Yahoo Finance Corcept Therapeutics Incorporated (NASDAQ:CORT) Q1 2024 Earnings Call Transcript
Corcept Therapeutics Incorporated (NASDAQ:CORT) Q1 2024 Earnings Call Transcript May 1, 2024
Corcept Therapeutics Incorporated beats earnings expectations. Reported EPS is $0.2503, expectations were $0.21. Corcept Therapeutics Incorporated isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Good day and thank you for standing by. Welcome to the Corcept Therapeutics Conference Call. [Operator Instructions] 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.
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. 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 may cause actual results to be materially different from those such statements expressed or implied. 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. 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 million to $650 million. Net income was $27.8 million in the first compared to $15.9 million in the first quarter of the prior year. Our cash and investments at March 31 was $451 million. I will now turn the call over to Charlie Robb, our Chief Business Officer. Charlie?
Charlie Robb: Thanks, Atabak. In March 2018, we sued Teva Pharmaceuticals to prevent it from marketing a generic version of Korlym in violation of our patents. The case was trialed in federal district court in September of last year. On December 29 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. We filed our opening brief on March 11. Teva filed its responsive brief on April 22. Our reply, which will complete briefing of the matter, is due later this month. These documents are available publicly at the government’s PACER website.
It’s impossible to predict exactly how long the appeal will take. The timing of oral argument and 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 the 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. We are eager to advance this appeal. As has always been the case, we strongly believe that our position is the correct one. We are confident that the Federal Circuit, with its deep expertise in this area of the law, will agree. I’ll now turn the call over to Joe Belanoff, our Chief Executive Officer. Joe?
Joe 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 4 late stage studies and we have reached open label data from our GRACE study that takes us one step closer to submitting our NDA and bringing relacorilant to patients with Cushing’s syndrome. Our commercial growth was driven by a record number of new Korlym prescribers and a record number of patients receiving the medication. Hydrocortisolism is commonly misdiagnosed in large part because it’s frequently expressed in burdensome symptoms, hyperglycemia and hypertension, have become so common in the population as a whole.
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 Korlym was prescribed, we used 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 Korlym treatment. 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 leading diabetologist in the United States and 25% of these patients were found to have hypercortisolism. 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 presented at a keynote session at the American Diabetes Association’s Annual Scientific Sessions next month. The second portion of the CATALYST study, the treatment phase is ongoing. As the awareness and diagnosis of Cushing’s syndrome increases, we are simultaneously working to advance our proprietary selective cortisol modulator, relacorilant. Relacorilant 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.
A pivotal trial for relacorilant GRACE has two parts. In its first open label phase, 152 patients with Cushing’s syndrome and either hypertension hyperglycemia or both receive relacorilant for 22 weeks. Patients who exhibited pre-specified improvements in either or both symptoms were given the opportunity to enter the trials randomized double-blind withdrawal phase, during which half of the patients continue to receive relacorilant and half receive placebo for 12 weeks. GRACE’s primary endpoint is maintenance of blood pressure control in the randomized withdrawal phase of the study with maintenance of glycemic control at 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, because excess cortisol activity affects nearly every tissue in the body, patients with Cushing’s 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 in 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. For the patients who entered the randomized withdrawal phase, improvements in mean systolic and diastolic blood pressure, a 12.6 and 8.3 millimeters of mercury from baseline with p-values of less than point 0.001 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.
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 relacorilant. 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, reduction in mean hemoglobin A1c of 0.7% and reduction in mean fasting glucose of 25.2 milligrams per deciliter. Oral p-values of 0.006 or less were observed. Relacorilant was well tolerated consistent with its known safety profile. Due to its unique mechanism of action which unlike Korlym does not increase patients’ cortisol levels, there were no relacorilant-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. All parts of GRACE aren’t complete. Our task now is to collect, review and analyze the full dataset, 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. 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 3 trial of relacorilant 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.
Patients with this etiology of Cushing’s 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 produced valuable data about the treatment of an etiology of Cushing’s syndrome that affects many patients. Enrollment is complete and we expect data in the fourth quarter of this year. We are also studying relacorilant 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.
The goal of using relacorilant 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 show that women who received relacorilant intermittently, the day before, the day of, and the day after they received nab-paclitaxel exhibited a statistically significant improvement in progression-free survival and duration of response compared to the group who received nab-paclitaxel monotherapy. Women in the intermittent relacorilant group also lived longer than those in the comparator arm, 29% of the patients who took intermittent relacorilant who are alive, 2 years after steady start versus only 14% who took nab-paclitaxel alone. Importantly, the women who received relacorilant plus nab-paclitaxel experienced no additional side effect burden compared to those who received nab-paclitaxel alone.
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. It’s design closely tracks our previous study. Women are randomized one to one to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone. The primary endpoint of ROSELLA is progression-free survival with overall survival of key secondary endpoint. We are conducting this study in collaboration with leading clinicians from the Gynecologic Oncology Group or GOG in the United States and the European network of gynecological oncology trials were in GOG group in Europe and deeply appreciate their enthusiasm and support.
Because of our confidence in the positive results of our Phase 2 trial, we have begun initial planning for relacorilant’s launch in oncology. The President of our Oncology division, Roberto Vieira rejoined Corcept earlier this year, is building the organization we need to help as many women as quickly as possible following approval. We are also evaluating relacorilant as a treatment for prostate cancer and adrenal cancer. Leading academic researchers and clinicians hypothesize the 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.
Deprived of androgen stimulation, their tumor switch to cortisol activity stimulates growth. Adding a cortisol modulator to androgen deprivation therapy could close this tumor escape route. Our collaborators at the University of Chicago are enrolling a randomized placebo-controlled Phase 2 trial of relacorilant 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, because cortisol suppresses the immune system and they blunt the effectiveness of cancer therapies 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 relacorilant 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. All of these compounds modulate the activity of cortisol, but they have distinct pharmacodynamic properties. Some are more potent in improving insulin sensitivity. Some are more potent in creating weight loss. Some get into the brain, some don’t. Some are very potent and oncologic models, some less so. One of these compounds, dazucorilant, which is highly brain penetrant has shown great promise in an animal model of ALS. We advanced dazucorilant in the clinical studies based on compelling preclinical data that showed improved motor performance and reduced neural inflammation and muscular atrophy.
Our double-blind placebo-controlled Phase 2 DAZALS trial of dazucorilant recently completed enrollment. 249 patients with ALS have been randomized to receive dazucorilant for placebo for 24 weeks. The primary endpoint is based on the ALS functional rating scale. DAZALS enrolled very briskly and we expect data by year end. Finally, I will turn to our program in MASH, MASH 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 1 dose-finding study of miricorilant on the patients who received 100 milligrams orally twice a week for 12 weeks experience a 30% reduction in liver fat and improvements in liver enzymes, markers of fibrosis and key metabolic and lipid measures just as Homa IR, serum triglycerides and LDL.
Importantly, miricorilant was also very well tolerated with no apparent GI side effects. We hope to expand on these encouraging results with our MONARCH study. MONARCH is a randomized double-blind placebo-controlled bass 2b trial now actively enrolling patients with biopsy confirmed MASH. The primary endpoint of the study is reduction in liver fat with MASH resolution and fibrosis improvement in key secondary endpoints. I will 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’s syndrome, our pivotal ROSELLA study in ovarian cancer, and our DAZALS study in ALS.
Our clinical and development teams have worked with great urgency to complete these studies. For many of the patients in these studies, time is short. Since we launched Korlym more than 12 years ago, we have kept the needs of patients, many of whom 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 Korlym business continues to thrive, we expect relacorilant’s improved profile and the results of our CATALYST study to cause our Cushing’s syndrome franchise to grow substantially for years to come. The results of the past quarter and all the progress on a 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’s syndrome and all the other disorders where cortisol modulation can make a difference. Operator, let’s proceed now to questions.
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