Axsome Therapeutics at Morgan Stanley: Strategic Growth and Innovation

On Monday, 08 September 2025, Axsome Therapeutics (NASDAQ:AXSM) presented at the Morgan Stanley 23rd Annual Global Healthcare Conference. The company outlined its strategic growth initiatives and innovation efforts, highlighting both achievements and challenges. While Axsome reported robust revenue growth and market expansion, it faces hurdles such as pending regulatory approvals and market undervaluation.

Key Takeaways

• Axsome reported $150 million in net revenue for Q2 2024, with significant contributions from Auvelity and Sunosi.
• The company is leveraging AI for commercial efficiencies and R&D, and is exploring partnerships in China.
• Axsome plans to submit an sNDA for AXS-05 in Alzheimer’s disease agitation, with potential market opportunities ranging from $1.5 billion to $3 billion.
• The company anticipates continued financial improvement, even without immediate regulatory approvals.

Financial Results

• Q2 2024 net revenue reached $150 million, with $120 million from Auvelity and $30 million from Sunosi.
• Symbravo, launched mid-June, contributed just under $0.5 million.
• Net loss for Q2 was $48 million, but on a cash basis, it was approximately $19 million.
• Cash reserves exceed $300 million, with R&D spending expected to remain around $50 million per quarter.

Operational Updates

• Auvelity’s sales force expansion increased new prescriptions by 25% weekly.
• Symbravo launched with a focus on 150 high-decile headache centers.
• Market access for Auvelity improved, now covering 83% of total covered lives.
• AXS-05’s sNDA submission for Alzheimer’s disease agitation is on track for Q3.
• AXS-12 in narcolepsy is set for NDA submission in Q4, leveraging existing Sunosi infrastructure.

Future Outlook

• Axsome anticipates peak sales of $500 million to $1 billion for Symbravo.
• The potential approval of AXS-05 in Alzheimer’s disease agitation could yield $1.5 billion to $3 billion in sales.
• Sunosi’s clinical trials for new indications, including shift work disorder and binge eating disorder, are expected to yield results by 2026.
• The company remains optimistic about financial improvements, regardless of immediate regulatory outcomes.

Q&A Highlights

• Axsome is considering partnerships for global rights, including in China, to leverage its biotech innovations.
• AI is being utilized for enhancing commercial and R&D operations.
• The company believes its stock is undervalued, with expectations of market correction following AXS-05’s regulatory resolution.
• Key drivers for Auvelity’s adoption include expanded sales force, improved market access, and direct-to-consumer advertising.

For more detailed insights, readers are encouraged to refer to the full transcript below.

Full transcript - Morgan Stanley 23rd Annual Global Healthcare Conference:

Sean Lammon, Head of U.S. Smidcap Biotech Equity Research, Morgan Stanley: Good afternoon, everyone, and welcome to the Morgan Stanley Global Healthcare Conference. I’m Sean Lammon, Head of U.S. Smidcap Biotech Equity Research here at the firm. Before we commence, for important disclosures, please see Morgan Stanley Research’s disclosure website at www.morganstanley.com/research-disclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. For this session, we have Axsome Therapeutics with CEO Mark Jacobson and CFO Nick Pizzie. Welcome, gentlemen, and thank you for your time today. I thought maybe to commence proceedings, if you want to make some remarks to set the scene before we begin Q&A. Welcome, and thank you for your time today.

Mark Jacobson, CEO, Axsome Therapeutics: Thanks, Sean. Really appreciate it and nice to be here. It’s a very busy and productive day for us, which is great. Just by way of intro, Axsome Therapeutics is focused on frontiers in brain health. What that means is we are focused on areas of unmet needs for central nervous system disorders. We do that through a variety of ways. We have three on-market products, which Nick will touch on shortly, and a very robust pipeline of a number of late-stage product candidates from Alzheimer’s disease agitation to ADHD, narcolepsy, et cetera. We’d be happy to run through the updates there. Very happy to be here today. I’ll turn it over to Nick, who can kind of frame where we are from a business perspective on the commercial side of things.

Nick Pizzie, CFO, Axsome Therapeutics: Sure. Thanks, Mark. As Mark mentioned, we have three commercial products. As of the end of Q2, we had $150 million in total net revenue, of which $120 million was related to Auvelity, $30 million for Sunosi. We just recently launched our most recent commercial product, Symbravo, in migraine. That was on the market for just two and a half weeks and did just under $0.5 million. Super excited about those three products, specifically Auvelity. Eleven quarters in now, tracking towards close to $0.5 billion annually. One other announcement that we had is that we were able to increase access for Auvelity up to 83% of total covered lives, 28 million additional lives covered with no degradation in that price. Super excited and have a lot of good things to look forward to on the back half of the year.

Sean Lammon, Head of U.S. Smidcap Biotech Equity Research, Morgan Stanley: Yeah, wonderful. We’ve got three macro questions. The first one of those is with China’s rise in biotech innovation, how do you think about Axsome Therapeutics’ competitive position here? Will this influence your R&D and business development strategy?

Mark Jacobson, CEO, Axsome Therapeutics: Sure. The developments in China and the rest of the world in terms of increased prowess or presence in R&D, and we’ve been aware of that and mindful of that. In terms of our day-to-day, we’re doing our thing, and it’s good to be aware of. Outside the U.S., what we’ve shared is we plan to, our general approach is to think about partnering the assets that we have global rights in. That’s obviously relevant for key markets, potentially including China, depending on what, to your point, what may be available or development in the space there. It’s also interesting in terms of R&D and development that’s happening there that may be interesting to explore opportunities in the U.S. I think that just we fold that in into our just general commercial intellectual property considerations and also potential pipeline development and expansion considerations.

It’s no big changes to how we go about our day-to-day business as of yet.

Sean Lammon, Head of U.S. Smidcap Biotech Equity Research, Morgan Stanley: Wonderful, wonderful. How are you currently leveraging AI or thinking about AI’s future disruption potential?

Mark Jacobson, CEO, Axsome Therapeutics: Definitely. AI is, you know, we see it and use it across a number of functions at the organization. Very, you know, first and foremost, we see it as a driver of efficiencies in some areas. We have already developed a broad kind of deployment and utilization framework on the commercial side of things. The team has developed and is utilizing actively an AI engine that helps detailing efforts in terms of engaging with clinicians and ensuring team members have access to data and information, detail aids, or components of the core visual aid that is most appropriate for any discussion in terms of responsiveness and helping to identify what areas to quickly engage with someone on or in terms of driving efficiency and responding to an inbound query, things like that.

All the way through data and analytics, how we’re thinking about analyzing commercial and R&D data, it’s relevant there. It’s also very interesting and useful in terms of looking at historical data in the industry in terms of R&D that can be data sets or, say, approval histories and things like that. We find it broadly useful and it drives efficiency. That comes with also a mindfulness in terms of how these language models work, what gets uploaded to them, what platforms and things like that. There’s a deep, you know, basically an AI champion team internally that helps with that.

Sean Lammon, Head of U.S. Smidcap Biotech Equity Research, Morgan Stanley: Wonderful. What has been the most impactful in Axsome on the regulatory side? Is it FDA, MSN, or tariffs?

Mark Jacobson, CEO, Axsome Therapeutics: I don’t know that we’ve seen disproportionate impact from any of those. You know, maybe you would say pleasantly, the state of the business is pretty much status quo with respect to all of those, and we can touch on them. Regulatory, the way we engage and the different divisions we engage with, it hasn’t manifested in a way such that we’ve seen any type of differential engagement or type of feedback or dialogue there. We know it is impacting how they go about their business, but nothing in terms of a material impact to us that we’re aware of. Do you want to touch on the other?

Nick Pizzie, CFO, Axsome Therapeutics: Sure. Maybe on tariffs and MSN, we don’t believe there’s any material impact. It’s an immaterial impact to the organization. For most favored nation pricing, the only product that we have that is commercialized ex-US is Sunosi. That is by our partner, Pharmanovia, in Europe. If there is any specific impact, that would relate specifically to the government channel, which is a small portion of the Sunosi business. As it relates to tariffs, the majority of, well, all of Auvelity and all of Sunosi is manufactured in the U.S. and Canada. Again, the only potential impact would be as it relates to Sunosi, which is manufactured ex-US. The tariff would be an immaterial impact. It’d be focused specifically on cost of goods. The material piece, the cost of goods is made up of royalties, material, labor, and so forth. The tariff only impacts the material piece.

It would be such a small subset of Sunosi that we don’t find that’s a material impact to the organization as a whole.

Sean Lammon, Head of U.S. Smidcap Biotech Equity Research, Morgan Stanley: Wonderful. More specific Axsome questions out of series on Auvelity and MDD and continue to show strong growth in MDD. You manage what the key drivers are behind this observation and adoption, and how do you see its usage evolving in primary care versus psychiatry?

Mark Jacobson, CEO, Axsome Therapeutics: Do you want to touch on some of the tactical things?

Nick Pizzie, CFO, Axsome Therapeutics: Yeah, yeah. Thanks, Mark. Maybe I’ll speak a little bit about the sales force at first. Axsome’s approach has always been a very disciplined approach in investing into the business. We started Auvelity, we launched with Auvelity with 160 reps. We added about 100 reps about a year and a half ago, and then we added an additional 40 reps this year. We’re seeing each time that we have added a field force to Auvelity to detail, we’ve seen that return come back pretty significantly. The first area that you will see the return on and the effectiveness of these investments is with the MBRXs. To kind of give a sense, just most recently on the expansion that we did of additional 40 reps, again, we put them in the field sometime in Q1.

In Q4 and Q1, we saw MBRXs in the neighborhood of around 2,000 average MBRXs per week. In Q2 and Q3, once these reps got their, let’s say, legs under them, we’re now seeing 2,500 MBRXs per week. Basically, a 25% inflection up because of those 40 reps, but also more importantly, the 260 reps that we currently have, that we originally had, are being able to be more focused and the GOs are smaller and tighter, so you’re getting better breadth and depth. That’s the first thing. Secondly, the payer access, as I mentioned in my introductory comments, has improved significantly over the last couple, last two and a half years, roughly. We’re at 83% of total covered lives. We are optimistic that that number can continuously be improved by the end of the year and into the start of 2026. We’re super excited about that.

Tertiary, we just launched our direct-to-consumer national TV campaign this morning. That’s super exciting for the business. The first commercial aired this morning. We did do a pilot study in Q2, saw inflections up in MBRXs as well as searches around Auvelity in those specific pilot areas. We’re super excited starting today, going through the end of the year on the campaign. Each one of those results in accelerated growth for Auvelity.

Mark Jacobson, CEO, Axsome Therapeutics: Maybe just to round that out with respect to primary care, right now we’re seeing of the prescriptions, about a quarter are coming from primary care. Another way to look at that is about half of the prescriptions are in first line or first switch, so first or second line, and about 15% to 16% is first line. That speaks to early utilization, relatively early in the product life cycle. If you layer on the potential growth dynamics that Nick is speaking to, we’d expect to see continued improvement or uptake in primary care as we go.

Sean Lammon, Head of U.S. Smidcap Biotech Equity Research, Morgan Stanley: Thank you. My next question, I think some of the answers you just provided answered some of this, but I’ll ask it as is anyway. I think in first line, second line versus third line, the mix is around 50%. How do you see that mix evolving, and how do you push more of the volume into first and second line?

Mark Jacobson, CEO, Axsome Therapeutics: Exactly. Early days of new branded entrants, kind of regardless of the category, they tend to be later line. There are, of course, a number of reasons for that. Typically, access is one of those. We have seen since launch steady improvements in earlier utilization of the product. We think that really ties to some of the awareness and access that Nick touched on, but also the product profile. We see the product, the feedback we’re getting from clinicians is that Auvelity works well in a variety of patient profiles, later line and earlier line. When you think about going further into primary care, I should also point out that it’s used approximately 50% in monotherapy, or as monotherapy. That also lines up nicely or advantageously with when you think about prescriptions and primary care.

We would expect that to continue to improve as we go, as awareness increases, as our engagements with clinicians, HCPs, and primary care increase. We expect that to continue to pick up steam.

Sean Lammon, Head of U.S. Smidcap Biotech Equity Research, Morgan Stanley: Wonderful. Could you talk about recent expansion of payer coverage for Auvelity? What are your expectations for prescription volume access improvements in the second half of the year?

Mark Jacobson, CEO, Axsome Therapeutics: Nick Pizzie touched on a recent development.

Nick Pizzie, CFO, Axsome Therapeutics: As I mentioned, we had the additional $28 million lives July 1, gets to 83% total covered lives. Pleased with that. Ongoing conversations to get that number even north of that. We feel solid and optimistic about that by the end of the year. I don’t know anything else you want to share.

Mark Jacobson, CEO, Axsome Therapeutics: Excuse me. That speaks to definitely a number of covered lives. The other work that’s underway is quality of coverage and ease of writing. In terms of reductions and improving or reducing barriers for clinicians, if clinicians see an appropriate patient, we want them to have as few barriers to writing the potential script as possible. We’re making headway there too. That’s great. Our expectation is that the overwhelming majority of lives and of total lives will be covered at steady state.

Nick Pizzie, CFO, Axsome Therapeutics: I think it’s actually important to note that even with these additional $20 million lives, again, price, we expect price to be stable or, if not, it’s potentially improved later this year. More importantly, the access that we brought on is either first line or first switch. It’s not we wouldn’t pay for, you know, inferior access behind, you know, PAs or multi-step. We’re super excited about the additional lives that we brought on, the additional coverage.

Sean Lammon, Head of U.S. Smidcap Biotech Equity Research, Morgan Stanley: Thanks. Let me switch gears to Symbravo and acute migraine. What are the early learnings from the Symbravo launch, and how are you addressing any access, sampling, and patient conversion challenges?

Mark Jacobson, CEO, Axsome Therapeutics: Yep. Very early, right, the product became available in the second half of June. The team has their ears to the ground and is surveying all of the functional areas of launch. Engagement from a detail perspective, there’s a targeted consumer app for their access wins, which are already coming online. We are looking for a number of things. One of the key things we’re listening for and looking to is just clinician feedback for the clinicians who have tried the product. To that point, there are samples. We do have samples and provide samples. There’s a sampling effort to support patients trying the product and HCPs trying the product. What we’re looking to hear is perspective for how the product does in its real-world setting. Does it line up from an efficacy and tolerability perspective with the clinical data that we’ve generated? So far, we like what we’re hearing.

We will continue to monitor that, and that can drive additional potential investment. Right now, the focus is on, we have approximately 100 reps that are in the field and primarily focused on headache specialists and headache centers. There are about 150 of those that we’re focused on. It’s learning directly from clinicians. Obviously, we’ll also be pouring over the data in terms of weekly scripts and claims data and things like that. It’s still so early. There’s a lot of still solidifying and crystallizing. I think we’ll have more to say on the Q3 call. Right now, it’s a targeted effort, and we like how we’re coming off the launchpad.

Nick Pizzie, CFO, Axsome Therapeutics: It’s a very similar playbook to what we did with Auvelity, right? We launched with 160. Some of our peers had north of 7,800 reps out there. We were very disciplined, focused on high-decile sites. This is more high-decile headache centers. We’ll see how adoption progresses and assess where we are, you know, say in 2026.

Sean Lammon, Head of U.S. Smidcap Biotech Equity Research, Morgan Stanley: Great. I’ll ask the question anyway, but you know, describe your launch expectations over the next 18 months.

Mark Jacobson, CEO, Axsome Therapeutics: We haven’t guided to, and just as a matter of course, we don’t offer quarterly guidance. We have detailed guidance, and Nick can share that. We’d like to see—this is not meant to be coy—just continued growth. We’d like to see healthy signals in terms of continued coverage coming online. That’s important. We’d like to see that the patient savings programs we have in place for patients with commercial insurance are working, and it’s easy if a clinician determines someone’s an appropriate patient, that it’s easy for them to get the product. That’s really important. What we’re aiming for is a steady state, a gross to net that we think makes sense for the value the product delivers. We’re looking for robust efficacy and a tolerability profile that’s commensurate or paired to that efficacy. Do you want to comment on that?

Nick Pizzie, CFO, Axsome Therapeutics: Yeah, maybe just on the peak sales of $500 million to $1 billion is what we anticipate for peak sales for Symbravo. I think that’s probably the main thing. Just, again, trial adoption. One of the things that we did do with market access for Auvelity is we did not give up, I’ll say, give up the farm early on to be able to get access. We wanted to show utilization. Early anecdotal feedback has been that Symbravo is in line with the clinical trial data that we shared. Super positive from that perspective. Standby. We’ll share more in Q3.

Sean Lammon, Head of U.S. Smidcap Biotech Equity Research, Morgan Stanley: Wonderful. Thank you. Moving forward to IDI, can you discuss the clinical commercial rationale for AXS-05 in Alzheimer’s disease agitation? How you expect it to differentiate from Rexulti and off-label antipsychotics?

Mark Jacobson, CEO, Axsome Therapeutics: Definitely. We’re really excited about this program. In terms of what’s next, we’ve got the sNDA submission in the third quarter. That’s on track. Stay tuned for next updates, which would potentially be a potential filing acceptance. That’s all moving along on the development side of things and the regulatory side of things. That’s good. What’s the rationale? This is an oral NMDA receptor antagonist and highly differentiated, though dramatic area of unmet medical need. There’s only one approved product with a very different mechanism. That’s an atypical antipsychotic. As mentioned, Auvelity or AXS-05 in this case is an oral NMDA receptor antagonist. That leads to a differential risk-benefit profile. Efficacy, we saw both short-term longitudinal data where we see separation, numerical separation from placebo as early as week two. That becomes statistically significant at week three.

We have data, maintenance of effect data, where that shows the efficacy is durable. Of course, we have long-term open-label data that gives us insights into both continued efficacy and tolerability profile, which is distinct from how the class is currently managed with atypical antipsychotics. We did not see a mortality signal. We did not see a fall signal. We’re very pleased with the efficacy and tolerability profile that we’ve generated. More to come, but that’s just the distilled rationale for the product in that indication.

Sean Lammon, Head of U.S. Smidcap Biotech Equity Research, Morgan Stanley: Wonderful. Thank you. What is your ideal patient profile for AXS-05 and ADHD? How do you see adoption in the long-term versus outpatient settings?

Mark Jacobson, CEO, Axsome Therapeutics: Exactly. Yeah. Given the unmet need, patient profiling is maybe those just with the, you know, it’s dementia of the Alzheimer’s type with agitation and either in a community dwelling setting or even potentially in a long-term care setting. One thing that’s interesting is agitation is the primary symptom of dementia that leads to placement in long-term care facilities. If you’re able to positively impact that dynamic where individuals can stay at home with their family or caretakers, that’s high value to individuals, families, and healthcare overall and clinicians overall. In the clinical data we generated, there wasn’t a very specific or precise patient profile. We saw if we enrolled just overall patients with dementia of the Alzheimer’s type and, of course, the associated agitation.

We’ll see if the product’s approved and then clinicians are writing it, we may be able to comment on that with a bit more accuracy, but we’re excited about the potential of the product.

Sean Lammon, Head of U.S. Smidcap Biotech Equity Research, Morgan Stanley: Awesome. Can you discuss your confidence in the sNDA filing and just some descriptions around that?

Mark Jacobson, CEO, Axsome Therapeutics: Sure. The package is going to include all of the clinical data that we generated to date, which includes three positive trials. That’s ADVANCE-1, ACCORD-1, and ACCORD-2. Then there’s the supportive data. We had to do a standalone long-term safety database. We also have additional controlled data from the ADVANCE-2 trial, which provides important controlled safety data. I touched on some of the considerations or some of the elements or questions that could come up in terms of longitudinal effect, separation from placebo, and also maintenance of effect. The feedback we’ve received from FDA from the very early days, we ran ADVANCE-1. We received breakthrough therapy designation for that. We maintained breakthrough therapy designation for AXS-05 and Alzheimer’s disease agitation. There has been very consistent feedback from the psychiatry division, which is that they’d like to see two adequate and well-controlled trials.

We will be showing up with three positive, adequate, and well-controlled trials. We feel good about that, and we feel good about the complementary safety data that we’ll have. We don’t have to speculate all that much longer, right? We’ll be able to be providing tangible updates in the not-too-distant future.

Sean Lammon, Head of U.S. Smidcap Biotech Equity Research, Morgan Stanley: Sure. Maybe just to remind everyone, how do you size the market opportunity for AXS-05 and Alzheimer’s disease agitation?

Nick Pizzie, CFO, Axsome Therapeutics: Yeah, for sure. There is, I believe, 7 million individuals that have Alzheimer’s, and we believe 75% or north of 5 million have agitation. A very sizable market.

Mark Jacobson, CEO, Axsome Therapeutics: We model for peak sales that we share, we model very, very modest and conservative, you know, uptake and potential penetration in the market. There’s a lot of need, and it’s rare where you have, you know, unmet needs that touch a lot of lives or with, you know, prevalence along the lines of what we see here.

Nick Pizzie, CFO, Axsome Therapeutics: Yeah. Peak sales for ADA, we’re modeling $1.5 billion to $3 billion. That’s in addition to the MDD indication of $1 billion to $3 billion.

Sean Lammon, Head of U.S. Smidcap Biotech Equity Research, Morgan Stanley: Right. Got you. I do have some pipeline questions, but just given the time, I really want to ask a series of questions on sort of corporate strategy. If I look at, you know, the stock price has been pretty mild. I’m not alone when I sort of put it out there. I think the stock’s worth a lot more than where it’s trading, but we’ve had a number of announcements. They’re giving pretty good earnings, but, you know, it kind of doesn’t seem to budge. One question I would have, you know, what do you think it’s going to take for the market to realize what you might think is fair value in the stock?

The other piece, which I find quite interesting, and you know, maybe my modeling is just poor, but you know, I look at you, you’ve got, you know, pretty good top-line growth out to 2030. I kind of struggle to keep up with the OpEx. You know, the cash flow looks pretty strong. Without modeling you doing anything, you know, in 2030, you know, there’s a fair wealth of cash sitting there. You know, how do you play all that off? Is it more investment in the pipeline? How do you think about that strategically? Is my modeling bad in saying?

Nick Pizzie, CFO, Axsome Therapeutics: No, all good things. I think that as we shared, I think we feel similar sentiment. Maybe taking a step back, there was a lot there. As it relates to the stock price, you know, we just try to do our thing, right? We’re just trying to execute, and we can’t manage that. I think there’s probably an overhang a little bit as it relates to the filing. Once that gets out of the way, I think people can be honest about their modeling about other additional assets as well. It’s such a binary event in, believe it, investors’ minds. As it relates to our cash and cash on hand currently, we’re just north of $300 million. We are trending in the right direction.

If you take a look at our net loss for Q2 of $48 million, and you take out non-cash charges as well as the one-time charge as it relates to refinancing to Blackstone our long-term debt, the net loss was around $19 million on a cash basis. Extrapolating that out for the first half of the year, it was around $50 million total net loss on a cash basis compared to the previous year of north of $100 million. Trending in the right direction from a cash perspective. We anticipate that to continue in the back half of the year and into 2026 with or without an approval from ADA. We feel like we’re in a really good spot.

Mark Jacobson, CEO, Axsome Therapeutics: Maybe I’d round that out with, you know, just if you zoom out and, you know, look at the chart on some longer time scales, it’s doing what it’s supposed to, right, in terms of reflecting the fundamentals of the company, which are just better and better and have, frankly, never been better since the company was founded, which is great. There’s the filing, which all eyes are on, which is great. I think simultaneously, we’ve kind of also been charting like the historical Bermuda triangle of biotech, which is launching into a large market for major depressive disorder, right? We now, you know, Nick mentioned how we started with a targeted launch in depression. There are a lot of eyes then watching.

I think we’ve, you know, we’ve had our building track record that reflects our level of execution, our discipline with respect to capital deployment, and how that ties to keeping shareholders in mind in terms of our dilution sensitivity. We like that, but that takes time, right? That takes time to show the strategy and tactics of the organization that they lead to value creation for patients, clinicians, and shareholders. I think we’re doing that layer on the filing and then it’s kind of a, for this year, definitely agree. I, you know, we think people are watching. In the meantime, as Nick said, we’re doing our thing both on the commercial side and on the development side. Obviously, we only have a couple of minutes left, but we’re not even touching on the rest of the development pipeline. It’s just that we have so much going on. It’s great.

We’ve been mindful not to tie our shoelaces together on the development side of things. There’s another NDA coming up for AXS-12 in narcolepsy, which is that submission is scheduled for the fourth quarter. There’s a bunch on the clinical development side. We think it’s just continued execution, and that’s our focus, commercial and regulatory and clinical execution, and layer in medical and all the other functions that are in that effort. We’re really pleased with the state of affairs at the moment.

Sean Lammon, Head of U.S. Smidcap Biotech Equity Research, Morgan Stanley: Sure. I appreciate there’s a lot going on in R&D at your R&D day. I guess you have the question I have, sort of given what we see with forecast cash flow in your business, you know, with commercialized products, you know, do you think that the R&D programs will be sucking up a lot of the cash, or do you think there’s going to be the excess to, you know, capital returns or further business development?

Nick Pizzie, CFO, Axsome Therapeutics: As it relates to R&D, I think we’ve always done it. One of the core competencies for Axsome Therapeutics is to be able to complete clinical trials very cost-effectively and with a disciplined approach in everything that we do. We’ve done that since the inception with the trials for major depressive disorder. From a commercialization perspective, we’ve been very disciplined in our approach. I don’t anticipate seeing a significant inflection up in R&D into 2026. What we’ve been sharing for the rest of this year is that we’ll be right around that $50 million range, which is where we’ve been over the last couple of quarters. I think from an investment, we will make those investments as needed, but we don’t anticipate, you know, doubling in R&D over the next couple of years.

Sean Lammon, Head of U.S. Smidcap Biotech Equity Research, Morgan Stanley: Great. I do have a bunch of pipeline questions, but conscious of the time, I’ll go to those. How do you see AXS-12 fitting into the narcolepsy treatment landscape if approved, especially with the emergence of the orexin 2 agonists and polypharmacy trends?

Mark Jacobson, CEO, Axsome Therapeutics: We like the profile. We think it checks a number of boxes in terms of when you think about the total product profile or the holistic product profile, daytime dosing. We don’t expect it to be scheduled. The efficacy we focused on in terms of primary endpoints on reductions in cataplexy. We saw improvements in sleep. We saw improvements in cognition. All that taken together with a differentiated tolerability profile with respect to what’s already approved and other things in development as additional data comes in for other programs in development. In our mind, we’re excited about 12 and both with respect to what’s available and other programs too, which is great, right? It’s an area of unmet need for patients, and it can be debilitating narcolepsy. We’re excited about the potential fit of AXS-12 and other programs too.

Nick Pizzie, CFO, Axsome Therapeutics: Maybe just one quick comment on the synergistic nature of 12. You already have an infrastructure for sleep, right? We have 70-some reps that are detailing Sunosi. That’s just a simple add to the bag, so very minimal additional SG&A.

Sean Lammon, Head of U.S. Smidcap Biotech Equity Research, Morgan Stanley: Wonderful. I guess in terms of the equity story, you’ve got AXS-05 and Alzheimer’s disease agitation sort of coming up. Beyond that and apart from quarterly delivery of quarterly earnings expectations, what are some of the other key catalysts over the next 12 to 18 months?

Mark Jacobson, CEO, Axsome Therapeutics: Yeah. Just recapping, continued commercial execution, AXS-05 and Alzheimer’s disease agitation, AXS-12 and narcolepsy, that NDA submission. When we think about other programs, clinical development programs, there’s Sunosi. We’re working on four different indications for Sunosi. That’s ADHD. We have one positive trial in adults that’s already completed in phase 3. We need to launch a trial in pediatric adolescents. That’s on track to happen in the fourth quarter. We’re looking at major depressive disorder, kind of a precision focus of individuals with MDD who have excessive daytime sleepiness. We did one proof of concept study there, so we need to launch another study. There are ongoing studies in shift work disorder and binge eating disorder. We expect top-line results there in 2026 for both studies. It goes from there.

Nick Pizzie, CFO, Axsome Therapeutics: We also have smoking cessation that will be commencing in Q4 as well as the fibromyalgia phase 3 trial.

Mark Jacobson, CEO, Axsome Therapeutics: Yeah. The smoking cessation for AXS-05, we see that as a really interesting area of focus. Those are the current areas of focus. Yeah, there’s, you know, as mentioned, there’s just a ton going on even after AXS-05 and Alzheimer’s disease agitation.

Sean Lammon, Head of U.S. Smidcap Biotech Equity Research, Morgan Stanley: Sure. We’re just on time. Is there anything that I didn’t ask that I should have?

Mark Jacobson, CEO, Axsome Therapeutics: I think that was a pretty good review. No, it should be. No, it’s just as mentioned, we’re pleased with the state of affairs right now at the business. We’re really looking forward to the balance of the year and the year ahead. We’ll keep everyone apprised of updates in the meantime.

Sean Lammon, Head of U.S. Smidcap Biotech Equity Research, Morgan Stanley: Wonderful. We’ll call it close to proceedings there. Wonderful, gentlemen, to host you, and thank you for attending.

Mark Jacobson, CEO, Axsome Therapeutics: Thanks, guys.

Nick Pizzie, CFO, Axsome Therapeutics: Thanks, guys.

Sean Lammon, Head of U.S. Smidcap Biotech Equity Research, Morgan Stanley: Thank you, sir.

Nick Pizzie, CFO, Axsome Therapeutics: Welcome.

Mark Jacobson, CEO, Axsome Therapeutics: Thank you.

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