Axsome Therapeutics at Guggenheim Conference: Strong Q3 and Future Prospects

On Monday, 10 November 2025, Axsome Therapeutics (NASDAQ:AXSM) presented at the Guggenheim Securities 2nd Annual Healthcare Innovation Conference, showcasing both its recent successes and future strategies. The company reported robust Q3 results, driven by Avelity's performance in major depressive disorder (MDD) and Sunosi's sales growth. While optimistic about its pipeline and financial outlook, Axsome also outlined challenges such as gross-to-net dynamics and potential sales force expansions.

Key Takeaways

• Axsome's Q3 revenue reached $171 million, with Avelity contributing $136 million, marking a 69% year-over-year increase.
• The company is preparing for the potential launch of AXS-5 for Alzheimer's disease agitation, supported by three positive clinical trials.
• Axsome's direct-to-consumer campaign for Avelity has led to increased prescriptions and Google searches.
• The company achieved a positive cash flow of approximately $1 million in Q3, with expectations of continued growth.
• Axsome plans strategic sales force expansion to support its pipeline, particularly upon potential AXS-5 approval.

Financial Results

Axsome reported strong financial performance in Q3, with total net sales of $171 million.

• Avelity sales in MDD reached $136 million, showing a 69% increase year-over-year and a 14% rise quarter-over-quarter.
• Sunosi sales grew by 35% year-over-year.
• Cymbravo, in its first full quarter post-launch, generated $2.1 million in sales.

Operational Updates

The company highlighted several operational advancements:

• Avelity's direct-to-consumer campaign, launched in September, resulted in increased prescriptions, with weekly new prescriptions surpassing 2,800.
• Axsome is leveraging its existing infrastructure for the anticipated launch of AXS-5, targeting Alzheimer's disease agitation.
• Cymbravo, aimed at treating migraines, is supported by a sales team of 100 representatives, focusing on headache centers.

Future Outlook

Axsome remains optimistic about its future:

• The company expects the direct-to-consumer campaign for Avelity to yield returns primarily from refills by 2026.
• AXS-5, if approved, will benefit from established market access and a planned sales force expansion.
• Sunosi and Cymbravo are projected to achieve peak sales potential of $300 million to $500 million and $500 million to $1 billion, respectively.

Q&A Highlights

During the Q&A session, executives addressed several key topics:

• The gross-to-net discount for Avelity stood in the high 40s percentage, with 85% of lives covered.
• Axsome anticipates continued evolution in the Alzheimer's disease agitation market, with increased awareness and formalization of patient profiles.
• The company noted that most Alzheimer's patients are still treated off-label, highlighting the potential for AXS-5 upon approval.

In conclusion, Axsome Therapeutics demonstrated strong performance and strategic foresight at the Guggenheim Conference. For a deeper dive into the conference call details, please refer to the full transcript below.

Full transcript - Guggenheim Securities 2nd Annual Healthcare Innovation Conference:

Yatin Suneja, Biotech Analyst, Guggenheim: Morning, everyone. Welcome to Guggenheim Healthcare Innovation Conference. My name is Yatin Suneja. I'm one of the biotech analysts here. Our next presenting company here is Axsome.

From the company, we have a few executive, but we will be chatting here with Maude Jacobsen and Nick Pizzi, from the company. Should I hand it over to you, Mark or Nick, to make some opening comments? How do you want to do it?

Mark Jacobsen, Executive, Axsome: Well, yes, first of all, thanks for having us, Jatin. Really appreciate it, and, you know, we're happy to be here. It's a, you know, especially now with everything that we have going on this this to end the year and to kick off the next year. So, you know, real quick, maybe Nick can talk about commercial performance, but, very pleased. We just reported Q3.

We'll go into that strong quarter. We expect that strength to continue. And then just operationally and on the development side, a ton going on, and I'm sure we'll cover it, but there are our NDA stage programs, AXS-five and AD agitation, AXS-twelve in narcolepsy, and then a number of, you know, ongoing or soon to be initiated Phase III programs. So just a ton going on, recent update where we are building out the earlier stage pipeline. So we can talk about that.

That was an announcement last week. So we're just very pleased overall in terms of the company's progress this year and then outlook. And I don't know, Nick, do want to touch on any of numbers?

Nick Pizzi, Executive, Axsome: Sure. Yatin, thanks again for having for hosting Axelm here. So Q3 was another strong performing quarter, dollars 171,000,000 in total net sales led by our soon to be blockbuster product availability in MDD. For the quarter, it did $136,000,000 which was 69% year over year growth, 14% quarter over quarter growth. So I was really pleased with that and we'll get into it a little bit, but really excited about what the future holds for that product specifically around how we've been able to execute just with the team that we currently have of 300 reps, but importantly as market access has continued to evolve.

And then also we've just launched our direct to consumer campaign, so national TV campaign. So really pleased about where we are and what's going to hopefully transpire in Q4 into 2026 along with the ADA indication. Additionally, Sunosi had a very strong quarter as well, 35% year over year growth. So pleased with that very lean team. We have roughly 74 employees detailing Sunosi, but that continues to grow and very pleased that it's beating a lot of the expectations.

And then finally we launched Cymbravo for an acute treatment of migraine and that was we launched at the end of the second quarter. So this is the first full quarter had just over 2,100,000 and really nice anecdotal data that we're seeing as well as seeing scripts growing. So very pleased with all three products thus far. So looking forward to 2020

Yatin Suneja, Biotech Analyst, Guggenheim: Very good, Nick. So maybe just let's just touch on the commercial piece first Now on that you are doing the DTC, can you just talk about the impact? When do we generally expect that impact to come? How should we think about the cadence of patient and maybe the type of patient that might change with DTC?

Nick Pizzi, Executive, Axsome: Sure. Yes, I'll talk maybe a little about the metrics and then Mark can handle the patient profile. But early data, we're already starting to see the impact of DTC. So very pleased with that. And what do I mean by data Specifically, the first thing you'll see, let me take a step back maybe.

We launched a campaign early September, so it's really only been live for two months. And the first data piece of data that we saw was the Google searches and that index had peaked for based on the history. So we're pleased with that and it continues to stay at a high level. So very, very happy with that. But more importantly is we're starting to see the NBRxs, and that's where we would expect to that would be the next main indicator.

NBRxs, maybe just a little bit of history on that, the NBRxs were around 2,000 per week in Q4 and Q1. We did an expansion in Q1 by roughly 40 reps to get to the 300. So we saw a 25% increase there in NBRxs. And that so went from 2,000 to roughly 2,500 NBRxs in Q2 and Q3. And then more recently, we've been seeing all time highs on The Weekly.

Most recently, this last week, we surpassed 2,800 for the first time. So we attribute that increase from the 2,500 level to the 2,700, 2,800 level, which we've seen in the last few weeks, mostly to the DTC. So super pleased with that. And then really the ROI on the DTC comes with the refills, right? So we would expect to see that ROI into 2026.

Yatin Suneja, Biotech Analyst, Guggenheim: Got it. How big how comprehensive or how big is the DTC from a spend perspective?

Nick Pizzi, Executive, Axsome: Sure. Yes, it's we're doing in the Axsome I'll say the Axsome way where we're not just throwing out $50,000,000 a month in trying to be on every channel. We're doing a very disciplined approach and maybe a little bit of qualitative behind that is in Q2, did a very small program in certain regions to take a look at to basically do test markets and see what worked and what didn't work. And then we were able to implement that in, like I said, Q3, Q4. From a dollar amount, we haven't specifically shared from a competitive nature how much we're spending and giving indicators that way.

However, what we have shared is that we anticipate our sales in Q4 to meet or exceed the additional spend that we are going to have on DTC, which is really would be driving our OpEx along with any additional spend in OpEx and R and D.

Yatin Suneja, Biotech Analyst, Guggenheim: Got it. Got it. In terms of the type of patient, are you able to given that DTC is now live, are you able to have a broader reach, maybe a little bit more? Sure.

Mark Jacobsen, Executive, Axsome: Yes. So obviously, when we when we first launched the product, you know, as with any new, new branded entrant, you you typically see later line use. Yeah. Right? And that's what we saw, right?

You're you're navigating new to market blocks and and things like that or starting with with, potential prescribers that that tend to have patients who are already on some type of treatment. And, you know, since the early days, we're we're now seeing early line use, say- say, first line or first switch, so- so first or second line, is- is about fifty percent of- of the patients that are receiving the product. And, you know, the latest numbers are, you know, mid teens for first line and the balance, second line, and and then so that's about fifty percent, and and then it goes from there, third, fourth line, etcetera. So that's great, and, you know, around a bit over fifty percent is monotherapy, that's also great, and we expect that trend to continue for earlier line use. So the product performs really well across patient profiles, and, you know, that makes sense to us mechanistically, that's what we saw clinically, and that's what we're seeing in with real world utilization.

So definitely as awareness increases, as your, another element of the sales force, right, is just focus on primary care, nurse practitioners, and things like that, so we expect that also to continue to drive earlier line utilization. What layers onto that is also just the market access evolution. Yeah. And, you know, we've been very disciplined in terms of the type of access that we would rebate for. And, so we're seeing access that facilitates or or, enables, earlier line utilization.

So so we're pleased with that, and we expect that to, also contribute to additional growth.

Yatin Suneja, Biotech Analyst, Guggenheim: Okay. Just two quick questions on Vaility and MDD. Can you talk about the gross to net dynamic? I think if I look at the gross to net that you or yield that you have is higher than some of the newer side. How are you able to do that?

And how will that evolve in 2026 or going forward? One. And then the second one is, are there more expansion plan from a sales force perspective just to further accelerate the growth?

Nick Pizzi, Executive, Axsome: Sure. Yes. So Jan, we've we announced this past quarter that our GTN for Q3 was in the high 40s. That's a high 40s discount. So that's the first time that we were able to share that we were below 50% from a discount.

So really pleased with how that's evolved. But more importantly, that came with 28,000,000 additional lives. So we are now at 85% total covered lives. That's 100 in the government channel and 75% in the commercial channel. Additionally, this is as important as those 28,000,000 lives came with first line or first switch access.

So if you think about everything then, net price is improving, access is improving and quality of access is improving. So we're really pleased with how that has evolved. We've also shared that we also signed the third GPO. So there's three main national GPOs. We signed an agreement with the third GPO this quarter.

So now there's a pathway for those additional, call it 25% of those lives, the additional 25% of lives that are not covered to be able to have a path forward to coverage. So super pleased with that. And I think your second question was on expansion of the sales force. So we have 300 reps currently. We're very pleased with how we're performing.

I think there's still more room for them to grow. So but I would say the next natural expansion of the field force would be within ADA approval and launch, and there's significant overlap between ADD and MDD. So we'll be sharing more about that in the near term. But as it relates to ADA, and I'm sure there'll be we're getting segueing to your next questions probably on is some of the back office team is already in place for Alzheimer's disease agitation. What I mean by that is the commercial infrastructure is already established.

The medical affairs infrastructure is already established for ADA. So team is well underway in preparing for launch. And from a field force perspective, we're doing the sizing currently.

Yatin Suneja, Biotech Analyst, Guggenheim: Got it. Very good. So then we just switch to ADA then. Mark, I think there is still debate or there is still debate from investor perspective like what is an approvable package. Maybe it's more clear to you.

Can you just explain to us what do you what sort of an agreement you already have with the FDA or what constitute a successful package for you to file? Sure.

Mark Jacobsen, Executive, Axsome: And what's great now is the clock is ticking. Right? So so the cycle started, so we feel, we're pleased with that. And, you know, we'll we'll all have answers very soon. A package, and and so this is feedback from FDA and also matches the statutory requirements, right, is that we need two positive, adequate, and well controlled trials.

And we our package includes three, and those are of different trial paradigms, of different durations, and with different types of controls. So that's that's a very robust, consistent package that we've generated from an efficacy perspective, also from perspective. As a reminder, so the product is approved. This is an efficacy supplement. As a reminder, given the patient population, it's elderly patient population at risk or has additional risks, from non elderly patients, FDA asked us to generate a standalone ICH safety database, right?

So not just the initial approval safety database, but another one. We've done that, and we didn't see a signal for falls or mortality and things like that. So in addition to, having three positive, you know, controlled randomized trials, we also have, what we think is, or the data that emerged, was a really compelling tolerability profile from a risk benefit perspective in this patient population. So we feel good about that. And, you know, all of that matches with the feedback we received from the very beginning of the program, and through the pre NDA meeting, outcomes that we announced earlier this year.

And so then it's, you know, been very consistent feedback wise and also consistency of feedback matching statutes and guidance.

Yatin Suneja, Biotech Analyst, Guggenheim: Got it. We will read from I think your read of the statute is that these are well controlled study, different type study. Basically, statute doesn't say that it needs to be randomized controlled or randomized withdrawal.

Mark Jacobsen, Executive, Axsome: Correct. Yeah. I mean, you can go further, right, in that there is guidance on on trial designs for appropriateness of when to utilize, say, designs beyond a parallel group trial, so a randomized withdrawal or or relapse prevention trial. There's there's guidance there. There's guidance on, in, say, take the guidance for substantial evidence of effectiveness.

In there, it states that, different trial designs are actually better for controlling type one error than than two of the same, right? So, you can they're they're all different inputs that that I think inform our package and and pertain to, that, the totality of data that we've put in.

Yatin Suneja, Biotech Analyst, Guggenheim: Got it. So in the pre sNDA meeting, you sort of must have reached an alignment or an understanding with the FDA is that, hey, look, this is what we're going to present because if there was difference, they would have told you not to.

Mark Jacobsen, Executive, Axsome: Sure. Yes. No. The the definitely, we we told them, you know, I've just gone through, that's what we we shared was gonna be in the package. And so, yeah, that that's great.

And one reason I was kind of highlighting, there's there's feedback we have from them from the beginning throughout the program. There's there's the statutory requirements. There's the guidance requirements. One reason that's all important, of course, is it's always a matter of review. So so right?

And so that's important. So we feel good going into said review.

Yatin Suneja, Biotech Analyst, Guggenheim: Got it. And then this is a breakthrough designation. Would you expect at least investor expects you to get out prior to review? I don't know where you stand on

Mark Jacobsen, Executive, Axsome: It's eligible for it. Right? So it it right. So we received breakthrough therapy designation after the first phase three, after advance one, and we've maintained it. Mhmm.

So it's eligible for prior to review. What what we've shared is is our we model a standard review. So first of all, both are fast compared to, say, a full NDA, right, given this is a supplement. And the reason we model a standard review is not because of the package itself, but rather just an awareness of, other programs that maybe have been eligible for priority review and maybe getting standard review or just resource constraints at a higher level. And mind you, that's not specific.

Yatin Suneja, Biotech Analyst, Guggenheim: Correct.

Mark Jacobsen, Executive, Axsome: We have, you know, the agency doesn't tell you one way or another about what they're gonna do. However, you know what you're eligible for, and you know, we've now been through a number of reviews. And, you know, with with the first review, I think we have an awareness, which, about, you know, timelines and things with that of the FDA. So we we prefer just to model a conservative approach.

Yatin Suneja, Biotech Analyst, Guggenheim: Got it. Just maybe one more question, then I want to discuss Cymbravo and then Sunosi. On the market evolution side, I mean, obviously, Rexulti still has its challenges. It's still I think it's sort of is an antipsychotic, has that black box. How do you see that market?

Like how is that evolving? Because Rexulti segment, I don't know how much it is growing.

Mark Jacobsen, Executive, Axsome: You want to talk about growth? I can maybe talk about market evolution or Sure.

Nick Pizzi, Executive, Axsome: Maybe I can talk a little about Rexulti and how they're performing. So if you take a look at their growth, so maybe first off the markets roughly seven million Alzheimer's disease patients, seventy percent roughly face agitation. So you're talking somewhere in the neighborhood of around 5,000,000 patients and Rexulti, I think launched in 2023 and they're seeing nice growth in that market. I know qualitatively they shared that their growth is somewhere in the neighborhood of 20% to 25%. If you actually take a look at sales for Rexulti from that period of time to where they are now, they're essentially doubled.

So on a quarterly basis, sales for Rexulti were 400,000,000 to $450,000,000 back then prior to launch in this past quarter, north of $825,000,000 looking at both manufacturers' financials. So you're seeing the growth and qualitatively, it sounds like 20% to 25% of their total sales are in that Medicare channel and related to Rexulti related to ADA.

Yatin Suneja, Biotech Analyst, Guggenheim: Got it.

Mark Jacobsen, Executive, Axsome: Yes. So maybe just to piggyback off that. So the market is changing, but it's also staying the same. And why? The majority of patients are still treated in an off label fashion with other, you know, atomical antipsychotics, SSRIs, SNRIs.

So that's still, you know, that's still the majority of scripts being written. But it's changing because now there's an approved product, right? There's one approved product, so patient profiles are starting to become more formalized perhaps, and then there's, of course, active promotion in the space, which generates awareness and things like that. So definitely, market is maybe, you know, it's becoming, so it is evolving, and Nick talked about the numbers too there, also there's still a lot that's steady state, you know, because there's only one approved treatment. And that, so mechanistically, there hasn't been a lot of innovation.

Yatin Suneja, Biotech Analyst, Guggenheim: Got it.

Nick Pizzi, Executive, Axsome: And maybe just furthering, it's helpful for them to be able to obviously educate the market on this disease state. One of the things that how we think about launching in ADA, so as I mentioned, we have the team, the current team of 300 reps. We would likely do an expansion upon an approval that would be focused on MDD as well as ADA. And then we would also focus on long term care centers. We haven't actually detailed an LTC's at all for the MDD space, and there is a lot of comorbidity between MDD as well as ADA.

And lastly, as we think about market access, I shared earlier that we're 100% covered in the government channel, which the majority of the ADA scripts would be in Medicare in that government channel. So we feel like coming out of the gate, we're set up really well to perform. Got it. Very good. Let me move to Cymbravo.

I think some early uptake that you're seeing right now.

Yatin Suneja, Biotech Analyst, Guggenheim: Can you articulate how do you how big you think the product could become? How is the access looking? I think the recent quarter of $2,100,000 was at least better than what we were hoping.

Nick Pizzi, Executive, Axsome: Yes. So I think maybe I'll start a little bit on it. So $2,100,000 in the quarter, we're pleased with how we're out of the gate. We're similar playbook to Avelity is how we're launching with Sunbravo, a very disciplined, discrete field team of 100 reps compared to some of our peers with north of around 600 reps where they launched with. So a very focused approach.

We have roughly 50% coverage of lives, and that is an increase from what we shared in Q2. So pleased with that.

Mark Jacobsen, Executive, Axsome: And the way we're approaching launch is a very targeted effort around, headache centers and headache specialists. We were very interested in, driving early trial in those areas or with those potential prescribers to see and understand how the product does in a real world setting. And so far, the feedback from prescribers is, matches expectations and the data we generated clinically, which is, you know, very robust efficacy, works well, and then, with with a really nice tolerability profile for said efficacy. And that early utilization, that will inform downstream strategy and tactics, which we'll pull through. But so far, the early days, we're pleased with the feedback we're hearing.

And then we'll do what we do, which is a data driven approach to expanding awareness and promotion and then obviously potential utilization.

Yatin Suneja, Biotech Analyst, Guggenheim: How big the product can become?

Nick Pizzi, Executive, Axsome: Yes. Was just going to share that. So we shared previously that $500,000,000 to $1,000,000,000 in peak sales, and we still we feel very confident in that. Got it. Then quickly on the narcolepsy, like what has

Yatin Suneja, Biotech Analyst, Guggenheim: been the gating factor for an NDA filing? And then can you just frame for us the market opportunity there?

Mark Jacobsen, Executive, Axsome: The gating factor is building the submission. So the clinical work is done, and there there were there wasn't ongoing clinical work or data generation or anything like that. It's us running air traffic control on the, non shutdown air traffic control on our programs. It's, you know, both our division of psychiatry and things like that. So we've we've got a complex choreography on our But side that we're really, it's the analysis, it's the writing of modules and things like that.

This is a new NDA. Yeah. So we wanna take our time to strengthen it as much as possible and dial the i's, cross the t's, etcetera, make sure all the modules link appropriately, you know, to get really into it. And so, I mean, that goes without saying that has to be done, but that that's the work that's happening.

Yatin Suneja, Biotech Analyst, Guggenheim: Okay. And then this is sort of as an orphan drug pricing. Just can you put in perspective how you think about the market?

Mark Jacobsen, Executive, Axsome: We haven't guided to pricing yet, but yes, it's an orphan market. And we have a pretty good sense of where products are priced right now and the range. And there's nothing about the product that, you know, we think the product's differentiated from an efficacy and tolerability perspective. So, you know, we there's nothing about the product that would lead us to plan for or anticipate some anomalous type of pricing framework. Got it.

Nick Pizzi, Executive, Axsome: It's But we feel super synergistic to our current So sleep course as basically, it's a plug and play for our team.

Yatin Suneja, Biotech Analyst, Guggenheim: Yes. Your Sunosi

Nick Pizzi, Executive, Axsome: in EDES, like how is

Yatin Suneja, Biotech Analyst, Guggenheim: the outlook for Sunosi in general? Good. Like where it could be, the product I mean, the last quarter was good, like we did $30 yes.

Nick Pizzi, Executive, Axsome: We did $33,000,000 in the quarter, nice growth year over year and continues to maintain the 300,000,000 to $500,000,000 guidance in peak sales in that indication with four indications behind it. So that will obviously get a tailwind if those any of those indications are approved.

Mark Jacobsen, Executive, Axsome: Yes, very disciplined from a business and investment perspective, right? The sales team is about seventy, seventy five reps, and so it's just incredibly efficient and product is growing, as Nick mentioned.

Yatin Suneja, Biotech Analyst, Guggenheim: Got it. Finally, on the P and L, I mean, I think we estimate that you should reach cash flow positivity next year. Just can you talk about where the leverage is coming from? I think you will have to make investment into ADA if it gets approved. All of that is going shake out for next year?

Nick Pizzi, Executive, Axsome: Yes. So a quick comment on the quarter as a milestone for the company. It's the first time that we actually hit cash flow positive. And if you take a look at our cash flow from operations, we actually were about roughly $1,000,000 positive for the quarter. So super pleased with that.

We'll continue to see operating leverage in Q4 and into next year. I would say, if you take a look at where we are currently in the P and L, we had $150,000,000 in SG and A and roughly $40,000,000 in R and D. You would anticipate that DTC spend into Q4 will continue slightly. There will be some stuff that was one time from Q3 that will not be carried into Q4. And then if you think about R and D, we're at $40,000,000 for Q3.

We do anticipate to start four trials in Q4 and really fully loaded in Q1 and so forth. So we would expect that $40,000,000 to probably tick up to closer to the $50,000,000 where we've been historically in that $50,000,000 to low $50,000,000 range. So pleased with where we're seeing. But overall, this quarter specifically, we saw revenue grow at 14%, OpEx grow at 5.5%, and that was with a launch, a full quarter's worth of launch for Sunbrella and hitting cash flow positive in that quarter, we feel very happy about. Got it.

Very good.

Yatin Suneja, Biotech Analyst, Guggenheim: Very good. I think that's all I have for you guys. Thank you so much. Thanks for having us. Thank you.

Mark Jacobsen, Executive, Axsome: Thanks, John. Thanks, Jan. Thank you.

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