Q1 2025 Corcept Therapeutics Inc Earnings Call
Speaker Change: Thank you for standing by, and welcome to Corcept Therapeutics First Quarter, 2025 Earnings Conference Call.
Speaker Change: At this time all participants are in a listen only mode. After the speaker presentation there will be a question and answer session.
Speaker Change: To ask a question during the session, you will need to press star 1-1 on your telephone to remove yourself from the key you may press star 1-1 again. I would now like to hand the call over to Atabak Mokari, CFO . Please, go ahead.
Hello everyone, good afternoon and thank you for joining us.
Speaker Change: Today we issued a press release announcing our financial results for the first quarter and providing a corporate update. The copy is available at Courset.com.
Speaker Change: Our complete financial results will be available when we file our form 10Q with FCC. Today's call is being recorded. A replay will be available at the Investors' Past Events tab of our website.
Speaker Change: Statements during this call other than statements of historical fact are forward looking statements based on our plans and expectations that are subject to risk and uncertainties which might cause actual results to be materially different than those statements expressed or implied.
Speaker Change: The risks and uncertainties that may affect our forward-looking statements are described in our annual report on Form 10K and our quarterly reports on Form 10Q, all of which are available at SCC's website. Please refer to those documents for additional information. We disclaim any intention or duty to update forward-looking statements.
Speaker Change: Our revenue in the first quarter of 2025 was $157.2 million compared to $146.8 million in the first quarter of last year. We are reiterating our 2025 revenue guidance of $900 to $950 million.
Speaker Change: Net income was $20.5 million in the first quarter of 2025 compared to $27.8 million in the first quarter of last year.
Our cash and investments at March 31st were $570.8 million.
Speaker Change: We acquired $43 million of our common stock in the first quarter of 2025, pursuant to our stock refurbished program, the net exercise is stock options by course up employees, and
Speaker Change: We'll now turn the call over to Sean Maduck, President of our Ender Chronology Division. Sean? Thank you, Atabak. We are on the cusp of a new diagnosis and treatment paradigm for patients with type of cortisolism. For many years, most physicians reserve both screening and treatment for the most physically obvious cases of type of cortisolism.
Speaker Change: Over the last 15 years, published data supported the identification and the treatment across a broader spectrum of disease.
Speaker Change: Screening for Heproportosolism is increased and is driving rapid patient growth in our business. I'm certain that this is, that this increase is, in screening is just beginning.
Speaker Change: I've never been more confident in both our current and future growth prospects, and most important are potential to help many, many patients for years to come.
Speaker Change: We now know that patients with hypercorders all of them exist in every medical practice. More and more physicians are starting to recognize that too.
Speaker Change: To put this in perspective, our new prescriber base has grown at a record rate for five straight quarters and the number of quarter of this year was almost double what we saw in the same period last year.
Speaker Change: Both our prescriber base and our patient base are growing rapidly and we expect growth to accelerate.
Speaker Change: In 2023 and 2024, we amplified our efforts to educate physicians about hypercortisolism and corollum. We also increased the size of our sales force, and we will continue to grow that team to reach and serve all our potential customers.
Speaker Change: We currently have 125 clinical specialists, up from 60 at the beginning of 2024, and our plan is to have 175 in place before your end in preparation for relic Orleans launch.
Speaker Change: 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 hypercordalism with their physician.
Speaker Change: 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 hypercordosolism.
Speaker Change: In that treatment with a cortisol modulator dramatically improves their hyperblicemia, even all the current medications including ozempic and manjaro have not.
Speaker Change: Our Q1 financial results do not reflect the tremendous patient growth or business as experiencing, or what we expect for the rest of this year.
Speaker Change: Our first quarter results, specifically in January and February , were affected by insufficient capacity at a pharmacy vendor.
Speaker Change: As I said on our last call, the rapid growth in our business in the second half of 2024 overwhelmed the pharmacy's operational capabilities and these challenges persisted into this year.
Speaker Change: This is translated to a record number of tablets dispensed in March and April .
Speaker Change: Our first quarter results were also affected by a greater portion of our business transitioning from branded Coralum to our authorized generic, which has a lower net price.
Speaker Change: As a result, our average price per tablet decreased by 13% relative to the prior year. 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
Speaker Change: Please let me emphasize that all factors, including pharmacy operations and pricing impact from our authorized generic are factored into our 2025 revenue guides.
I will end where I began.
Speaker Change: I've never been more confident in both our current and future commercial growth and most important are potential to help many more patients.
Speaker Change: Coralum is a great medication, but Rela Coralum is even better. 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, Rela Coralum will generate three to five billion in annual revenue in hypercortisolism alone.
Speaker Change: I will now turn the call over to Charlie Robb, our Chief Business Officer, Charlie. Thanks, Sean.
Charlie Robb: As was true last quarter, there's not much to report regarding our patent litigation with
Charlie Robb: In December of 2023, the trial court ruled against us in our lawsuit to stop Teva from marketing a generic version of Coralem and violation of our patents. We've appealed that decision to the Federal Circuit Court of Appeals, briefing is complete.
Charlie Robb: For anyone interested, the documents are available at the government's pace or website.
Charlie Robb: The Federal Circuit has still not scheduled oral arguments. The earliest clause will date for which is now July . The decision is from three or four months after that.
Charlie Robb: 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.
Charlie Robb: I will now turn the call over to Joe Bellanoff, our chief executive officer. Joe.
Joe Belanoff: Thank you, Charlie, and thank you everyone for joining us this afternoon. This is a very exciting time at Corcept.
Joe Belanoff: 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.
Joe Belanoff: Our new drug application for relic quarrelment and hypercordisolism 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 II trials.
Joe Belanoff: It is currently under review with an FDA action date of December 30, 2025.
Joe Belanoff: Patients treated with ombrella chloralent in these studies experienced clinically meaningful and statistically significant improvements across all of the signs and symptoms of hyperchlorosolism.
Joe Belanoff: In hypertension, hypoglycemia, weight, lean muscle mass, waist circumference, cognition, kitchens quality of life score, and other important clinical measures.
Joe Belanoff: There was a high level of consistency and durability of therapeutic benefit across our studies.
Joe Belanoff: In each of them, patients exhibited rapid improvements at the start of Brello Coral and Therapy and these improvements were maintained or continued to improve throughout the course of treatment.
Joe Belanoff: including in a long-term extension study where some patients have received relic to Coralent for more than six years.
Just as important as Relo-Coralance Advocacy, is its safety.
Robocorn has been well tolerated in all of its studies.
Joe Belanoff: 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.
Joe Belanoff: As expected, there have been no relic warrant induced instances of hypokalemia, endometrial hypertrophy, or drug induced vaginal bleeding, no cases of adrenal insufficiency, and no instances of cutie prolongation.
Joe Belanoff: These adverse events can have serious health consequences. Each of the currently available medications for patients with Cushing Syndrome can cause one or more of them.
Joe Belanoff: As we advance Reloq Coralent, we continue to work at increasing position awareness and understanding of hypercordisolism.
Joe Belanoff: Our catalyst study was the largest and most rigorous trial ever conducted to assess the prevalence and treatment of hypercorrosolism in patients with difficult to control type 2 diabetes.
Joe Belanoff: The prevalent phase of the study found that one in four patients with difficulty control type two diabetes has hypercourt assault.
A far higher rate than was assumed.
Joe Belanoff: These results were published last month in diabetes care, a peer-reviewed journal of the American Diabetes Association.
Joe Belanoff: The results from the treatment phase of the catalyst study were equally striking.
Joe Belanoff: Patients who received Coralum 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 0.001. [inaudible]
Joe Belanoff: 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 agonist.
Joe Belanoff: 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.
Joe Belanoff: A rapidly increasing number of physicians now know that hyper cortisolism is much more prevalent than was previously assumed.
Joe Belanoff: 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 hypercorrosolism.
Joe Belanoff: Many more patients with hypercorticism than are currently identified will be found. Corcept is well positioned to help them.
Joe Belanoff: As Sean said earlier, we are confident that our Cushing Syndrome business will continue to grow for years.
Thank you.
Joe Belanoff: 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.
Joe Belanoff: 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.
Joe Belanoff: In Rosella, 381 women with platinum-resistant ovarian cancer were randomized one-to-one to receive either napackletaxle, probably the most effective chemotherapy currently prescribed to women with platinum-resistant disease, or napackletaxle plus relicoralint.
Joe Belanoff: For these patients, Nat Pakletaxel, or any chemotherapies, have become much less useful than earlier in their course of treatment.
Joe Belanoff: We expected that Rela Corla would resensitize ovarian tumors to the effects of napackletaxle.
by blunting the anti-apoptotic effect of cortisol activity.
Joe Belanoff: The Rosela trial met its primary endpoint of improved progression-free survival as assessed by Blinded Independent Central Review.
Patients were treated with relic coerulent in addition to napackletaxal chemotherapy.
Joe Belanoff: Experience a 30% reduction in risk of disease progression compared to patients treated with Napakletaxle alone, with a hazard ratio of 0.70 and a p-value of 0.008.
Joe Belanoff: In the interim evaluation of overall survival, patients treated with revochorol and plus napakletaxel should a large improvement with a median overall survival of 16 months compared to 11.5 months in patients receiving napakletaxel alone.
Hazard Ratio was 0.69 with a p-value of 0.01.
Safety and tolerability were comparable in the two groups.
Joe Belanoff: Rosella clearly confirmed the positive efficacy and safety results that we saw in our Phase 2 study.
Joe Belanoff: The full results of the Resella study will present at an oral, late-breaker session at the American Society of Clinical Oncology's Annual Meeting next month.
Joe Belanoff: We expect to submit Relic Laurelant's NDA and platinum-resistant ovarian cancer next quarter, and a marketing authorization application in Europe shortly thereafter.
Joe Belanoff: In anticipation of a successful regulatory outcome, we've been building a standalone oncology division.
Joe Belanoff: We are fully prepared to move swiftly to bring Reload Coralant, plus Napaak LaTaxial to the woman who can benefit from it once it is approved.
Joe Belanoff: We expect to expand the findings from Rosella with a recently initiated Bela study, which will examine whether Relo Coralant with two medications, NAPAClet Axel and Devices Amab, will offer patients with platinum-resistant ovarian cancer and additional effective treatment
Joe Belanoff: We will then explore relic correlants used to help treat earlier stages of ovarian cancer and other solid tumors that express the glucocorticoid receptor.
Joe Belanoff: In addition to exploring cortisol modulation's potential to resensitize tumors to chemotherapy, we are evaluating its potential use in combination with Androgen Deprivation Therapy and Prostate Cancer.
Joe Belanoff: Leading academic researchers and clinicians hypothesized that cortisol modulation can block this tumor escape route
Joe Belanoff: Our collaborators at the University of Chicago are currently enrolling a randomized placebo controlled Phase II trial of relicoraland plus insoludomide in patients with early stage prostate cancer before these patients have had an initial prostatectomy.
Joe Belanoff: 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.
Joe Belanoff: Adding a cortisol modulator to immunotherapies such as checkpoint inhibitors may enhance their effectiveness.
Joe Belanoff: One of our proprietary compounds, Dasukurland, readily crosses the blood brain barrier, and is a candidate for the treatment of neurologic disorders.
Joe Belanoff: 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 control phase 2 trial of DASO Coralant in that dire disease.
Joe Belanoff: Unfortunately, patients who received as a quarrelant did not show improvement in the ALS functioning functional rating scale revised the study's primary end point.
Joe Belanoff: However, an improvement in overall survival, first seen at the 6th month mark, was also observed at year 1 of the study. An exploratory analysis showed that patients who were randomized to 300 milligrams of DAS equivalent at the start of the study.
Joe Belanoff: With significantly longer than patients who are randomized to placebo and then did not switch to DASA Coral in the long-term extension study.
With a hazard ratio of 0.16, a p-value of 0.009.
Joe Belanoff: We will immediately seek input from US and European regulatory authorities on the next steps for this program.
Joe Belanoff: Mash, Metabolic Disfunction, Associated Seattle Hepatitis, is a serious liver disorder that afflicts millions of patients in the United States and many millions outside the United States.
Joe Belanoff: Cortisol activity plays a role in both the initial development and progression of the disease, and Cortisol modulation may serve as a treatment.
Joe Belanoff: The Genobar proprietary molecule's Miracle Oralent has very potent activity in the liver. Our phase 1B dose-finding study of Miracle Oralent found the patient to receive 100 milligrams orelay just twice a week for 12 weeks.
Joe Belanoff: Experience 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.
Joe Belanoff: A randomized double blind placebo controlled phase 2B Monarch study aims to expand on our encouraging phase 1B results.
Monarch is enrolling two cohorts.
Joe Belanoff: In the first, patients with biopsy confirm ash are randomized 2-to-1 to receive either 100 milligrams of Miracle Island twice weekly or placebo for 48 weeks.
Joe Belanoff: The primary endpoint for this cohort is reduction in the liver fat, with biopsy confirmed or mass resolution and fibrosis improvement as key secondary endpoints.
The second cohort is enrolling patients with presumed mass David Amsellem, David Amsellem, David Amsellem,
Joe Belanoff: Patients in this cohort will be randomized 2-to-1 to receive either 100 milligrams Miracurlan twice weekly for six weeks, followed by 200 milligrams of Miracurlan twice weekly for 18 weeks, or placebo for the whole 24 weeks.
Joe Belanoff: In this cohort, the primary endpoint is also reduction in liver fat.
Joe Belanoff: As I said earlier, this is a truly exciting time at courtship.
Joe Belanoff: 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 troop prevalence continues to grow rapidly.
Joe Belanoff: More patients are being identified and treated than ever before. The results of the catalyst study will undoubtedly stimulate more physicians, screening for hypercorrosolism, and treat the patients if they identify.
Joe Belanoff: Our new drug application for relicoral and hypercorrhizalism is progressing towards approval by the end of this year.
Joe Belanoff: Relo-Coreland's strong efficacy and safety profile gives it the potential to become the new standard of care for patients with hyperchorusolism. We expect our Cushing Syndrome business to continue growing for years to come.
Joe Belanoff: The positive results of our Rosella study opens Corcept's oncology portfolio.
Joe Belanoff: The efficacy benefits observed in the context of no increased side of that burden.
Joe Belanoff: 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.
Joe Belanoff: 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.
Joe Belanoff: We continue to develop and discover proprietary selective cortisol modulators with potentially very distinct clinical attributes.
Joe Belanoff: We are comprehensively evaluating these attributes in their therapeutic applications and will advance the most promising compounds to the click.
Joe Belanoff: 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.
Operator, let's proceed now to questions.
Speaker Change: Thank you. As a reminder to ask a question, you will need to press star 11 on your telephone. To remove yourself from the queue, you may press star 11 again. Please stand by while we compile the Q&A roster.
Our first question.
Speaker Change: comes from the line of the Edward Nash of Canacord. Your line is open Edward.
Edward NASH: 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.
Edward NASH: Paradigm, Side of Things. Exactly where would the physicians start to employ and start to use Rola Coralant versus St. Ellie here. How would that, how does that in any way...
Edward NASH: Push Ella 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 oncologist based on the Rosela data? Yeah.
Edward NASH: Yeah, A. Edward, thank you, and that's a great opening question because it gives me a chance to introduce it for the first time on this call. Roberto Riera, 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 now, I have several questions into one there. So as far as our view for Relaqor Land. Relaqor Land, please double the tactics that was forced to become a new standard of care and back from resistance of air and cancer.
Speaker Change: When you look at the treatment parents, you see a very fragmentary landscape.
Speaker Change: So, most patients have limited options and suffer with very poor outcomes [inaudible]
Speaker Change: So we feel confident, Rela-Coreyland, please other Pactaxel sets the foundation for a new standard of care.
Speaker Change: Now, concerning your question about Ella here and positioning, the results from the Rosella Trials support reliquar land as an option in multiple lines of therapy, including before or after, a biomarker driven agent such as Ella here.
That's very helpful. Thank you. And then…
Speaker Change: I just had one additional question. That was just in the revenue. Given that it sounds like March and April , you really picked up significantly after the correction was made, just wanted to understand how that's going to affect.
Gary Robb
Speaker Change: Yeah, I think we understand the question and I'm going to reintroduce you to Sean Maduck who is the president of our endocrinology vision. Yeah, thanks Ed. So I'll start by saying 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 Corlan to end the quarter and as you've seen our first quarter.
Speaker Change: The financial results did not match the strength of the business. I do do everything I mentioned in the call but...
Speaker Change: 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
Speaker Change: 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 a bigger than what we once thought, and that we're on track for a range of 900 to 950.
Speaker Change: We're not expecting an instant bolus. We just think the growth will accelerate through the entire year and then into the next year.
Speaker Change: Got it. Okay, that makes sense. Thanks so much for taking your questions and also congratulations on that dazzle's overall survival data.
Thanks, Edward. Thanks very much for the questions.
David Amsellem, Matthew Kaplan,
Speaker Change: Thank you. Our next question comes from the line of David Amsellem, Piper Jeffrey. Please go ahead, David.
Speaker Change: Hey, thanks. So, I've got a Corlem question and then a couple of Rilla Corlin.
Speaker Change: Questions on Corlam. Can you talk about the mix between brand and authorized generic business?
for Corlam as the year progresses, and I guess.
Is it fair to say that...
Irrespective of that mix.
Speaker Change: 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 to $950 million. So that's that's my first question. And then on.
Relic Horlant: Relicorland, just two quick ones. Just remind us if you are expecting an adcom.
Relic Horlant: going into the December of Padufa, and are you preparing for one?
And then when are we going to hear more about
Relic Horlant: Additional Salatuma Studies for Rela Corland. Presumably, you're going to look at potentially earlier lines of therapy in Ovarian, other Salatumers. When are we going to get more details on your overall Salatuma strategy? Thank you.
Speaker Change: Okay, thank you, David. And yes, you've given us an opportunity for several people to respond to your various questions. So, Sean, why don't you take the first question about Coral?
Sean: Yeah, thanks for the question. So your last statement in the first part of the question on Coralem is exactly yet. And that's that we expect that future volume growth will overwhelm any price change that we see given given the mix of products. So the first part of the question, what's the mix?
Sean: of Corlum 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.
Charlie?
Charlie Robb: Yes, we do not expect to have an advisory committee, didn't have one for Corlam, most recently approved drugs, and of course, all of them didn't have them either, and we're not anticipating one here.
Speaker Change: Okay, and Bill, could you please answer the last question about the other two? Sure, future study. So, you know, it's really been on our mind for quite some time to look at Relic Orleans Inc. in combination with any therapy.
Speaker Change: in Solid Tumors. And space upon our phase one, phase two, and now with the phase three results, we've 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 Rela Coralent as the foundational drug to be used in combination with any agent in Solid Tumors.
Speaker Change: And so, Bel is that first foray into that next study in the earlier lines of therapy and combination, now with Nebapak and Bevisizumab.
Speaker Change: You'll shortly see later this year, and as you indicated, we're going to go to earlier lines with a variant cancer and then also expand the other gynecological oncology cancer.
Speaker Change: and then soon after that go into longer term into other solitumors. So, you're going to see, you know, many new studies coming, but again, all geared around relic
Okay, next question.
Sure. Thank you.
Thank you, our next question.
Speaker Change: Come from the line of Joon Lee, of truest securities. Please go ahead, Joon.
Thanks for the updates and for taking our questions.
June Lee: Can you help us understand the nature of the corrective measures, the pharmacy vendor to improve operations in March and April , and what is anything more needs be done for them to be able to meet the demand, so you can hit the guidance of 900 managers and 50 million, and I have a follow-up question.
June Lee: Thanks for the question. And again, in case anybody didn't get a chance too.
Overwhelmed the Pharmacy So,
June Lee: In general, there were some, I won't go into all those 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, been stepped up. And I'll just point to, again, having the strongest march to the strongest month, 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.
Speaker Change: And then, you know, with the measure set that they're taking to staff up, I mean, would you, would they be able to meet the demand of Reloq Orlan, which we think could be a much bigger product, and have a follow-up last question, pass it back.
Speaker Change: Yeah, no, that'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 Coralomis because the active ingredient in Coralomis is Mifapristone, and it was originally set up.
Speaker Change: to make sure there was no product diversion for termination of pregnancy or other uses. Now, Ralakorlan 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 Change: 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 some sort of an additional study to get this?
especially transformative disease drug out there. Thank you.
Speaker Change: Hey, Joon, thank you for the question. I'm going to give that to Charlie who runs our regulatory area.
So that...
Speaker Change: See what they think the appropriate next step is in terms of moving the drug forward, whether that's an accelerated approval or a rapid completion of another study or something else.
Speaker Change: to what the regulators are going to say. But we think these data are obviously promising and worth that discussion. And once we've subtle things, we'll let folks know.
Thank you.
Speaker Change: Thank you, Jim. Thank you. Our next question comes from the line of R.K. of AC Wayne Wright. Please go ahead.
Speaker Change: Thank you. Good afternoon, Jo. A couple of quick questions on Corlyn from me too.
Speaker Change: You know, a significant increase in scripts that you saw were filled in March and April . I know you won't be able to tell me the exact numbers, but you know, in general, what is that percentage increase as compared to like January and February ?
Speaker Change: And then when you say that you know 50% of your patients are moving towards
Outrage Genrex.
So...
Speaker Change: Yeah, I'm just trying to understand, like, what's the price differential between the Corlem and the authorized generic and the
Speaker Change: I'm trying to try and let between that and they increase the scripts to get to your stated 30-some percent increase in revenue or year-over-year.
Sean: Yeah, I really do think we understand your question, R.K., thank you, and I'm going to give you back to Sean to give you a broad answer to that question. Yeah, thanks for the question. So the first question was just around volume and volume increase.
Sean: and our first quarter enrollments were almost double what they were in the first quarter of last year.
Sean: So that's the first question. The second question around the authorized generic is a reminder we priced our authorized generic
at a 12% discount from...
Sean: from Coralung, but recognize that the pairs negotiate from there as they do with any list
Sean: 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.
Okay, did you have a follow-up question?
Speaker Change: 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.
Speaker Change: I have to admit that in the many years that I've run Corcept, considered lots of problems, and must admit to you that I did not anticipate that our Coralem business would overwhelm our pharmacy vendor.
Speaker Change: 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, they apologize to any patients who are terribly inconvenienced by this.
Speaker Change: Ashawn stated, the problem appears resolved, March and April were very strong months, and I have to now tell you, you know, of course as a result, we're intensely vigilant that this problem did not arise again.
Speaker Change: But I really want to focus you on three things which I think are real shifts in what's going on at Corcept.
Speaker Change: It's now certain that there are many more patients with hypercortisolism than have been assumed for, you know, in some sense, all of its study.
Speaker Change: We weren't the first people to look at this, but the catalyst that he definitively said that there just are many more patients who have potential to be screened and then found and treated.
Speaker Change: 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 hyperchorosalism was underrepresented before is not going to be true for much longer.
Speaker Change: The second thing is that for many years the only molecule to approach
Speaker Change: Glucocorticoid Receptor Antagonism, Cortisol Modulation in this way was Coralem, Mr. Pristhem.
Speaker Change: and that really dovetails with the third point I want to make. Resella unequivocally shows that cortisol modulation has utility outside of your basic kitchen syndrome patients.
Speaker Change: It clearly worked in a very difficult group of patients with platinum-resistant ovarian cancer.
Speaker Change: 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 and alvarian cancer and in other tumors where the glucocorticoid receptor is represented.
Speaker Change: 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.
Speaker Change: And all of you are familiar with the broad amount of work which are being done with another hormone, GLP1.
Speaker Change: My own opinion is that when the field is fully mined for the benefits of hypercortisolism you will see that kind of breach and breath. So thank you for all listening today, and I will see you next quarter.
Thank you, bye bye [inaudible]
Speaker Change: This concludes today's conference call. Thank you for participating. You may now disconnect.
David Amsellem, Matthew Kaplan, Joseph Belanoff, Asim Rana, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Joseph Belanoff, Asim Rana, Swayampakula Ramakanth David Amsellem, Matthew Kaplan, Joseph Belanoff, Asim Rana, Swayampakula Ramakanth, Joon Lee,