Q4 2022 Corcept Therapeutics Inc Earnings Call

Speaker 1: The.

Speaker 2: participants are in listen-only mode. The question and answer session will follow the formal presentation.

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Speaker 2: As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Adebak Mulkari, CFO . Thank you. Let's begin.

Speaker 3: Good afternoon and thank you for joining us. I'm Otto Buckinghart, our Substitute Financial Officer.

Speaker 3: Today, we issued a press release announcing our financial results for the fourth quarter in providing a corporate update.

Speaker 3: A copy is available at corset.com.

Speaker 3: Our complete donation results will be available when we file our form 10k with the SEC.

Speaker 3: Today's call is being recorded. A replay will be available at the Investors at Events tab of our website.

Speaker 3: Statements during the call other than statements of historical facts are forward-looking statements based on our plans and expectations that are subject to risk and uncertainties which might cause actual results to defer materially from those statements expressed or implied.

Speaker 3: 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 10K and our quarterly reports on Form 10Q.

Speaker 3: Please refer to those documents for additional information. We'd disclaim any intention or duty to update toward looking statements.

Speaker 3: Our revenue in the fourth quarter of 2022 was $103.1 million, compared to $98.8 million in the fourth quarter of 2021.

Speaker 3: We expect our revenue growth to continue and have provided 2023 revenue guidance of $430 to $450 million compared to 2022 revenue of $401.9 million. That income was $16.6 million in the fourth quarter.

Speaker 3: and $101.4 million for the full year 2020.

Speaker 3: Our cash in investments at December 31st was $436.6 million compared to $335.8 million at the end of the prior year.

Speaker 3: I will now turn the call over to Charlie Robb, our Chief Business Officer, to provide a legal update. Charlie? Thanks, Adebak. Since we last spoke, we have successfully terminated two lawsuits.

Speaker 4: On February 13th, we announced that we had reached an agreement in principle settling all claims in the reported securities class action known as Maluchi versus Core Therapeutics Incorporated.

Speaker 4: This lawsuit was brought by plaintiff's attorneys in March 2019. Since then, our position has not wavered.

Speaker 4: 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.

Speaker 4: I, and I know I speak for my colleagues as well, am proud of Corecept and the way we do business.

Speaker 4: Allegations such as those asserted in the Maluchi lawsuit are repugnant.

Speaker 4: We had looked forward.

Speaker 4: We have looked forward to our day in court where we can explain publicly the reasons for our pride in what we do and the way we do it.

Speaker 4: That being said, litigation is a distraction from more important matters.

Speaker 4: Simply put, time spent preparing for trial is time not spent developing medications or helping patients. We're presented with a chance to put the Maluchi distraction behind us for an amount covered by our insurance.

Speaker 4: we felt compelled to accept. The second terminated case concerns Sigma Pharmaceuticals. In March 2021, we sued Sigma to prevent it from marketing generic corollum in violation of our patents.

Speaker 4: As we announced in December , we have settled this case.

Speaker 4: HIPMA may begin selling a generic version of Corolam in the United States beginning October 1, 2034, more than 11 years from now, or earlier, under circumstances customary for settlement agreements of this type. This is the same entry date as our previous settlement with Sun Pharmaceuticals.

Speaker 4: Finally, there was a development yesterday in our lawsuit against Tava.

Speaker 4: In March 2018, we sued Teva to prevent it from marketing a generic version of Coral and Violation of our patents.

Speaker 4: In April 2021, we filed for summary judgment based on Teva's infringement of our 214 patent.

Speaker 4: SEVA's expected responded by filing its own motion for summary judgment.

Speaker 4: Summary judgment is a procedure where my courts decide a case without holding a trial.

Speaker 4: Yesterday, the court denied both our motion and Tevis motion, without prejudice, in order the parties to begin negotiating a schedule for pretrial activities.

Speaker 4: The court denied both our motion and tevus motion without prejudice in order the parties to begin negotiating a schedule for pre-trial activities. No trial day has been set.

Speaker 4: It is important to note that this change in the procedural posture of our action against TEPA does not change our point of view. We remain confident in the strength of our legal position and are very comfortable proceeding to trial if necessary. I now turn the call over to Dr. Joseph Bellinoff, our Chief Executive Officer. Joe, thank you, Charlie.

Speaker 4: Percushing Syndrome business is built on a solid foundation, a life-saving medication promoted by a commercial team that puts the interests of patients first.

Speaker 4: Leaving endocrinologists increasingly believe there are considerably more patients with Cushing's syndrome than was once assumed. Coronavirus is an excellent treatment for patients with Cushing's syndrome and there are many eligible patients who have yet to receive it.

Speaker 5: We are extremely optimistic about the growth potential of our Cushing syndrome business and are making substantial investments to improve the screening and treatment of these patients. We are providing 2023 revenue guidance for $430 million to $450 million.

Speaker 5: In addition to generating substantial cash in 2022, we significantly advanced the clinical development programs for proprietary selective cortisol modulators, RelaCoralent, DazuCoralent, and MiraCoralent. Sims pessimist Lou

Speaker 5: We expect to make further progress in the next 12 months with a submission of Brelich Corallant NDA and Cushing's syndrome, an enrollment of our confirmatory phase 3 trial of Brelich Corallant in platinum-resistant ovarian cancer, phase 2 trial of DASIC Corallant in ALS, and phase 2 trial of Miracorollant in NASH.

Speaker 5: 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.

Speaker 5: 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 the corallones, our approved products, with serious off-target effects. Interestingly, while our compounds modulate cortisol's activity without modulating progesterone's activity, they are not identical.

Speaker 5: 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.

Speaker 5: Some appear to be tissue specific, others have more global effects.

Speaker 5: These diverse qualities allow us to study a wide variety of disorders.

Speaker 5: Currently we are conducting programs in ovarian, adrenal, and prostate cancer, ALS, NASH, and of course Cushing's syndrome.

Speaker 5: We are investigating cortisol modulation's role in other diseases and have additional compounds in clinical and preclinical development. Our Cushing's Syndrome business has funded all of these activities and will continue to do so. As most of you know, we are evaluating reli-correlin for the treatment of hypercortisolism in two phase three trials, GRACE and GRADIENT.

Speaker 5: Rolichorolone is a selective cortisol modulator. Like corolone, it achieves its effects by competing with cortisol at the glucocorticoid receptor.

Speaker 5: Unlike Guarlam, it does not bind to the progesterone receptor, PR for short, and so does not cause PR related side effects including termination of pregnancy, endometrial thickening, and vaginal bleeding.

Speaker 5: By a different mechanism, relichorlon also does not appear to cause hypokalemia, low to low potassium.

Speaker 5: a serious side effect experienced by 44% of patients in Corolam's pivotal trial. Corolam induced hypokalemia is a leading cause of Corolam discontinuation.

Speaker 5: Reli-corel and 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's syndrome. There were no reli-corel-produced instances of endometrial thickening or vaginal bleeding and no drug-induced typokalemia.

Speaker 5: The trial results were published in Frontiers in Endocrinology in July 2021.

Speaker 5: We are pleased to announce that we believe that we have enough patients and 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 hypercoronavirus is a trial that will be conducted by the National Center for Disease Control and Prevention.

Speaker 5: Coralism gradient is studying relic correlants of facts and patients whose cushing syndrome is caused by an adrenal adenoma or adrenal hyperflasia.

Speaker 5: Patients with this etiology of Cushing's syndrome often experience less rapid decline, but their health outcomes are poor.

Speaker 5: While we do not expect our NDA and Cushing syndrome to depend on data from gradient, we do expect that its findings will improve the care of these patients.

Speaker 5: Finally, we plan to initiate a randomized double-blind placebo controlled phase four study for this quarter.

Speaker 5: We have named the study catalyst.

Speaker 5: Chattelists will examine the prevalence of hyperchorusolism in patients with difficult to control type 2 diabetes and treat the patients determined to have hyperchorusolism with corollum.

Speaker 5: Planned enrollment is 1,000 patients, which we expect to complete by the end of this year. The most prominent diabetologist in the country helped design and are participating in this study.

Speaker 5: 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.

Speaker 5: One mechanism is increasing apoptosis. The programmed cell death at chemotherapy is meant to induce in solid tumors.

Speaker 5: 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, Rilacorrelate, enhanced the effect of chemotherapy.

Speaker 5: likely by blending cortisol's anti-apoptotic effect. Relichlorolymph provided meaningful benefit to many of the women in our study. While these women's disease had progressed on two or more previous lines of treatment, including previous taxanes, Relichlorolypia are to resensitize the disease to chemotherapies beneficial effects in some women.

Speaker 5: Those who receive relic oral and intermittently, the day before, the day of, and the day after they receive now-packed attacks. So, they've been able to statistically significant improvement in progression-free survival and duration of response compared to the group who received now-packed attacks on mild therapy.

Speaker 5: Women in the intermittent reliquary group also live longer than those.

Speaker 5: to comparator alarm with a p-value that approached statistical significance. Our analysis to date indicates that 29% of the patients who took intermittent reliquorolant were alive two years after study start versus only 14% who took NAPAC with Taxel alone. 13% of patients who took intermittent reliquorolant are alive.

Speaker 5: The results from this study were featured in podium presentations at the 2021 and 2022 European Society for Medical Oncology, ESMO, meetings and at the 2022 American Society of Clinical Oncology ASCO Annual Meeting.

Speaker 5: Rosella, our pivotal phase 3 trial in platinum resistant ovarian cancer, is active in enrolling patients.

Speaker 5: Roselle's design closely tracks our phase two study with planned enrollment of 360 women, randomized one to one to receive either reliquorolone plus napaclitaxel or napaclitaxel alone. The primary endpoint will be progression-free survival with overall survival a key secondary endpoint. We are conducting the study in collaboration with leading clinicians...

Speaker 5: the colorolens potential benefit improved survival without increased side effect burden, we continue to constitute an important medical advance. The colorolens plus napacklet axel has the potential to become a new standard of care and women with platinum resistant ovarian cancer. A second mechanism by which cortisol modulation may prove useful.

Speaker 5: is by blocking an important tumor growth pathway.

Speaker 5: Cortisol stimulation is a major reason why patients with prostate cancer treated with the widely prescribed androgen receptor antagonist enzalutamide eventually experience resurgent disease.

Speaker 5: 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.

Speaker 5: By mid-year, our collaborators at the University of Chicago plan to begin a randomized placebo-controlled phase 2 trial of reliquorolone plus enzalutamide in patients with prostate cancer.

Speaker 5: before these patients have had an initial prostatectomy.

Speaker 5: A third therapeutic mechanism seeks to treat tumors by enhancing the body's immune response.

Speaker 5: Cortisol suppresses the immune system, which may blunt the effectiveness of Cortisol cancer therapies intended to stimulate the immune system.

Speaker 5: Our hypothesis is that adding a cortisol modulator to immunotherapies such as checkpoint inhibitors may enhance the effectiveness of these therapies.

Speaker 5: We are conducting a phase 1B trial of roloflorilib plus a PD-1 checkpoint inhibitor, hebrelizumab, 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.

Speaker 5: Pembrolyzumab is rarely effective in treating this form adrenal cancer. Our trial is evaluating with a relicoral end in treat these patients' cushion syndrome by reducing excess cortisol and by reversing cortisol-induced immune suppression, allow Pembrolyzumab to achieve its bone cancer killing effect.

Speaker 5: 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.

Speaker 5: DASLS are a 198 patient randomized double-blind placebo-controlled phase 2 trial of DASU Coroant in patients with ALS has begun enrolling patients.

Speaker 5: Dasacortland is a selective cortisol modulator that has shown great promise in animal models of ALS, improving motor performance and reducing neural inflammation and muscular atrophy.

Speaker 5: We are conducting this important study in collaboration with TRICALS, the leading ALS academic consortium in Europe .

Speaker 5: Finally, I'll turn to our program in NASH, a serious liver disorder that inflicts millions of patients in the United States.

Speaker 5: Miracorolant, an oral medication, continues to demonstrate great promise as a treatment for NASH. In our prior NASH study, patients who received Miracorolant exhibited large rapid reductions in liver fat, but also substantial, albeit transient, elevations of the liver enzymes ALT and ASC.

Speaker 5: our originally tested doses that appeared to cause substantial reductions in liver fat without causing excessive liver irritation.

Speaker 5: We expect to share results from this study by mid-year and plan to start a phase 2 trial later this year.

Speaker 5: In conclusion, we are extremely optimistic about the growth potential of our Cushing Syndrome business and are making significant investments to improve the screening and treatment of these patients.

Speaker 5: In the meantime, the business continues to generate substantial profits even after funding all of our development programs.

Speaker 5: Our development programs continue to generate

Speaker 5: Evidence validating our long-held belief that cortisol modulation has the potential to treat a wide range of diseases.

Speaker 5: Reducing cortisol activity is a straightforward and effective way to treat cushion syndrome.

Speaker 5: It is also clear that cortisol modulation can offer substantial benefits for many other serious disorders.

Speaker 5: ovarian cancer, ALS, and NASH are prime examples, but there will be others. In addition to reliquorolone, dazuquorolone, and miriquorolone, we have many other cortisol modulators in our portfolio with potentially different and valuable clinical attributes.

Speaker 5: Horse F continues to advance across multiple fronts.

Speaker 5: I thank our dedicated creative employees and loyal investors for making this possible. I'll stop here for questions.

Speaker 2: Thank you. At this time, we'll now be conducting the question and answer session.

Speaker 2: If you'd like to register a question at this time, please first star one from your telephone keypad, and then confirmation tone indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue.

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Speaker 2: One moment please while we poll for questions. Thank you. Thank you. Our first question is from the line of Matt Kaplan with Leidenberg-Salman. Please refuse your question.

Speaker 2: Hi guys, this is Raymond from that. Thanks for taking a question today. Congrats on all the progress. I just wanted to ask perhaps on the ALS program, specifically what endpoints are you kind of looking for in the study? Is it ALS, FRS? And do you have any specific guidance from the FDA if the study could serve as the basis for an NDA pilot? Thanks and I have one more question. Thank you.

Speaker 3: Yes, yes Matt. I want to just reintroduce you to Bill Guider who is our Chief Development Officer. Bill will address that question. Great, thank you. Appreciate the question. So again, DAS is a phase 2 multi-center randomized double-only placebo controlled trial evaluating the safety and efficacy of DAS correlated patients with ALS.

Speaker 3: In this phase 2 trial, we're going to look at 198 patients. 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.

Speaker 3: as well as other primary endpoints of safety to assess the safety and efficacy or the safety of DAS-coronavirus patients with ALS.

Speaker 3: These are all validated endpoints with the FDA. And if we complete this trial and we see positive results, this could end up with an NDA.

Speaker 2: I appreciate that comment. And I guess maybe just for the NASH program, what would you like to see from the Phase 1B studies to kind of increase your confidence as you enter the Phase 2 study? And is it possible you would try multiple dosing regimens? Thanks.

Speaker 3: Yeah, that is the goal. That's a great question. Since this is an open label trial, we're 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.

Speaker 3: We believe we've identified multiple doses or dosing regimens to move into phase two, where we've seen that progressive fat loss over time and no ALT rises. And so yes, our plan is to move to phase two in the fourth quarter of this year.

Speaker 2: Appreciate that. Thanks. I'll hop back in the queue. Our next question is from the line of dentists. Dentists name is Jefferies. Please receive your questions.

Speaker 2: Hi guys, thanks for taking my questions. I just have one around the base business. Maybe talk about the pushes and pulls on…

Speaker 2: you know, 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.

Speaker 5: Good, Dennis. Thank you. Thank you for those questions. I want to again reintroduce you to Sean Medo, who is the president of the Render Chronology Division, and Sean, the responsible for all of our business in pushing syndrome. We'll be glad to answer that question. Dennis, thank you for the question. I think your question was directly in regards to the range. Our range is driven by the number of patients that we add to our activation paste.

Speaker 5: Our pricing is known and our average dose and patient retention rates have been stable for many years. Where we fall within the range is really driven by the number of patients that we add to our...

Speaker 5: And that's the, the pushes in the poles are constant. It's really about patient

Speaker 2: 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 ads versus drive less patient ads appreciating that there's competition out there.

Speaker 5: Yeah, no, great question. So look, I'll start by just saying the evidence is clear that there are more hypercortisol patients out there than we once thought. Physicians, as they become more educated about screening and about 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 physician touchpoints, continue to raise disease awareness.

Speaker 5: educate on screening, and then educate on the benefits of Corlum. And the evolving market and our execution will really drive that growth into 2023 and beyond. You know in terms of initiatives, obviously we have many going on but there's 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 clinical specialists. We currently have 55 going to 60 in the next couple of months.

Speaker 5: physician awareness of the potential for cushioning syndrome in their patient population has 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.

Speaker 5: the phase four corollum 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 diapatologists and they are representative of a group of physicians that we have not historically called on.

Speaker 5: So we believe that patients with difficulty control diabetes is a very rich patient population for hypercordus olisom and I believe that this study will provide the definitive prevalence and treatment data needed to encourage increased screening and ultimately treatment for its patient. I've got a thanks and then on the seasonality question for Q1 and the growth re-exceleration for speed back up to the year.

Speaker 5: Yeah, so we always see a hit in the first quarter because of insurance reauthorizations and the donut hole. This year is no different than any other. But yeah, I guess that's all I would add there. Is there anything else?

Speaker 6: Joe, would you like to add? Yeah, Dennis, I really do understand what you're asking about. Yeah, as Sean said, one of the issues, not just for Corolain, but for all medications, particularly orthodontic medications, is that insurance companies make decisions, get a reauthorization at the beginning of the year.

Speaker 6: And on top of the C.R. job, see if we can turn those, health goes get turned around as quickly as possible. You know, one of the things I'll just point out is that it's been off-blusively from the beginning of the company, but any time a patient gets a prescription for cruel or pushing syndrome, they get the medication regardless of whether or not they have insurance.

Speaker 6: So they continue to get that medication. We never leave the patient off of that medication. But getting them back on paid insurance as they had before is in some sense, you know, a maneuver that occurs every year. And the quicker we do that, the more it gets back to the first point of revenues. And then once that's in place, we're on our arc for the rest of the year.

Speaker 3: Got it. Thank you. Our next question is from the line of Greg Fraser with Truist. Please just use your questions.

Speaker 2: Good afternoon, folks. Thanks for taking the questions. I got on a little late, so I apologize if you 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. I'm curious about it. It seems like it's a study that's...

Speaker 6: Obviously it's quite large and in a press sentence, it seems like a study that could potentially capture patients that would otherwise be started on Corlam. I know your study will be run by a doctor that you're not calling, not a doctor like, but just create a headwind for you and start on Corlam or am I thinking about that the wrong way? Hey Greg, just sort of sorting this out. I want to give the first part to Bill who's group is conducting the study. I should Bill can answer the questions he has for us.

Speaker 6: And the second is to understand the efficacy and safety of corlemanine patients.

Speaker 3: And in that patient population, we're going to be looking at a thousand patients. And we're going to be simply testing them for hypercortical ism 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 that treatment part of the study.

Speaker 3: As Sean had also previously mentioned, we're working with the top diabetologist and while this is a large study, these diabetologists have thousands of patients in the 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.

Speaker 3: 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-hyperglycemic drugs.

Speaker 3: plus many other things, but that's the simple design of the trial of how to get in. We believe by working with these top dive autologists 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.

Speaker 5: Second part of the question, Greg, I would give you a shot. Yeah, thank you. And the question was whether or not this study will impact potentially coral patients. It would have been on quote previously. The answer to that is no. Remember, this is a group of physicians. Not only are they not prescribing coral in today, they're not even aware that these hypercores also patients exist in their practice. They are treating these patients.

Speaker 5: 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 the group of physicians who currently aren't treating or diagnosing.

Speaker 6: Can you help with how to think about the growth for SG&A and R&D this year, given the investments that you're making on the commercial side and also on the clinical side with the catalyst study? Thank you for your attention.

Speaker 3: Sure, Craig, it's Ottobock, I'll take that one. We have, as you know, we've historically been profitable and fund or 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, Sean discussed the continuing...

Speaker 6: for the other civil cases that are put in and also for the DOJ investigation.

Speaker 4: Thank you. Charlie? Yeah, sure. So, just a brief background for those who haven't followed the story. Yeah. You know, we've been in this, you know, uh…

Speaker 4: We've defended in a class action or purported class action lawsuit since 2018, so quite some time. And you know, we, over time as we, you know, prepared for trial someday in the distant future, you know, we started off confident in our position and the confident in the way we were doing business and we really only got more so.

Speaker 4: I really hope that everyone will really take that on work. And imagine you had a day where you could spend your time, you know, helping to move a drug, promising drug candidates through say the regulatory process or the development process, or you could review a giant stack of emails from three years ago. And that's really the difference.

Speaker 4: between settling and not settling. So we chose to settle when we had an opportunity to do so on advantageous terms. Now what you're referring to are there are a handful of sort of

Speaker 4: associated civil cases brought by plaintiffs, law firms, sort of around the country. They think of these as sort of like their pilot fish that attach themselves to sharks as they move through the ocean and try to survive off the ocean.

Speaker 4: food that escapes from the shark's mouth. That's what these lawsuits are like. And there are a handful of them. We old dispose of those when we're the other shortly following. This is my expectation, but you know, one never can tell, but one thing I can say for sure is that we're very, very confident in our legal position with respect to them. So that's that's what...

Speaker 4: the Maloochi securities class action portends 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 and sort of, it did not loosely relate but sort of parallel civil cases.

Speaker 4: There's no actual legal connection between the Department of Justice action, our inquiry and the Maluji 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 what we see, which is a settlement on very advantageous terms for the company, which reflects the

Speaker 4: 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 that colors their 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.

Speaker 4: confidence that we have in the way we do business. So I hope that's the impression they take away from it and that that colors their 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. Thanks for taking the questions.

Speaker 6: Our next question is from the line of Arthur He with HTWInRIGHT. Please just use your question. Hey, good afternoon gentlemen. This is Arthur on 4RK. Thanks for taking my question. So first one is regarding the cushion business. Could you give us some color from your perspective there about the in-person clinical interactions in the second floor?

Speaker 5: 80 to 90 percent of pre-COVID levels and we expect that to be our new baseline. Some previously accessible positions close their doors to industry during the pandemic and I believe that some of those will keep restrictions in place permanently. So we're utilizing alternative means as a company to get in front of these positions whether it be virtual meetings, digital marketing.

Speaker 7: more color on the enrollment status and so far, how many sites are active for now?

Speaker 3: Bill, I'll give you some color around there. Well, I won't give you exact metrics. We don't really talk about metrics, but I'll give you more color. Momentum has continued and it's tracking two expectations for our ovarian cancer phase 3 trial. We expect to fully enroll this trial by the end of this year. We believe that because we've got great collaborators like the GOG, which is the gynecological oncology group here in the United States and end GOG.

Speaker 3: talked about all of the data and the investigators in the US came away with the excitement and the benefit that they saw of relic orlent that could be used in combination with that pack of tax.

Speaker 3: Next week, we're having an investigator meeting in Europe with all of the top investigators. I think there's about 50 investigators attending that investigator meeting. And we expect to see the same result of them seeing the same and having the same excitement of Reliquor-Lip plus NAVPAC attacks for women in their practice.

Speaker 7: So we expect very positive things now and before this trial. Thanks so much for the color. My last question is again regarding your capital allocation strategy with decent amount of cash. Do you guys have any idea on their...

Speaker 6: capital allocation. Thanks. Yeah, Arthur, thank you and thank you everyone for all of your questions.

Speaker 6: But we have a cash producing business as we have for many, many years. And so, you know, the exciting thing is we have very good things, of course, in which to invest it. Our clinical programs are advancing. And as you know, as they succeed and go into later stage studies,

Speaker 6: the program has become more expensive to do. Of course, you know, success is a good thing. We're very glad to spend money in that way. And so we're really always taking a careful look at where our money goes. It's not a secret we get solicited all the time from earnest investment bankers who have things that they would like us to invest in. We of course 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 in Corsa.

Speaker 6: And so we will proceed in that way. If anything changes, I will let you know, of course. Thank you. And so I want to thank all of you for tuning in this quarter. Hopefully big progress in the next three months and look forward to seeing you at that point in time. So good rest of the week. Thank you.

Speaker 2: This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.