CORT (2021 - Q2)

Good day, thank you for standing by and welcome to the Corcept Therapeutics Conference Call. At this time all participants are in a listen-only mode. After the speaker’s presentation there will be a question-and-answer session. I'd now like to hand the conference over to your speaker today Mr. Atabak Mokari. The floor is yours. Atabak M

Thank you. Good afternoon and thank you for joining us. I'm Atabak Mokari, Corcept's Chief Financial Officer. Today, we issued a press release announcing our financial results for the second quarter and providing a corporate update. The copy is available at corcept.com. Our complete financial results will be available when we file our Form 10-Q with the SEC. Today's call is being recorded. A replay will be available on the Investors past events tab of our website.

Thanks, Atabak. I'll briefly review our litigation against generic manufacturers Teva, Hikma and Sun Pharmaceuticals. In March 2018, we sued Teva in Federal District Court to prevent it from marketing a generic version of Portland in violation of our patents. Originally trial was set to start in February of this year. Last quarter, the court vacated this date in order for the parties to be ready for trial in March. That trial ready date was also vacated. A new trial date has not been set. In April, we asked the court's permission to file for summary judgment based on Teva’s alleged infringement of our 214 pack. The court granted permission and Teva responded by filing some summary judgment motion with respect to the same patent. Summary judgment is a procedure whereby courts can decide the case without holding a trial. We believe that believe the court has all it needs with respect to the Q1 core patents and decide the case in our favor. Having lots of action before the PTAB, so we can no longer challenge the 214 patents validity in the district court case. So we can only argue that this proposed product will not infringe, position we believe has no legal or factual support.

Thank you, Charlie. We are pleased with our commercial results in the second quarter. Pandemic related restrictions made it very difficult for our business to grow because those restrictions made it hard for physicians to provide patients to receive optimal care. Diagnosing and treating patients with a complex disease such as Cushing syndrome, requires frequent in person contact. For much of the pandemic. This level of contact was for many patients and physicians impossible. We are encouraged that in the second quarter, particularly at the end of the quarter, our commercial activity increased notably throughout the country with indication, countries opening more broadly, it is also heartening to patients recently introduced to Korlym, accrued towards their ideal dose more quickly than occurred in the last year, as many physicians are now seeing and testing their patients for the pre pandemic frequency.

Your first question comes from the line of Alan Leong from BioWatch News. Your line is now open.

-- my questions and congratulations on the quarter. But I want to send kudos especially to Sean for executing on the sales plan in a business environment that was under transition. So I don't know if he's there, but congratulations.

Thanks, Alan. Yes, this is Sean.

This is a question, I guess, for anyone, you mentioned -- Joe, you mentioned about titrate -- titrating Korlym quickly. Are the physicians more willing to venture into a stronger dose than say, even a couple of years ago, or a little more?

Joe, you what to take that question.

Yes. So just -- the question is, are physicians now more readily open to titration -- to titrating to a higher dose? Was that the question?

Yes.

And are you asking that specifically to, how it may be different than during the pandemic?

Well, could be, but more really -- really, as the physician community, I would expect, having more experience or reading more literature and talking to their mates about their experience of Korlym may feel a little bit less reluctant to raise the dose to an optimal level.

Yes. I mean, I would say that you hit the nail on the head of that right there. I mean, physicians that have had more experienced with a compound are more comfortable using it, are more comfortable with the cadence of patient visits that are required to follow up, have definitely moved to titrate to higher dose and the most efficacious dose for that patient. Now, an important point is that, it really does vary patient by patient. This is patient dependant. Is there anything Joe, you want to add to that.

Yes. I would. I think, Alan -- I think, really what you're getting at is, is the behavior different than it was several years ago. And the answer to that is right now, it really isn't at all. I think that's actually a real positive. It's a very interesting point, which is that we're now seeing patients titrate -- I’m sorry, physicians titrate their patients’ doses at the same cadence that we saw pre-pandemic, not more than that, because at that point in time, you really were getting the patients their ideal dose. The interesting thing -- and again, there were strange things in the pandemic in many areas, was that, because doctors could not see patients as frequently, seemed as if they were not on the same cadence of hydration. And so it's just heartening to see that they've returned to pre-pandemic behavior at this point. But overall, our average dose per patient is very similar to for now many years.

I have one more question. It could be to Joe, and to Andreas. Regarding, the recent NASH results you had a rapid liver fat reduction, and a little bit of inflammatory markers going up? Did you really -- did you see any notable similar phenomenon or with other NASH drugs either in preclinical or in human trials done in the literature?

Well, if you're referring to like a transit increase of contaminates as in patients with NASH that are treated with drugs to reduce liver fat. Calories reports, and there are reports in the literature that. It is a known phenomenon. It's just the scale was different when we look at those, both the scale of the liver fat reduction and the scale of the transaminase elevation, what you often -- what been described with some of the other NASH compounds is an increase of ASG and ALS like 20%. And we have looked at a much bigger increase. But, but that's why we're going forward and trying to find our sweet spot where we achieve a good reduction in liver fat without affecting the liver, liver negatively on the way to do that.

I mean, I think that's exactly right, Andreas, and I just want to add little color to that Alan, which is to say, you know, the question is has had this phenomenon been observed a simultaneous decrease in liver fat and increase in liver functions and the answer to that is yes. But, Andreas point is also an a second points also an important one. Never on scale, that we saw no one has seen the kind of rapid fat decrease in their studies. And, and at the same time, the liver elevation and liver function test, which normalized as soon as the drug was withdrawn. No one's ever seen that either. And so, really take Andres, conclusion as it is, what we're really looking through is that we can really harness this extreme activity without irritating the liver. That's really the goal. And that's what the next study, who were looking for the ideal dosing regimen is going to address.

Thanks for taking my question. It looks like a pretty interesting next 12 months.

Thank you, Alan.

Thanks, Alan.

Your next question comes from the line of Matt Kaplan from Ladenburg Thalmann.

Hi, good afternoon guys and that's for taking the questions. Just wanted to know, first, congrats on the strength of the quarter. Nice -- nice rebound and the revenues Korlym. So dig into your pipeline a little bit. Can you I guess first, give us a an update in terms of the pace of enrollment and how enrollment is going with the relevant Phase 3 gradient study in Phase 3 gradient study in Cushing's syndrome?

Yes. I mean, as I said, Matt, in my remarks, we have not changed the timeline at all. It's just as it was before, and the only caveat I would add to that is, it's - we're in an uncertain time in the world. We see no need at the moment to make any alterations. Things certainly are better than they were a year ago. But we'll just have to see what happens. So I just would refer you to that the timelines are unchanged.

Okay. Okay. That’s helpful. And then I guess you're on track to the start your Phase 3 study in ovarian cancer in the first quarter of next year. Can you give us a little color in terms of what that study will look like in terms of design and endpoints and stuff like that?

Yes. Let me just turn that question over to Andreas.

So we are finalizing some of those questions. And obviously, many of them are important. And I think there are a few things that are clear. One is to those that are the regimen that we're going to test is the intermittent regimen of relacorilant plus nab-paclitaxel. The comparator, we're favoring currently a physician's choice comparator, so we would give, like a dealer's choice, we would give physician the choice of a single, a single agent chemotherapy in these platinum resistant or refractory patients. And the primary endpoint I think are even going vision is overall survival is going to be required as a primary endpoint for approval. But we're having a lot of conversations with high level opinion leaders and will obviously eventually pretty soon have conversations with the regulators to form those assumptions.

Okay, that's helpful. And then I guess, lastly, in terms of the work you're doing with your miricorilant, and metabolic diseases, specifically anti-psychotic-induced weight gain, how are those studies progressing now? And when can we -- when can we expect them to meet out the most?

Yes, I mean, you've sure you've read what we shared in the press release, right. But we still want to complete enrollment in the GRATITUDE II study by year-end and mutual GRATITUDE study by mid 2022. We're on track for that. And, obviously, we'll have to flip the cards over and see what we see what we observe in these trials. So we're quite excited about it and hope that we can demonstrate the treatment benefit.

And then what I just add to that is, as you know, the pandemic create different pressures in different sorts of studies. At the moment, we're actually seeing things you know, progress quite a lot. I just, again, I just add what I said before, it's an uncertain world, but at this moment in time, we really are fine with what we're seeing and as we said, we’ve repeated our timeline.

And just a follow-up on that in terms of your sense in terms of moving what you need to see from an impact point of view on the weight gain and the unmet need, I guess, in this patient population. And where miricorilant could play a role there?

Well, let me address this one. Because, you know, Matt as you know, these are my patients. I mean, as a psychiatrist -- every psychiatrist prescribed these medications. They're very effective for what they're intended to treat, which is psychosis, we're as adjuncts to handling depressants in major depression or bipolar disorder. So from an advocacy point of view, they're, they're very good. Unfortunately, they have this terrible metabolic , which is that they really perturb that system, they cause weight gain and even though I didn't mention it in my remarks, that's actually a problem for treatment adherence, people don't like how they look, they don’t like how they feel. And if they are disciplined enough to stay on the medications, ultimately, they develop a lot of the diseases we see with 10% or 15% weighting or sometimes more than that. So there's no doubt among physicians who treat these patients that there's a great need for something to do with this problem. And so, we -- again, I sort of look at -- both halves here, as a trader of these patients, some in developing medications for them, I really believe that if you could come up with something which would help those issues, it would be very, very meaningful and a large market with a lot of suffering. And we'll just have to see, I mean, studies are set up to demonstrate for a week change. And I think, importantly, to metabolic perturbations that come with that in which change is good. But it would be much better if you could actually develop something which helps with some of the other problems, like things like increasing triglycerides or fasting insulin things which make people less prone to diabetes. So thanks for giving me an opportunity to expand in some ways. This is a mental illness as a whole, has a lot of stigma and is talked about within it. This is a big, big problem and we can do something about it.

Thanks Charlie. That's helpful, put into context. Thanks for taking questions.

Sure.

Your last question comes from the line of Arthur He from H.C. Wainwright. Your line is now open.

Good afternoon, everyone. This is Arthur He for RK . Thank you for taking my question. Most of my question being answered. So I'm just curious, beside the share buy program has the management discussed any other plan to further improve the shareholder value?

We discuss it continuously in our plan. No, and look the most important thing we can do to increase shareholder value is for our program to succeed in our commercial program to continue on the path that is there. Other ancillary things we really do review our board is very conscious of things like that. We feel that our stock is at an inexpensive price right now, as you know, we're committing our own funds to it and we will continue to do that. But beyond that, when we have something more specific, Arthur will talk about it.

Thank you. Thank you for that and congratulations on the strong quarter.

Thank you very much. And I want to just thank everyone else for listening in. I'm sure it's a hot summer afternoon, wherever you are. So stay cool and healthy and we'll talk to you next quarter.

This concludes today's conference. Thank you all for participating. You may now disconnect.