Corcept Therapeutics Incorporated (CORT) Q2 Earnings Call Transcript

Corcept Therapeutics Incorporated (CORT -3.78%)
Q2 2019 Earnings Call
August 1, 2019, 5:00 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good day and welcome to the Corcept Therapeutics conference call. Today's conference is being recorded. As a reminder, if you'd like to ask a question, please signal by pressing *1 on your telephone keypad. At this time, I would like to turn the conference over to Chief Financial Officer Charlie Robb. Please go ahead, sir.

Charlie Robb -- Chief Financial Officer

Thank you. Good afternoon and thanks, everyone for joining us. Earlier today, we issued a press release announcing our second quarter financial results and reviewing our research and development programs. 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 August 15th at 888-203-1112 from the United States and 719-457-0820 internationally. The 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 aren't necessarily subject to risks and uncertainties that might cause actual results to differ materially than those the forward-looking statements express or imply.

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 competing treatments for Cushing's syndrome, including generic versions of Korlym, our ability to obtain acceptable prices or adequate insurance reimbursement for Korlym, and risks related to the development of product candidates, including clinical outcomes, regulatory approvals, mandates, oversight, and other requirements. These and other risks are set forth in our SEC filings, which our available at our website and 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 as 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 court, the scope and protective power of our intellectual property, the clinical attributes of Relacorilant, Miracorilant, and Exacorilant.

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 Medicine 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 expire by its terms on June 30th. We believe our profits together with our cash on hand will be sufficient to fully fund our commercial business, complete our current development programs in Cushing's syndrome, solid tumors, anti-psychotic induced weight gain, and NASH, and advance to 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 and we have sued Teva for patent infringement. In addition, Teva asked 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. If 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 of 30 months from a receipt of Sun's notice letter, approximately December of 2021, and a decision by the District Court that the patents we have asserted against Sun are invalid, unenforceable, or not infringed. Despite overlap in subject matter and legal issues with our lawsuit against Teva, our dispute with Sun is separate and will likely follow its own timeline.

Finally, earlier this year, the PTAB instituted an inter partes review or IPR of another of our patents, the 348 patent, that was brought by Neptune Generics, a subsidiary of the litigation finance firm, 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 will now turn the call over to Joseph Belanoff, our Chief Executive Officer. Joe?

Joseph Belanoff -- Chief Executive Officer

Thank you, Charlie. We are very pleased with the performance of our Cushing's syndrome franchise last quarter. As we expected, patients taking Korlym worked through the insurance reauthorization process many of them must undergo at the start of each year. Their care was not interrupted because we gave them Korlym at no cost. But the temporary pause in reimbursement for some patients did reduce our first quarter revenue as it has every year since Korlym's 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's syndrome. To reach more physicians, we are increasing the size of our field salesforce 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 has shown first in its pivotal trial and then in commercial use that cortisol modulation can greatly benefit many patients. However, Korlym causes off-target effects that limit its use. Korlym treats Cushing's syndrome by modulating cortisol activity at the glucocorticoid receptor, GR, for short.

But 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 an abortifacient. In fact, the active ingredient in Korlym is the same as in the medication called 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 as hypokalemia. Potassium is important for the normal function of nerve and muscle cells, particularly part muscle cells. Low levels of potassium can be life threatening. Hypokalemia 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, 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 does not significantly increase cortisol levels and does not cause hypokalemia. These are major medical and commercial advantages.

In Relacorilant's Phase 2 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 posters at the investors, past events tab of our website.

Relacorilant's Phase 3 trial, which we call GRACE, is under way with a planned enrollment of 130 patients at 60 sites in the United States, Canada, Europe, and Israel. Each patient in the GRACE study receives Relacorilant for 22 weeks. Those who exhibit pre-specified improvements in hypertension or glucose metabolism enter a 12-week double-blind randomized withdrawal phase, which half 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 in the study, comparing patients continuing Relacorilant and those rnaodmized to placebo.

I'm pleased to announce that we plan to begin a second clinical trial in patients with less severe Cushing's syndrome later this year. These patients have adrenal adenomas and 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's syndrome on the results of GRACE. That being said, this etiology of Cushing's 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 program cell death, known as apoptosis. Since chemotherapy drugs kill tumors by promoting apoptosis, this effect to 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 1 and 2 trial of Relacorilant plus Nab-Paclitaxel, Celgene's taxane-based drug Abraxane, tested the hypothesis that adding a cortisol modulator to a chemotherapeutic regimen would turn down cortisol's anti-apoptotic effect and all chemotherapy to achieve its full potential.

We presented data from this trial at this year's ASCO Conference. Seven of 25 patients with metastatic pancreatic cancer and 5 of 11 patients with advanced ovarian cancer achieved durable disease control, meaning their tumors either shrank or ceased growing for 16 weeks or longer.

The duration of response in some patients was particularly notable. Tumors shrinkage two patients with pancreatic disease 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 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 1 and 2 results justify larger, more definitive studies. Earlier this year, we began a 180-patient placebo-controlled Phase 2 trial of Relacorilant plus Nab-Paclitaxel in patients with advanced ovarian cancer. In addition, we had completed writing the protocol for a Phase 3 trial of Relacorilant plus Nab-Paclitaxel in patients with metastatic pancreatic cancer and will 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 Medicine 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 1-2 findings in 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. Androgynes stimulate growth in tumors of the prostate, which is by androgyne 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 androgyne deprivation agents such as enzalutamide, Pfizer's drug Xtandi, the growth begins to be stimulated by cortisol.

Our hypothesis, which originates with investigators at the University of Chicago, is that adding a cortisol modulator to androgyne deprivation therapy will block this tumor escape route. Investigators at the University of Chicago are leading two controlled Phase 2 trials testing this hypothesis, one examining Korlym plus Xtandi and the other Relacorilant plus Xtandi.

We are conducting a dose-finding trial of our proprietary selective cortisol modulator, Exacorilant, formerly CORT 125281, 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 trials being led by the University of Chicago investigators once it is available to develop the appropriate next steps for our development program.

I will conclude with the discussion of our program in metabolic disease. Preclinical and clinical data have shown that 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 anti-psychotic 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 their side effects, including weight gain, hyperglycemia, and hyperlipidemia shorten the lives of patients, most of whom die from cardiovascular disease.

In April, we began dosing healthy subjects in a Phase 1B trial to test whether Miracorilant attenuates the weight gain caused by the commonly prescribed anti-psychotic medication Olanzapine. We modeled this trial on placebo-controlled studies we conducted in which Mifepristone significantly reduced the metabolic side effects of Olanzapine and another anti-psychotic medication, Risperidone.

Unfortunately, Mifepristone's status as the abortion pill prevented us from advancing as a treatment for common disorders. Miracorilant 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 Miracorilant or placebo for two weeks. Although the trial's primary endpoint is change in weight, we have a more fundamental goal. This is the first study of Miracorilant's potential pharmacodynamic activity. Its results in animal studies were very powerful. We know from our Phase 1 trial that Miracorilant is well-tolerated. Our objective for this study is to begin to learn about its metabolic properties and people. We will have results later this year.

Later this year, we will also begin a double-blind placebo-controlled Phase 2 trial in patients with recent anti-psychotic-induced weight gain. In 2020 after our program to optimize Miracorilant's formulation is complete, we will initiate a Phase 2 trial and the reversal of long-standing anti-psychotic-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, liver inflammation, and fibrosis. It is a precursor to cirrhosis. Mifepristone is potent in animal models in these conditions and appears to reverse fatty liver disease in patients with Cushing's syndrome. In animal models with these conditions, Miracorilant is even more potent. We expect to initiate a double-blind placebo-controlled Phase 2 of Miracorilant in patients with NASH next year.

To recap, our Cushing's 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 salesforce, which should begin to contribute to our commercial results next year. Relacorilant's Phase 3 NDA-enabling GRACE trial continues to enroll patients. Separately, we will begin a placebo-controlled double-blind trial in patients with less severe Cushing's syndrome later this year.

We continue to make important advances in our oncology program. We presented striking data from a Phase 1-2 trial at ASCO this year. The data showed durable disease control in patients with metastatic, ovarian, and pancreatic cancer well beyond what is expected from a population that received multiple prior lines of therapy, including prior use of taxanes. We're actively enrolling subjects in a 180-patient-controlled Phase 2 trial of Relacorilant plus Abraxane in ovarian cancer. We expect to begin a Phase 3 trial in patients with metastatic pancreatic cancer later this year.

Our trial of Exacorilant plus enzalutamide continues to generate data, as do trials being led by investigators at the University of Chicago with Korlym and Relacorilant. Our metabolic program achieved an important milestone. Our lead compound, Miracorilant, is being tested for the attenuation of anti-psychotic-induced weight gain in healthy subjects and two Phase 2 trials in anti-psychotic-induced weight gain will be conducted, one expected to begin later this year and another one to begin in 2020. We also expect to start a Phase 2 trial of Miracorilant to treat patients with NASH next year.

I'll stop here for questions.

Questions and Answers:

Operator

If you'd like to ask a question, please signal by pressing *1 on your telephone keypad. If you're using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. Again, press *1 to pose a question. We'll pause for just a moment to allow everyone an opportunity to signal for questions.

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

Pete Stavropoulos -- Cantor Fitzgerald -- Analyst

Hi, this is Pete Stavropoulos on for Charles Duncan. Congratulations on the quarter. I have a couple of questions about the GRACE study. How is enrollment going and could you give a sense in terms of timing for potential outcome in Phase 3? This is in light of some your competitors and one of your competitors having difficulties in enrollment and has delayed topline data for their program.

Joseph Belanoff -- Chief Executive Officer

Okay. I'd like to reintroduce everyone to Andreas Grauer, who's our Chief Medical officer. Andreas, why don't you take the question?

Andreas Grauer -- Chief Medical Officer

Hi. So, just to give you a quick update on how GRACE is going, we had a very good investigator leave Europe just recently with a lot of enthusiasm of all the involved investigators. You may remember in our Phase 2 program, the majority of patients were recruited in Europe and only a smaller percentage in the US.

So, at the moment, we're starting off all these sites in Europe. As you may know, 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, it's a six-month open label phase and a three-month randomized control phase. So, the last patient out should then be nine months later.

Joseph Belanoff -- Chief Executive Officer

And Pete, of course, Andreas speaks that as a one-time former European. We're working very hard to get all the sites up in Europe. There was great enthusiasm at that meeting. The fall will really tell us where we are in enrollment and we would be able to give you a better sense of that. We're confident that the Phase 2 results have prompted investigators to join the trial who might not otherwise have and we're confident they'll be able to use the medicine successfully in patients. Nothing changed from the last call and we'll give you an update as we have more data in the fall.

Pete Stavropoulos -- Cantor Fitzgerald -- Analyst

I have another question about the new study, the double-blind, placebo-controlled -- does it a have a similar design to GRACE, where you have the lead-in period, patients experience clinically meaningful benefit and then move on to the randomized control phase? What kind of outcomes are you looking at? Is it the same burden of disease and pricing?

Joseph Belanoff -- Chief Executive Officer

I'll point you to Andreas again. There was a lot in that, but Andreas, go for it.

Andreas Grauer -- Chief Medical Officer

Let me go through 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 start. So, we will respectively randomize the patients into two groups. One will receive the active treatment, Relacorilant, and the other half will receive placebo. We are planning for a study duration of six months. We will 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're enrolling in GRACE. These are patients with adrenal tumors and the hormonal changes are more or less pronounced but there is significant data pointing to the fact that these patients suffer serious long-term consequences if this disease remains untreated. That's why we feel it's important to treat these patients in this trial.

Joseph Belanoff -- Chief Executive Officer

Pete, I'll just add -- we really thought this meeting in Europe was a seminal investigators meeting. As someone who attended it I can tell you that the single period of greatest energy was for this study. Literature over the last six years has really indicated that these patients that watched and waited never got better, but it's never been studied in a rigorous way, although we think it's a big advantage to actually do the study, although there are certainly a number of case reports of individuals with this variant of Cushing's syndrome improving. This is really the first time a placebo study has been attempted that really specifies this group. We think it's very vengeful for the field as we go forward.

Pete Stavropoulos -- Cantor Fitzgerald -- Analyst

Thanks. Do you have any sort of timeline to data?

Andreas Grauer -- Chief Medical Officer

We're in the process of finalizing the protocol. The submissions across the US and Europe have to happen and we need to get approval for this trial. We will use pretty much the same centers that we are using currently for GRACE that will give us economies of scale that will make the approval and start-up for this study faster. We expect an enrollment period of approximately six to nine months in this trial. That gives you the drivers for the study and when we're going to be able to see results here.

Operator

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

Tazeen Ahmad -- Bank of America Merrill Lynch -- Analyst

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

Charlie Robb -- Chief Financial Officer

Hey, Tazeen. Thanks for the question. This is Charlie, obviously. This is the first price increase we've taken in about 18-19 months. It's something we look at every quarter trying to judge what the appropriate price is. 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 are denied Korlym on the basis of financial need. We've lived up to our part of that social contract.

We also are always careful to make sure we are never the tallest nail on the board. We have remained and will remain, I think, well within the middle of the heard. As to exactly what will shake out politically, we're not sure but I think we feel confident in the increases we've taken. I feel like they're justified and we're living up to our side of the bargain in this economy. That's really all the guidance I can give you on that point.

Joseph Belanoff -- Chief Executive Officer

I would just reemphasize that this is not a once in a while topic. We think about it all the time, evaluate it every quarter and we felt like this really was an appropriate time to take a price increase. I just want to point out to the group that there was no price increase in the second quarter. The price increase did begin today and so, the second quarter results are absent any price increase at all.

Tazeen Ahmad -- Bank of America Merrill Lynch -- Analyst

Great. Thanks for all the color. Maybe keeping in line that thought, you have reiterated your guidance for the full year. It didn't seem to me you would need that much growth in each quarter to get to the middle of your guidance range. Now that you have taken this 9% price increase, why not increase the range on the bottom end a little bit.

Joseph Belanoff -- Chief Executive Officer

So, first of all, our guidance and our pricing decisions really are independent matters. One of the things we don't take into account when setting our price is what we'd like our revenue to be. We determine our guidance based on our best estimate for the year and then we determine pricing on its own merits on its quarterly basis. For us, they're separate considerations.

We didn't narrow our guidance this quarter because we think our revenue will still fall within that range, but as the year goes on and we get closer to the end, guidance, like price, is something we will look at and decide if it's appropriate to lower it on the next call. We'll see.

Operator

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

Neil Carnahan -- Stifel Nicolaus -- Analyst

Hi, guys. It's Neil Carnahan on for Adam. On Miracorilant, can you tell us about the development path you guys are thinking about? You're going to launch a placebo-controlled Phase 2 study later this year, another in 2020 for anti-psychotic-induced weight gain. Can you expand on these? Have you guys given thought to design? Has that design finalized enrollment size? Any details you can share there?

Joseph Belanoff -- Chief Executive Officer

I'm going to punch it to Andreas for that question.

Andreas Grauer -- Chief Medical Officer

As Joe told you, Miracorilant has a very interesting pharmacology. The molecule is not very easy to formulate and we're optimizing the formulation. So, we're starting with one Phase 2 trial in which we think we can study the medication in its current format and that is a trial in patients that have recently gained weight on antipsychotic medication. The expected trial size here is approximately 100 patients and it will be placebo-controlled, one to one randomization, active versus placebo. We're expecting an enrollment period of approximately one year and to start that trial in the last quarter of this year.

The next trials we will start once we have a better, more suitable formulation for those and we're planning to start a second trial in anti-psychotic-induced weight gain and we're also planning to start the trial in NASH.

Joseph Belanoff -- Chief Executive Officer

Let me elaborate a little bit. This has been a very, very potent molecule in animal models on a per-kilogram basis, even significantly more potent than Mifepristone, which itself is very potent. So, we've alluded to this formulation issue. We now have 100-milligram tablets which really seem to work very well, but we think the dose is likely to fall in the 600-900-milligram basis. What we'd really like to be able to do is create a tablet that has more milligrams in it so people don't have to take 600-900 milligrams a day. We're hard at work at that. We have lots of resources attending to it. We think that is really a solvable problem. That's the issue.

In the meantime, the ways that we described it, we really are going to continue to accumulate data. It's very important that we can really show the data we've seen in animals does translate to people. The first study that we will see is the healthy subjects study that we've talked about. That will be later this year. Then the next study after that is in the patients that have recently gained weight on anti-psychotic medication. Both of those will be controlled double-blind studies. I think we'll get some indication of whether or not the medication activity is real and substantial.

Operator

We'll now take our next question from Matt Kaplan of Ladenburg Thalmann. Please go ahead.

Matthew Kaplan -- Ladenburg Thalmann -- Analyst

To follow up on Adam's question about Miracorilant and specifically the Phase 1b study. Is that going to be the next data readout that we have? Can you give us more color in terms of what we should be looking for in the Phase 1b study, specifically the metabolic effects we should be looking for?

Joseph Belanoff -- Chief Executive Officer

Matt, let me back up a little bit just so that -- I know you're very familiar with the program but others may not be quite as familiar. This is a compound which in models of anti-psychotic-induced weight gain among other things produce very potent results. 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 1 study that really established that the doses we had in mind were well-tolerated, which they did. So, it really is the first test of pharmacodynamic effect. It's a two-week study. So, we were obviously not going to see the results you would see if the medicine was active in a six-month study.

But I think it will give us some 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. You really should consider it an opening study. We're very excited about it, but we're learning.

I think more globally, this is a molecule that we think is going to be very meaningful to Corcept over a long period of time. 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. We think this one has long legs.

Matthew Kaplan -- Ladenburg Thalmann -- Analyst

Okay. That's helpful. Thanks, Joe. Then shifting gears a little bit to your oncology program -- with the 180-patient study in ovarian cancer enrolling, can you give us a sense in terms of where you are in that study in terms of being able to complete enrollment and what could be the timeline for that Phase 3?

Joseph Belanoff -- Chief Executive Officer

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 a Phase 1-2 study, but to enroll that number of patients, we have to enlarge that study. There's a whole European group who is going to be entering that study who isn't online yet. I can't give you a really good sense of when it's going to conclude. It's not going to be this year. There's no data readout this year.

Next year, it would be an ambitious goal. We're going to try to go for it. We'll see as quickly as we can. We'll just update you as we go along and get a better sense of it. We really are in for the bulk of it the site opening period at this point and we're hard at work at that.

Matthew Kaplan -- Ladenburg Thalmann -- Analyst

And then in terms of the pancreatic cancer in Phase 3, the potential pivotal study, when would you be meeting with the FDA to solidify the design of that study?

Joseph Belanoff -- Chief Executive Officer

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

Andreas Grauer -- Chief Medical Officer

For that, check the results at ASCO. At the same time, I had a meeting with our investigators for this trial and they were really 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 and developed a protocol and now the next step, in the fall, we're going to be seeking FDA feedback on our path to registration with this compound.

Joseph Belanoff -- Chief Executive Officer

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

Matthew Kaplan -- Ladenburg Thalmann -- Analyst

Great. Congrats on the progress. Thanks for taking my questions.

Operator

We'll now take our last question from Alan Leong from BioWatch News. Please go ahead.

Alan Leong -- BioWatch News -- Journalist

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

Joseph Belanoff -- Chief Executive Officer

I'm not sure I entirely understand your question. Are you referring to whether our prospects for commercializing our own molecules going forward?

Alan Leong -- BioWatch News -- Journalist

Yeah.

Joseph Belanoff -- Chief Executive Officer

It's a good question because I don't think we've ever been asked it. I think the issue is this -- we always consider -- and you know because you've followed Corcept for many years -- the buy versus build idea is always in the forefront of our mind. We've been very efficient about that over a long period of time.

I think with Cushing's syndrome as an example, we really have an understand of what the disease is 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 Relacorilant. 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? The second question is for the really large disorders, if we're fortunate enough to have a molecule, which makes it to be a product, something like Miracorilant in anti-psychotic-induced weight gain, whether 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. Those questions really are on our mind but we haven't come to decisions on them. As we do, we will fill you in as we go along.

Alan Leong -- BioWatch News -- Journalist

Okay. The other has to do with the new trial you're proposing. Are you taking a wide swath of patients from moderate to very modest? Are you hoping to capture diabetic and NASH subsets?

Joseph Belanoff -- Chief Executive Officer

What I was going to say is that first, I saw this with a little bit of humor -- sub-clinical Cushing's syndrome, I hope I never hear that again. It's Cushing's syndrome. People who have glucose intolerance, hypertension, and other metabolic issues have serious clinical symptoms. No. This is a group that all of them have Cushing's syndrome as it's described. What their difference is is the etiology of adrenal adenomas as opposed to pituitary adenomas. It tends to produce a more indolent course, but one that has great pathology associated with it. That's' been more and more recognized over the last six, seven years, although you see reports of it back to the 1990s.

And actually, an interesting historical point is it started to get examined when MRI imagining became good enough that when people had imaging for other reasons, they would note adrenal tumors and then wonder what to do with them. Over time, those birds have come home to roost and there is an increasing need to do something with them. There's a real pathology there. These are all patients with Cushing's syndrome. They may have fatty liver. They may have other things associated with them. Their primary issue is Cushing's syndrome, hypercortisolism.

Alan Leong -- BioWatch News -- Journalist

Yeah. You hit something pretty interesting. I wonder if you can provide some more color on the impact of adenoma versus regular severe Cushing's? For example, the percentage of elderly with metabolic syndrome with adenomas -- if I'm not mistaken, it's quite high. Maybe you can provide a little color on that.

Joseph Belanoff -- Chief Executive Officer

I think it's unknown exactly to what degree it exists. I have said this on previous calls. We always say there are about 20,000 patients with Cushing's syndrome and about half are cured with surgery. So, it leaves us about 10,000 patients. I think what nobody knows is instead of 20,000 at the top end, is it 30,000 or 40,000? No one really knows the answer to that. We do know that when more aggressive screening is done, these patients show up.

Our whole commercial effort around Cushing's syndrome is do the screening. It doesn't necessarily mean the patient is going to end up with Korlym, but diagnose whether they have Cushing's syndrome. This is actually from the Endocrine Society guidance, an example, "In one study, 2% to 3% of patients with poorly controlled diabetes had surgically confirmed Cushing's syndrome."

So, I think the real effort is that we want endocrinologists to consider this possibility because appropriately treated, whatever 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. That's really the story. Nobody really has the exact demographics. There are not a million patients with Cushing's syndrome, but could there be 30,000 or 40,000 instead of 20,000? There could be.

Alan Leong -- BioWatch News -- Journalist

Thank you very much. I appreciate it.

Joseph Belanoff -- Chief Executive Officer

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.

Operator

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

Duration: 47 minutes

Call participants:

Charlie Robb -- Chief Financial Officer

Joseph Belanoff -- Chief Executive Officer

Andreas Grauer -- Chief Medical Officer

Pete Stavropoulos -- Cantor Fitzgerald -- Analyst

Tazeen Ahmad -- Bank of America Merrill Lynch -- Analyst

Neil Carnahan -- Stifel Nicolaus -- Analyst

Matthew Kaplan -- Ladenburg Thalmann -- Analyst

Alan Leong -- BioWatch News -- Journalist

More CORT analysis

All earnings call transcripts

This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability.