Q4 2024 Corcept Therapeutics Incorporated Earnings Call & Business Update
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Speaker Change: Thank you for standing by and welcome to courts up Therapeutics Conference call. At this time, all participants are in a listen only mode.
Speaker Change: After the speaker presentation, there will be a question and answer session to ask a question. During the session you will need to press star one one on your telephone to remove yourself from the queue. You May Press Star one one again I would now like to hand, the call over to out of Macquarie CFO. Please go ahead.
Macquarie CFO: Hello, everyone. Good afternoon, and thank you for joining US today, we issued a press release announcing our financial results for the fourth quarter and providing a corporate update copies available of course that dot com, our complete financial results will be available when we file our Form 10-K with the SEC.
Macquarie CFO: Today's call is being recorded a replay will be available at the investors past events tab of our website.
Macquarie CFO: 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 may cause actual results to be materially different from those such statements expressed or imply the risks and uncertainties that may affect our forward statements are described in our annual report on Form 10-K and our.
Macquarie CFO: <unk> reports on Form 10-Q, all of which are available at the Sec's website. Please.
Macquarie CFO: Please refer to those documents for additional information, we disclaim any intention or duty to update forward looking statements.
Macquarie CFO: Our 2020 for revenue were $675 million, an increase of 40% compared to the prior year.
Macquarie CFO: We expect our revenue growth to continue and have provided 2025 revenue guidance of $900 million to $950 million.
Macquarie CFO: Net income was $141 million for the full year 2024, an increase of 33% compared to the prior year.
Macquarie CFO: Our cash and investments at December 31, 2024 were $603 million compared to $425 million at the end of the prior year.
Macquarie CFO: In 2024, we acquired $38 million of our common stock pursuant to our stock repurchase program. The net exercise of stock options by <unk> employees and the net vesting of restricted.
Macquarie CFO: Restricted stock grants.
Speaker Change: I will now turn the call over to Charlie Robb, our Chief business Officer Charlie.
Speaker Change: I don't have much to report this quarter as many of you know in March 2018, we sued Teva to stop it from marketing up version of Korlym in violation of our patents in December of last year. The trial court ruled against US we have appeal that decision to the federal Circuit Court of Appeals briefing in the matter.
Speaker Change: Is complete documents are available at the government's Pacer website and the next step is for the federal circuit schedule oral argument, which is still not done.
Speaker Change: The earliest possible date, given the court's scheduling process is for argument in may or later the decision issuing three or four months after that.
Speaker Change: A matter of the effluent schedule, if we prevail Teva Teva would lose FDA approval of its product and be required to withdraw from the market until the expiration of our patents in 2037.
Speaker Change: As I've said before we are eager to advance. This appeal, we strongly believe that our position is correct that the federal circuit will agree I will now turn the call over to Joe Belanoff, Our Chief Executive Officer Joe.
Joe Belanoff: Thank you Charlie and thank you everyone for joining us this afternoon.
Joe Belanoff: <unk> 24 was a great year for <unk>.
Joe Belanoff: Each successive quarter of 2024 brought a record number of new Korlym prescribers and patients receiving korlym.
Joe Belanoff: Rapidly increasing number of physicians now know that hyper quarters dualism is much more prevalent than was previously assumed.
Joe Belanoff: Our screening and treating many more patients than ever before we are confident that our cushings syndrome business will continue to grow for years.
Joe Belanoff: On December 30, we submitted a new drug application for our proprietary selective cortisol modulator rella correlate.
Joe Belanoff: Our NDA is based on compelling results from the Grace gradient long term extension and phase II <unk> studies.
Joe Belanoff: Our pivotal great Phase III study had two parts and the trial's open label Phase 152 patients with type of quarter, cortisol and either hypertension, hyperglycemia or bolt could keep relic Orleans for 22 weeks.
Joe Belanoff: Patients, who met Prespecified improvements were given the opportunity to enter the trials randomized double blind withdrawal phase in which half of the patients continuing to receive rolla Cortland and have received placebo for 12 weeks patients in the open label phase of Grace exhibited clinically meaningful and statistically significant improvements in.
Joe Belanoff: Hypertension, hyperglycemia weight lean muscle mass waist circumference cognition Cushing is quality of life score and other important clinical measures.
Joe Belanoff: In the randomized withdrawal phase of Grace, which compared patients taking relative floral into those taking placebo <unk> met its primary endpoint of retaining improved blood pressure control.
Joe Belanoff: The odds ratio, which was the study's primary endpoint.
Joe Belanoff: One seven with a P value of <unk> <unk>, an odds ratio of 0.17 means that patients taking rella Cortland were six times more likely to maintain their blood pressure response compared to those taking placebo.
Joe Belanoff: In addition patients who continued to take rolla correlate in the randomized withdrawal phase of the study maintained or increased the broad range of other improvements in the signs and symptoms of hype cortisol as have generated in the open label phase of the study while those who received placebo experienced a significant worsening of these signs and symptoms.
Joe Belanoff: Patients, who completed the phase III Grace and gradient studies were eligible to enter our long term extension study, where they continue to receive rella correlate or for patients in the placebo arm of gradient received <unk> for the first time.
Joe Belanoff: Patients in the extension study have now taken rella coral and for up to six years. This group of 116 patients has exhibited additional clinically meaningful and durable cardio metabolic improvements for instance at week 24 of the study.
Joe Belanoff: I'm sorry for instance at month 24 of the study they experienced a further reduction in their systolic blood pressure of 10 millimeters of Mercury a P value of 0.012 and their diastolic blood pressure of seven three millimeters of Mercury a P value of point of $1 six compared to those measurements at the time.
Joe Belanoff: <unk> entered the extension study again. Please remember these improvements were in addition to the improvements already exhibited in the phase III Grace or gradient parent study.
Joe Belanoff: <unk> efficacy and safety, which I will discuss in a moment is clearly evident when one follows the clinical course of patients as they enter the phase III, Greece or gradient study complete that study then participate in the long term extension study.
Joe Belanoff: As a group patients exhibit rapid improvement at the start of <unk> therapy.
Joe Belanoff: <unk> maintained or continues to improve in the extension study.
Joe Belanoff: <unk> Israel Coralline treatment is interrupted for instance by being assigned to placebo and the Grace randomized withdrawal phase exhibit rapid improvements at the startup.
Joe Belanoff: Coral and therapy than deterioration when switched to placebo followed by resumption of improvement Werent Railroad Korlym is restarted.
Joe Belanoff: Just as important as Rolla Rolla correlates efficacy is its safety Rolla correlate has been well tolerated in all of its studies. The most common adverse events have been mild to moderate nausea, demma pain in the extremities and back and fatigue.
Joe Belanoff: These symptoms are consistent with cortisol withdrawal that patients with hyper cortisol awesome experience following a rapid reduction in their cortisol activity, whether due to surgery that removes an ACTH are cortisol secreting tumor or at the start of medical therapy.
Joe Belanoff: As expected there have been no rella korlym 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.
Joe Belanoff: <unk> for patients with Cushings syndrome can cause one or more of them.
Joe Belanoff: As we advance <unk>, we continue to work at increasing physician awareness and understanding of hyper cortisol ism.
Joe Belanoff: The prevalence phase of our catalyst study showed that one in four patients with difficult to control type two diabetes is hyper cortisol lithium a far higher rate than was assumed.
Joe Belanoff: In December we completed catalyst treatment phase.
Joe Belanoff: Double blind placebo controlled study in which 136 patients identified in catalysts first phase is having hyper cortisol ism were randomized to receive either korlym or placebo the.
Joe Belanoff: The results were striking patients who received korlym exhibited a large reduction 147% and hemoglobin <unk> C. A key measure of glucose control compared to a one five decrease in patients who received placebo.
Joe Belanoff: Value of less than <unk> 0001 the.
Joe Belanoff: The magnitude of reduction seen in the treatment arm is especially striking given that these patients were already receiving the best start to ease treatment available, including <unk> and <unk>.
Joe Belanoff: Another catalyst finding is that hyper cortisol rhythm is even more common in patients who have cardiovascular disease. In addition to diabetes and substantial group of patients in the catalyst study, taking three or more medications to manage their hypertension more than a third were found to have hyper cortisol lesson.
Joe Belanoff: Later this quarter, we will start our newest study momentum, which will help establish the prevalence of hyper cortisol rhythm in patients with resistant hypertension.
Joe Belanoff: We are confident that increased physician awareness and understanding of hyper cortisol listen combined with the advancement of Gorilla Cortland are safe and effective therapy will improve the lives of patients who struggle with the devastating impact of this disease, we are already seeing it.
Joe Belanoff: As you know we are also studying rella korlym as a treatment for types of cancer cortisol plays a role.
Joe Belanoff: We expect data soon from our pivotal <unk> study.
Joe Belanoff: In this study 381 women with platinum resistant ovarian cancer have been randomized on a one to one basis to receive either Nab paclitaxel, probably the most effective chemotherapy currently prescribed to women with platinum resistant disease, or Nab Paclitaxel plus for Ela correlate for.
Joe Belanoff: Many of these patients Nab paclitaxel or any chemotherapy has become much less useful than earlier in the course of treatment.
Joe Belanoff: Our expectation is a relic korlym will re sensitize ovarian tumors to the effects of Nab paclitaxel by blunting, the anti apoptotic effects of cortisol activity.
Joe Belanoff: Brazil is designed tracks the design of our successful controlled phase II trial.
Joe Belanoff: In that study women, who received <unk> intermittently the day before the day hub and the day. After they received Nab paclitaxel exhibited a statistically significant improvement in progression free survival and duration of response compared to the group who received Nab Paclitaxel monotherapy.
Joe Belanoff: Women in the <unk> group also lived longer than those in the comparator arm.
29% of the patients who took intermittent rella correlate where life two years after study star compared to only 14% who took Nab paclitaxel alone.
Joe Belanoff: Importantly, the women, who received <unk> plus Nab Paclitaxel experienced no additional side effect burden compared to those who received Nab paclitaxel in mono therapy.
Joe Belanoff: We expect relatively orland to replicate these results.
Joe Belanoff: Enrollment in roads in Rosella is complete.
Joe Belanoff: We anticipate having progression free survival results by the end of this quarter.
Joe Belanoff: We are conducting rosella in collaboration with leading clinicians from the gynecologic oncology group or <unk> in the United States and the European network of Gynecologic oncology trials or end got group in Europe and deeply appreciate their enthusiasm and support in.
Joe Belanoff: In anticipation of a successful outcome, we have established a stand alone oncology division. So we can move swiftly after the conclusion of rosella to bring <unk> to the women who can benefit from it.
Joe Belanoff: Positive results, we'll also prompt us to explore rella korlym as a treatment for earlier stages of ovarian cancer and other solid tumors that express the glucocorticoid receptor.
Joe Belanoff: In addition to exploring cortisol potential to re sensitize tumors to chemotherapy, we are evaluating its potential use in combination with androgen deprivation therapy <unk>.
Joe Belanoff: Cortisol stimulation is a major reason why patients with prostate cancer treated with a widely prescribed androgen receptor antagonist and <unk> eventually experienced research and disease deprived of androgens stimulation their tumor switched to cortisol activity to stimulate growth.
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 III trial umbrella correlate plus <unk> in patients with early stage prostate cancer before these patients have had an initial prostatectomy.
Joe Belanoff: Another possible of cortisol receptor antagonist, it's in combination with immunotherapy, because cortisol suppresses the immune system. It may be lumpy effectiveness of cancer therapies intended to stimulate an immune response, adding.
Joe Belanoff: Adding a cortisol modulator to immunotherapies, such as checkpoint inhibitors may enhance their effectiveness.
Joe Belanoff: Knowing our phase one b trial in advanced adrenal cancer, when deciding how best to investigate the utility of our compounds in combination with Immunotherapies and other tumor types in earlier stages of cancer.
Joe Belanoff: One of our proprietary compounds dasa correlate readily crosses the blood brain barrier and as a candidate for the treatment of neurologic disorders.
Joe Belanoff: Based on compelling data showing improved motor performance and reduced neuro inflammation and muscular atrophy and a commonly used mouse models.
Joe Belanoff: We conducted a 249 patient randomized double blind placebo controlled phase II trial of <unk> in that dire disease.
Joe Belanoff: Unfortunately patients who received <unk> did not show improvement in the ALS functional rating scale. The study's primary endpoint. However, we did observe a statistically significant improvement in patient survival at week 24 of the study.
Speaker Change: No deaths occurred in the 83 patients who received 300 milligrams of data correlate while five deaths occurred in 82 patient placebo group a P value of point or two.
Speaker Change: The open label long term extension study is ongoing and we expect to receive one year overall survival results early in the second quarter.
Speaker Change: Mash metabolic dysfunction associated Seattle, hepatitis is a serious liver disorder that afflicts millions of patients in the United States alone Court.
Speaker Change: Cortisol activity plays a role in both the initial development and progression of the disease and cortisol modulation may serve as a treatment.
Speaker Change: One of our proprietary molecules mirror Corelogic has very potent activity in the liver.
Speaker Change: Our phase <unk> dose finding study of mirror correlate found that patients who received 100 milligrams orally just twice a week for 12 weeks experienced a 30% reduction in liver fat and improvements in liver enzymes markers of fibrosis, and key metabolic and lipid measures such as insulin resistance.
Speaker Change: Serum triglycerides and LDL.
Speaker Change: The compound is also very well tolerated with none of the Gi side effects, which commonly arise in patients being treated for mash.
Speaker Change: A randomized double blind placebo controlled phase two b monarch study aims to expand on our encouraging phase <unk> results Martin up here is enrolling two cohorts in the first 120 patients with biopsy confirmed Nash are randomized two to one to receive either 100 milligrams of <unk>.
Speaker Change: Twice weekly or placebo for 48 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 has a planned enrollment of 75 patients with presumed to match patients in this cohort will be.
Speaker Change: Randomized two to one to receive either 100 milligrams <unk> twice weekly for six weeks, followed by 200 milligrams of Mirror Cortland twice weekly for 18 weeks.
Speaker Change: Placebo for the whole 24 weeks in this cohort the primary endpoint is also reduction in liver fat.
Speaker Change: As I said earlier 2024 was a great year for <unk>.
Speaker Change: We expect even greater success for years to come.
Speaker Change: Physicians are becoming increasingly aware of hyper cortisol listen and its clinical consequences, we have seen that understanding translate to a long string of record quarters for new prescribers and patients receiving cortisol modulation therapy.
Speaker Change: Catalysts results provide potent evidence to further advance the field by demonstrating that hyper cortisol is clearly much more common than previously assumed and the treatment with a cortisol modulator is highly effective.
Speaker Change: <unk> strong efficacy and safety profile positions us to become the new standard of care for patients with type of cortisol listen.
Speaker Change: The positive results from our Grace gradient long term extension and phase II studies provide powerful support for successful rollout correlate NDA and hyper cortisol lithium.
Speaker Change: Meanwhile, our development programs continue to advance we expect results from our pivotal <unk> study in ovarian cancer and just a few weeks a prostate cancer ALS and Nash studies are ongoing and we plan to initiate our momentum study this quarter.
Speaker Change: We don't spend much time on these calls discussing the topic, but you should also note that we have a broad and active research portfolio. Many proprietary selective cortisol modulators with potential very distinctive clinical attributes we are comprehensively evaluating these attributes and their therapeutic applications.
Speaker Change: And we will advance the most promising compounds to the clinic.
Speaker Change: The problems caused by excess cortisol activity often have profoundly negative effects on patients.
Speaker Change: We are dedicated to finding new more effective and safer treatments to help them.
Speaker Change: Operator, let's proceed now to questions.
Speaker Change: Yes.
Speaker Change: As a reminder to ask a question you will need to press star one on your telephone to remove yourself from the queue. You May press Star one again, please standby, while we compile the Q&A roster.
Speaker Change: Our first question comes from the line of David <unk> of Piper Sandler.
Speaker Change: Go ahead David.
Thanks, So I just had a few on <unk> first.
Speaker Change: Can you talk to when we should hear about NDA acceptance and what are your thoughts on the potential for an AD com here and is that something youre preparing for so that's number one and then on the resolve trial.
Speaker Change: Turning the.
Speaker Change: The change in the endpoints or I guess elevating overall survival to a co primary I guess, what I'm what I'm wondering is.
Speaker Change: How unusual is something like that if this sort of advanced stage of <unk>.
Speaker Change: Trial.
Speaker Change: And what should we make of that number one and then number two can you talk to.
Speaker Change: Statistical penalties associated with now having a co primary endpoint instead of a single progression free survival endpoint. Thank you.
Speaker Change: Hey, David Thank you for the questions and I will turn them over to the.
Speaker Change: Pete Best people took answered in the in the company, but let me just clarify one small thing before we start which is that we don't have co primary endpoints, we have dual primary endpoints and thats, a very big difference and bill Guy or when he gets to it will actually answer that question, but the first question about the role of Korlym for Cushing syndrome.
Speaker Change: NDA is.
Speaker Change: <unk> best answered by Charlie Robb, our Chief business Officer, and head of regulatory.
Speaker Change: Sure so.
Speaker Change: Yes. Thanks for the question, we submitted our NDA on December 30th put out in our press release and the FDA has 60 days to review it for acceptance in that review is typically not.
Speaker Change: That's sort of a preview of the substantive review for drug approval, but it's.
Speaker Change: Sure all the parts of the application are there.
Speaker Change: There is sufficient data for them to review and then they can go ahead and proceed and it's.
Speaker Change: Typical to received during that 60 day period.
Speaker Change: <unk> information request from the agency for this data or that data and where could they find this or that piece of information and we've been receiving that very ordinary course routine correspondence and responding to it over the past 60 days. So the process has been moving exactly as we understood it to move and buy stock.
Speaker Change: <unk> or regulation. The FDA is due to give us a response within 60 days. So soon.
Speaker Change: Okay and the second question, Charlie about an AD com and we're not expecting an ad com.
Speaker Change: The.
Speaker Change: Past.
Speaker Change: Coupled medications for Cushing syndrome, where crude with ask them Korlym was approved at one and Theres nothing about ROIC korlym its efficacy or safety that we think would require one so we will be ready for one of course, if that occurred it would not bother us, but we don't expect it. Thanks. Thank you Charlie and now I'd like to reintroduce you to.
Speaker Change: <unk> <unk>, our Chief development officer in charge of the everything related to rella correlates to Dol.
Speaker Change: Thank you a question related with seller. So first before I answer that question I'm really proud to share that we just reached the number of events for PFS by Becker and that allows us to now work with every one of the 120 investigators to ensure that all the data for the 381 patients that were entered into the database. So we can then do our analysis.
Speaker Change: And Thats why we believe we will have our analysis done by the end of this quarter. So that's a very good positive thing for the <unk> study <unk>.
Speaker Change: Now specific to your question about the endpoint. We've how common is this I'd say very come because we've been actively working with regulators both the FDA and EMA related to the <unk> study and based upon the comments we came to an agreement to have a dual primary endpoint of PFS by Becker and OS to give us to shop.
Speaker Change: On goal so to chances for a positive study, where we only need to meet one of them to have this be defined as a positive study now with that change.
Speaker Change: From a statistical point of view the P value per PFS by Becker is now 0.0 for and for OS is 0.01, and we are adequately powered to detect a difference for both PFS and OS.
Speaker Change: But let me come back to dual primary end point, what does that mean.
Speaker Change: Basically for us to have a positive study all we need is for one of them to be successful in order to declare the resell of study a positive study and once we meet that PFS by bigger end point, we really don't have to wait for OS even though we expect to meet that OS endpoint.
Speaker Change: Of note also from a statistical point of view once we meet our PFS endpoint statistically we can recycle that alpha where now for OIS. It no longer becomes 0.01, we can now elevate that to be a peep RFP value of <unk> <unk> five.
Speaker Change: Now once we hit that PFS endpoint.
Speaker Change: By the end of this quarter. We then plan to proceed with an NDA and MAA.
Speaker Change: This change is in a very positive for the program and very positive for women with platinum resistant ovarian cancer.
Speaker Change: Thank you Bill Thank you.
Speaker Change: David.
Speaker Change: Thank you next question please.
Speaker Change: Thank you our next question.
Speaker Change: Comes from somebody on components.
Rami Camp: Rami camp of H C Wainwright.
Speaker Change: <unk> Your line is open hi.
Rami Camp: Hi, RK.
Speaker Change: Please go higher how are you doing.
Speaker Change: Really appreciate you taking questions.
Speaker Change: So a couple of questions one on <unk>.
Speaker Change: Catalyst so andreas on this dual endpoints.
Speaker Change: How does that work so bill just said that you're.
Speaker Change: If we hit the PFS endpoint at the end of the March at the end of March we can prime.
Speaker Change: And going forward.
Speaker Change: However.
Speaker Change: Hum.
Speaker Change: If it turns negative so what happens.
Speaker Change: Sure.
Speaker Change: And how long do you think we need to wait for the OIS data to come through.
Speaker Change: For our filing so that's question number one question number two on catalyst.
Speaker Change: It's great to see continued increase.
Speaker Change: Ah patients.
Speaker Change: Korlym on Korlym screening.
Speaker Change: Our screening patients for them for Cushing syndrome, that's what I meant.
Speaker Change: In terms of utilization Thats the catalyst data.
Speaker Change: The benefit of the catalyst study.
Speaker Change: Are you folks have already seen some of that.
Speaker Change: Either in terms of screening patients.
Speaker Change: We're also getting patients on the drug.
Speaker Change: And how would you.
Speaker Change: Scott.
Speaker Change: I'm talking more about <unk>.
Speaker Change: <unk> calculates their data.
Speaker Change: The privilege and the treatment.
Speaker Change: Thank you RK I think I caught your question. The first one is.
Bill Guy: Best answered by Bill Guy here again.
Bill Guy: Bill on the resolve study.
Bill Guy: Thank you for the question RK, So one related to our end points, we don't plan to Miss our PFS endpoint. So we do plan to hit that PFS endpoint and not have to wait for OS as I stated before but if we happen to Miss that PFS endpoint. We do then have that second chance for a positive study with OS and we would hit OS.
Bill Guy: Approximately one year from now.
Bill Guy: Thank you Bill.
Bill Guy: And Sean you.
Speaker Change: Let me reintroduce Shan Shan is the president of our Endocrinology Division.
Bill Guy: And.
Bill Guy: Really responsible for all of them.
Bill Guy: Therefore.
Bill Guy: Coming <unk>, Sean why don't you take the crack at the catalyst question RK. Thanks for the question. So in terms of catalyst. The question of are we starting to see an impact I would say that we started to see a small impact.
Bill Guy: <unk> is that there's always a delay between data generation and publication guideline inclusion and then medical practice changes. So when we really expect to see more of an impact is in the second half of this year and the years to come and why do we expect to see that and that's because more data is going to be released as the year goes on and so your question about.
Speaker Change: How are we utilizing that data now.
Bill Guy: We are.
Bill Guy: Can speak to and when the data is published we will be able to.
Bill Guy: More broadly communicate the complete story of both the prevalence as well as the treatment findings to physicians.
Bill Guy: Yes, okay.
Bill Guy: Thank you.
Speaker Change: Okay. Next question. Please. Thank you. Our next question comes from Joon Lee of Truest. Your line is open in June.
Joon Lee: Congrats on the quarter and thanks for taking the question. This is awesome run on for June just back on the <unk> study just wanted to understand a little bit better like was there something specifically that prompted the change in the endpoint and did you have buy in from the FDA on the change and then just on the 20 <unk> revenue guidance, what was baked into that revenue was flat quarter over quarter.
Speaker Change: Just wondering about that thank you.
Speaker Change: First question. Please up they'll go ahead, and let you answer that so again for a seller what prompted the change is just again, we've been actively discussing reseller with the FDA and EMA and just through those collaborative conversations we came in an agreement.
Speaker Change: Positive way to.
Speaker Change: To elevate OS is a dual primary end point to give us two chances for a positive trial.
Speaker Change: That really is what prompted it just having a collaborative conversation with the FDA. So yes. They are in agreement with this change.
Speaker Change: Okay.
Speaker Change: And Sean the second question please about guidance.
Speaker Change: Overall strength of the business.
Speaker Change: In endocrinology.
Speaker Change: We have a question was around sort of the flat to flat quarter. So we had a fantastic fourth quarter with a record number of patients and prescribers and in fact as Joe mentioned in his opening remarks. It was the best quarter, we've ever had.
Speaker Change: However, our pharmacy partner had some operational challenges that impacted our Q4 revenue. So why did that happen well more and more health care providers are recognizing the hyper cortisol all of them is more prevalent than they once thought and are aggressively shreveport in their practices and because of that we experienced significant prescription growth in 2024, and the majority of that growth came in the second half of the year.
Speaker Change: <unk>.
Speaker Change: Although growth is obviously fantastic it temporarily overwhelmed the operational capabilities of our pharmacy vendor and it took longer than expected to start patients on Korlym now are confident that these issues have been identified and are being resolved and we expect that the pharmacy will handle that amount of our business growth going forward things are moving in the right direction and we have.
Speaker Change: All of that into our guidance. So now in terms of the guidance, what's baked into that and we take all factors into account on one thing Thats emerged this year through catalyst and through all the other studies that preceded it is that this patient population is understated.
Speaker Change: Holder circle epic data would say that there were 10000 of these patients and we now know that that number is larger than the FDA agrees with us on that so we're focused on unlocking the full potential of the market and see continued growth through the rest of this year and I think more importantly, we.
Speaker Change: We see.
Speaker Change: We see ourselves in a more confident than ever that we're on track to grow our hyper cortisol and business from $3 billion to $5 billion in annual revenues in three to five years. This market is expanding and it's expanding rapidly.
Speaker Change: I'd just like to underscore just a very important thing. It's now clear that there are many more patients with hyper cortisol.
Speaker Change: Once presume and they are in many practices throughout the country.
Speaker Change: All are all large practices and even more important with catalyst showed was that treating these patients with cortisol antagonist like korlym or upcoming Rolla korlym.
Speaker Change: Very effective in treating patients, who often have not gotten any relief from other treatments and so thats really a very very beneficial thing now we've really taken this one step at a time you saw the catalyst treatment results at the end of last year, we are going to appear in major conferences throughout this year.
Speaker Change: Findings will be in substantial publications, starting soon and then going through the rest of the year, but there is.
Speaker Change: There's many many data points that will actually get out there now medicine changes slowly over time, sometimes to the detriment of patients, but as Sean has pointed out we've really seen that change pick up in the second half of last year and we think that is going to continue through this year accelerating as the year goes along.
Speaker Change: So yes.
Speaker Change: I think medicines really changed by this work and I think patient benefit will really be substantial as we go forward and thats going to go on for an extended period of time.
Speaker Change: Okay. Thank you.
Speaker Change: I don't see any more questions out there so I'm going to call. It now thank you very much for all listening in.
Speaker Change: As you've heard on this call this <unk>.
Speaker Change: <unk> will you will be getting other important information from core stepped in the upcoming weeks and months. So please stay tuned thank you very much.
Speaker Change: Yes.
Speaker Change: This concludes today's conference call. Thank you for participating you may now disconnect.
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Speaker Change: Thank you for standing by and welcome to course up Therapeutics 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 ask a question. During the session you will need to press star one one on your telephone to remove yourself from the queue you May press.
Speaker Change: Star one one again.
Macquarie CFO: I would now like to hand, the call over to out about Macquarie CFO. Please go ahead.
Macquarie CFO: Hello, everyone. Good afternoon, and thank you for joining US today, we issued a press release announcing our financial results for the fourth quarter and providing a corporate update copies available of course have dot com, our complete financial results will be available when we file our Form 10-K with the SEC.
Macquarie CFO: This 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 may cause actual results to be materially different from those such statements expressed or imply.
Macquarie CFO: The risks and uncertainties that may affect our forward statements are described in our annual report on Form 10-K, and our quarterly reports on Form 10-Q, all of which are available at the Sec's website.
Macquarie CFO: Please refer to those documents for additional information, we disclaim any intention or duty to update forward looking statements.
Our 2020 for revenue with $675 million, an increase of 40% compared to the prior year.
Macquarie CFO: We expect our revenue growth to continue and have provided 2025 revenue guidance of $900 million to $950 million.
Net income was $141 million for the full year 2024, an increase of 33% compared to the prior year.
Macquarie CFO: Our cash and investments at December 31, 2024 were $603 million.
Macquarie CFO: Compared to $425 million at the end of the prior year.
Macquarie CFO: In 2024, we acquired $38 million of our common stock pursuant to our stock repurchase program. The net exercise of stock options by of course that the employees and the net vesting of restricted.
Macquarie CFO: Restricted stock grants.
Speaker Change: I will now turn the call over to Charlie Robb, our Chief business Officer Charlie.
Speaker Change: I don't have much to report this quarter as many of you know in March 2018, we sued Teva to stop it from marketing up version of Korlym in violation of our patents in December of last year. The trial court ruled against US we have appeal that decision to the federal Circuit Court of Appeals briefing in the matter.
Speaker Change: Is complete documents are available at the government Pacer website and the next step is for the federal circuit to schedule oral argument, which is still not at the earliest possible date given the court's scheduling process is for argument in may or later the decision issuing three or four months after that.
Speaker Change: Out of the effluent schedule, if we prevail Teva Teva would lose FDA approval of its product and be required to withdraw from the market until the expiration of our patents in 2037.
Speaker Change: As I've said before we are eager to advance. This appeal, we strongly believe that our position is correct that the federal circuit will agree I will now turn the call over to Joe Belanoff, Our Chief Executive Officer Joe.
Joe Belanoff: Thank you Charlie and thank you everyone for joining us this afternoon.
Speaker Change: 24 was a great year for <unk>.
Speaker Change: Each successive quarter of 2024 about a record number of new Korlym prescribers and patients receiving korlym.
Speaker Change: Rapidly increasing number of physicians now know that hyper quarter Scillism is much more prevalent than was previously assumed.
Speaker Change: Our screening and treating many more patients than ever before we are confident that our cushings syndrome business will continue to grow for years.
Speaker Change: On December 30, we submitted a new drug application for our proprietary selective cortisol modulator rella correlate.
Speaker Change: Our NDA is based on compelling results from the Grace gradient long term extension and phase II <unk> studies.
Speaker Change: Our pivotal great Phase III study had two parts and the trial's open label Phase 152 patients with type of quarter cortisol laser any of their hypertension hyperglycemia or bowl could keep rolla orland for 22 weeks.
Speaker Change: Patients, who met Prespecified improvements were given the opportunity to enter the trial randomized double blind withdrawal phase in which half of the patients continuing to receive rella Cortland and have received placebo for 12 weeks patients in the open label phase of Grace exhibited clinically meaningful and statistically significant improvements in.
Speaker Change: Hypertension, hyperglycemia weight lean muscle mass waist circumference cognition Cushing is quality of life score and other important clinical measures.
Speaker Change: In the randomized withdrawal phase of Grace, which compared patients taking relative floral into those taking placebo <unk> met its primary endpoint of retaining improved blood pressure control the odds ratio, which was the study's primary endpoint was one seven with a P value of <unk> <unk> and <unk>.
Speaker Change: <unk> ratio of one seven means that patients taking rella Cortland were six times more likely to maintain their blood pressure response compared to those taking placebo.
Speaker Change: In addition patients who continued to take rella correlate in the randomized withdrawal phase of the study maintained or increased the broad range of other improvements in the signs and symptoms of hype cortisol as have generated in the open label phase of the study.
Speaker Change: While those who received placebo experienced a significant worsening of the signs and symptoms.
Speaker Change: Patients, who completed the phase III Grace and gradient studies were eligible to enter our long term extension study, where they continue to receive rella correlate or for patients in the placebo arm a gradient receive rella correlate for the first time.
Speaker Change: Patients in the extension study have now taken a railroad correlate for up to six years. This group of 116 patients has exhibited additional clinically meaningful and durable cardio metabolic improvements for instance at week 24 of the study Im sorry for instance at month 24 of the study they experienced a further.
Speaker Change: A reduction in their systolic blood pressure of 10 millimeters of Mercury a P value of 0.012, and Theyre diastolic blood pressure of seven three millimeters of Mercury a P value of point <unk> six compared to those measurements at the time they enter the extension study.
Speaker Change: Again. Please remember these improvements were in addition to the improvements already exhibited in the phase III Grace gradient parent study.
Speaker Change: <unk> efficacy and safety, which I will discuss in a moment is clearly evident when one follows the clinical course of patients as they enter the phase III, Greece, where gradient study complete that study then participate in the long term extension study.
Speaker Change: As a group patients exhibit rapid improvement at the start of <unk> therapy.
Speaker Change: But maintained or continues to improve in the extension study.
Speaker Change: Patients as real corollary treatment is interrupted for instance by being assigned to placebo and the Grace randomized withdrawal phase exited rapid improvements at the startup relative coral and therapy than deterioration when switched to placebo followed by resumption of improvement wont rella Korlym is restarted.
Speaker Change: Just as important as Roque rella correlates efficacy is its safety <unk> has been well tolerated in all of its studies. The most common adverse events have been mild to moderate nausea, edina pain in the extremities and back in <unk> <unk>.
Speaker Change: These symptoms are consistent with cortisol withdrawal that patients with hyper cortisol.
Speaker Change: Experience following a rapid reduction in their cortisol activity, whether due to surgery that removes an ACTH are cortisol secreting tumor or at the start of medical therapy.
Speaker Change: As expected there have been no rella korlym induced instances of hypokalemia, endometrial hypertrophy or drug induced vaginal bleeding no cases of adrenal insufficiency and no instances of Qt prolongation. These.
Speaker Change: These adverse events can have serious health consequences each of the currently available medications for patients with Cushings syndrome can cause one or more of them.
Speaker Change: As we advance <unk>, we continue to work at increasing physician awareness and understanding of hyper cortisol ism.
Speaker Change: Prevalence phase of our catalyst study showed that one in four patients with difficult to control type two diabetes is hyper cortisol lithium.
Speaker Change: Far higher rate than was assumed.
Speaker Change: In December we completed catalyst treatment phase.
Speaker Change: Double blind placebo controlled study in which 136 patients identified in catalysts first phase as having hyper cortisol wisam were randomized to receive either korlym or placebo the.
Speaker Change: The results were striking patients who received korlym exhibited a large reduction 147% and hemoglobin <unk> C. A key measure of glucose control compared to a one five decrease in patients who received placebo.
Speaker Change: Value of less than <unk> 0001 the.
Speaker Change: The magnitude of reduction seen in the treatment arm is especially striking given that these patients were already receiving the best start to ease treatment available, including <unk> and <unk>.
Speaker Change: Another catalyst finding is that hyper cortisol lithium is even more common in patients who have cardiovascular disease. In addition to diabetes and substantial group of patients in the catalyst study, taking three or more medications to manage their hypertension more than a third were found to have hyper cortisol lithium.
Speaker Change: Later this quarter, we will start our newest study momentum, which will help establish the prevalence of hyper cortisol rhythm in patients with resistant hypertension.
Speaker Change: We are confident that increased physician awareness and understanding of hyper cortisol lithium combined with the advancement of Rella Cortland are safe and effective therapy will improve the lives of patients who struggle with the devastating impact of this disease, we are already seeing it.
Speaker Change: As you know we are also studying rella korlym as a treatment for types of cancer, where cortisol plays a role.
Speaker Change: We expect data soon from our pivotal <unk> study.
Speaker Change: In this study 381 women with platinum resistant ovarian cancer have been randomized on a one to one basis to receive either Nab paclitaxel, probably the most effective chemotherapy currently prescribed to women with platinum resistant disease, or Nab Paclitaxel plus rella correlate for.
Speaker Change: Many of these patients Nab paclitaxel or any chemotherapy has become much less useful than earlier in the course of treatment.
Speaker Change: Our expectation is a relic korlym will re sensitize ovarian tumors to the effects of Nab paclitaxel by blunting, the anti apoptotic effects of cortisol activity.
Speaker Change: Brazil is designed tracks the design of our successful controlled phase II trial.
Speaker Change: In that study women, who received <unk> intermittently the day before the day hub and the day. After they received Nab paclitaxel exhibited a statistically significant improvement in progression free survival and duration of response compared to the group who received Nab Paclitaxel monotherapy.
Speaker Change: Women in the <unk> group also lived longer than those in the comparator arm.
Speaker Change: 29% of the patients who took intermittent rella correlate where life two years after study star compared to only 14% who took Nab paclitaxel alone.
Speaker Change: Importantly, the women, who received <unk> plus Nab Paclitaxel experienced no additional side effect burden compared to those who received Nab paclitaxel monotherapy.
Speaker Change: We expect relative orland to replicate these results.
Speaker Change: Enrollment in road in Rosella is complete.
Speaker Change: We anticipate having progression free survival results by the end of this quarter.
Speaker Change: We are conducting rosella in collaboration with leading clinicians from the gynecologic oncology group or <unk> in the United States and the European network of Gynecologic oncology trials or end got group in Europe and deeply appreciate their enthusiasm and support in.
Speaker Change: In anticipation of a successful outcome, we have established a stand alone oncology division. So we can move swiftly after the conclusion of rosella to bring <unk> to the women who can benefit from it.
Speaker Change: Positive results, we'll also prompt us to explore rella korlym as a treatment for earlier stages of ovarian cancer and other solid tumors that express the glucocorticoid receptor.
Speaker Change: In addition to exploring cortisol potential to re sensitize tumors to chemotherapy, we are evaluating its potential use in combination with androgen deprivation therapy.
Speaker Change: Cortisol stimulation is a major reason why patients with prostate cancer treated with a widely prescribed androgen receptor antagonist <unk> eventually experienced resurgent disease deprived of androgens stimulation their tumor switched to cortisol activity to stimulate growth.
Speaker Change: Leading academic researchers and clinicians hypothesized that cortisol modulation can block this tumor escape route.
Speaker Change: Our collaborators at the University of Chicago are currently enrolling a randomized placebo controlled phase III trial umbrella correlate plus <unk> in patients with early stage prostate cancer before these patients a pattern and initial prostatectomy.
Another possible of cortisol receptor antagonist is in combination with immunotherapy, because cortisol suppresses the immune system. It may be lumpy effectiveness of cancer therapies intended to stimulate an immune response, adding.
Speaker Change: Adding a cortisol modulator to immunotherapies, such as checkpoint inhibitors may enhance their effectiveness.
Speaker Change: Knowing our phase <unk> trial in advanced adrenal cancer, when deciding how best to investigate the utility of our compounds in combination with Immunotherapies and other tumor types in earlier stages of cancer.
Speaker Change: One of our.
Speaker Change: Terry compounds data correlate readily crosses the blood brain barrier and as a candidate for the treatment of neurologic disorders based on compelling data showing improved motor performance and reduced neuro inflammation and muscular atrophy and a commonly used mouse model of AOS, we conducted a 249.
Speaker Change: Patient randomized double blind placebo controlled phase II trial of <unk> in that dire disease.
Speaker Change: Unfortunately patients who received <unk> did not show improvement in the ALS functional rating scale. The study's primary endpoint. However, we did observe a statistically significant improvement in patient survival at week 24 of the study no deaths occurred in the 83 patients who received 300.
Speaker Change: Milligrams of data correlate while five deaths occurred in 82 patient placebo group a P value of point or two.
Speaker Change: The open label long term extension study is ongoing and we expect to receive one year overall survival results early in the second quarter.
Speaker Change: Mash metabolic dysfunction associated Seattle, hepatitis is a serious liver disorder that afflicts millions of patients in the United States alone.
Speaker Change: Cortisol activity played some role in both the initial development and progression of the disease and cortisol modulation may serve as a treatment.
Speaker Change: One of our proprietary molecules mirror Corelogic has very potent activity in the liver.
Speaker Change: Our phase <unk> dose finding study of mirror correlate found that patients who received 100 milligrams orally just twice a week for 12 weeks experienced a 30% reduction in liver fat and improvements in liver enzymes markers of fibrosis, and key metabolic and lipid measures such as insulin resistance.
Speaker Change: Serum triglycerides and LDL.
Speaker Change: The compound was also very well tolerated with none of the Gi side effects, which commonly arise in patients being treated for mash.
Speaker Change: A randomized double blind placebo controlled phase two b monarch study aims to expand on our encouraging phase <unk> results Martin appears enrolling two cohorts in the first 120 patients with biopsy confirmed Nash are randomized two to one to receive either 100 milligrams of mirror Korlym.
Speaker Change: Twice weekly or placebo for 48 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 has a planned enrollment of 75 patients with presumed to match patients in this cohort will be.
Speaker Change: You were randomized two to one to receive either 100 milligrams <unk> twice weekly for six weeks, followed by 200 milligrams <unk> twice weekly for 18 weeks or placebo for the whole 24 weeks in this cohort. The primary endpoint is also reduction in liver fat.
Speaker Change: As I said earlier 2024 was a great year for core shift, we expect even greater success for years to come.
Speaker Change: Physicians are becoming increasingly aware of hyper cortisol listen and its clinical consequences, we have seen that understanding translate to a long string of record quarters for new prescribers and patients receiving cortisol modulation therapy.
Speaker Change: Catalysts results provide potent evidence to further advance the field by demonstrating the hyper cortisol is clearly much more common than previously assumed and the treatment with a cortisol modulator is highly effective.
Speaker Change: <unk> strong efficacy and safety profile positions us to become the new standard of care for patients with type of cortisol listen.
Speaker Change: The positive results from our Grace gradient long term extension and phase III studies provide powerful support for successful railroad correlate NDA and hyper cortisol lithium.
Speaker Change: Meanwhile, our development programs continue to advance we expect results from our pivotal <unk> study in ovarian cancer and just a few weeks a prostate cancer ALS and Nash studies are ongoing and we plan to initiate our momentum study this quarter.
Speaker Change: We don't spend much time on these calls discussing the topic, but you should also note that we have a broad and active research portfolio. Many proprietary selective cortisol modulators with potential very distinctive clinical attributes we are comprehensively evaluating these attributes in their therapeutic applications.
Speaker Change: And we will advance the most promising compounds to the clinic.
Speaker Change: The problems caused by excess cortisol activity often have profoundly negative effects on patients.
Speaker Change: We are dedicated to finding new more effective and safer treatments to help them.
Speaker Change: Operator, let's proceed now to questions.
Speaker Change: Yes.
Speaker Change: As a reminder to ask a question you will need to press star one on your telephone to remove yourself from the queue. You May press Star one again, please standby, while we compile the Q&A roster.
Speaker Change: Our first question comes from the line of David <unk> of Piper Sandler. Please go ahead David.
David: Thanks, So I just had a few on <unk> first.
David: Can you talk to when we should hear about NDA acceptance and what are your thoughts on the potential for an AD com here and is that something youre preparing for so that's number one and then on the resolve trial.
David: Turning the.
David: The change in the endpoints or I guess elevating overall survival to a co primary I guess, what I'm what I'm wondering is.
David: How unusual is something like that if this sort of advanced stage of the trial.
David: And what should we make of that number one and then number two can you talk to.
David: Statistical penalties associated with now having a co primary endpoint instead of a single progression free survival endpoint. Thank you.
Speaker Change: Hey, David Thank you for the questions and I will turn them over to the.
Speaker Change: Pete Best people to answer in the in the company, but let me just clarify one small thing before we start which is that we don't have co primary endpoints, we have dual primary endpoints and thats, a very big difference and bill Guy or when he gets to it will actually answer that question, but the first question about the role of Korlym for Cushings syndrome.
Speaker Change: NDA is.
Speaker Change: <unk> best answered by Charlie Robb, our Chief business Officer, and head of regulatory.
Speaker Change: Sure so.
Speaker Change: Yes. Thanks for the question, we submitted our NDA on December 30, we put out in our press release and the FDA has 60 days to review it for acceptance in that review is typically not.
Speaker Change: That sort of a preview of the substantive review for drug approval, but it's.
Speaker Change: Sure all the parts of the application are there.
Speaker Change: There is sufficient data for them to review and then they can go ahead and proceed and it's.
Speaker Change: Typical to received during that 60 day period.
Speaker Change: <unk> information request from the agency for this data or that data and where can they find this or that piece of information and we've been receiving that very ordinary course routine correspondence and responding to it over the past 60 days. So the process has been moving exactly as we understood it to move and buy stat.
Speaker Change: <unk> or regulation. The FDA is due to give us a response within 60 days. So soon.
Speaker Change: Okay, and then a second question Charlie.
Speaker Change: <unk> com and we are not expecting an ad com.
Speaker Change: The.
Speaker Change: Past.
Speaker Change: Coupled medications for Cushings syndrome, where crude with asked them Korlym was approved at one and Theres nothing about ROIC korlym its efficacy or safety that we think would require one so we will be ready for one of course, if that occurred it would not bother us, but we don't expect it. Thanks. Thank you Charlie and now I'd like to reintroduce you to.
Speaker Change: Guy or built our chief development officer in charge of everything related to railroad correlates to it all right. Thank.
Speaker Change: Thank you a question related with seller. So first before I answer that question I'm really proud to share that we just reached the number of events for PFS by Becker and that allows us to now work with every one of the 120 investigators to ensure that all the data for the 381 patients that were entered into the database. So we can then do our analysis and.
Speaker Change: That's why we believe we will have our analysis done by the end of this quarter. So it's a very good positive thing for the <unk> study.
Speaker Change: Specific to your question about the endpoint. We've how common is this I'd say very calm because we have been actively working with regulators both the FDA and EMA relates to the <unk> study and based upon the comments we came to an agreement to have a dual primary endpoint of PFS by Decker and OS to give us to shop.
Speaker Change: On goal so to chances for a positive study, where we only need to meet one of them to have this be defined as a positive study now with that change.
Speaker Change: From a statistical point of view the P value for PFS by Becker is now 0.0 floor and for OS is 0.01, and we are adequately powered to detect a difference for both PFS and OS.
Speaker Change: But let me come back to dual primary end point, what does that mean base.
Speaker Change: Basically for us to have a positive study all we need is for one of them to be successful in order to clear the resell of study a positive study and once we meet that PFS by bigger end point, we really don't have to wait for OS even though we expect to meet that OS endpoint.
Speaker Change: Of note also from a statistical point of view once we meet our PFS endpoint statistically we can recycle that alpha where now for Oss. It no longer becomes 0.01, we can now elevate that to be a <unk> RFP value of points zero five.
Speaker Change: Now once we hit that PFS endpoint.
Speaker Change: By the end of this quarter. We then plan to proceed with an NDA and MAA. So I see this changes are very positive for the program and very positive for women with platinum resistant ovarian cancer.
Speaker Change: Thank you David.
Speaker Change: Thank you next question please.
Speaker Change: Thank you our next question.
Speaker Change: Comes from somebody on Coppola.
Rami Camp: Rami camp of H C Wainwright.
Speaker Change: <unk> Your line is open.
Speaker Change: Hi, RK.
Rami Camp: Please go higher.
Rami Camp: How are you doing.
Rami Camp: Uh huh.
Rami Camp: Appreciate you taking questions.
Rami Camp: So couple of questions one on <unk>.
Rami Camp: Catalyst so on Russia alone on this.
Rami Camp: Dual endpoints.
Bill Guy: So how does that work so bill just said that.
Rami Camp: So you hit that PFS and OS.
Rami Camp: At the end of the March at the end of March we can file.
Rami Camp: <unk>.
Rami Camp: Going forward.
Rami Camp:
Rami Camp: However.
Rami Camp: Okay.
Rami Camp: It turns negative so what happens.
Rami Camp: Im.
Rami Camp: Sure.
And how long do you think we need to wait for the OIS data to come through.
Rami Camp: For our filing so that's question number one question number two on catalyst.
Rami Camp: It's great to see continued increase.
Rami Camp: Ah patients.
Rami Camp: Korlym on Korlym screening.
Rami Camp: Our screening patients for them for Cushing syndrome, that's what I meant.
Rami Camp: In terms of utilization Thats the catalyst data.
Rami Camp: The benefit of the catalyst study.
Speaker Change: Are you folks have already seen some of that.
Rami Camp: Either.
Rami Camp: In terms of screening patients.
Rami Camp: Also getting patients on the drug.
Rami Camp: And how would you.
Rami Camp: Scott.
Rami Camp: Talking more about the entire calculates their data.
Rami Camp: The prevalence in the treatment.
Speaker Change: Okay. Thank you RK I think I caught your question. The first one is.
Rami Camp: Best answered by Bill Guy or again.
Rami Camp: Bill on the results study.
Rami Camp: Thank you for the question RK, So one related to our endpoint, we don't plan to Miss our PFS endpoint. So we do plan to hit that PFS endpoint and not have to wait for OS as I stated before but if we happen to Miss that PFS endpoint. We do then have that second chance for a positive study with us and we would hit OS.
Rami Camp: Approximately one year from now.
Bill Guy: Thank you Bill.
Rami Camp: Sean.
Speaker Change: Let me reintroduce Shan Shan is the president of our Endocrinology Division.
Speaker Change: We're really responsible for all of them.
Rami Camp: Therefore.
Coming Rella Korlym, Sean why don't you take the crack at the catalyst question RK. Thanks for the question. So in terms of catalyst. The question of are we starting to see an impact I would say that we started to see a small impact recognize that there's always a delay between data generation and publication guideline inclusion and then medical practice changes.
So when we really expect to see more of an impact is in the second half of this year and the years to come and why do we expect to see that and that's because more data is going to be released as the year goes on and so your question about how are we utilizing that data now we are we are.
You can speak to and when the data is published we will be able to.
More broadly communicate the complete story of both the prevalence as well as the treatment findings to physicians.
Rami Camp: Yes, okay.
Rami Camp: Thank you.
Thank you Arkady. Okay. Next question. Please. Thank you. Our next question comes from Joon Lee of Truest. Your line is open in June.
Congrats on the quarter and thanks for taking the questions. This is awesome run on for June just back on the <unk> study just wanted to understand a little bit better like was there something specifically that prompted the change in the endpoint and did you have buy in from the FDA on the change and then just on the 20 <unk> revenue guidance, what was baked into that revenue was flat quarter over quarter.
So wondering about that thank you.
The first question. Please go ahead and let you answer that again for a seller what prompted the change is just again, we've been actively discussing reseller with the FDA and EMA and just through those collaborative conversations we came in an agreement.
On a very positive way.
To elevate OS is a dual primary end point to give us two chances for a positive trial.
That really is what prompted it just having a collaborative conversation with the FDA. So yes. They are in agreement with this change.
Rami Camp: Okay.
And Sean the second question, please about guidance and.
Overall strength of the business.
Rami Camp: In endocrinology.
We have a question was around sort of the flat quarter. So we had a fantastic fourth quarter with a record number of patients and prescribers and in fact as Joe mentioned in his opening remarks. It was the best quarter, we've ever had.
Over our pharmacy partner had some operational challenges that impacted our Q4 revenue. So why does that happen well more and more health care providers are recognizing the hyper cortisol one of them is more prevalent than they once thought and are aggressively shreveport in their practices and because of that we experienced significant prescription growth in 2024, and the majority of that growth came in the second half of the year.
Rami Camp: <unk>.
Although growth is obviously fantastic temporarily overwhelmed the operational capabilities of our pharmacy vendor and it took longer than expected to start patients on korlym now we're confident that these issues have been identified and are being resolved and we expect that the pharmacy will handle that amount of our business growth going forward things are moving in the right direction and and we have.
All of that into our guidance. So now in terms of the guidance, what's baked into that and we take all factors into account on one thing Thats emerged this year through catalyst and through all the other studies that preceded it is that this patient population is understated.
Older Circle Epic data would say that there were 10000 of these patients and we now know that that number is larger than the FDA agrees with us on that so we're focused on unlocking the full potential of the market and we see continued growth through the rest of this year and I think more importantly.
Rami Camp: We see.
We see ourselves in a more confident than ever that we're on track to grow our hyper cortisol on business from $3 billion to $5 billion in annual revenues in three to five years. This market is expanding and it's expanding rapidly.
And I'd just like to underscore just a very important thing. It's now clear that there are many more patients with hyper cortisol.
Once presume and they are in many practices throughout the country.
All are all large practices and even more important with catalyst showed was that treating these patients with cortisol antagonist like korlym or upcoming Rolla korlym.
It's very effective in treating patients, who often have not gotten any relief from other treatments and so that's really a very very beneficial thing now we've really taken this one step at a time you saw the catalyst treatment results at the end of last year, we are going to appear in major conferences throughout this year.
Findings will be in substantial publications, starting soon and then going through the rest of the year, but theirs.
There's many many data points that will actually get out there now medicine changes slowly over time, sometimes to the detriment of patients, but as Sean has pointed out we've really seen that change pick up in the second half of last year and we think that is going to continue through this year accelerating as the year goes along.
Rami Camp: So yes.
I think medicines really changed by this work and I think patient benefit will really be substantial as we go forward and thats going to go on for an extended period of time.
Rami Camp: Okay. Thank you.
I don't see any more questions out there so I'm going to call. It now thank you very much for all listening in.
As you've heard on this call this <unk>.
<unk> will you will be getting other important information from core stepped in the upcoming weeks and months. So please stay tuned thank you very much.
Rami Camp: Yes.
This concludes today's conference call. Thank you for participating you may now disconnect.