Q4 2022 SAGE Therapeutics Inc Earnings Call
Please standby we're about to begin.
Good morning, welcome to Sage Therapeutics fourth quarter, and full year 2022 financial results Conference call.
Currently all participants are in a listen only mode.
This call is being webcast live on the investors and media section of sages website at say direct dotcom.
This call is the property of Sage Therapeutics and recordings reproduction or transmission of this call without the express written consent of Sage Therapeutics is strictly prohibited. Please note that this call is being recorded I would now like to introduce how and Rubens ninth director of Investor Relations at Sage.
Good morning, and thank you for joining Sage therapeutics fourth quarter and full year 2022 financial results conference call before we begin I encourage everyone to go to the investors and media section of our website at <unk> Dot Com, where you can find the press release.
Related to today's call as well as the 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 review the risk factors discussed in today's press release and in our SEC filings for additional details.
We will begin the call with prepared remarks by Barry Greene, Our Chief Executive Officer, who will provide an overview of our progress during the fourth quarter and full year 2022.
We will also be joined by Jim Doherty, Our Chief Development Officer, who will review recent progress and development activities across our programs, our Chief business Officer, Chris <unk>, who will provide an update on our launch preparations for us around alone in MTBE in PPD if approved.
We will then be joined by Canadian Gucci, Our Chief Financial Officer, who will review the financial results from the fourth quarter and full year 2022.
Laura <unk>, our Chief Medical 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.
Thanks, Alan and thank you everyone for joining us this morning.
At Sage, we are advancing potential treatments for brain by challenging convention and prioritizing what matters most to patients.
And today, our work matters more than ever.
We reached the public health crisis tipping point.
Brain health disorders are one of the leading causes of disability and threatened impact future generations.
See profound implications firsthand his friends and loved ones and neighbors continued to struggle.
Yes over the last half century.
We have been insufficient advances in the treatment of mood cognition and other disorders of the brain.
People deserve better and were determined to change the trajectory of this crisis.
This is an incredibly exciting time stage, we're progressing the promising and targeted bringing our pipeline with the potential to impact millions of people globally.
The pipeline as a result of our innovative approach to drug discovery and development.
It starts with our novel work on the Gaba and NMDA receptor systems.
These pathways are important regulators of brain function.
And the key to unlocking potential breakthroughs that may improve brain health.
Importantly, we believe our team and our strong financial Foundation.
Puts us in a position to further our pipeline ambitions with a goal of being able to launch new drugs or indications for years to come.
The time is now to unleash the potential of our science and make a meaningful impact on the lives of millions.
Moving to the next slide we're making progress across our pipeline as demonstrated by the latest regulatory milestone for <unk> alone.
Which we're developing in collaboration with Biogen.
As we recently announced we are encouraged by the FDA acceptance of our NDA filing for <unk> alone with priority review and major depressive disorder, and postpartum depression with a <unk> action date of August of this year.
If approved we expect the potential launch near the end of 2023, assuming no extension of the FDA review period.
With that timing in mind, we remain laser focused on preparing for the potential commercialization of <unk>.
Which Chris will walk through in more detail.
Our commitment to be an innovative is helping to enable access to treatment as we're developing our medicines will be a key aspect of our overall commercialization strategy.
To achieve that we're collaborating across the ecosystem with payers healthcare providers patient advocates and policymakers with a goal of providing a model for care that works in the best interest of patients with Mds and PPD.
We look forward to providing updates as appropriate I would like to note. Since we now are in an FDA review period, we will not be making comments on the potential label FTE interactions or related topics.
In addition to surround alone we have a robust pipeline of investigational programs.
The potential to help patients at all stages of their lifespan with nine clinical studies ongoing.
These include Sage 718, our first in class NMDA, Pam, which are currently advancing in for placebo controlled studies.
<unk> study across Huntington's, Parkinson's and Alzheimer's disease.
We're also making important progress in our neurology franchise led by Sage <unk> four which.
Which is being evaluated as a potential treatment for people suffering from a central tremor and other neurological disorders.
I'd also like to highlight some of our earlier stage programs, including Sage 319, and Sage 689.
These are great examples of our product engine that we believe will continue to deliver robust product candidates and have the potential for long term value creation.
To close I am confident 2023 will be a pivotal year for sage.
Particularly as we look forward to the potential approval of is around alone and the advancement of our brain health pipeline.
That I will turn the call over to Jim for a more detailed discussion of our recent portfolio progress and current clinical expectations Jim.
Thanks, Barry and good morning, everyone.
We've made important progress across our development pipeline throughout 2022, and I am pleased to detail our recent advancements.
Starting with depression, we're excited about the recent FDA acceptance of our NDA filing for us around loan and MDT in PPD with priority review as Barry mentioned earlier.
Our NDA package is supported by seven positive trials across the landscape at Nash clinical development program, which encompasses data from more than 3500 patients.
Importantly, we've seen a consistent clinical profile to date across the development program and MDT and PPD, including.
A rapid and sustained reduction in depressive symptoms as early as two or three days.
A generally well tolerated safety profile.
Improvements in quality of life and overall health across domains are feeling functioning and wellbeing, which I'll talk more about shortly.
And a short treatment course with the potential to be taken as needed with a novel mechanism of action and.
And finally, the potential for a flexible treatment approach in MTBE in PPD that may provide optionality to health care providers and patients if <unk> is approved.
And I'll note the potential for flexibility, we see what's around loan is exactly what hep's had been asking for to help their patients.
Let me expand on the well being and functioning data I referenced we touched on this during our jpn presentation, but it's important to highlight in the context of the recent acceptance for filing of our NDA. As these data suggest the potential for surround loan to improved measures of functioning and wellbeing that are important for patients with depression.
What you'll see here is an integrated analysis from completed placebo controlled trials across <unk> and PPD studies.
Selling that those treated with <unk> reported rapid and sustained improvements in health related quality of life compared to placebo as measured using SF 36 scores. These.
These results were consistent at the day 15, and the days 42 endpoints.
To summarize these data are an important indicator as it relates to quality of life and overall health.
Depression effects, a person's ability to feel and function.
<unk>.
Blunt sensations of pleasure closes off connectedness and stifles creativity.
It's important to note that patients don't want to feel less depressed they want to feel well and get back to their normal everyday lives.
So I don't know if approved has the potential to help patients achieve that.
We see the opportunity for people to feel well and we know thats what matters most to patients.
We also conducted interviews as a part of the open label shoreline study with over 30 patients who responded to 50 milligrams is around them and we're in the study for at least six months.
These interviews illustrated that a substantial majority of surveyed responders noticed improvements in their mental and physical symptoms and the first week and we're satisfied by it.
In addition, a majority of surveyed responders reported feeling fine positive or neutral about the need to be retreated and all were satisfied was around loan as a treatment.
This feedback reinforces the potential positive experience is around loan could provide for patients with Mds and PPD if approved.
I'll now move to Sage 700, our lead NMDA receptor Pam.
Is an investigational oral therapy being developed for certain disorders, where impairment of cognition is one of the main drivers of disability.
This is one of our wholly owned programs and was granted fast track designation by the FDA as a potential treatment for cognitive impairment and huntington's disease or HD.
We are also investigating sage 718 people with mild cognitive impairment due to Parkinson's disease, or PD and people with mild cognitive impairment and mild dementia due to all timers disease or <unk>.
These disorders represent some of the greatest areas of unmet need and we know that globally. They continue to become more prevalent and significantly disrupt lives.
On that basis, we're excited about the continued progress we've made across the program.
As we mentioned earlier this year, we recently initiated the Lightwave study a phase II study of Sage 708, and people with mild cognitive impairment and mild dementia due to all timers disease as well as the purview study the phase III extension study in people with Huntington's disease.
We expect data from the ongoing studies with Sage 708 to start reading out in 2024, and we will share more detailed timelines when appropriate.
We're also advancing a robust portfolio that has the potential to help patients at all stages of their life span.
Let me provide a couple of highlights starting with stage through Q4, and investigational positive allosteric modulator of Gaba a receptors.
We believe that phase III Q4 holds significant potential in the treatment of neurological conditions like essential tremor or ETE.
And we and our collaborator Biogen anticipate completion of enrollment in the ongoing phase <unk> kinetic two dose ranging study.
<unk> this year.
We're also excited about the opportunities in our early development programs, including Sage 319, or extra septic, preferring Gaba Pam, which we are advancing from IND, enabling studies into phase one studies.
We also continue to make progress with Sage 689, and Sage for 'twenty, one and believe that they will become important pipeline contributors over the coming years.
In closing I'm proud of our progress in the fourth quarter and full year 2022, and I believe that we are well positioned to execute against clinical objectives and advance our efforts to develop brain health medicines with the potential to deliver what matters most to patients.
Now I'll turn the call over to Chris to provide additional context on our planned approach as we prepare for the potential commercialization of surround alone and Mgd in PPD.
Yes.
Thanks, Jim I am pleased to be with you. All this morning to share updates on our commercialization preparations for <unk> alone.
To ensure the successful launches around alone if approved we made important progress last year on the commercialization front.
Core activities that have enabled our state of readiness include advancing conversations with Payors as permitted with the goal of enabling access at launch.
Engaging and educating hcp's through meaningful scientific exchange.
And hiring experienced commercial leaders to orchestrate plans intended to achieve a successful launch in saran alone if approved.
With the recent announcement of the acceptance of our NDA filings, we remain laser focused on preparations to execute our launch strategy.
Let me outline our thinking on the potential timelines for <unk>.
Based on our Paducah action date of August <unk>.
<unk> improved for the treatment of <unk> and PPD without extension of the FDA review period, we expect the potential launch near the end of 2023.
Following an anticipated three months DEA scheduling review.
We will be prepared and anticipate entering a market that is ready for the approval of <unk> alone.
As Youll see on slide 14, we believe the opportunity in MTBE is large with millions of patients not satisfied with current treatment options.
People, who continued to experience unresolved symptoms of depression or at risk. Many are unable to go to work or take care of their families.
It's difficult for these people to live their normal lives and the longer they wait to treat their symptoms the more likely they are to experienced negative outcomes, such as impaired functioning and subsequent relapse.
This is why rapidity matters, both in terms of initiating a therapy as soon as patients show symptoms as well as achieving the rapid improvement of depressive symptoms the.
The key takeaway here is a more rapid and sustained approach to treating a depressive episodes may increase the likelihood of better symptomatic and functional outcomes.
Given the rapid improvement seen in clinical trials to date, we believe that if approved zarin alone has the potential to provide a new treatment option to patients suffering with <unk> with the goal of helping them returned to a state of wellbeing sooner.
And TBD there is similarly, a large unmet need with an estimated $1 eight mothers and the U S experiencing symptoms for postpartum depression.
Despite being a common mental health disorder women experiencing symptoms may often go undiagnosed or untreated and we see that clearly in the low diagnosis rates.
Not only does PPD have an effect on our mothers overall function, but it can also have an impact on the ability for that mother to take care of her baby.
These mothers and their families deserve better.
Our goal is saran alone if approved is to work with the entire ecosystem to change the treatment paradigm by significantly improving diagnosis rates in women with PPD and provide hcp's with the first and only FDA approved oral treatments indicated for PPD that has the potential to help mom get better sooner.
As we enter 2023, we remain focused and diligent on our commercialization efforts in anticipation of potential launch.
We continue to engage with key stakeholders and scientific exchange and are also encouraged to see positive signals from the patient advocacy community on the importance of accelerating access to innovation in mental health and.
And as Barry mentioned earlier, we plan to be innovative on the patient access front.
Our goal for this launch is successful is that those living with MTT and TPG, who are prescribed the therapy have timely access with limited complications such as step edits and prior authorization.
In addition to our own work, we're seeing state governments across the nation make reforms to fail first policies and it historically restricted patient access to the right treatment prescribed by their physician at the right time.
People with MDM PPD deserve rapid and effective therapeutic options introduced early during treatment because early treatment is believed to deliver the best outcomes as I previously touched on.
Given the unmet need we believe that surround alone. It's approved is best positioned at launch MTV patients requiring a first add or first switch therapy. After continuing to experience depressive symptoms. Following their initial treatment course, including patients who have tolerability issues or noncompliance with chronic therapy.
In PPD, we strive for is around the one to become standard of care at launch with US as first line therapy for treatment nave patients who are newly diagnosed with PPD or in place of other therapies currently administered.
And the conversations we've had with payers they have been highly engaged and receptive and we believe they see a role for a potential rapid acting sustained 14 day course of oral therapy in treating both MVD and PPD.
We feel an urgency to deliver new treatment option to patients.
Given the profound unmet need that still exists in the treatment of <unk> in PPD.
We are dedicated in our efforts to continue to advance Saran alone with the goal of gaining approval and being able to offer a medicine with the potential to treat these patients rapidly and improve their symptoms now I will turn the call over to Kimi for a review of our financials Jimmy.
Thanks, Chris our financial results for the fourth quarter and full year of 2022 are detailed in our press release that we issued this morning I'd like to take a moment to provide some context and highlight a few key points.
We ended 2022 with a strong cash position, which provides us with the flexibility to support the launch of your analog mixed approach and strategically invest across our pipeline.
Our net loss for the fourth quarter of 2022 with $147 1 million and we ended the quarter with cash cash equivalents and marketable securities of approximately $1 3 billion.
Turning to operating expenses R&D expenses increased to $89 3 million in the fourth quarter of 2022.
Compared to $75 4 million for the same period in 2021.
The increase in spend was primarily related to ongoing investments in our wholly owned and partner programs, including Sage 324 on page 718.
SG&A expenses increased to $67 3 million in the fourth quarter of 2022 compared to $51 6 million for the same period of 2021.
The increase was primarily related to hiring employees to support ongoing activities in anticipation of potential launch.
As you heard from Chris we're continuing preparations to support the potential launch of their animals, while gaining approval and commercialization of <unk> remain our top priority. We're also committed to investing in our mid term and long term pipeline and our strategic and disciplined way.
To this end, we expect that our spend will increase as we continue our commercialization efforts.
And advanced planned and ongoing studies of Sage 718 at page 24.
We know that can achieve our long term vision of transforming the care of depression, we must begin with a focused strategy.
Scale quickly with success.
Therefore, we remain mindful of the capital allocation prior to launch.
As a reminder, as part of our collaboration with Biogen we are jointly.
Currently developing Duran alone and Sage 324, with a 50 50 cost sharing in the United States.
Looking ahead, we are reaffirming that based on our current operating plan, we anticipate cash cash equivalents and marketable securities.
Anticipated funding from ongoing collaborations and potential revenue will support operations into 2025.
Included in this guidance is the potential to achieve milestones totaling $225 million from Biogen related to the first commercial sales of <unk> and PPD.
Given how dynamic 2023, we'll be including preparing for a potential launch we will not be providing year end cash guidance at this time.
As we embark on a pivotal year for stage I am confident that our strong balance sheet will enable us to execute from a position of strength.
With numerous potential value, creating milestones on the horizon for stage, we remain focused on making strategic investments in developing pipeline program to best position ourselves as a leader in greenhouse.
We remain well capitalized as we continue to build a strong team executing on the objectives across our pipeline.
The time is now for patients and we are optimistic that our approach will lead to the development of treatments.
People are desperately waiting for.
I'll now turn it over to Helen to handle Q&A with the operator Alan.
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 I'll turn it over to the operator to handle Q&A.
Later.
Thank you if you would like to ask a question. Please signal by pressing star one on your telephone keypad. If you are joining us today using a speaker phone. Please make sure. Your mute function is turned off to a larger signal three tower equipment again that is followed by the digit one.
Pause for just a moment.
Yeah.
At this time, we'll hear from <unk> Ahmad from Bank of America. Please go ahead.
Hi, good morning, Thanks for taking my question.
Just wanted to clarify something that was said in the prepared remarks, I think Barry you said that.
Post the producer and I guess do you expect to be able to launch Saran alone is approved by the end of the year what would be rate limiting factors that would prevent you from immediately launching and can just narrow down. When you think you would be able to start recording sales would it be in calendar 'twenty three are with the assume it should be more.
24 thanks.
Yes.
And thanks for the question the attention, but we're really excited that the FDA has accepted the NDA filing for Israel for MTBE in PPD with a <unk> action date of August .
Well I'll remind you that following approval that occurred on August without delay. We then moved to a three month DEA scheduling a period. There are actions we can take during that period, but we can't start selling is around on recruiting sales until we have that official label with the DEA schedule. So that'll happen towards the end of the year and we'll be very.
Well prepared to launch and excited to do so.
Well move next to Celgene retzer from Goldman Sachs.
Good morning, Thanks for taking my question with regards to the payer work here could you just comment on that.
Their understanding of pricing of drugs.
Annual price for <unk>.
Every one of your two week period or using it maybe twice a year.
And then secondly, I think the commercial payer.
Mix is about 51% of the payer mix and so when you think about ppas and the strategy here.
Effective thats going to be to kind of help you.
Yeah.
Position the drug with the physician.
With the with the physicians in terms of adopting a new treatment paradigm.
And then what do you do with the remainder.
<unk> kind of non commercial.
Pay your aspect.
Yes.
A few different aspects of it.
And then I'll ask Chris to comment further so in terms of.
The proactive value based agreements strategy that we advisor employee.
Because of <unk>.
For us is to help payers with some budget certainty that's really what they want they know that.
This is not well managed and Chris will get into that.
But they want certainty in return we won a physician or health care provider believes that a patient requires the right along the road.
We want that script, so quickly so that's sort of the.
The exchange there and there's more detail that we can get into but that's sort of the high level.
So what we hear from payers from a pricing perspective is that they think about per patient per year, they're not thinking about per pill per pack. There is focused on understanding our per patient per year, Chris you want to comment further yes. So I think the BBA piece of this there is just frankly, one component I think to be true.
The transformation, we have to be accessible and that really starts with payers and in <unk>.
Around understanding unmet need I think in all of the interactions that we've had so far theres a high understanding of unmet need in and amongst the payers.
Truly a perception that they need something that works quite differently than what <unk> seen historically.
Been impressed with the data and I think they certainly understand from those interactions the opportunity that <unk> presents to deliver something that works.
Rapid acting fashion after just three days.
Decor, something that's durable over time doesn't come with the same type of side effects often associated with other therapies and actually has the potential to return patients with stated welding and in a sense. It takes a very complicated patient type that makes it far simpler to manage than historically, what they didn't have at their disposal. So incredible excitement around that which then sheets.
The conversation on proactive value based agreements I think you hit around the second question around payer types, we're going to work with all different payer types regardless.
The mix that they see to come up with solutions to making sure that it's Randall is accessible launch and again to really build on that understanding of unmet need and what sort of antelope can deliver from what we've seen in the data so far for both brands.
Thank you.
Moving next to on new pump Rama from Jpmorgan.
Hey, guys. Thanks, so much for taking the question.
Maybe expanding on some of your comments in the introductory remarks here, but how are you thinking about sort of the initial ramp curve in PPD and what are some of the pre commercial sort of education activities Youre doing in particular with the obgyn segment. Thanks, So much guys.
Yes, great to have you on board and Great question, Let me ask Chris to talk about the overall approach to PPD.
How we're educating and appropriate scientific exchange obgyn and others, yes. So as you might imagine there is a lot of focus on CTV within the organization.
If you pick up the newspaper, where you go online we see that just like MTBE. There is a significant mental health crisis occurred with months in postpartum depression.
We're talking about 500000, so cases appear to be on an annual basis or <unk> <unk>. So its absolutely Paramount that we continue to do the work that we're doing in and around working with obgyn than other prescribers that also to see patients that are suffering from PPD to help understand the importance of diagnosis are screening and diagnosis and subsequently.
The opportunity that our new therapy potentially license the railroad offers to them as it would be the first and only FDA approved oral therapy for the treatment of postpartum depression, where we believe that through the permitted scientific exchange that's happening right now through our medical affairs team, whether it's Congress is a one on one interactions.
With key opinion leaders, we're going to continue to heightened sensitivity and an urgency around the need to treat months that are suffering with CBD and we believe that that community. The obgyn community will be ready at the launch of the product.
And we'll be we'll happily receipts around a lot as I said as the first and only orally oral therapy as EBIT.
Yes, and just to.
Just to round that out.
Anna.
When you when you launch a.
Readily available oral medication like <unk> improved. This is this is exactly the kind of paradigm shift that happens in medicine.
As Chris mentioned about 5 million pounds per year.
To have <unk> less than 20% of those are diagnosed even lesser treated.
That's really because of the challenging them to get diagnosed treatment. When you have an agent like surround that works quickly with a 14 day regimen, we see the opportunity for physicians to look more rapidly for.
The diagnosis of PPD and certainly more around <unk>. So this is exactly the kind of medicine to change the diagnostic paradigm is indeed.
Yeah.
<unk> <unk> from Cowen Your line is open.
Good morning, guys. Thanks.
Thanks for the update today I wanted to just ask about the shoreline data contained in the submission.
Can you guys confirm that what we have in the public domain is sort of the extent of the shoreline.
Follow up and re treatment data contained in the dual NDA and can you give us any color as to what will be presented additionally control align midyear. Thanks.
Yes, Thank you to Jim you want to take that.
Yes of course, sorry, so the shoreline study.
<unk> designed designed to follow the patients with MTBE and evaluate both safety and Tolerability of xylem and the need for repeat dosing for up to one year.
Your line study, there's no growth in the program first and foremost it provides us with safety data or well over 1000 patients now.
Equally important to provide some real world evidence for houses around loan may be used if approved.
The shoreline is an important component in.
The NDA submission. So the data is completed to date is included in the NDA submission.
The shoreline study also continues so we have the newest cohort of shoreline.
Is completing.
Now that should that cohort is a rollover cohort from the coral study so that will provide some really additional interesting information.
For re treatment with.
Sure.
Yes.
We go through the data that you've seen today on shoreline is when presented multiple times as in essence lifted the NDA filing as Jim said, we'll use largely from the safety database will have an update mid year, which we think will be quite informative and when we get that update we'll let you know.
Great and will that update be submitted to FDA at that time.
There's regular communications with FDA on data updates, including Charlotte.
Awesome. Thank you.
Thanks Peter.
We'll hear next from Yasmin Rahimi from Piper Sandler.
Good morning. This is Chuck Meloy I'm pretty yes. Thank you for taking our questions. So first one is if you could provide a little bit more color on the lifecycle innovations 30, as I mentioned in the press release.
Related to designing decay in that mix timing of that study and then second one is on a.
When should we expect to see the health economic data off of the landscape in the next studies.
Yes.
Thank you and please center of SCS, Jim do you want to take that absolutely very so at the moment, we're not providing any additional details on the lifecycle management studies.
So the AQR data that you're referring to.
Lot of additional data was around loan that is coming out and keep publications and scientific conferences throughout 2023.
Yes.
Thank you I think we can move to the next question.
Well hear from Amit Bhatia from Needham.
Hi, Good morning. This is decently entre Robbie thanks for taking our question.
So biogen is comments on its earnings call yesterday continue to be positive on design alone opportunity. Maybe you could you provide some more details on how you all and Biogen are kind of working together with regards to things like prepping the market communicating with FDA payers et cetera. Thank you.
Yes, and thanks for the question.
Biogen Biogen from the start has been a phenomenal partner and clearly with Christy Bob you are coming on board given his.
His experience in leading larger as issues.
His leadership and pharma as well as experienced depression has really been an add to an already strong partnership together, we're very bullish on the opportunity for us around 10 million suffering from mbd in PPD and where like minded in terms of the paradigm shift we are looking to create in the treatment of depression I'd say from a.
Regulatory development commercialization CMC supply chain perspective, we're Stefan Stefan how we're working.
In the U S and at $50 50, Coco news, so we're well prepared together.
If approved the loss around.
Yes.
We'll move next to Jay Olson from Oppenheimer.
Oh, Hey, congrats on the progress and thank you for the update can you remind us what level of <unk>.
Scheduling you're expecting to receive cars around alone and how the scheduling will impact.
The launch of the drug and physician and patient perception and Saran alone. Thank you.
Yes, Matt Thanks for the question so.
Given this class of medicines that is around as an interactive steroid targeting Gaba, we anticipate that will be a schedule for drug in the three months of the year view.
After our <unk> action date, assuming we are approved.
It will be the process to confirm that what people need to understand is that the drug schedule has a lot to do with supply chain management and how these agents are and across the supply chain raw materials after degrees as well as how tenant in the pharmacy from in terms of patients getting a prescription from.
<unk>.
Their position.
Virtually every physician has a DEA number to right and there are millions of millions of prescriptions written for reschedule drugs by our target audience already so we really don't see as being an issue at all.
Great. Thank you very much.
Thanks, Matt.
Laura Chico.
With Wedbush Securities. Please go ahead.
Hey, good morning, Thanks for taking the question I wanted to circle back to one that's a little bit more logistical but on the commercialization.
Additional commentary around kind of how you envision patient management of patient flow management is going to be handled in the commercial setting I guess, what I'm trying to understand a little bit Morris, who in the offices, that's going to be primarily responsible for managing patient follow up patterns and I'm trying to understand a little bit more on the refill process.
How are they going to be monitored and what would trigger a rebuild of the authorized.
Yes, great Laura.
That's a really important question. So we think <unk> alone doesn't.
It doesn't change the practice of psychiatry or primary care that <unk>. So it really enhances is another tool to belt, where they'll understand if patients are managed.
Ah patients respond more rapidly than the tools, we have today, but let me let me ask Laurent has treated a bunch of these folks and how she thinks about the patient flow.
So thank you for the question.
It's my belief that <unk> is approved.
Got it.
Now agencies are currently treating patients with depression.
I think that they will continue to monitor patients over time and if there is a beer merchant attentive progestin.
Okay.
And they will.
LNG imports into China.
Okay.
The physician and patient compensation.
What remains on the table here.
That is different than that.
<unk> has been able to move in the past.
It is a drug that works rapidly.
Yes.
And that in the short term.
And from discussions with physicians, what we hear.
Loans that are highly valued and will be an important part.
The amendment teradyne's congestion moving forward yes.
Just to round that out with some of the basis of your question, Laura as sort of a common belief, which is a misconception that today a patient comes in they are put on a chronic medication. They stay on that medication and maybe a follow up at six months at all as well, but the data don't support that the data suggest that.
<unk>, given a new antidepressant only eminent depressant for a median of seven weeks and then patients who continue to seek treatment and some don't some discontinued.
And leave the system, but those are the PUC treatment.
Through two to three different medications for the year. So just think about it.
Not like today's films on a chronic med in there just fine they are not so we think that along with the potential rapid effect again as Laura said enhances the practice of treating that patient doesn't really change how you monitor that patient.
You also asked about Mexico.
There'll be a variety of ways that we feel good.
Some might write a script was around with a refill already constructing their patients.
They are feeling better for an extended period of time, but they're dark mood elevated anxiety and suddenly come back due to rebuilt and can try it again, if it doesn't work come and see me I might have other tools or refill can be called into pharmacy, just like any drug today.
Thanks.
Moving next to Sam Kulkarni from Canaccord. Please go ahead.
Good morning, and thanks for taking my question. So that alone is a relatively rapid acting to EDA in shoreline or in any other setting do you have any data on patients that may have stopped taking the product before completing the 14 day course of therapy simply because they are considered a depression had gone away into the feeling better.
Asking because this discretionary patient action could have important implications for pricing and potential sampling and the dynamic might lead to large distributions around the per patient per year pricing that payers are looking at versus maybe setting a flat price.
Yes, thanks for the question so.
I'll ask Jim to talk about specific data there.
Honestly, we've treated over 3500 patients and might there is probably some patients who took a drug for a period of time and stop because they are feeling better but thats been large part notwithstanding.
Right.
You are prescribed a CPAP or your lower respiratory tract infection and told we'll feel better to complete the full course that will be the instruction for was around alone and we don't really believe there can be much of a dynamic where a patient might take their animals were three or four days and clinical save the rest of the pack.
So there will be instructions completes a 14 day pack and the data are supported that those are complete the two week and the spun.
Remained responded so we don't really see that to give things dynamic that plays out here.
We'll hear next from your opinion to meter from Guggenheim.
Hey, guys. Thank you for taking my question just following up on a question that you asked earlier.
So the profile of the drug this is short term and you have a DEA scheduling.
Probably limit your ability to assemble can you maybe just talk about the relevance of sampling how could that impact too, especially in the PCP setting. Thanks.
Yes, and thanks for the question, let me ask Chris talked about our overall approach there.
From from what we're thinking about there is a number of different ways that we think about getting physicians early experience with the medications, while we haven't communicated yet and we're going to have an extensive sampling program. There's a number of different ways to think about this and the team is really thinking through that we know that from the experience that we've seen with investigators is that those physicians that.
<unk> experience.
They recognize the profound impacted sort of the loan path, so utterly experiences and critical with respect to DBA suddenly we don't anticipate it having a major impact on the way that we think about simply while there may be one or two states that may have some.
Language around sampling and sampling storage there is alternative ways to get physicians experiences. So we don't see DEA scheduling.
It's something that with in any way inhibitor physicians within their own.
Great is that we think that from the vast array of programs that we can employ literally experience is going to be something thats going to have a profound impact on the launched medications.
Okay.
Tim Lugo from William Blair has her next question.
Thanks for taking my question.
For the launch are you going to set up a central hub to deal with any preauthorization or access hurdles physicians may have to deal with kind of during the early parts of the launch.
Yes, Tim Thanks for the question.
Have a very we have a very robust channel strategy in place that deals with everything from <unk>.
To extent there is prior author steps to make sure that if a script is written that patient gets the drug so look that will all be set up and in place.
Okay great.
Thanks, Tim.
Well move next to none of the three co Garden City.
Hey, guys. Thanks for taking my question I just had a question on the Connecticut. Two study I was just wondering if you could give us an update on what youre seeing on the enrollment front, there and if some of the measures you check to see if enrollment have.
[noise] resulted in a faster pace.
Thanks for the question, Jim you want to take that yes of course, thanks Dana.
As you mentioned, we are currently very focused on completing the kinetic to phase.
Phase <unk> study for essential tremor in the <unk> four program.
The two studies currently open for enrollment and we are anticipating completion of enrollment in late 2023.
Spoken about previously a number of factors have challenged the kinetic two study one of those was.
Clearly some staffing challenges at sites in <unk> is coming out of pandemic, that's something that's being seen across the industry.
We saw a little bit of a slower patient enrollment than we had originally anticipated due to some specific criteria in the protocol.
And finally, there are multiple easy trials that are targeting a similar patient population that are going right now but.
But we as we mentioned previously we made some modifications to the program and we're confident that those modifications are having a positive impact as I say, we expect to complete enrollment in late 2023.
Thanks, Doug.
Douglas Tsao from H C. Wainwright. Please go ahead.
Hi, Good morning, Thanks for taking question just curious.
How long do you plan or do you plan on doing a post marketing study and I'm. Just curious just in order to understand how frequently patients need to be treated with Surat alone. Obviously, just given the fact that patients switch payers a lot.
So forth and obviously there is sort of.
Limitations with like <unk>, and so forth data just curious how do you over the long term plan to to understand the profile on how frequently patients need to be treated.
Yes, Thanks, Doug that's important question. So what we know today and as Jim commented on this earlier is.
Shoreline is the largest naturalistic study is pressure on state to our knowledge and the data are pretty clear no I'll throw it isn't.
Exactly real world close to reward is <unk> guess at this point and what we see for shoreline is for those that responded majority required only the initial two week course of treatment.
Then the numbers, 80% required either one or two course of treatment and the calendar year. So we believe that thats, how its going to pay out real world now once we launch if approved we will certainly work a number of different ways to understand what's happening over time, whether it's registries or payer collaborations we'll have we'll have those data at hand.
And of course, because we have.
We will have value based agreements in place those those will be informative as well. So it will be a number of sources for us to understand how many two recourses.
Our population needs over a period of time.
Okay.
Yeah.
Physicians do you get a sense are they going to using ran alone initially as an add on or do they want to use it as a monotherapy as sort of a switch.
So we in the scientific exchange that we have with <unk>.
Potential prescribers and our investigators were hearing different views in the.
Good news is that we have data moves around as a monotherapy.
On top of a stable entered the precedent of cognition and presence, we havent profiles around alone to use the medicine as the patient feel appropriate for a physician feels appropriate for.
The other patient.
Some some physician for a certain patient types like young adults and might want to use as a monotherapy for someone that.
Frequently suffers from depressive episodes did not want to <unk>.
Prescribing co administration, so we have the optionality and the data to support the way a health care provider access to treat their vision.
Great. Thank you very much.
We'll move next to Marc Goodman from <unk> Securities.
Thanks for taking my question Rudy online for Mark.
I have two questions for Sage 718.
The Lightwave dimension study using initial higher dose.
By a lower dose well the other two study using a fixed dose one two milligram, we can talk about the rationale for the dosing selection.
Secondly, can you talk about the difference between patients that use an inpatient versus outpatient settings. Thanks.
Okay.
Yes. Thanks for the question look we're really excited by Sage 718 is the first in class NMDA Pam that we're studying for.
Cognitive impairment across Nordic degenerative disease include Huntington's, Parkinson's and Alzheimer's programs are progressing very well and we're really excited to have data from that program in 2024 in terms of your specific Jimmy will talk about the dosing in an outpatient absolutely Barry.
And as Barry said, we're very excited about seven eight years. We're currently running five phase III studies across three different indications.
Huntington disease, Parkinson seasonal assignments disease, and really the dosing that you were referring to what the strategy is to achieve and maintain a certain level of exposure for sage 708, and some of what Youre seeing is as the program matures, we are doing that so.
The goal is in the case of the dimension study, which is dosing for over a three month period to achieve and maintain that.
Dosing level.
We are at this point looking at outpatient studies for the <unk> seven when a program.
The profile of Sage 708, both from a safety and PK perspective really allows us to do that so all of these studies are efficiencies.
I would just add and Rudy that the benefit risk we're seeing for Sage 718, an extremely broad we're seeing.
In rapid improvement and higher order cognition executive function learning and memory and an incredibly clean tolerability profile. So real excited about.
Can you move that forward.
Got it that's very helpful.
Yes.
Thanks, Randy Rochman from BMO capital markets. Your line is open.
Hi, good morning, with the priority review for US around alone do you still think there's a possibility for an AD.
That changed at all with priority review timeline, and where would you find that out.
And then the way the NDA has been filed you're obviously looking for an approval in both <unk> and PPD together, but is it possible for the FDA to split those up and approved one indication first.
And then the other at a later point if that ultimately wants to see more data.
Hey, Gary Thanks for the question. So let me take the second part first as you highlighted we filed an NDA for both MDA in PPD and we think the data warrant approval for both engineered TBD. So that's our current thought at the time and advisors as well along with that in terms of an AD com that solely at the discretion of.
The FDA.
If the FDA decides to hold an AD com, we would be excited to showcase the totality of those around data and as typical in AD comes adhere from patient and patient advocates to highlight really devastating unmet need that is out there with depression. So we'll be well prepared if they have an ad com.
If the FDA decides not to hold an AD com and net the signal of a faster approval, we'd like that too.
Okay.
Moving next to Brian Abrahams from RBC capital markets.
Hey, guys. Good morning, Thanks for taking my question and congrats on all the progress and on the filing acceptance.
I'm curious if you could talk about your latest views on how you might gate the launch focus and investment.
From targeting psychiatrists initially to ultimately moving and expanding into the primary care setting curious what feedback and metrics you might be looking for it to shape that potential progression.
Yes, Brian Thanks for the question and I think congratulations glad to hear that you are as excited as we are.
Look we live in a world of really strong information and have really good knowledge of those those health care providers that are seeing this.
<unk> patients those that are willing to write.
Prescriptions, particularly branded prescriptions, and we and Biogen will focus on where we think we'll get to.
The strongest patient flow that has the right kind of insurance coverage first and then expand rapidly with <unk>.
So that's the approach we're taking certainly to focus on.
Psychiatry, and those larger offices irrespective discipline and see a lot of these patients that'll be that'll be our focus Chris anything to add yes, I think I think there is a note and I think we've communicated. This in prior calls is there is a group of PCP that youll be calling on a PCP that deviate.
More like psychiatrist they see a number of patients with MTV and we'll also focus on obgyn side I don't want the piece about PPD to evolve, but I think as you said it vary based on the metrics that we have both physician level and patient level data that we have at our disposal, we're going to make decisions at the right time to consider the scale of success as we move forward.
Yes, I'd also add Brian that we're able to again in the world We live in to understand patient activation in the kind of patients that are frankly going to absolute Randall them by name and we believe that thats going to happen with the drug doses.
Thanks, so much.
Yeah.
Okay.
Danielle Brill from Raymond James Your line is open.
Hey, guys. This is Alex on for Danielle Thanks for taking our question.
So I know you're not targeting treatment resistant depression, and then your commercialization strategy.
But do you feel that it's a risk for clinicians to initially trials around alone in their patients that might skew towards this population potentially negatively coloring their perceptions of efficacy in other words do you think saran alone would work and TRT.
And just on that front, what's the gating factors now to initiating formal trials in treatment resistant depression anxiety bipolar.
Yes, let me, let me start with the second part of that.
So we believe the unmet need in <unk> and PPD is so great.
Talked about $6 million to $7 million dynamic patients.
Looking for new treatment options, and NBD 5 million moms that should be diagnosed with depression of the year that that patient population. So significant unmet need for a significant that will remain our focus for the foreseeable future. If we can win in depression.
We help millions of patients. So we'll provide future indications at later point in time, but right now the focus is absolutely win in depression to try to help as many people as we can in terms of how at launch the drug will be used as Chris already highlighted in PPD, we'd like to have <unk> standard of care to only do it.
Improve the only oral treatment approved specifically to treat PPD and MPD or our target is to educate physicians that.
<unk> should be used as your first switch where first add ons to the patient not be.
Controls with whatever they are taking and that will be our first area.
Kristina I think what I would add to that there is.
If if left two things to just happen I could see where physicians.
Cross all different.
Areas of treatment use new products later, but here, what we have through not only the positioning and the identification of appropriate places abuse.
The idea of proactive value based agreements proactive value based agreements are designed to really ensure that physicians have access earlier in the treatment paradigm. So that you don't have the onerous prior authorizations and step edits, which can ultimately take a new medication and push it to later utilization. That's why it's so important that we work across all stakeholder groups to make sure that physicians have.
The ability to really access really material process and use it where they say one launch.
Well hear next from Joon Lee from <unk> Securities.
Alright, thanks for taking our questions.
Looking forward to additional data from shoreline midyear.
Is that something youll be submitting to the FDA as part of the NDA package and also quickly you mentioned lifecycle management towards ran alone can you share what you have in mind. Thank you.
Yes, Jim Thanks for the question so.
We're not counting more on lifecycle management as we commented earlier on the call. We will have a regular series of updates with the agency clean shoreline.
Thank you everyone that will conclude the Q&A portion of today's call.
With that I will turn it back over to Mr. Cohen for closing remark.
Thanks, Lynette and thanks again to everyone for joining us this morning to review, our fourth quarter and full year 2022 results our progress in the fourth quarter and throughout 2022 is the direct result of teamwork and dedication from everyone in our and our partners' organization. So I'm going to thank everybody as we make critical.
<unk> progressing development activities across brain health, and we maintain a position of strength as we advance our mission to develop and launch transformative medicines for patients in need. Thanks, again, everyone and have a wonderful day.
That does conclude today's goodbye and thank you all for your participation.
Okay.