Q1 2021 Corcept Therapeutics Inc Earnings Call
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8720 to 77.
Your first and last name with spelling.
John Brown J O H N.
B R O W N.
And for a number for you please.
907, 8253 for for zero too.
And the company of the work for.
Error AI E R. A.
Your line placed on to the course of Therapeutics call.
Thank you.
Very welcome.
We have powered the trial of <unk>, 30% reduction after 12 weeks. These patients exhibit of the reductions ranging from 38, 5% 73, 8% after receiving mirror correlate for just for the six weeks.
Further the mris that measure of these data were performed 19th of 64 days after cessation of dosing.
Which suggest either that the reductions have been greater when dosing actually stopped when it mirror <unk> effect is durable or some combination of the two.
The purpose of the phase Iia trial is to confirm the drug is active and to determine the appropriate dose range for further study.
That measure of this trial was great success reductions in liver fat of this magnitude are rarely seen over any period of treatment. It.
It may be that the rapidity of Mira <unk> fat, reducing effect actually caused ASD and ALC to rise the law.
Liver may shed that breaking it down into fatty acid, which in excess of amounts irritate the liver.
On the outperform studies to determine the mirror Portland's optimum dose and dosing regimen.
We are excited to advance mirror korlym as a treatment for patients with Nash as.
As many of you know we are also evaluating mirror korlym as a potential treatment for patients with another serious.
Xolair anti psychotic induced weight gain.
In the United States 6 million people take anti psychotic medications, such as the land subpoena risperidone to treat illnesses, such as schizophrenia bipolar disorder and major depression.
While these drugs are very effective the exact steep price in the form of rapid and sustained weight gain cardiovascular disease and other metabolic disturbances.
<unk> can gain more than 50 pounds, while taking these medications and their life expectancy is decreased on average by 20 years due in part to increased cardiovascular events, such as heart attacks strokes.
We are conducting two double blind placebo controlled phase II trials of <unk> in patients with this disorder.
Gratitude and gratitude to.
These trials seek to build on the positive data from our study of mirror Cortland in healthy subjects.
Last year, we completed the phase <unk> trial in which 96 healthy subjects received olanzapine and either 600 milligrams of <unk> and 900 milligrams of mirror orally or placebo for 14 days subjects, who received mirror cortland gain significantly less weight and those who received placebo.
Also exhibited a smaller increase in triglycerides and in ASD and ALC, we plan to publish of paper describing these results later this year.
The gratitude trial is evaluating where the mirror korlym can reverse recent antipsychotic induced weight gain of 100 patients with schizophrenia or bipolar disorder, who will receive an addition to their established dose of antipsychotic medication in the 600 milligrams of <unk> or placebo for 12 weeks.
Gratitude is being conducted at 30 centers in the United States.
Our gratitude two study is testing mirror korlym as a treatment for long standing antipsychotic induced weight gain.
150 patients with schizophrenia will receive in addition to their established dose of anti psychotic medication, either 600 milligrams or 900 milligrams of mirror correlate or placebo for 26 weeks.
Our attitude to will be conducted of 35 centers in the United States. The primary endpoint in both studies is reduction in body weight.
Other important measures of metabolic activity will also be examined.
We expect to complete enrollment and gratitude to by the end of this year and of gratitude in mid 2022.
My discussion of our development program in Cushing syndrome syndrome, which continues to progress can be brief.
As many of you know we are evaluating relative correlate our planned successor to Korlym for the treatment of hyper cortisol ism in two phase III trials.
Reis ingredients to the.
Pete what I said earlier rella Cortland is the selective cortisol modulators like korlym it achieves its effects by competing with cortisol at the glucocorticoid receptor on.
Unlike korlym it does not bind to the progesterone receptor PR for short.
It is not the abortion pill and it does not cause other PR related side effects, including India, endometrial thickening and vaginal bleeding.
By of different mechanism Rella correlate also does not appear to cause hypokalemia low potassium of serious side effects experienced by 44% of patients Korlym <unk> pivotal trial.
Four of them induced hypokalemia is a leading cause of korlym discontinuation.
Our Grace trial has the planned enrollment of 130 patients with any etiology of Cushing syndrome at sites in the United States, Canada, Europe and Israel.
We are excited for it to complete.
<unk> phase II efficacy and safety data for strong patients experienced meaningful improvements in hypertension of glucose control as well as on a variety of other signs and symptoms of Cushing syndrome.
There were no relative correlate induced instances of endometrial thickening or Bachelor of bleeding and also no drug induced hypokalemia.
We and our investigators are eager to take race to the finish line.
We expect grades to serve as the basis for our NDA submission of <unk> Cushing syndrome, which we remain on track to submit in the second quarter of 2023.
Our second phase III trial gradient of studying relic Orleans effects in patients, whose cushings syndrome is caused by an adrenal adenoma or adrenal hyperplasia patient.
Patients with this etiology of Cushing syndrome, often experience of less rapid decline, but ultimately the health outcomes are poor.
<unk> is the planned enrollment of 130 patients and is being conducted at many of the sites participating in Grace.
<unk> is the first controlled study dedicated to patients with this type of Cushing syndrome.
While we do not expect our NDA in Cushings syndrome to depend on data from Radiant, we do expect that its findings will help improve the care of these increasingly recognized patients.
Finally, a brief word about court one on three $1 76, which has shown promise in animal models of ALS.
We are discussing our proposed development plan with leading clinicians in the FDA and plan to initiate a phase II trial by the end of this year.
In conclusion, our belief has always been the cortisol modulation can help treat many serious disorders.
Portland for patients with Cushings syndrome is one such treatments.
The clinical findings, we announced today positive results in women with platinum resistant ovarian cancer on railcar Owen is combined with Nab paclitaxel and large and rapid reductions in liver fat in patients with presumed national received mirror correlate take.
<unk> is a big step towards proving cortisol modulations broad worth.
While the pandemic depressed our first quarter financial results, we are confident growth will resume as conditions improve later this year.
Even in a difficult quarter, our commercial business generated more than enough cash to fund our advancing development activities.
At present, our oncology program is evaluating two of our propriety proprietary cortisol modulators in combination with three different anti cancer agents and for tumor types. Meanwhile, our metabolic program is conducting important trials in Nash and antipsychotic induced weight gain we continued.
To enroll patients in our flagship phase III trials of Rella correlates and Cushing syndrome.
Further studies are planned in other indications, we will advance <unk> 376 to treat patients with ALS later this year, new early stage compounds continued to advance towards the clinic.
The breadth of our program reflects the power of our fundamental scientific hypothesis cortisol modulation is a powerful therapeutic modality, we have proven that in patients with Cushings syndrome. Today, we added to the body of evidence that proves its worth for patients with other serious disorders.
Top here to answer questions.
Okay.
Yes.
Yeah.
And thank you as a reminder, if you would like to ask a question. Please signal by pressing star one on your telephone keypad.
If you're using the speaker phone. Please make sure. Your mute function is turned off to of all your signal to reach our equipment again press star one to ask the question, we'll pause for just a moment to allow everyone an opportunity the signal for questions.
And we'll go first to Chris Howerton with Jefferies.
Great wonderful of thanks, so much for taking the questions and congratulations on the certainly the the ovarian cancer data of Great result, there.
So maybe just just of yeah of course, so maybe just a couple of questions for me first on that program itself.
With the [noise].
Maybe if you could give us just on some of your initial thoughts in terms of what the phase III trial might look like there.
And I guess is there any opportunity whatsoever to have a discussion with the agency to say look these are clinically meaningful data is there any opportunity for an accelerated approval. So I guess, that's one general question or I suppose to there.
A quick one for Charlie on the legal update just wanted to clarify with respect to the P. G R that.
Teva can no longer challenge the validity of all arguments of validity or just those that were used during the pgi preceding.
Then the final question just relates to the commercial business.
Obviously.
Thank the discussion around dose titration and getting the right new patients to the right dose certainly makes a lot of sense, but I just wanted to check in on some of the the status of the existing patients.
If there is any of kind of changes with respect of discontinuation rates. Thanks.
Hey, Chris Thank.
Thank you very much for all of those questions and I'll.
Ill take a breath.
Just for a second and outside of these questions to various members of my executive team of our ear and then I'll come back of the year. So first let's take your patent question to Charlie.
Hi, Chris.
Teva is barred from using in district court any arguments it raised or could have raised before the patent office and that's actually quite a high standard it can't just be well, we didnt argue this because we didn't think of it at the time, but now we've thought of it so we'd like to throw it out there. They are they have to have essentially.
A very good reason.
And the the Classic example would be they just they learned something from discovery and the litigation that they did not know at the time of the P. G R. But in our case of discovery was over before the PDR was over so.
Nothing so I think that.
The they've got this very limited path and they will not be able to.
The challenge the validity in district Court Alright.
The question you asked on Chris I'll, let Andreas Grauer, our chief Medical officer of answering.
We'll be able to answer it which is potential design for the phase III study.
Yes. Thank you for the question I'm, obviously that is what we are working on very hard right now.
We will compare the combination of ROE requirement and.
Oh for all of the Courtland Nab Paclitaxel and I think we will look at the intermittent dose that based on the data that we have seen you know it seems to be the more effective.
The effective use of revenue Cortland in this particular tumor type.
And we will have to figure out what the best comparator true that it's most likely I think we will pick paclitaxel that makes a lot of sense as a comparator.
In the large face free trial alternative considerations are or we might look into the dealer's choice.
Comparator of where we get the investigators the opportunity between the number of.
The established standard and.
<unk> approved treatments for this condition.
<unk> will have to be figured out are dependent on the the.
As expected overall survival benefit that we would be looking for.
And that is obviously also a key factor for the ongoing trial that we're still waiting for its hot.
It's upgrading planning, but it will get to the launch of for a phase III trial.
To see the overall survival data from the study, Okay and Chris Let me handle your other question, which of course, we see intriguing one so it's Andreas just said we're already of the.
Really for the hooked up the.
Serious stage of planning for a phase III study on your question was the possible that the data would be sufficient to actually at the end of this study the results of all in to take that to the FDA to submitted the FDA and submit an NDA and the.
I'll give you the top line answer to that question is it's a slim possibility.
Our really our expectation is that we will have to do a phase III study, but let me give you a little bit more color on that it's highly likely that the primary endpoint for phase III study in fact for approval is overall survival and we're very pleased obviously with the.
Mystically significant improvement in progression free survival overall survival of will still be determined at this point.
And I'll leave it at this because obviously that data will come out towards the end of the year and we want to release other data as we have it we like what we're seeing.
We promised nothing at this point, but I can imagine an unusual circumstance where that data on overall survival was so strong.
It can lead to a discussion with the FDA at that point I don't want anybody to count on that I think it's not the likely direction, but yes, we're thinking about that in the same way the EUR.
The last questions you ask for commercial questions, Chris and I'm going to push us over to Sean The Duke who is our chief commercial officer, Hi, Chris Thanks for the questions.
Question was of a two part one one was around for the discontinuation of the existing patient basis or have you seen the change there and the answer to the that is no.
And your next question was around titration, so I thought I'd spend a minute talking about for what success looks like and what we need for sort of carload growth. It was really three key factors that were affected by the pandemic. One is of course of the ability to educate doctors on hyper partisan prism on korlym.
Two would be the doctor's ability to actually see their patients multiple times for an extensive work on prior to a diagnosis and then the last one being once the patient actually starts korlym.
On the frequent all of that's required with their physician to monitor progress on the guide of appropriate titration and with new patients that have come on during the pandemic. That's something that's really been it's been a challenge and the patience of either non titrated for titrated at a much more still right to get to the optimal dose on again directly related to durability.
<unk> to see their fish their position with the appropriate frequency or even their access to labs or the willingness to go and get lots of they may need to do so so you know on time as things open back up we believe the titration won't catch up but for the time being an aggregate of this has decreased our average overall of those.
Okay. Okay.
Okay.
The first of all of thanks for humour me on my questions and I'll hop back in the queue. Thanks again.
Thank you Chris.
We'll go next to or the he of HC Wainwright.
Hello Arthur.
Hey, good afternoon gentlemen.
Congratulations on the ovarian data.
And I just want the so that's which were then you could do we expect the the overall survival data for the in front of the study.
I'm, sorry, I didn't quite hear the question which of course.
Submitted with or we're going to realize Oh, which vantage point.
Yeah.
At this point in time of the answer is first overall survival is likely to take some amount of months from here, we will get other data before we actually get the final overall survival data and all I can tell you is that we will present this to conferences as quickly as we can just depending on conference deadlines. So we're really examining that.
As we go forward here, but whenever we receive in any kind of bullets of things, we will send out to a conference in percentage.
There I can't say with certainty which ones yet.
Okay. That's great. Thanks, Thanks for the and my second question is regarding to the Nash study.
So I just wondering beside the 10th in the Aoc and as the elevation is there any other safety signal observed in these for patients.
I'm going to give you again back to Andreas Grauer, Yes, no that was the safety signal that we did observe.
Tim.
Which obviously that was what we had seen first rate that's why we.
The stopped dosing in the trial.
The the <unk>.
Benefit that we observed that came after because we did a thorough investigation of all aspects of what happened for these patients.
Quite frankly, we were surprised to see such an improvement in liver fat so quickly and we share that with you.
And on some of our advisers and they were sort of price.
They have never seen something like the quite like that before which again incur.
Encouraged us to say, what we really wanted to try to figure out.
How we can.
Find the sweet spot and time.
On the dose or schedule of giving this drug in the way.
That is both effective and safe but at the.
The short answer to your question is we did not see anything besides elevated liver function tests at the time that we call the dose.
That's great and just a follow up on the the.
Efficacy thing of note wise.
On the fed reduction is really impressive just curious.
Have you guys the magic the or just take a look at the fibrosis for these.
For these patients.
Yes. So the first of all this was the noninvasive rates of this was a it was not a biopsy trials. So we didn't look at fibrosis. In this particular trial. We also did not.
Repeat like for example, the fibro scan measurement.
The the MRI data is really the only thing that we have.
Seeing a change in fibrosis within four weeks, which you know it wasn't the treatment duration most of the patients would be absolutely unexpected but.
We wouldn't know it doesn't but the just Arthur for Harrison and almost all of the studies the.
The issue the threshold numbers, 30% in terms of fat reduction is presumed to Ana and actually their studies, which show really correlates with reduction in Nash and fibrosis, and Nash and Thats, how we had set our 30% target and that's how I think others do the same thing so I'm just going to reiterate what what entre.
You said it was really extraordinary to see after such a short period of time for these patients to have much greater in some cases production back on 30% and so it's really.
It's really a potent medication and now we really have to figure out how the hearts.
Okay. That's great. Thank you very much for taking my question.
And so we'll move to our next question from I think Ahmad of Bank of America.
Hi, Good afternoon, guys. Thanks for taking my question on congrats as well for me on the ovarian data Hum. Thank you Susanne.
You go back for Korlym for one second your profit.
The in depth about all of the ways in which COVID-19 has.
Impacted sales and that is consistent with what we're hearing from other companies across multiple indications I am curious to know if youre getting any feedback from your sales force on if they're seeing any kind of.
You know competitive breath from the record body drug him.
That recently in line.
And if it is Jeff.
The back from a non quantitative aspect of it would be curious to hear your thoughts on that and then I have a couple of follow on.
Sure I'm going to pass you back to what Sean who really runs all of the Cortland business. Yes. Thanks for the same for the question on the short answer is no. We're not seeing on impact on our business from histories of specifically what you are referencing non.
I'm, saying virtually any impact on our existing base and we continue to add patients on korlym at our expected rate I just want to remind everybody on the call that just the reason is actually approved for Cushings disease, which is a subset of Cushing syndrome, and Korlym of course is approved for the broader somebody on syndrome, which encompasses all etiology sort of disease.
Okay, and then well around the topic you had mentioned some factors to highlight including getting doctors that concluded about korlym now for a drug that's been on the market, it's a relatively mature drug.
What were some of the Doctor population targeted Doctor population do you think it is still yet to be fully educated on on the benefits of the drug.
Yeah. So I mean, we have we reach out to as best we can sort of of all of all endocrinologists within the country. I mean, ultimately we believe of every one of them could potentially of of efficient with Cushing syndrome, we target a list of 1500 for 2000 and with greater frequency.
But there are many that have yet to prescribe so there's real opportunity within the existing endocrinology bes to write their first prescription of growth, yes, no what I add to that disease.
As Sean said, we focus on about 1500 for 2000 of about seven or 8000, but as I know I know you noticed that.
The most endocrinologists. These days are diabetologist, they're not really looking at other things like Cushing syndrome, but we now actually think that.
As a result of peer reviewed publications and more of looking to is that some of those diabetologist who have not previously taken cushings syndrome is something that they really wanted to take a look at are starting to do that and that that's what makes us hopeful that we can reach all of the patients who have Cushing syndrome as opposed to the fraction we have reached so far.
Okay cool. Thank you and then maybe one question on the line. If I could you are going to have this interim read of 40 patients what is the bar of.
Of the efficacy that we should be looking for and could you potentially file after that interim read.
I'm in the past you do Andreas on the second but.
I guess could is a pretty broad term is definitely not our expectation that that would be possible to file after just as 40 patients and the bar I think as we've mentioned in previous calls.
When you compare to a zero percent response rate and something like above 20% on something that everyone would say well that must be your medicine. If it's 10% to 20% you have to think about theres something going on and if it's below 10%. It's hard to know whether that's different than what you would ordinarily expect and we're very interested in seeing.
Now.
We sort of pick the great white whale of cancers.
Pancreatic cancer is terrible and metastatic Panther you out of cancer is really terrible. So we'll just have to wait and see where that is.
Yeah, I ask that only because of the under met need okay. Thank you.
No no right and that of course of the other side of it is the the.
The bar is lower of course because of that.
Yes.
We'll go next to Matt Kaplan of Ladenburg Thalmann.
Hi, good afternoon, thanks for taking the questions.
And yes can go add my congrats for the ovarian cancer are top line results here.
I wanted to dig in a little bit to the.
The differences that you're seeing on the dosing regimen in and what the makeup of those I guess, maybe how many how many patients.
And the 100 milligram daily dose were up titrated, the 150 milligrams.
Sure.
In the study.
Management will give you the questions over to Andreas Yeah. So.
Overall 30 per cent of the patients in the 100 milligram dose for upside traded not all of them to 150 of about two thirds of the one that we're up to a greater were up titrated to the 150.
So the.
Those are the exact data yeah. The other thing and maybe this is the longer answer sort of taken offline. There really is a theory as to why intermittent dosing actually might be effective in terms of the.
Glucocorticoid receptor.
<unk> debt.
Then on sort of needed at that soon and of course of treatment is always the combination of efficacy and potential for adverse events and so there's a real theory behind intermittent dosing. It wasn't just the random event and it was interesting to see that in fact it was it was sports superior at this point to every day therapy at a lower dose.
And then it was superior to the background therapy with the statistics.
Okay and then in the study of what what's your sense in terms of the overall response rate that youre seeing and was there a differentiated.
The overall response rate in the two dosing arms.
Alright, so I don't want to give too much information because from one of our early questions. We don't want our scale our chance to present this at important conferences and so really when a limit as to what the materially sort of half the talk about but I can give you of general answer to that question, which is that.
The overall response rate and I say this without specific numbers was relatively the same among the groups, but what was really different was the duration of response to those who respond and thats where the curve.
Okay.
Thanks.
Just shifting gears to two of the great the gray.
The study.
For Cushing syndrome.
What's your sense in terms of the.
Enrollment there is is it starting to accelerate now as we're turning the corner on the.
And the pandemic here hopefully at least in some parts of the world.
What are you seeing an acceleration of thin and enrollment.
I think we are.
Yeah.
Enrollment starts to pick up again and.
The the winter was kind of crazy.
Disappointing for us.
But now in the spring, we're seeing signs of confidence of progress both in the U S and in Europe.
Europe, obviously somewhat.
Slower than in the U S.
We're positive and hopeful that we can deliver.
Okay.
We are planning to deliver.
And just to underscore that.
Just again I know you noted the snack because you've followed the story for a long time, but those who don't do this is to some degree of a eurocentric study we expect in the end of our overall enrollments would probably be on about 70% European that's what it was in that in the.
In this phase II study so it's all of it.
Bit more of a wildcard, but the general answer as you as you know as things are getting better and we're at this point you know completely hopeful that we will keep our current timeline.
Okay, Great and then last question in terms of ROIC correlate.
The increase in the liver enzymes liver function tests that youre seeing in the Nash study can you talk about what you're seeing kind of across the board in general with a real call.
Paul Arndt and and other indication the other patient populations are you seeing any indications of liver enzyme increase the.
Hey, Matt I, just wanted to clarify one thing the drug in the Nash study and all of its mirror psychotic induced.
Tier of correlate relative whirling Hasnt has never produced any of these that that particular issue, but I'll leave you to Andreas here to answer the question related to mirror.
Yes, so for Miracle, but again, we've seen this elevation of liver enzymes in the Nash study and interestingly we've seen it in the patients that have shown the massive reduction in liver fat. So our best assumption of the moment is that those two events are related and maybe for simply resolving.
The liver fat too much too quickly and well.
Have to slow down the effect in order to make the palatable for the liver as the long term benefit in our anti psychotic induced weight gain studies, where we are using the same doses that we have initially used.
We are not seeing the.
These changes.
Yes.
And therefore.
There seems to be a true influence of the underlying disease on the side effect profile of the survey.
Thanks, Matt.
Thanks.
Yes.
And we'll hear next from out of meal on buy of Watson.
Hi, there congratulations.
Thank you Alan.
Going to the greater the Nash trial when you have the.
This amount of fat reduction did you say of global in the body I know it was the only one month, but are you seeing overall rate reductions.
We were able to even.
Do any of them for instance on fat reductions on the other organs.
So oh this is the personal question.
[laughter].
[laughter].
In a month.
Andrew I just can tell you for even looked at that but we were not expecting general weight loss.
Do you have an answer to that one, especially net inflow of patients.
We wouldn't have any robot, but it's an interesting question and we will we will look at that out.
Yeah.
I'm trying to go out on the side door on on Oh, that's psychotic weight gain well, let's pick the.
And I psychotic weight gain and the.
Any.
Sure of is whether any of them are the.
<unk>.
Uh huh.
The signals are where were slight is the current thinking of the consumption of anti psychotics with the break break on how much the fatty acid gets released.
Yes, that's in it.
I hope everyone heard that because thats sort of.
An intriguing idea so I'm just going to say it out loud and then I'll give you my opinions that somehow anti psychotic medications are protective against this for.
Probably not that's probably not the case I think it's just coincidental, but I want to underscore what Andreas said.
Even a bit more than I might have thought learned about this.
The Nash is really of different disease in the sense that the age of Nash hepatitis is its own the real problem you already have people, who have inflammation and so perhaps that's what makes the diseases.
The different and we're still studying about that because you know.
Andreas has really given you kind of the more global response to it.
As I said I don't think it's the anti psychotic medication I think it is just the underlying group of patients are not as identical as one of my thought.
No that's helpful.
The last question on ovarian cancer and the things stick out for the responders for example.
The number of true of prior treatments are shown on the separation of the curves are whether they had been on the vast them before or not.
You know as you always do you push me to the end of the map to be released okay.
Understood.
You know this is a wonderful time.
Thanks for having the asked the questions.
Looking forward to what's happening in the next over the next several months. Thank you.
That's very nice of you. Thank you Allen.
And so with that we have used an hour of your time. Thank you very excited about what we've seen today and as I mentioned before I really do you think of this is the most important results. We've had since the pivotal trial of Korlym and that was eight years ago. So this is this is the big day for us and we're very glad to answer any more questions offline very glad to.
Date, you as the year goes along.
Thank you.
And so.
Ladies and gentlemen that does conclude the call we would like to thank you for your participation.
You may now disconnect.
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