Corcept Therapeutics - Q4 2025

Transcript

Operator (participant)

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

Atabak Mokari (CFO)

Hello, everyone. Good afternoon, and thank you for joining us. Today, we issued a press release announcing our financial results for the 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 express or imply. The risks and uncertainties that may affect our forward-looking statements are described in our annual report on Form 10-K and our quarterly reports on Form 10-Q, 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 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-$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 31st, 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 grants. I will now turn the call over to Charlie Robb, our Chief Business Officer. Charlie?

Charlie Robb (Chief Business Officer)

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 many patients with Cushing's syndrome require for optimal health, such as widely prescribed antifungal and antiviral medications. We know there are physicians who 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 and protect. 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 endpoint, 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, were already taking one or more blood pressure-lowering medications. Of these patients, 39% were taking three or more. These patients needed a blood pressure treatment that worked 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's 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 waist circumference shrank, 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 that gave cause 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, adrenal insufficiency, hypokalemia, endometrial thickening, irregular vaginal bleeding, and termination of pregnancy. relacorilant would provide a treatment option for patients who find one or more of these risks disqualifying. 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 doubt relacorilant's approval. In addition to the efficacy and safety benefits I just described, there was still another reason for us to expect relacorilant's approval.

Our clinical development program writ large, by which I mean the design of our trials, the number of patients studied, and the amount of data included in our NDA, compare favorably to the development programs that led to the approval of other Cushing's syndrome medications. For example. Our pivotal GRACE trial employed the same design as the trials that led to the approval of Isturisa and Recorlev, the two 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. 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 approved medication.

In sum, our review of FDA precedent, just as much as our scientific evaluation of relacorilant's clinical data, gave us ample reason for optimism. I'll close with a 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 had tailored our development program to the FDA's guidance in all material respects. The FDA tells sponsors when it does not think they should submit an NDA. They did not tell us that, nor did the FDA tell us we would face significant re-review issues or a possible refusal to file a letter if we did submit.

Following the filing of an NDA, FDA's internal guidance calls for the agency to inform drug sponsors as quickly as possible if there are deficiencies in the form or substance of the NDA package that would preclude approval. We heard nothing of the sort till the very end of the process. At neither the mid, nor late-cycle meetings that are part of every NDA review was the word deficiencies 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 its thinking.

Outcomes from that meeting range from resubmission of our NDA, perhaps including additional analyses from our NDA's 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?

Sean Maduck (President of Endocrinology)

Thanks, Charlie. Our Cushing's syndrome business experienced a surge in demand in 2025. 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. 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 prior calls the inability of our previous pharmacy vendor to fully meet the rapidly increasing demand for our 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 pharmacy's capabilities, but the complex, time-consuming task of transferring prescriptions and medical files for thousands of patients from the old pharmacy to the new one 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 pharmacy 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.

The landmark CATALYST trial we completed last year proved this point definitively. CATALYST had two 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 them had hypercortisolism. CATALYST's second 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 waist circumference. 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.

As the prescribing community internalizes the CATALYST findings, screening for and treatment of Cushing's syndrome will increase, and so will the number of patients receiving our current medications. We expect our 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 Joe Belanoff, our Chief Executive Officer. Joe?

Joe Belanoff (CEO)

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 that treatment with a 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 ROSELLA trial proved this point in platinum-resistant ovarian cancer. Patients who received relacorilant, in addition to nab-paclitaxel, had 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 and 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 one would have thought that one in four patients with resistant diabetes had hypercortisolism, and no one would have thought that treating these patients with a cortisol modulator would produce such striking benefits, substantial reductions in hemoglobin A1C, weight, and waist circumference 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 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 CATALYST 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. Hypercortisolism plays 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 ROSELLA trial in patients with platinum-resistant ovarian cancer. ROSELLA met both of its dual primary endpoints. Patients who received relacorilant, in addition to the potent chemotherapy medication, nab-paclitaxel, experienced longer progression-free survival and longer overall survival than the patients who received nab-paclitaxel 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. At the survival curve's 75th percentile point, patients receiving relacorilant lived eight months longer than those who had received nab-paclitaxel alone. We will be presenting ROSELLA's full results at the Society of Gynecologic Oncology, the SGO meeting in April, and will publish them in a leading peer-reviewed 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, oral 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 11th 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's potential to augment immunotherapy. Because cortisol suppresses the immune system, it may blunt the 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 1b study of a 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 antagonism's use in combination with androgen deprivation therapy. Our collaborators at the University of Chicago are currently enrolling a randomized, placebo-controlled, phase II trial of relacorilant plus enzalutamide in patients with early-stage prostate cancer to determine if GR antagonism can block a cortisol-mediated tumor escape route. 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, 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 I-B 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 II-B 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 dysregulated cortisol levels, which is why we believe our proprietary selective cortisol modulator, dazucorilant, may be very useful. Results from our 249 patient, double-blind, placebo-controlled DASLES trial of dazucorilant in patients with ALS are encouraging. In DASLES, patients who received 300 milligrams of dazucorilant for one year exhibited an 84% reduction in risk of death compared to patients who received placebo. The P value for this finding was 0.0009.

Dazucorilant's apparent prevention of early death, that is, death early in the course of the disease, if 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 if dose titration can improve dazucorilant's gastrointestinal tolerability. Non-serious GI distress caused most of the discontinuations in DASLES, an outcome we think can be avoided. We expect to incorporate what we learn 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 in demand for Korlym in 2025 because of growing recognition among physicians of hypercortisolism's true prevalence and the 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 CATALYST 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 mid-year, 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.

The fact that glucocorticoid receptor antagonists have demonstrated such compelling results in this 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 BELLA 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 DASLES findings, we expect to begin a phase III study in patients with ALS by mid-year. 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 approved 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 (participant)

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

David Amsellem (Managing Director and Senior Research Analyst)

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

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 2026? Thank you.

Joe Belanoff (CEO)

Okay. Edward, I think that we caught all of your questions. I'm sorry, David, excuse me. I think we caught all of your questions, but if for some reason that we haven't, you know, specify at the end, and we'll try again, 'cause that was a good list. I'm gonna give you over first to Charlie to talk about the CRL.

Charlie Robb (Chief Business Officer)

Again, David, I'm not sure exactly what sort of moving the goalposts would have looked like, and I don't know exactly what was in the sort of FDA's mind in that regard. You know, what we did was looked at the data we had on a sort of scientific basis, and it clearly met the hurdle for approval. Then when we turned to look at the other drugs that the agency had approved, you know, both as sort of our trial design and program generally, and the results we had were clearly right in line with, you know, prior approved treatments. I don't know if the FDA's thinking shifted in any way, but we really just think they missed the mark in that regard.

I hope that sort of addressed...

Joe Belanoff (CEO)

Yeah. Yeah, please, David, does that, does that answer your question?

David Amsellem (Managing Director and Senior Research Analyst)

Well, I guess there is a redacted CRL, that lays out some very specific concerns. 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. I'm just trying to understand how we, in the investor and analyst community, can somehow bridge that gap, if that makes sense.

Charlie Robb (Chief Business Officer)

Again, I think that, you know, 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, you know, they acknowledges right up, right out of the gate that our pivotal trial met its primary endpoint, for instance. The confirmatory evidence we provided also met its endpoint, and, you know, until the agency mentioned sort of an analysis at the end that they performed, that we had never seen and really can't replicate. There is daylight between our position and their position, and again, I just have to return to, I think on the merits, compared to the other approved drugs, we got it right.

I can't really explain how they moved, you know, to their decision. 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. We will be able to move forward from there. That's why we're meeting with them.

Joe Belanoff (CEO)

Okay. Sean, there were several questions related to sales of Korlym.

Sean Maduck (President of Endocrinology)

Yeah, thanks for the question. In terms of the AG, the AG's net price is about a 30% discount on Korlym's WAC, 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 about 75%, 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 gonna maybe move a tick or so more, but it's essentially stabilized. But we have built in, you know, potential pricing pressures and discounting in through the remainder of 2026.

David Amsellem (Managing Director and Senior Research Analyst)

Okay, thanks. 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?

Joe Belanoff (CEO)

You know, 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 by many people, even five years ago. These patients reside in many important disease states and previously just simply didn't respond to conventional treatment. 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, there's really a group of non-responders. And of those non-responders, about a quarter of them have hypercortisolism. And what the treatment portion of the CATALYST study said is, if you treat their hypercortisolism, those symptoms improve, and they improve really very dramatically.

The results for hypertension, for resistant hypertension, are yet to be revealed, but, you know, please pay attention in a month because I think they're gonna be very important. 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. Where it leads us to do in terms of clinical development, I'm not, you know, 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. Okay, next, question.

Operator (participant)

Thank you. Our next question comes from the line of Joon Lee of Truist. Your line is open, Joon.

Jing He (Equity Research Associate)

Hi, this is Jing. I'm online for Joon. Thanks for taking my question. My first question actually is on the oncology side. Congratulations on your ROSELLA data by both OS and PFS. My question is, looking ahead to SGO in April, what should we expect to see for that completed data set? For example, like a specific subgroup or safety analysis? And also, full, safety, tables? Also, how do you expect that this will support early, adoption?

Joe Belanoff (CEO)

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

Bill Guyer (Chief Development Officer)

Thank you. Thank you for that question. One, I wanna respect what we're gonna present at SGO 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. 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'll be a key point to look at. Yes, we will have full safety data sets presented there as well. 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.

It really shows the tolerability of relacorilant in combination with that of nab-paclitaxel. There'd be a lot of data within that presentation. I think you'll find it very interesting, but I do wanna respect that embargo for that presentation. 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.

Joe Belanoff (CEO)

Okay. Very, very good, Bill. Roberto, I think you're called on to speak to early adoption.

Roberto Vieira (President of Oncology)

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 challenge and clinically challenging to treat. We look at this, especially in the context of the outcome indication, as being transformative. This has never been done before. The first time that we have overall survival data of this magnitude demonstrating the outcome of population. You look into the safety and tolerability. Bill was just alluding to that. We'll present the final data, but you can look at that in The Lancet publication from last year.

The bottom line of the safety is that relacorilant did not really add much to the safety burden compared to nab-paclitaxel. Nab-paclitaxel is a taxane, that there's great familiarity on how to treat it. I think that the best way to look at the safety is that a single digit discontinuation of the regimen. Overall, very tolerable regimen. It's also an oral therapy that actually doesn't add to the burden of treatment altogether. When you look into efficacy in the outcome of 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.

Joe Belanoff (CEO)

Thank you, Roberto. Okay, next question, please.

Operator (participant)

Thank you. Our next question comes from the line of RK with H.C. Wainwright & Co. Your line is open, RK.

Swayampakula Ramakanth (Managing Director and Senior Healthcare Equity Research Analyst)

Thank you. Good afternoon, Joe. A couple of quick questions here. One is on the supply chain issues and the specialty pharmacy. You know, how confident are you that all of those, which have been lingering for almost a year now, have been taken care of? 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? The last question is, as Bill was talking about safety, are we going to see the full picture of safety from relacorilant in that trial?

Because, you know, obviously you were thinking that you had all the safety stuff straight, but the FDA was not thinking so, with the relacorilant and the Cushing's syndrome. The last question for, again, for Bill is: How does he think about, you know, KEYTRUDA coming into the picture now? How was Roberto and Bill trying to think through it and message it?

Joe Belanoff (CEO)

Well, okay, thank you for the list of questions. You're gonna give our whole executive team an opportunity to weigh in here. Sean, why don't you start with the first question?

Sean Maduck (President of Endocrinology)

Yeah, no, thanks, RK. I'm gonna talk a little bit about the end of last year and then talk about what the expectations are moving forward. The transition with between the two pharmacies started in October, and it was challenging, as I talked about in my opening comments. One thing I wanna make clear is that all patients are actually now at CURAD. Now that those patients are all at CURAD, we're actually seeing improvement, and a lot of the metrics we look at are heading in the right direction. 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.

Now in terms of the new pharmacy partner, you know, what gives us confidence that we'll be able to see a different result, and that's based off, you know, I'd say, why we selected them and then what we're seeing today. 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. One of the most important pieces, which was our issue with sort of overloading the system last year, is that they actually have multiple locations....

They have the ability to scale their business very, very quickly. Our belief is that they are, well, they told us they're committed to doing that, and our belief is that they will scale with us as our business continues to grow. 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.

Joe Belanoff (CEO)

Good. Okay. Thank you, Sean. Atabak, why don't you take the revenues question?

Atabak Mokari (CFO)

Sure. Hey, RK. Regarding how much of our guidance, you know, 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, just given the anticipated timing of launch in oncology.

Joe Belanoff (CEO)

Bill, you have the safety question.

Bill Guyer (Chief Development Officer)

Safety question. I... Again, hopefully, I answer it in the way you are asking. Related to safety from ROSELLA, as I stated before, and I'll give you a little bit more detail maybe, 'cause you kind of related it back to Corcept Endocrinology. From ROSELLA, what we're seeing in the safety profile a year ago versus now a year later at the final survival analysis, we're seeing very similar safety profile, almost exactly the same. Again, you'll see that at SGO. By raising Corcept Endocrinology, I think you're probably raising, you know, are we seeing any, rises in ALT that we might have seen in that of the Corcept Endocrinology program? I'll go back to the Corcept Endocrinology program.

Our assessment within the endocrinology program is we did not have any cases of drug-induced liver injury, and we also have confirmation of that from our external independent safety committee, that also evaluated all that data. 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. I just wanna make it clear as well, we aren't seeing any rises in ALT elevations that are significant and of concern. As a background, when you look at within the ROSELLA trial, one, nab-paclitaxel on its own can rise ALTs, and you need to kind of understand that within platinum-resistant ovarian cancer. When we combine relacorilant with that of nab-paclitaxel in the ROSELLA study, we're gonna 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 nab-paclitaxel alone arm. We're not seeing any added toxicity. We're actually seeing reduction in that of ALT rises. That data, again, we'll be able to share with you in just the next two days. I feel very comfortable and confident with the safety profile of Endocrinology in both the Oncology area and also the Endocrinology area.

Joe Belanoff (CEO)

Roberto, the final question?

Roberto Vieira (President of Oncology)

Concerning KEYTRUDA, RK, let me just start by reminding us that their approval was for CPS greater than 1 or PDL1 expression greater than 1. In our dataset, in real world, we are talking about 50%-60% of the total population, of course, you have that limitation of the biomarker right there. Beyond this, it's important to remember that KEYTRUDA has been used in ovarian cancer for a while as part of the NCCN guidelines in other regimens that are taxane-sparing, that do not utilize paclitaxel. It has a use there. It's 10%-15% of those patients already in later lines of therapy. When we have engaged in our work with oncologists, that they are very much interested in maintaining options.

They, of course, are very interested in ROSELLA, and the way for them to maintain options is 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. overall, when you compare a regimen that came with a, you know, a safety button, and you can see in their data, hazard ratio of 0.76, there is a clear signal here that there's a utilization of a ROSELLA regimen in early lines and maintaining optionality for KEYTRUDA in later lines of therapy.

Joe Belanoff (CEO)

Okay. Well, thank you. Thank you, RK.

Swayampakula Ramakanth (Managing Director and Senior Healthcare Equity Research Analyst)

Thank you.

Joe Belanoff (CEO)

We will conclude our call, and we will plan on seeing you in three 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. Please do follow. There's a lot of news between now and the next three months. We look forward to talking to you again at that period of time. Thank you.

Sean Maduck (President of Endocrinology)

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