Corcept Therapeutics Incorporated (CORT) Q2 2019 Earnings Report, Transcript and Summary

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

Thank you. Good afternoon and thank you everyone for joining us. Earlier today, we issued a press release announcing our second quarter financial results and reviewing our research and development programs. 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 August 15, at 888-203-1112 from the United States and 719-457-0820 internationally. Passcode will be 9712194. Statements during this call other than statements of historical fact, are forward-looking statements based on our plans and expectations and are necessarily subject to risks and uncertainties that might cause actual results to differ materially from those the forward-looking expressed or implied. These risks and uncertainties include, but are not limited to our ability to generate sufficient revenue to fully fund our commercial operations and development programs. The availability and competitive viability of repeating treatments for Cushing syndrome including generic versions of Korlym. Our ability to obtain acceptable prices are adequate insurance reimbursement for Korlym and risks related to the development of our product candidates including clinical outcomes, regulatory approvals, mandates oversight and other requirements. These and other risks are set forth in our SEC filings which are available at our website in the SEC's website. On this call, forward-looking statements include those concerning our revenue guidance and our expected growth and cash generation in future years. Physician awareness of hypercortisolism and the selection of Korlym is the optimum medical treatment. The timing, cost and outcome of our lawsuit against Teva Pharmaceuticals and Sun Pharmaceuticals and the challenges to our intellectual property before the Patent Trial and Appeals Board. The scope and protective power of our intellectual property, the clinical attributes of Relacorilant, miricorilant and exicorilant, the progress, timing, design and results of our development programs, including the GRACE trial and the other current and planned clinical trials of our selective cortisol modulators. Final acceptance of the European Medicines Agency's recommendation of orphan drug designation for relacorilant for the treatment of pancreatic cancer, the benefits of orphan drug designation in the European Union and the United States. We disclaim any intention or duty to update forward-looking statements. Corcept's revenue in the second quarter was $72.3 million, a 16% increase from the second quarter of 2018. We reaffirm our 2019 revenue guidance of $285 million to $315 million. Second quarter GAAP net income was $20.2 million compared to $18.2 million in the same period last year. Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets together with related income tax effects, our non-GAAP net income in the second quarter was $31 million compared to $25.4 million in the second quarter of 2018. Our cash and investments at quarter-end were $225.7 million compared to $215.7 million at March 31, 2019. We repurchased 1.6 million shares of common stock in the second quarter pursuant to our stock repurchase program at a cost of $17.4 million. Our stock repurchase program expired by its terms only. We believe our profits, together with our cash on hand will be sufficient to fully fund our commercial business, complete our current development programs and Cushing syndrome, solid tumors, antipsychotic induced weight gain in NASH and advance of the clinic, additional proprietary selective cortisol modulators. Now a brief legal update. As many of you know Teva Pharmaceuticals is seeking to market a generic version of Korlym. We have sued Teva for patent infringement. In addition to Teva has asked to the patent office Trial and Appeals Board or PTAB to institute a post-grant review or PGR of our patent covering methods of co-administrating Korlym with CYP3A Inhibitors. This patent expires in 2037. The PTAB will decide whether or not to institute Teva's requested PGR in November. The PGR is instituted the earliest we expect final resolution of this matter, including any appeals is the first quarter of 2021. Sun Pharmaceuticals recently notified us that it is seeking FDA approval to market generic Korlym. On July 22nd, we sued Sun for patent infringement our lawsuit stayed FDA approval of Sun's proposed product until the earlier to occur 30 months from our receipt of Sun's notice letter approximately December 2021. And the decision by the district court that the patents we have asserted against on our invalid unenforceable or not infringed. Despite overlap in subject matter and legal issues within a lawsuit against our dispute with Sun is separate and will likely follow its own timeline. Finally, earlier this year the PTAB instituted an inter-parts review or IPR of another of our patents. The 348 patent that was brought by Neptune generics, a subsidiary of the litigation finance from Burford Capital. The earliest we expect final resolution of this matter, including any appeals is the third quarter of 2020. With respect to all these disputes we are confident in our legal position and will defend our intellectual property vigorously. I'll now turn the call over to Dr. Joseph Belanoff, our Chief Executive Officer. Joe?

Thank you, Charlie. We are very pleased with the performance of our Cushing syndrome franchise last quarter. As we expected, patients taking Korlym work through the insurance reauthorization process, many of them must undergo at the start of each year. There care was not interrupted because we gave them Korlym at no cost. But the temporary pause and reimbursement for some patients did reduce our first quarter revenue as it has every year since Korlyms launch. Meanwhile, we continue to add prescribers and patients, growth we expect to continue. There is much left to do. There are 8,000 endocrinologists in the United States nearly every Endocrinology practice in the country has a few patients with Cushing syndrome. To reach more physicians we are increasing the size of our field sales force from 41 clinical specialists to about 55. The exact number and the pace of hiring will depend on how quickly we find candidates with the skill, experience and dedication to helping patients required to work effectively with physicians treating patients with this complex disease. We expect the additional clinical specialists to contribute significantly to our commercial business in 2020 and beyond. Korlym is shown first, in its pivotal trial and then in commercial use the cortisol modulation can greatly benefit many patients however Korlym causes off target effects that limit its use. Korlym treats Cushing syndrome by modulating cortisol activity at the glucocorticoid receptor, GR for short. A Korlym does not just modulate the effect of cortisol, it also binds to the progesterone receptor PR for short. Korlym's affinity for PR makes it in a board of fashioned. In fact, the active ingredient in Korlym is the same as in the medication call the abortion pill. Korlym's PR affinity also causes endometrial thickening and vaginal bleeding in a significant portion of the women who take the medicine regardless of their age. By a different mechanism Korlym also causes low potassium in many patients, a condition known is hypokalemia. Potassium is important for the normal function of nerve and muscle cells particularly heart muscle cells low levels of potassium can be life threatening. Hypokalemiais is manageable but requires close monitoring and often prophylactic treatment, 44% of the patients in Korlym's pivotal trial experienced hypokalemia, it is one of the leading causes of Korlym discontinuation. Our planned successor to Korlym relacorilant it does not cause these off target effects. Like Korlym, relacorilant works by modulating excess cortisol activity at GR. Unlike Korlym, relacorilant is selective because it does not bind to PR, it is not the abortion pill and does not cause endometrial thickening or vaginal bleeding. In addition unlike Korlym relacorilant is not significantly increased cortisol levels and does not cause hypokalemia. These are major medical and commercial advantages and relacorilants Phase two trial patients exhibited meaningful improvements in the trial's primary endpoints of hypertension and glucose control and in a variety of secondary endpoints including weight loss, liver function, coagulopathy, insulin resistance, cognitive function, mood and quality of life. It was well tolerated. As expected, there were no adverse events caused by PR affinity and there were no drug-induced instances of hypokalemia. We presented these results in April at the annual meeting of the American Association of Clinical Endocrinologists, you can see our poster at the Investors Past Events tab of our website. Relacorilants Phase 3 trial, which we call GRACE is underway with the planned enrollment of 130 patients at 60 sites in the United States, Canada, Europe and Israel. Each patient in the GRACE study receives relacorilants for 22 weeks. Those who exhibit prespecified improvements in hypertension or glucose metabolism enter a 12-week double-blind randomized withdrawal phase in which have continue receiving relacorilant and the rest are switched to placebo. GRACE's primary endpoints are the rate and degree of relapse during the randomized withdrawal phase of the study comparing patients continuing Korlym -- relacorilant and those randomized to placebo. I'm pleased to announce that we plan to begin a second clinical trial in patients with less severe Cushing syndrome later this year. These patients have a adrenal adenomas an a more indolent disease trajectory. We expect that this study will enroll approximately as many patients as the GRACE trial with half of the participants receiving relacorilant and the rest placebo. Many of the sites, participating in the GRACE study will participate in this trial. It is important to note that this trial is not a required part of a relacorilant development program. We expect to base Relacorilant's NDA for Cushing syndrome on the results of GRACE. That being said, this etiology of Cushing syndrome has not been studied extensively and we expect our trial's results to contribute meaningfully to its understanding and treatment. I will now turn to our oncology program. In tumors that express glucocorticoid receptors, cortisol stimulation suppresses the programmed cell death known as apoptosis. Since chemotherapy drugs kill tumors by prompting apoptosis, this effective cortisol is harmful. Many solid tumor types, including pancreatic and ovarian have high levels of glucocorticoid receptors which unfortunately correlates with lower survival rates. Our Phase I-II trial relacorilant plus nab-paclitaxel, Celgene's taxane-based drug Abraxane tested the hypothesis that adding a cortisol modulator to a chemotherapeutic regimen will turn down cortisols anti-apoptotic effect and allow chemotherapy to achieve its full potential. We presented data from this trial at this year's ASCO Conference. 7 of 25 patients with metastatic pancreatic cancer and 5 of the 11 patients with advanced ovarian cancer achieved durable disease control, meaning their tumors either shrink or cease growing for 16 weeks or longer. The duration of response, in some patients was particularly notable. Tumor shrinkage in two patients with pancreatic diseases lasted longer than 50 weeks. A patient with ovarian cancer exhibited tumor shrinkage for 65 weeks. The target lesion in another patient with ovarian cancer disappeared completely. These are striking results. All of these patients had undergone multiple prior lines of therapy including treatments with nab- paclitaxel or another taxane that any of them responded when relacorilant was added to the therapy was surprising. Our ASCO poster is available at the Investors Past Events tab of our website. Our investigators believe as do we that our Phase I-II results justify larger more definitive studies. Earlier this year, we began 180 patient placebo-controlled Phase II trial of relacorilant plus nab-paclitaxel in patients with advanced ovarian cancer. In addition, we have completed writing the protocol for a Phase III trial of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer and we'll seek FDA guidance regarding the fastest path to approval in that indication. Our objective is to start this trial by year-end. The results, I've described are exciting. I will quote briefly from the opinion expressed by the European Medicines Agency's Committee for Orphan Medicinal Products the comp for short. When I recommended that relacorilant be designated as an orphan drug for the treatment of pancreatic cancer. This is a direct quote relacorilant has the potential to restore tumor sensitivity to taxane therapy. This was demonstrated by non-clinical and clinical results, that is the achievement of durable partial responses or disease control in some patients, despite previously failed treatment regimens. The COMP considered that the preliminary clinical data submitted by the sponsor supported the claim of significant benefit for the purpose of an initial orphan designation. "We agree if we can confirm our Phase I-II findings and subsequent larger trials it will constitute a major advance in the treatment of these dire cancers. Cortisol modulation may treat patients with metastatic prostate cancer by a different mechanism androgens stimulate growth in tumors of the prostate, which is why androgen deprivation is the standard treatment. Investigators at the University of Chicago and Memorial Sloan Kettering have shown that when prostate tumor cells are treated with Androgen Deprivation agents such as enzalutamide Pfizer's drug Xtandi, their growth begins to be stimulated by cortisol. Our hypothesis which originates with investigators at the University of Chicago. Is it adding a cortisol modulator to androgen deprivation therapy will block this tumor escape route. Investigators at the University of Chicago are leading to controlled Phase II trials, testing this hypothesis one examining Korlym plus standing and the other relacorilant plus Xtandi. We are conducting a dose finding trial of our proprietary selective cortisol modulator exicorilant formerly CORT125281 combined with Xtandi to treat patients with castration-resistant prostate cancer, and we'll evaluate data from that trial as well as data from the trial is being led by the University of Chicago. Investigators once it is available to determine the appropriate next steps for our development program. I will conclude with a discussion of our program in metabolic disease. Pre-clinical and clinical data have shown the cortisol modulation may play a role in treating two serious widespread metabolic disorders for which there are no FDA approved treatments. Weight gain caused by antipsychotic medications and non-alcoholic steatohepatitis or NASH, let me provide some background millions of patients rely on anti-psychotic medications to treat illnesses such as schizophrenia and bipolar disorder these medications are effective, but they're side effects, including weight gain hyperglycemia and hyperlipidemia shorten the lives of patients, most of whom die from cardiovascular diseases. In April we began dosing healthy subjects in a Phase 1b trial to test whether miricorilant attenuates the weight gain caused by the commonly prescribed antipsychotic medication olanzapine. We model this trial on placebo controlled studies we conducted in which mifepristone significantly reduce the metabolic side effects of olanzapine and another antipsychotic medication risperidone. Unfortunately mifepristone, status as the abortion pill prevented us from advancing it as a treatment for common disorders. Miricorilant is a viable candidate because it is a selective cortisol modulator. Like relacorilant it has no progesterone receptor activity. In our current trial 60 healthy subjects receive olanzapine and either miricorilant or placebo for two weeks. Although the trial's primary endpoint is change in weight. We have a more fundamental goal. This is our first study of miricorilant potential Pharmacodynamics activity. Its results in animal studies were very powerful. We know from its Phase I trial that miricorilant is well tolerated. Our objective for this study is to begin to learn about its metabolic properties in people. We will have results later this year. Later this year, we will also have a double, we will also begin a double-blind, placebo-controlled Phase II trial in patients with recent antipsychotic induced weight gain. In 2020 after our program to optimize miricorilant formulation is complete, we will initiate a Phase II trial and the reversal of long-standing antipsychotic induced weight gain. Now, I'll say a few words about NASH, another serious metabolic disorder that affects millions of people in the United States. NASH is characterized by fatty liver inflammation and fibrosis. It is a precursor to cirrhosis. If a person is potent in animal models of these conditions and appears to reverse fatty liver disease in patients with Cushing syndrome. In animal models of these conditions, miricorilant is even more potent. We expect to initiate a double-blind, placebo-controlled Phase II trial, at [indiscernible] in patients with NASH next year. To recap, our Cushing syndrome business had an excellent quarter. We reaffirm our 2019 revenue guidance of $285 million to $315 million for 2019. We are significantly increasing the size of our field sales force, which should begin to contribute to our commercial results next year. Relacorilants Phase III NDA enabling GRACE trial continues to enroll patients. Separately, we will begin a placebo-controlled double-blind trial in patients with less severe Cushing syndrome later this year. We continue to make important advances in our oncology program. We presented striking data from a Phase I-II trial at ASCO this year. The data showed durable disease control and patients with metastatic ovarian and pancreatic cancer will be on what is expected for a population that have received multiple prior lines of therapy including prior use of taxane. We are actively enrolling subjects in 180 patient-controlled Phase II trial relacorilant plus Abraxane in ovarian cancer. We expect to begin a Phase III trial in patients with metastatic pancreatic cancer later this year. Our trial of exicorilant plus enzalutamide continues to generate data as the trial is being led by investigators at the University of Chicago with Korlym and relacorilant. Our metabolic program achieved an important milestone, our lead compound miricorilant is being tested for the attenuation of antipsychotic induced weight gain in healthy subjects and two Phase, two trials and antipsychotic induced weight gain will be conducted one expect it to begin later this year and another one to begin in 2020. We also plan to start a Phase II trial of miricorilant to treat patients with NASH next year. I'll stop here for questions.

[Operator Instructions] I'll take our first question from Charles Duncan of Cantor Fitzgerald. Please go ahead.

Hi, this is Pete [ph] for Charles Duncan. Congratulations on the quarter. I have a couple of questions about the great study, how is the enrollment going and can you give us a sense in terms of timing for a potential outcome for the Phase III. I think it's a sort of, in light of some of your competitors having -- one of your competitors having difficulty in enrollment and have delayed topline data for their program?

Okay. I'd like to reintroduce everyone to Andreas Grauer who is our Chief Medical Officer and Andreas, why don't you take the question.

Yes, hi. So we, just to give you a quick update on how GRACE is going. We had a very good investigator meeting in Europe just recently with a lot of enthusiasm of all involves investigators and as you may remember in our Phase II program, the majority of the patients were recruited in Europe and only a smaller percentage in the US. So, in the moment we're starting up all these sites in Europe, and as you may know in July and August are relatively slow months for enrollment, but our goal is to make the fall extremely productive in terms of enrollment and to complete enrollment hopefully by the end of this year. The study design is the -- six-months open label phase and a three-months randomize the trial phase. So the last patient out, that -- should that be nine-months later.

Good. And Pete, of course, Andreas speaks that is a one-time former European. So, we're working very hard to get all the sites up in Europe. It was great enthusiasm at that meeting, but the fall will really tell us where we are in enrollment, it would be able to give you a better sense of that, but we're confident that the Phase II results have really prompted investigators to join the trial who might not otherwise have and we're confident that they'll be able to use the medicine successfully in patients. So really nothing changed from the last call and we'll give you an update as we have more data in the fall.

All right. Thanks. Appreciate that. I have another question about the new study. We had double-blind placebo-control. If you can have a similar designs to GRACE, we have the leading period patients experienced clinically meaningful benefit, and then they move on to the randomized controlled phase and what kind of outcomes are you looking at timelines to data and sorry, last one similar burden of disease less severe symptoms is at the same burden of disease and pricing?

I'll also point you to Andreas again and -- there was a lot in that, but Andreas go for it.

Yes. So let me, let me try to answer that step by step. So first of all, no it will not be the same design as in GRACE because it will be a placebo-controlled study right from the search. So, we will prospectively randomize substations into two groups. One, will receive the active treatment relacorilant, the other half will receive placebo. We are planning for a study duration of six-months and we'll be doing this study as a placebo-controlled study because the burden of disease in this particular population is somewhat lower than in the population that we are enrolling in GRACE. These are patients with adrenal tumors again the hormonal changes are somewhat less pronounced, but there is significant data pointing to the fact that these patients also suffer serious long term consequences if this disease remains untreated, and that's why we feel it's really important to treat those patients in this trial.

Yes. And Pete, what I'd like to just add because it came up earlier is we really thought that this meeting in Europe was a seminal investigators meeting and someone who attended it, I can tell you, that probably the single period of greatest energy and people were interested all along was for this study. This is literature over the last six years is really indicated that these patients who were often sort of watched and waited never got better and yet it's never been studied in a rigorous way and we really think it's a big advantage to the field to actually do the study although there certainly plenty of case reports with individuals of this variant of Cushing syndrome improvements. This is really the first time a placebo-controlled study has been attempted that really specifies this group and we think it's actually very, very meaningful for the field as we go forward.

All right, thanks. I don't know if I missed it. Do you have any sort of timelines to data?

Well, so the -- we're in the process of finalizing the protocol. Obviously at that point the submissions across the US and Europe will have to happen and we need to get approval for this trial. But we will use pretty much the same centers that we are using currently for GRACE, that should give us economies of scale and make the approval and start-up process of this trial faster. What we expect in enrollment period of approximately six to nine months in this trial. And then it's a six-month trial. So it's shorter than the GRACE trial and that kind of gives you the -- like the drivers for the study and when we're going to be able to see results in.

Okay.

Okay. Thank you, Pete. Next question.

All right. Thanks.

We'll now take our next question from Tazeen Ahmad from Bank of America. Please go ahead.

Hi, good afternoon. Thanks for taking my questions. Just wanted to ask you about your thoughts on recent rhetoric coming probably from both parties about price control. You guys did take -- it seems like a 9% price increase today on Korlym and I -- kind of wanted to ask you, your thought process about how you decide if you want to take a price increase. It seems like your last one was quite some time ago, it looks like it was 6% back in 2017. As we move into an election year, how are you thinking about your internal modeling about what kind of price sensitivity of the market might have, of course taking into account that you're a rare disease marketer. How should we -- as we model out, the out year assumptions for sales. Think about any contribution from price?

Tazeen, thanks for the question. This is Charlie, obviously. So this is the first as you point out, this is the first price increase we've taken in about 19 -- 18,19 months. And it's something we look at every quarter trying to judge with the appropriate price is. And we've sort of got a twofold view. One is that our obligation is to develop our compounds as efficiently and expeditiously as we can with the revenues that we bring in and make sure that patients aren't denied at Korlym on the basis of financial need, and we've had certainly lived up to our part of that -- our part of that, sort of the social contract. We also are always careful to make sure that we are never the tallest nail on the board. We're well have remained and will remain, I think well within the middle of the herd. As to exactly what will shake out politically. We are not sure, but I think we feel confident in the increases we've taken it, feel like they justified and we feel we're living up to our side -- our side of the bargain in this economy, in this policy and that's really all the guidance I can give you on that point, unless Joe you -- would you here to add any fresh thoughts?

No, but I just would -- just to reemphasize that, this is not sort of a once in a while topic. We think about it all the time we really evaluated every quarter. And we, and we felt like this really was an appropriate time to take a price increase. I just want to point out to the group if it wasn't clear to them that there was no price increase in the second quarter. So the price increase we took actually did begin today and so the second quarter results are absent -- any price increase at all.

Okay, great, thanks for all the color. Maybe I guess keeping in line with that thought you have reiterated your guidance for the full year. It didn't seem to me that you would need that much growth and sequentially in each quarter you even to get. So let's say the middle of your guidance range and now that you have taken this 9% price increase, why not -- increase the range, maybe even on the bottom end a little bit?

Yes, I think that we -- so first of all, our guidance and our pricing decisions just so everybody understands really are sort of independent matters, one of the things we don't take into account when setting our prices. What we'd like our revenue to be, we determined -- determine our guidance based on our best estimate for the year and then we determine pricing on its own merits on sort of quarterly basis. So for us, they're really separate considerations. And we didn't narrow our guidance this quarter because we think that our revenue will still fall within that range. But as the year goes along and we get closer to the end guidance like price and everything else is something we will look at and decide if it's appropriate to narrow it on the next call we'll see.

Okay. Thanks so much for the call.

Sure, thank you.

We'll now take our next question from Adam Walsh from Stifel. Please go ahead.

Hi, guys. This is Neil Carnahan, on for Adam. On miricorilant can you talk to us about the development path, you guys are thinking about you know launch placebo-controlled Phase II study later this year. Another in 2020 for antipsychotic-induced weight gain. Can you just expand on these? Have you guys given thought to design is a design finalized enrollment size, any details you guys can share there?

Yes, I'm going to -- I'm going to punch it to Andreas, just for that question.

Yes. So, Joe, told you that miricorilant is the -- has a very interesting pharmacology, the molecule is not very easy to formulate and we're still optimizing the formulation. So we have, what we're starting with one Phase II trial in which we think we can study at the medication and its current format and that is a trial in patients that have recently gained weight on antipsychotic medication. The expect trial size here is approximately 100 patient and the trial will be placebo-controlled, so it will be one-to-one randomization active versus placebo. We're and what we're expecting in enrollment period of approximately one year and to start that trial by, in the last quarter of this year. The next trial we will start once we have more better more suitable formulation for those and we're planning to start a second trial in antipsychotic induced weight gain and then we're also planning to start a trial in NASH.

Yes. And let me just elaborate a little because I brought -- I want to make sure that if it is something that's interesting to -- that you recently have the information this is been a very, very potent molecule in animal models, as I said before on a per kilogram basis even significantly more potent than mifepristone which itself was very potent. So the issue really is just we've alluded to this formulation issue is that we now have 100 milligram tablets, which really seem to work very well and we think that the -- but we think that the doses likely to fall sort of in the 600 to 900 milligram basis and what we'd really like to be able to do is create a tablet, they just had more milligrams in it, so people don't have to take six or nine milligrams a day and we are hard at work at that we have lots of resources attending to it and we think that is really a solvable problem, but that's the issue. In the meantime, in the ways that we've described that we really are going to continue to accumulate data because very important that we can really show that data we've seen in animals does translate to people. So the first study that you will see is the a healthy subject study, and we've talked about that will be later this year and then the next study after that is in the patients who have recently gain weight on antipsychotic medication and both of those will be controlled double-blind study. So I think we'll get some indication of whether or not the medications activity is real and substantial.

Great, thanks guys.

Now, I'll take the next question from Matt Kaplan of Ladenburg Thalmann. Please go ahead.

Hi guys, good afternoon and congrats on the quarter. Wanted to just follow up on question, Adam question in terms of miricorilant and specifically, there's Phase 1b study, as that's going to be the next data readout, that we have against for Corcept. Can you give us a little bit more color in terms of what we should be looking for in that Phase 1b study, as the data readouts, I guess specifically the metabolic effects that we should be, we should be looking for and what you're going key it on?

Yes. Matt, well, let me just back up a little bit, just so that everybody, I know you're very familiar with the program, but others may not be quite as familiar, this is, this is a compound which in models of antipsychotic induced weight gain among other things, produce very potent results in those states are actually we're recovering academics here. So, those studies are actually published and anyone can go -- read about them. This is the first study we've done in people, beyond the Phase I study that really establish it, the doses we had in mind were well-tolerated, which they did. So it really is the first test the pharmacodynamic effect. It's a two-week study. So you're obviously not going to see the effects that you might see if the medicine was active in a six-month study. But I think it will give us some beginning indications of whether we're in the right dose range and whether the metabolic effects like weight gain or change in glucose tolerance or change in lipid profile changes in that period of time. So you really should consider it an opening study. I'm very excited about it, to do it, but we're learning and I think part of the, just sort of more globally. This is a molecule that we think is going to be very, very meaningful to Corcept over a long period of time and we're in the fortunate position right now to really be able to do this in a very methodical way. We have the resources to do it and really get it right and we're going to do that because we think this one has long legs.

Okay, that's helpful. Thanks, Joe. And then just shifting gears a little bit to your oncology program. With the 180-patient study in ovarian cancer and rolling, can you give us a sense in terms of where you are in that study. In terms of being able to complete enrollment what could be the timeline for that Phase III ?

It's a little uncertain as to exactly what it's going to be. The initial sites are open at this point. They were actually sites that participated in the Phase I-II study. But to enroll that number of patients, we're having of course have to enlarge that study. In fact, there's a whole European Group, who is going to be entering that study, who isn't online yet. So I can't give you a really good sense of when it's going to conclude. It's certainly not going to be this year there is no data readout this year, next year would be an ambitious goal, but we're going to try to go forward, we'll see as quickly as we can and will just update you as we go along we get a better sense of it, but we really just are in for the bulk of it, the site opening period at this point and we're hard at work at that.

Okay, thanks. And then in terms of the pancreatic cancer Phase III. Potential, I guess pivotal study, when would you be meeting with the FDA to solidify to lock-in on the design of that study?

Yes, I'm going to give you back to Andreas for that.

Yes. So we presented the results at ASCO and at the same time also had a meeting with our investigators for this trial and they were really very excited about the results that we presented to them and encouraged us to go forward and to pursue registration. So based on their feedback we created a roadmap and developed a protocol and now as the next step in the fall we're going to be seeking FDA feedback on our path to registration with this compound.

Yes. So, Matt, the short answer is, as quickly as we can and we think that's going to occur, hopefully early in the fall.

Great, congrats on the progress. And thanks for taking the questions guys.

Thank you.

Thank you.

We'll now take the last question from [indiscernible]. Please go ahead.

Yes, thanks for taking me and I have a couple of questions. And Joe, Charlie, Sean and Andreas it's good to talk to you again.

Thank you.

Congratulation on the sales. And I have a question along those line. Your sales -- your increasing sales revenue and you've gotten to a certain company size as well as diversity of drug. I'd like to get your thoughts on how you view the vertical integration. For example, your drug candidates are small molecules may appear reasonably straightforward to manufacture. And so just going forward, your thoughts of how you view the company in terms of integrating?

I'm not sure, I entirely understand your question, Allen [Phonetic]. But are you referring to whether our prospects for commercializing our own molecules going forward.

Yes, yes.

Okay.

I think, right now -- yes, go ahead.

No, because it's a good question, because I don't think we've ever been asked it. But I think the issue is this, it's something that we always consider and you follow Corcept for many, many years, there's sort of buy versus build idea is always in the forefront of our mind and we've been very efficient about that over a long period of time. I think with Cushing syndrome as an example, we really have an understanding of what the diseases like and where the doctors are and we've learned a lot as we've commercialized Korlym many of those lessons are going to be very applicable to what we do with [indiscernible]. We also believe that for any reasonably sized disorder particularly any other orphan disorder we have the ability to commercialize those indications ourselves particularly in the United States. Open questions are -- will we commercialize our new compounds by ourselves in Europe or the rest of the world or have a partner. And then the second question is for the really large disorders, if we're fortunate enough to have a product to have a molecule which makes it to be a product something like miricorilant and in antipsychotic induced weight gain, whether it's the more efficient strategy is for us to be the commercial agent or whether we partner with a different company at that point in time and those questions really are on our mind but we just haven't come to decisions with them and as we do, we will fill and fill you in, as we go along.

Okay. The another one has to do with the -- the new trial that you're proposing for -- let's call [indiscernible] or what we kind of -- spot when we call it sub-clinical. Really kind of nature intent, are you taking a really wide swath of patients from moderate to so called very, very modest and are you hoping to capture diabetic and NASH subsets and lastly around that -- yes, go ahead.

Yes. No, what I was going to say is that first I say this was a little bit of human driving [ph] force; sub-clinical Cushing syndrome. I hope, I never hear that term again because this patients have Cushing syndrome. I mean people who have glucose intolerance, hypertension and other metabolic issues have serious clinical symptoms. So no, this is a group that has all of them have Cushing syndrome as it's described and there are differences of the etiology of adrenal adenomas is supposed to pituitary adenomas tends to producing more indolent course but one which has great pathology associated with it and that's been more and more recognized over the last six, seven years, although you see reports of it all the way back to the 1990's and actually an interesting historical point is it started to really get examine when MRI imaging became good enough that when people had imaging for other reasons they would note adrenal tumors and then wonder what to do with them. But overtime, those [indiscernible] have really come home to roost and there really is now an increasing need to do something with them whether it's a drug or surgery, whatever it is, there is a real pathology there. So these are all patients with Cushing syndrome. They're not particularly patients they may have fatty liver, they may have other things associated with them. But their primary issue is Cushing syndrome hypercortisolism.

Yes, you hit something pretty interesting. I wonder if you can provide some color on the impact of abnormal versus regular severe Cushing's for example the percentage of adrenal with metabolic syndrome with adenomas, I understand this -- if I'm not mistaken it's quite high. Maybe you could provide just, just a little bit of color on that?

Well, I think it's really unknown exactly to what degree it exists. And I have said this on previous calls, we always say that there are about 20,000 patients with Cushing syndrome and about half procured with surgery. And so it leaves us about 10,000 patients. Now, I think, nobody really knows it's instead of 20,000 at the top end is at 30,000 or 40,000. I mean, no one really knows the answer to that, but we do know that when more aggressive screening is done that these patients show up and in fact, our whole commercial effort I think around Cushing syndrome is do the screening, doesn't necessarily mean patients going to end up at Korlym, but actually diagnose whether they have Cushing syndrome and I actually like read to you a couple of things. This is actually from the enter cringe society guidance an example. In one study 2% to 3% of patients with poorly controlled diabetes had surgically confirm Cushing syndrome. So I think the real effort is that we want endocrinologist to at least consider this possibility because appropriately treated whatever the etiology if the, if the etiology -- if the problem is excess cortisol activity, reducing cortisol activity in whatever way you do it is going to improve the clinical condition. So that's really the story. I don't actually -- in fact nobody really has the exact demographics, not 1 million patients with Cushing syndrome but could there be 30,000 or 40,000 instead of 20,000 there could be.

Thank you very much. I appreciate it.

Okay. Allen, thank you. And thank you everybody for listening in, on a hot summer afternoon. Enjoy the rest of the summer, and we look forward to talking to you in the fall.

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