Q2 2023 Sage Therapeutics Inc Earnings Call
<unk> Dot com.
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Please note that this call is being recorded.
I would now like to introduce Ashley catheter with <unk>. Please go ahead.
Good morning, and thank you for joining Sage Therapeutics conference call to discuss business updates, including the FDA approval of the ran alone now branded in the United States, There's debate as a treatment for adults with postpartum depression or PPD before we begin I encourage everyone to go to the Investor and media section of our web.
Our stage, our rack dot com, where you can find the press release related to today's call as well as slides that we will be reviewing today I would like to point out that we will be making forward looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties and our actual results may differ materially. Please.
To review the risk factors discussed in today's press release and in our SEC filings for additional details.
We will begin the call with prepared remarks by Barry Greene, Our Chief Executive Officer, then Laura <unk>, Our Chief Medical Officer will review the label for Zumba and supporting clinical data, our Chief business Officer, Chris Becky will highlight our commercial preparations and launch plans for Zubaie in PPD, and Kimi and Gucci, our chief financial.
Officer will close with the financial update Jim Doherty, Our Chief Development Officer will also be available during the Q&A portion of the call with that I'll now turn the call over to Barry.
Thanks Ashley.
Thank you everyone for joining us today.
Stork moment for all women suffering from PPD.
Friday, we and our collaboration partner Biogen received approval from the FDA for <unk> now known as <unk>.
For the treatment of adults with PPD.
<unk> is the first and only oral treatment specifically indicated for PPD.
Hundreds of thousands of women have been waiting and hoping for this moment.
We hear so many devastating stories.
<unk> and <unk>.
Any of us have been personally touched those often neglected condition.
This reflects approximately 500000 women each year.
Today, there is a new source of oil.
Before we begin I'd like to take a moment to sincerely. Thank the dedicated health care providers patients caregivers and advocates who have made to date possible.
Especially the patients who place their most trusted us throughout our clinical trials.
We are and will always be an inspiration for us.
We applaud your dedication to seek new treatment options for PPD.
I'd also like to comment on the status of our NDA seeking approval for <unk> alone in the treatment of major depressive disorder or <unk>.
As many of you have seen late on Friday, we received a complete response letter from the FDA for <unk> alone as a treatment for adults with mbd.
We are devastated for patients and deeply disappointed with the fda's position and issuing the euro.
We are reviewing feedback from the FDA and evaluating next steps.
As we have clarity we will share more.
Many of your questions was that we can answer and others that we just simply can't at this time.
Now just to be clear progress in treating depression is not keeping pace with the accelerated prevalence and burden.
<unk> disease. Despite current treatment options people with depression continued to struggle.
A change in the treatment paradigm and approval of novel options is desperately needed.
Later in the call Jimmy will provide an update on the financial implications given this development.
For those of us who've been biopharmaceutical industry for decades.
Going through adversity, as an opportunity to come out more lean and agile on the other side.
We will work through this.
What I can say for now proceeds is that we'll be making smart disciplined decisions intended to maintain a robust balance sheet. This is an opportunity to emerge as a stronger company with a refined strategy and a focused approach.
Now turning back to our primary focus for today's call. Following Friday's approval, we have the first and only oral treatment specifically indicated for women with PPD.
As a 14 day short course treatment, we believe that <unk> will provide women with PPD, a desperately needed new treatment option with the potential to treat their depressive symptoms quickly without the need for chronic treatment.
Given the limited treatment options available for women with PPD, we're excited about the opportunity to bring <unk> to those patients.
We expect to resume to launch and be commercially available in the fourth quarter of 2023. Shortly following the completion of scheduling is a controlled substance. So the USDA, which is expected to occur within 90 days.
Of this approval.
The widespread national media attention on the approval of <unk> for the treatment of women with PPD reinforces that this is truly a critical milestone gives it given the significant unmet needs that currently exist for the treatment of women with this disease.
PPD is a serious medical condition.
We know that women with PPD, often face extreme challenges in their daily lives and Wilkinson funding.
Often feeling overwhelmed anxious and isolated.
Left untreated.
Symptoms can persist beyond a year post part, which can be associated with prolonged maternal morbidity and mortality.
<unk> CBD can be associated with short term consequences newborns that can also result in long term developmental psychological cognitive and physical remicade non vacations virtual.
The devastating generational impact of PPG has been often overlooked.
With the approval of <unk>, we now have the first and only oral treatment indicated for aluminum TBD and we stand ready to help.
I want to take a moment to recognize the entire sage and Biogen teams and our collaborators who brought us to this important day for women with PPD.
None of what we do is possible without your hard work dedication and faltering belief that together, we have the potential to change the mental health landscape.
I think everyone of you for your contributions towards our mission with that I'll now turn the call over to Laura.
Thanks, Terry and good morning, everyone.
The approval of <unk> in adults with PPD is a pivotal moment for the women who stand to benefit from this important therapy.
A great moment for station Biogen.
The approval of <unk> further builds upon the foundation laid with stages first approved treatment for PPD and.
And reaffirms our commitment to helping others in need.
I will start by providing background on Thursday, then I'll highlight details of the prescribing information.
The mechanism of action of <unk> and the treatment of PPD is thought to be related to its positive allosteric modulation of Gaba a receptors.
So the mechanism of action is not fully understood.
As the primary inhibitory neurotransmitter Gaba amenable to <unk> acid or Gaba is widely distributed throughout the brain.
It is present in brain major functionally associated with mood.
<unk>, making and other behavior.
<unk> Tec neurotransmission is vital for normal brain function and evidence shows <unk> function may be disrupted in postpartum depression.
Now I will summarize the clinical data supporting approval assess ebay amendment with PPD.
The approval was based on data from the nest clinical development program, which included the Skylark and Robin studies.
These studies were phase III randomized double blind placebo controlled trial.
That evaluated a 14 day treatment course of surgery, they once daily use.
Used alone or as an adjunct to oral antidepressant therapy in women, aged 18 to 45 with PPD.
Both studies met the primary endpoint showing a statistically significant improvement over placebo at day 15 on the 17 item Hamilton Depression rating scale, a common measure of depression severity.
As shown in the figures in both the Skylark and Robin studies and improvement in depressive symptoms were seen as early as phase III and was maintained at $45 four weeks post treatment.
The potential for rapid onset and the magnitude and durability of effect are all very important to women living with PPD.
Now I'll provide an overview of the prescribing information, including the safety information.
The recommended dosage of <unk> today is 50 milligrams taken orally once daily in the evening for 14 days with fat containing food.
The dose may be reduced to 40 milligrams once daily.
CNS depressant effects occurred.
Thursday can be used alone or as an adjunct to oral enter depressant therapy.
Importantly, there are no contra indications in our label.
In terms of safety the box warning space that says we may causes driving impairment.
And patients are advised not to drive or engage in other potentially hazardous activities until at least 12 hours after each dose.
Patients should also be advised that they may not be able to assess their own driving competence or the degree of impairment caused by Joseph Bank.
The label also describes the most common adverse reactions that occurred in at least 5% of patients who receive surgery bank and at a higher rate than placebo.
These were somnolence nasopharynx items.
<unk> fatigue, urinary tract infection and diarrhea.
And finally, while I'm personally disappointed that we will not be able to provide a new treatment option to patients living with mbd today as we had hoped.
I am also truly excited that we and Biogen will be offering the first oral rapid acting short course treatment for women with PPD.
I can tell you from my clinical experience that we have the potential to help a lot of women with this debilitating condition.
With that I'll turn it turn the call over to Chris Chris.
Thanks, Laura I am excited to be with all of you to share updates on our preparations for the planned commercial launch of <unk> as a treatment for adults with PGE.
Today is a day of celebration.
<unk> reaffirms our call to action and the urgency that exist to bring this critical new treatment for women suffering with PPD.
We know that PPD is all too prevalent in our society and the burden that it places on new mothers consumed and Surmountable.
With this in mind, we are incredibly excited about the opportunity to bring a novel treatment option to market that we believe brings us closer to transforming the care of women living.
Yes.
We have been preparing for a potential launch for many months by advancing permitted preapproval information exchange with Payors.
<unk> scientific exchange with healthcare providers and engagement with patient advocacy organizations.
Further we have built an internal team of experienced commercial leaders, whose depth and breadth of knowledge and experience further expand our go to market capability.
We believe our preparations will enable us to be fully ready to execute the launch of <unk> to treat women with PPD by year end.
A tremendous opportunity exists in PPD with estimates of approximately one in eight women experiencing TD symptoms in the U S. Each year.
About half a million women.
Today, we know that only about 50% in PPD cases are diagnosed due to inadequate screening.
Far too many women with PPD are not getting the care that they need because of the limited options available to them.
With the approval of <unk>, we believe we have the potential to be a first line therapy and become the standard of care.
Our planned launch focus will be on women diagnosed with PPD requiring treatment.
We believe the addressable patient population at launch includes those who are newly diagnosed and those experiencing unresolved symptoms. Despite taking ended depressant treatment.
We're not going to stop there with our efforts to help women with PPD.
We believe it will also be important to support efforts to increase diagnosis rates in PPD building. Upon the recent guidelines updated by the American College of Obstetricians, and Gynecologists, which recommend increased screening during the pre and post partum period.
While thinking about the unmet need in treating women with PPD, we alongside our collaboration partner Biogen expect to implement a focused launch strategy that can be scaled with success to reach more women with.
We plan to leverage our omnichannel capabilities powered by data and predictive analytics that we expect will enable us to efficiently reach a broad base of health care professionals, who treat them.
At launch we plan to have our focus field sales teams targeting high prescribing psychiatrists obgyn and PCP to treat women with PPD with a consistent frequency of promotional messages and resources.
Additionally, we plan to advance non personal promotion efforts with digital platforms designed to reach a broad set of hcp's treating these patients.
These digital platforms are intended to unite data from our content media and in person interaction.
It's also a vital that our omnichannel work directly reaches women with PPD at launch.
Our planned efforts are intended to directly engage these women with education and resources. So they are aware of <unk> as a treatment option in PPD and are prepared to have a meaningful discussion about zubair with their HCP.
Hcp's will be a central focus of this planned omnichannel approach.
Ultimately be directly responsible for making the decision to prescribe zumba and the treatment of women with PPD.
We believe early and positive clinical experience and accessibility for women with PPD will be critical to building confidence in accelerating adoption of <unk> in this indication.
HCP experienced has resumed and treating women with PPD will be instrumental to update.
We plan to have initiatives at launch and support of this.
First a full course of therapy sample program that will distribute a 14 day short course of therapy to appropriate hcp's to trials resume in the treatment of women with PPD.
We believe this targeted early experience program will be critical to enabling rapid clinical experience with <unk> that will ultimately drive long term uptick in this pve population.
The second planned initiative is intended to help enable our goal that every woman with <unk>.
Prescribes resume can access it regardless of their financial circumstances.
We plan to facilitate this effort through patient access programs that launch, including co pay assistance for eligible women with PPD, who are commercially insured.
We intend to discuss our planned commercial strategy these initiatives and other planned support for women with PPD closer to the time of March.
We're collaborating across the ecosystem with payers healthcare providers patient advocates and policymakers with the Goldman providing a model for care that works in the best interest of patients with PBC.
In every state there was a call to action to prioritize expanding and increasing access to treatment for maternal mental health.
There is a need for solutions to address the significant gaps in care.
As a new standard of care for women with PPD and a harbinger for change Zuma and could improve outcomes for these patients potentially lessen the overall burden and costs on society and more importantly support these mothers and their infants to help them thrive.
We believe that a combination of these efforts will help to build a positive experience with <unk>, both for women with PPD and <unk>, who treat them.
Finally, let's turn to market access.
While it's too early to talk about price here's how we're thinking about it.
We plan to implement a PC access strategy that recognizes the unmet need.
<unk> economic burden and the novel clinical profile of <unk>.
We will continue to work with payers with the goal of favorable access and identify ways, we might partner, including the potential role of value based agreements.
We've had numerous permitted engagements with payers in the months leading up to <unk>.
And payers recognize the significant unmet need for new treatment options in PPD.
Uzi asked it about the clinical profile of <unk> in this indication.
As we said our goal is that every woman with PPD was prescribes resume can access it regardless of financial circumstances.
As part of our final preparation stage and Biogen are currently working to determine adjustments to our thinking on price given the PPD label.
Plan to provide more clarity on our overall thinking closer to product launch.
While we can say now is that approximately 55% of U S. Births are covered by commercial insurance and our plan to patient access approach for women with PPD for commercially insured as the goal of enabling a vast majority of these women.
Access to <unk> with minimal cost.
The remaining berths receive coverage through Medicaid, which requires little or no financial responsibility for the patient.
We expect decisions by payers is that coverage is <unk> in the treatment for women with PPD to be made in the months following DEA scheduling.
We are prepared and eager to implement this launch strategy that we believe has the potential to maximize the impact of <unk>.
In the treatment of women with PPD by aligning with each of our stakeholders.
Through our planned commercialization efforts, we expect to rapidly reach both women with PPD and the agencies to treat them.
Finally, our goal is to enable a favorable access environments that women with PPD, who are prescribed so zubaie are able to get it both rapidly and accordingly.
We feel this urgency because women with PPD away.
I'll now turn it over to <unk> to provide a financial update.
Thanks, Chris and good morning, everyone.
To share my excitement for this new chapter of opportunity for women with PPD.
Energizer pushed forward and help so many of these women.
And as I noted earlier, we are reviewing the feedback from the FDA in CRM for Mbd and evaluating.
Given these recent developments I'd like to briefly comment on what this update is for our financial position.
We will continue to make smart disciplined decision as we work to balance cash on hand, and revenue generation with our operating expenses.
We believe we are well capitalized at $1 billion in cash as of June 30.
And based upon our current estimates, we expect that our cash cash equivalents and marketable securities along with anticipated funding some ongoing collaboration and potential revenue will support operations into 2025.
With that said given the update relating to the CRM and MPD, we are refining our strategy.
And to take action with the goal of extending our cash runway and are currently evaluating resource allocation, including pipeline prioritization and a workforce reorganization.
As a result, we also anticipate operating expenses to decrease in 2024.
As Barry said, we are working towards a successful launch in PPD and believe the changes we plan to make will enable us to be a stronger leaner and more focused company.
We expect to provide greater detail on next steps before the end of the third quarter as our plans unfold.
Before I turn the call over to Ashley for Q&A I want to reiterate our excitement around this monumental milestone per stage.
We look forward to the commercial availability of this new day later this year and we will act with urgency to help enable women with PPD, who are prescribed <unk> will have access to.
Let me also add that I know there are many questions out there given the CRM and digital.
As we always have we will provide updates when we can.
With that I'll turn the call over to Ashley.
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.
Thank you if you would like to ask a question. Please signal by pressing star one on your telephone keypad.
If youre using a speaker phone. Please make sure your mute function is turned off to allow your signal to reach our equipment. Please limit yourself to one question again. Please press star one to ask a question we'll pause.
For just a moment.
Yeah.
Okay.
We'll go first with <unk> Richter with Goldman Sachs.
Good morning, Thanks for taking my question and congratulations on the approval here in PPD.
Maybe just to start here with the launch you talked about the outreach effort with the prescribers could you just quantify the prescriber base for us and help us understand the targeted approach in.
And also how a sampling program for work in the context of you.
Ensuring youre not soaking up all of that initial demand. Thank you.
Yes solving thanks, and thanks for the congratulatory note, we're really excited about the approval of Zumba and the treatment of women for PPD and we're really looking forward to helping.
These women were excited about the opportunity and believe we have a strong business case, we cut with the right size organization and the right price. We got many tailwind that may help us in launching <unk> for the treatment of women.
Noted its a big unmet need about <unk> 5 million women in the U S experienced symptoms each year.
In fact in the first and only oral treatment approved for women with PPD and we believe health care providers are looking for a tool like this to solve the dilemma on what to do when they diagnose demand.
With PPD and we know that the.
Payers and I'll ask Chris to comment more about the sample program.
We're looking forward to a new option for PPD and certainly and then we mentioned in the script that every state and policies, they're implementing policies that we believe will enable access for women.
We can't talk about yet are targeting numbers per se, where the size of the sampling program, but maybe Chris can talk about the importance of full course treatment and.
Activating healthcare providers see the results in further on US yes. Thanks, Barry So so at launch we're going to focus on our field sales team as I said in my opening remarks on high prescribing obgyn psychiatrists and PCT and as you noted it's going to be really important for that group of physicians to have early experience with <unk> and what that.
It entails is giving them access to a 14 day full course therapy sample. So that they have that experience to see the impact that <unk> can have on women living with PPD in that practice.
Can I just follow up quickly just to get a sense of.
Line of vacation that.
Physician base that you're targeting initially and just help us understand the flexibility you have on pricing in PPD.
Yeah. So.
Right now.
We really can't talk about kind of the size of the physician base as youre, well aware, we and our collaborators Biogen.
<unk> been working wholeheartedly on preparing for our PPD. It Mbd launch had done a lot of work of of course, we are PPD scenarios that we've laid out but now the work begins for PPD.
<unk> as we are closer to launch we'll come back out with.
Specifics about how we are targeting as Chris said in his remarks, we're thinking big about the opportunity, but we have started a very focused way and have clear metrics to scale with success.
Terms of pricing as you know as I said, we think that with the right price and the right size organization. We have a very strong business case, and we are setting about to do that work now.
Thank you.
Thank you Jerry.
Mr. Richard Perle with TD Cowen.
Good morning, guys. Thanks for taking my question.
And I'd like to add.
Congratulations.
The Trump is available for patients.
Question.
I would like to focus a little bit on MTBE Barry.
No you can't talk too much about.
Okay.
The interactions and status.
Could you go through at least what happened during the review.
Any review issues that were discussed at the mid cycle review there now.
Our focus of unresolved questions and then.
What is your expectations of timing for a tightening reached clarity on well.
Yes again, thank you for the congratulatory note.
As you asked we will focus on <unk>. So just to be clear, we're extremely disappointed for patients with MTV.
Devastated that we're not able to help them.
Right now and actually we do not agree with the Fda's view.
On <unk> for Mbd Commensal crisis is having a devastating impact on our communities as you know and we are in desperate need of innovation. So if I back up.
In accordance with FDA last year filed our NDA package and we've started the rolling submission earlier in the year with some of the modules in the clinical section we had what we believe was six of seven.
Placebo controlled positive clinical studies to support that package, which we believe was supportive of both CBD and MBT <unk>.
Late in the review cycle about Fda's view on a proven ability for OLED.
And as we noted.
We received a zero late on Friday.
So.
The review of the NDA filing package involves analysis of the submitted information and we really can't speculate on the FDA is thinking of decision, making you can simply reflects in what they put in the CRO, which again, we got late Friday, So were reviewing the feedback and a value next steps. It we're excited to launch <unk>.
PPD as we work with our collaborators Biogen and understanding what our next steps with FTE on MD Dr.
Do you anticipate interaction even before a type a meeting.
I really can't say anything else through to accept that we advised and reviewing the feedback and evaluating next steps we got the right team on it.
Got it thank you.
Thank you.
Well go next to Paul Matisse with Stifel.
Hi, Thanks, so much.
I guess without being able to talk about the price, which are sort of my first question I wanted to ask a little bit about the label.
Because I think there are a few things on there that surprise investors, who might have read through on to the pipeline. One was commentary around abuse. Another was a commentary on our prior dog study, which seems like it might have been an impediment to chronic administration.
And then also restrictions around driving.
How are those surprising to you that they were on the label one and two did those put into question the profile of Sage three to four which is being given chronically and has the same mechanism of action. Thank you.
Hey, Paul. Thank you for the question, let me just start out and then I'll turn it to Lora to talk about the specifics. So we believe that both labeled as provided for for US for the treatment of PPD is defined label is the label that is as instructive is protective in a constructive for health care providers.
And their patient certainly a label that allows us to sell <unk> for the treatment of PPD for women.
We can move forward. So nothing in the label is surprising per se or problematic, but maybe Laura can talk more about that sure. Thanks for the question Paul.
I'll start first with your question related to driving that.
You see in the label there is a box warning for driving that instructs prescribers to counsel patients not to drive.
Or are engaged in other potentially hazardous activity until at least 12 hours after each dosages debate for the duration of the 14 day treatment course.
This recommendation was based on data that is included at the end of the label that summarizes the results of Q driving studies that stage conducted I.
I can summarize briefly the results from the 50 milligram dose because thats the most relevant since it's the clinical dose at.
At the 50 milligram dose.
These may cause driving impairment after one day of dosing and after seven days of dosing.
Which was the last time point measured.
The labor.
Very clear instructions for patients and from our perspective patient safety has to be top of mind and it's good that these clear instructions are in the label because it will enable physicians to have good discussions with their patients about the benefit risk profile of <unk>.
With regard to abuse liability.
This is <unk>.
Not unexpected for a drug with a mechanism of action like towards the bank.
<unk>.
As you can see from what's in the label there are results from abuse liability studies that show that does do they have at $30 60 milligrams has less abuse potential than the control, which was a benzodiazepine, but at the 90 milligram dose was approximately equivalent in at least potential to benzodiazepines.
Based on this we expect that they will be DEA scheduled likely scheduled for like similar drugs like benzodiazepines.
The prescribers, who will be prescribing medications for PPD are experienced in prescribing scheduled for agents and we don't expect this to be an impediment to us.
Yes, let me let me wrap back with your question about the rest of the pipeline are Gaba Pam. So as we stated we intend to complete the kinetic who study for phase III for at the end of the year.
Every new chemical entity has its unique entity and it's hard to understand if there are any read throughs in this labor. We're not typically labeling occurs on the basis of data for each and in each individual products. So that's what we can say right now.
Okay.
We'll go next to Yasmin Rahimi with Piper Sandler.
Good morning team and thank you so much for hosting the call and taking our question.
I know, there's a lot that you can tell us about MTBE, but could you maybe comment on.
What are some of the requirements that you would want to maybe not go through and keep them like you know if there is multiple additional studies required and thats something that you would want to do I guess, what we're trying to figure out is like your commitment to really moves us forward in getting this approved.
And then the second question for me is just sort of helping us understand how.
How many courses.
So they would be used in patients with PPD, whether you would recommend one or two wouldn't be could maybe help us understand on sort of the use of this product in all women with him when he and I will jump back into the queue. Thank you.
Yes. Thanks for the question, let me start with PPD and I'll circle back.
So what we saw in our clinical studies.
On the profile of Zumba was these women that took the hubei in the evening with a meal saw rapid response as early as three days.
Continued response at day, 15 that clinically relevant statistically different than placebo in that.
Effective this lasted out to day 45 with statistical significance to clinical road, so with that profile, we envision that a mom would take 114 day course in the course of the year because the trigger event was getting pregnant or having a net fee. So.
And getting this approved.
And then the second question for me, it's just sort of helping us understand.
How many courses are up to.
Our rate to rate would be used in patients with P. P. D. Whether you would recommend one or two wouldn't be kind of maybe help us understand on sort of the use of this product and out within within one year and I'll jump back into the queue. Thank you.
I guess, we get to the short answer is one now looping back to of the Sierra I'll repeat it we're extremely disappointed for patients and we don't agree with the Fda's view.
Yes. Thanks for the question look let me start with PPD and I'll circle back.
<unk> issued this year all related to NDA for <unk> treatment of adults with MTBE and look nice what I can say is what is the <unk>, which is the application did not provide substantial evidence of effectiveness to support the approval of <unk> treatment of MTV and then additional study or studies are needed.
So what we saw in our clinical studies.
Profiles zumba.
These women that took the hubei in the evening with a meal. So rapid response as early as three days.
Continued response at day 15 that clinically relevant.
We're reviewing the feedback of evaluating next steps and we really can't comment further.
Likely different than placebo in that.
Other than that.
This lasted out to day 45.
Okay. Thank you. Thank you. Thank you so much.
Significant clinical road, so with that profile, we envision that a mom would take 114 day course in the course of the year because the trigger event was getting pregnant or having having that big so I guess to get the short answer is one now looping back to this year I'll repeat it we're extremely disappointed for pace.
Yes.
Well go next to Ana Palm Rama with J P. Morgan.
Hey, guys. Thanks, so much for taking the question.
Congrats on the PPD approval here.
Barry.
Mentioned a couple of times.
Price in PPD, and maybe you could give us a little bit of color on the bookend kind of consider whether it's <unk> or other products and what are the key considerations to getting to that right price. Thanks. So much.
And so we don't agree with the Fda's view.
<unk> issued this year all related to NDA for <unk> for the treatment of adults with mbd in looks like what I can say is whats. The CIL says, which is the application did not provide substantial evidence of effectiveness to support the approvals around the treatment of MVD and then additional study or studies are needed.
Yes, no problem at all.
Start and ill turn it over to <unk>.
Chris and again, thank you very much for the congrats are so again, we're really excited to help.
Women suffering from PPD.
Viewing the feedback and evaluating next steps and we really can't comment further.
Just to be clear, we cant comment on price or bookends right now as I mentioned.
Other than that.
Okay. Thank you. Thank you. Thank you so much.
We did a significant amount of approved pre.
Thanks, Jeff.
Pre commercial payer introduction with a plan to launch <unk> in PPD, we had significant amount of conversations about what the value based agreements would look like.
Well go next to Ana Palm Rama with J P. Morgan.
Hey, guys. Thanks, so much for taking the question and congrats on the PPD approval here.
Frankly, we are preparing for PPD MVD launch with payers to move forward.
You've mentioned a couple of times.
Contracting we now have to go back given the <unk>.
Price in PPD, and maybe you could give us a little bit of color on the bookend kind of consider whether it's <unk> or other products and what are the key considerations to getting to that right price. Thanks. So much.
<unk> from Friday, and the fact that we got the serial Friday and re engaged payers, but we have some we have some basis to do that maybe you could talk more about that yes sure. Thanks.
Barry.
We've historically said that to be truly transformational we must be accessible zubaie. We're committed to the goal of rapid and equitable access to <unk> for the hundreds of thousands of women who live with PPD.
Yes, I'll start and I'll turn it over to <unk>.
Chris.
Then thank you very much for the congrats are though again, we're really excited to help.
Women suffering from PPD.
Just to be clear, we cant comment on price or bookends right now as I mentioned.
When we think about the approval is resuming in the treatment of women with PPD and the absence of an MTBE indications will need to consider the size of the patient population, obviously the strength of the clinical data, including statistical significance at all time points and the clinical potential zubaie to address significant unmet need for new innovative options in the treatment of.
We did a significant amount of approved pre.
Pre commercial payer introduction with a plan to launch and medium PPD, we had significant amount of conversations about what the value based agreements would look like.
Frankly, we are prepared for PPD NPD launch with payers to move forward.
Postpartum depression. These factors ultimately are what will influence our target wholesale acquisition cost however, regardless of the WAC. Our goal is that every woman as I said with PPD as prescribed resume can access it regardless of their financial circumstances.
In contracting we now have to go back given the the results from Friday, and the fact that we've got the serial Friday and re engage payers, but we have some we have some basis to do that maybe could you talk more about that yes sure. Thanks.
Thanks for taking our question.
Thanks Barry.
We've historically said to be truly transformational we must be accessible through zubaie. We're committed to the goal of rapid and equitable access to <unk> for the hundreds of thousands of women, who live with PPD. When we think about the approval is resuming in the treatment of women with PPD and the absence of an MDT indication will need to consider the size of the patient.
Thanks, Ed.
We'll go next to <unk> Ahmad with Bank of America.
Hi, Good morning, Thanks for taking my question I just wanted to clarify did FDA asking you to submit both applications for PPD and MVP at the same time, our Wednesday the preference was.
Operation, obviously, the strength of the clinical data, including statistical significance at all time points and the clinical potential of <unk> to address significant unmet need for new innovative options in the treatment of.
It seems a preference to do it together.
Also you mentioned that.
The comments from FDA about the concerns around MTBE didn't come until late in the review cycle.
Postpartum depression.
And ultimately what will influence our target wholesale acquisition cost however, regardless of the WAC. Our goal is that every woman as I said with PPD as prescribed to resume can access it regardless of our financial circumstances.
There have been any opportunities to have an.
An AD com when they brought up the concerns in order to be able to flush it out better. Thanks.
Yes.
Several different questions in there so if I go back here.
Thanks for taking my question.
Historically.
Thanks, Ed.
253 years, we did.
Well go next to convene Ahmad with Bank of America.
Sage announced that.
We're going to we're going to file the NDA for both PPD in MPD you might remember at some point it looked like our PPD study was delayed and at that point, we went out and said we're going to file <unk> and.
Hi, Good morning, Thanks for taking my question I just wanted to clarify did FDA asking you to submit both applications for PPD and MVP at the same time, our Wednesday the preference.
In PPD.
After that and then as the PPD study caught up we.
Was it seems a preference to do it together also you mentioned that.
We announced that we were going to start a rolling submission and then once both TBD.
<unk> all of that was done in concordance with FCA.
The comments from FDA about the concerns around M. D D didn't come until late in the review cycle.
In terms of what I can say about.
Would there have been any opportunity to have an.
The interactions.
As you noted we filed the NDA the FDA.
An AD com when they brought up the concerns in order to be able to flush it out better. Thanks.
In February we announced the FDA gave us a <unk> date.
Yes.
August 5th and priority review.
Several different questions in there so if I go back here.
And then about a month or so later the FDA told US there was no AD com required which at the time, obviously, we took as a positive sign.
Historically.
253 years, we did as Sage announced that.
And then just to add to that we found out late in the review cycle about the Fda's view on the approve ability of MDC.
We're going to we're going to file the NDA for both PPD MTB you might remember at some point it looked like our PPD study was delayed and at that point, we went out and said we're going to file <unk> and.
Other than that I can't say much more.
In PPD.
Okay.
After that and then as the PPD study caught up we announced that we were going to start a rolling submission and then once both TBD.
Okay.
We'll go next to Brian Abrahams with RBC capital markets.
At the end of the year all of that with southern Concordance with FDA.
Hi, Good morning, my congratulations as well on the on the approval in PPD.
In terms of what I can say about it.
Maybe a question on MDT.
The interactions.
See a potential for more narrow and refined indication like the treatment of acute depressive episode or adjunctive treatment.
As you noted we filed the NDA the FDA in February we announced the FDA gave us a <unk> date.
August 5th and priority review.
Something that was ever discussed with the agency or potentially on the table and if this is a possibility do you think additional studies would be required to support that or not thanks.
In about a month or so later the FDA told US there was no AD com required which at the time, obviously, we took as a positive sign.
Just to add to that we found out late in the review cycle about the Fda's view on the approve ability of MDC.
Brian . Thank you and thank you very much for a very insightful question I guess, we can say at this time as we were extremely disappointed for patients whether it's for the treatment of MTV or a different indication and we don't agree with the FDA for you we are evaluating with CRM.
Other than that I can't say much more.
Okay.
We'll go next to Brian Abrahams with RBC capital markets.
And as soon as we can provide more clarity we will what the next steps are we really do believe that surround alone.
Hi, Good morning, my congratulations as well on the on the approval in PPD.
B available to treat patients with Mg, but we've got to get there and so are there will be solely focused in marketing for <unk> to treat women with PPD.
A question on M D D D.
Do you see a potential for more.
More narrow and refined indication like the treatment of an acute depressive episode or adjunctive treatment is this something that was ever discussed with the agency or potentially on the table and if this is a possibility do you think additional studies would be required to support that or not.
Thanks.
Thank you.
We'll go next to Jay Olson with Oppenheimer.
Yes.
Oh, Hey, Thank you for taking the question and congrats on the PPD approval.
Brian . Thank you and thank you very much for a very insightful question I guess, we can say at this time, we were extremely disappointed for patients whether it's for the treatment of MPD or different indications and we don't agree with the FDA for you we are evaluating the CRM.
We have a financial question since you'll be eligible for 225 million dollar milestone from Biogen and Youll also experience potentially significant cost savings in the near term without an NPD launch are you in a financial position to accelerate the development of Sage 701, eight and two.
And as soon as we can provide more clarity we will on the next steps are we really do believe.
You plan to continue that development independently or potentially seek a partnership thank you.
Saran alone.
Should be available to treat patients with <unk>, but we've got to get there and so are there will be solely focused in marketing zubaie to treat women with PPD.
Yes, Jay first of all thanks for the congratulatory note can you talk about.
The milestone and some of our financial thinking but in terms of in terms of Sage 700 will continue to be really excited by.
Thanks.
Thank you.
Well go next to Jay Olson with Oppenheimer.
Developing stage simulate our wholly owned an NDA.
Yes.
Pam the data we've seen to date is as is exciting in terms of in terms of cognitive improvement that we saw in Huntington's, Parkinson's and Alzheimer's, albeit approach studies.
Oh, Hey, Thank you for taking the question and congrats on the PPD accrual.
We have a financial question.
You'll be eligible for 225 million dollar milestone from Biogen and Youll also experience potentially significant cost savings in the near term without them into the launch are you in a financial position to accelerate the development of stage 718.
<unk> open label studies.
As you are well aware, we have a significant number five well controlled studies underway right now several in Huntington's and then Parkinson's and Alzheimer's.
Do you plan to continue that development independently or potentially seek a partnership thank you.
Those should set us up for a very data rich year next year in terms of Sage 718, as we've commented before we believe that the Huntington's packages is set up in a way that if we see robust data and given that it's an orphan.
Yes, Jay first of all thanks for the congratulatory note I'll, let Kenny talk about.
The milestone and some of our financial thinking but in terms of in terms of seats. The Verizon continue to be really excited by.
Indication when we do believe there is some regulatory flexibility and we'll pursue that a flexible approach whether it accelerates or not is another question Thats a matter of clinic.
Development stage simulate our wholly owned an NDA.
Clinical studies enrolling and.
Pam.
The data we've seen to date is as exciting in terms of in terms of cognitive improvement that we saw in Huntington's, Parkinson's and Alzheimer's, albeit approach studies.
And.
How rapidly to enroll but we have said previously that we're excited as stage alone for launched Sage <unk> Huntington, given the orphan nature and the sort of smaller capital footprint.
Open label studies as you.
You're well aware, we have a significant number five well controlled studies underway right now several in Huntington's and then Parkinson's and Alzheimer's.
Knees, we're excited to do that Kenny can you talk about kind of milestones and other financial guidance sure.
Great question.
Just a reminder, earlier I talked about that based on our current estimate.
Should set us up for a very data rich year next year in terms of <unk> and as we've commented before we believe that the huntington's packages setup in a way that if we see robust data and given that it's an orphan <unk>.
We expect that the cash on hand.
As stated funding from collaborations and potential revenue will support our operations into 2025, and we also mentioned that we have the potential to earn a milestone payment of $75 million from Biogen related to the first commercial sale.
Indication, we do believe there is some regulatory flexibility and we'll pursue that a flexible approach whether it accelerates or not is another question thats a matter of clinical.
<unk> for the treatment of PPD.
But to be clear are based on the receipt of the CRM on Friday evening.
Clinical studies rolling in and.
And.
We are looking forward.
How rapidly to enroll but we have said previously that we're excited as stage alone to launch Sage 708, Huntington given the orphan nature and the sort of smaller capital footprint.
<unk> plans to refine our strategy and spend so that's going to really improve.
An evaluation of our resource allocation will be looking at the pipeline will be looking at a workforce reorganization and that all with the goal of extending our cash runway.
That means we're excited to do that can you talk about kind of milestones and other financial guidance sure Thats.
We expect our validation of our resource allocation will incorporate that feedback from the FDA that we have at that time and we.
Great question.
Just a reminder, earlier I talked about that based on our current estimate.
That will be able to update all of you by the debt and ended the third quarter.
We expect that the cash on hand.
<unk> certainly talked to you about the catalyst for enterprise and Jay just some additional color since you mentioned it.
It's finding from collaborations and potential revenue will support our operations into 2025, and we also mentioned that we have the potential to earn a milestone payment of $75 million from Biogen related to the first commercial sale.
As Chris said, we're thinking big about the opportunity to help models with PPD is 5 million women women, but it certainly starts with a very focused footprint in terms of commercialization Omnichannel and then we'll have markers that scale that was success, but we're certainly not going to over scale launch for PPD.
<unk> for the treatment of PPD.
But to be clear based on the receipt of the CRM on Friday evening.
We are looking forward.
<unk> plans to refine our strategy and spend so that's really include an evaluation of our resource allocation will be looking at the pipeline will be looking at a workforce reorganization and that all with the goal of extending our cash runway.
Great. Thank you very much.
Thanks Jay.
Well go next to Sam Kulkarni with Canaccord.
Good morning, Thanks for taking my question Hope collaborated with Biogen do you expect the Zoe launch to be and do you expect to announce pricing on PPD prior to interacting with the FDA on mbd or after.
We expect our validation of our resource allocation will incorporate the feedback from the FDA that we have at that point in time.
Can we expect that we'll be able to.
To update all of you and ended the third quarter.
<unk>. Thank you. Thank you for those questions. So in terms of Biogen, we <unk> been working extraordinarily collaboratively prepay.
We'll certainly talk to you what's the catalyst for enterprise and Jay just.
Some additional color since you mentioned it.
As Chris said, we're thinking big about the opportunity to help mountain TBD is 5 million women women, but it certainly starts with a very focused footprint in terms of commercialization Omnichannel and then we'll have markers that scale that was success, but we're certainly not going to over scale launch for PPD.
Preparing for the potential of our <unk> launch if approved.
We and they got.
<unk> on the approval for PPD Friday night, and zero for Friday Night, and then as you saw we together issued a joint press release.
A couple of hours later.
Now seem that we plan to launch Thursday for PPD and have that launch available in the fourth quarter of this year and shortly after the DEA scheduling, which we fixed it.
Great. Thank you very much.
Thanks Jay.
We'll go next to Sam Kulkarni with Canaccord.
Good morning, Thanks for taking my question Hope collaborated with Biogen do you expect the Zubair launch to be and do you expect to announce the pricing on PPD prior to interacting with the FDA on <unk>.
Approximately 90 days, so that was a joint collaborative press release.
Now with the approval of PPD in front of US in this year I'll now turn our attention to working towards the appropriate launch of PPD in response to zero and we plan on doing that as I sit together.
<unk>. Thank you. Thank you for those questions. So in terms of Biogen, we <unk> been working extraordinarily collaboratively.
In terms of in terms of price timing.
As we get closer to launch we will be talking about.
Preparing for the potential of our <unk> launch if approved.
Our access strategy as well as some of the other aspects of our commercialization, but that'll be closer to launch.
We and they got.
Label and the approval for PPD Friday night, and the cereal for Friday Night, and then as you saw we together issued a joint press release.
Thank you.
Thanks, Bob.
Well go next to Laura Chico with Wedbush Securities.
A couple of hours later.
<unk> that we plan to launch Thursday for PPD and have that launched available in the fourth quarter of this year and shortly.
Good morning, Thanks, very much for taking my question I guess, just kind of following up on that I don't know if theres any additional color you can provide on kind of the remainder of 'twenty three in terms of the acceleration on SG&A in terms of PPD launch preparation and I guess I'm trying to understand kind of the allocation of resources also between <unk> and Biogen and I.
Shortly after the DEA scheduling, which we fixed.
Fixed approximately 90 days, so that was a joint collaborative press release.
Now with the approval of PPD in front of US in this year I'll now turn our attention to working towards the appropriate launch of PPD in response to zero and we plan on doing that as I said together.
I'm just trying to understand more broadly you Barry you had some good comments with respect to how the two partners have interacted over the weekend here, but what is biogen's commitment to our PPD launch that would just seem a little bit.
In terms of in terms of price timing.
As we get closer to launch we will be talking about.
Different than MVD was involved not sure if you can add any color there. Thank you.
Our access strategy as well as some of the other aspects of our commercialization, but that'll be closer to launch.
Yes, Laura Thanks for thanks for all those questions in one question. So I guess, what I can say is that.
Thank you.
Thanks, a lot.
Well go next to Laura Chico with Wedbush Securities.
Yes.
I can point to the joint press release, where we advising.
Good morning, Thanks, very much for taking my question I guess, just kind of following up on that I don't know if theres any additional color you can provide on kind of the remainder of 'twenty three in terms of the acceleration on SG&A in terms of PPD launch preparation and I guess I'm trying to understand kind of the allocation of resources also between you and Biogen.
Committed that we'd have reserves or do they available for PPD.
In the fourth quarter shortly after D. A.
Scheduling I can't really talk more about the allocation resource, yes, as I said, we worked really hard and prepare for potential of an <unk> launch if approved and had that clearly well Matt.
I guess I'm just trying to understand more broadly you Barry you had some good comments with respect to how the two partners have interacted over the weekend here, but what is biogen's commitment to our PPD launched that would just seem a little bit.
With the news on Friday, the approval of PPD. The CIL for MTV, We're now turning our attention to do the work necessary for the launch of PPD looks like and.
As we get closer to launch we can talk more about.
What that looks like in terms of SG&A or other bills can be said, we anticipate looking.
The difference then MVD within Bob I'm not sure. If you can add any color there. Thank you.
Yes, Laura thanks for that.
Looking at all resources as well as our workforce and as.
After all of those questions in one question. So I guess, what I can say is that.
I've commented earlier, we do believe that even in PPD with the right price and the right size organization and we've got a really strong business.
Look I can point to the joint press release, where we advising.
Committed that we'd have the reserves or do they available for PPD.
Yeah.
In the fourth quarter shortly after D. A.
Scheduling I can't really talk more about the allocation resource, yes, as I said, we worked really hard and prepare for a potential of an <unk> launch if approved had that clearly well map.
Yeah.
Well go to our next caller.
Amy.
Needham <unk> company.
Hi, Good morning, then recently on for Amit Thanks for taking our question.
With the news on Friday, the approval PPD the CIL for MTV, we're now turning our attention to do the work necessary for the launch of PPD looks like and as.
Maybe just kind of on regarding kind of Biogen again.
As we get closer to launch we can talk more about.
Just I think just kind of the recent comment Todd.
What that looks like in terms of SG&A or other bill as Kimi said, we anticipate looking.
The acquisitions that you announced suggests.
I think it has created kind of a perception by some that maybe there could be less committed to MTBE.
Looking at all resources as well as our workforce and as I've commented earlier, we do believe that even in PPD with the right price and the right size organization, we've got a really strong business.
I kind of hear you on the.
The joint press release and stuff, but maybe like how much I mean can you give us a sense just like how much commitment do you think.
Barging is on surround alone in MTBE and then.
With regards to a potential resubmission not occurred and kind of.
Well go to our next caller.
The effort that would be required for that like I mean, what role.
Amy Satya Needham <unk> company.
You anticipate biogen kind of playing in that center.
Hi, good morning.
Yes. So again, thank you for the question I really can't say anything more than we've already said.
Currently on for Amit Thanks for taking our question.
Maybe maybe just kind of on.
We're preparing for the launch of <unk> in PPD and examining.
Kind of Biogen again.
Just I think I think just kind of the recent comment Scott.
The Crs for reviewing the feedback and are evaluating next steps I can't really comment more than that.
And the acquisitions that you announced suggests.
I think it has created kind of a perception by some that maybe there could be less committed to MTBE.
I kind of hear you on the.
The joint press release and stuff, but maybe like how much I mean can you give us a sense just like how much commitment do you think.
We'll go next to Vic or Peru.
Rohit with Morgan Stanley .
Arjun.
<unk> Serrano alone in MTBE and then.
Hi, This is Steve.
My question and congrats on a protocol that's a quick question about the PPD.
With regards to a potential resubmission that occurred in and kind of.
The effort that would be required for that like I mean, what role.
Maybe steve across from that to be for the roof and how long do you think you can.
Do you anticipate biogen kind of playing in that center.
Cathay here. Thank you.
Yes. So again, thank you for the question I really can't say anything more than we've already said.
Yes.
Since we.
Already talked about.
Idea that we're going to turn our attention to work on whack.
We're preparing for the launch of Zumba in PPD and examining.
And launch it's too early to talk about gross to net.
The Crs for reviewing the feedback and evaluating next steps I can't really comment more than that.
Thank you.
We'll go next to Marc Goodman with Leerink.
Yes, good morning.
My question is around <unk> and <unk>.
We'll go next to Vic or Pearl heat with Morgan Stanley .
And guidance from FDA, they talk about <unk>.
Hi, This is Steve.
Drug placebo controlled studies that have to show duration of effect.
My question and congrats on a protocol that's quick question about the PPD.
And you clearly had that in one of your studies, but it's not clear that you had that in a second study and I was curious since that was the reason.
Gross to net to be for the roof.
How long do you think you can.
Thank you.
The FDA has to approve.
Yes.
Approved.
Since we are.
<unk> and if that is the case or whatever the Kingston are you.
I already talked about the <unk>.
Idea that we're going to turn our attention to work on whack.
And your partner have committed to doing another study in order to do whatever the FDA needs to.
<unk> launched its too early to talk about gross to net.
Got it thanks.
Thank you.
Thanks for the question market as I said, we're extremely disappointed for patients with a zero and we don't agree with the Fda's views. So that's going to say right. Now we're all we can say is what.
We'll go next to Marc Goodman with Leerink.
Yes, good morning my.
My question is around <unk> and <unk>.
What we did which in concordance with FCA, we filed our NDA last year with what we believed was 6% to seven positive studies met their edge points of work with both studies that was our belief that when we filed the NDA of course.
Yes.
Guidance from FDA they talk about.
Drug placebo controlled studies that have to show duration of effect.
And you clearly had that in one of your studies, but it's not clear that you had that in a second study and I'm. Just curious if that was the reason that the FDA 2000.
And we cannot just say what's this year all stages of already said, which is that the application last substantial evidence of effectiveness in the additional study or studies required. So we intend on evaluating sterile and pursuing next steps at Biogen.
Approved.
And if that is the case or whatever the Kingston are you and your partner has committed to doing another study in order to do whatever the FDA needs to.
But but but if you need to do another study, which the FDA, saying are you were going to do another study will do whatever it takes to get MPD or it's not clear yet.
To get anything thanks.
So Mark let me, let me just repeat.
Thanks for the question market as I said, we are extremely disappointed for patients with a zero or we don't agree with the fda's views. So that's going to say right. Now we're all we can say is what.
Disappointed for patients that we don't agree with the FDA, we're evaluating with feedback and reviewing next steps.
Okay.
What we did which in accordance with FDA, we filed our NDA last year with what we believe was 6% to seven positive studies that met their edge points of World control study that was our belief that when we filed the NDA of course.
We'll go next to <unk> <unk> with Jefferies.
Hey, Thanks for taking my question and congrats on the PPD approval.
I guess in your collaboration agreement had mentioned that Biogen could terminate the contract on a product by product basis by giving 150 days and advanced written notice is there any development juncture, where biogen wouldn't be able to terminate the agreement, let's say for the ran alone and have you received any notice from Biogen at this point I just wanted to confirm thank you.
And we cannot just say what is the sheer all stages of already said, which is that the application last substantial evidence of effectiveness in the additional study or studies required. So we intend on evaluating material and pursuing next steps at Biogen.
But but but if you need to do another study, which the FDA, saying are you were going to do another study will do whatever it takes to get MPD or doctors that clear yet.
Yes, so I guess, what I can say is there are termination provisions in the agreement.
So Mark let me, let me just repeat.
I'd also say that after receiving the PPD approval and the CRM. We jointly work due to the press release that you saw committed to launch <unk> in the fourth quarter for PPD. Shortly after the DEA scheduling so I'll leave it at that.
Disappointed for patients that we don't agree with the FDA, we're evaluating the feedback and reviewing next steps.
Okay.
Well go next to <unk> <unk> with Jefferies.
Hey, Thanks for taking my question and congrats on the PPD approval.
We'll go next to Tim Lugo with William Blair.
I guess in your collaboration agreement as mentioned that Biogen could terminate the contract on a product by product basis by giving 150 days and advanced written notice is there any development juncture, where biogen wouldn't be able to terminate the agreement, let's say for the ran alone and have you received any notice from Biogen at this point I just wanted to confirm thank you.
Alright. Thanks for the question can you walk us through the scheduling process over the next few months. It seems like most of your viewing as a formality. However.
Had rises in terms of addiction and abuse in recent years and sometimes classify their students can get wrapped up into a single product discussion. So.
Just help us frame.
The risks around that process.
Yes, so I guess, what I can say is there are termination provisions in the agreement.
Yeah. Thanks, Thanks for the question Tim So.
I'd also say that after receiving the PPD approval and the CRA. All we jointly work issued a press release that you saw committed to launch <unk> in the fourth quarter for PPD. Shortly after the DEA scheduling so I'll leave it at that.
The FDA refers to as the way to the DEA for scheduled review.
We anticipate that to occur within 90 days.
As you heard Laura say, we expect to have a class for label, which is not an issue for for.
For prescribers or for for patients.
We'll go next to Tim Lugo with William Blair.
Great. Thank you.
Thanks, Tim.
Alright. Thanks for the question can you walk us through the scheduling process in the next few months. It seems like most are viewing as a formality. However.
Well go next to George Farmer with Scotiabank.
Hi, Thanks for taking my question.
Two things if I may real quickly how long do you think that the sampling program will last.
Had rises in terms of addiction and abuse in recent years and sometimes classify their students can get wrapped up in the single product discussion so.
As we think about.
Modeling.
Drug penetration in the market and also.
Just help us frame.
Frame the risk around that process.
Can you speak to your comfort level of risk to feeding new newborns and.
Yeah. Thanks, Thanks for the question Tim So.
You've done any particular studies to address that.
The FDA refers to Hubei the DEA for scheduled review.
Yes, thanks for the question Jordan.
I'm glad for some new questions and thank you. So let me start a little bit and then I'll ask Chris.
We anticipate that to occur within 90 days and as you heard Laura say, we expect to have a class for label, which is not an issue for up for.
Chris talked about sampling and then Loren talked about the press release, So if you take a step back.
We believe that that health care provider experience with <unk> in their own hands seeing the profound and rapid effects that we saw in clinical trials that really has the potential to have an models with PPD is critical to strategy.
Fibers or for for patients.
Great. Thank you.
Thanks, Tim.
Well go next to George Farmer with Scotiabank.
Hi, Thanks for taking my question.
Two things if I may real quickly how long do you think that the sampling program will last.
Physician or health care provider activation and.
And Thats will use Assembly program, if Chris can you talk about.
As we think about.
Modeling.
<unk> as a color on.
Drug penetration in the market and also.
On Houston, and then we can turn it over to Laura or.
Can you speak to your comfort level of risk to feeding new newborns and if you've done any particular studies to address that.
Breastfeeding, yes, so some very what I can say is that <unk>.
As in my prepared remarks, we see this as an early experience program that really focuses on giving physicians that experience in and around the time of launch once we have DEA scheduling.
Yes, thanks for the question Jordan.
I'm glad for some new questions and thank you. So let me start a little bit and then I'll ask Chris.
A window of opportunity for physicians to use that the actual duration more later as we talk about our actual go to market strategy and the details of commercialization, but it is a finite window that we see that in and around the time of launch.
Chris talked about sampling and then Loren talked about the press release, So if you take a step back.
We believe that that health care provider experience Linzer zoo, they in their own hands seeing the profound and rapid effects that we saw in clinical trials that really has the potential to have an models with PPD is critical to strategy.
And what I can add is we're not talking about all the markers, but it's likely in our quarterly calls.
After the launch of Zumba for PPD will providing some color on how many samples are out there and how thats going.
Physician or health care provider activation and.
And Thats will use the sampling program Kristy to talk about.
Lori you want to talk about the press release sure sure you raised an important question George given that this is going to be used in a population that specificity.
<unk> clusters with color on.
Unused in and then we can turn it over to Laura or.
Stay tuned done a clinical last patient study and the results of that study showed that the very low levels of surgery. They are present in human milk in fact, the calculated maximum relative to incentives versus today, it's less than 1%.
Breastfeeding, yes, so some very what I can say is that.
As in my prepared remarks, we see this as an early experience program that really focuses on giving physicians that experience in and around the time of launch once we have DEA scheduling.
Finite window of opportunity for physicians to use that the actual duration more later as we talk about our actual go to market strategy and the details of commercialization, but it is.
So what it says in the label then is.
That a physician and patient shall consider the development on health benefits of breastfeeding weighed with the potential exposure to Sears ebay in the breast milk.
My night window that we see that in and around the time of launch.
And what I can add is we're not talking about all the markers, but it's likely in our quarterly calls.
It's really important that we have this data in the label. It differentiate this label from other drugs that are used off label to treat MTBE, where this data is either absent or the levels present in breast milk are much higher.
After the launch of Zumba for PPD will providing some color on how many samples are out there and how that's going.
Lori you want to talk about breastfeeding sure sure you raised an important question George given that this is going to be used in a population that's fascinating.
Great. Thanks very much.
Thanks George.
States have done a clinical lab patient study and the results of that study showed that the very low levels and certainly they are present in human milk in fact, the calculated maximum relative to incentives.
We'll go next to me here with Mizuho.
Guys. Thanks for taking my question I have two quick ones. If that's okay. So the first one.
Do you think it's easier mountain would only PPD indications.
It's less than 1%.
So what it says in the label then is that a physician and patient should consider the development on health benefits of breastfeeding weighed with the potential exposure to Sears ebay in Nebraska milk.
For you to obtain value base and second one.
Could you just sort of remind us.
And the collaboration with Biogen.
Are there any fees if you came from.
The collaboration is terminated.
It's really important that we have this data in the label it differentiates <unk> from other drugs that are used off label to treat MBE, where this data is either absent or the levels president in breast milk are much higher.
And the payments in either directions, you have to pay biogen or by going to have to pay you. Thank you.
Yes, let me start with <unk>. So there is a certainly our termination provisions in the contract that's about as far as I can go on that one and then again very insightful.
Great. Thanks very much.
Thanks George.
Okay.
We have as I mentioned, we have many tailwind for our PPD focused launch.
We'll go next to me here with Mizuho.
Hey, guys. Thanks for taking my question I've two quick ones. If that's okay. So the first one.
It is a large unmet need with about a half a million women in the U S experienced symptoms each you're only about half of whom are diagnosed per year, so real estate opportunity on improving diagnosis.
Do you think it's easier mountain would only PPD indications.
This will be the first and only oral treatment approved for women with PPD. So that's a big advantage and then talking to health care providers, who prescribe.
Pleased to obtain value base and second one.
Could you just sort of remind us.
The collaboration with Biogen.
They are anxious to have.
Are there any fees if you came from.
Our product license over the issue they have today.
They can't get access to Zelle Russell is that.
The collaboration is terminated.
On the payments in either directions, you have to pay Biogen of Biogen have to pay you. Thank you.
The products they use take weeks to work.
If at all and as we know many patients cycle through many different drugs and these drugs are used today, often come with comorbidities weight gain sexual dysfunction Gi impact so at a prescriber level, let's say an obgyn level.
Yes, let me start with <unk>. So there are certainly there are termination provisions in the contract Thats about as far as I can go on that one and then and then again very insightful.
We have as I mentioned, we have many tailwind for our PPD focused launch.
The course attributes, which doesn't fit into how they're dealing with mom and baby, whereas we do that it could be the solution.
It's a large unmet need was about a half a million women in the U S experienced symptoms each you're only about half of whom are diagnosed per year, so a real big opportunity on improving diagnosis.
To that problem and certainly payers have been have been historically supportive.
Of this indication and then as we mentioned maternal mental health is on everybody's mind, it's been on TV. Almost every night. It's at every state level for policies and we have now the first world treatment that could be a solution set at least in PPD for material mental health and the policies that are happening.
This will be the first and only oral treatment approved for women with PPD. So that's a big advantage and then talking to health care providers have prescribed.
They are anxious to have.
Our product license over the issue they have today.
I can't get access to Zelle Russell is that.
The products they use take weeks to work.
At one level.
If at all and as we know many patients cycle through many different drugs and these drugs are used today, often come with with comorbidities weight gain sexual dysfunction Gi impact so at a prescriber level, let's say an obgyn level.
Thank you.
We'll go next to yet.
Asia with Guggenheim.
Hey, guys.
Thank you for taking my questions.
My congrats on the on the pool. So just two questions. One clarification and then one follow up so does that to be sampling comment. It is our understanding that the controls and has limitations from a Sam perspective could you quantify that would you be able to sample it and also just.
The course attributed it doesn't fit into how they're dealing with mom and baby, whereas there is do they could be the solution.
To that problem and certainly payers have been have been historically supportive.
Of this indication as we mentioned maternal mental health is on everybody's mind.
It's been on TV almost every night, it's at every state level for policies and we have now the first world treatment that could be a solution set at least in PPD for material mental health and the policies that are happening at the state wide level.
Just that.
Then with regard.
Onto the commercial build I understand.
You provide us more detail when should launch, but let's say if you've got a pool for MTBE and that requires 100 sales reps.
Just trying to understand the commercial build around PPD is it 'twenty sales dropped 30 sales reps with 20% just just some.
Thank you.
So ballpark just trying to gauge what the.
We'll go next to yet.
Nature with Guggenheim.
The spend will be also has a bit more of it. Thank you.
Hey, guys.
Yeah, Let me, let me quickly answer both questions.
Thank you for taking my questions.
My congrats on the on the pool. So just two questions. One clarification and then one follow up so does that to be sampling comment. It is our understanding that the controls and has limitation from a Sam perspective could you quantify that would you be able to sample and also yes just that.
Yeah. So.
What we said about the commercial build is that were thinking big with starting with a very focused way clearly is much more focused in Tvs.
MPD will you really can't provide numbers. We also you also heard from from kidney that we're prioritizing our pipeline and kind of a win will resize the organization appropriate for this opportunity in the pipeline in front of us So we'll communicate that.
Then with regard to the commercial build I understand.
You provide us more detail when should launch, but let's say if you've got a pool for MTBE and that requires 100 sales reps.
In the next month or so in terms of sampling there are certain limitations on control states, where they can use natural sample or a voucher, but we don't see that being a limitation to the concept on the sampling program.
Just trying to understand the commercial build around PPD is it 20 sales reps.
So 20% of that just just some.
So ballpark just trying to gauge what the spend will be also has been modeling. Thank you.
Okay.
This does conclude the question and answer portion of today's call I would like to turn the presentation back over to Barry Greene.
Yes, So let me let me let me quickly answer both questions are getting on top of the hour. So.
What we said about the commercial build is that were thinking big that starting with a very focused way clearly much more focused in Tvs.
Thank you Ruth and thanks again to everyone for joining US today. This is a special day for Sage Biogen and all the women with PPD, who stand to benefit from Zumba Wii.
But we really can't provide numbers. We also you also heard from kidney that we're prioritizing our pipeline and kind of a win will resize the organization appropriate for this opportunity in the pipeline in front of us So we'll communicate that.
We appreciate the continued support of all stakeholders and we look forward to providing more updates in the coming months.
Thanks, again, everyone and have a great day.
Goodbye.
In the next month or so in terms of sampling there are certain limitations on control states, where they can use natural sample or a voucher, but we don't see that being a limitation to the concept on sample program.
This does conclude today's call you may now disconnect.
Okay.
This does conclude the question and answer portion of today's call I would like to turn the presentation back over to Barry Greene.
Thank you Ruth and thanks again to everyone for joining us today.
Actual data for Sage Biogen and all the women with PPD, who stand to benefit from <unk>.
We appreciate the continued support of all stakeholders and we look forward to providing more updates in the coming months.
Thanks, again, everyone and have a great day.
Goodbye.
This does conclude today's call you may now disconnect.
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