Axsome Therapeutics at Citizens JMP Life Sciences: Strategic Growth Unveiled

On Wednesday, 07 May 2025, Axsome Therapeutics (NASDAQ:AXSM) presented at The Citizens JMP Life Sciences Conference 2025, showcasing a robust first quarter. The company reported significant revenue from key products and outlined strategic plans for future growth. While highlighting successful product launches and positive trial results, Axsome also addressed challenges in market expansion and regulatory submissions.

Key Takeaways

• Axsome reported $122 million in Q1 net sales, driven by OVALITY and Sunosi.
• The company plans to launch Symbravo for acute migraine treatment next month.
• Positive Phase 3 trial results for solriamfetol in ADHD were discussed.
• Axsome expanded its sales team to approximately 300 account managers.
• The company is preparing multiple regulatory filings, including an sNDA for AXS-05 in Alzheimer’s agitation.

Financial Results

• Q1 net sales totaled $122 million, with OVALITY contributing $96 million and Sunosi $25 million.
• The company expects continued growth in net sales with upcoming product launches.
• Axsome’s financial performance reflects strong execution and market adoption of its products.

Operational Updates

• Symbravo is set to launch next month, targeting headache centers with a 100-rep expansion.
• The sales team grew to approximately 300 account managers in Q1, showing early positive impact.
• Axsome plans to submit an NDA for AXS-12 for cataplexy in narcolepsy patients this year.

Future Outlook

• The company aims to submit an sNDA for AXS-05 in Alzheimer’s agitation in Q3.
• A pediatric adolescent trial for solriamfetol in ADHD is planned for this year.
• Axsome is focused on expanding commercial channel coverage for OVALITY to reach 80-85% coverage.

Q&A Highlights

• OVALITY adoption is expanding from psychiatrists to primary care, with over 50% of use in first or second line treatment.
• AXS-05 shows potential for early use in Alzheimer’s agitation due to its differentiated mechanism.
• Symbravo’s launch strategy includes targeting headache centers for rapid relief and durable symptom relief.

Readers interested in further details are encouraged to refer to the full transcript below.

Full transcript - The Citizens JMP Life Sciences Conference 2025:

Jason: Started, so, thank you everybody for joining us again, this afternoon at the Citizens Life Science Conference. Really excited to be joined next by Axsome Therapeutics. Axsome is a commercial stage, company focused on, CNS indications. It actually has a number of approved products as well as a broad pipeline. As usual, a ton of stuff going on both from a regulatory perspective, data that you’ve read out in the couple months, as well as as well as actually selling products.

So, you’re joined here today by Mark Jacobs, the company’s chief operating officer. So, Mark, with that, I’ll just say welcome and maybe hand it over to you to give a couple quick Yeah. Introductory remarks.

Mark Jacobs, Chief Operating Officer, Axsome Therapeutics: Great. And, you know, Jason for for having us. It’s good to be at the conference and this is our our first time out in a while. We reported on on Monday and so so far this year there’s there’s a ton going on and it’s it’s been a really strong year so far. We’re not even halfway through.

So Q1, ’1 hundred and ’20 ’2 million net sales, 96,000,000 of that coming from OVALITY. That’s our product for major depressive disorder that’s now just two years post launch, a little bit beyond that. And then our second product, Sunosi, dollars twenty five million for the quarter. And so we’re pleased with just the continued execution and growth on those products. Now we have three products that are approved.

So in January, our third product, our second fully developed internally product is Symbravo. That’s for the acute treatment of migraine with and without aurora. We’ll be launching that next month. So that’s proceeding on track and we’re excited for that. The final kind of finishing touches on the sales and marketing platform are in the works.

We can talk about that, and so that’ll be commercially available. We’re targeting for next month. And then if you shift to, what’s been going on on the development side of things, AXS-five for Alzheimer’s disease agitation, we had pre NDA meeting minutes that we announced, the feedback from FDA on our plan. So we are on track to submit an sNDA for that program in the third quarter of this year. Then we had a number of data readouts, in particular solriamfetol in ADHD positive trial the focus phase three trial in adults.

We can talk about next steps there. We had a proof of concept trial in Major Depressive Disorder where, we have a nice signal in Major Depressive Disorder patients with individuals living with Major Depressive Disorder with excessive daytime sleepiness. Then there were also results associated with Symbravo from the EMERGE open label trial, phase three trial, in individuals with an inadequate response to prior oral CGRP therapy. So that’s all just what’s happened so far this year. So it was just an incredible amount.

So we’re pleased with activities year to date and then there’s a bunch coming up. It’s a really exciting year for Axsome.

Jason: Yep. Totally agree. A lot lot going on there. So maybe to to start off with, Ovelity, like you said two years on the market now. Can you maybe speak to where you’ve seen the initial adoption, the kind of, sub segments of the MDD market where you’re getting utility?

Mark Jacobs, Chief Operating Officer, Axsome Therapeutics: Yeah, so initial focus in terms of detailing and engagement with, potential prescribers, HCPs, starting out with psychiatrists and then now going broader into primary care. Initial use, right now, where things stand and we’re pleased with it, is over fifty percent first or second line. So first line or first switch. So very pleased with those numbers and the growth and how it’s being used, which makes a lot of sense to us. The product is fast, it lasts, it’s differentiated, so we’re pleased to see the uptake.

And maybe just one note on the operational side of things, we recently expanded the sales team. So it’s now about 300 account managers, sales reps, and that expansion was completed in the first part of so in q one, and so now we are starting to see preliminary impact and we’d expect that to

Jason: grow over time. Got it. Okay. I think one thing you guys have done really well is securing reimbursement for the product as well. So can you maybe just give us an overview of it’s never easy right?

Payers don’t want to pay for anything but just, how you’ve ensured that patients get access and where you still think you have room to grow?

Mark Jacobs, Chief Operating Officer, Axsome Therapeutics: Sure. Where we have room to grow is in the commercial channel. Our expectations around steady state is, you know, the vast majority of lives will be covered so that, know, we haven’t guided to a specific number, but what you see for the class antidepressants, the steady state is, you know, north of eighty-eighty five percent of total lives covered. So that’s our expectation and that work is underway. And What we are seeking to do, I mentioned how it’s being used already first line first switch, so that speaks to the quality of coverage that’s currently in place.

We’d expect to continue to add lives, in particular in the commercial channel, and to evolve and improve the current coverage algorithms that are in place. Already we like where we started.

Jason: You mentioned speed of onset of activity, patients feel better really quickly on the drug so to what extent is, I guess I’m going ask it a different way, what’s driving the selection of the drug for that frontline patient? Because you know it’s not common for a CNS drug to be used in front line this quickly.

Mark Jacobs, Chief Operating Officer, Axsome Therapeutics: Yeah and it seems to be a number of things. We talked about the rapid onset of action, that’s really important. Durability, and then feedback we’re also getting is safety profile and the tolerability profile. You have different rates of kind of the classic AEs with typical antidepressants, weight gain, sexual dysfunction, we don’t see those same rates that are historically seen and often are what lead to discontinuation in treatment adherence and compliance. I think that’s another key element based on the feedback we’re getting from clinicians.

Jason: So two years into the launch, you have more information now than you did on persistence. Yes. Can you maybe just give us an idea of, what you’re seeing in terms of persistence rates? Yeah. And if there’s anything that you’ve learned along the way that maybe can help build that?

We

Mark Jacobs, Chief Operating Officer, Axsome Therapeutics: haven’t, we’re still monitoring what it is, but right now, qualitatively, we’re seeing persistence compliance adherence kind of beyond what you typically see. There’s still flux in it and part of that will likely depend on how additional coverage comes online and things like that. But right now we’re pleased. We’re outpacing what you typically see for the class of antidepressants, but we haven’t given a specific number yet. The class tends to be, say three to six months, So we’re we we like where how it’s being used to date and and the persistent numbers that we’re seeing.

Jason: So so maybe if we move on to 80 agitation, can you maybe just hit the high points from the the phase three program? What we know what saw and where you see the opportunity for the Yep,

Mark Jacobs, Chief Operating Officer, Axsome Therapeutics: thanks. And obviously we’re pretty excited about that, that we completed that clinical program at the end of this past year. We have, three positive trials in hand and long term safety and, very pleased with what we saw both from an efficacy and safety perspective. In particular, we did not see signals with respect to falls and mortality. So we’re pleased with that and we think that’s really important given it’s an elderly patient population.

Looking ahead, the next steps, so I mentioned we pre NDA, We shared the pre NDA feedback from FDA and that allows us to proceed with an sNDA submission in the third quarter. That’s what the package will be comprised on. Team is essentially the data generation is done. So it’s it’s building it’s building the package, right, writing the modules and assembling them.

Jason: Was there anything in particular you were looking for to get out of the pre NDA meeting? Anything that you thought could have been, something you needed to get clarity on or, you know, it’s definitely something you know, that you have to go through. Sure. Yeah,

Mark Jacobs, Chief Operating Officer, Axsome Therapeutics: no definitely. So aligning on content format, you know, in a way it lets the FDA know what your plans are for presentation of the data, and, that’s good because it’s, I think in our mind, the data that we have in hand, it’s a clear approach for us for the submission. But you do want to align with FDA just in case there’s something on their mind that you haven’t heard yet, or you want to preview something new just to make sure that, you’re giving them warning to that. They have a heads up that that’s coming. That’s a big effort on their part.

So it’s, you know, in our mind it’s a mutually beneficial interaction.

Jason: And then where do you see the drug fitting in? Obviously agitation is a symptom that develops throughout Alzheimer’s as the disease progresses. Are you, and again I guess there’s two questions here, where do you think you’ll be at launch and where do you think you’ll be down the road? Sure. Is it the earlier stage, get the patient as early as possible, or are you going to end up starting with a slightly more advanced patient?

Sure.

Mark Jacobs, Chief Operating Officer, Axsome Therapeutics: It’s a huge unmet need, right, and there’s now one product approved and that product is growing the space. But the majority of patients are treated off label. The agitation is a very challenging symptom. It’s often these symptoms that leads to placement in long term care facilities so it’s critical to be dealt with and clinicians, it requires intervention. Patients can be a danger to themselves and others.

Potentially early days, should the product be approved and launched, potential early days, you might imagine those who are already seeing clinicians may already be on some type of off label or now on label therapy. What we love is it’s differentiated mechanistically from the primary way that patients are now treated, which is atypical antipsychotics. We like that it’s differentiated mechanistically, that offers very compelling elements from an efficacy and tolerability perspective. So in our work engaging with KOLs and clinicians, when we completed the clinical program we had a call, Doctor. Jeffrey Cummings participated and so the feedback is such that, hey based on the clinical profile, that’s something that clinicians would envision using early in the treatment paradigm.

Challenge now is there is a black box warning for the use of atypical antipsychotics in elderly individuals with dementia because of a mortality risk. So that’s an important consideration and you know a potential, obviously we don’t have a label or an approval or a label in hand, but potential differentiation there.

Jason: And I think our experience is the same you know physicians hold off prescribing atypical antipsychotics for as long as they can do in Alzheimer’s patients because of that that safety overhang. Okay great. Can we move on to some Bravo? You said approved earlier this year, you’re about to launch. Just maybe start with the label.

What are the key points there that you’re really pleased with and how will you position the drug from day one? Maybe also let me just, how does this fit into your existing commercial infrastructure and

Mark Jacobs, Chief Operating Officer, Axsome Therapeutics: Sure, great. So the product is, what we like about it, it’s differentiated. The clinical data that we generated shows robust efficacy, which is where the need is for the patient need is. So we like that a lot. What’s interesting about the product is you have two rapidly acting mechanisms of action and then a very long half life for durable symptom relief.

So we think that’s very important. Indicated for acute treatment, so it’s not indicated for preventative treatment, I think that’s important. When you think about detailing or the sales infrastructure around that, right now the two facets of the Axon sales team right now are you can break them into psychiatry and sleep. I think it’s just a simple way to do it. So we’ll be adding about 100 reps to focus on the headache centers in The US.

To us, early days and beyond will be a very targeted effort to those centers. So we want to drive initial trial and utilization in those centers because they tend to be, where uptake begins and then expands from there for individuals with migraine. So we’re excited about that and that will be announcing that in the not too distant future. Great.

Jason: Maybe you can just talk a little bit about the detailed message here. Obviously we have newer therapies for migraine. Yes. Physicians have become comfortable with those therapies. Yes.

So what’s your marketing focus for medical education focus?

Mark Jacobs, Chief Operating Officer, Axsome Therapeutics: Yeah, team’s gonna be launching the marketing messages and the marketing effort and campaign soon. I won’t front run them too much, but what I’ll share the need and the data we’ve generated is differentiated from an efficacy perspective. So that’s rapid relief, that’s twenty four, forty eight hour symptom relief, and that’s important because when you talk to folks, there’s the current treatment individuals with migraine, this is debilitating pain, and there are a bunch of treatment options, if you survey patients and clinicians there’s high, high dissatisfaction even today, despite the number of options with pain and say most bothersome symptom relief. So the exact message we’ll we’ll we’ll share with everyone soon but it will be in in that vein.

Jason: Okay. Maybe let’s talk about the pipeline a little bit. Yep. So Rifmetol, ADHD, you reported positive phase three data. You’re also now showing, the timeline of the efficacy curve.

Can you maybe just walk us through that new data that you’re now showing?

Mark Jacobs, Chief Operating Officer, Axsome Therapeutics: Sure. Yeah, that’s the focus phase three trial and was in adults. And what you’re referring to just to frame and when we reported on Monday, we also provided an updated corporate deck and so in there is the efficacy curve on the primary endpoint. So that’s the first time we’ve shared that. I mean obviously we top line the data but there wasn’t an update to the deck at that time.

And so that’s there, so change in an endpoint for specific to adults with ADHD that’s an AISRS and very, very robust reductions. Tested two dose levels, one hundred and fifty milligrams and three hundred milligrams and the primary, the key dose we are interested in is one hundred and fifty milligrams. That’s the highest approved dose. We are interested to see if there’s a dose response or we think basically at one hundred and fifty milligrams you’re capping the dose response ceiling. So next steps here are to launch a pediatric adolescent trial.

So the second study that we need in order to file for solriamfetol and what we’ve guided to is starting that program this year or that trial this year.

Jason: Okay and the market in adult ADHD has grown. There’s definitely under diagnosis. How do you ultimately see the drug being positioned there versus in the pediatric athletic setting? Sure.

Mark Jacobs, Chief Operating Officer, Axsome Therapeutics: You know one thing and just to your question that I neglected to mention but I think that that could be informative with respect to positioning and the treatment landscape is that the changes that we saw on the AISRS were very robust and in line with studies that have been done with stimulants and using the same endpoint in line with changes that you see with stimulants.

Jason: So

Mark Jacobs, Chief Operating Officer, Axsome Therapeutics: that’s important and compelling because then of course challenges with stimulants are tolerability profile, scheduling considerations and things like that. Mechanistically, Sarayanfetol is differentiated from stimulants in that way. Just think scheduling and we don’t see, the product is approved as solriamfetol safety and tolerability consistent with what the prior clinical program. So, that’s really compelling in terms of what’s available now. Stimulants, non stimulants, which obviously have a distinct safety and tolerability profile from the stimulants.

Where we net out exactly on that spectrum to be determined, but right now the data we have in hand, gives us, you know, we’re excited about that.

Jason: You’re also now moving through a phase three trial in MDD with excessive daytime sleepiness. What’s the rationale for the drug and Sure, yep. Yeah, let’s start there.

Mark Jacobs, Chief Operating Officer, Axsome Therapeutics: Sure, the rationale was initially feedback from KOLs who have experience treating patients with solriamfetol and the feedback they shared about their thoughts on indications that could be interesting. When we acquired Sunosi, salriamfetol, we very quickly launched a broad development effort across four different indications initially. So one of those was MDD, that’s based on KOL feedback from mechanistic but also real world trial of how patients do. So this study that we ran, the paradigm trial, we were interested to look at overall potential impact in depression, but also with sleepiness given what we know about the product profile already. So we looked at patients with sleepiness and that’s about fifty percent patients with MDD have excessive daytime sleepiness.

What we wanted to do for this study is make sure we were honing in on severe EDS, and so that’s what that study looked at. And then next trials will be just MDD with EDS and so we’re planning to launch the next phase three for that program this year as well.

Jason: We said at the start there’s a lot going on here. I wanted to spend the last couple of minutes talking about a couple more NDA submissions that are now and coming. AXS fourteen and twelve.

Mark Jacobs, Chief Operating Officer, Axsome Therapeutics: Yes, thank you.

Jason: So maybe 14 real quick so the Correct. Fibromyalgia of the indication. Yes. Know kind of give us the high points here knowing that we got like a minute

Mark Jacobs, Chief Operating Officer, Axsome Therapeutics: or two. Sure, okay yeah very quick so it’s submitted. So next step is to, share you know potential acceptance decision from FDA, so stay tuned. So that’s based on, two randomized placebo controlled trials, short term trials, are long term data sets as well. So we that’s one of three submissions for the year.

Mentioned another, that’s AXS-twelve. So AXS-fourteen, that’s S Reboxetine, so that’s the S Enantiomer of Reboxetine. AXS-twelve is Reboxetine, so that’s that’s racemic Reboxetine, that’s what we’ve developed for cataplexy in patients with narcolepsy. So that clinical program we completed a few months ago as well and we plan to submit an NDA for AXS-twelve this year. Then the third of course we’ve already touched on which is AXS-five and AD agitation.

The commercial front, the clinical front, then the regulatory front. It’s just the organization is humming across all functions and it’s a pretty exciting year for us.

Jason: Maybe just to wrap it up with a higher level question is, you know, you think about investors that are new to the story, a ton going on. Where do you think there, you know, there still may be opportunities to get more attention where you haven’t got as much focus?

Mark Jacobs, Chief Operating Officer, Axsome Therapeutics: Sure. Historically, you know, say past twelve months and beyond, the focus has been on Avelity and the Avelity launch and Alzheimer’s disease agitation. Over the past few months the rest of the organization is starting to come into focus and I think there’s still much of the organization is just coming into focus. We’ve touched on it. Are very That’s a good service.

No, no, we are very efficient today, so which great, but I think most of it is just starting to come into focus. Which, you know, which makes sense because obviously some of these programs are now getting to a point where it’s your regulatory filings or launch, know upcoming to launch so it makes sense but that’s why it’s such a neat time for the company deep and broad foundation with all these layers that are starting to go on top.

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