Good day and thank you for standing by. Welcome to the Corcept Therapeutics Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Atabak Mokari. Please go ahead.

Hello, everyone 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 first 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-Q 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 first quarter of 2023 was $105.7 million, an increase of approximately 13% compared to the first quarter of last year, with about half of that growth being due to an increase in the number of patients receiving Korlym. To reflect that growth, we are raising our 2023 revenue guidance to a range of $435 million to $455 million, up from $430 million to $450 million. Net income was $15.9 million or $0.14 per share in the first quarter compared to $22.8 million or $0.20 per share in the same period last year due primarily to higher operating expenses as our development programs advance and we increased investment in our Cushing's syndrome business. Our cash and investments at March 31 was $465 million compared to $437 million at December 31. In April, we purchased 6.6 million shares of Corcept common stock for $145 million. I will now turn the call over to Charlie Robb, our Chief Business Officer, to provide a legal update. Charlie?

Thanks, Atabak. In March 2018, we sued Teva and Federal District Court to prevent it from marketing a generic version of Korlym in violation of our patents. Last quarter, the court ordered the party to negotiate a schedule for pretrial activities. Trial is now set to begin September 27 of this year. Keep in mind that Teva can no longer challenge the validity of one of the patents we are asserting against it, the 214 patent which was reaffirmed by the patent trial and appeals board following a proceeding initiated by Teva known as post grant review. Having lost at the patent office, Teva must concede the 214 patent validity at trial. Teva's only remaining defense is that its proposed product will not infringe our patent, a position, we believe, has no legal or factual support. Keep in mind also that the 214 patent is just 1 of 4 that we have asserted against Teva. Having recited these facts, it is customary to say we are confident in the strength of our legal position. That is certainly true. So I will say it. We are confident in the strength of our legal position. The problem is that this sort of stock phrase does not capture the depth of our conviction. So let me put it another way. My colleagues and I are glad a trial date has been set. We look forward to our day in court. We have never sought to delay or prolong this litigation because the law and the facts are on our side. We are absolutely confident we will win. I will now turn the call over to Dr. Joseph Belanoff, our Chief Executive Officer. Joe?

Thank you, Charlie. Our Cushing's syndrome business is built on a solid foundation, a life-saving medication promoted by a commercial team that puts the interest of patients first. Leading endocrinologists increasingly believe that there are considerably more patients with Cushing's syndrome that was once assumed. Korlym is an excellent achievement for patients with Cushing syndrome and there are many eligible patients who have yet to receive it. We are making substantial investments to improve the screening and treatment of these patients, most notably our recently initiated CATALYST study and are extremely optimistic about the growth potential of our Cushing's syndrome business. In the first quarter, we saw an increase in the number of patients receiving Korlym and in a number of physicians prescribing the medication. We are raising our 2023 revenue guidance range to $435 million to $455 million. We are also very encouraged by the progress of our clinical development programs. Since inception, our research and development efforts have built on the hypothesis that cortisol modulation can be a powerful therapeutic mechanism in many serious disorders. Our proprietary compounds modulate cortisol's effects binding to the glucocorticoid receptor or GR. The receptor which is activated when cortisol levels are high. They do not bind to the progesterone receptor and so don't cause some of Korlym's our approved products in the serious off-target effects. Interestingly, while our compounds modulate cortisol activity without modulating progesterones activity, they are not identical. Some cross the blood-brain barrier, others do not. Some perform best in models of solid tumors, others are more [indiscernible] 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 with 3 of our proprietary selective cortisol modulators, relacorilant, dazucorilant and miricorilant in…

[Operator Instructions] Our first question comes from the line of Matt Kaplan with Ladenburg.

Congrats on the results for the quarter. Can you give us a little bit more insight into the GRACE study? And how enrollment has evolved here and what your thoughts are? You said in the coming weeks, you expect to complete? Can you give us a little bit more detail where you are in that study so...

Sure, Matt. And good to speak with you. Let me reintroduce everyone to Bill Guyer, who's our Chief Development Officer and runs all of our clinical programs. Bill?

Great. Thanks for that question. I mean first and foremost, we're excited and focused on finishing the GRACE study as are each and every one of our investigators around the world because they see the benefit that relacorila can bring to their patients, not only from the Phase II trial but from what they're seeing currently in the Phase III trial. In the past few months, we've seen unprecedented number of patients coming into the clinic and being screened for this trial, more than we've ever seen previously. And therefore, based on that, all of the patients to complete the study have been identified and we're working them through the process to enter them into the study and we plan to complete enrollment in the coming weeks. And what you need to understand is for this trial for the GRACE trial, Cushing's syndrome is a very complicated disease and require multiple criteria to confirm that they qualify for this particular study. And the screening process takes on average about 6 weeks and sometimes it can be longer but we believe we do have all the patients needed to enroll this trial.

That's very helpful. And then just staying here, the CATALYST study, your new study in 1,000 patients. Can you give us a sense what you believe currently that the prevalence is of hypercortisolism in this type 2 diabetes patient population?

Good question - great question. And when you look at multiple independent European studies to be specific because that's where most of the research has been done that have been conducted over the last 2 decades. They found that the prevalence of hypercortisolism in patients with type 2 diabetes is substantially higher and it ranges on estimate between 17% and 33% with patients that fit this type of profile that we're looking at in the CATALYST study. Therefore, it's clear to us that there are more patients with hypercortisolism. However, there are no U.S. or American studies like this and this will be the first U.S. study and it will be the largest prospective study ever done.

Okay, great.

And Matt, just in case for the audience, I just want to remind you one thing. It's not 17% to 33% of those patients with diabetes, it's 17% to 33% of patients who have difficult -- refractory diabetes who can try on many different medications. So I understand it's a large number of a substantial subset but not the entire group of patients with diabetes.

Okay, fair enough. Great. I'll hop back in the queue now.

[Operator Instructions] And one moment for our next question -- and our next question comes from the line of David Amsellem with Piper Stanley.

Just had a couple. First, can you talk through margin expansion over the long term? I'm particularly interested in how we should think about the benefit of the sales force expansion and how we should ultimately think about operating margin expansion over time. And I guess as a collar [ph], just philosophically, just given with all the pipeline activity, how should we think about R&D spend longer term? And I guess more specifically, should we think about sort of a steady state figure or percentage of sales figure. How do you think about that? I'll stop there.

Okay. Thank you, David. And we'll try to sort that out as best we can. So first, again, for the group, let me reintroduce you to Sean Maduck, who's the President of our endocrinology division. And Sean, on several of those questions really fall under your domain. So please go ahead.

Yes, David, thanks for the question. So I'll touch on the sales force specific question of growth. Let me take everybody back to the beginning when we launched Korlym, we started with a very small sales force that -- as we've invested over time, we've added to and we've grown that team. So where are we now? We're really focused on continuing to develop and strengthen the team that we have and add to it. And we will complete our expansion to 60 clinical specialists in the coming months. Our newest clinical specialists that have joined in the last year are starting to contribute and we expect that contribution to continue to increase in the second half of this year. And the rationale of why have we continued to expand. It's the understanding and recognition of hypercortisolism continues to evolve and grow in the market. More and more physicians are being educated and are aware. And right now, we're in the best ways for us to get in front of them is obviously with our field support. So right now, we're planning to get to 60% in the coming months and we'll continue to assess that team over time and determine...

Yes. And David, let me address the other question you asked about research and development spending. Our philosophy has always been, we're going to support successful results to move drugs through the development pathway to approval. And so there's always some ebb and flow. I mean, when studies are in earlier stages, they're less expensive to run as they get to Phase III, they become more expensive to run. But we really think that we have the ability and will support anywhere where the data indicates that the drug is useful to patients in a substantial way and we can get approval. And so I think that our spending on research and development will be substantial over a long period of time but only some -- to the benefit of making the business more profitable and serving more patients. So, I'll give you like an example which we haven't talked about today. We're doing the study in platinum-resistant ovarian cancer. We feel that we're all obviously all funded for that and that's to the end and we feel very confident about that. However, we believe that, that study is successful, there are obvious places where relacorilant can also be used in oncology and we will fund those studies as well. So even as in the future, fingers crossed, we are earning money from platinum-resistant ovarian cancer business, we will be supporting other studies that enlarge our footprint in oncology. So, I guess the simplest way that I can answer that question is that our spending in research and development is not likely to decline, it's likely to increase as our business increases and our drugs are successful.

That's helpful. And if I may just sneak in a follow-up. Is it fair to say that beyond this initial -- this expansion that you're going to be rightsized in terms of the commercial infrastructure? Do you envision additional commercial infrastructure expansion over time?

Yes, I'm going to throw you back to Sean for that.

Yes. No, thanks for the question. At this moment in time, we believe that we'll be rightsized with that infrastructure. But as I said on your previous question, it's something that we look at very closely. And if we feel like there's an opportunity to add and grow that team, we will assess at that time and do so.

And our next question is going to come from the line of Edward Nash with Canaccord.

I wanted to ask about the ALS trial. You're conducting that trial with TRICALS [ph] in Europe. And I just wanted to understand kind of what the next step would be specifically as it relates to the U.S.?

Yes. Great question. Yes. We've designed this trial as a Phase II trial to be majority run in the European nation. And the reason for that is we've got 25 sites in Europe that are going to be active and enrolling and enrolling extremely well. I think Joe had stated that earlier, that they were a very brisk. When we look at the United States, we're actively working with the FDA to get our IND open to allow us to initiate the study here in the United States. But yet we only plan to have 5 sites in the United States for this trial.

Got it. And then just switching over to NASH. I assume that you're going to look to get into a Phase IIb trial. So I assume this - you're going to go straight into a - this will be a biopsy-driven trial?

Bill, please?

Yes. That is correct. I mean we believe in our Phase Ib study that we've accomplished our goal to find dose and dosing ranges that allow us to reduce liver fat over time at a steady pace without seeing any rises in ALT and that allows us to then feel confident to go forward in the Phase IIb trial which will be a biopsy-driven trial, correct?

Our next question comes from the line of Roanna Ruiz with SVB Securities.

Great. So I'll start with one on Korlym. I was curious, what recent trends are you seeing among prescribers that gives you confidence in your new guidance for 2023? And along those lines, any new strategies that your field force is using to help educate and drive more prescribing there, too?

Yes. Roanna, nice to meet you. Thanks for being on the call. I'm going to pass you again back over to Sean.

Yes. Thank you for the question. I think in terms of trends, there's just an increased understanding [indiscernible] and the realization for these physicians that these patients may exist in their practice. So there's more screening going on. And through more screening, more patients are being found. And that's something that we've seen sort of universally across the country which drove to the Q1 results. We have more patients on Korlym than we've ever had as a company and obviously factored in into the new guidance range. So, in terms of the second part of the question is tactics for the field. I think - I must speak about a couple of big initiatives that we're working on organizationally. One relates to the field and one not but they're both very important both for today and I think for the future of the business. I already mentioned on -- touched on the growth of the sales force. Again, that's on track. And we're really spending a lot of time working to strengthen that team. And we are definitely seeing results from that effort. We know that these patients are out there and that is all physicians have not been educated yet and recognize that through that education, their awareness of the potential applications in their practices is increasing. So, we think that this increase in disease awareness, our streamlined training efforts will make our clinical specialists more productive. And for our newest clinical specialists, obviously, more productive more rapidly. So we're seeing benefit on that side of things. The other is just CATALYST. I want to touch on it again. Joe mentioned it in the opening notes and Bill just spoke to it. And again, that's the Phase IV study that we initiated in Q1. But you have to understand that a great deal of the data in this patient population already exists. Bill touched on it but many small retrospective studies have shown that patients with difficult to manage diabetes have a disproportionately higher prevalence of underlying hypercortisolism. And as we've said, CATALYST is the largest prospective study ever done in this group of patients. And I believe that this is -- will be the definitive study for this patient population. It's going to provide physicians with prevalence and treatment data needed to encourage increased screening. Obviously, that will lead to diagnosis and then treatment. And over the last few months, I have actually been in the field talking to physicians and this is one of the things that we've talked about. And I can tell you that they are very interested in this study and its findings. Disease awareness is evolving across the board and the time is right for this study and all the other initiatives that we have underway. And ultimately, all these initiatives are going to improve patient care which we're very excited about.

And really, the bottom line from all of this is that we are confident in what our outlook is for the remainder of the year and really look forward to seeing the growth that Sean was talking about over an extended period of time.

Yes, makes sense. Super helpful. And one more for me. I was curious if you could remind us what is the bar for efficacy that you're looking for, both in the GRACE ingredient trials? And any other details that you hope to tease out from the data results?

Yes, Roanna, let me give you back to Bill.

So for the GRACE trial, let me remind you, it's a randomized study but yet there's an initial part to that study. There's an open label piece to it where we're evaluating patients who are on relacorilant for those who meet the criteria of response for hypertension and diabetes then get into the randomized withdrawal piece of that trial. And where we're looking at the results there is that loss of control as we randomize them to either stay on relacorilant or be randomized placebo. So that's the endpoint we're looking for is the portion of the patients who lose control versus that who maintain control and that's for GRACE. And then for the GRADIENT trial, at the outset, it is a randomized placebo-controlled trial. And so in those patients with hypercortisolism, we're looking at the comparison of relacorilant versus that of placebo and similar but yet slightly different. We're looking at the response to the hyperglycemia endpoints as well as the hypertension endpoints. And so we're looking for statistical significant changes there in either one and hopefully, both of those endpoints.

Our next question comes from the line of Greg Fraser with Truist.

Good afternoon, folks. On Korlym sales growth looks quite good for the quarter. I know historically, you've seen some pressure on net sales in the first quarter due to insurance resets that with other drugs. You bucked that trend this quarter. What went better than expected? Any color on that would be helpful.

Yes. Thanks. So every year in the first quarter, as you just mentioned, we expect the decline in paid [ph] tablets due to the impact of the donut hole and insurance reauthorizations. This year, however, that seasonal impact was muted somewhat by the increase in our patient base and our growing business.

What was volume growth in the quarter?

Year-over-year, it was around 6% volume growth.

And then on SG&A, spend was up significantly quarter-over-quarter. You mentioned spending more behind the Cushing's business. Were there any onetime items in the quarter? How should we think about SG&A spend over the next couple of quarters?

Yes. Not really any meaningful onetime expenses. I mean I think the only small portion is related to expenses related to the tender offer which was sort of in the million dollar range. But I'd say as you look through the rest of the year, operating expenses will approximate what we saw in the first quarter.

Got it. Okay. And then on the patent case, have you engaged in settlement discussions with Teva? Or are you still open to exploring a settlement? You're clearly confident in your position but wondering if the settlement that would bring certainty and also reduce the legal spend is still a possibility?

I just want to remind everyone of Charlie Robb, who's going to answer this question.

Sure. Well, settlement is always possible in every case and we're rational business people. So in that sense, yes, the settlement is possible. But I really think our focus and everyone's focus and expectation really should be on our going to court and meeting Teva. That's our plan. And I think that is -- that is the expectation we're working towards.

Our next question comes from the line of Arthur He with H.C. Wainwright.

Good afternoon, everyone. Congrats on the first quarter progress. Most of my questions have been asked. I have 2 quick one on the clinical study. One is for the ovarian cancer study, could you remind us for the inclusion/exclusion criteria, is there any specific color for the bevacizumab and PARP inhibitor usage for the patient?

Yes. Let me give you back to Bill Guyer.

Yes. So thank you for that question. So yes, we're looking at inclusion/exclusion criteria, women with platinum-resistant ovarian cancer who were previously had taken 1 to 3 lines of therapy with one of those lines being prior bevacizumab. There is no restriction to PARP inhibitor requirements in this trial. And so that hopefully answers your question.

It is. And so regarding the NASH study for the Phase II study upcoming, are you planning because I noticed you've mentioned the multiple dose and regimen could be working? And are you planning to take multiple dose level and regimen into the study?

That is our intention. We will be working with the top NASH specialists and hepatologists through this process to help advise us on how to best move forward into Phase IIb. But yes, our intention is to take multiple doses compared to placebo in our Phase IIb trial.

And Arthur, just let me add to that a little bit. When you're starting at the beginning of first trial in humans in some sense, you don't know exactly what you're getting is you know that things from animals don't always translate exactly. As it turned out, miricorilant, although it was very potent in animals and we expected some drop-off into humans was equally or more potent in humans. And as a consequence, the doses that Bill has been testing in this Phase Ib study really are substantially lower than the doses that we thought initially were going to be required. And frankly, there's more than one other that looks promising. So, we're really in the process of designing that Phase IIb study -- right Phase IIb study right now. We know we're going forward but exactly what it's going to encompass in terms of dose groups is being determined. And you'll know that in the next 3 months or so.

Awesome. Congrats.

Thank you very much. Thanks for everybody for listening in. I hope everyone has a good next 3 months and we look forward to catching you up at that point in time. Good afternoon.

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