Q4 2023 Corcept Therapeutics Inc Earnings Call
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I'd like to turn the call over to out of box Macquarie. 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 are available of course that dot com.
Our complete financial results will be available when we file our Form 10-K with the FCC.
Today's call is being recorded a replay will be available at the investors past events tab of our website.
Statements during this call other than statements of historical fact are forward.
Looking statements based on our plans and expectations and are subject to risks and uncertainties, which may cause actual results to differ materially.
It's expressed or implied.
These forward looking statements are described in today's press release.
Risks and uncertainties that may affect that 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.
We disclaim any intention or duty to update forward looking statements.
Our revenue in the fourth quarter of 2023 was $135 million, an increase of 31% compared to the fourth quarter of the prior year.
We expect our revenue growth to continue and are reiterating 'twenty 'twenty four revenue guidance of 600 $630 million.
<unk> 2023 revenue for.
<unk> hundred $82 $4 million.
Net income was $31 $4 million in the fourth quarter and $106 1 million for the full year of 2020.
Our cash and investments at December 31, 425 $4 million.
I will now turn the call over to Charlie Robb, our Chief business officer to provide a legal update.
Charlie.
Thanks, Adam.
In March 2018, we sued Teva pharmaceuticals to prevent it from marketing a generic version of Korlym in violation of our patents case went to trial in Federal District Court in September of last year.
Charlie Robb: On December 29 court found that Kevin's generic product would not infringe the patents we have asserted against it.
Charlie Robb: We believe the court's verdict is wrong. It was based on a misunderstanding of the law.
Currently we are seeking its reversal by the federal Circuit Court of Appeals.
It is impossible to predict exactly how long the appeal briefing.
Briefing will be complete no later than May our opening brief is due March nine.
Charlie Robb: We'll have up to 40 days after we filed to respond our.
<unk>.
Charlie Robb: Closing the breaching cycle will be due no later than 21 days after that.
These documents will be publicly available on the internet.
<unk> web site.
We can complete the timing of oral argument and insurance in our opinion are entirely up to the court.
Based on past practice, it's reasonable to expect oral arguments in the fourth quarter of this year and a decision early in the first quarter of 2025.
Charlie Robb: If we prevail.
Charlie Robb: Kevin would lead to FDA approval of its product at least until the expiration of our patents and 2037.
Charlie Robb: We are eager to advance this appeal.
Charlie Robb: I always been the case, we strongly believe that our position as the correct. One we are confident that the federal circuit.
Deep expertise in this area of the work will agree.
Charlie Robb: I will now turn the call over to Joe <unk>, Our Chief Executive Officer, Joe.
Thank you Charlie and thank you to everyone for joining us this afternoon.
On a box highlighted our strong commercial performance and the revenue guidance, we have set for 2024.
Joe: Weeks ago, I had the opportunity to meet our endocrinology team international yield meeting the enthusiasm about our prospects in hyper cortisol.
We have the opportunity.
<unk> to help many more patients with Cushings syndrome.
Reaching a tipping point of sorts and medical field increasingly understanding that hyper cortisol is far more prevalent than was previously assumed.
Our ongoing phase four catalyst study reinforced this emerging understanding and I believe the study will be a landmark and guiding the future screening and accurate diagnosis of patients with Cushings syndrome.
Catalyst is the largest clinical trial ever conducted to examine the prevalence of hyper cortisol patients with difficult to treat type two diabetes. It's.
Joe: Its investigators are unquestionably the country's top diabetologist.
Today, we announced preliminary results from the first 700 patients enroll.
Those results showed a hyper cortisol prevalence rate of 24%.
Our higher than many of the medical community I believe to be the case in this population.
This is a two part study the prevalence portion of catalyst continues to enroll patients those diagnosed with type of cortisol and enrolling the treatment phase and final results from the prevalent space will be presented in a keynote session at the American Diabetes Association annual meeting in June.
The result of the catalyst study will undoubtedly stimulator physicians to screen patients for hydrocortisone cortisol Ism and many more than are currently identified will be down.
Joe: Of course that is well positioned to help them.
For more than a decade, we've 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 type of cortisol list.
Joe: Our team is proud of these programs and we are prepared to help what.
Joe: What we know will be a growing number of patients in the years to come.
Joe: As the awareness and diagnosis Cushing syndrome increases we are working with a great sense of urgency to advance Marella korlym it.
This sense of urgency comes from knowing that the compound is compelling efficacy without many of the significant side effects of korlym.
All of our proprietary compounds, including rella, Korlym modulate cortisol setbacks by binding to the glucocorticoid receptor receptor, which is activated on cortisol levels are high.
They do not bind to the progesterone receptor and therefore don't cause korlym is most serious off target effects.
We are evaluating rella korlym for the treatment of hyper quarters I'll listen in two phase III trials Grace and gradient.
We expect grace to serve as the basis for our NDA submission in Cushings syndrome and to build on <unk> positive phase III efficacy and safety data.
She has experienced meaningful improvements in hypertension, and glucose control as well as well as the other signs of symptoms of Cushing syndrome, and a phase two study.
<unk> did not cause progesterone related side effects, including endometrial thickening or vaginal bleeding.
Rather korlym also did not cause drug induced hypokalemia.
<unk> related side effects, and hypokalemia are leading causes of korlym discontinuation.
Joe: Well the Korlym phase two trial results were published in Brent Pearson Endocrinology in July 2021.
Our second phase III trial in hyper quarter solid gradient studying relic Orleans effects in patients with Cushings syndrome is caused by an adrenal adenomas or adrenal hyperplasia.
Patients with this etiology of Cushing syndrome, often experience less rapid decline, but their health outcomes are poor, including a significantly higher risk premature death.
Joe: While we do not expect our NDA cushings syndrome, which depend on efficacy data from gradient. We do expect the study to provide valuable information about the treatment of an etiology Cushings syndrome X many patients.
It bears repeating that the first phase of our ongoing phase four catalyst study reinforces the findings for many smaller studies, indicating the hyper cortisol listen these are more prevalent than was previously assumed.
The findings from catalyst will be entirely relevant to quarter to rella Cortland as it emerges.
As I said, we are working with great urgency and we are on track to submit a relic Cortland Cushings syndrome NDA in the second quarter.
We are also studying rolla korlym as a treatment for different types of cancer.
Our most advanced oncology program is in platinum resistant ovarian cancer, a lethal cancer with few useful treatment options there.
There is great enthusiasm among the investigators participating in our phase III Red cell trial.
Enrollment in this study will close shortly and data will be available by the end of this year.
The goal of rosella simply to replicate our positive phase two ovarian cancer trial results.
Brazil, a study design closely tracks, our phase II study with a planned enrollment of 360 women.
Women enrolled in this study are randomized one to one to receive either relic korlym, plus Nab paclitaxel or Nab Paclitaxel alone.
The primary endpoint is progression free survival with overall survival of key secondary endpoints.
We are conducting this study in collaboration leading clinicians from the gynecological oncology group.
In the United States and the European network of Gynecological oncology trials and got group in Europe.
And our successful controlled phase II trial, rella color, well korlym to produce meaningful benefit to many women.
While these women's disease had progressed on two or more previous lines of treatment, including previous Taxane rella Korlym can appear to re sensitize their tumors to chemotherapy has beneficial effects.
Joe: Those are received rella korlym intermittently the day before the day.
And the day after they receive Nab paclitaxel exhibited statistically significant improvement in progression free survival and duration of response compared to receive Nab Paclitaxel monotherapy.
Women in the intermittent rella Korlym also lived longer than those in the comparator arm, 29% of the patients.
Ralcorp.
Two years after study start.
It is only 14% you took nab paclitaxel.
The addition of rail korlym enhance the effects of chemotherapy likely by blunting cortisol anti apoptotic effect.
Just as important women, who received Korlym plus Nab paclitaxel experienced no additional side effect burden compared to those who took not paclitaxel alone.
The results from this study were published in the journal of clinical oncology in June 2023, with an accompanying editorial.
<unk> have been featured in podium presentations and the 2021 and 2022 European Society for medical oncology ESMO meeting.
And then 2022 American society of clinical oncology <unk> annual meeting.
Joe: Leading gynecological oncologists have told us that relic Orleans potential benefit.
Joe: Improved progression free and overall survival without increased side effect burden would constitute an important medical advance in that realm of Korlym plus Nab Paclitaxel has the potential new standard of care in women with platinum resistant ovarian cancer.
Our second mechanisms by which cortisol modulation may prove useful 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 and solidified eventually experienced resurgent disease.
<unk> androgen stimulation there are tumors switched a cortisol activity stimulate growth.
Our hypothesis is that adding a cortisol modulator to androgen deprivation therapy and closed this tumor escape route.
Joe: Our collaborators at the University of Chicago are enrolling the randomized placebo controlled phase II trial umbrella Orland plus <unk> in patients with prostate cancer before these patients have had an initial prostatectomy.
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.
Joe: 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 one b trial umbrella korlym plus the PD, one checkpoint inhibitor embolism app to patients with advanced adrenal cancer, whose tumors produce excess cortisol.
Ambarella is a mab is rarely effective as mono therapy in treating this form of adrenal cancer.
While each of our compounds being evaluated in clinical studies selectively modulate cortisol activity.
Not identical and they produce distinct clinical effects.
Joe: <unk> cross the blood brain barrier, others do not some perform best in models of solid solid tumors, others are more important 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 task of Korlym is showing great promise in animal models of AOS, improving motor performance, and reducing neuro inflammation and muscular atrophy.
As you know ALS is a devastating disease with very poor prognosis and limited options to haul for slow its progression.
Our Dazzles trial is a randomized double blind placebo controlled phase two trial of task of Korlym in patients with ALS. The primary endpoint is based on the ALS functional rating scale.
Speed of enrollment and Dazzles exceeded 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.
Mirror Korlym has demonstrated compelling early evidence as a treatment for Nash our phase <unk> dose finding study and the patients who received 100 milligrams of mirror Korlym orally twice a week for 12 weeks experienced 30% reduction in liver fat with improvement in liver enzymes markers of fibrosis.
Joe: And key metabolic and lipid measures, including Homa, IR serum triglycerides and LDL.
Joe: Importantly, we require alone was also very well tolerated with no apparent Gi side effects.
Look forward to building on these promising results in our monarch study a randomized double blind placebo controlled phase two b trial now actively enrolling patients with biopsy confirmed Nash.
The primary endpoint of this 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 course.
Our Cushings syndrome franchise is built on a solid Foundation foundation.
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 positions are more regularly screening for hyper cortisol listen and underscore our ability to support them as they manage this complex disease.
Joe: We expect the findings from our catalyst study to help physicians better identify and treat patients whose difficult to treat diabetes is caused by hyper cortisol isn't a.
Population, whose cushings syndrome, too frequently goes miss or undiagnosed.
Joe: Rolla Korlym has demonstrated tremendous promise as a treatment for patients with Cushings syndrome, and we are on track to submit our NDA in the second quarter.
Beyond Cushings 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 <unk> and Nash are current examples we have abroad 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 and their potential therapeutic applications.
Joe: 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 syndrome are pivotal <unk> trial in ovarian cancer and our Dazzles trial in ALS.
This is an exciting time for <unk>.
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 or Toby era, who joined <unk> a few years ago.
Roberto as President of our oncology Division is responsible for the commercialization of <unk> in platinum 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.
Thank you would you like to ask a question. Please press star one on your telephone.
As a reminder, please wait for your name and company to be called before you proceed with your question.
One moment, while we compile the Q&A roster.
Our first question for today will be coming from Matt Kaplan of.
Matt Kaplan: Your line is open.
Matt Kaplan: Hey, guys.
Thanks for taking the questions just wanted to start off.
First with but 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 that courts decision.
Just one small point, but it's good to hear from you Matt.
Our guidance came after the court's decision. Okay. We are reiterating here.
Sean Duke who is president of our Endocrinology Division will take this question and Matt. Thank you for the question our revenue guidance, we'll always consider all the information that we have on our best estimates going forward. Our range includes a multitude of factors, including a potential type of launch of its impact.
We have reiterated the range of 600 to 630, because we're confident in our ability to both grow our own business and to defend our market share.
And then.
Matt Kaplan: In terms of I guess, maybe for Charlie a legal update.
You said that.
We remain confident in terms of.
Charlie Robb: Being able to win the argument as you appeal with the court's decision can you give us some more color in terms of.
Where are your thoughts what do you think the court erred in its decision and why you think you'll be able to reverse that.
Yes.
Unfortunately, Matt I really can't share sort of our <unk>.
Legal deliberations as we work through obviously haven't given the matter a great deal of thought but what I can say is what will really matter and will be available to everyone is the brief as we file it and I'm really going to have to let them speak for themselves and we will shortly be submitting our brief and you and everyone can.
Take a look at it.
And that's really the most I can tell you at this point.
Speaker Change: Okay fair enough.
And then.
I guess congrats on the.
The initial results from the catalyst study.
24%.
Uh huh.
Prevalence.
Of Hypercard, it's awesome.
That's higher than than I guess.
Speaker Change: We had expected.
Speaker Change: How does this translate help us translate this into <unk>.
Actual market size and number of patients given given that result.
Speaker Change: Yes, Matt I'll take that question I think it just really critical for people to understand that many people thought that the answer to that prevalence rate was going to be zero or zero to a couple of percent that wasn't born out by earlier evidence. There are many studies over the last decade that indicated in this group of.
Patients patients, who have otherwise with refractory diabetes difficult to treat diabetes, but the results were substantial there were substantial groups of patients with that but no. One would ever attempted as largest study and the way, we do that prospectively or frankly with the level of investigators who actually participated in this study.
Speaker Change: So I don't know exactly how that is going to reflect in what I don't prevalence turns out to be but what I can tell you is and its 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 20000 patients who had cushings syndrome and about half of them are matured.
But surgery, it's very clear to us right now the actual overall prevalence.
Cushing syndrome is considerably higher than that.
Alright.
Well.
I'll jump back in queue. Thanks for taking my questions. Thank you Matt.
Thank you.
Speaker Change: Next question.
And our next question is from Dan when he.
Of Canaccord your line is open.
Dan: Hi team congrats.
Congrats on the results and thank you for taking the question from US So we understand that when the patient stops taking korlym accordingly.
According to levels begin to rebound with the four to five weeks.
Dan: The randomized withdrawal phase in the Grace study is 12 weeks. So how confident are we that is 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. So please tell me if in the end I haven't answered what you said, but I think the question had to do with our patients who were successfully treated with rollout how how long does it take for stopping.
Right.
When you stop Korlym for there.
The effects of the Korlym.
Dan: Effects to rebound.
Dan: And now we remember we're talking at this milling about korlym not correlate our experience was much quicker than I think what I heard you said usually within a couple of weeks, we actually see rebound of patients stop taking korlym, which frankly is a.
A compelling reason for the high adherence rate, we see with Korlym when they stop taking their medicine, they get pre pretty much worse pretty quickly. We actually expect same sort of timeline with korlym does that obviously the study will give us the results to that but we think that we have.
No.
More of that are more than substantial length of time in order to see the rebound effect that comes from not taking relative korlym and the upcoming study.
Okay. Thank you.
Thank you one moment for the next question.
And our next question will be coming from David Awesome.
Of Piper Jaffray. Your line is open.
Hey, Thanks, just had a few so I wanted to come back to.
The generic korlym.
I got your comments I guess I just wanted to get more color on.
The.
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.
Can you just talk about those dynamics.
Number one and then secondly, youre talking about filing.
Sorry filing in the second quarter on Raila Korlym, but you're also going to have topline 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 raila korlym to tease out long term health benefits can you just talk about.
Additional clinical work you might do to support that product. Thank you.
Okay. So three different questions in three different areas. David. Thank you first of all and then I'm going to point to Sean to talk about how we run our endocrinology business go ahead, yes. 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 true.
Difficult pharmaceutical market and supporting Carlin patients, thus far more than just filling a prescription and automatic substitution does not happen at a walgreens pharmacy till like you'd see in a lot of these cases, we have a very high touch tightly controlled model every prescription that is written kicks up multiple high touch support initiatives to ensure that the patient.
And the prescribing physician have the optimal experience.
The other thing I would add here is that we spent over 12 years growing this business.
We've done that through the development of a deep understanding of the market and by building very strong relationships with providers Korlym is a very <unk>.
Promotional sensitive drug.
Have all the pieces go through the the initial part of the process of education of our position through the filling it up.
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.
New drug application, which is what we're going to submit for Reliv correlating Cushing syndrome.
In the second quarter really is a it's a.
So really it's a substantial document it's a lot of work and so that's why I think David's asking very good question, but I think what people also may not understand is that much of the information analysis submitted a new drug application stemmed from work that is done years before the last patient needs the pivotal study.
Dan: So think of all of the.
The preclinical research that's done all of the phase one trials the drug drug interaction studies the manufacturing development work. All of this is 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 will 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.
Already there.
File really promptly after that that's why we're confident.
Charlie and Bill Guyer, who is our Chief development Officer will answer the question.
<unk> and then longer term long term data. So thank you for that question. So there is a study thats actually ongoing we don't talk about much and it's a long term extension trial. So that is a study that is taking patients from our phase two trial that can roll into the long term extension trial Grace and great. When they completed those trials make enrollment to that long term extension trial.
At this point in time, we have patients out six years and that long term extension trial, we're going to continue that steady throughout to continue to provide long term data on the safety and efficacy around the chronic patients with Cushings syndrome.
Thank you Bill.
Next question please.
Thank you.
And one moment for the next question.
And our next question will be coming from.
Paula.
<unk> eight.
H C. Wainwright your line is open.
Thank you this is RK from H C Wainwright.
I have few questions, so I'm going to kind of.
Online.
RK: One at a time.
The first one is on the guidance itself.
So youre kind of guiding.
If I take the mid point.
Regarding from the 27%.
Increase from where we are now.
<unk> see.
You grew about 20% so I'm just trying to understand.
The tremendous growth that youre 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 coming from.
In the fourth quarter, we didn't see that.
That's quite a high rate compared to Q3.
RK I think I got the question is a little bit difficult to hear it sounded as if you are asking was you'd like to know what are the components of the growth that we see currently in the market, where we think it is going in the future.
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.
Sean: In terms of.
I guess the range.
And earlier in a multitude of factors and the biggest obviously right now is that we have more physicians prescribing korlym to more patients being prescribed for each position.
Over the last.
Year in growth that we see continuing we've added new patients for both existing and new prescribers around the country and we're really pleased with the results, we're seeing and driven by improved field execution and we've.
Sean: To see early returns from some of the investments that we've made both on the Salesforce side and on the disease education side and.
One of the areas.
Growth on our business has been on the sales force expansion, but I wanted to update you on that in terms of where the teams are now. We're currently at about 70 clinical specialists and we're cleaning are continuing to add clinical specialists around 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.
We believe that that expansion is going to also help drive.
Let me just sum that up for you RK.
More doctors prescribing and more patients from each doctor.
A trend, which really got very strong towards the end of last year and we're seeing it continue as we speak.
Is that a PRASM. Please include it in this.
So I can't I can't.
Is there a price increase included in this there is not.
Sean: Additional price increase included in the range for this year, we took a price increase on January one of this year, 949%.
Realize about six 5% of that but there's no other price increase included.
Okay and then.
Hum.
On the dot on the diabetes population itself.
I'm talking about trying to understand a little bit more about how the cabinets data is going to help you out.
So to start off in terms of.
The percent of population by diabetes population who are considered.
Nickel to treat.
Sean: Yes.
Can you give us a member like what percentage of the diabetes population is going to do that.
Then.
Do you need to do.
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 that work.
Yes.
I think the answer.
First question you were asking RK was what percentage are difficult to treat diabetics and thats specifically defined in the protocol patients who have.
Hemoglobin <unk>, despite having multiple treatments and optimal care. So in those patients who've been on all of the modern medicine, we've been told by our experts the diabetes that doesn't get firsthand.
<unk>, who is considered that.
What percentage of populations.
<unk>.
I'm getting there.
<unk> of the population that diabetic population that is considered to be in that group difficult.
To treat diabetic is about a quarter.
Okay.
Okay. Thanks.
Speaker Change: And the second question, Sean Yes, Im happy to take the second question. So the question was are we going to have to file to have this included within our label, but this catalyst catalyst patient population.
These patients are already included in our label.
Im going to redo the labor right now and sort of highlight exactly that shock, what's our label indication statement Korlym mifepristone is a cortisol receptor blocker indicated to control hyperglycemia secondary to hyper cortisol rhythm in adult patients with endogenous Cushings syndrome type two diabetes mellitus are glucose intolerance and a failed surgery or are not candidates for <unk>.
Surgery.
<unk>.
As a clear and exact description of the patient certain counts.
Speaker Change: Yes.
Speaker Change: Next question please.
Thank you the next question.
And we have a follow up question from David <unk>.
Of Piper Jaffray.
Please.
Yes.
David: Follow up so to the extent that.
Two other generic sun in Hikma and so the market later this year.
Does that change how you think about your sales expectations or does your 600 to 630 contemplate three generic entrants.
But in the second half of this year. Thank you.
Speaker Change: You heard the questions. Yes. Thank you, yes. Our guidance includes all of the scenarios I just want to state that we have been thinking about this for a long time and we've been preparing for this possibility such as 2020, we have a plan in place and we will continue to rise the plant as we received new market intelligence and as I said before and we're continuing to invest in our own business and we're confident in our ability.
We both grow and protect the share that we have but yes all of those scenarios are.
Speaker Change: Yes.
Thank you.
The next question.
And our next question will be coming from Julie If truth. Your line is open.
Thanks for the update and for taking our questions.
Yes, it's three 4%.
So 24% of the core.
<unk> 30 million diabetics in the U S is an attractive opportunity but.
With the phase III <unk>, not having appropriate that I see as an endpoint spelled out represent a headwind to utilization.
<unk> and diabetics or.
Do you think the data from the gradient could be supportive there.
And also.
Orphan pricing.
Yes.
Korlym or Raleigh, Portland 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 endpoint of blood glucose or blood pressure control and a secondary endpoint.
I'm in 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 that hierarchy to glucose control and we expect to meet both of those endpoints and we expect to have a robust response to both hypertension and diabetes control as well as other comorbidities and based upon meeting all of those endpoints, we expect abroad.
Indications from rally Korlym.
I think thats really an important thing and I'm, just going to emphasize and I don't have anything different to say that Bill said just I wanted to just underscore that is our anticipated label for relevant loral. It is to treat Cushing syndrome. There are many variables that we're measuring and that unnecessarily in the hierarchy hypertension is at the top of the list, but glucose intolerance.
Speaker Change: <unk> is on that list as are many other endpoints to describe Cushing syndrome.
Probably 20 different endpoints because switching cushings syndrome is a syndrome caused by excess cortisol activity cortisol cortisol goes everywhere in the body and many things go we're on what people have Cushing syndrome.
Yes.
An interesting question about price as we go forward and Thats.
That really is something that we really have to think about as the market and the largest and the largest the largest and we don't know if someone asked and answered to an earlier question on exactly what the market sizes, but we will certainly take all of 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.
A patient so it will be very interesting to see where that goes over time.
Yes.
Alright, looking forward to the full data and on generic are you seeing any impact to korlym since Teva generic launch six eight weeks ago and have you or the plan to institute any new sales strategy.
Speaker Change: Our response to generic months. Thank you.
I'm going to give you back to Sean for that question, Yes, Jay. Thanks for the question there has been no impact to our business since <unk> announced its launch we have seen no evidence of generic mifepristone in the marketplace and we're monitoring 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.
Thank you there are no further questions in the queue.
Alright, well, thank you everybody and look forward to three months can you again speaking with you again.
Good rest of the winter and early spring.
Okay.
Thank you all for joining today today's conference call you may disconnect.
Okay.
Yes.
Speaker Change: Okay.
Okay.
Yes.
Okay.
[music].
Okay.
Okay.