Corcept Therapeutics Inc
NASDAQ:CORT
Earnings Call Analysis
Q4-2023 Analysis
Corcept Therapeutics Inc
Positive results from trials of relacorilant have indicated that it may significantly improve survival rates in ovarian cancer patients without adding side effect burdens. Women who received relacorilant with chemotherapy showed a 29% 2-year survival rate compared to 14% for chemotherapy alone, suggesting that relacorilant could become a new standard in treating platinum-resistant ovarian cancer.
A Phase Ib trial is investigating the use of relacorilant combined with pembrolizumab for patients with advanced adrenal cancer, reflecting the company's commitment to expanding treatment possibilities for different indications. The company is also focusing on building a broad research portfolio and advancing the most promising compounds into clinical trials.
Within the year, data from key trials in Cushing's syndrome, ovarian cancer, and ALS are expected. Particularly, a New Drug Application (NDA) for relacorilant in Cushing's syndrome is planned for the second quarter, reflecting substantial pre-existing work spanning preclinical to Phase I trials and drug-manufacturing development.
The company issued revenue guidance predicting a range of $600 million to $630 million, showcasing confidence in its ongoing projects and commercial strategies.
A Phase Ib dose-finding study demonstrated that miricorilant significantly reduced liver fat by 30% with an improvement in liver enzymes and other key health indicators, setting the stage for the MONARCH study, aiming to address Non-Alcoholic Steatohepatitis (NASH) with the main endpoint being reduction in liver fat and key secondary endpoints involving NASH resolution and fibrosis improvement.
The company's growth in treatment is attributed to a larger number of physicians prescribing Korlym, bolstered by the addition of new patients across the country. This growth reflects the outcome of strategic marketing and strong relationships with healthcare providers.
Lambda Therapeutics leverages a high-touch, tightly controlled model for each Korlym prescription, ensuring optimal experiences for patients and prescribing physicians. This approach, combined with a deep market understanding and robust provider relationships developed over 12 years, presents barriers to entry for generic competitors and substitutes often seen in pharmaceutical markets.
Due to the pre-preparation of substantial parts of the NDA, the company is confident in a prompt filing immediately following the GRACE study conclusion. Furthermore, ongoing long-term trials, including patients out to 6 years, will continue to strengthen safety and efficacy data for relacorilant.
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Good day, and thank you for standing by. Welcome to the Corcept Therapeutics conference call. At this time, all participants under listen only mode. [Operator Instructions] Please be advised today's conference is being recorded. I would like to turn the call over to Atabak Mokari. Please go ahead.
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 at corcept.com. Our complete financial results will be available when we file our Form 10-K with the SEC. . Today's call is being recorded. A replay will be available at the Investors Past Events tab of our website. Statements during this call, other than statements of historical facts are forward-looking statements based on our plans and expectations that are subject to risks and uncertainties, which may cause actual results to differ materially from those such statements expressed or implied. These forward-looking statements are described in today's press release and the risks and uncertainties that may affect them are described in the press release and in our annual report on Form 10-K and our quarterly reports on Form 10-Q. Please refer to those documents for additional information. We disclaim any intention or duty to update forward-looking statements.
Our revenue in the fourth quarter of 2023 was $135.4 million, an increase of 31% compared to the fourth quarter of the prior year. We expect our revenue growth to continue and are reiterating 2024 revenue guidance of $600 million to $630 million compared to 2023 revenue of $482.4 million. Net income was $31.4 million in the fourth quarter and $106.1 million for the full year 2020. Our cash and investments at December 31 was $425.4 million.
I will now turn the call over to Charlie Robb, our Chief Business Officer, to provide a legal update. Charlie?
Thanks, Atabak. In March 2018, we sued Teva Pharmaceuticals to prevent it from marketing a generic version of Korlym and violation of our patents. Trial in Federal District Court in September of last year. On December 29, the court found that Teva's generic product would not infringe the 2 patents we asserted against it. We believe the court's verdict is wrong and it's based on a misunderstanding of the law. Accordingly, we are seeking its reversal by the Federal Circuit Court of Appeals. It is impossible to predict exactly how long the appeal will take. Briefing will be complete no later than May. Our opening brief is due March 9. Teva will have up to 40 days after we file to respond. Our applied brief closing the briefing cycle will be due no later than 21 days after that. These documents will all be publicly available on the Internet at the website. With briefing complete, the timing of oral argument and issuance in our opinion, are entirely up to the quarter. Based on past practice, it's reasonable to expect oral argument in the fourth quarter of this year and a decision early in the first quarter of 2025.
If we prevail, Teva would lose FDA approval of its product at least until the expiration of our patents in 2037. We are here to advance this appeal. As has always been the case, we strongly believe that our position is the correct one. We are confident that the Federal Circuit with its deep expertise in this area of the law will agree. I will now turn the call over to Joe Belanoff, our Chief Executive Officer. Joe?
Thank you, Charlie, and thank you, everyone, for joining us this afternoon. Atabak highlighted our strong commercial performance and the revenue guidance we have set for 2024. A few weeks ago, I had the opportunity to meet with our endocrinology team in our national field meeting. The enthusiasm about our prospects in hypercortisolism was palpable. We have the opportunity to help many more patients with Cushing's Syndrome. We are reaching a tipping point of sorts with the medical field increasingly understanding that hypercortisolism is far more prevalent than was previously assumed.
Our ongoing Phase IV CATALYST study will reinforce this emerging understanding -- and I believe this study will be a landmark in guiding the future screening and accurate diagnosis of patients with Cushing's syndrome. Catalyst is the largest clinical trial ever conducted to examine the prevalence of hypercortisolism in patients with difficult to treat type 2 diabetes. Its investigators are unquestionably the country's top diabetologists.
Today, we announced preliminary results from the first 700 patients enrolled. Those results showed a hypercortisolism prevalence rate of 24% far higher than many in the medical community are believed to be the case in this population. This is a 2-part study. The prevalence portion of CATALYST continues to enroll patients those diagnosed with hypercortisolism can enroll in the treatment phase. The final results from the prevalence phase will be presented in a keynote session at the American Diabetes Association's Annual Meeting in June. The results of the CATALYST study will undoubtedly stimulate physicians to screen patients for hypercortisolism and many more than are currently identified will be found. Corcept is well positioned to help them.
For more than a decade, we have invested in patient advocacy and education and patient support services that are all based on understanding the journey and needs of an individual diagnosed with hypercortisolism. Our team is proud of these programs, and we are prepared to help what we know will be a growing number of patients in the years to come.
As the awareness and diagnosis of Cushing's syndrome increases, we are working with a great sense of urgency to advance relacorilant. This sense of urgency comes from knowing that the compound has compelling efficacy without many of the significant side effects of Korlym. All of our proprietary compounds, including relacorilant, modulate cortisol effects by binding to the group of corticoid receptor, a receptor, which is activated when cortisol levels are high. They do not bind to the progesterone receptor and therefore, don't cause some of Korlym's most serious off-target effects. We are evaluating relacorilant for the treatment of hypercortisolism in 2 Phase III trials GRACE and GRADIENT. We expect GRACE to serve as the basis for our NDA submission in Cushing's syndrome and to build on relacorilant's positive Phase II efficacy and safety data.
Patients experienced meaningful improvements in hypertension and glucose control as well as the other signs of symptoms of Cushing's syndrome in the Phase II study. Relacorilant did not cause progesterone related side effects, including endometrial thickening or vaginal bleeding. Relacorilant also did not cause drug-induced hypokalemia. Progesterone related side effects and hypokalemia are leading causes a Korlym discontinuation. Relacorilant's Phase II trial results were published in Frontiers of Endocrinology in July 2021.
Our second Phase III trial in hypercortisolism, gradient is studying relacorilant effects in patients whose Cushing's syndrome is caused by an adrenal adenoma or adrenal hyperplasia. Patients with this etiology of Cushing's syndrome often experience a less rapid decline, but their health outcomes are poor, including a significantly higher risk of premature death. While we do not expect our NDA in Cushing's syndrome to depend on efficacy data from GRADIENT, we do expect the study to provide valuable information about the treatment of an etiology of Cushing's syndrome that affects many patients.
It bears repeating that the first phase of our ongoing Phase IV CATALYST study reinforces the findings from many smaller studies indicating that hypercortisolism is far more prevalent than was previously assumed. The findings from CATALYST will be entirely relevant to relacorilant as it emerges.
As I said, we are working with great urgency and we are on track to submit our relacorilant Cushing's syndrome NDA in the second quarter. We are also studying relacorilant as a treatment for different types of cancer. Our most advanced oncology program is in platinum-resistant ovarian cancer, a legal cancer with few useful treatment options. There is great enthusiasm among the investigators participating in our Phase III ROSELLA trial. Enrollment in the study will close shortly, and data will be available by the end of this year. The goal of ROSELLA is simply to replicate our positive Phase II ovarian cancer trial results. ROSELLA's study design closely tracks our Phase II study with a planned enrollment of 360 women. Women enrolled in the study are randomized 1:1 to receive either relacorilant plus nab-paclitaxel or paclitaxel alone.
The primary endpoint is progression-free survival with overall survival, a key secondary end point. We are conducting this study in collaboration with leading clinicians from the Gynecological Oncology Group GOG in the United States and the European Network of Gynecological Oncology trials and GOT Group in Europe. In our successful controlled Phase II trial well correlate produced meaningful benefit to many women. While these women's disease have progressed on 2 or more previous lines of treatment, including previous taxanes, relacorilant appear to resensitize their tumors to chemotherapy's beneficial effects. Those have received relacorilant intermittently, the day before, the day of 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.
Women in the intermittent relacorilant group also live longer than those in the comparator arm. 29% of the patients who do dermitielacora were alive 2 years after study start versus only 14% who took nab-paclitaxel alone. The addition of relacorilant enhance the effect of chemotherapy likely by blunting cortisol's anti-apoptotic effect. Just as important, the women who receive relacorilant plus nab-paclitaxel experienced no additional side effect burden compared to those who took nab-paclitaxel alone.
The results from this study were published in the Journal of Clinical Oncology in June 2023 with an accompanying editorial. Results have been featured in podium presentations in the 2021 and 2022 European Society for Medical Oncology, ESMO meetings and the 2022 American Society of Clinical Oncology, ASCO Annual Meeting.
Leading gynecological oncologists have told us that relacorilant's potential benefit improved progression-free and overall survival without increased side effect burden would constitute an important medical advance and that relacorilant plus nab-paclitaxel has the potential to become a new standard of care in women with platinum-resistant ovarian cancer.
A second mechanism by which cortisol modulation may prove useful is by blocking in an important tumor growth pathway. Cortisol stimulation is a major reason why patients with prostate cancer treated with a widely prescribed androgen receptor antagonist enzalutamide, eventually experience resurgent disease. Deprived of androgen stimulation, their tumor switched to cortisol activity to stimulate GRIP. Our hypothesis is that adding a cortisol modulator to androgen deprivation therapy will close this tumor escape route. Our collaborators at the University of Chicago are enrolling a randomized placebo-controlled Phase II trial of relacorilant plus enzalutamide in patients with prostate cancer before these patients have had an initial prostatectomy.
The third cortisol modulation mechanism seeks to treat tumors by enhancing the body's immune response. Cortisol suppresses the immune system, which may blunt the effectiveness of cancer therapies intended to stimulate the immune system. Our hypothesis is that adding a cortisol modulator to immunotherapies such as checkpoint inhibitors, may enhance the effectiveness of these therapies. We are conducting a Phase Ib trial of relacorilant plus the PD-1 checkpoint inhibitor pembrolizumab in patients with advanced adrenal cancer whose tumors produce excess cortisol.
Pembrolizumab is rarely effective as monotherapy in treating this form of adrenal cancer. While each of our compounds being evaluated in clinical studies selectively modulates cortisol activity, they are not identical, and they produce distinct clinical effects. Some cross the blood-brain barrier, others do not. Some perform investment models of solid tumors. Other more potent in models of metabolic disease. Some appear to be tissue specific, Others have more global effects. These diverse qualities allow us to study a wide variety of disorders using the best matched compound. One of these compounds, dazucorilant, has shown great promise in edible models of ALS improving motor performance and reducing neuroinflammation and muscular atrophy. As you know, ALS is a devastating disease with a very poor prognosis and limited options to halt progression. Our DAZALS trial is a randomized double-blind placebo-controlled Phase II trial of dazucorilant in patients with ALS. The primary endpoint is based on the ALS functional rating scale. The speed of enrollment in DAZALS our expectations. Enrollment will close shortly with data available by the end of this year.
Finally, I'll turn to our program in NASH, a serious liver disorder that afflicts millions of people in the United States. Miricorilant has demonstrated compelling early evidence as a treatment for NASH. Our Phase Ib dose-finding study found the patients who received 100 milligrams of miricorilant orally twice a week for 12 weeks experienced a 30% reduction in liver fat with improvement in liver enzymes, markers of fibrosis and key metabolic and lipid measures, including HOMA-IR, serum triglycerides and LDL. Importantly, miricorilant was also very well tolerated with no apparent GI side effects.
Forward to building on these promising results in our MONARCH study, a randomized, double-blind, placebo-controlled BACE IIb trial now actively enrolling patients with biopsy-confirmed NASH. The primary endpoint of the study is reduction in liver fat with NASH resolution and fibrosis improvement as key secondary endpoints.
In conclusion, we are extremely optimistic about the future of Corcept. Our Cushing's Syndrome franchise is built on a solid foundation, a foundation that is supported by scientific, medical and commercial expertise that we have been strengthening and holding for over 20 years. Our strong commercial results reflect the physicians are more regularly screening for hypercortisolism and underscore our ability to support them as they manage this complex disease. We expect the findings from our CATALYST study to help physicians better identify and treat patients whose difficult to treat diabetes is caused by hypercortisolism. A population whose Cushing's syndrome too frequently goes missed or undiagnosed.
Relacorilant has demonstrated tremendous promise as a treatment for patients with Cushing's syndrome, and we are on track to submit our NDA in the second quarter. Beyond Cushing's syndrome, our development programs are generating increasing evidence that cortisol modulation has the potential to treat a wide range of diseases. Ovarian cancer, prostate cancer, ALS and NASH are current examples. We have a broad and active research portfolio of many proprietary selective cortisol modulators with potentially very different clinical attributes. We will continue to invest in understanding these attributes in the potential therapeutic applications, and we will advance the most promising compounds to the clinic.
Over the course of this year, we expect data from our GRACE, GRADIENT and CATALYST studies in Cushing's syndrome, our pivotal Rosella trial in ovarian cancer and our DASL trial in ALS. This is an exciting time for Corcept.
I appreciate the efforts and dedication of our more than 350 employees who are working hard to achieve the ambitious goals we have set for ourselves.
Before we take questions, I want to take a moment to introduce Roberto Viera, who joined Corcept a few years ago. Roberto, as President of our Oncology Division is responsible for the commercialization of relacorilant in plate resistant ovarian cancer and the expansion of our oncology footprint. You'll have an opportunity to hear more from him over the course of 2024.
Operator, let's proceed now to questions.
[Operator Instructions] Our first question for today will be coming from Matt Kaplan.
Just wanted to start off first with the -- you're reiterating your guidance of $600 million to $630 million for 2024. Can you give us a little bit more color in terms of I guess, given the court's recent decision on the Teva case, why you're still confident and why you're reiterating the guidance that you had given before the court's decision?
Just 1 small point, but good to hear from you, Matt. Our guidance came after the court's decision, we are reiterating it here. Sean Maduck, who is President of our Endocrinology Division, we'll take this question.
Matt, thank you for the question. Our revenue guidance will always consider all the information that we have and our best estimates going forward. Our age includes a multitude of factors, including a potential type of launch in its impact. We have reiterated the range of $600 million to $630 million because we're confident in our ability to both grow our Korlym business and to defend our market share.
And then -- in terms of, I guess, maybe for Charlie, a legal update, you said that you remain confident in terms of being able to win the argument as you appeal the court's decision. Can you give us some more color in terms of where you thought -- where you think the court erred in this decision and why you think you'll be able to reverse it.
Yes. I mean Unfortunately, Matt, I really can't share sort of legal sort of deliberations as we work through. Obviously, given the matter a great deal of thought. But what I can say is what will really matter and will be available to and everyone is the brief as we file it, and I'm really going to have to let them speak for themselves. And we'll shortly be submitting our brief and everyone can take a look at it fit. And that's really the most I can tell you at this point.
Okay. Fair enough. And then, I guess, congrats on the initial results in the CATALYST study. 24% prevalence of hypercortisolism that's higher than, I guess, we had expected. And how does this translate -- help us translate this into potential market size and numbers of patients given that result?
Yes. Matt, I'll take that question. I think it's just really critical for people to understand that many people thought that the answer to that prevalence rate was going to be 0 or 0 to a couple of percent. That wasn't borne out by earlier evidence. There are many studies over the last decade that indicated in this group of patients, patients who have otherwise refractory diabetes, difficult to treat diabetes the results were substantial. There were substantial groups of patients with that. But no 1 has ever attempted as large a study in the way we did it prospectively or frankly, with the level of investigators who actually participated in this study. So I don't know exactly how that is going to reflect and what the final prevalence turns out to be. But what I can tell you is that it's substantially higher than what has previously been assumed. And what's been previously assumed, I'll remind you because we said it many times on this call, there were about 20,000 patients who had Cushing's syndrome and about half of them were cured with surgery. It's very clear to us right now that the actual overall prevalence or Cushing's syndrome is considerably higher than that.
And our next question is from Jen Wenyan of Canaccord.
Congrats on the results. from us -- so we understand that when the patient stops taking colon, the corridor level will begin to rebound within 4 to 5 weeks. And the randomized risk growth is in the great study is 12 weeks. So how confident are we that a statistical significant difference in the changes of blood pressure would be observed during that 12-week window.
I'm not sure I really understood the question, and so please tell me if in the end, I haven't answered what he said. But I think the question had to do with for patients who were successfully treated with Korlym, how long does it take for stopping for -- when you stop Korlym for their effects of the Korlym effects to rebound. And now remember, we're talking this million about Korlym not relacorilant. Our experience was much quicker than I think what I heard you said. Usually within a couple of weeks, we actually see a rebound for patients who stopped taking Korlym which frankly is a compelling reason for the high adherence rate we see with Korlym is, but when they stop taking their medicine, they get pretty much worse pretty quickly. We actually expect same sort of time line with relacorilant is that. Obviously, the study will give us the results to that. But we think that we have more than substantial length of time in order to see the rebound effect comes from not taking relacorilant in the upcoming study. .
Thank you. One moment for the next question. Our next question will be coming from David Amsellem of Piper Jefferies.
so I just had a few. So I wanted to come back to the generic of Korlym. And I got your comments. I guess I just wanted to get more color on the barriers to generic adoption that you think are in place. In other words, the specialty hub that serves all of these sort of high touch points that are related to Korlym? Is that something that ultimately proves to be a barrier to generics? And can you just talk about those dynamics? That's number one. And then secondly, you're talking about filing -- I'm sorry, filing in the second quarter on relacorilant, but you're also going to have top line data in the second quarter. So that's kind of a tight turnaround. So can you just talk about that and why you're confident you can file it so quickly? And then lastly, are you going to be running any additional trials on relacorilant to tease out long-term health benefits? Can you just talk about additional clinical work you might do to support that product.
Okay. So 3 different questions in 3 different areas, David. Thank you. The first 1 I'm going to point to Sean to talk about how we run our endocrinology business. Go ahead, Sean.
Yes. No, thank you for the question. And your question was specifically around sort of what we believe to be barriers to entry. And I'll just say that this is not your typical pharmaceutical market and supporting Korlym patients is far more than just filling a prescription. And automatic substitution does not happen at a Walgreens pharmacy tool like you see in a lot of these cases. We have a very high touch, tightly controlled model. Every prescription that is written kicks off multiple high-touch support initiatives to ensure that both the patient and the prescribing physician have the optimal experience. The only other thing I'd add here is that we spent over 12 years growing this business, and we've done that through the development of a deep understanding of the market and building very strong relationships with providers. Korlym is a very promotionally sensitive drug, and we have all the pieces go through the initial part of the process of education of a position through the filing of that precription.
Charlie, would you take the question about the NDA, please?
Sure. Just a little background for those who don't know this process is, I'm sure David does a new drug application, which is what we're going to submit for relacorilant in Cushing's syndrome in the second quarter. Really, it's a really -- it's a substantial document. It's a lot of work. And so that's why I think David was asking a very good question. But I think what people also may not understand is that much of the information and analysis that you submit in the new drug application stems from work that we that is done years before the last patient leaves the pivotal study. So think of all of the preclinical research that's done, all of the Phase I trials, the drug-drug interaction studies, the manufacturing development work. All this makes up a really substantial part of the NDA submission to the FDA and we've been working on that for almost a year now. So the reason we'll be able to submit this so quickly is that a great deal of the work will be complete before the last patient leaves the GRACE study. And we will be ready, therefore to file really promptly after that. That's why we're confident.
Thank you, Charlie. And Bill Guyer, who is our Chief Development Officer, will answer the question about relacorilant and then longer-term use. .
Yes. long-term data. So thank you for that question. So there's a study that's actually ongoing. We don't talk about much. and it's a long-term extension trial. And so that is a study that is taking patients from our Phase II trial. They can roll into the long-term extension trial. GRACE and GRADIENT when they completed those trials, they can roll into that long-term extension trial. At this point in time, we have patients out 6 years in that long-term extension trial. We're going to continue that study throughout to continue to provide long-term data on the safety and efficacy of relacorilant for patients with Cushing's syndrome.
Thank you, Bill.
We the next question. Then our next question will be coming from .
This is R. J. from its Wainright. I have a few questions. So I'm going to kind of ask if you don't mind, 1 at a time. The first 1 is on the guidance itself. So you're kind of guiding -- if I take the midpoint, you're guiding for like 27% increase from where we are now. And in '23, you grew about 20%. So I'm just trying to understand the tremendous growth that you're expecting from where you are now. So what is included in that? How much of that is price increase. And in terms of market growth itself, where do you see that market growth coming from? -- because in the fourth quarter, we didn't see that jump -- that's quite of a rate compared to Q3.
I think I got the question. It's a little bit difficult to hear. It sounded as if what you were asking was you'd like to know what are the components of the growth that we see currently in the market and where we think it's going in the future. So I think that's about right. Now it's not let us let us know, but I'll turn that over to Sean.
Yes. No, thank you for the question. In terms of, I guess, the range I mentioned earlier, it takes in a multitude of factors. And the biggest obviously right now is that we have more physicians prescribing Korlym and more patients being prescribed from each physician over the last year and growth that we see in treatment. We've added new patients from both existing and new prescribers or the country. And we're really pleased with the results we've seen. It's been driven by improved field execution, and we're starting to see sort of early returns from some of the investments that we've made, both on the sales force side and on the disease education side. And 1 of the areas of growth in our business has been on the sales force expansion, and I wanted to update you on that. In terms of where that team is at now, we're currently at about 70 clinical specialists. And we're planning -- continuing to add clinical specialists throughout the country. Our target right now is 100, and we're unlikely to stop there, and we'll continue to add top talent as we find it throughout the country. But -- we believe that expansion is going to also help drive growth.
Let me just sum that up for you, RK. More doctors prescribing and more patients from each doctor. It's a trend which really got very strong toward the end of last year, and we're seeing it continue as we speak.
Is there a price in please include that in this .
I couldn't hear the question.
There price increase included in this, there's not an additional price increase included in the range for this year. We took a price increase on January 1 of this year, 9.49%. We realized about 6.5% of that, but there is no other price increase included in that number.
Okay. And then on the diabetes population itself, talking about -- I'm trying to understand a little bit more about how the CATALYST data is going to help you out. So to start off, in terms of the percent of population, the diabetes population who are considered difficult to treat, can you give us a number. Like what percentage of the diabetes population is considered that -- and then do you need to do -- you need to -- how do you plan to include that into your label? Is this going to be -- do you need to file something? Or how does it work?
Yes. So the answer -- the first question you were asking, RK was what percentage are difficult to treat diabetics and that's specifically defined in the protocol, patients who have hemoglobin A1cs despite having multiple treatments and optimal care. So -- and those patients have been on all of the modern medicine. We've been told by our experts, the diabetologists...
That doesn't percentage just defines who is considered that, but what percentage of population is that? .
I'm getting there. the percentage of the population that a diabetic population that's considered to be in that group, difficult to treat diabetics is about 1/4.
Okay.
And the second question, Sean?
Yes, I'm happy to take the second question. So the question was, are we going to have to file to have this included within our label, this CATALYST patient population. These patients are already included in our label. I'm going to read you the label right now and sort of highlight exactly that fact. What's our label, our indication statement. is a cortisol receptor blocker indicated to control hyperglycemia, secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome with type 2 diabetes mellitus or glucose intolerance and a failed surgery or are not candidates for surgery. That is a clear and exact description of the patients that. Next question please.
SP1 And we have a follow-up question from David Amsellem. of Piper.
Yes. Just a follow-up. So to the extent that the 2 other generic Sun and Hikma enter the market later this year, -- does that change how you think about your sales expectations? Or does your 600 to 630 contemplate 3 generic entrants by the second half of this year?
I heard the question. Thank you. .
Yes, our guidance includes all those scenarios. And I just want to state that we've been thinking about this for a long time, and we've been prepared for this possibility since 2020. We have a plan in place, and we will continue to revise that plan as we receive new market intelligence. And as I said before, we're continuing to invest in our own business, and we're confident in our ability to both grow and protect the share that we have. But yes, all of those scenarios are included in our focus. The next question. .
And our next question will be coming from Julie of Truist.
Thanks for the update. So 24% of the quarter of 30 million diabetics in the U.S. is an attractive opportunity, but with the Phase III prices not having hypoglycemia as an endpoint spelled out, represent a to utilization of relacorilant in diabetics or do you think the data from the Gradient could be supportive there. And also with the orphan pricing of Korlym or relacorilant be prohibited in the utilization? And I have a follow-up.
Yes. June, I'm very glad that you asked the first question because it really gives us an opportunity to really clarify what the situation is. Bill, could you please take that one?
So yes, for the GRACE trial, we have a primary end fund blood so blood pressure control and a secondary endpoint of glycemic control. And so what we do is we have a hierarchy when we meet our blood pressure control, we plan to then have that as our primary endpoint. And therefore, we then move in the hierarchy to glucose control. And we expect to meet both of those end points and we expect to have a robust response to both hypertension and diabetes control as well as other comorbidities. And based upon meeting all those endpoints, we expect a broad indication for relacorilant.
I think that's really an important thing. I'm just going to emphasize that I don't have anything different to say than Bill said, just I want to just underscore that is our anticipated label for relacorilant is to treat Cushing's syndrome. There are many variables that we're measuring in that setting. And in the hierarchy, hypertension is at the top of the list. But glucose intolerance is on that list as are many other endpoints that describe Cushing's syndrome. It's probably 20 different endpoints because Cushing's syndrome is a syndrome caused by excess cortisol activity. Cortisol goes everywhere in the body and many things go on what people have Cushing's syndrome. Now you have to really an interesting question about price as we go forward, and that really is something that we really have to think about as the market the largest and then the largest, the largest. And we don't know if someone -- I asked -- I answered it to an earlier question, exactly what the market size is. but we will certainly take all those things into account as we go forward. One thing I want to just emphasize at this point is that we have not seen a single bit of influence yet from the catalyst information, not a patient. So it will be very interesting to see where that goes over time. .
Looking forward to the full data. And on generic, are you seeing any impact to Korlym since Tevo's generic on 6 weeks ago? And have you or do you plan to institute any new sales strategy in response to generic both.
Jule, I'm going to give you back to Sean for that question.
Yes. Jin, thanks for the question. There has been no impact to our business since have announced its launch. We have seen no evidence of generic mifepristone in the marketplace, and we're monitoring daily. And to your second question, I'm not going to go into any specifics, but again, we've been prepared. We have a plan in place and more to follow.
Thank you. There are no further questions in the queue.
All right. Well, thank you, everybody, and look forward to 3 months again speaking with you again, and hope you have a good rest of the winter and early spring. .
Thank you all for joining today's conference call. You may disconnect.