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Gary Robb

Thanks, Sean.
As was true last quarter, there's not much to report regarding our patent litigation with Teva. In December of 2023, the trial court ruled against us in our lawsuit to stop Teva from marketing a generic version of Korlym in violation of our patents. We've appealed that decision to the Federal Circuit Court of Appeals. Briefing is complete for anyone interested. The documents are available at the government's Pacer website. The Federal Circuit has still not scheduled oral argument, the earliest plausible date for which is now July, the decision issuing three or four months after that.
As I've said before, we're eager to advance this appeal. We strongly believe our position is correct and that the Federal Circuit will agree with us. If we prevail, Teva will lose FDA approval of its product until 2037, when the patents we have asserted against Teva in this lawsuit expire.
I will now turn the call over to Joseph Belanoff, our Chief Executive Officer, Joe.

Joseph Belanoff

Thank you, Charlie, and thank you everyone for joining us this afternoon. This is a very exciting time at Corcept. Our development programs have generated two profound medical findings in hypercortisolism and oncology and two potential avenues of substantial revenue growth.
Let's focus on hypercortisolism first.
Our new drug application for relacorilant and hypercortisolism is based on positive results from our pivotal phase 3 GRACE trial and is supported by the results from our GRADIENT, long-term extension, and phase 2 trials. It is currently under review with an FDA action date of December 30, 2025.
Patients treated with [relacorilant] in these studies experienced clinically meaningful and statistically significant improvements across all of the signs and symptoms of hypercortisolism in hypertension, hyperglycemia, weight, lean muscle mass, waist circumference, cognition, Cushing's quality of life score, and other important clinical measures.
There was a high level of consistency and durability of therapeutic benefit across our studies. In each of them, patients exhibited rapid improvements at the start of [relacorilant] therapy, and these improvements were maintained or continued to improve throughout the course of treatment, including in a long-term extension study where some patients have received [relacorilant] for more than six years.
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 are consistent with the cortisol withdrawal that patients with hypercortisolism experience following a rapid reduction in their cortisol activity, whether due to surgery or at the start of medical therapy.
As expected, there have been no relicorolent induced instances of hypokalemia, endometrial hypertrophy, or 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.
Our catalyst study was the largest and most rigorous trial ever conducted to assess the prevalence and treatment of hypercortisolism in patients with difficult to control type 2 diabetes. The prevalence phase of the study found that one in four patients with difficult to control type 2 diabetes has hypercortisolism.
A far higher rate than was assumed.
These results were published last month in Diabetes Care, a peer-reviewed journal of the American Diabetes Association.
The results from the treatment phase of the Catalyst study were equally striking.
Patients who receive 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 receive placebo, a P value of less than 0.0001. The magnitude of reduction seen in the treatment arm is especially striking given that these patients were already receiving multiple glucose lowering therapies, including the most potent GLP-1 agonists. Results from the treatment phase of Catalyst will be presented at a keynote session at the American Diabetes Association's annual scientific sessions next month.
A rapidly increasing number of physicians now know that hypercortisolism is much more prevalent than was previously assumed. They are screening and treating many more patients than ever before. The findings from Catalyst, once they are more broadly known, will undoubtedly stimulate even more doctors to screen for hypercortisolism. Many more patients with hypercortisolism than are currently identified will be found. Corcept is well positioned to help them. As Sean said earlier, we are confident that our Cushing's syndrome business will continue to grow for years.
Since the founding of Corcept, our research and development efforts have been built on the hypothesis that cortisol modulation is a powerful therapeutic mechanism in many serious disorders. The success of our pivotal ROSELLA trial in platinum resistant ovarian cancer is tangible proof of the therapeutic value of cortisol modulation and highlights the potential of this mechanism of action to be broadly useful.
In ROSELLA, 381 women with platinum resistant ovarian cancer were randomized one to one to receive either Nab-paclitaxel, probably the most effective chemotherapy currently prescribed to women with platinum resistant disease, or nab-paclitaxel plus relacorilant. For these patients, nab-paclitaxel or any chemotherapy have become much less useful than earlier in their course of treatment.
We expected that relacorilant would re-sensitize ovarian tumors to the effects of nab-paclitaxel by blunting the anti-apoptotic effect of cortisol activity.
The ROSELLA trial met its primary endpoint of improved progression free survival as assessed by blinded independent central review.
Patients treated with relacorilant, in addition to nab-paclitaxel chemotherapy, experienced a 30% reduction in risk of disease progression compared to patients treated with nab-paclitaxel alone with a hazard ratio of 0.70 and a P value of 0.008.
In the interim evaluation of overall survival, patients treated with relacorilant plus nab-paclitaxel showed a large improvement, with a median over overall survival of 16 months compared to 11.5 months in patients receiving nab-paclitaxel alone.
The hazard ratio was 0.69 with a P value of 0.01.
Safety and tolerability were comparable in the two groups.
ROSELLA clearly confirmed the positive efficacy and safety results that we saw in our phase 2 study.
The full results of the ROSELLA study will be presented at an oral late breaker session at the American Society of Clinical Oncology's annual meeting next month.
We expect to submit relacorilant's NDA and platinum resistant ovarian cancer next quarter, and a marketing authorization application in Europe shortly thereafter.
In anticipation of a successful regulatory outcome, we've been building a stand-alone oncology division. We are fully prepared to move swiftly to bring relacorilant plus nab-paclitaxel to the woman who can benefit from it once it is approved.
We expect to expand the findings from ROSELLA with our recently initiated BELLA study which will examine whether relacorilant with two medications, nab-paclitaxel and bevacizumab will offer patients with platinum resistant ovarian cancer an additional effective treatment regimen.
We will then explore relacorilant use to help treat earlier stages of ovarian cancer and other solid tumors that express the glucocorticoid receptor.
In addition to exploring cortisol modulation's potential to re-sensitize tumors to chemotherapy, we are evaluating its potential use in combination with androgen deprivation therapy and prostate cancer. Cortisol stimulation is a major reason why patients with prostate cancer treated with the widely prescribed androgen receptor antagonist enzalutamide eventually experience surge and disease. Deprived of androgen stimulation, their tumors switched to cortisol activity to stimulate growth.
Leading academic researchers and clinicians hypothesized that cortisol modulation can block this tumor escape route.
Our collaborators at the University of Chicago are currently enrolling a randomized placebo-controlled phase 2 trial of Relacorilant plus enzalutamide in patients with early-stage prostate cancer before these patients have had an initial [prostatectomy].
Another possible role of cortisol modulation 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 1b trial on advanced adrenal cancer, we are deciding how best to investigate the utility of our compounds in combination with immunotherapies and other tumor types and earlier stages of cancer.
One of our proprietary compounds, dazucorilant, 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 of ALS, we conducted a 249 patient randomized double blind placebo controlled phase 2 trial of dazucorilant in that dire disease.
Unfortunately, patients who received dazucorilant did not show improvement in the ALS function functional rating scale revised the study's primary endpoint.
However, an improvement in overall survival first seen at the six month mark, was also observed at year one of the study. An exploratory analysis showed that patients who were randomized to 300 mg of dazucorilant at the start of the study.
With significantly longer than patients who were randomized to placebo and then did not switch to dazucorilant in the long-term extension study with a hazard ratio of 0.16, a P value of 0.0009.
We will immediately seek input from US and European regulatory authorities on the next steps for this program.
MASH metabolic dysfunction associated to the hepatitis is a serious liver disorder that afflicts millions of patients in the United States and many millions outside the United States.
Cortisol activity plays a role in both the initial development and progression of the disease, and cortisol modulation may serve as a treatment.
One of our proprietary molecules, miricorilant, has very potent activity in the liver. Our phase 1b dose finding study of miricorilant found that patients who receive 100 mg orally just twice a week for 12 weeks experienced a 30% reduction in liver fat, and improvement in liver enzymes, markers of fibrosis, and key metabolic and lipid measures such as insulin resistant, serum triglycerides, and LDL.
Miricorilant 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. MONARCH is enrolling two cohorts. In the first, patients with biopsy confirmed [Mash] are randomized 2:1 to receive either 100 mg of Miricorilant twice weekly or placebo for 48 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 is enrolling patients with presumed MASH.
Patients in this cohort will be randomized 2:1 to receive either 100 mg Miricorilant twice weekly for six weeks, followed by 200 mg of Miricorilant twice weekly for 18 weeks or placebo for the whole 24 weeks. In this cohort, the primary endpoint is also a reduction in liver fat.
As I said earlier, this is a truly exciting time at Corcept. We have made substantial progress throughout the company and have established two potent drivers of long-term growth in entirely different areas of medicine, endocrinology and oncology.
Awareness of hypercortisolism's true prevalence continues to grow rapidly. More patients are being identified and treated than ever before. The results of the Catalyst study will undoubtedly stimulate more physicians to screen for hypercortisolism and treat the patients that they identify.
Our new drug application for Relacorilant and hypercortisolism is progressing towards approval by the end of this year.
Relacorilant's strong efficacy and safety profile gives it the potential to become the new standard of care for patients with hypercortisolism. We expect our Cushing's syndrome business to continue growing for years to come.
The positive results of our ROSELLA study opens Corcept's oncology portfolio. The efficacy benefits observed in the context of no increased side effect burden support a successful new drug application for platinum resistant ovarian cancer and create with further study the potential to treat earlier stages of ovarian cancer and other tumors that express the glucocorticoid receptor.
In addition, we continue to explore the potential of cortisol modulation to treat a broad range of diseases, including neurologic diseases like ALS and [hepatic] diseases. We continue to develop and discover proprietary selective [cortisol] modulators with potentially very distinct clinical attributes. We are comprehensively evaluating these attributes in their therapeutic applications and will advance the most promising compounds to the clinic.
Problems caused by excess cortisol activity often have profoundly negative effects on patients. We are dedicated to finding new, more effective, and safer treatments to help them.
Operator, let's proceed now to questions.

Question and Answer Session

Operator

Thank you.
(Operator Instructions)
Edward Nash, Canaccord. Your line is open, Edward.

Hi, thanks guys for taking my question. Wanted to ask, specifically on the oncology program. You have ROSELLA under your belt now, and now you've started BELLA. I just wanted to understand from the treatment paradigm side of things, exactly where would the physicians start to employ and start to use Relacorilant versus say [ELAHERE]? How would that, how does that in any way push [ELAHERE] here forward or back within the treatment paradigm? And then also, could you just give us any clarity or any granularity you have on the feedback you've been getting from oncologists based on the ROSELLA data?

Joseph Belanoff

Yeah, hey Edward, thank you, and that's a great opening question because it gives me a chance to introduce for the first time on this call Roberto Vieira, who is the President of our oncology division. I think he has the answers for both of those questions. Please go ahead, Roberto.

Roberto Vieira

Thank you, Joe. So [Matt], several questions into one there. So as far as our view for Relacorilant , Relacorilant that was poised to become a new standard of care in platinum reducing ovarian cancer.
When you look at the treatment patterns, you see a very fragmented landscape. So most patients have limited options and suffer with very poor outcomes. So we feel confident Relacorilant play another cell sets the foundation for a new standard of care. Now concerning your question about [ELAHERE] and positioning, the results from the ROSELLA trials support Relacorilant as an option in multiple lines of therapy, including before or after a biomarker ridden agent such as [ELAHERE] here.

Great, that's very helpful.
Thank you. And then I just had one additional question that was just in the revenue given that it sounds like March and April, you really think really picked up significantly after the correction was made. Just wanted to understand how that's going to affect the third, the second, third and fourth quarters. Are we going to expect to see a huge [bolus] in the second quarter in revenue and then Things kind of get back down to a normal level or just wanted to better understand how to model for that.

Joseph Belanoff

Yeah, I think we understand the question, and I'm going to Edward, reintroduce you to Sean Maduck, who is the President of our endocrinology vision.

Sean Maduck

Yeah, thanks, Ed. So I'll start by saying that, as I sort of ended my opening remarks on the fundamentals of our business are extremely strong and really strengthened in the fourth quarter of last year into Q1, and we do expect that through the rest of the year and We had a record number of prescribers, prescriptions, and patients on call to end the quarter, and as you know you've seen our first quarter of financial results did not match the strength of the business due to everything I mentioned on the call. But to your question, I mean, we expect the growth to continue through the second quarter and the rest of the year and actually accelerate in the half of the second half of the year given. All the initiatives we have on the commercial side as well as the publication of the full Catalyst data results. So very excited about it and more confident than ever that the market is bigger than we once thought and that we're on track for a range of $900 million to $950 million.

Joseph Belanoff

Edward, to answer your question directly, yeah, we're not expecting an instant [bolus]. We just think that growth will accelerate through the entire year and then into the next year.

Got it. Okay.
That makes sense. Thanks so much for taking the questions and also congratulations on that dazzle overall survival data.

Joseph Belanoff

Thanks Edward. Thanks very much for the questions.

Operator

David Amsellem, Piper Jaffray, please go ahead, David.

Hey, thanks, so, got a Korlym question and then a couple of Relacorilant questions on Korlym. Can you talk about the mix between brand and authorized generic business for Korlym as the year progresses, and I guess is it fair to say that irrespective of that mix between the AG. And the brand, this acceleration and volume growth and this expansion of the market that we're seeing ultimately is what gets you to that $900 million to $950 million. So that's my first question. And then on Relacorilant, just two quick ones, just remind us if you are expecting an ad com going into the December [PDUFA], and are you preparing for one. And then when are we going to hear more about additional solid tumor studies for Relacorilant presumably you're going to look at potentially earlier lines of therapy and ovarian, other solid tumors. When are we going to get more details on your overall solid tumor strategy?
Thank you.

Joseph Belanoff

Thank you, David. And yes, you've give us give us an opportunity for several people to respond to your various questions. So, Sean, why don't you take the first question about Korlym?

Sean Maduck

Yeah, thanks for the question. So, your last statement and the first part of the question on Korlym is exactly it, and that's that we expect that future volume growth will overwhelm any price change that we see, given the mix of products. So, the first part of the question, what's the mix? Of Korlym and our authorized generic, a little over half right now of our product, our patients are on our authorized generic. We expect that that percentage will continue to increase over the course of the year and we factor that into our guides.

Joseph Belanoff

Charlie.

Gary Robb

Yes, we do not expect to have an advisory committee.
Didn't have one for Korlym. The most recently approved drugs in hypercortisolism didn't have them either, and we're not anticipating one here.

Joseph Belanoff

Okay, and Bill, could you please answer the last question about other tumors.

So you know it's really been on our minds for quite some time to look at Relacorilant in combination with any therapy in solid tumors, and it's based upon our phase 1, phase 2, and now with the phase 3 results we have taken something from a concept to a reality, and we're now going to be hopefully rapidly expanding into that. And so, our goal is to really establish Relacorilant as the foundation. Drug to be used in combination with any agent in solid tumors. And so, BELLA is at first foray into that next study in the earlier lines of therapy in combination now with [nab-paclitaxel] and bevacizumab. You'll shortly see later this year and as you had indicated, we're going to go to earlier lines of ovarian cancer and then also expand into other gynecological oncology cancers and then soon after that go into longer term into other solid tumors, so.
You're going to see many new studies coming, but again all geared around Relacorilant is that core molecule in combination with any agent.

Joseph Belanoff

Okay, next question.
Sure, thank you.

Operator

Thank you.
Joon Lee, Truist Securities.

Thanks for the updates and for taking our questions.
Can you help us understand the nature of the corrective measures the pharmacy vendor took to improve operations in March and April, and what, if anything, more needs to be done to for them to be able to meet the demands so you can hit the guidance of $900 million to $950 million and I have a follow-up question.

Joseph Belanoff

Thanks, June, and I'll give you back to Sean to answer your question.

Sean Maduck

Thanks for the question. And again, in case anybody didn't get a chance to listen to the opening remarks, the issue that's being referenced at the pharmacy is really through the fourth quarter of last year through February of this year, there was really a massive prescription volume increase that sort of overwhelmed the pharmacy. So, in general, there were some, I won't go into all the specifics, but There were some staffing issues associated with enough individuals to pull through all the appropriate volume, and because of that, patients' prescriptions weren't filled on time. That has been remedied. It's been staffed up and I'll just point to again having the strongest March 2 of the strongest months, to the two strongest months we've ever had in our history in March and April, and we expect that the pharmacy will continue to scale up with our growth going forward.

And then, with the measures that they're taking to staff up, I mean, would you, would they be able to meet the demand of Relacorilant, which we think could be a much bigger product, and I a follow up last question after that.

Sean Maduck

Yeah, no, it's a great question and something we're exploring. I mean, I'll remind you that the reason we have such a narrow distribution network for Korlym is because the active ingredient in Korlym is mifepristone, and it was originally set up. To make sure there was no product aversion for termination of pregnancy or other uses. Now Relacorilant obviously doesn't have that same issue, and we do expect that the market is potentially much larger. So, there is the potential for a broader distribution network for that product, and that's something that we're actively exploring now.

Right. And last question regarding the ALS, is it your expectation that the existing data may be adequate for some sort of conditional approval, or are you anticipating some sort of additional study to get this [especiallyally] transformative a drug out there.
Thank you.

Joseph Belanoff

Hey Joon, thank you for the question. I'm going to give that to Charlie who runs our regulatory area.

Gary Robb

So, the question with data like this, we confronted the exact same questions and that's why we're going immediately to both the US and European regulators to sort of present them with the plans for further study and see what they think the appropriate. Step is in terms of, moving the drug forward whether that's an accelerated approval or rapid completion of another study or something else. So, I don't want to speak to what the regulators are going to say, but we think these data are obviously promising and worth that discussion. And once we've settled things, we'll let folks know.

Thank you.

Joseph Belanoff

Thank you, Joon.

Operator

Thank you. Our next question comes from the line of RK of H.C. Wainwright. Please go ahead.

Thank you, good afternoon, Joe. A couple of quick questions on Korlym and from me too, so in the opening remarks you said there was a significant increase in scripts that you saw got filled in March and April. I know you won't be able to tell me the exact numbers, but in general, what's a, what is that percentage increase as compared to like January and February. And then, when you say that you know 50% of your patients are moving towards, authorized generics, so yeah, I'm just trying to understand like what's the price differential between the Korlym and authorized generic and the I'm trying to triangulate between that and the and the increase in the scripts to get to, your stated, 30% increase in revenue year over year.

Joseph Belanoff

Yeah, I really do think we understand your question, RK.
Thank you, and I'm going to give you back to Sean to give you a broad answer to that question.

Sean Maduck

Yeah, thanks for the question. So, the first question was just around volume and volume increase. I mean our first quarter enrollments were almost double what they were in the first quarter of last year, and we've seen that continue on. So, a lot of growth driven by more screening. We're starting. See the impact of the catalyst results, and we expect with the publication of the catalyst treatment results in the second half of the year again we expect to see that growth to accelerate. So that's the first question. The second question around the authorized generic as a reminder we price our authorized generic at a 12% discount from quorum but recognized that the pairs negotiate from there as they do with sort of any list price. So. Net price varies by payer and again, the increased erosion that we expect to see over time as well as that price, we expect to be overwhelmed by volume through the course of 2025 and all of that is included in our range.

Joseph Belanoff

Okay, did you have a follow-up question?
Okay, it sounds like we have had a last question, but I would just like to take a minute. I don't do this often, but I think it's just important sort of speaking at this juncture. I have to admit that in the many years that I've run Corcept, I've considered lots of problems and must admit to you that I did not anticipate that our Korlym business would overwhelm our pharmacy vendor. Obviously the pro this problem set of problems had a short-term impact on our revenues, but more important, it delayed drug shipments to patients, which is inexcusable and I guess to some degree for whatever it's worth, I apologize to any patients who were you know terribly inconvenienced by this.
As Sean stated, the problem appears resolved. March and April were very strong months, and I have to now tell you, of course, as a result, we're intensely vigilant that this problem did not arise again. But I really want to focus you on three things which I think are real shifts in what's going on at Corcept.
It's now certain that there are many more patients with hypercortisolism than have been assumed in some sense all of its study. We weren't the first people to look at this, but the catalyst study definitively said that there just are many more patients who have the potential to be screened and then found and treated. And I really actually suggest to you that you read the paper in diabetes care. It's very accessible, plainly written, and will really describe in all the detail you need why the fact that hypercortisolism was underrepresented before is not going to be true for much longer.
The second thing is that for many years the only molecule to approach glucocorticoid receptor antagonism, cortisol modulation in this way was Korlym mifepristone, and now we can unequivocally say that we have follow-on molecules which are more specific, starting with Relacorilant, more selective, have a much better side effect profile, and give us an opportunity to really look at more places where they can be useful clinically. And that really dovetails with the third point I want to make. ROSELLA unequivocally shows that cortisol modulation has utility outside of your basic Cushing's syndrome patients. It clearly worked in a very difficult group of patients with platinum resistant ovarian cancer. And I think it gives you good reason to think that it's going to work in a much wider range of cancers, both earlier in ovarian cancer and in other tumors where the glucocorticoid receptor is represented.
And so I really want you to start to think about Corcept as a company with a very broad medicinal platform.
Tumors, sorry, hormones go everywhere. And all of you are familiar with the broad amount of work which are being done with another hormone, GOP 1. My own opinion is that when the field is fully mined for the benefits of hypercortisolism, you will see that kind of reach and breath. So, thank you for all listening today, and I will see you next quarter.
Thank you. Bye.

Operator

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