All right, thanks everyone for being here. Happy to have our first session after our keynote and lunch here with Axsome, represented by Mark Jacobson and Nick Pizzie. Thanks for being here.
Thanks for having us. Yeah, we're happy to be here. Thanks, Leo.
Great. A lot of exciting developments lately with the company. There's a lot to talk about, but maybe we can start off with the approval in Alzheimer's agitation recently came through. Maybe just by way of introduction, you can sort of remind us of, you know, the differentiation the drug offers and, you know, maybe weaving in now that you have a label, sort of how that met or exceeded your expectations and how you're feeling about that going forward.
Sure, yeah. Well, hi, everyone. We feel great about it. The label, you know, that was approved just over two weeks ago by FDA, breakthrough therapy designation priority review. We're very, very happy with the label. It's very clean and is a differentiated product profile. That starts with the mechanism of the product, targets NMDA and sigma-1, and that results in a profile which is in the label of rapid onset of action, in terms of separation from placebo, which starts at two weeks and carries forward through data that demonstrates duration of treatment, durability of treatment effect, in that if you remove, this is through the randomized withdrawal trial, the ACCORD-2 trial, if you remove treatment, then you see high rates of relapse, of agitation symptoms.
We see a differentiated safety and tolerability profile, wherein there's not a box warning for the indication. We did not see a mortality signal. We did not see a false signal. We did not see sedation. If you look in the adverse reactions section of the label, it's very clean and that ties to, again, the mechanism and the clinical data that we generated. We're very pleased with the label and what that means in terms of how we can deliver a new treatment option to patients and HCPs, and associated with that the potential market opportunity.
Got it. I guess with that in mind, can you talk about how you're positioning for the launch? Obviously, the drug's not going to be commercially available until June. You guys have talked about that. You know, there must be work that you're doing, you know, behind the scenes with the sales floor. Can you just talk about how that's been going? The progress that's been made to get yourselves ready for that formal launch.
Sure. you know, one interesting thing about this is it's AUVELITY, the product is on the market already for the initial indication of major depressive disorder, and it's the same, you know, it's the same maintenance dose. What's really happening right now between now and when we said we'd launch in June are educating the, and training the sales team and, you know, updating the core visual aid and marketing materials. Some of the discussions ongoing and have been ongoing with respect to set up and preparedness and long-term care, payer discussions. That's all moving along. But the rate-limiting step until, quote-unquote, "launch" is marketing materials and training the sales team on the indication and the label.
Got it. What have you been hearing from physicians, caregivers for excitement, for their interest in using this? I guess as we start thinking about what the shape of that launch could be, you know, how does, you know, interest in the drug play into how we should be thinking about our model?
Sure. The feedback we've received and, you know, there's high excitement for a new treatment option. Obviously, a significant unmet medical need, underserved. There are over 20 million scripts. This is about 21 million scripts a year and until this approval, there was only one previously approved product. Just in the majority, 99% of the scripts that I mentioned are off-label pharmacotherapies due to the dearth of approved products in the indication. Clinicians, so we were joined on the approval call by Dr. Jeffrey Cummings.
Feedback from Dr. Cummings and other KOLs is that we touched on some of the elements of the label, but that the label and the product profile are exciting in terms of addressing the treatment need. One, just additional therapies. Two, a new mechanism of action and product profile efficacy and tolerability profile that are distinct from what has previously been used both on and off label. There's interest in the product as a potentially first-line agent and beyond due to that, you know, the risk-benefit or the, you know, the safety and efficacy profile and that we've covered.
Yeah. In line with the in line with the approval, additionally, completely independently, but the FDA put out a press release as well as the Alzheimer's Association, you know, sharing their thoughts on AUVELITY.
Yeah. You mentioned long-term care. Can you talk a little bit about where these patients are that you'll be targeting, how much overlap there might be with the existing prescriber base? You know, any other work that you'd need to do to sort of minimize any friction to the new, you know, areas that you're pursuing?
The current split in scripts is, it's about 60% in community setting and about 40% in long-term care. Historically for AUVELITY, the AUVELITY sales team has only detailed and educated in a community setting before. We have not actively educated or engaged in the long-term care setting. We will be doing that now. Earlier this year, we announced an expansion in the sales team, in the AUVELITY sales team, which will be detailing and educating around both indications. It's gonna be about 630 reps. In a small percent of that will be exclusively focused on long-term care. In the community setting, about 80% of targets for both overlap for both indications.
In long-term care, up, you know, 50 to upwards of, you know, upwards of 75% of individuals are all have depression in long-term care settings. There's high overlap in both indications in long-term care as well. You know, as I mentioned, we have not actively educated and detailed in long-term care before. There is high overlap and high synergy with both indications.
Yeah. That, just to kinda double down on what Mark shared, we have not called on any LTC centers to date, and significant prevalence in MDD within these LTCs and comorbidity between AD agitation and LTC. If you take a look back, you can go back to when Lexapro was launching in LTCs back in the late aughts, and you could see that their sales in LTC in MDD alone were around $500 million, and that was with about a $200 WAC. Kinda can use that as a potential in LTC alone, in MDD alone. I know a lot of the focus is on AD agitation, but there is a significant potential for MDD in LTCs.
Got it. The other aspect of this is payer dynamics, and they've talked a lot about that, particularly on how discounting may evolve or actually improve. Can you just remind us what the balance is of how we should think about, you know, potentially more public pay patients, if anything's gonna evolve in the commercial side of the payer equation?
Sure. For ADA, we would anticipate at least 80% of total scripts to be in a Medicare Part D channel, of which we have 100% total covered lives. 100% covered lives within Part D, of which we anticipate 75% would not have any PA and would be either unrestricted or first step or one step. The other 25% would likely have a PA, but really a PA to indication, so not an overburdensome PA or a medical exception, just a PA to indication with a minimum of a single step. We feel coming out of the gate, with the launch in ADA, you know, access is fairly accessible.
It's not, again, it's not just for ADA, but that will also be for the MDD patients.
Another way to say that is, you know, net-net in the majority of cases, if a script is written, more often than not, and substantially more often than not, it should be filled.
Yeah. Thinking about what we did in 2022 when we launched in MDD, you know, we obviously had payer access was a bit of a hurdle. I think we launched in MDD with roughly 40% commercial lives. That was where the bulk of the scripts were on the commercial channel. We're obviously able to get to that. That number is now total covered lives is 86% for AUVELITY.
Got it. Maybe one more on this topic. You know, obviously, there's a branded antipsychotic in the market that launched a few years ago. You know, what should we take away from that launch? You know, what they did well, what maybe you could do better, and really how AUVELITY is ultimately gonna be positioned against antipsychotics, if it's gonna be earlier or switching. You know, I guess how comparable that launch, you know, even is as we think about, you know, comparables.
The one other branded agent, it's informative, but it's distinct. You know, their, you know, they've been the brexpiprazole Rexulti, it has been growing since launch, especially in the Medicare Part D channel. We watch that. We have given the profile and kind of just our commercial infrastructure and approach and current state of affairs. It's helpful in that, in terms of there's been active promotion and education on, you know, patient profiles and diagnosis. That's all great. It's great for patients, and it's informative to us, but I think we'll be charting our own course.
You know, Nick touched on access and not only is the number of covered lives important, but also the quality of that coverage Is such that it would facilitate early line utilization and potential first line utilization that we touched on with KOL perspectives and their thoughts on how they might use the product. That aligns very nicely with today's state of affairs with formulary placement and quality of coverage. You know, again, the sales and commercial teams, they always like to learn from others and what's happening in the marketplace. Again, we'll be focused on educating around the product profile and, you know, potential appropriate patients, and we'll go from there.
We, you know, as mentioned, the market is so large, it's not a zero-sum game. There's multiple products. That's a great thing for patients and, you know, we'll see how it goes, but we're excited.
Got it. Wanna touch on MDD, and you guys have talked about how long-term care can expand the MDD opportunity as well.
Sort of in the existing business for MDD, I mean, how should we think about the growth that's left there, you know, continued uptake in earlier lines, in the community? Should there be a halo effect? Is the broader sales force expansion gonna help that, or is it more steady as she goes?
I think the focus is really on primary care now that we're expanding from, you know, somewhere in the neighborhood of 300 reps, a little less than 300 reps to 630. As of today, we're around 22 basis points of the total antidepressant market. If you take it back, take a look back a year, beginning of 2025, we were at 0.15%. Increasing market share by 50% over, from the beginning of January of 2025 to today, and that's with the team of roughly, call it 300 reps. Now that we are further expanding, we're able to get more in primary care, so have better reach, better breadth, but more important or as importantly is to have better depth with our higher decile doctors.
Secondly, there's been minimal investment on our marketing and advertising spend. We did have a pretty robust spend in Q4. That was the first time that we ventured in direct-to-consumer advertising. We learned a lot from there. We're gonna refine that. When you have 630 reps out there, the investment that you have in DTC will be multiplied. We'll have a higher multiplier impact, because you have more reps speaking to the doctors and making them aware, so that when patients do come in and ask for the product, they're aware. Thirdly is payer access. We had a, you know, a nice evolution of an improvement of payer access in the back half of last year. We haven't even enjoyed that for a full year yet.
Now that we are 78% total covered, or 70% commercial lives, 86% total covered lives, and as I mentioned, 100% of government channel, you know, we feel like and with 56% being first line or first switch, we feel like we're in a really good spot to further drive to peak sales. You know, as we've shared, the peak sales for AUVELITY in totality is $8 billion+.
The first line, first switch of how the product is currently being utilized, that ties to growth and adoption in primary care. With the very lean sales team that we've had, which was by design, it's been highly productive. Right now, about 1/3 of scripts are written by primary care HCPs. There's just so much work to be done, and that ties to It's really a confluence of access where it is, you know, now multiple indications, adoption that we've seen to date, and then the investment that we're making in the sales team in particular. Nick touched on, you know, marketing efforts. That all comes together where we expect to be able to drive, you know, material continued growth.
You mentioned that $8 billion number. I guess if you were to think about then, say, you know, there's one part of that number that's really a pivot point or, you know, a critical aspect of that, you know, could make it more than $8 billion, could make it less than $8 billion. I guess, what do you think is, you know, sort of underpinning, you know, any potential variability or confidence in that $8 billion number?
It's an interesting question. You know, it ties to the confluence that I just mentioned, right? The label's very clean, and why is it clean? The product profile, it's really compelling in both indications, right? In MDD, it's rapid acting. It's right in. That's in the label. It works very quickly. It's sustained. You see different rates of adverse reactions, in particular sexual dysfunction and weight gain that you see historically. The adoption is there, and again, we're educating much more broadly than we have been historically. That comes together. AD agitation, you know, it's very similar.
Obviously, different patient population, but efficacy and tolerability profile, it's very, very distinct and we think very exciting as a new treatment option for that patient population. There will, of course, be variability and, you know, we think the growth curve we have, we feel very good about that. Maybe the variability comes from quarter to quarter. You know, what seasonality do you see? What's happening in the marketplace? I don't think there's one keystone consideration that everything hinges on or only works if that is in place, right? It really is all those elements that we touched on, access, investment, the product profile. They're all very robust and that's why we see a very robust opportunity.
Yeah. We've got a few minutes left, and there's a lot more to the Axsome business that makes it really exciting, so I want to touch on some of those. Now you've got another launch that's been in progress, SYMBRAVO, in migraine. You know, somewhat of a different market, you know, waiting for, you know, refills to start pulling through. Can you talk about some of the progress you've made there and, I think, some initiatives on the sales side?
I think the biggest progress that we've made thus far is Q4 to Q1 we had nice sales growth. We had nice script growth of 36% quarter-over-quarter, we had a nice payer access win, so we're able to increase covered lives now to roughly 57%. We're still in the early stages of negotiations with payers. With that, we feel like once we are able to get to a higher level with payer coverage, that will really start unlocking the sales, improve GTN. With this most recent win, we announced that we're actually increasing the team from 100 to 150. Similar story, similar playbook to what we did with AUVELITY.
When we launched AUVELITY, you know, big indication, we launched it with 160 reps. Here with SYMBRAVO we also launched it with a small amount of reps of 100, and growing SYMBRAVO as access comes on, as doctors are becoming more aware of it, and just being mindful of the investment.
Yeah. If you step back, the genesis of that product was to offer differentiated efficacy to patients, right? The overwhelmingly consistent need cited by patients and HCPs is better efficacy. We, you know, sought out to design a product that delivered very robust efficacy, and we did that. Now that the product's been on the market, it's still under, you know, it's still within the first year of launch, and that's the feedback we're getting from prescribers, from KOLs and clinicians, is that the product works really well. So that's fantastic and we're seeing that the real world use matches the clinical data.
It's a very different market than depression, and so we're navigating that now and we like what we're seeing. We'll do what we always do for everything, which is make data-driven decisions where we think the investment has high ROI potential. That's how we'll continue to execute and invest in the brand and continue to drive growth over time.
Got it. Also wanted to touch on sort of the work you've been doing in the wakefulness and sleep market. You guys have Sunosi, which you're actively commercializing, also AXS-12 NDA's been submitted in cataplexy. I guess how do you think about in general terms, you know, how Axsome's going to play in that market with multiple products, what you're hoping to achieve there, how they might work together?
Sure. The product that we have on market now in sleep, that's Sunosi for excessive daytime sleepiness in obstructive sleep apnea and narcolepsy. AXS-12, we've submitted the NDA for cataplexy in narcolepsy, as you noted. Next update there is an FDA acceptance decision on the package. If that's accepted for review and if it's ultimately approved, that sets up a very interesting and compelling opportunity in that we already have all of the commercial infrastructure in place for detailing and educating in sleep and to sleep HCPs that see patients with narcolepsy and write in narcolepsy. The infrastructure is there. If the product is approved, it is a very seamless addition to that infrastructure, and the products are distinct.
What they treat, right, is distinct. Sunosi, solely for our excessive daytime sleepiness. AXS-12, that is for cataplexy. You see really the whole product profile though is interesting. For cataplexy we also we do see improvements in sleep, we see improvements in cognition, and if the product is ultimately approved, what is the label, you know, to be determined. From a starting place are complementary and, you know, we'll have an update in the, you know, not too distant future about the acceptance decision, then we'll go from there. It's a very nice setup from an infrastructure and investment perspective.
Got it. You guys done a really successful job building AUVELITY into a franchise with sort of multiple wings and, you know, my words, not yours, but it looks like you may be trying to do that with Sunosi as well. You have a lot of, you know, different trials you're exploring. We're gonna get maybe a readout later this year, in binge eating, along with some others later. I guess how should we think about at least the first step of that? You know, what should we expect for binge eating? You know, we've got 30 seconds, but maybe, you know, how do we set that up?
Binge eating, Phase III trial ongoing, one of two potential studies is our expectation. If that's a positive study, that would lead us to the additional work that we've aligned with FDA on to complete a package and get that submitted for review. Stay tuned, but we're, you know, we're looking forward to the readout in that study later this year. If you just very quickly back up a little bit more on Sunosi, we have four different development programs ongoing which we think are very exciting, and the reason for that is the product profile, overall clinician feedback about that agent, global changes that clinicians see when using the product in CNS and, you know, neuropsychiatry.
Another program that is already, you know, through or partway through phase III development, that's ADHD. We have the adult ADHD phase III trial that was completed positive. We have two trials that we'll conduct in parallel in children and adolescents, where we said we're launching those very soon in the second quarter. Stay tuned there. The results of those trials will then inform if we can submit an NDA for that indication too. That's only two of the four ongoing programs. The other is in shift work.
MD.
Yeah, in MD, major depressive disorder, in patients with excessive daytime sleepiness symptoms. Very excited on that and, you know, we'll keep you posted on all those activities.
Unfortunately that's all the time we have. There's a few programs we didn't get to touch on, but, you know, we'll look forward to hearing from updates on those as well.
Yeah.
Thank you.
Thanks for having us, Leo.
Thanks, Leo. Appreciate it.
Thanks. Have a great day.