Corcept Therapeutics Inc

NASDAQ:CORT

Earnings Call Transcript 2020-Q2

[Operator]

Good day, and welcome to the Corcept Therapeutics Conference Call. Today’s conference is being recorded. [Operator Instructions] At this time, I would like to turn the conference over to Charlie Robb. Please go ahead, sir.

[Charlie Robb, Chief Financial Officer]

Thank you. Good afternoon, everyone. Today, we issued a press release announcing our financial results for the second quarter and providing a corporate update. A copy is available at corcept.com. Complete results will be available when we file our Form 10-Q with the SEC. Today’s call is being recorded. A replay will be available through August 18 at 888-203-1112 in the United States and 719-457-0820 internationally. The pass code will be 6800706.

Statements during this call, other than statements of historical fact, are forward-looking statements based on our plans and expectations that are subject to risks and uncertainties, which might cause actual results to differ materially from those such statements expressed or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business and achieve our goals during the COVID-19 pandemic and thereafter; including our ability to generate sufficient revenue and cash reserves, sufficient to fund our commercial operations and development programs; the availability of competing treatments, including generic versions of Korlym, the initiation or outcome of litigation, our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym, and risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates, oversight and other requirements, and the impact of the COVID-19 pandemic on our employees, consultants and vendors, as well as on physicians, patients, insurers, regulators and the practice of medicine generally. These and other risks are set forth in our SEC filings, which are available at our website and the SEC’s website.

On this call forward-looking statements include those concerning our 2020 revenue guidance, cash flow, and expected growth, impact of the COVID-19 pandemic on our commercial operations, financial performance, clinical development programs, physicians, payers and patients, physician awareness of hypercortisolism and the selection of Korlym as the optimum medical treatment. The timing, cost and outcome of litigation including our lawsuit against Teva Pharmaceuticals and Sun Pharmaceuticals, and Teva’s challenge to our intellectual property before the Patent Trial and Appeals Board, the scope and protected power of our intellectual property, the benefits of orphan drug designation, the progress enrollment, timing, design and results of our clinical trials, and the clinical and commercial attributes of relacorilant, exicorilant, miricorilant and our other selective cortisol modulators. We disclaim any intention or duty to update forward-looking statements.

Our revenue for the second quarter was $88.6 million, a 23% increase from the second quarter of 2019. It was $4.7 million lower than in the first quarter of this year, primarily because in March, some patients refilled their prescriptions a few days earlier than usual. So as to have a small amount of extra medicine on hand to safeguard against pandemic related delivery delays. These early refills increased our first quarter tablet shipments in revenue. When patients consumed their small safety stocks in the second quarter, they postponed refilling their prescriptions by a few days, which decreased our second quarter tablet shipments and revenue by a similar amount.

Let me illustrate with a hypothetical example. A patient who filled her Korlym prescription on March 2 and she would normally have refilled on April 2, instead refills on March 29. That is to say, in the first quarter, rather than the second quarter. In April, when it becomes clear that no deliveries are being delayed, she consumes those few extra tablets and rather than refilling her prescription on April 29, waits until May 2, skipping April. She didn’t return to her normal monthly refill cadence receiving another shipment on June 2. This patient received six shipments in the first half of 2020 in the average of one per month as one would expect. But four of those shipments were in the first quarter and only two were in the second.

Variations and refill timing such as I just described because our shipments of Korlym tablets and our revenue to increase in March, then decrease in the second quarter by a comparable amount, then resume their normal cadence. In effect about $4 million of revenue we would have recognized in the second quarter got shifted to March. We did not see this sort of early refill behavior in the second quarter.

Our second quarter GAAP net income was $28.3 million compared to $20.2 million in the same period last year, excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets together with related income tax effects. Non-GAAP net income in the second quarter was $39.7 million compared to $31.0 million in the second quarter of 2019. Our cash and investments increased $60.6 million in the second quarter to a balance of $409.6 million at June 30.

Now a brief legal update. In March 2018, we sued Teva Pharmaceuticals in Federal District Court to stop it from marketing a generic version of Korlym and violation of our patents. Our lawsuit stayed final FDA approval of Teva’s proposed product for 30 months, a period which ended at midnight on August 1. Discovery is underway. Trial is set to begin February 2, 2021.

In addition, Teva has challenged the validity of one of our patents, the 214 patent in a proceeding known as a post-grant review or PGR before the U.S. patent office’s Patent Trial and Appeal Board or PTAB. Three things in the PGR is complete. Oral argument is set for September 2. We expect the PTAB decision on November 19. The losing party may appeal to the Federal Circuit Court of appeals during which time those portions of the PTAB decision that are under appeal will have no effect. Federal Circuit appeals usually take about one year to resolve. As soon as we expect definitive resolution of the PGR is the fourth quarter of 2021.

Sun Pharmaceuticals is also seeking to market generic Korlym. Our lawsuit against Sun has stayed final FDA approval of Sun’s proposed product into the earlier of December 8, 2021. That is next year. And the decision by the District Court that the patents we have asserted against Sun are invalid, unenforceable or not infringed. Despite overlaps in subject matter and legal issues, our dispute with Sun is separate from our litigation against Teva and is following its own timeline.

A Markman hearing in the Sun case is set for November of this year. No trial date has been set. The impact of the COVID-19 pandemic on the timing of these disputes is impossible to know with certainty. We do not expect delays in the PGR because the patent office conducts much of its work, including PTAB hearings remotely as a matter of course. Predicting the ultimate timing of our District Court litigation is more difficult. The judge hearing our Teva and Sun lawsuits is not the later February trial date with Teva or our November Markman hearing in the Sun case. That being said, I would not be surprised if our District Court timelines are extended. Of course, we will be ready, whether there are delays or not. We’re confident in our intellectual property and look forward to putting our case before the judge.

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

[Joseph Belanoff, Chief Executive Officer]

Thank you, Charlie. I want to start by commending our clinical specialist, patient advocates and medical science liaisons who worked hard and successfully to assure patients continued access to Korlym during the COVID-19 pandemic. Over the past quarter, we have seen physicians adopt their practices so that they can safely care for their patients. Managing the complex multistep process of diagnosing and treating patients with Cushing’s syndrome is hard even under normal conditions. Adding the stress and uncertainty of Zoom office visits, patients who are reluctant to lead the safety of their homes and limited access to laboratory and scanning centers increases the challenge. In-person meetings of our clinical specialists and medical science liaisons with physicians and their staff are quite limited at this point. Our commercial team has done an excellent job devising ways to support physicians by video and teleconference. But these methods are just developing.

We are focused intently on helping physicians provide optimal care because COVID-19 is especially dangerous for patients with Cushing syndrome. The coronavirus enters cells by binding to the H2 receptor. Cortisol causes the H2 receptive to proliferate putting patients with Cushing syndrome at heightened risk. In addition, excess cortisol activity suppresses the immune system. As a result, patients with Cushing syndrome are 4 to 5 times more likely to suffer from severe infections of any type. Hypercortisolism also increases the risk of blood clots and thromboembolism, a leading cause of death in patients with COVID-19. I want to underscore our full confidence in the commercial potential of Korlym and its plan successor relacorilant. There remain many patients who could benefit from treatment with the cortisol modulator who have not yet received it. The challenge is temporarily posed by the pandemic are likely to vary in their impact and are subject to rapid change. We believe any further changes will be manageable and reaffirmed our standing revenue guidance of $355 million to $375 million.

We are now testing our proprietary selective modulator relacorilant, our plan successor to Korlym for patients with Cushing’s syndrome in two Phase 3 trials. Like Korlym, relacorilant achieves its effect against Cushing syndrome by competing with cortisol to bind to the glucocorticoid receptor, GR for short. Unlike Korlym, relacorilant does not bind to the progesterone receptor, PR for short, which means it does not cause the off target effects, including termination of pregnancy, endometrial thickening and vaginal bleeding caused by Korlym’s affinity for PR. By different mechanism, relacorilant also does not appear to cause hypokalemia, low potassium, a serious side effect experienced by 44% of patients in Korlym pivotal trial. That is a leading cause of Korlym discontinuation today.

Relacorilant’s clinical data have been positive. Patients in its Phase 2 trial experienced meaningful improvements in hypertension and glucose control, as well as in a variety of secondary end points. There were no relacorilant instances of endometrial thickening, vaginal bleeding or hypokalemia. Our patient presentation – a poster presentation of relacorilant’s Phase 2 results can be found at the Investors, Post Events tab of our website. Relacorilant’s Phase 3, GRACE trial, GRACE trial, which we believe will serve as the basis for our NDA submission continues to enroll patients and open – continues to enroll patients and open additional clinical trial sites.

Recruitment is now underway at 60 sites in the United States, Canada, Europe and Israel. Planned enrollment is 130 patients. We expect to submit our NDA in the second quarter of 2022. We dosed the first patient in relacorilant other Phase 3 trial as a treatment for patients with Cushing’s syndrome GRADIENT last week. GRADIENT will study relacorilant effects in patients whose Cushing’s syndrome is caused by an adrenal adenoma or adrenal hyperplasia. Although, patients with this etiology of Cushing’s syndrome usually have a less rapid decline in their condition, they ultimately have poor health outcomes.

GRADIENT is the first controlled study in patients with this etiology of Cushing’s syndrome. Study participants will receive either relacorilant or placebo for 22 weeks. The trials primary endpoints will be statistically significant improvements in either hypertension or glucose metabolism. Planned enrollment is 130 patients at sites in the United States and Europe. Many of the investigators who are participating in GRACE will also participate in GRADIENT. You can find the poster presentation of GRADIENT’s design at the Research & Pipeline/Publications tab of our website.

I will now turn to our oncology program, which has its origin and theories postulated by our academic collaborators at the University of Chicago more than 12 years ago. Our program now consists of multiple clinical trials, one of which are controlled Phase 2 trial in patients with recurrent platinum-resistant ovarian cancer just completed enrollment. We are investigating three mechanisms by which cortisol modulation may be helpful in the treatment of cancer. Cortisol activity blunts the effects of chemotherapy by suppressing the genes that trigger apoptosis. The program cell death chemotherapy is meant to cause.

By reversing cortisol’s anti-apoptotic effect, cortisol modulation may also allow chemotherapy to achieve its full cancer killing potential. We have tested this hypothesis in an open label Phase 1/2 trial in which patients with advanced solid tumors received relacorilant combined with nab-paclitaxel at cell genes drug Abraxane. Our results were striking. Tumors in seven of 25 patients with metastatic pancreatic cancer, and in five of 11 patients with platinum-resistant ovarian cancer, either shrank or cease growing for 16 weeks or longer. Two patients with metastatic pancreatic cancer exhibited tumor shrinkage for more than 50 weeks. One patient with ovarian cancer exhibits shrinkage for 65 weeks. The tumors in all of these patients had progressed despite multiple lines of prior therapy, including therapy with taxanes. You can find our poster presentation of these results at the Investors/Past Events tab of our website.

We’re excited to report that in July, we closed enrollment in our 178 patient controlled Phase 2 study of relacorilant plus nab-paclitaxel in patients with recurrent platinum-resistant ovarian cancer, a disease with a very poor prognosis. All of the patients in the trial received nab-paclitaxel. One-third of them also received relacorilant every day. Another one-third of them received relacorilant the day before, the day of, and the day after each infusion with nab-paclitaxel. The trials primary endpoint is progression free survival with secondary end points, including objective response rate, duration of benefit and overall survival. We expect results in the first half of next year. We are equally excited to report that in June, we began dosing patients in a Phase 3 trial of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer, a disease for which there are no good treatment options.

The trial is called RELIANT. RELIANT is an open label trial in which 80 patients will receive relacorilant plus nab-paclitaxel with the primary endpoint being the objective response rate assessed by RECIST criteria, with secondary endpoints, including progression free survival and overall survival. RELIANT will be conducted at 30 sites in the United States. We will perform an interim analysis of data from the first 40 patients and expect to have results of that analysis in the first half of next year. It is important to note that the expected response rate of patients with such advance disease to nab-paclitaxel monotherapy is zero. For this reason, we believe sufficiently positive results in RELIANT would support accelerated approval.

Cortisol activity suppresses the immune system and effect that it’s often beneficial as it controls the inflammatory response and helps protect against autoimmune diseases. Unfortunately, cortisol-induced immune suppression limits the body’s ability to kill tumor cells and blunts the efficacy of medications such as checkpoint inhibitors, which enlist the immune system to fight cancer. Modulating cortisol activity bolsters the immune system and may help checkpoint inhibitors and other immunotherapies achieve their full potential. This quarter, we are starting an open label Phase 1b trial of relacorilant plus the PD-1 checkpoint inhibitor, pembrolizumab, Merck’s drug KEYTRUDA, in 20 patients with advanced adrenocortical cancer. Because adrenocortical tumors produce cortisol, these patients also separate from Cushing’s syndrome. Our trial will examine whether relacorilant can, by reducing the effects of excess cortisol activity, treat these patients Cushing’s syndrome and by reversing cortisol-induced immune suppression, help pembrolizumab achieve its maximum effect. We presented posters at this year’s virtual ASCO and AACR with preclinical and clinical biomarket data supporting this hypothesis. They are available at the Research & Pipeline/Publications tab of our website.

I will conclude with an update on our program in metabolic diseases. As many of you know, we are developing a proprietary cortisol modulator, miricorilant, as a treatment for antipsychotic-induced weight gain and nonalcoholic steatohepatitis, or NASH. Like relacorilant and exicorilant, miricorilant is a selective cortisol modulator binding potently to GR but not PR. miricorilant was safe and well-tolerated in its Phase 1 trial. Millions of patients rely on antipsychotic medications to treat schizophrenia, bipolar disorder, major depression, and other serious illnesses. Unfortunately, patients often pay a terrible price in the form of extreme weight gain, impaired glucose and lipid metabolism and other manifestations of metabolic syndrome. These adverse effects reduce patient adherence and pose major health risks of their own. For example, death by heart attack or stroke is common in patients taking antipsychotic medication. Cardiovascular disease is the leading cause of death in patients with schizophrenia. Cortisol modulators are potent in animal models of antipsychotic-induced weight gain.

More importantly, we have conducted three double-blind, placebo-controlled clinical trials in which cortisol modulator, meaningfully reduced weight gain and other metabolic adverse events caused by antipsychotic medications. In two of these trials, healthy subjects received daily doses of either olanzapine or risperidone along with either mifepristone, the active ingredient in Korlym or placebo, subject to receive Korlym experienced significantly less weight gain and other metabolic adverse events than those who receive placebo. These results were published in the journals, Advances In therapy and Obesity in 2009 and 2010. Unfortunately, we could not advance mifepristone, because its qualities as an abortive fashion, disqualify it as a treatment for common disorders.

Miricorilant can be advanced, however, 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. Last quarter, we completed a double-blind, placebo-controlled, Phase 1B trial in which healthy subject receive olanzapine and either 600 milligrams of miricorilant, 900 milligrams of Miricorilant or placebo for 14 days. Study participants who received miricorilant gained significantly less weight than those who received placebo.

In addition, they exhibited a significantly smaller increase in triglycerides and in the liver enzymes, AST and ALT markers of liver damage that rise at the onset of olanzapine therapy. The full results of this study will be published later this year. Our double-blind, placebo-controlled, Phase 2 trial of miricorilant to reverse recent antipsychotic-induced weight gain known as GRATITUDE is in progress. 100 patients with schizophrenia will receive in addition to their established dose of antipsychotic medication, either 600 milligrams of miricorilant or placebo for 12 weeks. GRATITUDE will be conducted at approximately 20 centers across the United States.

I’m pleased to announce that we have completed one quarter ahead of schedule development of a miricorilant formulation available for use in Phase 3 trials and beyond. As a result, we have moved up the start to additional miricorilant trials. This quarter, we plan to start a placebo-controlled, double-blind Phase 2 trial in patients with the longstanding antipsychotic-induced weight gain called GRATITUDE 2. By year end, we also plan to start a double-blind, placebo-controlled, Phase 2 trial of miricorilant in patients with NASH, serious liver disease that affects millions of patients. In animal models, miricorilant prevents and reverses both fatty liver and liver fibrosis, two precursors of NASH.

Corcept had a strong second quarter. We reaffirmed our revenue guidance. Our cash and investments grew by $60 million to $410 million. Our strong financial position allows us to advance our growing portfolio of drug candidates, even in times of great uncertainty. Recently, our development programs to achieve significant milestones more are on the horizon. Although the COVID-19 pandemic continues to slow enrollment and make site activation more difficult, recruitment continues at 60 sites in relacorilant pivotal GRACE trial with an expected NDA submission in the second quarter of 2022. In addition, enrollment is now underway in GRADIENT, a double-blind Phase 3 trial of relacorilant in patients with Cushing’s syndrome from an adrenal origin and understands the etiology of the disease.

Our clinical trials in oncology have been less affected by the pandemic, most likely because our study participants are so gravely ill. They must seek treatment. No matter the conditions. We have completed enrollment in our controlled, Phase 2 trial of relacorilant plus nab-paclitaxel in patients with recurrent platinum-resistant ovarian cancer. We will have results in the first half of next year. Our Phase 3 RELIANT trial of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer is underway. We expect to perform an interim analysis of data from RELIANT’s first 40 patients in the first half of next year. We believe sufficiently positive results from RELIANT will qualify relacorilant accelerated approval in this indication. This quarter, we plan to start an open the label Phase 1b trial of relacorilant combined with a PD-1 checkpoint inhibitor, pembrolizumab to treat patients with advanced adrenal cancer.

Finally, by the end of this year, we expect to select a dose suitable for advancement in controlled Phase 2 trial of exicorilant in combination with enzalutamide to treat patients with castration-resistant prostate cancer. Our program in metabolic diseases has also made significant gains. Enrollment and site activation have resumed in our double-blind, placebo-controlled, Phase 2 trial of miricorilant to reduce recent antipsychotic-induced weight gain, although, the COVID-19 pandemic continues to slow the pace of both activities. Completion of formulation work in miricorilant has allowed us to advance the start dates of our other planned trials. GRATITUDE 2 a double-blind, placebo-controlled, Phase 2 trial of miricorilant patients with longstanding antipsychotic-induced weight gain is planned to start in the third quarter. We plan to start a double-blind, placebo-controlled, Phase 2 trial of miricorilant in patients with NASH by year-end.

I’ll stop here for questions.

[Operator]

Thank you. [Operator Instructions] And we will take our first question. This will come from Chris Howerton with Jefferies.

[Chris Howerton, Jefferies]

Great. Good afternoon, and thanks for taking the questions. So I guess maybe the first question might be on the corilant numbers. I think maybe Charlie, just to confirm, I think that you were saying that most of the discrepancy was respect to the refill rate. Can you just confirm to us that you’re seeing the same patient numbers there between the first and second quarter, or some way for us to calibrate that in another way?

[Charlie Robb, Chief Financial Officer]

Yes, sure. Yes, we are – it’s a phenomenon that occurred in the first quarter. We didn’t see it in the second quarter or in July, although our analysis of July isn’t complete yet. And so it doesn’t – it didn’t reflect a drop-off of patients or anything else. It is really patients worried about, FedEx delays taking their refills a couple of days early. So they’d have a little bit of extra medicine on hand and by shifting things up a few days, what that ended up doing was shifting some stuff into Q1 and then other stuff that would have been in Q2. And that’s all that was going on. So just giving our sort of average dose and price per tablet and so forth, you can think of it as about 80 to 100 patients, something like that. And those patients remain on medicine. There is nothing, no interruption their care at all.

[Chris Howerton, Jefferies]

Excellent. Okay. And then with respect to the pancreatic cancer trial, just curious, if duration of response would be part of the analysis. And if so, what in your view Joe or Andreas would you see as clinically meaningful in this patient population?

[Joseph Belanoff, Chief Executive Officer]

Yes, Chris. And thanks for the question. Good to talk to you. Yes, certainly duration of response is important. I mean, we’re looking at all of those variables. Now the second question you’ve asked is a harder one, because in some sense, these are about the sickest patients you get in oncology. I think, as I said before, sadly, we had patients who passed away in the earlier study between the time they consented in their first dose. So how long their responses’ lasts is difficult to assess, the expectations for longevity are quite low. And I think actually one of the things that was impressive in the study that has already been completed, is that there were several patients whose duration of response and disease control went out far longer than what’s an expected. A couple of them went out to duration of a year. So I don’t have it for a number for you, but that is a variable, that is consequential and I’m certain in the same way we will look at it, the FDA will look at it as well.

[Chris Howerton, Jefferies]

Got it. Okay. And then, perhaps, this is a naive question and I apologize. But just curious how we should think about the safety databases for relacorilant, utilization within an oncology setting relative to Cushing’s syndrome and how that may or may not impact any kind of view from a regulatory perspective?

[Joseph Belanoff, Chief Executive Officer]

Well, I know that you noticed, Chris. But all of the data for relacorilant becomes part of the safety package for everything that you do. And so it gets counted together in that way. I think the difference with some disease is that you had two diseases where for instance, the risk profile of the disease was very different. You can understand that there would be certain you probably would need a smaller safety database and you probably would be able to tolerate a worst adverse event profile, if the disease was more severe. Now really from our perspective Cushing’s syndrome and the oncology diseases that we’re talking about are really all severe diseases. And we actually think that the safety profile would be looked at roughly in the same way.

[Chris Howerton, Jefferies]

Okay. Okay, very good. And maybe one more question, if I may. Just curious, what has been your experience with respect to medication compliance in the antipsychotic-induced weight gain and kind of how you view that in terms of combination strategies with multiple oral therapies for patients that might be taking psychotics and just kind of switching?

[Joseph Belanoff, Chief Executive Officer]

Yes. That’s actually oppression question. Because as a psychiatrist myself, I can tell you that patients’ adherence to regiment is not 100%. And so I can’t give you actually any data that study that we’re actually running is still in progress right now. But we’ll – I think have a better sense of that as we go along, because we look at PK measures, we know where people stand and so forth. But it gives me an opportunity, Chris, I want to just be a little bit tangential, just so people understand it. I know you do because you’re much more steeped in the story, but what we’ve been able to show so far is that first corilant, but now especially miricorilant is clearly active in an antipsychotic-induced weight gain model.

We’ve given healthy people antipsychotic medication and really pretty potent ways in a short period of time, we can see that we reduce the effects, adverse metabolic effects of antipsychotic medication. The studies that we’re now conducting are really our first studies in patients. And so you’ve asked one of the questions which is important, but there are other questions that relate to the efficacy of the medication that we’ll get our first pieces of information on next year. Obviously, we’re excited and optimistic about it. But I just want to draw a difference between what we’ve seen so far, which is good medicine activity in animals and healthy people and how excited we are to actually see what happens in patients. And to return to your question, ability to adhere the regimen is also a meaningful thing that we will observe.

[Chris Howerton, Jefferies]

Sure. Okay. Well, thank you so much and I’ll hop back in the queue in the case that maybe follow-up questions are available. Thanks again for taking the question.

[Joseph Belanoff, Chief Executive Officer]

Nice to talk to you, Chris. Thank you.

[Operator]

And we will take our next question. This will come from Matt Kaplan with Ladenburg Thalmann.

[Matt Kaplan, Ladenburg Thalmann]

Hi guys. Thanks for taking my questions. Just wanted to follow-up on Chris’s question with respect to the RELIANT study, on the internal analysis of 40 patients, what are you looking to see there and what would kind of represent go, no-go decision on that interim of about half the patients you plan?

[Joseph Belanoff, Chief Executive Officer]

Yes. We don’t have the firm no-go, go level there. Again, as I started out by saying the response rate was really presumed to be zero or very close to it for patients with pancreatic cancer. I could tell you, stream numbers, obviously, almost all of the people had a tumor shrinkage that would be a fantastic result. And if none of them do, well that gives us something as well. I think that this is one disease where even a modest response rate I think would be viewed positively by practitioners. But beyond that I don’t really have any more information than that for you.

[Matt Kaplan, Ladenburg Thalmann]

Okay. Okay, very good. And then similar in terms of the Phase 2 study in platinum-resistant ovarian cancer, now you complete enrollment data coming in the first half as well. What are some of the benchmarks there that we should be looking for?

[Joseph Belanoff, Chief Executive Officer]

Yes. Again, this is a dire illness, not probably to the degree that pancreatic cancer is. But I’ll give you sort of rough numbers for sort of how the study is powered. We expect that there’s about for nab-paclitaxel alone, about 3.5 month average period for progression free survival. And we’re powering our study to add about another three months to that.

[Matt Kaplan, Ladenburg Thalmann]

Okay, great. That’s very helpful. Great, thank you. And then just shifting to the GRACE study, what’s really now the rate limiting step for filing the NDA in the second quarter of 2022. Is it the completion of the GRACE study? Are there – is there another moving part that you need to…

[Joseph Belanoff, Chief Executive Officer]

Yes. That’s it, Matt. That – everything else should be ready to go before then.

[Matt Kaplan, Ladenburg Thalmann]

Okay. Fair enough. And then last question, I guess, maybe more for Charlie on the litigation. Just to be clear in terms of the next kind of announcements we’re expecting on the Teva lawsuit will be a decision in November of this year from the oral arguments on the PTAB. Is that correct?

[Charlie Robb, Chief Financial Officer]

As far as the litigation’s concerned, yes. I mean, there’s – it’s the – November 19 is a scheduled date and I would expect it to be plus, or minus a day or two from there, trials in February. And the one other date that’s significant has already passed, which just to remind folks, when we sued Teva back in March of 2018. Our lawsuit instituted a 30-month stay of FDA approval of Teva’s product or final approval. And that stay expired midnight August 1, this weekend. So as far as the FDA is concerned, Teva is free to launch its product at risk. I have no evidence they’ve done, so I have not seen it. And I – from a business perspective, I think it makes – it doesn’t make sense for Teva to do that. They’d be at risk of treble damages and imminent they were going to – go on to lose their case with us. So it’s not an eventuality I expect, although, of course, I’m not the Teva manager and I don’t get to decide so. And we are ready to respond to them no matter what they do. But in terms of getting a full counter in front of people, there’s a date in the past that they should also just be aware of.

[Matt Kaplan, Ladenburg Thalmann]

Fair enough. And then similarly with the Sun litigation, you mentioned the end of December 2021. And then I guess early, before that, this year, the Markman hearing as times that we should expect. And in terms of other things that we should hear out of this litigation, those are the two kind of dates that we should expect?

[Charlie Robb, Chief Financial Officer]

Yes.

[Matt Kaplan, Ladenburg Thalmann]

Very good. Well, thanks for taking my questions, guys.

[Joseph Belanoff, Chief Executive Officer]

Yes, Matt, good to hear from you.

[Charlie Robb, Chief Financial Officer]

And if I could just add – revise and extend my response to Chris briefly about the revenue blip. Because I know it’s a little bit of an abstract concept. And I really was at pains to make sure people could follow what happened. I just wanted another way to look at it and one everyone understands. We are right, with six months of the year down, halfway through, we are right where we expected to be, which is why we could reiterate our guidance. So as explained kind of the movement of a refill from one quarter to the other by a few days, and the impact of that understand that at the halfway mark of the year, the net result of his all is that we are where we expect it to be. Just want to make that clear with folks.

[Operator]

And we can take our next question. This will come from Swayampakula Ramakanth with H.C. Wainwright.

[Swayampakula Ramakanth, H.C. Wainwright]

Thank you. Let’s start with Korlym one question and then I have a couple of pipeline ones. On the Korlym itself regarding the uptick, thanks Charlie for explaining what has been going on during the second quarter. But my question is on the third quarter. How do you see things moving along in this current quarter and Q3 for the last month or so?

[Charlie Robb, Chief Financial Officer]

Well, so just as background for folks. We provide annual revenue guidance, not quarterly revenue guidance. And at the start of the year, we – our guidance range was $355 million to $375 million and that’s still the case. And so I can’t really give you any particulars beyond saying that we’re still comfortably within that case in that range. And that’s what we’re seeing now.

[Swayampakula Ramakanth, H.C. Wainwright]

Okay. Thank you. And then on the pipeline, so for GRADIENT which is for – just for a genital hypoplasia. Is there any of an interim analysis? And also could you give us a little bit of an idea of data expectations from this study?

[Joseph Belanoff, Chief Executive Officer]

Yes. I can – I think, I can answer your questions, RK. The answer is no, we’re not expecting to do an interim analysis, but just for the whole group. Let me explain a little bit more about the study. I think as probably at this point anyone, as far the company knows, Cushing’s syndrome is a very severe illness and it’s difficult to do a standard double-blind placebo-controlled study, because placebo is really not perceived. And I would certainly share this point of view to really work at all. And very difficult for investigators to accept a study like that, it’s difficult for their higher B’s to accept a study like that. And so, that’s background.

Now, it’s been increasingly discovered in the last 10 years that once thought to be perhaps, sort of derisively called incidentalomas or officially adrenal adenomas really are a serious medical problem over time. But many of these patients at this point are treated for their symptoms. They’re treated for their blood glucose abnormalities, for their hypertension, for infections that they get. But they’re not necessarily treated for hypercortisolism. But as the field has really gotten more and more of that and so these patients are really patients who are deserving of hypercortisolism treatment.

We really came up with the idea since none had ever been done that it was possible to do the first and I think really definitive study on treating patients for hypercortisolism with a cortisol modulating agent in this case with relacorilant. And that investigator, since they weren’t already treating these patients in many cases for hypercortisolism, but were just treating symptoms around this would accept the idea that we could do a double-blind study. And that’s exactly what we’re doing. We’re doing sort of the gold standard double-blind placebo-controlled study for 22 weeks. At that point, we’ll break the blind and we’ll see how we did in this disorder. We think that obviously that we have a lot of confidence that it will work well. The main reason really we embarked on this is because so many people in the field said, now that we know this is a problem, really see if you can create a study that will give us competence to treat it. And the second question, please repeat RK. I think I lost it there.

[Swayampakula Ramakanth, H.C. Wainwright]

I was just wondering if there is any interim analysis or any updates?

[Joseph Belanoff, Chief Executive Officer]

No interim analysis.

[Swayampakula Ramakanth, H.C. Wainwright]

Perfect. Yes. Okay. So my next question is on – what’s the patient population for metastatic unresectable adrenal cancer that is caused due to excess cortisol production?

[Joseph Belanoff, Chief Executive Officer]

What is the population? So these are patients with adrenal cancer. And adrenal cancer is itself a rare disease, but a fair percentage of the people with adrenal cancer also have Cushing syndrome because their tumors produce cortisol. And again, this is for those of us who have followed us for a very long time. And the study that we use to get Korlym approved, we call the seismic study. We had patients with amongst other etiologies of Cushing syndrome, patients with adrenal cancer. And was Korlym equally effective in reducing the symptoms of Cushing syndrome in those patients which was very meaningful to them, although it did not treat their cancer.

Now, one of the things which happened after that study was the advent of immunotherapy, but unfortunately immunotherapy has had very poor responses in adrenal cancer where cortisol production is part of the picture. And so again, because we have quite a few academic connections with people who treat adrenal cancer, the idea came, could you improve the response to immunotherapy and treat these people’s Cushing syndrome? The effects of hypercortisolism by adding the cortisol modulating agent, like relacorilant to a drug like KEYTRUDA. And that’s the study that we’re doing.

So we’re very excited to give that a try. But if I was to order it, what I would say, and I think what really made it past our bar is we have a great deal of confidence that we will treat these patients Cushing syndrome, and that has great benefit to them. We also now hope and are certainly are testing to see if we can actually improve their cancer by improving the efficacy of the – at this point, not very well working immunotherapy.

[Swayampakula Ramakanth, H.C. Wainwright]

Okay. Thank you. Thank you both for taking my questions.

[Joseph Belanoff, Chief Executive Officer]

Yes. It’s good to talk to you, RK.

[Operator]

And we will take our final question in queue. This will come from Alan Leong with BioWatch News.

[Alan Leong, BioWatch News]

Hey, Joe and Charlie. Good to hear the progress on all fronts. The first question, can you provide some color on the competitive profile for adrenal adenoma. I can’t imagine it’s the same as traditional Cushing. Some of those common competitors sort of aren’t even in the ballpark considering adrenal with base disease. I maybe wrong on that, but if you could provide some color.

[Joseph Belanoff, Chief Executive Officer]

Yes. I think that that’s very important and you’re making an important distinction. I think that sometimes it’s overlooked. So just to back up a little bit, Cushing syndrome comes from the activity of cortisol. So higher cortisol activity causes hypercortisolism and Cushing syndrome really comes from two different sources, one adrenal tumors that produce cortisol or two, ACTH tumors, which stimulate the body to produce excess cortisol. ACTH tumors, which are found in the pituitary gland are called Cushing’s disease. And that is a subset of patients with Cushing syndrome.

Now the interesting thing, as I said before, about Cushing syndrome caused by adrenal tumors, is that, although it was always recognized a part of Cushing syndrome. The amount of people with Cushing syndrome caused by adrenal tumors and the pathology and morbidity of adrenal tumors has really only recently come forward in the last decade. Prior to that, these were tumors that were sometimes picked up on scans for other things, and doctors didn’t know what to do with them and so forth.

The interesting thing about that is that while measures like urinary free cortisol can pick up cases of very severe Cushing syndrome from a topic ACTH tumors or Cushing’s the disease, they often do not pick up Cushing syndrome that are caused by adrenal adenomas. Adrenal adenomas are more commonly picked up and it’s recommended by the book of European-American guidelines to use a different test dexamethasone suppression test, to begin your analysis of whether somebody has Cushing syndrome caused by adrenal adenomas. And of course you have to image an adrenal adenoma.

But the bottom line is that Korlym for instance, it’s approved for the treatment of all etiologies of Cushing syndrome. Other drugs, for instance, drug – I know you’re familiar with [indiscernible] it’s approved only for Cushing’s disease, the subset of patients that have pituitary tumors that produce ACTH that in the end cause Cushing syndrome. So adrenal adenomas really are sort of the newest frontier, not that they’re a new disease, but I think that their morbidity and the seriousness of the morbidity is really a last decade event. And as a consequence, it’s really the leaders in cortisol treating diseases. We’ve had a lot of interest in this and this was really the first opportunity to – again, combine kind of the gold standard study design with a disease that really was badly in need of further study.

[Alan Leong, BioWatch News]

I want to switch gears and get into the pancreatic RELIANT trial and congratulations with launching that. There’s lots of clinical trials out there for pancreatic cancer. Are you getting any feel about the reception for the RELIANT trial, the clinical sites? And are many of the RELIANT sites, where they also used for the ovarian cancer trial?

[Joseph Belanoff, Chief Executive Officer]

Again, let me just answer that question more broadly. In this pandemic, clinical trial enrollment has really been broiled. Not just for Corcept, but for every company that does clinical trials. It was really very interesting to see how it divided up, because at this time our portfolio really covers many different diseases. And the interesting thing was most severe diseases like as an example, metastatic platinum resistant, ovarian cancer continue to enroll briskly right through all of this. These patients really need care. Their life expectancy is short. They’re coming to the hospital anyway, they’re getting enrolled in clinical trials. The other end of the spectrum, something like anti-psychotic induced weight gain, which is often a chronic illness, it doesn’t kill people tomorrow. Less priority was put on enrolling in that sort of study.

And of course, all the companies you follow, you can figure out those things as you go through them. Pancreatic cancer and I think everyone’s estimation is really in the severe end of the spectrum. And we think that these patients will enter clinical trials. There’s at the stage of disease we’re talking about. There aren’t a whole lot of other proven drugs with efficacy. And we think that study will enroll relative to others, quite a brisk pace. And we are confident that we will enroll the first half of the trial in a quick enough period of time to be able to give out results in the first half of next year.

[Alan Leong, BioWatch News]

No, that’s great. Thank you.

[Joseph Belanoff, Chief Executive Officer]

All right. Well, thank you very much. Thanks for everybody. And hoping that by the time we see you again in November, things will be a little bit more open. We’ll be a little bit more back to normal. But in the meantime really everybody stay healthy and we’ll report progress as we make it. Thank you very much.

[Operator]

This concludes today’s call. Thank you for your participation. You may now disconnect.