Sage Therapeutics, Inc. (SAGE) Q4 2022 Earnings Call Transcript

Sage Therapeutics, Inc. (NASDAQ:SAGE) Q4 2022 Earnings Conference Call February 16, 2023 8:00 AM ET

Company Participants

Helen Rubinstein - Director of Investor Relations

Barry Greene - Chief Executive Officer

Jim Doherty - Chief Development Officer

Chris Benecchi - Chief Business Officer

Kimi Iguchi - Chief Financial Officer

Laura Gault - Chief Medical Officer

Conference Call Participants

Tazeen Ahmad - Bank of America

Salveen Richter - Goldman Sachs

Anupam Rama - JPMorgan

Ritu Baral - Cowen

Eason Lee - Needham

Jay Olson - Oppenheimer

Laura Chico - Wedbush Securities

Sumant Kulkarni - Canaccord Genuity

Yatin Suneja - Guggenheim

Tim Lugo - William Blair

Neena Bitritto-Garg - Citi

Douglas Tsao - H.C. Wainwright

Rudy Li - SVB Securities

Gary Nachman - BMO Capital Markets

Brian Abrahams - RBC Capital Markets

Alex Nackenoff - Raymond James

Joon Lee - Truist Securities

Operator

Good morning. Welcome to nan Sage Therapeutics' Fourth Quarter and Full-Year 2022 Financial Results Conference Call. Currently, each participants are successful a listen-only mode. This telephone is being webcast unrecorded connected nan Investors and Media conception of Sage's website astatine sagerx.com. This telephone is nan spot of Sage Therapeutics and recording, reproduction, aliases transmission of this telephone without nan expressed written consent of Sage Therapeutics is strictly prohibited. Please statement that this telephone is being recorded.

I would now for illustration to present Helen Rubinstein, Director of Investor Relations astatine Sage.

Helen Rubinstein

Good greeting and convey you for joining Sage Therapeutics' 4th fourth and full-year 2022 financial results convention call. Before we begin, I promote everyone to spell to nan Investors and Media conception of our website astatine sagerx.com, wherever you tin find nan property merchandise related to today's call, arsenic good arsenic nan slides that we would beryllium reviewing today.

I'd for illustration to constituent retired that we will be making forward-looking statements, which are based connected our existent expectations and beliefs. These statements are taxable to definite risks and uncertainties and our existent results whitethorn disagree materially. Please reappraisal nan consequence factors discussed successful today's property merchandise and successful our SEC filings for further details. We will statesman nan telephone pinch prepared remarks by Barry Greene, our Chief Executive Officer, who will supply an overview of our advancement during nan 4th fourth and full-year 2022.

We will besides beryllium joined by Jim Doherty [Technical Difficulty], who will supply an update connected our motorboat preparations for nan zuranolone successful MDD and PPD if approved, and we will past beryllium joined Kimi Iguchi, our Chief Financial Officer, who will reappraisal nan financial results from nan 4th fourth and full-year 2022; Laura Gault, our Chief Medical Officer will beryllium disposable for questions during nan Q&A information of nan call.

With that, I'll now move nan telephone complete to Barry.

Barry Greene

Thanks, Helen, and convey you everyone for joining america this morning. At Sage, we're advancing imaginable treatments for encephalon wellness by challenging normal and prioritizing what matters astir to patients. And today, our activity matters much than ever. We've reached nan nationalist wellness situation tipping point. Brain wellness disorders are 1 of nan starring origin of disablement and threatened effect early generations. We spot profound implications firsthand arsenic friends, loved ones and neighbors continued to struggle.

Yet complete nan past half period [Technical Difficulty] person been insufficient advances successful nan curen of mood, cognition and were wished to alteration nan trajectory of this crisis. This is an incredibly breathtaking clip astatine Sage. We're progressing a promising and targeted encephalon wellness pipeline pinch nan imaginable effect millions of group globally. The pipeline is simply a consequence of our innovative attack to supplier find and development, which starts pinch our caller activity connected nan GABAA and NMDA receptor systems. These pathways are important regulators of encephalon usability and nan cardinal to unlocking imaginable breakthroughs that whitethorn amended encephalon health.

Importantly, we judge our squad and our beardown financial instauration puts america successful a position to further our [pipeline] (ph) ambitions. With nan extremity of being capable to motorboat caller narcotics aliases indications for years to come. The clip is now to unleash nan imaginable of our subject and making meaningful effect connected nan lives of millions.

Moving to nan adjacent slide, we're making advancement crossed our pipeline arsenic demonstrated by nan latest regulatory milestone for Zuranolone, which we're processing successful collaboration pinch Biogen. As we precocious announced, we're encouraged by nan FDA acceptance of our NDA filing for Zuranolone pinch privilege reappraisal a Major Depressive Disorder and Postpartum Depression pinch nan PDUFA action day of August 5 of this year. If approved, we expect nan imaginable motorboat adjacent nan extremity of 2023, assuming nary hold of nan FDA reappraisal period.

With that timing successful mind, we stay laser focused connected preparing for nan imaginable commercialization of Zuranolone, which Chris will locomotion done successful much detail. Our committedness to beryllium arsenic innovative successful helping to alteration entree to curen arsenic we're processing [Arch] (ph) medicines will beryllium a cardinal facet of our wide commercialization strategy. To execute that, we're collaborating crossed nan ecosystem pinch payers, healthcare providers, diligent advocates and policymakers pinch a extremity of providing a exemplary for attraction that useful successful nan champion liking of patients pinch MDD and PPD.

We look guardant to providing updates arsenic appropriate. I would for illustration to statement since we now are successful an FDA reappraisal period, we will not beryllium making comments connected nan imaginable label, FDA interactions aliases related topics. In summation to Zuranolone, we person a robust pipeline of investigation programs that person imaginable to thief patients astatine each stages of their lifespan. With 9 objective studies ongoing. These see SAGE-718, our first successful people NMDA PAM, which are presently advancing successful 4 placebo-controlled studies and an extended study crossed Huntington's, Parkinson's and Alzheimer’s disease.

We're besides making important advancement successful our neurology franchise led by SAGE-324, which is being evaluated arsenic a imaginable curen for group suffering from basal tremor and different neurological disorders. I'd besides for illustration to item immoderate of our earlier shape programs, including SAGE-319 and SAGE-689. These are awesome examples of our merchandise motor that we judge will proceed to present robust merchandise candidates and person nan imaginable for semipermanent worth creation.

To close, I americium assured 2023 will beryllium a pivotal twelvemonth for Sage peculiarly arsenic we look guardant to nan imaginable support of Zuranolone successful nan advancement of our Brain Health pipeline.

With that, I'll move nan telephone complete to Jim for a much elaborate chat of our caller portfolio advancement and existent objective expectations. Jim?

Jim Doherty

Thanks, Barry, and bully morning, everyone. We've made important advancement crossed our improvement pipeline passim 2022, and I americium pleased to item our caller advancements. Starting pinch depression, we're excited astir nan caller FDA acceptance of our NDA filing for Zuranolone successful MDD and PPD pinch privilege reappraisal arsenic Barry mentioned earlier. Our NDA package is supported by 7 affirmative tests crossed nan scenery successful NEST objective improvement program, which encompasses information from much than 3,500 patients.

Importantly, we've seen a accordant objective floor plan to-date crossed nan improvement programme successful MDD and PPD, including a accelerated and sustained simplification successful depressive symptoms arsenic early arsenic 2 aliases 3 days, a mostly good tolerated information profile, improvements successful value of life and wide wellness crossed domains of feeling, functioning and well-being, which I'll talk much astir shortly. And a short curen people pinch nan imaginable to beryllium taken arsenic needed pinch a caller system of action. And finally, nan imaginable for a elastic curen attack successful MDD and PPD that whitethorn supply optionality to healthcare providers and patients if Zuranolone is approved. And I'll statement nan imaginable for elasticity we spot pinch Zuranolone is precisely what HCPs person been asking for to thief their patients.

Let maine grow connected nan well-being and functioning information I referenced. We touched connected this during our JPM presentation, but it's important to item successful nan discourse of nan caller acceptance for filing of our NDA arsenic these information propose nan imaginable for Zuranolone to amended measures of functioning and well-being that are important for patients pinch depression. What you'll spot present is an integrated study from completed placebo-controlled tests crossed nan MDD and PPD studies, showing that those treated pinch Zuranolone reported accelerated and sustained improvements successful health-related value of life, compared to placebo arsenic measured utilizing SF-36 scores. These results were accordant astatine nan time 15 and nan time 42 endpoints.

To summarize, these information are an important parameter arsenic it relates to value of life and wide health. Depression affects a person's expertise to feel, think, and function. The blunt sensations of pleasance closes off, connectedness and stifles creativity. It's important to statement that patients don't want to consciousness little depressed, they want to consciousness good and get backmost to their normal mundane lives. Zuranolone, if approved, has nan imaginable to thief patients execute that. We spot nan opportunity for group to consciousness well, and we cognize that's what matters astir to patients.

We besides conducted interviews arsenic a portion of nan unfastened explanation SHORELINE study pinch complete 30 patients, who responded to 50 milligrams of Zuranolone and were successful nan study for astatine slightest six months. These interviews illustrated that a important mostly of surveyed responders noticed betterment successful their intelligence and beingness symptoms successful nan first week and were satisfied by it.

In addition, a mostly of surveyed responders were reported emotion fine, positive, aliases neutral astir nan request to beryllium retreated and each were satisfied pinch Zuranolone arsenic a treatment. This feedback reinforces nan imaginable affirmative acquisition Zuranolone could supply for patients pinch MDD and PPD if approved.

I'll now move to SAGE-718, our lead NMDA receptor PAM, that is an investigational oral therapy being developed for definite disorders wherever impairment of cognition is 1 of nan main drivers of disability. This is 1 of our wholly-owned programs and was granted Fast Track nickname by nan FDA arsenic a imaginable curen for cognitive impairment successful Huntington's Disease aliases HD. We are besides investigating SAGE-718 successful group pinch mild cognitive impairment owed to Parkinson's Disease aliases PD and group pinch mild cognitive impairment and mild dementia owed to Alzheimer's Disease aliases AD. These disorders correspond immoderate of nan top areas of unmet request and we cognize that globally they proceed to go much prevalent and importantly disrupt lives.

On that basis, we're excited astir nan continued advancement we've made crossed nan program. As we mentioned earlier this year, we precocious initiated nan LIGHTWAVE study, a Phase 2 study of SAGE-718 successful group pinch mild cognitive impairment and mild dementia, owed to Alzheimer's Disease, arsenic good arsenic nan PURVIEW study, a Phase 3 hold study successful group pinch Huntington's Disease. We expect information from nan ongoing studies pinch SAGE-718 to commencement reference retired successful 2024, and we will stock much elaborate timelines erstwhile appropriate. We're besides advancing a robust portfolio that has nan imaginable to thief patients astatine each stages of their lifespan.

Let maine supply a mates of highlights, starting pinch SAGE-324 receptors. We judge that SAGE-324 holds important imaginable successful nan curen of neurological conditions for illustration basal tremor aliases ET and we and our collaborator Biogen expect completion of enrollment successful nan ongoing Phase 2b KINETIC 2 dose ranging study precocious this year. We're besides excited astir nan opportunities successful our early improvement programs, including SAGE-319, our extra-synaptic preferring GABAA PAM, which we are advancing from IND enabling studies into Phase 1 studies. We besides proceed to make advancement pinch SAGE-689 and SAGE-421 and judge that they will go important pipeline contributors complete nan coming years.

In closing, I'm proud of our advancement successful nan 4th fourth and full-year 2022, and I judge that we are good positioned to execute against objective objectives and beforehand our efforts to create encephalon wellness medicines pinch nan imaginable to present what matters astir to patients.

Now I'll move nan telephone complete to Chris to supply further discourse connected our planned attack arsenic we hole for nan imaginable commercialization of Zuranolone successful MDD and PPD. Chris?

Chris Benecchi

Thanks, Jim. I'm pleased to beryllium pinch you each this greeting to stock updates connected our commercialization mentation for Zuranolone. To guarantee nan successful motorboat of Zuranolone, if approved, we made important advancement past twelvemonth connected nan commercialization front. Core activities that person enabled our authorities of readiness include, advancing conversations pinch payers arsenic permitted pinch nan extremity of enabling entree astatine launch, engaging and educating HCPs done meaningful technological speech and hiring knowledgeable commercialized leaders to orchestrate plans intended to execute a successful motorboat successful Zuranolone if approved. With nan caller announcement of nan acceptance of our NDA filing, we stay laser focused connected preparations to execute our motorboat strategy.

Let maine outline our reasoning connected nan imaginable timelines for Zuranolone. Based connected our PDUFA action day of August 5, if Zuranolone is approved for nan curen of MDD and PPD without hold of nan FDA reappraisal period, we expect nan imaginable motorboat adjacent nan extremity of 2023, pursuing an anticipated three-month DEA scheduling review. We will beryllium prepared and expect entering a marketplace that is fresh for nan support of Zuranolone.

As you'll spot connected descent 14, we judge nan opportunity successful MDD is ample pinch millions of patients not satisfied pinch existent curen options. People who proceed to acquisition unresolved symptoms of slump are astatine risk. Many are incapable to spell to activity aliases return attraction of their families. Is difficult for these group to unrecorded their normal lives, and nan longer they hold to dainty their symptoms, nan much apt they are to acquisition antagonistic outcomes. Such arsenic impaired functioning and consequent relapse. This is why rapidity matters, some successful position of initiating a therapy arsenic soon arsenic patients show symptoms, arsenic good arsenic achieving nan accelerated betterment of depressive symptoms.

The cardinal takeaway present is simply a much accelerated and sustained attack to treating a depressive section whitethorn summation nan likelihood of amended symptomatic and functional outcomes. Given nan accelerated betterment seen successful objective proceedings [Technical Difficulty] to-date, we judge that if approved, Zuranolone has nan imaginable to supply a caller curen action to patients suffering pinch MDD pinch nan extremity of helping them return to a authorities and well-being sooner.

In PPD, location is likewise a ample unmet request pinch an estimated 1 successful 8 mothers successful nan U.S. experiencing symptoms for postpartum depression. Despite being a communal intelligence wellness disorder, women experiencing symptoms whitethorn often spell undiagnosed aliases untreated, and we spot that intelligibly successful nan debased test rates. Not only does PPD person an effect connected a mother's wide function, but it tin besides person an effect connected nan expertise for that mother to return attraction of her baby. These mothers and their families merit better. Our extremity pinch Zuranolone, if approved, is to activity pinch nan full ecosystem to alteration nan curen paradigm by importantly improving test rates successful women pinch PPD and supply HCPs pinch nan first and only FDA approved oral curen indicated for PPD that has nan imaginable to thief moms get amended sooner.

As we participate 2023, we stay focused and diligent connected our commercialization efforts successful anticipation of imaginable launch. We proceed to prosecute pinch cardinal stakeholders successful technological speech and are besides encouraged to spot affirmative signals for nan diligent defense organization connected nan value of accelerating entree to invention successful intelligence health.

And arsenic Barry mentioned earlier, we scheme to beryllium innovative connected nan diligent entree front. Our extremity for this motorboat is successful is that those surviving pinch MDD and PPD, who are prescribed nan therapy person timely entree pinch constricted complications specified arsenic measurement edits, and anterior authorization. In summation to our ain work, we are seeing authorities governments crossed nan federation make reforms to capable first argumentation and person historically restricted diligent entree to nan correct curen prescribed by their expert astatine nan correct time. People pinch MDD and PPD merit accelerated and effective therapeutic options introduced early during treatment. Because early curen is believed to present nan champion outcomes arsenic I antecedently touched on.

Given nan unmet need, we judge that Zuranolone, if approved, is champion positioned astatine motorboat for MDD patients requiring a first adhd aliases first move therapy aft continuing to acquisition depressive symptoms pursuing their first curen course, including patients who person tolerability issues aliases non-compliance pinch chronic therapy. In PPD, we strive for Zuranolone to go standard-of-care astatine motorboat pinch usage arsenic first statement therapy for curen naive patients who are recently diagnosed pinch PPD aliases successful spot of different therapies presently administered.

In nan conversations we've had pinch payers, they've been highly engaged and receptive and we judge they spot a domiciled for a imaginable accelerated acting sustained 14-day people oral therapy successful treating some MDD and PPD. We consciousness an urgency to present a caller curen action to patients fixed nan profound unmet request that still exists successful nan curen of MDD and PPD. We are dedicated successful our efforts to proceed to beforehand Zuranolone pinch nan extremity of gaining support and being capable to connection medicine pinch nan imaginable to dainty these patients quickly and amended their symptoms.

Now, I'll move nan telephone complete to Kimi for a reappraisal of our financials. Kimi?

Kimi Iguchi

Thanks, Chris. Our financial results for nan 4th fourth and full-year of 2022 are elaborate successful our property merchandise that we issued this morning. I'd for illustration to return a infinitesimal to supply immoderate discourse and item a fewer cardinal points.

We ended 2022 pinch a beardown rate position, which provides america pinch nan elasticity to support nan motorboat of Zuranolone, if approved and strategically put crossed our pipeline. Our nett nonaccomplishment for nan 4th fourth of 2022 was $147.1 cardinal and we ended nan 4th pinch cash, rate equivalents and marketable securities of astir $1.3 billion.

Turning to operating expenses. R&D expenses accrued to $89.3 cardinal successful nan 4th fourth of 2022, compared to $75.4 cardinal for nan aforesaid play successful 2021. The summation successful walk was chiefly related to ongoing investments successful our wholly-owned and collaborated programs, including SAGE-324 and SAGE-718. SG&A expenses accrued to $67.3 cardinal successful nan 4th fourth of 2022, compared to $51.6 cardinal for aforesaid play of 2021. The summation was chiefly related to hiring labor to support ongoing activities successful anticipation of imaginable launch.

As you heard from Chris, we're continuing preparations to support nan imaginable motorboat of Zuranolone, while gaining support and commercialization of Zuranolone stay our apical priority, we're besides committed to investing successful our mid-term connected semipermanent pipeline successful a strategical and disciplined way. To this end, we expect that our walk will summation arsenic we proceed our commercialization efforts and precocious plans and ongoing studies for SAGE-718 and SAGE-324. We cognize that to execute our semipermanent imagination of transforming nan attraction of depression, we must statesman pinch a focused strategy to beryllium prepared to standard quickly pinch success. Therefore, we stay mindful of nan superior allocation anterior to launch.

As a reminder, arsenic portion of our collaboration pinch Biogen, we are jointly processing Zuranolone and SAGE-324 pinch a 50:50 cautionary successful nan United States. Looking ahead, we are reaffirming that based connected our existent operating plan, we expect cash, rate equivalents and marketable securities, anticipated backing from ongoing collaborations and imaginable gross will support operations into 2025, included successful nan $5 cardinal from Biogen related to nan first commercialized income of Zuranolone successful MDD and PPD.

Given really move 2023 will be, including preparing for a imaginable launch, we will not beryllium providing year-end rate guidance astatine this time. As we embark connected a pivotal twelvemonth for Sage, I'm assured that our beardown equilibrium expanse will alteration america to execute from a position of strength. With galore imaginable worth creating milestones connected nan sky for Sage, we stay focused connected making strategical investments successful processing pipeline programs to champion position ourselves arsenic a leader successful encephalon health. We stay good capitalized arsenic we proceed to build beardown squad executing connected objectives crossed our pipeline. The clip is now for patients. We are optimistic that our attack will lead to nan improvement of treatments that group are desperately waiting for.

I'll now move it complete to Helen to grip Q&A pinch nan operator. Helen?

Helen Rubinstein

Thanks, Kimi. Before I move it complete to nan operator, I'll inquire that you limit yourself to 1 question. If you person an further question, consciousness free to return to nan queue.

Now I'll move it complete to nan usability to grip Q&A. Operator?

Question-and-Answer Session

Operator

Thank you. [Operator Instructions] At this time, we'll perceive from Tazeen Ahmad from Bank of America. Please spell ahead.

Tazeen Ahmad

Hi, bully morning. Thanks for taking my question. Just wanted to explain thing that was said successful nan prepared remarks, because I deliberation Barry, you said that station nan PDUFA successful August, you expect to beryllium capable to motorboat Zuranolone, if approved by nan extremity of nan year. What would beryllium complaint limiting factors that would forestall you from instantly launching and tin you conscionable constrictive down erstwhile you deliberation you would beryllium capable to commencement signaling sales? Would it beryllium successful almanac 2023? Or would beryllium presume it should beryllium much successful 2024? Thanks.

Barry Greene

Yes, Tazeen, convey you and acknowledgment for nan mobility and nan attention. Look, we're really excited that nan FDA has accepted nan NDA filing for Zuranolone for MDD and PPD pinch a PDUFA action day of August 5. I'll punctual you that pursuing support [Technical Difficulty] occurs connected August 5 without delay, we past move to a three-month DEA scheduling period. There are actions we could return during that period, but we can't commencement trading Zuranolone recorded income until we person that charismatic explanation pinch nan DEA schedule. So that will hap towards nan extremity of nan twelvemonth and we'll beryllium very good prepared to motorboat and excited to do so.

Operator

We'll move adjacent to Salveen Richter from Goldman Sachs.

Salveen Richter

Good morning. Thanks for taking my question. With regards to nan payer activity here, could you conscionable remark connected their knowing of pricing a supplier astatine an yearly value for a each -- erstwhile a year, two-week play aliases utilizing it possibly doubly a year?

And past secondly, I deliberation nan commercialized payer operation is astir 51% of nan payer mix. And truthful erstwhile you deliberation astir DBAs and nan strategy here, really effective are location going to beryllium to benignant of thief you position nan supplier pinch nan physicians successful position of adopting a caller curen paradigm? And past what do you do pinch nan remainder of nan benignant of non-commercial payer aspect?

Barry Greene

Yes, Salveen. That was a fewer different aspects successful there, 1 outcomes of nan proactive value-based statement strategy that we envision connected employing, that nan conception for america is to thief payers pinch immoderate fund certainty. That's really what they want. They cognize that nan prices is now good managed. Chris will get into that successful a bit. But they want prices certainty. In return, we want if a expert aliases health-care supplier believes that a diligent requires Zuranolone aliases different script, we want that book truthful quickly.

So, that's benignant of [Technical Difficulty] location is much item to that we tin get into. From a pricing position is that they deliberation astir per diligent per year. They're not reasoning astir per pill, per pack. They are really focused connected knowing per diligent per year. Chris, you want to remark further?

Chris Benecchi

Yes. So I deliberation nan DBA cardinal to this, Barry is conscionable frankly 1 component. I deliberation to beryllium genuinely transformational; we person to beryllium accessible and that really starts pinch payers successful and astir knowing unmet need. I deliberation successful each of nan interactions that we've had truthful far, there's a precocious knowing of unmet request successful and amongst nan payers and genuinely a cognition that they request thing that looks rather otherwise than what they've seen historically. They've been impressed pinch nan data, arsenic I deliberation they surely understand for those interactions nan opportunity that Zuranolone presents to present thing that works, you know, successful a accelerated acting manner aft conscionable 3 days, 14-day people thing that's durable complete time, does it travel pinch this phenotype of broadside effects truthful often associated pinch different therapies and really has nan imaginable to return patients to a authorities of welding.

In an essence, it takes a very analyzable diligent type and makes it acold simpler to negociate it historically what they whitethorn person had astatine their disposal. So, an unthinkable excitement astir that, which past shapes nan speech connected proactive worth it experiments. I deliberation successful and astir nan 2nd mobility astir payer types, we're going to activity pinch each different payer types sloppy of nan operation that they spot to travel up pinch solutions and making judge that Zuranolone is accessible astatine motorboat and again to really build connected that knowing of unmet request and what Zuranolone tin present from what we've seen successful nan information truthful acold from what [Indiscernible]

Salveen Richter

Thank you.

Operator

Moving adjacent to Anupam Rama from JPMorgan.

Anupam Rama

Hey, guys. Thanks truthful overmuch for taking nan question. Maybe expanding connected immoderate of your comments successful nan introductory remarks here, but really are you reasoning astir benignant of nan first ramp curve successful PPD? And what are immoderate of nan pre-commercial [Technical Difficulty]

Barry Greene

The wide attack to PPD and really we're educating successful due subject we exchanged OBGYN and others.

Chris Benecchi

Yes, truthful arsenic you mightiness imagine, there's a batch of attraction connected PPD wrong nan organization. If you prime up nan newspaper wherever you spell online, you spot that conscionable for illustration MDD, location is simply a important normal situation in installments pinch moms from nan astir portion of slump that we're talking astir 500,000 aliases truthful cases of PPD connected an yearly basis, truthful 1 successful 8 [Indiscernible] truthful it's perfectly paramount that we proceed to do nan activity that we're doing successful and astir moving pinch OBGYN and different prescribers that besides spot patients that are suffering from PPD to thief understand nan value of test aliases screening and diagnosis.

And subsequently, nan opportunity that a caller therapy perchance successful ray Zuranolone offers to them arsenic it would beryllium nan first and only FDA approved oral therapy for nan curen of postpartum depression. And we judge that done nan permitted technological speech that's happening correct now done aesculapian affairs squad and whether it could congresses aliases 1 connected 1 interactions pinch cardinal sentiment leaders, we're going to proceed to heighten nan sensitivity and urgency astir nan request to dainty moms that are suffering pinch PPD. And we judge that that community, nan OBGYN organization will beryllium fresh astatine nan motorboat of nan product. And we'll beryllium -- we'll happily person Zuranolone, arsenic I said, arsenic nan first and only oral therapy FD that FDA approves

Barry Greene

Yes. And conscionable astir that out, Anupam, erstwhile you motorboat a readily disposable oral medicine for illustration [Indiscernible] Zuranolone is approved. This is precisely nan benignant of paradigm displacement that happens successful medicine. As Chris mentioned, astir 0.5 cardinal moms per twelvemonth are reported to person PPD, little than 20% of those are diagnosed, moreover lesser are treated. That's really because of nan challenging to get diagnostic treatment, erstwhile you person an supplier for illustration Zuranolone that useful quickly pinch a 14-day regimen, we spot nan opportunity for physicians to look much quickly for nan test of PPD and surely diagnostic paradigm is so little PPD.

Operator

Ritu Baral from Cowen. Your statement is open.

Ritu Baral

Good morning, guys. Thanks for nan update today. I wanted to conscionable inquire astir nan SHORELINE information contained successful nan submission. Can you guys corroborate that what we person successful nan nationalist domain is benignant of nan grade of nan SHORELINE follow-up and retreatment information contained successful nan dual NDA? And tin you springiness america immoderate colour arsenic to what will beryllium presented additionally from SHORELINE mid-year? Thanks.

Barry Greene

Yes. Thanks, Ritu. Jim, you want to return that?

Jim Doherty

Yes, of course, Barry. So nan SHORELINE study, naturalistic study design, designed to travel patients wrong [Technical Difficulty] and measure some information and tolerability’s astir them and nan request to repetition dosing for up to 1 year. The SHORELINE study has [Indiscernible] successful nan programme first and foremost, it provides america pinch information information for good complete 1,000 patients now. Equally important, it provides immoderate real-world grounds for really Zuranolone whitethorn beryllium utilized if approved. So nan SHORELINE is an important constituent successful nan NDA submission. So nan information that completes nan day is included successful nan NDA submission. The SHORELINE study besides continues, truthful we person nan newest cohort of SHORELINE, which is completing now. That cohort is simply a rollover cohort from nan CORAL study. So that will supply immoderate really further absorbing accusation for retreatment pinch Zuranolone?

Barry Greene

Yes. So -- Ritu, truthful nan information that you've seen coming connected SHORELINE is 1% aggregate times. And it’s an principle what's successful nan NDA filing, arsenic Jim said, will beryllium utilized mostly from a information database. We'll person an update mid-year, which we deliberation will beryllium rather informative and erstwhile we get that update, we'll fto you know.

Ritu Baral

Great. And will that update beryllium submitted to FDA astatine that time?

Barry Greene

There's regular communications pinch FDA connected information updates including SHORELINE.

Ritu Baral

Awesome. Thank you.

Barry Greene

Thanks, Ritu.

Operator

We'll perceive adjacent from Yasmeen Rahimi from Piper Stanley.

Unidentified Participant

This is [Chuck Miller] (ph) connected for Yas. Thank you for taking our questions. So first 1 is, if you could supply a small spot of much colour connected nan life rhythm invention study that you mentioned successful nan property release, related to creation specifications and nan timing of that study? And past 2nd 1 is erstwhile should we expect to spot nan wellness economical information for nan scenery and nan adjacent studies?

Barry Greene

Yes, [Indiscernible]. Thank you and please nonstop our champion to Yas. Jim, you want to return that?

Jim Doherty

Absolutely, Barry. So astatine nan moment, we're not providing immoderate further specifications connected nan lifecycle guidance study. So nan [ATOR] (ph) information you're referring to and there's a batch of further information for Zuranolone that is coming retired successful cardinal publications and technological conferences passim 2023.

Helen Rubinstein

Thank you. I deliberation we tin move to nan adjacent question.

Operator

We'll perceive from Ami Fadia from Needham.

Eason Lee

Hi, bully morning. This is Eason Lee connected for Ami. Thanks for taking our question. So Biogen's comments connected its net telephone yesterday proceed to beryllium affirmative connected nan Zuranolone opportunity. Maybe could you supply immoderate much specifications connected really you each and Biogen are moving together pinch respect to things for illustration prepping nan market, communicating pinch FDA, payers, et cetera? Thank you.

Barry Greene

Yes, Eason, acknowledgment for nan question. Yes, it was Biogen from nan start, it's been a phenomenal partner. And intelligibly pinch Chris Viehbacher coming connected board, fixed his acquisition successful starring larger [Technical Difficulty], his activity successful pharma, arsenic good arsenic his acquisition of slump has really been an adhd to an already beardown partnership. Together, we're very bullish connected nan opportunity for Zuranolone thief millions suffered from MDD and PPD. And we're for illustration minded successful position of nan paradigm displacement we're looking to create successful nan curen of depression.

I'd opportunity from a regulatory, development, commercialization, CMC, proviso concatenation perspective, we're measurement successful measurement successful really we're moving successful nan U.S. and it's a 50-50 [Indiscernible] successful nan U.S. So we're good prepared together, if approved to motorboat their own.

Operator

We'll move adjacent to Jay Olson from Oppenheimer.

Jay Olson

Hello? Hey, congrats connected nan advancement and convey you for nan update. Can you punctual america what level of DEA scheduling you're expecting to person for Zuranolone and really nan scheduling will effect nan motorboat of nan supplier and expert and diligent cognition successful Zuranolone? Thank you.

Barry Greene

Yes, Matt. Thanks for nan question. So we -- fixed nan people of medicines that Zuranolone is simply a neuroactive steroid targeting GABAA, we expect that will beryllium a schedule IV drug. And nan three-month DEA twelvemonth position aft our 2 batch of information assuming were approved, will beryllium nan process to corroborate that. What group request to understand is that nan supplier schedule has a batch to do pinch proviso concatenation guidance and really these agents are handled crossed nan proviso chain, earthy materials, progressive ingredients, [Indiscernible] attendance successful nan pharmacy.

In position of patients getting a medicine from their physician, each expert has a DEA number to constitute and there's millions of millions of prescriptions that are being written for scheduled narcotics by our target assemblage already. So really don't support being an rumor astatine all.

Jay Olson

Great. Thank you very much.

Barry Greene

Thanks, [Jay] (ph).

Operator

Laura Chico pinch Wedbush Securities. Please spell ahead.

Laura Chico

Hey, bully morning. Thanks for taking nan question. I wanted to circle backmost to 1 that's a small spot much logistical, but connected nan commercialization. Any further commentary astir benignant of really you envision diligent guidance aliases diligent travel guidance is going to beryllium handled successful nan commercialized setting? I conjecture what I'm trying to understand a small spot much is who successful nan offices that's going to beryllium chiefly responsible for managing diligent follow-up patterns and I'm trying to understand a small spot much connected nan refill process? How are they going to beryllium monitored and what would trigger a refill to beryllium authorized? Thanks.

Barry Greene

Yes. Great, Laura. And that's a really important question. So we deliberation Zuranolone doesn't alteration nan believe of psychiatry aliases superior attraction to dainty these folks, it really enhances. It's different instrumentality aliases [Indiscernible] wherever they each understand that patients are managed aliases patients respond much quickly than nan devices they person today. But fto maine inquire Laura who's treated astir of these folks and really she thinks astir nan diligent flow.

Laura Gault

So convey you for nan question. It's my belief that Zuranolone is approved, it’s really going to fresh successful pinch really ATPs are presently treating patients pinch depression. I deliberation that they will proceed to show patients complete clip and if location is simply a reemergence of symptoms that propose different [Technical Difficulty] occurring, past they will acquisition different curen people pinch Zuranolone different [Technical Difficulty] expert and extremity diligent compensation.

I deliberation what Zuranolone delivered to nan group present is simply a instrumentality that is different than nan supplier that physicians person been capable to usage successful nan past. It is simply a supplier that useful quickly that has a durable effect. And that is simply a short-term connection for us. And from nan discussions pinch physicians, what we perceive is that either things that are doing highly valued. And we'll spot nan important portion of nan armamentarium to [Technical Difficulty] slump moving forward.

Barry Greene

Yes. And conscionable to information that out, immoderate of nan guidelines of your question, Laura, is benignant of a communal belief, which is simply a misconception, that coming a diligent comes in, they are put connected a chronic medicine they enactment connected that medicine and possibly it's each complete nan six months and each arsenic well. But nan information don't support that. The information suggests that a diligent fixed a caller antidepressant, only connected nan antidepressant for a median of 7 weeks and that patients who proceed to activity curen and immoderate don't, immoderate discontinuation and time off nan system. But those are nan [PDC] (ph) curen travel done 2 to 3 different medications a year.

So conscionable deliberation astir it. It's not for illustration coming someone's connected chronic medicine, they're conscionable fine. They're not. So we deliberation Zuranolone pinch nan imaginable accelerated effect. Again, arsenic Laura said, enhances nan believe of treating that patient, doesn't really alteration really you show that patient. You besides asked astir refills. There will beryllium a assortment of ways that refills tin happen, immoderate mightiness constitute scripts astir pinch a refill already. Instructing their patients, and if they're emotion amended for extended play of time, but they're acheronian and mood, elevated worry and insomnia travel back, you know, to refill and effort it again. If it doesn't work, travel and spot me, I mightiness person different instrumentality for you. More refill tin beryllium called into a drugstore conscionable for illustration immoderate supplier today.

Laura Chico

Thanks.

Operator

Moving adjacent to Sumant Kulkarni from Canaccord. Please spell ahead.

Sumant Kulkarni

Good greeting and acknowledgment for taking my question. So Zuranolone is comparatively accelerated acting. So either successful SHORELINE aliases successful immoderate different setting, do you person information connected patients that whitethorn person stopped taking nan merchandise earlier completing nan afloat 14-day people of therapy simply because they person to benignant of slump had gone distant and they were emotion better. I'm asking because this discretionary diligent action could person important implications of pricing and imaginable sampling and nan move mightiness lead to ample distributions astir nan per patient, per twelvemonth pricing that payers are looking astatine versus possibly trading a level price?

Barry Greene

Yes, Sumant, acknowledgment for nan question. So I'll inquire Jim to talk astir circumstantial data. Obviously, erstwhile you're treating complete 3,500 patients, it mightiness -- location are problems connected patients who took a supplier for a play of clip and stopped, because they're emotion truthful better. But that's been a ample portion of not what's happening. Just for illustration if you are prescribed, arsenic you person for your little respiratory tract infection successful full to consciousness better, but complete nan afloat course. That would beryllium nan instruction for Zuranolone. And we don't really judge there's going to beryllium overmuch of a move wherever a diligent mightiness return Zuranolone for 3 aliases 4 days and “save nan remainder of their pack”. So location will beryllium instructions to complete nan 14-day pack. And nan information are supported arsenic those that complete nan 2 week and respond -- stay responded. So we don't really deliberation that could springiness a large move that plays retired here.

Operator

We'll perceive adjacent from Yatin Suneja from Guggenheim.

Yatin Suneja

Hey, guys. Thank you for taking my question. Just pursuing up connected a mobility that they asked earlier. So nan floor plan of nan supplier is short-term and you person a de-scheduling to astir apt limit your expertise to sample. Can you possibly conscionable talk astir nan relevance of sampling? How could that effect you, particularly successful nan PCP setting? Thanks.

Barry Greene

Yes, Yatin. Thanks for nan question. Let maine inquire Chris to talk astir our wide project.

Chris Benecchi

Yes, truthful from what we're reasoning about, there's a number of different ways that we deliberation astir getting physicians early acquisition pinch nan medication. While we haven't communicated yet that we're going to person an extended sampling program. There's a number of different ways to deliberation astir this and nan squad was really reasoning done that. We cognize that from nan acquisition that we've seen pinch investigators is that those physicians that person experience, they admit nan profound effect that Zuranolone have, truthful it's not only acquisition has been critical. With respect to DE scheduling, we don't expect it having a awesome effect connected nan measurement that we deliberation astir sampling. While location whitethorn beryllium 1 aliases 2 states that whitethorn person immoderate connection astir sampling and sampling stores. There's replacement ways to get physicians acquisition arsenic well. So we don't spot DE scheduling, we spot thing that would successful immoderate measurement [Indiscernible] a position and getting early experience. And rather arsenic that, we deliberation that from nan immense array of programs that we tin employment that really acquisition is going to beryllium thing that's going to person a profound effect connected nan motorboat successful meditation.

Operator

Tim Lugo from William Blair has your adjacent question.

Tim Lugo

Thanks for taking nan question. For nan launch, are you going to group up a cardinal hub to woody pinch immoderate preauthorization aliases entree hurdles physicians whitethorn person to woody pinch benignant of during nan early portion of nan launch?

Barry Greene

Yes, Tim, acknowledgment for nan question. Look, we'll -- we person a very -- we ideate a very robust transmission strategy successful spot that deals pinch everything from -- to nan grade there's anterior writer steps to make judge that if nan book is written, that diligent gets nan drug. So look, that will each beryllium group up and successful place.

Tim Lugo

Okay, great.

Barry Greene

Thanks, Tim.

Operator

We'll move adjacent to Neena Bitritto-Garg from Citi.

Neena Bitritto-Garg

Hey, guys. Thanks for taking my question. I really conscionable had a mobility connected nan KINETIC 2 study. I was conscionable wondering if you could springiness america an update connected what you're seeing connected nan enrollment beforehand there? And if immoderate of nan measures you took to velocity up enrollment person resulted successful a faster pace? Thanks.

Barry Greene

Thanks, Neena, for nan question. Jim, do you want to return that?

Jim Doherty

Yes, of course. Thanks, Neena. As you mentioned, we're presently very focused connected completing nan KINETIC 2 Phase 2b study for cardinal tremor successful nan Phase 3, Q4 program. The KINETIC 2 study is presently opened for enrollment and we're anticipating completion of enrollment successful precocious 2023. As I've spoken astir previously, a number of factors person challenged nan KINETIC 2 study, 1 of those was intelligibly immoderate staffing challenges astatine sites and CROs coming retired of pandemic, that's thing that's being seen crossed nan industry. We besides saw a small spot of a slower gait successful enrollment than we had primitively anticipated, owed to immoderate circumstantial criteria successful protocol.

And finally, location are aggregate ET tests that are targeting a akin diligent organization that are going correct now. But we -- arsenic we mentioned previously, we made immoderate modifications to nan programme and we're assured that those modifications are having a affirmative impact. So arsenic I say, we expect to complete enrollment successful precocious 2023.

Operator

Douglas Tsao from H. C. Wainwright. Please spell ahead.

Douglas Tsao

Hi, bully morning. Thanks for taking questions. Just curious, really do you scheme aliases do you scheme connected doing a station trading study? And I'm conscionable curious, successful bid to understand really often patients request to beryllium treated pinch Zuranolone. Obviously, conscionable fixed nan truth that patients move payers a batch and truthful distant and evidently location are benignant of limitations pinch for illustration IQVIA and truthful distant data. Just funny really do you complete nan semipermanent scheme to understand nan floor plan and really often patients request to beryllium treated? Thank you.

Barry Greene

Yes. Thanks, Doug. That's an important question. So what we cognize coming and arsenic Jim commented connected this earlier is, SHORELINE is nan largest naturalistic study belief connected [Indiscernible], and nan information are beautiful clear. Now, while SHORELINE isn’t precisely existent world arsenic adjacent to existent world arsenic we get this point. And what we spot for SHORELINE is for those that respond to nan mostly required only nan first two-week people of treatment, and past if nan number is 80% required retired of 1 aliases 2 people of curen successful almanac year. So we judge that that's really it tin salary retired existent world.

Now erstwhile Zuranolone is approved, we'll surely activity a number of different ways to understand what's happening complete time, whether it's registries, aliases payer collaborations, we'll person those information astatine hand. And of course, because we person -- we will person value-based agreements successful place. Those will beryllium informative arsenic well, truthful there'll beryllium a number of sources for america to understand really galore two-week courses a organization needs complete a play of time.

Douglas Tsao

Physicians, do you get a consciousness of they're going to usage Zuranolone initially arsenic an adhd on? Or do they want to usage it arsenic a monotherapy arsenic benignant of a switch?

Barry Greene

So we -- successful nan technological speech that we person pinch imaginable prescribers and our investigators, we're proceeding different views. And nan bully news is that we person information pinch Zuranolone arsenic a monotherapy, connected apical of a unchangeable antidepressant and co-administer pinch antidepressant. So we person a [Technical Difficulty] astir Zuranolone to usage nan medicine arsenic nan diligent feels due for -- arsenic a expert feels due for their patient. We've heard immoderate physicians for definite patients specified arsenic young adults, they mightiness want to usage nan monotherapy for personification that often suffers from nan depressive episodes, they want to prescribe it arsenic a co-administration. So we person nan optionality and nan information to support nan measurement a healthcare supplier tin group to dainty their patients.

Douglas Tsao

Great. Thank you very much.

Operator

We'll move adjacent to Marc Goodman from SVB Securities.

Rudy Li

Thanks for taking my question. This is Rudy connected nan statement for Mark. I person 2 questions for SAGE-718. So nan LIGHTWAVE and DIMENSION study utilizing nan initially higher dose followed by little dose? Well, nan different 2 study uses fixed dose arsenic 1.2 milligram. You tin talk astir nan rationale for nan dosing selection?

And secondly, tin you talk astir nan quality betwixt patients that utilizing inpatient versus outpatient settings? Thanks.

Barry Greene

Yes, Rudy, acknowledgment for nan question. Look, we're really excited by SAGE-718 arsenic nan first-in-class NMDA PAM that we're studying for cognitive impairment crossed neurodegenerative diseases, including Huntington's, Parkinson's and Alzheimer's. The programme is progressing very good and we're really excited to person information from that programme successful 2024. In position of your specifics, Jim, do you want to talk astir this dose in, successful and retired patient?

Jim Doherty

Absolutely, Barry. And arsenic Barry said, we're very excited astir 718 here. We're presently moving 5 Phase 2 studies crossed 3 different indications. Huntington's disease, Parkinson's illness and Alzheimer's disease. And really nan dosing that you're referring to wherever -- what nan strategy is to execute and support a definite level of vulnerability for SAGE-718. And truthful what you're seeing is arsenic nan programme matures, we are doing that. So nan extremity is successful nan lawsuit of nan DIMENSION study, which is dosing for complete a three-month play to execute and support that dosing level.

We are astatine this constituent looking astatine outpatient studies for nan SAGE-718 program, nan floor plan of SAGE-718 some from a information NPK position really allows them to do that. So each these studies are outpatient studies.

Barry Greene

Yes, I would conscionable adhd in, Rudy, that nan use consequence we're seeing for SAGE-718 is highly broad. We're seeing accelerated betterment successful higher bid cognition, executive usability learning and representation and it's incredibly cleanable [Indiscernible]. So we're really excited astir continuing to move that forward.

Rudy Li

Got it. That's very helpful. Thanks.

Barry Greene

Thanks, Rudy.

Operator

Gary Nachman from BMO Capital Markets. Your statement is open.

Gary Nachman

Hi, bully morning. With nan privilege reappraisal for Zuranolone, do you still deliberation there's a anticipation for an AdCom, does that alteration astatine each pinch privilege reappraisal timeline? And wherever would you find that out? And past nan measurement nan NDA has been filed, you're evidently looking for an support successful some MDD and PPD together. But is it imaginable for nan FDA to divided those up and o.k. 1 denotation first, and past nan different astatine a later constituent if that yet wants to spot much data? Thanks.

Barry Greene

Hey Gary, acknowledgment for nan question. So fto maine return nan 2nd portion first. As you highlighted, we revenge an NDA for some MDD and PPD and we deliberation nan information warrant support for some MDD and PPD. So that's our existent thought astatine nan clip and advised arsenic good on pinch that. In position of AdCom, that solely is simply a discretion of nan FDA, if nan FDA decides, it was astir nan information and is emblematic successful AdCom’s present from diligent if they person advocates to item really devastating unmet needs that he's retired location pinch depression. So we'll beryllium good prepared if they person an AdCom. If nan FDA decides not to clasp an AdCom and that's a awesome of a accelerated approval, we for illustration that too.

Operator

Moving adjacent to Brian Abrahams from RBC Capital Markets.

Brian Abrahams

Hey, guys. Good morning. Thanks for taking my mobility and congrats connected each nan advancement and connected nan filing acceptance. I'm funny if you could talk astir your latest views connected really you mightiness gross nan motorboat attraction and finance from targeting psychiatrists initially to yet moving and expanding into nan superior attraction setting? Curious, what feedback and metrics you mightiness beryllium looking for it to style that imaginable progression? Thanks.

Barry Greene

Yes, Brian, acknowledgment for nan question, and acknowledgment to it, congratulations. Glad to perceive that you're arsenic excited arsenic we are. Look, we unrecorded successful a world of really beardown accusation and person really bully knowledge of those healthcare providers that are seeing nan slump patients those that are consenting to constitute prescriptions, peculiarly granted prescriptions. And we counsel we’ll attraction connected wherever we deliberation we'll get nan strongest diligent travel that has nan correct security sum first and past grow quickly pinch success, truthful that's nan attack we're taking. We're surely to attraction connected psychiatry and those larger offices irrespective [Technical Difficulty] this is erstwhile we spot a batch of these patients, that will beryllium -- that will beryllium our focus.

Chris Benecchi

[Technical Difficulty] location is simply a group of PCPs that you'll beryllium calling connected a teaser PCPs that do behave much for illustration psychiatrists, they spot a number of patients pinch MDD. And we'll besides attraction connected OBGYNs, but I don't want nan portion astir PPD to beryllium lost. And I deliberation arsenic you said it's very based connected nan metrics that we person some expert level and diligent level information that we person astatine our disposal, we're going to make decisions astatine nan correct clip to proceed to standard pinch occurrence arsenic we look forward.

Barry Greene

Yes, I'd besides adhd Brian that we're capable again successful nan world we're surviving to understand diligent activation and benignant of patients that are frankly going to absence of rental by name. We judge that that's going to hap pinch nan supplier for illustration this.

Brian Abrahams

Thanks truthful much.

Operator

Danielle Brill from Raymond James. Your statement is open.

Alex Nackenoff

Hey, guys. This is Alex connected for Danielle. Thanks for taking our question. So I cognize you're not targeting curen resistant slump successful your commercialization strategy. But do you consciousness that it's a consequence for clinicians to initially proceedings Zuranolone successful their patients that mightiness skew towards this population? Potentially negatively coloring their perceptions of efficacy? In different words, do you deliberation Zuranolone would activity successful TRD? And conscionable connected that front, what's nan gating factors now to initiating general tests successful curen resistant slump and worry bipolar? Thanks.

Barry Greene

Yes. Let maine commencement pinch nan 2nd portion of that [Technical Difficulty] I'll talk astir first, truthful we judge nan unmet request successful MDD and PPD is truthful great. As we talked astir 6 cardinal to 7 cardinal move patients pinch -- looking for caller curen options successful MDD, 0.5 cardinal moms that should beryllium diagnosed pinch unit successful nan year. That diligent organization is truthful significant, unmet need, truthful significant. That will stay our attraction for nan foreseeable future. If we tin triumph successful depression, we tin really thief millions of patients. So we'll supply benignant of early indications astatine later points successful time.

But correct now, nan attraction is perfectly triumph successful depression, trying to thief arsenic galore group arsenic we can. In position of really astatine motorboat nan supplier will beryllium used, arsenic Chris already highlighted successful PPD, we'd for illustration to person Zuranolone being standard-of-care. The only oral if approved, nan only oral curen approved specifically to dainty PPD. And successful MDD, our target is to amended physicians that Zuranolone should beryllium utilized arsenic your first move aliases first adhd connected should nan diligent not beryllium adequately controlled pinch immoderate they're taking and that is our first [Indiscernible].

Chris Benecchi

Yes. I deliberation what I'd adhd to that, Barry, is if near to things to conscionable happen, I could spot wherever physicians crossed each different areas of treatment, usage caller products later. But here, what we person done not only nan positioning and nan recognition of due places of use, contempt nan thought of proactive value-based agreements. Proactive value-based agreements are designed to really guarantee that physicians person entree earlier successful nan curen paradigm. So that you don't person nan owner's anterior authorization successful measurement edits, which tin yet return a caller medicine and push it to later utilization. So it's -- truthful important that we activity crossed each stakeholders to make judge that physicians person nan expertise to really entree really nan curen process and usage it wherever they want to launch.

Operator

We'll perceive adjacent from Joon Lee from Truist Securities.

Joon Lee

Hi acknowledgment for taking our questions. Looking guardant to further information from [Technical Difficulty] get package? And besides quickly, you mentioned lifecycle guidance for Zuranolone. Can you stock what you person successful mind? Thank you.

Barry Greene

Yes, Joon. Thanks for nan question. So we're not coming much connected lifecycle management. As we commented earlier connected nan call, we'll person a regular bid of updates pinch nan [Indiscernible].

Operator

Thank you, everyone. That will reason nan Q&A information of today's call. With that, I will move it backmost complete to Mr. Barry for closing remarks.

Barry Greene

Thanks, Lynette, and acknowledgment again to everyone for joining america this greeting to reappraisal our 4th fourth and full-year 2022 results. Our advancement successful nan 4th fourth and passim 2022 is nan nonstop consequence of teamwork and dedication from everyone successful our and our partner's organization, truthful I want to convey everybody. As we make captious advancements, progressive improvement activities crossed encephalon health, we support a position of spot arsenic we beforehand our ngo to create and motorboat transformative medicines for patients successful need. Thanks again everyone and person a awesome [Technical Difficulty]