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Edited Transcript of CORT earnings conference call or presentation 4-May-20 9:00pm GMT

Q1 2020 Corcept Therapeutics Inc Earnings Call

MENLO PARK May 18, 2020 (Thomson StreetEvents) -- Edited Transcript of Corcept Therapeutics Inc earnings conference call or presentation Monday, May 4, 2020 at 9:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Gary Charles Robb

Corcept Therapeutics Incorporated - CFO & Secretary

* Joseph K. Belanoff

Corcept Therapeutics Incorporated - Co-Founder, President, CEO & Director

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Conference Call Participants

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* Alan Leong

BioWatch LLC - Co-Founder & CEO

* Charles Cliff Duncan

Cantor Fitzgerald & Co., Research Division - Senior Analyst

* Christopher Lawrence Howerton

Jefferies LLC, Research Division - Equity Analyst

* Matthew Lee Kaplan

Ladenburg Thalmann & Co. Inc., Research Division - MD & Head of Healthcare Equity Research

* Swayampakula Ramakanth

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

* Tazeen Ahmad

BofA Merrill Lynch, Research Division - VP

* Xiaodong Zhang

Stifel, Nicolaus & Company, Incorporated, Research Division - Associate

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Presentation

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Operator [1]

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(technical difficulty)

our commercial business for the rest of the year. The risks COVID-19 poses to patients with Cushing's syndrome are likely to increase demand for Korlym. At the same time, restrictions imposed by state and local governments, hospitals and individual medical practices make it very difficult to work with physicians in-person. Some of the imaging centers and laboratories positioned to use when diagnosing patients with Cushing's syndrome and titrating to an optimum dose of Korlym are closed.

Many patients are hesitant to leave their homes even to visit the doctor. These factors are likely to reduce the rate at which new patients are introduced to Korlym and make it more difficult for physicians to monitor patients following dose titration. However, as physicians and patients adapt to a world in which COVID-19 is endemic, as they are beginning to do, the impact of these factors may diminish. We will reaffirm our 2020 revenue guidance of $355 million to $375 million based on our strong first quarter results and our best estimate of how the factors that determine our revenue, pandemic related and otherwise, will evolve over the coming months.

As many of you know, we are conducting a Phase III trial of relacorilant, our planned successor to Korlym, as a treatment for patients with Cushing's syndrome. The trial is known as GRACE. Our goal for GRACE is to confirm the positive efficacy and safety findings of relacorilant Phase II trial, in which patients exhibited meaningful improvements in glucose control and hypertension to the Cushing's syndrome's most pernicious manifestations as well as an important secondary endpoints without instances of Korlym's significant off-target effects. Our poster presentation of relacorilant's Phase II results can be found at the Investors/Past Events tab of our website. We believe relacorilant will constitute a major medical and commercial advance. While its Phase II efficacy data are comparable to Korlym's at the same time points in Korlym's pivotal trial, relacorilant promises to offer significant safety benefits. Korlym's affinity for the glucocorticoid receptor, GR for short, makes it a highly effective treatment for patients with Cushing's syndrome. Unfortunately, Korlym is not selective for the GR. It also binds to the progesterone receptor, which causes endometrial thickening and vaginal bleeding in many women regardless of age and requires Korlym's label to carry a black box warning, the most serious medication were inquired by the FDA for termination of pregnancy. By a different mechanism, Korlym causes hypokalemia, low potassium and manageable, potentially serious side effect that was experienced by 44% of patients in Korlym's pivotal trial and is a leading cause of discontinuation in patients taking the medication.

Unlike Korlym, relacorilant is a selective GR modulator with no affinity for the progesterone receptor. It does not cause endometrial thickening or vaginal bleeding. It is not the abortion pill. In addition, we saw no instances of drug-induced hypokalemia in relacorilant's Phase I or Phase II studies. These are side effects physicians and patients would strongly prefer to avoid. The COVID-19 pandemic has slowed the pace of enrollment in GRACE and delayed the opening of the last few of our planned 65 clinical trial sites. As public health restrictions ease, we expect our remaining sites to open and full enrollment to resume this fall.

We now plan to submit our NDA in the second quarter of 2022. This quarter, we will start a Phase III study of relacorilant in patients whose Cushing's syndrome is caused by an adrenal adenoma or adrenal hyperplasia. The study is called GRADIENT, G-R-A-D-I-E-N-T. It will be the first randomized double-blind placebo-controlled trial in patients with this etiology of Cushing's syndrome. GRADIENT has a planned enrollment of 130 patients at 60 sites in the United States and Europe. Participants will receive either relacorilant or placebo for 6 months, with the primary endpoints being improvements in glucose metabolism and hypertension. Many of the investigators for GRACE will also participate in GRADIENT. GRADIENT is part of our investment in development of relacorilant to treat patients with hypercortisolism. It is not a required part of relacorilant's NDA. Our goal is simply to help inform and improve the treatment of patients with this type of Cushing's syndrome. Our poster presentation of GRADIENT's design is available at the Research & Pipeline/Publications tab of our website. An abstract is also available in the April/May supplemental issue of the Journal of the Endocrine Society.

I will now turn to our oncology program, which is examining 3 potential mechanisms by which cortisol modulation may benefit patients. Cortisol activity suppresses apoptosis, the programmed cell death chemotherapy is meant to cause and tumors that express the GR. We are testing whether adding our selective cortisol modulator, relacorilant, to chemotherapy will blunt cortisol's anti-apoptotic effect, thereby allowing chemotherapy to achieve its full cancer-killing potential. Our goal is to confirm the striking data we presented in ASCO last year, where we reported results from our open-label trial of relacorilant plus nab-paclitaxel, chemotherapy drug, Abraxane. In our study, 7 of 25 patients with metastatic pancreatic cancer and 5 of 11 patients with advanced ovarian cancer achieved durable disease control, meaning their tumors either shrank or ceased growing for 16 weeks or longer. The duration of benefit in some patients was eye catching. Two patients with metastatic pancreatic cancer exhibited tumor shrinkage for more than 50 weeks. One patient with ovarian cancer exhibited tumor shrinkage for 65 weeks. The tumors in all of these patients had progressed during multiple lines of prior therapy, including therapy with taxanes. Our poster presentation of these results is available at the Investors/Past Events tab of our website.

Last year, we began a controlled Phase II trial of relacorilant plus nab-paclitaxel in patients with metastatic ovarian cancer with a planned enrollment of 180 patients at 25 sites in the United States and Europe. Primary endpoint is progression-free survival with secondary endpoints, including overall survival and duration of benefit. Despite challenges arising from the COVID-19 pandemic, we continue to expect results of this study during the first half of next year. This quarter, we will start a Phase III trial of relacorilant in combination with nab-paclitaxel in patients with metastatic pancreatic cancer, a disease with a dire prognosis. This trial will be called RELIANT, R-E-L-I-A-N-T. RELIANT will be an open-label trial in which 80 patients receive relacorilant plus nab-paclitaxel with the primary endpoint being the objective response rate assessed by RECIST criteria. We plan to perform an interim analysis on data from the first 40 patients. We believe sufficiently positive results could support accelerated approval. RELIANT will be conducted at 30 sites in the United States.

Cortisol modulation may also benefit patients by bolstering their immune response. Cortisol is the body's natural immunosuppressant. This effect is often beneficial. It helps to prevent, for example, autoimmune disorders such as rheumatoid arthritis. In patients with cancer, however, cortisol activity suppresses the ability of the immune system to recognize and destroy tumor cells. It also blends to cancer-killing attributes of immunotherapeutic agents, such as checkpoint inhibitors.

Next quarter, we are starting an open-label, Phase Ib trial of relacorilant plus the PD-1 checkpoint inhibitor, pembrolizumab; Merck's drug, KEYTRUDA, in 20 patients with metastatic or unresectable adrenocortical cancer. Because their tumors produce cortisol, these patients also have Cushing's syndrome, which cortisol modulation can treat. Our trial will examine whether relacorilant can, in addition to treating Cushing's syndrome in these patients, specifically help immunotherapy achieve its maximum effect by reducing the immunosuppressive effects of excess cortisol activity.

Finally, cortisol modulation may benefit patients with castration-resistant prostate cancer. Androgen stimulates the growth of prostate tumors, which is why androgen receptor antagonism with medications such as enzalutamide, Pfizer's drug Xtandi, are standard therapy. More recently, researchers at the University of Chicago and Sloan Kettering have shown that when colonies of prostate cancer cells are exposed to enzalutamide, growth is stimulated by cortisol activity at the GR. Our hypothesis is that a regimen combining a cortisol modulator with an androgen receptor antagonist will block this tumor escape route. Our selective cortisol modulator, exicorilant, is potent in animal models of castration-resistant prostate cancer. By the end of this year, we expect to select the optimum dose of exicorilant in combination with enzalutamide to bring forward in a controlled Phase II trial. In addition, a dose-finding trial of relacorilant plus enzalutamide is being conducted by investigators at the University of Chicago.

I will conclude with an update of our program in metabolic disorders. As many of you know, we are developing our selective cortisol modulator, miricorilant, for the treatment of antipsychotic-induced weight gain and nonalcoholic steatohepatitis, or NASH. Millions of patients rely on medications such as olanzapine to treat diseases such as schizophrenia and bipolar disorder. Unfortunately, these drugs cause serious metabolic abnormalities, including rapid weight gain and lipid disorders in nearly everyone who takes them. Patients are forced to make a terrible bargain, treat one dangerous disease but at the cost of acquiring another. Heart disease and stroke, not suicide, are the leading causes of death in patients taking antipsychotic medications. We conducted 2 double-blind, placebo-controlled trials in healthy subjects in which mifepristone reduced weight gain cost by taking olanzapine or risperidone. Our results were published in the journals, Advances In therapy and Obesity. Unfortunately, we could not advance mifepristone further for this indication because mifepristone's quality, as we abort a fashion, disqualify it as a treatment for common disorders. Miricorilant can be advanced because it is a selective cortisol modulator with no affinity for the PR. It is not the abortion pill and if approved, could be widely distributed. Miricorilant is more effective than mifepristone in animal models of antipsychotic-induced weight gain. And now our completed double-blind placebo-controlled Phase Ib study in healthy human subjects has demonstrated that miricorilant is active in reducing antipsychotic-induced weight gain in humans.

In the first part of our Phase Ib trial, 66 healthy subjects received olanzapine and either 600 milligrams of miricorilant or placebo for 14 days. Participants who receive miricorilant gain less weight than those who receive placebo. In addition, liver enzymes, markers of liver damage, increased less in patients who received miricorilant, suggesting that miricorilant has protective effects in the liver. In the second part of our trial, 30 healthy subjects received olanzapine and even miricorilant at 900 milligrams or placebo for 14 days. The results confirm our findings from the first part of the study. Patients receiving miricorilant gain less weight and had lower triglycerides and less sharply elevated liver enzymes and subject who received placebo. No side effects other than those commonly seen with olanzapine were seen with either dose of miricorilant. In fact, we plan to investigate considerably higher levels of miricorilant exposures in future studies. The full results of our Phase Ib study will be published later this year.

Our double-blind, placebo-controlled Phase II trial of miricorilant called GRATITUDE to reverse recent antipsychotic-induced weight gain is in progress. In the study, 100 patients with schizophrenia will continue to receive their established dose of antipsychotic medication and either 600 milligrams of miricorilant or placebo for 12 weeks. GRATITUDE will be conducted at approximately 20 centers across the United States. While the COVID-19 pandemic has effectively suspended new enrollment in this trial, we are confident enrollment will resume as public health restrictions ease. There has been no delay in our plans to start by year-end a placebo-controlled, double-blind Phase II trial in patients with long-standing antipsychotic-induced weight gain. In this trial, we plan to test the formulation of miricorilant that we believe will be achieved significantly higher exposures of miricorilant and will be reaching the GRATITUDE trial, which again, is examining the reversal of recent antipsychotic-induced weight gain.

Finally, in the first quarter of next year, we plan to start a double-blind placebo-controlled Phase II trial of miricorilant in patients with NASH, a serious liver disorder that afflicts millions of patients. In animal models, miricorilant prevents and reverses both fatty liver and liver fibrosis, which are precursors of NASH. We also intend to test our new more potent formulation of miricorilant in this study.

In conclusion, Corcept had an outstanding first quarter of revenue and profits. We increased our balance of cash and investments to $349 million. We have no debt. The COVID-19 pandemic has slowed enrollment and site activation in GRACE, our pivotal Phase III trial of relacorilant to treat patients with Cushing's syndrome. We now plan to file our NDA in the second quarter of 2022, 2 quarters later than we had originally planned. We now expect to start GRADIENT, our Phase III trial of relacorilant in patients with adrenal Cushing's syndrome this quarter.

We expect to -- we continue to expect results of our controlled Phase II trial of relacorilant plus nab-paclitaxel to treat patients with metastatic ovarian cancer in the first half of next year. This quarter, we plan to start a Phase III trial called RELIANT of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer. We believe sufficiently positive results in RELIANT will support accelerated approval.

Next quarter, we plan to start an open-label Phase Ib study of relacorilant combined with PD-1 check inhibitor, pembrolizumab, to treat patients with metastatic or unresectable adrenal cancer.

Finally, by the end of this year, we expect to select a dose suitable for advancement of exicorilant in combination with enzalutamide to treat patients with castration-resistant prostate cancer. The second part of our Phase Ib trial of miricorilant to reduce weight gain caused by olanzapine has confirmed our earlier positive results. Our double-blind, placebo-controlled Phase II trial of miricorilant to reduce recent antipsychotic-induced weight gain is open. We expect enrollment to resume as public health restrictions loosen. We plan to start a Phase II trial of miricorilant in patients with long-standing antipsychotic-induced weight gain by year-end as originally planned, using an improved formulation of miricorilant. We now plan to start our Phase II trial of miricorilant in patients with NASH in the first quarter of next year.

I'll stop here for questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) We'll hear first today from Charles Duncan from Cantor Fitzgerald.

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Charles Cliff Duncan, Cantor Fitzgerald & Co., Research Division - Senior Analyst [2]

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Let's see -- hopefully, you can hear me. Congratulations on a very good quarter and the recent IP update, Charlie and Joe.

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Joseph K. Belanoff, Corcept Therapeutics Incorporated - Co-Founder, President, CEO & Director [3]

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Thank you, Charles.

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Charles Cliff Duncan, Cantor Fitzgerald & Co., Research Division - Senior Analyst [4]

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Okay. Good. You can hear me. Let's see. I had a couple of questions from -- on the Korlym side and then in that pipeline. You got a ton of things going on in the pipeline, and I'm interested to explore that. But first, before I do, let me ask you a question on the commercial side. With regard to the revenue growth that you saw, could you help us understand better the contribution of demand versus, say, pricing and/or dose in the quarter?

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Gary Charles Robb, Corcept Therapeutics Incorporated - CFO & Secretary [5]

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Sure. Chaz, this is Charlie. I'll answer that question. So just a little background for folks. Traditionally and historically, every first quarter, we face a headwind -- our revenue faces a headwind due to a couple of factors primarily the annual reauthorization process that insurers put their patients through, which results in patients receiving sort of being -- essentially, their insurance being suspended. We work through those issues and providing a free drug in the meantime and then get them back on paid drug, but our revenue takes a hit in the first quarter every year as we deal with that administrative hurdle. Also, in the first quarter, virtually all of our Medicare patients go through the Medicare donut hole, which is -- of which we are obligated to cover about 3/4 of that cost. So that is another deduction to our revenue. And so as a result, sort of absent a price increase, our first quarter is typically flat or even down a little bit in terms of revenue. So with that as sort of background, I can tell you, we took a 5% revenue increase at the start of the year that I think had the effect of -- for the most part, kind of counterbalancing that headwind, okay? So that was the effect of a change in price.

Now the rest of the growth, I think, roughly speaking, think of it as about -- there were sort of 2 factors at play: One is that insurance companies allowed patients -- some insurance companies allowed patients to refill their prescription just a few days earlier than normal. I think the thinking was, in case there are logistical difficulties posed by the pandemic and say, Federal Express can't deliver on time, they didn't want patients to run out of medicine. So a very small minority of our patients received refills a few days earlier than they normally would. Let's say that's about half of the growth that you saw in the quarter. Roughly, the other half was due to improved patient adherence. Patients just took their medicine more regularly than they normally do, and I'd describe that as sort of pandemic conditions. But I think that's sort of the medical fact that perhaps, Joe, would you like to elaborate on at all.

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Joseph K. Belanoff, Corcept Therapeutics Incorporated - Co-Founder, President, CEO & Director [6]

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Yes. I think that -- I think everybody knows, including myself, patients don't always take their medicine every day even when they're supposed to. And there are some medications that they take sometimes only half the time, which obviously is not what their doctors intend. That's not really true with Korlym. Patients do take the medicine pretty much on schedule, but still data are missed. We saw very little of that in this quarter because I think that patients with Cushing's syndrome, understanding their doctors help them understand that they are particularly high risk for infections. And frankly, the fear of the contracting COVID-19, I think, added to that adherence percentage. Now for us, as a company, obviously, we think that, that's a very important benefit for patients, and we hope to really maintain that idea that this is a medication that is best taken every single day that is prescribed as we go forward.

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Charles Cliff Duncan, Cantor Fitzgerald & Co., Research Division - Senior Analyst [7]

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Okay. That's helpful, Charlie and Joe. And given those dynamics, could you provide any granularity on, say, new patient, new diagnoses, new scripts in the quarter because it -- Charlie mentioned adherence. So what about any additional patients?

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Joseph K. Belanoff, Corcept Therapeutics Incorporated - Co-Founder, President, CEO & Director [8]

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Well, as you know, that basically, starting in March, virtually every medical practice in the country shut down visits from medical -- personal visits by medical science liaisons or clinical specialists. And I thought our commercial team really did a terrific job in instantly adopting the idea that there were some doctors who were still interested in being reached but needed to be reached remotely. We were still even able to conduct various events where doctors could gain more information remotely. And a really interesting thing, I think, is that there is a -- namely a small minority of doctors who I think because of their own practices and perhaps their own personalities, actually seem to favor this remote contact as opposed to the standard inpatient contact.

Now on balance, of course, that's not the case. I think that it's difficult for patients to get through the doctor right now. Diagnosing Cushing's syndrome involves a lot of testing. Everyone knows all those sort of things that in the world. That being said, we did see new enrollments in the quarter. Not as many as we expect to see in a restriction absent time, but we did see new enrollments, and we continue to see new enrollments. And as I said, what we're really trying to do this -- at this point in time is learn all the things that this forced experiment forces us -- really good forces to learn and incorporate that as we go forward as things loosen up.

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Charles Cliff Duncan, Cantor Fitzgerald & Co., Research Division - Senior Analyst [9]

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Okay. That's helpful, Joe. And then if I could move on to the pipeline questions that I had, particularly with regard to relacorilant and GRACE timing. I think you provided pretty good explanation on the -- of the kind of impact of COVID-19 on that. But can you provide us more information with regard to the number of patients that are on hold or actual number of sites up and running? And any other work needed for the NDA in terms of, say, long-term tax or manufacturing processes optimization?

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Joseph K. Belanoff, Corcept Therapeutics Incorporated - Co-Founder, President, CEO & Director [10]

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Yes. No, I think I understand the question, and let me just provide a few more details. One, although the addition of patients to the study basically slow to a trickle or close to 0 at some points, I think it's important for everyone to understand that the patients who are on trial continue to be seen by their physicians and so that march their way through the study. It's a very interesting decision primarily at academic centers, which I think was their best compromised, was the patients who were already receiving medicine in the study should continue to receive the medications in study, but they didn't really with everything else that was going on. I want to add new patients to their caseload at that point in time. Now we have never actually given specific numbers that we have, but I think that you can add them up to understand sort of where we were at your best estimate and where it's going to end up. And we really do feel confident at this point that the 20 -- the data we've now given, which is essentially a 2-quarter delay really encompasses everything we need to get done. But to your specific question, yes, the long-term toxicology continued at pace. That's not an issue that will actually be done on what was the standard time line before. Our manufacturing issues and solutions move along at their same pace. So really the limiting variable for the study was already going to be the final efficacy and safety results and still going to be the case.

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Charles Cliff Duncan, Cantor Fitzgerald & Co., Research Division - Senior Analyst [11]

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That's helpful. Last question, and then I'll hop back in the queue, is relative to your broader platform. You've got a lot of candidates in the clinic or soon to be. And I guess I'm kind of wondering, you've been at this medicinal chemistry for glucocorticoid receptor modulator game for a while. And when you consider the breadth of those efforts relative to other approaches you've seen, perhaps even recently or in the past, such as those by a recent IPO. Could you compare and contrast your efforts versus others that have come along?

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Joseph K. Belanoff, Corcept Therapeutics Incorporated - Co-Founder, President, CEO & Director [12]

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Yes. Broadly, I can. I mean we thought for a very long period of time. And it was basically my research career and then my career course for the last 20 years that the cortisol modulation platform is an extremely important medical platform. Many diseases are affected by cortisol activity, and we really have followed the research to the places where we think they can be best served by treatment, and we'll continue to do that. We still have interesting programs that are even earlier in the pipeline because cortisol goes everywhere in the body and cortisol modulation really affects many, many different diseases. Now Chaz is somebody who really has followed our research for a very long time. You knew that one of the really limiting variables was the only drug which was available for cortisol modulation was mifepristone, which by the activity it has in a different receptor, the progesterone receptor had all of its notoriety as the abortion pill for a very long period of time. Korlym is an excellent drug for Cushing's syndrome, but it is not a selective drug. It gets to other receptors besides the glucocorticoid receptor. It affects other hormones activity besides cortisol. It also affects progesterone and to a lesser degree, androgen where it's a modest androgen receptor antagonist. Our medicinal chemistry goal, and many had tried it before we did, was to come up with a selective cortisol modulating drug, a drug which did not touch the progesterone receptor. And it's really a real medicinal chemistry feat. She's not often on these calls because she's in England, our lead chemist, a Head of Research is a skilled and medicinal chemist by background, named Hazel Hunt. And she really put together the original ideas as to how you could create a compound, which was a cortisol modulator but did not get to the progesterone receptor, and ultimately, was very, very successful in doing that. And our compounds are really profoundly selected for cortisol activity. They don't touch the progesterone receptor at all. And I think that's really a critical difference between that and all the other compounds, which are out in the world at this point being developed either there are no other modulators or the modulators aren't quite as selective as ours. They really get to more than one receptor. And I think that one of the really important -- I just -- I don't want to get too esoteric with that, but basically, a selective cortisol modulator, which is a flooring structure, a steroid, I think it's very difficult to come by. It really took a novel structure, one which would fit the glucocorticoid receptor and not the progesterone receptor that really got us to selectivity. So I'll sort of leave it at that, but I think that is a major difference between our compounds and others.

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Operator [13]

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We hear next from Tazeen Ahmad with Bank of America.

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Tazeen Ahmad, BofA Merrill Lynch, Research Division - VP [14]

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Can you guys hear me?

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Joseph K. Belanoff, Corcept Therapeutics Incorporated - Co-Founder, President, CEO & Director [15]

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Yes, we can, Tazeen.

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Tazeen Ahmad, BofA Merrill Lynch, Research Division - VP [16]

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Okay. Perfect. I just want to follow-up on the quarter and then congratulations for having a very strong number. Specifically, can you talk about any trends that you've seen in April? And I'm asking only because based on the numbers that you stated for 1Q, it seems like for the rest of the year, it shouldn't be too difficult to have a view on your guidance.

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Gary Charles Robb, Corcept Therapeutics Incorporated - CFO & Secretary [17]

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Right. So just -- because it was a little hard to hear you, Tazeen. I'm going to just repeat your question and make sure I got it right, which was: what are we seeing in April? And what is that for -- sort of portend for the rest of the year, given the results we had in the first quarter. And I guess I would say that we've given our -- reaffirmed our guidance for the year and that's -- and we don't give quarterly guidance or any kind of interim guidance unless we think that needs to change. And all I can say is that we looked at all of the drivers of our revenue, all the variables that we always look at, we adjusted them as we thought appropriate for the conditions we saw and expect to see for the rest of the year and landed right back in the same place in our revenue guidance that we gave originally, and so we reaffirmed it. And that's really all the detail I can give you. And Joe, do you want to add any detail?

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Joseph K. Belanoff, Corcept Therapeutics Incorporated - Co-Founder, President, CEO & Director [18]

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Look, I'll say something which is obvious, but worth stating. It's very tough to predict where things are going to be the rest of the year for anybody. We really took our best crack at it. We were very pleased to see how things went in the first quarter. We don't know what things currently in place will -- what the end results will be or frankly, new things which may come up as the year goes along. So we really did our best to come down where we thought it was, and you've heard it. Really don't have anything more to add at this point, yes.

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Tazeen Ahmad, BofA Merrill Lynch, Research Division - VP [19]

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So I guess based on what you saw for 1Q, which one of those things could still continue for the rest of the year? So you did a good job of explaining, I think Charlie give us about -- talking about the 5% price increase to offset some of the impact that you see every first quarter. And that if I remember correctly from the earlier question about half of the remaining growth might have come from a small minority of patients getting their scripts renewed a little bit early in anticipation of maybe not being able to be as affordable, meaning they can't get around as easily. Would you see that, for example, as something that will continue the rest of the year?

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Gary Charles Robb, Corcept Therapeutics Incorporated - CFO & Secretary [20]

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Well, what we've seen, this is -- again, I'll just repeat it. So you just -- for example, the insurance companies allowing patients to refill their prescriptions a few days earlier, do we see that continuing. I think that's something that we have seen continued so far, but again, we -- insurance companies don't tell us their plans. And so we kind of took our best stab at how we thought it would be able to the rest of the year, but our crystal ball in that regard is really no better than anyone else's. And that's -- I just can't speak with any more certainty than that.

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Joseph K. Belanoff, Corcept Therapeutics Incorporated - Co-Founder, President, CEO & Director [21]

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And Tazeen, I just add on the second point that it's really -- it's a good thing for patients to take their medicine every day, and we're really working hard to get that message out there, particularly in this time where they are at greater risk. Exactly what it's going to mean as time goes along, I don't know, but it's a very important medical thing, and we hope that it continues.

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Tazeen Ahmad, BofA Merrill Lynch, Research Division - VP [22]

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Okay. Fair enough. And then the last one for me, if I could squeeze it in, is how are you thinking about the sales force increase that you've been planning that previously you said could have impact starting in the second half of the year?

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Joseph K. Belanoff, Corcept Therapeutics Incorporated - Co-Founder, President, CEO & Director [23]

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Yes. Well, yes, thanks, because it seems like a distant time before thinking about that. But yes, we've actually filled out our sales force to some degree. Unfortunately, some of them have come on freshly as this began, and we're using this time for them to go to even a graduate school because we always teach our clinical specialists a lot, and this has really been an opportunity for them to have even more in-depth training. And we've really done that, which I give our training staff a lot of credit for. How it's going -- they will now come online as things loosen up over time, and we're hoping they're going to make a substantial contribution, but time will tell.

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Operator [24]

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And from Ladenburg Thalmann, we hear next from Matt Kaplan.

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Matthew Lee Kaplan, Ladenburg Thalmann & Co. Inc., Research Division - MD & Head of Healthcare Equity Research [25]

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Congrats on a nice quarter. Just, I guess, a question for Charlie. I just wanted to dig in a little bit to -- from a legal standpoint, thanks for the update. What events or what moving parts could we see this year with respect to Teva dispute? Is there a situation where we just wait for the trial to occur next February? Or what should go on this year?

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Gary Charles Robb, Corcept Therapeutics Incorporated - CFO & Secretary [26]

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Yes. So I think with respect to our sort of disputes with Teva, so both the District Court lawsuit and the patent office post grant review proceeding that we have underway. I think that there is really -- the things to look for, frankly, are the ruling from the PTAB in November on the post grant review. I mean we will be exchanging some legal briefs with Teva, which I think will be a matter of public record at the patent office. I think you can just go to the public records and lift them up as they're filed. And then after that, we'll have our hearing, and then they will issue a decision. So I think really the November decision from the patent office and really, nothing of sort of public note until the trial with Teva in February.

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Matthew Lee Kaplan, Ladenburg Thalmann & Co. Inc., Research Division - MD & Head of Healthcare Equity Research [27]

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Okay. Okay. That's helpful. And I guess a question for Joe in terms of pipeline and helping us think about the studies that you have or plan to start -- have an ongoing plan to start in the oncology space, most specifically in the pancreatic cancer. When should we expect potential results from that study as you get underway this quarter, the Phase III?

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Joseph K. Belanoff, Corcept Therapeutics Incorporated - Co-Founder, President, CEO & Director [28]

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With the caveat that we never really know what the pace of studies are going to be in -- are going to be until we begin them. I think that you actually -- and this is really the true forward-looking statements so take it in that context. No more than that because we haven't even begun the study. I think that we will be at a point where we will have results on the first half of the study about a year after it begins.

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Matthew Lee Kaplan, Ladenburg Thalmann & Co. Inc., Research Division - MD & Head of Healthcare Equity Research [29]

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Okay. Very good. And then in terms of additional use of Korlym in the oncology setting. I guess the metastatic ovarian cancer study and also the combination with PD-1 inhibitor, pembrolizumab, when do you think we should start with -- maybe more on -- put some time lines there? When do you think we should see the results from those 2 studies?

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Joseph K. Belanoff, Corcept Therapeutics Incorporated - Co-Founder, President, CEO & Director [30]

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I heard the second one about the adrenal cancer study with pembrolizumab. And what was the other study you're asking about, Matt?

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Matthew Lee Kaplan, Ladenburg Thalmann & Co. Inc., Research Division - MD & Head of Healthcare Equity Research [31]

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Metastatic ovarian cancer study. I guess that's all.

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Joseph K. Belanoff, Corcept Therapeutics Incorporated - Co-Founder, President, CEO & Director [32]

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Yes. Let me start with ovarian -- so let me just give a little bit of editorial comment. It's actually been interesting. I think we said it in the press release that while all studies were affected by -- are being affected by this pandemic, they're not 100% being affected the same. I think the oncology studies -- all diseases are bad but oncology is, in some sense, the tip of the iceberg of bad and a lot of these patients have to end up going in the hospital regardless for their care. So although the pace of enrollment, for instance, in the ovarian study -- ovarian cancer study has diminished, it has not gone to 0. And we still expect that we will have results in the same timetable that we thought we would previously, which is first half of next year.

As for the adrenal cancer study, very excited to get that started. Adrenal cancer, which we haven't talked much about, is really a rare cancer. Since its rate is very low, although it's very severe cancer, somewhat well understood. And we're really excited to get going in that because those patients already get treated with Korlym for their Cushing's syndrome. We're really -- and second, do unfortunately, poorly on immunotherapy currently. So there's really a good reason why a GR modulator, cortisol modulator might have the potential for success with these patients. And I can tell you, in animal models, it looks pretty good. So again, assuming that study gets started with the same caveat, very forward-looking statements, studies not started yet. I think there is 20 patients will produce results in about a year.

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Operator [33]

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We'll hear next from Chris Howerton with Jefferies.

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Christopher Lawrence Howerton, Jefferies LLC, Research Division - Equity Analyst [34]

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I will offer my congratulations on a successful quarter as well. Okay. So I guess, maybe ask for -- to start off, Charlie, if you could help us think about the operating expenses moving forward for the rest of the year. There is, obviously, some R&D that may be starting, but including specifically what the trends or trajectory we should expect for SG&A with maybe a different operating style with respect to detail in Korlym?

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Gary Charles Robb, Corcept Therapeutics Incorporated - CFO & Secretary [35]

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Sure. I think the way to think about -- so starting with SG&A, I mean the -- we have not had to lay anyone off because of pandemic. We've been able to administer the business pretty smoothly even at a distance, which is not too surprising since living in the Bay Area. There is a working from home and so forth is a pretty well-established practice. So we've been able to run the business smoothly. And just historically, if you look back at our SG&A, it tends to be pretty flat over the course of the year. So while, yes, there will be some less spending on travel and entertainment as the -- until pandemic restrictions ease, I wouldn't think that's going to be particularly material difference, and I wouldn't spend too much time trying to guesstimate what that reduction will be because I don't think if it's going to really matter. On the R&D side, while it is true that a sort of slower pace of site activation and slower patient enrollment will reduce our R&D expenses, again -- or spread steady costs out over a longer period of time. Again, I think the cost of actually enrolling and caring for a patient in a study is just a part of the overall expense. And so while it will reduce our spending a little bit, I mean, R&D includes very significant expenditures on manufacturing work, CMC work, preclinical research

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Christopher Lawrence Howerton, Jefferies LLC, Research Division - Equity Analyst [36]

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All right. And then maybe, I think, obviously, there is increased interest with respect to the oncology platforms and GI antagonism. So within your specific pipeline, maybe, Joe, you could describe for us the important differences between relacorilant and exicorilant. And what kind of the ideal settings might be for one or both of those?

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Joseph K. Belanoff, Corcept Therapeutics Incorporated - Co-Founder, President, CEO & Director [37]

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No, that's an interesting question, so thanks for letting me address it. And to do that, I really want to give you some context which I don't think I've really had a chance to provide in the past, which is just to be blunt about it, a decade ago when we were thinking about creating selective cortisol modulators, really, it was just -- in fact, sort of the program was entitled mifepristone without progesterone antagonism because that's really all we were going for. We wanted to have something which wasn't the abortion pill because the medical side effects of a progesterone antagonist, both in terminating pregnancy and all the other medical side effects. And many people had actually tried at that point to do it, and it was not an easy thing to do. But as I said -- mentioned before, Dr. Hunt actually was able to figure that out, and we were really on our way. But what was interesting about it was that she ultimately created 4 different series of compounds, all of which were cortisol modulators, none of which touch progesterone, a really very deep library. But initially, it was one compound we were looking for. The really interesting thing that happened was that when we started testing these compounds preclinically, all of them modulated cortisol, none of them touch the progesterone receptor, but they weren't identical. Some were better at preventing weight gain. Some are better at creating insulin sensitivity. Some got into the brain. Some didn't get into the brain. And some were more potent in oncologic models than others, and some of them are more potent in specific oncologic models than others. And so what it really ended up happening because of that, and I think we understand it's another whole lecture, and we'll talk about it off-line, if you're interested. But the bottom line was -- because I think we really understand the science of the tissue selectivity that we didn't understand before, but the bottom line was that instead of creating just a single follow-on compound, it created 4 or 5 different compounds, which might be specific for different disorders. While all of them might have effects, some of them had much more potent effects. And as you know, exicorilant, in particular, happens to be very potent in the prostate cancer model preclinically. We thought even more potent than relacorilant, but we're also testing relacorilant through the investigator study that we've described.

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Christopher Lawrence Howerton, Jefferies LLC, Research Division - Equity Analyst [38]

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Got it. Okay. That's very helpful. And I -- one -- I hope this isn't a problem that you have to deal with. But when we think about relacorilant in its mature stage, theoretically could be applied to both Cushing's syndrome as well as oncology. So strategically, how do you think about pricing and commercialization between those 2 settings?

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Joseph K. Belanoff, Corcept Therapeutics Incorporated - Co-Founder, President, CEO & Director [39]

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Well, I think that that's actually an easier one to bridge because I think that the cancers that we are talking about are really still orphan or small number of cancers, not so different than the population that we see in Cushing's syndrome. So again, without any kind of, again, sort of specific study of them, I don't think there is really a lot of pricing difference between those two. That would be very different if we were introducing relacorilant for some mass market disease where primary care pricing would be -- would sort of rule today. What's interesting is that miricorilant, the drug that we are developing for antipsychotic-induced weight gain and NASH, happens to be a very liver-specific drug. It's a very organ-specific drug and not a particularly good drug for Cushing's syndrome. There are other things like, you probably heard the term SERMs estrogen modulators, which are very tissue specific. Miricorilant is one as well. It is not particularly effective in Cushing's syndrome. It really is aimed at primary care disorders at the standard primary care pricing. So not an issue for relacorilant and miricorilant is different.

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Operator [40]

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We'll move to Swayampakula Ramakanth with H.C. Wainwright.

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Swayampakula Ramakanth, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [41]

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Most of my questions on the commercial front of your story have been asked. So I just want to explore a few of these studies with you. On the GRADIENT, which is a study in patients suffering from adrenal adenoma, which end up causing Cushing's disease. So how big this population? And if the study that you're planning progresses as you expected to, what would be the time line for data and also for filing, because this probably is going to come post GRACE?

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Joseph K. Belanoff, Corcept Therapeutics Incorporated - Co-Founder, President, CEO & Director [42]

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Yes. So again, let me just give a little background for this. It's been well understood for, I guess, as long as Cushing's syndrome has been understood that adrenal tumors can produce enough cortisol to really be symptomatic. What's been very interesting over the last 25 years is that with the advances in imaging, there have been more patients discovered who have had adrenal tumors that were producing cortisol, but not at the high enough level to produce really floored symptoms, but still to produce real symptoms that were -- caused morbidity, symptoms related to glucose intolerance and hypertension and so forth. That really become much better understood in the last 10 years. Now what's interesting about that as many of these patients never really got treated for their hypercortisolism. They get treated with 7 different medications for 7 different parts of their disease, but never with really a unifying diagnosis. And it's really been only in the last decade if that's true. An interest really of getting that right is important. Now a couple of interesting things. These patients, as a group, tend to not have severe cases of Cushing's syndrome, but they have real cases of Cushing's syndrome. An interesting thing from a study perspective is that this is a group of patients who can be studied in a double-blind fashion since many of them at the current time are not being treated for their hypercortisolism with an anti-cortisol agent at all. But could -- so from an ethical point of view, they can be randomized for cortisol modulating treatment like ours, like relacorilant or placebo, and do the sort of standard true double-blind study. It's very difficult to do with people who have more profound Cushing's syndrome because they're giving somebody a placebo, frankly, is unethical and people are resistant to it because placebo simply just doesn't work in that disease state.

Okay. Now to your specific question. Yes, it's still an orphan group. I mean we don't know exactly how many people actually have Cushing's syndrome caused by adrenal tumors. But -- and so the number really is unknown, and we will find that out basically over time. But it's not an insignificant group of people, and it certainly could be as many people as currently are diagnosed with the pituitary Cushing's syndrome.

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Swayampakula Ramakanth, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [43]

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Okay. Fair enough. And regarding the GRATITUDE study, which is the one in treating weight gain due to antipsychotic pills. How similar is that study to the Phase Ib in terms of the study design? And if there are any differences, what sort of differences are you having?

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Joseph K. Belanoff, Corcept Therapeutics Incorporated - Co-Founder, President, CEO & Director [44]

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I understand the question, and thanks for the opportunity to clarify this. So the Phase I study, remember, is in normal healthy subjects. So these are people who are just volunteers, and they are given olanzapine for 2 weeks with placebo or with miricorilant. And so they're not patients really at all, it's a Phase I study. And what we're really trying to find out is whether the medication miricorilant was active in reducing the effects that you quickly see with miricorilant even in healthy people. So it's, in that sense, a Phase I study where an important pharmacodynamic effect can be assessed. And we've told you in that kind of study, miricorilant look good, similar to what we have seen with mifepristone many years ago. And the Phase II studies are really quite different. They're in patients, and there are the one that we described, the GRATITUDE study, in patients who have gained weight recently within the last 6 months as an outlier thing from taking one of these antipsychotic medications. And the study is about reducing that weight. And those patients stay on their antipsychotic medication having gained the weight, then they're randomized to either miricorilant or placebo, and the study result is a reduction in weight as well as looking at all the other metabolic variables, which have already gone awry because of the use of the antipsychotic medication. So really, what we've learned in the Phase I study was and it's a big deal. This is a medication which is active and an important mechanism. Now comes the real test of whether it works in patients who are actually being affected by the disease.

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Swayampakula Ramakanth, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [45]

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And just to follow up on this. In this study, you have an endpoint, which is at the end of 12 weeks, what is the figure? What is the weight gain that is not -- I mean well, we really don't get the weight gain and the time point is 12 weeks. Is that good enough? Because these patients generally have weight gains depending on how long they have been on the dose. And sometimes some of these patients are still titrating their dose as the disease waxes and wanes. So I'm just trying to understand how do you...

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Joseph K. Belanoff, Corcept Therapeutics Incorporated - Co-Founder, President, CEO & Director [46]

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Okay. So the patient group in this study are on stable antipsychotics so their dose has now been titrated, but their weight gain is recent. So they started on the medication in a relatively recent period of time so that the weight gain that they've seen can be assessed not by just staying home during the pandemic virus -- during the coronavirus, but specifically due to the medication. And that's what we're really trying to suss out, whether that weight gain, which we think is a direct effect of the antipsychotic medication, can be reduced with our drug.

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Operator [47]

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And from Stifel, we hear next to Adam Walsh.

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Xiaodong Zhang, Stifel, Nicolaus & Company, Incorporated, Research Division - Associate [48]

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This is Edwin on for Adam. In the tumor studies, have you seen any drug-drug interaction between relacorilant and Abraxane from the clinical data to date?

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Joseph K. Belanoff, Corcept Therapeutics Incorporated - Co-Founder, President, CEO & Director [49]

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Yes. Yes, there is a drug-drug interaction. When you use relacorilant, you need to use less Abraxane to get to the same plasma level of Abraxane. And it's due to the CYP3A4 interaction.

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Xiaodong Zhang, Stifel, Nicolaus & Company, Incorporated, Research Division - Associate [50]

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So could this DDI be a potential problem for the combo therapy of these 2 drugs?

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Joseph K. Belanoff, Corcept Therapeutics Incorporated - Co-Founder, President, CEO & Director [51]

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Well, I'm not sure in what sense you mean a problem. I mean people have to use less Abraxane. So I guess whoever is making Abraxane is going to make a little less money from it. But in terms of its actual medical effect, no, I think that commonly, you have to look at drug-drug interactions, and I think that, that's really a portion of it. But as I said, no, we really had no issue, I think, with the investigators in the study having to account for that effect.

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Operator [52]

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And we'll move to Alan Leong with BioWatch News.

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Alan Leong, BioWatch LLC - Co-Founder & CEO [53]

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I wanted to ask, can you give a little more color on the recent miricorilant Phase Ib trial at the higher dose? At the higher dose at 900 milligrams, they create a significantly or consistently increased blood levels in the patients. And if so, did you see any dose or blood level-dependent patterns? Or is this kind of hard to tell because there is only a small incremental increase in the blood level?

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Joseph K. Belanoff, Corcept Therapeutics Incorporated - Co-Founder, President, CEO & Director [54]

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Yes. Well, what I think -- and I really wanted to hold it because I think this is going to be a nice publication when it comes out. I think the main thing to really glean from is, yes, we did see some increase in plasma level. And we were pleased to see that the same effect that we've seen at 600 milligrams also was true with 900 milligrams. The other important effect -- and I don't want this to get lost here, Alan, is that just as a prescribing doctor, I mean, I guess, it's just sort of like this as a doctor. I've never given a medication that has no side effects. If you get a dose high enough where you're really getting max, you begin to create some side effects. And we haven't seen really no side effects at this plasma level of miricorilant. So my sense of it is that we are not yet at that level where we actually are getting maximum effects. What was really nice to see in this particular phase of the study with miricorilant with the same activity, which you can never take for granted, really appeared just as well the second time around.

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Alan Leong, BioWatch LLC - Co-Founder & CEO [55]

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With -- just wanted to follow up on the adenoma question and answer. Korlym and Cushing's syndrome, are you seeing some prescriptions go to primary care now especially that less severe patients are being treated? And if true, do you envision that adenomas sub indication are eliciting primary care scripts? Could you provide any thoughts about that?

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Joseph K. Belanoff, Corcept Therapeutics Incorporated - Co-Founder, President, CEO & Director [56]

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Yes. We mostly do not -- in fact, almost all of our prescribers are endocrinologists. The only real exception to that is, there are some areas of the country where primary care physicians in more remote areas are sort of the only game in town, and they act as psychiatrist, endocrinologists and so forth to treat everywhere who goes along. Well, the broader answer to your question is, no, we think this is a disease which really is best treated by endocrinologists. They understand kind of all the ins and outs. Cortisol goes everywhere. And we expect that, that's going to continue to be the case as we go forward.

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Alan Leong, BioWatch LLC - Co-Founder & CEO [57]

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And let me just add that, that was a knockout quarter, well executed to help set up our year. So great work.

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Joseph K. Belanoff, Corcept Therapeutics Incorporated - Co-Founder, President, CEO & Director [58]

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Well, thanks, Alan. And for everyone who doesn't know Alan, he's calling from the epicenter of viral contagion, and I'm glad that you're well.

Okay. Listen, I think that, that clears our question queue. So thank you to everybody. Please stay healthy, and we look forward to talking to you next quarter.

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Operator [59]

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And that does conclude today's conference. Again, thank you all for joining us.