Corcept Therapeutics Q1 2025 Earnings Call Transcript

Quartr
Provided by Quartr
May 5, 2025

There are 10 speakers on the call.

Operator

Thank you for standing by and welcome to Corcept Therapeutics First Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. After the speaker presentation, there will be a question and answer session. To a question during the session, will need to press 11 on your telephone. To remove yourself from the queue, you may press 11 again.

Operator

I would now like to hand the call over to Atabak Makari, CFO. Please go ahead.

Speaker 1

Hello, everyone. Good afternoon, and thank you for joining us. Today, we issued a press release announcing our financial results for the first quarter and providing a corporate update. A copy is available at corcept.com. Our complete financial results will be available when we file our Form 10 Q with the SEC.

Speaker 1

Today's call is being recorded. A replay will be available at the Investors Past Events tab of our website. Statements during this call other than statements of historical fact are forward looking statements based on our plans and expectations that are subject to risks and uncertainties, which might cause actual results to be materially different than those such statements express or imply. The risks and uncertainties that may affect our forward looking 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.

Speaker 1

We disclaim any intention or duty to update forward looking statements. Our revenue in the first quarter of twenty twenty five was $157,200,000 compared to $146,800,000 in the first quarter of last year. We are reiterating our 2025 revenue guidance of $900,000,000 to $950,000,000 Net income was $20,500,000 in the first quarter of twenty twenty five compared to $27,800,000 in the first quarter of last year. Our cash and investments at March 31 were $570,800,000 We acquired $43,000,000 of our common stock in the first quarter of twenty twenty five pursuant to our stock repurchase program, the net exercise of stock options by Corcept employees and the net vesting of restricted stock. I will now turn the call over to Sean Madook, President of our Endocrinology Division.

Speaker 1

Sean?

Speaker 2

Thank you, Atabak. We are on the cusp of a new diagnosis and treatment paradigm for patients with hypercortisolism. For many years, most physicians reserved both screening and treatment for the most physically obvious cases of hypercortisolism. Over the last fifteen years, published data has supported the identification and the treatment across a broader spectrum of disease. Screening for hypercortisolism has increased and is driving rapid patient growth in our business.

Speaker 2

I am certain that this increase in screening is just beginning. I've never been more confident in both our current and future growth prospects, and most important, our potential to help many, many patients for years to come. We now know that patients with hypercortisolism exist in every medical practice. More and more physicians are starting to recognize that too. To put this in perspective, our new prescriber base has grown at a record rate for five straight quarters, and the number of colon prescriptions in the first quarter of this year was almost double what we saw in the same period last year.

Speaker 2

Both our prescriber base and our patient base are growing rapidly and we expect growth to accelerate. In 2023 and 2024, we amplified our efforts to educate physicians about hypercortisolism and Korlym. We also increased the size of our sales force. We will continue to grow that team to reach and serve all our potential customers. We currently have 125 clinical specialists, up from 60 at the beginning of 2024, and our plan is to have 175 in place before year end in preparation for relacorilant's launch.

Speaker 2

In 2024, we also introduced our first direct to patient disease awareness education campaign, in an effort to arm patients with the knowledge that they need to discuss hypercortisolism with their physician. Finally, the results of our CATALYST study are very powerful. The study unequivocally shows that one in four patients with difficult to control diabetes have hypercortisolism, and that treatment with a cortisol modulator dramatically improves their hyperglycemia, even though all the current medications, including Ozempic and Mounjaro, have not. Our Q1 financial results do not reflect the tremendous patient growth our business is experiencing or what we expect for the rest of this year. Our first quarter results, specifically in January and February, were affected by insufficient capacity at our pharmacy vendor.

Speaker 2

As I said on our last call, the rapid growth in our business in the second half of twenty twenty four overwhelmed the pharmacy's operational capabilities, and these challenges persisted into this year. That said, we have seen a substantial improvement in pharmacy operations in March and April. This has translated to a record number of tablets dispensed in March and April. Our first quarter results were also affected by a greater portion of our business transitioning from branded Korlym to our authorized generic, which has a lower net price. As a result, our average price per tablet decreased by 13% relative to the prior year.

Speaker 2

We expect that the transition to authorized generic tablets will continue to grow this year, but that this decrement in price will be overwhelmed by an increase in the number of tablets shipped. Please let me emphasize that all factors, including pharmacy operations and pricing impact from our authorized generic, are factored into our 2025 revenue guidance. I will end where I began. I have never been more confident in both our current and future commercial growth, and most important, our potential to help many more patients. Korlym is a great medication, but relacorilant is even better.

Speaker 2

It will be a great option for both prescribers and patients, and I expect that our patient numbers will accelerate when it emerges. I believe that in the next three to five years, relacorilant will generate 3,000,000,000 to $5,000,000,000 in annual revenue in hypercortisolism alone. I will now turn the call over to Charlie Robb, our Chief Business Officer. Charlie?

Speaker 3

Thanks, Sean. As was true last quarter, there's not much to report regarding our patent litigation with Teva. In December of twenty twenty three, 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.

Speaker 3

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.

Speaker 3

If we prevail, Teva will lose FDA approval of its product until 02/1937 when the patents we have asserted against Teva in this lawsuit expire. I will now turn the call over to Joe Belinoff, our Chief Executive Officer. Joe?

Speaker 4

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 in hypercortisolism is based on positive results from our pivotal Phase III GRACE trial and is supported by the results from our GRADIENT, long term extension and Phase two trials.

Speaker 4

It is currently under review with an FDA action date of 12/30/2025. 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.

Speaker 4

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 relacorilant 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.

Speaker 4

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 two diabetes. The prevalence phase of the study found that one in four patients with difficult to control type two 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.

Speaker 4

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 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-one agonist. 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.

Speaker 4

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.

Speaker 4

The success of our pivotal ROSELA 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 ROZELLA, three eighty one 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 resensitize ovarian tumors to the effects of nab paclitaxel by blunting the anti apoptotic effect of cortisol activity. The ROZELLA trial met its primary endpoint of improved progression free survival as assessed by blinded independent central review.

Speaker 4

Patients treated with relacorilant in addition to nab paclitaxel chemotherapy experienced a thirty percent reduction in risk of disease progression compared to patients treated with nab paclitaxel alone with a hazard ratio of 0.7 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 overall survival of sixteen months compared to eleven point five 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. ROSELA clearly confirmed the positive efficacy and safety results that we saw in our Phase II study.

Speaker 4

The full results of the ROCCELLA 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 in 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 standalone 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 ROSELA 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.

Speaker 4

We will then explore relacorilant's use to help treat earlier stages of ovarian cancer and other solid tumors that express the glucocorticoid receptor. In addition to exploring cortisol modulations potential to resensitize tumors to chemotherapy, we are evaluating its potential use in combination with androgen deprivation therapy in prostate cancer. Cortisol stimulation is a major reason why patients with prostate cancer treated with the widely prescribed androgen receptor antagonist enzalutamide eventually experience resurgent disease. Deprived of androgen stimulation, their tumors switch to cortisol activity to stimulate growth. Leading academic researchers and clinicians hypothesize that cortisol modulation can block this tumor escape route.

Speaker 4

Our collaborators at the University of Chicago are currently enrolling a randomized placebo controlled Phase II 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 Ib trial in advanced adrenal cancer, we are deciding how best to investigate the utility of our compounds in combination with immunotherapies in other tumor types and earlier stages of cancer.

Speaker 4

One of our proprietary compounds, dazicorilant, 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 neuroinflammation and muscular atrophy in a commonly used mouse model of ALS, we conducted a two forty nine patient randomized double blind placebo controlled Phase II trial of dazicorilant in that dire disease. Unfortunately, patients who received dazicorilant did not show improvement in the ALS 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 three hundred milligrams of dazequivalent at the start of the study with significantly longer than patients who were randomized to placebo and then did not switch to dazicorilant in the long term extension study, with a hazard ratio of 0.16, a p value of 0.0009.

Speaker 4

We will immediately seek input from U. S. And European regulatory authorities on the next steps for this program. MAH, metabolic dysfunction associated with steatohepatitis, is a serious liver disorder that afflicts millions of patients in The United States and many millions outside of 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.

Speaker 4

One of our proprietary molecules, miricorilant, has very potent activity in the liver. Our Phase Ib dose finding study of miricorilant found that patients who received one hundred milligrams orally just twice a week for twelve 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. Miracorilant was also very well tolerated with none of the GI side effects which commonly arise in patients being treated for NASH. Our randomized double blind placebo controlled Phase IIb MONARCH study aims to expand on our encouraging Phase Ib results. Monarch is enrolling two cohorts.

Speaker 4

In the first, patients with biopsy confirmed NASH are randomized two:one to receive either one hundred milligrams of miricorilant twice weekly or placebo for forty eight weeks. The primary endpoint for this cohort is reduction in liver fat with biopsy confirmed NASH resolution and fibrosis improvement as key secondary endpoints. The second cohort is enrolling patients with presumed NASH. Patients in this cohort will be randomized two: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.

Speaker 4

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.

Speaker 4

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 us the potential to become the new standard of care for patients with hypercortisolism. We expect our Cushing syndrome business to continue growing for years to come. The positive results of our ROSELA 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.

Speaker 4

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 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 to help them.

Speaker 4

Operator, let's proceed now to questions.

Operator

Thank you. Our first question comes from the line of Edward Nash of Canaccord. Your line is open, Edward.

Speaker 5

Hi, thanks guys for taking my question. 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 Elijer? How does that in any way push Elijer forward or back within the treatment paradigm?

Speaker 5

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 ROSELA data?

Speaker 4

Yes. 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.

Speaker 2

Thank you, Joe. So, Matt, several questions into one there. So as far as our view for relacorilant. Relacorilant plus nabupac TAC cell is poised to become a new standard of care in platinum resistant ovarian cancer. When you look at the treatment patterns, you see a very fragmented landscape.

Speaker 2

So most patients have limited options and suffer with very poor outcomes. So we feel confident relacorilant plus nadupaclitaxel sets the foundation for a new standard of care. Now concerning your question about ELAHERE and positioning, the results from the ROSELLA trial support relacorilant as an option in multiple lines of therapy, including before or after a biomarker driven agent such as ELAHERE.

Speaker 5

Great. That's very helpful. Thank you. And then I just had one additional question that was just on the revenue. Given that it sounds like March and April, really things really picked up significantly after the correction was made.

Speaker 5

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 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?

Speaker 4

Yes, I think we understand the question, and I'm going to, Edward, reintroduce you to Sean Madook, who is the President of our Endocrinology Division.

Speaker 2

Yes, 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. Had a record number of prescribers, prescriptions and patients on Korlym to end the quarter. As you've seen, our first quarter financial results did not match the strength of the business due to everything I mentioned on the call. But to your question, I mean, expect the growth to continue through the second quarter and the rest of the year and actually accelerate in 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.

Speaker 2

So very excited about it and more confident than ever that the market is a, bigger than we once thought and that we're on track for a range of 900,000,000 to $950,000,000

Speaker 4

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

Speaker 5

Got it. Okay, that makes sense. Thanks so much for taking the questions and also congratulations on that DAZZLE's overall survival data. Thanks, Edward. Thanks very much for the questions.

Operator

Thank you. Our next question comes from the line of David Amsellem of Piper Jaffray. Please go ahead, David.

Speaker 6

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 in volume growth and this expansion of the market that we've seen ultimately is what gets you to that 900,000,000 to $950,000,000 So that's my first question. And then on relacorilant, just two quick ones.

Speaker 6

Just remind us if you are expecting an AdCom 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 in ovarian, other solid tumors. When are we going to get more details on your overall solid tumor strategy?

Speaker 6

Thank you.

Speaker 4

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

Speaker 2

Yes, thanks for the question. Your last statement and the first part of the question on Korlym is exactly it, that's that we expect that future volume growth will overwhelm any price change that we see, given the mix of products. 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 guidance.

Speaker 2

Charlie?

Speaker 3

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.

Speaker 4

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

Speaker 2

Sure, future

Speaker 7

studies. So it's really been on our mind for quite some time to look at relacorilant in combination with any therapy in solid tumors. And it's based upon our Phase I, Phase II, and now with the Phase III 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 foundational drug to be used in combination with any agent in solid tumors.

Speaker 7

And so BELLA is that first foray into that next study in the earlier lines of therapy in combination now with NaPaq 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.

Speaker 4

Okay. Next question, please. Sure. Thank you.

Operator

Thank you. Our next question comes from the line of June Lee of Truist Securities. Please go ahead, June.

Speaker 8

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 free for them to be able to meet the demand, so you can hit the guidance of 900,000,000 to $950,000,000 And I have a follow-up question.

Speaker 4

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

Speaker 2

Thanks for the question. 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 overwhelmed the pharmacy. 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. Because of that, patients' prescriptions weren't filled, on time. That has been remedied.

Speaker 2

It's been staffed up. And I'll just point to, again, having the strongest March 2 of the strongest months 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.

Speaker 8

And then with the measures they're taking to step up, I mean, they be able to meet the demand of REL or Korlym, which we think could be a much bigger product? And I have

Speaker 4

a follow-up. Last question after that.

Speaker 2

Yeah, no, that's 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 diversion 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.

Speaker 8

Great. 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 in some sort of additional study to get this partially transformative drug out there? Thank you.

Speaker 4

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

Speaker 3

So the question is with data like this, we've 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 plans for further study and see what they think the appropriate next 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.

Speaker 8

Thank you.

Speaker 4

Thank you, June.

Operator

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

Speaker 9

Thank you. Good afternoon, Joe. A couple of quick questions on Korlym from from me too. Please. So so in the opening remarks, you said there was a significant increase in scripts that you saw were filled in March and April.

Speaker 9

I know you won't be able to tell me the exact numbers, but, you know, in general, what's a you know, 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, you know, I'm just trying to understand, like, what's the price differential between the Korlym and authorized generic? And and the I'm trying to triangulate between that and the and the increase in the scripts to get to, you know, your stated, you know, 30 some percent increase in revenue year over year.

Speaker 4

Yes, 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.

Speaker 2

Yes, thanks for the question. So the first question was just around volume and volume increase. Our first quarter enrollments were almost double what they were in the first quarter of last year. And we've seen that continue on. A lot of growth driven by more screening.

Speaker 2

We're starting to 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 priced our authorized generic at a 12% discount from Korlym, but recognize that payers negotiate from there as they do with sort of any list price. So net price varies by payer.

Speaker 2

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.

Speaker 4

RK, did you have a follow-up question? Okay. It sounds like we have had our 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.

Speaker 4

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, 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 really terribly inconvenienced by this. As Sean stated, the problem appears resolved.

Speaker 4

March and April were very strong months. And I have to now tell you, of course, a result, we're intensely vigilant that this problem did not arise again. But I really wanna 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 for, 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.

Speaker 4

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 hypercorticism was underrepresented before is not gonna 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.

Speaker 4

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. Tumor's, sorry, hormones go everywhere.

Speaker 4

And all of you are familiar with the broad amount of work which are being done with another hormone GLP-one. My own opinion is that when the field is fully mined for the benefits of hypercortisolism, you will see that kind of breach and breadth. So thank you for all listening today and I will see you next quarter. Thank you. Bye bye.

Operator

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

Powered by Quartr
Earnings Conference Call
Corcept Therapeutics Q1 2025
00:00 / 00:00