Q3 2022 SAGE Therapeutics Inc Earnings Call
Yeah.
The conference will begin shortly to raise your hand during Q&A you can dial star one one.
[music].
Good morning, welcome to the Sage Therapeutics third quarter 2020 financial results Conference call.
All participants are in a listen only mode.
All is being webcast live on the investors and media section of stages webcast website at S. A G E. R X dot com. This call is the property of Sage Therapeutics and recordings reproduction or transmission of this call without the expressed written consent of Sage Therapeutics is strictly prohibited. Please note that this call is being recorded.
I would now like to introduce Helena Rubinstein director of Investor Relations at Sage.
Please go ahead.
Good morning, and thank you for joining Sage Therapeutics third quarter 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 this call as well as the slides that contains supplemental detail.
I'd like to point out that we will be making forward looking statements, which are based on our current expectations and beliefs.
Fitments are subject to certain risks and uncertainties and our actual results may differ materially. Please consult the risk factors discussed in today's press release and in our SEC filings for additional detail.
We will begin the call with prepared remarks by Barry Greene, Our Chief Executive Officer, who will provide an overview of our progress during the third quarter.
We'll also be joined by Chris <unk>, Our Chief business Officer, who will provide an update on our progress in preparation for the potential launch of the ran alone in MTV TBD.
Jim Doherty, our Chief Development Officer will review recent progress and development activities across our program and can you Gucci, Our Chief Financial Officer will review the financial results from the quarter.
With that I'll now turn the call over to Barry.
Thanks Alan.
Thank you everyone for joining us this morning.
2022 has been a year of focused execution stage.
And we're extremely pleased with all the progress we've made across our three brain health franchises.
Our vision is clear.
Once the fearlessly lead the way to create a world with better Brian Hill.
I believe we are well on our way to accelerating our leadership and break now and reaching our goal to become a top tier biopharmaceutical company.
As we reflect on our accomplishments, including reported positive data from multiple clinical studies and initiating trials across our pipeline, we remain confident our ability to execute for the remainder of this year.
And we believe that we have the team to successfully advance our programs across strengthen disorders for years to come.
All of us at Sage are driven by a tremendous sense of urgency to create novel medicines for people, who currently lack adequate treatment options and we're focused on addressing what matters most to patients.
To that end, we've made great progress in building our organization this year to support the exciting milestone we haven't had.
With that I will review, our recent progress starting with our depression franchise led by <unk>.
The national dialog is finally shifting to focus on a better approach to support the millions of people who are living with depression.
We know that depression is complex and then failing to address it negatively impact people's ability to maintain relationships.
Productive at work and engage in activities they enjoy.
As we said for years and the recently published just last month in the journal of clinical Psychiatry. Further supports the pressure that is associated with an increased incidence of dementia.
<unk> cardiovascular disease metabolic syndrome, diabetes, obesity and certain autoimmune diseases.
It doesn't have to be this way.
We have a clear opportunity to help people living with depression and are encouraged by our progress.
And we continue to move forward on the Rolling NDA submission was around alone for major depressive disorder, or <unk>, and postpartum depression, or PPD, which is on track to be completed in December of this year.
If the FDA grants priority review of our NDA, our producer date would likely be in the third quarter of 2023.
If we achieve those milestones and <unk> is approved for the treatment of <unk> 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 ready.
Based on totality of data generated across those ran on development program.
We believe that <unk> has the potential to be a differentiated treatment option for people suffering from MTT in PPD.
As we prepare for potential launch, we and our collaborators at Biogen are thinking big.
Taking these state data driven approach and are prepared to scale fast with success.
We know that to launch successfully will need to continue to deepen our engagement with key stakeholders, including healthcare providers patients.
Advocacy groups policymakers and fares.
Over the past year, we presented key analysis owns around alone at several important medical Congresses.
The analysis highlight the data on rapid and durable effect and a generally well tolerated safety profile seen our clinical studies in <unk> and PPD.
Used either as monotherapy or adjunctive therapy.
Chris will share more detail on the positive reaction, we've received and faster community as.
As well as feedback from key stakeholders that continued to be vital as we advance our commercial plans, whereas around.
Now I'll turn to our neuroscience franchise led by Sage 718, a wholly owned first in class NMDA Pam.
We're excited to continue progressing a robust clinical program with multiple ongoing and planned phase II studies in Huntington's disease, Parkinson's disease, and Alzheimer's disease.
Today, we are excited to share the design of our planned phase II study in Alzheimer's disease, which Jim will walk through later in the call.
Impaired cognition is a significant morbidity and the indications we are studying sage <unk> and can negatively impact people's ability to live life independently.
Committed to advancing the C 17 program with the goal of further demonstrating its therapeutic potential and novel approach.
I'd also like to highlight key corporate updates included in this morning's press release.
First I'm delighted to welcome Dr. Laura Gulf to Sage as Chief Medical Officer.
In her new role Laura will be a strategic member of the stage leadership team focused on advancing stages current and emerging product pipeline through all stages of development.
Laura brings more than 15 years of experience as their strategic global Cross functional leader with an established track record of neuroscience drug development and designing innovative clinical trials from first in human through post marketing trials.
<unk> complements our very experienced leadership team is well prepared to lead stage for years to come.
Additionally, Jeff Jonas will be transitioning from his role as our Chief Innovation officer as he embarks on a new journey global private equity firm.
While Jeff will no longer hold a full time role of states. We're pleased to have them continue as a member of our board of directors and other committees.
Jeff has made significant contributions to stage over the past decade.
Joining the company first the CEO and then playing a critical role in our drug development strategies as Chief Innovation Officer.
We extend our sincere thanks for his leadership and growing the company and helping advance our mission of creating a world with better breakout.
We wish him great success in his future endeavors I would now like to like just to say a few words Jeff.
Thanks Barry.
I appreciate it stages commitment to developing new therapeutics, but neurological and psychiatric disorders I'm convinced stage hasnt unique pipeline that has the potential to contribute to innovate treatments for brain health.
Barry having worked with you over the last two years and watching how <unk> successfully grown the company are more confident than ever in stages potential to advance at a top tier biopharmaceutical company.
It's a privilege to stay involved in stages growth as a member of the board.
With that I'll turn it back to Barry.
Thanks, Jeff.
Confident that our accomplishments so far this year will translate into continued success as we execute our strategic goals.
We remain laser focused on execution through the end of this year as we embark on what we believe will be productive journey ahead.
Our goal is clear to.
To deliver the promise.
Our science and Fearless and lead the way to change the trajectory of care for millions of people living with brain health disorders.
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 <unk> Chris.
Thanks, Barry I'm pleased to update you. This morning on the significant progress we've made in preparing for the potential launch of <unk>.
As Barry mentioned, we expect to complete our rolling NDA submission for <unk> and PPD in December .
With this important milestone on the horizon.
And our collaborator Biogen are focused on preparing for the potential launches around alone with the goal of transforming the way depression is treated.
There is a clear need for a differentiated approach to treating depression.
The treatments currently available often fail to adequately address the unmet needs of people with MPD and TBD in a timely fashion.
Resulting in a countless number of people lost to the trial and error approach to treatment before their symptoms resolved.
From the perspective of people living with depression weeks matter.
These matter in the moment missed matter.
Patient strongly desire rapid and lasting resolution of their symptoms without the stigmatising side effects that can be associated with many current and are depressants.
We believe the rent alone if approved has the potential to enable healthcare providers to treat episodes of depression and people with MTT and PPD with the goal of improving symptoms and helping people rapidly return to a state of wellbeing.
As we look ahead, we believe our ability to launch <unk> successfully is predicated upon four key points.
First executing on areas, where we believe <unk> will be most impactful launch with complete focus.
Our market research and KOL engagements in the course of scientific exchange have pointed to clear potential initial use cases for <unk>.
We believe there is an important opportunity to use this novel therapy as an add on or switch for patients with <unk> and PPD when another therapy isn't meeting expectations.
Our rent alone may provide a versatile treatment option that could potentially be used early in a patient's journey.
Additionally, based on our clinical trial data, we believe <unk> alone has potential in areas in MTBE, where management has historically been complex such as in <unk> patients with elevated anxiety <unk> comorbid insomnia.
And our research Hcp's point to the rapid onset of action and Tolerability profile observed in our clinical trials whats around alone as key attributes that they believe may enable them to quickly and confidently determine whether it's randall known as working for their patients.
It is the rent alone is approved we intend to narrow in on these use cases early in the launch as we pursue a focused strategy.
Second maintaining high engagement with physicians by disseminating our clinical data through scientific exchange.
Throughout the past year, we presented key analyses in several important medical congresses, highlighting the rapid onset and durable effect is around alone and MDT and PPD seen in our clinical trials.
Feedback to these presentations has been positive.
As we are engaged in discussions about the unmet need in MTBE.
Physicians have highlighted that the potential to achieve both a rapid and durable effect matters deeply to them and remains critical to their patients.
So are increasingly recognizing the episodic nature of depression, and the MDT could potentially be treated episodically with treatment free period.
I'm inspired and motivated by discussions we've had with the medical community on the unmet need and MDT.
And the feedback we've received from them on this rent alone clinical data thats been presented.
It reinforces our belief in the potential of the ran alone in the treatment of MDT in PPD.
Third advancing payer discussions around innovative tools designed to help enable broad access to <unk> alone and MDM PPD, such as proactive value based agreements.
And our early engagements payers have been receptive to the potential utilization of <unk> given the attributes seen in our clinical trials.
They note that based on the data generated to date Zarin alone may offer a treatment option that aligns with their objectives are better managing MDT and PPD.
Further payers have expressed interest in collaborating with sage and Biogen on addressing access and reimbursement hurdles through innovative contracting value based agreements are an example of an innovative contracting approach we're exploring.
Our plan is to work with payers with the goal of enabling people with MDM, PPD, who desperately need new treatment options to be able to access the renova quickly and affordably.
To truly be transformative zarin alone must be accessible.
And finally executing our launch plan with a goal of reaching stakeholders across multiple channels.
We plan to employ an omnichannel approach that integrates personal and digital channels to maximize stakeholder reach.
To reach these stakeholders, we believe we will need to think big take a staged data driven approach and scale quickly with success.
Looking forward to 2023, we are strategically building towards a potential launch we've made key hires in supply chain technical operations Medical affairs marketing and sales leadership roles over the last quarter as we work to ensure that we are ready if they ran in Lotus approved.
These individuals increase the depth and breadth of functional expertise with successful track records of commercializing novel therapies and significant partnership experience.
As we continue to advance our launch preparations we look forward to sharing more detail on our plans to commercialize rattler, if our regulatory efforts are successful.
With that I will turn the call over to Jim for a more detailed discussion of our portfolio of progress and current clinical expectations Jim.
Thanks, Chris and good morning, everyone.
'twenty two is marked an important year of development across our three franchises and the team has made tremendous progress across the board from advancing on our rolling NDA submission for their envelope to delivering multiple positive data readouts.
And successfully presenting new analyses at key scientific Congresses, we're proud of where we are today and look forward to continuing to execute on the pipeline moving forward.
What I find even more rewarding is the feedback we received from the scientific community as you heard Chris walked through earlier, having been part of 10 years of growth at Sage and reflecting on all that we've achieved to date. It is extremely rewarding to see the scientific community to take note of our progress and continued execution.
Now, let me provide an update on our three brain health franchises, starting with our depression franchise.
We recently shared new analyses and additional data from those around loan clinical development program at the 2022 site Congress and the 35th European College of Neuropsychopharmacology or <unk>.
Congress.
These presentations included data from the shoreline study.
And health economic and outcomes research as well as the presentation of data from our Skylark study.
The analyses and data presented continue to build on the positive data we've shared earlier in the year.
I want to highlight a few of the key themes that support the potential for us around loan.
First the analysis highlight the rapidity of onset of is around loan seen in patients with both <unk> and PPD in our clinical trials.
In particular results from the waterfall study showed a treatment effect compared to placebo as early as day three ins around alone 50 milligrams.
Additionally, a post hoc analysis of MTV patients from the study suggest the improvements was around 50 milligrams compared to placebo were clinically meaningful.
Further in the Skylark study patients with PPD treated withdrawn 150 milligrams experienced rapid clinically meaningful and statistically significant improvements in depressive symptoms as early as day three that were sustained through day 45.
In both studies the results were clinically meaningful across the early time periods further reinforcing our belief in the rapid acting nature of it was around alone in patients with both MPD and PPD.
Second the analyses speaks to the effectiveness and durability seen in our clinical trial in patients who are on <unk>.
Specifically the shoreline study demonstrated that among patients with Mds, who responded to the initial two week treatment with Saran alone, 80% received one or 214 day treatment courses during their time in the study.
Where patients had the opportunity to be followed up for a year.
Median time to first re treatment for those who responded to the initial two week treatment was 249 days in the 50 milligram cohort.
As it relates to the potential durability of the round one for patients with PPD data from our Skylark study demonstrated positive results across all primary and secondary endpoints, including statistically significant responses across all time periods measured which further highlights durability.
It's important to note that the durability of effect in our clinical trials, we've seen broadly across MTV patients, both with and without anxiety symptoms at baseline.
As we know from the literature in studies like Star D. Mbd patients with elevated anxiety as one of the symptoms of depression, among those with the poorest outcomes.
Based on the data seen in our studies to date, we believes around level may be well suited to address a clear unmet need for a broad range of people with MTT.
Third the data from our clinical trials suggests potential flexibility and is around alone as a monotherapy or as add on therapy in the treatment of NBD additional analysis from the landscape program.
Joe that whether used as a monotherapy or as an add on therapy with existing ABTS around loan performed similarly, well.
These data provide further insight on the flexibility clinicians may have to meet the needs of their patients with MPD with the railroads if approved.
Lastly, the round one was generally well tolerated with safety profile seen in the Skylark shoreline studies consistent with prior clinical studies.
Common adverse events seen in the landscape and mess programs were headache, somnolence, dizziness, and sedation with no signals of weight gain or sexual dysfunction that often lead to discontinuation of current treatment options.
Overall, these analyses and the data observed consistently across the us around on our clinical development program reinforced the potential opportunity for us around alone as a novel treatment for both MTBE in PPD.
Now I would like to turn to our neuropsychiatry franchise led by Sage 708, our lead NMDA receptor Pam.
So you said one eight is being developed for certain disorders, where impairment of cognition is one of the main drivers of disability.
This is a wholly owned program that was granted fast track designation by the FDA as a potential treatment for cognitive impairment is huntington's disease or HD.
We are also investigating sage 718 people with mild cognitive impairment due to Parkinson's disease, where PD and people with mild cognitive impairment and mild dementia due to alzheimers disease or <unk>.
To date, we have seen encouraging data across multiple open label studies, which have demonstrated consistent improvement in measures of cognitive and executive function.
We are progressing enrollment in the phase III dimension study and the phase two survey or study in people with HD cognitive impairment with <unk>.
Recently reported additional results from the paradigm part B study at ECP showing that improvements in executive function could be sustained through 28 days of dosing and day 42 follow up.
Supporting the possibility of durable response with extended treatment.
Sage 718 was generally well tolerated with extended to 2008, the exposure and the observed adverse events were consistent with the safety profile of <unk>, 7% <unk> reported to date.
We are also progressing enrollment in the precedent study a phase II placebo controlled study of Sage 708, and people with mild cognitive impairment due to PD.
Additionally, we are on track to initiate a placebo controlled phase II study would save some money in patients with AAV cognitive impairment, which we are calling the lightwave study.
That is planned to begin in late 2022 today, we're excited to provide more detail around the study design for this trial, which can also be found on slide 34, the corporate deck on our website.
This phase II randomized double blind placebo controlled study is intended to evaluate the safety tolerability and effects on cognitive performance of Sage 708 in patients with mild cognitive impairment or mild dementia due to AG.
The study design includes a 12 week treatment period, followed by a four week follow up period. The primary endpoint is the change from baseline at day 84 in the coding test from the Wexler adult intelligence scale position.
This is one of the most widely used measures of cognitive performance for adults and older adolescents in.
In this trial, we're looking for changes in cognitive performance that will be apparent to both patients and their families that can provide meaningful effects to their lives.
In addition, we plan to measure a variety of additional endpoints to assess the effects of Sage 718 on cognitive performance and functioning, including CGI C. Boca 10 tab and the Amsterdam instrumental activity of daily living questionnaire.
Looking ahead, we plan to share program update our key upcoming scientific Congresses and further the exchange of ideas, which we believe has never been more important in the quest to help bring helped patients get better sooner.
Now I'll move to our neurology franchise led by <unk> for our next generation positive allosteric modulator of Gaba a receptors.
We believe that stage three to four holds significant potential in the treatment of neurological conditions like essential tremor, where ETE.
A disease that has limited treatment options and no new innovation for over 50 years.
We announced in the last quarter's earnings call that our phase two long term open label study with Sage three to four and ETE was initiated.
With regard to our phase two be kinetic two dose ranging study evaluating sage through Q4 in EP. We are updating our guidance on completion of enrollment we now expect to fully enroll the study in late 2023.
The change in guidance as a result of a number of factors that have had a particular impact on our <unk> study.
We look forward to sharing more updates on these studies in the coming quarters.
To close I continue to be amazed by the team that has moved this dynamic pipeline forward. We have an exciting path ahead of us and we remain laser focused on execution across our three franchises.
Look forward to advancing and accelerating our efforts to develop brain health and medicine to help patients get better sooner.
Now I'll turn the call over to Kimi for a review of our financials Kimi.
Thanks, Tom before I dive in I'd like to acknowledge the team's effort resilience in driving the business forward.
Especially in the face of a challenging market environment. The work our team has accomplished this year that the rest of reflection of the dedication we have ah patients urgency to find new therapies for that.
Now turning to our financial results details on the third quarter I disclosed in our press release issued this morning.
A moment to provide some context I'll highlight a few key takeaways.
At the end of the third quarter, we maintained a strong cash position, which we believe will allow us to support the largest analog if a third.
To build a strong team and provide flexibility to strategically invest across our pipeline.
While we expect our cash balance to enable us to execute from a position of strength, we're closely monitoring external environment and maintaining a disciplined approach to turn basketball.
Our net loss for the third quarter of 2022 with $137 3 million and we ended the quarter with cash cash equivalence and marketable securities of $1 4 billion.
Turning to operating expenses R&D expenses were $81 6 million in the third quarter 2022, primarily driven by the ongoing investments in our wholly owned and partner programs, including 224 <unk> thousand 18.
Looking forward, we expect R&D spend to increase in the coming quarters as we advance six planned ongoing safety studies with Sage 718 in Sage 324, I mentioned earlier.
SG&A expenses increased to $61 5 million in third quarter of 2022, primarily due to hiring in place to support ongoing activity, although constipation cultural launch.
As you heard from Barry and Chris If I can.
Can you make preparations to support the potential launch at their analyst.
We expect that SG&A spend will increase as we continued commercialization preparations.
As a reminder, as part of our collaboration with Biogen.
Hey, develop things around alone in page 24, with a 50 50 cost sharing in United States.
We're thinking about this around a loan opportunity, though we remain mindful of the capital allocation prior to launch.
We plan to invest appropriately scale with supply.
During the third quarter, we recorded $18 3 million in reimbursement from Biogen related to our collaboration and license agreement.
Looking ahead to the remainder of 2022, we're reaffirming the financial guidance that we provided earlier this year.
We anticipate having cash cash equivalents and marketable securities of approximately $1 3 billion at 1% to 2022.
We do not anticipate receipt of any milestone payments from collaborations in 2022.
We believe that our current cash cash equivalents anticipated funding from ongoing collaboration.
Potential revenue will support operations into 2025.
While the market environment remains uncertain, we are fortunate to be in a strong financial position.
Flexibility to invest strategically as always we're monitoring developments across the macro and regulatory environment, especially as it relates to bring health and are preparing a puzzle as new information comes to light.
We embarked on the transformation of payments to the company I'm confident that our solid balance sheet enable us to execute from a position of strength.
They are focused on prioritizing disciplined investments across our pipeline to ensure that our plans are scalable flexible and most importantly patient centric as we pursue our vision for leading the way to create a wells but better.
I'll now turn it over to Hal to handle Q&A with the outbreak Helen.
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. Please feel free to return to the queue now I'll turn it over to the operator to handle Q&A operator.
Certainly as a reminder to ask a question you will need to press star one one on your telephone.
Please standby, while we compile the Q&A roster.
Yes.
Yeah.
One moment.
And our first question will come from Yasmin Rahimi of Piper Sandler Your line is open.
Good morning team and congrats on all the updates a quick question for you as you're getting ready to complete the NDA and preparing for the AD Com can you just maybe provide us some.
Some color around what are some of the topics that could arise as youre doing the mark outcome reviews.
Anything that could just sort of prepare us into that and I know, we have a little bit to go before that comes out that greatly appreciate any color you could share with us this morning, and I'll jump in the queue for a follow up question.
Yes, yes. Thank you for the question and good morning to you appreciate the congrats on the strong quarter. We've had we're well underway to file the NDA and as we've narrowed the guidance we're prepared to file the NDA in December the second half of the year as guided.
Just to be clear, whether or not we have an AD com is up to the discretion of the FDA.
If we have an AD com and I'll ask Jim to comment on what it might look like we'll be well prepared.
Listen the patient testimony is to really showcase the totality of his around on data so it'd be excited for that.
The FDA decides not to have an AD com as a signal of an earlier approval. So it will be ready for that as well Jim you want to talk about isn't add some what kind of questions. We'd anticipate third fourth so very happy to.
Sorry.
Since we don't know, whether we're going to add programs. The team is currently preparing.
Preparing as if you will.
Not surprisingly when you think about what the.
You've got no cheaper than that.
Really trying to understand efficacy and tolerability for as.
As long as I think in cases, where there is a novel approach trying to understand is that novel approach. So in.
In all of those areas, we are well prepared for landscape and that program was designed to provide interlocking set of data to describe the totality of data and that includes the totality of the efficacy data whether the drug is used as monotherapy or in combination with.
Standard after the preference.
With patients who have anxiety or not and then in the <unk>.
Tolerability area, what we're seeing is a very consistent picture across all of our clinical trials.
A very novel and benign safety profile relative to some other agents that are available and then finally on the novelty piece with.
The Gaba mechanism of action I think that's something that we've spent a lot of time.
Now for all of these we will look forward to the ability to really tell the whole story is around one one times.
Thank you Tim.
Okay.
One moment.
Okay.
And our next question will come from Ritu <unk> of Cowen Ritchie. Your line is open.
Good morning, guys. Thanks for thanks for taking the question.
Mine is going to be focused on commercial strategy forgive me. It's got two parts one I'll have to ask about.
Biogen and.
Where they are currently contributing to setting the strategy.
And the second part is basically.
Talked about.
Access, but as you think about psychiatry versus potentially PCP prescribing add on your switch do you see that sort of.
Add on and switch.
The PCP setting furnaces, especially with setting, especially given all of the constraints.
Certainly in the U S for patients trying to access psychiatry.
At all thanks.
Okay.
Hey, good morning, and thank you for the question. So two parts Biogen and then access so on the buying piece.
Then well partner value from the beginning of the collaboration we've got strong relationships.
All over the organization and working very well together on the regulatory front check upfront supply chain as well as commercialization and are well aligned on our commercialization strategy, which Chris spoke with spoke on the call.
Could you talk about access, but we have seen.
We have seen.
On the payer front lots of receptivity to our leaning in with proactive value based agreements and appreciation that.
There's over 20 million people with depression, and $7 million of whom every year looking for new treatment considering the unmet need remains very very high Chris you want to talk about.
Psychiatry, and primary care and where we see.
Patients gaining access to their own sugar. Thank you.
This past weekend I spent time at the <unk>.
Neuroscience Education Institute out in Colorado Springs, Colorado.
In large part a psychiatrist.
And let me say that the tenor of that conversation was that.
Excitement runs around alone in that.
There is a belief in and amongst them that their pizza funding benefits.
Looking for medications that work rapidly they've been looking for medications work and sustained effects over time.
That can be delivered through a short course income without the stigma type of side effects of other presence and they are excited about that because they know that they have patients many of whom are still early in the treatment journey, who would benefit from from that treatment intervention, whether that is a patient that needs monotherapy or patient that needs switch to a different medications because they are not.
And the type of efficacy that they are looking for.
Got that same sentiment from primary care physicians, who we've spoken to as well as you know oftentimes many patients go to a primary care physician first and Theyre looking for that kind of treatment intervention something that works rapidly and less over time.
If they don't need to be on in perpetuity. So in sum total both primary care physician and psychiatrist we're looking for those.
Interventions that we believe will be successful first and foremost.
We've only choose to focus but then over the course of time as we expand into primary care and we ultimately.
Our position as an omnichannel effort they'll use it in that same population.
Thanks, Chris Thanks Ritu.
Thanks.
One moment.
Okay.
And our next question will come from <unk> Richter of Goldman Sachs.
One moment.
Your line about it.
Good morning, Thanks for taking my question.
Spoken about.
Potentially.
<unk> based approach with with the Polaris here for the <unk> franchise.
Franchise.
Curious about receptivity to that in your initial discussions.
Yes, so I mean, I'll start and then I'll kick it over to Chris So as you're well aware a proactive value based agreements that have been used by many kind of in the orphan space. We believe we can apply the same principles to large market like <unk> and PPD as mentioned earlier, there's millions of people will be with depression.
And rapid access without significant prior off the step edits are important and we think that by.
Value based agreements that we're sharing risk with payers it will lead to more rapid access.
I'll start and Chris will dive in I can tell you that the receptivity to appreciate and compression is a significant unmet need is certainly there and payers are very open to understanding how we make sure isn't them VBA approach Chris Matt.
Thanks, Barry So we've spoken to the vast majority of payers already at this stage and Barrett.
Payers are highly engaged and they're receptive conversation, particularly at this stage of our launch readiness efforts. The reason why or the reasons why they are receptive.
<unk> highly engaged from my point of view is its first they recognize that there is still as profound unmet need in the treatment of patients living with both NPV and PPD, that's not just with payers, but thats the people to like many of US payers have loved ones that are suffering from.
Being unable to achieve a diagnosis and to ultimately get the kind of treatment that they need to continue to go on living their lives.
The second point that I would note is that they are incredibly excited about the data that we've shared that.
That shows that patients can be treated rapidly that theres. Some states sustained effect over time that these therapies don't come with Stigmatising side effects and then they can be delivered over a short course and patients whether they have elevated anxiety or difficulty with insomnia. They can be treated with this medication as well. So this is keeping a very complex patient population.
Repair and streamlining our maintenance treatment of it much simpler.
Okay.
Thank you.
One moment.
Yes.
Okay.
Okay.
And our next question will come from Paul <unk> of Stifel. Your line is open.
Great. Thanks, So much just one question for me.
Wrapping up with Saran alone NDA filing I wanted to specifically ask about how you're framing the shoreline study from a regulatory perspective I know we've talked about this before but specifically are you framing the shoreline study as a maintenance trial and offering maintenance of benefit or are you framing this as a long term safety.
Study that offer some information on efficacy, but the reality is you may need to do a maintenance trial post marketing. Thanks, so much.
Yes, Paul Thanks, Thanks for the question so.
Again, we're excited to be filing the NDA in December we're in good shape, all modules and revise your QA mode ask Jim to comment a bit on shoreline.
You May remember that there was a study at the beginning of the landscape, where we're treating patients at a regular basis.
And meeting with the FDA we agreed.
Agreed that the shoreline study.
Could serve as a understanding of long term safety and re treatment of needs and we're filing the shoreline study along with the NDA as part of the safety database.
Also informative to understand when we treat somebody with two week course of treatment with.
The durability of the effect you heard on the call that for those that respond to the first treatment of shoreline majority required only one or two too of course in the course of year and the median time to retreat with 249 days really speaks to the durability.
Jim you want to talk about more about shoreline, how we'll use it.
Yes, absolutely.
Paul.
As you've heard me talk about a number of bonds each of the studies and the dry loan programs have their own intended purpose and they all sort of lumped together really as Barry mentioned shoreline.
Service multiple roles in the program.
First and foremost it provides us the safety data from well over 1000 patients in there.
Alone, but perhaps even more importantly, it really provides real world evidence for how those around them is likely to be delivered.
As you heard me say in the prepared remarks, what we find remarkable problems the shoreline data today that one of the things we've got remarkable.
Is that.
In the 50 milligram cohort Youre seeing a median recruitment time with 249 days.
It's over eight months. So we're very excited about the data set the date when we are presenting this in our regulatory information, we will provide all of that context.
And really that's going to be part of the dialogue with the FDA is looking at the multiple ways that the shoreline data amplifies those around months or.
Okay.
Alright, operator next question certainly.
Okay.
Our next question comes from Laura Chico of Wedbush. Your line is open.
Hi, good morning, Thanks for taking the question I guess.
One on stage three Q4, and the kinetics study it looks like there is a bit of an issue in the moment and just wondering if you could offer perhaps any additional color here.
In terms of maybe the major issues that have been training recruitment and kind of steps are being taken to address thanks very much.
Hey, Laura Thanks for the question. Good morning, Yeah, So phase III, two four which is a Gaba Pam.
For chronic treatment initially being studied right now in a sense of tremor. The Kinect two study is a dose ranging study over over a three month period of time and yes, we've updated the guidance that we will fully enroll the trial.
By the end of late next year, Jim you want to talk about sort of how we've thought about it and what's going on there.
Good morning, Laura.
As you know, we take a pretty robust approach to the conduct of our clinical trials.
That really include constant assessment of ongoing studies like genetics do.
I'd say to summarize our analysis to date, we've seen several challenges to enrollment.
Those would include first patient access we have seen a slower pace of patients entering the trial that we had originally expected.
In part due to some specific entry criteria that are part of the protocol that we're addressing.
I would say the competition there are multiple central tremor trials that are currently underway from different sponsors all targeting a similar patient profile.
And finally say delivery that their staffing challenges it faces zeros coming out of the pandemic and available sites are loaded with active study, but we do think it's a combination of a number of factors.
Our leading to the new guidance for the Connecticut siting, yes.
Yes, Thanks, Tim and just just to be clear Laura we're still very excited about three to four in essential tremor and potentially other indications and as Youre well aware there hasn't been innovation the central tremor for over 50 years. So the fact that.
Multiple companies are working studying essential tremor, it's actually great for the patient population.
Yes.
Thanks, a lot.
Yes.
Sure.
Our next question comes from Jay Olson of Oppenheimer. Your line is open.
Oh, Hey, thanks for the update and thanks for taking the question.
Curious about stage 718 in the dimension study can you talk about the pace of enrollment and when we should expect to see data from that study and then what are the incremental learnings that you hope to capture from the survey or study. Thank you.
Yes, Jim I'm going to kick it over to Jim in a moment, but thanks for asking.
718, we're excited too.
Could be developing sage 718, our wholly owned and an NMDA Pam and neuro degenerative diseases. As you mentioned starting in Huntington's, but also focused on our Parkinson's and Alzheimer's.
Way, we thought about the Huntington.
The study is very robustly, we've got multiple studies running and we've suggested that if the data are robust and positive we won't be shy and working regulators too.
I tried to step forward and we're learning each and every study.
Jim you want to talk more about about the Huntington study and how we set them up absolutely happy to.
Jamie as you know we've talked about we've been working in.
The space for a number of years now and one of the things we've been doing along the way is building our communication with us.
And I think we're seeing that with the dimension and survey or study in the sense that.
It really is.
Impacting getting patients into the study so we're very pleased to see that as far as the strategy.
As you know is about a three months in duration study placebo controlled format really building on the work that we've already done in the open label format. So what we're trying to do with dimension is too.
That's confirmed.
In a placebo controlled study the signals that we've seen with sage seven money to date.
The survey are studying plays a couple of different roles in the program.
It certainly will allow us to look at another.
The study at the role of 708 relative to do a placebo group looking at the primary endpoint again.
<unk> HD cab, so improved recovery performance, but in survey or study. We're also looking at the impact of the changes to cognitive function on real world function and.
In addition, we will have.
Control group that is not treated.
Allowing us to compare relative to the decline that's occurring.
Duration of the study so we do see that these studies provide complementary information.
We continue to enroll.
As we've done in the past what we'll do is as we get a little bit farther along in our enrollment will give projections on what we think.
Sure.
Hey, This is Jamie just one more point on <unk> I think this is a really good example of our expand and accelerate strategy. Let me say good data when we talk a good profile, we made the investments and.
We'll continue to do that in a similar vein to the rest of the pipeline. So we look forward to updating you more security team.
Great that's super helpful. Thank you.
Thanks Jake.
One moment.
Okay.
Okay.
Our next question.
Will come from Amit <unk> of Needham <unk> Company. Your line is open.
Hi, Good morning, everyone. Thanks for taking my question and congrats on all the progress.
I have a follow up question on.
Thanks to one seven and as you get ready to compete here filing can you talk about how you're thinking about.
The product I know, it's too early to actually.
On pricing specifically, but.
Can you.
Some of the set of activities ongoing with respect to identifying the right price and some of the feedback you might have received from payers.
Around the price change thanks.
Thanks, Tommy and I appreciate the congratulations in the quarter, we're very excited by that as well, Chris you want to talk about how we're thinking about accessories around I think.
Yeah for sure. Thank you. So so while while pricing is an important part of the value and access strategy.
No it's not the only component that we're focused on at this point, we want to make sure that with respect to the access strategy. We're doing everything we can to enable physicians want to prescribe the medication that launched the medication with minimal friction and for patients who want to experience that.
Benefits around alone if approved at launch that they are able to access that medications rapidly and also accordingly. So those are really critical so with respect to how we're thinking about the pricing within our pricing in line with the value that we believe that <unk> brings to the market based upon the differentiated value proposition that I noted earlier that it actually does it.
Office, where I think you hit it earlier, we want to make sure that we stay out of the high cost specialty tier associated with medications, we know that that specialty tea are often comes with prior authorizations and step edits that can make it difficult for physicians to prescribe the product and the patient to get it in order to do that we're going to lean in with value based agreements or <unk>.
We've already initiated conversations with payers and in around how we're thinking about valuing assets and in particular DBA and as I said earlier, there is a high degree of engagement and receptivity to that with respect to how we think about the value of an exit strategy in totality, we want to make sure that we are innovative with our value and access strategy as we are with our discoveries.
The third case, we intend to bring to market.
Thank you.
Thanks, Tony.
One moment.
Okay.
And our next question will come from Simeon Kearney of Canaccord Genuity. Your line is open.
I'll start with a quick good luck good luck too Jeff that you walk into a different type of products at this time involving private equity my.
My question is for Chris.
Early market research on <unk>, you mentioned that some have started depreciating the episodic nature of a component of MBT do you have any quantitative details you can shed about physicians or payers that may already be on board with this concept and if not on board. What is the main source of resistance simply tradition or are there more factors, perhaps related to physician liability for example, and docs want.
Patients to be on the baseline level of scatter that standalone results.
Thanks, Mike.
Suggest modeling I appreciate your support of him moving into private asset I'm sure he'll call with any helping needs.
Look I think what we're dealing with is we are dealing with historic.
Historic context in terms of how precious thought about and treated in the chronicity of treatment. What I can tell you and Chris will dive into some more specifics is that the lift here has gotten much less the fact is that.
The median time of patients on a new prescription seven weeks and most patients cycle through two or more drugs in the course of the year. So this belief that ah patients diagnosed as on chronic treatment forever.
Not supported by the data and given this hotel is around data and the opportunity to treat someone for two weeks is resonating with a number of positions I think you've heard quotes from many physicians that.
Being able to take a pill for two weeks and then not being reminded for the rest of the year that they have the press is actually a major benefit. So the lift has gotten much much less the totality of data and there's tremendous receptivity to assure a rapid acting and short course treatment, Chris you want to add yeah. Thanks, Craig well I can.
Can't answer the number directly at this point, what I can say.
Provide some color on Barry's comment again at the Nei conference that I was just that over this past weekend.
There is a lot of conversation going on right now about the ability to treat patients episodically and to return them back to us visibility.
That's really important and that is shifting.
Shifting priority that I have seen occur over the last 12 months is as we've continued to put data out into the market at two scientific exchange has a number of us meaningful conversation with clinicians now graph is that there is an urgency to treat patients to diagnose and treat patients because they understand the clinical outcomes are enhanced by earlier diagnosis.
And earlier treatment that we can go into at a later time, but that is a priority as we move forward I think sometimes what we take for granted when we have this conversation around.
So we're living in and amongst a brain health pandemic, our mental health crisis. These clinicians are living squarely in the midst of it and you don't change your crisis by doing the same things that you always done again and again you look for different ways to treat patients and now they have novel therapies coming to market that allowed us to do that with <unk> being a very important one completed.
Thanks, Thanks Mark.
And one moment.
Okay.
Our next question will come from young Li of Truest. Your line is open.
Okay.
Alright, thanks for taking our questions.
Correct me, if I'm wrong, but our understanding is that human abuse studies required.
In terms of proposed dose.
In the case of surround alone would be 150 milligrams have you tested that dose.
And abuse liability study and if so.
What sort of flexibility score did you guys. Thank you.
Yes, let me let me just.
To say that we've done the human abuse potential studies are well done will be part of the filing and we've done it in alignment with the agency on procuring more color yes.
Absolutely.
As we have done that.
Looking at Likeability.
Measured relative to.
<unk>, what we've seen is there are multiple doses towards around alone the liability is.
At therapeutically relevant doses not different than placebo.
At Super therapeutic doses multiples above.
The therapeutic dose you were seeing a liability that is comparable to what you see with.
Therapeutic dose intensity.
Let me I'll just add that.
When we when you look at the human clinical trials, such as shoreline largest natural for study of Orion in depression.
Sure. These data the majority of patients that responded required only a two week course of treatment and 80% required one or two two week course of treatment.
Exited all of those trials there are like ability like questions that possess nothing anything in shoreline that suggests that patients are desiring to get back on drug as you've seen with other anti depressants.
Thank you.
One moment.
Our next question will come from Vikram per head.
Again Stanley one moment.
Your line is open.
Well on for Vikram.
On the quarter guys and thanks for taking my question just one follow up on 701 eight.
For the data that's expected throughout the rest of this year can you provide just a little bit more color on what we could expect to see and what you might be presenting thanks.
Hey, well, thanks and welcome on the call, let me turn it over to Jim.
Yes, absolutely system.
Is in a phase right now what I would call.
Yes.
Consistent execution. So the team has been working to open and conduct multiple clinical trials. So we talked earlier on the call about the Huntington study.
And so there.
These are enrolling.
Moving forward.
Team is also working on Parkinson's.
Parkinson's study.
And so I think that that study was opened a little bit later in the year, but it is also enrolling.
And then the really the focus right now in addition to getting those studies.
Moving is the work on the likelihood study that we've described today. So that's study in Alzheimer's disease cognitive impairment.
Early dementia and Alzheimer's, we're hoping to get that study we intend to get that study started by the end of the year. So it really the team is mostly focus at the moment on those studies and getting all of those clinical trials in good shape. In addition to that Prescientific exchange, we're looking at results from.
The earlier open label Phase studies or are you starting to see deeper analysis from this study, including as I talked about on the call earlier the longer duration dosing from the paradigm study, where we extended from 14 day dosing out the 28 day dosing.
Really what we found encouraging about those results as you see a prolonged improvement that we've seen at the 14 day time point maintained out at least at that 28 day time point with no real change in Tolerability profile.
Hopefully that gives you a flavor of.
A large amount of work that's going on in the face of lending program.
That does thanks.
Thanks will.
Thank you and I would now like to hand, the call back to Barry for closing remarks.
Thank you Latanya and thanks again to everyone for joining us this morning to review our third quarter progress.
Like to take a moment to thank everyone at sage for their hard work and dedication to advancing our mission of pioneering solutions to deliver life changing brand health medicine. So every person can thrive.
I am truly inspired by our exceptional people and our collaborators and the relentless commitment to patients as we continue to make critical advances across our brand health franchises, we're pleased to be executing from a position of strength.
Forward to continuing our quest to develop and launch transformative brain health medicines for patients in need in the quarters ahead.
Thanks, again, everyone and have a great day, and please get out and vote.
Ladies and gentlemen. This concludes today's conference. Thank you for your participation you may now disconnect.
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