Q1 2024 Corcept Therapeutics Inc Earnings Call
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Operator: Good day, and thank you for standing by. Welcome to the Corcept Therapeutics conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to turn the conference over to your speaker for today, CFO Atabak Mokari. Please go ahead.
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CFO: Your speaker for today CFO.
Macquarie: Macquarie. Please go ahead.
Atabak Mokari: Hello everyone, and thank you for joining us. Today we issued a press release announcing our financial results for the first quarter and providing a corporate update. A copy is available at Corcept.com. Our complete financial results will be available when we file our Form 10-Q with the SEC. This call is being recorded.
Unknown Executive: Hello, everyone and thank you for joining US today, we issued a press release announcing our financial results for the first quarter and providing a corporate update copies available of course that dot com.
Unknown Executive: Our complete financial results will be available when we file our Form 10-Q with S. A C T.
Atabak Mokari: A replay will be available on 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. These forward-looking statements are described in today's press release, and the risks and uncertainties that may affect them are described in the press release and in our annual report on Form 10-K and our quarterly reports on Form 10-Q. Please refer to those documents for additional information.
Unknown Executive: Today's call is being recorded a replay will be available at the investors past events tab of our website.
Atabak Mokari: We disclaim any intention or duty to update forward-looking statements. Our revenue in the first quarter of 2024 was $146.8 million, an increase of 39% compared to the first quarter of the prior year. We expect our revenue growth to continue and have increased our 2024 revenue guidance to $620 to $650 million. Net income was $27.8 million in the first quarter compared to $15.9 million in the first quarter of the prior year. Our cash and investments at March 31st were $451 million. I will now turn the call over to Charlie Robb, our Chief Business Officer. Charlie.
Unknown Executive: Statements. During this call other than statements of historical fact are forward looking statements based on our plans and expectations and are subject to risks and uncertainties, which may cause actual results to be materially different from those such statements express or imply these.
Unknown Executive: These forward looking statements are described in today's press release, and the risks and uncertainties that may affect them are described in the press release and in our annual report on Form 10-K, and our quarterly reports on Form 10-Q.
Unknown Executive: Please refer to those documents for additional information, we disclaim any intention or duty to update forward looking statements.
Unknown Executive: Our revenue in the first quarter of 2024, it was $146 $8 million, an increase of 39% compared to the first quarter of the prior year. We expect our revenue growth to continue and have increased our 2020 for revenue guidance to $620 million to $650 million net.
Unknown Executive: Net income was $27.8 million in the first quarter compared to $15 $9 million in the first quarter of the prior year.
Unknown Executive: Cash and investments at March 31 was $451 million.
Unknown Executive: I will now turn the call over to Charlie Robb, our Chief business Officer Charlie.
Gary Charles Robb: In March 2018, we sued Tepa Pharmaceuticals to prevent it from marketing a generic version of Coraline in violation of our patents. The case was tried in federal district court in September of last year. On December 29th of last year, the court found that Teva's generic product would not infringe the two patents we had asserted against it. We believe the court's verdict is wrong and have asked the Federal Circuit Court of Appeals, which has appellate jurisdiction over all patent matters, to reverse it.
Gary Charles Robb: Thanks <unk>.
Gary Charles Robb: In March 2018, we sued Teva pharmaceuticals to prevent it from marketing of generic version of Korlym in violation of our patents. The case was tried in federal District Court in September of last year.
Gary Charles Robb: December 29th of last year. The court found that Teva generic product would not infringe the two patents we had asserted against it.
Gary Charles Robb: We believe the court's verdict is wrong and have asked the federal Circuit Court of Appeals, which has appellate jurisdiction overall patent matters to reverse it.
Gary Charles Robb: We filed our opening brief on March 11th, and TEVA filed its responsive brief on April 22nd. Our reply, which will complete the briefing of the matter, is due later this month. These documents are available publicly on the government's PACER website.
Gary Charles Robb: We filed our opening brief on March 11th Teva filed its responsive brief on April 22nd a reply, which will complete briefing of the matter is due later this month.
Gary Charles Robb: These documents are available publicly at the government's Piecer website.
Gary Charles Robb: It's impossible to predict exactly how long the appeal will take. The timing of oral argument and the issuance of an opinion are entirely up to the Federal Circuit. Having said that, it's reasonable to expect oral argument in the third or fourth quarter of this year and a decision early in the first quarter of 2025. If we prevail, Teva would lose FDA approval of its product, at least until the expiration of our patents in 2037.
Gary Charles Robb: It's impossible to predict exactly how long the appeal will take the timing of oral argument and the issuance of an opinion or entirely up to the federal circuit having.
Gary Charles Robb: Having said that it's reasonable to expect oral argument in the third or fourth quarter of this year and the decision early in the first quarter of 2025.
Gary Charles Robb: If we prevail Teva would lose FDA approval of its product at least until the expiration of our patents in 2037.
Gary Charles Robb: We're eager to advance this appeal. As has always been the case, we strongly believe that our position is the correct one. We're confident that the Federal Circuit, with its deep expertise in this area of the law, will agree. And Joe? Thank you.
Gary Charles Robb: We're eager to advance. This appeal is has always been the case, we strongly believe that our position as the correct one.
Gary Charles Robb: We're confident that the federal circuit with its deep expertise in this area of the law will agree.
Gary Charles Robb: I'll now turn the call over to Joe Belanoff, Our Chief Executive Officer and Joe. Thank.
Joseph K. Belanoff: Thank you, Charlie, and thank you, everyone, for joining us this afternoon. This has been a tremendously active period at Corcept. Our commercial business is thriving, and we are making substantial progress in every one of our development stage programs. In the past few weeks, we completed enrollment in four late-stage studies, and we released open-label data from our GRACE study that takes us one step closer to submitting our NDA and bringing Reliquoriline to patients with Cushing's.
Joseph K. Belanoff: Thank you Charlie.
Joseph K. Belanoff: And thank you everyone for joining us this afternoon and this has been a tremendously active period of course at our commercial business is thriving and we are making substantial progress in every one of our development stage programs.
Joseph K. Belanoff: In the past few weeks, we completed enrollment in four late stage studies and we released open label data from our Grace study. It takes us one step closer to submitting our NDA and bringing rella korlym to patients with Cushings syndrome.
Joseph K. Belanoff: Our commercial growth was driven by a record number of new Quorulum prescribers and a record number of patients receiving the medication. Hypercorticalism is commonly misdiagnosed, in large part because it's frequently expressed in burdensome symptoms, hyperglycemia and hypertension, which have become so common in the population as a whole.
Joseph K. Belanoff: Our commercial growth was driven by a record number of new Korlym prescribers and a record number of patients receiving the medication.
Joseph K. Belanoff: Hydrocodone Holism is commonly misdiagnosed in large part because it is frequently expressed and burdensome symptoms hyperglycemia and hypertension because have become so common in the population as a whole.
Joseph K. Belanoff: As physicians become increasingly aware that hypercortisolism is much more prevalent than previously assumed, they are screening and treating more patients for hypercortisolism than ever before. When Corallum is prescribed, we use the expertise and infrastructure that we have developed and refined over many years to support physicians and patients. This additional care helps create a life-changing impact for patients who receive core limb treatment.
Joseph K. Belanoff: As physicians become increasingly aware that hyper cortisol is much more prevalent than previously assumed they are screening and treating more patients for hyper cortisol than ever before when Korlym is prescribed we use the expertise and infrastructure that we have developed and refined over many years to support physicians and patients.
Joseph K. Belanoff: This additional care helps create a life changing impact for patients who received korlym treatment.
Joseph K. Belanoff: We have known for some time that there are large groups of patients who are far too infrequently screened for Cushing's Syndrome. The initial findings of the CATALYST study make that clear. CATALYST is the largest and most rigorous clinical study ever conducted to examine the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes. Over 1,000 patients were enrolled by the leading diabetologists in the United States, and 25% of these patients were found to have hypercortisolism.
Joseph K. Belanoff: We have known for some time that there are large groups of patients who are far too frequently infrequently screened for Cushing syndrome.
Joseph K. Belanoff: This is a far higher prevalence rate than is generally assumed, with potentially far-reaching implications for patient care. The final results from the prevalence portion of the study were presented at a keynote session at the American Diabetes Association's Annual Scientific Sessions in Orlando, Florida. The second portion of the Catalyst Study, the Treatment Phase, is ongoing.
Joseph K. Belanoff: The initial findings of the catalyst study make that clear catalyst is the largest and most rigorous clinical study ever conducted to examine the prevalence of hybrid cortisol ism and patients with difficult to control type two diabetes.
Joseph K. Belanoff: Over 1000 patients were enrolled by the leading diabetologist in the United States and 25% of these patients were found to have hyper cortisol ism.
Joseph K. Belanoff: This is a far higher prevalence rate is generally assumed with potentially far reaching implications for patient care.
Joseph K. Belanoff: The final results from the prevalence portion of this study will be presented at a keynote session at the American Diabetes Association annual scientific sessions in Orlando next month.
Joseph K. Belanoff: The second portion of the catalyst study the treatment phase is ongoing.
Joseph K. Belanoff: As the awareness and diagnosis of Cushing syndrome increases, we are simultaneously working to advance our proprietary selective cortisol modulator, Relacorrelate. Relacorollant has unique characteristics, and our confidence in its efficacy and safety profile has only been increased by the open-label results from the GRACE study. Our pivotal trial for Gorilla Correlant, GRACE, has two parts.
Joseph K. Belanoff: As the awareness and diagnosis of Cushing syndrome increases we are simultaneously working to advance our proprietary selective cortisol modulator rella correlate.
Joseph K. Belanoff: <unk> has unique characteristics and our confidence in its efficacy and safety profile has only been increased by the open label results from the Grace study.
Joseph K. Belanoff: Our pivotal trial for Gorilla Cortland Grace has two parts.
Joseph K. Belanoff: In its first open-label phase, 152 patients with Cushing syndrome and either hypertension, hyperglycemia, or both received rel-chloralant for 22 weeks. Patients who exhibited pre-specified improvements in either or both symptoms were given the opportunity to enter the trial's randomized double-blind withdrawal phase, during which half of the patients continue to receive brela-correlate and have received placebo for 12. Grace's primary endpoint is maintenance of blood pressure control in the randomized withdrawal phase of the study, with maintenance of glycemic control as the key secondary endpoint. Last week, we released results from Grace's open label phase. As I review these data here, please keep in mind this important point.
Joseph K. Belanoff: In its first open label Phase 152 patients with Cushings syndrome, and either hypertension hyperglycemia or bowl received <unk> for 22 weeks patients.
Joseph K. Belanoff: Patients, who exhibited pre specified improvements in either or both symptoms were given the opportunity to enter the trial is a randomized double blind withdrawal phase.
Joseph K. Belanoff: During which half of the patients.
Joseph K. Belanoff: Continue to receive Raila correlate and have received placebo for 12 weeks.
Joseph K. Belanoff: Grace's primary endpoint is maintenance of blood pressure control and the randomized withdrawal phase of the study with maintenance of glycemic control as the key secondary endpoint.
Joseph K. Belanoff: Last week, we released results from Grace's open label Phase as a review of these data here. Please keep in mind. This important point because excess cortisol activity affects nearly every tissue in the body patients with Cushings syndrome exhibit a wide array of signs and symptoms hyper.
Joseph K. Belanoff: Because excess cortisol activity affects nearly every tissue in the body, patients with Cushing syndrome exhibit a wide array of signs and symptoms. Hypertension and hyperglycemia are among the most common and destructive. Patients in the open-label phase of GRACE exhibited clinically meaningful and statistically significant improvements in hypertension, hyperglycemia, weight, waist circumference, cognition, Cushing's quality of life score, and other measures of clinical importance. In the open-label phase of GRACE, 63% of patients with hypertension met the study's response criteria.
Joseph K. Belanoff: Hypertension, and hyperglycemia are among the most common and destructive.
Joseph K. Belanoff: Patients in the open label phase of Grace exhibited clinically meaningful and statistically significant improvements in hypertension hyperglycemia weight waist circumference cognition Cushing is quality of life score and other measures of clinical importance.
Joseph K. Belanoff: And the open label Phase of Grace, 63% of patients with hypertension met the study's response criteria.
Joseph K. Belanoff: For the patients who entered the randomized withdrawal phase, improvements in mean systolic and diastolic blood pressure, 12.6 and 8.3 millimeters of mercury from baseline with P values of less than 0.0001, were observed. To ensure accuracy, hypertension was measured by 24-hour Ambulatory Blood Pressure Monitoring, or ABPM, which is the gold standard for hypertension monitoring.
Joseph K. Belanoff: Patients who entered the randomized withdrawal phase improvements in mean systolic and diastolic blood pressure, a 12.6 and $8 three millimeters of Mercury from baseline with P values of less than 0.0001 or observe.
Joseph K. Belanoff: To ensure accuracy hypertension, which measured by 24 hour ambulatory blood pressure monitoring or a b P M, which is the gold standard for hypertension monitoring.
Joseph K. Belanoff: 50% of the patients who entered GRACE with hyperglycemia, which included patients with diabetes and patients with impaired glucose tolerance or pre-diabetes, responded to Reliquoril. For the patients who entered the randomized withdrawal phase, improvements in the oral glucose tolerance test, or mean glucose area under the curve, of 6.2 millimoles per liter were seen. Reduction in mean hemoglobin A1c of 0.7% and reduction in mean fasting glucose of 25.2 milligrams per deciliter, all with p-values of 0.006 or less were observed.
Joseph K. Belanoff: 50% of the patients who entered grace with hyperglycemia, which includes patients with diabetes and patients with impaired glucose tolerance or pre diabetes responded to relic orland for.
Joseph K. Belanoff: For the patients who entered the randomized withdrawal phase improvements in the oral glucose tolerance test or mean glucose area under the curve of $6 2 million newly moles per liter.
Joseph K. Belanoff: Reduction in mean hemoglobin, <unk> or <unk>, 7% and reduction in mean fasting glucose or 25, two milligrams per deciliter, all with P values of 0.006 or less were observed.
Joseph K. Belanoff: Rellocorrelant was well-tolerated, consistent with its known safety profile. Due to its unique mechanism of action, which, unlike Correlant, does not increase patients' cortisol levels, there were no Rellocorrelant-induced instances of hypokalemia. In addition, no cases of drug-induced endometrial hypertrophy, with or without vaginal bleeding, adrenal insufficiency, or QT prolongation, which was independently confirmed, were reported.
Joseph K. Belanoff: <unk> was well tolerated consistent with its known safety profile.
Joseph K. Belanoff: Due to its unique mechanism of action, which unlike korlym <unk> does not increase patients cortisol levels. There were no railroad correlate induced instances of hypokalemia.
Joseph K. Belanoff: In addition, no cases of drug induced endometrial hypertrophy with or without vaginal bleeding adrenal insufficiency, or Qt prolongation, which was independently confirmed were reported.
Joseph K. Belanoff: Both parts of Grace are complete.
Joseph K. Belanoff: Our task now is to collect, review, and analyze the full data set, including the currently blinded results of the randomized withdrawal phase, and incorporate it into our new drug application, which we are on track to submit this quarter. We plan to present data from both the open-label and randomized withdrawal phases at a medical conference in June. Grace is not our only Phase III trial of brolicoronelectin in patients with hypercortisolism. Gradient is a randomized, double-blind, placebo-controlled study in 137 patients whose hypercortisolism is caused by an adrenal tumor or adrenal hyperplasia.
Joseph K. Belanoff: Our task now is to collect review and analyze the full data set including the currently blinded results of the randomized withdrawal phase and incorporated into our new drug application, which we are on track to submit this quarter.
Joseph K. Belanoff: We plan to present data from both the open label and randomized withdrawal phases at a current at a medical conference in June.
Joseph K. Belanoff: Grace is not our only phase III trial umbrella correlate in patients with hyper cortisol lithium gradient is a randomized double blind placebo controlled study in 137 patients, whose hyper cortisol ism is caused by an adrenal tumor or adrenal hyperplasia page.
Joseph K. Belanoff: Patients with this etiology of Cushing syndrome often experience a less rapid decline, but their health outcomes are poor and include a significantly higher risk of premature death. We expect the study to produce valuable data about the treatment of an etiology of Cushing syndrome that affects many patients. Enrollment is complete, and we expect data in the fourth quarter of this year.
Joseph K. Belanoff: Patients with this etiology of Cushing syndrome, often experience a less rapid decline, but their health outcomes are poor and include a significantly higher risk of premature death, we expect the study to produce valuable data about the treatment of an etiology of Cushing syndrome that affects many patients enrollment is complete and we expect data.
Joseph K. Belanoff: In the fourth quarter of this year.
Joseph K. Belanoff: We are also studying Relaquarelant as a treatment for different types of cancer mediated by cortisol activity. Our most advanced oncology program is in platinum-resistant ovarian cancer. We recently completed enrollment of 381 women in our Pivotal Rosella study, and we expect data by the end of the year. Women with platinum-resistant ovarian cancer are in urgent need of new treatment options.
Joseph K. Belanoff: We are also studying rella korlym as a treatment for different types of cancer mediated by cortisol activity.
Joseph K. Belanoff: Most advanced oncology program is in platinum resistant ovarian cancer.
Joseph K. Belanoff: We recently completed enrollment of 381 women in our pivotal Rosella study and we expect data by the end of the year.
Joseph K. Belanoff: Women with platinum resistant ovarian cancer are in urgent need of new treatment options. The goal of using <unk>. In this context is to re sensitize or re sensitize ovarian tumors to the effects of chemotherapy by blunting, the anti apoptotic effect of elevated cortisol activity.
Joseph K. Belanoff: The goal of using Reliquoriline in this context is to resensitize ovarian tumors to the effects of chemotherapy by blunting the anti-apoptotic effect of elevated cortisol activity. Our successful Phase 2 trial showed that women who received Reliquorilant intermittently, the day before, the day of, and the day after they received nabpaclitaxel exhibited a statistically significant improvement Women in the Intermittent Relaquorulin group also lived longer than those in the comparator arm.
Joseph K. Belanoff: Our successful phase two trial showed that women, who received rella correlate intermittently the day before the day of and the day after they receive Nab paclitaxel exhibited a statistically significant improvement in progression free survival and duration of response compared to the group who received Nab Paclitaxel manav.
Joseph K. Belanoff: Therapy.
Joseph K. Belanoff: Women in the intermittent rella Cortland group also lived longer than those in the comparator arm, 29% of the patients who took intermittent <unk> or alive. Two years. After study start versus only 14% who took nab paclitaxel alone.
Joseph K. Belanoff: 29% of the patients who took Intermittent Relaquorulin were alive two years after study start, versus only 14% who took Nantpaclitaxel alone. Importantly, the women who received relacloralin plus napaclitaxel experienced no additional side effect burden compared to those who received napaclitaxel alone.
Joseph K. Belanoff: Importantly, the women, who receive rella korlym plus Nab paclitaxel experienced no additional side effect burden compared to those who received Nab paclitaxel alone.
Joseph K. Belanoff: The results from the study were published in the Journal of Clinical Oncology in June 2023 with an accompanying editorial and presented at multiple U.S. and European medical conferences. Rosella aims to replicate our Phase 2 study results, and its design closely tracks our previous study.
Joseph K. Belanoff: The results from this study were published in the journal of clinical oncology in June 2023, with an accompanying editorial and presented at multiple U S and European medical conferences.
Joseph K. Belanoff: Brazil aims to replicate our phase two study results its design closely tracks our previous study we.
Joseph K. Belanoff: Women are randomized one-to-one to receive either Rella Chloraline plus Napaq Litaxil or Napaq Litaxil alone. The primary endpoint of Rosella is progression-free survival, with overall survival a key secondary endpoint. We are conducting this study in collaboration with leading clinicians from the Gynecological Oncology Group, or GOG, in the United States and the European Network of Gynecological Oncology Trials, or NGOT, group in Europe and deeply appreciate their enthusiasm and support. Because of our confidence in the positive results of our Phase 2 trial, we've begun initial planning for Relichoron's launch in oncology. The President of our Oncology Division, Roberto Vieira, who joined Corcept earlier this year, is building the organization we need to help as many women as quickly as possible following approval.
Joseph K. Belanoff: Women are randomized one to one to receive either <unk>, plus Nab paclitaxel or Nab paclitaxel alone the.
Joseph K. Belanoff: The primary endpoint of Rosella is progression free survival with overall survival a key secondary endpoint. We are conducting this study in collaboration with leading clinicians from the gynecological oncology group or <unk> in the United States.
Joseph K. Belanoff: And the European network of gynecological oncology trials or in got group in Europe, and deeply appreciate their enthusiasm and support.
Joseph K. Belanoff: Because of our confidence in the positive results of our phase II trial, we've begun initial planning for <unk> launch in oncology the.
Joseph K. Belanoff: The president of our oncology Division, Roberto Vieira, who joined <unk> earlier. This year is building the organization, we need to help as many women as quickly as possible following approval.
Joseph K. Belanoff: We are also evaluating relacorrelant as a treatment for prostate cancer and adrenal cancer. Leading academic researchers and clinicians hypothesize that cortisol modulation may block an important tumor growth pathway in prostate cancer. Cortisol stimulation is thought to be a major reason why patients with prostate cancer treated with the widely prescribed androgen receptor antagonist, enzalutamide, eventually experience resurgent disease. When they are deprived of androgen stimulation, their tumors switch to cortisol activity to stimulate growth. Adding a cortisol modulator to androgen deprivation therapy could close this tumor escape route.
Joseph K. Belanoff: We are also evaluating <unk> as a treatment for prostate cancer, an adrenal cancer, leading academic researchers and clinicians hypothesize that cortisol modulation may block and important tumor growth pathway in prostate cancer cortisol stimulation is thought to be a major reason why patients with prostate cancer treated with the <unk>.
Joseph K. Belanoff: Widely prescribed androgen receptor antagonist and <unk> eventually experienced resurgent diseased.
Joseph K. Belanoff: Deprived of androgen stimulation their tumor switched to cortisol activity to stimulate growth.
Joseph K. Belanoff: Adding a cortisol modulator to androgen deprivation therapy could close this tumor escape route or.
Joseph K. Belanoff: Our collaborators at the University of Chicago are enrolling a randomized placebo-controlled phase 2 trial of relachloralent plus enzalutamide in patients with prostate cancer before these patients have had an initial prostatectomy. In adrenal cancer, patients' tumors produce excess cortisol in about 50% of cases. Unfortunately, patients with this form of adrenal cancer virtually never respond to immunotherapy.
Joseph K. Belanoff: Our collaborators at the University of Chicago are enrolling a randomized placebo controlled phase II trial of <unk> plus <unk> in patients with prostate cancer before these patients have had an initial prostatectomy.
Joseph K. Belanoff: And adrenal cancer patients' tumors produce excess cortisol and about 50% of cases, Unfortunately patients with this form of <unk> cancer virtually never respond to immunotherapy.
Joseph K. Belanoff: Because cortisol suppresses the immune system, it may blunt the effectiveness of cancer therapy intended to stimulate the immune system. Our hypothesis is that adding a cortisol modulator to immunotherapies such as checkpoint inhibitors may enhance their effectiveness. We are conducting a Phase 1b trial of rolocorlin plus the PD-1 checkpoint inhibitor pembrolizumab in patients with advanced adrenal cancer whose tumors produce excess cortisol. Our research team, led by Hazel Hunt, has designed a library of over 1,000 selective cortisol modulators.
Joseph K. Belanoff: Because cortisol suppresses the immune system it may be lumpy effectiveness of cancer therapies intended.
Joseph K. Belanoff: Intended to stimulate the immune system.
Joseph K. Belanoff: Our hypothesis is that adding a cortisol modulator to immunotherapies such as checkpoint inhibitors may enhance their effectiveness. We are conducting a phase <unk> trial of <unk> plus the PD, one checkpoint inhibitor <unk> in patients with advanced adrenal cancer, whose tumors produce excess cortisol.
Joseph K. Belanoff: Our research team led by Hazel Hunt has designed a library of over a thousand selective cortisol modulators.
Joseph K. Belanoff: All of these compounds modulate the activity of cortisol, but they have distinct pharmacodynamic properties. Some are more potent at improving insulin sensitivity. Some are more potent at creating weight loss. Some get into the brain, and some don't.
Joseph K. Belanoff: All of these compounds modulate the activity of cortisol, but they have distinct pharmacodynamic properties. Some are more potent at improving insulin sensitivity. Some are more potent to creating weight loss some get into the brain. Some don't some are very potent and oncologic models some less so.
Joseph K. Belanoff: Some are very potent in oncologic models, some less so. One of these compounds, dazacorrelent, which is highly brain penetrant, has shown great promise in an animal model of ALS. We advanced dazacorrelent into clinical studies based on compelling preclinical data that showed improved motor performance and reduced neural inflammation and muscular atrophy. A double-blind, placebo-controlled Phase II DASLs trial of DAS at Quarrelman recently completed enrollment. 249 patients with ALS have been randomized to receive Daziquirulent or placebo for 24 weeks. The primary endpoint is based on the ALS Functional Rating Scale. Dazzles has enrolled very briskly, and we expect data by year end.
Joseph K. Belanoff: One of these compounds dazzle Cortland, which is highly brain penetrant is showing great promise in an animal model of AOS. We had advanced ASIC, who are linked into clinical studies based on compelling preclinical data that showed improved motor performance and reduced neuro inflammation and muscular atrophy.
Joseph K. Belanoff: Our double blind placebo controlled phase two dazzles trial of Desert Coralline recently completed enrollment 249 patients with ALS have been randomized to receive <unk> or placebo for 24 weeks.
Joseph K. Belanoff: The primary endpoint is based on the ALS functional rating scale.
Joseph K. Belanoff: <unk> enrolled very briskly, and we expect data by year end.
Joseph K. Belanoff: Finally, I'll turn to our program in MASH, M-A-S-H, which stands for Metabolic Dysfunction Associated Steatohepatitis. MASH is a serious liver disorder that affects millions of patients in the United States. Cortisol modulation may serve as an effective treatment for MASH because cortisol activity has been implicated in both the initial development and progression of this disease. Our phase one dose-finding study of miracorrelant found that patients who received 100 milligrams orally twice a week for 12 weeks experienced a 30% reduction in liver fat and improvements in liver enzymes, markers of fibrosis, and key metabolic and lipid measures such as HOMA-IR, serum triglycerides, and LDL.
Joseph K. Belanoff: Finally, I'll turn to our program in mash Maa's age, which stands for metabolic dysfunction associated Seattle hepatitis.
Joseph K. Belanoff: Matches, a serious liver disorder that afflicts millions of patients in the United States.
Joseph K. Belanoff: Cortisol modulation may serve as an effective treatment for Nash because cortisol activity.
Joseph K. Belanoff: Implicated in both the initial development and progression of this disease.
Joseph K. Belanoff: Our phase one dose finding study of mirror correlate found that patients who received 100 milligrams orally twice a week for 12 weeks experienced a 30% reduction in liver fat and improvements in liver enzymes markers of fibrosis, and key metabolic and lipid measures such as homa IR.
Joseph K. Belanoff: Serum triglycerides and LDL.
Joseph K. Belanoff: Importantly, mirror-correlate was also very well-tolerated with no apparent GI side effects. We hope to expand on these encouraging results with the MONARCH study. Monarch is a randomized, double-blind, placebo-controlled Phase IIb trial now actively enrolling patients with biopsy-confirmed MASH. The primary endpoint for this study is reduction in liver fat with MASH resolution and fibrosis improvement in key secondary
Joseph K. Belanoff: <unk> Mirror correlate was also very well tolerated with no apparent Gi side effects.
Joseph K. Belanoff: We hope to expand on these encouraging results with our monarch study.
Joseph K. Belanoff: Monarch is a randomized double blind placebo controlled phase <unk> trial, now actively enrolling patients with biopsy confirmed Nash the primary endpoint for this study is reduction in liver fat with Nash resolution and fibrosis improvement in key secondary endpoints.
Joseph K. Belanoff: I'll conclude where I began; there has been an exceptional amount of progress at Corcept since we last met. We recently completed enrollment in four late-stage trials that we expect will provide powerful evidence that cortisol modulation is a potent therapeutic mechanism in many serious disorders. This year, we expect data from our GRACE, Gradient, and Catalyst Studies in Cushing Syndrome, our Pivotal Rosella Study in Ovarian Cancer, and our DASL Study in ALS. Our clinical and development teams have worked with great urgency to complete these studies.
Joseph K. Belanoff: Ill conclude where I began there has been an exceptional amount of progress at <unk> since we last met.
Joseph K. Belanoff: We recently completed enrollment in four late stage trials that we expect will provide powerful evidence that cortisol modulation as a potent therapeutic mechanism and many serious disorders.
Joseph K. Belanoff: This year, we expect data from our Grace gradient and catalyst studies in Cushing syndrome.
Joseph K. Belanoff: Our pivotal rosella study in ovarian cancer and our dazzle study in ALS.
Joseph K. Belanoff: Our clinical and development teams have worked with great urgency to complete these studies.
Joseph K. Belanoff: For many of the patients in these studies, time is short. Since we launched Corallim more than 12 years ago, we have kept the needs of patients, many of whom have suffered for years without proper treatment, at the forefront. Our support programs are unique, comprehensive, and necessary for a complex disease such as hypercortisolism. They are highly valued. While our Coralline business continues to thrive, we expect Rella Coralline's improved profile and the results of our Catalyst Study to cause our Cushing Syndrome franchise to grow substantially for years to come.
Joseph K. Belanoff: For many of the patients in these studies time is short.
Joseph K. Belanoff: Since we launched Korlym more than 12 years ago, we have kept the needs of patients many of whom separate for years without proper treatment at the forefront.
Joseph K. Belanoff: Our support programs are unique comprehensive and necessary for our complex disease, such as court hyper cortisol listen they are highly valued.
Joseph K. Belanoff: While our Cortland business continues to thrive, we expect relic Orleans improved profile and the results of our catalyst study to cars, our Cushings syndrome franchise to grow substantially for years to come.
Joseph K. Belanoff: The results of the past quarter and all the progress on our horizon are a credit to our employees, academic collaborators, and commercial partners. Collectively, we are driven by an unwavering dedication to support patients with Cushing syndrome and all the other disorders where cortisol modulation can help. Operator, let's proceed now to questions.
Joseph K. Belanoff: The results of the past quarter and all the progress on our horizon are a credit to our employees academic collaborators and commercial partners.
Joseph K. Belanoff: Collectively we are driven by an unwavering dedication to support patients with Cushings syndrome, and all the other disorders, where cortisol modulation can make a difference.
Operator: Thank you. As a reminder, if you would like to ask a question, please press star 1-1 on your telephone. If you would like to withdraw your question, please press star one one again. As well, please wait for your name and company to be announced before proceeding with your question. Our first question comes from Matt Kaplan of Leidenberg. Your line is open.
Speaker Change: Operator, let's proceed now to questions.
Speaker Change: Thank you as a reminder, if you would like to ask a question. Please press star one on your telephone.
Speaker Change: If you would like to withdraw your question. Please press star one again as well. Please wait for your name a company to be announced before proceeding with your question.
Speaker Change: First question comes from.
Matthew Lee Kaplan: Matt Kaplan.
Ladenburg: The Ladenburg your line is open.
Matthew Lee Kaplan: Hey guys, congrats on the quarterly results. A nice, nice quarter.
Matthew Lee Kaplan: Hey, guys. Congrats on the quarterly results nice nice quarter. Thank you.
Unknown Executive: Thank you. Thank you, Matt.
Unknown Executive: Douglas Goldstein, CFP®, is the director of Profile Investment Services and the host of the Goldstein on Gelt radio show.
Joseph K. Belanoff: Yes.
Matthew Lee Kaplan: Just focusing on the quarter, a little bit and Korlym.
Joseph K. Belanoff: What are you seeing now that are I guess the court has ruled.
Joseph K. Belanoff: That type of a.
Joseph K. Belanoff: It doesn't infringe your patents how.
Joseph K. Belanoff: Have you seen having in the marketplace and any generic competition hasnt yet.
Unknown Executive: Matt, let me reintroduce Sean Maduck, who is the president of our endocrinology division, and Sean will take that question.
Joseph K. Belanoff: Yeah, Matt let me reintroduced to the group Shama, Duke Who's the president of our Endocrinology Division and Shawn I'll take that question. Yes. Thanks for the question, Matt. So as you know to have announcements launch on January 19th are.
Sean Maduck: Yeah, thanks for the question, Matt. As you know, Teva announced its launch on January 19. Our business is robust and continues to grow. At this point, we're not aware of losing any patients to Generic Mifepristone, and based on our analysis at this point, we believe Generic Corallum has been available to some degree for a couple of months, but it hasn't had any impact on our business. Something I think it's important to just remind people of, and it's something I've said in the past, is that our situation is unique and not like most generic situations.
Shawn: Our business is robust and continues to grow to this point, we're not aware of losing any patients to generic mifepristone and based on our analysis at this point, we believe generic Korlym has been available to some degree for a couple of months, but it hasn't had any impact on our business and something I think that's important to just remind people love and its something Ive said in the past.
Joseph K. Belanoff: It's that our situation is unique and not like most generic situations.
Sean Maduck: We utilize one single-source pharmacy that is highly staffed to distribute Quorlum and the other specialty products they have. And when Quorlum is prescribed, both the physician and the patient receive a high level of support, both at intake and ongoing, from both the pharmacy and Corcept, and this is support that is tremendously valued by doctors and by patients. For this reason, physicians who prescribe Corallim have a very strong brand preference.
Joseph K. Belanoff: <unk> utilized one single source pharmacy that is highly staffed to distribute korlym and the other specialty products that you have and when Korlym is prescribed both the physician and the patient receive a high level of support both on intake and ongoing.
Joseph K. Belanoff: From both the pharmacy and <unk> and this has supported us tremendously valued by by doctors and by patients and for this reason physicians who.
Joseph K. Belanoff: Who prescribed korlym have a very strong brand preference.
Joseph K. Belanoff: Okay.
Matthew Lee Kaplan: Okay, that's really helpful. And, and just shifting to your pipeline and specifically, the GRACE study, given, I guess, the open-label results that you've, you've announced, can you give us a sense of how those results, in terms of the effect on hypertension, these patients, and hyperglycemia, compare with what you've seen historically with Coraline?
Speaker Change: Okay, that's really helpful and and just shifting to your pipeline and specifically the Grace study given I guess the open label results that you've you've announced can you give us a sense of how those results in terms of the effect on hypertension.
Joseph K. Belanoff: These patients in hyperglycemia compare with what you've seen historically with with Korlym.
Unknown Executive: Sure Matt, and again I want to reintroduce Bill Guyer. Bill is our Chief Development Officer, runs all of these programs, and Bill will take that question. Thanks, Matt.
Bill: Sure, Matt and again I want to reintroduce Bill Guy or Bill Bill is our Chief Development Officer runs all of these programs and Bill will take that question. Thanks, Matt. Thanks for that question I mean overall, we're very excited about these results because we basically hit every endpoint across the broad range of the signs in terms of the Cushings syndrome and these are positive.
William Guyer: Yeah, thanks, Matt. Thanks for that question.
William Guyer: I mean, overall, we're very excited about these results because we basically hit every endpoint across the broad range of the signs and symptoms of Cushing syndrome. And these are positive results, given how clinicians will have insight into how to use a drug like ralochorlin. You know, it's really tough to make comparisons between drugs when a drug like Chorlin was launched 12 years ago with the seismic study. But when I look at the results, I see the efficacy results as very similar or even better, and the safety profile as better than that of Chorlin, based on what we've seen.
Joseph K. Belanoff: Results, given how clinicians will have insight into how to use a drug like <unk>.
William Guyer: It's really tough to make comparisons between drugs when a drug like Korlym was launched 12 years ago with the seismic study, but when I look at the result, I see the efficacy results as very similar or even better and the safety profile is better than that of Korlym based upon what we've seen.
William Guyer: When we look at overall efficacy, we're seeing comparable efficacy, but distinctly, we're seeing rapid and sustained improvement in hypertension, as well as improvement in all the safety profiles because we really haven't seen any relacorlin-induced adverse events like hypokalemia, endometrial hypertrophy, vaginal bleeding, adrenal insufficiency, or acute deprolongation. So overall, we think we've achieved our goal of coming up with a drug that can be approved and can improve patient lives.
William Guyer: When we look at the overall efficacy were seeing comparable efficacy, but distinctly we're seeing rapid and sustained improvement in hypertension as well as improvement in all of the safety profiles, because we really haven't seen any <unk> induced.
William Guyer: Aes like hypokalemia, endometrial hypertrophy, vaginal bleeding adrenal insufficiency or Qt prolongation. So overall, we think we've achieved our goal of coming up with a drug that can be approvable and can improve patient lives with Cushing syndrome.
William Guyer: Okay, that's helpful. And then in terms of the upcoming results for the randomized withdrawal phase, given, I guess, the 63% response rate and, in hypertension, the 50% in hyperglycemia, what should we be looking for? And in terms of the randomized withdrawal phase?
Speaker Change: Okay. That's helpful and then in terms of the upcoming results for the randomized withdrawal phase.
William Guyer: Given I guess, the 63% response rate.
William Guyer: And the hypertension and 50% in hyperglycemia.
William Guyer:
Speaker Change: What should we be looking for in terms of.
Speaker Change: The randomized withdrawal phase.
William Guyer: So in the randomized withdrawal phase, as you've seen in our press release, and I would really point you to those patients who responded and went into the randomized withdrawal phase, and you look at those graphs of that continuous decline in both hypertension and improvement in hyperglycemia endpoints. It's those patients who will then get randomized to either continue on Relic Horlant or get switched to placebo. And then we're going to look for a reversal of those effects.
Speaker Change: Bill so in the randomized withdrawal phase <unk> seen in our press release and I would really point you to those patients who responded and went into the randomized withdrawal phase and you look at those graphs of that continuous decline and both hypertension and improvement in hyperglycemia endpoints. It's those patients who will then get randomized to either continue on rail.
William Guyer: Korlym or get switched to placebo and then we're going to look for a reversal of those endpoints and so specifically for a primary endpoint of hypertension, we're looking for and loss of response of greater than five millimeters of mercury for either systolic and diastolic blood pressure and then on glucose the same things we're looking for.
William Guyer: And so specifically for our primary endpoint of hypertension, we're looking for a loss of response of greater than 5 millimeters of mercury for either systolic and or diastolic blood pressure. And then on glucose, the same things. We're looking for reversal of the improvements in the oral glucose tolerance test and all its components, and reversal of the changes in hemoglobin A1C.
William Guyer: <unk> of all of the improvements in the oral glucose tolerance test in all its components and reversal of the changes in hemoglobin ANC.
Unknown Executive: Great, great. Thanks for the detail. I'll jump back into the queue. Thank you, Matt.
Speaker Change: Alright, great.
Speaker Change: Thanks for that detail and I'll jump back into the queue.
Operator: Excellent. Thank you. One moment for the next question. And our next question is coming from David.
Speaker Change: Thank you Matt Thanks, Matt. Thank you one moment for the next question.
William Guyer: Okay.
William Guyer: Okay.
William Guyer: And our next question is coming from David <unk>.
Unknown Speaker: Unknown Speaker: Your line is open.
David: Your line is open.
David A. Amsellem: Thanks. So just a couple. First, just on Corelim and generics, can you talk about how the market might evolve to the extent that Sun and Hikma enter the market, perhaps later this year, and how you're thinking about your response to heightened generic competition? For instance, could you even enter with an AG of your own?
David: Thanks, So just a couple first.
David: Just.
David: On Korlym and generics can you can you talk about how the market might evolve to the extent that sun and hikma enter the market. Perhaps later this year.
David: And how you're thinking about your response to heightened generic competition for.
David A. Amsellem: So just talk about that. And then secondly, clearly, there's some acceleration happening, much more so than we've really seen for quite some time. So is it because of Catalyst? Is it because of just greater awareness of Cushing's just beyond what you're doing with Catalyst? Just help us better understand, you know, what's happening in the marketplace that's driving this. Thank you.
William Guyer: For instance, could you even enter with with an AG of your own so just talk to that.
William Guyer: And then and then secondly, clearly theres some acceleration happening.
William Guyer: Much more so than we've really seen.
William Guyer: For quite some time so is it because of catalyst is it because of just greater awareness.
David A. Amsellem: <unk> just beyond what Youre doing with catalysts, just help us better understand whats happening in the marketplace.
David A. Amsellem: That's driving this thank you.
Sean Maduck: Sure, David. And I'm going to give you over to Sean to answer that question.
Sean Maduck: Sure, David and I'm going to give you over to Sean to answer that question. David. Thank you for the question I think I'll start with number three and talk a little bit of a catalyst and just want to make it clear that we have not yet seen the impact of catalyst.
Sean Maduck: So, David, thank you for the question. I think I'll start with number three and talk a little bit of Catalyst. I just want to make it clear that we have not yet seen the impact of Catalyst. This year and it is not built into our into our forecast and we believe that the catalyst results are going to Increase screening for for some positions today But ultimately data generation takes time to translate into guidelines Which then takes time to translate to the medical practice and ultimately we expect the full impact of catalyst will be felt in You know 2025 and in the years after that so in terms of what drove q1 I mean, I'll reiterate something Joe said at the beginning of the call We had more first-time prescribers more prescriptions and more patients on Corlin than ever before We've added new patients from existing physicians and new physicians throughout the country and and we're very pleased with with the result.
Sean Maduck: This year and then it is not built into our into our forecast and we believe that the catalyst results are going to increase screening for for some physicians today, but ultimately data generation takes time to translate into guidelines, which then takes time to translate to the medical practice and ultimately we expect the full impact of catalyst will be felt in.
William Guyer: Two.
Sean Maduck: <unk> 25 in the years after that so in terms of what drove Q1, I mean, I'll reiterate something Joe said at the beginning of the call. We had more first time prescribers more prescriptions and more patients on korlym than ever before we've added new patients from existing physicians in new physicians throughout the country and we're very pleased with the result, driven by <unk>.
Sean Maduck: It's driven by improved field execution, which we've seen over the last few quarters, and the investments that we've made on the marketing side. We're starting to see some results from that, but another component, and you touched on this, is disease awareness. We're more confident than ever about the potential size of the Cushing syndrome market and that this is a multi-billion dollar market.
Sean Maduck: <unk> field execution, which we've seen over the last few quarters and the investments that we've made on the marketing side, we're starting to see some some results from that but another component and you touched on it is disease awareness is increasing and we're more confident than ever about the potential size of the crushing center market and that this is a multibillion dollar market.
Unknown Executive: And David, the only other thing I would point out is that we've seen this building now over the last five or six quarters; it really wasn't just particularly this quarter. And I would just second what Sean said, you know, sort of the weight of evidence is now out there that this has been an under-recognized disorder; people should screen more for it. And when they screen it, they should figure out a way to treat it, and it's really organic in that way. Alright, so your next question was around some sort of future market.
Unknown Executive: And then David the only other thing I would point out as we've seen this building now over the last five or six quarters. It really wasn't just particularly this quarter and I would just second what Sean said.
Unknown Executive: Sort of a weight of evidence is now out there that this has been an under recognized disorder people should screen more for it and.
Unknown Executive: When they screen, if they should figure out a way to treat it.
Unknown Executive: And it's really organic in that way.
Unknown Executive: All right, so your next question was around sort of future market dynamics from a generic standpoint. And I'll say I cannot speculate on when or if other generic manufacturers may enter the market. I understand that the legal process, as Charlie touched on, is still ongoing, and we don't expect it to be resolved until the early part of next year, which is a risk. And to our knowledge, no other generic manufacturer besides Teva has received FDA approval at this point.
Unknown Executive: Alright. So your next question was around sort of future merchant market dynamics from a generic standpoint, and I'll, just say I cannot speculate on when or if other generic manufacturers made.
Unknown Executive: I understand that the legal process is Charlie touched on is still ongoing and we don't expect it to be resolved until the early part of next year, which is a risk and to our knowledge no. Other generic manufacturer. Besides Teva has received FDA approval at this point so what I will say just from a from our standpoint, we've been thinking about this for a long time we've had.
Sean Maduck: So what I'll say just from our standpoint: we've been thinking about this for a long time. We've had a plan for a long time. We've been prepared since since at least 2020 for this, so we have a plan in place. We continue to revise that plan with any new intelligence that we get. We're continuing to invest in our business, and we're confident in our ability to both continue to grow our business today and also defend our market.
Sean Maduck: Our plan for a long time, we've been prepared since since at least 2020 for this so we have a plan in place we continue to revise that plan with any new intelligence that we get.
Sean Maduck: We're continuing to invest in our growing business and were confident in our ability to both continue to grow our business today, but also defend our market share.
Sean Maduck: Okay.
Operator: Thank you. And one moment for the next question. Our next question will be coming from Sinsway Allen of Connacourt. Your line is open.
Speaker Change: Next question please.
Unknown Attendee: Thank you.
Unknown Attendee: And we'll move to the next question.
Unknown Attendee: Our next question will be coming from since Wang Ann.
Unknown Attendee: Of Canaccord your line is open.
Swayampakula Ramakanth: Thank you for taking our questions. Hi.
Unknown Attendee: Thank you for taking my questions.
Swayampakula Ramakanth: Yes, thank you for taking our questions. My questions are regarding the ALS program. So the first part of the question is on the primary endpoint. We know that it uses the ALS functional rating scale, a numerical scoring system. So I would like to ask you for your comments about, you know, what level of a change would be considered a clinically meaningful change on that endpoint. Because, as we know, with the approved therapy, REDCOVA, each historical Phase III trial showed a drop in the score by approximately 2.5 points.
Swayampakula Ramakanth: Hi.
Speaker Change: Yes, thank you for taking our questions.
Swayampakula Ramakanth: And I believe that was considered equivalent to four to five months of survival. And then the second part of my question is, do you believe that DASL correlates would have a chance to be approved based on Phase II data? Let's assume the data is positive.
Swayampakula Ramakanth: My questions are regarding the <unk>.
Swayampakula Ramakanth: Thank you.
Swayampakula Ramakanth: Program. So the first part of your question on the primary end point, we know that.
Swayampakula Ramakanth: Using the ALS functional rating scale, a numerical scoring system.
Swayampakula Ramakanth: I would now like to ask you for your comments about.
Swayampakula Ramakanth: What level of change would be considered.
Swayampakula Ramakanth: Clinically meaningful change on that endpoint, because as we know with the approved therapy or <unk>.
Swayampakula Ramakanth: <unk> historical phase III trial showed a drop off this score by approximately two five points.
Swayampakula Ramakanth: I believe that was considered as equivalent to Q4 to five months of survival and then the second part of my question.
Swayampakula Ramakanth: Do you believe that dazzle, Korlym, who would have a chance to be approved based on the phase II data.
Swayampakula Ramakanth: Let's assume the data it's Paul Thank you.
William Guyer: Yes, and I'd like, again, to bring Bill on the line.
William Guyer: Yes, and I would like again to bring bill on the line Bill could you. Please take those questions sure. So in relation to your first question around our primary endpoint and efficacy. So yes, you're absolutely correct. The efficacy is the change from baseline at week 24 of the ALS functional rating scale.
William Guyer: Sure, so in relation to your first question around our primary endpoint and efficacy, so yes, you're absolutely correct. The efficacy is the change from baseline at week 24 of the ALS functional rating scale, but we're also looking at ALS and its side effects, and overall effects of patients, and a long-term extension study is going to look at survival because it's a three-year study. But for specifics, we're powered at 80% to see a 2.4% difference in the ALS functional rating scale, which the researchers, clinicians, and ALS experts have advised us, as you stated, as being clinically relevant. As related to this, could this be a regulatory enabling study? Yes, we believe so.
William Guyer: But we're also we're looking at AOS and its and <unk> and overall effects.
William Guyer: Outpatient and a long term extension study is going to look at survival because it's a three year study, but for specifics we're powered at 80% to see a two 4% difference in the ALS functional rating scale, which the researchers clinicians and AOS experts have advised us as you stated as being clinically relevant.
William Guyer: As it related to could this be a regulatory enabling study yes. We believe so at 249 patients. We designed this study from the very beginning to be potential for regulatory enabling because AOS as a very devastating progressive disease and the need for new medications is very high and even higher probably today.
William Guyer: At 249 patients, we designed this study from the very beginning to be a potential for regulatory enabling because ALS is a very devastating progressive disease, and the need for new medications is very high and probably even higher today. I believe that regulators would welcome new therapies that could help slow or reverse the progression of this disease. And again, DAZLS, the trial was designed specifically as a Phase IIb trial with the intention to be a regulatory enabling study. Thank you.
William Guyer: I believe that regulators would welcome new therapies that could help slow or reverse the progression of this disease and again thousands with that trial was designed specifically as a phase <unk> trial with the intention to be a regulatory enabling study.
Unknown Executive: And the only thing I'd add to that is, I think I don't have to really particularly remind everyone on the call about what an awful disease ALS is and how there's really nothing available that works particularly well. It was, you know, we really saw excellent pre-clinical data. We'll find out if it works. But yes, I think the study is of such size that if the effect is real and substantial, it has to be very interesting to regulators, who I know want to bring better treatments for that.
Unknown Executive: Only thing I'd add to that is I think I don't have to really particularly remind everyone on the call when an awful disease AOS is and how theres really nothing available that works, particularly well.
Unknown Executive: It was we really saw excellent preclinical data, we'll find out at the translated but yes. I think the study is of a size that if the effect is real and substantial that has to be very interesting to regulators, who I know want to bring better treatments to that disease.
Unknown Executive: Okay, that's very, very helpful. And if I may, I also have a simple or straightforward question about relic correlators in GRACE. So for the randomized withdrawal phase data, that period of the trial is for 12 weeks. And I know we have asked about that before, but we don't have withdrawal data with relic correlants, but we do have withdrawal data with other correlants. I think you stated before that the rebound effect was usually observed at four to five weeks after patients stopped using it.
Speaker Change: Okay. That's very very helpful and if I may I also have a simple or.
Unknown Executive: Straightforward question about railcar lithium grades so far the randomized withdrawal phase data.
Unknown Executive: That's the Aspira.
Unknown Executive: Trial and for 12 weeks and.
Unknown Executive: I know, we have asking about does before but.
Unknown Executive: We don't want to have withdraw data, whereas reliquary lens, but with korlym.
Unknown Executive: I think you stated it before that.
Unknown Executive: The <unk> was.
Unknown Executive: Usually observes that four to five weeks after patient stopped using that so I was wondering you know into establishing the confidence that 12 week long enough.
Unknown Executive: So I was wondering, you know, whether establishing the confidence that 12 weeks is long enough for us to see a difference, a statistically significant difference, besides the experience with correlates, would there be something else that we could trace back to?
Unknown Executive: The difference is statistically significant difference.
Unknown Executive: Besides besides the experience with Korlym would there be something else that we could trace back to you.
Unknown Executive: [inaudible]
Unknown Executive: Yes.
Speaker Change: I understand the question and it's a really very reasonable question I want to make sure everyone on the line understands it which is that is 12 weeks enough to see patients.
Speaker Change: Were randomized placebo have a loss of their very potent effect that they they got in the open label phase. So so you raised a couple of points I want to address both of them Youre absolutely right within Korlym, we see a rapid loss of efficacy.
Unknown Executive: Yes, I understand the question, and it's a really very reasonable question. I want to make sure everyone on the line understands it, which is, is 12 weeks enough to see patients who were randomized to placebo have a loss of the very potent effect that they got in the open-label phase? So, you raised a couple points, and I want to address both of them. You're absolutely right; within Corla, we see a rapid loss of efficacy. Unknown Attendee, Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, William Guyer, But we have even more evidence now.
Unknown Executive: Sometimes you see it within the first two weeks, but you often see it by four or five weeks. So certainly that's one reason why 12 weeks.
Unknown Executive: It is a very reasonable guests for loss of efficacy, but we havent, even more evidence now and.
Unknown Executive: And when you look at the curves for grace, for the rate of improvement, particularly in hypertension, you're seeing that rate of improvement in the first couple of weeks. And I suspect that this medicine doesn't just cure patients. When they come off the medicine, they lose that effect. So you're right. We've never done a randomized withdrawal study before. We can't say with certainty that that's enough time, but we have a very strong belief that it is, and we'll find out soon.
Unknown Executive: And when you look at the curves for Grace for the rate of improvement, particularly in hypertension, youre seeing that rate of improvement in the first couple of weeks.
Unknown Executive: And I suspect that this.
Unknown Executive: Medicine doesn't just cure patients where they come off the medicine. They have a loss of that effect. So you're right. We've never done a randomized withdrawal study before we can't say with certainty that that's enough time, but we have a very strong belief that it is and we'll find out soon.
Unknown Executive: Okay, great. Thank you so much. Thank you so much, Keith.
Speaker Change: Okay, great. Thank you so much.
Speaker Change: Thanks Keith.
Operator: One moment for the next question.
Speaker Change: One moment for the next question.
Speaker Change: And our next question is coming from Slam Pakula roadmap.
Speaker Change: H C. Wainwright your line is open.
Unknown Speaker: Thank you. This is RK from IT2AW.
Art: Thank you Hi, RK this is art.
Unknown Speaker: This is RK from <unk>.
RK: Hey, Doug.
Unknown Speaker: Transcribed by https://otter.ai
RK: We figured it was okay.
Unknown Speaker: Yes.
RK: It's a name that makes me.
Unknown Speaker: Okay.
RK: Tom's of commercialization.
Unknown Speaker: In terms of commercialization, Um, you know, with
Unknown Speaker: Rick.
Unknown Speaker: Q getting ready to file the NDA based on the greatest data.
Unknown Speaker: We can kind of.
Unknown Speaker: Sure ourselves that data probably is looking pretty good.
Unknown Speaker: The rest of the study.
Unknown Speaker: That you're going for it. Having said that, sir, let's say in a year we have this drug approved. So how are you thinking on the commercial front in terms of switching patients from CoreLIM to RelacoreLIM? That's part A of the question. Part B is, again, looking at catalyst data which has been generated with CoreLIM. What's the strategy there? Because again, within a year, if you have relacorrelent, do you need to do something with the relacorrelent as well?
Unknown Speaker: Okay growing product.
Unknown Speaker: Having said that let's say.
Unknown Speaker: We have this drug approved.
Unknown Speaker: So how are you thinking.
Unknown Speaker: On the commercial front in terms of switching.
Unknown Speaker: Patients from Korlym to Rolla Cortlandt, that's part of the question.
Unknown Speaker: B is.
Unknown Speaker: Again looking at catalyst data.
Unknown Speaker: Rich has been generated with korlym.
Unknown Speaker: If you need to grab that patient population, or is this going to be a bifurcation of the market where you will let correlent run through the diabetics and the hypertension folks but keep relacorrelent for the Cushing's?
Unknown Speaker: What's the strategy there because again within a year if you're a.
Unknown Speaker: Our railcar inland.
Unknown Speaker: Do you need to do something with gorilla Cortlandt as well.
Unknown Speaker: If you would need to grab that patient population or is this going to be a bifurcation of the market.
Unknown Speaker: You will let's call them run through the diabetics and hypertension folks.
Unknown Speaker: But keep the relic orman for the questions.
Unknown Executive: Okay, let's start off with Sean, and I may have a few comments to add at the end.
Speaker Change: Okay, let's start off with Sean and I may have a few comments to add at the end yes.
Sean Maduck: Yeah, thanks, RK. So the question in terms of switching, Coraline's obviously a great medication, but we believe Relacoraline will be even better. Our belief is that Relacoraline's efficacy and safety profile will be well received by treating physicians, and once approved, uptake will be very swift, so there's no reason both the physician and the patient wouldn't want to choose it.
Speaker Change: Thanks RK. So the question in terms of switching Korlym is obviously, a great medication, but we believe <unk> will be even better our belief is that the railcar once efficacy and safety profile will be well received by treating physicians and once approved uptake will be very swift.
Sean Maduck: Theres No reason, both the physician and the patient would want to choose.
Unknown Executive: So, you know, RK, look, the critical thing, and it's something that we say every time, and we say it internally, and it's absolutely the truth. The main thing to understand is that hypercortisolism is an unrecognized disease in many patients who could be treated for hypercortisolism and get a lot of benefit. And that's whether they're treated with corallum or not. I mean, again, I remind everyone that really, the optimal first-line treatment is if there's a tumor that's causing this, and you take it out, you take out the tumor, and that's that.
Speaker Change: So RK look the critical thing and it's something that we say every time and we say it internally and it's absolutely. The truth. The main thing to understand is that hyper cortisol ism is an unrecognized disease in many patients who could be treated for hyper corrosive them and get a lot of benefit and Thats why.
Unknown Executive: Either they are treated with korlym or not I mean, again, I remind everyone that really the optimal first line treatment is if there is a tumor that's causing this and you take it out you would take out the tumor and that's that now we know unfortunately that is not the case with many of these patients that surgical cure it doesn't work or they can't find the tumor.
Unknown Executive: Now, unfortunately, that is not the case with many of these patients, that surgical cures either don't work, or they can't find the tumor or something like that, and that leaves them in need of medical treatment. And so, the question, you know, I'll just emphasize what Sean said.
Unknown Executive: Like that and that leaves them in need medical treatment and so the question I'll just emphasize what Sean said.
Unknown Executive: Reloquelrolone is really a good medication. I really believe that it is a superior medication in a variety of ways to the very good, you know, effects that you get from corallum. And I think that people will, what they'll get from the catalyst information is that they need to really screen for these patients, and then that's up to them what they ever do for them next. But I think that people will understand that what Catalyst is really proving to them is that hypercortisolism is in every single diabetology practice in the United States, and there are many patients these days who are getting optimal care for diabetes and still have another problem that isn't allowing it to be treated, namely hypercortisol.
Unknown Executive: Korlym is really a good medication I really believe that it is a superior medication in a variety of ways to the very good.
Unknown Executive: <unk> that you get from Korlym and I think that people will put they will get from the catalyst information is that they need to really screen for these patients and then that's up to them what they ever do for.
Unknown Executive: Next but I think that people will understand that with catalyst is really proving to them is it hyper cortisol as am is in every single die Battology practice in the United States and there are many patients. These days. So we're getting optimal care for diabetes and still have another problem that it isn't allowing it to be treated.
Unknown Executive: Namely hyper cortisol.
Unknown Speaker: Fantastic. Thanks for that. And then on the adrenal cancer study, and you said that data is expected from that in mid-2024. Assuming it's one of the cancer conferences, so what's the thought process there, you know? If the data is good, would you turn around and start a larger study right away, or do you need to kind of look at the data from other oncology indications before deciding where you want to put your money in?
Speaker Change: Fantastic. Thank you for that and then on the.
Unknown Speaker: Adrenal cancer study.
Unknown Speaker: And you said the data is expected.
Unknown Speaker: From that in mid 2024.
Speaker Change: Jimmy it's one of the cancer conferences.
Unknown Speaker: Its award.
Unknown Speaker: What's the thought process there.
Unknown Speaker: <unk> data is good.
Unknown Speaker: You turnaround.
Unknown Speaker: And start a larger study right away or do you need to kind of look at the data from the oncology indications before deciding where do you want to put your money.
Unknown Executive: Yeah, RK, you know, thank you for asking that question. I don't get that question that often, and so I'm just going to back up a little bit to make sure everybody understands the situation and why we've been testing. You know, immunotherapy has changed the world, and it's fantastic.
Unknown Executive: Yes.
Speaker Change: Okay. Thank.
Unknown Executive: Thank you for asking that question I don't get it that often and so I'm just going to back up a little bit to make sure everybody understands the situation and why we are even testing this.
Unknown Executive: Immunotherapy has changed the world.
Unknown Executive: But unfortunately, it doesn't work for even a majority of patients. I mean, for those who it works, it's fantastic. But there are many patients, unfortunately, for whom it doesn't really work. What immunotherapy does is it relies on your own immune system to actually capture and defeat the cancer. And that's great, as I said, when it works.
Unknown Executive: And it's fantastic, but unfortunately, it doesn't work for even a majority of patients.
Unknown Executive: Those who works it's fantastic.
Unknown Executive: There are many patients since unfortunately for whom it does not really work with immunotherapy does are alive on your own immune system to actually capture and defeat cancer and that's great as I said when it works.
Unknown Executive: The issue is that cortisol is your natural immunosuppressant, and so mechanistically, it's fighting against the benefits that one gets with immunotherapy. The idea is that if you can normalize or reduce cortisol activity, immunotherapy can work significantly better.
Unknown Executive: Issue is that cortisol is your natural immunosuppressant and so mechanistically, it's fighting against the benefits that one gets with immunotherapy.
Unknown Executive: Dia is that if you can normalize or reduce cortisol activity immunotherapy can work significantly better and it's not limited at this ideas right two adrenal cancer renal cancer as Justin.
Unknown Executive: And it's not limited, if this idea is right, to adrenal cancer. Adrenal cancer is just a piece of the puzzle where we can really gather some evidence. But the idea really is this direction proves correct, to really look at the whole body of cancers, where immunotherapy is less than as potent as physicians think it could be. And all I can tell you is, this is the first study we've done with this, and we'll learn a lot from it, and we'll figure out what to do next.
Unknown Executive: A piece of a place where we can really gather some evidence but the idea really is is this direction proves correct to really look at the whole body of cancers, where immunotherapy is a less than as potent as physicians think it could be and all I can tell you is this is the first study we've done with this one.
Unknown Executive: Aren't a lot from it we'll figure out what to go next we have a lot of other things on our plate, but this is really a crucial thing if we've gotten it right I think it could be very very meaningful to many patients.
Unknown Executive: We have a lot of other things on our plate, but this is really a crucial thing. If we've gotten it right, I think it could be very, very meaningful. And I'd like to add to that, Joe, if you don't mind.
Unknown Executive: Yes.
Speaker Change: And I would like to add.
Unknown Executive: Bill has a comment. I'd like to add to that, too. Just to add to that,
Speaker Change: If you don't feel has a comment to add to that too just to add to that because while we're doing studies in ovarian cancer and prostate cancer on an adrenal cancer. Our vision really is to establish rolla cortlandt as the agent that can really synergize with many different chemotherapy agents by adding efficacy, but not adding any toxicity and we fully.
Unknown Executive: Because while we're doing studies in ovarian cancer and prostate cancer and adrenal cancer, you know, our vision really is to establish Relacorlant as an agent that can really synergize with many different chemotherapy agents by adding efficacy but not adding any toxicity. And we fully plan to explore broader applications of a drug like Relacorlant in cancer throughout the lifecycle management plan. It's been on our minds internally with the addition of our new president of Oncology, Roberto.
Unknown Executive: Plan to explore broader applications of a drug like rolla correlate in cancer throughout the lifecycle management plan, it's been on our minds internally with the addition of our new President of oncology Roberto Eni had been partnered and looking at all the various different types of studies and where we should be investing our research dollars and so you'll see a more broad plan in the coming months.
Unknown Executive: He and I have been partners in looking at all the various different types of studies of where we should be investing our research dollars. So you'll see a more broad plan in the coming months throughout this year.
Unknown Executive: Throughout this year.
Unknown Executive: Great, great. I appreciate the comments. Thank you, gentlemen, and talk to you folks soon.
Unknown Executive: Great great.
Speaker Change: I appreciate the comments, thank you gentlemen.
Operator: Thanks, Arkit. Thank you. And we'll now have one moment for our final question.
Speaker Change: Talk to you folks.
Speaker Change: Alright, Thanks Mark.
Speaker Change: Thank you and well not one moment for our final question.
Operator: And our final question of the day will be coming from Joon Lee of <unk>.
Speaker Change: Your line is open.
Unknown Speaker: Hi, this is Jeremy. I'm from June.
Operator: Hi, This is Jeremy on for Jim Congrats on the quarter and thanks for taking our questions.
Unknown Speaker: Incrementally.
Jeremy: From your initial guidance ensure that led to the guidance range range and is generic impact baked into the guidance.
Jeremy: And then just a quick follow up can you Kevin Pcs are enrolled in the double blind portion of the study which will be seeing data in June.
Unknown Speaker: Okay.
Unknown Speaker: I think I caught both of your questions I'm going to give you. The first one to Sean Thanks, Jeremy So our revenue guidance, we'll always consider all the information that we have on our best estimates going forward and our range includes a multitude of factors, including generic impact.
Unknown Speaker: Congratulations on the quarter. And thanks for taking our questions. Just what incrementally changed from your initial guidance intro that led to the guidance range and is generic impact based in the guidance? And then just a quick follow-up. How many teachers are enrolled in the double-blind portion of the study, which we'll be seeing data on in June?
Unknown Speaker: Okay, I think I've caught both of your questions. I'm going to give the first one to Sean. Thanks, Jeremy.
Sean Maduck: Thanks, Jeremy. So our revenue guidance will always consider all the information that we have on our best estimates going forward, and our range includes a multitude of factors, including generic impact, and the range from earlier in the year to now is driven by more physicians prescribing Coral and more patients.
Sean Maduck: The range from earlier in the year to now is driven by more physicians prescribing korlym and mark patients taking korlym.
Unknown Executive: And the second question, I think, was just a numbers question. How many people pay?
Jeremy: And second question I think was just a numbers question how many yeah.
Unknown Speaker: Yeah, I don't. Yeah, that was it. So how many patients were there in the rent?
Unknown Speaker: Yes.
Unknown Executive: So how many patients are going to be in the randomized withdrawal set of the... Okay, so we haven't publicly disclosed that, but I will tell you that we have 62 patients who are in the randomized withdrawal phase of the study, and that's what will be the basis for our trial, with a mixture of those with hypertension or diabetes and or having both.
Speaker Change: Got it.
Speaker Change: So how many patients were in the <unk> are going to be in the randomized withdrawal set of okay. So we haven't publicly disclosed that but I will tell you that we have 62 patients who are in the randomized withdrawal phase of the study and Thats what will be the basis for our trial with a mixture of those with hypertension or diabetes.
Unknown Executive: Diabetes and are having both.
Speaker Change: Thank you.
Unknown Executive: Okay, I think that concludes our questions. Thank you very much. Corcept has become, you know, very, very, very much more complex than it was years ago, and I appreciate you really trying to capture all the information that we've sent. See you next quarter.
Speaker Change: Okay, I think that concludes our questions.
Speaker Change: Thank you very much cost left has become.
Unknown Executive: Very very much more complex than it was years ago and I appreciate you're really trying to capture all the information that we've said to you see you next quarter.
Unknown Executive: Okay.
Operator: This concludes today's conference call. Thank you all for joining us. You may now disconnect.
Speaker Change: This concludes today's conference call. Thank you all for joining you may now disconnect.
Operator: Okay.
Operator: Yeah.
Operator: [music].
Operator: Okay.
Operator: Yeah.