDA's office of new drugs to deciding we need to conduct a new study.

I'll now turn the call over to Sean Maduck, President of our Endocrinology division. Sean?

Thanks, Charlie. Our Cushing's syndrome business experienced a surge in demand in 2025. And -- we saw a record number of new prescriptions for our medications and a record number of first-time prescribers. We delivered 37% more tablets than we did in 2024 with a record number of patients receiving our medications than ever before. But we should have delivered more.

We had a 61% increase in the number of new prescriptions, but only a 37% increase in tablets sold. That gap is an illustration of the lack of capacity at our pharmacy vendor. I've discussed on our prior call, the inability of our previous pharmacy vendor to fully meet the rapidly increasing demand for medications. We took a major step towards solving this problem in October when we began transitioning our business to a new specialty pharmacy with much greater capacity.

We have been pleased with the new pharmacies capabilities, but the complex, time-consuming task of transferring prescriptions and medical files for thousands of patients from the old pharmacy to the new 1 disrupted our business in November, December and January. The headwinds created by this transition work have subsided.

The new pharmacy received a final batch of patient files earlier this month, and we are seeing promising signs of improved performance. For example, we are on track to set a monthly record for new patient starts in February. I've never been more confident in the future of our commercial business.

For many years, physicians screened and treated only the most physically obvious cases of Cushing's syndrome. In the last 15 years, many studies have shown how important it is to identify and treat patients across a much broader spectrum of disease. But the Landmark Catalyst trial we completed last year proved this point definitively.

Catalyst had 2 parts. Its first prevalence phase screened 1,000 patients with diabetes that was uncontrolled despite receiving the best care, including GLP-1s, and found that 24% of [ tatypiportisol ] is. Catalyst second, the treatment phase, randomized 136 patients with uncontrolled diabetes and hypercortisolism to receive either Korlym or placebo. After 24 weeks of treatment, the mean decrease in HbA1c in patients who received Korlym was 1.47% compared to a 0.17% mean decrease in patients who received placebo.

Patients in the Korlym Group also exhibited large decreases in weight and waste or comforts. These data fully published in December are transformative. Physicians have begun to incorporate these findings into their practices, but a change of this magnitude takes a bit of time to fully absorb. The prescribing community internalizes the catalyst findings, screening for and treatment of Cushing syndrome will increase and sold the number of patients receiving our current medications.

We expect our Cushing Center business to grow to at least $2 billion in annual revenue by the end of this decade. When [ Relacare ] is available, growth will accelerate further. I will now turn the call over to Joe Belanoff, our Chief Executive Officer. Joe?

Thank you, Sean, and thank you, everyone, for joining us this afternoon. Since Corcept's inception, our work has had a single focus, fully exploring the potential of cortisol modulation to treat patients with serious diseases. That potential is vast. We have made important advances. It is now established that hypercortisolism is much more prevalent than previously thought and the treatment with the cortisol modulator can benefit many patients.

There is now growing acceptance that cortisol activity at the glucocorticoid receptor, or GR, worsens the prognosis of patients with many types of solid tumors, while reducing cortisol activity at the GR can be beneficial. Our IZEA trial proved this point in platinum-resistant ovarian cancer. Patients who receive relacorilant in addition to nab-paclitaxel has longer progression-free and overall survival than those who received nab-paclitaxel alone.

As our oncology research continues, I am optimistic that relacorilant and other cortisol modulators will provide treatments for patients with other solid tumors and will be effective in combination with other anticancer therapies. Looking beyond hypercortisolism in oncology, our work in metabolic and neurologic indications is advancing quickly. I'm also optimistic that our proprietary compounds will prove beneficial in these areas as well.

I want to underscore Sean's comments about the CATALYST trial. It is transforming medicine. Prior to CATALYST, no 1 would have thought that 1 in 4 patients with resistant diabetes had hypercortisolism. And no 1 would have thought to treating these patients with the cortisol modulator would produce a striking benefits, substantial reductions in hemoglobin A1c, weight and waste [ comforts ] compared to those patients who received placebo.

Patients experienced these improvements, even as many of them decreased or entirely discontinued their other glucose-lowering medications, including the most potent GLP-1 agonists. These are landmark findings. We've recently completed the 1,000-patient MOMENTUM trial. With everything else that has been going on, there's not been much focus on momentum, but it is a very important study.

Momentum complements catalysts by examining the prevalence of hypercortisolism in patients with resistant hypertension. We will announce its findings next month in a featured oral presentation at the annual conference of the American College of Cardiology. Catalyst offers physicians struggling to treat patients with resistant diabetes, a paradigm shifting insight.

Hypercortisol is in place a foundational role in many of their patients' conditions and treating that hypercortisolism can provide important benefits. Momentum may begin to provide the same insights about patients with resistant hypertension. These findings and the change in patient care that they will stimulate will drive growth in our Cushing's syndrome business for years to come.

Last month, we announced the positive final results of our Phase III ROZELA trial in patients with platinum-resistant ovarian cancer. ROZELA met both of its dual primary end points patients who receive relacorilant in addition to the potent chemotherapy medication nab-paclitaxel experienced longer progression-free survival and longer overall survival than the patients who received nappaclitaxel alone.

To quantify these benefits, patients treated with relacorilant and nab paclitaxel experienced a 35% reduction in risk of death a hazard ratio of 0.65 compared to patients who were treated with nab paclitaxel alone with a p-value of 0.0004. Median overall survival for patients receiving relacorilant was 4.1 months longer than it was for patients on nab-paclitaxel monotherapy. A significant number of patients responded even better to the addition of relacorilant to their anticancer regimen than these results suggest.

As the survival curves 75th percentile point patients receiving relacorila like 8 months longer than those who had received nappaclitaxel alone. We will be presenting Rosella's full results at the Society of Gynecologic Oncology at the [ SGO ] meeting in April, and we'll publish them in a leading peer review journal later this year.

As you can imagine, the world-class managers and salespeople, we have recruited to run our commercial oncology division are eager to bring relacorilant to patients. They and leading oncologists believe strongly that relacorilant with its best-in-class efficacy and safety data world administration and lack of biomarker selection requirements is likely to become the new standard of care for women with platinum-resistant ovarian cancer.

Our FDA PDUFA date is July 11 of this year. As I mentioned earlier, Rosella is just the beginning. We are currently evaluating relacorilant in combination with other anticancer therapies and in other solid tumors, including platinum-sensitive ovarian endometrial, cervical and pancreatic cancers.

Data from these studies will be national comprehensive cancer network or NCCN guideline enabling and will inform our future development decisions. We expect results from these studies by the end of next year. We are also evaluating GR antagonism potential to augment immunotherapy. Because Cortisol suppresses the immune system, and made lumpy effectiveness of therapies intended to stimulate an immune response.

A treatment regimen that combines an immunotherapy agent with a GR antagonist may stimulate a stronger, more effective immune response. We have started a Phase Ib study of our proprietary selective GR antagonist, nenocorilant, in combination with nivolumab, a PD-1 directed immunotherapy to treat patients with a broad range of solid tumors.

Finally, we are exploring glucocorticoid receptor antagonist used in combination with androgen defrabation 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 [ taganism ] can block a cortisol mediated tumor escape route.

Cortisol activity plays a role in the initial development and progression of a serious liver disorder known as metabolic dysfunction associated steatohepatitis or MASH. MASH afflicts millions of patients in the United States and globally, and it is a significant and rapidly growing cause of liver and cardiometabolic morbidity and mortality.

Our proprietary selective cortisol modulator, miricorilant, is very potent in the liver. In a Phase Ib study, it rapidly reduced liver fat and improved other important markers of liver health, including fibrosis. The drug was very well tolerated without the GI side effects commonly seen in patients being treated for MASH. Our 175-patient double-blind, placebo-controlled Phase IIb MONARCH study is fully enrolled and will produce results by the end of this year. If they are positive, we will advance to Phase III.

Patients with ALS have disregulated cortisol levels. which is why we believe our proprietary selective cortisol modulator, dazacorulant may be very useful. Results from our 249 patients double-blind, placebo-controlled [ Dazels ] trial of dazecorilant in patients with ALS are encouraging.

In [ dazzles ], patients who received 300 milligrams of dazacorilant for 1 year, exhibited an 84% reduction in risk of death compared to patients who received placebo. The p-value for this finding was 0.0009. Dazecorilant's apparent prevention of early death, that is death early in the course of the disease confirmed by a pivotal trial would be a tremendous benefit to patients, many of whom die relatively quickly after the onset of symptoms before they have lost significant function and quality of life.

We have initiated a small study to see a dose titration in approved dazecorilant's gastrointestinal tolerability. Nonserious GI distress caused most of the discontinuations in dazzles an outcome we think can be avoided. We expect to incorporate what we learned from our dose titration study into the design of the pivotal trial we plan to start later this year.

To sum up, our Cushing's syndrome business experienced a surge demand for Korlym in 2025 because of growing recognition among physicians of hypercortisolism's true prevalence necessity of appropriate treatment. With expanded pharmacy capacity now in place, we are confident that we will meet future demand, which we expect will grow significantly as the findings from our catalysts and MOMENTUM studies are recognized by physicians.

We are working with the FDA to obtain approval of relacorilant in Cushing's syndrome. As Sean said earlier, our Cushing's syndrome business is poised for substantial growth with our existing medications and will grow even faster upon the approval of relacorilant. By midyear, we expect relacorilant's first oncology approval in platinum-resistant ovarian cancer, a particularly challenging form of ovarian cancer.

We are very pleased with the groundbreaking results of our pivotal Phase III ROSELLA trial, which met both of its primary endpoints without changing the safety burden borne by patients. Back the glucocorticoid receptor antagonist have demonstrated such compelling results and is extremely difficult to treat cancer type, gives us confidence in relacorilant's potential in earlier stages of ovarian cancer as well as in other tumor types and in combination with other anticancer therapies.

We expect results from our BELLUS study in platinum-resistant ovarian cancer by the end of this year and from our other new oncology trials by the end of 2027. Following up on our positive Phase II DASL findings, we expect to begin a Phase III study in patients with ALS by midyear.

By year-end, we will know the outcome of our Phase II MONARCH trial in patients with MASH and will proceed to Phase III if that outcome is positive. We are also continuing to discover and develop new cortisol modulators, advancing the most promising of them to the -- the potential of cortisol modulation to benefit patients is vast.

It is a privilege to help convert that potential to approve medications that can really make a difference in people's lives. We thank the patients who participate in our trials, our employees, our clinical investigators and our academic collaborators for being part of this important work. Operator, let's proceed to questions.

[Operator Instructions] Our first question comes from the line of David Amsellem of Piper Sandler.

I have a few. First, on the CRL. It sounds like you believe that the agency for maybe lack of about the better term moved the goalpost on you, but I wanted to get more detailed thoughts on how you're thinking about it.

And then secondly, your willingness to run a more conventional randomized trial of relacorilant in type 2 diabetes and/or hypertensive patients who are poorly controlled. I guess, something along the lines of momentum and catalyst and how likely is it that ultimately that's the path you go down -- so that's my first set of questions.

And then on Korlym, can you just talk about some of the assumptions in your guide, particularly erosion of net price percentage of the business going through the AG and also just the net price, the discounts or net price off of the list price? How should we think about that for '26.

Okay. Edward, I think that we caught all of your questions -- I'm sorry, David, a I think we caught all of your questions. But if for some reason that we haven't we specify at the end and we'll try again. That was a good list. So I'm going to give you a first to Charlie to talk about CRL.

So David, I'm not sure exactly what sort of moving the goalpost would have looked like. And I don't know exactly what was in the sort of FDA's mind in that regard. But what we did was looked at the data we had on a sort of a scientific basis and it clearly met the hurdle for approval.

And then when we turn to look at the other drugs that the agency had approved, both sort of our trial design and program generally and the results we had were clearly right in line with prior approved treatments. So I don't know, if the FDA is thinking shifted in any way, but we really just think we just missed the market in that regard.

Is that I think I hope that sort of address.

Yes, please, David, does that answer your question?

Well, I guess there is a redacted CRL that lays out some very specific concerns. So it just seems that there's a lot of daylight between how the FDA is thinking about this filing and how you're thinking about this filing. And I'm just trying to understand how we in the investor and analyst community can somehow bridge that gap, if that makes sense.

Yes. I mean I think the Again, I think that without sort of parsing the CRL line by line, there are things in it that are sort of curious and hard to follow. For example, leading with -- the acknowledge is right out of the gate that our pivotal trial met its primary endpoint for instance. The confirmatory evidence we provided also met it's end point until the agency mentioned sort of an analysis at the end that they performed that we had never seen and really can't replicate.

So there is daylight between our position and their position. And I think the -- again, I just have to return to, I think, on the merits on compared to the other approved drugs, we got it right. I can't really explain how they moved to their decision. And that's what we're going to find out when we meet with them at the meeting in April. That's really the purpose of it. We do want to understand, we think they will be able to articulate it to us and we will be able to move forward from there. That's why we're meeting with them.

Okay. And John, so there were several questions related to sales of Korlym?

Yes. No, thanks for the question. So in terms of the AG, the AG's net price is about a 30% discount on Korlym's lack. And that's been consistent really since we launched the AG -- now over the course of 2025, more volume shifted from Korlym prescriptions, obviously, to AG prescriptions. And we ended the year at a -- and that really was what the pricing impact was in our 2025 revenues.

Now in terms of 2026. We're at about 78% AG. We expect it's going to maybe move a tick or so more, but it's essentially stabilized. But we have built in potential pricing pressures and discounting in through the remainder of 2026.

Okay. And then just my -- and then just my question on running a randomized relacorilant trial. If it came to that, can you just talk about the likelihood of ultimately going down that path -- is that the outcome you envision here? And how long would such a study take?

Again, I really want to -- important point I really want to clarify for the whole audience, our medicines are for the treatment of hypercortisolism. And what we found is that the pool of patients with hypercortisolism is significantly larger than I think was believed 15 years ago or 10 years ago or many people even 5 years ago.

These patients reside in many important disease states and previously just simply didn't respond to conventional treatment. So for instance, what the catalyst study showed us was that in patients who have resistant diabetes, even with the best medications treated by the best doctors, is really a group of nonresponders.

And of those nonresponders, about 1/4 of them have hypercortisolism and what the treatment portion of the CATALYST study set is, if you treat their hypercortisolism those symptoms improve, and they improve really very dramatically. Now the results for hypertension, for resistant hypertension are yet to be revealed. But please pay attention in a month because I think they're going to be very important.

And I think the general point that we're making is that hypercortisolism is an important driver of many symptoms and the patients with hypercortisolism are currently undiagnosed in many important disease states. So where it leads us to do in terms of clinical development. I'm not -- I can't tell you with certainty at this point, but really understand that mechanistically what's going on is the identification of patients with hypercortisolism and then their treatment.

Our next question comes from the line of Jing Dang of Truist.

This is Jim online for June. My first question actually is on the oncology side. Congratulations on your Rosella data has by both OS and PFS. But my question is looking ahead to SGO in April. So what should we expect to see for that complete data set for example, like a specific group or safety analysis and also full safety tables? And then also, how do you expect this will support early adoption.

Okay. I think I'd like to start that answer to question with Bill Guyer, who our Chief Development Officer. And then at the end, maybe Roberto Vieira, who have not had a chance to introduce you to who is the President of our Oncology a few additional comments. Bill, go ahead.

Thank you for that question. So one, I want to respect what we're going to present at -- so and not give you too much details, but yet still try to answer your question as well as respect our publication that we hope to have come out as soon as possible as well. But at SGO, on the whole, we expect to show the full Kaplan-Meier curve, where you can see the percentage of patients who are alive in both arms and the separation of those arms. That will be a key point to look at.

And yes, we will have full safety data sets presented there as well. And an important finding, I think you'll see is that the safety isn't really any different than the analysis we did about a year ago. And so it really shows the tolerability of relacorilant in combination with that of all -- so there'll be a lot of data within that presentation. I think you'll find it very interesting, but I do want to respect that embargo for that presentation. But yes, you'll see a full analysis and a full data set presented at SGO and hopefully soon published right after or similarly close to that time.

Okay. Very good. And Roberto, I think you've called out to speak to early adoption.

Yes. So thank you for the question about the adoption. I want to go back to the point that Joe made in his opening remarks, a 35% reduction in the risk of death a 4.1 month extension of median overall survival in a population that is incredibly refractory and clinical and clinically challenging -- so we look at this, especially in the context of the outcome indication has been transformative.

This has never been done before. It's the first time that we have overall survival data of this magnitude demonstrating the outcome population. And then you look into the safety and tolerability, you was just alluding to that, we'll present the final data, but you can look at that in the lansoplication from last year. The bottom line of the safety is that relacorilant did not really add much to the safety but in comparing to abupactaxel.

Now the package is a taxane that there's great familiarity on how to treat it -- and I think that the best way to look at the safety is that a single-digit discontinuation of the regimen. So overall, very tolerable regimen. It's also an oral therapy that actually doesn't add to the burden of treatment altogether. So when you look into efficacy in the all-comer population, the safety and the conveniency of this regimen, our expectation for adoption is really a very early adoption lines of therapy and very broad adoption, establishing what we consider to be a potential new standard of care in the category.

Our next question comes from the line of RK with H.C. Wainwright.

Good afternoon. A couple of quick questions here. One is on the supply chain issues and specialty pharmacy. How confident are you that all of those which have been lingering for almost a year now have been taken care of. And when we think about the guidance that you gave us, how much of that is being taken into account the relacorilant revenues from the oncology franchise, how much of that is included in there?

And then the last question is, as Bill was talking about safety, -- do you -- are we going to see the full picture of safety from relacorilant in that trial? Because obviously, you were thinking that you had all the safety stuff straight, but FDA was not thinking so with the relacorilant and the Cushing syndrome.

And then the last question for -- again, for Bill is, how does he think about [ KEYTRUDA ] coming into the picture now. And how was Roberto and Bill try to think through it and message it?

Well, okay. Thank you for the list of questions. You're going to give our whole executive to have an opportunity to wait in here. So Sean, why don't you start with the first question?

Yes. No, thanks, RK. I'm going to talk a little bit about the end of last year and then talk about what the expectations are moving forward. So -- the transition with -- between the 2 pharmacies started in October, and it was challenging, as I talked about in my opening comments, 1 thing I want to make clear is that all patients are actually now at [ Ceron ]. Now that those patients are all [ current ], we're actually seeing improvement and a lot of the metrics we look at are head in the right direction. So we've got a record number of new starts. We're on track for that in February and we're serving our existing patient base in a more timely and efficient manner.

So now in terms of the new pharmacy partner, what gives us confidence that we'll be able to see a different result. And that's based off -- I would say why we selected them and then what we're seeing today. So this is a pharmacy that has over 25 years of expertise in the orphan space. They have a patient-first mindset, which is very much aligned to Corcept and how we support our patients -- they have extremely strong leadership. They have strong people. They have very sophisticated technology and processes actually on how they manage a patient from enrollment all the way through to distribution.

And 1 of the most important pieces, which was our issue with sort of overloading the system last year is that they actually have multiple locations. So they have the ability to scale their business very, very quickly. And our belief is that they are well, they told us they're committed to doing that. And I believe is that they will scale with us as our business continues to grow.

So we've been working very closely with them over the last many months through the transition, and we're very happy with what we've seen and have a lot of confidence in that vendor.

Good. Okay. And Atabak, why don't you take the revenue question?

Sure. RK, so regarding how much of our guidance, the mix of it, almost all of our guidance range comes from our Cushing's syndrome business at this point, only a small portion of the -- of our guidance range comes from our oncology business is given the anticipated timing of launch in oncology.

Bill, you have the safety question.

Safety question. So -- and again, hopefully, I'll answer it in the way you were asking. So related to safety from Rosella as I stated before, and I'll give you a little bit more detail a because you kind of related it back to endocrinology. So from Rosella, what we're seeing in the safety profile a year ago versus now a year later at the final overall survival analysis, we're seeing very similar safety profile, almost exactly the same.

And again, you'll see that at SGO, now by raising endocrinology, I think you're probably raising -- are we seeing any rises in ALT that we might have seen in that of the endocrinology program. And I'll go back to the endocrinology program, our assessment within the endocrinology program we did not have any cases of drug-induced liver entry. And we also have confirmation of that from our external independent safety committee that also evaluated all that data.

So no real issue there in endocrinology, and I know it has been raised, but we then went to look at oncology and we looked at the ROSELLA data. And I just want to make it clear as well, we aren't seeing any rises in ALT elevations that are significant kind of concern because as a background, when you look at within the ROSELLA trial, one, nataclitaxel on its own can rise ALTs and you need to kind of understand that within platinum-resistant ovarian cancer. But when we combine relacorilant with that of net paclitaxel in the ROSELLA study, we're going to be presenting this data in just a couple of days. We actually see half the amount of ALT rises in the combination arm compared to that of the map paclitaxel alone arm.

So we're not seeing any added toxicity. We're actually seeing a reduction in that of ALT rises. And that data, again, we'll be able to share with you in just the next 2 days. So I feel very comfortable and confident with the safety profile of endocrinology in both the oncology area and also the endocrinology area. Roberto the final question?

Yes. So starting you through the RK, let me just start by reminding us that their approval is for CTS greater than 1 or a PD-L1 expression greater than 1 -- so in our data sets in real world, we are talking about 50% to 60% of the total population. So of course, you have that limitation of the biomarker right there.

Now beyond this, it's important to remember that KEYTRUDA has been used in ovarian cancer for a while was part of the NCCN guidelines in other regimens that are taxing sparing that do not utilize -- he has a use there is 10% to 15% of those patients already in later lines of therapy. Now when we have engaged work with oncologists, they are very much interested in maintaining options.

They, of course, they are interested in ROSELLA the way for them to maintain options to continue to use as they have done in their combination that does not require paclitaxel and to use that in later lines of therapy. So overall, when you compare a regimen that came with a safety button that you can see in their data, had ratio of 0.76. There is a clear signal here that there's within of our ROSELLA regimen in other lines and maintaining optionality for you through the late let of therapy.

Thank you, RK. And I think we'll -- we will conclude our call, and we will plan on seeing you in 3 months. Before I get off, though, I just want to let you know, there really is a lot of important news to pay attention to as we go forward. We have our MOMENTUM study results. We have our oncology presentations. We have publications coming.

And so please do follow. There's a lot of news between now and the next 3 months, and we'll look forward to talking to you again at that period of time. So thank you.

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

Thank you for standing by, and welcome to Corcept Therapeutics' Third Quarter 2025 Earnings Conference Call. [Operator Instructions]

I would now like to hand the call over to Atabak Mokari, CFO. Please go ahead.

Hello, everyone. Good afternoon, and thank you for joining us. Today, we issued a press release announcing our financial results for the 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 that are subject to risks and uncertainties, which might cause actual results to be materially different from those such statements expressed 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 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 to $850 million. Net income was $19.7 million compared to $47.2 million in the third quarter of last year. Our cash and investments at September 30 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 divesting of restricted stock grants.

We'll now turn the call over to Charlie Robb, our Chief Business Officer. Charlie?

Thanks, Atabak. There is 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. Case went to trial in September 2023 and then December 2023, the trial court ruled against us. We appealed that decision to the Federal Circuit Court of Appeals. Three judge panel that court heard oral argument on July 7 of this year. Although it is impossible to say exactly when the court will issue its decision enough time is passed, but 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.

I'll now turn the call over to Sean Maduck, the President of our endocrinology division. Sean?

Thanks, 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 subscriptions written for Corcept. Importantly, our base of prescribers has expanded substantially over the last 2 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. While capacity constraints may continue for the next few months as we complete the transition we are very encouraged by the new pharmacy 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 risk it poses for patients were not well understood. As a result, physicians only screen for and treated the most physically obvious cases of the disorder. In 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 Manzaro 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. 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 and I eagerly anticipate relacorilant approval. [indiscernible] is a great medication but 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 3 to 5 years, I believe relacorilant will generate $3 billion to $5 billion in annual revenue in hypercortisol alone.

I will now turn the call over to Joe Belanoff, our Chief Executive Officer. Joe?

Thank 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 2 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 30, 2025. Our NDA for relacorilant as a treatment for women with platinum-resistant ovarian cancer has a PDUFA date of July 11, 2026. We believe the FDA will meet both deadlines.

We submitted the European analog to our ovarian cancer NDA known as a marketing approval authorization, or MAA, to the European Medical -- Medicines Agency, or EMA, in October. -- with a regulatory decision likely by year-end 2026.

Some 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 the regulators, we are finalizing the design of a Phase III trial of our proprietary selective cortisol modulator, dazucorilant in patients with ALS. We plan to start this trial by the middle of next year with a simple goal of replicating the strong results we saw in ENCALS, 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, BELLA 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?

Thanks, 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 I hypothesize that cortisol activity at the glucocorticoid receptor promotes solid tumor growth in 3 ways. First is anti-apoptotic, so it blunts the effective advance 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 blending cortisol activity is a very broad platform. It applies to all solid tumors that express glucocorticoid receptor. Hubbis Research has shown that about 60% of solid tumors express the GR and they do so at every stage of treatment. Our 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 relevant in addition to nab-paclitaxel and experienced extended progression-free survival and live longer than the women who were treated with just nab-paclitaxel alone.

Now remember, nab-pac is 1 of the most potent treatments for women with this disease and adding relacorilant leads in even better result and remarkably without adding to the safety burden who received it. Adverse events with relacorilant plus nab-pac were comparable in type, frequency and severity to nab-pac monotherapy. As I review the data recons remarkably well-tolerated drug. The 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, 1 of the world's most preeminent journals.

Our goal now is to undertake studies that will extend this work in 3 ways: first, in earlier lines of therapy for ovarian cancer; second, in new types of solid tumors; and third, combining our proprietary GR antagonist 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 relacorilant may bring when combining it with nab-pac as well as bevacizumab, which is a potent drug that is commonly used to treat patients with platinum-resistant ovarian cancer.

Due 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 2 new arms. The first will evaluate relacorilant plus nab-pac and bevacizumab to treat patients with platinum-sensitive ovarian cancer in earlier stage of the disease.

In order to enroll in this arm, patients must have progressive 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-pac to treat patients with endometrial cancer.

Separately, we are also initiating a Phase II study of relacorilant plus nab-pac in patients with cervical cancer in collaboration with ARCAGY-GINECO, 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-pac 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. The results will be guideline enabling with a particular focus on the National Comprehensive Cancer Network or NCCN guidelines, these studies will also inform our future development decisions. In addition to exploring cortisol receptors antagonisms potential to resensitize tumors to chemotherapy, we are evaluating its use in combination with antigen deprivation therapy.

Our collaborators at the University of Chicago are currently enrolling a randomized, placebo-controlled Phase II trial of relacorilant [indiscernible] zalutamide 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, and it made blunt the effectiveness of cancer therapies intended to stimulate an immune response.

Adding a GR antagonist to immunotherapy may enhance their effectiveness. Therefore, 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.

I'll now turn the call back over to Joe.

Thanks, Bill. 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. Prevalent phase of our CATALYST trial demonstrated that 1 in 4 patients with resistant diabetes has hypercortisolism, a far higher rate than was previously assumed. These results are transforming medicine.

Patients who are 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 water conference. Notably, patients and catalysts experienced these improvements even as they decreased or entirely discontinued their other glucose-lowering medications, including the most potent GLP-1 agonists.

Our MOMENTUM trial builds on the findings from CATALYST by evaluating the prevalence of hypercortisolism in patients with resistant hypertension. Results from 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 30 PDUFA date.

Relacorilant's NDA is supported by our pivotal Phase III GRACE trial as well as our gradient long-term extension and Phase II trials. In these studies, patients treated with relacorilant experienced clinically meaningful improvements in all the measures of hypercortisol including hypertension, hyperglycemia, weight, lean muscle mass water conference 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.

As 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.

Our randomized double-blind placebo-controlled Phase IIb MONARCH study aims to expand on our encouraging Phase Ib results. MONARCH enrolled 175 patients in 2 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, dazucorilant, 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 dazucorilant exhibited an 84% reduction in the risk of death at the 1-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.

As I mentioned earlier, we plan to start a Phase III trial in 2026 designed with input from the FDA, European regulators and leading clinicians that 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 the 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. Results from the ROSELLA trial showing improved progression-free and overall survival without additional safety burden or groundbreaking.

Back the 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. It is a very exciting time for Corcept.

Operator, let's proceed to questions.

[Operator Instructions] Our first question comes from the line of Edward Nash of Canaccord Genuity.

I wanted to ask, I know sometimes you give the numbers, I just want to get an idea of how many patients at the end of the quarter that you had on drug. And then also, can you give us some idea of -- I know you're going to be bringing on a second new distributor at the beginning of the year, as you mentioned, I 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 started come on in October have over your old distributor?

Thank 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.

Thanks, 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 1, it's a great pharmacy and we think we're going to -- they're going to do just a fantastic job supporting patients. And they've got about 25 years of experience, which is in serving orphan and 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.

And 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 2 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 relacorilant begins to come on to 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.

Great. That's helpful. And I just had 1 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?

Yes. Let me give you back to Atabak for that question.

Edward. No, we have not seen that, and we don't expect that.

Our next question comes from the line of David Amsellem of Piper Sandler.

Just a couple of quick ones. One, can you just remind us what the -- what net pricing looks like relative to brand pricing, just given that more and more of the business is going through the AG, how much of your business is coming from the AG. And then also, as you look to the PDUFA 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 launches and given all the clinical studies.

Thanks, David. And I think we'll give your questions to the person who could each answer them best. Sean, why don't you begin?

Yes. Thanks, David. In terms of our authorized generic in the second quarter, we were -- about 2/3 of our business were on the authorized generic. In the third quarter, and 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.

Charlie, answer about the ovarian cancer NDA.

Yes. So we requested priority review, we didn't receive it. And they -- 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, I'm not surprised, and that's just, I think, the way dealing with the FDA on this kind of question has to be.

And Atabak?

Sure. So regarding your question on R&D spend and SG&A. So -- we've talked a lot about the huge opportunity that we see ahead of us on multiple fronts across all of our businesses. And so we're going to invest to capture that. So on the R&D side, Bill walked you through many new studies that we're planning, there are many studies that we've been running this year that will -- that are completing and winding down 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 larger market opportunity. So I would expect those SG&A expenses to continue to increase.

Okay. Next question please.

Our next question comes from the line of Joon Lee of Truist Securities.

This is [ Asana ] on for Joon. Just a couple from us. So you said previously that the second former you would have more meaningful contribution in the fourth quarter. Now that the first form out of the picture seems to be how confident are you that Korlym can handle the increase in volume over, say, fourth quarter and the quarters going forward? It's current fully online as of the fourth quarter? And then just as a follow-up on the upcoming PDUFA relacorilant, have you had a late cycle review for relacorilant? And if so, what can you share?

Sure. Thank you very much for these questions. I think I understand all the first 1 we'll send to Sean.

Yes. So I'll answer your second question first. [indiscernible] is fully online. They started taking new patients on October 1 and almost all new enrollments are going to -- 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 in the fourth quarter.

And Charlie?

Yes. So just can you repeat the question for me. I just want to make sure I answer it really correctly. What do you say?

Just on the upcoming PDUFA for relacorilant, have you had an elite cycle review -- and if so, what can you share?

Sure. So just a little background for people who don't -- we're not familiar with NDAs as you are -- when the FDA agrees to review your new drug application, they give you a letter that sets up sort of the key milestones that are going to happen during the review process. And one of them is the mid-cycle review meeting with the -- between the sponsor and the FDA and the second is, as you know, another 1 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.

We held them both exactly on the schedule the FDA set up in this additional and it's original letter to us. Things have moved per schedule, very ordinary course, and we are very confident as a result that the FDA will meet its target date in December 30.

And if I could just have a quick follow-up. Is still selling core line? And if so, like how long will they have to?

Yes. Sean, please take that.

Yes. So Optimy is still servicing patients just as they were before as they were all gated the contract.

Our next question comes from the line of RK with H.C. Wainwright.

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

Go ahead, please.

Sorry. And the second question is on the new molecule that I see on the pipeline. [indiscernible], how different is that from rela? And do you plan to release any preclinical data from that molecule as you start thinking about the study in solid tumors as a combination therapy with the PD-1 inhibitors.

Okay. I think we have both of those questions. The first one is Sean. Please go ahead, Sean.

Yes. So RK, just to be clear, you said in your question that we only have 1 pharmacy, that's incorrect. We actually have 2 pharmacies. Optimy Care is continuing to service the active patient base and all new prescriptions are going to front. 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.

And Bill, any comments you'd like to make about nenocorilant.

Yes. Thank you. So related to nenocorilant and in our oncology portfolio, when we look at relacorilant, you heard all the studies we're doing with relacorilant. Relacorilant is a great molecule and it's shown its benefit not only in oncology, but also endocrinology, but we're always looking at and evaluating new molecules preclinically to help us broaden our reach in every therapeutic area and especially in oncology. And as we looked at the opportunity with combinations with PD-1 inhibitors, we felt that a drug like nenocorilant has unique properties that allowed us to dose it on a regular basis to help us look at other solid tumors. And we really felt it was the best partner for PD-1 inhibitors compared to that of relacorilant. And so when it comes to publishing our preclinical data, yes, we always publish our data. And I would expect us to have that data in the public domain next year.

Let 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 chemists at that point. Now our Chief Scientific Officer, Hazel Hunt, was able to come up with 1 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 touch the progesterone receptor, so they were really thing she sort of accomplished our mission in separating the activities.

As 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 the on various oncology models than others. And so where it left this with not a single follow-on compound, which is frankly what I had anticipated but with 4, 5, 6, 7 compounds each paired with the best treatment opportunity and best disorder for which it could make progress.

So 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 will really help us learn very much as to what the next thing to do is.

So thank you all for your questions. Thank you for listening in. Really an exciting time, and I look forward to talking to you next quarter. Thank you. Bye-bye.

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