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spk05: Good morning, ladies and gentlemen, and welcome to Intra Cellular Therapy's second quarter 2024 earnings conference call. At this time, all participants are in a listen-only mode. A slide deck that you may find helpful while you listen to this call is available on the investor relations section of the company's website. After the speaker's presentation, there will be a question and answer session. To ask the question during this session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I will now like to turn the call over to Dr. Juan Sanchez, Vice President, Corporate Communications, and Investor Relations. Sir, you may begin.
spk36: Good morning, and thank you all for joining us on our second quarter 2024 earnings call. Joining me on the call today are Dr. Sharon Mates, Chairman and Chief Executive Officer, Mark Newman, Chief Commercial Officer, Dr. Suresh Durgan, Chief Medical Officer, and Larry Heinlein, Chief Financial Officer. During today's call, we will be making certain forward-looking statements. These forward-looking statements are based on current information, assumptions, and expectations. Those statements are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports. Your caution not to place a new reliance on these forward-looking statements. These statements are made only as of the date of this conference call, and the company disclaims any obligations to update such statements. I will now turn the call over to Sharon.
spk30: Thanks, Juan. Good morning, and thank you for joining us today. We are pleased to report our strong progress in Q2. In addition to Keplida's impressive growth trajectory, during the quarter, we announced robust positive results from our -phase-3 clinical trials in major depressive disorder, or MDD. These results form the basis for an expanded label for Keplida, and we are on track to submit a supplemental MDA for Keplida for the adjunctive treatment of MDD later this year. In addition, we continue to advance our broad development pipeline, which I will discuss later. We are very pleased with the company's progress. Our vision has been to establish Keplida as a first-choice treatment across multiple depressive disorders, and we are well on our way to achieving this goal. Keplida has already become an important treatment option for schizophrenia and bipolar depression, and we now have generated strong efficacy data and favorable safety and tolerability data in our phase-3 studies in MDD. Pending FDA approval, we are confident in Keplida's potential to become a leading medication to the treatment of MDD and a commercial success in this large market. This confidence is bolstered by our proven commercial capabilities and our strong financial position. Before discussing progress with our pipeline, let me list highlights of our second quarter financial performance. In the second quarter, Keplida net product sales increased to $161.3 million, representing a 46% growth versus the same period in 2023. The uptake of Keplida remains strong, and we look forward to continued growth. Consequently, we are increasing our Keplida net product sales guidance range for the full year 2024 to $650 to $680 million. As we continue to maximize Keplida's opportunity in bipolar depression, we plan to expand our reach in primary care during this quarter. Mark and Larry will provide further details on our expansion plans during their remarks. I would now like to further discuss our Adjunctive MDD program. Last quarter, we announced robust positive top line results from studies 501 and 502. These studies evaluated lumenetepurone 42 milligrams as an adjunctive treatment to antidepressants in patients with MDD. We are particularly proud to have two global face-leave studies with robust and consistent positive results. Both studies demonstrated robust efficacy of lumenetepurone added to an antidepressant for the treatment of MDD in the primary endpoint, the Madras total score, with a large separation versus placebo of 4.9 points in study 501 and 4.5 points in study 502, and a robust effect size of 0.61 in study 501 and 0.56 in study 502. In both studies, symptom improvement occurred as early as one week. Both studies also met the key secondary endpoint, CGIS, and showed statistically significant efficacy in the patient's self-reported measure of symptom severity of depression, or the QUID score. The favorable safety and tolerability profile for lumenetepurone in these studies was consistent with our other Kepler studies. We previously described the metabolic profile of lumenetepurone in study 501. We are now pleased to share the lumenetepurone metabolic profile in study 502. Similar to study 501, mean changes in key metabolic parameters, including glucose, insulin, triglycerides, and total cholesterol, including LDL and HDL cholesterol, were similar between lumenetepurone and placebo. Importantly, mean changes in weight were also similar to placebo. Our team is currently preparing our supplemental NDA submissions, which we expect to file with the FDA later this year. We look forward to sharing additional results from study 501 and 502 with the medical community this fall at upcoming conferences, including ECNT and psych congress. The opportunity for Keplida and MDD is sizable. Current antidepressant therapies do not adequately address depressive symptoms in more than half of patients receiving treatment. We believe these patients deserve new treatment options. Depression now represents about 30% of all antipsychotic prescriptions in the US, similar to the percentage of antipsychotic prescriptions generated for bipolar disorder. We are very excited about the possibility of bringing Keplida to patients with MDD and believe its efficacy, tolerability, and safety profiles, coupled with its convenient dosing, have the potential to make it a first choice for adjunctive treatment of MDD. We continue to invest in lumenetepurone's development with the objective of helping a greater number of patients. To that end, our pediatric program is underway. This pediatric program includes an open label safety study in schizophrenia and bipolar disorder, a double blind placebo controlled study in bipolar depression, and two double blind placebo controlled studies in irritability associated with autism spectrum disorder. Currently, pediatric patients have limited treatment options. There are only two antipsychotics approved for the treatment of irritability associated with autism spectrum disorder and two antipsychotics approved for the treatment of bipolar depression in the pediatric population. These treatments are associated with treatment limiting side effects. Given the characteristics of this patient population and Keplida's favorable profile, we believe Keplida may play an important role for this patient population. In addition, we have initiated two phase three studies evaluating lumenetepurone for the acute treatment of manic or mixed episodes associated with bipolar one disorder commonly known as bipolar mania. Our adult bipolar mania program is the result of an agreement with the FDA in connection with our lumenetepurone pediatric exclusivity program. This agreement provides that pharmacokinetic studies in adolescents and children together with bipolar mania studies in adults would be sufficient to satisfy our obligations with respect to obtaining pediatric exclusivity. Completing the overview of our lumenetepurone programs, we continue to advance our long acting injectable lumenetepurone program and expect to initiate phase one study with several formulations shortly. I also wanna share updates on other candidates in our pipeline. ITI 1284 represents the most advanced product candidate in our pipeline. I am pleased to point out that we recently initiated patient enrollment in our phase two clinical trial evaluating ITI 1284 for generalized anxiety disorder or GAD as adjunctive therapy to generalized anxiety medication. We also initiated patient enrollment in our phase two clinical study evaluating 1284 as monotherapy for psychosis associated with Alzheimer's disease. We also anticipate commencing patient enrollment in our phase two program with 1284 for agitation in Alzheimer's disease shortly. These studies are large and designed as potential registration studies. In our GAD study, we expect to enroll approximately 705 patients randomized to three arms, placebo and two doses of 1284. The primary end point of the study is the improvement of anxiety symptoms versus placebo at week six as measured by the Hamilton anxiety rating scale or HAM-A. The key secondary end point is the CGIS. We expect to initiate a second GAD study evaluating ITI 1284 as monotherapy later this year. In our Alzheimer's disease psychosis study, we expect to enroll approximately 370 patients randomized to two arms, placebo and a flexible dose of ITI 1284. The primary end point is to evaluate the efficacy of ITI 1284 versus placebo as measured by change from baseline to the end of week six in the behavioral pathology in Alzheimer's disease rating scale or BEHAVE-AD, psychosis subscale score. The key secondary end point is the CGIS. Continuing with our pipeline, next year we expect to report top line results from our ongoing phase two study with Lenin-Lispegin and Parkinson's disease. The primary end point of the study relates to motor symptom improvements and we are also exploring the effects of Lenin-Lispegin in cognition, a key non-motor manifestation of the disease and measuring biomarkers of neuroinflammation to help inform next steps. ITI 1020, our second PDE1 inhibitor, is being developed for oncology indications and continues in a phase one single ascending dose study in healthy volunteers. Regarding ITI-333, our multiple ascending dose study and a positron emission tomography study are both ongoing. ITI 1549 continues to advance in preclinical development and we expect to begin clinical testing in 2025. ITI 1549 is a non-hallucinogenic psychedelic, which we now refer to as a neuroplastogen, that we believe lacks hallucinogenic and cardiovascular side effects associated with psychedelics. Certain neuropsychiatric diseases, including MDD and anxiety, are associated with loss of synaptic connectivity, primarily in prefrontal cortical regions of the brain. These drugs have the potential to resort lost functional activity. Therefore, ITI 1549 has the potential to be a safe, effective medicine with a novel mechanism of action that can be safely and conveniently administered to patients for the treatment of these disorders. In summary, we are thrilled with our second quarter results and progress with our pipeline. We are in a strong financial position, ending the second quarter with approximately $1.025 billion in cash, cash equivalent and investment securities, and we have no debt. Lastly, we are excited to welcome Sanjeev Narula as our Chief Financial Officer later this month. Sanjeev is a finance leader with extensive experience in the pharmaceutical industry, and I look forward to working with him as we continue to build on ITCI's success. You can read more about Sanjeev's background in the press release we issued earlier this morning. I also want to thank Larry for his significant contributions and wish him all the best in his well-deserved retirement. I'll now turn the call over to Mark to provide details on Capilita's performance and our expansion plans. Mark.
spk16: Thanks, Sharon. Good morning, everyone. It's great to be with you today. Capilita's strong performance continued in Q2 with robust -over-year growth in total prescriptions of 36% and an acceleration in -over-quarter sequential growth of 10%. Once again, Capilita's quarterly prescription growth outpaced both the branded and overall antipsychotic, reflecting its continued strong uptake and market share gains in bipolar depression. We have also seen significant strength in -to-brand prescriptions, hitting new all-time highs several times during the quarter, which is a leading indicator of robust future growth. This growth is being driven by increases in both the breadth of our prescriber base, which now stands at nearly 43,000 unique healthcare providers since launch, having added more than 3,600 new first-time prescribers in Q2, as well as an increase in the average depth of prescribing as healthcare providers continue to identify more and more patients who are appropriate for Capilita treatment. The commercial opportunity for Capilita within its current indications of schizophrenia and bipolar depression is large, with those two indications representing nearly 50% of the approximately 68 million annual antipsychotic market prescriptions in the US. An important dynamic in the bipolar market has been the increasing role of primary care in treating bipolar depression. Capilita's broad label, which includes both bipolar I and bipolar II depression, provides us with an opportunity to expand our reach and educational activities with primary care physicians.
spk27: We believe Capilita's
spk16: clinical profile, including strong efficacy and a very favorable metabolic weight and movement disorder profile, coupled with once daily dosing with no titration, will be beneficial attributes for these providers in treating patients with bipolar depression. To capitalize on this opportunity and optimize the growth of Capilita in our base business, we are expanding our sales force by approximately 150 representatives during the third quarter of this year.
spk38: Through this
spk16: sales force expansion, we will be increasing our reach into this increasingly important prescriber segment and expanding our overall target audience to over 70,000. Once our new sales representatives are on boarded and trained by the end of the third quarter, they will promote Capilita for bipolar depression in primary care offices. It will take some time for these representatives to be fully optimized in their territories, so while we expect some positive effect in the fourth quarter this year, most of the impact will be seen in 2025. We have also made substantial progress in our commercialization planning for a potential label expansion in MDD, which would increase our total addressable market for Capilita from nearly 50% of antipsychotic prescriptions for schizophrenia and bipolar depression to nearly 80% with the addition of MDD. To fully optimize the launch in MDD, we expect to further expand our sales team next year, and we will share more details of those plans with you as we get closer to potential approval by the FDA. In summary, we are very pleased with the continued adoption of Capilita and are highly confident in continued growth in both the short and longer term. I'll now turn the call over to Larry to further discuss our financial performance.
spk23: Larry. Thank you, Mark. I will provide highlights of our financial results for the second quarter ending June 30th, 2024. In the second quarter, net product sales of Capilita were $161.3 million compared to $110.1 million for the same period in 2023, representing a -over-year increase of 46%. Our net sales grew 11% sequentially versus Q1 2024, primarily driven by increased prescription demand. Our gross to net percentage in the second quarter was in the mid-30s and consistent with our guidance for the full year. We expect that gross to net percentage to be in the mid-30s for the remainder of the year. We believe underlying demand for Capilita will remain strong, and thus we are raising our Capilita full year 2024 net product sales guidance range to $650 to $680 million. Selling general and administrative expenses were $121.6 million for the second quarter of 2024 compared to $101 million for the same period in 2023. Research and development expenses for the second quarter of 2024 were $56.2 million compared to $49.8 million for the same period in 2023. As Sharon and Mark described, we expect to increase our sales force during the third quarter to continue to maximize Capilita's opportunity in bipolar depression, and as a result, we are increasing our full year SG&A expense guidance range to $480 to $510 million. This increase is primarily the result of sales, marketing, and other expenses associated with our sales force expansion in the primary care segment in the second half of 2024. We are also reducing our full year R&D expense guidance range to $210 to $230 million. Our financial position remains strong. Cash, cash equivalents, investment securities, and restricted cash totaled $1.025 billion at June 30th, 2024 compared to $499.7 million at December 31st, 2023. This concludes our prepared remarks. Operator, please open the line for questions.
spk05: Thank you. Ladies and gentlemen, as a reminder to ask the question, please press star one one on your telephone and then wait to hear your name announced. To withdraw your question, please press star one one again. We ask that you limit yourself to one question and one follow-up. Please stand by while we compile the Q&A roster. Our first question comes from the line of Andrew Tai with Jeff Rees, your line is open.
spk13: Hi, good morning, congrats on the strong quarter. Thanks for taking my questions. So the first one is, as we think about your revised guidance range, do you expect scripts in Q3 to grow at a similar pace or even a stronger pace than what you saw in Q2 or are you factoring in some potential slowdown due to summer seasonality, holidays and occasions? And then secondly, for MDD, it's very clear you're preparing for that potential approval and launch. So the question would be, would you expect the potential script inflection in MDD to be larger than what you saw in the bipolar depression launch say within the first six to 12 months? Thank you.
spk30: Great, thanks, Andrew. Maybe Mark, do you wanna take the first question and then you can also take the second and then I'll chime in.
spk16: Yeah, sure, Sharon. So, Andrew, thanks for the question. As you know, our guidance has been increased for 2024 and we're confident in that guidance and in both the near-term and the long-term growth prospects for Capilita. As you know from past years, typically we see some summer seasonality during the third quarter and then we have a stronger fourth quarter. So I would say that that's all factored into the guidance that we've provided for the year. And then in terms of our preparations for MDD, they are well underway. We do expect if and when we get approved for MDD that we will see a significant increase in the trajectory of prescriptions similar to what we saw with bipolar depression. And I think if you look back at some of the recent launches in MDD, the kind of uplifts that you get from a new indication in MDD is quite significant and we would expect to see another inflection
spk17: upon approval with MDD as well.
spk19: I think that covers both. Sharon, was there anything you wanted
spk17: to add to that? Yep, okay.
spk19: No, I
spk31: think that covers both of your questions, Andrew. So operated and we can move to the next question, please.
spk05: Thank you. Yep, thank
spk31: you.
spk05: Please stand by for our next question. Our next question comes from the line of Jessica Fye with JPM Chase. Your line is open.
spk11: Hey guys, good morning. Congrats on the results and thanks for taking my question. First, with respect to the Salesforce expansion, can you confirm what that will bring your total Salesforce size to? And what's the right way to think about the additional Salesforce expansion plan for next year? Could that be similar in size to this increase, larger, smaller, and then separately? The press release mentions that you received notice from CMS that Capilita qualified for the specified small manufacturer exception under the IRA. Can you confirm what you expect that to mean for the product? Thank you.
spk32: Mark, I think this goes to you as well.
spk16: Yeah, sure. Thanks for the questions, Jess. Yes, in terms of the size of the Salesforce, we'll be adding approximately 150 sales representatives. So that will take us north of 500 representatives out in the field for us. Could you just repeat your second question on MDD, Jess?
spk11: Next year's expansion that you alluded to, should we think of that as similar in size, larger, smaller?
spk16: Yep, so what I would say is we're excited about the commercial opportunity of a potential label expansion in MDD, and we will be looking to invest behind the brand at a level that we feel optimizes the launch and the growth prospects for the brand. As we've done in the past, we'll share more details of those efforts with you as we get closer to potential approval by the FDA.
spk30: And then you asked about what we put in the press release about being a specified small manufacturer and having the exemption. So we, that status. And so what it means is that we would be minimal phase-in rebates. So we don't expect to have a big impact on the company at all, at least until the end of the decade, into the next decade.
spk05: Thank you. Thank you. Please stand by for our next question. Our next question comes from the line of Brian Abraham with RBC Capital Markets. Your line is open.
spk26: Hey guys, congrats on the quarter. Thanks for taking my question, and congrats and best of luck to Larry as well. So I guess I'm curious as we look to the presentations of the MDD data this fall, I'm curious the key things that you're looking to hide highlight to the community and how we should be thinking about potential for an inflection once those data are in the scientific literature versus potential label expansion. And then I guess as a followup on the label expansion, I'm curious the key elements kind of that you're thinking about as you build commercial, as you build out commercial infrastructure, and what are the key elements towards achieving comparable share of voice to competitors? Is it all about boots on the ground or are there other important elements as well that you're considering strategically as you look towards next year? Thanks.
spk30: Great, thanks Brian. That's a lot of questions. So hopefully we remember all of them. We'll try and take them one by one. Maybe Suresh, would you like to start talking about what we're going to be highlighting to the medical and scientific community as we go forward?
spk03: Yes, in terms of the data from the two studies, we will be presenting at different conferences starting this second half of this year right now. And then we also have going to highlight the robust efficacy of the study, both studies we have seen in terms of what we have seen in an objective setting. These are unprecedented results we have seen and we will be highlighting those. And also the safety profile that we have seen, which was similar to placebo in key aspects for antipsychotics mainly the cardiometabolic side effects, the prolactin issues, weight gain, all these things will be highlighted at conferences.
spk30: As well as what will be highlighted is the lack of movement disturbances as well, such as dysplasia, Parkinsonism, et cetera. And then I guess going to the label expansion, talking to what we're looking at in terms of Salesforce and how we will maintain our equal share of voice. Mark, would you like to address that?
spk16: Yeah, sure, Brian. When we think about achieving a comparable share of voice in an area, it's really across the whole promotional mix that we have with the main elements being covered. Some of the ones that you cited, certainly the size and the activities of our Salesforce is an important one. Our activities around medical education and educating physicians on the profile of Capilita and then on the consumer side, maintaining a comparable share of voice in our DTC efforts and our digital presence. I think those are the three that are probably the main ones that we look at, but it really is across the whole promotional mix that we have.
spk17: That's really helpful, thanks so much.
spk06: Thank you. Please stand by for our next
spk05: question. Our next question comes from the line of Jason Gerbery with Bank of America, your line is open.
spk12: Hi, good morning, this is Deena Ramadhin on for Jason Gerbery. Congrats on the quarter and thank you so much for taking our question. We just had a couple on IPI 1284. Do you view the RICSULTI launch as a representative comp for an atypical launching into the Alzheimer's disease neuropsych space? We'd be curious what your thoughts are on the challenges in displacing generics and the resistance to prescribing atypicals in a nursing home setting and just how do you think Luma Tepperone could win in a market with these barriers? Thank you. So I'll
spk30: start and I'll then ask Mark and or Suresh if they wanna chime in. First on the RICSULTI launch, I think it's early days and so I think what we're only seeing is exactly that. And sometimes these markets take time to develop and there is a great medical need in these patient populations. And I think that there is a large opportunity for a product with the right profile. And I'd like to emphasize again, the safety and tolerability profile of Luma Tepperone across every area where we have been investigating the use of Luma Tepperone. So and I think that we will see in larger studies whether the side effect profile we've seen in our early studies, whether this in elderly patients if this again holds true as we are in larger patient populations. I think then maybe Mark, did you wanna add anything to that?
spk16: No, I think you're exactly right Sharon and this is a launch that we're watching carefully and seeing how the market there evolves. I would re-emphasize the point that Sharon made that we believe it is still in the early innings for the use of antipsychotics in a chronic sense for agitation and it takes some time for treatment paradigms like this to develop. So I think the story still needs to be told there
spk17: and we're watching that very carefully.
spk06: Thank you.
spk21: Thank you.
spk06: Please stand by for our next question.
spk05: The next question comes from the line of Charles Duncan with cancer, your line is open.
spk34: Hey, morning Sharon and team. First of all, congratulations on a really nice quarter and thanks for taking our questions. I had a question on regulatory strategy in adjunctive MDD. You may not answer it but I was curious as to what indications you'll be seeking. Will it be adjunctive MDD alone or would you include mixed features or would you seek to just have that data in the label? And then I did have a question on 1284.
spk30: So I'm going to take that and then I'll ask Suresh if he wants to add anything. So just to remind you, the clinical studies, the phase three program was in adjunctive treatment of MDD. So you can assume that that is the label that we are going for. I think it's a little bit early for us to discuss any more about the label other than that it's for the adjunctive treatment of MDD.
spk19: Suresh, did you wanna add anything?
spk04: No, that's good.
spk19: Okay.
spk34: Got it and then I did have a question on 1284 and it kind of dovetails into your luma teprone expansion. On 1284 study in generalized anxiety disorder, it seems to me that given that that's often a comorbidity of depression, I'm wondering why you're not looking at luma teprone in that indication and what it is about 1284 that you think suits it well for generalized anxiety disorder. And then on luma teprone in terms of pediatric data, do you think that we could see some pediatric information in 12 or in 2025?
spk31: Suresh, did you wanna take that or do I need to?
spk03: Yes, in terms of the last question about the pediatric indications you're talking about. So we have posted on printouts.gov. These are pediatric studies that take a little longer time than adults. So we will not be seeing the results in 2025 if it's a little bit later than that. In terms of your question on looking at other indications for 1284, we are going to be looking at, we are constantly reevaluating new indications. Right now our first indication, as we said, we started the GAD program in a GENQ program in GAD. We have also started the psychosis in Alzheimer's patients. We have indicated that we have announced that we are going to start soon the agitation program as well as the monotherapy in GAD. Other indications, stay tuned. As we reevaluate, we will keep updating.
spk30: As we go forward, we will be announcing new studies, other studies that we'll be doing with 1284. So as Suresh said, just stay tuned. Have a little bit of patience. We'll tell you as soon as we get very close to or start enrolling those patient populations.
spk34: Absolutely, thanks for taking the question.
spk05: Thank you. Please stand by for our next question. Our next question comes from the line of Mark Goodman with Lee Reen, your line is open.
spk15: Good morning Sharon. Can you talk about how you're thinking about business development these days and obviously a massive sales force you'll have in a year with one product, just curious how you're thinking about leveraging that sales force. And then just secondly, how are you thinking about Capilita XUS and if there's any partnership arrangements that you're thinking about and
spk19: thanks. Sure,
spk30: so we do look at BD opportunities constantly and obviously what would be terrific would be if we are able to find a product that fits into the present sales force. We continue to look for that and then we have also moved to adjacencies. So far we haven't found products that we think fit the bill there, but we do continue to look. In addition, we look earlier as you heard on this call today, we have a very, very robust internal pipeline and while we progress that internal pipeline, we do also look to supplement it with external opportunities. So we look at all opportunities. Our head of external innovation is in charge of doing that and we will keep you informed on our progress there. Additionally, XUS, we continue to evaluate that. It is a landscaping, a landscape that has been rapidly changing. And so we will keep you updated as we go forward in the XUS landscape as well.
spk06: Thank you.
spk05: Please stand by for our next question. Our next question comes from the line of Michael DeFarori with Evercore ISI. Your line is open.
spk39: Hi, guys. Thanks so much for taking my question and congrats on all the progress this quarter. Two questions for me. Number one, with regards to the NDD trial study 505, any plan to shut this trial down? And if so, how should we think about R&D spend throughout the balance of the year? And my second question is on ITI 1284, specifically the phase two anxiety trial, what's your powering and expectations for a placebo response here and how you're controlling for it, especially since the trial has two active arms? Thank you.
spk30: Maybe we wanna go in reverse since that's top of our mind. So, Rush, you wanna talk about the powering that we do? I can give you a very broad summary and that's we always power our study. Well, why don't I let Suresh take it?
spk04: Yeah, so these
spk03: studies are powered in our registrational studies. So all of them are powered at 90% power. That's what we typically do. And in terms of controlling for placebo response, as we adjudicate every patient that goes into the trial to make sure that they actually meet the criteria and there is different levels of that and we do adjudicate each patient that is coming into the trial so that they have the correct symptomatology and also the severity also is there. And throughout the study, we monitor for any inconsistencies across different scales and things like that so that we have done in other trials and we continue to do that in these upcoming studies also.
spk30: And I'll address the study 505. We are coming down the home stretch in our evaluation of what will happen, what will be the fate there. But why don't you just give us just a little bit more time and we'll update you on the fate of 505. And then I think you had another question in there, but I'm not sure I remember it.
spk39: No, that's it, thank you very much.
spk30: Okay,
spk39: great, thanks.
spk05: Thank you. Ladies and gentlemen, due to the interest of time, we ask that you limit yourself to one question only. Please stand by for our next question. Our next question comes from the line of Jeff Hung with Morgan Stanley, your line is open.
spk14: Thanks for taking my questions. I guess for 1284 and Alzheimer's disease psychosis, can you just talk about your approach versus what others are doing for the indication and then just your confidence in 1284 for AD psychosis? Thank you.
spk30: So thanks for, Jeff, maybe I take it you're referring to the scale that we're using, is that correct?
spk14: I mean, partially, but then also just in terms of candidate itself, your confidence in that versus competing approaches for treating AD psychosis.
spk30: Okay, maybe Suresh, would you like to just know what we're doing, that would be great, thanks.
spk03: So for psychosis and Alzheimer's, first point based on the mechanism of action of the drug, we believe that based on its influence, its effect on the dopamine system, serotonin and glutamate system, we believe that this will be effective in psychosis of Alzheimer's disease. In terms of the study itself, we have, this is a six week study, that is going to be a four week of spin period, followed by six weeks of double blind treatment and a follow up period of 30 days. And in terms of the study scales, we have picked the Behave AD psychosis subscale, which focuses mainly, the subscale focuses mainly on the psychosis element of the disease, and it has 15, sorry, it says 12 items, seven items from the paranoid and delusional ideation domain, five items from the hallucination domain, and then we have a total score of 36. And we also have a key secondary as the CGIS, that is the global severity improvement in patients with psychosis in Alzheimer's dementia. All these are the design elements, and in terms of, again, I have indicated that in terms of the patients that get into the trial, we ensure that patients have the right diagnosis and also the right severity, and that is very key to successful of a clinical trial to have, to make sure that the patients have enough severity so that we can detect the change
spk17: at
spk03: the end of the study.
spk06: Thank you. Thank you. Please stand by for our next question.
spk05: Our next question comes from the line of Amy Fadia with Needham & Company, your line is open.
spk02: Hi, good morning, thanks for taking my question. Maybe just with regards to 1284, what doses will you be evaluating across the three indications, and what's your rationale for evaluating two doses, as well as in mono and injective treatment in GAD? And maybe just to follow up to the previous question on Alzheimer's disease psychosis, you explained the endpoint that you're using, but why do you believe that that is the appropriate one for 1284 versus what some of the other companies are using? Thank you.
spk30: So I'm gonna start, and this goes to Jeff's question as well, I need to understand a little bit better, there are a few different studies, but very few, and so I think we have chosen our parameters after interactions with the FDA, and conclusions about the best design for our studies, which includes the best scales to use, or the appropriate scales to use, as well as the different doses that we're doing. So that's why we say, we think we have early evidence of safety, of efficacy with different doses, and so now we're testing them, you get a lower range, you get an upper range, and that's the reason for choosing two doses. I don't know, Suresh, do you wanna add anything?
spk03: Yeah, and yeah, the scales, definitely the scale, as you have indicated that this was based on discussions we had with the agencies.
spk30: If there's another question about the trials that were missing, maybe you could let us know, and we can try and address it.
spk02: Just to get back to GAD, the path that is behind evaluating it, both as a mono and
spk18: a jumbo therapy, thank you.
spk19: We think it's appropriate, as you know, there are very few drugs
spk30: that are approved for GAD, and there are a few clinical studies ongoing, and we think that there's an opportunity for a drug with a good tolerability and safety profile, as well as demonstrated efficacy. So I think that's why both a mono therapy and a jumbo therapy. Thank you.
spk05: Thank you. Please stand by for our next question. Our next question comes from the line of Joseph Thone with TD Cohen, your line is open.
spk25: Hi there, good morning, and thank you for taking my question. Maybe on the, what proportion of bipolar depression patients are treated by primary care physicians, just to get a little bit of an idea of what growth you could see from this expanded sales force, and was the expansion related to something that you're seeing in the field specifically, or was this because of the MDV trial, or just the normal cadence of launch? Thank you.
spk07: Mark?
spk16: Yeah, I can take that Sharon. Thanks Joseph for your questions. So the primary care, as we said, is playing an increasingly important role in the treatment of bipolar depression. And we believe that they account for about 25% of all the prescriptions written for bipolar depression. So they play an important role. Psychiatry is still the main treater of the disease, but they play an important role, and that role has been increasing over time. And so for us, this was a couple things. Up until this point, our primary promotional efforts have been concentrated on psychiatrists and the nurse practitioners that support them. However, we've also been targeting a smaller segment of primary care that represents the highest volume prescribers in primary care. And we've actually had good success with the primary care physicians. We've seen that capillet is broad label, including both bipolar one and bipolar two depression, coupled with the strong efficacy and favorable safety and tolerability, and the convenient once daily dosing with no titration is a very compelling profile for primary care treating patients with bipolar depression. So to fully leverage that growing opportunity, this expansion is allowing us to go deeper into primary care and extend our reach and frequency in this setting. And to your other point, yes, the robust results that we've seen in the two phase three MDD studies gives us a high degree of confidence in the long-term growth prospects of capilleta and gives us increased confidence to invest in the brand today at an even higher extent for our base business in bipolar depression. So for all those reasons, we believe now is the right time to be extending our reach in the primary care.
spk33: Thank you.
spk05: Thank you. Please stand by for our next question. Our next question comes from Alana Gregg-Sibanovich with Mizzou Health Security. Shealine is open.
spk24: Thank you very much. And congrats on the progress in the quarter and congrats, Larry, on your retirement. Maybe Sharon, this question is for you. It's a bigger picture strategy question. As you think about the pipeline that you have, which is quite extensive and with increased investment in either additional studies with luma teparone or 1281, I'm sorry, 1284, I'm just trying to think about how you're thinking about some of the other programs, whether it be the 333 program or 1020 or the Parkinson's program and kind of the interest in getting the data but then either investing further in those assets or perhaps using those assets as opportunities to perhaps find a partner to offload some of the R&D spend in order to advance those programs. So just philosophically, how you were thinking about the pipeline.
spk30: So first, thank you for acknowledging that we have a very robust pipeline and we are very data-driven. So the first thing to do is get the data and these early studies with 1020, with 333, with, you didn't mention, but a program we're extremely excited about, 1549, while they will generate extremely valuable data, they're your earlier phase studies and they are less costly than your later stage programs. So I think the first thing for us to do is get the data and see if the data looks robust and is both in efficacy and also what the safety and tolerability profile looks like and we'll make our decisions as to do we move it along alone or do we move it along with a partner or do we not move it along? Based on data. This company was founded on data-driven events and we continue to look at the science and drive our decisions based on data that we get.
spk22: Okay, thank you.
spk05: Please stand by for our next question. Our next question comes from Alanna Corrine Johnson with Goldman Sachs. Alanna's over. Hi,
spk10: this is Polak on Corrine. Just one question from us. How are you thinking about the past with profitability from here? As you saw the balance building out of the motion infrastructure and your adding the effort against the backdrop of continued revenue growth?
spk30: Wait, I'm sorry. You came through very muffled. I could not understand. Yeah, I couldn't.
spk08: Any... Can you repeat, please? Sure, sure, I can go again. Is this better? Yes. Much better, thank you.
spk09: Awesome, yeah. I was just asking, how are you thinking about the past to profitability from here as you thought of balance building out a commercial infrastructure and R&D efforts against the backdrop of continued revenue growth?
spk30: I think we're asking, you're asking about our past to profitability and balancing it against R&D and our continued growth. Larry, do you wanna take that?
spk23: Yeah, sure. We haven't given any guidance as far as profitability. I mean, we feel we're very excited about the growth in scripts and the path that that's taking. We've given you guidance on R&D spend for the rest of this year. We intend to finance these R&D projects to the best of our ability. And so having said that, we are focused on becoming profitable but at this point we can't give you any guidance. We'll keep you updated on the components of that as we go further.
spk05: Understood,
spk10: thank you.
spk05: Please stand by for our next question. Our next question comes from the line of Joel Beatty with Bayer, your line is open.
spk37: Thanks. For the next self support expansion, is that something you're looking to do early in 2025 or later around the time of MDD approval?
spk20: Mark?
spk16: Yeah, so as I mentioned in my prepared remarks, we're very excited about the commercial opportunity of this potential label expansion in MDD for Capelita and we intend to invest behind the brand at a level that will help us optimize the launch and our longer term growth prospects. As we've done in the past, we'll share more of those details both in terms of the magnitude of the expansion and the timing of the expansion as we get closer to potential approval by the FDA. So hang in there for a little while and we'll come back to you as we get closer to
spk17: that launch.
spk10: Thanks.
spk20: Operator, I think we have time for
spk05: one more question if there is one. Our final question will come from the line of David Amsell with Piper Stanley. David, your line is open.
spk28: Hey, thanks. Just a quick one from me. Just a quick one from me on the Bipolar Mania program. Can you talk about how additive you think it is to the overall sales potential of Capelita or maybe put it differently? I mean, what's the extent to which you're getting usage in patients who are manic and just help us understand your rationale for doing that program
spk27: and getting that into the label.
spk29: Rush, do you wanna start and I'll try now?
spk03: Yes,
spk35: I can.
spk03: We are looking at adults and pediatrics for any unmet needs that we have for drugs, for looking for any drugs with efficacy, safety, and tolerability needs. Coming specifically to your question on bipolar mania, we have an agreement with the FDA in connection with our pediatric exclusivity program. This agreement provides that the PK studies in adolescent and children, together with the bipolar mania studies in adults, would be sufficient to satisfy the obligation with respect to obtaining pediatric exclusivity. And that is the reason we were planning and conducting the studies.
spk06: Thank you.
spk05: At this time, I would like to turn the call back over to Sharon for closing remarks. Great, thanks
spk30: everybody. As you can see, I think we've had a great quarter and we're moving forward. And we really look forward to our, to an approval on the launch in adjunctive treatment and MDD and to advancing all of our other programs. So we thank you for your support and for listening. And we have great opportunities ahead of us and we look forward to informing you of yet more progress from ITCI as we move forward. With that operator, you can disconnect.
spk05: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.
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