Corcept Therapeutics' (CORT) CEO Joseph Belanoff on Q3 2017 Results - Earnings Call Transcript

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About: Corcept Therapeutics Incorporated (CORT)
by: SA Transcripts

Corcept Therapeutics Incorporated (NASDAQ:CORT) Q3 2017 Earnings Conference Call November 2, 2017 5:00 PM ET

Executives

Charlie Robb - Chief Financial Officer

Joseph Belanoff - Chief Executive Officer

Sean Maduck - Senior Vice President, Commercial

Robert Fishman - Chief Medical Officer

Analysts

Charles Duncan - Piper Jaffray

Peter Stapor - Bank of America Merrill Lynch

Neil Carnahan - Stifel, Nicolaus & Company, Inc.,

Matthew Kaplan - Ladenburg Thalmann & Co., Inc.

Operator

Welcome to the Corcept Therapeutics' Conference Call. At this time, all participants are in a listen-only mode and later we will conduct a question-and-answer session. Please note this conference is being recorded.

And I will now turn it over to Charlie Robb. Charlie, you may begin.

Charlie Robb

Thank you. Good afternoon. I am Charlie Robb, Corcept's Chief Financial Officer. Thank you all for participating in the call. Earlier today, we issued a news release giving our third quarter financial results, a corporate update and an upward revision of our 2017 revenue guidance.

For a copy, go to corcept.com and click on the Investors tab. Complete financial results will be available when we file our Form 10-Q. Today's call is being recorded. A replay will be available through November 16 at 1888-843-7419 from the United States and 1630-652-3042 internationally. The pass code will be 45799161.

Any statements made during this call that are not statements of historical fact are forward-looking statements subject to known and unknown risks and uncertainties that might cause actual results to differ materially from those expressed or implied by such statements.

Forward-looking statements include statements regarding our financial results, revenue guidance and expense estimates for 2017 and beyond, the anticipated performance of our sales organization, the cost, timing and results of preclinical and clinical trials, including the trials of relacorilant the generic name for CORT125134 in Cushing's syndrome and solid tumor; CORT125281 in castration resistant prostate cancer; and CORT118335 for antipsychotic induced weight gain, fatty liver disease and other disorders; the utility of our FKBP5 gene expression assay; the protections afforded by Korlym's orphan drug designation for Cushing's syndrome and our other intellectual property rights, including the composition of matter patents covering our selective cortisol modulators and patents concerning the use of cortisol modulators to treat patients with Cushing's syndrome, triple-negative breast cancer, castration-resistant prostate cancer and other indications. These and other risks are set forth in our SEC filings, which are available at our website or from the SEC's website. We disclaim any intention or duty to update any forward-looking statements made during this call.

Now, I will review our financial results. Corcept's revenue in the third quarter was $42.8 million compared to $21.7 million in the second quarter of last year, an 97% increase. Compared to the second quarter of this year, revenue grew 20% due entirely to increased Korlym's sales volume.

Our fully diluted third quarter GAAP net income was $0.11 per share compared to $0.02 per share in the third quarter of 2016. Excluding the non-cash expense of stock-based compensation and implied interest on our royalty financing debt, our fully diluted non-GAAP net income for the third quarter was $0.14 per share, up from $0.04 per share in the third quarter last year. We expect our revenue growth to continue.

Based on our recent performance and expectations for the rest of this year and beyond, we've increased our 2017 revenue guidance from a range of $145 million to $155 million to $157 million to $162 million. Our cash and investments at quarter end increased to $76.7 million from $67.7 million at June 30, 2017. This increase is after making a final payment of $4.6 million under our capped royalty financing.

Our royalty transaction was a source of flexible non-dilutive financing. Shortly after the launch of Korlym in 2012, we borrowed $30 million. In return, we agreed to pay back $45 million, with payments to equal 20% of our quarterly revenue. In July, we made our final payment; the obligation is now completely extinguished.

As we have said in past calls, we believe revenue from our Cushing's syndrome business together with our cash on hand will be sufficient to fund our planned activities which include fully funding our commercial activity. Conducting Phase II and Phase III trials of our proprietary selective cortisol, cortisol modulator relacorilant in both Cushing's syndrome and solid tumors, conducting Phase I and Phase II trials of CORT125281 for castration-resistant prostate cancer and CORT118335 for antipsychotic induced weight gain and non-alcoholic study liver disease and advancing to the clinic additional compounds from a proprietary portfolio of selective cortisol modulators.

I will now turn the call over to Dr. Joseph Belanoff, our Chief Executive Officer. Joe?

Joseph Belanoff

Thank you, Charlie, and thank you to everyone on the phone for joining us. Corcept had an excellent quarter. Our revenue grew to $42.8 million, an increase of 97% from the third quarter of 2016 and 20% more than the second quarter of this year. We generated $13.8 million in GAAP net income. Excluding non-cash expenses, our non-GAAP net income was $17.4 million. Cash and investments increased by $9 million even as our clinical development programs progressed and we've retired our royalty debt, we are now debt free. Our revenue growth is not slowing.

We have raised our 2017 revenue guidance to between $157 million and $162 million. We anticipate significant revenue growth in 2018, 2019 and beyond. It is worth pausing here to note, how one common it is for a biotech company to be in Corcept's position. Our Cushing's syndrome business generates enough cash to fund both itself and the development of our rich portfolio, proprietary selective coritsol modulators, our cash reserves have increased, we have no debt.

These attributes give us the freedom and resources we need to build our business and optimally advance coritsol modulation as a treatment for a wide range of serious disorders. With strong growth in Korlym revenue in the third quarter was sustained by the same trends in medical practice that we have described in previous calls. Growing awareness among physicians of Korlym's efficacy, the increasing frequency with which physicians are screening for and treating patients with hypercortisolism, and our commercial organization is focused on the endocrinologists who treat most patients with hypercortisolism.

Before I discuss the first of these two trends in more detail, I need to make an important point about terminology. We use the terms hypercortisolism and Cushing's syndrome interchangeably because they are the same thing. When Harvey Cushing more than 100 years ago identified the constellation of symptoms that became known as Cushing's syndrome coritsol had not yet been discovered. 50 years later when coritsol was discovered immediately became clear that what Cushing had described was caused by excess coritsol activity.

I often say hypercortisolism sometimes characterizing a case of it as more or less severe because I find that term medically more precise, but I could say Cushing's syndrome instead there is no difference. Our FDA approved label for Korlym uses Cushing's syndrome and hypercortisolism interchangeably.

I'll now briefly discuss two of the trends in medical practice that are driving Korlym uptake. The growing understanding among physicians that for many patients Korlym is a very effective medication coupled with increasing willingness of physicians to screen patients for Cushing's syndrome. Korlym's greatest commercial strength has always been that it works very well for almost all patients. In our Phase III trial, 87% of the patients as adjudicated by independent outside experts, experienced significant clinical improvement.

Korlym is effective because it reduces excess coritsol activity. Coritsol is secreted by the adrenal glands with the diurnal rhythm that is essential for health. It peaks just after we wake up and then falls through the day rising again just before dawn. Patients with Cushing's syndrome have a tumor that produces either excess coritsol or ACTH hormone that causes the body to produce coritsol. In these patients coritsol does not follow a healthy rhythm. They have instead an elevated flat coritsol curve. This is why a prominent symptom of hypercortisolism is insomnia.

Other symptoms include impaired glucose tolerance, high blood pressure, central obesity, increased fat around the neck, thinning arms and legs, weak muscles and severe fatigue. Irritability, anxiety, cognitive disturbance and depression are common. Korlym competes with cortisol at a glucocorticoid receptor, GR, for short. The receptor to which cortisol binds when levels are elevated. Korlym turns down cortisol activity causing the symptoms suffered by Cushing's syndrome patients to abate.

It also helps to restore cortisol's healthy diurnal rhythm. By contrast, drugs such as ketoconazole, commonly used generic antifungal agent that lowers cortisol levels by inhibiting cortisol production do not restore cortisol's diurnal rhythm. A lower level of the cortisol pool with no regard for cortisol's extremely important natural rhythm. As it was true last quarter, increasing number of physicians are realizing that using Korlym to modulate cortisol activity is often the optimum medical treatment. Although, we enroll patients who are switching to Korlym from generic cortisol synthesis inhibitors such as ketoconazole or metyrapone is increasingly common for physicians, particularly those who have used Korlym previously to prescribe Korlym as the first medical treatment for their patients with Cushing's syndrome.

Physicians are becoming more aware that even less severe hypercortisolism is dangerous and should be treated. They are becoming quicker to screen patients who exhibit one or more symptoms of the disorder such as glucose intolerance or hypertension, but who have not responded to conventional therapies for those conditions. These patients now correctly diagnose readily benefit from treatment that modulators cortisol activity.

As many of you know, we are developing a successor to Korlym, selective cortisol modulator in its Phase II trial that we believe for many patients will be - with Cushing's syndrome will be a superior medication. And so recently we referred to this compound by its number, CORT125134. Now the international and United States regulatory authorities have given CORT125134 its generic name relacorilant. I mentioned this to avoid confusion that was once CORT125134 is now relacorilant. A compound has not changed, but the name is new. But there's a deeper significance to this new name.

Corcept develops medications that modulate the effects of cortisol. In the same way of the Genentech created a suffix mAb to describe its first monoclonal antibodies and every monoclonal antibody that was subsequently discovered, every non-steroidal cortisone modulator that has ever developed will now end with the suffix corilant.

We are proud that our work led by Dr. Hazel Hunt, our Senior Vice President of Research designed all of our compounds has given rise to an entire class of molecules with its own naming convention. This is a rare accomplishment that underscores the uniqueness of our science. The clinical development of relacorilant continues to progress. It was safe and well tolerated in its Phase I trial where demonstrated in healthy subjects the key attribute of an effective treatment for hypercortisolism, the ability to model a cortisol's activity at GR.

As fully expected, it also displayed no affinity for the progesterone receptor, abbreviated as PR. It is Korlym's affinity for PR that causes endometrial thickening and irregular vaginal bleeding in many women, manageable side effects that nonetheless cause some patients and physicians to avoid Korlym.

Even more important PR antagonism is what makes Korlym's active ingredient, the abortion pill. Lacking that quality relacorilant could be distributed much more broadly both in the United States and abroad and should be readily accepted by the physicians and patients who currently avoid Korlym.

Relacorilant's Phase II trial is an open label study that is in rolling up to thirty patients and sites in the United States and Europe. We expect results by the end of the first quarter of next year and our continuing preparations for an end of Phase II FDA meeting and Phase III clinical trial.

We are pleased to report that we recently achieved clear validation of our FKBP5 gene expression assay. Today's most commonly used test measure cortisol that spills over into the urine or saliva as crude proxies for the only clinical significance clinically significant fact cortisol activity.

By allowing physicians to measure a direct marker of cortisol activity, the phenomenon that is causing all of their patients Cushing's syndrome symptoms, our assay may help physicians to better identify patients with hypercortisolism and arrive at an optimal treatment of regimen. It is hard to overstate the medical advances such an assay may represent.

Clear validation it means the assay will become available for physicians to use and important first step. We have previously proven that FKBP5 gene expression rises in healthy subjects given prednisone a synthetic cortisol and that this rise is blocked at the same subjects are given prednisone together with Korlym or relacorilant.

We are conducting research to confirm that FKBP5 levels are elevator in patients with Cushing's syndrome and normalize with effective treatment. Preliminary results are positive. We expect to conclude our study in the first quarter of next year and will move quickly to publish our results.

After making both the assay available and supporting clinical data available to physicians, we could take one more step undertaking in parallel with our Phase II and Phase III clinical trials that relacorilant for Cushing's syndrome, the clinical and regulatory work needed to secure FDA approval of the assay. FDA approval would allow us to promote the assay to physicians. We plan to make this decision around the time we announced the results of relacorilant Phase II trial.

Our oncology program will take important steps this quarter. Let me provide a bit of background. In cancers where the tumors express GR such as pancreatic triple negative breast and ovarian cancer cortisol stimulates genes that retard an apoptosis the programmed cell death chemotherapies are meant to provoke. Preventing the stimulation of apoptosis suppressing genes by adding a cortisol modulator to a chemotherapy regimen should allow that regimen to achieve its optimal effect.

Cortisol modulation may also help the immune system to fight cancer. Not everyone realizes that a healthy body produces cancer cells, but the immune system almost always identified and destroys them. There is great interest in therapies that stimulate the immune system to fight cancer, because the immune system is a very effective therapeutic tool.

Cortisol even at normal levels suppresses the immune system. Unfortunately the physiological and psychological stress of cancer and its treatment raise cortisol activity above normal levels creating even greater immunosuppression. Cortisol modulators counter this effect allowing the immune system to act more potently. It is well known that androgen stimulate growth in tumors of the prostate. That is why androgen deprivation therapy known as chemical castration is a common treatment.

It's been shown more recently in several top laboratories the patients treated with the androgen receptor blocker and enzalutamide the Astellas Medivation drug XTANDI. Quickly developed colonies of cells where cortisol becomes the tumors growth factor. Combining a cortisol modulator with an androgen modulator such as enzalutamide from the outset of treatment may block this cancer escape route.

This quarter, we advance to the clinic our proprietary selective cortisol modulator, CORT125281 as a treatment for patients of metastatic castration-resistant prostate cancer. In September, we began a Phase I trial in healthy subjects by year end we plan to start enrolling patients in a dose ranging trial that combines CORT125281 with XTANDI. As we develop CORT125281 University of Chicago investigators continue to enroll patients in their 84 patient controlled multicenter Phase II study of Korlym plus XTANDI in patients with metastatic castration-resistant prostate cancer.

The Department of Defense and the prostate cancer foundation are funding the trial. Astellas is providing XTANDI. We are providing Korlym and possess the intellectual property for the use of this combination of medications. By year-end we also plan to open the first expansion cohort in our Phase I/II trial of relacorilant plus ABRAXANE to treat patients with solid tumors. This cohort will enroll patients with metastatic pancreatic cancer, a dire disease for which there are few if any effective treatments.

The trial dose finding portion will continue with respect to other solid tumors and we will explore opening additional expansion cohorts next year most likely in patients with metastatic triple negative breast or ovarian cancer. As is the case with castration resistant prostate cancer our development of relacorilant in combination with ABRAXANE is proceeding in parallel with the work of investigators at the University of Chicago are studying Korlym plus ABRAXANE to treat patients with triple negative breast cancer.

The 64 patient double blind placebo controlled multicenter Phase II trial built on their extensive preclinical and clinical studies as well as the promising results of Corcept's Phase I/II trial of Korlym plus ABRAXANE to treat patients with this disease. Celgene is funding the trial we are providing Korlym. Again, we possess the intellectual property for the use of these combinations of medications.

We've begun the Phase I trial of another promising proprietary selective cortisol modulators CORT118335. As many of you know this compound is particularly potent in the liver. In animal models it prevents and reverses not alcoholic fatty liver disease as well as liver fibrosis and the weight gain caused by anti-psychotic medications such as Zyprexa and Risperdal. These disorders afflict tens of millions of people in the United States and people have few good treatment options. If Phase I results are positive we plan to initiate one or more Phase II trials in the third quarter of next year.

To sum up, Corcept had a great third quarter. Revenues increased 97%. We raised our 2017 revenue guidance to between $157 million and $162 million. We generated a GAAP profit for the quarter of $13.8 million compared to $2.6 million in the same period last year. Our cash increased by $9 million in the quarter even as we advanced our clinical programs and retired our royalty debt. We continue to expect significant growth in the years ahead.

We will have results of the Phase II trial of CORT125134 in Cushing's syndrome a compound we believe will offer significant advantages over Korlym in the first quarter next year. We have begun preparing for our end of Phase II meeting with the FDA and our Phase III trial. Our FKBP5 gene expression assay has achieved clear validation. We have an advanced CORT125134 to the clinic and plan to begin a dose ranging trial in patients with castration resistant prostate cancer by year end.

University of Chicago investigators are enrolling patients in their Phase II trial pairing Korlym with XTANDI. We plan to open an expansion cohort in patients with pancreatic cancer in our Phase I/II trial of relacorilant plus ABRAXANE and additional cohorts next year. With financial support from Celgene, University of Chicago investigators are enrolling patients in their Phase II trial of Korlym combined with ABRAXANE to treat patients with triple-negative breast cancer.

One of our most promising compounds, CORT118335 has entered Phase I. Results are positive, we will advance it to Phase II for the treatment of metabolic disorders likely including antipsychotic-induced weight gain and non-alcoholic fatty liver disease by the third quarter of next year

I will stop now to answer questions.

Question-and-Answer Session

Operator

[Operator Instructions] Our first question comes from Charles Duncan from Piper Jaffray. Please go ahead.

Charles Duncan

Hi guys. First of all congratulations on very nice quarter and thanks for taking my questions. One of the questions that I've heard recently is whether or not you could characterize where the growth is coming from in the quarter or perhaps more importantly as you look out towards the end of this year and next year and look at maybe five different kind of contributors one of them being new patients another being new doctors writing scripts and now there is increasing persistence for patients on the drug and perhaps dose for those patients. And then the last is price, and I guess if you look at those five contributors which one is most important to you? Could you provide us any even semi quantitative metrics around them?

Joseph Belanoff

Yes. Charles, thanks very much for the question. And what I'd like to do is reintroduce all of you out there to Sean Maduck. Sean is our Senior Commercial Officer and runs the whole Cushing's syndrome franchise and I think he'd like to answer this question.

Sean Maduck

Thanks Joe, and thanks Charles for the question. And the answer really is a simple one and that's that more patients are being prescribed Korlym of all the metrics that you described. As I previously said on earlier calls, I mean our greatest challenge in the commercialization of Korlym has really been to get endocrinologist to write their first prescription. Once they do, they see the efficacy of the product and then they look for more eligible patients.

And we've had many new physicians prescribed for the first time this year, and in fact, so far in 2017 the prescriptions from this group of physicians have exceeded those of our legacy prescribes. And we expect this group of physicians to perform similar to the earlier cohort and become multi prescribes as well and we expect to continue to add new prescribes as we move forward. Again, our growth is due entirely in the quarter to more Korlym prescriptions and not price or titration which are two of the other metrics that you mentioned. We took a price increase at the beginning of this year and we have not taken a price increase sense.

And in terms of titration, we do continue to see a slight rise in our average dose and we do believe over time at some point we will come close to the average dose that we saw in our pivotal study seismic which was approximately 730 milligrams, but we are not there yet.

I mean as a reminder to everybody, when new patients are initially prescribed Korlym, they prescribed 300 milligrams and it does take some time for their physicians to titrate them to the dose that is most efficacious for that specific patient. So the more patients that we have coming on a 300 milligrams and the longer it takes for our overall average dose to rise.

Charles Duncan

Good, thank you Sean.

Operator

Our next question comes from Tazeen Ahmad from Bank of America. Please go ahead.

Peter Stapor

Hi, guys. This is Peter Stapor on for Tazeen. Thanks for taking my question. First question, I'm on the FDA adverse events report system order right now. See the Korlym has 91 that case associated with it. You could you talk about whether those are drug related and what the cost might be?

Joseph Belanoff

I'm not sure exactly what you're looking at. So I can't really refer to what's specifically, but patients with Cushing's syndrome are a very ill group of patients, some of them have cancer and some of them die in their own, but to say, be more specific on that, I can't really refer to it, I'm not sure. I'm not sure what exactly what you're referring to.

Peter Stapor

Okay, it's publicly available FDA website?

Joseph Belanoff

Yes.

Peter Stapor

So my next question is whether - why the relacorilant [indiscernible] pushed and so it's going to be 1Q, but it was previously fourth quarter?

Joseph Belanoff

We actually have revised that, I believe a quarter or two ago to be on the first quarter of next year.

Peter Stapor

Right, I'm wondering why that was the case?

Joseph Belanoff

Yes, I'm glad to address that question again. The reason that really occurred was the start-up time for many sites, particularly academic sites has grown over time and that's equally true in Europe as it is in the United States. This is a Phase II study that's taking place really at all academic sites. And unfortunately, I can tell you as an academic investigator myself many years ago that used to go much more quickly what used to take two or three months to get going is now taking 10, 11, 12 months to get on. So that was really the cause of the initial delay.

Peter Stapor

Gotcha, that makes sense. And do you have an expectation for Phase III whether you'll need one or two studies?

Joseph Belanoff

Yes, our expectation although I want to really put an important caveat on that. Our expectation is that we will do one Phase III study as we did previously. But the real caveat is we haven't yet filed to the FDA. So we can't really say with any certainty, exactly what's going to happen. But that is our expectation at the current time.

Peter Stapor

Gotcha, okay. And another one that's come up a few times for us, but our sales continue to increase if the trend continues, what are your expectations for generic challenger entering the market when you lose exclusivity in early 2019?

Joseph Belanoff

I apologize, because I'm still seeing Tazeen name on the screen, I apologize. I didn't catch your first name Peter. Peter, I'd like to reintroduce Charlie to - who really manages all of our lifecycle management to answer that question.

Charlie Robb

Sure. Well I think there are a couple of things important facts to keep in mind as you think about this. On the one hand there are facts about Korlym and Corcept. The active ingredient in Korlym is the abortion pill and while I think that's often glossed over, it's an important fact that I think really needs to be weighed. I don't hear anyone clamoring for broad distribution of generic abortion pill in the United States. So that's one fact.

Another factor as you've heard us talk about the importance of our sort of high touch business model, or the close support we provide patients and physicians and that our pharmacy provides to patients and physicians, really been central to our the success of our commercial business. That a generic company could replicate that model, but it would be off the ordinary - the beaten path for them.

And then finally and most importantly, got to remember we have a what we believe will prove to be a superior successor molecule in development and when I say superior in this context, I mean something very specific. Relacorilant as Joe mentioned, does not have affinity for the progesterone receptor and that means it will not be the abortion pill.

And furthermore it won't cause the side effects such as endometrial thickening in a regular vaginal bleeding that caused some patients and the patients and physicians would both strongly prefer to avoid and cause some to avoid Korlym of them right now. So yes set those considerations to one side and keep those in your head. And then take a look at you know the path that any generic company would need to walk to get approval for generic Korlym.

The first they would need to obtain Korlym tablets so they could generate - they could demonstrate as part of their new drug application bioequivalents. Second they have to submit their writing file their application or submit their application to the FDA, which takes some months of a few months to review it for completeness for agreeing to file it.

Once that happens the generic company has to certify that it's generic Korlym will not infringe our intellectual property. I mean not everyone knows we have one patent that we believe would cover the use of mifepristone of Korlym to treat patients with Cushing's syndrome. There are other patents working their way through the patent office that we believe will result in additional patients application rather that we believe will result in additional patents. So this IT portfolio is going to grow.

The generic has to certify that it's product would not infringe this patent. These patents are listed in repository maintained by the FDA called the Orange Book by the way. So we have one such patent and there are others in the works. So once now the generic has certified this. We have 45 days to sue them for infringement and our lawsuit will trigger an automatic 30 months day of FDA approval of the application even if we were not to prevail legally.

So if the generic company gets past the initial factual hurdles I described and decided to proceed anyway. If you're looking at a path to approval that by regulatory law extends years into the future and I think those are the things you need to keep in mind when you analyze this problem and that's certainly what we look to.

Operator

Our next question comes from Adam Walsh for Stifel. Please go ahead.

Neil Carnahan

Hi, guys, Neil Carnahan on for Adam. Congratulations on a good quarter. Just a couple questions, upon the possible approval your second generation relacorilant. How would you expect transition of patients from Korlym on to that second generation cortisol modulator to go and would there be any reason for patients to remain on Korlym even with the second generation approved drug out there with a better safety profile?

Joseph Belanoff

I'll just give you my opinion obviously we don't know that with certainty. But I think the Korlym sales will essentially go to zero. I think that this drug really is superior and extremely important ways not the least of which is that it will be - potentially much more easy to obtain. There really is a serious process to getting it Korlym at this point in time. It's intended so that there will be very tight control of where Korlym tablets are we know where they all essentially every single tablet goes and because relacorilant is not the abortion pill I think that portion of the equation really changes tremendously.

In addition to that while we're not expecting relacorilant have any better efficacy than Korlym because Korlym has super efficacy taking away the protest around side effects particularly for women who are the majority of patients with Cushing's syndrome things get much, much easier for them and for their doctors and prescribing the medication. So I'll just some up to say I think the transition will be rapid and approach complete. I can't really think of any particular reason why anyone would stay at Korlym, if CORT125134 or relacorilant actually proves to be as efficacious as we think it is.

Neil Carnahan

Okay. And then on the FKBP5 gene assay, if you guys were to pursue FDA approval for that, what would that mean for physicians, what would that mean for patients, and what would that mean for you guys overall?

Joseph Belanoff

I'd like to introduce another member of our senior team, so thank you for the question. That speaker is Bob Fishman, who is a Medical Doctor and our Chief Medical Officer and he will address your FKBP5 question.

Robert Fishman

Hi, Neil. Thanks very much for your question. First to say, that we think the FKBP5 is a useful tool and we plan to help build the literature that will enable eventual interpretation of the meaning of results et cetera. So this we hope will be a major innovation for the diagnosis and management of Cushing's syndrome in future years helpful both in the diagnosis and monitoring of patients. So a complement to everything else that we're doing.

Neil Carnahan

Thanks guys.

Joseph Belanoff

Thank you.

Operator

Our last question comes from Matt Kaplan from Ladenburg Thalmann. Please go ahead.

Matthew Kaplan

Hi, guys. With respect to the Phase II study that's coming up in the first quarter. Help us understand what we should be looking for from a safety and efficacy point of view in that 30 patient open-label study?

Joseph Belanoff

Yes. So let me just review an important thing. I alluded to it in my opening comments, but I sometimes think that it's a little hard for people to kind of integrated all once I'm going to - I'm going to say something that in some sense, again maybe in a slightly different way. Cushing's syndrome is just that. It is a syndrome. Cortisol goes everywhere in the body and when it is in excess it has symptoms that are across all organ systems of the body, so it causes psychiatric issues, it causes metabolic issues, it causes cardiovascular issues, it causes issues related to immunosuppression and infection, it causes issues related to fat deposition. So many, many different things going on.

And just to get some sense of this, in our registration trial for Korlym, we actually measured 24 different endpoints because all of them had meaning in patients with Cushing's syndrome. And essentially we're going to be doing the same thing in the Phase II study. We're really looking to see whether Cushing's syndrome, all the symptoms of Cushing's syndrome improve as they do with cortisol modulation with Korlym.

Now prominent symptoms you'll be familiar with will be things like improvements in glucose tolerance and improvements in blood pressure, but the other symptoms are also very meaningful to like improvement in mood, improvement in weight, improvement in waist circumference. So all of those things will be read out and obviously with 30 patients, we will be looking at each individual patient to see how they did in terms of each of those broad effects.

Operator

And there are no further questions at this time.

Joseph Belanoff

Thank you very much and really looking forward to talking to you in 2018.

Operator

Thank you. Ladies and gentlemen, this concludes today's call. Thank you for participating. You may now disconnect.