Corcept Therapeutics Incorporated Price & Performance (CORT)

Hello, everyone.

Good afternoon, and thank you for joining us.

Today, we issued a press release announcing our financial results for fourth quarter and providing a corporate update. A copy is available at corcept.com Corcept. Our complete financial results will be available when we file our Form 10 ks with SEDAR Today's call is being recorded. A replay will be available to investors past events tab of our website. Statements during this call other than statements of historical facts 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 The risks and uncertainties that may affect our forward statements are described in our annual report on Form 10 ks and our quarterly reports on Form 10 Q. All of which are available at the SEC's website. Please refer to those documents for additional information. We disclaim any intention or duty to update forward looking statements. Our 2024 revenue was $675,000,000 an increase of 40% compared to the prior year.

We expect our revenue growth to continue and have provided 2025 revenue guidance of 900 to $950,000,000 Net income was $141,000,000 for the full year 2024, an increase of 33% compared to the prior year. Our cash and investments at 12/31/2024 were $6.00 $3,000,000 compared to $425,000,000 at the end of the prior year. 2024, we acquired $38,000,000 of our common stock pursuant to our stock repurchase program, the net exercise of stock options by Corecept employees and the net vesting of Restricted stock gains. I will now turn the call over to Charlie Rob, our Chief Business Officer. Charlie? Thanks, Ottavak. I don't have much to report this quarter.

As many of you know, in March 2018, we sued Teva from to stop it from marketing version of Korlym in violation of our patents. In December of last year, the trial court ruled against us.

We have appealed that decision the Federal Circuit Court of Appeals briefing in the matter is complete. Documents are available at the government's PACER website. The next step is for the Federal Circuit to schedule oral argument. Which is still not done. The earliest plausible date given the court scheduling process is for argument in May or later the decision issuing three or four months after that. No matter the effort schedule, if we prevail, Teva would lose FDA approval of its products and be required to withdraw it from the market until the expiration of our patents in 02/1937. As I've said before, we are eager to advance this appeal. We strongly believe that our position is correct that the Federal Circuit will agree now turn the call over to Joe Belanoff, our Chief Executive Officer. [indiscernible] Thank you, Charlie, and thank you everyone for joining us this afternoon. 2024 was a great year for Corecept Corcept. Each successive quarter of twenty twenty four brought a record number of new Korlym prescribers and patients receiving Korlym. A rapidly increasing number of physicians now know that hypercortisolism is much more prevalent than was previously assumed. Are screening and treating many more patients than ever before.

We are confident that our Cushing's syndrome business will continue to grow for years. On December 30, we submitted a new drug application for our proprietary selective cortisol modulator relacorilant. Our NDA is based on compelling results from the GRACE Gradient long term extension and Phase two relacorilant studies. Our pivotal GRACE Phase three study had two parts. In the trials open label phase, one hundred and fifty two patients with hypercholar cortisolism and either hypertension hyperglycemia or both proceed bralacorilant for twenty two weeks Patients who met pre specified improvements were given the opportunity to enter the trial's randomized double blind withdrawal phase in which half of the patients continue to receive reliquorilant and half received placebo for twelve weeks. Patients in the open label phase of GRACE exhibited clinically meaningful and statistically significant improvements in hypertension, hyperglycemia, weight, lean muscle mass, waist circumference, cognition, Cushing's quality of life score and other important clinical measures. In the randomized withdrawal phase of GRACE, which compared patients taking relacorilant to those taking placebo, relacorilant met its primary endpoint of retaining improved blood pressure control The odds ratio, which was the study's primary endpoint, was zero point one seven an odds ratio of zero point one seven means that patients taking relacorilant were six times more likely to maintain their blood pressure response compared to those taking placebo.

Addition, patients who continue to take relacorilant in the randomized withdrawal phase of the [indiscernible] maintained or increased the broad range of other improvements in the signs and symptoms of hypocortisolism generated in the open label phase of the study. While those who received placebo experienced a significant worsening of these signs and symptoms. Patients who completed the Phase two GRACE and Gradient studies were eligible to enter our long term extension study where they continue to receive relacorilant or for patients in the placebo arm of gradient received relacorilant for the first time.

Patients in the extension study have now taken relacorilant for up to six years This group of one hundred and sixteen patients has exhibited additional clinically meaningful and durable cardiometabolic improvements. For instance, at week twenty four of the study, I'm sorry, for instance at month twenty four of the study, they experienced a further reduction in their systolic blood pressure of 10 millimeters of mercury a P value of 0.012 their diastolic blood pressure of 7.3 millimeters of mercury, a P value of 0.016. Compared to those measurements at the time they entered the extension study. Again, please remember these improvements were in addition to the improvements already exhibited in the Phase [indiscernible] [indiscernible] Relacorilant's efficacy and safety, which I will discuss in a moment, is clearly evident when one follows the clinical course of patients as they enter the Phase two GRACE or GRADIUM study. Complete that study then participate in the long term extension study. As a group, patients exhibit rapid improvement at the start of relacorilant therapy but it's maintained or continues to improve in the extension study.

Patients as relacorilant treatment is interrupted for instance, by being assigned to placebo in the GRACE randomized withdrawal phase exhibit rapid improvements at the start of relacook relacorilant therapy then deterioration when switched to placebo, followed by resumption of improvement when relacorilant is restarted. Just as important as relacorilant's efficacy is its safety. Relacorilant has been well tolerated in all of its studies. The most common adverse events have been mild to moderate nausea, a Dima in the extremities and back and fatigue These symptoms are consistent with cortisol withdrawal that patients with hypercortisolism experience following a rapid reduction in their cortisol activity. Whether due to surgery that removes an ACTH or cortisol secreting tumor or at the start of medical therapy. As expected, there have been no relacorilant induced instances of hypokalemia endometrial hypertrophy drug induced vaginal bleeding. No cases of adrenal insufficiency and no instances of QT prolongation These adverse events can have serious health consequences Each of the currently available medications for patients with Cushing's syndrome can cause one or more of them. As we advance relacorilant, we continue to work at increasing physician awareness and understanding of hypercortisolism, The prevalence phase of our catalyst study showed that one in four patients with difficult to control type two diabetes has hypercortisolism Corcept.

A far higher rate than was assumed In December, we completed Catalyst treatment phase, a double blind placebo controlled study which one hundred and thirty six patients identified in Catalyst first phase as having hyper Cortisolism were randomized to receive either Korlym or placebo. The results were striking. Patients who received Korlym exhibited a large reduction 1.47% in hemoglobin A1c a key measure of glucose control, compared to a 0.15 decrease in patients who received placebo. A P value of less than point zero zero zero one The magnitude of reduction seen in the treatment arm is especially striking given that these patients were already receiving the best diabetes treatment available including Ozempic and Mongeiro.

Another catalyst finding [indiscernible] even more common in patients who have cardiovascular disease in addition to diabetes.

In a substantial group of patients in the CATHALYST study, taking three or more medications to manage their hypertension, more than a third were found to have hypercortisolism. Later this quarter, we will start our newest study MOMENTUM, which will help establish the prevalence of hypercortisolism in patients with resistant hypertension.

We are confident that increased physician awareness and understanding of hypercortisolism combined with the advancement of relacorilant a safe and effective therapy, will improve the lives of patients who struggle with the devastating impact of this disease We are already seeing it. As you know, we are also studying relacorilant as a treatment for types of cancer cortisol plays a role. We expect data soon from our pivotal Rosella study In this study, three eighty one women with platinum resistant ovarian cancer have been randomized on a one to one basis to receive either nab paclitaxel probably the most effective chemotherapy currently prescribed to women with platinum resistant disease or nap paclitaxel plus relacorilant. For many of these patients, napaclataxel or any chemotherapy has become much less useful than earlier in the course of treatment. Our expectation is that relacorilant will resensitize ovarian tumors to the effects of nab paclitaxel, By blunting, the anti apoptotic effects of cortisol activity, Brazil's design tracks the design of our successful controlled Phase two trial In that study, women who received relacorilant intermittently the day before, the day of and the day after they received napaclitaxel exhibited a statistically significant improvement in progression free survival and duration of response compared to the group who received nafaclitaxel monotherapy.

Women in the relacorilant group also lived longer than those in the comparator arm. Twenty nine percent of the patients who took intermittent relacorilant were live two years after Studystar.

Compared to only fourteen percent who took nab paclitaxel alone. Importantly, the women who received relacorilant plus nab paclitaxel experienced no additional side effect burden compared to those who received nab paclitaxel monotherapy. We expect relacorilant to replicate these results.

Enrollment in rosela is We anticipate having progression free survival results by the end of this quarter. We are conducting rosela in collaboration with leading clinicians from the gynecologic oncology group or GOG in The United States and the European Network of Gynecologic Oncology Trials or ENGOT Group in Europe and deeply appreciate their enthusiasm and support. In anticipation of a successful outcome, we have established a standalone oncology division so we can move swiftly after the conclusion of Rosella to bring relacorilant to the women who can benefit from it. Positive results will also prompt us to explore relacorilant as a treatment for earlier stages of ovarian cancer and other solid tumors that express the glucocorticoid receptor. In addition to exploring cortisol's potential to resensitize tumors chemotherapy, we are evaluating its potential use in combination with androgen deprivation therapy. 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 androgens, stimulation, their tumors switched to cortisol activity to stimulate growth. Leading academic researchers and clinicians hypothesize that cortisol modulation can block this tumor escape brute. Our collaborators at the University of Chicago are currently enrolling a randomized placebo controlled Phase two trial of relacorilant plus enzalutamide in patients with early stage prostate cancer before these patients have had an initial prostatic Another possible role of cortisol receptor antagonist is in combination with immunotherapy, Because cortisol suppresses the immune system, it may blunt the effectiveness of cancer therapies intended to stimulate an immune response.

Adding a cortisol modulator to immunotherapies such as checkpoint inhibitors may enhance their effectiveness.

Following our Phase Ib trial in advanced adrenal cancer, we're deciding how best to investigate the utility of our compounds in combination with immunotherapies in other tumor types and earlier stages of cancer. One of our proprietary compounds, dasacorilant, readily crosses the blood brain barrier and is a candidate for the treatment of neurologic disorders. Based on compelling data showing improved motor performance, and reduced neural inflammation and muscular atrophy, in a commonly used mouse model ALS we conducted a two forty nine patient randomized double blind placebo controlled Phase two trial of dacicorilant in that dire disease. Unfortunately, patients who received dacicorilant did not show an improvement in the ALS rating scale, the study's primary endpoint. However, we did observe a statistically significant improvement in patient survival at week twenty four of the study.

No deaths occurred in the eighty three patients who received three hundred milligrams a [indiscernible] while five deaths occurred in the eighty two patient placebo group. A p value of 0.02. The open label long term extension study is ongoing and we expect to receive one year overall survival results early in the second quarter.

MASH metabolic dysfunction associated steatohepatitis, Cortisol activity plays a role in both the initial development and progression of the disease cortisol modulation may serve as a treatment. One of our proprietary molecules miricorilant has very potent activity in the liver. Our Phase Ib dose finding study of miricorilant found the patients who received one hundred milligrams orally just twice a week for twelve weeks, experienced a 30% reduction in liver fat and improvements in liver enzymes, markers of fibrosis, and key metabolic and lipid measures such as insulin resistance, serum triglycerides and LDL. The compound was also very well tolerated with none of the GI side effects which commonly arise in patients being treated for MASH. Our randomized double blind placebo controlled Phase 2b MONARCH study aims to expand on our encouraging Phase 1b results MARIO-two is enrolling two cohorts. In the first, one hundred and twenty patients with biopsy confirmed MASH are randomized two to one to receive either one hundred milligrams of miricorilant twice weekly placebo for forty eight weeks. The primary endpoint for this cohort is reduction in liver fat, with biopsy confirmed MASH resolution and fibrosis improvement as key secondary endpoints. The second cohort has a planned enrollment of seventy five patients with presumed MASH.

Patients in this cohort will be randomized two to one to receive either one hundred milligrams miricorilant twice weekly for six weeks followed by two hundred milligrams of miricorilant twice weekly for eighteen weeks. Or placebo for the whole twenty four weeks. In this cohort, the primary endpoint is also reduction in liver fat. As I said earlier, 2024 was a great year for Corecept Corcept. We expect even greater success for years to come. Physicians are becoming increasingly aware of hypercortisolism its clinical consequences. We have seen that understanding translate to a long string of record quarters for new prescribers and patients receiving cortisol modulation therapy. The Catalyst results provide potent evidence to further advance the by demonstrating that hypercortisolism is clearly much more common than previous [indiscernible] and the treatment with the cortisol modulator is highly effective. Relacorilant strong efficacy and safety profile positions it to become the new standard of care for patients with hypocorazoleism Corcept. The positive results from our Grace Gradient long term extension in Phase two studies provide powerful support for successful relacorilant NDA in hypercortisol Meanwhile, our development programs continue to advance. We expect results from our pivotal Rossella study in ovarian cancer just a few weeks.

Our prostate cancer ALS and MASH studies are ongoing we plan to initiate our MOMENTUM study this quarter. We don't spend much time on these calls discussing the topic but you should also know that we have a broad and active research portfolio many proprietary selective cortisol modulators, with potential very distinctive clinical attributes. We are comprehensively evaluating these attributes and their therapeutic applications and will advance the most promising compounds to the clinic. The problems caused by excess cortisol activity often have profoundly negative effects on patients. We are dedicated to finding new, more effective and safer treatments help them. Operator, let's proceed now to questions. Our first question comes from the line of David Amsellem. Of Piper Sandler. Thanks. So I just had a few on relacorilant. First, can you talk to when we should hear about NDA acceptance [indiscernible] what are your thoughts on the potential for an ADCOM here and is that something you're preparing for So that's number one. The change in the endpoints or I guess elevating overall survival to a co primary. I guess what I'm wondering is how unusual is something like that at this sort of advanced stage [indiscernible] what should we make of that, number one?

And then number two, can you talk to statistical penalties associated with now having a co primary endpoint instead of a single progression free survival endpoint? Thank you. Hey, Steve. Thank you for the questions. And I will turn them over to the Best people to answer in company. But let me just clarify one small thing before we start, which is that we don't have co primary endpoints. We have dual primary endpoints and that's a very big difference And Bill Guyer, when he gets to it, will actually answer that question. But the first question about the relacorilant for Cushing's syndrome NDA is, I think best answered by Charlie Rob our Chief Business Officer and Head of Regulatory. Sure. So, yes, thanks for the question. We submitted our NDA on December 30, as we put out in our press release. And the FDA has sixty days to sort of review it for acceptance and that review is typically not it's not a sort of a preview of their substantive review for drug approval, but it's I'm sure all the parts of the application are there that the that there's sufficient data for them to review and then they can go ahead and proceed.

And it's typical to receive during that sixty day period your various information requests from the agency this data or that data, where could they find this or that piece of information, And we've been receiving that very ordinary course routine correspondence and responding to it over the past sixty days. So the process has been moving exactly as we understood it to move. And by sort of statute or regulation the FDA is due to give us a response within sixty days. So [indiscernible] Okay. And the second question, Charlie, about an adcom. Yes. And we are not expecting an adcom. I mean, the the past couple of medications for Cushing's syndrome were approved with ASTAM. Korlym was approved at one. And there's nothing about relacorilant's efficacy or safety that we think would require one. So will be ready for one of Corcept it occurred. It would not bother us, but we don't expect it.

Thank you, Charlie. And now I'd like to reintroduce you to Bill Guy. Bill is our Chief Development Officer and in charge of everything related to Great.

And thank you for the question related to Rosella.

So first, before I answer that question, I'm really proud to share that we just reached the number of events for PFS by Bicker. And that allows us to now work with every one of the 120 investigators to ensure that all the data for the three eighty one patients are entered into the database we can then do our analysis and that's why we believe we will have our analysis done by the end of this quarter. So it's a very good positive thing for the ROCELA study. Now specific to your question about the endpoints, we how common is this? I'd say very common because we've been actively working with regulators, both the FDA and EMA related to the rosela study.

And based upon their comments, we came to an agreement to have a dual primary endpoint of PFS by Dicker and OS to give us two shots on goal. So two chances for a positive study where we only need to meet one of them to have this be defined as a positive study. With that change, from a statistical point of view, the P value for PFS by Bicker is now 0.04. And for OS is 0.01 and we are adequately powered to detect a difference for both PFS and OS. But let me come back to dual primary endpoint, what does that mean? Basically for us to have a positive study, all we need is for one of them to be successful. In order to declare the rosela study a positive study.

And once we meet that PFS by BICR endpoint, we really don't have to wait for OS even though we expect to meet that OS endpoint. Of note also from a statistical point of view, once we meet our PFS endpoint, statistically, we can recycle that alpha where now for OS, it no longer becomes 0.01. We can now elevate that to be a P value of 0.05. Now once we hit that PFS endpoint, by the end of this quarter, we then plan to proceed with an NDA and MAA. So I see this change as a very positive for the program. And very positive for women with platinum resistant ovarian cancer. [indiscernible] Thank you, Bill. Thank you, David.

Thank you.

Next question please. Thank you.

Our next question [indiscernible] Ramakanth of H. C. Raintree, Swayankopoula, your line is open.

Hi, Arjay. Hi, how are you doing?

Really appreciate taking questions. So a couple of questions, one on Rosella and the other is Catalyst. So on Rosella, on this dual endpoints, so how does that work? So, Bill just said that if we hit the PFS endpoint at the March, we can file and go forward. However, if If it turns negative, so what happens? And And how long do you think we need to wait for the OS data to come through for filing? So that's question number one. On question number two on Catalyst, It's great to see Continued increase of patients on Korlym and Korlym screening. Or screening patients for Cushing's syndrome, that's what I meant. In terms of utilization of the catalyst data and the benefit of the catalyst study, are you folks already seeing some of that either in terms of screening patients or also getting patients on the drug And how would you start Talking more about the entire catalyst that data, both the prevalence and the treatment. Thank you, RK. I think I caught your question. For the first one, is best answered by Bill Guyer again. Bill on the Rossello study. So thanks for the question, RK. So one related to our endpoints.

We don't plan to miss our PFS endpoint. So we do plan to hit that PFS endpoint. And not have to wait for OS as I stated before. But if we happen to miss that PFS endpoint, we do then have that second chance for a positive study with OS. And we would hit OS approximately one year from now. Thank you, Bill.

And Sean, you in fact, let me reintroduce Sean. Sean is the President of our endocrinology division. And really responsible for all of So Sean, why don't you take the crack at the catalyst question? RK, thanks for the question. So in terms of Catalyst, the question of are we starting to see an impact, I would say that we started to see a small impact Recognize that there's always a delay between data generation, publication, guideline inclusion and then medical practice changes.

So when we really expect to see more of an impact is in the second half this year and in the years to come. And why do we expect to see that? And that's because more data going to be released as the year goes on. And so your question about how are we utilizing that data now, we are speaking to what we can speak to and when the data is published, we'll be able to more broadly communicate the complete story of both the prevalence as well as the treatment findings to physicians. [indiscernible] Thank you. Thank you, Arke. Okay, next question please.

Thank you. Our next question comes from Jun Li of Truist. Your line is open, June.

Congrats on the quarter and thanks for taking the questions. This is Asam Rana on for June. Just back on the rosela study. Just want understand a little bit better like was there something specifically that prompted the change in the endpoint? And did you have buy in from the FDA on the change? And then just on the 2025 revenue guidance, what was baked into that? Revenue was flat quarter over quarter. Just wondering about that. Thank you. First question, please Bill, go ahead and why don't you answer that.

So again, for Rosella, what prompted the change is just again, we've been actively discussing RoCELLA with the FDA and EMA and just through those collaborative conversations, we came in an agreement in a very positive way to elevate OS as a dual primary endpoint to give us two chances for positive [indiscernible] And that really is what prompted it. Just having a collaborative conversation with the FDA. So yes, they are in agreement with this change.

Okay. And Sean, the second question please about guidance and overall strength of the business and endocrinology.

And I believe the question was around sort of the flat quarter. So we had a fantastic fourth quarter with a record number of patients and prescribers. And in fact, as Joe mentioned in his opening remarks, it was the best quarter we've ever had. However, our pharmacy partner had some operational challenges that impacted our Q4 revenue. So why did that happen? Well, And because of that, we experienced significant prescription growth in 2024 and the majority of that growth came in the second half of the year. Although growth is obviously fantastic, it temporarily overwhelmed the operational capabilities of our pharmacy vendor. Took longer than expected to start patients on Korlym. Now we're confident that these issues have been identified and are being resolved and we expect that the pharmacy will handle the demand of our business growth going forward. Things are moving in the right direction and we have incorporated all of that into our guidance. So now in terms of the guidance, what's baked into that? And we take all factors into account. One thing that's emerged this year through Catalyst and through all the other studies that preceded it is that this patient population is understated.

The older circle Epi data would say that there were ten thousand of these patients and we now know that that number is larger and the FDA agrees with us on that. So we're focused on unlocking that full potential of the market and see continued growth through the rest of this year. And I think more importantly, we see we see ourselves and we're confident than ever that we're on track to grow our hyper cortisol and business from $3,000,000,000 to $5,000,000,000 in annual revenues in three to five years. Market is expanding and it's expanding rapidly. I'd just like to underscore just a very important thing. It's now clear that there are many more patients with hyperchorusolum than were once And they are in many practices throughout the country all large practices. And even more important, what Catalyst showed was that treating these patients with cortisol antagonists like Korlym or an upcoming relacorilant. Is very effective in treating patients who often have not gotten any relief from other treatments. And so that's really a very, very beneficial thing. Now we've really taken this one step at a time. You saw the Catalyst treatment results at the end of last year.

Are going to appear in major conferences throughout this year. These findings will will be in substantial publications starting soon and then going through the rest of the year, but there's There's many, many data points that will actually get out there. Now medicine changes slowly over time. Sometimes to the detriment of patients.

But as Sean has pointed out, we've really seen that change pick up in the second half of last year. We think that is going to continue through this year accelerating as the year goes along. So, I think medicine has really changed by this work. And I think patient benefit will really be substantial as we go forward. And that's going to go on for an extended period of time. Okay. Thank you. I don't I don't see any more questions out there.

So I'm going to call it now. Thank you very much for all listening in. As you've heard on this call, this probably will you will be getting other important information from Corcept in the upcoming weeks and months. So please stay tuned. Thank you very much.

This concludes today's conference call. Thank you for participating. You may now disconnect. [indiscernible] [indiscernible]