Corcept Therapeutics Inc (CORT) 2017 Q3 法說會逐字稿

Welcome to the Corcept Therapeutics conference call. (Operator Instructions) Please note that this conference is being recorded.

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

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 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 1 (888) 843-7419 from the United States and 1 (630) 652-3042 internationally. The passcode 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 tumors; 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'll 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, a 97% increase. Compared to the second quarter of this year, revenue grew 20%, due entirely to increased Korlym 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 noncash expense of stock-based compensation and implied interest on our royalty financing debt, our fully diluted non-GAAP net income for third quarter was $0.14 per share, up from $0.04 per share in the second quarter last year -- 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, nondilutive 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 activities; conducting Phase II and Phase III trials of our proprietary selective 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 nonalcoholic fatty liver disease; and advancing to the clinic additional compounds from our proprietary portfolio of selective cortisol modulators.

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

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 dollars, 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 noncash 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 uncommon 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 of proprietary selective cortisol 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 cortisol modulation as a treatment for a wide range of serious disorders.

The strong growth in Korlym revenue in the third quarter was sustained by the same trends in medical practice that I 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 organizations focused on the endocrinologists who treat most patients with hypercortisolism.

Before I discuss the first of these 2 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, cortisol had not yet been discovered. 50 years later, when cortisol was discovered, it immediately became clear that what Cushing had described was caused by excess cortisol 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 2 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 cortisol activity.

Cortisol is accreted by the adrenal glands with a 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 cortisol or ACTH, a hormone that causes the body to produce cortisol.

In these patients, cortisol does not follow a healthy rhythm. They have instead an elevated flat cortisol 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 disturbances and depression are common.

Korlym competes with cortisol at the 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 restore cortisol's healthy diurnal rhythm.

By contrast, drugs such as ketoconazole, a commonly used generic antifungal agent that lowers cortisol levels by inhibiting cortisol production, do not restore cortisol's diurnal rhythm. They lower the level of the cortisol pool with no regard for cortisol's extremely important natural rhythm.

As was true last quarter, increasing numbers 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, it 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 diagnosed, readily benefit from treatment that modulates cortisol's activity.

As many of you know, we are developing a successor to Korlym, a 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.

Until 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 mention this to avoid confusion. What was once CORT125134 is now relacorilant. The 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 that Genentech created the suffix -mab to describe its first monoclonal antibodies and every monoclonal antibody that was subsequently discovered, every nonsteroidal cortisol modulator that is 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 who 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 it demonstrated in healthy subjects the key attribute of an effective treatment for hypercortisolism, the ability to modulate cortisol 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 enrolling up to 30 patients at sites in the United States and Europe. We expect results by the end of the first quarter of next year and are continuing preparations for an end-of-Phase II FDA meeting and Phase III clinical trial.

We are pleased to report that we recently achieved CLIA validation of our FKBP5 gene expression assay. Today's most commonly used tests measure cortisol that spills over into the urine or saliva as crude proxies for the only clinical significant -- 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 regimen. It is hard to overstate the medical advance such an assay may represent. CLIA validation means the assay will become available for physicians to use, an 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 if the same subjects are given prednisone together with Korlym or relacorilant. We are conducting research to confirm that FKBP5 levels are elevated in patients with Cushing's syndrome and normalized 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 of 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 announce the results of relacorilant's 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 apoptosis, the programmed cell death chemotherapies are meant to provoke. Preventing the stimulation of these 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 fight cancer. Not everyone realizes that a healthy body produces cancer cells but the immune system almost always identifies and destroys them. There's 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 androgens stimulate growth in tumors of the prostate. That is why androgen-deprivation therapy, known as chemical castration, is a common treatment.

It has been shown more recently in several top laboratories that patients treated with the androgen receptor blocker, enzalutamide, the Astellas Medivation drug XTANDI quickly develop colonies of cells where cortisol becomes the tumor's 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 advanced to the clinic our proprietary selective cortisol modulator, CORT125281, as a treatment for patients with 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's 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, who are studying Korlym plus Abraxane to treat patients with triple-negative breast cancer. The 64-patient, double-blind, placebo-controlled, multicenter Phase II trial builds on their extensive preclinical and clinical studies as well as the promising results of Corcept's Phase I/II trial of Korlym plus eribulin 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 this combination of medications.

We have begun the Phase I trial of another promising proprietary selective cortisol modulator, CORT118335. As many of you know, this compound is particularly potent in the liver. In animal models, it prevents and reverses nonalcoholic fatty liver disease as well as liver fibrosis and the weight gain caused by antipsychotic 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. Revenue 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'll 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 CLIA validation. We have advanced CORT125281 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 definitive 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. If results are positive, we will advance it to Phase II for the treatment of metabolic disorders, likely including antipsychotic-induced weight gain and nonalcoholic fatty liver disease by the third quarter of next year.

I'll stop now to answer questions.

(Operator Instructions) Our first question comes from Charles Duncan from Piper Jaffray.

First of all, congratulations on a very nice quarter. 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, I look at maybe 5 different kind of contributors, one of them being new patients, another being new doctors writing scripts, another is increasing persistence for patients on the drug and perhaps dose for those patients. And then the last is price. And I'm -- I guess, if you look at those 5 contributors, which one is most important to you? Or could you provide us any even semiquantitative metrics around them?

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.

Thanks, Joe. And thanks, Charles, for the question. I mean, the answer really is a simple one, and that's, that more patients are being prescribed Korlym out of all the metrics that you described. As I've previously said on earlier calls, I mean, our greatest challenge in the commercialization of Korlym has really been to get endocrinologists to write their first prescription. Once they do, they see the efficacy of the product, and they look for more eligible patients. And we've had many new physicians prescribe 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 prescribers. We expect this group of physicians to perform similar to the earlier cohort and become multi-prescribers as well, and we expect to continue to add new prescribers as we move forward. Again, growth is due entirely in the quarter to more Korlym prescriptions and not price or titration, which are 2 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 since.

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. And as a reminder to everybody, when new patients are initially prescribed Korlym, they're prescribed at 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 at 300 milligrams, then the longer it takes for our overall average dose to rise.

Good. Thank you, Sean.

Our next question comes from Tazeen Ahmad from Bank of America.

This is Peter Stapor on for Tazeen. So first question, I'm on the FDA Adverse Events Reporting System portal right now. I see that Korlym has 91 death cases associated with it. Could you talk about whether those are drug-related and what the cause might be?

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

Okay. It's a publicly available FDA website. And so I -- my next question is whether the -- why the relacorilant readout got pushed, and when you're -- so it's going to be 1Q, but it was previously fourth quarter.

We actually had revised that, I believe, a quarter or 2 ago to be on first quarter of next year, and...

Right. I'm wondering why that was the case.

Yes -- no, and 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 fortunately, I can tell you, as an academic investigator myself many years ago, it used to go much more quickly. What used to take 2 or 3 months to get going is now taking 10, 11, 12 months to get on. So that was really the cause of the initial delay.

Got you. That makes sense. Okay, and do you have any expectation for Phase III, whether you'll need 1 or 2 studies?

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 talked to the FDA. So we can't really say with any certainty exactly what's going to happen. But yes, that is our expectation at the current time.

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

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

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 a broad distribution of generic abortion pill in the United States. So that's one fact.

Another fact is you've heard us talk about the importance of our sort of high-touch business model. All the close support we provide patients and physicians and that our pharmacy provides to patients and physicians have really been central to our -- the success of our commercial business. That's -- 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, you 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. That means it will not be the abortion pill. And furthermore, it won't cause the side effects, such as endometrial thickening and irregular vaginal bleeding, that cause some patients -- and the patients and physicians would both strongly prefer to avoid and cause some to avoid Korlym right now.

So you got to set those considerations to one side and keep those in your head, and then take a look at the path that any generic company would need to walk to get approval for a generic Korlym. First, they would need to obtain Korlym tablets so they could generate -- they could demonstrate, as part of their new drug application, bioequivalence. Second, they have to submit their -- file their application with the -- submit their application to the FDA, which takes some months, a few months, to review it for completeness before agreeing to file it.

Once that happens, the generic company has to certify that its 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 patent applications rather, that we believe will result in additional patents. So this IP portfolio is going to grow.

The generic has to certify that its product would not infringe this patent. These patents are listed in a 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 time -- we have 45 days to sue them for infringement, and our lawsuit will trigger an automatic 30-month stay 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 decides to proceed anyway, they're looking at a path to approval that, by law -- 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.

Our next question comes from Adam Walsh from Stifel.

This is Neil Carnahan on for Adam. Congratulations on a good quarter. Just a couple questions. Upon the possible approval of 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?

I'll just give you my opinion. Obviously, we don't know this with certainty. But I think the Korlym sales will essentially go to 0. I think that this drug really is superior in 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 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 are 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 to have any better efficacy than Korlym because Korlym has superb efficacy, taking away the progesterone 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 in prescribing the medication. So I'll just sum up to say I think the transition will be rapid and approach complete. I can't think -- I can't really think of any particular reason why anyone would stay on Korlym if CORT125134, relacorilant, actually proves to be as efficacious as we think it is.

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?

I'd like to introduce another member of our senior team. So thank you for the question. About to speak is Bob Fishman, who is a medical doctor and our Chief Medical Officer, and he'll address your FKBP5 question.

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, eventually, 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.

Our last question comes from Matt Kaplan from Ladenburg Thalmann.

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.

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 integrate it all at once. I'm going to say something that in some sense, again, maybe a slightly different way.

Cushing's syndrome is just that. It is a syndrome. Cortisol goes everywhere in the body, and it -- 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 gone on.

And just so you 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 of 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 too, 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'll be looking at each individual patient to see how they did in terms of each of those broad effects.

And there are no further questions at this time.

All right. Well, thank you very much, and really looking forward to talking to you in 2018.

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