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spk04: And thank you for standing by. Welcome to the Course of Therapeutics conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 1 1 on your telephone. You will then hear an automated message advising you your hand is raised. To withdraw your question, please press star 1 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today. Ottobock McCurry, please go ahead.
spk10: Ottobock McCurry Hello, everyone, and thank you for joining us. I'm Ottobock McCurry, CORSEP'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 CORSEP.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 might cause actual results to differ materially from those such 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 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 percent 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 Coraline. To reflect that growth, we are raising our 2023 revenue guidance to a range of $435 to $455 million, up from $430 to $450 million. Net income was $15.9 million, or 14 cents per share, in the first quarter compared to $22.8 million, or 20 cents 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 Syndrome business. Our cash and investments at March 31st was $465 million, compared to $437 million at December 31. In April, we purchased 6.6 million shares of Corecept 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?
spk08: Thanks, Atabak. In March 2018, we sued TEVA and Federal District Court to prevent it from marketing a generic version of Corelum in violation of our patents. Last quarter, the court ordered the parties to negotiate a schedule for pretrial activities. Trial is now set to begin September 27th 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's validity at trial. Teva's only remaining defense is that its proposed product would not infringe our patent, a position we believe has no legal or factual support. Keep in mind also that the 214 patent is just one of four 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 depths 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 Felinoff, our Chief Executive Officer. Joe?
spk12: Thank you, Charlie. Our Cushing Syndrome business is built on a solid foundation, a life-saving medication promoted by a commercial team that puts the interests of patients first. Leading endocrinologists increasingly believe that there are considerably more patients with Cushing Syndrome than was once assumed. Quorum is an excellent treatment 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 syndrome business. In the first quarter, we saw an increase in the number of patients receiving Quorum and in the 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, of 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 Chloralum's, our approved products, most serious off-target effects. Interestingly, while our compounds modulate cortisol activity without modulating progesterone's 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 potent in models of metabolic disease. Some appear to be tissue-specific. Others have more global effects. These diverse qualities allow us to study a wide variety of disorders. Currently, we are conducting programs with three of our proprietary selective cortisol modulators, relacoralant, dasucoralant, and miracoralant, in ovarian, adrenal, and prostate cancer, ALS, NASH, and, of course, Cushing's syndrome. We have additional compounds in clinical and preclinical development. In the next 12 months, we expect data from our GRACE, GRADIENT, and NASH Phase 1b studies, submission of the NDA for rilichloroquine in Cushing syndrome, completion of enrollment of our CATALYST, ROSELLA, and DAZZLE studies, and initiation of a Phase 2b trial of mirichloroquine in patients with NASH. This is a very exciting time for CORSEPT. We are evaluating relacoralin in the treatment of hypercortisolism in two Phase III trials, GRACE and GRADIENT. Relacoralin is a selective cortisol modulator. Like coralin, it achieves its effect by competing with cortisol at the glucocorticoid receptor. Unlike coralin, 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. By a different mechanism, relacoralin also does not cause hypokalemia, low potassium, a serious side effect experienced by 44% of patients in corallum's pivotal trial. Corallum-induced hypokalemia is a leading cause of corporeal discontinuation. Relacoralin's Phase II 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 reliquaryland-induced instances of endometrial thickening or vaginal bleeding, and no drug-induced hypokalemia. The trial results were published in Frontiers in Endocrinology in July 2021. We are pleased to share that we have identified all the patients necessary to complete our GRACE trial. We plan to complete enrollment in the coming weeks. GRACE will serve as the basis for our NDA submission in Cushing syndrome, which we plan to submit in the first half of 2024. Our second Phase III trial in hypercorrosolism, Gradient, is studying relic-correlance effects in patients whose Cushing syndrome is caused by an adrenal adenoma or adrenal hyperplasia. Patients with this etiology of Cushing syndrome often experience a less rapid decline, but their health outcomes are poor, including a higher risk of death. While we do not expect our NDA in Cushing syndrome to depend on data from Gradient, we do expect that its findings will improve the care of these patients. We are also excited that our recently initiated CATALYST study is now enrolling patients. CATALYST is a 1,000-patient phase 4 trial examining the prevalence of hyperchorizalism in patients with difficult-to-control type 2 diabetes. Patients diagnosed with hyperchorizalism may enter a randomized double-blind placebo-controlled study of Chloralom. Many independent studies conducted over the last 15 years have found that the prevalence of hypercortisolism in patients with type 2 diabetes is substantially higher than in the general population. The most prominent diabetologists in the United States helped us design and are participating in CATALYST, which will be the largest study of its kind. Data from CATALYST will enable physicians to better identify and care for these patients. We expect to complete enrollment by the end of this year. Our oncology program is testing three anti-cancer mechanisms, first postulated by investigators at the University of Chicago and later confirmed by other prominent researchers. One mechanism is increasing apoptosis, the program cell death that chemotherapy is meant to induce in solid tumors. Cortisol works against the beneficial effect of chemotherapy by suppressing apoptosis. In our successful controlled Phase II trial in women with platinum-resistant ovarian cancer, the addition of our selective cortisol modulator, relacoralin, enhanced the effect of chemotherapy, likely by blunting cortisol's anti-apoptotic effect. Relacoralin 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, Relichlorine appeared to resensitize the disease to chemotherapy's beneficial effects in some women. Those who received relichlorine intermittently, the day before, the day of, and the day after they received nabpaclitaxel, exhibited a statistically significant improvement in progression-free survival and duration of response compared to the group who received nabpaclitaxel monotherapy. Women in the intermittent relacoralin group also live longer than those in the comparator arm, with a p-value that approaches statistical significance. 29% of the patients who took intermittent relacoralin were alive two years after their study start, versus only 14% who took nabpaclitaxel alone. Perhaps even more important, the women who received relacoralin plus nabpaclitaxel experienced no additional side effect burden compared to those who received nabpaclitaxel alone. The results from this study have been submitted for peer review publication and were featured in podium presentations at the 2021 and 2022 European Society for Medical Oncology ESMO meetings and the 2022 American Society of Clinical Oncology ASCO annual meeting. ROSELLA, our pivotal Phase III trial in recurrent platinum-resistant ovarian cancer, is enrolling patients. ROSELLA's design closely tracks our Phase II study. Planned enrollment is 360 women, randomized one-to-one to receive either relacoralin plus napaclitaxel or napaclitaxel alone. The primary endpoint is progression-free survival, with overall survival a key secondary endpoint. We are conducting this study in collaboration with leading clinicians from the Gynecological Oncology Group in the United States and the European Network of Gynecological Oncology Trials Group in Europe. We are on track to complete enrollment in Rosella by the end of this year. Our goal in Phase III is simply to replicate our positive Phase II results. Leading gynecological oncologists have told us that, in their view, relucoralin's potential benefit, improved progression-free and overall survival without increased side effect burden, would constitute an important medical advance, and that relucoralin plus napaclitaxel has the potential to become a new standard of care in women with platinum-resistant ovarian cancer. A second mechanism by which cortisol modulation may prove useful is by blocking an important tumor growth pathway. Cortisol stimulation is a major reason why patients with prostate cancer treated with the widely prescribed androgen receptor antagonist enzalutamide eventually experience resurgent disease. Deprived of androgen stimulation, their tumors switch to cortisol activity to stimulate growth. Our hypothesis is that adding a cortisol modulator to androgen deprivation therapy will close this tumor escape route. By mid-year, our collaborators at the University of Chicago plan to begin a randomized placebo-controlled phase 2 trial of relacoralin plus enzalutamide in patients with prostate cancer before these patients have had an initial prostatectomy. A third therapeutic mechanism seeks to treat tumors by enhancing the body's immune response. Cortisol suppresses the immune system, which may blunt the effectiveness of cancer therapies intended to stimulate the immune system. Our hypothesis is that adding a cortisol modulator to immunotherapies such as checkpoint inhibitors may enhance the effectiveness of those therapies. We are conducting a phase 1B trial of relacoralin plus the PD-1 checkpoint inhibitor, pembrolizumab, in patients with advanced adrenal cancer whose tumors produce excess cortisol. Pembrolizumab is rarely effective as monotherapy in treating this form of adrenal cancer. ALS, commonly known as Lou Gehrig's disease, is a devastating illness with an urgent need for better treatment. Dazzles, Our 198-patient randomized double-blind placebo-controlled phase 2 trial of dazocoralin in patients with ALS is briskly enrolling patients. Dazocoralin 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. We are conducting this important study in collaboration with TRICALS, the leading ALS academic consortium in Europe. We are on track to complete enrollment in DASLs by early next year. Finally, I'll turn to our program in NASH, a serious liver disorder that afflicts millions of patients in the United States. Miracoralant, an oral medication, continues to demonstrate great promises of treatment for NASH. In a prior NASH study, patients who received Miracoralant exhibited large, rapid reductions in liver fat. but also substantial, albeit transient, elevations of the liver enzymes ALT and AST. The improvement in liver fat in these patients was greater and occurred much more rapidly than we had expected and is rarely seen over any period of treatment. Our Phase 1b dose-finding study, which has completed enrollment, has identified a range of doses, all substantially lower than our originally tested doses, that appear to cause large reductions in liver fat without causing excessive liver irritation. We expect to share results from the study by mid-year and plan to start a Phase II trial in the fourth quarter of this year. In conclusion, we are extremely optimistic about the growth potential of our Cushing Syndrome business, which continues to generate substantial profits even as our development programs advance. We have raised our revenue expectations for this year and expect growth for years to come. Our newest study, Catalyst, represents a significant investment to improve the screening and treatment of patients whose difficult-to-control diabetes is caused by hypercorizalism, a population whose Cushing syndrome too frequently goes undiagnosed. Our development programs are generating increasing evidence that validates our long-held belief that cortisol modulation has the potential to treat a wide range of diseases. Reducing cortisol activity is a straightforward and effective way to treat Cushing syndrome and can offer substantial benefits to patients with other serious disorders. Ovarian cancer, ALS, and NASH are current examples, but there will be others. In addition to relacoralin, dazocoralin, and miracoralin, We have many other proprietary selective cortisol modulators in our portfolio with potentially very different clinical attributes. In the next 12 months, we will see data from our development programs in Cushing syndrome and liver disease. We'll submit Relacorlin's NDA in Cushing syndrome, and we'll complete enrollment in large controlled studies of recurrent platinum-resistant ovarian cancer, ALS, and diabetes caused by hypercortisolism. We will also begin a phase 2B trial in patients with NASH. As I said, it is an exciting time for CoreSIP. I thank our dedicated creative employees and loyal investors for making that possible. I'll stop here for questions.
spk04: Thank you. As a reminder, to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. One moment while we compile the Q&A roster. Our first question comes from the line of Matt Kaplan with Lattenberg. Your line is open. Please go ahead.
spk09: Hi. Congrats on the results of 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 far.
spk12: Sure, Matt, and good to speak with you. Let me reintroduce everyone to Bill Geyer, who's our Chief Development Officer and runs all of our clinical programs.
spk11: 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 Relic-Orlet 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, you know, Cushing 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 six weeks, and sometimes it can be longer. But we believe we do have all the patients needed to enroll this trial.
spk09: That's very helpful. Thank you. And then just staying here, the CATALYST study, your new study in 1,000 patients, can you give us a sense of what you believe currently the prevalence is of hypochlorosolism in this type 2 diabetes patient population? that could benefit from quality?
spk11: Yeah, yeah, great question. I mean, 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 two decades, you know, 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 percent 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 US or American studies like this, and this will be the first US study, and it will be the largest prospective study ever done.
spk09: Okay, great. No, thank you.
spk12: And, Matt, just in case for the audience, I just want to remind you of one thing. It's not 70% to 33% of those patients with diabetes. It's 70% to 33% of patients who have difficult or refractory diabetes who can try on many different medications. So understand, it's a large number of a substantial subset, but not the entire group of patients with diabetes. Okay.
spk09: Fair enough. Great. I'll hop back into the queue now. Thank you.
spk04: Thank you, and one moment for our next question. And our next question comes from the line of David Anselm with Piper Sandler. Your line is open. Please go ahead.
spk02: Hey, thanks. So 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 Salesforce expansion and how we should ultimately think about operating margin expansion over time. And I guess as a corollary to that, just philosophically, just given with all the pipeline activity going on, 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, a percentage of sales figure? How do you think about that? I'll stop there. Thanks.
spk12: 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 Maduke, who's the president of our endocrinology division. And Sean, several of those questions really fall under your domain, so please go ahead.
spk07: Yeah, David, thanks for the question. So I'll touch on the Salesforce specific question of growth. Let me take everybody back to the beginning when we launched Corlum. We started with a very small Salesforce, then as we've progressed 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 one of 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. Yeah.
spk12: And David, let me address the other question you asked about research and development spending. You know, 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 three, they become more expensive to run. But we really think that, you know, we have the ability and will support anywhere where the data indicates that a drug's useful to patients in a substantial way and we can get approval. And so, you know, I think that our spending on research and development will be substantial over a long period of time, but only, you know, in some sense 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 we're obviously all funded for that. That's the end, and we feel very confident about that. However, we believe that if that study is successful, there are obvious places where relucoralin can also be used in oncology, and we will fund those studies as well. So even as in the future, you know, 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, you know, 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.
spk02: Okay, that's helpful. And if I may just make a follow-up, is it fair to say that beyond this initial, this expansion, that you're going to be right-sized in terms of the commercial infrastructure, or do you envision additional commercial infrastructure expansion over time?
spk07: Yeah, I'm going to throw you back to Sean for that one. Yeah, no, thanks for the question. At this moment in time, we believe that we'll be right-sized 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.
spk04: Thank you.
spk07: Thank you, David.
spk04: Thank you. And one moment for our next question. And our next question is going to come from the line of Edward Nash with Canaccord. Your line is open. Please go ahead.
spk14: Hi. Thanks for taking my question. I wanted to ask about the ALS trial. You're conducting that trial with tricals in Europe, and just wanted to understand kind of what the next step would be specifically as it relates to the U.S.
spk11: Yeah, great question. Yeah, we've designed this trial as a Phase II trial to be majoritally run in the European nations. And the reason for that is we've got 25 sites in Europe that are going to be active in enrolling and enrolling extremely well. I think Joe had stated that earlier, that the enrollment is 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 five sites in the United States for this trial.
spk14: Got it. And then just switching over to NASH, I see that you're going to look to get into a Phase 2B trial. So I assume you're going to go straight into a – this will be a biopsy-driven trial?
spk02: Bill, please.
spk11: Yeah, that is correct. I mean, we believe in our Phase 1B 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 into Phase 2B trial, which will be a biopsy-driven trial, correct?
spk14: Great.
spk11: Thank you very much.
spk14: Thank you.
spk04: Thank you. And one moment for our next question. Our next question comes from the line of Rona Ruiz with SVB Securities. Your line is open. Please go ahead.
spk05: Please go ahead. Great, thanks for taking the question. So I'll start with one on Coralim. 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 thereto?
spk12: Yeah, and nice to meet you. Thanks for being on the call. I'm going to pass you again back over to Sean. Yeah, thank you for the question.
spk07: I think in terms of trends, there's just an increased understanding of hyperprotozoalism 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 universally across the country, which strove to the Q1 results. We have more patients on Coraline than we've ever had as a company, and obviously factored into the new guidance range. So in terms of the second part of the question is tactics for the field, I think I'll, I want to 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, that, these patients are out there and that all physicians have not been educated yet and recognize that through that education, their awareness of the potential for patients 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 it on again. Joe mentioned it in the opening notes, and Bill just spoke to it. And again, that's the Phase 4 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 smaller 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 in this group of patients. And I believe that this will be the definitive study for this patient population. It's going to provide physicians with the prevalence and treatment data needed to encourage increased screening. Obviously, that will lead to diagnosis and then treatment. And, you know, 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.
spk12: 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 is talking about over an extended period of time.
spk05: Yes, makes sense. Super helpful. And one more from me. I was curious if you could remind us, what is the bar for efficacy that you're looking for, both in the GRACE and GRADIENT trials, and any other details that you hope to tease out from the data results?
spk12: Yeah, Ron, let me give you back to Bill.
spk11: 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 relacoralin. And 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 reliquorlin or be randomized placebo. So that's the endpoint we're looking for is the portion of 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 relacorlin 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.
spk05: Got it. Great. Thank you.
spk00: You're welcome.
spk04: Thank you, and one moment for our next question. Our next question comes from the line of Greg Frazier with Truist. Your line is open. Please go ahead.
spk03: Thank you, and good afternoon, folks.
spk13: On Corlin, sales growth looked quite good for the quarter. I know historically you've seen some pressure on net sales in the first quarter due to insurance resets, but you see with other drugs, you bucked that trend this quarter. What went better than expected? Any color on that would be helpful.
spk07: Yeah, thanks. So every year in the first quarter, as you just mentioned, we expect a decline in paid 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?
spk10: Year over year was around 6% volume growth.
spk13: Thank you. And then on SG&A, spend was up significantly quarter over quarter. You mentioned spending more behind the Cushing business. Were there any one-time items in the quarter? How should we think about SG&A spend over the next couple of quarters?
spk10: Yeah, not really any meaningful one-time 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.
spk13: 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 I'm wondering if a settlement that would bring certainty and also reduce the legal spend is still a possibility. Thank you.
spk12: I just want to remind everyone of Charlie Robb, who's going to answer this question.
spk08: Sure. Well, a settlement's always possible in every case, and we're rational business people. So in that sense, yes, a settlement's possible. But I really think our focus and everyone's focus and expectation really should be on our going to court and beating Teva. That's our plan, and I think that is the expectation we're working towards.
spk00: Thank you.
spk04: Thank you, and one moment for our next question. Our next question comes from the line of Arthur He with HC Wainwright. Your line is open. Please go ahead.
spk03: Hey, good afternoon, everyone. This is Arthur for RK. Thanks for taking my question, and congrats on the first quarter progress. Most of my questions have been asked. I have two quick ones 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 the PARP inhibitor usage for the patient?
spk12: Yeah, let me give you back to Bill Geier.
spk11: Yeah, so thank you for that question. So, yeah, we're looking at inclusion-exclusion criteria. Women with platinum-resistant ovarian cancer who previously had taken one to three 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.
spk03: It is. Thanks for that. So regarding the NASH study for the Phase II study upcoming, are you planning, because I noticed you mentioned the multiple dose and regimen could be working, and are you planning to take multiple dose level and regimen into the study?
spk11: Oh, 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.
spk12: And, Arthur, just let me add to that a little bit. You know, when you're starting at the beginning of the first trial as a human, in some sense, you know, you don't know exactly what you're getting. You know that things from animals don't always translate exactly. As it turned out, miracoralin, 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 his Phase 1b study really are substantially lower than the doses that we thought initially were going to be required. And frankly, there's more than one of them that looks promising. So we're really in the process of designing that phase 2B 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 three months or so.
spk03: Awesome. Thank you for taking my question, and congrats.
spk12: Thank you very much. Thanks for everybody for listening in. I hope everyone has a good next three months, and we look forward to catching you up at that point in time. Good afternoon.
spk04: This concludes today's conference call. Thank you for participating. You may now disconnect.
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