Sage Therapeutics, Inc. (SAGE) Earnings Call Transcript & Summary

Al-righty. Let's go ahead and get started. Welcome, everybody, to the Tuesday morning of the JPMorgan Healthcare Conference -- 41st Annual JPMorgan Healthcare Conference. My name is Anupam Rama, I'm one of the senior biotech analysts here at JPMorgan. I'm joined by my squad, Malcolm Kuno and Priyanka Grover. The next presenting company is Sage. Presenting on behalf of the company, we have CEO, Barry Greene. Barry?

Thanks, Anupam, and squad. And thanks for the organizers of JPMorgan for having us here today. It's great to be here live in sunny San Francisco, live again. I'm Barry Greene, as Anupam said, the CEO of Sage Therapeutics. It's an absolute pleasure to provide an update on the extraordinary progress that we at Sage are making, progressing a pipeline of novel brain health medicines. I will be making forward-looking statements. As we stand here as an industry, we can be extraordinarily proud of the significant innovative and life-saving progress we've made in many therapeutic areas, things like cardiovascular disease, oncology, rare diseases and of course, infectious diseases. We can't say the same for brain health, however. And why is that? Brain health disorders are among the leading cause of disability in the world. And we need significant change. We need the world to appreciate that brain health is associated with good health. And for us to get on a path to recover from this disability, a healthy brain is important for a long robust lifestyle. We're focused at Sage, making sure that we're developing drugs that matter most to patients. The good news is, I do see change coming. We're certainly at a tipping point. The medical need is clear. We're seeing tremendous scientific advancement, political pressure, a changing population demographic that is feeding to the momentum that brain health is fundamental to good health. And there's certainly an urgent need to think differently. At Sage, we're driven to develop brain health medicines that matter most to patients. The time is now for us to get moving forward. So what we're doing at Sage is focused investigation of novel mechanism of brain function that could be key to unlocking therapies that may improve brain health. Our work starts with GABA and NMDA. These are the regulatory pathways that control brain circuitry. GABA being the inhibitory pathway and NMDA being the excitatory pathway. We know that disruptions in these pathways often lead to brain health disorders. And we're focused on restoring normal brain function in a very particular way. We spent a decade understanding natural neuroactive steroids that are endogenous to the brain and manipulate these pathways in very specific ways. And at Sage, we're using our chemistry capability, that of neuroactive steroids, including oxysterol chemistries, to design new chemical entities that [ extensively ] mimic these neuroactive steroids that reregulate these neuronal networks. And we're excited by the tremendous progress that we've made to date. It's a really exciting time for Sage, both in 2023 and in our future. Just last year, in December, we and Biogen filed the rolling NDA for zuranolone for MDD and PPD. We're excited to hear from the agency in the next couple of months, whether we have a standard or priority review, and we certainly will let everybody know. We continue to progress our rich pipeline of innovative brain health medicines given the deep expertise we have in brain circuitry. Our medicines have an opportunity to impact millions of people worldwide suffering from brain health disorders. We are well positioned with an incredibly strong balance sheet to execute our long-range plan, investing in near, mid- and long-term value creation. This year should be tremendous momentum for Sage, and we look forward to the years to come. Now the Sage product engine and methodology works. We have a pipeline of very specific pharmacologically specific molecules for very precise indications. And as a proof point to that methodology working Sage is the first company to get a drug specifically approved for postpartum depression that's followed the Sage methodology. Let me turn to depression. I think we all appreciate that we are in a brain health pandemic and that we are in a crisis stage with depression. We know that all of us know somebody, whether it's you, a loved one or a family member that has depression and is suffering from depression. We all know that depression is not well served, although there might be common wisdom that it is. Let's look at the data. In 2020, there was a survey in the United States of the United States adults, 21 million people reported to have a depressive episode in the last 12 months alone. We know that 6 million to 7 million people dynamically are seeking new treatment options. And on the PPD front, 1 in 8 live birth results in a depressive episode. So that's 0.5 million moms suffering from depression. So clearly, a number of people out there that absolutely need help. And we need to do more to help these folks. Right now, we have many, many medicines to treat depression. But there's been really a paucity of innovation over the last several decades. And the way depression patients are treated is on a trial-and-error basis. Those that get help can take weeks to months to feel better. And for those that need multiple treatment options, it could take months to years of lost productivity and lost time. So we really need to do something different. I had an analyst approach me and saying they spoke to an expert who told them that their depression patients were well managed with generic medicines. Well, let's look at the facts. That's just not true. The Journal of Managed Care & Specialty Pharma published a study of depression. And in this publication, they wrote that the average time of patients on a newly prescribed antidepressant is 7 weeks. And that these patients, if they continue to seek treatment, many discontinue, cycle through 2 or more treatments in the course of the year. So the common wisdom that, I diagnose my patient, I put them on a chronic medication, I see them in 6 months, and all is well, it's just not supported by the facts. When we look at STAR*D and other publications, we see that those that are undertreated are often -- lead to other depressive episodes. And those with depression have downstream comorbidities, like cardiovascular disease, diabetes, cancer and infectious diseases. And just look at the economic burden. In 2018, depression cost the U.S. $300 billion. That was pre-COVID. We know that exacerbated by COVID, depression has increased 3 to 4 fold since that time. So those numbers and costs are only going up. And just think about it from a personal perspective. Who among you would want your adult child in her freshman year of college suffering a depressive episode and requiring the entire semester to get well when there's an option to get well in 2 or 3 days? I certainly wouldn't want mine. Or someone in the prime of their career doing very well in their 40s that loses a parent, suffers a depressive episode and takes months to recover, potentially even losing their job and their ability to support their family. So at a societal and economic level, we just need to do something different. Our hope for zuranolone is that we have a new medicine that can help alleviate some of this burden. Now there is good news. At medical congresses for years, there's been a plea for new depression drugs that work faster, for new depression drugs that are short course, or even both. And there's been a wave of new treatment options, some FDA approved, some being used, things like esketamine, FDA approved, a combination drug that purports to work in 1 to 2 weeks. So there's an answer to this. We're also seeing ketamine used and psychedelics used to try to alleviate. All of these approaches have some challenges. But what it tells me is that there's a desperate need for new approaches to treat depression. Zuranolone, if approved, has the potential to scale. It's an oral med taken for 14 days, and address many of these unmet need areas. What we see across 3,500 patients in our MDD and PPD clinical trials to date is that we see a rapid and sustained improvement of depressive symptoms as early as 2 to 3 days. That's after 1 to 2 evening courses of drug. We see a well-tolerated safety profile without the stigmatizing side effects often associated with antidepressants like weight gain and sex dysfunction, GI effect. We have a novel mechanism of action. As I shared, our goal with zuranolone was to rewire that dysregulated neural network back to a normal state so that someone who responds after 2 weeks of drug does not need drug potentially for the rest of the year or longer. We have improvement in feel and functioning in our patient-reported outcome data. I'm going to cover that in a moment because it's really important and frankly, impressive data. And importantly, a very flexible approach. We've studied zuranolone as monotherapy on top of the stable antidepressant or co-administered with an antidepressant. And importantly, let me reference back to STAR*D again. We know that depressed patients with certain comorbidities, so MDD with elevating anxiety, MDD with insomnia, are not well treated with today's antidepressants. These are some of the most difficult patients to treat. And the data we see with zuranolone is consistent whether you have MDD, MDD with elevated anxiety or MDD with insomnia. And importantly, the profile of zuranolone is the kind of profile that health care providers have been asking for, for years. Now let me turn to the patient reported outcomes that I referenced. What I'm sharing with you are the 8 domains of the SF-36, or Short Form 36. This is a patient-reported outcome measure. And what these data suggested that after 15 days, so after the 2-week course of treatment is completed, and importantly, after 42 days, that's 4 weeks off drug, across all of the physical and mental dimensions, patients are reporting that they're better. These are the kind of data that, if successful in the real world, can help patients not be less depressed but actually feel well. And let's look at what patients are telling us directly. In the SHORELINE Study, the -- to our knowledge, the largest naturalistic study in MDD done to date, we surveyed over 30 patients that responded to the initial 2-week course of zuranolone and were on the study for over 6 months. And you can read the quotes and this is available on our website. But let me just pick one on the durability question. This is a patient who talked about the after goal after 2 weeks treatment. And then importantly, I'll read this. I didn't have to think about it constantly, his depression. I didn't have to take medication. I wasn't having to think about my depression and try to manage it. So just step back and think about it. When you take a medication once, twice, 3 times a day, you're reminded every single day that you're dealing with your depression. At least this one patient shared with us that after 14 days, they were well, and they didn't have to think about their depression every single day. And then look at the retreatment comment. I felt better both times. This is clearly a patient that required another course of treatment. These direct quotes talk about the vitality that patients feel with zuranolone. And again, people with depression don't want to be less depressed, people with depression don't want to be less anxious. They don't want to have their insomnia be less, they want to feel well. And when we look at the SHORELINE data, the majority of patients required only 2 weeks of drug in the course, that initial 2-week course. And 80% required only 1 to 2 weeks of drug in the course of a year. The median time to retreatment on SHORELINE for the 50-milligram was 249 days, indicative that if you responded to the initial 2-week course, you might not have needed drug until another depressive episode. Let me now turn to the commercialization and plans for launch. I will remind you that on December 6, Sage and Biogen held an investor-focused commercial spotlight. Chris Benecchi, who will come up on the stage, Sage's Chief Business Officer; Alisha Alaimo, the Head of Biogen U.S.; and Dr. Greg Mattingly, among others on the team, spend a significant amount of time talking about the use cases for zuranolone, the data and our launch plans and strategy. So I encourage you to listen to that. It's really -- it was really well done. But let me hit a couple of things. We and Biogen are aligned with clear health care provider, patient-to-patient advocacy and payer strategies. Our strategic focus at launch for MDD will be using an omnichannel approach to address the widest prescribers we can for both MDD and PPD. We'll use digital, virtual, and of course, live interaction. The target patient population for MDD at the beginning will be those that have a diagnosis of MDD and are not doing well either on or off a drug that they recently tried. These are about 6 million to 7 million dynamic patients that meet this profile. So it's just a lot of people. With PPD, of course, our goal is to reach moms as early in their diagnosis as possible. And since zuranolone, if approved, will be the only oral medicine specifically approved for PPD, our goal is for PPD to have zuranolone be the standard of care. Strategically, we're starting with a very focused approach and scaling with success. Now if zuranolone is approved, I can tell you, we and Biogen are extremely excited to launch a completely new approach to treating depression. And we'll be well prepared for AdComs and anything that comes our way. Let me now turn to neuropsych where there is a significant unmet need characterized by cognitive impairment. Cognitive impairment plays a key role in many, many diseases. In some diseases often thought about as psychiatric or movement disorders, the thing that patients complain about first is their cognitive impairment. There are multiple domains of cognition, executive function, learning and memory, attention, language and visual-spatial dimension. But I'm going to focus on the higher order aspects of cognition, executive function and learning and memory. These 2 domains together, executive function kind of being the conductor of the brain orchestra, and learning memory, of course, being how we store and recall memory. These 2 higher order domains together are what we need to do things like manage our finances or make a shopping list, drive to the store, buy the items on our list, drive home, put those items away and remember where you put them. Some of you may have left them in the car, but that's a different issue. So our goal here is to allow people to do those tasks. And when you talk to people suffering with mild cognitive impairment, which in many cases is not mild, they want to be able to do these activities. They want to maintain their independence. That's the most important aspect of the disease pathophysiology is the loss of independence. And the goal for us with our neuropsych franchise is to preserve independence by providing rapid noticeable and sustained improvement in cognitive function early in the disease pathophysiology as we can. Let me turn to SAGE-718. SAGE-718 is the first-in-class NMDA positive allosteric modulator, or PAM. We know that NMDA receptors play a critical role in maintaining cognition. And in fact, NMDA hypofunction is implicated in cognitive impairment across several disorders. Our hypothesis is that by modulating NMDA, we can improve cognitive impairment rapidly in a sustained fashion. Now using Sage methodology, we focused on an endogenous neuroactive steroid, 24S-hydroxycholesterol, which we and others observed was downregulated in certain neurodegenerative diseases like Huntington's. SAGE-718 is invented to extensively mimic this natural endogenous modulator to restore and improve cognition in the brain and restore NMDA function. This certainly is a disorder of significance. We are working on Huntington's, Parkinson's and Alzheimer's, where together the loss of independence because of the cognition in these disorders cost the U.S. $300 billion to $400 billion a year. That doesn't account for the drug cost, which is another couple of hundred billions a year. So besides the societal burden, the cost burden here is extensive. Let me share some of the data to date that gives us enthusiasm for progressing SAGE-718 as I described. What you can see here on the left is the ketamine challenge study. The bar furthest to left are placebo patients whose cognition was significantly impaired in the study. And importantly, the next bar over are those on SAGE-718. You'll note that these people did not only get back to their baseline, they actually improved cognitive function. And we're using the two-back test and the digital symbol substitution test to see there's a higher order test to really measure the true impact of SAGE-718. The rest of the data on this slide are our single-arm studies. And what's important in our eyes is that the data are consistent with the placebo-controlled data and consistent across diseases, giving us enthusiasm to move forward in all 3 diseases with SAGE-718. Now I mentioned that we are conducting clinical trials in Huntington's, Parkinson's and Alzheimer's. We've got 4 placebo-controlled trials going on and an extension trial. Let me dive into the Huntington's disease set up to give you a sense of how we're thinking about progressing SAGE-718 in a very novel way. And we have worked with regulators on this approach. And of course, data matter here, but we think we have a package that, if the data are positive, we can bring forward to try to get SAGE-718 to the market as quickly as possible. Let me go through it. We have a 3-month placebo-controlled study, called DIMENSION, up and running. DIMENSION is 178 patient study that's focused on improvement in HD cog, the numerical measure, at 3 months. We're coupling that study with the SURVEYOR study. So the SURVEYOR study is meant to be the so what. If at the end of the trial, we see improvement in HD-CAB, can people do activities of daily living, can they do finances, can they drive and make their way. So coupled together, we think these studies provide the so what, what does the numerical improvement in memory due to activities of daily living. The PURVIEW study is the rollover study. Patients that -- where the placebo or drug can roll over to PURVIEW and we'll also have some de novo patients, giving a robust database and long-term data. Then not pictured on the slide, but also part of the potential regulatory pathway, is the natural history for Huntington's. It's a well-documented natural history. So together, we think this is a very robust package to move forward. We are starting with Huntington's as a genetically defined population and a more homogeneous population and an orphan/rare population. If the studies are positive, our plan would be to commercialize SAGE-718 as a wholly owned program in every country that it makes sense for Sage to commercialize. Given the orphan nature and more concentrated commercial base, that's the kind of opportunity that Sage would pursue. And if positive, that we can follow that on with Parkinson's and Alzheimer's as well. So we have a very robust pipeline of brain health medicines focused on GABA and NMDA from early developmental issues to later-stage disorders. And I don't have time to cover all of them, but let me make 2 highlights. We and Biogen are excited by SAGE-324. It's a GABA PAM that we're focused on developing for essential tremor, maybe orphan epilepsies and Parkinsonian dyskinesia. The KINETIC 2 study is up and running, and our goal is to have that fully accrued this year with data soon thereafter. And I'm very excited, and this is no small feat, to announce that we're moving SAGE-319, our extrasynaptic targeted GABA PAM, into Phase I. An extrasynaptic GABA PAM is quite a feat, and we're really proud of our product engine, our research team, for coming up with that. So data there as well. We have an incredibly exciting year ahead of us with a very milestone-rich year, including the potential approval this year of zuranolone. In closing, we're capitalizing on this incredible momentum and laser-focused at addressing what matters most to patients. We think the time is now to have a paradigm shift in depression. We think the time is now to think about cognition in a fundamentally different way and to work on movement disorders. And we plan on doing so. At Sage, we're very focused on bringing our pipeline forward, and we realize that these disorders have economic and societal issues and the patients are waiting. Thank you for your attention. And for those on the webcast, I'll note the standing ovation. Let me welcome the team up.

Barry, do you want to introduce who's...

Yes, I'll have them -- why don't you all introduce yourselves? And then we'll get to Q&A.

Good morning. My name is Chris Benecchi. I'm the Chief Business Officer at Sage.

Good morning. I'm Kimi Iguchi, the Chief Financial Officer at Sage.

Hello, Jim Doherty, Chief Development Officer at Sage.

[Operator Instructions] And I'd also like to state for the record that I was not the analyst that said MDD patients are well controlled on generics.

I can verify that.

Barry, you've submitted for MDD and PPD. And I guess, as you're sitting waiting for a PDUFA date, how do you think about standard review, priority review? What keeps you up at night about the filing?

Yes. So as you know, I'm not a very good sleeper. So the things don't keep me up at night, or everything keeps me up at -- look, we -- and I'll let Jim talk about this in a bit. So as you noted, we filed the NDA for zuranolone in December, we and Biogen. We will, in the next couple of months, hear from the agency. It's our perspective that the unmet need is clear as we've noted. And the benefit/risk for zuranolone over 3,500 patients is very clear. So we believe, given the breakthrough status and fast track, that zuranolone warrants a priority review. Standard reviews can happen. The agency has noted, and I think Califf noted this yesterday, it's slightly understaffed. So to me, a standard review would be more indicative of staffing. So either time line that works, we'll be ready for it. Jim, do you want to talk about AdCom and how we're thinking about that aspect?

Yes. Absolutely, Barry. So again, similar to a priority versus standard review, it's the FDA's decision on whether or not to conduct an AdCom. From our perspective, we plan to be ready if they choose to do an AdCom. And as you saw from one of Barry's slides today, the LANDSCAPE and NEST programs, a substantial program really intended to flesh out all of the opportunities available with this new way of treating depression. So we would see this as a great opportunity to present the entire story of zuranolone. And we will plan to be ready if the AdCom is decided.

Question from the audience? Maybe for Chris, I mean do you -- what challenges and hurdles do you see in changing like the KOL, the physician mindset that treating MDD has to be a chronic endeavor versus the data that you have, which is really shifting the paradigm?

Yes, let me start and then Chris can talk about it. So I'm glad you asked that, Anupam. I did not make this in the prepared remarks. But let me comment that chronic treatment of depression is really a manifest because of the tools we have to treat, not because of the nature of the disease, which in most patients is largely episodic. And why is that? So just think about it. I'm a health care provider, I find someone that's got depression. It might take me 4 weeks, 8 weeks, maybe a couple of cycles to figure out the drug or the polypharmacy that gets that patient better. Now we know through the literature that many people with depression have other episodic events. So if it took me months to get that patient well or better, I'm not going to discontinue drug because that next episodic event might take another couple of months to get that patient well. So we're really seeing chronic treatment, not because of the disease, but because the tools we have to treat disease, and we're offering something different. And Chris, do you want to talk about that?

Yes. So what I would say is as an organization, we believe that we have in our hands a transformational product. Given the data that we've seen, and if approved, we have a profound opportunity to really make sure that we're changing the way the depression is treated. Now while certainly, that's our perspective over the course of the last several years in the engagements that we've had with key opinion leaders and in physicians and market research as well as with investigators who actually have the most experience with this medication, that's what we're hearing from them as well, that they believe that there's truly a transformational opportunity with this product if approved. So what we're going to continue to do is to be as ready for the launch of this product as possible, continue to advance through scientific exchange. The dialogue that we're having around the opportunity to fundamentally change the way the depression is treated because the medication works rapidly. It's durable. It works as a 14-day course, so it gives physicians the opportunity to really treat this condition episodically and really return patients back to a state of well-being, which is really novel in this space. So we're excited about introducing the medication.

Yes. And just to kind of slightly round that out, and Chris said this very well, when an investigator or other health provider has used zuranolone, they've seen results in patients that they haven't seen in their professional careers. And we think, and I mentioned this in the prepared talks, that at launch, there are 6 to 7 people that have been on 1, 2, 3 or more antidepressants that are seeking treatment. So at launch, we're going to have a lot of patients that aren't doing well on something. We think the highest number of scripts coming in will be for those patients on something or just off something where zuranolone will be tried. We do want, over the course of time, to get as frontline as possible, particularly for those young adults and elder that we've talked about.

Could you expand a little bit on what sort of medical affairs, medical education efforts you're going to be doing between now and, say, launch?

Yes. Chris, you want to take that?

Yes. So as I mentioned, scientific exchange over the course of the last few years has been really important and whether it's been one-on-one interactions with key opinion leaders and investigators or it's been engagements that we've had at major medical meetings or publications. When it comes to the work that's already been done that's changed the way physicians think about how to treat depression, that scientific exchange has played a vital role. So over the course of the next year, as we prepare for our launch, effectively, what we'll continue to do is through scientific exchange, advance that thinking, again, leveraging the data that we've already demonstrated from LANDSCAPE and NEST and data that we haven't put out to continue to tell the story. And we'll initiate disease state awareness or disease state education efforts for both physicians and for patients. And in fact, there's already a disease state website out there in terms of rethinking or reexamining depression that already exists to advance that degree of education, where we're really focused on highlighting the unmet need in depression as well as the opportunity to rapidly treat patients and the impact that, that can have. And again, later this year, introducing a disease state awareness campaign for patients as well, too, because it's actually paramount that we're not only educating physicians, but patients as well so that when the product is approved, we'll be prepared.

And Chris, maybe you can also talk about patient activation before and then at launch?

Yes. So patient activation is going to be absolutely key here. I think if you take a step back and you think about it, the impact of not treating or undertreating depression is absolutely devastating. So while there is going to be a significant effort with urgency to engage with physicians in and around the peri-launch period, it's also going to be vital that the work that we do in and around launch is around activating patients as well. They deserve to hear the message and to be informed and well educated, if zuranolone is approved, about the medication and the impact that it can have. And we'll continue to work on those efforts up and through launch around disease state education and awareness for patients as well as post-approval in and around DTC and DTP efforts that I think will truly activate patients in the way we want to see them activated.

Yes. I mean, simply stated, I think zuranolone is a kind of drug that patients are going to ask for by name.

Questions from the audience? Go.

What are your plans for zuranolone outside the U.S.?

The question is what is -- what are your plans OUS for zuranolone.

Yes. So we've got a Japanese partnership in Japan, Korea and Taiwan. And then Biogen is responsible for all the ex U.S. and I'm going to leave it to them to articulate at their pens. We're happy to support them in any way possible.

Barry, we talk a lot about MDD, but PPD is also part of this filing. And I think there's a view on the Street is that if you price zuranolone for MDD that PPD is more of a nichey type opportunity. Where would you agree or push back on that type of thesis?

Yes. Chris, do you want to take that?

Yes. So as we know, there are 500,000 or so moms in the U.S. that suffer with PPD on an annual basis or approximately 1 in 8 live births. And as it currently stands, there is no existing orally approved medication that's available for those moms that are suffering with PPD. And we know that there's a profound impact not only on those moms, but on those families as well, too. So with respect to the opportunity there, we believe that with zuranolone, there is significant opportunity to really introduce this medication and with approval to really push for earlier first-line use with the medication. That's absolutely paramount. And based on what we've seen from the NEST program, we believe that the data is compelling. It's not only our perspective, but in the interactions that we have with key opinion leaders, they recognize the opportunity there. And I'd be remiss if I didn't say that as an organization, we've learned a tremendous amount about the PPD community through our interactions with ZULRESSO, as you may be aware, that's in the market again, not an orally available product, but one that's delivered through IV administration. That's enabled us really to establish strong working relationships with key opinion leaders. It's enabled us to really understand the treatment or the referral patterns in the PPD marketplace itself and establish strong working relationships with patient advocacy groups as well. And again, with respect to payers, those are foundational relationships in PPD that we're going to be able to leverage as we move forward with zuranolone for PPD as well as MDD.

And so we don't think PPD is niche. We think there's a significant number of patients. And the data support that. Of the potentially 0.5 million moms that are PPD a year, less than 20% are diagnosed and treated. And why is that? Well, think about it. It's the OB/GYNs or the pediatricians that often see those moms depressed. If it takes months to get well, that's not in the time frame that they're treating that mom and that baby. Something like zuranolone in 2 weeks actually fits that time line. So we do believe that we'll have prescribers for mom in areas outside psych. Today, they often get referred to psych, and it could take months to get that psych evaluation. And when moms aren't well and can't attach to their baby, that's bad for the mom, the baby, and can have generational impact.

Maybe a similar question. You talked a lot -- you learned a lot about PPD from ZULRESSO, but what type of market initiatives are you going to be doing between now and launch for the PPD market specifically?

Yes, Chris, do you want to take that?

Yes. So we'll continue to stay engaged through scientific exchange, as I mentioned, with MDD with PPD treaters. I think that's going to be absolutely important as we continue to advance and appreciation for the data from the NEST program as we move forward with the various groups of prescribers that Barry mentioned, I think that's going to be key. Disease state education and awareness is also going to play an important role in our preparations for the effective launch of zuranolone, if approved. And I think it's also going to be important that we continue to engage with advocacy organizations who understand the importance of new technologies like zuranolone and the impact that it can have on a mom and her family by virtue of being able to treat mom rapidly with the new medication. And that will work in concert with the work that we're doing in and around MDD. Because, again, as I said earlier, we believe that we have a transformational medication in zuranolone, but not just for MDD, PPD as well, too.

Any final questions from the audience? Maybe a final one for you, Kimi. Cash position and runway and what's assumed in terms of next phases for the pipeline? Any guidance?

Super. Thank you for that question on the balance sheet. And I'm happy to say that we're in a great financial position, especially in this environment today. That is by design. So we are -- continue to be very diligent about how we think about our investing and deploying our capital, and that has resulted in us having a strong balance sheet. So at the end of September, we had $1.4 billion on the balance sheet. And we had financial guidance that said we'll have $1.3 billion at the end of the year. We'll talk about that at our earnings call that will happen over the next -- upcoming months. We also talked about runway, and we talked about runway into 2025, which includes not only the cash on hand, but the ongoing funding from the collaboration with Biogen, our strategic collaboration with Biogen, which includes cost sharing on zuranolone and SAGE-324 in the U.S. It includes potential milestones and potential royalties and also potential product revenue, which should get us into 2025. So we're in a great financial position. We'll continue to be very disciplined in how we think about investing in this environment, for sure. And -- but we're in a very comfortable spot right now.

Thank you, Barry and team.

Thanks for having us.