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Corcept Therapeutics Incorporated (CORT 1.28%)
Q3Â 2019 Earnings Call
Nov 7, 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. [Operator Instructions]
At this time, I would like to turn the conference over to Charlie Robb. Please go ahead, sir.
Charles Robb -- Chief Financial Officer
Good afternoon. My name is Charlie Robb, I am Corcept's Chief Financial Officer. Thank you all for joining us. Earlier today, we issued a press release announcing our third 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 Novermber 21, at (888) 203-1112 from the United States and (719) 457-0820 internationally. The passcode will be 8532239.
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 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. The initiation or outcome of litigation, our ability to obtain acceptable prices or 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 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 litigation including our lawsuits 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 benefits of orphan drug designation in the European Union and the United States.
The clinical attributes of relacorilant, miricorilant and exicorilant, and the progress, timing, design and results of our drug product formulation efforts and our current and planned preclinical and clinical development studies and trials. We disclaim any intention or duty to update forward-looking statements.
Corcept's revenue in the third quarter was $81.5 million, a 26% increase from the third quarter of 2018. We narrowed our 2019 revenue guidance to between $300 million and $315 million, the upper half of our original range. Third quarter GAAP net income was $26.3 million, compared to $17.7 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, non-GAAP net income in the third quarter was $37.8 million, compared to $27.9 million in the third quarter of 2018. Our cash and investments at quarter-end were $266.9 million compared to $225.7 million at June 30. We believe our profits, together with our cash on hand will be sufficient to fully fund our commercial business and complete our planned development programs.
I will now turn the call over to Dr. Joseph Belanoff, our Chief Executive Officer. Joe?
Joseph K Belanoff -- Chief Executive Officer, President and Director
Thank you, Charlie. As you've just heard, our Cushing's syndrome business had an excellent quarter. The number of patients receiving Korlym increased as it the number of physicians prescribing the medication. We expect growth to continue. There are thousands of patients with Cushing's syndrome who could benefit from Korlym who have yet to receive it. To reach more doctors we have begun the planned expansion of our sales force from 40 clinical specialists to 55. These new clinical specialists will complete their training and begin calling on physicians next quarter and should start contributing to our results in the second half of next year. Korlym is an effective and well tolerated medication, 87% of patients in Korlym's pivotal trial demonstrated significant clinical benefit, the years long growth in the number of patients taking Korlym to treat Cushing's syndrome stems from an essential fact, the medicine works. Unfortunately Korlym's off target effects make it not the optimal treatment for me [Phonetic] and make it completely unsuitable for others.
Korlym benefits patients by modulating cortisol activity at the glucocorticoid receptor GR for short. However, Korlym also binds the progesterone receptor PR for short, which is why Korlym is an a Board of fashion and carries a black box warning for termination of pregnancy. Korlym's PR affinity also causes endometrial thickening and vaginal bleeding in many women regardless of their age. These adverse events are particularly significant in the medication for patients with Cushing syndrome approximately 70% of whom are women.
By a different off target mechanism, Korlym can also lower blood potassium potentially life-threatening medical condition known as hypokalemia. These adverse events are not there, one-third of the female patients in Korlym's pivotal trial experienced endometrial thickening or vaginal bleeding. 44% of the participants both men and women developed hypokalemia. These conditions are manageable, but can be problematic and require close monitoring. Patients and physicians which strongly prefer to avoid them. Our planned successor to Korlym relacorilant binds to GR but not PR and so it does not cause endometrial thickening or vaginal bleeding.
It is not the abortion pill. It also does not cause hypokalemia. Without causing these side effects relacorilant's efficacy and its Phase 2 trial was comparable to what was observed at similar time points in Korlym's pivotal study. We presented our findings in April at the annual meeting of the American Association of Clinical Endocrinologists, you can see our presentation at the investors' Events tab of our website. Earlier this year, we began a Phase 3 trial called GRACE, that we expect will support an NDA for relacorilant in the treatment of Cushing syndrome. GRACE has two parts. In the initial open label phase patients received relacorilant for 22 weeks.
Those who exhibit prespecified improvements in glucose metabolism or hypertension are randomized to a double-blind, placebo-controlled phase in which half continue receiving relacorilant and the rest are switched to placebo. GRACE is primary endpoints are the rate and degree of relapse in patients receiving relacorilant compared to those receiving placebo during this randomized withdrawal phase. To learn more about GRACE visit our website or cushingresearch.com. GRACE is planned enrollment is 130 patients at sites in the United States, Canada, Europe and Israel. 42 of our planned 62 sites are recruiting patients. We expect to open 13 more sites by the end of this year. The activation screening and enrollment pace of ex-US sites, which we expect will provide the majority of patients has allowed us to refine our estimate of GRACE's completion date.
We believe we will be ready to submit an NDA in the fourth quarter of 2021. Apart from GRACE, we plan to open an additional Phase 3 trial, a double-blind, placebo-controlled study in patients whose Cushing's syndrome is caused by cortisol secretion from an adrenal adenoma in the first quarter of next year. The symptoms experienced by patients with adrenal Cushing's syndrome tend to be slower in onset and those are patients, we are studying in GRACE. Although there is increasing evidence that these patients eventually experienced serious metabolic and cardiovascular problems. The trials planned enrollment is 130 patients, half of whom will receiving relacorilant and the rest placebo, treatment duration will be 22 weeks. The primary endpoints will be improvement in glucose metabolism and hypertension.
Most of the investigators participating in Grace will also participate in this trial. The FDA has not required us to conduct a study in patients with adrenal Cushing's syndrome. We plan to base relacorilant's NDA on the results of GRACE. Cushing's syndrome and patients with adrenal adenomas has not been rigorously studied and there is great interest in the field in doing so. We expect our study to contribute meaningfully to the understanding of Cushing's syndrome and it's optimal treatment.
I'll now turn to our program in metabolic disorders, which has made several important advances since our last conference call. As some of you know, preclinical and clinical data with mifepristone suggest that cortisol modulation may play a role in treating two serious and widespread metabolic disorders, weight gain caused by antipsychotic medication and Nonalcoholic Steatohepatitis or NASH.
I'll begin by discussing antipsychotic-induced weight gain. Millions of people rely on medications such as olanzapine to treat psychosis and bipolar disorder. Unfortunately the side effects of these life saving medications, which include rapid and sustained weight gain, hyperglycemia and hyperlipidemia shorten life expectancy and cause many patients to discontinue treatment. We have conducted placebo-controlled trials in healthy human subjects in which cortisol modulation with mifepristone, significantly reduced weight gain caused by two of the most commonly prescribed antipsychotic drugs olanzapine and risperidone.
These results were published in the journals advances in Therapy in October 2009 and in Obesity in December 2010. Despite these positive data, we could not advance mifepristone as a treatment for this disorder, because it is the active ingredient in the abortion pill mifepristone cannot be developed as a treatment for any highly prevalent disorder. By contrast our proprietary molecule miricorilant is a viable drug candidate for this indication, unlike mifepristone miricorilant is a selective cortisol modulator with no progesterone receptor activity. It is not the abortion pill. What's more in animal models miricorilant is even more potent on a per kilogram basis than mifepristone in preventing and reversing olanzapine and risperidone induced weight gain.
We've just completed the first phase of a Phase 1b trial of miricorilant for the prevention of antipsychotic induced weight gain. We modeled this trial on our successful trials with mifepristone 66 healthy subjects received 10 milligrams of olanzapine and either placebo or 600 milligrams every day. The duration of the trial was two weeks. The primary endpoint was change in weight from baseline. This is the first time we have tested miricorilant in humans as a potential treatment for any indication.
The question we sought to answer was limited is miricorilant active at all in people taking olanzapine. I'm pleased to say the answer to this question is yes. Top line data from our trial showed that miricorilant significantly reduce the amount of weight gain by healthy subjects taking the olanzapine even when administered at a low dose and for only two weeks. After seven days subjects receiving the olanzapine plus placebo gain [Phonetic] an average of 3.5 kilograms subjects receiving olanzapine plus miricorilant gain 2.6 kilograms. At 14 days following an additional seven days of dosing the difference in widened average weight gain in the placebo group was 5 kilograms in the miricorilant group it was 3.9 kilograms.
We are also pleased to observe that the levels of liver enzymes ALT and AST markers of liver damage that temporarily increase at the start of the olanzapine therapy increased less markedly in the miricorilant group. In addition, five subjects in the olanzapine plus placebo group let this study due to elevated liver enzymes compared to just one subject in the olanzapine plus miricorilant group. This finding is an early indicator that miricorilant may a protective effects in the liver. This topline results are especially encouraging because they were observed so quickly and it's such low plasma levels of miricorilant. We will present the full results of the study at a scientific conference next year.
Our program continues to advance. The second part of our Phase 1b trial, which will start in December will test 900 milligram dose of miricorilant. We have also begun a double-blind, placebo-controlled Phase 2 trial of miricorilant for the reversal of a recent antipsychotic induced weight gain in patients with schizophrenia. The plan is to enroll 100 patients who will continue to receive there is establishing antipsychotic medication with either miricorilant or placebo added to their regimen for 12 weeks.
Finally, we are pleased to report that we have made significant progress developing a formulation of miricorilant that will more easily allow us to achieve optimal miricorilant plasma levels, which we estimate our several times higher than those we have tested so far. The availability of an improved formulation will also allow us to advance our program in NASH, a severe form of non-alcoholic fatty liver disease. And then it's characterized by excess fat in the liver and inflammation. NASH is often a precursor to liver fibrosis and cirrhosis, which can lead to liver cancer.
Millions of people in the United States suffer from the disorder. As with antipsychotic induced weight gain there is evidence that cortisol modulation may offer a treatment for NASH. Fatty liver disease is a common symptom of Cushing's syndrome and we have seen the condition resolved when patients are treated with Korlym. In animal models of fatty liver disease and cirrhosis miricorilant is again more potent than mifepristone. We plan to start a double-blind, placebo-controlled Phase 2 trial in patients with NASH next year.
I will conclude with a brief discussion of our oncology programs. Many solid tumors including pancreatic and ovarian tumors express GR. Unfortunately cortisol activation of GR inhibits apoptosis program cell death, which is the mechanism by which chemotherapy achieves its intended effect. Co-administration of a cortisol modulator, may allow chemotherapy to achieve its full cancer-killing potential. As many of you know, we have tested this hypothesis by combining relacorilant with nab-paclitaxel Celgene's taxane-based drug, Abraxane, in a Phase 1/2 trial in patients with solid tumors.
The results which we presented at ASCO earlier this year was striking. Seven of 25 patients with metastatic pancreatic cancer and five 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 benefit in some patients was eye-catching. Tumor shrinkage in two patients with metastatic pancreatic cancer lasted longer than 50 weeks. A patient with ovarian cancer exhibited tumor shrinkage for 65 weeks. All of these patients tumors had breast despite multiple lines of prior therapy including treatment with taxanes, that any of them responded when relacorilant was added to their chemotherapy regimen seems extraordinary. The study poster we presented at the ASCO conference is available at the Investors Past Events tab of our website.
We expect to receive FDA guidance concerning the optimal development plan for relacorilant plus nab-paclitaxel to treat patients with metastatic pancreatic cancer this quarter. These patients have a poor prognosis and few good treatment options. We plan to start a Phase III trial, following completion of our discussions with the agency and expect to be able to provide more details about our plans soon. Our Phase II controlled study of relacorilant plus nab-paclitaxel and metastatic platinum resistant ovarian cancer is in progress with sites in both the United States and Europe.
Cortisol modulation may also help treat castration-resistant prostate cancer. A disease with a poor prognosis, stimulation of the androgen receptor causes prostate cancer cells to grow, which is why androgen receptor antagonism medications such as enzalutamide, Pfizer's drug XTANDI is a standard therapy. Investigators at Memorial Sloan Kettering and the University of Chicago have shown that when prostate tumor cells are exposed to enzalutamide their growth shifts to being stimulated by cortisol. Adding a cortisol antagonist to androgen deprivation therapy blocks this tumor escape route in preclinical models and we are testing whether these findings translate to men with the disease.
We are concluding a dose -- excuse me. We are conducting a dose finding trial of our proprietary selective cortisol modulator exicorilant combined with enzalutamide to treat patients with castration-resistant prostate cancer. Our collaborators at the University of Chicago are leading controlled Phase 2 trials, testing Korlym plus enzalutamide and relacorilant plus enzalutamide. We expect data from these trials to be available next year.
To summarize Corcept had an excellent third quarter. Our Cushing's syndrome business added patients and prescribers and we expect this growth to continue. We have begun hiring additional clinical specialist who will enter the field early next year. We narrowed our 2019 revenue guidance to between $300 million and $315 million. Our Grace trial is now active at 42 sites. We expect to be able to file relacorilant's NDA for the treatment of patients with Cushing's syndrome in the third quarter of 2021. In the first quarter of next year, we plan to start a double-blind, placebo-controlled Phase 3 trial in patients with Cushing's syndrome caused by adrenal adenomas. We expect to receive feedback from the FDA soon and start a Phase 3 trial of relacorilant plus nab-paclitaxel in metastatic pancreatic cancer in the first quarter next year.
Our controlled Phase 2 trial of relacorilant plus Abraxane in metastatic platinum resistant ovarian cancer is in progress at sites in the United States and Europe. Exicorilant and relacorilant are being tested in combination with enzalutamide for the treatment of patients with castration-resistant prostate cancer.
Finally, our program in metabolic disease took important steps forward since our last call. Top line results from the first part of our Phase 1b trial of miricorilant to prevent antipsychotic-induced weight gain were positive. That trial second part will soon begin testing a higher dose of miricorilant to double blind placebo-controlled Phase 2 trial of miricorilant in patients with the antipsychotic-induced weight gain. We will start a Phase 2 trial with miricorilant and long-standing antipsychotic-induced weight gain and a Phase 2 trial and NASH next year. I'll stop here for questions.
Questions and Answers:
Operator
Thank you. [Operator Instructions] We'll take our first question from Charles Duncan of Cantor Fitzgerald.
Charles Duncan -- Cantor Fitzgerald -- Analyst
Hi guys. First of all, congrats on the progress in the quarter in the revenue and all the things that you have going on lots -- lots going on. Appreciate, yes. So, appreciate the granularity with regard to the GRACE study and it looks like a pretty interesting design randomized withdrawal relatively high-power to show efficacy. I guess I'm wondering if you could provide a little color on the rate for the percentage of relapse that you'd expect within a certain period of time, or that you're kind of modeling off with that patient population.
Joseph K Belanoff -- Chief Executive Officer, President and Director
Thanks for the question. I just -- I think, I think we really absorb it. I want to introduce reintroduce you to Andreas Grauer who is our Chief Medical Officer, and I'll turn the question over to Andreas.
Andreas Grauer -- Chief Medical Officer
Yeah, great question. And the primary endpoint for -- so as you may recall we are enrolling these patients with Cushing's syndrome based on, there are two main clinical manifestations so they either have diabetes or impaired glucose tolerance or they have hypertension and the relapse will be measured with regard to the relapse in their glucose control or there hypertension. So for the glucose control, we're assuming and we are assuming an average increase of the glucose area under the curve of 3.7 [Indecipherable] that doesn't mean much for most clinicians. But it is the area under the curve of glucose in the -- to our glucose tolerance test is what -- what the FDA really likes to see as an endpoint in these patients. So I hope that answers your question.
Charles Duncan -- Cantor Fitzgerald -- Analyst
It does partially and would you anticipate that to take months or a year or six months for most patients once they've responded to [Indecipherable].
Joseph K Belanoff -- Chief Executive Officer, President and Director
That's great. Again that also is a great question. The randomized withdrawal phase that we have in this study is three months long based on our experience that we have in our Phase 2 study and also that we have previously with Korlym. We think that the relapse especially of the glucose control parameters and of the hypertension should happen within that three month time period.
Andreas Grauer -- Chief Medical Officer
And just to give you a little context for this Charles. So I don't know if you remember back to the seismic study and that study, the FDA required us at the end of the treatment period -- in that case was 24 weeks to take patients off of the medicine for six weeks before they could reenter essentially reenter an extension study, and within that six-week period, suddenly -- unfortunately, many of them, many of them relapse. It actually was useful for us because when they went back on medicine in the extension phase they got better again. So I think that sort of that zone of four to eight weeks is where most people really begin to show clinical decrement, although for some patients, I can tell you who were in the seismic study, it was as early as two weeks.
Charles Duncan -- Cantor Fitzgerald -- Analyst
That sounds like a pretty neat protocol. I guess, question regarding timing and definitely appreciate you helping us with regard to gauging that timing on NDA. Joe, would you say then that the rate limiting step in terms of timing is really related to enrollment and then driving patients to a response, because it seems like the three month part is pretty well set. The second --
Joseph K Belanoff -- Chief Executive Officer, President and Director
Yeah, I think -- I would even if anything really start and tried to really talk a little bit about this before the rate limiting step really start out with any of the studies these days in at site activation which has become in the 20 years and I've been doing this more and more complex, with the number of IRB's and contracts, but we spent a lot of time on that since the last conference call, we've really -- we ahead on that. And it really gives us visibility into what we think the actual timing. So yes, the rate limiting variable is patient enrollment and we feel like we have a pretty good handle on what that rate is going to be.
Charles Duncan -- Cantor Fitzgerald -- Analyst
Okay. And then my last question is more commercial it's oriented toward the increase in the number of sales folks are clinical specialists that you plan to bring on board. I guess you did mention that you would anticipate they be able to contribute to results in the third quarter of next year. But how would you really measure effectiveness and what is the goal for those specialists, is that to brand the geographic reach or increase the number of -- or intensity of prescriber outreach within -- a certain geography?
Joseph K Belanoff -- Chief Executive Officer, President and Director
Hi. Charles. I'm going to pass you over to Sean Maduck, who I know you know and who runs on all of our commercial area.
Sean Maduck -- Senior Vice President, Commercial
Great. Yeah, thanks for the question. And I think, before I answer the direct question, I'll step back a little bit so that everybody on the call understands what our impetus was for the expansion. So, as a reminder to everyone that at launch, our goal was to reach 1500 high potential prescribers and we've reached that goal. I mean we have over that number of prescribers and in reaching that goal, we've learned a couple of really important things about our market. The first being time matters and you just sort of alluded to that and prescribing physicians do require a lot of attention.
We are shifting and a trench mindset where patients are diagnosed very slowly and treatment is reserved for the most severe cases in this disease. So to shift that mindset multiple in-depth conversations are required to move our position from Korlym naive his or her first prescription and given the many touchpoints required to accomplish this smaller territories are proven to be highly productive for us. So I was wondering, one I think learning to really is that we believe that hypercortisolism patients exist in every single endocrinology practice, some who have previously in the diagnosed and some who have yet to be identified.
So with both of those in mind as we look to reach our next 1500 prescribers. We see an opportunity our territories that we believe will be very productive. It will decrease the size of some of our existing territories and it will allow for more frequent touch points with both existing prescribers and potential new prescribers. So we've previously stated, we -- the goal is to move from 40 clinical specialists to 55. We're about halfway through that expansion and we expect those territories to add value, next year as you stated. So success is measured really by all the points that you targeted, increased touch points with the prescribers we have and reaching a new potential prescribers out there.
Charles Duncan -- Cantor Fitzgerald -- Analyst
Helpful. Added color. I appreciate you taking my questions. Congrats on a good quarter.
Sean Maduck -- Senior Vice President, Commercial
Thank you.
Operator
Thank you. We'll take our next question from Adam Walsh of Stifel.
Adam Walsh -- Stifel -- Analyst
Hey, can you hear me guys?
Joseph K Belanoff -- Chief Executive Officer, President and Director
Yeah, Adam. Please go ahead.
Adam Walsh -- Stifel -- Analyst
Okay. Perfect. Hey, thanks a lot. Nice quarter to you, on the Korlym question, I'm just wondering, Joe, this came up last call, I know that you did take a price increase during, I think it was this quarter. And I'm just curious how much kind of flat pricing flexibility you believe you have going forward for Korlym that's number one. And then, Charlie, I know there is a decision whether or not to institute PGR for the 214 patents this month. Can you kind of bring us up to speed on the timing, the dates, when we might hear things and what kind of what you interpret is the potential outcomes. Thank you.
Joseph K Belanoff -- Chief Executive Officer, President and Director
Sure. Sure, sure. Adam, I'll answer both questions. So I think as most folks on the call are aware, they some of you, we took a price increase for Korlym on August 1, what effectively net amounts to a little less than 8%, that's the first price increase we've taken in 18 months. As to pricing flexibility, pricing is something we look at every quarter with sort of a fresh set of eyes. And I guess all I can comment on in response to your question is that we are we like any drug company was growing revenues are. We are on the radar of payers in terms, you know they're paying attention to our pricing decisions. But we have been -- have received excellent reimbursement and things have gone through smoothly so far, and that was the case here. And we'll just have to keep that in mind, next quarter when we look at this question again, that's really sort of all the insight, I can give you on that.
As for that I appreciate the question about the IPR -- the PGR our institution. And again there -- let me give for folks who haven't followed as closely as you have, Adam, a little bit of background. We have two generic companies are attempting to get approval to Mark clearance to market and so a generic version of Korlym. Teva Pharmaceuticals gave us notice that they wanted to do that back in February of 2018. So here we are about, about 20 months later and just undergoing the typical litigation back and forth driving to a Markman it was called a Markman hearing in the first quarter of next year where the judge will decide the meaning if there are any of our patent terms are in dispute with Teva that those decisions will be made, clearing the way for a trial some period after some quarters after that.
So there is no real news there but what for folks who again need a little more background what Adam's referring to is a separate proceeding that Teva has brought in administrative challenge to one of our patents. We have a patent covering the co-administration of Korlym and a class of drugs, known as strong CYP3A inhibitors. Teva has -- we received that patent earlier this year. Teva has asked the Patent Office to review that patents validity. And in a procedure known as a request for post-grant review. Now that -- what is going on now and it's been going on for the past few months is we of course opposed Teva's request. And at the end of this month, the Patent Office is set to announce whether it will agree to hear to perform Teva's requested review or not, let's call will they institute Teva's challenge that's called institution decision.
Now something to keep in mind here is this is a bit of an asymmetrical risk or outcome for Teva here because on the one hand, the bar for instituting this sort of review is quite low. The Patent office simply has to decide that Teva's arguments have a reasonable chance of prevailing not that they will prevail, that is a reasonable set of arguments. And if they think that they institute the challenge -- which follow with that point is a year worth of essentially administrative litigation with regard to this question a decision a year later, that would be November of 2020. And if there is any element of that, that either Teva or we are dissatisfied -- we would have the right to appeal that decision to the federal courts, which will add another six months to nine months to the whole process.
So the bar for institution, which is -- which we'll learn about at the end of this month is pretty low. We wouldn't be surprised if it was instituted. On the other hand if the Patent Office does not institute it issues a decision, saying they essentially don't think Teva's arguments have a reasonable chance of prevailing, that's pretty bad news for Teva, because although they will still be able to pursue their arguments in district court, they will have had a panel of disinterested adjudicators, and pronounce a negative opinion on their legal position. So news at the end of this month, relatively low threshold for institution. If it is instituted, we have great confidence in the validity of the patent and what will proceed is essentially additional sort of litigation type arguing just in a slightly different form.
Adam Walsh -- Stifel -- Analyst
Fairly, thanks. That's really helpful to lay it all out like you did. The other question is, Joe, in the graph that you have for micro corilant in the antipsychotic weight gain the pictures that you included in the press release. I noticed that, and I know, look, it's an early study, it's difficult to kind of parse these things out. But the body weight in the liver enzymes are measured on different days, I think, can you just help kind of contextualize what was done and what you're showing us in terms of assuming the timeline from the trial? Thanks, and the measurement points also?
Joseph K Belanoff -- Chief Executive Officer, President and Director
And this is essentially a two-week study. And in terms of the weakening, it's really just measured baseline, day eight after one week and day 15. And what you can see, and I'll give you kind of my own opinion in a second is that the people who were on olanzapine alone gained significantly more weight than the people who are on olanzapine and miricorilant. And I think just sort of olanzapine, that I mean with my eyes was it's very surprising and particularly positive response. I mean we didn't know what was the right dose of this drug. We saw it worked very well in animals, but we didn't know what plasma level was going to be effective in humans. And it would not have stunned me if we didn't see anything in two weeks or really anything much to speak of and just to provide a little context for this. I give them great credit because in some ways, Alkermes has really sort of ploughed new ground here with a -- with the study for -- serious of studies to really try to address this very strong clinical need in patients who have to attend again as psychotic medication. And their case, if you look at their charter two weeks. The combination of their drug in olanzapine patients that actually gain more weight than those who were taken olanzapine alone.
So this is a surprising positive results where it came to what we had seen in animals and really is sort of the main point of the study. Now the second part is interesting. So olanzapine I think even most psychiatrists and Adam, I know, you know this, I am a psychiatrist most psychiatrist are unaware that when you give olanzapine initially you get real what is essentially an acute hepatitis, it tends to be asymptomatic, but you can really measure at the beginning that liver enzymes go up because there's real irritation to deliver. And the interesting thing about that particular effect is has what most psychiatrist probably wouldn't measure this until three months we're out by the time three months have gone out it's really returned to pretty much normal. And so it's really an effect that you measure it really in an acute stage and what you're seeing here is that the liver enzymes did impact rise more in the group that got olanzapine and was mitigated to a degree in fact in one case with statistical significance by the addition of miricorilant.
So again, it just shows you from our perspective that what we thought was true, which is that miricorilant has particular sensitivity in the liver and that is essentially preventing what is impact in inflammatory effect liver actually seem to be happening in this case. Now I really look forward to giving you the full dataset will be presenting next year when it's all in there, but this was a really heartening first step for us. I just want to, I alluded to it in my comments before. We saw the same effects with Korlym almost a decade ago, but we couldn't get a single one at that point, the large pharmaceutical companies interested in all of this simply because Korlym was the abortion pill. And it really took us this length of time to get to a second generation of compound that didn't have the progesterone effects and showed what appears to be the same clinical effects first in animals and now in people.
Adam Walsh -- Stifel -- Analyst
That's helpful. Thanks so much.
Joseph K Belanoff -- Chief Executive Officer, President and Director
Sure.
Operator
Thank you. We'll take our next question from Chris Howerton of Jefferies.
Chris Howerton -- Jefferies -- Analyst
Congrats on the quarter and thanks for taking the questions. It's been too long Joseph and Andreas, it's nice to speak with you.
Joseph K Belanoff -- Chief Executive Officer, President and Director
Welcome back.
Chris Howerton -- Jefferies -- Analyst
So I guess. Yes, thank you. So I guess what I was wanted to figure out with respect to the GRACE trial on their enrollment. We had a competitor also announce a delay in their enrollment and expectation to readout for their Cushing's syndrome trial. So curious if you think it's a broad effect within the Cushing's syndrome space with respect to recruitment or perhaps there is two different scenarios going on here?
Joseph K Belanoff -- Chief Executive Officer, President and Director
Well, I really can't speak, I don't really know the ins and outs of really anybody's business except for our own. We've been involved in Cushing's syndrome now for about a decade, and I think we really kind of know this market and know the patients pretty well. There's no escaping that it's an orphan disease and so unlike a disease like diabetes in general or something where there is a resilient patients out there and you just really sampling from them. This is a disease where you're adding to your enrollment total by ones and twos everywhere you go. We feel at this point like knowing the market as we do and knowing sort of what's occurred to this moment that we have enough visibility to really -- to really tell you guys what we think is going to happen next, and obviously, it's never 100% guarantee. But we feel pretty confident that the timeline that we're now presenting is a reasonable one and one that we are certainly I'm working toward.
Chris Howerton -- Jefferies -- Analyst
Okay. All right. Cool. And then now that you have that timeline and perhaps into sharper focus. Does that change you are thinking in any way with respect to the challenge for mifepristone and the potential timing of any decisions and things like that in any material changes to strategy?
Charles Robb -- Chief Financial Officer
Hi, Chris. This is Charlie. I'll respond to that. I mean, the short answer is no. We -- obviously, there is no direct impact on any litigation associated with this. But I mean that the fundamental -- our fundamental belief is we have real confidence in intellectual property. We are pleased with how things are going. And in the fact that relacorilant's we have a refined estimate that is sort of where it is now, is something where we're comfortable with that, leasing it from a legal perspective anyway.
Joseph K Belanoff -- Chief Executive Officer, President and Director
Yes, I mean, I think the question is, I'm going to just enlarge it just to make some comments that I have made previously. There is no doubt in our mind that relacorilant if it continues to result -- show the results that it showed you so far will replace Korlym. In many respects, it's just a superior medication. I love Korlym it was our first trial, we brought it forward it helped lots of people, but we really had an opportunity to improve on it. And I think we've really done that. And so now it's really a question of doing the appropriate blocking and tackling to bring it to the finish line, that's why the really steam Dr. Grauer is here with us right now and we think we're going to do that. So you know Charlie has been managing the litigation in a way that -- at this point to me not surprising it's gone very much the way our lawyers anticipated it would. We think we have excellent intellectual property. But the real game is getting relacorilant Korlym into the market, this is going to be the thing which is most helpful to patients.
Chris Howerton -- Jefferies -- Analyst
Sure. Okay. Totally makes sense. And the -- I guess for the adrenal adenomas Cushing's syndrome study. How do you see the differences if any in terms of potential enrollment cadence to that type of thing? And then what the expected you know effects size or clinical meaningfulness within that specific patient population, any more color you can provide to us with respect to the above Cushing's syndrome?
Joseph K Belanoff -- Chief Executive Officer, President and Director
Sure, Chris. I'm going to turn you back to Andreas.
Andreas Grauer -- Chief Medical Officer
Yeah. So these patients with Cushing's caused by an adrenal tumors are they do have a less severe form of Cushing's disease. so they usually don't have the -- a classic symptoms that people know like the -- central obesity or as a buffalo hump, but they do have clinical manifestations. They do have impaired glucose tolerance. They do have hypertension and actually interestingly in a number of K-series has been shown that, that these patients have increased cardiovascular mortality for example compared to patients that have adrenal tumors with no hormone activity.
So they do have -- they are sick, but they're not as sick as the Cushing's patients that we're studying in GRACE. That allows us to --and currently, many of these patients are not treated at all watch and wait is -- a strategy that many physician supply. That allows us to do something that we couldn't do in the GRACE population that allows us to do a placebo-controlled study, that is placebo controlled from the start and that will again allow us to treat these patients over six months and to look at the key endpoints high improvement of glucose control and improvement of blood pressure.
And -- answer the question that the field has been waiting for whether medical intervention is a winning strategy in this patients. So we're actually quite excited to do this study and we are, and we talk to the leaders in this field. We have received a lot of positive feedback because they all say yeah that, that question really is a question that needs to be answered.
Chris Howerton -- Jefferies -- Analyst
Okay. Great. It makes sense. And then just maybe one more question if I may. The -- when you think about the antipsychotic-induced weight gain. They obviously the positive result through the encouraging results or whatever adjective you'd like to put on there for the Phase 1b. How do you expect that to translate into neuropsychiatric patients? Do you feel like there is any reason to believe that there would be a difference response in the two different patient populations, or any -- maybe potential adverse event that would be theoretically different between the two or anything with respect to translate ability from the healthy volunteers to the disease population would be great? Thank you.
Joseph K Belanoff -- Chief Executive Officer, President and Director
So, I really do understand the question. And first, I'll give you kind of the standard answer and then I'll tell you what I really think. So the standard answer is, well, we'll find out because we're actually doing that study right now. But I'll -- since I can't make forward-looking statements, and I'll answer your question in a more speculative way. I don't think there is really a lot of reason to think in this variable that healthy subjects are really any difference in patients with psychiatric diseases. These are really metabolic problems that are shared because of the mechanism of the drug and so forth now a more subtle question is this one. What we just demonstrated and what we demonstrated with mifepristone was that we prevent weight gain with these drugs.
The real question that's coming up next is, can we remove the weight gain, which is already there for patients who have taken these drugs, and that is a bit of a different question. Now that what we have to go on right now and we don't have human data it's in our animal data, the drug was just as potent as we're moving standing weight gain as it was preventing it at the beginning. And this next study will help us a figure out whether that does in fact translate to humans. I'm hoping so, because there's a lot of patients out there. Many of them, I mean -- many of my own patients, who actually had great benefit psychiatrically from these medications, but have really made their metabolic status much, much worse.
And as you know the audience might know or the unfortunate truth is that patients who chronically take antipsychotic medications on average have a life span of 55, 20 years less than the population in general. And it's not because of suicide, it's because of metabolic and cardiovascular disease and not all of it's the medication. But having to take these medications is really a terrible detriment for them and frankly causes many of them to not want to take them at all. So all that information is still to come, very excited about it, but what we really learn from this study is we have an active compound and we will really have to figure out how to optimize it to help with these patients.
Chris Howerton -- Jefferies -- Analyst
Excellent. Okay. Well, I appreciate both flavors of the answers. And thanks again for taking my questions. Appreciate it.
Operator
Thank you. We will take our next question from Matt Kaplan of Ladenburg Thalmann.
Matt Kaplan -- Ladenburg Thalmann -- Analyst
Hey guys, thanks for taking questions and nice quarter. Just wanted to take on a little bit to the oncology programs we have ongoing. And help us think about if you can help us think about in terms of, obviously, you're going after is a need Phase 2 program the area, with the largest unmet need in terms of pancreatic cancer and also given that -- give that unmet need is driven obviously by the difficulty is that indication. Can you help us think about that in context of the other programs we have ongoing as well in terms of castrate-resistant prostate cancer and ovarian cancer, and then the opportunities there and how we're thinking about in a pipeline and property point of view?
Joseph K Belanoff -- Chief Executive Officer, President and Director
Okay. So, Matt just because you're call broke up a little bit. I'm going to rephrase your question. And then you tell me if -- if I've gotten it right. Okay. So the question is how does where we're sort of at the one end of the spectrum, you have a disease like pancreatic cancer, which appears to have some responsiveness to the medications that were treating and very little other choices. And at the other end, you have other serious diseases like castration-resistant prostate cancer where a bad disease where lot is going on, how do we prioritize? Where we are? Is that the question?
Matt Kaplan -- Ladenburg Thalmann -- Analyst
Exactly. Yeah.
Joseph K Belanoff -- Chief Executive Officer, President and Director
Okay. Andreas, would you like to take that?
Andreas Grauer -- Chief Medical Officer
Yeah. And I think the answer to that is we really follows the science here, right. We have in our, in fact that we are focusing on pancreatic and ovarian cancer in our combination with Abraxane is the result of our experience in our solid tumor Phase 1, Phase 2 study where those where the tumor types where we did bit surprisingly good results and thought that -- that was worthy of further investigation and also got a lot of positive feedback from our investigators who really told us that their feeling is we're onto something here and that is worth studying further. With regard to the prostate cancer situation again this was one of the situations where the initial, some of the initial observations were made in collaboration by outside investigators who showed additional effects and to who developed a very interesting scientific hypothesis that made us believe that we could potentially help these patients mechanistically and which is why we want to explore that we have a -- we feel is a very interesting compound that in a discipline -- studying both relacorilant and exicorilant in this patient population and we feel that this really sort of deserve studying and then we'll follow the signs again and see what we whether that's worth expanding and pushing forward.
Joseph K Belanoff -- Chief Executive Officer, President and Director
Matt, let me just add a couple of comments to this. One is this, not all cancers are appropriate candidates for our treatment, because not all cancers have glucocorticoid receptors. And we actually did a few years ago you may have sort of the largest tumor bank screening and we could find some cancers like for instance pancreatic cancer, metastatic ovarian cancer are rich in glucocorticoid receptors, but there are other cancers like stomach cancer where it just didn't exist. So our treatment would not be useful in that regard.
Now, the practical part of your question, which maybe is what you were getting at is just the truth of this is that some of these cancers because of the other treatments are unavailable, do have a different bar for approval, then there is a continuum, and you are correct, cancer, like pancreatic cancer really has very little to offer for people who have already tried the first couple lines of treatment. So that does influence is to a bit but Andreas this point is correct, it really starts with where the science and the evidence is.
Matt Kaplan -- Ladenburg Thalmann -- Analyst
Okay. That's helpful. And then just on -- relative to Korlym, help us understand in terms of the commercial opportunity there versus Korlym given its improved, let's call it safety profile and tolerability profile and kind of going forward?
Joseph K Belanoff -- Chief Executive Officer, President and Director
Well, we -- I can't give you exact projections, but what I'm really comfortable telling you is the market for relacorilant is substantially larger than is for Korlym. Korlym is an excellent medicine. It really has great efficacy, but it's got some serious Achilles' heels. The progesterone receptor effect means that in some places, it's politically too toxic to take, it also means that there are medical issues like the endometrial hypertrophy and vaginal bleeding that are very problematic. And frankly the effect on potassium that you get with Korlym which you know experienced practitioner can get ahead of, but really has to be observed, it's probably the single biggest reason why people drop off the medication. So if those -- if the efficacy that we've seen so far, taking away those side effects, really turns out to be the case. My own opinion is that Korlym is really going to go to zero. And I think that relacorilant over replace it in it's in entirety.
How big that market can be. I don't know, I will point you to what Sean said before, which is our biggest sell sales tactic is just having patients screened because we believe that there are patients with Hypercortisolism and Cushing's syndrome in every endocrine practice in the country and not every doctor screening for them at this point. I think that if you give them a more tolerable medication the screening for that disease will increase and some of them will eventually use relacorilant. So again I'll give you the simple answer, bigger. I don't know how much bigger but bigger for sure.
Matt Kaplan -- Ladenburg Thalmann -- Analyst
Well, thanks for taking the questions and good luck.
Joseph K Belanoff -- Chief Executive Officer, President and Director
Thanks. Thank you, Matt.
Operator
Thank you. We'll take our next question Sean Kang of HC Wainwright.
Sean Kang -- HC Wainwright -- Analyst
Hi, guys. Thank you for taking my question and congrats on your strong quarter. I have a question about, as you know Cushing's syndrome program basically. First of, what's the patient percentage of and adrenal Cushing's syndrome within the whole Cushing's syndrome patients?
Joseph K Belanoff -- Chief Executive Officer, President and Director
Yeah, I think it's really unknown at this point. I think what's been very interesting is that over the past basically decade and, but particularly in the last five years has been a lot of academic research in this area, and while this was understood it to be a real form of Cushing's syndrome prior to that point as scanning got better and you actually could be able to see what percentage of the population actually had these tumors and then they began to be tested for how many of those tumors are actually producing cortisol the numbers have grown with each year, nobody has an exact amount for it, but it is not an insubstantial number.
Sean Kang -- HC Wainwright -- Analyst
Oh, I see. In terms of syndrome cardio, is there any difference between in terms of standard of care treating adrenal Cushing's syndrome patients compared to non-adrenal patients.
Joseph K Belanoff -- Chief Executive Officer, President and Director
I think I think for both cases standard of care is if you can find the tumor and take it out, you do it. And certainly my own opinion. But in some of these cases it's really in fact, the patients will end up on medicine that really wasn't possibly that they can't exactly find the tumor it's a place they can take it out. People have more than one tumors, they have been taking out long time to cure the disease. And so from a mechanistic point of view, the standard of care is the same reduce cortisol activity that's what you want to do in any of these cases, but in fact, I think that many of the patients with adrenal care with adrenal adenomas are actually never really getting treatment because they really first, many of them haven't been diagnosed. And second, because they don't present as floridly doctors are able to kind of push them from one appointment to a next and they decline over time as opposed to instantly.
Sean Kang -- HC Wainwright -- Analyst
I see. One last quick question. It's regarding financial modeling, I see that you have planned for multiple trials in 2020 and also expect to increase the clinical specialists from 40 to 55. So should we expect a similar level of yearly increase in operating expenses for next year?
Joseph K Belanoff -- Chief Executive Officer, President and Director
Well, the addition of the clinical specialists will not really add all that much to our cost. I mean, I think, and I think sort of a good sort of rule of thumb per clinical specialist is put in a quarter of a million dollars per added person for the cost of their salary and travel and so forth. And then any revenue production, that they would have any commissions they might earn would just be the result of revenue they are helping us to produce. So in terms of increasing the operating expenses. I would add sort of no more than sort of a few million dollars for the added folks. And want to ask for that -- for the other information, obviously where we will have early in the next year, we'll have our revenue guidance for the coming year and so forth and we have been able to address the sort of the spending side of the question to.
Sean Kang -- HC Wainwright -- Analyst
Okay. That's all. Thank you for taking my questions.
Joseph K Belanoff -- Chief Executive Officer, President and Director
Sure. Nice to talk to you.
Operator
Thank you. We will take our next question from Alan Leong of BioWatch News.
Alan Leong -- BioWatch News -- Analyst
Thanks for taking my questions. I wanted to drill down a bit -- I wanted to drill down a bit on the liver protection. I know there was a hint that -- that miricorilant it's suggestive that's protective of the liver. Do you have some sense in the liver enzyme data that miricorilant is exerting some protective effects independent of the degradation of metabolic or weight metrics. Are you getting some sense of the preclinical studies or lastly, are you going to have to add or where you have to wait the answer in future studies of the already obese patients?
Joseph K Belanoff -- Chief Executive Officer, President and Director
All right. So, Alan, since you're an academic, I can give you a homework. There is an excellent paper. First off, there is 20 which really describes the effect on liver toxicity and you may have already read it. I'm just kidding around, but it really explains how in animal models you really can both prevent and reverse the liver injury, which is caused in that case by high fat diet. And mechanistically, it was really very elegant how it was shown whether it translates to people or not. I can't say for certain and what we've shown you so far it's just a glimpse of what I think we might see, but I was actually surprised that we could pick it up in this two-week study, but I think it was the same effect that we were seeing in the animal models. That's all the data we have for now. But it's really going to be a big part of the program as we go forward.
Alan Leong -- BioWatch News -- Analyst
I remember [Speech Overlap] I hope you have add, I remember on the original studies with mifepristone 108297, that the metrics are turned independent of weight, I wanted to give you a chance to you've got some early data the treatment period went 14 days rather than 21 or longer. Any thoughts on comparing what you saw just now with miricorilant with the prior studies with mifepristone and CORT 108297.
Joseph K Belanoff -- Chief Executive Officer, President and Director
Yeah, well, particularly with mifepristone and we knew what the dose really should be. I mean we had a lot of experience with what the plasma levels should be and so we knew kind of what to pick here we were really just guess the first thing. And just so you get some sense of this. The plasma level that we generated with miricorilant in this study was about the 10th of the plasma level that we generated with mifepristone it's studies. So, and we saw no adverse events in this study that we're specifically related to olanzapine. So I'm convinced that a higher dose will be tolerable and more effective, but the evidence will prove me right or wrong, but we have a good sense that this is just the beginning.
Alan Leong -- BioWatch News -- Analyst
Yeah, it's pretty potent. A question, you have the better formulation. Are you going to use any of that? Or have you see any of that with the higher dosage cohort or we waiting really in future trials for it?
Joseph K Belanoff -- Chief Executive Officer, President and Director
Coming up, not so far, we have not used the new formulation yet.
Alan Leong -- BioWatch News -- Analyst
All right. Hey, thanks a bunch. I look forward to seeing you again.
Joseph K Belanoff -- Chief Executive Officer, President and Director
Yeah, all right. Nice to talk to you. And thank you all for spending an hour with this today really look forward to the next call, and we do have it, we will have information that's coming out between now and year-end and we'll release it as soon as it's available to us. So thank you very much.
Operator
[Operator Closing Remarks]
Duration: 61 minutes
Call participants:
Charles Robb -- Chief Financial Officer
Joseph K Belanoff -- Chief Executive Officer, President and Director
Andreas Grauer -- Chief Medical Officer
Sean Maduck -- Senior Vice President, Commercial
Charles Duncan -- Cantor Fitzgerald -- Analyst
Adam Walsh -- Stifel -- Analyst
Chris Howerton -- Jefferies -- Analyst
Matt Kaplan -- Ladenburg Thalmann -- Analyst
Sean Kang -- HC Wainwright -- Analyst
Alan Leong -- BioWatch News -- Analyst
