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spk05: Good morning. Welcome to Sage Therapeutics' first quarter 2022 financial results conference call. Currently, all participants are in a listen-only mode. This call is made webcast live on the investors' website at sagerx.com. Call is the property of Sage Therapeutics and recording, reproduction, or transmission of this call without the express written consent of Sage Therapeutics is strictly prohibited. Please note that this call is being recorded. I would now like to introduce Helen Rubenstein, Investor Relations at Sage.
spk10: Good morning, and thank you for joining Sage Therapeutics' first quarter 2022 financial results conference call. Before we begin, I encourage everyone to go to the investors and media section of our website at sagerx.com, where you can find the press release related to today's call, as well as the slides that contain supplemental details. I'd like to point out that we will be making forward-looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. Please consult the risk factors discussed in today's press release and in our SEC filings for additional details. We will begin the call with prepared remarks by Barry Green, our Chief Executive Officer, who will provide an overview of the progress during the first quarter. We will also be joined by Jim Daugherty, our Chief Development Officer, who will review recent progress in development activities across our programs, and Kimi Iguchi, our Chief Financial Officer, who will review the financial results in the quarter. We will be joined for Q&A by Chris Bonecki, our Chief Commercial Officer. With that, I'll now turn the call over to Barry.
spk22: Thanks, Helen, and thank you, everyone, for joining us this morning. For SAGE, 2022 is off to a strong start. We've laid the groundwork for a year of execution as we make progress on our goals to become the leader in brain health and a top-tier biopharmaceutical company. Our efforts come at a pivotal time, as we are amid an ongoing brain health pandemic, triggering substantial societal and lifestyle disruptions across communities. The severity and prevalence of symptoms facing our nation require all of us to strengthen our response. As we mark Mental Health Awareness Month, which has been observed in the United States since May 1949, we recommit ourselves to our mission of pioneering solutions to deliver life-changing brain health medicine. Mental Health Awareness Month provides an important reminder of the great unmet need in this area. It's never been more important to prioritize mental health as an essential component to overall health and well-being. I want to take a moment to underscore the need for novel therapies for people living with MDD and PPD, disorders where advancement has lagged other critical disease areas. With little innovation in the last 60 years, the profile of treatments remains unchanged despite 35 approved treatments in the last 30 years. Current treatments in the dominant model of mental health care do not address the complex challenges of depression, and they're simply not scalable. Not all patients with depression achieve an adequate response to treatment, and many continue to live with symptoms of their condition, resulting in continued functional impairment. Further, current antidepressants that often take six to eight weeks, if ever, for patients to experience benefits from treatment. Tolerability is also frequently an issue. Current antidepressants often cause stigmatizing side effects, like sexual dysfunction and weight gain, which can be associated with patient non-adherence. Further, the prevalence and impact of depression continue to increase, with an estimated three- to four-fold increase in people experiencing symptoms of depression since the start of the COVID-19 pandemic. And it's well documented in the literature and in studies like STAR-D that those MDD patients with elevated anxiety as one of the symptoms of their depression are among the least well served. In addition, an estimated one in eight mothers in the United States report experiencing symptoms of PPD each year. That's approximately 500,000 women. PPD remains the leading complication of childbirth and is associated with considerable maternal mortality and morbidity, which continues to rise driven largely by increases among women of color. The current treatment approach in depression is often trial and error. Simply put, people with MDD and PPD deserve better treatment. They deserve a chance to thrive. That's why we believe there's a significant opportunity to advance the standard of care for treating MDD and PPD with Zoranilone, if approved. To this end, yesterday, we and our collaborator Biogen announced a very exciting step towards bringing Zoranilone to market. we began our rolling NDA submission to the FDA for Zoranilone to treat MDD, and we remain on track with our plan to complete the submission in the second half of this year. We'll provide the next update when we complete the submission. In addition, we anticipate making an associated NDA filing for Zoranilone in PPD in early 2023, pending results from our Skylark study, which we continue to expect mid-2022. Jim will provide more details regarding the SCAR-like study and our overall NDA submission plan. We believe that the totality of the data that we plan to submit to the FDA from data generated in multiple studies evaluating Zoranolone in PPD and MDD patients supports the potential of Zoranolone to make a difference for patients. We've seen rapid and sustained improvement of depressive symptoms with a well-tolerated safety profile across six positive studies. Based on these data, we believe Zoranolone has the potential to fill the unmet need and serve both people with MDD and PPD and advance the standard of care. Such advancement will require partnership and engagement with all stakeholders, patients, healthcare professionals, payers, patient advocate groups, and policymakers. And to that end, SAGE is already collaborating with these stakeholders to gain the insights we need to effectively prepare our go-to-market approach for Zoranolone to help those living with MDD and PPD. Our goal, if Zorano is approved, will be to execute a fit-for-purpose launch that prioritizes deep stakeholder insight driven by data, analytics, and monitoring that we believe will enable us to strategically deploy our resources across all channels at the right scale. These targeted engagements are needed to enact the change necessary for MDD and PPD patients to get the care they deserve and for appropriate patients with MDD and PPD to receive xeraniline. From our stakeholder interactions, we know that there are many types of people with MDD who could potentially benefit from a treatment like xeraniline. They include treatment-naive young adults, such as college students who have an acute stressor that triggers depressive symptoms that derail their lives. People are receiving an antidepressant treatment but still suffering. Those with breakthrough symptoms or an acute trigger, such as a death in the family, amplifies MDD symptoms despite current treatment. Adherence challenge individuals, and importantly, older adults where chronic polypharmacy is a challenge and adding another chronic treatment would not suffice. As we think about those we could potentially treat, it's important to highlight the unmet need among patients diagnosed with MDD who present with elevated anxiety as a symptom of their depression. Current literature suggests that nearly 55% of people with MDD experience elevated anxiety as part of their depressive symptoms. And when treated with antidepressants, this patient group experiences poor depression treatment outcomes and lower remission rates. We've learned that from a clinician's perspective, these patients are incredibly challenging to treat, as current antidepressants are inadequate at resolving the totality of lifelong symptoms these patients experience, and they may increase associated challenges like anxiety and sleep deprivation. However, Zoranilone's mechanism of action is distinct from current antidepressants. Based upon data seen in our MBD study to date, which have included both patients with elevated anxiety as a symptom of their depression and those without symptoms of anxiety, including data on improvements in quality of life, we believe Zoranilone may be well-suited to address a clear unmet need for people with MBD regardless of their baseline anxiety symptoms. It's also important to note that for women struggling with PPD, many present with anxiety as an important feature of their disease. I'm confident in the profile we've seen with Zoranil and clinical studies to date, including the data we've generated showing improvement in both core depression symptoms as well as anxiety symptoms in patients with MDD and PPD, and the differentiated tolerability profile to date, and look forward to sharing more on this program throughout the rest of the year. Now, beyond Zoradalom, we continue to make sustained progress across both our neuropsych franchise, led by SAGE 718, a wholly-owned first-in-class NMDA receptor PAM, being developed as a potential oral therapy for cognitive disorders associated with NMDA receptor dysfunction, and our neuro franchise, led by SAGE 324, which is being evaluated with our collaborator Biogen as a potential treatment for patients suffering from essential tremor and other neurological disorders. Across both franchises, we have six ongoing and planned phase two studies in the neuropsych franchise with stage 718. These include dimension and surveyor, both for patients with Huntington's disease cognitive impairment, precedent for patients with Parkinson's mild cognitive impairment, and a phase two in patients with mild cognitive impairment and mild dementia due to Alzheimer's disease. In the neurology franchise, these include panic two and a long-term open label safety study, both studying patients with essential tremor. Each of these studies has been intentionally designed to inform paths forward for both SAGE 718 and SAGE 324 that focus on outcomes which are most important to patients. We look forward to providing updates on these studies as they become available. I'm also really excited to welcome Dr. Mark Pollack to SAGE as Senior Vice President, Medical Affairs. Mark brings significant experience in scientific research and medical practice across industry and academia to organizations. In his role at SAGE, he will lead our global medical affairs efforts across our programs. Scientific exchange, KO insights, publications, presentations at scientific congresses, and plans for phase 3B4 studies are critical aspects of our medical affairs strategy. I'm confident that Mark's contributions across SAGE will help to further support our relationships with the medical community and patient advocates in support of our goal to become the leader in brain health. In reflecting on our progress during the first quarter and recent weeks, I'm proud of the effort and commitment across our organization as we continue on our mission of pioneering solutions to deliver life-changing brain health medicine. I want to extend my thanks to the entire SAGE team for their hard work and dedication on behalf of patients and their families. Looking ahead to the remainder of this year, I believe it's truly an exciting time at SAGE as we endeavor to bring long-term value to patients, our employees, and key stakeholders alike. With that, I'd like to turn the call over to Jim for a more detailed discussion of our portfolio progress and current clinical experience. Jim? Thanks, Barry, and good morning, everyone. In the first quarter of 2022, we made important progress across each of our three brain health franchises. Beginning with our depression franchise, we're pleased to have initiated the rolling NDA submission in MDD for this program. As a reminder, we're developing Zoranilone in collaboration with Biogen. With the choral study data shared earlier this year, we now have six positive clinical trials with Zoranilone in MDD and PPD across the landscape and nest programs and the Shianogi Phase II trial in MDD. The clinical profile we have seen to date includes, one, a rapid and sustained reduction in depressive symptoms, two, a well-tolerated safety profile, three, improvements in quality of life and overall health across domains of feeling, functioning, and well-being that were reported by patients and continued post-treatment in the studies where we collected these data, or a short treatment course with potential to be taken as needed and a novel mechanism of action. And five, the potential for a flexible treatment approach in MDD and PPD that may provide optionality to healthcare providers and patients if Zoran Loan is approved. Turning to PPD, we are on track to report top-line data from the Skylark study in mid-2022. And pending completion and results of the Skylark study, we plan to submit an associated MDA submission for Zoran Loan in PPD in early 2023. The Skylark study forms an important component for our planned NDA filing package for Zoranilone and PPD. The design of the Skylark study is similar to the Robbins study, where we saw positive results in moms with PPD. As a reminder, the Robbins study was a Phase III study evaluating the effects of Zoranilone 30 mg on depressive symptoms in approximately 151 adult women diagnosed with PPD. In the Robin study, we saw a statistically significant reduction in depressive symptoms in the Zoranilone R compared to placebo at day 15, the primary endpoint, as well as day 3, day 8, day 21, and day 45. Additionally, Zoranilone was well-tolerated in the study with a safety profile consistent with what we've seen across the totality of the program. The Skylark study incorporates the learnings from the Robin study. and was developed as a placebo-controlled Phase III clinical trial evaluating a two-week course of Zoranilone in women with PPD with an additional short-term follow-up. Notably, the Skylark study differs from the Robin study in three key areas. First, the dose. The Skylark study is evaluating a 50-milligram dose of Zoranilone, whereas Zoranilone 30 milligrams was used in the Robin study. Second, the Skylark study is larger than the Robbins study. As a reminder, the target enrollment for the Skylark study is 200 participants. Third, the Skylark study enrolled patients with PPD who were within 12 months postpartum, rather than limiting enrollment to those within six months postpartum. This change casts a wider net for enrollment, but patients are meaningfully different. We recently announced in March that enrollment in the Skylark study has been completed. We believe that the trial's primary endpoint, the change from baseline as measured by the HamD total score at day 15, is a valuable measure for this study and population, as shown in other studies across the program. Specifically, we believe that achieving statistically significant separation from placebo at day 15 with a tolerability profile consistent with that seen in other studies with Zoranilone would constitute success in the Skylark study. We believe these kinds of results including a rapid reduction in depressive symptoms with a short two-week course of treatment in women with PPD, would support a target profile for Zoranlin that would be meaningful in addressing unmet needs for women with PPD. Additionally, based on our conversations with the FDA to date, we believe statistical significance of day 15 in the Skylark study, along with the Robin study and safety data from the entire Zoranlin program, would support the associated MDA filing in PPD we've planned for early 2023. I will also point out that because PPD often presents very similar to MDD with elevated anxiety, we are encouraged by the positive results we've seen in patients with MDD presenting with elevated anxiety as a symptom of the depression in the landscape program. Most importantly, we believe the Skylark study can positively contribute to the body of evidence that we have assembled for Zoranlin and PPD, so that if Zoranlin is improved, moms with PPD and their doctors can be informed and empowered in assessing Zoranlin as a treatment option for PPD. We look forward to updating you on the top-line results of the Skylark study mid-year and providing more detail on our planned associated MDA filing for Zoranlin and PPD. I'm also excited to share that we've completed our clinical pharmacology studies with Zaranloan, including a human abuse potential, or HAP, study. In the HAP study, doses of Zaranloan representative of the planned target range of 30 to 60 milligrams were significantly less preferred than alprazolam at either 1.5 or 3 milligrams by recreational depressant users, the standard population for this type of trial. We plan to present the data from this study at the College on Problems of Drug Dependence annual meeting in June. We also look forward to sharing several exciting presentations of data from CORAL, Shoreline, and the totality of the Landscape and Nest clinical development programs at the upcoming American Society of Clinical Psychopharmacology annual meeting, also in June. I'm proud of our work with Zoradalyn, and I believe the progress we've made with this important product candidate demonstrates our commitment to delivering life-changing brain health medicines so every person can thrive. I look forward to providing more updates on Zoranilin in the future. Now I'd like to discuss the progress in our neuropsychiatric franchise led by SAGE718, our lead NMDA receptor positive allosteric modulator that is a potential oral therapy for disorders where impairment of cognition is one of the main drivers of disability. As a reminder, SAGE718 was granted fast-track designation by the FDA as a potential treatment for cognitive impairment in Huntington's disease, or HD, which is an important benefit in our development efforts to bring this therapy to patients. In addition to exploring the use of SAGE718 in HD, we are also evaluating its treatment potential for patients with mild cognitive impairment due to Parkinson's disease, or PDE. and patients with mild cognitive impairment and mild dementia due to Alzheimer's disease, or AD. Starting with SAGE 718 in HD, we are currently enrolling the DIMENSION study, a placebo-controlled phase two study of SAGE 718 in HD cognitive impairment. Additionally, we recently announced that we have initiated the SURVEYER study, our second phase two study of SAGE 718 in HD cognitive impairment. We designed the dimension study to be robust with a target enrollment of 178 patients with HD cognitive impairment that we expect to enroll across 40 clinical sites. Given the tremendous unmet global need in treating HD, we believe that there is a unique urgency to deliver an efficacious, safe therapeutic for patients with HD cognitive impairment. As we've previously stated, if the dimension and surveyor studies generate robust and compelling data, then we will consider the opportunity to engage with regulators to identify a potential path forward to expeditiously bring SAGE 718 to HD patients in need. Turning to our progress in evaluating SAGE 718 for patients with mild cognitive impairment due to PD, we recently announced the initiation of the PRECEDENT study, which is a Phase II placebo-controlled study of SAGE 718 in patients with mild cognitive impairment due to PD and acts as a follow-on study to the open-label paradigm study in which SAGE 718 showed a positive impact on multiple domains of cognition in patients in that study. Finally, we are advancing our efforts to evaluate SAGE 718 in patients with mild cognitive impairment and mild dementia due to AD. Following the positive results from the open-label luminary study in which patients with mild cognitive impairment and mild dementia due to AD who were on SAGE-718 experienced improved performance from baseline on multiple tests of cognitive function. We are on track with our plans to initiate a placebo-controlled phase two study with SAGE-718 in patients with mild cognitive impairment and mild dementia due to AD in late 2022. I would also like to spotlight data that we presented at recent medical meetings and scientific congresses that underscore the potential for our SAGE 718 program. In March, we presented data at the ADPD 2022 Advances in Science and Therapy International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders, showing that SAGE 718 was associated with improvements on multiple tests of executive functioning and learning and memory, in patients with MCI due to PD in the Open Label Phase II Paradigm Study, Part A. Additionally, in April, we presented data from the Phase II Luminary Study that showed SAGE-718 was generally well-tolerated and associated with improvements on multiple tests of executive function and learning and memory in patients with MCI and mild dementia due to AD at the 74th Annual Meeting of the American Academy of Neurology. With these presentations at important scientific forums, we're proud that the Sage 718 program has generated positive reactions from the scientific community regarding its unique potential to be developed to treat brain health disorders where impairment of cognition is one of the main drivers of disability. We are excited about the tremendous progress made with our Sage 718 program and look forward to providing updates as they become available. Now I'd like to highlight the advancements made in our neurology franchise, led by SAGE324, a next-generation positive allosteric modulator of GABA-A receptors, which we believe holds significant potential in the treatment of neurological conditions like essential tremor, or ET. As a reminder, SAGE324 is being developed as part of our collaboration with Biogen. Based in part on the positive data from the Kinetics study, We recently started enrollment in the Phase 2b Kinetic 2 dose-ranging study evaluating Sage 324. Kinetic 2 is designed to optimize the dose and frequency of Sage 324 in ET. We also shared the study design for our planned Phase 2 long-term open-label safety study with Sage 324 in ET this morning. This study is designed to assess the long-term safety and tolerability of Sage 324. Our plan is for this to be a multi-year study with the incidence of treatment-emergent adverse events as the primary endpoint. More details are available on slide 45 of the corporate deck on our website. To close, I believe we have made important progress across our pipeline throughout the first quarter, leaving us well-positioned for focused execution in 2022 and beyond. Now I'll turn the call over to Kimi for a review of our financials. Kimi?
spk08: Thanks, Jim. Our financial results for the first quarter of 2022 are detailed in our press release issued this morning. So I'll only highlight some of the key points here. I believe 2022 so far has seen us continue to execute as planned. Backed by a strong balance sheet and with upcoming milestones, I'm confident that our progress during the first quarter and in the period since then moves us closer to our goal of delivering life-changing brain health medicine and bringing long-term value for patients, communities, and key stakeholders. Our net loss for the first quarter of 2022 was $122.1 million, and we ended the quarter with cash, cash equivalents, and marketable securities of $1.6 billion. Turning to operating expenses, R&D expenses increased to $78 million in the first quarter of 2022, compared to $58.1 million for the same period in 2021. The increase in spend was related to advancement of our pipeline beyond serone alone, including spending on stage 324 and our wholly-owned pipeline, which includes stage 718. As a reminder, we have six planned and ongoing phase 2 studies across our neurology and neuropsychiatry franchises. We're excited to continue advancing programs across our franchises with efficient study designs that allow us to be proactive and predictive in our R&D approach. SG&A expenses increased 46.5 million in the first quarter of 2022, compared to 39.8 million for the same period of 2021. The increase is primarily related to hiring employees to support ongoing activities in anticipation of potential future launches of our product candidates. Also notable this quarter, we recorded $20 million in reimbursement from Biogen related to our collaboration and license agreement. Recall, the collaboration includes a 50-50 cost sharing in the United States for Xeranolone and Sage 324. The savings from the cost sharing for Xeranolone and Sage 324 enabled us to use our cash on hand to continue to invest in advancing our wholly-owned pipeline in a smart and disciplined way. Looking forward, we're reaffirming the financial guidance we provided earlier this year. We anticipate having cash, cash equivalents, and marketable securities of approximately $1.3 billion at the end of 2022. We do not anticipate receipt of any milestone payments from collaborations in 2022. But we believe that our current cash cash equivalents, anticipated funding from our ongoing collaborations and potential revenue will support operations into 2025. I believe that we're well positioned to continue the focused execution we've demonstrated throughout the beginning of this year. At SAGE, we pride ourselves on being courageous, innovative, and efficient across everything we do, always with line of sight on how this work can benefit patients. I look forward to providing additional updates on our progress throughout this year. I'll now turn it over to Helen to handle Q&A with the operator.
spk10: Helen? Thanks, Kimmy. Before I turn it over to the operator, I'll ask that you limit yourself to one question. If you have an additional question, please feel free to return to the queue. Now, I'll turn it over to the operator to handle Q&A. Operator?
spk05: To ask a question, you need to press star 1 on your telephone. And to withdraw the question, just press the pound key. Please stand by while we compile the Q&A roster. Our first question will come from the line of Laura Chico from Wedbush. Your line is open.
spk17: Hey, good morning, guys. Thanks for taking that question. I guess one question on Skylark. Just wondering if you could remind us on a clinical rationale for extending that eligible window to 12 months for a depressive episode. I realize that this probably facilitates enrollment, but from a scientific perspective, how does this affect the heterogeneity of your enrollment population? Thank you.
spk22: Hey, Laura. Thanks for the question. I really appreciate it. Look, we're really excited by The Skylark study, and as Jim highlighted on the call, it really is a repeat of the Robin study with a couple notable changes. The 50 milligram change, the bigger N, which is important. And as you highlighted, seeing women with depression out to 12 months versus just six months. They really aren't that different. And Jim, do you want to just highlight that rationale? Yeah, Barry, absolutely. And Laura, as you mentioned, it certainly... gives us a wider net for patients to enroll in the study. But importantly, you know, the case that women with PPD have onset of PPD sometime between the third trimester of the first six months, but the symptoms persist, and we've known that for some time. So in our estimation, it really isn't changing the population all that much. It just gives a wider set of women the opportunity to participate in the trial.
spk17: Thanks, guys.
spk21: Thanks, Laura.
spk05: Our next question is from the front line of Yasim Rahimi from Piper Sandler. Your line is open.
spk09: Hi, yes, this is Lauren. I'm for Yasmin. Thanks for taking my question. So looking across the landscape studies, when you look into the safety profile for xeranolone, what rates of stimulants were you seeing, and what do you consider mild, moderate, and severe percentage-wise? And then kind of a follow-up to that, do you see similar rates of somnolence and sedation in patients with and without anxiety? Thank you.
spk22: Yeah, Lauren, thanks for the question. Please say hi to Yaz for us. So, you know, if we step back, what we're seeing is an incredibly broad therapeutic index with Zoranilone. Jim highlighted the efficacy profile, the rapid reduction of depression and anxiety without any impact to sleep, the long duration of effect, and a really well-tolerated profile. Keep in mind that in MDD patients, PPD patients, with or without anxiety, there's often a challenge for them sleeping, and many of them have sleep aids. So having some degree of somnolence is actually a benefit to these patients. Jim, you want to talk about rates? Yeah, absolutely, Barry. And, of course, now that we have the entire landscape program assembled, of course, we have the ability to measure rates. somnolence and sedation in the efficacy trials, which we spent a lot of time talking about. These are also metrics that are included in the clinical pharmacology trials, for example. And so we have the ability to look at sedation and somnolence rates across multiple doses. And so, of course, as we talked about before, rates are dose-dependent. But I do think probably the ranged quote would be somewhere in the teens for somnolence, depending on the trial. low teens to high teens in other trials, depending on specific trials and specific dose. And that, we think, is consistent with the mechanism of action and consistent and compares quite well with the rates of safety and stop and lengths associated with current standard of care antidepressants. And I will highlight, to keep in mind, that we're not seeing the stigmatizing side effects often seen with antidepressants, things like weight gain, sexual dysfunction. And as we report out of CORAL, you see a significant amount of GI upset with antidepressants, too. And we don't have those side effects, which often lead to compliance challenges.
spk09: Perfect. Thank you.
spk05: Our next question will come from Jay Olson from Oppenheimer. Your line is open.
spk21: Hey, guys. Congrats on the process, the progress. This is Matt on for Jay, and appreciate you taking our questions. So we were just curious about any physician feedback that you received at AAN on page 718. Particularly curious how they view the patient-reported outcomes data in early HD patients, along with any feedback on luminaries. That would be great. Thank you.
spk22: Matt, thanks. Appreciate it. And please send our best to Jay. And really appreciate the congratulatory note on starting a rolling submission. That's a big deal, and we're really proud that we hit our guidance and started the rolling submission. We can say that what was encouraging at AAN with Sage 718 is when, you know, Aaron Honig presented the data, both in terms of live presentation and poster session. It was probably the most crowded presentation and one of the most exciting things presented at AAN. His poster was packed, and the rooms were mobbed with presentations. And I can say that the feedback we saw from those attending, the physicians attending and other health care providers, was incredibly encouraging. As you know, what's gone on in this world are amyloid hypotheses and other approaches. We really haven't seen an opportunity for a drug to improve cognition. And there was a lot of excitement with the data presented both in Alzheimer's and Parkinson's. Chris, you were there. Do you want to Talk a little bit more about what you heard personally?
spk20: Yeah. So personally, there was a great deal of excitement, as Barry mentioned. I think in standing back and reflecting on it, I think from a clinician's perspective, they really understand the impact that this can have on the patients that they see day in and day out. And right now, there are not other options available for patients, whether they have Huntington's disease, Parkinson's disease, or Alzheimer's disease, living with mild cognitive impairments. And what we heard is there really is nothing mild about mild cognitive impairment. These are patients who are really suffering from the effects associated with cognitive impairment and a loss of independence. And it's really important as we think about going forward the difference that we can make in these patients with SAGE-718 because those moments are precious for patients that are living with these diseases. As someone who has a dad with Parkinson's disease with mild cognitive impairment, those moments are few and families and friends would like to get those back.
spk21: Got it. Thank you so much. Thanks, Matt.
spk05: Our next question is on the line of Corey Casimo from J.P. Morgan. Your line is open.
spk13: Hey, guys. This is Tiffany. I'm for Corey. Just one to add on 718. Can you just talk about the trials design differences in the recently initiated Phase II Parkinson's study versus the prior paradigm study, and what are you kind of hoping to see with this, and also any sense of cadence for updates? Thank you.
spk22: Hey, Tiffany, thanks for the question. So, I'll do the update part first and then ask Jim to talk about the different trial designs and, you know, why we did such robust trials. So, look, the trials are, as we highlighted in the call, are up and running. As we like to do, we want to get sites activated and see what the trial accrual looks like, and then once we're comfortable, we'll provide clear guidance on when we believe the trial will come to fruition. But, Jim, you want to talk about the different designs and how we size them? Absolutely, Barry. Yeah, so the precedent study represents what will be the first placebo-controlled study for CH718 in patients with cognitive impairment due to Parkinson's disease. And, of course, as you know, we think about this as a concept of serial de-risking. So the earlier study in Parkinson's disease was a small open-label study designed to give us both an early look at whether or not, say, 718 was providing benefit to this patient group, but also the opportunity to really hone the safety, sorry, the study design for the precedent study. So the precedent study, unlike the earlier study, is a 42-day duration dosing, so the dosing period is longer in precedent. Of course, it is a placebo-controlled study, and then we'll have a follow-up period after the dosing period. So three months dosing, placebo-controlled study.
spk13: Great, thanks.
spk05: Thanks, Tiffany. Our next question comes from . You may begin.
spk14: Good morning, everyone. Thanks for taking the question. I wanted to ask about the rolling submission and what you're going to be asking for. I guess one, can you, Barry, can you go through just the outstanding items before you guys can submit the clinical module and what the most important gating gating steps are to that. And second, just given you're going after sort of a broad population, you outlined, you know, treatment naive, but also patients who are sort of resistant to previous treatment attempts, whether through adherence or efficacy, what will you be asking for on the label and what sort of, you know, benzo black boxes do you think will translate, especially that most recent one? Thanks.
spk22: Yeah, Ritu, thanks for the question. So, a couple things. Let's start with the NDA rolling submission, and then we can talk about what we'll be looking for. So, as you saw today, we're very excited to have started the rolling submission with the non-clinical section. As Jim highlighted, all the pharmacology work is done, and all of the clinical studies are done. So, it's really a matter of compiling the studies, going through the QA processes, and making sure we have the highest quality submission. We will let everybody know when we've finished filing the NDA in the second half of the year, and then we'll communicate further when the NDA is accepted. So those will be the communication. But I can say that all of the sections, all of the modules are in very good shape. It's really a matter of getting the work done. As we've highlighted in previous calls, the two items that are getting wrapped up, we announced the CORAL study very excitingly, and we're translating the Japanese study into an NDA filing study. So that's a chunk of work that the team is working through. But we're well on track to finish in the second half of the year. In terms of what we're asking for, it's too early to talk about label specifics or any kind of warnings But what we are seeing and studying is we have a drug here, Zoranolin, for the treatment of MDD and PPD with or without elevated anxiety. So that's the kind of discussions we envision having with the agency. In terms of warnings, again, too early to talk about specifics. We'll have some of the typical things in there. Don't operate heavy machinery until you know how the drug works, things like that. But we're not sure if we'll have durandalin-specific issues or warnings or class-like warnings. It's too early to tell. We're certainly going to, you know, accept certain warnings that are classic, like I just highlighted, and, you know, maybe push back on some others because if we're not seeing certain effects, we don't think we should have warnings there.
spk14: Got it. Great. Thanks. I'll get back in the queue.
spk22: Thanks. You too.
spk05: Our next question we'll find now is from . You may begin.
spk15: Hi. Thanks so much for taking our question. This is Tommy on for . And we wanted to ask about 718. You've seen some interesting results in both Parkinson's and Alzheimer's suggesting a durable benefit beyond the dosing period. And so how are you thinking about the potential dosing regimens going forward? Do you feel like chronic dosing is necessary, or is there the possibility of shorter or less frequent dosing? Thanks.
spk22: Yeah, Tommy, great question. Appreciate the attention on stage 718. So, you know, as Jim highlighted, you know, we continue to learn and serial de-risk the studies. We're excited by the efficacy we've seen and by the very, very broad therapeutic endo. We're talking about really low doses of stage 718 as a NMDA-PAM. So we do believe that CH70, at this point, will be chronically dosed. It's too early to know if there'll be any kind of dosing breaks, but it doesn't seem to be required because while the effects are durable due to brain circuitry rewiring, we don't see any kind of tolerability challenges or tachyphylaxis that would warrant any kind of periodic dose or dose interruption. So right now, we believe it's a chronic drug. Jim, anything to add? No, just, Barry, that part of what the status studies are designed to do is to give us further information about how the drug is performing with repeat dosing. As Barry said, our current assumptions are chronic dosing, and we have enough diversity amongst clinical trials to give us a little bit better sense of how the drug performs specifically. And so I think this is just part of the process. So up to date, we have data from relatively short-duration dosing, 7 to 14 days, But as we go to the next round of studies, we'll have long-duration dosing and really get more detailed into the specific questions about how 718 can be delivered.
spk08: Thank you.
spk22: Thanks, Tommy.
spk05: Our next question comes from the line of Akash Tiwari from Jeffery. You may begin. Hi.
spk07: This is Leo for Akash. Thank you for taking our questions. Previously, you mentioned you have VBAs with payers and payers could use ICD-9 or TAMCO to monitor the use of seranolone at the population level. How should we think about the mechanics of revenue recognition for seranolone? Do you set a reserve for potential callback from the payers if patients use more courses of seranolone in one year? In addition, When you have conversations with payers, do they mention any potential requirement for prioritizations or requirement of patients to try generic antidepressants first? And then does VBA actually lower the payer's requirement for prescribing to run alone? Thank you.
spk22: Yeah, thanks, Leo. Let me try to unpack a couple of those questions, and then I'll ask Kim to talk about... revenue rec, and then Chris to talk about sort of what we're hearing from payers. So if I step back, we've articulated that part of our commercialization strategy is leaning in with proactive value-based agreements. Our ask of payers is that if a healthcare provider writes a script that patient deserves Zoranilone, get Zoranilone without step-throughs and without prior-offs. It's very important, given the features of Zoranilone, that if someone's depressed, they get Zoranilone quickly so they can get better in two or three days. Every day to these patients is is a lifetime and matters. So waiting weeks to get better is just not okay. And as we know from health and health economic perspective, undertreated or delayed treatment results in long-term comorbidities and costs. So getting patients better fast and keeping them better is critical. And our agreement or our ask with payers is that, again, if a script comes in, it gets filled without a lot of hurdles. Our give for that is to understand what challenges payers might have. So, for example, a payer might be nervous about epidemiologically how many of their patient population is suitable for seranolone. We can protect them if it goes over that. They might be concerned that their patient population, instead of needing one to two TUI courses the course of the year, which they budgeted for, might need three or four or five, which they didn't budget for. And what they want is budget certainty. So we can protect them against that. And every payer conversation is unique, and I can say they're going incredibly well. Kimmy, do you want to talk about sort of RevRec and how that might work in Biogen's hands? And then Chris can talk about some of the feedback we're actually hearing from payers at this time.
spk08: Great. Sure. Thanks. So let me just give you a little color on how to think about the revenue from the perspective of the P&L. So, you know, currently our collaboration R&D expense and SG&A expense are all included and recognized in our operating expense line. We net our reimbursements in that line. So that's how it will show until commercial launch. But as we get to commercial launch, if Zorin alone is approved, we expect that our net profit share will be recorded in the profit share revenue line in our P&O. And that profit share revenue line would reflect 50% of the product revenue and then we would reduce it by the collaboration-related SG&A expenses. So that would be in the revenue line. We'll continue to show the R&D expenses in the R&D line, net of any reimbursement. We'll certainly provide additional clarity as we get closer to launch on exactly how that will look. So I'll turn it over to Chris now.
spk20: Yeah, sure, and I'll take it, Barry. Leo, thanks for the question. So right now, as you might imagine, we are deeply engaged with national and regional payers, as well as PBMs and IDNs. And what we're hearing is that there remains a profound unmet need with respect to the treatment of both MDD and PPD for patients that are coming in at the plan level. Despite the fact that there's been 35 therapies over the last 30 years, there's not been significant advance that's provided the solution not only for physicians and patients, but for the payers who are working in this space. So now with that said, as they step back and they think about treating this patient population, they also recognize that there are complex comorbidities that these patients often suffer from. Quite often it's cardiovascular disease or other neurological conditions, and that has real long-term costs associated with it for the plans that they need to actually consider as they think about the treatment of this patient population. So when we begin to have discussions around Zoranolone, the idea of a therapy that gets patients better faster, that's well-tolerated, that can be delivered in a short-course therapy, that doesn't carry those stigmatizing side effects of sexual dysfunction and waking that often are determinants of adherence, this is a highly attractive therapy for payers. And it has been really positive and productive conversations that we've initially had, and we look forward to continuing on with those.
spk07: Thank you very much.
spk22: Thanks, Leo.
spk05: Our next question comes from Paul Matase from Stifel. You may begin.
spk16: Hi, this is James on for Paul. Thanks for taking the question. Maybe just a quick one on regulatory now that the process has kicked off. I guess I'm curious, how are you thinking about redosing and, you know, in Shoreline there was restrictions around, you know, when a patient can be redosed, and I guess how are you thinking about the potential of of any sort of restrictions around, you know, labeling or anything like that when it comes to redosing, and if there are, you know, how that may play out commercially. Thanks.
spk22: Yeah, James, thank you for the question on the regulatory pathway. And, again, you know, we're excited to have started the rolling submission this week. So Shoreline will be a critical part of our submission. And just to remind everybody, what we saw in Shoreline, which is the largest naturalistic study run in MDD, where patients are actually asked after the two-week dosing every other week how they're doing. So while it's not placebo-controlled, patients are often asked how they're doing. So what we've seen is the majority of patients in the course of the year only required one two-week course of treatment, and then 80% only required one or two two-week courses of treatment. So in the real world, we think that the majority of patients treated in will require only one or two-week courses. And of course, as I explained with Leo's question, part of the value-based agreements will be providing protections over a couple two-week courses of treatment. So we don't know exactly how the discussion will go. We have data up to five retreatment courses. We have not seen any additive safety with retreatment. In fact, The adverse event numerically actually goes down with each and every course. So we've got a good argument to allow retreatment when allowed as rapidly. As Jim already highlighted, in the pharmacology studies, we've got higher doses, extended doses. So there's no reason in the real world that if someone... is better after two weeks and then a month later per se needs another retreatment, there's no reason why they couldn't get it from a data perspective. Now, don't go into an extreme. If the agency were to restrict the retreatment to a timeframe or only to two TUI courses in the course of a year, While we think that's terrible for patients and not the right thing to do, it really won't have much of a commercial impact because our commercial estimates are that one to two week course of treatment for the majority of patients.
spk05: And our next question will come from the line of Mark Goodman from SVB Securities. You may begin.
spk02: Thanks for taking my question. This is really on the line for Mark. Can you grant an initiation of the rolling and day submission? So I have a question regarding the phase two surveyor study of stage 718. So it seemed like we have both Huntington's disease and a healthy subject in the study. Can you provide more color on the trial design and what is the rationale of adding the healthy participants as the comparator arm? Thanks.
spk22: Yeah, Rudy, again, and thank you for the congratulatory note. So as we're thinking about Huntington's disease and starting with Huntington's, as everyone's aware, it's an orphan disease where a drug designed to improve cognition has just not been developed. So we're really forging new regulatory pathways. We believe that the sizing of dimension in the surveyor study in totality, should the data be positive, would give us significant energy to approach regulators for the fastest way to get the drug to market. So as an overall package, that's how we're thinking about the study. The numerical values and dimension coupled with the real-world evidence in surveyor. So that's the overall strategy and thought process. But, Jim, you want to talk more about surveyor? Sure. Yeah, absolutely, Barry. Now, probably the thing to know first about Surveyor is this is the study where we're beginning to understand how the cognitive measures that we've been studying so far will translate into measures of function that are going to be meaningful to patients. And so really, Surveyor is designed to be complementary to the dimension study. And what we're trying to do in Surveyor is to understand the linkage between the primary endpoint, which is looking at the composite score from the Huntington's disease cognitive assessment battery. But many of the tests are quite similar to the types of tests that we've been studying so far. We want to be able to link that to performance in a variety of real-world-based assessments. So that's really the purpose of Surveyor. As you mentioned, there is, in addition to that, a healthy participant groups. So there are three arms in Surveyor. So the subjects from the HD group will be randomized either to, say, 718 or to placebo. So we get that placebo control looking at the endpoints I was mentioning. But in addition to that, we're including a healthy participant group. And that really is to begin to get some assessments of healthy performance with the batteries. So those folks are not being tested with, say, 718, but they are going to be tested with the battery's of cognitive tests and real-world endpoints that we're looking at. Got it. That's very helpful. Thanks, Rudy.
spk05: Our next question will come from the line of Yatin Sunidja from Guggenheim.
spk03: You may begin. Hey, guys. Thank you for taking my question. Question on Kylar, can you just talk about the expectation? What feedback have you received from the KOLs in terms of the efficacy that different for PPD versus MDD? Just trying to get a sense of the delta that we should be expecting on the MDD. And then how would the redosing work in PPD, which is generally defined as a little bit of a temporary depression? Will those women be eligible to get only one dose or could they get an additional dose? Thanks.
spk22: Yeah, thanks for the question. So, look, we're excited by the Skylar study, and as we highlighted, we're on track to read that out mid-year. We've, you know, Jim highlighted this in the call. We have Robin and a number of other positive studies, and as we highlighted, PPD is very much like MDD with elevated anxieties, depression. So we believe that with a positive Skylark study, and just to be clear, stat sig at day 15 without any surprising side effects is what we're looking for for a submittable study for PPD. In terms of redosing, that will really be up to a healthcare provider and the patient. As you said, what's generally believed is that the depressive episode is caused by pregnancy or childbirth. and that what we've seen is that most moms, when given either Zolreso, which we have commercially, or Zoranil in our studies, stay better for a long period of time. If six months, 12 months, 18 months later, they have another depressive episode, that typically gets classified as MDD, and they can be retreated at that point, but more from an MDD diagnosis.
spk03: Thank you.
spk05: Our next question will come from the line of Ami Fadia from Needham. You may begin.
spk06: Hello, guys. Thank you for taking the question. This is Amin for Ami. The question we have is related to the discussions you have with the payers. You mentioned that so far the discussions that are going on are very positive. I wondered if you engaged in any discussions that the peers were kind of concerned about the priority that you prefer to have compared to what they have in mind is usually the generics and the approved drugs, the recent approved drugs. If you can elaborate on that, that would be great.
spk22: Yeah, I mean, thanks for the question. So, you know, again, within the context of proactive value-based agreements, the overall view, we have engaged payers. We're certainly talking about disease state awareness. Some payers have certainly read everything that's been publicly released, so the discussion of Zoran alone and data come up. And Chris highlighted this earlier, but I'll summarize it quickly. What we're hearing from payers is is that while depression is no longer a very large category because of the generic nature of available antidepressants, they have recognized, and the words they use is patients cycle through many drugs. It's a problem for them. Even though it's going from one cheap drug to another, having patient population that are depressed remain depressed, they recognize leads to longer-term comorbidities. They stay depressed. People that stay depressed have a higher likelihood of cardiovascular events, diabetes, and even infectious diseases. It's been well documented that the depressed population, for example, has a higher prevalence of getting COVID or being hospitalized. All that costs payers. So what we're hearing from them is, you know, if under the context of value-based agreements, so we're being fair to them, they'll be fair back, they're actually seeing agreement that if a health care provider writes a script for Xeran alone, they fill the script. And what we're trying to do, to the extent we can, is we're trying to avoid prior auths, we're trying to avoid step-throughs, because that's the wrong thing to do for patients.
spk06: Thank you. That was very helpful.
spk05: Our next question will come from Gary Machman from PMO Capital Markets. You may begin.
spk19: Hi, thanks for taking our question. This is Evan Huang for Gary Nachman. I just had a question. Would you be able to talk about the timing of PPD and MDD approvals and when that could come? Given that PPD has fast track designation, could PPD approval come at the same time or even earlier than MDD?
spk22: David, thanks for the question. So I can give you generalities, and we were very much aided by our strategic discussion with the agency in the fall of last year. Just to remind everybody, we had highlighted that when we started the Landscape and NETS programs, we had alignment with the agency that we needed one more positive study for a file of a package. Waterfall was that positive study. Following Waterfall, we met with the agency in the fall of last year. And the agency was very helpful understanding that while we had to file the package, we had two studies up and running, the coral study, which we've announced is positive, and the upcoming Skylark study, which we plan on announcing mid-year. And, again, the strategic discussion said, let's file MDD first, which we've just started the rolling submission, and then file PPD as an additional NDA after that. And what we're hopeful for, although, you know, timing's not perfect, in our hand is that with approval of Zoranilone for MDD, we then commence a DEA review, which is typically a three-month review. And given, as you said, the priority review, we're hopeful in that period that we can get PPD approved and launch both indications at the same time. You know, if MDD comes first and PPD comes a month or two after, that's fine as well, but that's the goal. And, you know, sometime, you know, after we submit, sometime next year, we hope to get the approval of MDD and then followed by PPD thereafter. Got it. Thanks. Thanks, Evan.
spk05: Our next question will come from the line of Emil Devine from Mizzou. You may begin.
spk04: Great, thanks for taking my question. Maybe just one higher-level question that we get from investors periodically, and just obviously for both Serana Loan and 324, you're partnered with Biogen, and there's obviously a lot of transition and changes happening at Biogen, and it looks like more to come. So I'm just curious if you can sort of talk about the relationship, and sort of on the product level, I guess, as sort of the data, obviously you're doing good progress with the submission and everything along those lines. Those things seem to be on track, but can you just sort of reassure that on the product level, things are still on track in terms of the community you're seeing from your partner? That would be helpful. Thank you.
spk22: Yeah, Vimeo, thank you for that question. Very important question. And, obviously, we all saw the press release this morning of Biogen, you know, unfortunate further restructuring given the challenges they've had with Adelhelm and the search for CEO with Michelle's replacement. Well, you know, what I can tell you is, and the other highlight, I think, in the press release is that they're looking at Xeranolone as a key growth driver for the company. So that's an important comment from them. It's been consistent that their long-range plan is heavily dependent on Xeranolone, which we and they believe will be very important in the depression landscape. So at a team level, we are incredibly well aligned from a CMC perspective, a clinical development perspective, a commercialization perspective. And, of course, we're co-calling the United States, and they're responsible for the rest of the world, except for Japan, Korea, and Taiwan. So things are going incredibly well. Michelle has been a wonderful partner. You know, I wish them well in their search, and I wish him well in his future endeavors. But things are very strong at the senior level and the team level. And, again, you know, that should not be surprising because Zorano is strategically important to Biogen. It's recognized by the board. It's recognized by the entire team, leadership team and community at Biogen. So things are going very well. Okay, thank you.
spk05: Our next question comes from the line of Nina Betrito-Garg from Citi. You may begin.
spk11: Hey, guys. Thanks for taking my question. I was just wondering if you could share a little bit more about the Skylark final population that was enrolled, if you can you know, share how many patients were ultimately enrolled and any notable, I guess, baseline characteristics or differences versus Robin other than, you know, kind of those that you already described in regards to study design. Thanks.
spk22: Yeah, Nina. So, there's not a lot we can say about Skylark until we have the top line results. But, Jim, any color to add? Right. So, I think that's right, Barry. I mean, what we can say is the target enrollment was 200 subjects. So, As we are able to talk about the results in the study coming up, we'll be able to talk about the specifics that were enrolled in the study. But the target was 200. Got it.
spk10: Thank you.
spk22: Thanks, Nina.
spk05: Our next question comes from Simone Carney from Canaccord. You may begin.
spk18: Good morning. Thanks for taking my question. Given the time you have to complete the submission, could you share any latest thoughts you have on how you might be able to target MDD with elevated anxiety as a use case to include in the label?
spk22: Yeah, Suman, thanks for the question. So, you know, what we've highlighted is that we've seen effects of seranolone in MDD with or without elevated anxiety. The reason that we're highlighting the elevated anxiety component is we know through the literature, including studies like STAR-D, that when patients present with MDD and have elevated anxiety as a feature of their depressive symptoms, they often are very much underserved by standard of care. So we think that by highlighting that more from a commercial perspective will help potential prescribers see a patient that might have elevated anxiety and reach for Zoranilone first. Of course, as we highlighted, there's a number of use cases I won't repeat of patient characteristics like the young adult, the elderly, that also with or without elevated anxiety is a piece. You know, whether the data are in or not is too early to tell. I'll remind everybody that in the CORAL study, we prospectively defined that group of MDD with elevated anxiety. So we do have a prospective study that hit very robustly, and we'll see how we can use those data. Thank you. Thanks, Samant.
spk05: Our next question will come from Brian Abrahams from RBC Capital Markets. You may begin.
spk01: Hi, this is Joe for Brian. Thank you for taking our question and congrats on the progress. Just quickly on 324, could you help us better understand the segmentation of essential tremor market? What portion of the patients are currently not well controlled and actually looking for additional efficacy? And are you primarily focused on monotherapy use, or are there any potential for a combinational approach? Thank you.
spk22: Yeah, great question, Joe. Chris, you want to highlight, you know, just the significant essential tremor population and how we're thinking about approaching it?
spk20: Yeah, so initially what we can say is that, you know, essential tremor is one of the most common movement disorders seen in the U.S., and it's estimated to impact approximately 6.4 million Americans and that's approximately one in six with essential tremor are diagnosed and seeking treatment. So clearly there is unmet need, and there's still a gap with respect to our ability to serve all the patients that are suffering from essential tremor. So as we take a step back and we think about it right now, we see it as a sizable opportunity with profound unmet need for which Phase 324 has the opportunity or the potential to be a very important therapy for patients with essential tremor.
spk22: Yeah, and I would just add, Joe, that, you know, based upon the data we've seen in Kinetic, that, you know, 30 to 40-some percent improvement in tremor amplitude associated with improvement in activities of daily living is critical. And when you talk to a patient with essential tremor, that is critical. may be branded as mild. If they can't lift their spoon to their mouth and feed themselves, that's not so mild. So we think there's a very broad opportunity here for a chronic treatment. People with essential tremor want to be covered at all times because whether it's trying to button their shirt or eat or text, they don't want those last moments where they can't do that or need to take a drug and wait several hours. So we're pretty happy with the profile we have, and we'll prove in Kinetic II that you know, a dose and frequency for chronic treatment. Got it. Thank you. Thanks, Joe.
spk05: Our next question will come from Tim Little from William Blair. You may be welcome.
spk12: Hey, guys. This is Lachlan on for Tim. Thanks for taking the question. I had another one similar to Vermeer's question on just the collaboration with Biogen. I had a couple of questions on if they go a new CEO that they wanted to take the company in a different direction, what does the sort of collaboration allow for and how would that impact your plans for Zoranlin and 324?
spk22: Yeah, Laughlin. Again, so Biogen. As we highlighted, from a Biogen perspective, they highlighted in their press release several different times that one of their key growth drivers going forward is Zoranilone. We certainly agree it's a major growth driver for them and for us. We're going to co-co in the United States, but they have the opportunity. to lancetranolone in countries around the world. Depression is as big a problem around the world as it is here, particularly post-COVID. So, it is a very big strategic driver for Biogen. I really don't believe that there's a different direction other than what they've done, which is continue to partner with us effectively, both on the regulatory, the clinical development front, the Phase 3 and 4 studies, as well as the commercialization strategy. So, Things are going incredibly well. We also are partnered with Sage 324, and they're excited about the opportunity there in essential tremor, which we also think will be another growth driver for them. So, you know, unless there's sort of an M&A move, the partnership with Sage, with Serenal, and 324 are a big part of growth drivers.
spk05: Got it. Thanks.
spk18: Thanks, Laughlin.
spk05: And our last question will be from the line of Yasin Brahimi from Pepper Sandler. Your line is open.
spk09: Hi, guys. Thanks again. So just one last question. For the 50-meg dose group, are you planning to share some of the findings from inability of driving the next morning for patients? And then just any color on that. Thank you.
spk22: Hi, Lauren. Yes, we've completed the driving studies, and while it's too early to give specifics and we haven't really negotiated with the agency, there's likely, as we see with many drugs, including OTC drugs, to be those kind of commentary, you know, don't operate heavy machinery until you know the effects of the drug. And a warning like that will not be a problem.
spk09: Perfect. Thanks.
spk05: And I will now turn the call back over to Barry for any closing remarks.
spk22: Thanks, Victor, and thanks, everyone, again, for joining us this morning to review our first quarter progress. I'm really grateful to the entire SAGE team, our patients, caregivers, and clinical investigators, and all who have dedicated so much to help us advance our mission to become the leader in brain health. Current events have put a spotlight on the need for significant progress in brain health disorders and it's never been more important to prioritize addressing these disorders, including mental health disorders, as an essential component to overall health and well-being. At SAGE, we recognize the great unmet need in this space and are working with a sense of urgency to make a difference for patients. In reflecting on our progress achieved during the first quarter, coupled with our expectations for what we hope to achieve in the balance of 2022 and beyond, I'm confident that we're making important progress towards our mission to pioneer solutions to deliver life-changing brain health medicines so every person can thrive. Thanks again, everyone. Have a great day.
spk10: Goodbye.
spk05: This concludes today's conference call. Thank you for participating. Everyone have a great day.
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