Q1 2024 Sage Therapeutics Inc Earnings Call

Operator: Good morning, and welcome to SAGE Therapeutics' first quarter 2024 financial results conference call. Currently, all participants are in a listen-only mode.

Good morning, and welcome to fate Therapeutics first quarter 'twenty 'twenty four financial results conference call.

Currently all participants are in a listen only mode.

Operator: This call is being webcast live on the Investors and Media Selection section of SAGE's website at sagerx.com. This 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.

This call is being webcast live on the investors and media selection section of sages website.

S. A G E R X dot com.

This call is the property of Sage Therapeutics and recordings 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 Ashley Kaplowitz, Vice President of Investor Relations and capital markets at Sage.

Ashley Kaplowitz: Good morning, and thank you for joining SAGE Therapeutics' first quarter 2024 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 and slides related to today's call. I would like to point out that we will be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially.

Ashley Kaplowitz: Good morning, and thank you for joining Sage Therapeutics first quarter 2024 financial results Conference call.

Before we begin I encourage everyone to go to the investors and media section of our website at <unk> Dot com.

Ashley Kaplowitz: You can find the press release and slides related to today's call.

Ashley Kaplowitz: I would like to point out that we will be making forward looking statements, which are based on our current expectations and beliefs. These.

Ashley Kaplowitz: Statements are subject to certain risks and uncertainties and our actual results may differ materially.

Ashley Kaplowitz: Please review 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 Greene, our Chief Executive Officer, who will provide an overview of our progress during the first quarter of 2020. Our Chief Business Officer, Chris Benecchi, will provide an update on the ongoing commercialization of Zerzuba. We will also be joined by Laura Gault, our Chief Medical Officer, who will review development activities across our program.

Ashley Kaplowitz: Please review the risk factors discussed in today's press release and in our SEC filings for additional details.

Ashley Kaplowitz: We will begin the call with prepared remarks by Barry Greene, Our Chief Executive Officer, who will provide an overview of our progress during the first quarter of 2024.

Ashley Kaplowitz: Our chief business Officer, Crispy Lucky, we'll provide an update on the ongoing commercialization of <unk> you bet.

We will also be joined by Lorchel, Our Chief Medical Officer, who will review development activities across our programs.

Ashley Kaplowitz: We will then be joined by Kimi Iguchi, our Chief Financial Officer, who will review our financial results for the first quarter of 2020. Mike Quirk, our Chief Scientific Officer, will be available for questions during the Q&A portion of the call. With that, I'll now turn the call over to Barry.

Crispy Lucky: We will then be joined by community Ritchie, Our Chief Financial Officer, who will review our financial results from the first quarter of 2024.

Crispy Lucky: Mike Clarke, our Chief Scientific officer will be available for questions. During the Q&A portion of the call.

Crispy Lucky: With that I'll now turn the call over to Barry.

Barry E. Greene: Thanks, Ashley, and thank you, everyone, for joining us this morning. As we progress through 2024, we are singularly focused on addressing unmet needs in brain health. And while the science is extremely challenging, we remain motivated toward a common goal, improving human health. As you may have seen, last week, we announced negative results from our precedent study in the DALS and MDAR programs in participants with mild cognitive impairment. Related to Parkinson's, I was deeply disappointed for patients who suffer from this.

Thanks, Ashley and thank you everyone for joining us this morning.

Crispy Lucky: As we progress through 2024, we are singularly focused on addressing unmet needs in brain health.

Barry E. Greene: And while the science the extremely challenging we remain motivated toward a common goal improving human health.

Barry E. Greene: As you May have seen last week, we announced negative results from our precedent study and the Delta vendor program participants with mild cognitive impairment related to Parkinson's disease.

Barry E. Greene: We're deeply disappointed for patients and their families. As you know a mild cognitive impairment in Parkinson's disease can have a devastating impact on an individual's life.

Barry E. Greene: As we know, mild cognitive impairment in Parkinson's disease can have a devastating impact on an individual's life. However, we continue to believe that these results are not necessarily predictive of the results in our ongoing studies. It's important to remember that all cognitive impairment is common across Huntington's disease and Alzheimer's disease.

Barry E. Greene: We continue to believe that these results are not necessarily predictive of the results in our ongoing studies.

Barry E. Greene: Important to remember that all cognitive impairment is common across huntington's disease and Alzheimer's disease.

Barry E. Greene: The underlying pathophysiology and symptomatology of these diseases are very, We look forward to data across the Dalzin-Emder program expected throughout 2024, as well as top-line data from our KINETIC-2 study in essential tremor expected mid-2024. I'd now like to focus on a very encouraging area of opportunity for SAGE and for women with PPD. As you'll soon hear from Chris, the launch of Zoozoovay is off to a strong start, as reflected by our first full quarter performance.

Barry E. Greene: Underlying pathophysiology and symptomatology of these diseases are very distinct.

Barry E. Greene: We look forward to data across the <unk> program expected throughout 2024 as well as the topline data from our kinetic two study in essential tremor expected mid 2024.

Speaker Change: I would now like to focus on a very encouraging area of opportunity for sage and for women with PPD.

Speaker Change: Soon hear from Chris the launch of <unk> is.

Speaker Change: Is off to a strong start.

Speaker Change: As is reflected by our first full quarter performance.

Barry E. Greene: I'm inspired by the positive anecdotes and success stories we're starting to hear from women with PPD who have been treated for a long time. The impact of ZooZooVie on these moms and their families is profound, and it's energizing all of us. We continue to believe Xerzube is the key to unlocking the blockbuster potential of PPD, enabling us to help many women suffering from this devastating disease. While early, we're beginning to see signs of practice patterns, particularly among OBGYNs.

Speaker Change: I am inspired by the positive anecdotes and success stories, we're starting to hear from women with PPD, who have been treated since launch.

Speaker Change: The impact of <unk> on these moms and their families is profound.

Speaker Change: It's energizing all of us.

Speaker Change: We continue to believe <unk> is the key to unlocking the blockbuster potential of PPD, enabling us to help many women suffering from this devastating disease.

Speaker Change: While early we are beginning to see signs of practice patterns changing particularly among obgyns.

Barry E. Greene: With approved oral treatment specifically for PVD, we believe healthcare prescribers have started to shift from suspect and refer to screen, diagnose, and treat. I'll highlight a few of the encouraging signals we're seeing in the first quarter of one. Demand for TBD has been strong and continues to grow. Interest among healthcare prescribers with whom we've engaged or have learned about Zuzube has been high. This is evidenced by Xerzube being prescribed for women with PPD across a wide range of healthcare prescribers.

Speaker Change: We have approved oral treatment specifically for PPD, We believe health care prescribers have started to shift from suspect and refer to screen diagnose and treat.

I'll highlight a few of the encouraging signals, we're seeing the first full quarter of watch.

Speaker Change: Demand in PBT has been strong and continues to grow.

Speaker Change: Interest among health care prescribers with whom we are engaged we have learned about zubair has been high.

Speaker Change: Evidenced by Zubaie being prescribed for women with PPD across a wide range of health care prescribers.

Barry E. Greene: We're also highly encouraged by the progress we made with commercial and government payers. Payers are beginning to develop policies, and for the majority of plans to date, we're not seeing onerous prior authorization or step edits to PB&E.

Speaker Change: We're also highly encouraged by the progress we've made with commercial and government payers payer.

Speaker Change: Payers are beginning to develop policies and for the majority of plans to D. We're not seeing onerous prior offs or step edits a TBD.

Chris Benecchi: Our teams in the field remain busy, engaging with critical stakeholders, educating prescribers, and contributing to the recognition of PPD as an urgent medical condition. We believe the PPD opportunity is significant and have thought broadly about the initiatives needed to achieve commercial success with Zerzuba. Our strategy is to launch with a focused approach and scale as we see... As the early signs of launch have been encouraging, we've been increasing our marketing and non-personal promotion resources.

Speaker Change: Our teams in the field remained busy engaging with critical stakeholders educating prescribers and contributing to the recognition of PPD.

Speaker Change: Medical condition.

Speaker Change: We believe the PPD opportunity is significant and a thought broadly about the initiatives needed to achieve commercialization success with ebay.

Speaker Change: Our strategy is to launch with a focused approach and scale as we see success.

Speaker Change: As the early signs of launch have been encouraging we've been increasing our marketing and non personal promotion resources.

Chris Benecchi: If the positive trends continue, we believe additional scaling this year makes sense. Our goals are clear. Establish ZUZUVE as a first-line therapy and standard of care for women with PPD and advance our brain health pipeline. Our work is more important than ever, and the countless lives we have the potential to positively impact continue to serve as our North Star. With that, I'll turn the call over to Chris to provide additional context on the ongoing commercialization of Zerzouveh.

Speaker Change: If the positive trends continue we believe additional scaling this year makes sense.

Speaker Change: Our goals are clear established.

Speaker Change: Establish <unk> as the first line therapy and standard of care for women with PPD and advance our brain health pipeline.

Speaker Change: Our work is more important than ever and the countless lives with potential to positively impact continues to serve as our north star.

Speaker Change: With that I will turn the call over to Chris to provide additional context on the ongoing commercialization of <unk>.

Chris Benecchi: Thanks, Barry. The Zerzubei launch is off to a strong start and exceeding expectations. We've made important progress during the first full quarter of commercial availability, and I'm excited to share our recent launch accomplishments and ongoing initiatives. As we've engaged with healthcare professionals, patient advocacy organizations, payers, and policymakers, our mission is clear. There is desperate need and critical gaps in care for women with PPD. SAGE is committed to working with all stakeholders with the goal of rapid, affordable access to Zuzube for women with PPD, as there often can be incredibly heartbreaking and unintended consequences for the mother, her baby, her family, and future generations when PPD is not adequately treated.

Speaker Change: Yes.

Chris: Thanks, Barry because theres <unk> launch is off to a strong start and exceeding expectations. We've made important progress during the first full quarter of commercial availability and I'm excited to share our recent launch of accomplishments and ongoing initiatives.

Chris: As we've engaged with health care professionals patient advocacy organizations payers and policymakers. Our mission is clear there is a desperate need in critical gaps in care for women with PPD.

Chris: Sage is committed to working with all stakeholders with the goal of rapid affordable access to <unk> for women with PPD as Theyre, often can be incredibly heartbreaking and unintended consequences for the mother or baby her family and future generations. When PPD is not adequately treated.

Chris Benecchi: It is critical to diagnose, treat, and provide care and support for all women with PPD. We're beginning to see the initial signs of hope and progress in the first few months following the launch of Zerzubeh. As Barry noted, we are starting to see signs of practice patterns changing, particularly among the OB-GYN community. In a short period of time, we believe we are already beginning to see PPD move from a disease where some healthcare professionals would suspect PPD and then refer the patient for evaluation and treatment to a disease that they are confident to diagnose and treat. I'm proud to be part of this important movement and grateful for the countless SAGEans working to accelerate our impact in collaboration with our partner, Biogen.

Chris: It is critical to diagnose treat and provide care and support for all women with PPD.

Chris: We're beginning to see the initial signs of hope and progress in the first few months following the launch of <unk>.

Chris: As Barry noted, we are starting to see signs of practice patterns changing particularly among the obgyn community.

Chris: In a short period of time, we believe we are already beginning to see PPD move from a disease, where some hcp's would suspect PPD and then refer the patient for evaluation and treatment.

Chris: The hcp's are confident to diagnose and treat.

Chris: I am proud to be part of this important movement and grateful for the countless agents working to accelerate our impact in collaboration with our partner Biogen.

Chris Benecchi: As we've said previously, our goal is to establish Rezuve as the first-line therapy and standard of care for women with PPD, and we believe we are already making meaningful progress. Before I dive into the specifics of early launch performance, it's an important reminder to note that IQVIA data does not reflect all shipments of Zerzuviax. The key takeaway is that right now there is variability in the data, and it may not provide a complete picture of Zerzube demand in PPD. Even in the future, we see the potential for variability in the data.

Chris: As we said previously our goal is to establish a debate as the first line therapy and standard of care for women with PPD.

Chris: We believe we are already making meaningful progress.

Chris: Before I dive into the specifics of early launch performance. It's an important reminder to note that IQ via data does not reflect all shipments of zubair.

The key takeaway is that right now there is variability in the data and it may not provide a complete picture of zubaie demand in PPD.

Chris: Even in the future, we see potential for variability in the data.

Chris Benecchi: With that said, I'm now excited to share more detail on the Encouraging Progress theme during our first full quarter of launch. Zerzube generated $12.4 million in total revenue, of which SAGE recognized $6.2 million in collaboration revenue during the first quarter of 2024. In the first quarter, more than 1,200 prescriptions were written. The growth in prescriptions this quarter was strong and reflective of the interest and enthusiasm we're seeing for Zerzube in the treatment of women with PPD.

Chris: With that said I'm now excited to share more detail on the encouraging progress theme during our first full quarter of launch.

Chris: <unk> generated $12 4 million in total revenue at which stage recognized $6 2 million in collaboration revenue during the first quarter of 2024.

Chris: In the first quarter, there were more than 1200 prescriptions written.

Chris: The growth in prescriptions this quarter was strong and reflective of the interest and enthusiasm we're seeing for <unk> in the treatment of women with PPD.

Chris Benecchi: While we believe the number of prescriptions is an important early indicator, in the coming quarters as the launch matures, we plan to focus primarily on shipments and collaboration revenues. We were pleased to see prescribing across a wide breadth of HCPs who treat PPD, with the largest percentage of prescriptions coming from OBGYN. OBGYNs are on the front line of care for women with PPD and are often the first opportunity for an HCP to recognize symptoms, diagnose, and treat the disease. However, as we know, the patient journey can vary greatly for women suffering from this disease.

Chris: While we believe the number of prescriptions is an important early indicator in the coming quarters as the launch matures, we plan to focus primarily on shipments and collaboration revenue.

Chris: We were pleased to see prescribing across a wide breadth of hcp's, who treat PPD.

Chris: With the largest percentage of prescriptions coming from Obgyns.

Chris: <unk> are on the frontline of care for women with PPD and are often the first opportunity for an HCP to recognize symptoms diagnose and treat.

Chris: As we know the patient journey can vary greatly for women suffering from this disease.

Chris Benecchi: We also continue to expect growth in prescriptions from psychiatrists and PCPs for also actively diagnosing and treating women with PPD. Further, we are encouraged that the breadth of adoption of Zerzube and the treatment of PPD continues to grow, with the number of new Zero Zube prescribers increasing each month during the first quarter. We are also beginning to see signs of depth with repeat prescribing. A growing number of HVPs have already written multiple prescriptions for Zerzuvia.

Chris: We also continue to expect growth in prescriptions from psychiatrist and Pcp's for also actively diagnosing and treating women with PPD.

Chris: Further we are encouraged that the breadth of adoption of <unk> in the treatment of PPD continues to grow.

Chris: With the number of users who pay prescribers, increasing each month during the first quarter.

Chris: We are also beginning to see signs of depth with repeat prescribing a growing number of hcp's have already written multiple prescriptions for Zubaie base.

Chris Benecchi: Based on early claims data, we see that many Zerzoubi patients appear to be receiving Zerzoubi as first-line therapy for PPD. As of the end of the first quarter, more than 700 prescriptions were shipped and delivered to patients.

Chris: Based on early claims data, we see that many zubaie patients appear to be receiving zubaie as first line therapy for PPD.

Chris: As of the end of the first quarter of more than 700 prescriptions were shipped and delivered to patients.

Chris Benecchi: Our goal is to get Zerzuvia to women with PPD who are prescribed the medication as quickly as possible, and we continue to make improvements intended to help optimize the experience for HCPs and patients. This includes educating HCPs on the specialty pharmacy system, as well as operational improvements designed to expedite the prescription process. We expect the process will get better and quicker through these efforts and as formulary coverage decisions are made. Working towards broad and equitable access for women with PPD continues to be a key priority, and we know access is critical for successful legislation. Discussions continue to advance at an accelerated pace across national, regional, and government payers.

Chris: Our goal is to get through Zubaie to women with PPD, who are prescribed the medication as quickly as possible and we continue to make improvements intended to help optimize the experience with <unk> and patients.

Chris: This includes educating hcp's on the specialty pharmacy system as well as operational improvements designed to expedite prescription processing.

Chris: We expect the process will get better and quicker through these efforts and as formulary coverage decisions were made.

Chris: Working towards broad an equitable access for women with PPD continues to be a key priority and we know access is critical for successful launch.

Conversations continue to advance in an accelerated pace across national regional and government Payors, notably two or three national Pbms have published policies for <unk> and PPD without step therapy or complex prior authorization and we're progressing in conversations with the third national PVM.

Chris Benecchi: Notably, two of the three national PBMs have published policies for Zerzube and PPD without step therapy or complex prior authorization, and we're progressing in conversations with the third national PBM. We're encouraged by similar trends with national and regional insurers.

Chris: We are encouraged by similar trends with national and regional insurers.

Chris Benecchi: Today, we have over 65% of commercial lives covered for Zizou Bay and PPD, with the majority having no step therapy or complex prior authorization, and we expect this number to increase over the coming months as we continue engaging with payers who have not yet published policies. With respect to Medicaid, we are pleased to see almost half of the states, including several of the largest states, have completed their reviews much more quickly than is typically seen for a product launch.

Chris: Today, we have over 65% of commercial lives covered for Zubaie in PPD with the majority having no step therapy or complex prior authorization and we expect this number to increase over the coming months as we continue engaging with payers who have not yet published policies.

Chris: With respect to Medicaid we were pleased to see almost half of the states, including several of the largest states have completed reviews much more quickly than is typically seen for product launch.

Chris Benecchi: While Medicaid policies continue to develop, most states that have made a decision to date are covering CERZUVE for women with BPD, in line with our expectation of no-step therapy and no complex prior authorization. Where Medicaid policies are in place, we are seeing most women with PPD access their Zubay at a nominal cost or zero copay. We expect the majority of Medicaid coverage decisions in PPD by the end of the year.

Chris: While Medicaid policies continue to develop most states that have made a decision to date are covering <unk> for women with PPD in line with our expectation of no step therapy and no complex prior authorizations.

Chris: Where Medicaid policies are in place we are seeing most women with PPD access through <unk> at a nominal cost towards zero copay.

Chris: We expect the majority of Medicaid coverage decisions in PPD by the end of the year.

Chris Benecchi: We believe the strong payer progress we and Biogen have seen to date is the result of our active and longstanding engagement with payers, our knowledge of the PPD market, and the strong value proposition for Zerzouve in the treatment of women with PPD. It is also critical that we continue to work to enable access to Zerzuvia for all women with PPD who are prescribed treatment, regardless of financial means and coverage. Through our patient support and financial assistance programs for those who are eligible.

Chris: We believe the strong payer progress, we and Biogen have seen to date is the result of our active and longstanding engagement with payers our knowledge of the PPD market and a strong value proposition for <unk> in the treatment of women with PPD.

Chris: It is also critical that we continue to work to enable access to <unk> for all women with PPD, who are prescribed treatment, regardless of financial means and coverage for our patient support and financial assistance programs for those who are eligible.

Chris Benecchi: While we did see use of these programs, the majority of shipments were covered by commercial and government payers in the first quarter, even as coverage policies were being developed. We anticipate that if formulary coverage decisions continue to be favorable, and as the SP process is further optimized, the need for the Functionally Uninsured Program will decrease over time.

Chris: While we did see use of these programs. The majority of shipments were covered by commercial and government payers in the first quarter, even if coverage policies were being developed.

Chris: We anticipate that a formulary coverage decisions continue to be favorable and as the FTE processes further optimized the need for the functionally uninsured programs will decrease over time.

Chris Benecchi: Lastly, I'm excited to share some color on our ongoing marketing. Based on our experience, we believe this is a highly promotionally sensitive market that benefits from the surround sound of omni-channel apps. We continue to see enthusiasm from HCPs to learn more about Zerzube and have expanded commercialization efforts across stakeholders, with the goal that Zerzube is top of mind as a first-choice treatment for women with PPD. For example, we have executed ACP peer-to-peer live and virtual branded educational platforms, attracting wide attendance across multiple specialties that treat women with PPD.

Speaker Change: Lastly, I am excited to share some color on our ongoing marketing efforts.

Speaker Change: Based on our experience. We believe this is a highly promotional sensitive market, which benefits from the surround sound of Omnichannel effort.

We continue to see enthusiasm from Hcp's to learn more about zubaie and have expanded commercialization efforts across stakeholders with the goal that <unk> Zubaie is top of mind as first choice treatment for women with PPD.

Speaker Change: For example, we have executed ACP peer to peer live and virtual branded educational platforms, attracting wide attendance across multiple specialties that treat women with PPD.

Chris Benecchi: We also launched our fully operational Zerzuvia.com healthcare professional website at the end of February, in conjunction with several media drivers encompassing paid search, programmatic displays, banner ads, and HCP-targeted email. Recently, we launched the Zerzube.com Full Consumer website, where women with PPD can find branded education, support resources, and opt-in to receive proactive Zerzube communication. We're highly encouraged by what we're seeing so far, and the launch has reaffirmed our belief that Zerzube is an important treatment option to address the urgent and profound unmet need for women living with PPD.

Speaker Change: We also launched our fully operational Zubaie Dot Com health care professional website at the end of February in conjunction with several media drivers encompassing paid search programmatic displays banner ads and HCP targeted E mail.

Recently, we launched <unk> dot com for consumer website, where women with PPD can find branded education support resources and opt in to receive proactive Zubaie communications.

Speaker Change: We're highly encouraged by what we're seeing so far in the launch has reaffirmed our belief that <unk> is an important treatment option to address the urgent and profound unmet need for women living with PPD.

Chris Benecchi: We want to build on the momentum we have seen in the first full quarter of launch to reach even more of the women with PPD who need ZUVAC. We know we have more work to do to get... We know that women living with the disease cannot afford to wait, and now that Zerzubei is available as a treatment option, they should not have to wait. I look forward to sharing additional details in the coming quarters. With that, I'll turn it over to Laura for a more detailed discussion of our recent pipeline progress. Laura?

Speaker Change: We want to build on the momentum we've seen in the first full quarter of launch to reach even more of the women with PPD who need zubair.

We know we have more work to do to get there.

Speaker Change: We know that women living with the disease cannot afford to wait and now with <unk> available as a treatment option they should not have too.

Speaker Change: I look forward to sharing additional details in the coming quarters with that I will turn it over to Laura for a more detailed discussion of our recent pipeline progress Laura.

Laura Gault: Thanks, Chris. And good morning, everyone. As a clinician, I've seen firsthand the challenges that women with PPD and their families face. And so it is gratifying to see the impact we are already making on these women. I'm excited to be part of such a significant moment in maternal health as we continue to execute on the launches through ZooBay and PPD. Now, I'll turn to Belz and Mdor, our wholly owned, first-in-class, NMDA-receptor positive allosteric modulator, or PAM, as a potential oral therapy for certain cognitive disorders associated with neurodegenerative disease.

Laura: Thanks, Chris and good morning, everyone.

Laura: As a clinician I've seen firsthand the challenges that women with PPD and their families safe.

And so it is gratifying to see the impact we are already making for these women.

Laura: I'm excited to be part of such a significant moment in maternal health as we continued to execute on the launches.

<unk> and PPD.

Laura: I'll now turn to 1000 dollar a wholly owned first in class NMDA receptor positive allosteric modulator or Pam.

Laura: As a potential oral therapy for certain cognitive disorders associated with Neurodegenerative disease.

Laura Gault: Last week, we reported top-line data from the PRECEDENCE study, a double-blind, placebo-controlled phase 2 study in people with mild cognitive impairment, or MCI, in Parkinson's disease. After six days of treatment, patients who received Delsalemdor did not demonstrate a statistically significant difference from baseline compared to placebo on the primary endpoint, the WAIS-IV coding test score at day 42. Based on this data, we do not plan any further development of Delsin-MDOR in Parkinson's disease.

Laura: Lastly, we reported topline data from the precedent study a.

A double blind placebo controlled phase III study in people with mild cognitive impairment or NCI and Parkinson's disease.

Laura: After six weeks of treatment patients have received <unk> did not demonstrate a statistically significant difference from baseline compared to placebo on the primary endpoint the wasteful coding test score at day 42.

Laura: Based on the data we do not plan any further development of <unk> thousand door in Parkinson's disease.

Laura Gault: As we said on our call last week, it is important to remember that these results are not necessarily predictive of the results we may see in our ongoing Huntington's disease and Alzheimer's disease studies given the very distinct underlying pathophysiology and symptomatology of these diseases. While we're disappointed by the results of the precedent study, we continue to believe in the potential of delta-MDOR and the other indications we are studying and look forward to the various data readouts anticipated later this year.

Speaker Change: As I said on our call last week is important to remember that these results are not necessarily predictive of the results. We may see in our ongoing Huntington's disease, and Alzheimer's disease study, given the very distinct underlying pathophysiology and symptomatology.

Speaker Change: While we are disappointed by the results of the precedent study we continue to believe in the potential of <unk> thousand door and the other indications we are studying and look forward to the various data readouts anticipated later this year.

Speaker Change: Specifically in mid 2024, we expect to report topline data from Mr. Baier study a phase II study designed to generate evidence linking cognitive performance to real world functioning and people living with H D.

Laura Gault: Specifically, in mid-2024, we expect to report top-line data from the Surveyor Study, a Phase II study designed to generate evidence linking cognitive performance to real-world functioning in people living with HIV. In late 2024, we expect to report top-line data from the Light Wave Study, a double-blind, placebo-controlled, phase 2 study of Dalton M. Dorr in people with MCI and mild dementia due to Alzheimer's disease. We also expect to report top-line data in late 2024 from the DIMENSION study, a double-blind placebo-controlled Phase 2 study designed to evaluate the efficacy of galvanemdor and cognitive impairment in HD over a three-month treatment period.

Speaker Change: In late 2024, we expect to report topline data from the lightweight study.

Speaker Change: A double blind placebo controlled phase II study of <unk> thousand door and people at the NCI and mild dementia due to Alzheimer's disease.

Speaker Change: We also expect to report topline data in late 2024 from the dimension study.

Speaker Change: Double blind placebo controlled phase II study designed to evaluate the efficacy of <unk> thousand them door and cognitive impairment and HD over a three months treatment period.

As we've described previously we want to underscore that the primary objective of the survey or study is to understand the magnitude of the cognitive impairment and HD relative to healthy individuals.

Speaker Change: I cant secondary objective is to advance our understanding of the effects of thousand GOR on cognition and function in participants with HD.

Laura Gault: As we've described previously, we want to emphasize that the primary objective of the Surveyor Study is to understand the magnitude of the cognitive impairment in HD relative to healthy individuals. A key secondary objective is to advance our understanding of the effects of Dalzin-MGOR on cognition and function in participants with HD. It's important to emphasize that the surveyor study is not designed, nor powered, to show statistically significant differences between Delsin and Doremcocebo

Speaker Change: It's important to emphasize that the survey of study is not designed nor powered to show a statistically significant differences between <unk> and.

Speaker Change: Placebo.

Speaker Change: These data are meant to complement the dimension study by generating evidence to better define clinically meaningful change in the relationship between changes in cognition and function.

Speaker Change: We look forward to sharing these results with you as they become available.

Speaker Change: I'll now turn to page. Thank you for.

Laura Gault: These data are meant to complement the dimension study by generating evidence to better define clinically meaningful change and the relationship between changes in cognition and, We look forward to sharing these results with you as they become available. I'll now turn to SAGE 324, an investigational positive allosteric modulator of GABA-A receptors with potential for the treatment of essential tremor, or ET. We are developing SAGE 324 in collaboration with Viagra. There has been a lack of innovation in treatments for ET, with no new approved treatments in more than 50 years. A central tremor can have a significant impact on an individual's ability to perform everyday tasks.

Speaker Change: An investigational positive allosteric modulator of Gaba a receptors with potential in the treatment of essential tremor.

Speaker Change: We are developing stage. Thank you form in collaboration with Biogen.

Speaker Change: There has been a lack of innovation in treatments for <unk> with no new approved treatments and more than 50 years.

Speaker Change: Essential tremor can have a significant impact on an individual's ability to perform everyday tasks.

Speaker Change: Developing new treatment option that could help an individual maintain his or her quality of life, David functioning and independence is critical.

Speaker Change: Following the encouraging data from our completed kinetics study, which demonstrated statistically significant reduction from baseline in upper limb tremor amplitude.

Laura Gault: Developing new treatment options that could help an individual maintain his or her quality of life, daily functioning, and independence is critical. Following the encouraging data from our completed kinetic study, which demonstrated a statistically significant reduction from baseline in upper limb tremor amplitude, we look forward to seeing the data from the KINETIC-2 study. This study is a three-month study designed to identify a dose with a safety and tolerability profile that is suitable for chronic dosing and further development of SAGE 324 as a potential treatment for ET.

Speaker Change: We look forward to seeing the data from the kinetic case study.

This study is a three months study designed to identify a dose with a safety and tolerability profile that is suitable for chronic dosing and further development of stage three Q4 as a potential treatment for <unk>.

Speaker Change: We look forward to sharing these data expected in mid 2024.

Speaker Change: Lastly, I'd like to reiterate our excitement around our earlier stage pipeline, including phase III, one nine or extra synaptic, preferring Gaba a receptor Pam and page 41, our NMDA receptor Pam.

Speaker Change: We look forward to sharing more about these programs as they progress.

Laura Gault: We look forward to sharing this data, expected in mid-2024. Lastly, I'd like to reiterate our excitement around our earlier SAGE pipeline, including SAGE 319, our extra synaptic-preferring GABA-A receptor PAM, and SAGE 421, our NMDA receptor PAM. We look forward to sharing more about these programs as they progress. With that, I'll turn the call over to Kimi for a review of our financial

Speaker Change: With that I'll turn the call over for a review of our financial Kimi.

Kimi: Thanks, Laura.

Kimi: Financial results for the first quarter of 2024 are detailed in our press release issued this morning.

Speaker Change: Just wanted to I think into the financials I want to share my excitement around the launches are today and the opportunity to help so many women suffering with PPD.

We and Biogen are mobilized with the goal of capitalizing on early success and jointly supporting the launch of <unk> in the United States.

Kimi E. Iguchi: Laura, our financial results for the first quarter of 2024 are detailed in our press release issued this morning. But before diving into the financials, I want to share my excitement around the launch of Zerzouvet and the opportunity to help so many women suffering with PPD. We in Biogen are mobilized with the goal of capitalizing on early success and jointly supporting the launch of Zerzuvia in the United States. Commercialization of Zerzube remains a key priority for us as we work to expand access to treatment of women with PPD and build momentum. We also plan to continue to make disciplined pipeline investments backed by data to support our goal of near, mid, and long-term value creation.

Speaker Change: Commercialization as Theres, New Bay remains a key priority for us as we work to expand access in the treatment of women with PPD and build momentum.

Speaker Change: We also plan to continue to make disciplined pipeline investments backed by data to support our goal of near mid and long term value creation.

Speaker Change: I'll now turn to the financials.

Speaker Change: We announced collaboration revenue in Q1 from sales of New survey of $6 2 million.

Speaker Change: Our reported collaboration revenue is 50% of the net revenues Biogen reports versus debate.

And as a reminder, net revenues are recorded by Biogen winters do they are shipped to the wholesalers and are not calculated based on the number of shipments to patients or prescriptions written for <unk>.

Kimi E. Iguchi: I'll now turn to the financials. Today we announce collaboration revenue in Q1 from sales of Zerzouve of $6.2 million. Our reported collaboration revenue is 50% of the net revenues Biogen reports versus Ubex. As a reminder, net revenues are recorded by Biogen when Zerzuviae is shipped to wholesalers and are not calculated based on the number of shipments to patients or prescriptions written for Zerzuviae. Net revenues for the first quarter can be attributed to a combination of wholesalers purchasing Zerzuvia to fill orders, as well as building inventory in anticipation of increasing demand for Zerzuvia in the treatment of women with PPD.

Speaker Change: Net revenues for the first quarter can be attributed to a combination of wholesaler purchases zubaie to fill orders as well as building inventory in anticipation of increasing demand.

Speaker Change: <unk> in the treatment of women with PPD.

Speaker Change: We're not guiding today on gross to net other than to say given the fact that you use as a novel medications.

Speaker Change: The only oral treatment specifically approved for women with PPD, we do not anticipate the type of discounting we see for other branded TNF agents.

Kimi E. Iguchi: We're not guiding today on gross to net other than to say, given the fact that DERZUVE is a novel medication and the only oral treatment specifically approved for women with PPD, we do not anticipate the type of discounting we see for other branded CNS agents.

Speaker Change: Turning to operating expenses R&D expenses were $71 7 million in the first quarter of 2024.

Speaker Change: SG&A expenses were $52 6 million in the first quarter of 2024.

Speaker Change: The decrease in both R&D and SG&A expenses compared to the first quarter of last year was primarily related to decreased head count.

Kimi E. Iguchi: Turning to operating expenses, R&D expenses were $71.7 million in the first quarter of 2024, and SG&A expenses were $52.6 million in the first quarter of 2024. The decrease in both R&D and FG&A expenses compared to the first quarter of last year was primarily related to decreased headcount, overhead in technology, as well as decreased spend on the early stage pipeline, the run-along clinical trials, and manufacturing, primarily as a result of the Q3 2023 restructuring.

Speaker Change: Overhead and technology as well as decreased spending on the early stage pipeline. They ran around clinical trials and manufacturing primarily as a result of the Q3 2023 restructuring.

Speaker Change: As we previously stated we expect operating expenses to decrease in 2024 relative to 2023.

Speaker Change: Our net loss for the first quarter of 2024 with $108 5 million and we ended the first quarter of 2024 with cash cash equivalents and marketable securities of approximately $717 million.

Kimi E. Iguchi: As we've previously stated, we expect operating expenses to decrease in 2024 relative to 2023. Our net loss for the first quarter of 2024 was $108.5 million, and we ended the first quarter of 2024 with cash, cash equivalents, and marketable securities of approximately $717 million.

We are reaffirming that based on our current operating plan, we anticipate cash cash equivalents and marketable securities anticipated.

Speaker Change: The anticipated funding from ongoing collaborations and estimated revenues will support operations into 2026.

Speaker Change: As we said on our last earnings call, we do not anticipate receipt of any additional milestone payments from collaborations in the remainder of 2024.

Kimi E. Iguchi: We are reaffirming that based on our current operating plan, we anticipate cash, cash equivalents, and marketable securities, anticipated funding from ongoing collaborations, and estimated revenues will support operations into 2026. However, as we said on our last earnings call, we do not anticipate receipt of any additional milestone payments from collaborations in the remainder of 2024. Before I turn the call over to the audience for Q&A, I want to reiterate that we remain dedicated to progressing our mission of better brain health for patients.

Before I turn the call over for Q&A I want to reiterate that we remain dedicated to progressing our mission of better greenhouse for patients.

Speaker Change: Further we believe there are strong financial foundation as we continue to progress through a catalyst rich year for Sage.

We look forward to providing updates on our progress in the coming quarters.

Speaker Change: I'll now turn it over to Ashley to handle Q&A with the operator Ashley.

Ashley Kaplowitz: Thanks, Kimi I'll ask that you limit yourself to one question.

Ashley Kaplowitz: Do you have an additional question feel free to return to the queue.

Kimi E. Iguchi: Further, we believe there is a strong financial foundation as we continue to progress through our catalyst-rich year for SAGE. We look forward to providing updates on our progress in the coming quarter. I'll now turn it over to Ashley to handle Q&A with the operator.

Ashley Kaplowitz: Now I'll turn it over to the operator to handle Q&A.

Ashley Kaplowitz: Operator.

Operator: Thank you and if you would like to ask a question. Please now by pressing star one on your telephone keypad. If you are using a speaker phone. Please make sure. Your mute function is turned off to allow your signal to reach our equipment again, you can press star one to ask a question and we'll pause for a brief moment to allow everyone an opportunity to signal.

Ashley Kaplowitz: Thanks, Kimi. I'll ask that you limit yourself to one question. If you have an additional question, feel free to return to the queue. Now, I'll turn it over to the operator to handle Q&A. Operator. Thank you, and if you would like to ask a question, please signal by pressing star 1 on your telephone.

Operator: Yeah.

Operator: Okay.

Operator: And our first question is coming from Jasmine Rami with Piper Sandler Your line is open.

Operator: Thank you, and if you would like to ask a question, please signal by pressing star 1 on your telephone keypad. If you are using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. Again, you can press star 1 to ask a question, and we'll pause for a brief moment to allow everyone an opportunity to signal for questions. And our first question is from Yasmeen Rahimi with Piper Sandler. Your line is open.

Jasmine Rami: Hi, guys. Good morning. This is lauren on for years.

Jasmine Rami: Just a quick one for US further kinetic two study have you guys guided any powering assumptions.

Jasmine Rami: And with that have you.

Jasmine Rami: Detailed in efficacy and safety signal that would warrant moving forward into phase III and then just coinciding with that have you started to engage with FDA and kols in regard to a phase III for this program. Thank you.

Lauren: Hi guys. Good morning. This is Lauren on PRE-AS. We have just a quick one for us.

Speaker Change: Yes, Laurent thanks for the question.

Speaker Change: About sage three two for our Gaba Pam for chronic administration, that's partnered with Biogen and movement disorders, initially starting with the central tremor.

Lauren: For the KINETIC-2 study, have you guys guided any powering assumptions? And with that, have you outlined an efficacy and safety signal that would warrant moving forward into phase three, and then, just coinciding with that, have you started to engage with the FDA and KOLs in regard to a phase three for this program? Thank you.

Speaker Change: Lori you want to take the question, yes, sure. So with regard to the study design. We have provided study design details on Quintiles Dot Gov and it's also in the Investor deck. That's on our website, we don't provide additional information beyond what's available there.

Barry E. Greene: Yeah, Lauren, thanks for the question about SAGE 324, our GABA PAM for chronic administration that's partnered with Biogen in movement disorders, initially starting with essential tremor. Laura, do you want to take the question?

Lori: For phase III of course in any development program as you come close to finishing phase two you start to think about phase III planning, we are certainly doing that in conjunction with Biogen and as part of that we are engaging experts.

Laura Gault: With regard to the study design, we have provided study design details on clintrials.gov, and it's also in the investor deck that's on our website. However, we don't provide additional information beyond what's available there. For Phase 3, of course, in any development program, as you come close to finishing Phase 2, you start to think about planning for Phase 3. We are certainly doing that in conjunction with Biogen, and as part of that, we are engaging experts.

Speaker Change: And the key the key to connect to as a follow up from the kinetics study, where we saw at 28 days a statistically significant improvement in tremor amplitude as well as activities of daily living genetic twos now we want to see that at three months and the real key is to make sure that we have.

Laura Gault: And the key to KINETIC-2 is a follow-up from the KINETIC study where we saw, at 28 days, a statistically significant improvement in tremor amplitude as well as activities of daily living. Now KINETIC-2 is, we want to see that at 3 months, and the real key is to make sure that we have a benefit-risk dose to move forward with chronic administration. So that's really what we're looking for in KINETIC-2.

A benefit risk dose to move forward for chronic administration. So that's really what we're looking for it to connect to.

Speaker Change: Perfect. Thank you I'll hop back in the queue.

Speaker Change: Thanks Lauren.

Speaker Change: Our next question is coming from Anna <unk> Rama with Jpmorgan. Your line is open.

Anupam Rama: Hey, guys. Thanks, so much for taking the question.

Anupam Rama: One of the key questions, we've gotten sort of post Biogen and you guys report.

Anupam Rama: This morning.

Anupam Rama: Any more color on the inventory build in the quarter versus the orders filled for Zubair.

Anupam Rama: Perfect. Thank you. I'll hop back in the queue. Thanks, Lauren. Our next question is coming from Anupam Rama with JP Morgan. Your line is open.

Anupam Rama: And how we should think about this moving forward. Thanks, so much.

Barry E. Greene: Yeah, Anupam, thanks for the question, and we share your enthusiasm off to a strong start. I'll turn it over to Chris to talk about, Kimi to talk about that, and then I'll provide some color.

Speaker Change: Yes, thanks for the question.

Speaker Change: We share your enthusiasm after the strong start ill turn it over to Chris to talk about can you give me just talk about that and then ill provide some color.

Yes, well thanks Barry.

Kimi E. Iguchi: Zerzoubi generated $12.4 million in total revenue, of which SAGE recognized $6.2 million in collaboration revenue during Q1, which we talked about during our opening remarks. The net revenues for the first quarter can be attributed to a combination of wholesalers purchasing inventory to fill orders, as well as building inventory, and that's in anticipation of increasing demand for Zerzoubi in the treatment of women with PPD. As the launch progresses, and we have a better understanding of the demand and inventory levels, we'll be able to share more at that point.

Chris: We generated $12 4 million in total revenue of which sage recognized $6 2 million in collaboration revenue during Q1, which we talked about during our opening remarks.

Chris: The net revenues for the first quarter can be attributed to a combination of wholesalers purchasing inventory to fill orders as well as building inventory and that's of course in anticipation of increasing demand for <unk> in the treatment of women with PPD.

Chris: As the launch progresses, and we have a better understanding of the demand and inventory levels we'll.

Speaker Change: We'll be able to share more at that point, yes, just color.

Barry E. Greene: Yeah, I just did some color there, Anupam. It's an important question. I know it's gotten a lot of attention.

Speaker Change: An important question I know, it's got a lot of.

Speaker Change: <unk>.

Speaker Change: I will comment that the wholesalers are very smart they don't want products sitting on the shelf.

Barry E. Greene: Yeah, and I just did some color there, Anupam. It's an important question. I know it's gotten a lot of attention. I will comment that the wholesalers are very smart. They don't want products sitting on the shelf and aging. So we really believe what we're seeing is demand driven. Thanks so much for taking our question and congratulations on the strong launch. Thanks, Anupam.

Speaker Change: <unk>. So we really believe what we're seeing is demand driven.

Speaker Change: Thanks, so much for taking our.

Speaker Change: Question and congrats on the strong launch.

Speaker Change: Thanks Anna.

Speaker Change:

Speaker Change: Our next question is coming from Salvino richer with Goldman Sachs. Your line is open.

Salveen Jaswal Richter: Hi, This is John <unk>. Thank you for taking my question and congratulations on the quarter.

Could you speak to the process through which will be gains are diagnosing CBD and at what point do these visits happening is it proactive on the part of the Doctor the patient and also any general feedback you've received from doctors on the efficacy and safety profile.

Salveen Jaswal Richter: Our next question is coming from Salveen Richter with Goldman Sachs. Your line is open.

Barry E. Greene: Yeah, sure. I'll start and then, you know, see if Laura or Chris want to add any color after I answer it.

Speaker Change: Yes, sure I'll start and then I'll see if.

Speaker Change: Laura or Chris want to add.

Speaker Change: Any color after I answer it so.

Barry E. Greene: So what's really important and what you've highlighted here is that health care providers in general are recognizing that PPD is a medical condition with urgency to treat, and it's not a moral failing, and that theme is critically important. The other practice pattern that we've highlighted, and this is really important, is that OBGYNs, who are on the front line of seeing moms with the potential for PPD, are moving from the practice pattern of suspecting depression and referring to either primary care or psychiatry for screening, diagnosing, and treating depression.

Speaker Change: What's really important and what you've highlighted here is that health care providers in general are recognizing that CBD is a medical condition with urgency to treat and it's not a moral selling and that theme is critically important.

The other practice pattern that was highlighted in this is really important is that is that obgyn's, where the frontline of seeing moms with potential for PPD.

Speaker Change: Moving from the pack this pattern of suspecting depression, and referring to either primary care of psychiatry to screening diagnosing and treating and that paradigm shifts continue we will see accelerating so.

Barry E. Greene: And that paradigm shifts and continues when we see it accelerating. So that's really, really important. In terms of what's happening out in the real world, we've got a lot of anecdotes, and lots of anecdotes don't add up to data per se, but they do give us a flavor. What we're hearing from the field is that Zerzouve is performing in the real world as it did in our clinical trials, and that is a very broad benefit-risk profile, rapid onset within as early as 2 or 3 days, and that women appreciate this is a 14-day course of treatment or completing that treatment.

Speaker Change: That's really really important.

In terms of what's happening out in the real World. We've got a lot of anecdotes and lots of anecdotes don't add up to data per se, but just give us a flavor. We're hearing from the field is that <unk> is performing in the real world as it performed in our clinical trials and that is a very very broad benefit risk profile.

Speaker Change: Rapid onset.

Speaker Change: It really is two or three days and that women I. Appreciate this is a 14 day course of treatment or completing that treatment.

Chris Benecchi: Yeah, what I would add, and I included it in my opening remarks, is that in the first quarter of 2024, we saw that OBGYNs accounted for the largest percentage of prescriptions. As Barry noted, that's important because what that begins to signal is that treatment practice for women with PPD is beginning to change, as you have OB-GYNs on the front line of care for so many of these women. I'd be remiss, though, if I didn't mention that we expect growth in prescriptions from psychiatrists and PCPs as well as OBGYNs moving forward if they continue to actively diagnose and treat women with PPD, representing more broadly the adoption of Zerzuvia and really the need to change the way that we think about and treat PPD moving forward. So, encouraged by all of those physicians really leaning in.

Speaker Change: Yes, what I would add and I included in my opening remarks is that in the first quarter of 2024, we saw that obgyns accounted for the largest percentage of prescriptions as Barry noted that's important because what that begins to signal is that treatment practice for women with PPD is beginning to change as you have what would your lands on the frontline of care for so many of these women.

I'd be remiss, though if I didn't mention that we expect growth in prescriptions from psychiatrist in Pcbs as well as Obgyn's moving forward as they continue to actively diagnose and treat women with PPD, representing more broadly the adoption for <unk> and really the need to change the way that we think about <unk> moving forward. So encouraged by all of those physicians really.

Chris Benecchi: Yeah, and Chris, I would add that when you think about diagnosing PD, there actually are a lot of tailwinds, and those tailwinds come from professional organizations like ACOG and the American Academy of Pediatrics that have both issued guidance and practice guidelines that suggest that patients should be screened throughout their pregnancies and in the postpartum period. In the case of AAP, they recommend that moms are screened at all well-child care visits.

Speaker Change: And again.

Speaker Change: Yes, and Chris I would add that when you think about diagnosing PPD. There actually are a lot of tailwind and those tailwind come from professional organizations like a cog and the American Academy of Pediatrics that have been.

Speaker Change: <unk> issued guidance practice guidelines that suggests that patients should be screened throughout their pregnancies and in the postpartum period in the case of AAP they recommend that.

Chris Benecchi: So in most health care settings at this point, this routine screening is happening, which enhances the ability to detect women with PPD earlier in their disease. Thanks Srinath, it's a great question and, as you hear, we're

Speaker Change: The models are screened at all the well child care visits.

Speaker Change: In most health care settings at this point this routine screening is happening which enhances the ability.

Speaker Change: Women with PPD earlier in their disease evolution.

Speaker Change: Yeah. Thanks, Ron that's a great question as you're hearing we're pretty excited by the paradigm shift that we're accelerating was there some day.

Barry E. Greene: Thanks, Renaud, that's a great question. And as you can hear, we're pretty excited by the paradigm shift that we're accelerating with Zerzubek. Thank you for the call. Our next question is coming from Ritu Baral. Amy D. Cowan, your line does not exist. Good morning, guys. Thanks for taking the question.

Speaker Change: Thank you for Docomo.

Speaker Change: Our next question is coming from Ritu morale with TD Cowen Your line is open.

Ritu Subhalaksmi Baral: Good morning, guys. Thanks for taking the question I wanted to ask about the difference between the 1200 prescriptions written and the 700 shipped and delivered how should we think about the delta there are those prescriptions.

Ritu Subhalaksmi Baral: Our next question is coming from Ritu Baral with TD Cowan. Your line is open, Paula.

Ritu Subhalaksmi Baral: That may result in free drug are those prescriptions that are.

Chris Benecchi: Yeah, Ritu, thanks for the question. Let me start with Chris, see if Kimi has anything to add about free goods, and I'll loop back at the end.

Ritu Subhalaksmi Baral: Right now sort of in that time to fill period and can you comment on percentage free drug and that time to sell period. Thanks.

Chris Benecchi: So, as we noted, Zerzube's launch is off to a strong start and exceeding expectations, and we're encouraged by the breadth of adoption of Zerzube and the treatment of PPD and to see it continue to grow with new prescribers each and every month. And not just new prescribers, but a number of repeat prescriptions coming from many of those same providers as we move forward. As you note, Ritu, with respect to written versus shipped prescriptions, you always expect, particularly at a launch, there to be a delta between written and shipped prescriptions.

Speaker Change: Yes. Thanks for the question, let me start with Chris you've Kimi has anything to add on fragrances and I'll move back to the end, yes. So so as we noted <unk> launch is off to a strong start in exceeding expectations and we are encouraged by the breadth of adoption that Susan and the treatment of PPD and see it continue to grow with new prescribers.

Speaker Change: Every month and not just new prescribers, but a number of repeat prescriptions coming from many of those same providers as we move forward.

Speaker Change: As you know Ritu with respect to written versus shipped prescriptions, you always expect particularly at a launch there to be a delta between written and ship prescriptions. Although over time, what you would anticipate as that would actually catch up as the number of shipped prescriptions catches up with the number of written prescriptions. We continue to see a trend of growing prescriptions each month in Q.

Chris Benecchi: However, over time, what you would anticipate is that it would actually catch up as the number of shipped prescriptions catches up with the number of written prescriptions. We continue to see a trend of growing prescriptions each month in Q1 with the 700 prescriptions that were actually shipped and delivered to patients, and we'll see that number catch up to the prescriptions that were actually written. Our goal really is to ensure that Zerzube gets to all women who have been prescribed the medication as quickly as possible, and we continue to make improvements to, in effect, the system that we have in place to optimize the physician-patient experience to make sure that the SP model is working as efficiently and effectively as possible.

Speaker Change: One with the 700 prescriptions that are actually shipped and delivered to patients and we'll see that number catch up to the prescriptions that were actually written our goal really is to ensure that <unk> gets to all women who are prescribed the medication as quickly as possible and we continue to make improvements to in effect. The system that we have in place to optimize the physician.

Speaker Change: <unk> patient experience to make sure that the SP model is working as efficiently and effectively as possible and as coverage policies come online, where there aren't onerous prior authorizations and step edits the medication flows from prescription to shipment quicker and quicker with each successive day. So really excited about the work that we're doing behind the scenes to make that happen because moms deserve to have.

Chris Benecchi: And as coverage policies come online where there aren't onerous prior authorizations and step edits, the medication flows from prescription to shipment quicker and quicker with each successive day. So, really excited about the work that we're doing behind the scenes to make that happen, because moms deserve to have this medication. Women with PPD deserve to have this medication as rapidly as possible.

Speaker Change: This medication women with PPD deserve to have this medication as rapidly as possible.

Chris Benecchi: Okay, great. Thanks, Ritu.

Speaker Change: Okay, great. Thanks, Thanks Ritu.

Laura Kathryn Chico: Our next question is coming from Laura Chico with Weblish Securities. Your line is open.

Speaker Change: Okay.

Speaker Change: Our next question is coming from Laura Chico with Wedbush Securities. Your line is open.

Barry E. Greene: Hey, good morning, guys. Thanks very much for taking the time to answer the question. I guess one thing you mentioned in the prepared remarks centered on potentially scaling up the salesforce at a given point, but trying to better understand what type of metrics you would need to see to warrant that kind of scaling up. And then, kind of related to that, how far from symptom onset are women typically receiving their Zubay prescription? I realize that might change over time, but just curious, at what point from diagnosis are they getting the prescription?

Laura Kathryn Chico: Hey, good morning, guys. Thanks, very much for taking the question.

Laura Kathryn Chico: I guess, one thing you mentioned in the prepared remarks centered on potentially scaling up the sales force.

Laura Kathryn Chico: At a given point, but I'm trying to better understand what type of metrics would you need to see to warrant kind of scaling up and then kind of related to that.

Laura Kathryn Chico: How far from symptom onset, our womens typically receiving of prescription and realize that might change over time, but just curious.

Laura Kathryn Chico: At what point from diagnosis are they getting the prescriptions.

Barry E. Greene: Thanks. Yeah, Laura, thanks for the feedback...

Barry E. Greene: Yeah, Laura, thanks for the couple of questions there. I'll start and then see if Chris wants to add a quote. Let me start with the second point.

Speaker Change: Yes, Laura thanks, Thanks for the thanks for the couple of questions. There I'll start and then see if.

Speaker Change: Chris wants to add Nicole let me start with the second point.

Barry E. Greene: So, you know, we don't have solid data on the exact timing from onset of symptoms to treatment. But the great sign we're seeing, however, is the number of scripts coming from OB-GYN. You can imagine the patient journey here. If a woman who has previously suffered depression and therefore is at risk, you might expect that the diagnosis and prescription come from her treating primary care doctor or primary care office or psychiatry.

Speaker Change: So we don't have we don't have solid data on the exact timing from onset of symptoms and treatments. The great sign we are seeing however is the number of scripts coming from <unk> you can imagine the patient journey.

Speaker Change: If a woman who has previously suffered depression, therefore is that risk.

Speaker Change: Suffers you might expect that the diagnosis and prescription comes from her treating primary care prescribers are primary care office or or psychiatrist. The fact that we're seeing the <unk> prescribed and then about half.

Barry E. Greene: The fact that we're seeing the OBGYNs prescribed and that about half of the women treated with this early claims data, so take it with a grain of salt, but about half the women treated were naive, meaning they had not been on antidepressants last year, suggests to us that PPD is being picked up fairly early on in the treatment, in the landscape here, so that's a great sign. Back to your first question, as we talked about, we really do believe that Zerzube is the key to unlocking the blockbuster potential of TPD, helping as many moms as we can.

Speaker Change: The women treated this early claims data so take it with a grain of salt, but about half the women treated meaningly had not gone into impressed last year suggest to us that the PPD is being picked up fairly early on in the treatment.

Speaker Change: In the landscape.

Speaker Change: That's a great sign.

Speaker Change: Back to your first question as we talked about we really do believe that zumba is to keep the keto and lock the blockbuster potential of.

Barry E. Greene: As you know very well, Laura, we started with a focused approach, and we're already scaling. As we highlighted, we've increased our personal and non-personal promotion, as well as some of the other efforts around specialty pharma and others, which Chris talked about. So we're excited. As we see continued prescribing patterns, we invite you; we'll talk about the field force and other aspects of expansion. You'll hear about that in the quarters to come.

Speaker Change: TBD, helping as many months, we can as you know very well or are we started with a focused approach and we're already scaling as we highlighted we've increased our personal and non personal promotion.

Speaker Change: As well as some of the other efforts around specialty pharma and others, which Chris talked about so we're excited as we see continued prescribing patterns, we and Biogen will talk about field force and other aspects of its expansion you'll hear about that in the quarters to come.

Speaker Change: Thanks, Karen.

Karen: Thank you.

Karen: Our next question is coming from Pablo <unk> with Stifel. Your line is open.

Pablo: Hey, Thanks, so much I was wondering if you could expound upon what this midyear Huntington's readout is going to look like.

Paul Andrew Matteis: Thank you. Our next question is coming from Paul Matteis with Stifel. Your line is open. Hey, thanks so much. I was wondering if you could expound...

Pablo: Like what are the key couple of analyses that youre going to be doing and more specifically I was wondering if you could sort of talk about your current thinking on endpoints and specifically the HD cap, which I think you are using as a primary and dimension but.

Paul Andrew Matteis: Our next question is coming from Paul Matteis with Stifel. Your line is open.

Paul Andrew Matteis: Yeah, Paul, thanks. Thanks for that.

Laura Gault: I guess the three or four questions in one. Let me turn it over to Laura to tackle the Dalton Endor questions you're asking. Thanks for the question, Paul. The Surveyor Study is the study that we expect to read out next.

Pablo: But more recently another company in this space had trouble getting the FTE onboard with that measure. Thank you.

Speaker Change: Yes, Paul Thanks, Thanks for that I guess, the three or four questions in one let me turn it over to Laura to tackle the 1004 questions Youre asking.

Laura Gault: Thanks for the question, Paul. So the Surveyor Study is the study that we expect to read out next in mid-2024. And that study is designed with a particular purpose in mind. It is designed to provide data to put context around the HC-CAB to help us understand what clinically meaningful change looks like. And so with regard to how we designed the study, there are really two parts. The first part is comparing baseline HC-CAB scores for healthy participants versus patients with Huntington's disease.

Laura Kathryn Chico: Sure. Thanks for the question Paul So the survey our study is the study that we expect to read out next in mid 2024.

Laura Kathryn Chico: And that study is designed with a particular purpose in mind. It is designed to provide data to put context around the HD cap to help us understand what clinical meaningful clinically meaningful change looks like.

Laura Kathryn Chico: So with regard to how we design. The study there's really two parts. The first part is comparing baseline HD cap scores or healthy participants versus patients with huntington's disease and not looking at that Delta is going to help us understand what the <unk>.

Laura Gault: And looking at that delta is going to help us understand what the magnitude of the impairment is in this population and also help to anchor the meaningfulness of any improvements that we see in the study. The second part of the study takes those patients with Huntington's disease and randomizes them one-to-one to Dalzin-Mdor or placebo. Now this is a very small group. Forty patients were randomized, so you're talking about 20 subjects in arms. And they're treated for one month.

Laura Kathryn Chico: I'm with you that the impairment is in this population and also help to anchor the meaningfulness of any improvements that we see in this study.

Laura Kathryn Chico: The second part of the study takes us patients with Huntington's disease, and randomize them, one to one 2000 door or placebo. Now. This is a very small group of people 40 patients were randomized so you're talking about 20 subjects.

Laura Kathryn Chico: In and Theyre treated for one month and so what we're looking at here is looking at trends in the data we're trying to understand how the magnitude of the change in cognition and how that pulls through to changes on the global measures on the functional measures and again. These data are really important to help put the results of the <unk>.

Laura Gault: And so what we're looking at here is looking at trends in the data. We're trying to understand how the magnitude of the change in cognition pulls through to changes in the global measures and the functional measures. And again, these data are really important to help put the results of the HC-CAB in context. Operator, we can go to the next question.

Laura Kathryn Chico: In context.

Speaker Change: Operator, we can go to the next question.

Laura Kathryn Chico: Yeah.

Laura Kathryn Chico: Our next question is coming from Jay Olson with Oppenheimer. Your line is open.

Jay Olson: Oh, Hey, congrats on the <unk> launch progress since Pcp's are relatively less familiar with scheduled drugs for mood disorders compared to psychiatrist and maybe Obgyns can you talk about the strategy for increasing zubaie awareness in prescribing among PC piece and then.

Jay Olson: Our next question is coming from Jay Olson with Oppenheimer. Your line is open.

Jay Olson: Any color you could provide on your strategy for DTC. Thank you.

Barry E. Greene: I'll start, and I'll kick it over to Chris. And thanks, Jay. We're also incredibly excited by the trends we're seeing with the launch of Zerzuba. So, as you highlighted, while a majority of scripts are coming from OBGYN, we are seeing prescriptions from psychiatrists and primary care. And that pattern may shift over time, although we're very excited that OBGYNs are on the front line of picking up prescriptions. Picking up depression in moms here are the key prescribers, and we think that trend will continue.

Speaker Change: Yeah, I'll start and then I'll kick it over to Chris and Thanks, Jay We're also incredibly excited by.

Speaker Change: The trends, we're seeing with the launch of <unk>. So as you highlighted.

Speaker Change: While the majority of scripts are coming from Ob Joanne we are seeing prescriptions from Sykes and primary care and that pattern may shift over time, although we're very excited that obgyns, who are the frontline of picking up.

Speaker Change: Ah picking up depression moms here are the key prescribers and we think that trend will continue.

Barry E. Greene: Now, I talked about the patient journey. So what we are likely seeing, if there's been a prior history of depression, and the mom's diagnosed with depression in pregnancy or postpartum, and they're under the care of a psychiatrist or primary care physician, we're likely seeing scripts coming from that.

Speaker Change: I talked about the patient journey. So what we are likely seeing if theres been a prior history of depression, and the moms diagnosed with with.

Speaker Change: With depression, and pregnancy or post partum.

Speaker Change: And they are under the care of a psychiatrist is a primary care physician, we're likely seeing scripts coming from that.

Barry E. Greene: If they're newly diagnosed, that's where the OBGYNs are coming in. Actually, you know, primary care doctors are very familiar with prescribing antidepressants. In fact, the majority of SSRIs come from primary care versus, especially just the volume. So they're familiar with it. They've got licenses, and they're very familiar with scheduling drugs as needed. Chris, do you want to add any more? Yeah, I think the color that I would add to PCPs here, Barry, is the group...

Speaker Change: If they're newly diagnosed that's where the <unk> are coming in actually.

Speaker Change: I'm Mary care are very familiar with prescribing antidepressants back the majority of Ssris, that's already come from from primary care versus especially the volume so they're familiar with it they've got licenses they are very familiar with scheduling scheduled drugs.

Chris Benecchi: Yeah, I think the color that I would add to PCPs here, Barry, is the group of PCPs that we're calling on with Salesforce right now. It's a core group of PCPs, frankly, who behave more like psychiatrists. They may be in a community where there is not a psychiatrist, and therefore, they become the de facto clinician to treat many of these patients.

Speaker Change: Chris you want to add any more yes, I think the color that I would add to Pcp's here. Barry is the group of Tcp's that were calling on with the sales force right now it's a core group of Tcp's, frankly, who who behave more like psychiatrist they may be in a community where there is not a psychiatrist and therefore, they become the de facto clinician to treat many of these patients but that's those are the.

Chris Benecchi: But those are the PCPs that are being called on from a Salesforce perspective. Obviously, as I mentioned in my prepared remarks, we're continuing to increase digital means in order to reach and broaden our reach and to increase our frequency across all physician types. Digital has been particularly effective in going forward and doing that and dialing up the investment in that over the course of the year. It's going to have that impact in terms of reaching PCPs as we go forward because, oftentimes, they're the ones who become the first line of care after a woman has seen a pediatrician or other types of clinicians seeing women outside of OBGYN in psychiatry.

Speaker Change: <unk> that are being called on from a salesforce perspective.

Speaker Change: Obviously as I mentioned in my prepared remarks, we're continuing to increase digital means in order to reach you can broaden our reach and to increase our frequency across all physician types in digital has been particularly effective and actually going forward and doing that in dialing up the investment in that over the course of the year is going to have that impact in terms of reaching pcp's as we.

Speaker Change: Go forward, because we know oftentimes they are the ones who become the first line of care. After a woman has seen her pediatrician or other types of clinicians.

Chris Benecchi: So we'll continue to invest in that. I think your question around DTC is also an important one and certainly one I'm sure is on the mind of many people on this call today. We've talked about being focused with our investment in scaling with success. Obviously, the first step in this is making sure that we have a very well-educated and prepared clinician audience so that when patients come in and ask for the medication by name, they're ready to effectively prescribe the medication with an understanding of its efficacy and the safety profile. Obviously, the first step is educating clinicians. We use both personal and non-personal methods to do that.

Speaker Change: Women outside of Obgyn and psychiatry. So we'll continue to invest in that I think your question around DTC is also an important one and certainly one that I'm sure is on the minds of many people on the call here today, and we've talked about being focused work with our investment in scaling with success for obviously the first step in this is making sure that we have a very well educated and prepared.

Speaker Change: Clinician audience, so that when patients come in and ask for the medication by name that they are ready to effectively prescribes a metaphysician with an understanding of the efficacy and the safety profile.

Speaker Change: The first step is educating clinicians, we useful personal and non personal to do that and when the time is right to expand DTC. So that patients can go in and have that informed discussion will actually invest in that what I would be remiss. If I Didnt mentioned was the helping tailwind that we have with respect to online and social media activity in and around <unk> and <unk>.

Chris Benecchi: And when the time is right to expand DTC so that patients can go in and have that informed discussion, we'll actually invest in that. But what I would be remiss, though, if I didn't mention the helping tailwind that we have with respect to online and social media activity in and around Zerzube. This is a popular topic of conversation. In many senses, it's going to precede and has preceded the DTC effort that we know will come in the future. And when the time is right, we'll invest in DTC.

Speaker Change: This is a popular topic of conversation in many senses thats going to proceed that have preceded the DTC effort that we know will come in the future and when the time is right, we'll invest in DTC and we look forward.

Speaker Change: Thank you Super helpful. Congrats again.

Ami Fadia: Our next question is coming from Ami Fadia on Needham. Your line is open.

Speaker Change: Thanks Jay.

Speaker Change: Our next question is coming from Amit <unk> with Needham Your line is open.

Ami Fadia: Hi, good morning. Thanks for taking my question and congrats on the progress on delivery. Sorry about that.

Amit: Hi, Good morning, Thanks for taking my question and congrats on the progress when it goes away.

Barry E. Greene: Could you talk a little bit more about... The use of ZOVA in first-line versus second-line, and in what situations do patients get ZOVA as a second-line treatment, and are they getting it in combination with any existing SSRI, or SNRI treatment? And just to follow up from an earlier topic, could you sort of go over in what way the surveyor data will inform the dimension study?

Amit: Sorry about that.

Amit: Could you talk a little bit more about.

Amit: The use of <unk> in first line versus second line and in what situations to patients get it gets us really.

Amit: As a second line treatment.

Amit:

Amit: Are they getting it in combination with any existing SSRI or SNRI treatment.

Amit: And just a follow up from an earlier topic.

Amit: Could you sort of go over and what greatest purveyor data will inform the Dodd mentioned study.

Barry E. Greene: Let me start with your Zubit question, then I can ask... Laura to talk about the Dowson-Ember question. So, you know, as we stated, Zerzuvia is the first and only oral medication specifically approved for postpartum depression. Our goal is for Zuzuvate to be used frontline, and what we're seeing from a payer perspective is, in fact, support for that. As Chris highlighted, we're seeing very strong payer coverage, I call it kind of payer tailwinds, with no steps for the majority of cut plans and very limited prior costs, so that's a very important thing.

Amit: Thanks.

Speaker Change: Yeah, Let me let me start with your Zoom a question then I can ask.

Speaker Change: Florida to talk about.

Speaker Change: The number of questions. So.

Speaker Change: As we said as we stated.

Speaker Change: <unk>, the first and only oral medication, specifically approved for postpartum depression.

Speaker Change: Our goal is for <unk> to be used frontline.

Speaker Change: And what we're seeing from a payer perspective is in fact support of that.

Speaker Change: As Chris highlighted we're seeing a very strong payer coverage I call some kind of payer tailwind.

Speaker Change: With no steps from majority of cut plans and very limited prior offs. So that's a very important thing.

Barry E. Greene: We're seeing women step up to be treated, we're seeing healthcare prescribers prescribing it, and OBGYNs leading that chart, so all signals are that Zuzuvate is becoming a front-line, first choice for the treatment of postpartum depression. I highlighted this earlier, but when we look at early claims data, almost half of the claims data suggests that those being prescribed Zuzuvu already in the first quarter, which is pretty remarkable, have not had an antidepressant for the previous year. So we are seeing the trend for Zuzuvu to be used on the front line and really no obstacles to make that happen. Laura, do you want to talk about Dels and Emdor? Sure.

Speaker Change: Seeing.

Speaker Change: Women step up to be treated we're seeing health care prescribers prescribing <unk> Liam.

Speaker Change: That chart. So all signals are that this debate is becoming a frontline <unk>.

Speaker Change: First choice for the treatment of postpartum depression, I highlighted earlier, but when you look at early claims data.

Speaker Change: Almost half of the claims data suggest that those being prescribed <unk> already in the first quarter, which is pretty remarkable.

Speaker Change: <unk> not had an antidepressant for the previous year. So we are seeing the trend towards <unk> to be used frontline and really no obstacles to make that happen whether you want to talk about <unk> sure. So your question was related to health survey or will inform the dimension study and I think there are really two main ways that we would see this.

Barry E. Greene: Sure. So your question is related to how Surveyor will inform the Dimension Study. And I think there are really two main ways that this is going to happen. The first is that we will get some data that will help us understand the performance of the different scales that we've included in the studies because the scales included in Dimension and Surveyor are largely overlapped. The second is, as I mentioned earlier, we'll be looking to really better identify clinically meaningful change in patients with Huntington's disease on the HD-CAB and other endpoints, and so that will help inform the data interpretation for dementia. Of course, when we get the surveyor data, we're going to learn as much as we can from it, but we don't have plans at this time to change the

Speaker Change: Happening. The first is we will get some data that will help us understand the performance of the different scales that we've included in the studies because the scale is included and dimension that survey are largely overlapping.

Speaker Change: Second is as I mentioned earlier, we will be looking to really better identify clinically meaningful change in patients with huntington's disease on the HD cabin other endpoints and so that will help inform the data interpretation from dimension.

Speaker Change: Of course, when we get the survey of data are we going to learn as much as we can from it but we don't have plans at this time to change the dimension study design.

Laura Gault: Would you change any part of your function or dimension?

Speaker Change: What are you seeing any time Tommy.

Laura Gault: But as I mentioned, we'll learn as much as we can from the data, but we don't have plans right now to change the study. Thank you. Our next question is coming from Brian Abrahams with RBC Capital Markets. Your line is open. Hey, good morning, guys. Thanks for taking my question and congratulations on the early progress of the law.

Tommy: Well as I mentioned.

Tommy: Well as I mentioned, we'll learn as much as we can from the data, but we don't have plans right now to change the study.

Speaker Change: Thank you.

Speaker Change: Our next question is coming from Brian Abrams with RBC capital markets. Your line is open.

Brian Corey Abrahams: Hey, good morning, guys. Thanks for taking my question and congrats on the early progress with the launch.

Brian Corey Abrahams: Our next question is coming from Brian Abrahams with RBC Capital Markets. Your line is open.

Brian Corey Abrahams: I'm curious what.

Brian Corey Abrahams: Where are you seeing in these early days is that what are you seeing in these early days of the biggest reasons why a diagnosed PPD patient might not receive a written prescription for of course, sometimes you may have.

Brian Corey Abrahams: Yeah, Brian, thanks for the question, and I appreciate the congratulatory note. Chris, do you want to take that?

Brian Corey Abrahams: A matter of awareness or coverage or are there certain types of practices and regions, where these are there more later adopters tend to be later adopters versus early adopters I'm curious what you're seeing on the ground there. Thanks.

Chris Benecchi: Yeah, so let me start with the payer piece here, because I think it's important to highlight that. I think with respect to where we stand today, we're in a very privileged position with this medication and its launch within and around payer coverage, as I noted in my prepared remarks. We're encouraged by the progress that we've made with commercial and government payers. We know that as payers are beginning to develop policies, the majority that we've seen to date don't come with onerous prior authorizations and step edits.

Speaker Change: Yes, Brian Thanks for the question and I appreciate the congratulatory note, Chris do you want to take that yes. So let me start with the payer piece here because I think I think it's important to highlight this I think with respect to where we stand today. We're in a very privileged position with this medication and it's launching in around payer coverage as I noted in my prepared remarks, we're encouraged by the progress.

Chris: Egress that we've made with commercial and government payers, we know that as payers are beginning to develop policies. The majority of that we've seen today don't come with onerous prior authorizations and step edits and importantly that enables a clinician when he or she wants to prescribe the medication to choosers due the first line and we have 65% of all commercial.

Chris Benecchi: And importantly, that enables a clinician when he or she wants to prescribe the medication, to choose their first line. And we have 65% of all commercialized coverage. That's 180 million lives that are already under coverage, with the majority of those being, or most of those being, So, from a commercial perspective, we're in good shape. Also, with Medicaid, we see that with respect to the Medicaid coverage that we've had, that in the first quarter of the year, almost half of the Medicaid states, including several of the largest states, have already completed reviews.

Chris: Covered that's a 180 million lives that are already under coverage with the majority of those being or most of those being.

Chris: Plans that don't have onerous prior authorizations and step edits so from a commercial perspective, we're in good shape also with Medicaid.

Chris: With respect to the Medicaid coverage that we've had over the first quarter of the year almost half of the Medicaid states, including several of the largest stated already completed reviews and again those don't come with onerous prior authorizations and step edits effectively meaning that the patients can get access to this medication, both equitably and affordably as we go forward so what.

Chris Benecchi: And, again, those don't come with onerous prior authorizations and step edits, effectively meaning that patients can get access to this medication both equitably and affordably as we go forward. So, what I would say to sort of round out my response is that, ultimately, if a physician hasn't prescribed Zerzube yet, it's a matter of getting to that clinician with the education that's needed to ultimately understand the efficacy and safety profile of the medication.

Chris: I would say to sort of round out my response is that ultimately if a physician hasnt prescribed zubaie, yet, it's a matter of getting to that clinician with with the education, that's needed to ultimately to understand the efficacy and safety profile of the medication between what we're doing from a personal promotion perspective, and now with increased and ongoing investment in non personal efforts in.

Chris Benecchi: Between what we're doing from a personal promotion perspective and now with increased and ongoing investment in non-personal efforts in addition to what we're seeing from what's being communicated socially and online, we believe that we're going to be able to enact that change to help a clinician who may not have heard the message hear it and begin to prescribe it. Yeah, Brian, just to round that out, I'd say that, you know, just like...

Chris: To what we're seeing from what's being communicated socially and online we believe that we're going to be able to enact that change to help the clinician who may not have heard the message here and begin to prescribes receiver, yes, Brian just to round that out I'd say that just like in drug development, the biology of the launches working meaning.

Barry E. Greene: Yeah, Brian, just to round that out, I'd say that, you know, just like in drug development, the biology of the launch is working, meaning patients are advocating, healthcare prescribers, particularly OBGYNs, are prescribing, and payers are paying, as Chris highlighted. The rest of it is, you know, classic engineering of a launch.

Chris: <unk> are advocating health care prescribers for <unk> ones are prescribing and payers are paying as Chris highlighted the rest of it is classic engineering of a launch we need to get reach and frequency to educate and as you very well know new changing health care provider.

George Farmer: We need to get reach and frequency to educate, and as you very well know, changing healthcare provider practice behavior is the key to success, and that's what we're in the midst of doing. Thanks, Barry. Thanks, Chris. Thanks, Brian. Our next question is coming from George Farmer with Scotiabank. Your line is open.

Chris: This behavior is the key to success and that's what we're in the midst of doing.

Speaker Change: Thanks, Barry and thanks, Chris.

Speaker Change: Thanks, Brian.

Chris: Our next question is coming from George Farmer with Scotiabank. Your line is open.

Barry E. Greene: So George, when you say geographies, are you talking about the ex-U.S.? Yeah. Yeah, so to remind you that the relationship that we have, the partnership that we have with Biogen is that we're 50-50 COCO in the United States, and as you've heard over and over, that's going incredibly well. And outside Japan, Korea, and Taiwan, where we have another partner, Biogen is responsible for the rest of the world. So it's really a Biogen question to answer. Okay, thanks. Thanks, George. Our next question is coming from Sumant Kulkarni with Canaccord. Your line is open. Good morning, nice to see the progress on the ZOE, and thanks for taking the time to join us.

George Farmer: Hi, good morning, Congratulations on all the progress I was wondering if you could comment on expanding geographies for <unk> and how.

George Farmer: How that might be progressing and what other.

George Farmer: Are there steps might be necessary I think Biogen mentioned, maybe another trial would be required. So wondering if you could potentially comment on that.

George Farmer: So George you talked about leasing geography, you talked about ex U S.

George Farmer: Yeah.

George Farmer: Yeah. So so remind you that.

George Farmer: The relationship that we have partnered with Biogen as we're 50 50 Coco.

George Farmer: I would state that <unk> heard over and over that's going incredibly well.

George Farmer: And outside Japan, Korea, and Taiwan, where we have another partner Biogen responsible for the rest of the world. So it's really a biogen question to answer.

Speaker Change: Okay. Thanks.

Speaker Change: Thanks George.

Speaker Change: Our next question is coming from somewhat corny with Canaccord. Your line is open.

Corny: Good morning, nice to see the progress on visibly and thanks for taking my question, which is on doesn't them do so.

Sumant Satchidanand Kulkarni: Our next question is coming from Sumant Kulkarni with Canaccord. Your line is open.

Corny: So other than some factors you mentioned before that might make read throughs to upcoming trial Readouts challenging is there anything specific that makes cognitive impairment and huntington's Alzheimer's different pushes back and since I'm asking because they are most likely some nuances involved in specific areas of loss in these disease states and to see if there is a potential mechanistic basis for doesn't know.

Sumant Satchidanand Kulkarni: Yeah, Sumant, well, thanks for the congratulations, and a great question on Down's syndrome, and a very important one. Let me ask Mike to start with sort of the biologic appreciation that started in Huntington's with 24-significant cholesterol, and maybe Laura can talk a little bit about that, and why we think the results we see are not necessarily predictive of future results. Mike?

Corny: Target specific parts of the brain in different ways.

Speaker Change: Yes, Mike Thanks for the congratulations and great question on <unk> and a very important one let me ask Mike to start with sort of the biologic appreciation that started in Huntington to 'twenty for US first of all maybe worth talking about.

Speaker Change: Why are we seeing.

Michael Quirk: Thanks, Barry. So, what I would say is that there are decades of research that have really implicated NMDA receptor hypofunction in a range of disorders associated with cognitive impairment. And furthermore, there is increasing evidence specifically of NMDA receptor loss or expression changes in disorders such as Huntington's disease, Parkinson's disease, and Alzheimer's disease. That being said, while cognitive impairment is a common feature across these diseases, the underlying pathophysiology and the relative contribution of NMDA receptor dysfunction are likely to be distinct across these groups.

Speaker Change: <unk> are not necessarily predictive of future results, Mike. Thanks, Barry So what I would say is that there are decades of research that heavily implicated NMDA receptor hypofunction in a range of disorders associated with cognitive impairment and further there is increasing evidence specifically of.

Speaker Change: Of NMDA receptor loss of expression changes and sort of such as Huntington's disease, Parkinson's disease, and Alzheimers disease that being said, while cognitive impairment is a common feature across these diseases, the underlying pathophysiology and the relative contribution of NMDA receptor dysfunction is likely to be distinct across these group.

Michael Quirk: And we really have different hypotheses that we're testing across the three studies that we're running. And so for this reason, we've always seen the studies in HD, Parkinson's disease, and Alzheimer's disease as distinct and independent tests of the NMDA receptor hypofunction, where we're really looking at different pathophysiological consequences there. So as Barry mentioned, in the context of Plankton's disease, which is our lead indication, we're really focusing on the loss of the endogenous modulator, 24S-hydroxycholesterol, as the rationale for why a molecule such as dalzinemder should work in treating these cognitive impairments. So that's sort of the scientific rationale across these diseases. I'll let Laura comment a little bit more about this distinct symptomology and as we think about the disorders.

Speaker Change: And we really have different hypothesis that we're testing across the three studies that we're running and so for this reason we've always seen the studies in HD, Parkinson's disease, and <unk> disease as distinct and independent test of the NMDA receptor Hypofunction, where we're really looking at different pathophysiological consequences. There so as Barry mentioned in the call.

Speaker Change: So clinton's disease, which is our lead indication, we're really focusing on the loss of the endogenous modulator 24 us hydroxy cholesterol as the rationale for why a molecule such as thousand number should work in treating these cognitive impairment. So thats sort of the scientific rationale across these disease I'll, let Laura comment a little bit more about this distinct symptomology.

Laura Gault: So, these disorders are obviously characterized by cognitive impairment, but they have accompanying symptoms that are quite different. As we talked last week about Parkinson's disease, that's a disorder where you see the onset of cognitive impairment after motor symptoms appear in most cases. In Huntington's disease, the reverse is true. The onset of symptoms can be 10 or 15 years even before the onset of motor symptoms.

Laura Kathryn Chico: And as we think about the disorders.

Laura Kathryn Chico: That's right.

Laura Kathryn Chico: These disorders, obviously are all characterized by cognitive impairment, but they have accompanying symptoms that are quite different across as we talked last week about Parkinson's disease.

Laura Kathryn Chico: The disorder, where you see the onset of cognitive impairment after motor symptoms appear in most cases and Huntington's disease. The reverse is true.

Laura Kathryn Chico: The onset of symptoms can be 10, or 15 years, even before the onset of the motor symptoms and so it's a very different progression youre looking at a younger population Youre also looking at a much more homogeneous population based on the underlying etiology.

Laura Gault: And so, it's a very different progression. You're looking at a younger population. You're also looking at a much more homogeneous population based on the underlying etiology. And then you move over to Alzheimer's disease, a very different population again in terms of the underlying pathophysiology. We have the amyloid plaques and the neurofibrillary tangles, which are driving the downstream pathology and NMDA receptor hyperfunction, but that is a very distinct driver So, for all these reasons, as Mike said, these are really distinct disorders with differences in the symptomatology, differences in the study design, and we expect that each of these is an independent test of hypertension.

Laura Kathryn Chico: And then you move over to Alzheimer's disease, a very different population again in terms of the underlying pathophysiology, we have the amyloid plaques in the center of Fibrillary tangles, which are driving the downstream.

Laura Kathryn Chico: Downstream pathology and NMDA receptor hypofunction, but that is a very distinct driver compared to Huntington's Parkinson's so for all these reasons.

Laura Kathryn Chico: As Mike said these are really distinct disorders with differences in the symptomatology differences in the study design and we expect that each of these is an independent test of the hypothesis.

Laura Kathryn Chico: Thanks.

Yatin Suneja: Our next question is coming from Yatin Suneja with Guggenheim. Your line is open.

Speaker Change: Thanks, so much.

Speaker Change: Our next question is coming from <unk> <unk> with Guggenheim. Your line is open.

Yatin Suneja: Thank you for taking my question and congratulations on the nice launch. Question on 324 with regard to the Kinetics 2 study: could you maybe help us understand the difference between the endpoint, between kinetic and kinetic 2, what you would like to show? And then how should we think about the pivotal endpoint because I think there are other companies that are using ADL as an endpoint for pivotal development. So anything you can talk about from the regulatory perspective on the endpoint side would be great.

Guggenheim: Thank you for taking my question and congrats on a nice lunch.

Speaker Change: A question on three to four with regard to the kinetics. Two study could you maybe help us understand the difference between the end point.

Guggenheim: Con Edison kinetic to what you would like to show and then how should we think about typical at this point because I think there are other companies that are using video as an endpoint from appropriate development. So anything you can tell from the regulatory perspective on the endpoints that that'd be great. Thank you.

Laura Gault: Yeah, yeah, Tina, and thank you for... Congratulatory Nodal Launch. Laura, you want to take the... Thank you for your questions. Sure, so with regard to

Speaker Change: Yes, and thank you for.

Speaker Change: Congratulatory note on launch Laura you want to take the thank.

Laura Gault: Sure, so with regard to the original kinetic study and the Kinetic 2 study that's currently ongoing, we actually use the same primary endpoint, which is the upper limb extremity score from the Tetris performance scale. We use that measure because it's a sensitive measure for detectors. We are aware, as you are, that there has been regulatory feedback about using the ADL scale associated with Tetris. We are collecting all of that data in the ongoing Kinetic II study, and we will be poised, with a lot of data, to have discussions with regulators at the end of Phase II about which instrument would be the best for a Phase III end.

Laura Kathryn Chico: Thank you thank you for questions.

Laura Kathryn Chico: Sure So with regard to the original kinetics study and the kinetic to say that's currently ongoing we actually use the same primary endpoint, which is the upper limb extremity score from the Tetris performance scale are we is that I'm not sure because it's a sensitive measure to detect change. We are aware as you are that there has been regulatory feedback.

Laura Kathryn Chico: About using the ADL scale associated with the Tetris, we're collecting all of that data in the ongoing kinetic two study and we will be poised with a lot of data to discussions with regulators at the end of phase II about which instrument would be the best for a phase III endpoint.

Douglas So: Thank you, Ateem. Our next question is coming from Douglas Sow, The Wainwright. Your line is open.

Speaker Change: Thank you Tim.

Laura Kathryn Chico: Okay.

Laura Kathryn Chico: Our next question is coming from Douglas Tsao with H C. Wainwright Your line is open.

Douglas Tsao: Hi, good morning, Thanks for taking the questions and congrats on the progress just curious.

Barry E. Greene: Our next question is coming from Douglas So with HC Wainwright. Your line is open.

Douglas Tsao: What percentage of the overall sort of sales detail. So far have been made by you versus Biogen and I'm just curious in terms of how when you contemplate sort of scaling up the launch how do you coordinate that and sort of determine.

Chris Benecchi: Let me start, and then Chris can follow up. So I was actually with our field team a couple weeks ago, and I can tell you that whether you're SAGE or Biogen, they're working incredibly well together as a well-functioning machine. And the team is very well integrated, and they help each other literally every day to do what's right, which is help moms get diagnosed and treated with Zerzuvia. Chris, do you want to talk about the scaling aspect?

Douglas Tsao: Sort of a theme that needed resources.

Speaker Change: Hey, Doug Let me start and then Chris can control. So I was actually with our field team a couple of weeks ago and I can tell you that.

Doug: Whether youre stage or biogen, they're working incredibly well together as a well functioning machine.

Doug: Jean and the team is very well integrated are helping each other literally every day.

Douglas Tsao: Do do what's right, which is diagnosed and treated with <unk>.

Douglas Tsao: As quickly as possible so it's a very well coordinated.

Chris Benecchi: Yeah, I think in terms of the activity at a field level, it's 50-50 between the two organizations. We really work well and collaboratively around how we operate at a field level with respect to reach and frequency. I think in terms of scaling, those are conversations that are ongoing. The teams talk about the future of this product on a daily basis. It's everything from the strategy that we employ all the way through to the tactics and specifically how we're going to execute. Again, as Barry noted, that's an ongoing interaction between the two organizations that are committed to fundamentally changing the way PPD is thought about and treated for women that are suffering with the condition.

Douglas Tsao: Chris you want to talk to we've talked about is just mentioned the scaling I think I think in terms of the activity at a field level. It's 50 50 between the two organizations here, we really work well and collaboratively around how we executed a field level with respect to reach and frequency I think in terms of scaling those are conversations that are ongoing.

Douglas Tsao: Teams talk about the future of this product on a daily basis, and it's everything from the strategy that we employ all the way through to the tactics and specifically, how we're going to execute it and again I think as Barry noted that's an ongoing interaction between the two businesses to organizations that are committed to fundamentally changing the way PPD is thought about and treated.

Douglas Tsao: The women that are suffering with the condition.

Chris Benecchi: Okay, great. Thank you. Thank you, guys. Our next question is coming soon.

Speaker Change: Okay, great. Thank you.

Speaker Change: Thanks, Doug.

Douglas Tsao: Our next question is coming from Vikram <unk> with Morgan Stanley. Your line is open.

Vikram Purohit: Our next question is coming from Vikram Purohit with Morgan Stanley. Your line is open.

Douglas Tsao: Hi, Thanks for taking my question. This is Morgan on for Vikram.

Vikram Purohit: Thanks for the question, Morgan. Kimi, you want to take that? Yeah, as we mentioned and as you just mentioned, we are not guiding to growth today.

Morgan: So on reimbursement for <unk> I know you had mentioned not guiding to gross to net just yet, but where would you expect steady steady state gross to net to potentially settle out and how long do you think it would take to reach the steady state.

Kimi E. Iguchi: Yeah, as we mentioned, and as you just mentioned, we are not guiding to Growth2Net today, but, you know, again, we've been talking about the fact that we don't anticipate this kind of discounting that you're seeing for recent branded antidepressants. And so, and another thing is, if you think about the key components of what we expect in our Growth2Net, they're the typical components, they're the rebates and discounts we'll see, the patient assistance programs, you know, including financial assistance. And so, all the similar kinds of things you'll see, but we just don't anticipate the same type of discounting you see for other recent antidepressants.

Douglas Tsao: Sure.

Speaker Change: Thanks for the question Mario and Kim you want to take that yeah. As we as we mentioned and as you. Just mentioned we are not guiding to growth to that today, but you know again, we've been talking about the fact that we don't anticipate.

Kim: Kind of of discounting that Youre seeing for recent branded anti depressants.

Kim: And another thing is if you think about the key components of of what we expect in our gross to net Theres. A typical components are the rebates and discounts will see the patient assistance programs.

Speaker Change: Including financial assistance, so all the similar kinds of things Youll see but we just don't anticipate the same type of discounting you see for other recent antidepressants.

Barry E. Greene: Thank you, and that will conclude the Q&A portion of today's call. With that, I will turn it back over to Mr. Greene for closing remarks.

Speaker Change: Thanks Martin.

Speaker Change: Yeah.

Speaker Change: Yeah.

Martin: And then that will come that will conclude the Q&A portion of today's call with that I will turn it back over to Mr. Green for closing remarks.

Operator: Thanks, Shelly. And thanks again to everyone for joining us this morning to review our results for the first quarter of 2024. Just to close it out, the full quarter of the Zerzouve launch has been completed, and we remain highly encouraged by the progress, and we're excited to help the many moms suffering with PPD. Of course, we were disappointed with the outcome of the precedent study, but as you heard from Mike and Laura, we remain on track to read out important data from across our pipeline throughout the remainder of the year.

Martin: Thanks Shelly.

Shelly: Thanks, again to everyone for joining us this morning to review our results from the first quarter of 2024.

Barry E. Greene: Just to close it out.

Barry E. Greene: Zubair launch has been completed and we remain highly encouraged with the progress.

Barry E. Greene: And we're excited to help the many moms suffering with PPD of course, we were disappointed with the outcome of the precedent study, but as you heard from Mike Laura We remain on track to read out important data from across our pipeline throughout the remainder of the year and we do not believe the precedent is necessarily predictable future studies as as you heard on the call. We're also.

Operator: And we do not believe the precedent is necessarily predictive of future studies, as you heard on the call. We're also well positioned financially to take us through key milestones, and we remain focused on our mission to develop and launch life-changing brain health medicine so every person can thrive. Thanks again, everyone, and have a great day. Bye.

Barry E. Greene: Well positioned financially to take us through key milestones and we remain focused on our mission to develop and launch life changing brain health medicine. So every person can thrive. Thanks.

Operator: This concludes today's call. Thank you for your participation. You may now disconnect.

Speaker Change: Thanks, again, everyone and have a great day.

Speaker Change: This concludes today's call. Thank you for your participation you may now disconnect.