Earnings Labs

Corcept Therapeutics Incorporated (CORT)

Q4 2021 Earnings Call· Tue, Feb 15, 2022

$46.73

+1.10%

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Transcript

Operator

Operator

00:04 Hello. Thank you for standing by and welcome to the Corcept Therapeutics Conference Call. At this time all participants are in a listen-only mode. After the speaker presentation there will be question-and-answer session. Please be advised that today's conference maybe recorded. . 00:26 I would now like to hand the conference over to your speaker today, Atabak Mokari. Please go ahead.

Atabak Mokari

Management

00:34 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. The 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 on the Investors Past Events tab of our website. 01:00 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 results -- those statements express or imply. These forward-looking statements are described in today's press release and the risks and uncertainties that may affect them are described in our Annual Report on Form 10-K and our quarterly reports on Form 10-Q. Please refer to those documents for additional information regarding these forward-looking statements and the factors that may affect them. We disclaim any intention or duty to update forward-looking statements. 01:40 Our revenue in the fourth quarter of 2021 was $98.8 million, an increase of 15% compared to the prior year period. We expect our growth to continue and have provided 2022 revenue guidance of $400 million to $430 million compared to 2021 revenue of $366 million. 02:00 GAAP net income was $32.1 million in the fourth quarter and $112.5 million for the full year 2021. Non-GAAP net income, which excludes non-cash expenses related to stock-based compensation, the utilization of deferred tax assets, together with related income tax effects was $42.6 million in the fourth quarter and $149.5 million for the full year. 02:26 Our cash and investments of $335.8 million at December 31 reflects the purchase of 10 million Corcept shares, or about 9% of our shares outstanding for $207.5 million in the fourth quarter. 02:39 And now, Charlie Robb, our Chief Business Officer will provide a legal update. Charlie?

Charlie Robb

Management

02:44 Thank you. Atabak. I'll begin by reminding everyone that in December of last year, there was an important positive development in our dispute with Teva Pharmaceuticals. As many of you know, in March 2018 we sued Teva in Federal District Court to prevent it from marketing a generic version of Korlym in violation of our patents. Two years ago, in the midst of our Federal Court litigation, Teva challenged one of our patents, the 214 patent before the Patent Trial and Appeals Board in a procedure known as post-grand review, or PGR. 03:18 In November of 2020 the PTAB rejected Teva's arguments, upholding the 214 patent in its entirety. Teva appealed its loss to the Federal Circuit Court of Appeals, where in December -- this past December, it lost again. The deadline for Teva to file further appeals or seek reconsideration of its claims have passed. This matter is closed. 03:43 This now final determination by the PTAB means that Teva is barred from challenging the 214 patent's validity in District Court and so is reduced to arguing that its proposed product would not infringe, position we believe has no legal or factual support. So where do things stand? 04:01 Last April the District Court granted us permission to file for summary judgment based on Teva's infringement of the 214 patent. Teva responded by filing its own summary judgment motion. Summary judgment, as a reminder, is a procedure whereby courts can decide a case without holding a trial. We believe the court has all it needs to decide this case in our favor. If it grants our motion, we will have won. 04:25 Teva will be barred from marketing generic Korlym until the 214 patent expires in 2037. If the court rules in Teva's favor, we will proceed the trial, perhaps sometime this year. There is at present no timetable for the court summary judgment ruling, no trial date and no schedule for any trial-related activities. 04:48 In March 2021, we sued another ANDA filer at Hikma Pharmaceuticals, in the same Federal District Court that is hearing our case against Teva. In this matter, the court has set a fact discovery deadline of July 1. Nothing is scheduled after that. With respect to both Teva and Hikma, we are confident in the strength of our legal position. 05:09 I will now turn the call over to Dr. Joseph Belanoff, our Chief Executive Officer. Joe?

Joseph Belanoff

Management

05:15 Thank you, Charlie. The past 2 years have shown how sensitive the growth of our commercial business is to pandemic conditions. Public health restrictions and precautions taken by patients and physicians make it more difficult for physicians to identify, diagnosing and optimally treat all of their patients. And especially those with the complex disorders, such as Cushing syndrome. Having acknowledge the challenges posed by the pandemic, I want to stress how optimistic we are about the present and the future of our Cushing syndrome business. 5:48 Our Cushing's syndrome business is built on a strong foundation and effective lifesaving medication promoted by a dedicated commercial team that puts the interests of patients first. Leading endocrinologist increasingly believe that there are substantially more patients with Cushing syndrome and was once assumed. For many of these patients Korlym is an excellent treatment. 06:09 As pandemic conditions and fears recede, as they already have in certain locations. We expect our growth to continue and we are providing 2022 revenue guidance of $400 million to $430 million. We are also extremely optimistic about our clinical development programs. We have said for years the cortisol modulation has the potential to help treat many serious diseases. In 2021, the data generated by our ovarian cancer and NASH programs provide an evidence of cortisol modulation broad application. In 2022, we will see important results for many of our ongoing clinical programs. 06:49 These programs are examining lead candidates from our portfolio of more than 1,000 proprietary cortisol modulators, many of which are attractive candidates for development. Like Korlym, these compounds bind strongly to the glucocorticoid receptor or GR, unlike Korlym they have no affinity for the progesterone receptor and so don't cause some of Korlym most serious off target effects. Beyond sharing the qualities of strong…

Operator

Operator

24:10 Thank you. Our first question comes from Matt Kaplan with Ladenburg Thalmann. You may proceed with your question.

Matt Kaplan

Analyst

24:24 Hi, good afternoon, and congrats on the progress. I just wanted to -- I guess, one for Charlie, just a follow-up on the legal update. What's your sense in terms of the potential timing for the summary judgment motion decision?

Charlie Robb

Management

24:46 Well -- Hi, Matt. The answer to that is simple as it is unsatisfying. I have no idea new judge some time ago and that's always -- new judges take a while to get their feet under them, they have the backlog in place already, criminal cases take priority over civil cases. And so, really things have been extremely quiet and we just can't say, just cannot tell you.

Matt Kaplan

Analyst

25:18 Okay, fair enough. And then in terms of your clinical development programs. What's your current thinking or current plan for the pivotal study in ovarian cancer? And I guess, what were your proposal look like to FDA when you meet with them?

Joseph Belanoff

Management

25:39 Thanks, Matt, and good to hear from you. I'm going to turn you over to Bill Guyer, who is our Chief Development Officer to address that question.

Bill Guyer

Analyst

25:48 Great. Thanks very much. First and foremost, I going to reiterate what Joe had stated. I'm really excited about 2022, because I've even told my team that this is going to be an epic year for not only development, but for of Corcept, because there are a lot of ongoing trials and we will see results throughout this year and that would may move this company forward. 26:07 One of those being in ovarian cancer. So our plan next study in ovarian cancer is going to be with the intermittent dose of relacorilant plus nab paclitaxel in a controlled study versus investigator choice of treatment. While the study will be larger than our Phase II trial, we plan to have approximately 360 patients, but we basically just want to replicate the great results we saw in Phase II where we saw statistically significant improvements in PFS and duration of response. 26:36 We actively work with 2 leading organizations one being the GOG, which is the gynecological oncology group here in the US and another being ENGOT, which is the European Network of Gynecological Oncologist Trial Group in Europe. Collectively they are both very excited to partner with us in starting this trial and we plan to start this trial in the second quarter.

Matt Kaplan

Analyst

26:59 Great. Okay. Thanks for taking the question.

Joseph Belanoff

Management

27:04 Thanks, Matt.

Operator

Operator

27:06 Thank you. Our next question comes from Chris Howerton with Jefferies. You may proceed with your question.

Chris Howerton

Analyst · Jefferies. You may proceed with your question.

27:13 Great. Thanks so much and congratulations on all the progress. For me, I think, maybe just two -- Yeah. Hey, thanks, Joe. Just maybe two quick questions from me. One is on the Phase III GRACE trial. I know you just kind of went through the high level design, but is there -- maybe you could help us understand what the timelines are leading up to your expected 2Q '23 NDA submission? Just what kind of gives you the confidence in those timelines at this point? 27:46 The second question I have would be around the commercial business and the guidance that you're expecting. Just to what degree do you expect kind of dose titration in in-person visits to be a continued headwind? And how has that kind of played into your thinking in terms of those top line numbers for next year? Thank you.

Joseph Belanoff

Management

28:11 Thanks, Chris. I think we got both of your questions, but if need clarification let us know. The first question, let me turn you back to Bill to talk about the GRACE trial.

Bill Guyer

Analyst · Jefferies. You may proceed with your question.

28:20 So for the GRACE trial we're driving towards our timeline of submitting an NDA in the second quarter of 2022 and here at Corcept we're taking all hands on deck approach with the Corcept team internally as well as with our partnership with investigators to drive towards those timelines. Just recently, we've completed 2 investigator meetings, one in the US and one in Europe, both meetings were very successful because we personally saw the engagement of each investigator and their excitement for the trial. But I think most importantly their commitment to increasing recruitment for this trial to help us drive towards those timelines.

Joseph Belanoff

Management

28:55 Hey, Chris. Just one small thing, I think Bill said 2022 for the NDA Let me next turn this over to Sean Maduck who runs all of our hypercortisolism business commercially. And I think has got the answer to your question.

Sean Maduck

Analyst · Jefferies. You may proceed with your question.

29:16 Thanks, Joe, and thanks Chris for the question. As you all know, forecasting revenue during the pandemic has been and continues to be challenging. But we're confident that the forecasting range that we put forth accounts for both sort of internal and external drivers that we believe have the potential to impact our whole business. It's something I've said in the past, in-person visits matter. It's really a key driver for our business, both for patients and for specialists. And as restrictions continue to ease, we're going to be able to engage more frequently with physicians and more patients are going to be screened, which ultimately we believe will lead to more follow on discussions. But we are seeing an improvement in access after the Omicron surge back at the end of last year and through the first part of this year. 30:07 The only other thing I'll touch on briefly is dose, as you brought that up. And I want to remind everybody, just on previous calls, we've talked a little bit about how we had seen a modest decrease in our average dose. I mean, over the course of the pandemic and we were concerned that patients were not being optimally treated. We've actually seen that dose decline stabilized, and in fact, we've seen a modest reversal of that trend. So positive on both fronts.

Chris Howerton

Analyst · Jefferies. You may proceed with your question.

30:34 Excellent. That's fantastic. I really appreciate it. And I don't know if you let me, but I do have another quick question if you wouldn't mind.

Joseph Belanoff

Management

30:42 Yeah. Go ahead, Chris.

Chris Howerton

Analyst · Jefferies. You may proceed with your question.

30:44 Great. Yes, so I was actually -- I was thinking about a couple of years ago when I initiated coverage on the company, there was a discussion around urinary biomarker of activity of Korlym and glucocorticoid receptor blockade. And as we're kind of getting closer to the GRACE finish line, I guess I was just curious if there is any update or progress on that scientific front in terms of how you could evaluate glucocorticoid receptor blockade clinically?

Joseph Belanoff

Management

31:16 Yeah. Chris, At the risk of taking people off a little bit into the scientific I'm really pleased that A, you remember that, and B, to give me a chance really talk about just a little bit. So what Chris is really referring to is that, all of the measures we have now in cortisol are all cortisol level, the amount of cortisol in the urine or the blood or the saliva. But they don't really represent one way. What's really important, which is the amount of cortisol activity. And it's really stems from the fact that patients who have modestly elevated cortisol levels can actually have very bad symptoms of Cushing syndrome and people with pretty high cortisol levels can have only moderate symptoms of Cushing syndrome. So clearly what matters is in fact the activity really at the gene level, and so we began to work on a specific gene, which is measuring that can't be specific which is activated by cortisol, and it's called FKBP5, that's just the name of the gene. 32:15 And although we haven't talked about it in a while, research has continue that there is a very interesting publication from late last year where we really able to demonstrate a study up surgically treated patients with Cushing's disease that FKBP5 levels are in fact quite for successful surgery and then decline to normal levels with surgery and if the surgery is unsuccessful, they don't decline. So that measures actually being captured, Chris, in all of our studies, we think it's really a potentially very important advance of actually maybe both diagnosing and treating patients with Cushing syndrome. I don't have sort of anything further to tell you except that the research continues. And since I know you're an avid reader of the scientific literature, if you paying us, I'll be sure to send you a copy of the published paper.

Chris Howerton

Analyst · Jefferies. You may proceed with your question.

33:07 Okay. Well, that's fantastic. I really appreciate it, Joe. Thanks so much.

Joseph Belanoff

Management

33:12 Sure.

Operator

Operator

33:15 Thank you. Our next question comes from Greg Fraser with Truist Securities. You may proceed with your question.

Greg Fraser

Analyst · Truist Securities. You may proceed with your question.

33:22 Thank. Good afternoon folks. I was wondering if you could comment perhaps higher level on Korlym demand trends year-to-date and whether you've seen any breaks from the typical trends that you see early in the year that might be pandemic related?

Joseph Belanoff

Management

33:37 Yeah. I'm going to just turn it back to Sean just so everyone knows who speak.

Sean Maduck

Analyst · Truist Securities. You may proceed with your question.

33:40 Hi, Greg. Thanks for the question. I'll just speak a little bit on sort of Omicron and the impact it did have on our business. It definitely effected the end of 2021 and the early part of this year. I would say similar to other times during the pandemic, over the last 2 years, restrictions increase and it became much more difficult for us to meet with physicians and physicians to meet with patients. And I just mentioned on the last question that obviously that's a key to our business. 34:03 And the other interesting thing about this wave is with Omicron and it's broad and rapid spread, we actually had some of our own field employees attract the virus. And although everybody is vaccinated and is fine, they require quarantine which affected time in the field and affected some normal promotional activity. I would say though that the positive -- there is a positive in any of this with Omicron is that the surge was rapid and unlike what we saw with the prolonged impact of Delta, things seem to be improving very quickly. So restrictions are easing throughout the country and our sales personnel are healthy and back out there and things are slowly returning to normal. And we're optimistic that we'll continue on that path.

Greg Fraser

Analyst · Truist Securities. You may proceed with your question.

34:48 Got it. That's helpful. I know it's early days for Recorlev, but I'm curious if any feedback has come through your sales team on how docs are viewing that drug? And whether there has been a counter-detailing the Korlym that you've heard about?

Joseph Belanoff

Management

35:01 It's very early with Recorlev and we have not heard that feedback, but I'll say, both with Recorlev history to this date we have not seen any impact on our business. And interestingly, I mean we're happy that other companies are out there educating physicians on the illness, on hypercortisolism and on proper screening, because this improve patient care overall. So to get back.

Greg Fraser

Analyst · Truist Securities. You may proceed with your question.

35:25 Got it, okay. And then for prostate cancer, once you select the optimal dose of either exicorilant or relacorilant in the second quarter, will you then move immediately into a Phase II study this year?

Joseph Belanoff

Management

35:38 So thank you for that question. We're going to take a look at both of the study data in the second quarter of this year and make that decision. It depends upon which drug we choose, both drugs we're excited about, exicorilant end relacorilant, but we will evaluate the safety data, we will evaluate what efficacy data we get from that trial and then we will determine internally with the best path forward is for us to take either one of those drugs into a Phase II trial. The plan would be, yes, we would go to a next trial with one of the drugs and pick the optimal dose.

Greg Fraser

Analyst · Truist Securities. You may proceed with your question.

36:13 Great. Thank you.

Operator

Operator

36:19 Thank you. Our next question comes from Tazeen Ahmad with Bank of America. You may proceed with your question.

Tazeen Ahmad

Analyst · Bank of America. You may proceed with your question.

36:25 Hi, good afternoon and thank you for taking my questions. Could I ask two. The first would be on the GRATITUDE studies. So, can you just remind us, Joe, about what is the average amount of weight gain a patient endorse during treatment with antipsychotics? And is there a minimum amount of weight loss that you think would be needed to be clinically meaningful, just based on your conversations with physicians? 36:56 And then the second question is on ovarian cancer. So you did give some guidance on what you think the trial design will be for the pivotal study, but is there anything that you would want to wait to see from your upcoming update of the Phase II data, which is due later this quarter? Or I think you're going to have updated overall survival data that you would need to potentially tweak that trial design for the pivotal? Thank you.

Joseph Belanoff

Management

37:24 I think I -- Tazeen, thank you. And I think I do understand both your questions. And I know Tazeen because she knows the company for a very long time. But I'm a psychiatrist by training and so the weight gain and metabolic issues are very close to me, because these are my patients and they need to take anti-psychotic medications, which are often very effective for the psychosis, but really have tremendous metabolic achilles heel. It is rare for patients to not gain weight and sometimes the weight gain they gain is, I think, you'd very surprised. I mean, I personally have had patients who between 50 to 100 pounds on these medications. Weight gain tends to be rapid which is why there is actually really an issue about treating healthy people in Phase I studies for very long. 38:17 The average amount of weight gain that we saw in 2 weeks in patients in our healthy studies, it's about 10 pounds, which really is obviously would be problematic for all of us. So it's a very potent effect and when that -- of great concern to all treating psychiatrists. So you asked me a question which is a little harder to answer, which is how much of a weight loss would actually be beneficial to patients. I don't really know exactly what the answer to that is. I will tell you this, that weight gain is -- we loss would be looked at in the context of what are the other metabolic perturbations together. It's not just the amount of weight, it's all the other things that happens when people gain weight, it's really very meaningful. And I think it's treating psychiatrists should want to look at that entire picture. 39:13 So for instance a drug which…

Bill Guyer

Analyst · Bank of America. You may proceed with your question.

40:20 Great. Thank you for that question. So in regarding the OS data, to me, we have a solid regulatory path forward with or without the OS data with what we have today, because I will remind you, we saw great results from the Phase II study showing that the intermittent arm of relacorilant plus nab paclitaxel showed statistically significant improvements in PFS. That was the primary endpoint of that study, that will be the primary endpoint of our next study as well. So that's the key piece there. But then also back to OS, this study, the Phase II study was not powered to see a difference in OS. And to be honest, there is no study or no drug that has shown a statistic significance and improvement in overall survival in these types of patients with recurrent platinum resistant ovarian cancer patients. And so if we were to see a significant difference in OS, that would be unprecedented and very positive. But we will see when we reach that total, when we get the total events of 120 events, which we hope to see later this quarter.

Tazeen Ahmad

Analyst · Bank of America. You may proceed with your question.

41:21 Okay. And would that be in a press release that you would reveal some updated data.

Bill Guyer

Analyst · Bank of America. You may proceed with your question.

41:26 Once we get the data, we will make it available, as soon we get the data.

Tazeen Ahmad

Analyst · Bank of America. You may proceed with your question.

41:31 Okay. Excellent. Thanks for taking my questions.

Joseph Belanoff

Management

41:34 Thanks Tazeen.

Operator

Operator

41:37 Thank you. Our next question comes from Michelle Gilson with Canaccord Genuity. You may proceed with your question.

Michelle Gilson

Analyst · Canaccord Genuity. You may proceed with your question.

41:44 Hi, thank you for taking my question. So I was hoping that you guys could give us a better sense of what's in the guidance and what might get you to the high end of that guidance and some of the factors that you considered in there? And then you spoke already about the in-person interactions and the dose starting to normalize or trends towards the dose starting to normalize from what you've seen previously prior to COVID, but I was wondering if you are also seeing any upticks in terms of the diagnostic? I guess the diagnosis of patients with Cushing syndrome. And maybe some of those COVID delays in diagnosis starting to subside?

Joseph Belanoff

Management

42:33 Yeah. Thank you, Michelle and I'm going to -- again, just so people recognize the person, turn you over to Sean again.

Sean Maduck

Analyst · Canaccord Genuity. You may proceed with your question.

42:40 Perfect. Thank you for the question, Michelle. In terms of the first question of sort of the range, again, interactions are really an important part of it. So that's been built in, assuming that we're going to see easing of some of the restrictions that have existed for quite a window of time here, where practices have been close to becoming specialists and in some cases some of their patients. The other piece that I haven't touched on yet today is our field expansion that we actually undertook prior to, actually COVID occurring. We scaled up our sales force, they were new to the field and immediately they were basically at home and not able to go into the field. And so with the opening up of the country. We're going to have a more specialist actively calling on physicians than we've ever had. And I believe that will also add to the value and the ability to educate more physicians and through that seeing more patients being screened. 43:37 So to your second part of your question around diagnosis. Patients are -- when they are able to see their doctors and their physician has been educated on this, they are actively being screened. During COVID that was not occurring, because it takes many visits to take a patient from sort of first concern and first half through, the multitude of tests and following the guidelines. And as again restrictions have eased, these patients are seeing their physicians more frequently through that are able to get sort of the multiple tests that they need to be diagnosed and through that we've seen an increase in the diagnosis.

Michelle Gilson

Analyst · Canaccord Genuity. You may proceed with your question.

44:15 And if I can also ask a question on relacorilant. Previously you've said that the market for relacorilant you would expect to be substantially larger than the market for Korlym. And I was wondering if you could just expand on that a bit more in sort of the biggest drivers that you would expect for relacorilant to be able to grow the market if it's persistence or patients dropping off, coming back on or patients that never have considered Korlym that maybe would consider relacorilant. If you could expand a little bit on what you would expect from the Cushing syndrome market for relacorilant versus Korlym.

Joseph Belanoff

Management

45:00 Yes, yes. Michelle glad you ask. And it's an important question. So first, again and I know we have listeners have various degrees of their understanding, Korlym is an excellent medication, people have hypercortisolism. It really turns that down in a way which makes for a much more of a normal situation. And I'd just remind people, it's now, I missed a decade ago. But when we did our clinical study, which got the drug approved 87% of the patients got substantial clinical improvement as adjudicated by outsiders. So it really works in that regard. And so, we love Korlym. Unfortunately Korlym were active ingredient. It is not a specific drug for cortisol, it does a couple of things, which actually are problematic. 45:54 One and it was known as this before it was ever used for Cushing syndrome is a potent progesterone receptor antagonist. And as you know, as we've said, it's the active ingredient what's frequently call the abortion pill. So nothing to do with cortisol it's affected entirely by progesterone receptor antagonism and so our full discovery program was really to see if we can find a mechanism which could take away that problem. And in fact our wonderful Head of Medicinal Chemistry at that time is our Chief Scientific Officer, Hazel Hunt was actually able to create 3 different series of compounds of which relacorilant comes from series and do exactly that. 46:33 Potent cortisol modulation, no effective progesterone. And so that was really sort of first and obvious benefit to take away that particular medical problem and frankly political problem. But the second one is, it turned out to really something that we discovered. As we were developing it which is that, is the relacorilant unlike Korlym doesn't seem to cause what's called hyperkalemia or low potassium. We understand the mechanism why that occurs with Korlym it's a manageable problem, we really have to pay attention to it with Korlym. Relacorilant, it does not seems that's really an issue at all. And it just creates for ease of use. 47:11 So I think those medical things are really important reasons why relacorilant is not just another purple pill, it really is a significantly better medication. And I just -- I have to say in the United States the idea of being related to termination of pregnancy or abortion creates political toxicity that I think will also be -- it's meaningful that that will really be not an issue with relacorilant.

Michelle Gilson

Analyst · Canaccord Genuity. You may proceed with your question.

47:44 Great. Thank you. And maybe if I can just ask one more. The Phase Ib that you're running in NASH, the dose exploration study. Are you starting to see anything in that study so far that's validating your hypothesis of the LFT signals were may be related to the magnitude or the rapidity of that you saw in the Phase II around the liver fat reductions.

Joseph Belanoff

Management

48:13 Michelle, I'm going to have to keep you on the edge of your seat. We do actually -- I'm not -- tonight we have information, it's an open label study, but we will resell all that information only after accumulated.

Michelle Gilson

Analyst · Canaccord Genuity. You may proceed with your question.

48:26 All right, thanks for taking my questions.

Joseph Belanoff

Management

48:29 Sure;

Operator

Operator

Thank you. Our next question comes from Arthur He with H.C. Wainwright. You may proceed with your question.

Arthur He

Analyst · H.C. Wainwright. You may proceed with your question.

48:40 Hey, good afternoon, Joseph. And thank you for taking my question. So I just follow up on the NASH study. Could you give us more color on the enrollment status for the dosing escalation part?

Joseph Belanoff

Management

48:56 Yes. Bill would you like to answer that question.

Bill Guyer

Analyst · H.C. Wainwright. You may proceed with your question.

48:59 Sure. So for the enrollment status. I mean our Phase Ib study is started with multiple cohorts looking at lower doses of miricorilant. Each cohort was gated by valuation safety and efficacy every 6 weeks, and we saw great enrollment in the end of the year and even at the beginning of this year. We see great excited by the investigators and for patients into this trial. So we're seeing good steady enrollment for this trial.

Joseph Belanoff

Management

49:25 And I'll just add to that, Arthur important thing, we really think we have hoped a big one here. We really do think that this medication is very potent, all the investigators we work with have really describe it as perhaps not just a potent medication, but the most potent medication that we have ever seen for a from the liver. And so we really do think it's worth doing the work to get it as precise dose as is possible to actually provide the maximum benefit. And with the greatest ease of use. And so I'll just reiterate Bill's point, we've had no trouble attracting people to be in this study. I think it offers them even in this space real benefit. And we're going to work hard to get some fastest dose as quick as we can, we can't tell you exactly when that is, because the protocols are in the process of running.

Arthur He

Analyst · H.C. Wainwright. You may proceed with your question.

50:19 Thank you for that additional color. And regarding the GRATITUDE study, beside the -- could you remind like, besides the way lot data, is there any biomarker data we can get from the data update later this year?

Joseph Belanoff

Management

50:40 Yes, the answer is all of the standard metabolic deal like triglycerides and lipids and so forth. All of those things are being measured in the study. And again, as a practitioner, I can tell you all of them are meaningful.

Arthur He

Analyst · H.C. Wainwright. You may proceed with your question.

50:54 That's great, thanks for that. The last one I would want to pick up your brand for -- considered the current macro environment what's your appetite for the BD idea?

Joseph Belanoff

Management

51:11 All right. Well, I was wondering when someone would ask us that question. The answer is that, we have good business, we produce enough money to run our development programs, as you know. And so we -- I just sort of get you to the bottom line, un pitched ideas on a very regular basis. But let me really say the most important understanding. We really like what we're doing. We think our development program is terrific and it's going to provide benefit to many different types of patients. It is by far our highest priority to make sure that this program is going to their finish line, get us the best results we can and then we are not distracted from doing that in the optimal way. 51:59 So yes, we take a look at a lot of things that have come in the door, some are easy to dismiss, some require more thought and then obviously some -- it's potentially something could be so attractive that we really have to give a serious thought. But keep in mind, that's not our priority, our priority is really to optimize cortisol modulation and all of the diseases that we feel can be effective in treat.

Arthur He

Analyst · H.C. Wainwright. You may proceed with your question.

52:25 Sounds great. Thank you. Thank you for answering my questions.

Operator

Operator

52:30 Thank you. Our next question comes from Greg Fraser with Truist Securities. You may proceed with your question.

Greg Fraser

Analyst · Truist Securities. You may proceed with your question.

52:38 Thanks for taking the follow-up. I just want to see if there's been any progress or if there is anything new to report on than New Jersey, USA investigation? Thanks.

Joseph Belanoff

Management

52:49 Yeah. I'm happy to happy to answer that. So there has been no developments put forth. But I think there are a couple of things that folks should keep in mind as they think about that. And some -- and before I sort of talked about that. Let me just back up and give just a little bit of background for those who aren't familiar with what we were talking about. Back in December of last year we disclosed that we received a document subpoena from the Department of Justice, actually the New Jersey US attorney’s Office seeking documents related to sort of broadly speaking for commercial business, our relationships with health care providers, our promotional practices to Korlym prior authorization information, things of that nature. 53:36 And I think the first thing to keep in mind is that, a subject matter covered by those documents is the same as the sort of swirled which has been kicked up around us for years, starting with the short seller report that was published back in January in 2019 which led sort of as night follows day, it's a mysterious class action suit that we are grinding through right now. And now we have this Department of Justice. And the first thing that's to keep in mind. It's sort of an entire ecosystem. 54:12 The second thing is that, it's very common to, say, as is true with us that we are cooperating fully with the government's investigation because we most certainly are. First and foremost, that's the right thing to do. But what is not as commonly seen where it is don't never stated is that many companies, not all, but many companies while the cooperate simultaneously hope that things will move it slowly. That is not the case with us. As I should have mentioned with respect to the Teva lawsuit and it's certainly true here. We want things to go as quickly as possible, we are producing documents and information to the Department of Justice as fast as we can. And our goal is to always be ahead of that. Because we believe that the best half forward, the best outcome for course of and our shareholders is to get all the facts before the government as quickly as we can and that's what we are going to do. So nothing to announce in the moment, but I think it's important for folks to keep those couple of things in mind.

Greg Fraser

Analyst · Truist Securities. You may proceed with your question.

55:19 Great, thanks for the movements.

Joseph Belanoff

Management

Thanks for all those who tuned in. Thank you very much. We'll talk to you in another quarter. This is really a very exciting year for Corcept. I really -- if you're just being introduced to the company, this is a good time to take a serious look. We'll talk to you in another quarter. Thank you very much. And have a good rest of the day.

Operator

Operator

55:47 Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.