Axiom Therapeutics at Bank of America Conference: Strategic Growth Plans

Published 14/05/2025, 00:10
Axiom Therapeutics at Bank of America Conference: Strategic Growth Plans

On Tuesday, 13 May 2025, Axiom Therapeutics (NASDAQ:AXSM) presented at the Bank of America 2025 Healthcare Conference. The company shared a strategic overview highlighting both opportunities and challenges. Key discussions focused on Avelity, a treatment for Major Depressive Disorder (MDD), and the upcoming launch of Symbravo for migraines. While optimistic about growth, Axiom is balancing investment with achieving operating leverage.

Key Takeaways

  • Axiom is expanding its sales force to drive growth, particularly for Avelity and Symbravo.
  • The company is focusing on market access and favorable coverage terms for its drugs.
  • Avelity’s expansion into Alzheimer’s agitation is anticipated to create significant market opportunities.
  • Revenue growth is currently outpacing operating expenses, with increased leverage expected in the coming years.
  • The company is preparing for several product launches and regulatory filings in 2025.

Financial Results

  • Avelity (MDD): Gross to Net (GTN) ratio in Q1 was in the mid-50s, expected to remain stable. Commercial coverage stands at 63%, with overall coverage at 78%. Peak sales potential is estimated between $1 billion and $3 billion.
  • Symbravo (Migraine): Estimated peak sales potential ranges from $500 million to $1 billion.
  • Avelity (Alzheimer’s Agitation): Peak sales potential is projected between $1.5 billion and $3 billion.
  • General Outlook: Revenue growth is surpassing operating expense growth, with increased operating leverage anticipated in 2025 and 2026.

Operational Updates

  • Sales Force Expansion: The team has grown to approximately 300 representatives, with impacts on New-to-Brand prescriptions expected in the next 3-6 months.
  • Market Access: Axiom is aiming for over 80% coverage for Avelity, with government channels already at 100%.
  • Avelity (Alzheimer’s Agitation) sNDA: A third-quarter submission is targeted, with all clinical studies completed.
  • Symbravo (Migraine) Launch: Scheduled for June, with the field force ready and trained.
  • AXS-12 (Narcolepsy) Filing: Filing expected in the second half of the year, supported by three efficacy studies.

Future Outlook

  • Avelity (MDD): A national Patient Persistency Program campaign is planned for the latter half of the year.
  • Avelity (Alzheimer’s Agitation): Expected initial access through Medicare Part D, with 70% of scripts anticipated in this channel.
  • Symbravo (Migraine): Focused on headache centers and key opinion leaders, aiming for a strong market position compared to 2022.
  • AXS-12 (Narcolepsy): The existing field force will support the launch, leveraging experience with Sunosi.

Q&A Highlights

  • MDD Market Dynamics: Axiom views MDD as sensitive to promotional efforts, justifying direct-to-consumer campaigns.
  • Alzheimer’s Agitation Clinical Trials: The company engaged closely with the FDA, feeling confident about the trial design and outcomes.
  • Symbravo Launch Dynamics: Feedback indicates Symbravo’s versatility in various patient profiles, enhancing its competitive position.

Readers are encouraged to refer to the full transcript for a detailed account of the conference call discussions.

Full transcript - Bank of America 2025 Healthcare Conference:

Jason Gerber, SMINT Cap biotech analyst, SMINT Cap: Next company presenter, Axiom Therapeutics and Mark Jacobsen, Chief Operating Officer and we’ve got Nick Pizzi, CFO as well. And my name is Jason Gerber. I’m one of the SMINT Cap biotech analysts. And so guys, thanks so much for joining us.

Mark Jacobsen, Chief Operating Officer, Axiom Therapeutics: Thanks very much for having us, Jason. Good to be here. Happy to feel any questions you may have, but obviously a really good start to the year for us so far.

Jason Gerber, SMINT Cap biotech analyst, SMINT Cap: Yes. So I mean, I think you know, in in terms of ability and the the commercial uptake that’s been solid. The patent settlement, I think has taken a part of the discussion out that you probably don’t want to have to have with investors and you’ve got like better line of sight in terms of long duration of asset and some clinical development for other assets not named Avelity, including the Symbravo approval. So we’ve got a lot to talk about. Maybe we’ll kick it off just with Avelity and MDD.

You know, solid quarter. Where do you feel like you’re at in terms of the the launch cycle, in terms of, you know, added initiatives to try to grow that? How you think you’re you’re you’re relative to other MBD launches at the similar stage of the life cycle?

Mark Jacobsen, Chief Operating Officer, Axiom Therapeutics: Sure. So we’re a bit past two years from launch, and we’re still very much on growth trajectory and continued launch. And like Q1, pleased with that execution and we’re really looking forward to the balance of the year. There are a number of initiatives and activities underway that we think will continue to drive growth. And one of which has been implemented and that is the field force expansion.

So we recently increased the field force to about 300 reps. That was completed in the first quarter. And we’re just starting to see impact in terms of NBRx, and we’d expect that impact in growth to continue through the balance of the year. And typically, what we saw with last year’s expansion is that changes really start to manifest three to six months after expansion. So that’s one category and one potential growth driver.

Another is just continued execution with respect to coverage, so the number of lives covered and the quality of coverage, but we expect to see drive positive development on that side of the business. And then third, in the second half of this year, we’ll be launching a national PPP campaign. So those are kind of classic categories of that can catalyze people’s growth and we would expect that. And also we would just continue to expect both trial a trial and patient trial and and when we see that, it’s a good update with with a We we expect that, you know, kind of underlying dynamic to grow.

Jason Gerber, SMINT Cap biotech analyst, SMINT Cap: So, you’ve since you’ve launched, you’ve stepped up, I think some of the resourcing behind it in terms of sales reps. You’ve got planned pieces of spend coming in. Imagine with like a lot of different brands, you reach a point of like, alright, this is sort of fully resourced and we can get to a point of like incremental growth and starts to become a source of positive operating leverage in the model. So right now, I get the sense that you’re kind of investing to drive better area under the curve with a better top line for the longer term, and that’s a good trade off. But do you feel like with some incremental amount of investment for DTC this year and where the sales force is, we’re kind of getting to that more fully resourced level, and then we start to get some operating more operating leverage going forward into 2026 plus.

I think we’ll see further efficiency from the field force. As Mark mentioned earlier, we just completed the expansion in Q1 of the 40 reps. So we are seeing the NBRx growth nicely. And then as payer dynamics change or evolve, we would expect to see further growth from those additional covered lives. And then the DTC campaign, as Mark mentioned, we’re planning for a national campaign that we would anticipate have a very nice ROI.

So seeing that operating leverage in the P and L, I think we will we’re seeing it now. Revenues growth are outpacing our operating expense growth across the board, and we will anticipate to see that in rest ’twenty five and ’twenty six. Yeah.

Mark Jacobsen, Chief Operating Officer, Axiom Therapeutics: Yeah, don’t know though if we see on the near horizon where there’s diminishing return with respect to driving growth. So, I think we still expect to be a growth mode for, you know, the course of that.

Jason Gerber, SMINT Cap biotech analyst, SMINT Cap: Yeah. Yeah, I mean, a lot of peer brands, I look at like Abi Bralar, right? BTC has been a

Mark Jacobsen, Chief Operating Officer, Axiom Therapeutics: very

Jason Gerber, SMINT Cap biotech analyst, SMINT Cap: seemingly important element of that, and most of Vraylar’s utilization is in depressive states, either bipolar or unipolar depression. So when you look at sort of the comps and how promotionally sensitive do you think MDD is and how important this

Mark Jacobsen, Chief Operating Officer, Axiom Therapeutics: could be as a growth accelerant to the franchise? I think promotion sensitive and so what we’ll continue where we scale to 300 and that gives us flexibility for work within and additional potential indications come online. There’s leverage there with from a targeting perspective or overlap and potential targets and things like that. So, that’s in house already so to speak but then, I think your point even within MB or with potential other future indications, there there could be scenarios where we continue to expand kind of the investments in in the brand and the commercial infrastructure

Jason Gerber, SMINT Cap biotech analyst, SMINT Cap: Okay. And then as a in a protected class, you get a good government insurance right out of the gate. Commercial coming up, I think it’s 68% on the commercial side or so. Where are you at? I think there was some mention on the earnings call about the potential to improve the commercial side of the coverage over the course of the year.

And do you feel like you have enough leverage now given how big Avelity has gotten to where when you go to payers who maybe were trying to maybe force your hand, right, with a tougher deal, that that you can strike deals and kinda keep that sort of net pricing or gross to net as we we think about it right within the range of your kinda steady state guide. Yes, I think it goes to the efficacy of the product, right? So our strategy out of the gate negotiating with payers was always long term. And as a reminder, you know, our IP takes us through 02/1939. So we’re always being mindful of long term value for the product, not getting covered lives day one or even day three sixty five to where we anticipate them to be.

So to answer your question, Jason, I think we’re pleased with how conversations are going with payers. Currently, covered lives in the commercial space is at 63%. So just again, with the 300 team field force that we have, if we’re able to improve those lives, we think it’s benefit to the patients as well as to Vaxam. Were you going to say something, Mark?

Mark Jacobsen, Chief Operating Officer, Axiom Therapeutics: Yeah, no, I didn’t stop myself. I wasn’t sure if it going to be redundant. But know we haven’t guided to steady state expectations for say a certain number of covered lives. Except to say that that you know so in the government channel essentially 100 live or you know 100% are live are are covered now. And then, our expectation for the commercial channel is that, you know, you will be in line with what you take it through the sequence.

I think that that steady state which is, you know, north of, you know, 80 of covered lives in the commercial. That’s the that’s the you know, those are steady state dynamics for the class and and we don’t see any reason why we would be out of line with that.

Jason Gerber, SMINT Cap biotech analyst, SMINT Cap: And just maybe the further that, so 62% commercial covered lives, 78% on the 78% overall. And importantly, as Jason, as you mentioned, our GTN in Q1 was in the mid-50s. And what we shared to The Street is that we anticipate that GTN to remain constant throughout the year. And the reason being, you will see seasonality. However, as potential additional coverage comes online or also payer access evolves, we would anticipate that there that would adjust the GTN accordingly.

So you may see favorability from a seasonality, but you may see an impact from additional covered lives or how utilization and management evolves. So maybe going from two steps to one step, but GTN would adjust accordingly. Yeah. I think consensus for LDMVD is kind of at the midpoint of your $2 to $3,000,000,000 or so guidance. As we think about sort of the variables that can drive the bull case, right, to the higher end of that, how much of that do you think is, in your own mind, did you guys think about the launch, just maybe faster coverage or how responsive the market proved to BPC?

Is the proof points in your mind maybe in the next twelve to eighteen months as to like where you’re at within that sort of growth

Mark Jacobsen, Chief Operating Officer, Axiom Therapeutics: trajectory? I think that makes sense to what we see over the time frame that you suggested, how the growth curve changes or reflects, you think that will impact sort of where we net out from a sales potential but right now, the range we gave is 1 to 3,000,000,000 in MBD and and that’s where we’re we’re we’re very comfortable with right now. So, it’s it’s really where you are above that. And I think that’s right in terms of outlook for the next year, year and a half how some of the growth drivers come to fruition and when they come online and the confluence of those that they synergize. And I think just another important consideration, part of the reason for the field force expansion is that allows us to have more engagement with primary clinicians and we think that’s really important and how you or potential prescribing the dynamics in in in that group where that kind of coalesces around.

Right now, we’re at about the north of fifty percent first and second line use, first line or first week. If we see that continue in primary care and things like that, I think that will also be an important point for exactly where we lead

Jason Gerber, SMINT Cap biotech analyst, SMINT Cap: that out from a consultant perspective. Okay. Maybe shifting gears to the Alzheimer’s agitation label expansion opportunity and you know, if you can maybe just outline, you know, you had data in December I think you’re indicating a second half

Mark Jacobsen, Chief Operating Officer, Axiom Therapeutics: twenty twenty five

Jason Gerber, SMINT Cap biotech analyst, SMINT Cap: filing into some of the lag factors and where you’re at with FDA in terms of, not with FDA, but where you’re internally to get that over the goal line.

Mark Jacobsen, Chief Operating Officer, Axiom Therapeutics: Yes, so right now, it’s it’s building the package. So, right. We we completed the clinical program in December and then earlier this year, we announced the shared the FDA feedback we have received for pre NDA meeting feedback in meeting minutes. So we’re good there. We completed that part of the choreography, so to speak.

Now it’s it’s building the package, writing the modules and assembling them and guided to the third quarter submission for an sNDA. So the data generation in the clinical studies, that’s done. So it’s bringing it all together in a quality fashion and so the team and as you might imagine, that’s that’s a key effort internally and a key corporate priority for you. So, we’re we’re you know, that’s that’s very healthy work going on and and we’re excited about it.

Jason Gerber, SMINT Cap biotech analyst, SMINT Cap: Yeah. There’s I guess some debate out there like FDA like some people can say FDA doesn’t like randomized withdrawal studies. KOLs would say, hey, this is two studies with diverse study protocols, and that’s more robust evidence of that because FDA has approved CNS drugs on the basis of randomized withdrawal studies. Can you maybe speak to any, like I imagine there’s some alignment with FDA before you even headed down this pathway around choosing the types of studies and the study designs that

Mark Jacobsen, Chief Operating Officer, Axiom Therapeutics: you did? Yep, definitely. So the very first study we did that was advanced one, but that was the parallel group study. And that study was positive and once that study completed, we shared the engagement with FDA, shared shared the results that led to the receipt of the therapy designation for the program and then that was the start of the feedback for what the rest of the the clinical program would look like. And since then we’ve we’ve been continuing to engage with the FDA for what a package could and should be and what’s acceptable and we feel very good about, you know, that we have three studies to correct their different paradigms.

We have three positive studies and so we have, you know, looking at marginal change over a short term period of time like five weeks, that’s not too advanced studies and then we also have maintenance studies. So, maintenance is a fact. So, it’s a randomized withdrawal study. So, we feel we feel very good about the package we have and also it’s congruence with the feedback we’ve received from from FDA in terms of supporting a filing point of view.

Jason Gerber, SMINT Cap biotech analyst, SMINT Cap: Yes. Okay. And if if approved, I mean, can you maybe frame the the synergy? I know you you’re looking at this as a supplemental. NDA.

We have seen other what we call indication stacking situations. You know, with other CNS drugs where drugs just step into the coverage, right, of

Mark Jacobsen, Chief Operating Officer, Axiom Therapeutics: the

Jason Gerber, SMINT Cap biotech analyst, SMINT Cap: preexisting indication. But yet, I think when we look at how the Rixalti launch is going, think that there are some unique challenges to building out the ADA market. And so maybe what have you learned from the early Rixulti rollout? And are those concerns about sort of a heavy lift on the market build side substantiated in your view? You want me to take your own Yes.

Mark Jacobsen, Chief Operating Officer, Axiom Therapeutics: So I don’t want

Jason Gerber, SMINT Cap biotech analyst, SMINT Cap: to speak too much about Nexulti, but if you just take a look at growth in channel in Medicare Part D channel, if you take a look at growth from ’24 versus ’23, it’s roughly a 50% growth Just in the Medicare Part D channel where it’s completely outperforming your Medicaid and your commercial channel, I think they’re in like single digits. And then even growth Q1 twenty five versus ’24, it’s a 41% growth. So there is robust growth, I would say, for Rexulti in Medicare Part D channel. Presumably that’s the ADA indication, even with the black box warning. So from that perspective, we’re seeing that growth with Rexulti.

From a market access standpoint, with it being under the brand name of Evelity, we would anticipate that we would have access out of the gate in the Medicare Part D channel. So having an sNDA and using the brand name of Evali, we would anticipate that we would have coverage out of the gate in Medicare Part D. We would anticipate that to be roughly 70% of

Mark Jacobsen, Chief Operating Officer, Axiom Therapeutics: the total scripts. Maybe to layer on to that a bit, touched on this a little bit with the current commercial infrastructure and account managers. There’s overlap now with some of the targets and and and growing that and in terms of any type of realignment or retargeting that we need to be done that that work is underway now and and even if one would want to compliment the current team with with additional posting. So, for example, we are we are not currently targeting in long term care facilities and things like that. That’s that’s something that’s being assessed right now.

If that’s something one would want to do with the principal approval. But yeah, there there’s dramatic unmet need that is now one approved product is growing as Nick mentioned, there are certain key differences in in the product profile that we think could offer compelling framework for our reality, but we’ll see, but we’re excited about the opportunity.

Jason Gerber, SMINT Cap biotech analyst, SMINT Cap: In terms of this the market and and some of the segmentation considerations, you know, I I know in the past, you guys have talked about wanting to maybe get the patient before they get to the nursing home, right? Mhmm. When they get to the nursing home, my understanding at least in talking to some doctors is perhaps the coverage shifts to Medicaid in the nursing home and there’s some capitated payment models that maybe make it more challenging to absorb the cost of a proprietary brand medicine. So, how meaningful is that, you know, as a proportion of the market? Do you have a sense of that?

You know, sometimes we can get little bit of sample bias in the doctor calls that we do.

Mark Jacobsen, Chief Operating Officer, Axiom Therapeutics: I’m, do you have, do you have numbers? I mean, I’m I’m sure the the team, the team does. I don’t have them handy but there are considerations with respect to your long term care facilities. There are initiatives in place to monitor and change the incentive for know, prescription of anti psychotic utilization in elderly patients with dementia. So, right there’s a star rating and and things like that and and obviously, ability is is is a distinct mechanism of action but there are there are structural considerations that that are distinct that I know that’s adjacent to your question, but I think it’s informative and are potentially interesting.

The basis of the question think is correct is that, right? Agitation is really a key symptom that leads to placement in long term care facilities.

Nick Pizzi, Chief Financial Officer, Axiom Therapeutics: And if you are able to interrupt that, that is for patients, for their caregivers, for their loved ones, that’s a huge area of unmet need. That’s great, but then also individuals within long term care facilities, additional treatment options for them, that’s important too.

Jason Gerber, SMINT Cap biotech analyst, SMINT Cap: Yeah. And maybe just double clicking on what our data is showing is that, like I said, seventy percent, roughly seventy percent, maybe even a little bit more of that is Medicare, of which twenty five percent of the patients in Medicare are LIS patients, which make up roughly seventy five percent of lot of the scripts. So as a reminder, LIS patients really pay nothing out of pocket, so we feel that we’ll be able to get the product to patients without the issue that we’re seeing that came about with MDD, with the co pay and having that obviously, you can’t do co pay in government channels. So from that perspective, we feel LIS patients will be able to get the product. And the non LIS patients, you have the cap and smooth provision of $2,000 So that also should be a tailwind or supportive of patients being able to smooth out or budget their spend on an annual basis.

Okay. Maybe shifting gears to some Bravo, the launch for migraine, where you’re at in terms of the launch readiness. I believe you’ll be launching that product pretty soon. Remind us where are you in terms of peak sales for Simbravo Migraine relative to Evelity MDD? It’s $500,000,000 to $1,000,000,000 is for Simbravo, and for MDD we have peak sales of 1,000,000,000 to 3,000,000,000, and for ADA, it’s 1,500,000,000.0 to 3,000,000,000.

Nick Pizzi, Chief Financial Officer, Axiom Therapeutics: Launch for Sunbravo, Eric, that’s targeted for June or slated for June, so that that’s on track. We’re excited for that. The The preparations, well underway. The the the field force, they’re hired. They’re going through training now.

They’re they’re on board. And so it’s basically final final steps before product is in channel, and and the the field force is engaging and and engaging with h HCP. So it’s it’s a it’s a exciting time for us, and, you know, that’s obviously the second product that we’ve developed internally that we’ve obtained approval for and we’ll be launching. So it’s a pretty exciting time. We’re looking forward to it, especially because based on the clinical data we generated, highly differentiated in in terms of efficacy for patients and which is still remains the overwhelming move in in the market.

Jason Gerber, SMINT Cap biotech analyst, SMINT Cap: In terms of maybe the the more conservative outlook relative to, say, MBD, both big markets, right? Like, is it, you feel like the level of genericization or maybe shorter use scripts, what are some of the factors that maybe would drive a more conservative PEEP number for migraine versus

Mark Jacobsen, Chief Operating Officer, Axiom Therapeutics: MDD? Oh,

Nick Pizzi, Chief Financial Officer, Axiom Therapeutics: yeah. The nature of prescribing product utilization is much different. Right? It’s chronic intermittent migraine, and so with depression, whereas that’s chronic for the duration of a major depressive episode. So migraine, you have that distinction.

And so what does that translate into? That translates into a different type of refill number and frequency. Just the current treatment landscape is much different, You have two well, you have a few recent branded launches, and the dust is kind of settling, or maybe it’s better to say it’s the framework prior to the Sunbravo launch has started to crystallize with respect to that. So there’s that, you know, WAC prices and and rebating dynamics are are distinct across the categories. I think that’s another element.

Anything you’d add to that?

Mark Jacobsen, Chief Operating Officer, Axiom Therapeutics: I don’t think so. Okay.

Jason Gerber, SMINT Cap biotech analyst, SMINT Cap: And so where do you see Cymbravo kind of like finding its position within the space? Is it sort of a post CGRP drug? Do you think you can compete with CGRP as sort of a post triptan treatment option for for doctors who maybe have explored triptans to the fullest and are now migrating to different therapeutic options. The feedback

Nick Pizzi, Chief Financial Officer, Axiom Therapeutics: that we’re receiving from clinicians, based on the clinical data and the profile and the label is that the clinical data, it’s very interesting, very compelling because of the types of patient profiles that the registration trials and other efficacy trials that we’ve run were done in. And so the feedback from KOLs is that they can actually see it being used in a variety of patient profiles, say post a post a triptan or or post an oral CGRP. Earlier this year, we read out the the EMERGE base retrial, which was in inadequate responders to oral CGRP therapy and compelling data there. So what’s great is the efficacy of the product, the responses that we saw clinically. It’s across patient profiles.

And so a key consideration will be access dynamics. But in our mind, the product can offer benefit to patients and HCPs in a number of different niches is maybe the wrong word, but in a number of different patient profiles. And

Mark Jacobsen, Chief Operating Officer, Axiom Therapeutics: so it’ll be

Nick Pizzi, Chief Financial Officer, Axiom Therapeutics: you know, the confluence of access, clinician experience, you know, patient outcomes, and and we’ll we’ll we’ll start to see that and and have those data very soon. Migraines pretty heavily on

Jason Gerber, SMINT Cap biotech analyst, SMINT Cap: the commercial insurance, I believe. Right? So when we looked at other drugs, I guess, that have that sort of channel mix, there’s a lot of, I guess, subsidized free drug in the early days, right, to get physicians using the product. You know, and so as investors think about early days launch ramp and revenue recognition, is that something you’d caution folks that, like, perhaps there could be a high growth to net as there’s sort of a lot of, like, subsidized drug in the early days? I think what you saw from Niratec and Ubrellvy, there were GTN’s in north of 80%, somewhere in that vicinity.

We don’t anticipate that we’re going to have as ubiquitous of a free drug program. We are focused on headache centers and major KOLs out of the gate. So I think from that perspective, we’re going to be mindful of DTM, but we also want to ensure that product does get to patients and that the KOLs are able to write the product and see the patient utilization and

Mark Jacobsen, Chief Operating Officer, Axiom Therapeutics: see how efficacious the product is. Yes, definitely,

Nick Pizzi, Chief Financial Officer, Axiom Therapeutics: to add on to what Nick said is the the, you know, it’s it’s it’s very it’s a very distinct from say depression, right? So, you know, depression you that’s still heavy in in the commercial channel. Right? But even so, the the categories are are different with respect to gross to net and, you know, sampling and and helping patients obtain therapy, and a lot of it just has to do with market access dynamics.

Jason Gerber, SMINT Cap biotech analyst, SMINT Cap: Yep. And maybe well up there is that we’re we feel like we’re in a much better spot than in 2022 when we launched AVELITY with now we have two products that the payers are aware of. We have an experienced payer access market access team that has good contacts, good networks with the team. So we’ve been having, I would say, quality conversations with the payers thus far. Okay.

And then AXS-twelve for narcolepsy, just remind us where you’re at in terms of gating items for the submission and have you had your pre NDA meeting with regulators and kind of where you stand on the single study being, I guess, the sufficient basis for Sure. The filing.

Nick Pizzi, Chief Financial Officer, Axiom Therapeutics: The so we we’ve got into a filing this year. We’ve said second half. So more to come more to come with respect to, you know, pre NDA, you know, engagements with the FDA prior to a submission. But the efficacy packages, actually have three studies now that everything is set and done. There was an early phase two, that’s the CONCERT trial.

Then just over a year ago, we had the results from the Symphony phase three. And then towards the end of last year, we had results from ENCORE, which was another phase three trial we conducted. So we’re really pleased with the package that we have, and that will be submitting, and that work is underway. But I think maybe a couple more. You know, there it wouldn’t surprise me if we have additional updates in terms of, you know, say, tightening of potential, you know, submission expectations, as I mentioned Yep.

Things like that. Is it fair

Jason Gerber, SMINT Cap biotech analyst, SMINT Cap: to think about this as like going after the installed base of generic venlafaxine? Do you see a broader role in how you envision launching basically, I guess, in parallel with Takeda’s orexin receptor two agonist, given the move of their phase three data midsummer, it looks like they’re phase two. I think they’re on a good track

Mark Jacobsen, Chief Operating Officer, Axiom Therapeutics: to get approved as well.

Nick Pizzi, Chief Financial Officer, Axiom Therapeutics: Yeah. No. So so, you know, launch dynamics, commercial infrastructure, that’s already in place. We have a leapfiled force already, and they’re detailing Sunosi right now. So it’s there, and that would be very easy to add a product to to that bag and to to leverage that infrastructure.

So we feel really good about about that. Exactly how it might fit with other entrants and other potentially contemporaneous entrants, that’s okay. It’s difficult to I mean, we’re fine if that dynamic is playing out. And we’ve seen other cases where actually that increases HCP awareness, attention, which

Jason Gerber, SMINT Cap biotech analyst, SMINT Cap: is a

Nick Pizzi, Chief Financial Officer, Axiom Therapeutics: good thing. And exactly how that would work, though, I think it’s a little difficult to comment on without label. But when you step back and say, what’s the clinical data we’ve generated so far? Focus and indication would be cataplexy. And then we have additional other considerations of the product profile, daytime dosing, likely distinct scheduling from what’s currently available.

And then we also had other efficacy measures on sleepiness, cognition, etcetera. So again, it’s difficult to know how that might manifest on the label and then how one might position versus other new entrants. But we feel very good about the totality of data we have and the product profile itself. All right.

Jason Gerber, SMINT Cap biotech analyst, SMINT Cap: We’re out of time. So, gentlemen, thanks so

Nick Pizzi, Chief Financial Officer, Axiom Therapeutics: much for joining us. Thanks for having

Mark Jacobsen, Chief Operating Officer, Axiom Therapeutics: us. Thanks. Appreciate it.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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