Good day everyone and welcome to the Corcept Therapeutics Conference Call. Today's call is being recorded. [Operator Instructions]. At this time, I would like to turn the call over to Charlie Robb. Please go ahead sir.

Thank you. Good afternoon everyone. I’m Corcept Chief Financial Officer. And thank you for joining us. Earlier today, we issued a press release announcing our first quarter financial results and reviewing our clinical progress. A copy is available at corcept.com. 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 through May 23, at 888-203-1112 from the United States and 719-457-0820 internationally. Passcode will be 4773625. Statements made during this call other than statements of historical fact are forward-looking statements which are based on our plans and expectations and are subject to risks and uncertainties that might cause actual results to differ materially from those such statements expressed or implied. These risks and uncertainties include, but are not limited to our ability to generate sufficient revenue to fund our commercial operations and development programs. The availability and competitive viability of competing treatments including generic versions of Korlym; our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym; and risks related to the development of our product candidates including regulatory approvals, mandates, oversights and other requirements. These and other risks are set forth in our SEC filings, which are available at our website and the SEC’s website. On this call, forward looking statements include those concerning our 2019 revenue guidance and our expected growth in future years. Our stock repurchase program, physician awareness of hypercortisolism and the selection of Korlym as the optimum medical treatment for many patients, the timing, cost and outcome of our lawsuit against Teva Pharmaceuticals and the challenges to our intellectual property before the Patent Trial and Appeal Board. The scope and protective power of our intellectual property, the clinical attributes of relacorilant, the progress timing, design and…

Thank you, Charlie and thank you everyone for joining us today. While our Cushing’s Syndrome business continues to add prescribers and ship more Korlym to more patients. Please note that our revenues decline from the fourth quarter of last year to the first quarter of this year. As some of you insurance companies typically require patients receiving orphan medications such as Korlym to secure reauthorization of insurance at the start of each year. We do what we can to help patients and physicians surmount this annual administrative obstacle and we provide three Korlym until coverage is restored. Nonetheless our revenue was reduced. It’s further reduced by the statutory requirement that we recover a portion of the doughnut hole in a patient's Medicare Part D insurance plans, a gap and coverage most patients experienced in the first quarter. This year our mandated portion increased from 50% to 70%. In prior years price increases at the start of the year often offset these revenue losses. The impact was more noticeable this year because we did not increase Korlym’s price. This quarter's revenue decline obscures a commercial progress. We are working with more physicians and shipping more Korlym to more patients. We remain confident in our revenue guidance of $285 million to $315 million for 2019 and expect significant growth in the future. Let me pause now for a brief and pleasant housekeeping note. As some of you know, Korlym is the first company to advance nonsteroidal selective cortisol modulators to the clinic led by our Senior Vice President of Research, Hazel Hunt. We invented this entire class of compounds. About a year ago the international and United States regulatory authorities determined that the name of every molecule in the class will end with the syllables corilant, in the same way that other…

Thank you. [Operator Instructions]. So we have a question from Matt Kaplan, Ladenburg Thalmann. Please go ahead.

Guys, thanks for taking the question. I guess a question for Charlie, just wanted to dig in a little bit more to the litigation with Teva and kind of the next steps in that process? And I guess specifically the new announcement in terms of the post grant review filed by Teva for the 214 patent. Can you give us a little bit of detail in terms of what that process looks like and your position there?

Sure, sure. Well, just to give a little bit more background for folks as they don't follow this perhaps as closely as we do. So we are litigating in Federal Court where we have alleged against Teva infringement of our -- of certain of our patents. The – what Teva has done is to also challenge, one to challenge itself, one of the patents or attempt to challenge one of the patents from that litigation and then an administrative proceeding. So after a patent is issued anyone can challenge that patent for a period of nine months after issuance by going to the patent office trial and appeals board and asking for a post grant review where the patent trials and appeals board will review and determine whether they think the patent or some of his claims are valid or not. So, the process is like this. Teva requested this that this review be made. The patent trials and appeals board will spin in the next six -- within the next six months will determine whether they going to accept that or not. If they determine that that Teva is not likely to succeed on the merits. They will reject the institution and we'll just return proceedings to district court. So what to expect is within six months a decision by the Patent Trial and Appeal Board whether this plus grant review will proceed. If they do decide that it will proceed, we will have a decision from them about a year after that. So that's 18 months from now. And then however they decide the losing party has a right to appeal the decision to the Federal Circuit Court of Appeal, which will add another six to 12 months to the process. So we're talking about a two or two and a half month -- two and a half year procedure sort of soup to nuts. The last thing I want to stress really is that this kind of maneuver by Teva is exactly how these disputes play out. There are multiple forms folks can take advantage of and they do. And so when this challenge came in it was by no means a surprise to us. We're other than I can't comment on the merits of it beyond saying we're confident in our legal position and we'll defend our patent vigorously. But this is very much how these disputes are fought and I think everyone should expect and as this litigation proceeds that these kind of maneuvers will be -- it will take place. It's just part of the part of how they -- how it all works.

Right. Thanks for the added detail. I guess for Joe, question about the great study and how that's rolling in and give us a sense in terms of the timing for a potential outcome for obviously this Phase 3 trial in Cushing's syndrome?

Matt, I'd be glad to answer your question, but I actually want to use this as an opportunity to introduce you to Andreas Grauer. Andreas is our Chief Medical Officer joined us about three months ago from Amgen where he'd been the Vice President of Global Development and he had been responsible for many programs and all aspects of many programs as they work their way to the finish line. So please meet Andreas and Andreas if you like to answer that question.

Yes. Hi, Matt. Pleasure to meet you over the phone and over the line. The great study is progressing well. We have been able to open sites both in the U.S. as also now starting to open sites in Europe and we're excited to have our European investigator meeting coming up soon in June which will probably jumpstart enrollment there in your event further than it's already started right now. And you may recall that in the Phase 2 study of relacorilant, we actually recruited approximately 70% of the patients in Europe because they do not have a treatment like Korlym available there for the management of the patients and therefore are even more interested in participating in the trial. So we're progressing well. We're on track so far with what we've previously communicated, and so we'll obviously keep you posted on the progress there.

Great. It's so nice to talk to you about even though I put Andreas. Thank you. I guess final question in terms of the upcoming ASCO meeting and data that's expected there. What should we be looking for from that Phase 1/2 trial?

Yes. I'll take this. As you as you may remember we presented data at last year's ASCO conference and in some sense this is really an update of that study has continued now. A portion of it sort of the punch line has already been spoken. The data that was produced at last year's ASCO with the additional patient data from the less end of the year really got our investigators in ovarian cancer to a place where they said, it's time to move forward and we have already begun that. But you'll see that additional data as well. You'll also see the data which was produced over the last year both from the patients who were already on treatment at last year ASCO meeting for pancreatic cancer and those who came on in the last 12 months. But there are also interesting things in as long as you're asking, this was a Phase 1/2 study that allowed essentially all solid tumors that were GR positive that had a possibility for cortisol modulation and you'll see the first data in those tumors as well. So it'll be a range of things. But early stage, remember this is just the beginning of these aren't controlled studies but you'll get to see where the science has taken us over the last year.

Great, great. And maybe one more before I jump back in the queue. Can you give us a little bit more detail on 335, I guess it's called miricorilant now. In terms of the antipsychotic weight gain study and what we should be looking for in terms of impact on weight gain on these atypical antipsychotics?

Well, I guess the really exciting for us is this is a proprietary compound and it's its first study in patients that did very well in phase 1. But of course that doesn't really give any indication whether that's going to work in a clinical disorder. The studies that it's actually now running dosing is already taking place and it's -- a portion of it is already completed is in patients -- isn't normal a people who have been introduced to Zyprexa and then put in a study where they're being treated with Zyprexa plus miricorilant or Zyprexa alone. And obviously the reason we're doing study is to find out where it goes. But I just refer you back to the studies that we did with on Korlym and Zyprexa, the ones from really almost a decade ago and there was a pretty even in a study of essentially 50 to 100 patients, there really was a striking difference in two week period between those who were on the combination drug and those who were on Zyprexa alone. And so we don't know exactly how this is going to go. The preclinical models would indicate that miricorilant is equal or more potent than Korlym was. But that's why you do the experiments and we're going be very excited to see those results and we'll have them basically by year end.

Very good. Thanks for taking the questions.

We will now take our next question from Falcon [ph] Duncan from Fitzgerald. Please go ahead sir.

I think that's Charles Duncan or someone working with him.

Hi. This is [Indiscernible] on for Charles. Can you hear me?

Yes. We can hear you.

Good. So, I have a couple of questions about relacorilant in Cushing’s. Do you think there will be a need for a longer term follow up study?

Well, I think what we're going to do is we're going to have an extension study, in fact we already have the people who are in the Phase 2 study and yes, we plan an extension studies part in the same respect that we did with Korlym when it was approved. In fact I can tell you just as a smaller side there actually some patients from the Korlym study eight years ago who were actually still on medicines who passed through the pivotal study and into the extension study and then into commercial use. So yes, we’re very interested in following those patients for as long as possible.

All right. And beyond the current Phase 3 is all the work completed or being completed to support an NDA like fact studies manufacturing scale up and the commercial batches?

Much is completed and much remains to be done, but we expect that by the time we have the NDA we know what we need to do and it all will be completed.

And how long do you think after you see the Phase 3 data, you'll need to prepare an NDA and now file with the NDA with the FDA?

Well I'm going to say this and I hope Andreas isn't going to kick me under the table. But obviously as fast as we can. But I think it would be reasonable to assume three to six months.

All right. Thank you for taking my questions and congratulations on all the progress.

Thank you, Pete.

We will now take our next question from Adam Walsh from Stifel. Please go ahead sir.

Hi guys. Neil Carnahan on for Adam. just with all the activity you have going on the clinic can you provide any OpEx guidance going forward. And then I got one follow-up?

Hey, Neil, this is Charlie. So as we don't provide sort of specific earnings guidance. But I think that if you just look at the activities we have planned during the year. We talked about these trials ramping up which is certainly true. But at the same time a good portion as Pete alluded to of our spending has to do with things like CMC work; manufacturing work other bonuses of activity as well as new compound development that we don't talk about yet because it's so early that really provide as it turns out a rough offset as it turns up against ramped up actual clinical spending. So although the trajectory of our spending on research development as you note is increasing as our programs proliferate and become more advanced. I think that the best way to think of it is not as a sharp up ramp and activity well over the over the rest of the year. Beyond that I really can't give you more specific guidance than that?

Okay. I just saw the verbiage in the document you filed volume related distribution costs. Sorry go ahead.

So, I'm happy to talk about that. That is -- what that really is things like we pay a fee to our specialty pharmacy per shipment, so as shipments rise those expenses rise, you have pharmacy costs, there are operating expenses obviously we pay incentive compensation to the sales force and so forth. So that is not a particularly large portion percentage of our revenues by any means, but it increases as our revenue increases.

Okay. Okay. And then maybe a question for Andreas; can you can you walk us through why relacorilant doesn't cause the hypokalemia issues that you guys see with Korlym. Is it somehow linked to the difference in the binding of any of the glucocorticoid receptor. Could you just walk us through that?

Yes. So the affinity to the glucocorticoid receptor is actually very similar. The big difference to Korlym in comparison is with the progesterone receptor. But to your point that is not what is explaining the fact that it's not causing hypoglycemia. So what we do see and what we do see and what we do know is that it doesn't increase cortisol and it doesn't increase ACTH sharply as Korlym done. So that’s the mechanism why it doesn't cause hypokalemia. Why it doesn't increase cortisol and ACTH [ph] is a more complex question. We have some hypotheses. But as I said, that that's -- those are hypotheses. One of them is that it potentially the tissue binding, the binding two receptors in specific organs is somewhat different to Korlym which may lead to this very desirable different profile.

Yes. Just a little bit of follow up on that Neil just in a couple of ways. Directionally it is the same. So ACTH does rise a little and cortisol does rise a little maybe 30% or 40% whereas with Korlym rises three or four times, 300% or 400% and I think that's really all the difference in the world. And we notice this tissue selectivity actually as early as Phase 1 and I think I actually remember talking to you at last year's meeting in Boston how we saw and even in the Phase 1 study, but I wasn't sure in the Phase 2 study whether it was just dose related at the lower dose you wouldn't see it in the higher dose, we would see it more but it really didn't pop up in that way. And I think that's probably what it's related to that there is some issue of tissue selectivity just in terms of potency particularly at the level of the pituitary and where you get the antagonism of the feedback mechanism. And it really is a very happy result for us because hypokalemia is very annoying and sometimes bad side effect for people who have it. So we were very pleased that we were able to confirm that in the higher dose of the Phase 2 study.

Okay. Thanks for the time guys.

We’ll now take our next question from Cameron McCain [ph] from Baywatch News. Go ahead sir.

Yes. Thanks for having me on guys. So, I know you've reported that a number of chronology conferences and those studies have had some supporting indications of preoperative usage, severe diabetes, hypertensive diabetics, but you also have the full plate on your current portfolio, so I was wondering how the company is going to move forward with potential extensions if you are pursuing clinical trials, waiting for funding or pursuing independent investigators?

Yes. So Cam, I know the story very well, but I just want to enlarge the conversation a little bit for others. So one of the strategies that we have taken as a pharmaceutical company which is really very different than reasons I understand the other pharmaceutical companies is that we really encourage investigators to use our medication to see if we can push the science forward. And so what you're noting is that at these scientific meetings there's often a lot of information about our drugs and things that are not in the center of where we're working, but are also interesting clinical questions and academic questions and that's what you're referring to those appear and people can access this post. It's very interesting. Now as a practical matter it served as a very nice farm system for us to bring things in-house and move them faster. So just sort of two points that we've discussed today our oncology program really came out of longstanding collaboration we had with the University of Chicago here in the United States and our metabolic program really came out of a longstanding collaboration we have with the University of Leiden in the Netherlands. But my point really is that we really go where the data takes us and if anything really emerges that is strong enough to really be feel like it's worth our resources to do that. We will bring it in-house and make it go faster. We will make room to do that. Yes we have a very full plate right now. There's certainly things that are interesting, but if they cross the threshold of where we think they can provide real value to patients in a relatively short period of time, we will figure out a way to fund them and do them ourselves.

Very nice. And then yes just to touch on the antipsychotic weight gain program. I know you're proposing clinical trials that span a pretty wide variety of patients. So I was wondering if you provide some color on that space because I know the drugs currently have a difficulty being a complete solution. So I was wondering what the competitive landscape looked like and what you're trying to accomplish with the CORT335?

Thanks for asking that particular question. Again for the people who followed course up for a long time I can tell you I can answer this question with a lot of energy because as you know I'm a practicing psychiatrist. I prescribe these medications on a regular basis, our patients badly need to take them. Psychosis is a terrible thing. And medications we have are pretty good at treating psychosis. I mean I don't want to give a critic I prescribe them all the time, but they have a real metabolic Achilles heel and it's dramatic problem for these patients keep them from taking their medication, it adds to their cardiovascular and metabolic right. The average age of death like someone who take chronic antipsychotic medications in the United States its 55 and it’s not because of suicide. It’s because of metabolic and cardiovascular disease. So the clinical need is really, really, really high and unfortunately at this point in time we just don’t have anything for those patients. And I’m encouraging of anybody who sort of has an idea. One of the really hard parts of our story was that about decade ago in sort of first group of experiments but control double blind human experiments we were able show that Korlym prevented antipsychotic-induced and people nearly taking it and we just couldn’t go forward because Korlym was not a drug that could be develop for just a mass market. And its not taken us almost a decade to get back to where we were at that point with a new drug. So the competitive landscape is modest. I wish it were greater, because our patients really need treatments for this and we’re going to try to push this forward as aggressively as we can.

Welcome. Thank you. I appreciate it.

Well thank you guys very much. Really appreciate it and we’ll talk to you next quarter or see you at conferences in the middle.

This concludes today’s call. Thank you for your participation. You may now disconnect.