Axsome at RBC Healthcare Conference: Strategic Growth and Expansion

On Tuesday, 20 May 2025, Axsome Therapeutics (NASDAQ:AXSM) presented at the RBC Capital Markets Global Healthcare Conference 2025, unveiling a strategic focus on growth and expansion. The company shared optimistic projections for its key products and highlighted a robust financial position, while acknowledging challenges in regulatory pathways.

Key Takeaways

• Axsome anticipates AUVELITY’s peak sales to reach between $1 billion and $3 billion for major depressive disorder (MDD) alone.
• The launch of SINBRAVO for migraines is set for next month, targeting headache centers with a specialized sales team.
• The Alzheimer’s agitation program is on track for a third-quarter submission, backed by three positive Phase 3 trials.
• Axsome aims for cash flow positivity, with $301 million in cash on hand at the end of Q1.
• A settlement with Teva extends AUVELITY’s market runway to 2039.

Financial Results

• AUVELITY Sales: Currently annualizing approximately $400 million, with peak sales guidance of $1 billion to $3 billion for MDD.
• Sunosi Impact: Minimal impact from international sales.

• Overall Financial Position:

- $301 million in cash at the end of Q1.

- Top-line revenue guidance for the year is between $500 million and $600 million.

- Cash flow positivity is anticipated soon.

Operational Updates

• AUVELITY Expansion:

- The field force expanded by 100 representatives in Q1, boosting new prescription growth.

- Market access coverage has reached 63% in the commercial channel.

- A national direct-to-consumer campaign is under consideration.

• SINBRAVO Launch:

- Scheduled for next month with a dedicated team of 100 reps.

- Initial focus on specialist targeting at headache centers.

• Alzheimer’s Agitation Program:

- Supplemental New Drug Application (sNDA) submission is on track for Q3.

- Supported by three positive Phase 3 trials.

• Sunosi Studies:

- ADHD pediatric study on track for 2025.

- Depression studies progressing, with a focus on MDD with excessive daytime sleepiness.

Future Outlook

• AUVELITY: Continued growth expected from expanded sales force and improved market access.
• SINBRAVO: A specialist-focused launch strategy to drive initial adoption.
• Alzheimer’s Agitation Program: Potential launch following successful sNDA submission.
• Profitability: Cash flow positivity is a near-term goal, supported by strong financial resources.

Q&A Highlights

• Macroeconomic Factors: Axsome’s US-centric operations insulate it from major macroeconomic risks like tariffs.
• AUVELITY Usage: 15% of prescriptions are first-line, with over 55% as monotherapy.
• Teva Settlement: Extends AUVELITY’s patent protection, allowing market entry in 2039.
• Regulatory Pathway: Confidence in Alzheimer’s agitation program approval, based on consistent FDA feedback.

For a detailed account of the conference call, please refer to the full transcript below.

Full transcript - RBC Capital Markets Global Healthcare Conference 2025:

Leo, Interviewer: Thanks everyone for joining us. For our next fireside, we have Axsome represented by their chief operating officer, Mark Jacobson. So thanks for being here. Yep.

Mark Jacobson, Chief Operating Officer, Axsome: Thanks a lot, Leo. Really appreciate it. It’s been a super productive day for us so far at the conference. I’m happy to happy to answer any questions you may have.

Leo, Interviewer: Yeah. Great. You know, maybe starting off bigger picture, your Axsome is obviously a commercial company. So, you know, I wanted to talk about some of the macroeconomic impacts just to start off. I guess, what are you seeing in terms of potential impacts to the business from either the manufacturing potential tariffs, either from most favored nation, potential impacts from Sunosi, or through any IP redomiciling that the administration might try to enforce?

Mark Jacobson, Chief Operating Officer, Axsome: Sure. So so that’s a number of angles. And maybe just just a broad observation about the company, which is Axsome is at now at a point where it’s a highly diversified business commercially on the regulatory side and on the development side. And the the overwhelming bulk of the business, current and anticipated, is is lies in The US, and that that ties to a number of of questions that you have. So Ovelity and Sunosi are are the two products that are on market right now, and SINBRAVO will be launching next month.

Two of those, OVALITY and SINBRAVO, are commercial only in The US. So that right away has read through or or lack of read through, I should say, with respect to most favored nation, pricing considerations, and things like that. So that’s good. So NOSI is available in a few select countries outside The US, but we we think the impact is minimal. We can talk about that if if you’d like to.

IP, the all of the IP, Avelity, Symbravo, all the other programs that Axsome has developed, it’s domiciled in The U. S. The exception to that is Sunosi, which is domiciled in Europe. And the reason for that is, as a reminder, we acquired that product, and the IP was initially domiciled outside The U. S, so it was kept there.

And right now, though, we don’t see an impact to Sunosi with respect to that. Tariffs, we think the impact is immaterial. With respect to it’s a de minimis portion of cost of goods when you model, say, drug substance or drug product manufacturing, So we feel good there. And so the business is really insulated from a number of these, say, macro factors that are at play, both of those of which that are that are being pulled through and then ones that have been stated as as concepts that are being looked at.

Leo, Interviewer: Yeah. No. That that’s great to hear. And, obviously, your main commercial product’s AUVELITY, and it’s delivered fairly consistent growth since the launch in 2022. Guess can you talk about what you expect to see for the balance of the year in terms of demand growth?

Where are you seeing the drug being used? How has that evolved since the initial launch?

Mark Jacobson, Chief Operating Officer, Axsome: Sure. So, so far, product is growing nicely, and we’re pleased with what we’re seeing when you look through different lenses. So when you look at how it’s being used, patient profiles, about fifteen percent is in first line use, about thirty five percent is in second line, and then it goes from there. And so that’s great, and we think that speaks to the differentiated outcomes for patients both with respect to efficacy, onset of action, rapid acting, durability of effect, then the tolerability profile being distinct for from what was previously or what is what is currently available otherwise. So we like that.

Another way to think about it or another lens to use is monotherapy, and so we’re already over fifty percent. I think it’s about 55% of the use is monotherapy, which is great when you think about reduction of polypharmacy and things like that for patients. So we like that, too. And then with respect to outlook and continued growth, we’re very pleased with where we are. So currently annualizing about $400,000,000 in sales, which is great.

We recently expanded the field force in the first quarter. That completed, and we’re starting to see an impact in NBRx. We’d expect that to continue that impact to continue and to see pull through into TRx through the balance of the year. We expect to drive continued improvements in market access. So that’s both the quantity, so the number of lives covered in the commercial channel, which is currently at 63%, and also improvements in quality of coverage.

So we expect that to also continue to drive growth. And the one other approach that we’ve shared that is that’s in the works potentially for later this year is a national DTC campaign. So that’s being contemplated. And what we’re doing right now is we have some testing that’s underway, which would inform a potential national rollout. So a lot of opportunity there, and and, you know, it’s really just boiling down to patient outcomes, differentiated outcomes.

So we think that bodes really well for the long term prospects or opportunity, and we’ve guided to peak sales of 1,000,000,000 to $3,000,000,000 for OVELITY and MDD alone.

Leo, Interviewer: Got it. You mentioned the DTC campaign. I’m curious how you’re thinking about that and with the sales force expansion, how you’ve sort of targeted them. Are you trying to move more into the primary care market? Are you sort of continuing to push into, you know, more of the psych specialists?

I guess yeah.

Mark Jacobson, Chief Operating Officer, Axsome: Sure. So the initial focus of of launch and still to this day, but the initial focus was was was psychiatrists. And what we’ve been doing so we expanded about a year ago in the first quarter of twenty twenty four. We had we expanded with an additional 100 reps. That allows increased reach and frequency.

So that allows us to go that allowed us to start to go into primary care. And then we recently expanded I, you know, I mentioned I touched on this already a little bit, but we we expanded with 40 additional account managers. So the sales team right now is 300 account managers. That expansion completed in the first quarter, and that allows essentially, that allows for smaller territories, and that allows us to for the HCPs that we’ve been engaging with or calling on, detailing, allows us to see them more frequently and allows us to see additional additional targets, and would be in primary care. So that work continues to evolve as we get further out into further into primary care.

So that’s underway.

Leo, Interviewer: Got it. And you mentioned the long term guidance of 1,500,000,000.0 to $3,000,000,000 I think. I guess, you talk about sort of what goes into the lower end, what goes into the top end? Is it how much of that is driven by expanding coverage from 63% up? How much of that is driven by greater expansion into the primary care?

I mean, are there other factors that sort of fit into that, potential pricing dynamics?

Mark Jacobson, Chief Operating Officer, Axsome: Yeah. I I think all of that. And so, you know, you can I think all of that when and the confluence of those factors, which it’s frankly, it’s still the early days, right? We have runway to 02/1939, early ’2 thousand ’30 ’9, which is fantastic. So that’s a very long time for you to see synergy across some of these developments that you mentioned, access, utilization management, expansions with respect to trial and then potential uptake prescribing behavior changes.

So it is we’re very comfortable with that as a floor, right, and it becoming a potential blockbuster. So we’re very comfortable there. And the range is such that when some of these things might occur, that just impacts the slope and ultimate trajectory. So we’ll continue to refine that potentially as things move forward, and and we have a better line of sight into what we think ultimate peak is, but we feel very good where we are right now. On

Leo, Interviewer: that February, you guys had a settlement with Teva. I guess, how confident are you that that 2039 is the runway and that there can’t be anyone coming in earlier?

Mark Jacobson, Chief Operating Officer, Axsome: Sure. Well, Teva was was the only first filer, you know, under under Hatch Waxman. So there there were no co first filers. So there was no process where we had to settle with multiple parties or a settlement with one, and there was still ongoing litigation. Teva was the only one, and and we can talk about why that is.

But because they’re the only co first filer, that sets the entry date. So the right, the patents go to 02/1943, and the agreement with Teva is that they’d be able to enter the market 02/1939 with pediatric exclusivity or the February

Leo, Interviewer: without that. Got it. Maybe shifting gears to Alzheimer’s agitation. You guys have four studies, three of them positive. If you can start with what’s left for you guys to complete in the package before it gets submitted to the FDA?

Mark Jacobson, Chief Operating Officer, Axsome: It’s it’s the lift of building the package, which is primarily writing, and the the data generation, the patients aren’t being treated, you know, the the clinical studies are done. And so so that’s great. So it’s it’s compiling the data. It’s, you know incorporating the clinical study reports it’s completing the integrated summaries and and and it will be an sNDA right so that’s an efficacy supplement so we’re we’re only updating certain modules of the initial NDA. So it’s the build out, and we’re tracking very nicely.

Remain on track to a 3Q submission.

Leo, Interviewer: Got it. And there’s been a lot of discussion over, you know, what’s necessary for the FDA to see for that package to be approvable. Can you remind us sort of how those regulatory discussions started that led to sort of the next set of trials that you ran, if there’s been any evolution since you’ve had those readouts, and I guess, ultimately, confident you are that, you know, having the three positive phase three trials is sufficient and that, you know, one trial that missed is something that just happens in in Sure.

Mark Jacobson, Chief Operating Officer, Axsome: So the feedback so the history of that is the the very first trial we ran was ADVANCE-one. And so that was a that was a parallel group trial, and that study was positive. And when that read out, we spoke to FDA and shared top line with them. That’s what led to breakthrough therapy designation for the program. And then the feedback we’ve received or we received and that we’ve received throughout the program, which has been consistent, is we need two adequate and well controlled studies.

We want two positive, adequate, and well controlled studies. And we you know, if it’s helpful, I can walk through the exact evolution of how the trial started. But what we have now with the package is three positive studies. We have another parallel group study, which is great and is consistent with the other three. And then we have a stand alone long term safety database, which we needed because it’s an elderly patient population.

So FDA asked us to generate a stand alone ICH safety database with, you know, a certain number of exposures for twelve months, six months, and then they also importantly wanted randomized controlled safety data, which we have coming from two studies. That’s ADVANCE-one and ADVANCE-two. So feedback has been consistent and has been robust during the clinical program. In the spring, we shared the pre NDA meeting minutes the outcome of that, which enable us to file. So we feel good about the package that we have, and we’re excited about the work.

And as I shared, we’re on track to the 3Q target of submission.

Leo, Interviewer: Got it. I think a lot of the debate centers at times around having a with a randomized withdrawal study versus the parallel design randomized control studies. I guess, is there any difference in the way the FDA views those two study designs? Is there any difference in the way ultimately physicians look at the data coming out of those two study designs, or is it sort of the same for regulators and physicians?

Mark Jacobson, Chief Operating Officer, Axsome: The I mean, there are different designs, and so it may depend on with respect to the FDA and, you know, and being able to make an assessment of efficacy, no. Right? So the the and there’s there’s precedent for that. There’s written guidance for that, and there’s also the feedback we’ve received about the nature of the package. So we feel good about that, you know, precedent even within the division of psychiatry and and across across prior programs.

So the it’s all it’s all consistent there. When initially started that it depends is there are different types of studies. Right? So you can you you can they can tell you right? So parallel group, you can track longitudinal change.

Change, right? You don’t do that with a randomized withdrawal design study. There, you’re essentially looking for maintenance of effect, durability of effect or removal of a treatment response. So you can see different things, but in terms of demonstration of efficacy, both are both can do that. Right?

And so that’s important. There are differences with respect to the type of safety data that come out of those. And that’s why I mentioned we needed the two randomized, you know, parallel group trials, controlled parallel group trials, so that’s ADVANCE-one and ADVANCE-two, because FDA wanted in addition to the ICH safety database, they wanted the controlled data. And so, you know, that helps. That does provide those trials do provide a different type of safety assessment versus randomized withdrawal where everyone is treated in an open label fashion with the product before they’re randomized.

Got it.

Leo, Interviewer: What do you think the launch curve for Alzheimer’s agitation might look like, and what parts of the product are gonna resonate most and help drive that uptake?

Mark Jacobson, Chief Operating Officer, Axsome: The we haven’t quantitated that. I mean, internally, there there’s modeling, of course, and that informs the the targeting assessments that are underway right now and vice versa. We’ve shared that we think peak is similar to to depression, say, one and a half to three three billion. The so so we’ve offered that. The but in in terms of quantitating, you know, I I think that’s a that’s we’ll have to see how how it goes in the early days, but we we feel very good about the current infrastructure and and team that’s in place.

Many of the HCPs that the team is engaging with now are are appropriate and and would be there would be overlap in those with with HCPs that we’d want to engage with if the product is approved for ADA agitation. So that work is is well underway, and and we feel good about impact that should the product be approved, that that there’s it’s a relatively quick process to start engaging and detailing on the new

Leo, Interviewer: indication. Got it. Shifting gears to Symbravo, which is a product you’re gonna be launching at the end of the quarter, actually. I I guess, can you talk about how you’re thinking about that launch strategy, who you’re gonna be targeting, as it can be more specialists, and maybe how we should think about the contribution from Cymbravo this year.

Mark Jacobson, Chief Operating Officer, Axsome: Sure. The so you’re right. We’ll be launching next month, and so that’s you know, the the countdown clock is is underway internally, and it’s what are the next steps? Just just practically, the the the sales team, it’s gonna be about a hundred reps. So they’re they’ve joined, and they’re going through training and onboarding right now.

So that’s great, and that’s the rate limiting step. And we will be focused on specialists, and it’s a discrete sales team for for migraine because we’ll be focused on headache centers. And throughout The U. S, that will be the initial call point, if you will, and then we’ll go from there. So right now, it’s going to be looking to facilitate trial and utilization with patients who are are seen by headache specialists.

Leo, Interviewer: Got it. And there have been a number of different launch strategies in in the migraine space. You had sort of the high gross to net discounting early on. You guys took a very different approach with depression, with Avelity. You know, how should we think about, you know, that end of of the strategy?

Is it gonna look more like what you’ve done historically in the past?

Mark Jacobson, Chief Operating Officer, Axsome: The it it will in terms of having a a very, say, disciplined approach for identifying the areas we want we want to be in from a territory perspective and then who we want to be calling on within those territories. That that differs from from trying to go as broadly as possible into primary care as quickly as possible. Now what we so with that, the the my payers manage the utilization management for migraine, and it is distinct for depression. Right? So nearly every payer requires a, you know, a PA to label, so confirmation of age and and diagnosis.

And then in a similar fashion, nearly every payer requires, say, at least one generic triptan step. So it’s different from from depression, so sampling strategies are are different. And depending on the press and the case studies you mentioned or, say, the the launch strategy, there can be different strategies to patient savings and patient patient support, wherein to help get patients, you know, appropriate patients, the medicine if they’re prescribed it to make that process easy. So we’ll have some of those things in place, but I I would say how long the duration of those for any given patient or the amount on an annual basis, those things will be will, I think, will look a little bit different, but they will be in place. And so it’s distinct from depression, but it is I think it’ll also be our approach will be kind of in our in our vein of or our kind of the Axsome way of of looking to have a data driven, you know, deploy capital there in a very disciplined fashion.

So you’ll still see that, but but within the migraine category.

Leo, Interviewer: Yeah. You guys have a lot of programs. That’s a lot to cover in twenty five minutes, but I wanted to shift now to Sunosi Sure. Solriamfetol. You guys had two different phase three trials readout in short order.

Maybe starting with ADHD, you know, positive data there. Next steps are to run pediatric studies. So I guess maybe two questions. Mhmm. First, what’s the translatability usually been from an adult study to a pediatric study in this indication?

I guess, how derisking is the data you’ve shown?

Mark Jacobson, Chief Operating Officer, Axsome: Yeah. The I don’t have a, you know, a a coefficient for you of but but, generally, they’re you know, generally, the the the two go hand in hand. Right? Not always, but but oftentimes, if if you have activity in adults, historically, that indicates the molecule is active and then, you know, running a pediatric study, you know, it’s it’s it ties to signal detection and the type of study, but but generally they they go hand in hand, right? Not always.

So, you know, our job is to determine that, right? And that’s the next study, so that’s on track for 2025. And with respect to a potential package, the feedback we’ve received from the FDA is we need two studies, so one adult and one pediatric adolescent trial, because the initial indication we’ll be targeting is both adults and pediatric patients.

Leo, Interviewer: Got it. And I guess what’s remaining to launch that pediatric study? I know at one point last year, you were talking about potentially studying that starting that in parallel with with the adult study. Now it’s, you know, sort of shifted into this year. Yeah.

Can you talk about maybe, you know, what’s left on the design and getting that running?

Mark Jacobson, Chief Operating Officer, Axsome: Yeah. It’s it’s really just the the clinical development and clinical clinical operations prep work for, you know, protocol, you know, just just get everything lined up, protocol, clinical trial material, things like that, some of which are are lined up already, but it’s it’s us just running air traffic control on on the clinical side of the house and choreographing what studies are are coming online. And, of course well, I don’t think, of course, anything else. I think that that it’s it’s you know, we’ll we’ll be providing an update there, and it’s the work is the work is well underway.

Leo, Interviewer: Yeah. And then the other study you ran was in depression with EDS. So can you maybe talk a little about the strategy here? I mean, should we be thinking about this as EDS with comorbid depression, more depression with comorbid EDS? And Yes.

Are you gonna be launching multiple parallel phase threes given what you saw or or sort of one at a time, staging it more?

Mark Jacobson, Chief Operating Officer, Axsome: That’s a good question. So it it it will be major depressive disorder with excessive daytime sleepiness. So individuals who have major depressive disorder and also have excessive daytime sleepiness. And so, you know, we we looked at MADRS, and so that that’s you know, we’d expect to continue to look at that. And so we’ll be starting the first study.

You know, likely, we would need two studies or just consistent with you know, the first was a proof of concept, and we we like what we saw, obviously, to that warranted additional additional work in the next in the next phase three. But to answer your question, we we do think, you know, as as per as per usual, two studies are would be needed.

Leo, Interviewer: Got it. In the last ten seconds we have left, wanted to sort of zoom back out bigger picture on the company. You guys launched seeing a top line number this year, 500 to 600,000,000. Are you guys thinking about profitability, reaching breakeven, of the next step for the company?

Mark Jacobson, Chief Operating Officer, Axsome: Yeah. The I I think that’s that’s insight. And so we haven’t guided to a specific quarter, but with with the resources we have on hand, so that was $3.00 1,000,000 at the end of the end of the first quarter, that enables us to reach cash flow positivity. So just in the company and the foundation or and the impact of patients, the potential value we can deliver to shareholders, it’s the best position we’ve ever been in for the company, and cash flow positivity is in sight. So our job is to keep putting on the elbow grease to continue to deliver on the commercial, regulatory, and clinical fronts, and and that’s what we’re working on this year and and beyond.

Leo, Interviewer: Yeah. Sounds great. Yeah. Cool. Thanks, so much.

Thank you.

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