Q3 2023 Sage Therapeutics Inc Earnings Call
Speaker 1: Please stand by. Your conference is about to begin.
Please standby.
Our conference is about to begin.
Speaker 1: Good morning. Welcome to Sage Therapeutic's third quarter 2023 conference call. Currently all participants are in a...
Good morning, welcome to Sage Therapeutics third quarter 2023 conference call.
All participants are in a listen only mode.
Speaker 1: This call is being webcast live on the Investors and Media Section of Sages website at sagerx.com.
This call is being webcast live on the investors and media section of sages website at Sage are ex Dot com.
Speaker 1: This call is the property of sage therapeutics and recording reproduction or transmission of this call without the expressed written consent of sage therapeutics is strictly prohibited. Please note this call.
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 this call is being recorded.
Speaker 1: I would now like to introduce Ashley Kaplowitz, director of investor relations at SAID.
I would now like to introduce actually carpal Kaplowitz director of Investor Relations at Sage.
Speaker 2: Good morning and thank you for joining Sage Therapeutics third quarter 2023 Financial Results Conference CAHL. Before we begin, I encourage everyone to go to the investors and media section of our website at sagearex.com where you can find the press release related to today's call as well as slides that we will be reviewing today.
Good morning, and thank you for joining Sage Therapeutics third quarter 2023 financial results Conference call.
Before we begin I encourage everyone to go to the investors and media section of our website at Sage Rx Dot Com, where you can find the press release related to today's call as well as slides that we will be reviewing today.
Speaker 2: I would like to point out that we will be making forward-looking statements which are based on our current expectations and beliefs.
I would like to point out that we will be making forward looking statements, which are based on our current expectations and beliefs.
Speaker 2: 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 filing for additional details.
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 detail.
Speaker 2: We will begin the call with prepared remarks by Barry Green, Archief Executive Officer, who will provide an overview of our progress during the third quarter of 2020.
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 third quarter of 2023.
Speaker 2: Our Chief Business Officer, Chris Panekki, will provide an update on our preparations for the planned commercial availability and launch of Zerzoo.
Our chief business Officer, CRISPR, Nike will provide an update on our preparations for the planned commercial availability and launch of <unk>.
Speaker 2: We will also be joined by Laura Galt, our Chief Medical Officer, who will review recent progress across our pipeline. And by Kimi Gucci, our Chief Financial Officer, who will review their financial results from the third quarter of 2020.
We will also be joined by Laura <unk>, Our Chief Medical Officer, who will review recent progress across our pipeline and by commute Gucci, Our Chief Financial Officer, who will review the financial results from the third quarter of 2023, Mike.
Speaker 2: My clerk, our chief scientific officer, will be available for questions during the Q&A portion of the call. With that, I'll now turn my...
<unk>, 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.
Speaker 3: Thanks Ashley, and thank everyone for joining us this morning.
Thanks Ashley.
Everyone for joining us this morning.
Speaker 3: We at SAID have a purpose and the momentum that unite us all.
We would say have a purpose and the momentum that unites us all.
Speaker 3: The recent approval of Zerzuve as a treatment for adults with postpartum depression sparked a national dialogue.
A recent approval of <unk> as a treatment for adults with postpartum depression, sparking national dialogue with countless women sharing their stories online.
Speaker 3: countless women sharing their stories online, building community and expressing anticipation for a desperately needed nutrient option. These brave
Building community and expressing anticipation for a desperately needed new treatment option.
These brave and inspiring women our Northstar.
Speaker 3: and making a meaningful impact to women's health by focusing on the maternal mental health crisis brought about by PPD.
And making a meaningful impact to women's health by focusing on the maternal mental health crisis brought about by PPD is our ambition.
Speaker 3: The approval of the ZUVE further validates our innovative approach to drug discovery and development, which starts with our work targeting the GABA and NMDA receptor systems in the brain.
The approval of <unk> further validates our innovative approach to drug discovery and development, which starts with our work targeting the Gaba and NMDA receptors in the brain.
Speaker 3: These pathways are key regulators of brain function and the main driver's brain circuit
These pathways are key regulators of brain function and the main drivers brain circuit activity.
Speaker 3: Research suggests that disruptions in these circuits are an underlying factor in many brain health disorders. Our deep understanding of these pathways
Research suggests that disruptions in the circuits are underlying factor in many brain health disorders.
Our deep understanding of these pathways.
Along with a robust neuro active steroid platform are vital to unlock the potential therapeutic breakthroughs for patients.
Speaker 3: are vital to unlock the potential therapy for egg-dews for patients. They're not...
We are not satisfied with the speed of innovation for brain health treatments.
Speaker 3: Brain health disorders are one of the leading causes of disability worldwide. If the pace of innovation has not met the moment.
Brain health disorders are one of the leading causes of disability worldwide.
Pace of innovation has not met the moment.
Speaker 3: To address this innovation gap, we're advancing our pipeline with the goal of elevating the standard of care to what truly matters most to patients.
To address this innovation gap, we're advancing our pipeline with the goal of elevating the standard care.
Truly matters most to patients.
Speaker 3: We're working to help people living with the billitating, neurodegenerative disorders, with the seeking treatments to address cognitive impairment early in order to maintain their independence once.
We're working to help people living with debilitating neurodegenerative disorders have been seeking treatments to address cognitive impairment early in order to maintain their independence longer.
Speaker 3: and we strive to be the first company to deliver a new treatment for a central tremor in over 50 years. Patients are waiting. The first company is going to be the first company to deliver a new treatment for a central tremor in over 50 years.
And we strive to be the first company to deliver a new treatment for central tremor in over 50 years.
Patients are waiting and I'm proud to lead <unk> forward.
Speaker 3: This starts with postpartum depression or PPD. As the first and only oral treatment approved for adults with PPD, the Resurvey has the potential to transform the treatment landscape as a new option.
This starts with postpartum depression or PPD.
As the first and only oral treatment approved for adults with PPD.
<unk> has the potential to transform the treatment landscape as a new option in care.
Speaker 3: Women with PPD need new solutions to devastating this order that have potential to act rap.
Women with PPD need new solutions to the devastating disorder.
Potential to Acura.
Speaker 3: And we are now one step closer to helping these patients and their
And we are now one step closer to helping these patients and their families.
Speaker 3: Untreated PPD is a burden and can have lasting consequences for the mom And it's also associated with negative outcomes for her baby and the entire family
Untreated PPD as a burden and kept lastly consequences for the mom is often associated with negative outcomes for her baby and the entire family.
Speaker 3: Additionally, under-traded and untreated PPD has significant societal costs.
Additionally, undertreated and untreated PPD is significant societal costs.
Speaker 3: We are pleased that the DEA completed its scheduling of Zerzu-Vey as a schedule for drugs, which is consistent with our actual case.
We are pleased that the DEA completed its scheduled observes who is the schedule for drug which is consistent with our expectations.
Speaker 3: We remain on track to make the ZUVE commercially available in December of the
We remain on track to make Zubaie commercially available in December of this year.
Speaker 3: Now Chris will provide specific updates related to this time.
Chris will provide specific updates related to this timeline.
Speaker 3: The heightened and persistent engagement we've seen from a diverse community of stakeholders since the FDA approved of Zorzuve in August . We believe we'll ultimately translate into strong talons for the launch success.
The heightened and persistent engagement, we've seen from a diverse community of stakeholders since the FDA approval of <unk> in August we believe will ultimately translate into strong tailwind.
With the launch success of <unk>.
Speaker 3: While we recognize that referral patterns, insurance coverage and current practices require change.
While we recognize that referral patterns insurance coverage and current practices required change we believe those women suffering from PPD deserve our full support efforts starting now.
Speaker 3: believe those women suffering from PPD deserve a full support effort starting.
Speaker 3: PPD is a serious medical condition and deserves attention.
<unk> is a serious medical condition and deserves attention.
Speaker 3: We plan to join others in prioritizing, normalizing, and destigmatizing this condition. While we remain focused on preparing.
We plan to join others and prioritizing normalizing and Destigmatize this condition.
While we remain focused on preparing for the launch of <unk>.
Speaker 3: We're also excited about entering what we believe will be a Cadillus Rich 2020
We're also excited about entering what we believe will be a catalyst rich 2024 with multiple data readouts expected across our Sage 708, and say three to four programs.
Speaker 3: With multiple data readouts expected across our SAID 718 and SAID 324 program.
Speaker 3: Today Laura will provide updates and more details on these.
Today, Laura will provide updates and more details on these programs.
Speaker 3: Looking ahead, we believe our future is bright. Following the reduction in our workforce and pipeline prioritization in Nelson Lake, August of the year, we continue to operate from a strong...
We believe our future is bright.
Following the reduction of our workforce and pipeline prioritization and then ultimately August of this year, we continue to operate from a strong financial Foundation.
Speaker 3: Importantly, we remain well-capitalized to accomplish our upcoming...
Importantly, we remain well capitalized to accomplish our upcoming milestones.
Speaker 3: Kimmy will provide more detail on our financial position later in the call.
Kimi will provide more detail on our financial position later in the call.
Speaker 3: Now many continue to ask about the status of development of the Rantel owner.
Now many continue to ask about the status of development of the Durant alone It mbd.
Speaker 3: To be clear, our focus is on the successful launch of Zerzuve for women with PPD and working to enable broad and equitable access for these patients to this important new treatment option.
To be clear our focus is on the successful launch of <unk> for women with PPD and working to enable broad and equitable access to these patients to this important new treatment option.
Speaker 3: On MDD, we plan to provide updates when sage and bides and have made decisions on the program. For now, we're focused on commercializing Zuzuvay for the treatment. We're focused on commercializing Zuzuvay for the treatment.
On M. D D. We plan to provide updates on stage and Biogen have made decisions on the program for now we're focused on commercializing <unk> for.
For the treatment of adults with PPD.
Speaker 3: To close, I want to reiterate that this is an exciting time to save with many upcoming milestones on the horizon.
To close I want to reiterate that this is an exciting time to say with many upcoming milestones on the horizon.
Speaker 3: As we look ahead, I'm confident we're positioned to make important progress in pursuit of our mission.
Looking ahead I'm confident we are positioned to make important progress in pursuit of our mission.
With that I'll turn the call over to Chris to provide additional context on our upcoming commercialization plan preserves do that Chris.
Speaker 3: Turn the call over to Chris to provide additional context on our upcoming commercialization plan for Zuzive. Chris?
Speaker 4: Thanks, Barry. I'm pleased to be with all of you this morning to share updates on our preparations for the commercialization of Zerzuve as a treatment for women with BP.
Thanks, Barry I am pleased to be with all of you. This morning to share updates on our preparations for the commercialization of <unk> as a treatment for women with PPD.
Speaker 4: Since the FDA approval in August , we've been working closely with our collaboration partner biogen on the commercialization strategy for Zerzuve. Urgency is top of mind given the significant unmet need that currently exists in BP.
Since the FDA approval in August we have been working closely with our collaboration partner Biogen on the commercialization strategy for Zubaie urgency is top of mind, given the significant unmet need that currently exists in PPD.
Speaker 4: In the U.S., it is estimated that approximately one in eight women who have a live birth experience symptoms of PPD each year, representing around half a million women.
In the U S. It is estimated that approximately one in eight women, who have a live birth experienced symptoms of PPD each year, representing around half a million women.
Speaker 4: Only half of those cases are diagnosed and even fewer are treated leaving a substantial number of women experiencing harmful symptoms of this disease.
Only half of those cases are diagnosed and even fewer treated leaving a substantial number of women experiencing harmful symptoms of this disease.
Speaker 4: These statistics highlight the tremendous unmet need and compel us to act with urgency to bring forward SIRS-UV-A, the first and only oral treatment specifically approved for women with PPD.
These statistics highlight the tremendous unmet need and compel us to act with urgency to bring forward <unk>, the first and only oral treatment specifically approved for women with PPD.
Speaker 4: We believe Zerzue has the potential to be a first line therapy and quickly become the standard of care for the many women with this disease.
We believe Zubaie has the potential to be a first line therapy and quickly become the standard of care for the many women with this disease.
Following the approval of <unk> by the FDA in August and the recent DEA scheduling, we and Biogen remains committed to making zubaie commercially available in December.
Speaker 4: Making this treatment commercially available as soon as possible is our top priority.
Making this treatment commercially available as soon as possible is our top priority.
Speaker 4: We know that weeks, days, and even hours matter in the lives of women with PPD and their families who struggle to live their daily lives.
We know that weeks days and even hours matter in the lives of women with PPD and their families who struggled to live their daily lives.
Speaker 4: The broader complement of our commercialization capabilities are expected to roll out in early 2024, including planned promotional activities delivered through Omnichannel F.
The broader complement of our commercialization capabilities are expected to rollout in early 2024, including planned promotional activities delivered through omni channel efforts.
Speaker 4: To support the commercial availability of Zerzuvia, we and Biogen have continued to progress our commercialization preparation.
To support the commercial availability of Zubaie, we and Biogen have continued to progress our commercialization preparations I.
Speaker 4: I would like to detail a few specific developments essential to understanding our approach to launch.
I would like to detail a few specific developments essential to understanding our approach to launch.
Speaker 4: First, we are pleased to announce the completion of the hiring of the Sage Field Salesman.
First we are pleased to announce the completion of the hiring of the stage field sales teams.
Speaker 4: Our field sales team of neuropsychiatry account managers are seasoned sales professionals with deep experience launching treatments essential to improving brain health conditions.
Our field sales team of Neuropsychiatry account managers are seasoned sales professionals with deep experience launching treatments essential to improving brain health conditions. They.
Speaker 4: They come to sage with strong track records of success, promoting innovative products, and bringing established relationships within the neuro-psychiatry community, enabling them to rapidly and effectively engage with high prescribing psychiatrists, OBGYNs, and PCPs who treat women with PPD.
They come to stage with strong track records of success promoting innovative products and bringing established relationships within the neuropsychiatry community, enabling them to rapidly and effectively engage with high prescribing psychiatrists obgyn, and PCP, who treat women with PPD.
Speaker 4: We will aim to amplify their selling efforts with a dynamic digital platform that provides HCP level insights designed to enable timely, improved, and personalized experiences for customers.
We will aim to amplify their selling efforts with a dynamic digital platform that provides HCP level insights designed to enable timely improved and personalized experiences for customers.
Speaker 4: This includes tools and AI models to help communicate with HCPs at the right time with the right content.
This includes tools and AI models to help communicate with Hcp's at the right time with the right content.
Speaker 4: Second, we are inspired by the consistent feedback we've received from HCPs that Zerzuvia has the potential to be a breakthrough treatment for women with HIV.
Second we are inspired by the consistent feedback we've received from Hcp's that Zubair has the potential to be a breakthrough treatment for women with PPD.
Speaker 4: Achieving such status is predicated on our ability to reach the broader HCP community who treat women with PPD with our promotional efforts.
Achieving such status is predicated on our ability to reach the broader HCP community, who treat women with PPD with our promotional efforts quite simply we will need to do more than just deploy a highly experienced focused sales force.
Speaker 4: Quite simply, we'll need to do more than just deploy a highly experienced focus sail.
Speaker 4: We also planned to execute targeted digital communications as part of a larger omni channel effort to reach the broader audience of HCPs with PPD disease data education, product information, and access to tools and resources so that women with PPD can find the care that they need.
We also plan to execute targeted digital communications as part of a larger omnichannel effort to reach the broader audience of Hcp's with PPD disease State education.
Alex information and access to tools and resources, so that women with PPD can find the care that they need.
Speaker 4: Third, our discussions with Pairs remain highly productive. We are actively engaged with national, regional, and government Pairs, communicating unmet need in PPD, reinforcing the weight of the evidence observed in our PPD studies, discussing the economic burden associated with untreated people.
Third our discussions with payers remain highly productive we are actively engaged with national regional and government payers communicating unmet need in PPD.
Reinforcing the weight of the evidence observed in our PPD studies.
Scuffing, the economic burden associated with untreated PPD and engaging in dialogue about access and reimbursement for women with PPD.
Speaker 4: an engaging in dialogue about access and reimbursement for women with people.
Speaker 4: To be a truly breakthrough therapy in PPD, we recognize that Zerzuwe must be both accessible and affordable. And we found most pairs to be aligned with its potential to be a first line therapy for women with this disorder.
To be a truly breakthrough therapy in PPD, we recognize that <unk> must be both accessible and affordable.
And we found most payers to be aligned with its potential to be a first line therapy for women with this disorder.
Speaker 4: Historically, health plans and PBMs conduct formal formulary reviews once the product label is final.
Historically health plans and Pbms conduct formal formulary reviews once the product's label was final.
Speaker 4: As we've just received DEA scheduling, which now completes the Zerzouve label, we now anticipate formulary reviews to begin and to continue over the course of 2020.
As we've just received DEA scheduling, which now completes dessert zubaie label.
Now anticipate formulary reviews to begin and to continue over the course of 2024.
Speaker 4: Considering the futility of evidence from our ongoing interactions, we believe our stakeholders are increasingly recognizing that Dr. Zouvet has the potential to fill an important patient need as the first can only oral once daily, 14-day treatment that can provide rapid improvements into press of symptoms for women with PPT.
Considering the totality of evidence from our ongoing interactions. We believe our stakeholders are increasingly recognizing that there is debate has the potential to fill an important patient need as the first and only oral once daily 14 day treatment that can provide rapid improvements in depressive symptoms for women with PPD.
Speaker 4: I'd like to now go into more detail on our planned access strategy for Zürzube and approach to establishing the wholesale acquisition.
I'd like to now go into more detail on our planned access strategy for Zubaie, an approach to establishing the wholesale acquisition cost.
Speaker 4: Resolving PPD symptoms early is not only what's best for mom and baby but can also begin to address the significantly higher healthcare resource utilization costs associated with PPD.
Resulting TBD symptoms early is not only whats best for mom and baby, but can also begin to address the significantly higher health care resource utilization costs associated with PPD.
Speaker 4: For example, according to a 2017 model, the multi-year average societal cost of untreated perinatal mood and anxiety disorders for mother child pair was approximately 32,000.
For example, according to a 2017 model the multiyear average societal cost of untreated perinatal mood and anxiety disorders for mother child care was approximately $32000.
Speaker 4: Women with PPD experienced more hospital admission and overall higher healthcare resource utilization and healthcare expenditures than women who did not.
Women with PPD experienced more hospital admissions and overall higher healthcare resource utilization and healthcare expenditures than women, who did not have PPD.
Speaker 4: Additionally, untreated PPD can have a generational impact.
Additionally, untreated PPD can have a generational impact.
Speaker 4: Perinatal mood and anxiety disorders can be associated with delayed or impaired long-term developmental, psychological, cognitive, and physical outcomes in children.
Perinatal mood and anxiety disorders can be associated with delayed or impaired long term developmental <unk>.
Psychological cognitive and physical outcomes in children.
Speaker 4: And societal costs for these outcomes in one study were estimated at nearly $2 billion for all impacted children through their first five years.
And societal costs for these outcomes in one study were estimated at nearly $2 billion for all impacted children through their first five years of life.
Speaker 4: Broad and affordable access for women with PPD who are prescribed Zizouve has been and will continue to be a critical goal for SAGE.
Broad and affordable access for women with PPD, who are prescribed zubaie has been and will continue to be a critical goal for sage and Biogen.
Speaker 4: Over the last few years, sage and biogen have done significant stakeholder research and directly engage payers to understand critical access considerations and the perception of value that Zerzuwe can deliver in PP.
Over the last few years Sage and Biogen has done significant stakeholder research and directly engaged payers to understand critical access considerations and the perception of value that <unk> can deliver in PPD.
Speaker 4: We have also been engaging with advocates and HCPs to gain their insights in these important areas.
We have also been engaging with advocates and HCP to gain their insights in these important areas.
Speaker 4: Access for women with PPD, clinical value, the existing unmet need, cost of sectiveness, and innovation have all been key considerations for the wholesale acquisition cost of Zizouve.
Access for women with PPD clinical value the existing unmet need cost effectiveness and innovation have all been key considerations for the wholesale acquisition cost of <unk>.
Speaker 4: With all of this in mind, we have set the planned wholesale acquisition cost of Zerzube at $15,900.
With all of this in mind, we have set the planned wholesale acquisition cost of Zubaie at $15900.
Speaker 4: We believe the wholesale acquisition cost accurately reflects the innovation, clinical value, and impacts Urzube can have for women with PPP.
We believe the wholesale acquisition cost accurately reflects the innovation clinical value and impacts are zubaie can have for women with PPD.
Speaker 4: What we heard from payers in our market research in one-on-one meetings is that Zerzuve remains a significant advancement for the treatment of PPD and has the potential to be a first-line therapy.
What we've heard from Payors in our market research and one on one meetings is that Zubaie remains a significant advancement for the treatment of PPD and has the potential to be a first line therapy.
Speaker 4: Zerzuvia is within the annual wholesale acquisition cost range of other commonly prescribed branded medications used to treat brain health disorders.
<unk> is within the annual wholesale acquisition cost range of other commonly prescribed branded medications used to treat brain health disorders.
Speaker 4: And the wholesale acquisition cost of Zerzuve is within the value range for the impact it can deliver.
And the wholesale acquisition cost or Zubaie is within the value range for the impact it can deliver.
Speaker 4: The Asian biogen are working diligently with the goal of enabling all women with PPD.
Page and Biogen are working diligently with the goal of enabling all women with PPD prescribed zubaie after commercial availability be able to access it rapidly and affordably.
Speaker 4: you have an after commercial availability, be able to access it rapidly and affordable.
Speaker 4: that is ultimately achieved by working closely with payers with the intent to drive formulary acceptance with coverage that does not require onerous utilization management tactics like prior authorizations that are complex and step-by-step.
That is ultimately achieved by working closely with payers with the intent to drive formulary acceptance with coverage that does not require onerous utilization management tactics like prior authorizations that are complex and step edits.
Speaker 4: To this end, we invite dinner actively engaged with National Regional End Government.
Does this and we and Biogen are actively engaged with national regional and government payers.
Speaker 4: Further, both sage and biogen are committed to the goal of delivering broad patient access immediately at launch for women with PPD and where possible with little to no copay, regardless of financial.
Further both sage and Biogen are committed to the goal of delivering broad patient access immediately at launch for women with PPD and where possible with little to no copay, regardless of financial means.
Speaker 4: We believe lack of financial means should not prevent any woman with PPD from a
We believe lack of financial means should not prevent any women with PPD from obtaining access deserves hubei.
Speaker 4: Beyond these updates today, we in Biogen expect to share more details related to our patient support programs, distribution strategy, and overall commercialization plans at the appropriate time.
Beyond these updates today, we and Biogen expect to share more details related to our patient support programs distribution strategy and overall commercialization plans at the appropriate time.
Speaker 4: With that, I will turn it over to Laura for a more detailed discussion of our recent portfolio progress in current expectations. Laura? Laura?
With that I will turn it over to Laura for a more detailed discussion of our recent portfolio progress and current expectations Laura.
Thanks, Chris and good morning, everyone.
Speaker 5: Over the third quarter we have made important progress on our pipeline program.
Over the third quarter, we have made important progress on our pipeline programs and.
Speaker 5: And I'm pleased to detail our recent advancement and our plans for continued execution over the coming
And I am pleased to detail, our recent advancements and our plans for continued execution over the coming quarters.
Speaker 5: I'd like to start by sharing my excitement around the FDA's approval of Juzube and the treatment of adults with CPD.
I'd like to start by sharing my excitement around the Fda's approval HSA bank and that treatment of adults with <unk>.
Speaker 5: It's a proof of reinforces state's commitment to supporting mothers. As our first FDA approved Madison, so Russell was also approved in PPD.
It's a critical reinforcement status commitment to supporting and others.
Our first FDA approved medicine, so Russell with all corporate and PPD.
Speaker 5: Bringing the first oral 14 day treatment to the market will be immensely impactful and marks of watershed moment for brains.
Bringing the first oral a 14 day treatment to the market will be immensely impactful and marks a watershed moment for greenhouse.
Speaker 5: Women with a disease will finally have the option of a novel oral therapy specifically indicated for CPD. That has the potential to rapidly improve symptoms and enable these women to fully engage with their baby and their families during this important time in the-
Living with the disease will finally have the option of a novel oral therapy, specifically indicated for PPD. So it has the potential to rapidly improve symptoms and enable these women to fully engage with her baby and their families. During this important time in Hawaii.
Speaker 5: For a full description of the risk-benefit prophylaxis rebate and the treatment of PPD in adults, including important safety information, I encourage you to read the product information.
For a full description of the risk benefit profile of <unk> in the treatment of PPD in adults, including important safety information I encourage you to review the product insert.
Speaker 5: We are also encouraged to see strong enthusiasm from the medical and scientific community towards this event.
We are also encouraged to see strong enthusiasm from the medical and scientific community based services.
Speaker 5: And we look forward to continuing to understand new insights from clinicians. As they had directly observed in their practices, the benefits of this survey in my memory is
And we look forward to continuing to understand new insights from clinicians as they are directly observe in their practices the benefits such as ebay and women with PPD.
Speaker 5: Turning to our neuropsychiatry pipeline, we continue to advance SAID 718, our wholly-owned first-in-class NMBA receptor positive-alistered module.
Turning to our neuropsychiatry pipeline, we continue to advance Sage 718.
Our wholly owned first in class NMDA receptor positive allosteric modulator.
Speaker 5: This is a potential oral therapy for cognitive disorders associated with NMDA receptor system.
This is a potential oral therapy for cognitive disorders associated with NMDA receptors dysfunction.
Speaker 5: Along with Weise due to highest Labour grants other 100 newly school temperature benefits exchanges on the
Including Huntington's disease, Parkinson's disease, and Alzheimers disease.
Speaker 5: These disorders continue to grow in public globally and represent some of the greatest areas of unmet need in medicine.
These disorders continues to grow in Brooklyn globally represent some of the greatest areas of unmet need in medicine.
Speaker 5: The burden of cognitive impairment among people with these disorders is top. And for many, a close during their primal
The burden is cognitive impairment among people with these disorders is hot and for many of course during their prime working years.
Speaker 5: As a consequence, employment changes resulting from cognitive impairment and associated functional decline can affect financial injuries.
As a consequence, importantly changes, resulting from cognitive impairment and associated functional decline.
In fact financial independence.
Speaker 5: Our goal is to reshape the treatment of patients with cognitive impairment starting with our SAGE 718 program.
Our goal is to reshape the treatment of patients with cognitive impairment starting with our states stepping one eight program.
Speaker 5: I'd like to take the opportunity to highlight our clinical development strategies with SAVE 718, where we are currently in rolling in five clinical trials with data regals expected next.
I'd like to take the opportunity to highlight our clinical development strategy for <unk>, where we are currently enrolling in five clinical trials with data Readouts expected next year.
Speaker 5: Starting with hunting conceive or HD. I was pleased to see the FDA grant also drug designations for safe, sub-no-waying and the treatment of HD last month.
Starting with Huntington's disease or HD.
I was pleased to see the FDA granted orphan drug designation for say separately and that youre going to basically last month.
Speaker 5: Work and drug designation is an encouraging regulatory milestone in our HC development program, and it further advances our strategy to prioritize HC as a lead indication for phase 7.
Often drug designation is an encouraging regulatory milestone and our HBV development programs and have further advances our strategy to prioritize SC as the lead indications for Sage 718.
Speaker 5: We are currently enrolling in three studies. The Dimension Study is a placebo controlled safety study that will evaluate the efficacy and safety of safe 7-1-8 compared to placebo and patients with HC with the HDCAB as the primary.
We are currently enrolling in three study the dimension study.
It's a placebo controlled phase III study that will evaluate the efficacy and safety of Facebook and <unk>.
Compared to placebo in patients with a steep with the HD cab as the primary endpoint.
Speaker 5: The surveyor study is designed to advance our understanding of the effects of stage 1-8 on cognition and functioning of such as sense with HP.
This survey or study.
Designed to advance our understanding of the effects of phase one eight on cognition and function at your participants with HD.
Speaker 5: It is designed to complement the dimension study by generating evidence to better define the clinically meaningful change and the relationship between changes in cognition and function.
It is designed to complement the dimension study by January evident to better define the clinically meaningful change in the relationship between changes in cognition and function.
Speaker 5: Importantly, the dimension study is powered to evaluate the SAGE 718 placebo difference in changes in cognition and function.
Importantly, as I mentioned the study is powered to evaluate the stage 718, placebo difference and changes in cognition and function.
Speaker 5: Well, the severe studies look for the relationship between changes in condition and function and is not designed or powered to show statistically significant differences between.
While the severe study will explore the relationship between changes in cognition and function and is not designed or powered to show statistically significant differences between groups.
Speaker 5: Finally, the purportary study is an open label, SAVE 3 Safety Study, and people with cognitive impairment due to HD. Designed to evaluate the long-term safety profile of SAFE 7.
Finally, the purpose of this study is an open label Phase III safety study and people with cognizant permit due to HD design.
Designed to evaluate the long term safety profile of say something money.
Speaker 5: For our Parkinson's disease indication for stage 7, 1, 8, we are enrolling in the precedent study. A placebo controlled phase 2 study and people with cognitive impairment due to Parkinson's disease. We are also.
For our Parkinsons disease indications for phase <unk>, we are enrolling in the precedent study a placebo controlled phase II study in people with cognitive impairment data Parkinson's disease.
We are also conducting the lightweight study.
Speaker 5: A placebo controlled safety study, a state 7-1-8, and people with mild cognitive impairment or mild dementia due to ulcerness.
The placebo controlled phase two study of Sage <unk> and people with mild cognitive impairment or mild dementia due to Alzheimer's disease.
Speaker 5: The treatment for these studies remains on track, and we look forward to sharing more detail on the timing of data readouts in the coming.
Recruitment for the study remains on track and we look forward to sharing more detail on the timing of data readouts in the coming quarter.
Speaker 5: Now, I'll turn to stage 324. An investigational next generation positive alesteric modulator of GABA Aver's stuff.
Now I'll turn to phase III cheerful and investigational next generation positive allosteric modulator of Gaba a receptor.
Speaker 5: Rebelief Stage 324 holds significant potential in the treatment of missing disorders like essential trauma or ET.
We believe stage three to four holds significant potential in the treatment of movement disorders, like essential tremor or <unk>.
Speaker 5: CT is a disease that has limited treatment options and high unmet needs, as there's been no innovation in the space for over 50 years. When you listen to
He is a disease that has limited treatment options and high unmet need and there's been no innovation in this space for over 15 years.
When you listen to patients living with the team.
Speaker 5: You realize that the terminal can affect nearly every aspect of the daily lives. It can make the simplest task difficult. If not impossible.
You realize there's a tremor can affect nearly every aspect of our daily lives and can we.
Make the simplest task difficult if not impossible.
Speaker 5: Currently, patients with VTE often cycle through many ET treatment and have roughly twofold to help care spending of similar patients without ET. V-
Currently patients with BT, often cycles through many ETE children and have roughly two fold the health care spending a similar patients without <unk>.
Me and our collaboration partner Biogen.
Speaker 5: recognize the high unmet need in that space, and we remain on track to complete enrollment in the ongoing phase 2b kinetic 2 dose ranging study for phase 3 to 4 this year.
Recognize the high unmet need in this space and we remain on track to complete enrollment in the ongoing phase two be kinetic two dose ranging study the phase three to four this year.
Speaker 5: As a reminder, the purpose of the kinetic tube study is to define the dose and the associated safety colorability profile for phase 2, 2, 4 for users of the kinetic tube.
As a reminder.
The purpose of the kinetic case study is to define the dose and the associated safety Tolerability profile for phase III two four for use as a chronic treatment.
Speaker 5: We look forward to providing updates on this program, including the top line data readout of the Kinetic 2 study, expected in mid 2020.
We look forward to providing updates on this program, including the topline data readout epigenetic study expected in mid 2024.
Speaker 5: Lastly, we remain excited on the potential of our earlier stage program, including stage 421, stage 319, and stage 689.
Lastly, we remain excited on the potential of our earlier stage programs, including phase four to one.
The one nine and Facebooks eight nine.
Speaker 5: And we are looking carefully at early data to this term of potential signals or area of opportunity for this.
And we are looking carefully at early data to determine a potential signals our area of opportunity for the future.
Speaker 5: As I said, our near-term focus remains on bringing forward SAG718 and SAG224.
With that said our near term focus remains on bringing forward Sage <unk> and Sage 54.
Speaker 5: In closing, I am proud of our pipeline effort this year. And I look forward to our future progress as we prepare to enter what we believe will be a catalyst-rich 2020.
In closing I'm proud of our pipeline efforts this year and I look forward to our future progress as we prepare to enter what we believe will be a catalyst rich 2024.
Speaker 5: Now I'll turn the call over for a review of our financial. Give me.
Now I'll turn the call over for a review of our financial Kimi.
Speaker 6: Thanks, Laura. Our financial results for the third quarter of 2023 are detailed in our press release issue.
Thanks, Laura.
Our financial results for the third quarter of 2020 are detailed in our press release issued this morning.
Speaker 6: I'd like to take a moment to provide some context and highlight a few key points. Before discussing specifics with respect to the third quarter financial, I wanna reiterate my gratitude to the entire stage team for their resilience.
I'd like to take a moment to provide some context and highlight a few key points before discussing specifics with respect to the third quarter financials I want to reiterate my gratitude to the entire sales team for their resilience and continued dedication to our mission to support brain health patients in the face of difficult circumstances.
Speaker 6: new dedication to our mission to support brain health patients in the face of difficult
Speaker 6: Following our strategic reorganization announced in August 2023, we maintain our strong financial foundation and continue to pursue focused execution across our pipes.
Following our strategic reorganization announced in August 2023, we maintain our strong financial foundation and continue to pursue focused execution across our pipeline.
Speaker 6: As a reminder, we believe the financial impact of the reorganization will result in annualized savings of approximately $240 million, which includes $100 million related to the workforce reduction.
As a reminder, we believe the financial impact of the reorganization will result in annualized savings of approximately $240 million.
Which includes a $100 million related to the workforce reduction.
Speaker 6: Looking ahead, we're prepared to execute on key milestones with the plan launches of the Juve and multiple expected top-line data readouts for stage 718 and stage 324.
Looking ahead, we're prepared to execute our key milestones with the planned launch of <unk> in multiple expected top line data Readouts for Sage 718 and stage 324.
Speaker 6: In the near term, we're laser focused on the commercialization of the Rizuve in the treatment of adults with PPB.
In the near term, we're laser focused on the commercialization of their survey and the treatment of adults with PPD.
Speaker 6: As a reminder, we in Biogen are jointly supporting the plan launch of the ZUVE with a 50-50 cost sharing in the United States.
As a reminder, we and Biogen are shortly supporting the planned launch of their day to day with a 50 50 cost sharing in the United States.
Speaker 6: While we're thinking big about the launch opportunity and the syndication, we intend to start with a focused approach and scale fast as we see success.
While were thinking big about the large opportunity in the syndication we intend to start with a focused approach is scale fast as we see success.
Speaker 6: Once launched, we expect to provide updates in the ZUVE during our quarterly earnings call, including metrics such as revenue and...
Once launched we expect to provide updates during our quarterly earnings call, including metrics, such as revenue and prescription data.
Speaker 6: In addition, we remain committed to making smart, disciplined investments across our people.
In addition, we remain committed to making smart disciplined investments across our pipeline.
Speaker 6: While our current focus remains on phase 17 and stage 324, we've successfully built a strategic reservoir of molecules ranging from research through clinical phase 2 ready that we believe provides optionality and agility in our portfolio.
While our current focus remains on page 17, and <unk> 24, we successfully built a strategic reservoir of molecules ranging from research to clinical phase II ready that we believe provides optionality and agility in our portfolio.
Speaker 6: With a variety of programs across GABA, NMDA, and new exciting targets, we will continue to make portfolio decisions informed by opportunity, timing, and outcomes of our late stage portfolio and explore.
With a variety of programs across Gaba NMDA and new exciting targets, we will continue to make portfolio decisions informed by opportunities timing and outcomes of our late stage portfolio and exploratory impact.
Speaker 6: Thirty-two are financial results for the third quarter. Our net loss for the third quarter of 2023 was $2002 million.
Turning to our financial results for the third quarter, our net loss for the third quarter of 2023 was $202 million.
Speaker 6: As a reminder, we ended the third quarter with cash, cash equivalents and marketable securities that will approximately $876 million.
Reminder, we ended the third quarter with cash cash equivalents and marketable securities of approximately $876 million.
Speaker 6: Turning to operating expenses, R&D expenses were 102 million in the third quarter of 2020.
Turning to operating expenses R&D expenses were $102 million in the third quarter of 2023.
Speaker 6: The increase compared to the third quarter of last year, which primarily due to expenses relating to canceling excess purchase commitments, from manufacturing as a result of the CRL received from FDA for Zera loan for the treatment of MDD.
The increase compared to the third quarter of last year was primarily due to expenses relating to canceling excess purchase commitments for manufacturing as a result of the Sierra received from FDA for <unk> for the treatment of MTBE.
Speaker 6: SGNA expenses were 78 million in the third quarter of 2023.
SG&A expenses were $78 million in the third quarter of 2023.
Speaker 6: The increase compared to the third quarter of last year was primarily due to stop these compensation expense related to performance-based testing criteria during the third quarter of 2023. We're also reaffirming...
The increase compared to the third quarter of last year was primarily due to stock based compensation expense related to performance based vesting criteria during the third quarter of 2023.
We're also reaffirming that based on our current estimates.
Speaker 6: We anticipate current cash, cash equivalents, and marketable securities, along with anticipated funding from ongoing collaboration.
We anticipate current cash cash equivalents in marketable securities along with anticipated funding from ongoing collaborations.
Speaker 6: Collaboration revenue from sales of Zürzuvay and a potential milestone payment to only 75 million from Viagen related to the first commercial sale of Zürzuvay for the treatment of PPD will all support operations into 2020.
<unk> revenue from sales of Jersey today.
A potential milestone payment totaling $75 million from Biogen related to the first commercial sale of theirs do they for the treatment of PPD will all support operations into 2026.
Speaker 6: As we near a major expected clinical catalyst, I'm confident there are balance sheet with expected runway into 2026 will enable focused execution toward our mission.
As we near major expected clinical catalyst I'm confident that our balance sheet with expected runway into 2026 will enable focused execution toward our mission.
Speaker 6: We look forward to 2024, as we believe we'll make a difference in the lives of brain health patients by accelerating our progress to bring medicines that matter to Mark.
We look forward to 2024 as we believe will make a difference in the lives of brain health patients by accelerating our progress to bring medicines that matter to market.
Speaker 6: I'll now turn it over to Ashley to handle Q&A with the operator. Ashley?
I'll now turn it over to Ashley to handle Q&A with the operator Ashley.
Speaker 2: Thanks, Kimmy. Before I turn it over to the operator, I'll ask that you limit yourself to one question. If you have an additional question, feel free to return to the queue. Now, I'll turn it over to the operator to handle Q&A. Operator.
Thanks, Kimi before I turn it over to the operator I'll ask that you limit yourself to one question. If you have an additional question feel free to return to the queue now.
Now I'll turn it over to the operator to handle Q&A.
Operator.
Speaker 1: Thank you. If you'd like to ask a question, please signaled by pressing star one on your telephone keypad. If you're using a speaker phone, please make sure your mute function is turned off to allow your signal to reach our equipment. Once again, we ask that you limit yourself to a single question today. And if you have any additional questions, please re-signal. Let us just briefly to a similar queue.
Thank you if you'd like to ask a question. Please signal by pressing star one on your telephone keypad, if you're using a speaker phone. Please make sure. Your mute function is turned off to allow your signal to reach our equipment. Once again, we ask that you limit yourself to a single question today and if you have any additional questions. Please.
Re signal.
Plus just briefly to assemble our queue.
Speaker 5: And we go to our first question from RIDU BARAR with KEDI Cowan. Please go ahead.
And we go to our first question from a redo Bora with TD Cowen. Please go ahead.
Speaker 7: Good morning guys, thanks for taking the question. I wanted to ask for a little more detail on your HCP targeting effort. I guess you mentioned OBGYNs, Neurofikes, and I guess HCP to see a large volume of...
Good morning, guys. Thanks for taking the question I wanted to ask for a little more detail on your HCP targeting effort I guess, you mentioned obgyns nearer hikes, and I guess HCP to see a large volume.
Speaker 7: for other specialties and the same thing. How are you going to balance proportionally the targeting effort between those three groups and in so far as you talk about it?
TPG patients.
From other specialties I'm, assuming how long are you going to sort of.
<unk> proportionally that targeting effort between those three groups and in so far as you can talk about Hcp's alongside with PPD are you talking about primary care nurse practitioner or sort of how should we be thinking about that thanks.
Speaker 7: a large volume of PPD. Are you talking about primary care nurse practitioners, sort of how should we be thinking about that?
Speaker 3: Thanks, R2. I'll start and then ask Chris to dive into some more details. So you've got to write as we said in our prepared remarks, we believe that a majority of...
Thanks, Ritu I'll start and then.
Chris to dive into some more.
Details so you've got it right as we said in our prepared remarks, we believe that a majority of.
Speaker 3: Women suffering from postpartum depression will be seen by their OB-GYNs.
Women suffering from postpartum depression will be seen by their obgyns.
Speaker 8: psych and PCP in terms of treating their postpartum. One of the big, big changes we see is...
So like in PCP in terms of treating.
There are there.
Postpartum one of the big Big changes, we see occurring in the market with PPD is that obgyns and certain of our guidelines and they now have really the solution that they haven't had before.
Speaker 8: With PVD is that OBGYNs who search now guidelines and they now have really the solution that they haven't had before, is a big uptick in OBGYNs screening, diagnosing, and treating.
If a big uptick in Obgyns screening diagnosing and treating.
Speaker 8: these moms. So those are the three groups. Now we talk about the UN cycle or primary care. We're talking about the offices. So it's the healthcare providers in general.
These loans. So those are the three groups, we talk about EBITDA in psych or primary care, we're talking about the office and health care providers in general physicians physicians assistants, and nurse practitioners and those two latter group. So we actually see as a big part of the treatment pattern going forward, we're seeing groups like that set up.
Speaker 9: Physicians, assistants and nurse practitioners. And those two latter groups, we actually see as a big part of the treatment pattern going forward. We were seeing groups like that that are specifically the treatment and the health. So that's how we're approaching.
Specifically to treat maternal mental health so that's how we're approaching it.
Speaker 8: We also are enhancing the kind of reaching frequency with our omitown approach, for our visual approach, providing healthcare, provider education as they want to suit, given this big shift for seeing our ability just to treat PCD with the first oral treatment available. That's clearly what can be very rapid acting. Chris, you wanna add some more?
We also R R.
Hence in the kind of reach and frequency with our Omnichannel approach a broad digital approach, providing health care provider education as they as they wanted to see if given this big shifts we're seeing in our abilities to treat <unk> with the first oral treatment available.
Clearly 14 days and very rapid acting Chris do you want to add some more.
Speaker 10: Barry, what I would add, and I mentioned in my opening remarks, is we're going to use insights and analytics to provide our sales organization with effectively real time insights to effectively target their messaging and their resources to augment what we're also going to be doing from a non-personal or additional perspective. So we're going to really engage high prescribing.
What I would add and I mentioned in my opening remarks is we're going to use insights and analytics to provide.
Our sales organization with effectively real time insights to effectively target their messaging and their resources to augment what we're also going to be doing from non personal or additional perspective, so we're going to really engage high prescribing.
Speaker 10: physicians, whether OBGYNs, PCTs, or psychiatrists, with the right message at the right time, with the right resource, to effectively move this market with Zerzube, because moms can't afford to wait. We need to be out there. We need to be delivering messages rapidly in effect.
Physicians, whether obgyns tcp's or psychiatrist with the right message at the right time with the right resource to effectively.
This market with Zubaie, because moms can't afford to wait we need to be out there, we need to be delivering messages rapidly and effectively.
Yeah.
Okay.
Thank you.
Okay.
Speaker 1: Next, we go to the line of Yasmeen Rahimi with Piper Sandler. Please go ahead.
Next we go to the line of Yasmin Rahimi with Piper Sandler. Please go ahead.
Speaker 11: Hi, this is Liam on for Yaz. Thank you for taking our questions. I was just wondering if you could talk about if there are any prior authorization requirements for patients getting their due pay, and if so, what would those be?
Hi, This is Liam on for you guys. Thank you for taking our questions. I was just wondering if you could talk about if there are any prior authorization requirements for patients getting there as do they and if so what would those be.
Speaker 3: Yeah, basically, we're gonna outstart and ask Chris to chime in. So as we thought about the host opposition cost that are approached for Jusue, our goal is to ensure the largest number of women with DVDs that are prescribed Jusue, they are able to access it while at the same time recognizing the value.
Yeah, Thanks, Duane I'll start and ask Chris to chime in so as we thought about the wholesale acquisition cost that our approach for <unk>. Our goal is to ensure the largest number of women with PPD that are prescribed this do they are able to access it while at the same time recognizing the value.
Speaker 3: our innovation. We, at Sage and Biology, were delivered in Boccle, when we can determine the hostile position cost. And the prior off, some step that is the part of that, that calculus. Chris, you want to add some more?
Our innovation.
At Sage and Biogen were deliberate and thoughtful in determining the wholesale acquisition cost.
Prior offs and step edits for part of that calculus, Chris do you want to add some more.
Speaker 10: Yeah, Barry, what I what I'd add is we're right now actively engaged with national regional and government pairs and based on the feedback that we've received to date, we don't anticipate complex prior authorization.
Yeah, what I'd add is we're right now actively engaged with national and regional and government payers and based on the feedback that we've received to date, we don't anticipate complex prior authorizations.
Speaker 10: and step-ed it associated with the prescription as a ZUVA. It's, you know, we really believe that we're introducing a medication that is a breakthrough medication and offers really unique value to patients that are part of these plans. What that said, most pairs are aligned with the drug sources. You may be personalized therapy for women with post-pargative pressure.
Step edits associated with the prescription of <unk>.
Yes.
We really believe that we're introducing a medication that is a breakthrough medications and offer is really unique value.
Patients that are part of the plan with that.
Most payers are aligned.
The first line therapy for women with postpartum depression.
Speaker 10: And as we've heard from many of those pairs, the whole cell acquisition causes a Zube is within the value range to the impacted delivers. It is within the annual wholesale acquisition range of other commonly prescribed branded medication used to treat gray health disorders. And Zube remains a significant advancement in the minor pairs for the treatment of both part of the question and has the potential to be first line therapy. Let's see if they are within the particularly top notch testing. Is there a scientific collaboration oringa-ing in the
And as we've heard from many of those payers the wholesale acquisition cost such as ebay is within the value range for the impacted deliveries.
It is within the annual wholesale acquisition range of other commonly prescribed branded medications used to treat brain health disorders.
<unk> remains a significant advancement in the minds of payers for the treatment of depression and has the potential to be a first line therapy.
Great. Thanks, Jay Thanks, Lee for the question.
Thank you.
Once again, if you would like to ask a question, please sign up by pressing star one. If you find that your question has been asked, you can remove yourself from the queue by pressing star two. And next we go to the line of a new program, Rama with JP Morgan. Please go ahead.
Once again, if you would like to ask a question. Please signal by pressing star. One if you find that your question has been asked you can remove yourself from the queue by pressing star two and next we go to the line of <unk> Rama with J P. Morgan. Please go ahead.
Hey guys, thanks so much for taking a question. Maybe following up on some of the prior comments here, but maybe you could give us a little color on what you're seeing from the initial formular reviews. And I think you said this process could go into 2024, but just maybe speak about the urgency of completing some of these formular reviews, given the nature of the PPD and the need to treat quickly. Thanks so much.
Hey, guys. Thanks, so much for taking the question maybe following up on some of the prior comments here, but maybe you could give us a little color on what you're seeing from the initial formulary reviews and I think you've said this process could go into 2024, but just maybe speak about the urgency of completing some of these formulary reviews given the.
Charles of PPD and the need to treat quickly. Thanks, so much.
Yeah, thanks, Ed. If I'm up, that's a really important question. We are certainly with bias in moving with urgency, which is why we highlighted that we're going to make through movie commercially available.
Yes, Thanks, Dennis that's a really important question, we are certainly with Biogen moving with urgency which is why we have.
Delighted that we're going to make <unk> commercially available.
you know, in December with the Florida Law and the capability early next year. And the parent here engaged in the truth comment and I'll ask in the comment further, we've already started.
In December with four logs capability early next year.
The payer and payer engagement, which was commented all I'll ask him to comment further we've already we've already started.
One of the tailwinds we're seeing here given the clinical profile of Jorzuve is an appreciation that under-unitreated PPD costs payers, cost of health to a system of significant amount of money. And I think of course there's the humanistic side, which is really what we're focused on, helping that mom connect with her baby. So that...
What are the tailwind we're seeing here given the clinical profile of <unk> is the depreciation that honor undertreated in PPD.
Payers cost the healthcare system, a significant amount of money.
Of course, there's the humanistic side, which is really what we're focused on helping that mom, helping that mum connect with her baby so that.
And an under-under-treated PPD mom does not have a general impact and become a burden to themselves or baby. So that's a big focus. From a payer front, I think the payers are recognizing, I think the payers are recognizing the value of, of the reviews, they can just talk about some of the economic.
And then another Undertreated BBB bond does not have generate full impact and become a burden themselves a baby so.
Big focus from a payer front I think the payers are recognizing.
The payers are recognizing the value of the review that and Chris can talk about some of the economics now of course formulary review take some amount of time and there are certain players that will be online quickly and other plans and.
Now of course, formulary review takes some amount of time. And there are certain plans that will be online quickly. And other plans and you know, everyone knows this. Unfortunately, part of their policy is kind of a six month wait until they will review. So we'll, we'll, you know, we'll be moving as quickly as possible. And that's being said, we'll have programs in place which Christian talk about so that when a prescription is written for someone suffering with PPD, that prescription is filled. Christian, I'd like to provide some more.
In Windows. Unfortunately, as part of their policy is kind of a six month wait until they will review so well.
We'll be moving as quickly as possible that being said, we will have programs in place with Chris can talk about so that when a prescription is written for someone suffering with PPD that prescriptions filled Chris will provide some more color there.
Yeah, very what I would add is that we've engaged with Pairs, and as I noted earlier, we're engaging with National Regional Government Pairs. What resounds is the same.
Yes, Barry.
I would add is that we've engaged with payers and as I noted earlier, we are engaging with national regional and government payers.
What resounds is that they appreciate.
the unmet need that exists in the PPD market. They certainly appreciate the clinical value that Zerzube has the potential to offer to many of their unrolleyed.
<unk> needs that exists in the PPD market. They certainly appreciate that.
Clinical value Zubair.
<unk> has the potential to offer too many of their enrollees and they also understand that there is an economic impact of untreated depression, whether it's decidedly or on their plans themselves. So so all of those conversations has really bolstered the dialogue that we've had with payers over the course of the.
And they also understand that there's an economic impact of untreated depression, whether it's societally or on their plans themselves. So, so all of those conversations that really bolstered the dialogue that we've had with pairs over the course of
The time that we've spent with them specifically talking about PPD since the PIDUFA announcement. With that being said, we're going to do everything that we can to enable broad and affordable and equitable access.
Time that we start with and specifically talking about PPD.
Since the <unk> announcement with that being said, we're going to do everything that we can to enable broad and affordable and equitable access with minimal restrictions. So that patients that are a part of these plans where appropriate have little to no co pay with possible because we don't want financial.
with minimal restrictions so that patients that are part of these plans where appropriate have little to no copay when possible, because we don't want financial.
Financial barriers to prevent any mom for being able to act that his medications were out to him worth the credit.
Financial barriers to prevent any month for being able to access their medications without doing work with payers.
Thanks, Chris Thanks, John.
We go next to the line of peasant Ahmad with Bank of America. Please go ahead.
Well go next to the line of <unk> Ahmad with Bank of America. Please go ahead.
Hi, good morning. Thanks for taking my questions. Two relatively simple ones. Maybe Barry, can you tell us?
Hi, good morning, Thanks for taking my questions two relatively simple ones.
Maybe Barry can you tell us how long its going to take I don't know, it's a little bit difficult because we're just starting from the time a script is written to the time, it's actually dispense to the patients on a commercial basis at least early in the launch I'm I'm just trying to get a sense of how the early ramp could progress even though clearly there is high demand.
How long is going to take? I know it's a little bit difficult because you're just starting. From the time a script is written to the time it's actually dispensed to the patients on a commercial basis, at least early in the launch.
I'm just trying to get a sense of how the early ramp could progress even though clearly there's high demand.
but assuming that payment is a major driver holding back uptake, just want to get a better sense of how you're thinking about it. And then secondly, on your pricing, you talked about it in the prept remark.
But assuming that that payment is the major driver holding back uptake just wanted to get a better sense of how you're thinking about it and then secondly on on your pricing and talked about it as perhaps remarks, but I wanted to get a sense of can you give us a little bit of color on how this price.
But I wanted to get a sense of, can you give us a little bit of color on how this price might have differed from the price that you would have gone with if you were also launching with MDD? Thanks.
Might have differed from the price that you would've gone worse. If he were also launching with M. D D. Thanks.
Yeah, so thanks for the question. Let me start with the host office as you can cross side. And then Chris can talk about how we've set up the specialty pharma and time from script.
Yes. Thanks for the question, let me, let me start with the wholesale acquisition cost side and then Chris can talk about how we've set up a specialty pharma and time from script to face and of course, Chris can certainly weigh in on the wholesale acquisition cost so as I said earlier.
at the patient, of course, Christy, had concerned the way in on the host-activity cost. So as I said earlier, to Zene, we were very thoughtful and very deliberate in setting the host-activity cost for Zune, to do that, we believe reflects the clinical and economic value, and importantly, other key considerations, including access.
We were we were very thoughtful and very deliberate and setting the wholesale acquisition cost for <unk> that we believe reflects the clinical and economic value.
Importantly, other key considerations, including access for women with PPD, the unmet need the cost effectiveness innovations some of which we've we've talked about before we believe that the wholesale acquisition cost.
for women with TBB, the unmet need, the cost effect for this innovation, some of which we've talked about.
for it. We believe that the HOSF position cost set
You help the idea that will limit complex price loss, that's that is...
You helped the <unk>.
Idea.
It will limit complex Ross step edits and if you kind of go too high and we had some of those if you go too low clear, leaving too much value on the table.
And you know, if you kind of go too high, and you have some of those, if you go too low, clearly then leave them.
too much value on the table. Chris mentioned this before, but it's important to understand that.
Chris mentioned this before but it's important to understand that.
In a health, you know, in a model done by Mathematica in 2017 studying the value that we're potentially adding to the healthcare system
Health and a model done by Mathematica 2017, studying the values that were particularly in the health care system. They understood that the multiyear average societal cost of untreated.
day understood the multi year average societal cost of untreated PPD and and brought up for the conditions for the process $32,000. So we believe that with the host of acquisition costs, we are providing value to the health care system.
PPD.
And broader cradle conditions is approximately 32000, and so we believe that with the wholesale acquisition cost we are providing value to the health care system, you can't really compare that against the.
You can't really compare that against how many of the patients have different locations. As I mentioned earlier, we're solely focused on a successful law and for helping as many suffering from PVD as we can. And if another indication comes back on the table later, we'll make those adjustments later.
Our net of inflation in different locations as I mentioned earlier, we're solely focused on a successful launch of helping as many suffering from PPD as we can.
And if another indication comes back on the table later, we'll make those adjustments later.
Hopefully that helps the Z. Chris, you wanna talk at the ad, you see any color there, but talk about a time from script to patient's getting through Z.
Hopefully that helps to see Christine will talk as you can see.
You had any color there, but talk about time from script to patients getting through.
Yes, yes.
Yeah, very what I would add is that we'll say goodbye and expect to make. So, resume they commercially available in December of 2023. And that to do that, we've created a distribution model designed to provide rapid access and high quality patient experience for women with PDD. So, in effect, when a prescription is written that the physician can get the medication seamlessly for the patient. And when the patient is able to access the medication, here she can do so affordably. And we have the...
Yeah, very what I would add is that we will say goodbye and expect to make Susie made commercially available in December of 2023, and then to do that we've created a distribution model designed to provide rapid access and high quality patient experience for women with PPD. So in effect when a prescription is written that the physician can.
Get the medications seamlessly for the patient and when the patient is able to access to medication he or she can do so affordably and we have the educational resources to support services and the financial assistance programs in place to make sure that the patient is able to access to medication within days and as I mentioned earlier, we know that for this part.
educational resources, the support services, and the financial assistance programs in place to make sure that the patient is able to access the medication within days. And as I mentioned earlier, we know that for this population days matter, so that's where we squirrely going to be focused on with respect to the distribution model that we've set up.
Population days matter, so that's where we're squarely focused on with respect to the distribution model that we've setup.
Okay thanks for all that color. Sorry it's as Chris said it will be very fast from the prescription going to the electronic medical system to patients getting it at home will be very rapid you know as he said within days.
Okay. Thanks for all that color.
Alright, Chris.
Chris and it will be very fast.
The prescription go into electronic medical system to patients getting it at home will be very rapid dealers. He said within days is the goal. Okay. That's good yeah. That's good to know and maybe just to wrap it up what should we expect the gross to net in the early part of the launch to be.
Okay, that's good. Yeah, that's good to know and maybe just to wrap that up. What should we expect the growth to net and the early part of the launch to be?
Can you just talk about that.
So it's a little early to be providing that kind of guidance when we can provide more will update you.
Yeah. So.
It's a little early to be providing that kind of guidance. When we can provide more we'll update you.
Okay. Thanks.
Thank you.
We're going next to the line of Salzean Richter with Goldman Sachs. Please go ahead.
We go next to the line of Celgene Richter with Goldman Sachs. Please go ahead.
Good morning, thanks for taking my question. With regard to your partnership here with Biogen, how has the partnership evolved since the CRL in MDD and in what aspects of commercialization do you expect them to take the lead? Thank you.
Good morning, Thanks for taking my question with regard to your partnership here with Biogen how has the partnership evolves since these hero and and M. D D and what aspects of commercialization do you expect them to take the lead thank you.
Yeah, thanks for the question, Selvian. So, you know, when we issued our press release in early August and now seeing the approval of Zerduvay for PGG, we advise them together committed to having Zerduvay commercial available by the end of the year. And we reaffirm that on this call that we'll have Zerduvay commercial available in December with...
Yes, thanks for the questions solving so when we issued our press release in early August announcing the approval of <unk> for PPD, we advise them together committed to having a commercially available by the end of the year.
And we've reaffirmed that on.
On this call that will usually commercially available in December with the full complement of large capabilities early next year. It's.
Before a compliment of launch capabilities early next year, as Chris noted in his comments, we've been working diligently with biogen to roll out and fully commercialize the Zubein. We're handing in that. We have not talked about the specific division of laborers or some things that we're taking to lead on others that they're taking to lead on. But I think sitting here right now we're very well positioned for commercial available to Zubein and the fuller launch on the Mutarium happening early next.
As Chris noted in his comments, we've been working diligently with Biogen to rollout and fully commercialized Suzhou, then work nor hand in hand in the well.
Have not talked about the specific division of labor or is there some things that we're taking the lead on others that they are taking a lead on but I think sitting here right now, we're very well positioned for commercial availability.
<unk> launch armamentarium happening early next year.
Our next question or comment comes from the line of J. Olson with Oppenheimer. Please go ahead.
Our next question or comment comes from the line of Jay Olson with Oppenheimer. Please go ahead.
Oh, he congrats on the progress. Thanks for the update. Can you talk about the total potential commercial opportunity for PPD? And when do you expect these, or ZOVPNL to become profitable? Thank you.
Oh, Hey, congrats on the progress and thanks for the update.
Can you talk about the total potential commercial opportunity.
Or P. P D and when do you expect these are adobe P&L to become profitable. Thank you.
Yeah, thanks. Yeah, I appreciate the congratulatory note. We certainly have made a lot of progress. Let me start with the opportunity, you know, ask Chris to add any color there and then can we follow up with how we're thinking about the financial. So.
Yes. Thanks I appreciate the congratulatory note. We certainly have made a lot of progress let me start with the <unk>.
Opportunity.
Chris.
Any color there and then can you can follow up with how we're thinking about the financials. So.
As you talked about Jay on the call, epidemiologically approximately one in eight live verse results.
As we talked about during the call Epidemiologically approximately one eight live births results.
and the potential for PPV. That's about a half a million women in the United States.
In the potential for PPD, that's about a half a million women in the United States per year and.
Unfortunately, less than half of that is diagnosed and even far fewer are treated. Now, think about the condition today, because as is, we have the Zoress about there, of course, for treat PPD, but as we all know, there are certain access hurdles given the IV infusion.
Unfortunately less than half of that is diagnosed and even far fewer are treated now do you think about the condition today.
As we have this the rest of our third course for treat TBD, but as we all know there are certain access hurdles given the IV infusion.
But mostly those that have the good fortune being diagnosed with treated or treated with antidepressants that could take weeks to month to work a favor and end up working through a very complex.
But mostly.
Had the good fortune of being diagnosed and treated or treated with anti depressant that can take weeks to months towards work if ever ended up.
Working through a very complex.
referral process. As you heard Chris talk about earlier on the call, we believe that Zerzuve as a rapidly acting oral 14 day course of therapy.
<unk> process.
Heard Chris talk about earlier.
Call, we believe that Zubaie as a rapidly acting oral 14 day course of therapy.
fit into the physician's practice pattern, whether it's OB, GYN, cycle, PCP, and they're much more incentive to diagnose and scream. So, we believe the opportunity is significant in the early years, but really continues to grow in the out of years as...
This into the physician's practice pattern, whether it be UN cycle, PCC and theres much more incentive to diagnose and screen. So we believe the opportunity is significant in the early years, but really continues to grow in the outer years as.
diagnosis and treatment rates should continue to increase. So we think it...
Diagnosis and treatment rates should continue to increase so we think it's.
We had a blockbuster potential and even more importantly, the ability to help all of us.
These women suffering from PPD.
Chris you want to add some more color on the key follow up with some of our financial thinking.
You're very, what I would add is you hit it. You cover the epidemiology and the blockbuster potential for this medication, but the thing that I would add to those comments is that when we receive...
We're very what I would add is you hit you cover the epidemiology and the blockbuster potential for this medication, but the thing that I would add to those comments is that when we received approval for <unk>. The media coverage was remarkable the social media activity was really impressive so what's that.
Approval for Zubey at Padufa, the media coverage was remarkable. The social media activity.
really impressive. So what's that really stignal that you have an active group of patients?
Really signals is that you have an active group of patients clinicians and patient advocacy organizations waiting for this medication and thats an opportunity that we're going to capitalize on this launch because as I said earlier, we know that patients can't afford to wait for medication like this but we're going to do everything we can to drive broad and rapid.
clinicians and patient advocates, the organizations waiting for this medication. And that's an opportunity that we're going to capitalize at once. Because as I said earlier, we know that patients can't afford to wait for medication like this. And we're going to do everything that we can to drive broad and rapid and equitable.
And equitable access to this medication.
And just to follow up on the financials, we certainly are thinking big about the PPD opportunity as Chris and Barry just talked about, but when we think about the commercialization strategy, we're thinking that we're gonna start small and then scale with success. We don't wanna get ahead of ourselves with regard to building an infrastructure and building a cost structure, so we're gonna scale that as we see success. How do we address your work? First is easy success.
And just to follow up on the financials, we certainly are thinking big about the PPD opportunity as christenberry, just talked about but when we think about the commercialization strategy. We're thinking that we're going to start small and then scale. It success. We don't want to get ahead of ourselves with regard to building an infrastructure and built.
Our cost structure. So we're going to we're going to scale that as we see success.
Great. Thank you very much thanks, guys. Thanks Jay.
We go next to Brian Abrams with RBC Capital, you may proceed.
Well go next to Brian Abrahams with RBC capital you May proceed.
Hi guys, this is Alina Donfer, Brian . Thanks for taking our question. I actually wanted to follow up on some of what you've been hearing on the ground with respect to providers and physicians. You guys had mentioned the initial enthusiasm from the media coverage. And I guess I'm curious, has that been pulling through into a request for information from physicians and providers? And are there any challenges in having, I guess, to launch, take place a few months after you had all the fan of hair from the media? And is there any effort to recapture that rebuild it so you can pull that momentum into the launch? Thanks.
Hi, guys. This is a lean it on for Brian. Thanks for taking our question I actually wanted to follow up on some of what you've been hearing on the ground with respect to providers and physicians and you guys had mentioned the initial enthusiasm from the media coverage and I guess I'm curious has that been pulling through into a request for information from.
<unk> <unk> providers that are there any challenges and having I guess the launch take place a few months. After you had all the all the fanfare from the media and is there any any effort to sort of recapture that and rebuild it. So you can pull that momentum into the launch thanks.
Yeah, thanks Lou. That's a very insightful question. Let me start now ask, oh that's Christopher Pumlin for there. So the quick answer is that the media attention clearly has filled over into patients, patient advocacy, healthcare providers.
Yes, absolutely.
Very insightful question, let me start and I'll ask I'll ask Chris to comment further so quickly.
Quick answer is that the media attention clearly has spilled over into patients patient advocacy as health care providers.
There's tremendous enthusiasm for improving diagnosis and to treat PPD in a whole new way. And now that we've announced that we're making...
There is tremendous enthusiasm for <unk>.
Improving diagnosis and to treat PPD in a whole new way and now that we've announced that we're making usually with a commercially available in December I believe that uptick will continue and it will also add before turning over to Chris.
years you've been torsially available in December . I believe that up to
We'll continue and we'll also add before the term of the crisp that the media attention was not by accident. There are very important outlets that are very interested in maternal mental health. We're going to have some dialogue with them and providing information that they importantly want to hear. So, Chris, you want to
The media attention does not by accident, they're very important.
For us that are very interested in maternal mental health and we're in constant dialogue with them in providing information that they importantly water here.
So Chris you want to add some color there.
Very what I would add is that I see enthusiasm continuing to build amongst all of our stakeholders, whether it's the interactions that we're having with pairs or the dialogue that we're having with clinicians and key opinion leaders at various medical meetings and in one on one conversations or with patient advocacy organizations.
What I would add is that I see enthusiasm continuing to build amongst all of our stakeholders, whether it's the interactions that we're having with payers or the dialogues that we're having with our clinicians and key opinion leaders at various medical meetings and in one on one conversations or patient advocacy organizations.
we continue to have all of those conversations. We would expect that that enthusiasm to continue to build up and true and announcement around commercial availability. So we're going to capitalize on those dialogues over the course of the coming weeks to make sure that when we ultimately are commercially available, everybody's aligned and from a stakeholder perspective ready to prescribe this medication for women with BPD.
As we continue to have all of those conversations we would expect that that enthusiasm to continue to build up into an announcement around commercial availability. So we're going to capitalize on those dialogues over the course of the coming weeks to make sure that when we ultimately are commercially available everybody's aligned from a stakeholder perspective ready to prescribe this medication for women.
With CBD.
Thanks, Joe.
Yes.
We go next to Pal Matisse with Steve. Please go ahead.
We go next to Paul Matisse with Stifel. Please go ahead.
Hey, thanks so much for taking the question. I was curious now that you're getting ready to launch. How many PPD patients specifically are actively treated in the care of a psychiatrist right now? And do you have any kind of data or any grounded data you can give us on just patient flow for PPD? And it'll be guide practices. How many patients get either a benzodiazepine or an SSRI, just any kind of...
Hey, thanks, so much for taking the question.
I was curious now that you're getting ready to launch how many PPD patients specifically are actively treated in the care of a psychiatrist right now.
And do you have any kind of data or any grounded data you can give us on just patient flow for PPD and Ob gyn practices, how many patients get either a benzodiazepine or an SSRI.
Any context, there would be helpful. Thanks.
Yeah, Paul said, I appreciate this is important for your modeling. We certainly understand the high-prescribing positions, but don't have perfect information about that slow and do things that will change. So let me go through again at high level in the next.
Yes, Paul Thanks I. Appreciate this is important for your modeling.
We certainly understand the high prescribing physicians that don't have perfect information about that flow into a legal change. So let me go through again, a high level of announced.
Kristen and Laura to comment about how we see it today and changing over time. So, the numbers are already pretty significant. There's, you know, there's a couple hundred thousand women diagnosed a year and about half of those are treated, so 100 plus women treated with various.
Chris and Laura can comment about how we see it today and changing over time so the.
The numbers are already pretty significant there is there.
As a couple of hundred thousand women diagnosed a year and about half of those are accretive to 100, plus women treated with various anti depressants today. So if we can simply get for those women with a better oral rapidly acting 14th Street in the course of the debate.
I have to say the questions today. So if we can, you know, simply get to those women with a better oral graphically action for keeping treatment courses in the Zube, you know, we're in pretty good shape. Of course, our drive is to see the diagnosis rates improve and obviously the treatment rates improve now that we have a different solution for them. But Chris, you wanna add more, I'm or maybe you wanna round it out.
We're in pretty good shape of course, our drive is to see the <unk>.
Diagnosis rates improve and obviously the treatment rates improve now that we have a different solution for them, but but Chris do you want to add more and more maybe want to round it out.
What I would add is, roughly speaking, as we look at the prescriber universe, roughly third of patients are coming through right now, OB-GYN practice.
What I would add is roughly speaking as we look at the prescriber universe roughly a third of patients are coming through right now obgyn practices in effect, what I would anticipate over the course of time with things like the ACOG guidelines and now the availability of a medication like <unk> Hubei, which has.
In effect, what I would anticipate over the course of time with things like the ACOG guidelines and now the availability of a medication like Zerzube, which has the opportunity to be the first oral therapy for the treatment of PPD, that prescribing to only increase with an OBGYN practice.
The opportunity the first oral therapy for the treatment of PPD.
Prescribing to only increase within <unk> and practices as we go forward, we know that historically through our interactions with Obgyns from Russell perspective that they're having something like this it is an oral therapy is going to profoundly change the way that what would you think about utilizing a medication like <unk> to help there.
We know that historically through our interactions with OBGYNs from a Zoresco perspective that, you know, having something like this that is an oral therapy is going to profoundly change the way that OBGYNs think about utilizing a medication like Zoresco to help their patients. So we'll continue to focus on OBGYNs. We'll also capitalize on the opportunity.
So we'll continue to focus on Obgyns will also capitalize on the opportunity within psychiatry practices to make sure that they are well aware of this therapy and the impact that it could have on their patients or anything like that yeah.
within psychiatry practices to make sure that they are well aware of this therapy and the impact that it can have on their patients or anything that's like that. Yeah and to add, you know, I'd like to emphasize that you
I'd like to emphasize that.
So Zube was a 14 day treatment course really fits well into the practice pattern of the OB-GYN and it's very different from what they've been able to access previously using treatments off label to treat TBD. So I do think that when there's a solution to a problem, you see people much more ready to identify the problem and then use the solution they have in.
So Sue Bay with a 14 day treatment course, really fits well into their practice pattern of the Ob Gyn and it's very different from what they've been able to access previously using treatments off label to treat TBD. So I do think that when there's a solution to a problem you see people much more ready to identify the problem.
Then use a solution they have at hand, I think with regard to psychiatrist what youll see is that they will engage their patients.
I think with regard to psychiatrists, what you'll see is that they will engage their patients who are already in their practices with depression and talk with them about their risk for postpartum depression during the pregnancy and also have a plan in place to treat them rapidly should those symptoms emerge.
We're already in their practices with depression and talk with them about their risk for postpartum depression. During the pregnancy and also have a plan in place to treat them rapidly should those symptoms emerge as the first program period.
Thanks, Christy. We appreciate the questions, Paul.
Great. Thanks, Chris Thanks, Laura I appreciate the question Paul.
Okay.
We go next to the line of Ami Sadeer with Needham. Please go ahead.
Well go next to the line of Amit <unk> with Needham. Please go ahead.
Hi, good morning and congrats on the progress. I have a question on the clear coverage. You mentioned you don't expect any complex prior authorization. Would there be any prior authorization? And so what type of prior odds are you anticipating? And as we think about the initial launch, how should we think about access for patients while they are making the coverage decision?
Good morning, and congrats on the progress I had a question on the coverage you mentioned you don't expect any complex prior authorization.
Would there be any transition and if so what type of pilots are you anticipating.
And as we think about the initial launch how should we think about access for patients while payers are making the published decision. Thank you.
Yeah, I mean, very, very important question. It's important, as you said, that we're leaning in to make sure that access for patients with or without coverage is there. Chris, you want to take it?
Yes.
Important question and it's important as we've said that we are leaning in to make sure that access for patients with or without coverages, there, Chris you want to take it.
Yeah, very, so with respect to the first part of the question, types of prior authorizations, you know, when pairs look at utilization of medications like Zerzu, they want to make sure that the right patient gets the right medication at the right time. So any prior authorization would be around something like...
Yes, Barry so with respect to the first part of the question types of prior authorizations.
Here is look at utilization of medications like <unk>, they didn't want to make sure that the right patient gets the right medication at the right time, so any prior authorization would be around something like.
The patient being a woman diagnosed with postpartum depression. So that's the kind of prior authorization that I would expect, which is not a complex prior authorization. That's a checkbox PA that clinicians are very familiar in dealing with.
The patient being of women diagnosed with postpartum depression. So that's the kind of prior authorization that I would expect which is not a complex. Prior authorization. That's a checkbox PGA that clinicians are very familiar and dealing with it.
In terms of managing patients who don't have insurance cover, I said earlier that is an organization we're going to lean in with support services, with education and financial assistance resources at the time of launch. So if a patient in effect is functionally uninsured,
In terms of managing patients, who don't have insurance coverage I said earlier that as an organization, we're going to lean in with support services with education and financial assistance resources at the time of launch so if a patient ineffective functionally uninsured.
Stages in organizational on with biogen is going to lead in to make sure that that patient doesn't have to wait an extensive period of time to get access to Zuzuzai. We're going to do everything that we can to get that patient on medication because as I said earlier, women with PPD can afford the wait.
As an organization along with Biogen is going to lean in to make sure that that patient doesn't have to wait an extensive period of time to get access to as you say, we're going to do everything that we can to get that patient on medications because as I said earlier women with PPD can't afford to wait.
Thanks, Chris Thanks Ali.
Yeah.
We go next to George Farmer with Scotiabank. You may proceed.
We'll go next to George Farmer with Scotiabank you May proceed.
Yeah.
Hi, thanks for taking my question. I'm just wondering if you could go into some detail about what the diagnostic criteria are gonna be?
Hi, Thanks for taking my question.
Just wondering if you could go into some detail about what the diagnostic criteria are going to be in order for pre off to get approved.
in order for a pre-off to get approved. It seems to me with such an expensive drug that one would want to differentiate, say, from just general baby blues to full on diagnostic, the diagnosed people.
It seems to me with such an expensive drug.
That one would want to differentiate say from just general Baby Blues too.
<unk> diagnostic diagnosed PPD can you speak to that.
Yeah.
Yeah, let me start now. I'll ask Laura and Chris has more blood ed, Chris is coming up. So let me start with George, I think.
Yes, let me start and I'll ask.
I'll ask Laura.
Chris is more quota coming up so look let me start with George.
As we said at the beginning of the call, we in Biogen, we're deliberate and thoughtful when determining the wholesale acquisition cost for Zerzuvia, and I actually believe that we're adding value to the healthcare system. We will publish the relative cost effectiveness of Zerzuvia versus what's being used today, SSRIs, SRAs, and others, which as you heard Laura talk about, takes weeks to months to work.
Yes.
As you said, it's as we said at the beginning of the call, we and Biogen were deliberate and thoughtful in determining the wholesale acquisition cost for <unk> and I actually believe that.
We're adding value to the health care system.
We will publish the relative cost effectiveness zubaie versus what's being used today, ssris et cetera and others.
Which as you heard Laura talked about takes weeks to months to work.
and the societal cost of under-undertreated of PPV on the mom and baby very, very, very.
And the societal cost of under Undertreated.
PPD on mom and baby very good.
So we actually think that the way we position a hostilex2 cost is adding value to help your system not quote unquote expense
Significant so we actually think thats the way, we positioned <unk> to cost is adding value to the health care system not quote unquote expenses.
In terms of how the diagnosis, let me ask Lord to talk about how we believe the various healthcare providers will diagnose and then a test to that diagnosis.
In terms of.
In terms of how the diagnosis, let me let me ask Laura to talk about how we believe the various health care providers will will diagnose and then attached to that diagnosis.
So, thanks, Barry. So, I know when people think about PPD, they think about the baby blues as well. And the baby blues is a real thing. It happens in about 80% of pregnancies in the first week or so following delivery. But the presentation of the baby blues is very, very different.
Sure. Thanks, Barry so.
No.
When people think about PPD, they think about the baby blues as well and the baby Boomers is a real thing it happens in about 80% of pregnancies in the first week or so following delivery.
The presentation of the babies is very very different from the presentation that postpartum depression, and baby boomers people might be a little we'd be that might have some changes in mood might be a little anxious, but that loss of only a few days and it results with postpartum depression.
And baby blues people might be a little weepy, they might have some changes in mood, might be a little anxious. But that lasts only a few days. And it...
With postpartum depression, the magnitude of these symptoms, the severity is much higher, and it lasts for a much longer time. And it really interferes with the ability of the mom to take care of her baby, and to take care of the other children and the family. It has real functional comfort.
The magnitude of these symptoms severity is much higher and it lasts for much longer time, and it really interferes with the ability of demand to take care of her baby and to take care of the other children and the family. It has field functional consequences and so the differences between these two are really abundantly obvious to people who are used to.
And so the differences between these two are really abundantly obvious to people who are used to treating women in the postpartum period, and they don't think that these will be confused. As a consequence, I believe that pairs are also going to recognize that clinicians are appropriately diagnosing the patient's food will benefit from treat.
<unk> of women in the post partum period, and they don't think that this will be confused.
As a consequence I believe that payers are also going to recognize that.
<unk> are appropriately diagnosing the patients who will benefit from treatment.
Yeah, Chris, you want to order on how we think where we have prior off, they might work.
Yeah, Chris you want to order and how we think.
We had prior offs they might work.
Yes, so to talk about prior authorization there, and let me take a step back and just say that, you know, based on the therapy back today, we don't anticipate complex prior authorization associated with the prescription of Zerzuvae. In effect, what we would anticipate is that if there is any prior authorization, it would be a checkbox PA around something like the patient having a diagnosis of postpartum depression from her clinician. That's really the feedback that we're getting at this point today. No problem.
Yes, so so to talk about prior authorization there is and just let me take a step back and just say that.
Based on the payer feedback to date, we don't anticipate complex prior authorizations associated with the prescription of <unk> in effect, what we would anticipate as if there is any prior authorization it would be a checkbox PAA around something like the patient having.
Diagnosis of postpartum depression from from her condition, that's really the feedback that we're getting at this point to date.
So it will be just as simple as that just just a check the box side.
Notice.
Yeah, George, that's what we're working towards. I mean, it's a sole indication. So in prescription to go in, there'd be a potential electronic question back, please confirm it, which is PPD without a whole bunch of other heavy baguettes. It's, you know, again, the...
Yes, George that's what we're working towards a maintenance of sole indications so.
And prescriptions go in potential electronic question, but please confirm this is PPD.
Without a whole bunch of other heavy diagnose it again.
The.
The payer system understand the economic burden associated with an underarm diagnosed at PPD and it's extreme to that mom and in the baby as well as the side of the cases. I think it's very long. Okay.
The payer system understand the economic burden associated with an under diagnosed.
And at its extreme to that mom and.
And the baby as well as societal implications I think it's very well understood.
Okay, great. Thank you very much.
Thanks for the question.
We go next to the line of Sumon Cool Cardi with Canacord. Your line is certain.
We go next to the line of Sumani Kulkarni with Canaccord. Your line is open.
Good morning, thanks for taking my questions and I have to see that Zuzu is available for patients in the near future here. So we went through the review documents for Zuzu and we're looking specifically at the post marketing requirements and commitments. And you expect these studies, especially the non-tinical safety study to have the potential to make any adjustments in the language at the label as it stands today. And would those have any bearing on your potential ability to still pursue Zirama on for major dep?zom.
Good morning, Thanks for taking my questions and nice to see that Z wave will be available for patients in the near future here.
Went through the review documents Zoe and when looking specifically at the post marketing requirements and commitments.
We expect these studies, especially the non clinical safety study have the potential to make any adjustments in the language of the label as it stands to be and we don't have any bearing on your potential ability to still push who's at Amazon for major depressive disorder.
Hey, Sioum on the back. Tell them, let me start. And I can turn it over to Lauren. So as you are, we're very excited after all this time to make.
Hey, Simona. Thanks, So let me start and I can turn it over to Laura.
Well as you are we are very excited after all this time to make there.
There's a commercially available to those suffering from post-partum distress. We're really looking forward to getting out there and helping as many women as we possibly can.
This is a commercially available to to those suffering from postpartum depression, we're really looking forward to getting out there and.
And helping as many women as we possibly can.
In terms of our focus is a mission on the call we're very very focused on the success and watching
And in terms of our focus as I mentioned on the call. We're very very focused on the successful launch of reserves for PPD as I commented on if there are any other indications that come into the label will revise or make any definitive.
As I comment on, if there are any other indications that come into the label or revives you making a definitive
We'll certainly let you know, but I think everybody should
Determinations, we'll certainly let you know, but I think everybody should be solely focused on as you do this for PPD for the foreseeable future Laura you want to talk about.
So, if you're starting to do so, do they put PPDs for the foreseeable future? What you want to talk about is that they're not very significant, the post-marketing requirements you have.
They're not very significant the post marketing requirements you have.
Sure. So we received two postmarketing requests on the approval of Suzuki for PPD. One is to conduct an embryo fetal toxicity study in a second species. And the other is to understand the PT safety and tolerability of Suzuki in females age 16.
Sure. So we receive two post marketing request on the approval of <unk> for PD. One is to conduct an embryo fetal toxicity study and a second species and the other is to understand the PK safety and Tolerability and females, aged 16 to 18.
So each of these studies is in the process of being conducted. When we have the data, we will approach the agency and share that data with them. And we will have a discussion with them about whether changes to the label are warranted based on these new dates.
So each of these studies is in the process of being conducted when we have the data we will approach the agency and share that data with them.
And we will have a discussion with them about whether changes to the label are warranted based on new data.
Thank you. Yes, thanks. We certainly it's not necessarily anticipate the 14 to 16 year old plus.
Got it thank you yeah. Thanks.
We certainly it's not and certainly anticipate.
The 14th the 16 year old plus.
Data as we did was the RSO being something that is the label and changing activity. Whether anything else is to be determined.
Data as we did was the RSO being something that is the labor and changing activity, but was there anything else that needs to be determined.
Thanks.
Yeah.
We go next to the line of Laura Chico with Webboost securities. Please go ahead.
We go next to the line of Laura Chico with Wedbush Securities. Please go ahead.
Hey, good morning guys. Thanks very much for fitting in. It's just referencing Zolreso. I'm wondering if you could kind of circle back to that timeline between writing a script and getting it issued for Zolreso's Juve. And just to remind us, what did that kind of evolution look like over the course of Zolreso's time on the market? Were you able to condense that down and any learnings there in terms of how it might help with Zolreso's Juve? Thanks.
Hey, good morning, guys. Thanks, very much for fitting me in.
Just referencing the rest so I'm wondering if you could kind of circle back to that timeline between writing a script and getting issued further zoo, there and just to remind us.
What did that kind of evolution look like over the course of the rest of his time on the market, where you're able to condense that down and any learnings there in terms of how it might help with the Thursday, okay. Thanks.
Yeah, well, let me take that. So in terms of, let's start with the rest of them. In terms of the rest of them, if a healthcare provider doesn't defend a diagnosis on TBD, start form is sent to because the rest of it requires a infusion site.
Yes.
Let me take that so in terms of in terms of let's start with the Russell in terms of the RSO.
If a health care provider doesn't definitive diagnosis on PPD.
Start form of sensitive because the rest of it requires a infusion sites.
And then a lot of logistical support. It could be flights carrying their children. You know, the fact that we had such an increase and the numbers were small, but such an increase from the beginning of the rest of the two last quarter, almost a three or fourfold increase in the number of women were helping. Really shows.
And then a lot of logistical support that could be flights carrying their children.
The fact that we had such an increase in the numbers are small, but such an increase from the beginning of the Russell two last quarter, almost three or four fold increase in the number of women where help them really shows.
of the end that meet the end that meet and the desire to treat even all the logistical challenges.
Does that mean.
Need and desire to treat given all the logistical challenges.
Was there a survey? You know, it's an oral treatment that comes in a pack as we showed on our slides during the call. And it works like any other script that will host a specialty farm. So the script will be sent into the electronic medical system.
Hey.
It's an oral.
Treatments that comes in APAC as we showed on our slides during the call and it works like any other script.
We're close to a specialty pharma so the script will be sent into the electronic medical system.
questions maybe asked back to the firm, it's PPD. And that script, our goals and days should arrive in the hands of the post-partum woman and ready to treat. And hopefully...
Questions may be asked back to confirm its with PPD and that's good our.
Kohl's in days to arrive in the hands of the.
Pardon women and ready to treat and hopefully.
Each and every woman sees the counter-result and so on, clinical practice, a rapid or clinical development. A rapid improvement in depression symptoms as early as three days, complete your 14-day impact and you know, goals to re-engage with baby and family. So we really do believe that there's new day in TB, works like other prescription's out there. Schripps are written, both suffering received, that drug is very, very rapid.
Each and every woman sees the current result in solid clinical practice of rapid or in clinical development.
Rapid improvement in depressive symptoms as early as three days complete your 14 impacting.
The goal is to Reengage in baby and family. So we really do believe that you view the MTBE works like other prescriptions out there scripts written.
Those suffering receive that drug very very rapidly.
And all those lessons have been applied to the commercialization of their duty.
And all of those lessons have been applied to.
The commercialization of their journey.
That's great. Thanks Barry.
Thanks, Laura.
We now turn to Barry Green for any additional or closing remarks.
Please now turn to Barry Greene for any additional or closing remarks.
Thanks, Belinda, and thanks again to everyone for joining us this morning through your results from the third quarter of 2023.
Thanks, Linda and thanks again to everyone for joining US this morning to review our results from the third quarter of 2023 as.
As we look ahead in the commercial availability and subsequent launches of Zuzube and the treatment of women with TBD and prepare to enter what we believe will be a catalyst rich 2024 with multiple data readouts expected that provide the potential for long-term value creation, I'm confident that we're making important progress to deliver our mission to develop and launch life-changing brain health medicines so every person can thrive. Thanks again, everyone, have a great day.
As we look ahead to the commercial availability and subsequent launch of Zumba and the treatment of women with PPD and prepare to enter what we believe will be a catalyst rich 2024 with multiple data readouts expected that provide the potential for long term value creation of confidence that we're making important progress to deliver our mission.
To develop and launch like changing brain health medicines. So every person can thrive.
Thanks, again, everyone have a great day.
Thank you. This does conclude today's teleconference. We thank you for your participation. You may disconnect your lines at any time.
Thank you. This does conclude today's teleconference. We thank you for your participation you may disconnect your lines at any time.
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