Corcept Therapeutics Incorporated (CORT) Q4 2022 Earnings Call Transcript

Corcept Therapeutics Incorporated (NASDAQ:CORT) Q4 2022 Earnings Call dated Feb. 28, 2023.

Corporate Participants:

Atabak Mokari — Chief Financial Officer

Charles Robb — Chief Business Officer

Joseph Belanoff, MD — Chief Executive Officer, President and Director

William Guyer — Chief Development Officer

Sean Maduck — President, Corcept Endocrinology

Analysts:

Raymond — Ladenburg Thalmann — Analyst

Dennis Ding — Jefferies — Analyst

Gregory Fraser — Truist — Analyst

Arthur He — H.C. Wainwright — Analyst

Presentation:

Operator

[Operator Instructions] As a reminder, this conference is being recorded.

I would now like to turn the conference over to your host, Atabak Mokari, CFO. Thank you. You may now begin.

Atabak Mokari — Chief Financial Officer

Good afternoon and thank you for joining us. I’m Atabak Mokari, Corcept’s Chief Financial Officer. Today, we issued a press release announcing our financial results for the fourth quarter and providing a corporate update. A copy is available at corcept.com. Our complete financial results will be available when we file our Form 10-K with the SEC. Today’s call is being recorded. A replay will be available at the Investors Past Events tab of our website.

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 may cause actual results to differ materially from those such statements expressed or implied. These forward-looking statements are described in today’s press release and the risks and uncertainties that may affect them are described in the press release and in our Annual Report on Form 10-K and our quarterly reports on Form 10-Q. Please refer to those documents for additional information. We disclaim any intention or duty to update forward-looking statements.

Our revenue in the fourth quarter of 2022 was $103.1 million compared to $98.8 million in the fourth quarter of 2021. We expect our revenue growth to continue and have provided 2023 revenue guidance of $430 million to $450 million compared to 2022 revenue of $401.9 million. Net income was $60.6 million in the fourth quarter and $101.4 million for the full year of 2022. Our cash and investments at December 31st was $436.6 million compared to $335.8 million at the end of the prior year.

I will now turn the call over to Charlie Robb, our Chief Business Officer to provide a legal update. Charlie?

Charles Robb — Chief Business Officer

Thanks, Atabak. Since we last spoke, we have successfully terminated two lawsuits. On February 13th, we announced that we had reached an agreement in principle selling all claims and have reported securities class action known as Melucci versus Corcept Therapeutics Incorporated. This lawsuit was brought by the plaintiff’s attorneys in March 2019, since then our position has not wavered. We said in March 2019 that we were confident in the strength of our legal position. Having spent four years litigating we are even more confident.

I and I know, I speak for my colleagues as well, am proud of Corcept and the way we do business. Allegations such as those asserted in the Melucci lawsuit are repugnant. We look forward to our main court where we can explain publicly the reasons for our pride in what we do and when we do it. That being said, litigation is a distraction from more important matters. Simply put, time spent preparing for trial is time not spent developing medications or helping patients. We were presented with the chance to put the Melucci distraction behind us for an amount covered by our insurance, we felt compelled to accept.

The second terminated case concerns Hikma Pharmaceuticals. In March 2021, we sued Hikma to prevent it from marketing generic Korlym in violation of our patents. As we announced in December, we have settled this case. Hikma may begin selling a generic version of Korlym in the United States, beginning October 1, 2034, more than 11 years from now or earlier under circumstances customer for settlement agreements of this type. This is the same entry date as our previous settlement with Sun Pharmaceuticals.

Finally, there was a development yesterday in our lawsuit against Teva. In March 2018, we sued Teva to prevent it from marketing a generic version of Korlym in violation of our patents. In April 2021, we filed for summary judgment based on Teva’s infringement of our 214 patent. Teva’s expected responded by filing its own motion for summary judgment.

A summary judgment is procedure whereby courts decide a case without holding a trial. Yesterday the court denied both our motion and Teva’s motion without prejudice in order for the parties to begin negotiating schedules for free trial activities. No trial date has been set. It is important to note that this change in the procedural posture of our action against Teva has not changed our point of view, we remain confident in the strength of our legal position and are very comfortable proceeding with the trial if necessary.

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

Joseph Belanoff, MD — Chief Executive Officer, President and Director

Thank you, Charlie. Our Cushing’s Syndrome business is built on a solid foundation. A lifesaving medication promoted by the commercial team that puts the interest of patients first. Leading endocrinologists increasingly believe there are considerably more patients with Cushing’s Syndrome than was once assumed. Korlym is an excellent treatment for patients with Cushing’s Syndrome and there are many eligible patients who have yet to receive it. We are extremely optimistic about the growth potential of our Cushing’s Syndrome business and are making substantial investments to improve the screening and treatment of these distributions. We are providing 2023 revenue guidance of $430 million to $450 million.

In addition to generating substantial cash in 2022, we significantly advanced the clinical development programs for proprietary selective cortisol modulators, relacorilant, dazucorilant, and miricorilant. We expect to make further progress in the next 12 months with the submission of relacorilant’s NDA in Cushing’s Syndrome and enrollment of our confirmatory Phase 3 trial of relacorilant in platinum-resistant ovarian cancer, Phase 2 trial of dazucorilant in ALS, and Phase 2 trial of miricorilant in NASH.

Since inception, our research and development efforts have built upon the hypothesis that cortisol modulation can be a powerful therapeutic mechanism in many serious disorders. Our proprietary compounds modulate cortisol’s effects by binding to the glucocorticoid receptor or GR. They do not bind to the progesterone receptor. So don’t cause some of Korlym’s are approved products with serious off-target effects.

Interestingly, while our compounds modulate cortisols activity without modulating progesterone activity, they’re not identical. Some cross the blood-brain barrier others do not. Some perform best in models of solid tumors, others are more potent in models of metabolic disease. Some appear to be tissue-specific, others have more global effects. These diverse qualities allow us to study a wide variety of disorders. Currently, we are conducting programs in ovarian, adrenal, and prostate cancer, ALS, NASH, and of course, Cushing syndrome. We are investigating cortisol modulation’s role in other diseases and have additional compounds in clinical and preclinical development.

Our Cushing Syndrome business has funded all of these activities and will continue to do so. As most of you know, we are evaluating relacorilant for the treatment of hypercortisolism in two Phase 3 trials, GRACE and GRADIENT. Relacorilant is a selective cortisol modulator, like Korlym it achieves its effect by competing with cortisol at the glucocorticoid receptor. Unlike Korlym it does not bind to the progesterone receptor, PR for short and so it does not cause PR related side effects, including termination of pregnancy, endometrial thickening, and vaginal bleeding.

By a different mechanism, relacorilant also does not appear to cause hypokalemia, low potassium, serious side effects experienced by 44% of patients in Korlym’s pivotal trial. Korlym induced hypokalemia is leading cause formal discontinuation. Relacorilant’s Phase 2 efficacy and safety data were compelling. Patients experienced meaningful improvements in hypertension and glucose control, as well as in a variety of other signs and symptoms of Cushing syndrome. There were no relacorilant induced in system endometrial thickening or vaginal bleeding and no drug-induced hypokalemia. The trial results were published in Frontiers in Endocrinology in July 2021.

We are pleased to announce that we believe that we have enough patients in screening in our GRACE trial to complete enrollment in the coming weeks. We expect GRACE to serve as the basis for our NDA submission in Cushing’s Syndrome, which we plan to submit in the first quarter of 2024. Our second Phase 3 trial in hypercortisolism GRADIENT is studying relacorilant’s effects in patients whose Cushing’s Syndrome is caused by an adrenal adenomas or adrenal hyperplasia. Patients with this etiology of Cushing’s Syndrome often experience less rapid decline, but their health outcomes are poor. While we do not expect our NDA in Cushing’s Syndrome to depend on data from GRADIENT, but we do expect that its findings will improve the care of these patients.

Finally, we plan to initiate a randomized double-blind placebo-controlled Phase 4 study for Korlym’s this quarter. We have named the study CATALYST. CATALYST will examine the prevalence of hypercortisolism in patients with difficult to control type 2 diabetes and treat the patients determined to have hypercortisolism with Korlym. Planned enrollment is 1,000 patients, which we expect to complete by the end of this year. Most prominent diabetologists in the country help design and are participating in the study.

Our oncology program is testing three anti-cancer mechanisms first postulated by investigators at the University of Chicago and later confirmed by other prominent researchers. One mechanism is increasing apoptosis. The programmed cell death to chemotherapy is meant to induce in solid tumors. Cortisol works against the beneficial effect of chemotherapy by suppressing apoptosis.

In our successful controlled Phase 2 trial in women with platinum-resistant ovarian cancer, the addition of our selective cortisol modulator relacorilant enhanced the effect of chemotherapy likely by blunting cortisol’s anti-apoptotic effect. Relacorilant provided a meaningful benefit to many of the women in our study. While these women’s diseases had progressed on two or more previous lines of treatment including previous taxanes, relacorilant appears to re-sensitize to disease to chemotherapy’s beneficial effects in some women.

Those who received relacorilant intermittently the day before, the day off, and the day after they receive nab-paclitaxel, it is statistically significant improvement in progression-free survival and duration of response compared to the group who received nab-paclitaxel monotherapy. Women in the intermittent relacorilant group also live longer than those comparator arm with a p-value that approached statistical significance.

Our analysis to date indicates that 29% of the patients who took intermittent relacorilant were alive two years after study start, versus only 14% who took nab-paclitaxel alone. 13% of patients who took intermittent relacorilant are alive three years after the study start compared to none who took nab-paclitaxel alone. Perhaps even more important, the women who received relacorilant plus nab-paclitaxel experienced no additional side effect burden compared to those who received nab-paclitaxel alone.

The results from this study were featured in podium presentations at the 2021 and 2022 European Society for Medical Oncology, ESMO meetings, and the 2022 American Society of Clinical Oncology, ASCO Annual Meeting.

ROSELLA, our pivotal Phase 3 trial in platinum-resistant ovarian cancer is active and enrolling patients. ROSELLA’s design closely tracks our Phase 2 study with a planned enrollment of 360 women randomized one-to-one to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone. The primary endpoint will be progression-free survival with overall survival of key secondary endpoints. We are conducting this study in collaboration with leading clinicians in the gynecological oncology group in the United States and the European network of gynecological and oncology trials group in Europe.

Our goal in Phase 3 is simply to replicate our positive Phase 2 results. Leading gynecological oncologists have told us that in their view, relacorilant’s potential benefit improved survival without increased side-effect burden, would constitute an important medical advance. Relacorilant plus nab-paclitaxel has the potential to become a new standard of care in women with platinum-resistant ovarian cancer.

The second mechanism by which cortisol modulation may prove useful is by blocking an important tumor growth pathway. Cortisol stimulation is a major reason why patients with prostate cancer treated with the widely prescribed androgen receptor antagonist enzalutamide eventually experience resurgent disease. Deprived of androgen stimulation their tumors switch to cortisol activity to stimulate growth.

Our hypothesis is that adding a cortisol modulator to androgen deprivation therapy will close this tumor escape route. By midyear, our collaboration with the University of Chicago plans to begin a randomized, placebo-controlled Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer. Before these patients have had an initial prostatectomy.

A third therapeutic mechanism seeks to treat tumors by enhancing the body’s immune response. Cortisol suppresses the immune system which may blunt the effectiveness of cortisol — cancer therapies intended to stimulate the immune system. Our hypothesis is that adding a cortisol modulator to immunotherapy such as checkpoint inhibitors may enhance the effectiveness of these therapies.

We are conducting a Phase 1b trial of relacorilant plus the PD-1 checkpoint inhibitor pembrolizumab Merck’s drug Keytruda in patients with advanced adrenal cancer, whose tumors produce excess cortisol. These patients suffer the effects of adrenal cancer and Cushing’s Syndrome, a usually quickly lethal combination. Pembrolizumab is rarely effective in treating this form of adrenal cancer.

Our trial is evaluating whether relacorilant can treat these patients Cushing’s Syndrome by reducing excess cortisol and by reversing cortisol-induced immune suppression, allow pembrolizumab to achieve its full cancer-killing effect. The primary endpoint of this study is objective response rate with secondary endpoints including progression-free survival, duration of response, and overall survival.

ALS, commonly known as Lou Gehrig’s disease is a devastating illness with an urgent need for better treatment. DAZALS, our 198 patients randomized double-blind, placebo-controlled Phase 2 trial dazucorilant in patients with ALS has begun enrolling patients. Dazucorilant is selective cortisol modulator, it has shown great promise in animal models of ALS improving motor performance in reducing neuroinflammation and muscular atrophy. We are conducting this important study in collaboration with TRICALS, a leading ALS academic consortium in Europe.

Finally, I’ll turn to our program in NASH. A serious liver disorder that afflicts millions of patients in the United States. Miricorilant an oral medication continues to demonstrate great promise as a treatment for NASH. In our prior NASH study, patients who received miricorilant exhibited large rapid reductions in liver fat but also substantial albeit transient elevations and liver enzymes ALT and AST. The improvement in liver fat in these patients was greater and it cut much more rapidly than we’d expected and is rarely seen over any period of treatment.

Our Phase 1b dose-finding study has identified a range of doses all substantially lower than our originally tested doses that appear to cause substantial reductions in liver fat without causing excessive liver irritation. We expect to share results from this study by mid-year and plan to start a Phase 2 trial later this year.

In conclusion, we are extremely optimistic about the growth potential of our Cushing’s Syndrome business and are making significant investments to improve the screening and treatment of these patients. In the meantime, the business continues to generate substantial profits even after funding all of our development programs. Our development programs continue to generate evidence validating our long-held belief that cortisol modulation has the potential to treat a wide range of diseases.

Reducing cortisol activity is a straightforward and effective way to treat Cushing’s Syndrome. It is also clear that cortisol modulation can offer substantial benefits for many other serious disorders ovarian cancer, ALS, and NASH are prime examples, but there will be others. And in addition to relacorilant, dazucorilant, and miricorilant, we have many other cortisol modulators in our portfolio with potential — potentially different and valuable clinical attributes. Corcept continues to advance across multiple fronts. I thank our dedicated creative employees and loyal investors for making this possible.

I’ll stop here for questions.

Questions and Answers:

Operator

Thank you. At this time, we’ll now be conducting a question-and-answer session. [Operator Instructions]. Thank you. And our first question is from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.

Raymond — Ladenburg Thalmann — Analyst

Hi guys, this is Raymond in for Matt. Thanks for taking my questions and congrats on all the progress. I just wanted to ask, perhaps on the ALS program, specifically sort of what endpoints are you kind of looking for in this study is it ALS, FRS? And do you have any specific guidance from the FDA if the study to serve as the basis for the NDA filing? Thanks. And I have one more question. Thank you.

Joseph Belanoff, MD — Chief Executive Officer, President and Director

Yes, yes, Matt. I want to just reintroduce you to Bill Guyer who is our Chief Development Officer. Bill will address that question.

William Guyer — Chief Development Officer

Great, thank you. I appreciate the question. So again, DAZALS is Iike Phase 2 multi-center randomized double placebo-controlled trial evaluating the safety and efficacy of dazucorilant in patients with ALS. In this Phase 2 trial, we’re going to look at 198 patients. So, the primary endpoint is a 24-week endpoint where we’re going to be evaluating those patients related to placebo and we’re going to look at the efficacy and change from baseline for the ALS functional rating scale and that is a validated FDA endpoint, as well as other primary endpoints of safety to assess the safety and efficacy for the safety of dazucorilant in patients with ALS. And these are all valid at endpoints with the FDA. And if we complete this trial and we see positive results this could end up with an NDA.

Raymond — Ladenburg Thalmann — Analyst

So, I appreciate the color. I guess maybe just for the NASH program, what would you like to see from the Phase 1b data to increase your confidence that you enter the Phase 2 study and is it possible you would try multiple dosing regimens? Thanks.

William Guyer — Chief Development Officer

Yeah, that is the goal. That’s a great question. Since this is an open-label trial, we are evaluating all the various different doses and our goal has been to find the right dose or dosing regimen, where we get a progressive fat loss over time with then no ALT rises and hopefully, we see ALT improvements. We believe we’ve identified multiple doses or dosing regimens to move into Phase 2, or we’ve seen that progressive fat loss over time and no ALT rises. And so, yes, our plan is to move to Phase 2 in the fourth quarter of this year.

Raymond — Ladenburg Thalmann — Analyst

Okay. I appreciate that. Thanks. I’ll hop back in the queue.

Operator

Our next question is from the line of Dennis Ding, Jefferies. Please proceed with your question.

Dennis Ding — Jefferies — Analyst

Hi guys, thanks for taking my question.

Joseph Belanoff, MD — Chief Executive Officer, President and Director

Sure.

Dennis Ding — Jefferies — Analyst

I just had one around the base business. Maybe talk about the pushes and pulls on 2023 revenue in terms of what can get you towards the high end versus the low end of your guidance and perhaps what are some of the different assumptions for you to get there? And as a follow-up maybe remind us of the seasonality issue for Q1 and when might we get better visibility towards growth acceleration in 2023? Thank you.

Joseph Belanoff, MD — Chief Executive Officer, President and Director

Hi, Dennis. Thank you. Thank you for those questions. I want to again re-introduce you to Sean Maduck who is the President of Endocrinology division and Sean is responsible for all of our business in Cushing’s Syndrome will be glad to answer that question.

Sean Maduck — President, Corcept Endocrinology

Hey, Dennis. Thank you for the question. I think your question was directly in regards to sort of the range. Our range is driven by the number of patients that we add to our artificial base. Our pricing is known and our average dose and patient retention rates have been stable for many years. So, where we fall within the range is really driven by the number of patients that we add to our base and that’s the — to put the pushes and the pulls are constant, it’s really about patient pulls.

Dennis Ding — Jefferies — Analyst

Right, but as a follow-up, maybe talk about what can you do or what are you guys doing in terms of initiatives that are ongoing, that could drive more patient adds versus trying to be less patient adds, appreciating that there is competition out there?

Sean Maduck — President, Corcept Endocrinology

Yeah. No. Great question. So, look, I’ll start by just saying the evidence is clear that there are more hypercortisolism patients out there than we once thought. Physicians as they become more educated about screening and of our treatment options that are available to them more patients are going to be diagnosed and treated. And our job as an organization is to maximize our position touchpoints, continue to raise disease awareness, educate on screening and then educate on the benefits of Korlym and the evolving market and our execution will really drive that growth in 2023 and beyond.

In terms of initiatives, obviously that we have many going on. Just a couple I want to touch on that I think are very important for the organization. The first is the growth of our sales force. Last year we had 45 specialists. We currently have 55 going to 60 in the next couple of months. Physician awareness of the potential for Cushing’s Syndrome in patient population is increased substantially and we think that, that disease awareness and our streamlined training efforts will make our clinical specialists more productive and for our newest clinical specialists more productive more rapidly.

In terms of the second initiative, which is more long-term is what was just discussed and that’s the CATALYST study. A Phase 4 Korlym study that we announced on the call today. It’s not going to have an impact in 2023, but it’s the largest prospective study that’s ever been done in this patient population. As Joe stated the investigators are a very prominent group of diabetologists and they are representative of a group of physicians that we have not historically called on. So, we believe that patients with difficult to control diabetes, is a very rich patient population for hypercortisolism and I believe that this study will provide the definitive prevalence and treatment data needed to encourage increased screening and ultimately trigger patient adds.

Dennis Ding — Jefferies — Analyst

Got it, thanks. And then on seasonality. The question for Q1 and re-acceleration towards the back half of the year?

Sean Maduck — President, Corcept Endocrinology

Yeah. So, we always see a hit in the first quarter because of insurance re-authorizations and the donut hole, this year has been no different than any other but yeah, I guess that’s all there, anyone has anything else, Joe you like to add?

Joseph Belanoff, MD — Chief Executive Officer, President and Director

Dennis, I really do understand what you’re asking about. Yeah, as Sean said one of the issues, not just for Korlym but for all medications particularly [Indecipherable] medications is that insurance companies make decisions, get a re-authorization at the beginning of the year and that’s obviously our job to see if we can turn, help us get turned around as quickly as possible.

One of the things I’ll just point out is that it’s been our philosophy from the beginning of the company, that anytime a patient gets a prescription for Cushing’s Syndrome they get the medication regardless of whether or not they have insurance. So, they continue to get that medication. We never leave the patient off of that medication but getting them back on a insurance as they had before is in some sense maneuver that occurs every year and the quicker we do that, the more back to first quarter revenues. And then once that’s in place we’re on our arc for the rest of the year.

Dennis Ding — Jefferies — Analyst

Got it. Thank you.

Joseph Belanoff, MD — Chief Executive Officer, President and Director

Sure.

Operator

Your next question is from the line of Greg Fraser with Truist. Please proceed with your question.

Gregory Fraser — Truist — Analyst

Good afternoon, folks, thanks for taking the questions. I got on a little late, so I apologize if you’ve covered this already, but I was hoping to comment on the protocol for the CATALYST study and talk about the enrollment criteria, the types of patients that will be enrolled? And I’m curious about, it seems like it’s a study that will obviously is quite large and unprecedented. It seems like a study that could potentially capture patients that would otherwise be started on Korlym. I know the study will be run by dots that you’re not calling on, it sounds like, but it does create a headwind for new starts on Korlym or am I thinking about that the wrong way?

Joseph Belanoff, MD — Chief Executive Officer, President and Director

Hey, Greg. Just sort of sorting this out. I want to give the first part to Bill whose Group is conducting the studies. So, Bill can answer the questions you have protocols and so forth?

William Guyer — Chief Development Officer

Yeah. So, CATALYST is an example that I think we are showing our continued investment in our compounds whether approved or investigational. And the catalyst as Sean had mentioned is the largest study of its kind, where we’re going to be testing two really rigorous important points. One is to understand the prevalence of hypercortisolism in patients with difficult to control type 2 diabetes, and the second is, to understand the efficacy and safety of Korlym in these patients. And in that patient population, we’re going to be looking at a 1,000 patients and we’re going to be simply testing them for hypercortisolism with a simple DST. And from there we’re going to be then evaluating them and for those who are positive will then be selected to and have a choice to go into the second part of the study, which is the treatment part of the study.

As Sean had also previously mentioned, we’re working with the top diabetologists, and while this is a study, these diabetologists have thousands of patients in their practice and have already identified many of them who could meet the inclusion-exclusion criteria of this study, and when you look at that inclusion-exclusion criteria, I’ll give you a few points there. It’s for adult patients who are age 18 to 80. Those who are difficult to control diabetes and that’s defined simply by having a hemoglobin A1c of greater than 7.5, but less than 11.5 and are taking multiple anti-hypoglycemic drugs plus many other things, but that’s the simple design of the trial of how to get, and we believe by working with these top diabetologists that we’ve designed a trial that’s easy to enroll and we’re on track to start the trial next month in March and complete enrollment of this trial by the end of this year.

Joseph Belanoff, MD — Chief Executive Officer, President and Director

Second part of the question, Greg, I would give you to Sean.

Sean Maduck — President, Corcept Endocrinology

Yeah, thank you. And the question was whether or not this study will impact potentially Korlym patients who have been on Korlym previously. The answer to that is no. Remember, this is a group of physicians, not only are they not prescribing Korlym today, they are not even aware that these hypercortisolism patients exist in their practice. They’re treating these patients for their diabetes and aren’t aware. So again, I’ll go back to what I said a moment ago, is that — that’s the hope of this study is that, that will provide definitive prevalence and treatment data that will help, I’ll say sway and motivate this group of physicians who currently are treating or diagnosed.

Gregory Fraser — Truist — Analyst

Got it. That’s very helpful. Thank you. Can you help us how to think about the growth for SG&A and R&D this year given the investments that you are making on the commercial side and also on the clinical side with the CATALYST study?

Joseph Belanoff, MD — Chief Executive Officer, President and Director

Sure, Greg, I will take that one. We have, as you know we historically have been profitable and plan to remain profitable. Our R&D expenses will increase as we invest in our development programs and our investment programs advance. And on the SG&A side as Sean discussed the continued investments we are making on the commercial side there. So, you will see some increases on both sides.

Gregory Fraser — Truist — Analyst

Got it. Okay. My last question, I just wanted to ask about the recent, you recently had the class action settlement. Curious about what you think that might mean if anything for the other locations and also for the DOJ investigation? Thank you.

Joseph Belanoff, MD — Chief Executive Officer, President and Director

Charlie?

Charles Robb — Chief Business Officer

Yes, sure. So just a brief background for those who haven’t followed the story. We’ve been in this defendant class action, reported class action lawsuit since 2018. So quite some time. And we over time as we prepared for trial someday in the distant future, we started off confident in our position and are confident in the way we are doing business and we have really only gotten more so as things developed and as we got over ducks in a row and really reviewed all possible evidence we just felt better and better, but had the opportunity recently to settle it because when I said that litigation is a distraction for more important matters, I really hope that everyone will really take that on board and imagine you had a day where you could spend your time helping to move a drug, promising drug candidates through say the regulatory process with the development process or you could review a giant stack of e-mails from three years ago, and that’s really the difference between settling and not settling. So, we chose to settle when we had an opportunity to do so on advantageous terms.

Now what you are referring to are, there are a handful of sort of associated civil cases brought by plaintiffs’ law firms sort of around the country. They think of these as sort of like pilot that impact — attach themselves to sharks as they move through the ocean and try to survive off the food that escapes from the shark’s mouth. That’s what these lawsuits are like and there are a handful of them.

We will dispose of those one way or the other shortly following this is my expectation but one never can tell. One thing I can say for sure is that we’re very, very confident in our legal position with respect to that. So that’s what the Melucci securities class action pertains for those ancillary cases. I think with respect to the Department of Justice, of course, I have no idea what the attorneys at the Department of Justice are thinking.

However, my understanding is that generally speaking, the Department of Justice does pay attention to what happens as you would imagine in sort of not loosely related, but sort of parallel civil cases there is no actual legal connection between the Department of Justice action or inquiry and the Melucci class action. But they probably have their eye on it and I don’t know what they’re thinking, because they don’t and wouldn’t tell me obviously, but I hope what they see is the way is what we see, which is a settlement on very advantageous terms for the Company, which reflects the sort of the confidence that we have in the way we do business.

So, I hope that’s the impression they take away from it and that colors they’re thinking, but of course, I cannot be sure, and that inquiry proceeds and we’ll just have to see how that plays out. We are very comfortable with respect to that inquiry also.

Gregory Fraser — Truist — Analyst

Okay. Thanks for taking the questions.

Operator

Our next question is from the line of Arthur He with H.C. Wainwright. Please proceed with your question.

Arthur He — H.C. Wainwright — Analyst

Hey, good afternoon, gentlemen. This is Arthur on for RK. Thanks for taking my question. So first one is regarding the Cushing business. Could you give us contrary if from your perspective there about the in person clinical in actions, in the second — fourth quarter and also what are you seeing first quarter this year?

Sean Maduck — President, Corcept Endocrinology

Yeah. No, thanks for the question. And the question was what are the in-person interactions in the Fourth quarter of last year into this year? And in the past we’ve discussed some of the obstacles that we face because of COVID restrictions. And I’ll tell you that through the Fourth quarter and today our in-person interactions are at about 80% to 90% of pre-COVID levels and we expect that to be our new baseline.

Some previously accessible positions closed their doors to industry during the pandemic. And I believe that some of those will keep restrictions in-place permanently. So, we’re utilizing alternate means as a company to get-in front of these positions, whether it be virtual meetings, digital marketing and educational programs to try to make-up some of that gap and we’ve seen some success on that.

Arthur He — H.C. Wainwright — Analyst

Awesome. Thanks for the color. And so, regarding the ovarian cancer study, could you give us more color on enrollment status and so-far how many sites are active for now?

Joseph Belanoff, MD — Chief Executive Officer, President and Director

Well, I’ll give you some color around there. Well, I won’t give you exact metrics on it, we don’t really talk about metrics, but I’ll give you more color. Momentum has continued and is tracking to expectations for our ovarian cancer Phase-3 trial, we expect to fully enroll this trial by the end of this year and we believe that because we’ve got great collaborators, like the GOG which is the Gynecological Oncology Group here in the United States and ENGOT, which is the European Network of Gynecological Oncology Trial group. Those groups are helping us get enrolled in number of sites that we need and we’re determined, we need about 125 sites globally. And of those sites, we’ve had an investigator meeting in the United States, and it was probably the most positive investigator meeting we’ve ever had. Well, we talked about all of the data and the investigators in the U.S. came away with the excitement and the benefit that they saw for relacorilant that can be used in combination with nab-Paclitaxel.

Next week, we are having an investigator meeting in Europe with all of the top investigators who think there’s about 50 Investigators attending that investigator meeting and we expect to see the same result. I’m seeing the same and having the same excitement of relacorilant plus nab-Paclitaxel for the women in their practice. So, we expect very positive things, now and moving forward to this trial.

Arthur He — H.C. Wainwright — Analyst

Thanks so much for the color. And my last question is again regarding your capital allocation strategy with decent amount of cash, do you guys have any idea on the allocations? Thanks.

Joseph Belanoff, MD — Chief Executive Officer, President and Director

Yeah. Arthur, thank you and thank you everyone for all of your questions. Look, we have a cash producing business as we have for many-many years. And so, the exciting thing is we have very good things at Corcept in which to invest it. Our clinical programs are advancing. And as you know — as they as they succeed and go into later-stage studies, the programs become more expensive to do, of course success is a good thing, we’re very glad to spend money in that way.

So, we’re really always taking a careful look at what we are when it goes side, it’s not a secret, we get solicited at all-the-time from Earnnest investment bankers who have things that they would like us to invest in. We fortunately take a careful look at that, but at this point, we really believe that the best thing for us to invest in is the business that we’re doing at Corcept. And so, we will proceed in that way. Anything changes, I will let you know, of course. Thank you.

And so, I want to thank all of you for treating in this quarter. Hopefully, big progress in the next three months and we look forward to seeing you at that point in time, so, enjoy the rest of the week. Thank you.

Operator

[Operator Closing Remarks]