Q2 2024 Sage Therapeutics Inc Earnings Call
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Unknown Executive: 2nd Quarter 2024 Financial Results Conference Call. Currently, all participants are in listen-only mode.
Good afternoon.
Speaker Change: Welcome to Sage Therapeutics second quarter 2024 financial results conference call.
Unknown Executive: This call is being webcast live on the Investors & Media section of Sage's website at www.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.
Speaker Change: Currently, all participants are in listen-only mode. This call is being webcast live on the Investors and Media section of Sage's website at SageRx.com.
Speaker Change: This call is a property of Sage Therapeutics and recording, reproduction, or transmission of this call without the express written consent of Sage Therapeutics is strictly prohibited.
Ashley Kaplowitz: I would now like to introduce Ashley Kaplowitz, Vice President of Investor Relations and Capital Markets at Sage. Good afternoon, and thank you for joining Sage Therapeutics' second quarter 2024 financial results conference. Before we begin, I encourage everyone to go to the Investors & Media section of our website, sagerx.com, where you can find the press release and slides related to today's webinar. I would like to point out that we will be making forward-looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ.
Speaker Change: 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: Please review the risk factors discussed in today's press release and in our SEC filings for additional, 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 second quarter of 2020. Our Chief Business Officer, Chris Benecchi, will provide an update on the ongoing commercialization of Zerzube and postpartum depression, or PPD. Laura Gault, our Chief Medical Officer, will review development activities across our program.
Ashley Kaplowitz: Good afternoon and thank you for joining Sage Therapeutics second 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.
Speaker Change: I would like to point out that we will be making forward-looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. Please review the risk factors discussed in today's press release and in our SEC filings for additional details.
Barry E. Greene: 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 second quarter of 2024.
Speaker Change: Our Chief Business Officer, Chris Benecchi, will provide an update on the ongoing commercialization of Zerzube and postpartum depression, or PPD. Laura Gault, our Chief Medical Officer, will review development activities across our programs.
Kimi E. Iguchi: We will then be joined by Kimi Iguchi, our Chief Financial Officer, who will review our financial results from the second quarter of 2024.
Barry: 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.
Ashley Kaplowitz: We will then be joined by Kimi Iguchi, our Chief Financial Officer, who will review our financial results for the second quarter of 2020. Mike Quirk, our Chief Scientific Officer, will be available for questions during the Q&A portion of the webinar. With that, I'll now turn the call over to Ashley. Thanks, Ashley, and thank you, everyone, for joining us this afternoon.
Barry: Thanks, Ashley, and thank you, everyone, for joining us this afternoon.
Barry E. Greene: As we progress through 2024, we remain focused on addressing unmet needs in brain health. Our successes and setbacks provide valuable learnings, and we push forward in our efforts to advance our science for patients in Need of New Treatment. As you may have seen, last week, we and Biogen announced negative results from our KINETIC-2 study of SAGE-324 in essential tremor, or ET. Given these results, we plan to close the ongoing Open Label Safety Study and do not plan to conduct further clinical development of SAGE 324 in E2.
Barry: As we progress through 2024, we remain focused on addressing unmet needs in brain health.
Barry: Our successes and setbacks provide valuable learnings, and we push forward in our efforts to advance our science and support patients in need of new treatment options.
Barry: As you may have seen, last week, we and Biogen announced negative results from our Kinetic II study of SAGE-324 in essential tremor, or ET.
Barry: Given these results, we plan to close the ongoing Open Label Safety Study and do not plan to conduct further clinical development of SAGE 324 in ET.
Barry E. Greene: We recognize there's a high unmet need in this disease with limited innovation treatments over the past 50 years, are deeply disappointed with this outcome, and importantly for ETP, but now we continue to work to accelerate launch momentum for Zuzuvan PPD and to progress our brain health pipeline and look forward to providing additional data readouts expected later this year. Now, where we are helping patients is postpartum depression. Turning to Zerzuve, I'm energized by the profound impact we're making on women with PPD and their families. Zerzuve is the first and only oral medication approved for the treatment of PPD in adults.
Barry: We recognize there's a high unmet need in this disease with limited innovation treatments over the past 50 years and are deeply disappointed with this outcome and importantly for ET patients.
Barry: Now, we continue to work to accelerate launch momentum for Zuzuvan PPD and to progress our brain health pipeline and look forward to providing additional data readouts expected later this year.
Barry: Now where we are helping patients is postpartum depression. Turning to Zerzuve, I'm energized by the profound impact we're making on women with PPD in their families.
Barry: The first and only oral medication approved for the treatment of PPD in adults.
Barry E. Greene: We're also seeing firsthand a progressive evolution in the treatment of PPD, particularly as OBGYNs are on the forefront of a movement to vastly improve screening, diagnosis, and treatment. It's encouraging to see the progress we've made as we near the one-year anniversary of the FDA approval of Zerzuva. The increasing demand and the growth in prescriptions and shipments in the second quarter is indicative of that progress and supports our goal to establish Zuzuve as a first-line therapy and standard of care for women with TB. I'll highlight a few of the encouraging signals we saw this quarter, which Chris will dive into in more detail.
Barry: We're also seeing firsthand a progressive evolution in the treatment of PPD, particularly as OBGYNs are on the forefront of a movement to vastly improve screening, diagnosis, and treatment.
Barry: It's encouraging to see the progress we've made as we near the one-year anniversary of the FDA approval of Zerzuvia.
Speaker Change: The increasing demand and the growth in prescriptions and shipments in the second quarter is indicative of that progress and supports our goal to establish ZUZUVE as a first-line therapy and standard of care for women with PPD.
Speaker Change: I'll highlight a few of the encouraging signals we saw this quarter which Chris will dive into in more detail.
Barry E. Greene: We observed strong quarter-over-quarter growth, Q1 to Q2, in prescriptions and shipments of Zuzuva. Shipments delivered to patients nearly doubled in the second quarter relative to the first quarter, reflecting the strong demand and level of interest we're seeing from healthcare professionals for Zerzuviae in treating women with PPD. HCP prescriber momentum continues with prescriptions in Q2 seen across the breadth of HCP-Sutree PPD, and in particular OB-GYN. Notably, early data suggest that OB-GYNs who have prescribed Zerzube are treating significantly more patients with PPD than they were previously. This is based on written prescriptions for all medications.
Chris: We observe strong quarter-over-quarter growth, Q1 to Q2, in prescriptions and shipments of Zuzume.
Chris: Shipments delivered to patients nearly doubled in the second quarter relative to the first quarter, reflecting the strong demand and level of interest we're seeing from HCPs or Xerzuvé in treating women with PPD.
Speaker Change: HCP prescriber momentum continues with prescriptions in Q2 seen across the breadth of HCP-suture PPD and in particular OBGYNs.
Speaker Change: Notably, early data suggests that OBGYNs who have prescribed Zerzube are treating significantly more patients with PPD than they were previously. This is based on written prescriptions for all medications.
Barry E. Greene: This is an important metric that shows how Zerzuvia is beginning to change the HCP treatment paradigm for postpartum depression. In addition, the number of new and repeat Zuzuvuvae prescribers grew during the second quarter of 2020, and we're seeing many OBGYNs right through Zubei for multiple patients. We continue to have strong commercial and government access for Zuzulian PPD, with the majority of plans to date not imposing onerous prior auths or step edits for Postpartum Pressure.
Speaker Change: This is an important metric that shows how Zerzuvia is beginning to change the HCP treatment paradigm in postpartum depression.
Speaker Change: In addition, the number of new and repeat Zerzuve prescribers grew during the second quarter of 2024, and we're seeing many OBGYNs write Zerzuve for multiple patients.
Speaker Change: We continue to have strong commercial and government access for Zuzulian PPD with the majority of plans to date not imposing onerous prior offs or step edits for postpartum depression.
Barry E. Greene: We are also seeing momentum across the ecosystem with broad policymaker interest across the country to advance policies to improve maternal mental health outcomes. For example, the state of Louisiana recently signed a bill that generally permits women with TPD to bypass step therapy requirements by commercial insurers and gain direct access to FDA-approved treatments for people. We believe this law will help enable women with PPD in the state to gain direct access to Zuzuva when prescribed.
Speaker Change: We are also seeing momentum across the ecosystem with broad policymaker interests across the country to advance policies to improve maternal mental health outcomes.
Speaker Change: For example, the state of Louisiana recently signed into law a bill that generally permits women with PPD to bypass step therapy requirements by commercial insurers and gain direct access to FDA approved treatments for PPD.
Speaker Change: We believe this law will help enable women with PPD in the state to gain direct access to Zerzuvia when prescribed. As we highlighted at launch, our strategy has been to launch with a focused approach and scale as we see success.
Barry E. Greene: As we highlighted at launch, our strategy has been to launch with a focused approach and scale as we see success. As the signs of success have been encouraged In addition to expanding marketing and non-personal promotion, Sage plans to strategically expand its sales force in early Q4, where we believe additional resources will help accelerate demand for Zerzouve in the treatment of COVID-19. We believe this planned expansion of our sales force is well-timed with access coverage and improvements in the specialty pharmacy process.
Speaker Change: As the signs of launch have been encouraging, in addition to expanding marketing and non-personal promotion, Sage plans to strategically expand its sales force in early Q4, where we believe additional resources will help accelerate demand for Zerzouve in the treatment of PPD.
Speaker Change: We believe this planned expansion of our sales force is well-timed with access coverage and improvements in the specialty pharmacy processing. It will help to support the growing focus to treat PPD and to accelerate commercial momentum.
Barry E. Greene: It will help to support the growing focus on treating PPD and to accelerate commercial momentum. 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. And we look forward to sharing more updates on our launch progress in the coming quarter. Moving to our clinical stage pipeline, we recently announced data from our Phase 2 kinetic tube study in essential tremor, as I highlighted previously.
Speaker Change: We continue to believe Xerzuve is the key to unlocking the blockbuster potential of PPD, enabling us to help many women suffering from this devastating disease, and we look forward to sharing more updates on our launch progress in the coming quarters.
Speaker Change: Moving to our clinical stage pipeline, we recently announced data from our phase two kinetic tube study in essential tremor, as I highlighted previously.
Barry E. Greene: We also continue to progress our clinical development program for Dalsyn-MDOR, our wholly-owned NMDA receptor-positive allosteric modulator, or PAM, formerly known as CH718. In June, we reported results from our Phase 2 Surveyor Study of Dalzin-Amdor, which reinforces the cognitive impact of CDH, a historically under-recognized aspect of HD for which there are no approved treatments. As you may have seen in our press release this afternoon, based on our review of relevant data, we have decided to adjust the primary endpoint in our ongoing placebo-controlled dementia study in HD from the HD-CAB composite to the Symbol-Digit Modalities Test, or SDMT, one of the cognitive tests included in the composite.
Speaker Change: We also continue to progress our clinical development program for Dalsyn-MDOR, our wholly owned NMDA Receptor Positive Allosteric Modulator, or PAM, formerly known as CH718.
Speaker Change: In June , we reported results from our Phase II Surveyor Study of Dowell's and Amdor, which reinforces the cognitive impact of Huntington's Disease or HD, a historically under-recognized aspect of HD, for which there are no approved treatments.
Speaker Change: As you may have seen in our press release this afternoon, based on our review of relevant data, we have decided to adjust the primary endpoint in our ongoing placebo-controlled dementia study in HD from the HD-CAB composite to the Symbol-Digit Modalities Test, or STMT,
Barry E. Greene: Laura will provide additional context and information for this. Both the Phase II Light Wave and Dimension Studies remain on track to read out late 2025. Additionally, we remain encouraged about the potential of our earlier stage pipeline, including Stage 319 and Stage 421, and believe there are important development opportunities as we explore areas of unmet need and breakthrough. With that, I'll turn the call over to Chris to provide additional context on the ongoing commercialization of Zerzuviae in postpartum depression. Chris?
Speaker Change: One of the cognitive tests included in the composite. Laura will provide additional context and information for this change.
Laura: Both the Phase II Light Wave and Dimension Studies remain on track to read out late 2024.
Laura: Additionally, we remain encouraged about the potential of our earlier stage pipeline, including SAGE 319 and SAGE 421, and believe the important development opportunities as we explore areas of unmet need in brain health.
Laura: With that, I'll turn the call over to Chris to provide additional context on the ongoing commercialization of Zerzuvia in postpartum depression. Chris?
Christopher Benecchi: Thanks, Barry. We've made important progress on the launch of Zerzouve during the second quarter, and I'm excited to share details on our recent achievements and ongoing initiatives. Since the launch of Zerzuve in December of 2023, SAGE and Biogen have been focused on our shared goal of establishing Zerzuve as the first line therapy and standard of care for women. Our commercialization efforts have enabled us to exceed expectations, and we look forward to the potential to further maximize patient impact over the coming quarter.
Chris: Thanks, Barry. We've made important progress in the launch of Zerzouve over the second quarter, and I'm excited to share details on our recent achievements and ongoing initiatives.
Chris: Since the launch of Zerzuve in December of 2023, Sage and Biogen have been focused on our shared goal of establishing Zerzuve as the first-line therapy and standard of care for women with PPD.
Chris: Our commercialization efforts have enabled us to exceed expectations and we look forward to the potential to further maximizing patient impact over the coming quarters.
Christopher Benecchi: First, I'll review key performance metrics that highlight the strong progress made throughout the second quarter. Zerzube generated $14.8 million in total revenue in the second quarter of 2024, of which Sage recognized $7.4 million in collaboration revenue.
Speaker Change: First, I'll review key performance metrics which highlight the strong progress made throughout the second quarter.
Speaker Change: Zerzube generated $14.8 million in total revenue in the second quarter of 2024, of which Sage recognized $7.4 million in collaboration revenue.
Christopher Benecchi: In the second quarter, approximately 2,000 prescriptions were written, with more than 1,400 prescriptions filled and delivered to patients. The number of shipments delivered to patients nearly doubled compared to the first quarter. We are pleased to see our ongoing commercialization efforts positively impacting demand for Zerzuvia and PPE and feel these figures are reflective of the interest and enthusiasm we're seeing from healthcare professionals and women with BPD for this important medication. As a reminder, while we believe the number of prescriptions was an important early indication, next quarter and going forward, we plan to focus on shipments and collaboration revenue. Training to Prescriber Trend
Speaker Change: In the second quarter, there were approximately 2,000 prescriptions written, with more than 1,400 prescriptions filled and delivered to patients.
Speaker Change: The number of shipments delivered to patients nearly doubled compared to the first quarter.
Speaker Change: We are pleased to see our ongoing commercialization efforts positively impacting demand for Zerzuvia and PPD, and feel these figures are reflective of the interest and enthusiasm we're seeing from HCPs and women with PPD for this important medication.
Speaker Change: As a reminder, while we believe the number of prescriptions was an important early indicator, next quarter and going forward, we plan to focus on shipments and collaboration revenue.
Christopher Benecchi: We are seeing Zerzuvia prescribed across a breadth of healthcare professionals who treat PPD, with more than 70% of prescriptions in the second quarter coming from OBGYNs, followed by psychiatrists and PCPs. As we've underscored, OB-GYNs are critical to this launch and the ongoing success of Zyzuve for women with PPD, as these healthcare professionals are on the front line of peripartum care and therefore When you reflect on our performance over the first and second quarters, including revenue, prescriptions, shipments, and prescribing patterns, And we believe that Zerzube is squarely at the center of this paradigm.
Speaker Change: Turning to prescriber trends, we are seeing Zerzuvia prescribed across a breadth of HCPs who treat PPD, with more than 70% of prescriptions in the second quarter coming from OBGYNs, followed by psychiatrists and PCPs.
Speaker Change: As we've underscored, OB-GYNs are critical to this launch and the ongoing success of Zazuvay for women with PPD, as these HCPs are on the front line of peripartum care, and therefore the earliest and best place to screen, diagnose, and treat.
Speaker Change: When you reflect on our performance over the first and second quarter, including revenue, prescriptions, shipments, and prescribing patterns, it's clear that there is a fundamental change in the way PPD is now thought about and treated. And we believe that Zerzube is squarely at the center of this paradigm shift.
Speaker Change: I'll take a moment now to highlight a few notable signs that reflect the changes we are seeing unfold in the treatment of women with PPD.
Speaker Change: As Barry noted earlier, we are beginning to see changes in the PPT treatment paradigm, particularly among OBGYNs.
Christopher Benecchi: Notably, early data suggest that OBGYNs who have prescribed Zerzube are treating significantly more patients with PPD than they were previously, based on written prescriptions for all medications. We see this as a clear uptick in OBGYNs increasing screening, diagnosis, and treatment. In terms of other trends, adoption of Zerzuvia as a treatment for women with PPD continues to increase. The total number of new and repeat Zerzuvia prescribers also continues to grow.
Speaker Change: Notably, early data suggests that OBGYNs who have prescribed Zerzube are treating significantly more patients with PPD than they were previously, based on written prescriptions for all medications.
Speaker Change: We see this as a clear uptick in OBGYN's increasing screening, diagnosis, and treatment.
Speaker Change: In terms of other trends, adoption of Zerzuve as a treatment for women with PPD continues to increase. The total number of new and repeat Zerzuve prescribers continue to grow in Q2.
Christopher Benecchi: It's encouraging to see that more than 30% of HCPs have now written multiple prescriptions, indicating both interest in using Zerzube and satisfaction with the impact it can have on a woman with PPE. In summary, the data in totality suggest that a movement is occurring in PPD care, particularly among OBGYNs who are moving from the old model of suspecting depression and referring patients to a psychiatrist to now Screening, Diagnosing, and Treating Women with PPD with Zerzube when they present with symptoms.
Speaker Change: It's encouraging to see that more than 30% of HCPs have now written multiple prescriptions indicating both interest in using Zerzube and satisfaction with the impact it can have on a woman with PPD.
Speaker Change: Notably, we are seeing that the majority of Zerzuvia patients are receiving Zerzuvia as their first treatment for PPD after giving birth.
Speaker Change: The prescribing trends I've described are what we would expect to see based on our promotional and educational efforts and suggest that these efforts are effectively informing stakeholders about Zerzube.
Speaker Change: In summary, the data in totality suggest that a movement is occurring in PPD care, particularly OBGYNs who are moving from the old model of suspecting depression and referring patients to a psychiatrist, to now screening, diagnosing, and treating women with PPD with Zerzube, when they present with symptoms.
Christopher Benecchi: This is much needed progress in the ongoing effort to ensure that women with PPE get the treatment that they need. As I noted previously, women experiencing PPD will have the potential, through this platform, to get matched with and see a psychiatrist. Provide women with PPD first-line access to Zuzu Bay without onerous prior authorizations or, with the majority having no step therapy or complex prior authorization. We expect to see the use of free goods.
Speaker Change: This is much needed progress in the ongoing effort to ensure that women with PPE get the treatment that they need.
Speaker Change: As I noted previously, this is a promotionally sensitive market which reinforces the importance of our field force and omnichannel efforts, which are intended to build awareness, underscore urgency to treat, and inspire excitement in Zerzuvia as a new treatment option for women diagnosed with PPD.
Speaker Change: The majority of prescriptions for Zizouve are coming from HCPs who have been reached either through personal or digital promotion.
Speaker Change: To that end, we remain active in our educational efforts across all channels to engage stakeholders with the goal of making Zerzube top of mind as a first choice treatment for women with PPD.
Speaker Change: We recently launched our full consumer website which includes information and resources for people experiencing PPD symptoms and provides a link to an independent leading telepsychiatry practice.
Speaker Change: Women experiencing PPD will have the potential through this platform to get matched with and see a psychiatrist.
Speaker Change: We are also making progress on our social media platforms with more to come in the second half of 2024.
Speaker Change: Turning to access, in the lead up to the launch, we stated that rapid and affordable access to Zerzube in the treatment of women with PPD, regardless of coverage type, was paramount to successful commercialization.
Speaker Change: To that end, SAGE and Biogen have been proactively focused on the shared goal of helping women who are prescribed Zerzuvia for PPD receive the medication as quickly as possible, regardless of coverage type.
Speaker Change: Our conversations with payers have been highly productive.
Speaker Change: We are encouraged to see the majority of plans finalizing policies that provide women with PPD first-line access to Zuzube without onerous prior authorizations or step edits.
Speaker Change: Today, we have approximately 80% of commercial lives covered for Zuzuva and PPD.
Speaker Change: with the majority having no step therapy or complex prior authorizations, including two or three national PBMs who developed coverage policies for Zuzube and the disease.
Speaker Change: We continue to progress conversations with the third national PBM.
Speaker Change: With respect to Medicaid, reviews are ongoing, with additional states, including several of the larger states, completing reviews during the second quarter of 2024.
Speaker Change: While Medicaid policies continue to develop, most states that have made a decision to date are covering Zerzuvia for women with PPD in line with our expectations of no-step therapy and no complex prior authorizations.
Speaker Change: The majority of Medicaid coverage decisions have already been made, with the remainder expected to occur in the second half of 2024.
Speaker Change: This type of progress with respect to coverage is not typical for new product launches.
Speaker Change: We attribute this payer progress to the profound need for women with PPD to receive treatment, the value proposition of Zerzube and the willingness of SAGE and Biogen to work closely with payers to rapidly make robust access a reality in PPD.
Speaker Change: To that end, we continue to work to enable affordable and equitable access to Zerzuve for eligible women with PPD for our patient support and financial assistance programs.
Speaker Change: While the majority of shipments were covered by commercial and government payers in the second quarter, we did see an uptick in our free goods programs.
Speaker Change: A free goods program is intended to help accelerate access to Zerzuve for eligible women with PPD who are prescribed treatment.
Speaker Change: As more payers come online and as the specialty pharmacy process is further optimized, we expect to see the use of free goods decrease.
Speaker Change: In summary, we remain highly encouraged by and proud of the launch progress made to date with Zerzube. There is a fundamental change occurring with respect to how PPD is thought about, diagnosed, and treated.
Laura Gault: We are highly committed to helping women living with PPD and engaging the HCPs who do. With that, I will now turn it over to Laura for a more detailed discussion of our recent developments. I'll begin with Selznamdor, our wholly owned, first-in-class NMDA receptor positive allosteric modulator, and Alzheimer's disease or AIDS, and ultimately, their ability to remain. As previously reported, the surveyor study suggested the potential for directionally positive..., and a number of individual component tests of the HD-CAP composite, and in some functionalism.
Speaker Change: We are highly committed to helping women living with PPD and engaging the HCPs who treat them.
Speaker Change: As Barry noted, Sage plans to strategically expand our sales force in early Q4, which we believe will help accelerate commercial momentum by broadening our reach and increasing the frequency of our interactions with HCPs who treat PPD.
Barry: I look forward to sharing additional updates on Launch Progress in the coming quarters.
Barry: With that, I will now turn it over to Laura for a more detailed discussion of our recent development activities.
Laura: Laura. Thanks, Chris, and good afternoon, everyone.
Laura: Before I discuss the pipeline, I'd like to share my excitement to be part of this pivotal moment in maternal health as we make progress with the launch of SousVive, enabling critical access for women with PPD.
Speaker Change: I'll begin with Selznamdor, our wholly owned, first-in-class NMDA-receptor positive allosteric modulator, or PAM.
Speaker Change: at the Potential Oral Therapy for Cognitive Impairment Associated with Neurodegenerative Diseases, including cognitive impairment in Huntington's disease, or HD, which is our lead indication, and in Alzheimer's disease, or AD.
Speaker Change: Disorders with Cognitive Impairment, such as HD and AD, present significant challenges to patients worldwide by limiting their ability to perform activities of daily living.
Speaker Change: and ultimately their ability to remain independent.
Speaker Change: The incidence and prevalence of these disorders are increasing, and addressing this unmet need remains crucial for improving patient well-being.
Speaker Change: In June , we reported data from the Phase II Surveyor Study, a small learning study designed to help inform our Delta Number Program and HD, including the Ongoing Dimensions Study.
Speaker Change: As previously reported, the surveyor study suggested the potential for directionally positive signals in a number of individual component tests of the HDCAP composite and in some functional assessments.
Laura Gault: We have made the decision to adjust our primary endpoint to measure dementia, from the ACAB Composite to the Symbol-Digit Modalities Test, or SDMT. The UHDRS Independent Scale will remain the key secondary endpoint; other secondary endpoints will include additional measures of cognition, function, and safety. The primary endpoint of the Light Wave Study is the change from baseline to Day 84 on the Wechsler Adult Intelligence Scale 4, or WISC-IV, Coding. The WAIS-IV Coding Test is an assessment of executive function that has a similar design as the SPS.
Speaker Change: Based on the data from Surveyor and other relevant information, we have made the decision to adjust our primary endpoint in the DIMENSION study from the ACCAB composite to the Symbol-Digit Modalities Test, or SDMT.
Speaker Change: The SDMT is one of the assessments included in the HDCAP composite, and our analysis of the surveyor data suggested the potential for a directionally positive signal.
Speaker Change: The SPMT is considered a reliable measure of executive function, and researchers, clinicians, and regulators have some familiarity with the test.
Speaker Change: The UHDRS independent scale will remain the key secondary endpoint.
Speaker Change: Other secondary endpoints will include additional measures of cognition, function, and safety.
Speaker Change: We continue to expect to report top-line data from the Dementia Study in late 2024, and we will continue to work closely with the Huntington's community in this important area of patient needs.
Speaker Change: We are also running the LIGHTWAVE study, a double-blind, placebo-controlled, phase 2 study of DALS and MDOR in people with mild cognitive impairment and mild dementia due to AD.
Speaker Change: The primary endpoint of the Light Wave Study is the change from baseline to Day 84 in the Wechsler Adult Intelligence Scale 4, or WAIS-IV, coding test.
Speaker Change: The WAIS-IV coding test is an assessment of executive function that has a similar design as the SDMT.
Laura Gault: We continue to expect to report top-line data from this study in late 2020. Page 324 is an investigational GABA-A receptor. Last week, we reported top-line data from the Phase II, Kinetic II study of SAGE-324 in essential... The KINETIC-2 study did not demonstrate a statistically significant dose-response relationship and change from baseline to day 91 based on the primary endpoint, Tetris PS item 4, upper limb total, the Tetris Performance Scale Item 4 total score, or the Tetris ADL.
Speaker Change: We continue to expect to report top-line data from this study in late 2024.
Speaker Change: Page 324 is an investigational GABA-A receptor, PAM, that is being developed in collaboration with Biogen.
Speaker Change: Last week, we reported top-line data from the Phase II, Kinetic II study of Sage 3-2-4 in essential tremor.
Speaker Change: The KINETIC-2 study did not demonstrate a statistically significant dose-response relationship and changed from baseline to day 91 based on the primary endpoint, Tetris-PS item 4, upper limb total score.
Speaker Change: In addition, there were no statistically significant differences demonstrated for any dose of stage 3-4 versus placebo in the change from baseline to day 91 on the Tetris Performance Scale Item 4 total score or the Tetris ADL composite score.
Laura Gault: Given these results, SAFE and Biogen do not plan to conduct further clinical development at stage 3 to 4 in a century, and we will close the ongoing Open Label Safety Study. We are grateful to the Essential Trauma Community, researchers, study participants, investigators, and site staff for their contributions to this. I am also deeply appreciative of our incredibly talented and committed teams who have worked tirelessly to support our efforts in the EPA.
Speaker Change: Given these results, SAFE and Biogen do not plan to conduct further clinical development of Stage 3-4 in essential tremors, and we will close the ongoing Open Label Safety Study of Stage 3-4.
Speaker Change: We are deeply disappointed by the results of the KINETIC-2 study, and we are evaluating next steps, if any, for other potential indications.
Speaker Change: We are grateful to the Essential Trauma Community, researchers, study participants, investigators and site staff for their contributions to this study. I am also deeply appreciative of our incredibly talented and committed teams who have worked tirelessly to support our efforts in the ET.
Laura Gault: Lastly, I'd like to reiterate our excitement for our early stages, including SAGE 319 and the extrasynaptic GABA A receptor, and Sage 421, and NMDA. We look forward to sharing more about these programs as they progress. Now, I'll turn the call over to Kimi for a review of our financials. Kimi?
Speaker Change: Lastly, I'd like to reiterate our excitement for our early stage pipeline.
Speaker Change: Including Sage 319 and Extrasynaptic GABA-A Receptor PAM and Sage 421 and NMDA Receptor PAM.
Speaker Change: We look forward to sharing more about these programs as they progress.
Kimi E. Iguchi: Thanks, Laura. Our financial results for the second quarter of 2024 are detailed in our press release issued this afternoon. Before discussing some of our financial results from the quarter, I'd like to add my enthusiasm for Journée L'Enfant. We're building a new market opportunity in an area where innovation was long overdue and, as a result, have accelerated a paradigm shift in the treatment of PPD. The commercialization of Zerzouve remains a top priority as we seek to expand access and build momentum.
Speaker Change: Now I'll turn the call over for a review of our financials. Kimi?
Kimi: Thanks, Laura. Our financial results for the second quarter of 2024 are detailed in our press release issued this afternoon. Before discussing some of our financial results from the quarter, I'd like to add my enthusiasm for the resume launch.
Kimi: We're building a new market opportunity in an area where innovation was long overdue and as a result have accelerated a paradigm shift in the treatment of PPD.
Kimi: The commercialization of Zerzure remains a top priority as we seek to expand access and build momentum.
Kimi E. Iguchi: Beyond Zerzoudeh, we plan to continue to make decisions on strategic pipeline investments supported by data, and we look forward to the additional data readouts expected later in the year. I'll now turn to the funding. Today, we announce collaboration revenue from the sales of J'Zouvé of $7.4 million in the second quarter, representing 50% of the net revenues, buys, and records for J'Zouvé.
Kimi: Beyond Zerzoudeh, we plan to continue to make decisions on strategic pipeline investments supported by data, and we look forward to the additional data readouts expected later in the year.
Speaker Change: I'll now turn to the financials.
Speaker Change: Today we announce collaboration revenue from the sales of the J'Zouvé of $7.4 million in the second quarter, representing 50% of the net revenues, buys, and records for J'Zouvé.
Kimi E. Iguchi: This represents a 19% revenue growth from Q1 to Q2. The growth in total underlying demand grew by greater than 95% from Q1 to Q2, as measured by the number of units shipped to commercial, government, and functionally uninsured people. A key factor impacting revenue in the second quarter was wholesalers bringing down initial inventory levels, which is typical for product launches.
Speaker Change: This represents a 19% revenue growth from Q1 to Q2.
Speaker Change: The growth in total underlying demand grew by greater than 95% from Q1 to Q2, as measured by the number of units shipped to commercial, government, and functionally uninsured patients.
Speaker Change: A key factor impacting revenue in the second quarter was wholesalers bringing down initial inventory levels, which is typical as product launches progress.
Kimi E. Iguchi: In the second quarter, we saw an average of five and a half weeks of inventory as compared to an average of eight weeks of inventory in the first quarter of 2024. Our target inventory levels are in the three and a half to four weeks. Definitely, we saw a slightly higher use of free goods relative to the first, although, as Chris detailed, we expect the use of these programs to decrease as additional payer coverage comes online in the second half of the year and as the FP process is further optimized. Journey to Operating Expense. R&D expenses were $62.6 million in the second quarter of 2024. SG&A expenses were $56 million in the second quarter of 2024.
Speaker Change: In the second quarter, we saw an average of five and a half weeks of inventory as compared to an average of eight weeks of inventory in the first quarter of 2024.
Speaker Change: Our target inventory levels are in the three-and-a-half to four-week range.
Speaker Change: Definitely, we saw a slightly higher use of free goods relative to the first quarter. Although, as Chris detailed, we expect the use of these programs to decrease as additional payer coverage comes online in the second half of the year and as the FP process is further optimized.
Chris: Turning to operating expenses, R&D expenses were $62.6 million in the second quarter of 2024.
Kimi E. Iguchi: The decrease in both R&D and SG&A expenses, compared to the second quarter of last year, was primarily related to the Q3 2023 restructuring, which reduced headcount and decreased spend on the early stage pipeline, geranolone clinical development, manufacturing, and overhead. As we've previously stated, we expect operating expenses to decrease in 2024 relative to 2023, and we are already seeing this decrease in the first half of 2024. Our net loss for the second quarter of 2024 was $102.9 million, and we ended the second quarter of 2024 with cash, cash equivalents, and marketable securities of approximately $647 million.
Chris: SG&A expenses were $56 million in the second quarter of 2024.
Chris: The decrease in both R&D and SG&A expenses compared to the second quarter of last year was primarily related to the Q3 2023 restructuring, which reduced headcount and decreased spend on the early stage pipeline,
Chris: Durandalone Clinical Development, Manufacturing, Overhead, and Technology.
Chris: As we previously stated, we expect operating expenses to decrease in 2024 relative to 2023. We are already seeing this decrease in the first half of 2024.
Chris: Our net loss for the second quarter of 2024 was $102.9 million, and we ended the second quarter of 2024 with cash, cash equivalents, and marketable securities of approximately $647 million.
Ashley Kaplowitz: With increased investment in the launch of Zerzuze, as well as ongoing clinical readouts expected in 2024, we will not be making changes to our runway guidance. With that, 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 2020. Before I turn the call over to the audience for Q&A, I'd like to emphasize our ongoing commitment to advancing our mission of promoting better brain health. We look forward to sharing updates in the coming quarters. I'll now turn it over to Ashley to handle the Q&A with Yasmeen.
Chris: With increased investment in the launch of Zerzoudeh, as well as ongoing clinical readouts expected in 2024, we will not be making changes to our runway guidance.
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 Q&A. Now I'll turn it over to the operator to handle the Q&A. Operator.
Chris: With that, 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.
Chris: Before I turn the call over for Q&A, I'd like to emphasize our ongoing commitment to advancing our mission of promoting better brain health for everyone. We look forward to sharing updates in the coming quarters. I'll now turn it over to Ashley to handle Q&A with the operator. Ashley? Thank you.
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.
Speaker Change: Now I'll turn it over to the operator to handle Q&A. Operator?
Operator: Thank you. If you would like to signal with questions, please press star one on your touchtone telephone. If you're joining us today using a speaker phone, please make sure your mute function is turned off to allow your signal to reach us. Again, that will be star 1 if you would like to signal with questions. And the first question comes from Salveen Richter with Global News. Good afternoon.
Operator: Thank you. If you would like to signal with questions, please press star 1 on your touchtone telephone. If you join us today using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. Again, that will be star 1 if you would like to signal with questions.
Operator: Star 1. And the first question comes from Salveen Richter with Goldman Sachs.
Barry E. Greene: Thank you for taking my question. Could you speak to, with regard to the survey, the difference that we're seeing in sales versus shipments or demand, and then also how the free drug dynamics play a role in this? Thank you. Yeah, Salveen, thanks for the interest. I'll start, and I'll ask Chris to comment.
Salveen Jaswal Richter: Good afternoon, thank you for taking my question. Could you just speak to, with regard to the survey, the difference that we're seeing in sales versus shipments or demand, and then also how the free drug dynamics play a role in this? Thank you.
Barry E. Greene: So, as we commented, we're highly encouraged by the launch dynamic to date, both in terms of prescription shipments and revenue. And there's certainly some temporality to how each of those flows, and Chris will cover that. The other comment I'd highlight is that, you know, we're absolutely seeing this very important paradigm shift, particularly among OBGYNs from the behavior of suspect depression to refer to screen, diagnosis, and treatment. So all dynamics and growth metrics are very, very strong. You know, Chris, do you want to talk about some of the temporal differences?
Speaker Change: Yeah, Salveen, thanks for the interest. I'll start and I'll ask Chris to comment. So as we commented, we're
Chris: Highly encouraged by the launch dynamic to date.
Chris: both in terms of prescription shipments and revenue and there's certainly some temporality to how each of those flow and Chris will cover that. The other comment I'd highlight is that you know we're absolutely seeing this very important paradigm shift
Chris: Particularly, among OBGYNs from the behavior of suspect, depression, referrer to screen, diagnose, and treat. All dynamics and growth metrics are very strong. Chris, do you want to talk about some of the temporal differences? With respect to the shipment process, In effect, the shipment here is the measure of when the prescription goes to the speciality pharmacy.
Christopher Benecchi: Yeah, so with respect to the shipment process, in effect, what a shipment here is, it's the measure of when the prescription goes to the specialty pharmacy; it's the movement of the product from the specialty pharmacy into the hands of the patient. And as Barry noted, we saw encouraging performance in and around shipments over the course of the second quarter, with a 95% increase, so more than 1400 shipments. Over the course of the second quarter, again, as I said, a 95% increase over that time, reflective of the strong demand that we saw from OBGYNs, psychiatrists, and primary care physicians.
Chris: It's the movement of the product from the specialty pharmacy into the hands of the patient. And as Barry noted, we saw encouraging performance in and around shipments over the course of the second quarter with a ninety five percent increase. So more than fourteen hundred shipments.
Chris: Over the course of the second quarter, again, as I said, a 95% increase over that time, reflective of the strong demand that we saw from OBGYNs.
Kimi: Psychiatrists and Primary Care Physicians. That's different than the the revenue that we reported and I think Kimi hit it, you know, with regard to the revenue that we reported over the course of the second quarter, you know, a key factor impacting revenue in the second quarter were wholesalers bringing down inventory levels.
Christopher Benecchi: That's different than the revenue that we reported, and I think Kimi hit it. With regard to the revenue that we reported over the course of the second quarter, a key factor impacting revenue in the second quarter was wholesalers bringing down inventory levels to what we would see as being where you would be in the second quarter versus the first year. And Kimi actually hit it. It was five and a half weeks of inventory as compared to an average of eight weeks in the second quarter versus the first quarter.
Kimi: to what we would see as being where you would be in the second quarter versus the first year. And, and Kimi actually hit it, you know, it's five and a half weeks of inventory is compared to an average of eight weeks, second quarter versus the first quarter. So that in effect is the difference that we're seeing here. But again, strong performance over the course of the quarter with respect to prescriptions and shipments.
Christopher Benecchi: That, in effect, is the difference that we're seeing here, but again, strong performance over the course of the quarter with respect to prescriptions and shipments, as we noted in our opening remarks. Now, on free goods, we, in various comments, mentioned that the majority of shipments that we saw were covered by commercial and government payers over the course of the second quarter and that we did see an uptick in terms of free goods.
Kimi: As we noted in our opening remarks. Now, in and around free goods, you know, we in Barry's comments mentioned that the majority of shipments
Speaker Change: that we saw were covered by commercial and government payers over the course of the second quarter, and that we did see an uptick in terms of free goods.
Christopher Benecchi: Free goods are a part of our strategy. We want to ensure that if there's ever a prescription that needs to speed into the hands of mothers with PVD, that we're able to do that rapidly, and the uptick that we saw in the second quarter was a byproduct of making sure that as we continue to optimize the SP to patient model, women with PVD can get the medication and get it. Thanks, Salveen.
Speaker Change: free goods are a part of our strategy. We want to ensure that if there's ever a prescription that needs to speed into the hands of mothers with PBD, that we're able to do that rapidly. And the uptick that we saw in the second quarter was a byproduct of making sure that as we continue to optimize the SP to patient model, women with PBD can get the medication and get it rapidly.
Barry E. Greene: And the next question will come from Anupam Rama with J.P. Moore. Hey, guys, thanks so much for taking the question. Just a quick question on physician dynamics here. How are you tracking relative to your initial expectations for ZUZUVE in each of the physician segments? It seems like OBGYN is kind of leading the charge here, but how are you tracking relative to what you first thought? Thanks so much.
Alvin: Thanks, Alvin.
Alvin: And the next question will come from Anupam Rama with J.P. Morgan.
Anupam Rama: Hey guys, thanks so much for taking the question. Just a quick question on position dynamics here. How are you tracking relative to your...
Anupam Rama: Initial expectations for Zuzube in each of the physician segments. It seems like OB-GYN is kind of leading the charge here, but How are you tracking relative to what you first thought? Thanks so much
Barry E. Greene: Yeah, Anupam, thanks. And we're highly encouraged as well. Thank you. Thank you for that. So the image you're seeing is actually a lot, very much what we expected.
Speaker Change: Yeah, thanks, and we're highly encouraged as well. Thank you. Thank you for that.
Speaker Change: So the image you're seeing is actually a lot, very much what we expected. As you know, we've been a PPT company for quite a while, and OBGYNs are the front line of where disease is seen and diagnosed, just like any disease.
Speaker Change: You want to pick the disease up at the point of getting the disease, and OBGYNs are the right part. I mentioned this earlier to Salveen's question, but the dynamic previously, because of the lack of tools,
Barry E. Greene: As you know, we've been a PPD company for quite a while, and OBGYNs are on the front line where disease is seen and diagnosed. Just like any disease, you want to pick the disease up at the point of getting the disease, and OBGYNs are the right part. I mentioned this earlier in response to Salveen's question, but the dynamic previously, because of the lack of tools that OBGYNs had, was to suspect depression, but refer out to either a psychiatrist or primary care.
Speaker Change: that OBGYNs had was...
Speaker Change: to suspect depression but refer out to either a psychiatrist or primary care.
Speaker Change: As we've said previously, we think Xerzuvia is the key to unlock the blockbuster potential PPD, helping men and women suffering. So now...
Speaker Change: OBGYNs have a tool in their in their armamentarium that fits their treatment paradigm.
Speaker Change: So, we're seeing this major dynamic now of...
Speaker Change: Screening, Diagnosing, and Treating While Mom's Under the Care of the OBGYN. That's exactly what we thought.
Speaker Change: Now, it's encouraging not only to see OBGYNs, but also psych and PCP prescribed.
Speaker Change: Those might be other kind of patient journeys, either someone previous under care or someone whose symptoms really don't worsen or develop until after they're done with their OBGYN. So it's good to see prescriptions coming from all those patient groups, all the healthcare provider groups.
Speaker Change: Thanks so much for taking the question.
Adam: Thanks Anupam.
Adam: And our next question will come from Yasmeen Rahimi with Piper Sandler.
Yasmeen Rahimi: Good afternoon, team, and thank you so much for all the color, I guess.
Yasmeen Rahimi: Do you think the PPD market is like an OB-GYN market that really needs to be unlocked and if that's the case, could you quantify, you know, how many out of the target OB-GYNs have been reached out currently in the last few months?
Yasmeen Rahimi: or do you think it really to unlock the PPD opportunity one has to think about you know expansion into
Speaker Change: I would love to think about what is the perfect audience to introduce this product to patients early on. I will jump back into the queue.
Speaker Change: Thanks guys. I think that was like six questions in one, so congratulations for that.
Chris: You nailed the dynamic here. Let me comment on it and I'll ask Chris to provide some further color. So, if we step back and think of any disease course, of any disease, you want to pick the disease up closest to the source.
Barry E. Greene: As we've said previously, we think Zerzuvia is the key to unlocking the blockbuster potential of PPD, helping men and women suffering. So now OBGYNs have a tool in their armamentarium that fits their treatment paradigm. And we're seeing this major dynamic now of screening, diagnosing, and treating while mom is under the care of the OB-GYN. That's exactly what we thought.
Barry E. Greene: Now, it's encouraging not only to see OBGYNs, but also psychiatric and PCP prescribed. Those might be other kinds of patient journeys, either someone who has been under care before or someone whose symptoms really don't worsen or develop until after they're done with their OBGYN. So it's good to see prescriptions coming from all those patient groups, and all the healthcare provider groups. Thanks so much for taking the question. Thanks, Anupam. And our next question will come from Yasmeen. Ramahi with Piper Sandler.
Chris: And the healthcare providers, in the case of PPD, are OBGYNs, either in consultation with a patient for a prior history, or during pregnancy, or in the first several weeks after giving birth. That's exactly where PPD starts, mostly.
Barry E. Greene: Good afternoon, team, and thank you so much for all the color. Let's do you think the PPD market is like an OB-GYN market that really needs to be unlocked? And if that's the case, could you quantify, you know, how many out of the target OB-GYNs have been reached currently in the last few months? Or do you think to really unlock the PPD opportunity, one has to think about, you know, expansion into sort of primary care physicians or the psychiatric division? So, we'd love to kind of think about, like, who is the perfect audience to introduce this product to patients early on? And I'll jump back into the queue.
Chris: Of course, it can worsen in the course of months after birth, but that's generally where it starts. So the OBGYNs are the right healthcare provider group to pick it up. It's wonderful that ACOG has guidelines and this group is wanting to own.
Barry E. Greene: Thanks, guys. I think that was like six questions in one, so congratulations on that. You nailed the dynamic here.
Chris: the disease of PPD. Now when we talk to psychiatrists they of course
Barry E. Greene: Let me comment on that, and I'll ask Chris to provide some further color. So, if we step back and think of any disease course, of any disease, you want to pick the disease up closest to the source. And the health care providers, in the case of PPD, are OBGYNs, either in consultation with a patient about their prior history or during pregnancy or in the first several weeks after giving birth. That's exactly where PPD starts, mostly. Of course, it can worsen in the course of months after birth, but that's generally where it starts.
Speaker Change: are picking up some of these mothers as well. But they actually believe that having a standard operating procedure, WIS or ZUVE for PPD, relieves them of a patient group that another health care provider can prescribe and diagnose. So they're happy about that.
Barry E. Greene: So, OBGYNs are the right health care provider group to pick it up. It's wonderful that ACOG has guidelines, and this group is wanting to own the disease of PPD. Now, when we talk to psychiatrists, they, of course, are picking up some of these mothers as well. But they actually believe that having a standard operating procedure, WIS or ZUVE for PPD, relieves them of a patient group that another health care provider can prescribe and diagnose.
Barry E. Greene: So, they're happy about pushing this to OBGYNs. Now, to your point, when we launched, we thought big about the PPD opportunity, but we started at a focus scale in our scaling. Now that we've seen such great success, particularly among OB-GYNs, it's time to increase the spend, not just for our personal promotion, non-personal promotion, and marketing, but to now expand our field force so we can continue to unlock the OB-GYN marketplace. And, you know, as you commented, we're expanding the sales force. It's something that Sage is paying for in 2024. We haven't made any decisions yet for 2025, but that's how we're moving forward. You know, Chris, any additional color to add?
Speaker Change: Pushing this to OBGYNs. Now to your point, when we launched, we thought big about the PPD opportunity, but we started it at a focus scale in our scaling.
Speaker Change: Now that we've seen such great success, particularly among OBGYNs,
Speaker Change: It's time to increase.
Speaker Change: to spend not just for our personal promotion, non-personal promotion, and marketing, but to now expand our field force so we can continue to unlock
Speaker Change: The OB-GYN Marketplace. And, you know, as we commented, we're expanding the sales force to something that Sage is paying for in 2024. We haven't made any decisions in 2025, but that's how we're moving forward.
Christopher Benecchi: So, Barry, you mentioned that, you know, what we're seeing here is a paradigm shift starting to occur. In the OB-GYN community, it's moving from suspect and referral to screen, diagnose, and treat. And one of the really interesting things that we're seeing, even at this early stage of the launch, is that the physicians who we reach who begin to prescribe Zerzuve begin to diagnose more patients at the practice level.
Barry: Chris, any additional color to add? So Barry, you mentioned that what we're seeing here is a paradigm shift starting to occur. In the OB-GYN community, it's moving from
Barry: Suspect and Refer to Screen Diagnose and Treat and one of the really interesting things that we're seeing even at this early stage of the launch is that physicians who we reach who begin to prescribe Zerzuve begin to diagnose more patients at the practice level.
Christopher Benecchi: So, fundamentally, what that's telling us is not only is Zerzuve doing its job with respect to the efficacy and safety profile of the medication and delivering a degree of satisfaction to those clinicians, but it's causing them to go back and reflect again on patients that they see on a regular basis and to really probe in and around the signs and symptoms of PPD and to recognize more women in their practice with PPD who may be viable And that's a very exciting thing for the treatment of PPD in the near term and over the long term. Thank you so much. Thanks, guys. And the next question will come from Paul. Hey, thanks so much.
Speaker Change: Fundamentally, what that's telling us is not only is Zerzuvia
Speaker Change: Doing this job with respect to the efficacy and safety profile of the medication.
Speaker Change: Delivering a degree of satisfaction to those clinicians, it's causing them to go back and reflect again on patients that they're seeing on a regular basis, and to really probe in and around the signs and symptoms of PPD, and to recognize more women in the practice with PPD who may be viable for Zerzuvia. And that's a very exciting thing for them.
Speaker Change: that the treatment of PPD in the near term and over the long run.
Speaker Change: Thank you so much.
Speaker Change: Thanks guys.
Speaker Change: And the next question will come from Paul Matteis with Stiefel.
Barry E. Greene: I was wondering if you could explain a little bit more the thought behind the change in the Huntington endpoint, your level of confidence in the validity of this subcomponent of HC-CAB, and whether it would be acceptable to the FDA for evidence of benefit in cognition. Thanks. Yeah, Paul, thanks. I'll start. I'll turn it over to Laura. So you're talking about DALS and MDOR, which we are studying for cognitive improvement, specifically executive function, learning, and memory, in Huntington's and Alzheimer's. As we talked about, we did a learning study, and we learned, and that learning is what we're applying to dementia. But Laura, why don't you take us through that?
Paul Andrew Matteis: Hey, thanks so much. I was wondering if you could explain a little bit more thought behind the change in the Huntington endpoint, your level of confidence in the validity of this subcomponent of HDCab, and whether it would be acceptable to the FDA for evidence of benefit on cognition. Thank you.
Speaker Change: Yeah, Paul, thanks. I'll start. I'll turn it over to Laura. So you're talking about DALS and MDOR.
Speaker Change: that we are studying for cognitive improvement in specifically executive function learning and memory in Huntington's and Alzheimer's. As we talked about, we did a learning study and we learned, and that learning is what we're applying to dementia. But Laura, why don't you take us through that?
Laura Gault: Yeah, sure. So thanks for the question, Paul. So, as we look through the data from Surveyor, we announced last month that we saw small numerical differences between DALS and MDOR and placebo on the HC-CAB composite score at day 28, but we also saw, in other pre-specified analyses, a number of directionally positive signals for some of the individual component tests of the HC-CAB. And so, based on that information and on consultations with experts and publicly available information within the HD community, we made the decision to adjust the endpoint to the SDM.
Laura: Yes, sure. So thanks for the question, Paul. So as we look through the data from Surveyor, we announced last month that we saw small numerical differences between delta-NMDOR and POSIPO on the HDCAP composite score at day 28.
Laura: But we also saw, in other pre-specified analyses, a number of directionally positive signals for some of the individual component tests of the HC-Cas.
Laura: And so based on that information and based on consultations with experts and publicly available information within the HD community, we made the decision to adjust the endpoint to the SDMT.
Laura Gault: Now, the SEMP is actually a widely used clinical assessment of cognition in Huntington's disease and in other disorders, and we believe it is a reliable and standardized measure of executive, It's one of the assessments of the HC-CAB composite, as I mentioned, and because we've seen positive data, directionally positive data in the surveyor study, we decided to choose that for the, In addition to the FCMP, we continue to evaluate the HDRS independent scale as the key secondary and other secondary endpoints include measures of cognition.
Laura: Now, the SEMP is actually a widely used clinical assessment of cognition in Huntington's disease and in other disorders. And we believe it is a reliable and standardized measure of executive function.
Laura: It's one of the assessments of the HC-CAB composite, as I mentioned, and because we've seen positive data, directionally positive data, in the surveyor study, we decided to choose that for the primary input.
Laura: In addition to the FCMT, we continue to evaluate the HDRS independent scale as the key secondary, and other secondary endpoints include measures of cognition, function, and safety.
Laura Gault: And we look forward to reporting these data out later this year. And the next question will come from Jay Olson with, Oh, hey, thanks for providing this update and for taking the question. Can you talk about how you plan to increase the diagnosis rate for PPD and then expand the uptake of Zerzuvia amongst psychiatrists? For example, are you planning to invest in more resources? Sales Rep.
Speaker Change: Thank you.
Laura: Thanks Paul, and we look forward to reporting these data out later this year.
Laura: And the next question will come from Jay Olson with Oppenheimer.
Jay Olson: Oh, hey, thanks for providing this update and for taking the question.
Jay Olson: Can you talk about how you plan to increase the diagnosis rate for PPD and then expand the uptake of Zuzuvi amongst psychiatrists and PCPs?
Jay Olson: For example, are you planning to invest in more resources such as additional sales reps? Thank you.
Barry E. Greene: Thanks, Chris. I'll start, and then I'll ask Chris to comment on the dynamics. So every health care provider that can help mom and prescribe Zuzu is important for us. But as we talked about on the call, the really key interception point for this disease is the OB-GYN. So the major increase in the non-personal marketing as well as the additional sales force that we talked about will be aimed at OB-GYN. Now, of course, if a mom gets through that whole period and, for example, her symptoms worsen four or five months after giving birth, which can happen, that's where we want psychiatric or primary care to intervene.
Jay Olson: I'll start and then I'll ask Chris to comment on the dynamic. So every health care provider that can help mom and prescribe Zuzu is important for us. But as we talked about on the call, the really key interception point of
Chris: of this disease is the OBGYN. So the major increase in the non-personal marketing as well as the additional sales force that we talked about will be aimed at OBGYN. Now, of course,
Chris: If a mom gets through that whole period, and for example, her symptoms worsen, you know, four or five months after giving birth, which can happen, that's where we want psych or primary care to intercept. So we are applying resources there, but a big part of
Barry E. Greene: So we are applying resources there, but a big part of the improvement in screening and diagnosis will come among OB-GYNs. And as Chris already said, this paradigm shift of suspecting depression, referring out because they didn't have the tools, to screening, which most states require, diagnosing, and treating, is the paradigm shift we're seeing. Chris, anything to add? What I would add, Barry, and I think you noted it in your opening remarks, but it's really worth coming back to, is that the ACOG guidelines play an important role in increased screening and diagnosis, and subsequently treatment. And it's a tailwind.
Chris: The improvement in the screening and diagnosis will come among OBGYNs, and as Chris already said, this paradigm shift of suspecting depression, referring out, because they didn't have the tools, to
Chris: Screening, which most states require, Diagnose and Treat, is the paradigm shift we're seeing. Chris, anything to add? What I would add, Barry, and I think you noted it in your opening remarks, but it's really worth coming back to, is the ACOG guidelines play an important role in
Chris: Increased Screening and Diagnosis and Subsequent Treatment and it's a tailwind. It's a clear tailwind.
Christopher Benecchi: It's a clear tailwind when we're out and engaged with OB-GYNs; they're aware of the guidelines, and I think that's going to have an impact here. I think, as you noted, in and around what we do with psychiatrists and primary care physicians, there's an opportunity there for us with both personal and non-personal promotion to broaden our reach and deepen our frequency, with the right education around the need to screen and diagnose as well as to treat when you have patients that are the right patients, a woman with BPD for Zerzube.
Chris: When we're out and engaged with OBGYNs, they're aware of the guidelines, and I think that's going to have an impact here.
Chris: I think, as you noted, in and around what we do with psychiatrists and primary care physicians, there's an opportunity there for us with both personal and non-personal promotion to broaden our reach and deepen our frequency.
Chris: with the right education around the need to screen and diagnose as well as to treat when you when you have patients that are the right patient, a woman with BPD for Zerzube. All of that's going on right now and we're scaling as we've seen science with success.
Christopher Benecchi: All of that's going on right now, and we're scaling as we've seen signs. Just to kind of close it out, Jay, with that question, and Chris, comment on this, but let me make a point of emphasis. What we're seeing is when a health care provider, primarily an OB-GYN, prescribes Zerzuve for the first time, we're seeing them increase the number of women they're diagnosing in general in their practice. We get that from broader treatments It's not always Zerzuve, but generally it is.
Chris: Just to kind of close it out, Jay, with that question, and Chris, comment on this, but let me make a point of emphasis.
Jay Olson: What we're seeing is when a health care provider, primarily OBGYN,
Jay Olson: Prescribe Zuzuvate for the first time. We're seeing them increase the number of women they're diagnosing in general in the practice. We get that from broader treatment. So it's not always
Barry E. Greene: So we're seeing them actually pick up on this now and screen and diagnose and own it rather than pass it on. And that paradigm shift, we've got the data to support that, and it's exciting to see. And the next question comes from Ritu Baral with TD.
Chris: We're seeing them actually pick up this now and screen and diagnose and own it rather than pass it on. And that paradigm shift, we've got the data to support that, and it's exciting to see.
Chris: And the next question will come from Ritu Baral with TD Cowan.
Barry E. Greene: Hi guys, thanks for taking the question and apologies for the noise at the airport gate here. I wanted to ask about the 600 prescriptions that were the difference between the 2,000 prescriptions and the 1,400 shipped prescriptions. Were the free drug prescriptions included in that 600? Were those all insurance denials? If I could squeeze one more in there.
Ritu Subhalaksmi Baral: Hi guys, thanks for taking the question and apologies for the noise at this.
Ritu Subhalaksmi Baral: Airport gate here
Ritu Subhalaksmi Baral: I wanted to ask you about the 600 prescriptions.
Ritu Subhalaksmi Baral: That was the difference between the 2,000 prescriptions and the 1,400 shipped prescriptions.
Ritu Subhalaksmi Baral: were the free drug prescriptions included in that 600? Were those all insurance denials? And if I could squeeze one more in there, you're hiring up, first of all, can you tell us how many reps?
Barry E. Greene: You're hiring up, first of all, can you tell us how many reps you will be increasing the Salesforce by and was that informed at all by the ACOG conference that just happened? Yeah, Ritu, a couple different questions there. So, you know, as we talked about previously, and again, you know, Chris can comment. We're highly encouraged by the growth of prescriptions, shipments, and revenue across all dimensions. We have a successful and growing launch.
Speaker Change: You will be increasing the sales force by and was that informed at all by the ACOG conference that just happened. Thanks.
Barry E. Greene: There are temporal differences because of when the quarter cuts off between prescriptions and shipments. So when we report out prescriptions, we're reporting out all the prescriptions that we're seeing, whether they become paid shipments or free shipments. The shipments are all the shipments, both paid and free shipments, and the revenue is the revenue. Kimi can comment after I'm done on how the revenue flows. So those are the totality of numbers. We really aren't seeing a great deal of coverage denial within the free goods category, which did click up. Some of those free goods are for functionally uninsured patients, and some are patients where the paperwork didn't fully get set out, and we have a pretty liberal free goods program.
Speaker Change: Yeah, Ritu, couple different questions there. So, you know, as we talked about previously, and again, you know, Chris can comment, we're highly encouraged by the growth of prescriptions, shipments, and revenue across all dimensions. We have a successful and growing
Chris: launch, there are temporal differences because of when the quarter cuts off between prescriptions and shipments.
Speaker Change: So we'll report out prescriptions. We're reporting out all the prescriptions that we're seeing whether they become
Speaker Change: Paid shipments or free shipments.
Speaker Change: The shipments are all the shipments, both paid and free shipments, and the revenue is the revenue. Kimi can comment after I'm done on how the revenue flows. So those are the totality of numbers.
Kimi: We really aren't seeing a great deal of coverage denial. In the free goods, which did click up, some of those free goods are functionally uninsured patients.
Kimi: And some are patients where the paperwork didn't fully get set out, and we have a pretty liberal free goods program, so rather than delaying drug to mom, as Chris commented earlier, they get shipped a free good, and that mom gets better, and the healthcare provider's prescriptions fill. So we think that's strategically
Barry E. Greene: So rather than delaying the drug to mom, as Chris commented earlier, they get shipped a free good, and mom gets better, and the health care provider's prescription is filled. So we think that strategically is the right thing to do. As coverage comes online and as the ST processes continue to get better, and they're getting better month to month, we see the free goods falling off in the third, fourth quarter into next year. There will always be some, of course, because they're functionally uninsured patients.
Chris: is the right thing to do. As coverage comes online, and as the ST processes continue to get better, and they're getting better month to month.
Chris: We see the free goods falling off.
Kimi E. Iguchi: But to help, maybe, Kimmy, you could talk about how the revenue is recorded and where that comes from. Sure, sure. Thanks, Barry.
Kimi: 3rd, 4th quarter into next year. There'll always be some of course because they're a functionally uninsured patients, but to help me, maybe Kimi you could talk about how the revenues.
Kimi E. Iguchi: Just a reminder, revenue is booked when Biogen actually ships Zerzube to wholesale distributors. So, again, that's different than the shipments that we talked about, which are shipments to patients. So that's the 1,400 units we talked about. And it's different from the prescriptions written, right?
Kimi: recorded and where that comes from? Sure, sure, thanks Barry. As a reminder, revenue is booked by when Biogen actually ships
Kimi E. Iguchi: So that's the 2,000 prescriptions that we talked about. So just wanted to make sure people got grounded on revenue. And, again, I just say, again, the key factor we saw impacting revenue this quarter was that wholesalers were starting to bring down initial inventory levels. You know, it's typical as product launches progress, and we did see that decrease in the number of weeks of inventory outstanding.
Speaker Change: So just wanted to make sure people get grounded on revenue. And again, I just say again, the key factor we saw on impacting revenue this quarter was that wholesalers were starting to bring down initial inventory levels.
Barry E. Greene: Right, and then just to your second part of your one question question, the expansion. We're not commenting on numbers. What we said is that we see a tremendous opportunity to expand marketing, non-personal, and personal promotion. So at Sage's expense in the fourth quarter, we're going to expand our field for us in strategic areas. We think it makes a lot of sense given the coverage and the success we're seeing, and particularly, again, because once an OBGYN writes their ZUVE, they write another and another and another, and they're increasing their practice, the amount of PPD that they're covering. So it all makes sense to us. We're not talking specific numbers, however.
Barry E. Greene: Got it, thank you. Thanks Ritu, safe flight. And we'll take a question from Brian Abrahams with RBC Capital Markets. Hey there, good afternoon.
Speaker Change: And we'll take a question from Brian Abrahams with RBC Capital Markets.
Barry E. Greene: Thanks for taking my question. Maybe back to Delzem Endor, I'm curious, what should we be thinking about as a potential clinically meaningful change on this SDMT scale when dimension reads out later this year? And do you have a sense of the mechanistic rationale as to why this scale might more sensitively pick up on a drug effect in this population?
Brian Corey Abrahams: Hey there, good afternoon. Thanks for taking my question. Maybe back to Dalzim and Dur.
Brian Corey Abrahams: I'm curious what we should be thinking about as a potential clinically meaningful change on this SDMT scale when dimension reads out later this year and do you have a sense to the mechanistic rationale as to why this scale might more sensitively pick up on a drug effect in this population? Thanks.
Barry E. Greene: Thanks. And Brian, thanks for the question on the mechanism. I mean, first, starting with the SDMT, I think it's important to mention that it's a test that looks at a variety of different domains within executive function, such as sustained attention, processing speed, visual scanning, and psychomotor speed. And then when you think about the brain circuits that are involved in that, it's classically those areas of the striatum and frontal cortex that are very much damaged in HD patients, or where you see deficits there.
Brian Corey Abrahams: Thank you for your time.
Brian Corey Abrahams: And Brian , thanks for the question on the mechanism. I mean, I think first, starting with the SDMT, I think it's important to mention that it's a test that looks at a variety of different domains within executive function, such as sustained attention, processing speed, visual scanning, and psychomotor speed. And then when you think about the brain circuits that are involved in that, it's classically those areas of the striatum frontal cortex that are very much damaged in HD patients or where you see deficits there. And then I think the other part to add is that if you go back to some of our original thesis when we were talking about 24S hydroxycholesterol as the endogenous ligand correlating with changes on cognitive tests, one of those tests that we've looked at is the SDMT in that patient
Barry E. Greene: And then I think the other part to add is that if you go back to some of our original thesis when we were talking about 24S hydroxycholesterol as the endogenous ligand correlating with changes on cognitive tests, one of those tests that we've looked at is the SDMT in that patient population. So I think both from the endogenous modulation point of view, as well as from the brain circuits that are impacted in Huntington's, we think there's a really tight correlation between the SDMT test and those domains of cognition.
Brian Corey Abrahams: and the rest of the population. So I think both from the endogenous modulation point of view as well as from the brain circuits that are impacted in Huntington's, we think there's a really tight correlation between the SDMT test and those domains of cognition.
Barry E. Greene: Super helpful. Thank you. Thanks, Barry. And moving on to David Hong with.
Brian Corey Abrahams: Super helpful, thank you.
Brian Corey Abrahams: Thanks, Brian .
Speaker Change: And we'll take a question from Laura Chico with Wedbush Securities.
Laura Kathryn Chico: Hey, good afternoon, guys. I'm going to just ask one, and I think that's going to be, how has the timing evolved for when a physician writes a resume script to the point of delivery? And I'm just trying to understand if you're at your target goal yet in terms of the pace to get medicine to the patients yet. Thanks very much.
Speaker Change: Hey Laura, thanks for the question and thanks for asking one question. We appreciate it.
Speaker Change: So you're highlighting a very important point.
Speaker Change: A major value proposition of Zerzouve is the rapidity of onset, and of course, it's only a 14-day course, which is also very helpful. So that's very helpful in...
Speaker Change: and health care providers making decisions prescribed and mom saying yes I want to take a drug because before Zuzube many moms say you know I don't want to take anything I'm going to try to suffer through it so
Speaker Change: It's really created this major, major paradigm shift. We won't be satisfied.
Speaker Change: Until moms get the drug as quickly as possibly possible. So this is, put this in the area of continuous...
Speaker Change: Improvement. There are many moms that that after getting diagnosed get the drug in two to three days, deliver to their home. Some take longer so
Speaker Change: We want to increase the number that get there in two to three days and shorten the median time for everybody.
Speaker Change: And we won't be satisfied until the time keeps coming down. So we're doing well. I classify it as doing well, but always can get better.
Barry: Thanks, Barry.
Laura: Thanks, Laura.
Laura: And moving on to David Hong with Citigroup.
David Hong: Hi there, thanks for taking the question. I just wanted to ask a little bit about your perceived perception of the level of commitment to the Zerzouve launch on the Biogen side and whether they would be expanding the sales force.
Speaker Change: Yeah, in concert with your planned expansion and then post-expansion, should we anticipate any type of acceleration or inflection in scripts, shipments, and other metrics? Thanks.
Barry E. Greene: David, thanks. Let me start with the second part of your two-part question and turn it over to Chris for Biogen. So the reason to expand is to have better reach and frequency in our target audience. So yes, we should see a profound uptick next year because of that expansion.
Speaker Change: David, thanks. Let me start with the second part of your two-part question and then turn it over to Chris for budget. So, the reason to expand is to...
Speaker Change: have better reach and frequency in our target audience. So yes, we should see a profound uptick next year in because of that expansion. So the answer to that is yes. Chris, you wanna talk about sort of what we're doing versus Biogen and commitment?
Chris: Thanks, Barry. So Sage is investing in expanding our field force in Q4, as you noted in your opening remarks. Now, while we're doing this, Biogen is working with their existing resources to pilot a few approaches that will inform any additional investments from their perspective.
Chris: We believe we have a strong business case to support expansion, and collectively, between the two organizations, it all supports our shared mission of really helping as many women with PPD as possible, as quickly as possible.
Barry E. Greene: So the answer to that is yes. Chris, you want to talk about sort of what we're doing versus Biogen and commitment? And our next question will come from Tazeen Ahmad with Bank of America. Quarter: How should we be thinking about that for the rest of the year?
Speaker Change: And our next question will come from Tazeen Ahmad with Bank of America.
Tazeen Ahmad: Hi guys, thanks so much for taking my question. Mine's also inexpensive. Can you just maybe level set for us how we should think about R&D for the rest of the year? You did have a nice decrease in expenses.
Tazeen Ahmad: and the R&D line item at least this quarter. How should we be thinking about that for the rest of the year and also taking into account your expectation for the 4Q sales force hires? Thanks.
Barry E. Greene: Yeah, I'll start and then Kimi can comment on something more specific. So, yeah, Tazeen, as we highlighted, the restructuring was meant to bring costs in R&D and SG&A down, and we saw that this quarter, which we're happy about, and you'll continue to see savings. But Kimi, do you want to add more color there?
Speaker Change: Yeah, I'll start and then.
Kimi: Kimi can comment on something more specific. So, yeah, Tazeen, as we highlighted, you know, the restructuring was meant to bring costs in R&D and SG&A down, and we saw that this quarter, which we're happy about, and you'll continue to see savings.
Kimi E. Iguchi: Yeah, sure. As Sage always does, we try to focus on being very disciplined and focused about how we do our investing. Last year, as Barry mentioned, we made several key strategic cost savings initiatives, and that included the pipeline prioritization of workforce reduction. You know, we said that both R&D and SG&A were both going to decrease into 2024, and we've been seeing that. Obviously, you saw that in the first half of 2024.
Tazeen Ahmad: But Kimi, you want to talk?
Kimi: More color there? Yeah, sure. You know, as Sage always does, we try to focus on being very disciplined and focused about how we do our investing. Last year, as Barry mentioned, we made several key strategic cost savings initiatives, and that included the pipeline prioritization of workforce reduction. We said that both R&D and SG&A were both going to decrease into 2024, and we've been seeing that. Obviously, you saw that in the first half of 2024. And we did reaffirm our cash guidance of cash runway into 2026.
Kimi E. Iguchi: And we did reaffirm our cash guidance of cash runway into 2027. Hi, good afternoon. I was intrigued by your comments related to the new law in Louisiana, which is basically... Yeah, George, great question.
Speaker Change: And we'll take a question from George Farmer, Wisconsin Bank.
George Farmer: Hi, good afternoon. I was intrigued by your comments related to the new law in Louisiana, which is basically...
George Farmer: Mandating that all women with PPD get coverage. Was that in any way related to lobbying efforts by you and or Biogen? And if so, was that continuing throughout other states?
Barry E. Greene: So, you know, as Chris highlighted the action on the access front, both Commercial and Government are going incredibly well. And the next question will come. Sumant Kulkarni, with Kennecott.
George Farmer: Yeah George, great question. So you know as Chris highlighted, on the access front, both commercial and government, is going incredibly well.
Speaker Change: Whether you're in a blue office or a red office, and I was down in D.C. a couple of weeks ago, everybody cares about maternal health and everybody cares about brain health or mental health. So we're at the intersection of two, unfortunately, growing issues that people care about.
Tazeen Ahmad: There were several people in Louisiana, which has not had a great history of maternal health, very, very interested in making sure that if a prescription is written, it's delivered directly to moms. So that was a direct effort of our people in government affairs lobbying. And, you know, big shout out.
Tazeen Ahmad: What's going on with the tailwinds of this launch, whether it's the coverage or what's happening state by state and the media, none of this is by accident.
Tazeen Ahmad: We actually have a solution for an issue that's bothering many people, so it's garnered the interest across all fronts, and that will continue. We're seeing really good Medicaid coverage at the state, and I think the pharmacoeconomics at a state level support that if a mom
Tazeen Ahmad: is under, you know, underdiagnosed or not treated properly, she'll never get off Medicaid and that child will have development issues probably and might become a Medicaid.
Tazeen Ahmad: So we're really seeing a strong dynamic. And what we're seeing in Louisiana, we'll likely see in other states.
Barry: Great. Thanks, Barry.
George Farmer: Thanks, George.
Tazeen Ahmad: And we'll take a question from Vikram Purohit with Morgan Stanley .
Vikram Purohit: Hi, thanks for taking my question. We had one on stage three, two, four. So you've obviously mentioned that you're winding down in ET, but are there other indications you're exploring the molecule for? And if so, what could those indications be? And how are you and Biogen thinking about next steps for this program? Thanks.
Speaker Change: Thanks, Laura, you want to take that? Yeah, sure. So as we mentioned in the press release and in our prepared remarks, we and Biogen together are evaluating potential next steps for SAGE 324, if any, and we will certainly relay those decisions when they're made.
Tazeen Ahmad: And the next question will come from Sumant Kulkarni with Canaccord.
Sumant Satchidanand Kulkarni: Good afternoon. Thanks for taking our question, which I guess is a bit outside the box. With $647 million in cash and equivalents, at what point do you think it might make sense to shop for outside assets to bring in so you could supplement Tarzan M. Dor and what recently happened with 324?
Barry E. Greene: Yeah, thanks for that question. So, you know, we've commented on this previously; we're, we're intellectually curious. So we've got teams scanning what's going on out there, and we're examining a lot of potential opportunities. If we see something that we're highly intrigued by and that fits into our strategic focus, we'd certainly make a move on that. However, nothing has happened there to date. But that, you know, that's one of the places we could go.
Speaker Change: Thanks for that question. So, we've commented about this previously. We're intellectually curious, so we've got teams scanning what's going on out there, and we're examining a lot of potential opportunities. If we see something that
Speaker Change: We're highly intrigued by and that fits into our our strategic focus. We'd certainly make a move on that. Nothing has happened there to date But that you know, that's one of the places we could go and and we've talked about before nothing active to report obviously right now But it's not it's on our radar screen
Uy Sieng Ear: And the next question will come from Uy Ear with Mizuho.
Uy Sieng Ear: Hey guys, thanks for taking my question. It seems like you made significant progress on coverage, particularly at the state level. Just maybe help us understand, in the second half, how did you see the curve launch? What kind of shape do you think we should expect? Thanks.
Speaker Change: Thanks for the question. So, you know, to your question, we're seeing
Speaker Change: Strong coverage, both on the government and the commercial side. As we reported, 80% of commercial lives are covered.
Speaker Change: And importantly, the coverage does not impose step edits or onerous prior auths. So, really encouraged by what we're seeing right now and truly have a lot of momentum.
Speaker Change: As we talked about, we believe, given the success we're seeing, particularly with OB-GYNs who are writing the vast majority of scripts and now are growing their practice,
Speaker Change: of PPD as we highlighted.
Uy Sieng Ear: That increasing our sales force there makes a lot of sense. We're doing that in the fourth quarter, and we believe that the work that we at Sage are doing should see an uptick, particularly in the territories where we're adding resources into next year. So we do see an uptick coming with the added resources and further success.
Uy Sieng Ear: Thanks.
Barry E. Greene: And, as we've talked about before, nothing active to report, obviously, right now, but it's not, it's on our radar screen. H.C. Hi, good afternoon. Thanks for taking the questions. So just on Dalvin-MDOR and the change in endpoints, I guess I'm just curious, have you consulted with the FDA in terms of the change? And, you know, I think that question was asked, but I'm not sure you fully discussed just the potential implications for filing based on this data set, given the shift in endpoints.
Uy Sieng Ear: And the next question will come from Douglas Tsao with HC Wainwright.
Douglas Dylan Tsao: Hi, good afternoon. Thanks for taking the questions. So just on Dalvin M. Doar and the change on endpoints, I guess I'm just curious, have you consulted with the FDA?
Douglas Dylan Tsao: in terms of the change and you know I think it was asked but I'm not sure you fully talked about I mean just the potential implications for filing based on this data set given the shift in endpoints.
Barry E. Greene: Hey Doug, yeah, thanks for the question. So look, we're highly, you know, we're looking forward to the readouts for Dalvin-MDOR. What we talked about, you know, we've been talking about this for the last couple years, is the reason for the Surveyor Study was to confirm that, as measured by HC-CAB, there is a significant difference in cognition between normal volunteers and Huntington's patients. We saw a significant deficit in cognition in Huntington's patients.
Speaker Change: Hey Doug, yeah, thanks for the question. So, look, we're highly, you know, we're looking forward to the readouts for DALS and MDOR.
Speaker Change: What we talked about, we've been talking about this for the last couple years, is the reason for the Surveyor Study was both to confirm that as measured by HC-CAB,
Barry E. Greene: So that confirms the unmet need. It's really important. It's an orphan disease with a big unmet need, and there's nothing for these patients.
Speaker Change: The significant difference in cognition between normal volunteers and Huntington's patients, we saw a significant deficit.
Speaker Change: in Cognition in Huntington's. So that confirms you have many. That's really important. It's an orphan disease with a big unmet need and there's nothing for these patients. So that's really important in terms of benefit risk.
Barry E. Greene: So that's really important in terms of benefit-risk. Secondly, we said we were going to learn from the Surveyor Study and apply that dimension. I won't repeat everything that Laura said, but we learned, and we're putting, you know, SDMT as the primary endpoint, as well as other secondary endpoints. So not in its entirety at this point, but we are looking at other components of the HC-CAB in the secondary end. Going into Surveyor, and again, a small study, right, a 40 patient study, one-to-one, which aspects of HC-CAB would move, and what might not move? We learned, and we used all that learnings to modify dimensions.
Barry E. Greene: So, HD as a composite endpoint no longer makes sense, but some of its components do. Okay, great. Thank you. Thanks, Doug. We'll go ahead and take a question from June Lee with Truist Security. Good afternoon. This is Asuman from June.
Speaker Change: Secondly, we said we're going to learn from the Surveyor Study of Planet Dimension. I won't repeat everything that Laura said, but we learned, and we're putting SDMT as the primary endpoint, as well as other secondary endpoints.
Speaker Change: It's a large study, over 175 patient study, double-blind, placebo-controlled, well-run study. And this is a place where data matter. If the data are positive and robust across
Speaker Change: The primary and other secondary endpoints.
Speaker Change: Then we have a package to move forward with regulators, both in the U.S. and outside the U.S., and we'll do that. In terms of specific interactions we've had with, you know, FDA or other regulators, you know, we don't comment on specific interactions, other than say that we've had interactions and we will continue to do so.
Speaker Change: Can I jump in? Is the HDCab a secondary still?
Speaker Change #103: So, not in its entirety at this point, but we are looking at other components of the HC-CAB in the secondary end.
Speaker Change: Again Doug, thanks for asking. The idea of HC-CAB, we had several hypotheses.
Speaker Change: Going into Surveyor, and again, small study, right, 40 patient study, one-to-one, which aspects of HC-CAB would move and what might not move? We learned, we used all that learnings to modify dimensions. So HD as a composite endpoint no longer makes sense, but some of its components do.
Doug: Okay, great. Thank you.
Doug: Thanks, Doug.
Doug: And we'll take a question from Mark Goodman with Learinc Partners.
Speaker Change: And again, Mark Goodman, your line is open. Please go ahead with your questions.
Speaker Change: I have lost Mark.
Doug: Oh.
Speaker Change #106: We'll go ahead and take a question from June Lee with Truist Securities.
Barry E. Greene: Thanks for taking the questions. We're just wondering if you could quantify the Zerzubei prescriber-based growth you saw from 1Q to 2Q and how you expect the prescriber base to continue growing after the Salesforce expansion. Thank you. Half are diagnosed, and fewer than half are treated. We just talked about 2,000 prescriptions in the second quarter.
Asuman: Good afternoon. This is Asuman from June . Thanks for taking the questions. We're just wondering if you could quantify the Zerzubeh prescriber-based growth you saw from 1Q to 2Q, and how you expect the prescriber base to continue growing after the Salesforce expansion. Thank you.
Speaker Change #104: Great question. Please send our best to June . I guess I'll start and Chris can provide some more color.
Speaker Change #100: We continue to see prescriber growth. The denominator grows quarter to quarter. We see that continuing for many quarters to come.
Speaker Change: Part of the reason for Salesforce expansion is to get in front of more prescribers, educate them about through Zoovay PPD, because again, as we're seeing, once someone
Chris: learns about and prescribes Zuzuve, they start treating far more PPD patients.
Speaker Change: at the
Chris: The level we want to see it, which is the OB-GYN level. So we see that continuing. You know, Chris, any other color? What I would add, Barry, and I think we've lost a little bit of sight of this, but it's important to bring back up that 1 in 8 live births are affected by postpartum depression. That's 500,000 or so women.
Christopher Benecchi: There is a lot of room in this market for us to continue to lean in not just on patients that have severe PPD but the totality of women that are suffering with PPD and to really make sure that not only are we reaching these women, but with respect to the paradigm shift that we've talked about, there's an opportunity for Zuzube to continue to be not only a first-line treatment, but the standard of care. Thank you.
Speaker Change #102: Half are diagnosed and fewer than half are treated. We just talked about 2,000 prescriptions in the second quarter. There is a lot of room in this market for us to continue to lean in, not just on patients that have severe PPD, but the totality of women that are suffering with PPD, and to really make sure that not only are we reaching these women, but with respect to the paradigm shift that we've talked about, that there's an opportunity for Zuzube to continue to be not only a first-line treatment, but the standard of care.
Speaker Change: Thank you.
Christopher Benecchi: That will conclude the Q&A portion of today's call. With that, I'll turn it back over to Mr. Greene for closing remarks. These are critical milestones. And importantly, we believe strongly in the important mission to help people suffering from brain health disorders. That really motivates us every day.
Speaker Change: Thank you.
Speaker Change: 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.
Barry E. Greene: Thanks, Justin, and thanks, everyone, for joining us this afternoon to review our results from the second quarter of 2024. As you heard many times, we're highly encouraged by the ongoing launch with Zerzube and PPD.
Barry E. Greene: bolstering our confidence in our ability to positively impact women's suffering from PPD and as you just heard from Chris we're just scratching the surface of the number of people we can help out there which is really important.
Chris: This is a big and growing market and we're going to have major impact for the foreseeable future. We're on track to read out data from the Dalton-MDOR program in the second half of this year. We believe our strong financial foundation enables us to progress.
Barry E. Greene: So, you know, thank you for the clinicians and patients out there helping. Thanks for those at Sage and Biogen moving this along, and thanks everyone, and have a great day. Thank you. That does conclude today's conference. We do thank you for your participation.
Speaker Change: These three critical milestones.
Speaker Change: Importantly, we believe strongly in the important mission to help people suffering from brain health disorders. That's really what motivates us every day.
Speaker Change #105: Thank you for the clinicians and patients out there helping. Thanks for those at Sage and Biogen moving this along. And thanks everyone, and have a great day.
Speaker Change #107: Thank you. That does conclude today's conference. We do thank you for your participation. Have an excellent day.