Corcept Therapeutics Incorporated

Good day, and thank you for standing by. Welcome to the CORE-CEP Therapeutics conference call. At this time, all participants are on 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 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 Ottobock McCrory. Please go ahead.

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. The copy is available at courseup.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 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. 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 was $451 million. I will now turn the call over to Charlie Robb, our Chief Business Officer. Charlie?

Thanks, Adivac. In March 2018, we sued Teva 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. We filed our opening brief on March 11th. Teva filed its responsive brief on April 22nd. 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 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. 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. I'll now turn the call over to Joe Belanoff, our Chief Executive Officer. Joe?

Thank you, Charlie, and thank you, everyone, for joining us this afternoon. This has been a tremendously active period at Corecept. 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 reliquarylin to patients with Cushing syndrome. Our commercial growth was driven by a record number of new coralline prescribers and a record number of patients receiving the medication. Hypercortisolism 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 Coralim 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 Coralim treatment. We have known for some time that there are large groups of patients who are far too infrequently screened for Cushing 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. 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 will be presented at a keynote session at the American Diabetes Association's annual scientific sessions in Orlando next month. The second portion of the catalyst study, the treatment phase, is ongoing. As the awareness and diagnosis of Cushing syndrome increases, we are simultaneously working to advance our proprietary selective cortisol modulator, relacoralant. Relacoralant 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 relacoralant, GRACE, has two parts. In its first open-label phase, 152 patients with Cushing syndrome and either hypertension hyperglycemia, or BOLD, received reliquarylant 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 continued to receive reliquarylant and half received 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 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. 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. 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 .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. 50% of the patients who entered GRACE with hyperglycemia, which includes patients with diabetes and patients with impaired glucose tolerance, or prediabetes, responded to reliquarylate. 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, all with p-values of 0.006 or less were observed. Reliquarylin was well-tolerated, consistent with its known safety profile. Due to its unique mechanism of action, which, unlike quaralim, does not increase patients' cortisol levels, there were no reliquarylin-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. Both parts of GRACE are complete. 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 relucoronilin 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 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. We are also studying reliquaryland 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 reliquorolin 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 II trial showed that women who received reliquarylate intermittently, the day before, the day of, and the day after they received nabpaclitaxel, exhibited a statistically significant improvement in progression-free survival and duration of response compared to the group who received nabpaclitaxel monotherapy. Women in the intermittent relucoralin group also lived longer than those in the comparator arm. Twenty-nine percent of the patients who took intermittent relucoralin were alive two years after study start versus only 14 percent who took napaclitaxel alone. Importantly, the women who received relucoralin plus napaclitaxel experienced no additional side effect burden compared to those who received napaclitaxel 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 II study results. Its design closely tracks our previous study. Women are randomized one-to-one to receive either relacloralin plus napaclitaxel or napaclitaxel 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 two trial, we've begun initial planning for relacoralin's launch in oncology. The president of our oncology division, Roberto Vieira, who joined CORSEP earlier this year, is building the organization we need to help as many women as quickly as possible following approval. We are also evaluating relacoralin 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. 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. Our collaborators at the University of Chicago are enrolling a randomized placebo-controlled Phase II trial of reliquarylin 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, 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 relacorlin 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 at improving insulin sensitivity. Some are more potent at creating weight loss. Some get into the brain, some don't. Some are very potent in oncologic models, some less so. One of these compounds, dazocorylate, which is highly brain penetrant, has shown great promise in an animal model of ALS. We advanced dazocorylate into clinical studies based on compelling preclinical data that showed improved motor performance and reduced neuroinflammation and muscular atrophy. Our double-blind, placebo-controlled Phase II DASLS trial of DAS-equivalent recently completed enrollment. 249 patients with ALS have been randomized to receive DAS-equivalent or placebo for 24 weeks. The primary endpoint is based on the ALS functional rating scale. DASLs enrolled very briskly and we expect data by year end. 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 afflicts 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 miracoralin 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. Importantly, Miracorlant 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 endpoints. I'll conclude where I began. There has been an exceptional amount of progress at CORSSEP 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. For many of the patients in these studies, time is short. Since we launched CORALIN 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 coralline business continues to thrive, we expect relacoralline's improved profile and the results of our catalyst study to cause our Cushing syndrome franchise to grow substantially for years to come. 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 make a difference. Operator, let's proceed now to questions.

Thank you. As a reminder, if you would like to ask a question, please press star 11 on your telephone. If you would like to withdraw your question, please press star 11 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.

Hey, guys. Congrats on the quarterly results. Nice quarter.

Thank you, Matt. Thanks.

Yep. Just focusing on the quarter a little bit and Coraline, What are you seeing now that, I guess, the court has ruled that Teva doesn't infringe your patents? Have you seen Teva in the marketplace and any generic competition as of yet?

Yeah. Matt, let me reintroduce to the group Sean Madduke, who's the president of our endocrinology division, and Sean will take that question.

Yeah, thanks for the question, Matt. So, as you know, Teva announced its launch on January 19th. 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 Coraline 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 of, and it's something I've said in the past, is that our situation is unique and not like most generic situations. We utilize one single-source pharmacy that is highly staffed to distribute Coraline and the other specialty products they have. And when corallum is prescribed, both the physician and the patient receive a high level of support, both at intake and ongoing, from both the pharmacy and Corsept. And this is support that is tremendously valued by doctors and by patients. And for this reason, physicians who prescribe corallum have a very strong brand preference.

Okay, that's really helpful. And just shifting gears, to your pipeline and specifically the GRACE study, given, I guess, the open label results that you've announced. Can you give us a sense in how those results in terms of the effect on hypertension in these patients and hyperglycemia compare with what you've seen historically with Corllum?

Sure, Matt. And again, I want to reintroduce Bill Geyer. 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 and symptoms of Cushing's syndrome. And these are positive results given how clinicians will have insight into how to use a drug like relacorlin. You know, it's really tough to make comparisons between drugs when a drug like corlin 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 coralline based upon what we've seen. When we look at the 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 relic coralline-induced 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.

Okay, that's helpful. In terms of the upcoming results for the randomized withdrawal phase, given, I guess, the 63% response rate in the hypertension and the 50% in the hypoglycemia, what should we be looking for in terms of... the randomized withdrawal phase.

Bill? 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 relacoralin or get switched to placebo. And then we're going to look for a reversal of those endpoints. And so specifically for our primary endpoint of hypertension, we're looking for a loss of response of greater than 5 millimetres 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.

Great, great. Thanks for the added detail. I'll jump back into the queue.

Thank you, Matt. Thanks, Matt. Thank you. One moment for the next question. And our next question is coming from David. Your line is open.

Thanks. So just a couple. First, just on Coraline 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? So just talk to 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 competition? awareness of Cushing's just beyond what you're doing with Catalyst. Just help us better understand what's happening in the marketplace that's driving this. Thank you.

Sure, David. And I'm going to give you over to Sean to answer that question.

So, David, thank you for the question. I think I'll start with number three and talk a little bit of Catalyst. And 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 forecast. We believe that the catalyst results are going to increase screening 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 2025 and 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 we're very pleased with the result. 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 it, is disease awareness has increased. And we're more confident than ever about the potential size of the Cushing Center market and that this is a multi-billion dollar market.

And David, the only other thing I would point out is 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.

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 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 has received FDA approval to this point. 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 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 core business, and we're confident in our ability to both continue to grow our business today, but also defend our market share.

Next question, please.

Thank you. And one moment for the next question. Our next question will be coming from Senseway, Anne of Conocord. Your line is open.

Thank you for taking our questions. Hi. 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's using the ALS functional rating scale, a numerical scoring system. So, I would like to ask for your comments about, you know, what level of a change would be considered as a clinically meaningful change on that endpoint? Because as we know, with the approved therapy, RETCOVA, each historical phase three trial showed a drop of the score by approximately 2.5 points. And I believe that was considered as 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 the Phase II data? Let's assume the data is positive. Thank you.

Yes, and I'd 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 But we're also looking at ALS and dazocorlin 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 could this be a regulatory enabling study, yes, we believe so. 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 even higher probably today. I believe that regulators would welcome new therapies that could help slow or reverse the progression of this disease. And again, Dazzles was The trial was designed specifically as a Phase IIb trial with the intention to be a regulatory enabling study.

The only thing I'd add to that is I think I don't have to really particularly remind everyone on the call, you know, 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 preclinical data. We'll find out if it 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.

Okay, that's very, very helpful. And if I may, I also have a simple or straightforward question about relic or lentine graze. So for the randomized withdrawal phase data, that period of the trial is for 12 weeks, and I know we have asked about those before, but we don't have withdrawal data with reliquary lens, but with corollary lens. I think you stated before that the rebounds was usually observed at four to five weeks after patients stopped using that. So I was wondering, you know, into establishing the confidence that 12 weeks is long enough for us to see a difference, a statistically significant difference. Besides the experience with Colin, would there be something else that we could trace back to?

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 that is 12 weeks enough to see patients who were randomized 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 corallum, we see a rapid loss of efficacy. 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 is a very reasonable guess for loss of efficacy. But we have even more evidence now, 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 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.

Okay, great. Thank you so much.

Thank you. One moment for the next question. And our next question is coming from . Your line is open.

Thank you. Hi, R.K. This is R.K. from H2AW. We figured it. So a couple of things. If it's a name, then it's me. In terms of commercialization, You know, with you getting ready to file the NDA based on the GRACE data, you know, we can kind of assure ourselves that the data probably is looking pretty good on the rest of the study that you're going for it. Having said that, so 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 Coraline to Relacoraline? That's part A of the question. Part B is, again, looking at catalyst data which has been generated with Coraline. What's the strategy there? Because, again, within a year, if you have Relacoraline, do you need to do something with Relacoraline as well if you need to grab that patient population? Or is this going to be a bifurcation of the market? where you will let coralline run through the diabetics and the hypertension folks, but keep the relicoralline for the Cushing's.

Hey, RK, let's start off with Sean, and I may have a few comments to add at the end.

Yeah, thanks, RK. So the question in terms of switching, coralline is obviously a great medication, but we believe relicoralline will be even better. Our belief is that the relicoralline's efficacy and safety profile will be well-received by treating physicians, and once approved, uptake will be very swift. There's no reason both the physician and the patient wouldn't want to choose it.

So, you know, R.K., 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. Now, we know, unfortunately, that is not the case with many of these patients. That surgical cure either doesn'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. Relacoraline is really a good medication. I really believe that it is a superior medication in a variety of ways to the very good effects that you get from coraline. And I think that people 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 it 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 hypercortisolism.

Fantastic. Thank you 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? If we assume 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?

Yeah. R.K., you know, 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've even been testing this. You know, immunotherapy, you know, has changed the world, and it's fantastic. But unfortunately, it doesn't work for even a majority of patients. I mean, for those who works, it's fantastic, but there are many patients, unfortunately, for whom it does not 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. 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. And it's not limited, if this idea is right, to adrenal cancer. Adrenal cancer is just a piece of place where we could 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. We'll learn 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.

I'd like to add to that, Joe.

Bill has a comment.

I'd like to add to that, too, just to add to that. Because while we're doing studies on ovarian cancer and prostate cancer and adrenal cancer, our vision really is to establish relic-correlant as the 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 relic or lit in cancer throughout the life cycle management plan. It's been on our minds internally with the addition of our new president of oncology, Roberto. He and I have been partnered in looking at all the various different types of studies of where we should be investing our research dollars in So you'll see a more broad plan in the coming months throughout this year.

Great. Appreciate the comments. Thank you, gentlemen, and talk to you folks soon. Thanks, Harkin.

Thank you. And one moment for our final question. And our final question of the day will be coming from June Lee of Truist. Your line is open.

Hi, this is Jeremy. I'm from June. Congrats 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 into the guidance? And then just quick follow-up, can you share how many patients are enrolled in the double-blind portion of the study, which we'll be seeing data in June? Thanks. Okay.

I think I caught both of your questions. I'm going to give the first one to Sean.

Thanks, Jeremy. So our revenue guidance will always consider all the information that we have and 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 Coraline and more patients taking Coraline.

And the second question, I think, was just a numbers question. How many patients? Yeah?

Yeah, that was it.

Is that it?

So how many patients are going to be in the randomized withdrawal set? Okay, so we haven't publicly disclosed that, but I will tell you that we have 62 patients who were 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 of having both. Thank you.

Okay, I think that concludes our questions. Thank you very much. CoreSept has become very much more complex than it was years ago, and I appreciate you really trying to capture all the information that we've sent to you. See you next quarter.

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