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

All right. Welcome, everybody, to the JPMorgan Healthcare Conference. My name is Anupam Rama. I'm one of the senior biotech analysts here at Jacob Morgan. I'm joined by my Squad, Malcolm Kuno, Priyanka Grover and [indiscernible]. Our next presenting company is Sage and presenting on behalf of the company is CEO, Barry Greene.

Thanks, Anupam. And I'd love to thank the organizers of JPMorgan for having us here. It's actually sunny here in San Francisco. I will be making forward-looking statements, and I refer you to our SEC filings. So as Anupam said, I'm Barry Greene, the CEO of Sage Therapeutics. It is my pleasure to give an update on the progress we're making in brain health. Before I do that, though, I just -- I want to respond to the SEC filing from Biogen on Friday. We did receive an unsolicited acquisition proposal from Biogen. And we, with our both financial and legal advisers and our Board will do our fiduciary responsibility and take a look at that proposal. That's about all I can say about that matter at this point. I'm now going to turn to our regularly scheduled program. I hope there's 3 big things that you take away from my presentation. Number 1 is we believe that the opportunity in PPD is significant. We believe that Zurzuvae has blockbuster potential, and I'll talk more about that. The second big takeaway is that we've recalibrated our R&D approach and are making selected investment decisions in our pipeline. And the third is we'll continue to maintain a very strong balance sheet. With our strategic restructuring last year, we have cash runway into mid-2027. As we exited 2024, and entered in 2025, we had some big decisions to make. And I think the decisions we made position Sage to create short-, medium- and long-term value. Rather than move away from our vision and mission or sway from that, we have to lean into our mission, pioneering solutions to deliver life-changing brain health medicines is a noble task. It's difficult, but highly, highly required. I believe the successes we've seen with postpartum depression are examples of success that we can have in brain health. Brain health disorders across the world are the leading cause of disability. In the United States alone, brain health disorders cost the U.S. economy $800 billion. So think about that $1 trillion of cost to disabilities due to brain health. It's incumbent for the industry to make strides, and we at Sage, will certainly try to do our part. And most importantly, patients are waiting. As we think about 2025, there's 3 core priorities. The first is, continue the outstanding momentum we have on the commercial success of Zurzuvae. The second, as I highlighted, is to continue to make targeted pipeline investments in their neurodevelopmental disorders and neuropsych. These are our focus areas. And the third is to maintain a strong balance sheet. So let me go through each of those. We believe, as I said, that Zurzuvae is the key to unlock the blockbuster potential in PPD, which is an urgent medical condition. Our launch success is demonstrating a shift in practice patterns particularly among OB/GYNs and igniting a dialogue in maternal mental health. We believe Zurzuvae, this oral 14-day short course rapid-acting treatment is meeting the unmet need in PPD. It's certainly highly rewarding to see the growing recognition of the success of Zurzuvae. We believe that Zurzuvae should be used frontline and will emerge as a new standard of care. The other interesting dynamic, and I'll talk more about this later is that Zurzuvae and its innovation is an accelerant in discussions about maternal mental health. And it's really igniting that discussion between OB/GYN and mom about the potential for PPD. With all this, we believe that we'll see top line significant quarter-on-quarter growth with Zurzuvae and we have very exciting growth plans, which I'll talk about later. Turning to the pipeline. The data from 2024 in essential tremor and cognition were not what we wanted. For those -- for many of us, it's highly personal because we all know that we need breakthroughs in those areas. However, as I mentioned, we recalibrated our R&D approach and are making targeted investments in SAGE-319 which I'll talk about later, and our discovery platform in the NMDA, negative allosteric modulators, a different target and highly validated. And finally, with our prioritized pipeline and our strategic restructuring in 2024, we have runway into mid-2027. It's really important that you will see significant reductions in R&D and G&A in the first quarter of 2025. And of course, we'll continue to leverage business development to bring other opportunities forward. As I mentioned, we believe Zurzuvae is a tremendous spring forward for success for Sage and it's certainly very helpful for moms suffering with PPD. Epidemiologically, 1 in 8 women suffer from PPD. As you can see from these 2023 numbers, that's about 0.5 million women, think about that. 500,000 families every year in the United States suffering from PPD, there's a lot we need to do. Unfortunately, if you look at the 2023 data, of those 500,000, less than half are diagnosed and less than half are treated. So you can imagine our opportunity here is very significant. If we gain penetrance as standard of care in frontline and those that are currently treated today, and we're able to move the needle on diagnosis rates and medical penetration with Zurzuvae, you can see that these numbers get very significant and become a springboard for significant growth. There's certainly a lot we can do in PPD. Let me just share the progress to date because it's been rewarding and significant. When we stood here last year, we said that we would think big about the opportunity in PPD, start with focus and scale with success. In 2024 of the third quarter, over 4,100 women have been treated with PPD. Importantly, a majority of those treated were receiving Zurzuvae as their first treatment for PPD. And I will note that it was 2,000 in the third quarter alone. So you can see the significant quarter-on-quarter growth of women getting treated. Now importantly, there's growing awareness of Zurzuvae among our target group, which is OB/GYNs and sites with a 90% brand awareness. Just think about that, a year into launch, having 90% brand awareness for those of you that have launched medicines, is highly significant. Importantly, over 70% of the prescriptions are written by OB/GYNs. That's the right specialty to write for Zurzuvae. And just think about a mom's journey. During -- before, during and after baby gets delivered, the OB/GYN office is where mom is treated. As with any disease, early intervention typically leads to favorable outcomes. PPD is no different. If we can get mom 2, 3, 4 weeks after giving birth that's suffering and they're screened, diagnosed and treated in the OB/GYN's office, that should lead to ultimate outcomes. And importantly, with the work that we're doing, we see significant growth in new and repeat prescribers quarter-on-quarter. Now, this would all -- this does -- this wouldn't matter unless moms can get drug. One of our key metrics was equitable and broad access to Zurzuvae across the United States. And we've achieved that year into launch. It's pretty remarkable that we have over 90% commercial and Medicaid lives that are favorably coverage -- covered. So if a prescription is written, that we want that shipment to be delivered to mom's home in 2 to 3 days. So really great progress a year into launch. Now, I mentioned that we would scale with success in 2025. We have a joint investment plan with our partners in 2025. That's the right level of investment, and there's room to scale further in 2025 to reach more health care providers that are potential prescribers. Our growth plan starts with a joint sales force expansion to cover a wider range of health care providers who treat PPD. You can imagine that the majority of those call points will continue to be OB/GYNs and it's remarkable that once an OB/GYN office is open, we see scripts coming on a very regular basis. The second is the media. You can imagine that maternal mental health, PPD, Zurzuvae have really energized the media to report about this change in maternal mental health and PPD, both TV media and written media. And when the media talk about postpartum depression as a significant and urgent medical condition and not as a moral failing, that's instructive, it's promotional, and it's even potentially saving lives. So for any of you out in the media, I encourage you to help us get the message out that PPD is an urgent medical condition and not a moral failing. That certainly helps moms not believe in the stigma behind PPD. The third area of investment is expanding social media into Facebook, TikTok, if it's still out there and other social media outlets including an influencer campaign, where influencers have stepped up and want to talk about their PPD experience and potentially their experience with Zurzuvae as well, as well as investing in direct-to-TV, direct-to-consumer. With the technology we have today, it's quite amazing that we can reach moms on the channels they are investigating so that they get information about postpartum depression and understand the signs and symptoms help educate them so they can talk to their health care provider properly, including if Zurzuvae is the right treatment option for them. And finally, we're increasing our investment in disease state awareness to support improved PPD screening and diagnosis. Any time that there's a breakthrough medicine like Zurzuvae in a new disease, it takes some time for the disease to be completely understood. Even a health care provider, equipped with knowledge about PPD, in fact, even Zurzuvae will miss a number of PPD. I had a virtual field visit late last year talking to an OB/GYN who is really excited to tell me about the successes they had with Zurzuvae, gave me a number of patient stories. It's really quite rewarding to listen, very grateful for the Sage team to bring a breakthrough like Zurzuvae through specifically for postpartum depression. But when this OB/GYN described the moms that they were looking for, they described a mom that was historical with the dishevel baby. And we talk further about things like anxiety. Mom's not connecting with baby, moms not sleeping well. All potential signs and symptoms of PPD that wasn't fully understood. So we have significant work to do to capture all those moms following through those offices and make sure that no mom is left behind and they're all appropriately diagnosed. So our work there is in front of us. The other accelerant we're seeing to the system is actually system-wide change. When OB/GYN particularly uses Zurzuvae, they talk about it being a major advancement in the treatment of PPD. And the vast majority of OB/GYNs that have experience talk about PPD being used -- Zurzuvae being used for all PPD for all the moms they have us suffering. It's important that we continue to work on PPD and destigmatize the issue. Now the good news there is through the education we're doing and frankly, the generation of women having PPD right now, it's a generation much more willing to talk about their issues with their friends and, in fact, in social media. So we see both the educational component and the generational component, bringing the stigma down, leading to more discussions about PPD. The other really important driver in the system is being recognized that PPD is PPD, irrespective of a severity label and what people are beginning to understand is PPD is not a stagnant disease. A mom could present with mild or moderate PPD on Monday, only to have severe PPD later that week. And while it's rare, these can lead to devastating consequences if not caught. And the other piece of data that is really helpful for the system here is that once an OB/GYN has prescribed Zurzuvae, they see a significant increase in the number of women they treat with PPD measured by all prescriptions. So just think about that. Once an OB/GYN office ignited and understands PPD in the use of Zurzuvae, they're changing practice patterns to screen and treat more and more moms with PPD, and we believe that will continue to grow. The other aspect is that we're working besides health care providers. We're working with policymakers at the state and federal level. I'll give you an example. Just this week, the State of Illinois Medicaid program added Zurzuvae to their preferential drug list with no prior auths. That's exactly what we want to see around the country. If a mother needs the drug, they can get the drug without huge paperwork, steps or issues. So kudos to the state of Illinois for recognizing the pharmaco and health economic benefits of Zurzuvae and their help to maternal mental health. Now, in addition to Zurzuvae adding value, I believe our pipeline can also add significant value in the future. As I mentioned, we have recalibrated our R&D approach and focused our pipeline on neuropsych and neurodevelopmental disorders. We still believe in our neurosteroid platform, including Oxy Sterile chemistries, and we still believe that disruptions in brain circuitry can be reregulated with our chemistries, reversing or changing disease pathophysiology. That belief set has led to very specific investments in our pipeline in this recalibrated approach. We have a significant amount of knowledge on the GABA receptor system that appreciates that when the GABA system is dysregulated, it can lead to disease pathophysiology. The importance is that we get the pharmacology right. We believe that SAGE-319, an extrasynaptic preferring GABA PAM delivers that differential opportunity in pharmacology, and it's different than the other balance of GABA PAMs. By being extrasynaptic preferentially targeting or modulating, what we're looking to do is have the same efficacy as we see with other GABA PAMs, but with a broader therapeutic index. SAGE-319 is in a Phase I multiple ascending dose study later this year that we'll report out late 2025. We know through our preclinical brain mapping work and the EEG work in healthy volunteers that we are seeing a differential EEG signal. That's the first step. It is different than the other GABA PAMs. The next step is to demonstrate in our MAD study that we do have this broader therapeutic index. And excited to read that out late this year, which should set up patient studies in early 2026. Our focus with SAGE-319 is on behavioral symptoms associated with neurodevelopmental disorders. Now, there's a number of neurodevelopmental disorders, autistic spectrum decision -- disorder, Tourette's and some rare neurological disorders. If we just look at ASD as an example, there's about 7 million children diagnosed with ASD per year. And they suffer greatly from things like anxiety, irritability, anger, frustration. And these behavioral issues prevent learning and disrupt family dynamic. So if we can come forward with a treatment that helps, we can add tremendous value to that suffering patient population. With SAGE 324, we're focused on developmental and epileptic encephalopathies or DEEs in terms of seizures. We have great data with GABA in terms of helping seizures. Now, just to be clear, we're not spending developmental dollars on 324, but rather evaluating 324 as part of our overall portfolio decision, and we'll make a decision to move forward to 324 if we do mid-2025. So as I talked about, we are committed to brain health. We believe Zurzuvae has an opportunity to help many, many women suffering from PPD as the first and only oral product, specifically for adults in postpartum depression. We have a focused approach and a recalibrated approach to R&D with our focus on 319 and also our NMDA negative allosteric modulators, so think ketamine without the dissociative effects. We're also working on those, and we talk about that more throughout the course of the year. The milestones for 2025, in addition to quarter-on-quarter growth for Zurzuvae are the data for 319 late in 2025 and a decision about 324 mid-2025. We're excited by the road ahead and the value that we can create. Through our successes, and failures, patients remain our North Star. We have -- we're grateful for the focus team at Sage and all of our collaborators and believe that we have a important year in 2025 ahead of us. I'm proud of the progress we've made, and I'm proud to lead Sage forward into the future. Thank you.

I'd like to welcome Chris Benecchi and Laura Gault on the stage for Q&A. I just want to remind folks, there are 3 ways to ask a question. There is the old way where you can raise your hand and I'll call on you. There's the -- you can send a question in the question portal or you can just e-mail me and Barry can read my e-mail.

Okay. I can do that while you work.

So, Barry, I know you can't comment too much on the headlines that we saw on Friday, but maybe if I could ask, what would be your strategic objectives in this type of process?

Yes. Anupam, as you said, I said when I said upfront, we got the unsolicited acquisition proposal on Friday -- via -- we saw it first via filing that they did with the SEC. The proposal was attached and it was delivered later via the e-mail, we'll do our fiduciary responsibility. We've got -- we're a well-run company. We've got a great set of financial and legal advisers. We have a very seasoned board, and we will work the process to do ultimately what's right for Sage and our shareholders.

I want to dig in a little bit on Zurzuvae. Can you help us understand what pull-through you've seen from sort of the sales force expansion, particularly, I think there was a focus on the OB/GYN segment.

Yes, absolutely. Chris, do you want to start and then I can add some color.

Yes. So as Barry noted in his opening remarks, we thought really big about the opportunity with Zurzuvae, but that we were going to start in a focused way and scale with success. And over the course of 2024, what we saw is that the physicians that we were calling on, whether they were OB/GYNs or psychiatrists or PCPs, we're very responsive to personal promotion through Salesforce. So over the course of the year, as we looked at quarter-over-quarter growth amongst our prescriber base, really, what was obvious to us is that in the fourth quarter, it was important for us to expand the size of our sales organization, which we in fact did more on that performance at a later point in time, but with respect to the promotional response that we saw from the sales force, in alignment with our collaboration partner, there are plans to expand the sales force jointly in 2025 and to really leverage that as a way in which we can continue to expand that prescriber base and really influence OB/GYNs who have, as Barry noted again in his opening remarks, have played a real leadership role in the diagnosis and treatment of PPD and the utilization of Zurzuvae. So very excited about that plan that we have in front of us.

And what are you seeing in terms of new prescribers for the product versus what's seen depth with repeat prescribers?

So we've seen -- as I noted, both really encouraging new and repeat prescriber growth quarter-over-quarter. And as Barry noted, OB/GYNs have played a leadership role in all of this. In fact, whenever you're looking at instituting system-wide change and creating a paradigm shift, you need a prescriber base that's really willing to step-up and to utilize the product that I think differently, maybe about how a condition has historically been treated like PPD. And that's what we've seen with Zurzuvae and the OB/GYN community. And in fact, 70% of our prescriber base are OB/GYNs, and they're writing not only new prescriptions, but repeat prescriptions at scale, which is very encouraging to us over the course of 2024. They've also demonstrated that they're increasing the number of patients that they're treating at a practice level. Once they prescribe Zurzuvae, they treat more patients, which means that they're increasing their screening and diagnosis in parallel path again, which is very encouraging from a system-wide change paradigm shift perspective. So we'll continue to focus on OB/GYNs as we go into 2025. As Barry noted, really focusing on generating new and repeat prescribers across a broader prescriber base that we'll cover with an enhanced sales organization and the investments that we're going to make.

Yes. The only thing I'd add, and you touched on this, Chris, is it's really helpful for our efforts that the Congress ACOG has very specific guidelines to -- for their OB/GYN community to screen, diagnose and treat. And they named Zurzuvae specifically. I've launched many, many drugs in my career. I've never had guidelines in place before launch to talk about our drug specifically that's incredibly helpful. The other dynamic that we're seeing is that we're seeing office-wide shifts. So once an OB/GYN office has a champion, could be an office of 6 to 10 OB/GYNs with nurse practitioners, once there's a champion, the entire office ignites to screen, diagnose and treat PPD once they learn about PPD, once they learn about Zurzuvae and once they learn about how to work with specialty pharmas that moms get drug.

Questions from the audience? We've got a question in the portal here, which is, does your sales force sort of also think about reaching out to pediatricians, most moms have on postpartum event with their OB/GYN, however, they will see their pediatricians at least 1 to 3 months over a 12-month period. What does your market research tell you about the percent of moms who developed PPD within the first week, first 6 weeks versus sometime after?

Okay. But several questions there. Let me start with a couple of those and see if Laura or Chris, have something to add. So in terms of symptom onset, typically, mom developed some level of symptoms in the first weeks after giving birth. Now, there are some that are very clear, and there are some that kind of grow over time. Think about a mom that is anxious and isn't sleeping well. They might try to deal with it for the first 3 or 4 weeks. But after a couple of months of that kind of condition, they might really need to get some help. So it can range. We do think that, as I mentioned, OB/GYNs are in the front end of the patient journey, and the best place to pick up symptoms of PPD. Of course, moms can get through that period, which is where we need primary care in sight. It is true that in the well visits for pediatrician, there's often a mental health questionnaire that moms have to ask. That might be a future point for us. Right now, pediatrician treats treating baby, not necessarily mom, but through things like telehealth and referral systems, that could be an important base going forward. Anything to add?

Yes, I think you hit it. I think the teams are really contemplating how to augment what we're currently doing to reach a broader audience of health care professionals through nonpersonal promotion. There's a significant amount of effort that goes into disease awareness, disease education for physicians and for patients. So there's an opportunity there for us to broaden our base as we think about extending that to groups like pediatricians and other healthcare professionals that may be in a position to detect the signs and symptoms of PPD and then refer to another physician to actually provide the treatment.

Got an e-mail question here, which is could we get some clarity on the partnership with Shionogi and its updates around the MDD and PPD partnership in Asia.

Yes. So Shionogi is our partner in Japan, in Taiwan and in South Korea. I can't talk for them, but we can say what they've disclosed. They disclosed that they filed with the Japanese authorities for MDD. They've disclosed that they believe the discussions are going well, and they believe they'll get approval later this year.

Question from the audience, Alana?

Very nice presentation. Can you tell me a little bit about the process of deciding to move from indications like essential tremor to an indication that's a behavioral change? Because it seems like a pretty big move, although I'm suspecting that you actually have lots of data and reasons to choose that new -- those indications for a new focus.

Yes. Thank you for your comments on the presentation. We do have a lot of data, and let me ask Laura to talk about how we actually came back to DEEs.

Yes. Sure. So as we looked at our pipeline and consider the mechanisms in our pipeline that we would be moving forward over the next few years, we realized that many of these compounds could provide a useful benefit in neurodevelopmental disorders and in neuropsych disorders. Clearly, we have expertise in neuropsych from our work previously and as well as in neurodevelopmental disorders. So this is a way that we can really leverage the internal expertise that we have. . In addition, for these disorders, we are intending to treat behavioral symptoms associated with neurodevelopmental disorders. And we have a lot of preclinical data for our compounds that demonstrate that they are effective in treating different types of behavior. And so as we move forward, we'll be looking to match the mechanism of our compound to a disease state where we think it would be beneficial and look to treat various behavioral symptoms associated with the disorders.

Questions from the audience? Yes. On the front.

What's your treatment persistence rate over the 14-day treatment or the average duration of therapy if you're able to share anything on that at all?

Yes. So we have -- so Zurzuvae is a pill that moms take every night for 14 days. It's a 14-day course of therapy. What we saw in our clinical trials, and we are hearing anecdotally in the real world is that moms start feeling better as soon as 2 or 3 days. So a couple of nights after taking Zurzuvae, we saw a statistically significant difference versus placebo in our clinical studies. Also in the clinical studies, we saw that difference out at 45 days. So several weeks off treatment, moms stayed well. They got better with Zurzuvae, and they stayed well. We have anecdotes and so lots of anecdotes don't actually add up to data, but we've lots of anecdotes in the real world that Zurzuvae is working as well or better than it did in the clinical trials. If you think about that in clinical trials, you want to minimize placebo effect. In the real world, placebo plus drug is not a bad thing. If mom is getting better bonding with babies. So that's what we're hearing. We're not hearing a lot of stories about Zurzuvae not working or any kind of treatment resistance at this point.

And then maybe you could talk a little bit about your disease awareness efforts. You've touched on them in the presentation, but that seems like something that -- the more you do, the bigger pull-through you have on some of the scripts data that's coming in.

Yes. And maybe, Laura, maybe you could talk about the tools that already exist and what ACOG is doing? And then Chris, some of our other efforts.

One of the things that's been really gratifying about working in this space is seeing how we are supported by an environment outside of Sage in terms of raising awareness of PPD, raising awareness of how to screen and Barry mentioned earlier that ACOG published guidelines, the 3 or 4 months before our drug was approved for PPD that laid out what they expected their physicians to do for screening. And they recommended screening at each visit during pregnancy and in the postpartum period. And they actually provided a number of suggestions for tools that could be used, tools that are widely accessible. They're easy to use and interpret. So we have that sort of tailwind pushing things forward and making sure that physicians are aware of how to screen.

So disease education is an important part of our plan for 2025. And as you take a step back and think about it in context relative to everything else that we're doing, our vision here is to do everything that we can to drive top line growth with Zurzuvae, quarter-over-quarter growth, but to reach as many women with PPD as possible. So disease education is an important piece, but it starts with, as I noted earlier, the sales organization and really doing everything that we can from a promotional perspective, to ensure that they are active and engaged with health care professionals with a strong focus on OB/GYNs who are playing a leadership role in the screening diagnosis and treatment with Zurzuvae and PPD. We also have, as Barry noted in his presentation, work that's ongoing through very number of paid social media platforms like Instagram and Facebook, where we know we can meet not only patients, but health care professionals when they're consuming content in a timely fashion. We have a social media influencer campaign that's initiated in December of 2024 that we envision that we're going to continue to keep going with in 2025. And we have plans for effectively a targeted DTC campaign during the course of 2025, really working through channels like connected TV, where you can effectively communicate with specific women when they're suffering with the signs and symptoms of PPD versus a broad-based mass media campaign. But disease state is going to play a critical role in all of this, making sure that physicians are aware of the signs and symptoms of PPD and have a propensity to screen, diagnosis and treat. And patients are as well educated as they can be as they go in to have educated conversations with their health care professionals. So that disease education, along with the promotional work that we intend on doing in 2025 has that ability to impact that top line growth that I talked about, but to help as many women with PPD as possible.

I got another e-mail question here, which is some of the questions from the moms online forums center around is Zurzuvae safe or safe for breastfeeding mothers? Any commentary on that?

Yes, Laura, you want to take that?

Yes, sure. So developing a drug for PPD, we knew it would be very important to have data on breast feeding, and we conducted a study to measure the amount in the breast milk and to predict then what the relative infant dose would be. What we learned from that study is that the relative infant dose is very low, it's less than 1% of the maternal dose. And this is information that's in our label that physicians can use to have informed discussions with patients about the risk benefit of moving forward with Zurzuvae. Those discussions or discussions physicians have every day when they write a prescription for a woman in the postpartum period who is breastfeeding. And one of the things that's really important in that conversation is that they emphasize the risk of not treating a particular disorder as well as the small risk that's associated with the amount of drug and the price of milk.

Yes. What we're dealing with breast milk in breast feeding is some assumption by us. So many health care providers that I've spoken with assumed that because we did the study and we have the data in the label, it's an issue. As Laura noted, there's very, very, very little breast milk that we get through to baby. So once educated, many health care providers are advising their moms. It's a benefit risk, but many of them are advising their moms that they believe it's safe to feed their babies. And then those that decide not to, this is not like other antidepressants, it's not a chronic treatment. So if they decide not to it's a 2-week decision.

What is the time to script look like? You get diagnosed and OB/GYN says, okay, hey, we need to move on Zurzuvae. What is the time to script -- and like Barry is usually saying it's a 14-day course treatment. So many, many companies go through some sort of 1Q seasonality on reauthorizations and things like that, but this is just a 14-day treatment. So how do we think about that like 1Q seasonality.

Yes. I'll start with the specialty. So as I mentioned before, one of the areas of education, particularly with OB/GYN office is how to work with specialty pharma. That's not something they knew how to do. It's not complicated. It's clerical, but it is something you have to learn. So we see that if the prescriptions entered properly, the prior auth, if it's needed is entered properly, patient address, insurance company codes, the drug can get to mom in 2 to 3 days, delivered directly to the home. The patient does need to answer and can confirm the desire to get the drug and make sure that someone is there to get the drug and the drug is delivered. Moms at home would be, it's not a big issue. If there are clerical issues, it can take 6, 7 and 8 days. So it can take longer if there are issues in the system. But we have a very liberal free drug program. So our goal is that if a prescription is written, that shipment is sent to mom.

Yes. I would add that our sales organization, inclusive of our field access and reimbursement managers work very closely with physicians and their practices to ensure that when a prescription is written, that it gets to the specialty pharmacy directly that, that prescription gets fulfilled and it gets to mom as quickly as possible. There's a number of educational efforts that go into educating physicians and educating patients, but it's something that we've really focused strongly on since the beginning launch, and we'll continue to focus on it until we feel like in totality, every woman is able to get Zurzuvae in just a matter of days as rapidly as possible.

We haven't -- we're not externally talking about our metrics, but I will share that our internal metrics, the time to mom has gotten better every single quarter.

1Q seasonality?

I wouldn't expect to see 1Q seasonality in terms of the way that prescriptions move or the experience of PPD. I think when it comes to what we've seen over the course of time that there's a fairly stable flow-through of prescriptions, which come from patients being diagnosed. I think the one exception is, as you look at a quarter like the fourth quarter, there's just fewer selling days in the fourth quarter due to the holidays and that does have some impact.

Just to round that out Anupam. The reimbursement environment here is commercial and Medicaid. So there's not a Medicare donut hole issue to deal with the first quarter. So we think, again, we should continue to see demand growth quarter-to-quarter-to-quarter.

Any final questions from the audience? All right. Thanks, Barry and the team.

Thank you.

Thank you.