Q4 2025 Corcept Therapeutics Inc Earnings Call
Operator: Thank you for standing by, and welcome to Corcept Therapeutics' Q4 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.
Speaker #1: After the speaker presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press *11 on your telephone.
Speaker #1: To remove yourself from the queue, you may press *11 again. I would now like to hand the call over to Atabak Mokari, CFO, please.
Speaker #1: Go ahead.
Speaker #2: 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.
Atabak Mokari: 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.
Atabak Mokari: 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.
Speaker #2: A copy is available at corsept.com. Our complete financial results will be available when we file our Form 10-K with the SEC. Today's call is being recorded.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: 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.
Atabak Mokari: 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 31 December 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.
Atabak Mokari: 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 31 December 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.
Speaker #2: 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.
Speaker #2: Our 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 CORSEPT stock options and divesting of restricted stock grants.
Speaker #2: I will now turn the call over to Charlie Robb, our Chief Business Officer. Charlie?
Atabak Mokari: I will now turn the call over to Charles Robb, our Chief Business Officer. Charlie?
Atabak Mokari: I will now turn the call over to Charles Robb, our Chief Business Officer. Charlie?
Speaker #3: Thanks, Atabak. As many of you know, last Thursday, the Federal Circuit Court of Appeals ruled against us in our lawsuit to stop Tepa Pharmaceuticals from marketing a generic version of Corlim in violation of our patents.
Charles Robb: 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?
Charles Robb: 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?
Speaker #3: We believe the court made a mistake. Patents we have asserted as included in Corlim's label and Tepa's copy of Corlim's label instruct physicians how to administer Corlim safely with drugs many patients with Cushing's syndrome require for optimal health.
Speaker #3: 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.
Speaker #3: We plan to appeal. I'll now turn to the FDA's failure to approve relic Corlim as a treatment for patients with Cushing's syndrome. We were surprised by the FDA's decision.
Speaker #3: Why? Because Relicorlim 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 Relicorlim's prospects.
Charles Robb: Relacorilant benefits patients with Cushing's syndrome, 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 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.
Charles Robb: Relacorilant benefits patients with Cushing's syndrome, 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 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.
Speaker #3: 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.
Speaker #3: 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.
Speaker #3: 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.
Speaker #3: 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.
Charles Robb: 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. 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.
Charles Robb: 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. 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.
Speaker #3: These patients needed a blood pressure treatment that worked for them. Relic Corlim's demonstrated benefit addressing an unmet need in patients with a serious condition by itself would be ample reason to expect its approval.
Speaker #3: But we had additional causes for optimism. Throughout relic Corlim's development program, patients exhibited meaningful improvements in other signs and symptoms of Cushing's syndrome, not just hypertension.
Speaker #3: 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 weight circumference shrank, and their glucose control improved.
Speaker #3: 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 relic Corlim is the gave cause for optimism is that relic Corlim confers its benefit without giving rise to serious adverse events and off-target effects, associated with the currently approved treatments.
Charles Robb: 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 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.
Charles Robb: 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 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.
Speaker #3: Including QT interval prolongation, adrenal insufficiency, hypokalemia, endometrial thickening, irregular vaginal bleeding, and termination of pregnancy. Relic Corlim would provide a treatment option for patients who find one or more of these risks disqualifying.
Speaker #3: 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 doubt relic Corlim's proof.
Speaker #3: In addition to the efficacy and safety benefits I just described, there was still another reason for us to expect relic Corlim'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.
Charles Robb: 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 pro-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 improved medication.
Charles Robb: 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 pro-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 improved medication.
Speaker #3: For example, a pivotal GRACE trial employed the same design as the trials that led to the approval of Estrace and Recorlab. The two most recently approved Cushing's syndrome medications.
Speaker #3: 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.
Speaker #3: 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.
Speaker #3: In sum, our review of FDA precedent just as much as our scientific evaluation of relic Corlim's clinical data gave us ample reason for optimism.
Charles Robb: 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, 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 review issues or a possible refusal to file a letter if we did submit.
Charles Robb: 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, 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 review issues or a possible refusal to file a letter if we did submit.
Speaker #3: I'll close with a final reason. We worked with the FDA for years to bring relic Corlim to the point of NDA submission. During that time, the FDA made recommendations regarding various aspects of our program.
Speaker #3: 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.
Speaker #3: The FDA telesponsors when it does not think they should admit 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.
Speaker #3: 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.
Charles Robb: 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. 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.
Charles Robb: 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. 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.
Speaker #3: We heard nothing of the sort until the very end of the process. Neither the mid nor late-cycle meetings that are part of every NDA review was the word "deficiencies" used.
Speaker #3: To reiterate my original point, we were surprised and for good reason that relic Corlim was not approved. Where do we go from here? Our priority is to make relic Corlim available to patients as quickly as possible.
Speaker #3: 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.
Charles Robb: 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?
Charles Robb: 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?
Speaker #3: I'll now turn the call over to Sean Maduck, president of our endocrinology division. Sean?
Speaker #2: 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.
Sean Maduck: 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.
Sean Maduck: 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.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: 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 one disrupted our business in November, December, and January.
Sean Maduck: We have been pleased with the new pharmacy's capabilities, 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.
Sean Maduck: We have been pleased with the new pharmacy's capabilities, 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.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: 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.
Sean Maduck: 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, a change of this magnitude takes a bit of time to fully absorb.
Sean Maduck: 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, a change of this magnitude takes a bit of time to fully absorb.
Speaker #2: Catalyst's second treatment phase randomized 136 patients with uncontrolled diabetes and hypercortisolism to receive either Corlim or placebo. After 24 weeks of treatment, the mean decrease in HbA1c in patients who received Corlim was 1.47%, compared to a 0.17% mean decrease in patients who received placebo.
Speaker #2: Patients in the Corlim 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.
Speaker #2: 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.
Sean Maduck: 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?
Sean Maduck: 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?
Speaker #2: We expect our Cushing's syndrome business to grow to at least $2 billion in annual revenue by the end of this decade. When relic Corlim is available, growth will accelerate further.
Speaker #2: I will now turn the call over to Joe Belanoff, our chief executive officer. Joe?
Speaker #3: 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.
Charles Robb: 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.
Charles Robb: 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.
Speaker #3: 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.
Speaker #3: 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.
Speaker #3: Our Rosella trial proved this point in platinum-resistant ovarian cancer. Patients who received relic Corlim, in addition to Naphaclitaxel, had longer progression-free and overall survival than those who received Naphaclitaxel alone.
Joseph K. Belanoff: ... 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.
Joe Belanoff: ... 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.
Speaker #3: As our oncology research continues, I am optimistic that relic Corlim and other cortisol modulators will provide treatments for patients with other solid tumors and will be effective in combination with other anti-cancer therapies.
Speaker #3: 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.
Speaker #3: 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.
Joseph K. Belanoff: 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 have 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.
Joe Belanoff: 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 have 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.
Speaker #3: 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.
Speaker #3: 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.
Speaker #3: We have recently completed the 1,000-patient momentum trial. With everything else that has been going on, there has not been much focus on momentum, but it is a very important study.
Speaker #3: 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.
Speaker #3: 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.
Joseph K. Belanoff: 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 3 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.
Joe Belanoff: 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 3 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.
Speaker #3: 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.
Speaker #3: 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 relic Corlim in addition to the potent chemotherapy medication Naphaclitaxel experienced longer progression-free survival and longer overall survival than did patients who received Naphaclitaxel alone.
Speaker #3: To quantify these benefits, patients treated with relic Corlim and Naphaclitaxel experienced a 35% reduction in risk of death, a hazard ratio of 0.65, compared to patients who were treated with Naphaclitaxel alone.
Joseph K. Belanoff: 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 4.11 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 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, the SGO meeting in April, and will publish them in a leading peer-review journal later this year.
Joe Belanoff: 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 4.11 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 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, the SGO meeting in April, and will publish them in a leading peer-review journal later this year.
Speaker #3: With a p-value of 0.0004, median overall survival for patients receiving relic Corlim was 4.1 months longer than it was for patients on Naphaclitaxel monotherapy.
Speaker #3: A significant number of patients responded even better to the addition of relic Corlim to their anti-cancer regimen than these results suggest. At the survival curve's 75th percentile point, patients receiving relic Corlim lived 8 months longer than those who had received Naphaclitaxel alone.
Speaker #3: 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.
Speaker #3: As you can imagine, the world-class managers and salespeople we have recruited to run our commercial oncology division are eager to bring relic Corlim to patients.
Joseph K. Belanoff: 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 11 July 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.
Joe Belanoff: 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 11 July 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.
Speaker #3: They and leading oncologists believe strongly that relic Corlim, 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.
Speaker #3: Our FDA PDUFA date is July 11th of this year. As I mentioned earlier, Rosella is just the beginning. We are currently evaluating relic Corlim in combination with other anti-cancer therapies and in other solid tumors, including platinum-sensitive ovarian, endometrial, cervical, and pancreatic cancers.
Speaker #3: 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.
Speaker #3: 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.
Joseph K. Belanoff: 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 2 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.
Joe Belanoff: 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 2 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.
Speaker #3: 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 a proprietary selective GR antagonist, Nenacorlin, in combination with nivolumab, a PD1-directed immunotherapy to treat patients with a broad range of solid tumors.
Speaker #3: 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 relic Corlim plus enzalutamide in patients with early-stage prostate cancer.
Speaker #3: 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.
Speaker #3: 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.
Joseph K. Belanoff: 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 1b 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 2b MONARCH study is fully enrolled and will produce results by the end of this year. If they are positive, we will advance to Phase 3. Patients with ALS have dysregulated cortisol levels, which is why we believe our proprietary selective cortisol modulator, dazucorilant, may be very useful.
Joe Belanoff: 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 1b 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 2b MONARCH study is fully enrolled and will produce results by the end of this year. If they are positive, we will advance to Phase 3. Patients with ALS have dysregulated cortisol levels, which is why we believe our proprietary selective cortisol modulator, dazucorilant, may be very useful.
Speaker #3: Our proprietary selective cortisol modulator, Miracorlin, 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.
Speaker #3: 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.
Speaker #3: 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, dasacorlin, may be very useful.
Speaker #3: Results from our 249-patient, double-blind, placebo-controlled dasals trial of dasacorlin in patients with ALS are encouraging. In dasals, patients who received 300 milligrams of dasacorlin for one year exhibited an 84% reduction in risk of death compared to patients who received placebo.
Joseph K. Belanoff: 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 mg 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, 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 DAZALS, an outcome we think can be avoided.
Joe Belanoff: 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 mg 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, 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 DAZALS, an outcome we think can be avoided.
Speaker #3: The p-value for this finding was 0.0009. Dasacorlin's apparent prevention of early death, that is, death early in the course of the disease, is 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.
Speaker #3: We have initiated a small study to see if dose titration can improve dasacorlin's gastrointestinal tolerability. Non-serious GI distress caused most of the discontinuations in dasals, an outcome we think can be avoided.
Speaker #3: 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.
Joseph K. Belanoff: 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.
Joe Belanoff: 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.
Speaker #3: To sum up, our Cushing syndrome business experienced a surge in demand for Corlim in 2025 because of growing recognition among physicians of hypercortisolism's true prevalence and the necessity of appropriate treatment.
Speaker #3: 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.
Speaker #3: We are working with the FDA to obtain approval of relic Corlim in Cushing syndrome. As Sean said earlier, our Cushing syndrome business is poised for substantial growth with our existing medications, and will grow even faster upon the approval of relic Corlim.
Speaker #3: By mid-year, we expect relic Corlim'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 formed by patients.
Joseph K. Belanoff: 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 3 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 2 DAZALS findings, we expect to begin a Phase 3 study in patients with ALS by mid-year.
Joe Belanoff: 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 3 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 2 DAZALS findings, we expect to begin a Phase 3 study in patients with ALS by mid-year.
Speaker #3: The fact that glucocorticoid receptor antagonists have demonstrated such compelling results in this extremely difficult-to-treat cancer type gives us confidence in relic Corlim's potential in earlier stages of ovarian cancer as well as in other tumor types and in combination with other anti-cancer therapies.
Speaker #3: 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.
Speaker #3: Following up on our positive Phase II dasals 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.
Joseph K. Belanoff: By year-end, we will know the outcome of our Phase 2 MONARCH trial in patients with MASH and will proceed to Phase 3 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.
Joe Belanoff: By year-end, we will know the outcome of our Phase 2 MONARCH trial in patients with MASH and will proceed to Phase 3 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.
Speaker #3: We are also continuing to discover and develop new cortisol modulators, advancing the most promising of them to the clinic. The potential of cortisol modulation to benefit patients is vast.
Speaker #3: 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.
Speaker #3: Operator, let's proceed to questions.
Speaker #2: Yes, sir. As a reminder, to ask a question, you will need to press star 11 on your telephone. To remove yourself from the queue, you may press star 11 again.
Operator: 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.
Operator: 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.
Speaker #2: Please stand by while we compile the Q&A roster. Our first question comes from the line of David Anselem, of Piper Sandler. Your line is open, David.
David Amsellem: 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.
Speaker #3: Thanks. So 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 and then secondly, your willingness to run a more conventional randomized trial of relic Corlim in type 2 diabetes and/or hypertensive patients who are poorly controlled I guess something along the lines of momentum and catalyst.
David Amsellem: 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.
Speaker #3: 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 Corlim, 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 of the discounts or net price off of the list price?
David Amsellem: 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.
David Amsellem: 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.
Speaker #3: How should we think about that for '26? Thank you.
Speaker #4: 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, specify at the end and we'll try again because that was a good list.
Joseph K. Belanoff: Okay. E-Edward, I think that we caught all of your questions. I'm sorry, David. Excuse me. I think we caught all of your questions. If for some reason that we haven't, you know, specify at the end, and we, and we'll try again, because that was a good list. I'm gonna give you over first to Charlie to talk about the CRL.
Joe Belanoff: Okay. E-Edward, I think that we caught all of your questions. I'm sorry, David. Excuse me. I think we caught all of your questions. If for some reason that we haven't, you know, specify at the end, and we, and we'll try again, because that was a good list. I'm gonna give you over first to Charlie to talk about the CRL.
Speaker #4: So I'm going to give you our first to Charlie to talk about the CRL.
Charles Robb: you know, David Amsellem, 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 FDA's mind in that regard. you know, what we did was looked at the data we had on a scientific basis, and it clearly met the hurdle for approval. when we turned and looked at the other drugs that the agency had approved, you know, both as 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. Does that...
Speaker #5: So again, 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.
Charles Robb: you know, David Amsellem, 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 FDA's mind in that regard. you know, what we did was looked at the data we had on a scientific basis, and it clearly met the hurdle for approval. when we turned and looked at the other drugs that the agency had approved, you know, both as 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. Does that...
Speaker #5: 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.
Speaker #5: And then, when we turned and looked at the other drugs that the agency had approved, both our trial design and program generally, and the results we had, were clearly right in line with prior approved treatments.
Speaker #5: So I don't know if the FDA is thinking shifted in any way, but we really just think we just they missed the mark in that regard.
Speaker #5: Does that I think I hope that sort of addressed it.
Charles Robb: I think, I hope that sort of addresses-
Charles Robb: I think, I hope that sort of addresses-
Joseph K. Belanoff: Yeah. Yeah, please, David, does that answer your question?
Joe Belanoff: Yeah. Yeah, please, David, does that answer your question?
Speaker #4: Yeah, please, David. Does that answer your question?
Speaker #3: Well, I guess in 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.
David Amsellem: Well, I guess there is a redacted CRL that lays out some very specific concerns. It just seems.
David Amsellem: Well, I guess there is a redacted CRL that lays out some very specific concerns. It just seems.
Charles Robb: Mm-hmm.
Charles Robb: Mm-hmm.
David Amsellem: -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.
David Amsellem: -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.
Speaker #3: And I'm just trying to understand how we in the investor and analyst community can somehow bridge that gap, if that makes sense.
Speaker #5: Yeah. 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.
Charles Robb: Yeah. I mean, 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 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 I think again, I just have to return to, I think on the merits compared to the other approved drugs, we got it right.
Charles Robb: Yeah. I mean, 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 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 I think again, I just have to return to, I think on the merits compared to the other approved drugs, we got it right.
Speaker #5: For example, leading with the acknowledges right out of the gate that our pivotal trial met its primary endpoint. For instance, the confirmatory evidence we provided also met its endpoint until the agency mentioned sort of an analysis at the end that they performed that we had never seen.
Speaker #5: 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 compared to the other approved drugs, we got it right.
Speaker #5: 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.
Charles Robb: 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.
Charles Robb: 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.
Speaker #5: 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.
Speaker #5: That's why we're meeting with them.
Speaker #4: Okay. And Sean, so there were several questions related to sales of Corlim.
Joseph K. Belanoff: Okay. Sean, there were several questions related to sales of Korlym.
Joe Belanoff: Okay. Sean, there were several questions related to sales of Korlym.
Speaker #2: Yeah. No, thanks for the question. So in terms of the AG, the AG's net price is about a 30% discount on Corlim's WAC. And that's been consistent really since we launched the AG.
Sean Maduck: Yeah, 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'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. We ended the year at about 75%, and that really was what the pricing impact was in our 2025 revenues. 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.
Sean Maduck: Yeah, 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'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. We ended the year at about 75%, and that really was what the pricing impact was in our 2025 revenues. 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.
Speaker #2: Now, over the course of 2025, more volume shifted from Corlim 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.
Speaker #2: 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.
Speaker #2: But we have built in potential pricing pressures and discounting in through the remainder of 2026.
Speaker #3: Okay. Thanks. And then just my and then just my question on running a randomized relic Corlim trial if it came to that, can you just talk about the likelihood of ultimately going down that path?
David Amsellem: Okay, thanks.
David Amsellem: Okay, thanks.
Joseph K. Belanoff: And, uh-
Joe Belanoff: And, uh-
David Amsellem: Just my question-
David Amsellem: Just my question-
Joseph K. Belanoff: Go ahead.
Joe Belanoff: Go ahead.
David Amsellem: ... 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?
David Amsellem: ... 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?
Speaker #3: Is that the outcome you envision here? And how long would such a study take?
Joseph K. Belanoff: 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've 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 5 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. Of those non-responders, about a quarter of them have hypercortisolism. What the treatment portion of the Catalyst study said is, if you treat their hypercortisolism, those symptoms improve, and they improve really very dramatically.
Joe Belanoff: 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've 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 5 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. Of those non-responders, about a quarter of them have hypercortisolism. What the treatment portion of the Catalyst study said is, if you treat their hypercortisolism, those symptoms improve, and they improve really very dramatically.
Speaker #4: 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 by many people, even 5 years ago.
Speaker #4: 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 and treated by the best doctors, there's really a group of non-responders.
Speaker #4: 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.
Speaker #4: 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.
Joseph K. Belanoff: Now, 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.
Joe Belanoff: Now, 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.
Speaker #4: And I think the general point that we're making is that hypercortisolism is an important driver of many symptoms and patients with hypercortisolism are currently undiagnosed in many important disease states.
Speaker #4: 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.
Speaker #4: Okay. Next question.
Speaker #2: Thank you. Our next question. Comes from the line of Jing Dang. Of truest, your line is open, Jing.
Operator: Thank you. Our next question comes from the line of Joon Lee of Truist. Your line is open, Jing.
Operator: Thank you. Our next question comes from the line of Joon Lee of Truist. Your line is open, Jing.
Speaker #5: Hi. This is Jing. I'm on the line for June. Thanks for taking my question. My first question actually is on the oncology side. Congratulations on your Rosella data has been both OS and PFS.
Charles Robb: Hi, this is Jing. I'm online for June. Thanks for taking my questions. 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?
[Analyst] (Truist Securities): Hi, this is Jing. I'm online for June. Thanks for taking my questions. 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?
Speaker #5: But my question is looking ahead to SGO in April. So what should we expect to see for that completed data set? For example, specific subgroup or safety analysis and also full safety tables and then also how do you expect this will support early adoption?
[Analyst] (Truist Securities): ... 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?
[Analyst] (Truist Securities): ... 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?
Speaker #4: Okay. I think I'd like to start that answer to question with Bill Geier, who is our chief development officer. And then 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.
Joseph K. Belanoff: Okay. I think I'd like to start that answer to the question with William Guyer, who is our Chief Development Officer, and then, 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.
Joe Belanoff: Okay. I think I'd like to start that answer to the question with William Guyer, who is our Chief Development Officer, and then, 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.
Speaker #4: A few additional comments. Bill, go ahead.
William Guyer: 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.
William Guyer: 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.
Speaker #2: Thank you. Thank you for that question. So one, I want to respect what we're going to present at SGO and not give you too much details, but yet still try to answer your question.
Speaker #2: 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.
Speaker #2: That'll 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.
Speaker #2: And so it really shows the tolerability of relic Corlim in combination with that of NAPAC/Lataxel. So there'll be a lot of data within that presentation.
William Guyer: 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 at close to that time.
William Guyer: 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 at close to that time.
Speaker #2: 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.
Speaker #2: And hopefully soon published right after or similarly close to that time.
Speaker #4: Okay. Very good. And Roberto, I think you're called on to speak too early adoption.
Joseph K. Belanoff: Okay. Very, very good, Bill. Roberto, I think you're called on to speak to early adoption.
Joe Belanoff: Okay. Very, very good, Bill. Roberto, I think you're called on to speak to early adoption.
Speaker #2: Yeah. So thank you for the question about the adoption. I want to go back to the point that Joe made in his opening remarks.
Roberto Vieira: Thank you for the question about the adoption. I wanna 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. 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 present the final data, but you can look at that in The Lancet publication from last year.
Roberto Vieira: Thank you for the question about the adoption. I wanna 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. 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 present the final data, but you can look at that in The Lancet publication from last year.
Speaker #2: A 35% reduction in the risk of death, a 4.1-month extension of median overall survival, in a population that is incredibly refractory in clinical challenge in clinically challenging to treat.
Speaker #2: So we look at this especially in the context of the outcome or 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 outcome of population.
Speaker #2: And then you look into the safety and tolerability. It was just alluding to that. We'll present the final data, but you can look at that in the Lancet publication from last year.
Roberto Vieira: 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, and 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.
Speaker #2: The bottom line of the safety is that relic Corlim did not really add much to the safety buzz in comparison to another Pactaxel. Now the Pactaxel is a taxane that there's great familiarity on how to treat it.
Roberto Vieira: 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, and 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.
Speaker #2: 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.
Speaker #2: 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 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.
Speaker #2: Establishing what we consider to be a potential new standard of care in the category.
Speaker #4: Thank you, Roberto. Okay, next question, please.
Joseph K. Belanoff: Thank you, Roberto. Okay, next question, please.
Joe Belanoff: Thank you, Roberto. Okay, next question, please.
Speaker #2: Thank you. Our next question comes from the line of RK with HC Wainwright. Your line is open, RK.
Operator: Thank you. Our next question comes from the line of RK with H.C. Wainwright & Co. Your line is open, RK.
Operator: Thank you. Our next question comes from the line of RK with H.C. Wainwright & Co. Your line is open, RK.
Speaker #6: Thank you. Good afternoon, Joe. A couple of quick questions here. One, is on the supply chain issues and the specialty pharmacy. How confident are you that all of those which have been lingering for almost a year now have been taken care of?
Raghuram Selvaraju: 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?
Swayampakula Ramakanth: 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?
Speaker #6: And when we think about the guidance that you gave us, how much of that is being taken into account the relic Corlim revenues from the oncology franchise?
Speaker #6: 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 relic Corlim in that trial?
Raghuram Selvaraju: 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 Cushing's syndrome. The last question for, again, for Bill is: How does he think about, you know, KEYTRUDA coming into the picture now, and how was Roberto and Bill trying to think through it and message it?
Speaker #6: Because obviously, you were thinking that you had all the safety stuff straight, but FDA was not thinking so. With relic Corlim in the Cushing syndrome.
Swayampakula Ramakanth: 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 Cushing's syndrome. The last question for, again, for Bill is: How does he think about, you know, KEYTRUDA coming into the picture now, and how was Roberto and Bill trying to think through it and message it?
Speaker #6: 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 trying to think through it and message it?
Joseph K. Belanoff: 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?
Speaker #4: 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?
Joe Belanoff: 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?
Speaker #2: Yeah. 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.
Sean Maduck: 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 Corcept. Now that those patients are all at Corcept, 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.
Sean Maduck: 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 Corcept. Now that those patients are all at Corcept, 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.
Speaker #2: So 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 want to make clear is that all patients are actually now at Toronto.
Speaker #2: Now, that those patients are all at Toronto, we're actually seeing improvement. And a lot of the metrics we look at are heading in the right direction.
Speaker #2: 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.
Speaker #2: 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.
Sean Maduck: 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, 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.
Sean Maduck: 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, 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.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: And 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.
Sean Maduck: 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.
Speaker #2: 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.
Sean Maduck: 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.
Speaker #2: And our belief 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.
Speaker #4: Good. Okay. Thank you, Sean. And Atabak, why don't you take the revenues question?
Joseph K. Belanoff: Good. Okay. Thank you, Sean. Atabak, why don't you take the revenues question?
Joe Belanoff: Good. Okay. Thank you, Sean. Atabak, why don't you take the revenues question?
Speaker #3: Sure. Hey, RK. So regarding how much of our guidance, the mix of it, almost all of our guidance range comes from our Cushing 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.
William Guyer: 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 our guidance range comes from our oncology business, just given the anticipated timing of launch in oncology.
William Guyer: 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 our guidance range comes from our oncology business, just given the anticipated timing of launch in oncology.
Speaker #4: Bill, you have the safety question.
Joseph K. Belanoff: Bill, you have the safety question.
Joe Belanoff: Bill, you have the safety question.
William Guyer: Safety question. And again, hopefully, I answer it in the way you were 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 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. Now, by raising 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 endocrinology program? I'll go back to the endocrinology program.
William Guyer: Safety question. And again, hopefully, I answer it in the way you were 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 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. Now, by raising 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 endocrinology program? I'll go back to the endocrinology program.
Speaker #2: Safety question. So and again, hopefully, I 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, maybe, because you kind of related it back to endocrinology.
Speaker #2: 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.
Speaker #2: 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?
Speaker #2: And I'll go back to the endocrinology program. Our assessment within the endocrinology program is we did not have any cases of drug-induced liver injury.
William Guyer: Our assessment within the endocrinology program is we did not have any cases of drug-induced liver injury. We also have confirmation of that from our external independent safety committee, that also evaluated all that data. No real issue there in endocrinology. I know it has been raised. We then went to look at oncology. 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. You need to kinda 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.
William Guyer: Our assessment within the endocrinology program is we did not have any cases of drug-induced liver injury. We also have confirmation of that from our external independent safety committee, that also evaluated all that data. No real issue there in endocrinology. I know it has been raised. We then went to look at oncology. 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. You need to kinda 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.
Speaker #2: And we also have confirmation from that from our external independent safety committee that also evaluated all that data. So no real issue there in endocrinology.
Speaker #2: 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 and of concern because as a background, when you look at within the Rosella trial, one, Natpaclitaxel on its own can rise ALTs.
Speaker #2: And you need to kind of understand that within platinum-resistant ovarian cancer. But when we combine relic Corlim with that of Natpaclitaxel in the Rosella study, we're going to be presenting this data in just a couple of days.
Speaker #2: We actually see half the amount of ALT rises in the combination arm compared to that of the Natpaclitaxel alone arm. So we're not seeing any added toxicity.
William Guyer: 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.
William Guyer: 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.
Speaker #2: We're actually seeing reduction in that of ALT rises. And that data, again, we'll be able to share with you in just the next two days.
Speaker #2: So I feel very comfortable and confident with the safety profile of endocrinology in both the oncology area and also the endocrinology area.
Speaker #4: Roberta, the final question?
Joseph K. Belanoff: Roberto, the final question?
Joe Belanoff: Roberto, the final question?
Speaker #2: Yeah. So once I think you through the RK, let me just start by reminding us that their approval is for CPS greater than one or PD-L1 expression greater than one.
Roberto Vieira: Yeah. Concerning KEYTRUDA, RK, let me just start by reminding us that their approval is for CPS greater than one or PDL1 expression greater than one. In our dataset in real world, we are talking about 50% to 60% of the total population. 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 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% to 15% of those patients already in later lines of therapy. Now, when we have engaged in our work with oncologists, that they are very much interested in maintaining options.
Roberto Vieira: Yeah. Concerning KEYTRUDA, RK, let me just start by reminding us that their approval is for CPS greater than one or PDL1 expression greater than one. In our dataset in real world, we are talking about 50% to 60% of the total population. 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 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% to 15% of those patients already in later lines of therapy. Now, when we have engaged in our work with oncologists, that they are very much interested in maintaining options.
Speaker #2: So in our data sets in real world, we are talking about 50 to 60 percent of the total population. So of course, you have that limitation of the biomarker right there.
Speaker #2: Now, beyond this, it's important to remember that a Keytruda has been used in ovarian cancer for a while as part of the NTCN guidelines in other regimens that are taxane-sparing, that do not utilize paclitaxel.
Speaker #2: It has a use there. It's 10 to 15 percent of those patients already in later lines of therapy. Now, when we have engaged in our work with oncologists, they are very much interested in maintaining options.
Speaker #2: 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.
Roberto Vieira: 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 that you can see in their data, hazard ratio of 0.76, there is a clear signal here that there's a position about ROSELLA regimen in early lines and maintaining optionality for KEYTRUDA in later lines of therapy.
Roberto Vieira: 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 that you can see in their data, hazard ratio of 0.76, there is a clear signal here that there's a position about ROSELLA regimen in early lines and maintaining optionality for KEYTRUDA in later lines of therapy.
Speaker #2: 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 how that ratio of 0.76, there is a clear signal here that there's a utilization of our Rosella regimen in other lines.
Speaker #2: And maintaining optionality for Keytruda in later lines of therapy.
Speaker #4: Okay. Well, thank you. Thank you, RK. And I think. That we will conclude our call. And we will plan on seeing you in three months.
Joseph K. Belanoff: Okay. Well, thank you. Thank you, RK. I.
Joe Belanoff: Okay. Well, thank you. Thank you, RK. I.
William Guyer: Thank you.
William Guyer: Thank you.
Joseph K. Belanoff: we will conclude our call, and we will plan on seeing you in three months. Before I get off, though, I just wanna 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 three months, and we look forward to talking to you again at that period of time. Thank you.
Joe Belanoff: we will conclude our call, and we will plan on seeing you in three months. Before I get off, though, I just wanna 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 three months, and we look forward to talking to you again at that period of time. Thank you.
Speaker #4: 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.
Speaker #4: 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 three months.
Speaker #4: And we look forward to talking to you again at that period of time. So, thank you.
Sean Maduck: This concludes today's conference call. Thank you for participating. You may now disconnect.
Sean Maduck: This concludes today's conference call. Thank you for participating. You may now disconnect.