Earnings Call Transcript - CORT Q4 2025

Operator, Operator

Thank you for joining us for Corcept Therapeutics' Fourth Quarter 2025 Earnings Conference Call. I will now turn the call over to Atabak Mokari, CFO. Please proceed.

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 expressed or implied. The risks and uncertainties that may affect our forward-looking statements are described in our annual report on Form 10-K and our quarterly reports on Form 10-Q, which are available on the SEC's website. Please refer to those documents for more information. We disclaim any intention or duty to update forward-looking statements. Our 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 units. I will now turn the call over to Charlie Robb, our Chief Business Officer. Charlie?

Gary 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 in many patients with Cushing's syndrome that are required 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 that 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 reasons 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 of 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 elevation 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 adapt. 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 compared 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 gives 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 had tailored our development program to the FDA's guidance in all material respects. The FDA tells sponsors when it does not think they submitted an 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 a letter if we did submit. Following the filing of an NDA, the 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 to the very end of the process, and neither the mid nor late-cycle meetings that are part of every NDA review used the word deficiencies. 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 filing 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, Endocrinology Division

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, 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 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 the 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. But 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?

Joseph K. 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 treatment with cortisol modulators can benefit many patients. There is now growing acceptance that cortisol activity at the glucocorticoid receptor (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 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 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 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'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 the CATALYST study 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. As the survival curves' 75th percentile point, patients receiving relacorilant lived 8 months longer than those who had received nab-paclitaxel alone. We will be presenting ROSELLA's full results at the Society of Gynecologic Oncology (SGO) meeting in April, and we'll 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, along with leading oncologists, believe strongly that relacorilant, with its best-in-class efficacy and safety data, convenient 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 (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, it may dampen 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 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 antagonism used 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 (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, relacorilant, 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, dazucorilant, may be very useful. Results from our 249-patient double-blind, placebo-controlled DAZALS trial of dazucorilant in patients with ALS are encouraging. In DAZALS, patients who received 300 milligrams of dazucorilant 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. Dazucorilant'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 evaluate the dose titration in order to improve dazucorilant's gastrointestinal tolerability. Non-serious GI distress caused most of the discontinuations in DAZALS, 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 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 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 to the glucocorticoid receptor antagonists that have demonstrated such compelling results in an 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 DAZALS 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. The potential of cortisol modulation to benefit patients is vast. It is a privilege to help convert that potential into 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, Operator

Our first question comes from David Amsellem of Piper Sandler.

David Amsellem, Analyst

I have a few questions. First, regarding the Complete Response Letter, it seems you feel that the agency may have shifted its expectations. I would like to hear your detailed thoughts on this matter. Secondly, could you elaborate on your willingness to conduct a more traditional randomized trial of relacorilant in type 2 diabetes or hypertensive patients with poor control? Specifically, how do you view the momentum and potential catalysts in relation to this path? That's my first set of questions. Additionally, can you discuss some of the assumptions in your guidance for Korlym, particularly concerning the erosion of net price and the percentage of the business going through the authorized generic, as well as the net price compared to the list price? How should we approach this for 2026?

Joseph K. Belanoff, CEO

Okay, David, I believe we've addressed all of your questions. If there are any that we've missed, please let us know at the end and we'll revisit them. That was a solid list. Now, I'll hand it over to Charlie to discuss CRL.

Gary Robb, Chief Business Officer

So David, I'm not sure what moving the goalpost would have looked like. I also don’t know what the FDA was thinking in that regard. However, we examined the scientific data we had, which clearly met the approval criteria. When we compared our trial design and program with other drugs the agency approved, we found that our results were consistent with previously approved treatments. I can't say if the FDA's perspective changed, but we believe we fell short in that aspect. I hope that answers your question.

Joseph K. Belanoff, CEO

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

David Amsellem, Analyst

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.

Gary Robb, Chief Business Officer

Yes. I think that without going through the CRL in detail, there are aspects that are somewhat puzzling and difficult to understand. For example, they acknowledged right from the start that our pivotal trial met its primary endpoint. The confirmatory evidence we provided also met its endpoint until the agency referenced an analysis at the end that we had never encountered and cannot replicate. There is a significant difference between our perspective and theirs. On merit, compared to other approved drugs, I believe we have the right stance. I cannot explain how they reached their decision. We will learn more about this when we meet with them in April, which is the purpose of the meeting. We want to gain clarity, and I think they will be able to explain it to us so we can move forward from there. That’s why we are meeting with them.

Joseph K. Belanoff, CEO

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

Sean Maduck, President, Endocrinology Division

No, 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 has been consistent since we launched the AG. Over the course of 2025, more volume shifted from Korlym prescriptions to AG prescriptions, and we ended the year at about 75%. That was the pricing impact on our 2025 revenues. For 2026, we're at about 78% AG and expect it to possibly increase slightly, but it has essentially stabilized. However, we anticipate potential pricing pressures and discounting for the remainder of 2026.

David Amsellem, Analyst

Can you discuss the likelihood of pursuing a randomized relacorilant trial if it comes to that? Is that the outcome you envision? Also, how long would such a study take?

Joseph K. Belanoff, CEO

I want to clarify an important point for everyone. Our medicines are intended for the treatment of hypercortisolism. We have discovered that the pool of patients with hypercortisolism is much larger than was believed 15 years ago, 10 years ago, or even five years ago. These patients often suffer from several significant health issues and historically have not responded to standard treatments. For example, the CATALYST study demonstrated that patients with resistant diabetes, despite receiving the best medications from the most skilled doctors, represent a group of nonresponders. Approximately one-fourth of these nonresponders have hypercortisolism, and when we treat their hypercortisolism, their symptoms improve significantly. We are still awaiting the results for resistant hypertension, which should be available soon and may be very important. The key takeaway is that hypercortisolism plays a crucial role in many symptoms, and many patients with this condition remain undiagnosed across various significant health issues. As for our clinical development going forward, while I cannot provide specific details at this time, it is essential to focus on identifying patients with hypercortisolism and providing them with appropriate treatment.

Operator, Operator

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

Jing Deng, Analyst

This is Jing online for Joon. My first question actually is on the oncology side. Congratulations on your ROSELLA data at 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 subgroup or safety analysis and also full safety tables? And then also, how do you expect this will support early adoption.

Joseph K. Belanoff, CEO

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

William Guyer, Chief Development Officer

Thank you for that question. So one, I want to respect what we're going to present at SGO and not give you too many 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. 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 nab-paclitaxel. 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.

Joseph K. Belanoff, CEO

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

Roberto Vieira, President, Oncology Division

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 clinically challenging to treat. So we look at this, especially in the context of the all-comer indication, as being transformative. This has never been done before. It's the first time that we have overall survival data of this magnitude demonstrating the all-comer population. And then 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, and 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, a 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 convenience of this regimen, our expectation for adoption is really a very early adoption and broad adoption, establishing what we consider to be a potential new standard of care in the category.

Operator, Operator

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

Swayampakula Ramakanth, Analyst

I have a few quick questions. First, regarding the supply chain issues and specialty pharmacy, how confident are you that the lingering problems, which have persisted for almost a year, have been resolved? Secondly, when considering the guidance you provided, how much of it accounts for the relacorilant revenues from the oncology franchise? Finally, as Bill discussed safety, will we see a complete view of safety data from the relacorilant trial? It seems that while you believed all safety matters were addressed, the FDA had a different perspective concerning relacorilant and Cushing syndrome. Additionally, for Bill, how does he view the role of KEYTRUDA in this context, and how are he and Roberto planning to address this?

Joseph K. Belanoff, CEO

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

Sean Maduck, President, Endocrinology Division

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 between the two pharmacies started in October, and it was challenging, as I talked about in my opening comments. One thing I want to make clear is that all patients are actually now at Curant. Now that those patients are all at Curant, we're actually seeing improvement and a lot of the metrics we look at are heading 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 is based on 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 with Corcept and how we support our patients. They have extremely strong leadership, strong people, and very sophisticated technology and processes on how they manage a patient from enrollment all the way through to distribution. And one of the most important pieces, which was our issue with sort of overloading the system last year, is that they 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. I believe 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.

Joseph K. Belanoff, CEO

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

Atabak Mokari, CFO

Sure. RK, 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 our guidance range comes from our oncology business just given the anticipated timing of launch in oncology.

Joseph K. Belanoff, CEO

Bill, you have the safety question.

William Guyer, Chief Development Officer

Regarding the safety question, I hope to answer it as you intended. With respect to safety from ROSELLA, as mentioned earlier, I can provide a bit more detail, especially since you linked it to endocrinology. The safety profile from ROSELLA a year ago compared to now, at the final overall survival analysis, shows a very similar safety profile, almost exactly the same. This will be further discussed at SGO. Relating to endocrinology, I believe you are inquiring about any increases in ALT that may have been observed in that program. In the endocrinology program, our assessment indicates that we did not encounter any cases of drug-induced liver injury, which is also confirmed by our external independent safety committee that evaluated all data. Therefore, there are no significant issues in endocrinology. We then examined the ROSELLA data in oncology and I want to clarify that we are not observing any concerning rises in ALT levels. It's important to note that nab-paclitaxel alone can elevate ALTs, particularly in the context of platinum-resistant ovarian cancer. However, in the ROSELLA study, when relacorilant is combined with nab-paclitaxel, we see half the amount of ALT increases compared to the nab-paclitaxel alone group. Thus, we aren't experiencing additional toxicity; in fact, we are seeing a reduction in ALT rises. We will share this data in just the next two days. I feel very comfortable and confident regarding the safety profile in both oncology and endocrinology.

Joseph K. Belanoff, CEO

Roberto, the final question?

Roberto Vieira, President, Oncology Division

Yes. So concerning KEYTRUDA, RK, let me just start by reminding us that their approval is for CPS greater than 1 or a PD-L1 expression greater than 1. So in our data sets in the 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 and was 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% 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, are interested in ROSELLA. 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. So overall, when you compare a regimen that came with a safety burden, you can see in their data, a hazard ratio of 0.76. There is a clear signal here that there is a utilization of our ROSELLA regimen in other lines and maintaining optionality for KEYTRUDA in later lines of therapy.

Joseph K. Belanoff, CEO

Thank you, RK. And I think we'll 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 that 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. 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.

Operator, Operator

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