Corcept Therapeutics Incorporated. Aktie

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.

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

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

Thank you. 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, 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 second quarter of 2025 was $194.4 million compared to $163.8 million in the prior year period. We have modified our 2025 revenue guidance to $850 million to $900 million. Net income was $35.1 million compared to $35.5 million in the second quarter of last year. Our cash and investments at June 30 were $515 million. Balance reflects our acquisition of $115 million of our common stock in the second quarter, pursuant to our stock repurchase program, the net exercise of stock options by Corcept employees and the net vesting of restricted stock rates.

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

Thank you, Atabak. The endocrinology division had an excellent second quarter. For the sixth quarter in a row, we added a record number of new prescribers and new prescriptions, and there are a record number of patients on therapy. We more tablets to patients than ever before, 49% more than the second quarter last year. Our financial results don't fully reflect the surge in demand. While our quarterly revenue growth was substantial, a $37 million increase over the first quarter, it should have been more. I discussed on the last call the insufficient capacity of our pharmacy vendor. Its capacity has increased in the second quarter, but not as much as we expected and not enough to keep pace with our growth. Capacity will increase further in the second half of the year. We dispensed another record number of tablets in July with more increases to follow. We are also bringing online a second pharmacy. You will see the financial impact of this addition in the fourth quarter.

Increased pharmacy capacity is important because I'm certain our growth is poised to accelerate. For many years, physicians only screened and treated the most physically obvious cases of hypercortisolism. In the last 15 years, many studies have been published supporting the identification and the treatment across a much broader spectrum of disease. The results of the CATALYST study confirm and build on these findings and will lead to much higher rates of screening and treatment of hypercortisolism. The study unequivocally shows that 1 in 4 patients with difficult to control diabetes of hypercortisolism and that treatment with a cortisol modulator dramatically improves many of their signs and symptoms. Even when all current medications including Ozempic and Mounjaro have not. The CATALYST results are now published in Diabetes Care, the field-leading journal. This crucial information is now being absorbed by the broader physician community. We have amplified our efforts to educate physicians about hypercortisolism and we will ramp those activities even further.

For example, we have increased the size of our sales force substantially and we'll continue to grow that team. We currently have 145 clinical specialists, up from 60 at the beginning of 2024, and our plan is to have 175 in place before year-end. In the increasing context of a much better understanding of the prevalence of hypercortisolism, I'm eagerly anticipating relacorilant's approval. While Korlym is a great medication, relacorilant is even better. Relacorilant 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 when it becomes available.

I've never been more confident in both our current and future commercial growth and most important, our potential to help many more patients. I believe that in the next 3 to 5 years, relacorilant will generate $3 billion to $5 billion in annual revenue in hypercortisolism alone. I'll now turn the call over to Charlie Robb, our Chief Business Officer. Charlie?

Thanks, Sean. At last, there is something to report regarding our patent litigation with Teva. Recall that in 2018, we sued Teva to keep it from marketing a generic version of Korlym in violation of our patents. took place in September 2023. In December 2023, the District Court ruled against us. We appealed that decision to the Federal Circuit Court of Appeals and completed briefing in May 2024. A few weeks ago on July 7, the court heard oral argument in the case, the last step before issuing an opinion. The 3-judge panel was led by Chief Judge Kimberly Moore. In 2021, Judge Moore was a member of the panel that rejected Teva's challenge to the validity of one of the patents we asserted a trial and wrote the opinion in our favor. I don't mean to suggest that Judge Moore's favorable decision in 2021 means she is more likely to rule for us now. The issues now are different. Judge Moore's decision in 2021 concerned the validity of our patent. She founded valid. .

The current argument concerns infringement will Teva infringe our patent an entirely different question. My point is simply that Judge Moore is not new to this dispute. She understands our particular situation, not just the law and the abstract for a party that believes, as we do, that the law and the facts are on its side, Judge Moore's patent expertise and depth of knowledge is a good thing. It is impossible to say when the Federal Circuit will issue its decision sometime in the next 2 to 3 months would be a reasonable guess. If we prevail in this case, Teva will lose FDA approval of its product until the expiration of our patents in 2037. As I've said before, we are eager to resolve this appeal. We strongly believe our position is correct and that the Federal Circuit will agree. I will now turn the call over to Dr. Joe Belanoff, our Chief Executive Officer. Joe? .

Thank you, Charlie, and thank you, everyone, for joining us this afternoon. After many important years building this point, the next era at Corcept is about to arrive. As we have always known, cortisol enters all organs of the body and modulating its effects has the potential to be useful in many diseases. We now have 2 new drug applications, NDAs in progress in hypercortisolism and platinum-resistant ovarian cancer. The results of the studies leading to these NDAs were published in major medical journals in the second quarter. We have also generated promising results in our ALS and liver disease programs.

In short, we have established a new medical platform useful to many patients suffering from serious disorders. The results of our CATALYST trial, the largest and most rigorous trial ever conducted to assess the prevalence and treatment of hypercortisolism in patients with difficult to control type 2 diabetes will transform medicine. The prevalence phase of CATALYST demonstrated that 1 in 4 of these refractory patients has hypercortisolism, a far higher rate than was previously assumed. In April, these results were published in Diabetes Care, a leading peer-reviewed journal of the American Diabetes Association. Patients who enrolled in the treatment phase of CATALYST had uncontrolled diabetes despite receiving multiple glucose-lowering therapies, including the most potent GLP-1 agonists. Even so, in only 24 weeks, patients treated with Korlym experienced a 1.47% reduction in hemoglobin A1c compared to just 0.15% for those receiving placebo. The p-value of this result was less than 0.001.

In addition, patients saw significant improvements in a range of additional endpoints, including reductions in body weight and waist conference. Notably, patients CATALYST experienced these improvements even as they decreased or entirely discontinued their other glucose-lowering medications. The results were presented last month during a keynote session at the American Diabetes Association's 85th Scientific session with a simultaneous publication in diabetes care.

CATALYST findings will substantially accelerate the screening and treatment of hypercortisolism. Leading diabetologists are advocating for their quick integration into treatment guidelines. Concurrent with the rapidly increasing physician awareness of hypercortisolism, relacorilant is approaching approval. Its PDUFA date in hypercortisolism is December 30. 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 across all of the signs and symptoms of hypercortisolism including hypertension, hyperglycemia, weight, lean muscle mass, waist conference, cognition, Cushing's quality of life score and other important clinical measures.

These benefits were observed consistently and durably with improvements emerging early and continuing or deepening over time. Equally noteworthy relacorilant  safety characteristics. Relacorilant has been well tolerated in all of its studies. Importantly, no instances of drug-induced hypokalemia, endometrial hypertrophy, vaginal bleeding, adrenaline efficiency or QT prolongation have been observed. These adverse events can have serious health consequences and are associated with 1 or more of the currently available therapies. We expect that relacorilant's efficacy and safety will make it a new standard of care for hypercortisolism. As awareness of the disease and its ability to be treated grows, many more patients with hypercortisolism 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. Since the founding of Corcept, our research and development has been built on the hypothesis that cortisol modulation can be a powerful therapeutic mechanism in many serious disorders. The success of our pivotal ROSELA trial in platinum-resistant ovarian cancer provides clear evidence that cortisol receptor antagonism has substantial potential in oncology. In ROSELA, 381 women with platinum-resistant ovarian cancer were randomized 1:1 to receive either nab-paclitaxel, the most potent chemotherapy currently available for these patients, or nab-paclitaxel plus relacorilant.

In these patients, the efficacy of nab-paclitaxel and chemotherapy in general, had diminished markedly. Our expectation was that relacorilant would the anti-apoptotic effect of cortisol activity, thereby resensitizing ovarian tumors to the effective nab-paclitaxel. This expectation was resoundingly confirmed. ROSELA trial met its primary endpoint of improved progression-free survival. Patients treated with relacorilant plus nab-paclitaxel experienced a 30% reduction in the risk of disease progression compared to patients treated with nab-paclitaxel alone, the hazard ratio of 0.7 and a p-value of 0.008.

At 12 months, 25% of patients in the relacorilant arm remained progression-free almost twice as many as in the control arm. In the interim evaluation of overall survival, patients treated with relacorilant plus nab-paclitaxel had a median overall survival of 16 months compared to 11.5 months for those receiving nab-paclitaxel alone. The hazard ratio was 0.69, with a p-value of 0.01. These results were obtained without the need for a biomarker diagnostic test, a prerequisite of many currently available treatments and were even observed in patients with particularly poor prognosis such as patients who had received multiple lines of prior therapy and patients who have progressed while on standard of care therapy. Relacorilant plus nab-paclitaxel was well tolerated.

The adverse events observed were consistent with the known safety profile of nab-paclitaxel. Because patients in the relacorilant plus nab-paclitaxel arm, they are better than those in the nab-paclitaxel monotherapy arm. They had an approximately 30% longer duration of nab-paclitaxel therapy. When adjusted for treatment duration, the safety profile of relacorilant plus nab-paclitaxel was very similar to that of nab-paclitaxel alone. The results of the ROSELA study were presented last month in an oral late-breaker session at the American Society of Clinical Oncology's Annual Meeting and simultaneously published in the Lancet, the general medical journal with the world's highest impact factor. Physicians have responded with great enthusiasm to these results, improving progression-free survival and overall survival without an added safety burden positions relacorilant to become the new standard of care for patients with platinum-resistant ovarian cancer.

We submitted relacorilant's NDA in platinum-resistant ovarian cancer earlier this month and will submit a marketing authorization application in Europe soon. In anticipation of a successful regulatory outcome, we have made substantial progress in establishing a dedicated oncology division. We are prepared to move swiftly to bring relacorilant plus nab-paclitaxel to the women who can benefit from it once it is approved. ROSELA established relacorilant's therapeutic value in a highly challenging stage of ovarian cancer. These results support relacorilant's potentially broader utility, including in earlier stages of ovarian cancer and in other solid tumors. The first step in advancing this strategy is with our BELLA trial, which is enrolling briskly and will test whether combining relacorilant plus nab-paclitaxel with bevacizumab offers an additional effective option for patients with platinum-resistant ovarian cancer. We will soon begin additional studies.

In addition to exploring cortisol receptors antagonisms potential to resensitize tumors to chemotherapy, we are evaluating its use in combination with androgen deprivation therapy in prostate cancer. Cortisol stimulation is a major reason why patients with prostate cancer treated with the widely prescribed androgen receptor antagonist enzalutamide, eventually experience resurgent disease. Deprived of androgen stimulation, their tumor switched to cortisol activity to stimulate growth. 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 cortisol receptor antagonism can block this tumor escape group.

Another possible role of cortisol receptor antagonism is in combination with immunotherapy. Because cortisol suppresses the immune system, it may blunt the effectiveness of cancer therapies intended to stimulate an immune response. Adding a cortisol receptor antagonist to immunotherapies such as checkpoint inhibitors, may enhance their effectiveness. Following our Phase Ib trial in advanced adrenal cancer, we are deciding how best to investigate the utility of our compounds in combination with immunotherapies in other tumor types and earlier stages of cancer.

Our proprietary compound, dazucorilant, is an excellent candidate for the treatment of neurologic disorders. While our DAZALS trial, a 249 patient randomized double-blind placebo-controlled Phase II trial of dazucorilant in patients with ALS did not meet its primary endpoint of improvement in the ALS functional rating scale. The data did suggest a powerful benefit, prevention of early death. One year after entering DAZALS, patients who received 300 milligrams of dazucorilant daily exhibited an 84% reduction in death -- the risk of death compared to patients who only received placebo.

The p-value for this finding was 0.0009. The benefit emerged in the first 24 weeks of the study during which time 5 patients randomized to placebo had died compared to no deaths in the group that received 300 milligrams of dazucorilant. An important point to know about the survival benefit is that it emerges from the start of treatment when patients still retain considerable function and quality of life. The common understanding of ALS is that it progresses by degrading motor function until patients are completely paralyzed with death following. While this is true in some cases, many more patients die long before then from conditions such as pneumonia that they would have survived had it not been for their ALS, is these early deaths that patients receiving dazucorilant experience less frequently. We presented these notable findings last month at the European Network to Cure ALS Annual Meeting. We are engaged with regulatory authorities to determine the fastest path for advancing dazucorilant.

NASH metabolic dysfunction associated steatohepatitis 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. Proprietary molecules, miricorilant has very potent activity in the liver. Phase Ib study showed that miricorilant rapidly reduced liver fat and improved other markers of liver health, fibrosis and metabolism. 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 has 2 cohorts. The first cohort of patients has biopsy-confirmed MASH. The second cohort consists of patients with presumed MASH. Enrollment in MONARCH will be completed in the next few weeks, and results will be available late next year.

As I said earlier, this is the dawn of a new era at Corcept. Let me reiterate our important developments. The CATALYST trial, the largest and most rigorous of its kind proves that there are far more patients with hypercortisolism than was previously believed, and that cortisol modulation is very beneficial for these patients. With results from both phases of CATALYST now published, leading physicians are recognizing the significance of the findings and joining us in raising awareness. We are certain that this will lead to many more patients being screened, identified and properly treated.

While Korlym's effectiveness in treating hypercortisolism is well established, relacorilant is a substantial advance. Its strong efficacy and safety positions it to become a new standard of care. We expect its approval on hypercortisolism by the end of this year, and are eager to make it available immediately thereafter. The ROSELA trial validated cortisol receptors antagonisms utility in oncology. Relacorilant delivered a clear clinical benefit with no added side effect safety burden in patients with platinum-resistant ovarian cancer treated with nab-paclitaxel.

We expect relacorilant approval in oncology next year. We are working to unlock its potential in earlier stages of cancer, other tumor types and in combination with other anticancer agents. In addition, we are actively exploring the potential of cortisol modulation to treat a broad range of additional severe diseases, including neurologic and hepatic diseases. We continue to discover and develop proprietary selective console 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 at Corcept. 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 Korlym specific questions. First, actually, I want to ask you about the authorized generic, what portion of your business came from the authorized generic during the quarter relative to 1Q? And can you talk about the pricing headwind in percentage terms year-over-year? So that's number one. Number 2 is just with the supply chain issues and fulfillment issues, can you talk about the disconnect between prescriptions that are actually written and prescriptions that are actually filled. In other words, what portion of prescriptions that were actually written were pull-through to actually -- to actual filled prescriptions. And did that gap narrow in the second quarter? In other words, were the fulfillment issues for lack of a better term, less bad in 2Q versus 1Q. So I'll stop there.

All right. Thank you, David. I think we understand exactly what you're asking. And I just want to pass it over to Sean Maduck. Sean as you know, is the President of our Endocrinology division, and these are things that are on every day.

David, thanks for the question. I'm going to touch on the AG question first. So if you recall on the last call, we had stated that just over 50% of our business had transitioned over to the AG. Over the course of the second quarter, we're now at about 2/3 of our business. So we've seen sort of that transition slow. We expect over the next 6 months, maybe a little bit more movement, but we have seen some stabilization. So a percentage point here or there. But I think we'll settle at the end of the year around 2/3 of our business. In terms of the pricing question you asked, I mean, when we launched our AG in June of last year, we launched it at a 12% discount to Korlym's list price, but you know that's a starting point with payers, right? Payers negotiate. And so it varies by fair contracts. But when you look on average across all of our contracts, it's about a 30% discount to Korlym's list price.

Okay. So now in terms of your question, before I talk about the supply chain specifics, I do want to spend a couple of minutes talking about the health of our business, and then I'll talk specifically about the pharmacy. So we had an excellent quarter. I mean, we grew our volume by 49% year-over-year, and it could have been more. And I'll talk about that in a minute when I talk about the pharmacy. So why is our business growing and why is it so strong? Well, the first point is the market is expanding. There has been a significant amount of data over the last couple of years, most notably CATALYST, and Joe referenced this in his comments. But it has made a real splash. Physicians are way more interested today than they were a couple of years ago. It's expanding the conversation. We're getting in front of them. And a real-life example of this, we monitor this, of course. A real-life example is at the Endo conference about 3 weeks ago here in San Francisco, the Endo Society Conference, we had a presentation on the CATALYST data in a room that had seats for about 225 people. 500 people attended that session. There were more people standing than sitting. And that would have been absolutely unheard of 2 years ago.

And here we are today. That's driving, again, more conversation, more outreach with Corcept, and we're working hard to make sure that information is disseminated broadly so that physicians are actively looking for these patients, which is exactly what they're doing. There's more screening going on and more patients are being diagnosed. And because of that, our Korlym prescriptions have increased significantly over the last few months. And that's just going to continue. We expect -- we're just really at the start of that. And to put that in perspective, I mean we now have days that we get more Korlym new patient prescriptions than we used to get in a month. And again, it's just the start of that. We're just at the start of CATALYST. We think that's going to accelerate through the rest of the year and really lay a very strong foundation for for relacorilant, which, of course, we're very excited for, which is going to come at the beginning of next year. So in terms of your specific question around the pharmacy, I mean, in short, the pharmacy just did not meet our expectations. They improved in Q2. They got closer to where we were, but not all the way. And the best way that I think I can explain this is to use a bit of an analogy. And bear with me for a second, I'm going to talk about cars for a second year. But assume that a few months ago, was operating in a car that was driving about 60 miles per hour. Of course, that was in a car that was driving 70 miles per hour, and we needed them to catch up, not just catch up, but sustain their speed to support our business. They improved. They got closer to where we were, but that's the operative word. Where we were is not where we are today.

This is not a static business. Our business continues to grow and to accelerate. And we're now driving at 80, 85 miles per hour. So you asked specifically, as the gap narrowed, I mean, there's been such a flood of volume has continued to create a problem. And when you look to quantify that, that probably had about a $15 million impact on our second quarter results. So heading into the second half of the year, where are we? Well, we saw improvement. We expect that we're going to continue to see improvement in the third quarter, and we expect that we're going to continue to see even more improvement with our current pharmacy vendors or through the end of the year. But as we said in our opening statements, we're also onboarding a second pharmacy, which we're very excited about that will support our business both today and in the future with relacorilant, and we expect them to start contributing in the fourth quarter.

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

Regarding the $3 billion to $5 billion in peak sales opportunity for your hypercortisolism franchise that mentioned on the call, how much of that is coming from Korlym. And given the pending approval of relacorilant, how important is it to you that you win the -- on the ongoing appeals process with Teva? And I have a follow-up.

I'll be glad to take that question. I want to reiterate a few of the points we've made already, but they're important, which is that relacorilant is a better medication. Korlym works extremely well, but relacorilant has very, very tangible advantages. And we think that relacorilant ultimately will entirely replace Korlym. There's also another point, which is that we think that we have penetrated a very small percentage of the overall potential market. There are many more patients with hypercortisolism to be treated that have ever been treated. So our longer-term estimates when you referenced $3 billion to $5 billion certainly takes into account relacorilant, really has, in some sense, very little impact from at that point. But maybe just another important point to make, which we don't often say wow, we don't think $3 million to $5 million peak sales. I mean, $3 million to $5 million is what we think we can do in 3 to 5 years. But we think that this market is substantially larger than that, and we will have a substantial piece of that substantial mark.

The other part of the question was around the patent.

Please repeat the other part of the question .

The other part of this question was winning the patent case impact of $3 billion to $5 billion.

Winning the case does not impact the $3 billion to $5 billion, what impacts the pie because that's a patent case. We think that, of course, maybe everyone in our situation, we think we have a very good reason to win the patent case. But in some sense, that's looking through the rearview mirror. This is really about the advancement of relacorilant and its future growth.

Understood. I had a quick follow-up. When will the second pharmacy come online? And at what point would you consider activating more distributors because isn't that sort of the plan for relacorilant, which you think and we think will have a broader adoption?

Yes. I'm going to pass you back to Sean for that answer. .

Yes. So thanks for the question. So the onboarding of that pharmacy is in process, and we expect them to attribute sort of value and have an impact in the fourth quarter. We -- to your second question and comment, we had always planned to expand this network for for relacorilant. And it really was the surge of demand that we saw with Korlym that caused us to sort of pull that back a quarter, and that's why we're accelerating this. But to your question about will we expand further, it's something that we're looking into. I mean, we're being very thoughtful as we set up our current structure with the addition of the second pharmacy so that we have the ability to add to that should we see fit. So something we're always looking at, and we will do that if we see fit into the future.

Our next question comes from the line of Swayampakula Ramakanth of HCW.

A couple of quick questions. So you have initiated the CATALYST today a couple of years ago. So you were -- even before you kind of confident that the way the data was going to come from CATALYST because you are always aware that the patients are not being identified as much as they should be. Having -- where I'm leading to that question is, what kind of -- what steps were missed in not having a second pharmacy onboard earlier in time because you knew that there was going to be an upsurge of this demand from the market, especially once the data comes out. And the other question is, the expectation that the second pharmacy is going to come on board in the fourth quarter, why are we still pulling down the guidance? Does that mean there is something else that we are not understanding?

Okay. Let me see if I can order those questions. I think I'll try the first question, and I'll give Sean, the second question. First question is, why didn't we get it a second quarter sooner? And I'll be honest, hindsight 2020, good question. And I think that part of it was that sort of a combination of things to build from the CATALYST information has gone much more rapidly than we thought. And frankly, we thought that our original pharmacy would be able to keep up. And within the demand has been even greater than we thought it was, and our current pharmacy wasn't able to stay with it. So Sean, the second question? .

Yes. So the second question was. Given the second pharmacy coming on and adding value in the fourth quarter, why change. So look, we take all factors into account when we look at our range. And one of the challenges is as I mentioned earlier, the impact of the patient delays, and that's what's happening here. It's taking longer for patients to a medication. It was a $15 million impact in the second quarter, but that doesn't just go away. I mean, that sort of flows through the model. It takes longer to start patients, it takes longer to titrate up. And when you do sort of the math throughout the course of the year, it has the potential to be a larger impact than that So that was the main driver.

On the BELLA study, what's the time line for that? And also in terms of evaluating relacorilant in other solid tumors, is that basically the prostate cancer that you're talking about? Or is there any additional solid tumors that you would be looking at?

Thank you very much for asking that and that gives me an opportunity to reintroduce you to Bill Guyer, who is our Chief Development Officer. This is all his domain, and I'll let him get started.

Great. Thanks, RK, for that question. So for the BELLA trial, enrollment has gone better than expected. I mean, our Phase II and a Phase III study is using relacorilant plus nab-paclitaxel enrolled also very quickly. This is going even faster than that. And so we will have this study enrolled by the end of this year, and therefore, we'll see results about a year after that. And when it comes to other solid tumors, I'll comment on there. Yes, prostate cancer is 1 of those, but we're thinking much bigger than that because our vision for is to establish its role as an agent capable of synergizing with many other agents to enhance efficacy with no added toxicity in many different tumor types. Now in the near term, we're going to study and move forward in looking at moving up in the treatment paradigm in ovarian cancer, and we'll be expanding in and across gynecological oncology spaces like endometrial cancer and cervical cancer. And when we look at other solid tumors, I'll give you more details in the coming weeks by the end of this year, but we're going to be also looking at other selective glucocorticoid receptor antagonist in combination with other agents like immunotherapy. So finalizing our oncology development plans is ongoing. We've got a great plan, and we will give you the details very soon.

And the last question from me, Joe, is, yes, on the conversation with the FDA on the ALS front. Did you already have that conversation with the FDA? And if not, what's the strategy there? Do you think as soon as you get the for another study, would you be doing another study? Or would you want to utilize whatever data you have to file?

I think we heard and understand your question. And I'm going to pass you back to Charlie Robb. Charlie is our Chief Business Officer, and he oversees all of our regulatory interactions.

So we've not yet had the meeting. We said in the last call that we were going to contact the regulators immediately, which we did. And so we have a meeting scheduled later in August to discuss the path forward. And one of the options is certainly an approval based on the data we have now, that would be an unusual thing no 1 should count on, but that's one we're putting that forward as a very serious possibility and subject to a conversation with the regulators. The other, of course, would be the optimum design of a confirmatory trial, which we would expect to conduct in any event, whatever the use of the Phase II data we have now turns out to be. So when we have that meeting and settle on our plans, we will let folks know about it, but that's sort of the state of play right now.

Our next question comes from the line of Edward Nash of Canaccord Genuity.

This is Xinwei An for Edwards. My questions are -- my questions are focused on the BELLA for platinum resistance overian cancer side of things. So the first part of my question is maybe -- could you help us understand BELLA positioning in the current treatment paradigm? Because you mentioned that it is the expectation that BELLA can help treat earlier stages of ovarian cancer. So does this also include patients that are not platinum...

Yes. I think I caught most of your questions. And if we've missed anything, ask clarify. But I'd like to introduce everyone to Roberto Vieira, who is President of our Oncology division, and he is all over this material. So please Roberto start. And if we've missed something, let us know. .

Thank you for the question. So let me just start by saying that since we have presented our bid at ASCO, we have had the opportunity to speak. We've got a wide range of key open leaders in the field. We have also ran a comprehensive market research getting input from a large number of treating physicians across all major U.S. regions. And the feedback on the ROSELA result has been very, very encouraging to us. It speaks really to the strength of the data we have. So we are very confident about our path to market leadership, specifically in platinum-resistant ovarian cancer, and we believe relacorilant has the potential to deliver over $1 billion in long-term revenues. Now specifically to your question about positioning, the ROSELA trial data supports relacorilant is a flexible option that can be used in multiple lines of therapy, both before and after biomarker specific agent by Gallaher, for example, which was very much corroborated by the market research I alluded to before.

Okay. Yes. That's very helpful. So I guess, since you already mentioned maybe squeezing in a follow-up over here that your discussion with physicians, are you finding that they will tend to use relacorilant in the earlier stage patients were rather to preserve or sort of preserve the drug for late-stage patients because of its safety profile, which is positive? And for late-stage patients, usually, there's not that many options out there?

Please, Roberto.

Yes. So our data, as you know, looks into patients with multiple lines of therapy early and late. So it supports flexible utilization, as I mentioned before. But as we speak to physicians about this, it's not just the efficacy. They're actually look into the safety as a very strong attribute of this regimen and the as well, it's also something that really appeals to them. So we see significant utilization getting earlier lines of platinum resistance ovarian cancer and potential for utilization even earlier as the data evolves.

And I would just like to add to that 1 point that Bill alluded to. I think that our trial in platinum-resistant ovarian cancer ROSELA enrolled twice as fast as any other study which is ever been completed in that disease. And I think that the current study -- the BELLA study, we really have to keep up. I mean, the enrollment is really so risk there. And I think it speaks to the ease of use of this drug in combination. So look, we're -- we've done our research, and we're only speculating until we actually get to the market, but it seems as if physicians kind of all along the spectrum of disease severity are interested.

Okay. Great. And very last part of my question, is regarding BELLA with the potential of being used in combination with other therapies like immunotherapy, as you mentioned before, or ADCs in the future, any specific concerns on overlapping toxicities over here?

I'm going to give you to Bill Guyer.

Yes. Thank you for that question. No, there are absolutely no concerns of overlapping toxicities. We look to see, again, to be the agent of choice in combination with any immunotherapy or chemotherapy. And we will do that in many future studies to come to prove that.

And there really is no mechanistic reason to think that there will be that problem. It looks like we're out of questions. Thank you very much for everybody who has called in. We look forward to really what's next. It is -- I really do view this personally. It's an exceptionally exciting time. We really have an opportunity to help many, many people, and you'll be a part of it. So thank you very much, and we'll talk to you next quarter. .

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