NASDAQ:CORT Corcept Therapeutics Q3 2023 Earnings Report $69.59 +2.16 (+3.20%) Closing price 04/15/2025 04:00 PM EasternExtended Trading$68.10 -1.49 (-2.13%) As of 04/15/2025 07:36 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Corcept Therapeutics EPS ResultsActual EPS$0.28Consensus EPS $0.22Beat/MissBeat by +$0.06One Year Ago EPS$0.30Corcept Therapeutics Revenue ResultsActual Revenue$123.60 millionExpected Revenue$119.71 millionBeat/MissBeat by +$3.89 millionYoY Revenue Growth+21.50%Corcept Therapeutics Announcement DetailsQuarterQ3 2023Date11/1/2023TimeAfter Market ClosesConference Call DateWednesday, November 1, 2023Conference Call Time5:00PM ETUpcoming EarningsCorcept Therapeutics' Q1 2025 earnings is scheduled for Tuesday, April 29, 2025, with a conference call scheduled on Wednesday, April 30, 2025 at 5:00 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Corcept Therapeutics Q3 2023 Earnings Call TranscriptProvided by QuartrNovember 1, 2023 ShareLink copied to clipboard.There are 10 speakers on the call. Operator00:00:00Good day, and welcome to the Corcept Therapeutics Conference Call. Automated message, advising your hand is raised. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Adhbak Mokari, CFO. Please go ahead. Speaker 100:00:33Hello, everyone. Good afternoon and thank you for joining us. Today, we issued a press release announcing our financial results for the Q3 Speaker 200:00:42and providing a corporate update. Speaker 100:00:44Copy is available at corecept.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 list. 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 differ materially from those such statements expressed or implied. Speaker 100:01:16These 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 presentation, we will be conducting a discussion 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 Q3 of 2023 call, we are raising our 2023 revenue guidance again to a range of $470,000,000 to $480,000,000 up from $455,000,000 to $470,000,000 Net income was $31,400,000 call, we will now begin the call for $0.28 per share in the Q3. Our cash and investments at September 30 were $414,800,000 call, an increase of $51,500,000 in the quarter. Speaker 100:02:21I will now turn the call over to Charlie Robb, our Chief Business Officer, to provide a legal update. Charlie? Speaker 300:02:27Thanks, Adamak. In March 2018, we sued Teva Pharmaceuticals Prevented from marketing a generic version of Korlym in violation of our patents. This September 26 through 28, the case went to trial Federal District Court in Camden, New Jersey. At trial, we asserted 2 patents against Teva, both of which concern the co administration of Korlym commonly prescribed class of medications known as strong CYP3A inhibitors. Teva does not and cannot dispute the validity of our patents. Speaker 300:03:02That matter was settled in our favor by the post grant review proceeding Teva initiated and lost in 2019. Teva's only defense at trial was to argue that their generic product would not infringe either of our patents. This was the sole issue, infringement of either patent before the court. With trial over, here is what will happen next. As is customary, each party has submitted a post trial brief, arguing that it should win, given the applicable law and the facts induced at trial. Speaker 300:03:36In In about a week, we will each submit a short reply brief responding to the arguments in the primary briefs. These documents are publicly available at the government's PACER website, that's PACER, P A C E R. Once briefing is complete, the judge may or may not ask for oral argument. Verdict will follow, most likely in the Q1 of next year. Of course, the timing is entirely at her discretion. Speaker 300:04:03The losing party is entitled to appeal any adverse decision to the Federal Circuit Court of Appeals. Such an appeal will likely take call, we will conduct between 12 18 months to complete. All in all, this dispute will likely not be completely resolved until the 2nd or Q3 of 2025. Those of you who have joined our prior calls have heard me say in increasingly emphatic tones that we are confident in our case. I will say it again. Speaker 300:04:31We are confident in the strength of our case, supremely confident. We walked into court certain that the law and the facts are on our side. Call, we left even more certain that the law and the facts are on our side. We look forward to the judge's verdict. Call, I will now turn the call over to Joe Belanoff, our Chief Executive Officer. Speaker 200:04:51Joe? Thank you, Charlie. Our strong results in the 3rd quarter reflects physicians increasing awareness of hypercortisolism and the harm it causes. A screening for the disease becomes more common, More physicians prescribe and more patients receive Korlym. This changing behavior has led to another record high in our quarterly revenue. Speaker 200:05:14We expect this trend in medical practice and with it our commercial growth to continue. Korlym is an excellent treatment for patients with Cushing's syndrome There are considerably more patients with Cushing's syndrome than was once assumed. The results of our catalyst study will likely provide further evidence to bolster this belief, which will in turn lead physicians to identify and provide effective treatment for the large group of patients whose hypercortisolism currently goes undiagnosed. This advance in medical thinking buoy our Cushing's syndrome business, we are raising our 2023 revenue guide range again this time to $470,000,000 to $480,000,000 We're also very excited by the potential of our clinical development programs. Since inception, our research and development efforts Built on the hypothesis, the cortisol modulation is a powerful therapeutic mechanism in many serious disorders. Speaker 200:06:21Our proprietary compounds modulate cortisol's effects by binding to the glucocorticoid receptor or GR. The receptor which is activated in cortisol levels are high. They do not bind to the progesterone receptor and don't cause some of Korlym's, our approved product, most serious off target effects. Interestingly, while all our compounds modulate cortisol activity, They produce distinct clinical effects. Some cross the blood brain barrier, others do not. Speaker 200:06:53Some perform best in models solid tumors, others are more potent models of metabolic disease. Some appear to be tissue specific, others have more global effects. These diverse qualities allow us to study a wide variety of disorders. Currently, we are conducting programs with 3 of our proprietary selective call, Cortisol modulators, relacorilant, dasicorilant and miricorilant in ovarian, adrenal and prostate cancer, ALS, NASH and of course Cushing's syndrome. Additional compounds are in earlier stages of development. Speaker 200:07:30Important late stage clinical development milestones are approaching. In 2024, we expect data from our GRACE, Gradient, Catalyst, Rosella and DASL study. We also plan to submit an NDA for relacorilant in Cushing's syndrome and to complete enrollment of our Phase 2b MONARCH study in patients with NASH. This is a very exciting time for Corcept. We are evaluating relacorilant for the treatment of hypercortisolism in 2 Phase 3 trials, GRACE and GRADIENT. Speaker 200:08:06Relacorilant is a selective cortisol modulator. Like Korlym, it achieves its effect by competing with cortisol at the glucocorticoid receptor. Unlike Korlym, it does not bind to the progesterone receptor and so does not cause progesterone related side effects. Relacorilant Phase 2 efficacy and safety data were compelling. Patients experienced meaningful improvements in hypertension and glucose control, as well as in the other signs and symptoms of Cushing's syndrome. Speaker 200:08:35There were no relacorilant induced instances of endometrial thickening or vaginal bleeding progesterone related side effects and no drug induced hypokalemia, a leading cause of prokarylindiscontinuation. The Phase 2 trial results were published in the journal Frontiers in Endocrinology in July 2021. We are focused on finishing our GRACE trial and preparing our NDA, which we plan to submit in the Q2 of 2024. Relacorilant has tremendous promise as a treatment for patients with all etiologies of endogenous Cushing syndrome and we are eager to make it available. Our 2nd Phase 3 trial in hypercortisolism, GRADIENT, is studying relacorilant's effects in patients whose Cushing's syndrome is caused by an adrenal adenoma or adrenal hyperplasia. Speaker 200:09:28Patients with this etiology of Crutcheson syndrome often experience a less rapid decline, event on data from Gradient, we do expect the study to produce valuable data about the treatment of an ideology of Cushing's syndrome that affects many patients. Our Phase 4 CATALYST trial is the largest study ever conducted to establish the prevalence of hypercortisolism in patients with difficult to control diabetes. Many independent studies conducted over the last 15 years I found that the prevalence of hypercortisolism in patients with type 2 diabetes is substantially higher than in the general population. The most prominent diabetologist in the United States helped us design and are participating in Catalyst, which has the potential to become a landmark in guiding physicians understanding of Pridgen's syndrome. We expect data from the prevalence phase of the catalyst study call early next year. Speaker 200:10:38Our oncology program is testing 3 anticancer mechanisms, 1st postulated by investigators at the University of Chicago and later confirmed by other prominent researchers. One mechanism is increasing apoptosis. The program cell death in chemotherapy is meant to induce in solid tumors. Cortisol works against the beneficial effect of chemotherapy by suppressing apoptosis. In our successful controlled Phase 2 trial in women with platinum resistant ovarian cancer, the addition of our selective cortisol modulator relacorilant enhanced the effect of chemotherapy, likely by blunting cortisol's anti apoptotic effect. Speaker 200:11:23Relacorilant provided meaningful benefit to many of the women in our study. While these women's disease had progressed on 2 or more previous lines of treatment, including previous taxanes, relacorilant appear to resensitize their tumors Nav paclitaxel exhibited a statistically significant improvement in progression free survival and duration of response period, compared to the group who received mapaplitaxel monotherapy. Women in the intermittent relacorilant group also live longer the notice of the comparator arm with a p value that approach statistical significance. 29% of the patients who took intermittent relacorilant were alive 2 years after study start versus only 14% of those who took nab paclitaxel alone. Call, just as important, the women who received relacorilant plus nab paclitaxel experienced no additional side effect burden compared to those who received nab paclitaxel alone. Speaker 200:12:33The results from this study were published in the Journal of Clinical Oncology in June of this year. Results have also been featured in podium presentations at the 2021 2022 European Society For Medical Oncology ESMO meetings and at the 2022 American Society of Clinical Oncology ASCO Annual Meeting. Rosella, our pivotal multinational Phase 3 trial in platinum resistant ovarian cancer is enrolling patients. Rosella's goal is simply to replicate our positive Phase 2 results in a larger group. Rosella's design closely tracks our Phase 2 study. Speaker 200:13:15Planned enrollment is 360 women randomized 1 to 1 to receive either relacorilant plus nab paclitaxel or nab paclitaxel alone. The primary endpoint is progression free survival With overall survival a key secondary endpoint. We are conducting the study in collaboration with leading clinicians From the gynecological oncology group in the United States and the European Network of Gynecological Oncology Trials Group in Europe. Call, we expect data by the end of next year. Leading gynecological oncologists have told us that relacorilant's potential benefit, Improved progression free and overall survival without increased side effect burden would constitute an important medical advance And the relacorilant plus nap paclitaxel has the potential to become a new standard of care in women with platinum resistant ovarian cancer. Speaker 200:14:12A second mechanism by which cortisol modulation may prove useful is by blocking an important tumor growth pathway. Cortisol stimulation is a major reason why patients with prostate cancer treated with a widely prescribed androgen receptor antagonist enzalutamide eventually experienced resurgent disease. Deprived of androgen stimulation, Their tumor switched to cortisol activity to stimulate CRIT. Our hypothesis is that adding a cortisol modulator androgen deprivation therapy will close this tumor escape route. Our collaborators at the University of Chicago have initiated a randomized placebo controlled Phase 2 trial, labrelacorilant plus enzalutamide in patients with prostate cancer, Before these patients have had an initial prostatectomy. Speaker 200:15:06A third therapeutic mechanism seeks to treat tumors by enhancing the body's immune response, Cortisol suppresses the immune system, which may 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 the effectiveness of those therapies. We are conducting a Phase 1b trial of relacorilant plus the PD-one checkpoint inhibitor pembrolizumab in patients with advanced adrenal cancer, whose tumors produce excess cortisol. Pembrolizumab is rarely effective as monotherapy and treating this form of adrenal cancer. ALS commonly known as Lou Gehrig's disease is a devastating illness with an urgent need for better treatment. Speaker 200:15:58DASLs, our 198 patient randomized double blind placebo controlled Phase 2 trial dasucorilant in patients with ALS is enrolling patients briskly. Dasicorilant is a selective cortisol modulator that has shown great promise in animal models of ALS, improving Motor Performance and Reducing Neuroinflammation and Muscular Atrophy. We are conducting this important study at sites in Europe and the United States. We expect data by the end of next year. Finally, I'll turn to our program in NASH, Serious liver disorder that afflicts millions of patients in the United States. Speaker 200:16:41Miricorilant, an oral medication, continues to demonstrate great promise as a treatment for NASH. In our prior NASH study, patients who received 600 milligrams quarter, 900 milligrams of miricorilant daily exhibited large rapid reductions in liver fat, but also substantial albeit transient elevations of the liver enzymes ALD and AST. The improvement in liver fat in these patients was greater and occurred much more rapidly than we had expected and is rarely seen over any period of treatment. Our Phase 1b dose finding study found that patients who received just 100 milligrams of miricorilant orally twice a week for 12 weeks experienced an approximately 30% reduction of liver fat and showed improvements in liver enzymes and markers of liver disease. These patients also experienced improvements in key metabolic and lipid measures such as HOMA IR, serum triglycerides and LDL. Speaker 200:17:47Importantly, miricorilant was very well tolerated with no apparent GI side effects. We will present these results at the upcoming AASLD meeting in Boston. We intend to build on the promising results Phase 1b study with our 150 patient randomized double blind placebo controlled Phase 2b MONARCH trial Miricorilant in patients with biopsy confirmed NASH. Patients will receive either 100 milligrams of miricorilant or placebo orally, Twice weekly or 48 weeks. The primary endpoint is reduction in liver fat with NASH resolution and fibrosis improvement In conclusion, we are extremely optimistic about the future of Corcept. Speaker 200:18:37Partition syndrome business has tremendous growth potential and generates substantial profits even as we invest in our advancing development programs. We are again raising our 2023 revenue guidance and anticipate growth for years to come. Data from our large catalyst study will help physicians better identify and treat patients whose difficult to control diabetes is caused by hyper quarter, a population whose Cushing's syndrome too frequently goes undiagnosed. Our development programs are generating increasing evidence that cortisol modulation has the potential to treat a wide range of diseases. Cushing's syndrome, ovarian cancer, prostate cancer, ALS and NASH are current examples. Speaker 200:19:27There will be others. We have many more proprietary selective cortisol modulators in our portfolio with potentially very different clinical attributes. We will advance the most promising of these to the clinic. In 2024, we expect data from our GRACE, gradient and catalyst studies in Cushing's syndrome, our pivotal Rosella trial in ovarian cancer and our DASL study in ALS. Call, we expect to submit an NDA for relacorilant in Cushing's syndrome and to complete enrollment in our MONAC Phase 2b study in NASH. Speaker 200:20:05As I have said, it is an exciting time for Corcept. Before we take questions, I want to take a moment to introduce the newest member of our executive team, Monica Toledo, whose first day at Corcept is today. Monica, as President of Emerging Markets, We'll be responsible for our newer therapeutic areas such as ALS and NASH. We look forward to her contributions. Monica, welcome to Corcept. Speaker 200:20:33Let's proceed now to questions. Operator00:20:37Thank you. Question and answer session. Our first question comes from Matt Kaplan with Ladenburg. Your line is Speaker 400:21:03open. Hey, guys. Thanks for taking the questions and congrats on a strong quarter. To delve into your pipeline a Speaker 200:21:16little bit and specifically the Speaker 400:21:18near term readouts that you have coming up in 2024. I guess specifically, first, can you talk a little bit more about the GRADE study and the primary endpoint there that you're looking to show in that pivotal study? Speaker 200:21:31Hey, Matt, I apologize. I'm really having trouble hearing your question. Why isn't so good? Is it possible to Matt, question? Speaker 400:22:00Is that any better? Speaker 200:22:03No, we're just not hearing you. I'm sorry, Matt. Okay. Operator00:22:15One moment for our next question. Our next question comes from David Amsellem with Piper Sandler. Your line is open. Speaker 500:22:31Hey, thanks. Hope you can hear me well. Speaker 100:22:34Yes, we can. Speaker 500:22:35Good. So a couple of questions. First, Can you provide specifics on the year over year volume growth for Korlym? That's number 1. And then I guess as part of that question, my understanding is Q3 last year was somewhat weaker. Speaker 500:22:57So potentially we're looking at more favorable year over year comp. So just talk about the volume growth dynamics. I know there was also pricing action earlier this year. So just help us understand What was volume? What was price? Speaker 500:23:12And then in terms of your comments on screening for hypercortisolism and greater diagnoses and treatment starts, what does that mean Going forward, I know you're not in a position to guide for 2024, but is what we're seeing, this seeming inflection, Is that something that you're looking at as sustainable? Thanks. Speaker 200:23:39Okay. Thank you, David. I think we got both of those questions. I first want to introduce everyone reintroduce everyone to Shah Mandhuk, who is the President of our Endocrinology division, and he can address your first question. Speaker 600:23:52Yes, David, thank you for the question. So in terms of year on year growth, we had 22% growth, 12% of that was driven by volume And 9% was driven by price. Speaker 200:24:03And I think your next question Speaker 600:24:05was sort of the sustainability through Q4. I mean that's built into our range. We expected the growth we experienced in Q3 and we expect that growth to continue for many quarters. We had more new physicians and existing physicians prescribed Korlym for patients across the country and that's what drove our increased guidance range and the revenues that we see. Speaker 200:24:24Yes. And David, as a general answer to your second question, I think what we're really seeing out in the world is the recognition that hypercortisolism is considerably more common than I think people want to assume. Well, it's not there are not a 1000000 people with hypercortisolism, it's not the ultra rare disease that people once thought it was. So we actually think that this expansion because of really screening is going to continue for a substantial period of time. Some of those patients will eventually fall to Korlym, others will be treated in different ways. Speaker 200:24:58But the idea that this is an important medical therapeutic area that has really been under addressed, I think is gaining acceleration. Speaker 500:25:07That's helpful. If I may sneak in a quick follow-up. In terms of the new starts and just the growth, are you getting a good chunk of that growth from physicians who are New to Korlym treatment. Speaker 200:25:23I'm going to pass you back to Sean. Speaker 600:25:25Yes. Thank you for the questions. We're getting a mix of both. We have new prescribers every single month, every single quarter and we also have physicians that have previously prescribed Korlym, prescribe Again, for many subsequent patients potentially. So the short answer is yes across both groups. Speaker 200:25:42Okay. That's helpful. Thank you. Operator00:25:46Moment for our next question. Our next question comes from Matt Kaplan with Ladenburg. Your line is open. Speaker 400:26:00Hi. Can you hear me now? Speaker 200:26:02Much better. Thank you, Matt. Speaker 400:26:04Yes. Great, great, great. Yes, so first off, congrats on a very strong quarter. Thank you. This Just wanted to focus a little bit on your pipeline. Speaker 400:26:15Obviously, 2024 is going to be a significant year for you guys with a lot of data readouts. And just in terms of the near term readouts, can you give us a little bit more color on the GRACE study And what you're looking to show there, primary endpoint and I guess the results should be potentially available in the Q1 given your desire to file an NDA in the second quarter. Speaker 200:26:45Thanks, Matt. We heard all of that. I want to reintroduce the group to Bill Guyer. Bill runs all of our development programs and he can answer your specific question. Speaker 700:26:54Great. Thanks, Matt. So let me remind you the GRACE trial is an ongoing study with 2 parts in it. It's basically 2 studies in 1. The first part is the open label part of the study where we're evaluating escalation of dosing from 100 milligrams up to the maximum dose of 400 milligrams. Speaker 700:27:11And for those who meet response criteria for diabetes and or hypertension, both, then get into the randomized withdrawal study, which is primary endpoint of that study. We're going to share as you put it, top line results and overall results when there is material information within that first half of the year as we progress towards our NDA. When you think of the success, the success for this program would be treating patients with Cushing's syndrome, when you're seeing their Cushing's syndrome Improve dramatically. I mean, we're really treating very sick patients with Cushing's syndrome in the GRACE trial. And relacorilant is a key in that treatment, because it modifies the underlying disease of Cushing's syndrome. Speaker 700:27:52A success when you look at the primary endpoint would be to evaluate those patients who respond to relacorilant. And When they go into the randomized withdrawal part, they get switched to either staying on relacorilant or switching to placebo. And so we're Evaluating the maintenance of their response to hypertension and or diabetes control or losing that response and that's what we're going to be evaluating. Speaker 400:28:17Okay. That's very helpful. Thank you, Bill. And then if you could, A little bit more color in terms of the data that you're expecting from the first part of the study where you're taking a look at the catalyst in terms of the prevalence, what should you what should we be expecting as you announce the prevalence results in the Q1? Speaker 700:28:43Sure. Thank you for that second question. The goal for the Catalyst trial is pretty simple. It's to replicate and confirm the research from the past 15 years from publications of cohort studies showing the patients with difficult to control diabetes will have a positive dexamethasone suppression test or what we call a DST study, with a prevalence in the range of approximately 10% to 20%. And so right now, we're well within that range for the catalyst study. Speaker 700:29:10We look Speaker 200:29:10to complete that study By the Speaker 700:29:12end of this quarter and publicize that within the Q1 of next year. Speaker 400:29:19Okay. Okay. Thank you. And I'll jump back in the queue now. Thanks. Speaker 100:29:25Thanks, Matt. Thanks, Matt. Operator00:29:27One moment for our next question. Our next question comes from Roanna Ruiz with Leerink. Your line is open. Speaker 800:29:41Hi, afternoon, everyone. So first question. Curious if you could update us about remind us about your IP expectations for Korlym and relacorilant and endogenous Cushing's. I was just curious if there are any implications that we should think about with the recent developments with your litigation with Teva there. Speaker 200:30:03Yes. I'm going to pass you back to Charlie Rob, who release responsible for all of our legal issues. Speaker 300:30:11Yes. Hi. Yes, I guess I'll start Taken into 2 parts, obviously, our because our IP protections for Korlym and Orrelacorilant are really completely separate. As far as the developments go With respect to Korlym, as I mentioned, we had the trial at the end of September. And I really want to stress that There, the patents we are defending that we are asserting against Teva really concern the co administration of quarter, we really broadly prescribed class of drugs that are important drugs for everyone, but also are commonly prescribed to patients with Cushing's syndrome. Speaker 300:30:56So the trial I think went very well. I think we made exactly the case we needed to make. And so in terms of commentary on our Korlym IP, I feel very good about it. I think we brought it out into court. It performed very well and I'm confident that it's now enhanced to judge. Speaker 300:31:16That IP runs through 2,037. So those two patents and there will or maybe further patents that come out of our work in the coming months years with respect to Korlym. But right now, we're protected through 2,037. Now relacorilant is as a novel proprietary compound unlike Korlym, which is the active ingredient is a generic compound. And so with respect to relacorilant, we have patents on its composition of matter. Speaker 300:31:47We have patents for a variety of uses for the compound and for its sister compounds in a range of disorders, including the ones that we're studying now. And that protection runs past 2,040. So we have, I think, extremely robust sort of multilayered sort of IP surrounding relacorilant and there will be more being developed as our investigations continue to make new inventions that are worthy of patent protection. So I hope that answers your question. Speaker 800:32:20Yes, that helps. And then a second one I had just Tagging on about the GRACE trial reading out soon. I was just curious if you could explain what the statistical powering is for the endpoint there and anything else we should think about in the data? Speaker 500:32:40Sure. I'll answer that question. So the Speaker 700:32:42disc overpowering is to look at the loss of response. We have 90% power to detect A loss of response of about a 50% difference between staying on relacorilant and maintaining that response or switching to placebo and losing their response. Speaker 800:33:00Got it. Thanks for clarifying. Speaker 200:33:02Sure. Operator00:33:04One moment for our next question. Our next question comes from Joon Lee with Truist. Your line is open. Speaker 900:33:16Hey, congrats on the strong quarter. I have a question on timing of the NDA submission in Q2 of next year. Would you want to wait for the gradient study by mid year to submit a more fuller picture of the drug? What's the rush there? And would the FDA want to see it? Speaker 900:33:32And the other question is, what are the drivers of coiled and franchise that keeps surprising you to the upside? Speaker 200:33:40Okay. Two different questions. Let me, June, give you first to Charlie for the NDA question. So, Yes. We are we Speaker 300:33:52think that the most important demonstrator of INGRACE's safety and relacorilant safety and efficacy in Cushing's syndrome will be the GRACE trial. We think that's sufficient to support our NDA. And so we're going to go with that Because it will be ready, Speaker 200:34:09and ready first, ready Speaker 300:34:10to proceed and just continue to move our business forward as expeditiously as possible. We will be in a position just procedurally to submitting additional data to the FDA as gradient comes in if that's important to pressing the NDA forward. So I think we retain some real optionality there without having to sacrifice the pace of our timelines. Speaker 200:34:35And June, second question, would you please repeat that? Speaker 900:34:39Yes, yes. So one of the drivers of call and franchise that keep surprising you to the upside, you upgraded guidance, I think, 2 quarters in a row, I'm not mistaken. Yes. So just curious what's the driver what's the driver of that? Speaker 200:34:55Good. No, I understand the question. I'm going to pass it back to Sean. Speaker 600:34:59Yes, June. Thank you for the question. I mean these results have been expected given this is where we have been investing. And in the past, I've talked a little bit about some of the initiatives we've been investing in to grow our business and I thought I'd take a minute to update everybody on where those are at now. Before I do that though, I want to highlight, I think an important fact. Speaker 600:35:18And that's that we have a very clear understanding now more so than in the past that this is a multibillion dollar market opportunity. And the investments that we have made to grow our business and we will continue to make are highly leveraged and we expect that they will both capture the opportunity and then yield a higher rate of return. So from an initiative standpoint, which is what we're talking about, There's 3 that we previously discussed on calls. The first being the expansion of our sales force. The second is the increased effectiveness of team and then the third being the initiation of the catalyst study, which Bill just spoke about. Speaker 600:35:53Now in terms of the sales force And the size of that team, we're currently in the mid-60s and we are continuing to add clinical specialists throughout the country. Our target right now is about 75, but we're unlikely to stop there and we're going to continue to add top sales talent as we find it. And so part of the driver of the result is seeing that our both our existing clinical specialists and some of our newer clinical specialists are starting to become more effective and produce more. The second initiative really has been around that productivity driver. And what we've done is strengthened and streamlined our training program with the goal to do what I just touched on, make our existing people more effective and make our newer hires Speaker 100:36:32more effective more quickly. Speaker 600:36:33And again, we're starting to see results So the last piece is from an investment standpoint is catalyst. Bill just talked through the historical studies and the 10% to 20 spend range. But what I want everyone listening to recognize is that Catalyst is going to be the largest prospective study Speaker 100:36:53ever done for this group. Speaker 600:36:54I believe personally and others do as well that it will be the definitive study for this patient population. And it's really going to cement these findings from the studies that came before it. Now, if we can replicate that 10% to 20% prevalence rate, it is going to be an extremely meaningful driver for our business. You have to recognize that there are still many physicians out there that think the prevalence in this patient population is near to 0. Our growth today has been driven by slowly educating physicians to both screen and look for this disease. Speaker 600:37:24But we expect that with the addition of that data, we'll see that continue to evolve. So in summary, we have a lot of different initiatives at play, but we're at the very early stages of seeing value from those, many of them are just getting going and we expect to see growth not just through the rest of this year, but into 2024 and beyond. Speaker 900:37:46Excellent. Thank you so much. I'm looking forward to all the catalysts. Speaker 200:37:51Thank you, Jim. All right. Well, listen, thank you all for tuning in this quarter. Happy day after Halloween, Operator00:38:11Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.Read moreRemove AdsPowered by Conference Call Audio Live Call not available Earnings Conference CallCorcept Therapeutics Q3 202300:00 / 00:00Speed:1x1.25x1.5x2xRemove Ads Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Corcept Therapeutics Earnings HeadlinesAre these the best UK shares to consider buying as US stocks whiplash?April 12, 2025 | msn.comInsider Buying: Safestore Holdings Plc (LON:SAFE) Insider Acquires 65,000 Shares of StockApril 10, 2025 | americanbankingnews.comTrump’s betrayal exposed Trump’s Final Reset Inside the shocking plot to re-engineer America’s financial system…and why you need to move your money now.April 16, 2025 | Porter & Company (Ad)Safestore CEO Increases Stake with Significant Share PurchaseApril 9, 2025 | tipranks.comSafestore CEO Purchases Significant ShareholdingApril 8, 2025 | tipranks.comA dirt cheap FTSE 250 stock to consider buying todayMarch 24, 2025 | msn.comSee More Safestore Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Corcept Therapeutics? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Corcept Therapeutics and other key companies, straight to your email. Email Address About Corcept TherapeuticsCorcept Therapeutics (NASDAQ:CORT) engages in discovery and development of drugs for the treatment of severe endocrinologic, oncologic, metabolic, and neurologic disorders in the United States. It offers Korlym tablets medication for the treatment of hyperglycemia secondary to hypercortisolism in adult patients with endogenous cushing's syndrome; and who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. The company is also developing relacorilant, which is in phase III clinical trial for the treatment of cushing's syndrome; treatment for adrenal cancer and cortisol excess which is in phase 1b clinical trial; treatment for prostate cancer which is in phase II clinical trial; and nab-paclitaxel in combination with relacorilant, which is in phase III clinical trial to treat platinum-resistant ovarian tumors. In addition, it develops dazucorilant, which is in phase II clinical trial for the treatment of amyotrophic lateral sclerosis; miricorilant, which is in phase IIb trial for the treatment of nonalcoholic steatohepatitis; and treatment for antipsychotic induced weight gain that is in phase I trial. The company was incorporated in 1998 and is headquartered in Menlo Park, California.View Corcept Therapeutics ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Why Analysts Boosted United Airlines Stock Ahead of EarningsLamb Weston Stock Rises, Earnings Provide Calm Amidst ChaosIntuitive Machines Gains After Earnings Beat, NASA Missions AheadCintas Delivers Earnings Beat, Signals More Growth AheadNike Stock Dips on Earnings: Analysts Weigh in on What’s NextAfter Massive Post Earnings Fall, Does Hope Remain for MongoDB?Semtech Rallies on Earnings Beat—Is There More Upside? 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There are 10 speakers on the call. Operator00:00:00Good day, and welcome to the Corcept Therapeutics Conference Call. Automated message, advising your hand is raised. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Adhbak Mokari, CFO. Please go ahead. Speaker 100:00:33Hello, everyone. Good afternoon and thank you for joining us. Today, we issued a press release announcing our financial results for the Q3 Speaker 200:00:42and providing a corporate update. Speaker 100:00:44Copy is available at corecept.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 list. 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 differ materially from those such statements expressed or implied. Speaker 100:01:16These 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 presentation, we will be conducting a discussion 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 Q3 of 2023 call, we are raising our 2023 revenue guidance again to a range of $470,000,000 to $480,000,000 up from $455,000,000 to $470,000,000 Net income was $31,400,000 call, we will now begin the call for $0.28 per share in the Q3. Our cash and investments at September 30 were $414,800,000 call, an increase of $51,500,000 in the quarter. Speaker 100:02:21I will now turn the call over to Charlie Robb, our Chief Business Officer, to provide a legal update. Charlie? Speaker 300:02:27Thanks, Adamak. In March 2018, we sued Teva Pharmaceuticals Prevented from marketing a generic version of Korlym in violation of our patents. This September 26 through 28, the case went to trial Federal District Court in Camden, New Jersey. At trial, we asserted 2 patents against Teva, both of which concern the co administration of Korlym commonly prescribed class of medications known as strong CYP3A inhibitors. Teva does not and cannot dispute the validity of our patents. Speaker 300:03:02That matter was settled in our favor by the post grant review proceeding Teva initiated and lost in 2019. Teva's only defense at trial was to argue that their generic product would not infringe either of our patents. This was the sole issue, infringement of either patent before the court. With trial over, here is what will happen next. As is customary, each party has submitted a post trial brief, arguing that it should win, given the applicable law and the facts induced at trial. Speaker 300:03:36In In about a week, we will each submit a short reply brief responding to the arguments in the primary briefs. These documents are publicly available at the government's PACER website, that's PACER, P A C E R. Once briefing is complete, the judge may or may not ask for oral argument. Verdict will follow, most likely in the Q1 of next year. Of course, the timing is entirely at her discretion. Speaker 300:04:03The losing party is entitled to appeal any adverse decision to the Federal Circuit Court of Appeals. Such an appeal will likely take call, we will conduct between 12 18 months to complete. All in all, this dispute will likely not be completely resolved until the 2nd or Q3 of 2025. Those of you who have joined our prior calls have heard me say in increasingly emphatic tones that we are confident in our case. I will say it again. Speaker 300:04:31We are confident in the strength of our case, supremely confident. We walked into court certain that the law and the facts are on our side. Call, we left even more certain that the law and the facts are on our side. We look forward to the judge's verdict. Call, I will now turn the call over to Joe Belanoff, our Chief Executive Officer. Speaker 200:04:51Joe? Thank you, Charlie. Our strong results in the 3rd quarter reflects physicians increasing awareness of hypercortisolism and the harm it causes. A screening for the disease becomes more common, More physicians prescribe and more patients receive Korlym. This changing behavior has led to another record high in our quarterly revenue. Speaker 200:05:14We expect this trend in medical practice and with it our commercial growth to continue. Korlym is an excellent treatment for patients with Cushing's syndrome There are considerably more patients with Cushing's syndrome than was once assumed. The results of our catalyst study will likely provide further evidence to bolster this belief, which will in turn lead physicians to identify and provide effective treatment for the large group of patients whose hypercortisolism currently goes undiagnosed. This advance in medical thinking buoy our Cushing's syndrome business, we are raising our 2023 revenue guide range again this time to $470,000,000 to $480,000,000 We're also very excited by the potential of our clinical development programs. Since inception, our research and development efforts Built on the hypothesis, the cortisol modulation is a powerful therapeutic mechanism in many serious disorders. Speaker 200:06:21Our proprietary compounds modulate cortisol's effects by binding to the glucocorticoid receptor or GR. The receptor which is activated in cortisol levels are high. They do not bind to the progesterone receptor and don't cause some of Korlym's, our approved product, most serious off target effects. Interestingly, while all our compounds modulate cortisol activity, They produce distinct clinical effects. Some cross the blood brain barrier, others do not. Speaker 200:06:53Some perform best in models solid tumors, others are more potent models of metabolic disease. Some appear to be tissue specific, others have more global effects. These diverse qualities allow us to study a wide variety of disorders. Currently, we are conducting programs with 3 of our proprietary selective call, Cortisol modulators, relacorilant, dasicorilant and miricorilant in ovarian, adrenal and prostate cancer, ALS, NASH and of course Cushing's syndrome. Additional compounds are in earlier stages of development. Speaker 200:07:30Important late stage clinical development milestones are approaching. In 2024, we expect data from our GRACE, Gradient, Catalyst, Rosella and DASL study. We also plan to submit an NDA for relacorilant in Cushing's syndrome and to complete enrollment of our Phase 2b MONARCH study in patients with NASH. This is a very exciting time for Corcept. We are evaluating relacorilant for the treatment of hypercortisolism in 2 Phase 3 trials, GRACE and GRADIENT. Speaker 200:08:06Relacorilant is a selective cortisol modulator. Like Korlym, it achieves its effect by competing with cortisol at the glucocorticoid receptor. Unlike Korlym, it does not bind to the progesterone receptor and so does not cause progesterone related side effects. Relacorilant Phase 2 efficacy and safety data were compelling. Patients experienced meaningful improvements in hypertension and glucose control, as well as in the other signs and symptoms of Cushing's syndrome. Speaker 200:08:35There were no relacorilant induced instances of endometrial thickening or vaginal bleeding progesterone related side effects and no drug induced hypokalemia, a leading cause of prokarylindiscontinuation. The Phase 2 trial results were published in the journal Frontiers in Endocrinology in July 2021. We are focused on finishing our GRACE trial and preparing our NDA, which we plan to submit in the Q2 of 2024. Relacorilant has tremendous promise as a treatment for patients with all etiologies of endogenous Cushing syndrome and we are eager to make it available. Our 2nd Phase 3 trial in hypercortisolism, GRADIENT, is studying relacorilant's effects in patients whose Cushing's syndrome is caused by an adrenal adenoma or adrenal hyperplasia. Speaker 200:09:28Patients with this etiology of Crutcheson syndrome often experience a less rapid decline, event on data from Gradient, we do expect the study to produce valuable data about the treatment of an ideology of Cushing's syndrome that affects many patients. Our Phase 4 CATALYST trial is the largest study ever conducted to establish the prevalence of hypercortisolism in patients with difficult to control diabetes. Many independent studies conducted over the last 15 years I found that the prevalence of hypercortisolism in patients with type 2 diabetes is substantially higher than in the general population. The most prominent diabetologist in the United States helped us design and are participating in Catalyst, which has the potential to become a landmark in guiding physicians understanding of Pridgen's syndrome. We expect data from the prevalence phase of the catalyst study call early next year. Speaker 200:10:38Our oncology program is testing 3 anticancer mechanisms, 1st postulated by investigators at the University of Chicago and later confirmed by other prominent researchers. One mechanism is increasing apoptosis. The program cell death in chemotherapy is meant to induce in solid tumors. Cortisol works against the beneficial effect of chemotherapy by suppressing apoptosis. In our successful controlled Phase 2 trial in women with platinum resistant ovarian cancer, the addition of our selective cortisol modulator relacorilant enhanced the effect of chemotherapy, likely by blunting cortisol's anti apoptotic effect. Speaker 200:11:23Relacorilant provided meaningful benefit to many of the women in our study. While these women's disease had progressed on 2 or more previous lines of treatment, including previous taxanes, relacorilant appear to resensitize their tumors Nav paclitaxel exhibited a statistically significant improvement in progression free survival and duration of response period, compared to the group who received mapaplitaxel monotherapy. Women in the intermittent relacorilant group also live longer the notice of the comparator arm with a p value that approach statistical significance. 29% of the patients who took intermittent relacorilant were alive 2 years after study start versus only 14% of those who took nab paclitaxel alone. Call, just as important, the women who received relacorilant plus nab paclitaxel experienced no additional side effect burden compared to those who received nab paclitaxel alone. Speaker 200:12:33The results from this study were published in the Journal of Clinical Oncology in June of this year. Results have also been featured in podium presentations at the 2021 2022 European Society For Medical Oncology ESMO meetings and at the 2022 American Society of Clinical Oncology ASCO Annual Meeting. Rosella, our pivotal multinational Phase 3 trial in platinum resistant ovarian cancer is enrolling patients. Rosella's goal is simply to replicate our positive Phase 2 results in a larger group. Rosella's design closely tracks our Phase 2 study. Speaker 200:13:15Planned enrollment is 360 women randomized 1 to 1 to receive either relacorilant plus nab paclitaxel or nab paclitaxel alone. The primary endpoint is progression free survival With overall survival a key secondary endpoint. We are conducting the study in collaboration with leading clinicians From the gynecological oncology group in the United States and the European Network of Gynecological Oncology Trials Group in Europe. Call, we expect data by the end of next year. Leading gynecological oncologists have told us that relacorilant's potential benefit, Improved progression free and overall survival without increased side effect burden would constitute an important medical advance And the relacorilant plus nap paclitaxel has the potential to become a new standard of care in women with platinum resistant ovarian cancer. Speaker 200:14:12A second mechanism by which cortisol modulation may prove useful is by blocking an important tumor growth pathway. Cortisol stimulation is a major reason why patients with prostate cancer treated with a widely prescribed androgen receptor antagonist enzalutamide eventually experienced resurgent disease. Deprived of androgen stimulation, Their tumor switched to cortisol activity to stimulate CRIT. Our hypothesis is that adding a cortisol modulator androgen deprivation therapy will close this tumor escape route. Our collaborators at the University of Chicago have initiated a randomized placebo controlled Phase 2 trial, labrelacorilant plus enzalutamide in patients with prostate cancer, Before these patients have had an initial prostatectomy. Speaker 200:15:06A third therapeutic mechanism seeks to treat tumors by enhancing the body's immune response, Cortisol suppresses the immune system, which may 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 the effectiveness of those therapies. We are conducting a Phase 1b trial of relacorilant plus the PD-one checkpoint inhibitor pembrolizumab in patients with advanced adrenal cancer, whose tumors produce excess cortisol. Pembrolizumab is rarely effective as monotherapy and treating this form of adrenal cancer. ALS commonly known as Lou Gehrig's disease is a devastating illness with an urgent need for better treatment. Speaker 200:15:58DASLs, our 198 patient randomized double blind placebo controlled Phase 2 trial dasucorilant in patients with ALS is enrolling patients briskly. Dasicorilant is a selective cortisol modulator that has shown great promise in animal models of ALS, improving Motor Performance and Reducing Neuroinflammation and Muscular Atrophy. We are conducting this important study at sites in Europe and the United States. We expect data by the end of next year. Finally, I'll turn to our program in NASH, Serious liver disorder that afflicts millions of patients in the United States. Speaker 200:16:41Miricorilant, an oral medication, continues to demonstrate great promise as a treatment for NASH. In our prior NASH study, patients who received 600 milligrams quarter, 900 milligrams of miricorilant daily exhibited large rapid reductions in liver fat, but also substantial albeit transient elevations of the liver enzymes ALD and AST. The improvement in liver fat in these patients was greater and occurred much more rapidly than we had expected and is rarely seen over any period of treatment. Our Phase 1b dose finding study found that patients who received just 100 milligrams of miricorilant orally twice a week for 12 weeks experienced an approximately 30% reduction of liver fat and showed improvements in liver enzymes and markers of liver disease. These patients also experienced improvements in key metabolic and lipid measures such as HOMA IR, serum triglycerides and LDL. Speaker 200:17:47Importantly, miricorilant was very well tolerated with no apparent GI side effects. We will present these results at the upcoming AASLD meeting in Boston. We intend to build on the promising results Phase 1b study with our 150 patient randomized double blind placebo controlled Phase 2b MONARCH trial Miricorilant in patients with biopsy confirmed NASH. Patients will receive either 100 milligrams of miricorilant or placebo orally, Twice weekly or 48 weeks. The primary endpoint is reduction in liver fat with NASH resolution and fibrosis improvement In conclusion, we are extremely optimistic about the future of Corcept. Speaker 200:18:37Partition syndrome business has tremendous growth potential and generates substantial profits even as we invest in our advancing development programs. We are again raising our 2023 revenue guidance and anticipate growth for years to come. Data from our large catalyst study will help physicians better identify and treat patients whose difficult to control diabetes is caused by hyper quarter, a population whose Cushing's syndrome too frequently goes undiagnosed. Our development programs are generating increasing evidence that cortisol modulation has the potential to treat a wide range of diseases. Cushing's syndrome, ovarian cancer, prostate cancer, ALS and NASH are current examples. Speaker 200:19:27There will be others. We have many more proprietary selective cortisol modulators in our portfolio with potentially very different clinical attributes. We will advance the most promising of these to the clinic. In 2024, we expect data from our GRACE, gradient and catalyst studies in Cushing's syndrome, our pivotal Rosella trial in ovarian cancer and our DASL study in ALS. Call, we expect to submit an NDA for relacorilant in Cushing's syndrome and to complete enrollment in our MONAC Phase 2b study in NASH. Speaker 200:20:05As I have said, it is an exciting time for Corcept. Before we take questions, I want to take a moment to introduce the newest member of our executive team, Monica Toledo, whose first day at Corcept is today. Monica, as President of Emerging Markets, We'll be responsible for our newer therapeutic areas such as ALS and NASH. We look forward to her contributions. Monica, welcome to Corcept. Speaker 200:20:33Let's proceed now to questions. Operator00:20:37Thank you. Question and answer session. Our first question comes from Matt Kaplan with Ladenburg. Your line is Speaker 400:21:03open. Hey, guys. Thanks for taking the questions and congrats on a strong quarter. To delve into your pipeline a Speaker 200:21:16little bit and specifically the Speaker 400:21:18near term readouts that you have coming up in 2024. I guess specifically, first, can you talk a little bit more about the GRADE study and the primary endpoint there that you're looking to show in that pivotal study? Speaker 200:21:31Hey, Matt, I apologize. I'm really having trouble hearing your question. Why isn't so good? Is it possible to Matt, question? Speaker 400:22:00Is that any better? Speaker 200:22:03No, we're just not hearing you. I'm sorry, Matt. Okay. Operator00:22:15One moment for our next question. Our next question comes from David Amsellem with Piper Sandler. Your line is open. Speaker 500:22:31Hey, thanks. Hope you can hear me well. Speaker 100:22:34Yes, we can. Speaker 500:22:35Good. So a couple of questions. First, Can you provide specifics on the year over year volume growth for Korlym? That's number 1. And then I guess as part of that question, my understanding is Q3 last year was somewhat weaker. Speaker 500:22:57So potentially we're looking at more favorable year over year comp. So just talk about the volume growth dynamics. I know there was also pricing action earlier this year. So just help us understand What was volume? What was price? Speaker 500:23:12And then in terms of your comments on screening for hypercortisolism and greater diagnoses and treatment starts, what does that mean Going forward, I know you're not in a position to guide for 2024, but is what we're seeing, this seeming inflection, Is that something that you're looking at as sustainable? Thanks. Speaker 200:23:39Okay. Thank you, David. I think we got both of those questions. I first want to introduce everyone reintroduce everyone to Shah Mandhuk, who is the President of our Endocrinology division, and he can address your first question. Speaker 600:23:52Yes, David, thank you for the question. So in terms of year on year growth, we had 22% growth, 12% of that was driven by volume And 9% was driven by price. Speaker 200:24:03And I think your next question Speaker 600:24:05was sort of the sustainability through Q4. I mean that's built into our range. We expected the growth we experienced in Q3 and we expect that growth to continue for many quarters. We had more new physicians and existing physicians prescribed Korlym for patients across the country and that's what drove our increased guidance range and the revenues that we see. Speaker 200:24:24Yes. And David, as a general answer to your second question, I think what we're really seeing out in the world is the recognition that hypercortisolism is considerably more common than I think people want to assume. Well, it's not there are not a 1000000 people with hypercortisolism, it's not the ultra rare disease that people once thought it was. So we actually think that this expansion because of really screening is going to continue for a substantial period of time. Some of those patients will eventually fall to Korlym, others will be treated in different ways. Speaker 200:24:58But the idea that this is an important medical therapeutic area that has really been under addressed, I think is gaining acceleration. Speaker 500:25:07That's helpful. If I may sneak in a quick follow-up. In terms of the new starts and just the growth, are you getting a good chunk of that growth from physicians who are New to Korlym treatment. Speaker 200:25:23I'm going to pass you back to Sean. Speaker 600:25:25Yes. Thank you for the questions. We're getting a mix of both. We have new prescribers every single month, every single quarter and we also have physicians that have previously prescribed Korlym, prescribe Again, for many subsequent patients potentially. So the short answer is yes across both groups. Speaker 200:25:42Okay. That's helpful. Thank you. Operator00:25:46Moment for our next question. Our next question comes from Matt Kaplan with Ladenburg. Your line is open. Speaker 400:26:00Hi. Can you hear me now? Speaker 200:26:02Much better. Thank you, Matt. Speaker 400:26:04Yes. Great, great, great. Yes, so first off, congrats on a very strong quarter. Thank you. This Just wanted to focus a little bit on your pipeline. Speaker 400:26:15Obviously, 2024 is going to be a significant year for you guys with a lot of data readouts. And just in terms of the near term readouts, can you give us a little bit more color on the GRACE study And what you're looking to show there, primary endpoint and I guess the results should be potentially available in the Q1 given your desire to file an NDA in the second quarter. Speaker 200:26:45Thanks, Matt. We heard all of that. I want to reintroduce the group to Bill Guyer. Bill runs all of our development programs and he can answer your specific question. Speaker 700:26:54Great. Thanks, Matt. So let me remind you the GRACE trial is an ongoing study with 2 parts in it. It's basically 2 studies in 1. The first part is the open label part of the study where we're evaluating escalation of dosing from 100 milligrams up to the maximum dose of 400 milligrams. Speaker 700:27:11And for those who meet response criteria for diabetes and or hypertension, both, then get into the randomized withdrawal study, which is primary endpoint of that study. We're going to share as you put it, top line results and overall results when there is material information within that first half of the year as we progress towards our NDA. When you think of the success, the success for this program would be treating patients with Cushing's syndrome, when you're seeing their Cushing's syndrome Improve dramatically. I mean, we're really treating very sick patients with Cushing's syndrome in the GRACE trial. And relacorilant is a key in that treatment, because it modifies the underlying disease of Cushing's syndrome. Speaker 700:27:52A success when you look at the primary endpoint would be to evaluate those patients who respond to relacorilant. And When they go into the randomized withdrawal part, they get switched to either staying on relacorilant or switching to placebo. And so we're Evaluating the maintenance of their response to hypertension and or diabetes control or losing that response and that's what we're going to be evaluating. Speaker 400:28:17Okay. That's very helpful. Thank you, Bill. And then if you could, A little bit more color in terms of the data that you're expecting from the first part of the study where you're taking a look at the catalyst in terms of the prevalence, what should you what should we be expecting as you announce the prevalence results in the Q1? Speaker 700:28:43Sure. Thank you for that second question. The goal for the Catalyst trial is pretty simple. It's to replicate and confirm the research from the past 15 years from publications of cohort studies showing the patients with difficult to control diabetes will have a positive dexamethasone suppression test or what we call a DST study, with a prevalence in the range of approximately 10% to 20%. And so right now, we're well within that range for the catalyst study. Speaker 700:29:10We look Speaker 200:29:10to complete that study By the Speaker 700:29:12end of this quarter and publicize that within the Q1 of next year. Speaker 400:29:19Okay. Okay. Thank you. And I'll jump back in the queue now. Thanks. Speaker 100:29:25Thanks, Matt. Thanks, Matt. Operator00:29:27One moment for our next question. Our next question comes from Roanna Ruiz with Leerink. Your line is open. Speaker 800:29:41Hi, afternoon, everyone. So first question. Curious if you could update us about remind us about your IP expectations for Korlym and relacorilant and endogenous Cushing's. I was just curious if there are any implications that we should think about with the recent developments with your litigation with Teva there. Speaker 200:30:03Yes. I'm going to pass you back to Charlie Rob, who release responsible for all of our legal issues. Speaker 300:30:11Yes. Hi. Yes, I guess I'll start Taken into 2 parts, obviously, our because our IP protections for Korlym and Orrelacorilant are really completely separate. As far as the developments go With respect to Korlym, as I mentioned, we had the trial at the end of September. And I really want to stress that There, the patents we are defending that we are asserting against Teva really concern the co administration of quarter, we really broadly prescribed class of drugs that are important drugs for everyone, but also are commonly prescribed to patients with Cushing's syndrome. Speaker 300:30:56So the trial I think went very well. I think we made exactly the case we needed to make. And so in terms of commentary on our Korlym IP, I feel very good about it. I think we brought it out into court. It performed very well and I'm confident that it's now enhanced to judge. Speaker 300:31:16That IP runs through 2,037. So those two patents and there will or maybe further patents that come out of our work in the coming months years with respect to Korlym. But right now, we're protected through 2,037. Now relacorilant is as a novel proprietary compound unlike Korlym, which is the active ingredient is a generic compound. And so with respect to relacorilant, we have patents on its composition of matter. Speaker 300:31:47We have patents for a variety of uses for the compound and for its sister compounds in a range of disorders, including the ones that we're studying now. And that protection runs past 2,040. So we have, I think, extremely robust sort of multilayered sort of IP surrounding relacorilant and there will be more being developed as our investigations continue to make new inventions that are worthy of patent protection. So I hope that answers your question. Speaker 800:32:20Yes, that helps. And then a second one I had just Tagging on about the GRACE trial reading out soon. I was just curious if you could explain what the statistical powering is for the endpoint there and anything else we should think about in the data? Speaker 500:32:40Sure. I'll answer that question. So the Speaker 700:32:42disc overpowering is to look at the loss of response. We have 90% power to detect A loss of response of about a 50% difference between staying on relacorilant and maintaining that response or switching to placebo and losing their response. Speaker 800:33:00Got it. Thanks for clarifying. Speaker 200:33:02Sure. Operator00:33:04One moment for our next question. Our next question comes from Joon Lee with Truist. Your line is open. Speaker 900:33:16Hey, congrats on the strong quarter. I have a question on timing of the NDA submission in Q2 of next year. Would you want to wait for the gradient study by mid year to submit a more fuller picture of the drug? What's the rush there? And would the FDA want to see it? Speaker 900:33:32And the other question is, what are the drivers of coiled and franchise that keeps surprising you to the upside? Speaker 200:33:40Okay. Two different questions. Let me, June, give you first to Charlie for the NDA question. So, Yes. We are we Speaker 300:33:52think that the most important demonstrator of INGRACE's safety and relacorilant safety and efficacy in Cushing's syndrome will be the GRACE trial. We think that's sufficient to support our NDA. And so we're going to go with that Because it will be ready, Speaker 200:34:09and ready first, ready Speaker 300:34:10to proceed and just continue to move our business forward as expeditiously as possible. We will be in a position just procedurally to submitting additional data to the FDA as gradient comes in if that's important to pressing the NDA forward. So I think we retain some real optionality there without having to sacrifice the pace of our timelines. Speaker 200:34:35And June, second question, would you please repeat that? Speaker 900:34:39Yes, yes. So one of the drivers of call and franchise that keep surprising you to the upside, you upgraded guidance, I think, 2 quarters in a row, I'm not mistaken. Yes. So just curious what's the driver what's the driver of that? Speaker 200:34:55Good. No, I understand the question. I'm going to pass it back to Sean. Speaker 600:34:59Yes, June. Thank you for the question. I mean these results have been expected given this is where we have been investing. And in the past, I've talked a little bit about some of the initiatives we've been investing in to grow our business and I thought I'd take a minute to update everybody on where those are at now. Before I do that though, I want to highlight, I think an important fact. Speaker 600:35:18And that's that we have a very clear understanding now more so than in the past that this is a multibillion dollar market opportunity. And the investments that we have made to grow our business and we will continue to make are highly leveraged and we expect that they will both capture the opportunity and then yield a higher rate of return. So from an initiative standpoint, which is what we're talking about, There's 3 that we previously discussed on calls. The first being the expansion of our sales force. The second is the increased effectiveness of team and then the third being the initiation of the catalyst study, which Bill just spoke about. Speaker 600:35:53Now in terms of the sales force And the size of that team, we're currently in the mid-60s and we are continuing to add clinical specialists throughout the country. Our target right now is about 75, but we're unlikely to stop there and we're going to continue to add top sales talent as we find it. And so part of the driver of the result is seeing that our both our existing clinical specialists and some of our newer clinical specialists are starting to become more effective and produce more. The second initiative really has been around that productivity driver. And what we've done is strengthened and streamlined our training program with the goal to do what I just touched on, make our existing people more effective and make our newer hires Speaker 100:36:32more effective more quickly. Speaker 600:36:33And again, we're starting to see results So the last piece is from an investment standpoint is catalyst. Bill just talked through the historical studies and the 10% to 20 spend range. But what I want everyone listening to recognize is that Catalyst is going to be the largest prospective study Speaker 100:36:53ever done for this group. Speaker 600:36:54I believe personally and others do as well that it will be the definitive study for this patient population. And it's really going to cement these findings from the studies that came before it. Now, if we can replicate that 10% to 20% prevalence rate, it is going to be an extremely meaningful driver for our business. You have to recognize that there are still many physicians out there that think the prevalence in this patient population is near to 0. Our growth today has been driven by slowly educating physicians to both screen and look for this disease. Speaker 600:37:24But we expect that with the addition of that data, we'll see that continue to evolve. So in summary, we have a lot of different initiatives at play, but we're at the very early stages of seeing value from those, many of them are just getting going and we expect to see growth not just through the rest of this year, but into 2024 and beyond. Speaker 900:37:46Excellent. Thank you so much. I'm looking forward to all the catalysts. Speaker 200:37:51Thank you, Jim. All right. Well, listen, thank you all for tuning in this quarter. Happy day after Halloween, Operator00:38:11Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.Read moreRemove AdsPowered by