Q4 2024 Axsome Therapeutics Inc Earnings Call
Thank you.
Speaker Change: Good morning and welcome to the Axiom Therapeutics fourth quarter and full year 2024 conference call. Currently all participants are in listen-only mode. Later there will be a question and answer session and instructions will be given at that time. As a reminder today's conference call is being recorded.
I'll now turn the call over to Darren Opland, Director of Corporate Communications at Axon Therapeutics. Please go ahead.
Speaker Change: Thank you. Good morning and thank you all for joining us on today's conference call. This morning we issued our earnings press release providing a business update and details of the company's financial results for the fourth quarter and full year of 2024.
Speaker Change: The release crossed the wire a short time ago and is available on the investors section of our website along with the earnings presentation accompanying today's call Those joining by a webcast may advance through the slides at any time during the discussion
Speaker Change: During today's call, we will be making certain forward-looking statements regarding, among other things, the efficacy, safety, and intended utilization of our investigational agents
are clinical and non-clinical plans.
Speaker Change: are planned to present or report additional data, the anticipated conduct, and the source of future clinical trials, regulatory plans, future research and development plans, commercial plans, and possible intended use of cash and investments.
Speaker Change: These forward-looking statements are based on current information, assumptions, and expectations of future events that are subject to change and involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements.
Speaker Change: These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports.
Speaker Change: You are cautioned not to rely on these forward-looking statements, which are made only as of today's date, and the company disclaims any obligations to update such statements.
Speaker Change: Joining me on the call today are Dr. Herriot Tabuteau, Chief Executive Officer, Nick Pizzie, Chief Financial Officer, Ari Maizel, Chief Commercial Officer, Hunter Murdoch, General Counsel, and Mark Jacobson, Chief Operating Officer.
Speaker Change: Herriot will begin with opening remarks including an overview of the important progress we've made in 2024 and a look ahead into the rest of 2025. Following Herriot, Nick will review our financial results and then Ari will provide a commercial update.
Speaker Change: We will then open the line for questions, which will be taken in the order they are received.
And with that, I'll turn the call over to Herriot.
Thank you, Darren, and good morning, everyone.
Speaker Change: In the last two and a half years, as a fully integrated R&D and commercial organization, Axiom has both expanded and deepened its leadership within CNS.
Our portfolio today comprises three differentiated in-market products.
three innovative product candidates in regulatory submission stage.
and numerous ongoing phase 3 trials.
Speaker Change: This broad portfolio positions us to potentially commercialize seven products or indications through 2027, allowing us to deliver significant innovation to patients and value to shareholders.
2024 was another year of strong execution for Axiom.
Speaker Change: For the year, we delivered total net product revenue of $386 million, reflecting high double-digit year-over-year growth for Ability and Synozi.
We expect continued growth in 2025.
supported by our second completed sales force expanded in Corvallity
Further Improvements in Market Access Dynamics.
and increasing awareness of our differentiated products.
Speaker Change: Based on the recent performance, Ovelity is on track to reach blockbuster potential.
most recently
Speaker Change: We received U.S. approval of Simbravo on January 30th for presenting a novel oral acute treatment for migraine.
Speaker Change: Based on its clinical profile, Simbravo represents an important development for patients living with migraines.
Speaker Change: With Simbravo, we now have three commercial stage products and are actively preparing for its commercial launch.
Speaker Change: Before turning the call over to Nick and Ari, who will expand on the strong financial and commercial performance in the year, I'd like to provide an update on our rapidly advancing late-stage pipeline and speak about key priorities for 2025.
2024 was highly productive from a clinical development perspective.
Speaker Change: as we read out five pivotal trials and initiated three phase three trials across our portfolio.
Speaker Change: Starting with AXS05 for the treatment of Alzheimer's disease agitation, last year we completed a phase 3 clinical program in this indication which consisted of four controlled phase 3 efficacy trials and a long-term safety trial.
Speaker Change: With the positive results from this comprehensive program in hand, we plan to submit an NDA for AXS05 for the treatment of Alzheimer's disease agitation to the FDA in the second half of 2025.
Speaker Change: Moving on to AXS 12 for the treatment of narcolepsy with cataplexy.
Speaker Change: Last year we also completed the clinical program for the SPRADA candidate, which included three controlled efficacy trials and a long-term safety trial.
Speaker Change: Based on the positive results from these studies, we plan to submit an NDA for AXS-12 for the treatment of cataplexy in patients with narcolepsy to the FDA in the second half of 2025.
Speaker Change: As it relates to our NDA for AXS 14 in fibromyalgia, we are in the publication stage of the submission and expect to submit the NDA to the FDA this quarter.
Speaker Change: Apart from the activity related to these NDA submissions, we anticipate top-line readouts from several Phase III trials in the near term.
Speaker Change: These include the eMERGE Phase III trial evaluating Sombravo in patients with prior inadequate response to oral CGRP inhibitors.
The FOCUS Phase III trial of solar anthracite in ADHD.
Speaker Change: and the PARADIGM Phase III trial of sulrianfetal, a major depressive disorder.
Speaker Change: Top-line results for all three of these studies are on track for the first quarter of 2025.
Speaker Change: Enrollment for the Engaged Study of Solvary Invertol in Binge Eating Disorder and the Sustained Study of Solvary Invertol in Shift Work Disorder continue to progress, with top-line results for both studies anticipated in 2026.
Speaker Change: All in all, across our development portfolio, we expect NDE submissions for three product candidates and top-line readouts from three Phase III trials in the coming months.
Speaker Change: I am proud of the excellent progress we've made as an organization and look forward to another transformative year as we build upon our commercial success and advance our CNS pipeline.
With that, I'll hand the call over to Nick.
Thank you, Herriot, and good morning.
Speaker Change: Today we'll discuss our fourth quarter and full year 2024 results and provide some financial guidance.
Speaker Change: Total product revenues were $118.8 million and $385.7 million for the fourth quarter and full year, representing year-over-year growth of 66% and 88% respectively.
Speaker Change: This consisted of net product sales of $117.3 million and $381.7 million for the fourth quarter and full year of 2024, and royalty and milestone revenue of $1.4 million and $4 million, respectively.
Speaker Change: Total product revenues for the comparable periods in 2023 were $71.5 million and $204.9 million.
Speaker Change: Availability net product sales were $92.6 million and $291.4 million for the fourth quarter and full year of 2024, representing 89% and 124% year-over-year growth.
Speaker Change: Availability net product sales for the comparable periods in 2023 were $49 million and $130.1 million.
Speaker Change: So noticing that product revenues were $26.2 million and $94.3 million for the fourth quarter and full year of 2024.
representing 16% and 26% year-over-year growth.
Speaker Change: consisting of 24.7 million and 90.3 million in net product sales and 1.4 million and 4 million dollars in royalty and milestone revenue associated with Sanosi sales in outlicensed territories.
Q4 includes a one-time, half-a-million-dollar regulatory-based milestone earned by Axiom.
Speaker Change: The NOSI net sales for the comparable periods in 2023 were $21.7 million and $72.4 million.
Speaker Change: Total CENOSI revenue for the full year of 2023 was $140.5 million, which includes licensed revenue of $65.7 million from out licensing CENOSI in certain ex-U.S. territories.
Speaker Change: Total cost of revenue were $10.5 million and $33.3 million for the fourth quarter and full year of 2024.
Speaker Change: Total cost of revenue for the comparable periods in 2023 were $7.4 million and $26.1 million.
Speaker Change: Q4 cost of revenue includes a one-time $2.5 million expense for the achievement of a sales-based milestone related to worldwide Sanosi sales.
Speaker Change: Total cost of revenue for the full year of 2023 included a one-time cost of five million dollars associated with the revenue received on outlicing CENOSI in certain ex-U.S. territories.
Speaker Change: Research and development expense were $55 million and $187.1 million for the fourth quarter and full year of 2024, respectively, compared to $30.8 million and $97.9 million for the comparable periods in 2023.
Speaker Change: The increase was primarily related to the company's ongoing phase 3 trials of sulrienfetal in ADHD, MDD, binge eating disorder, and shift work disorder.
Speaker Change: the advancement of phase 3 trials of AXS05 and AXS12, manufacturing costs for AXS07 and AXS14, as well as higher personnel costs, including non-cash stock-based compensation associated with organizational growth.
Speaker Change: Selling, general, and administrative expenses were $113.3 million and $411.4 million for the fourth quarter and full year of 2024 respectively, compared to $86.8 million and $323.1 million for the comparable periods in 2023.
Speaker Change: The increase was primarily related to commercialization activities for Ability and Synosy, including Salesforce and marketing expenses.
Speaker Change: and higher personnel costs, including non-cash stock-based compensations associated with organizational growth.
Speaker Change: Net loss for the fourth quarter of 2024 was $74.9 million, or $1.54 per share, compared to a net loss of $98.7 million, or $2.08 per share, for the comparable period in 2023.
Speaker Change: The net loss in the fourth quarter of 2024 includes $35.9 million in non-cash charges, comprised primarily of $22 million in stock-based compensation expense and $11 million in acquisition-related contingent consideration expense.
Speaker Change: Net loss was $287.2 million, or $5.99 per share, for the full year of 2024, compared to a net loss of $239.2 million, or $5.27 per share, for the full year of 2023.
Speaker Change: The net loss for the full year includes total non-cash charges of approximately $125 million.
which includes $85.2 million in stock-based compensation expense.
Speaker Change: $28.1 million in acquisition-related contingent consideration expense, and $6.4 million in intangible amortization, compared to $62.6 million, $48.9 million, and $6.4 million respectively for the full year of 2023.
Speaker Change: Aveliti and Sanosi GTN discount in Q4 of 2024 were both approximately 50%. Due to negative seasonality effects in Q1, we anticipate that GTN discount for Aveliti and Sanosi to be in the mid-50s.
Speaker Change: We ended 2024 with $315.4 million in cash and cash equivalents compared to $386.2 million at December 31, 2023.
Speaker Change: We believe that our current cash balance is sufficient to fund anticipated operations into cash flow positivity based on the current operating plan.
Ari Maizel: I would now like to turn the call over to Ari, who will provide a commercial update.
Ari Maizel: Thank you, Nick. Axiom delivered another strong quarter of demand growth for alveolity and cyanosis in the fourth quarter of 2024, capping off a successful year of increased awareness and utilization of our medicines.
Ari Maizel: For both products, patients and providers continue to report a significant positive impact on both symptoms and quality-of-life measures.
Ari Maizel: Our performance throughout 2024 is a testament to the impact of Axiom's dynamic, digital-centric commercialization platform, which has enabled consistent growth across our portfolio and is poised to support the launch of Symbravo as an acute migraine treatment for adults in the coming months.
Ari Maizel: Alveoli once again led the market in total demand growth for the quarter with approximately 158,000 prescriptions representing 10% quarter-over-quarter growth and 87% growth compared to the fourth quarter of 2023.
Ari Maizel: By comparison, the antidepressant market grew less than 1% sequentially and grew 2% compared to the fourth quarter of 2023.
Ari Maizel: Nearly 26,000 new patients were prescribed Alveolity in the quarter, bringing the total number of new patients started on Alveolity since launch to approximately 165,000.
Ari Maizel: Our sales team successfully activated 4,100 new providers in Q4, with primary care providers representing the greatest source of prescriber growth.
Ari Maizel: Aveliti experienced meaningful positive impact of improved coverage dynamics in Q4 with increases in total covered claims.
Ari Maizel: Availability access is 78% of all lives across channels and 63% of lives in commercial. Importantly, our market access team is actively engaged with payers across the payer landscape to expand and improve access in 2025.
Ari Maizel: Moving on to CINOSI, total prescriptions were approximately 49,000, representing 4% sequential growth and 16% growth versus Q4 2023.
Ari Maizel: By comparison, the Waste Promoting Agent market grew 1% sequentially and grew 5% compared to the fourth quarter of 2023.
Ari Maizel: Approximately 4,100 new patients started Cynosi in the quarter, bringing the total number of new patients started on Cynosi to approximately 81,000 since launch.
Ari Maizel: Approximately 400 new riders were activated in Q4, resulting in a total cumulative prescriber base of nearly 14,000 healthcare providers since launch.
Ari Maizel: Payer coverage for Cynosi and Q4 was stable, with 83% of lives covered across channels.
Ari Maizel: Finally, we are excited to launch our third product, SimBravo, in the coming months.
Simbravo represents an innovative and highly differentiated treatment for migraines.
Ari Maizel: Migraine remains the leading cause of disability among neurological conditions for the more than 39 million migraine sufferers in the U.S. and more than 80 percent of migraine patients discontinue their acute migraine treatment in the first year of treatment.
Ari Maizel: Feedback from headache specialists and neurologists clearly positioned Sombravo as a compelling treatment option for patients who have been frustrated by the limited impact of existing treatments.
Ari Maizel: We look forward to sharing additional details of our commercial launch plan soon.
Ari Maizel: In closing, 2024 was a very successful year for Axiom, our second full year as a commercial enterprise, and we are very pleased with the growth of both Aubelity and Synosy.
Ari Maizel: Our robust commercial capabilities and innovative digital-centric commercialization platform position Axiom to deliver on the promise of our pipeline and improve the lives of those impacted by CNS conditions.
Darren Opland: I will now turn the call back to Darren for Q&A.
Darren Opland: Thanks, Ari. Operator, may we please open the line for questions?
Darren Opland: Thank you. At this time we will be conducting a question and answer session.
Darren Opland: If you would like to ask a question, please press star 1 from your telephone keypad, and a confirmation tone will indicate your line is in the question queue.
Darren Opland: You may press star 2 to remove yourself from the queue.
Darren Opland: For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys.
Darren Opland: To allow as many as possible to ask questions, we ask you please limit yourself to one question.
Speaker Change: Thank you and the first question today comes from the line of Ram Selviju with HC Wainwright. Please proceed with your question.
Ram Selviju: Thanks very much for taking my question. With respect to DTC promotional activities, whether those are for Ovelity or Simbravo, can you comment on the cadence with which you expect those to be initiated and what strategies you might employ in order to optimize the efficiency of DTC buys?
Sure, yeah, thanks for the question, Ram.
Ram Selviju: As we've discussed previously, we intend to launch a broad-based media outreach plan for Aubelity this year, in the coming months.
Ram Selviju: and the way we think about it is, you know, ensuring that our spend is sufficient to drive awareness amongst patients.
Ram Selviju: and remain competitive in the depression market where most of the branded agents are advertising pretty broadly.
Ram Selviju: You know, in terms of sort of the media plan, we haven't commented on that specifically, but there are some, you know, calendar year seasonality considerations that we'll take into account and just make sure that when we are investing in media that it's during a time of the year that makes sense where patient flow in HCP offices is at a high level.
Ram Selviju: All of those are very special go-to-market plans yet, but expect to share some more details in the coming months.
Thank you.
Speaker Change: Our next question is from the line of Charles Duncan with Cantor Fitzgerald. Please proceed with your question.
Charles Duncan: Yes, good morning Herriot and team. Thanks for taking the question and congratulations on a nice year.
Velody. I'm wondering...
Charles Duncan: if you could provide any color on the relative size or change and then whether or not that is going to create synergies with the prescriber base, the future prescriber base for Cibrabo and how that might happen.
Charles Duncan: Sure. Yeah, thanks, Charles. So as we mentioned previously, we added approximately 40...
Charles Duncan: additional representatives to the Albeldi sales team. That's about 10 to 15 percent increase in sort of the overall sales force size.
Charles Duncan: And yes, I think your question about synergy with Zimbravo, particularly when you think about migraine treaters in the primary care setting.
Charles Duncan: We do believe that there's some overlap that we'll be able to take advantage of.
Charles Duncan: And so, you know, more to come on that, but one of the key aspects of our portfolio is the high overlapping comorbidities with depression across all of the indications that we're studying. And so there does create some synergy or efficiencies with certain providers.
Speaker Change: analysis ongoing. So I'm wondering if you have any greater color, would you anticipate that in third quarter or fourth quarter? I know you're really busy with a lot of NDA submissions now.
Speaker Change: Hey, Charles. It's Mark. Good morning. Thanks for the question. So, just to clarify one thing, is
The Gating Factor.
Speaker Change: And second half, you can expect updates from us, but it is a top priority for the organization. And so we'll be looking to do that as early in the second half as possible, but we'll provide more granularity as we get closer.
Thanks, Mark. Thanks for taking the questions. Thanks, Charles.
Speaker Change: The next question is from the line of June Lee with Truist Securities. Please proceed with your question.
Speaker Change: This is awesome, Rana, on for June, congrats on the quarter and thanks for taking the questions. Will the Alzheimer's disease agitation filing be an NDA or an SNDA? And then, have you had the pre-NDA meeting for AXS 12 for narcolepsy and what are some of the wiggling scenarios? Thank you.
Speaker Change: I'll take the first one. This is Mark again. So we haven't communicated the filing approach just yet, but you can expect to hear that from us in the not-too-distant future.
Speaker Change: And I'm sorry, could you repeat the second question as well?
Speaker Change: Yeah, sure. Just have you had the pre-MDA meeting for AXS 12 for narcolepsy and just in the labing scenarios that you might see. Thank you.
We, um...
Speaker Change: We haven't yet confirmed the timing around the meeting, but I think as soon as we have outputs, we'll look to share that with you all. And, you know, scenario planning, I think,
Speaker Change: We're so close, so that's, or commenting on different scenarios, the hypotheticals, we're so close I think we can, in the not too distant future, to share specifics with you on the strategy.
Thank you.
Speaker Change: Our next question is from the line of Joseph Stone with T.D. Callan. Please proceed with your question.
Speaker Change: Hi there. Good morning. Congrats on the progress and thank you for taking my question. Maybe just given the upcoming data in ADHD, what is sort of a clinically meaningful change on the AIS-RS?
Speaker Change: that you're looking for. And is Superness's Kelbree a good comp here in terms of, I guess, overall data package and sort of the progress of their launch? Anything different, you know, with Surya Ambatal that you can point out that might be particularly differentiated would be helpful. Thank you.
Thank you.
Thanks, Joe.
Speaker Change: We're very close to announcing results for the Phase III trial in ADHD, so a lot will depend upon what the results show.
Speaker Change: We're just as excited as the rest of you to open the envelopes and learn about the clinical profile in a multi-center study.
Speaker Change: As it relates to what we're looking for, with regards to the study, what we're looking for is this would be a positive trial.
Speaker Change: That is a study which meets its primary endpoint, and we're not looking for any specific difference.
Speaker Change: between the treatment arms. This is the first study that we are conducting with Soviet info in ADHD and as relates to your question comparing it to Calgary
Speaker Change: That remains to be seen, so we'll have to look at the data and we'll know soon.
Thank you.
Speaker Change: The next question is from the line of David Hong with Deutsche Bank. Please proceed to your question.
David Hong: Hi there. Thanks for taking my question. Congrats on a successful quarter and fiscal year.
Speaker Change: I was wondering if you could just talk a little bit about the expectations for seasonal cadence of scripts and revenues for Aveliti in 2025, particularly Q1, where we typically see some headwinds, how the Salesforce expansion efforts might pull through, and if you would feel comfortable providing forward-looking guidance for the product at some point. Thanks.
a growth quarter, but something somewhat
Speaker Change: slower growth than what we experienced in the back half of the year.
Speaker Change: We are optimistic of the impact of the Salesforce expansion. We've already seen very good
Speaker Change: leading indicators in terms of sales activity, call activity. And if you recall from last year when we had another expansion, we started to see the impact of that team towards the end of Q1, which initially showed up as incremental growth in weekly NBRX or new patient starts.
Speaker Change: So we would expect something similar. I think historically when you look at the depression market, Q1 and Q3, you know, the summer months tend to be somewhat slower than others for the overall market. But, you know, Auvelity is a growth brand. We expect to drive meaningful growth throughout the course of the year, but there will be some dynamics that the overall market will experience.
Speaker Change: which include payer coverage, field force expansion, and other promotional efforts that could have material impacts. We don't plan to provide
sales guidance currently. What we have shared
David Hong: You can reference the deck that's been filed, is that peak sales for Aveliti in MDD alone are in the $1-$3 billion range.
David Hong: for Cendosian, as current indications, $300 to $500 million, and then also for Sombravo, half a billion to $1 billion in peak revenue. So we remain confident in these ranges, and as we continue to commercialize, we can provide further guidance.
Thank you.
David Hong: The next question is from the line of David Ansell with Piper Sandler. Please receive your question.
David Ansell: Hey, thanks. So, my one question is this. So, with the exclusivity runway for Ability,
David Ansell: shored up and with good visibility to significant cash generation. How are you thinking about M&A slash BizDev in terms of your ability and willingness to bring in an asset or assets where you can leverage the commercial infrastructure that you have in place? Or alternatively, would you even bring in a development stage asset? Just let us know how you're thinking about that philosophically. Thanks.
David Ansell: Yeah, hey David, it's Nick again. We are always looking for opportunities. We're obviously very satisfied with
Speaker Change: where we are with our late-stage pipeline and our commercial assets, but something that potentially can complement something earlier stage in our pipeline, we are open to. We have dedicated resources internally now to evaluate opportunities, and that is something that's on our radar.
Speaker Change: Thank you. The next question is from the line of Mark Goodman with Laring Partners. Pleased to receive your question.
Mark Goodman: Nick, can you help us with how to think about expenses this year? And secondly, just on AXS 12, second half for filing, can you just give us what the gating factors are?
to wait for that filing. Thank you.
Thank you for watching. Bye!
Yeah, sure.
Mark Goodman: Mark, it's Nick. So I'll speak a little bit about the OPEX and the quarter as well as 2025. R&D spend was slightly higher during the quarter as we were closing out the 3 ADA trials.
Mark Goodman: and continuing to progress on all the other programs. We anticipate the R&D spend peaked this quarter, Q4, and do expect R&D spend to moderate in 2025, given the conclusion of the ADA trials and other trials concluding in Q1.
Mark Goodman: As it relates to OpEx, we do expect to see an increase versus Q4.
Mark Goodman: However, we expect sales to increase at a faster rate, putting us on track to achieve cash flow positivity. We're starting to see leverage in the P&L and sales growing faster than OPEX, which we're super excited about.
Good morning, Mark.
with respect to ASIS-12 and the NDA.
Speaker Change: So, we did share, we plan to have a pre-NDA meeting with the FDA, so that's a component. But the rest is just building the modules and building the submission itself. The clinical program's done. So it's really a lot of back-office work now.
Speaker Change: in order to get to that filing date. And then the other consideration that I'll just mention is this is the same division as AD Agitation, so you might expect that we'll be running some air traffic control in terms of how we how we're working to choreograph workflows and things like that.
and Nick Pizzo. Thank you. Thank you.
Thanks.
Speaker Change: Our next question is from the line of Greg Savangia with Missouho Security. Please receive your question.
Thanks so much
Greg Savangia: Thanks for taking my questions. Congratulations on all the progress in the quarter in the past year. Just two quick questions for me.
One, just on the paradigm study for solarium-fatal and MDD.
Greg Savangia: Expectations there, and could you just remind us of the positioning if you were to see a positive readout in MDD, the positioning of that product, especially vis-a-vis
Greg Savangia: Would the expectation be a relatively smooth uptake, or do you think it could be more gradual, given maybe some education around the product? Thanks so much.
Greg Savangia: Great. Thanks for the questions. I'll take the first one. It relates to the paradigm study and expectations. This is a paradigm will be the first study that we're conducting.
with solar amplitude in MDD.
Greg Savangia: So, um, we're very close to having a readout, so we'll learn a lot from that as it relates to potential positioning. As you know, sorbitol is approved to treat excessive daytime sleepiness.
Greg Savangia: And there is a lot of overlap in terms of comorbidities between excessive daytime sleepiness and depression. So, a natural fit or a natural way to look at this product, if it were to have an effect on MDD, would be to...
position it for patients who have those two comorbidities.
Greg Savangia: So, we've disclosed that one of the ways that we conducted the study is to also look at patients who have EDS and MDD versus those who have MDD without.
Greg Savangia: EDS, and so that will provide us some very nice information about how the product works and how the mechanisms of action, which we think are very relevant, would translate clinically to an appropriate patient population.
Ari Maizel: Hey, Greg. This is Ari. So, regarding the Sembrava uptake, obviously, we're very optimistic about the impact Sembrava will have on the acute migraine market. When you look at analogs, we believe the more recent launches are probably more accurate in terms of uptake. I'm referring to the oral CGRPs.
Ari Maizel: does have a unique clinical profile relative to both the tryptans as well as the oral CGRPs, so we do think that there is a very compelling position for the product. But that said, you know, one of the things that
You should think about when modeling for Bravo is...
Ari Maizel: We are being very targeted, very focused on headache specialists and neurology practices.
Ari Maizel: that make up you know roughly 70% of the overall branded market and so and we'll be launching with something smaller than the two large oral CGRP competitors out there so it remains to be seen exactly what the uptake will look like but I do think that those are probably the closest analogs to assess.
Speaker Change: Thank you. The next question is from the line of Vikram Khurra with Morgan Stanley. Please proceed with your question.
Vikram Khurra: Hi, good morning. Thanks for taking our questions. We have two on the pipeline.
Speaker Change: So, first, going back to the ADA filing plan for the second half of the year.
Vikram Khurra: I know you're not guiding to specifics on the filing strategy, but...
Could you help us understand...
Vikram Khurra: I guess some of the regulatory and commercial factors kind of feeding into how you're thinking about
Vikram Khurra: NDA versus SNDA, you know, what the practical implications could be of one path versus the other.
And then secondly,
I think your release mentioned that the AXS-14...
Speaker Change: NDA submission is on track for 1q25 for fibromyalgia, so I was just wondering if you could talk a bit about which patient segments AXIS-14 could be a good fit for within fibromyalgia, assuming it's approved, and what you see as the commercial potential there. Thank you.
Speaker Change: I'll start with the question about the different considerations for the filing strategy for AD agitation.
Speaker Change: It's cross-functional, right? There are considerations with respect to brand names, there are considerations with respect to intellectual property, market access strategy.
Speaker Change: and some regulatory considerations. So it really touches on every element of development and launch, and I think we'll be able to comment specifically in the not-too-distant future which path we're taking.
Thank you. Thank you.
Thank you.
Yes, as it relates to fibromyalgia.
Speaker Change: One of the aspects of the disease is that it has multiple symptoms and the current treatment options do not adequately address all of those symptoms.
So, uh...
Speaker Change: So, what's nice about the profile of AXS-14 to date is that not only does it reduce pain, but it also
Speaker Change: reduces, it improves function and it reduces multiple symptoms of fibromyalgia. One key symptom of fibromyalgia that the data has shown could be really
impactful to patients and and that
AXS4T does have an effect on is fatigue, which is...
Speaker Change: which is very difficult to treat. And patients consider it to be one of the top three symptoms of fibromyalgia that result in their disability.
Speaker Change: So we're very excited about the potential for AXS14 in fibromyalgia, especially given the large patient population.
Got it, thank you.
Speaker Change: The next question is from the line of Jason Gregory with Bank of America. Please receive your question.
Speaker Change: Hi, good morning. This is Dina on for Jason. Thanks for taking our questions and congrats on all the progress this year We just had a couple on full re-emphatol for ADHD Just one follow-up regarding the phase 3 clinical profile Would your 1 to 1.5 billion in peak sales estimates
Speaker Change: change at all if we did see stimulant-like efficacy in the PARADIGM trial, which is, you know, maybe around that 20 to 25 percent placebo-adjusted benefit on
Speaker Change: AISRS endpoint. And then can you just remind us what your plans are for the adolescent population, you know, and maybe how we should be thinking about the size of the adult versus adolescent opportunity, you know, in terms of market share. Thanks.
Sure.
Speaker Change: The ADC patient population is so large and still remains underserved despite the various treatments that are available. I think that will be a very sizable market opportunity.
Speaker Change: for Solari Ampital should the studies be positive. So we're very close to having a data readout so we look forward to learning more about the efficacy profile of the drug potentially in ADHD.
Speaker Change: As it relates to the pediatric population, as a reminder, we must generate data in the pediatric population in order to be able to submit an NDA to the FDA.
Speaker Change: for consideration for ADHD, and so that is something that we plan to do, so we've talked about.
Speaker Change: initiating that study and launching that study. In order to do that we do need to get feedback from the FDA on the pediatric study plan and that is in progress.
Speaker Change: Thank you. The next question is from the line of Leonid Timyshev with RBC Capital Markets. Please proceed with your question.
Speaker Change: Hi guys, congrats on the progress. I just wanted to ask on maybe some additional color on the patent settlement around Aveliti with Teva. I guess first, how did you end up deciding on sort of the 2038-2039 boundaries and then
Speaker Change: maybe a bigger picture. I guess, how does it change your peak assumptions for ovality versus sort of what you put forth in the slide deck around both MDD and Alzheimer's agitation? Thanks.
Speaker Change: So this is, thanks for the question. This is Hunter. I'll take the first part first and then Nick, do you want to take the second part? Great.
Speaker Change: So the dates were just a negotiated resolution. It didn't tie to a specific event or a specific occurrence. It was just what was sort of negotiated at an arm's-length transaction, Teba. Nick, do you want to? Yeah, with the recent developments on the LOE, you know, we do plan to update and refine our guidance as
Speaker Change: as the launch progresses, and having the LOE day will help facilitate that process, so stay tuned.
Speaker Change: Our next question is from the line of Serena Chin with Wells Fargo.
Speaker Change: Hi, thanks for taking my question. I wanted to ask about Zimbravo. Just given the high rebating environment around oral CGRPs, how should we think about factors that could impact net price and anything differentiated Axum is doing to compete there? Thank you.
Speaker Change: Yeah, thanks for the question. We'll obviously have a lot more to share as we prepare for the commercial launch, but as you mentioned, you know, this is a high rebate category.
Speaker Change: We also saw the OralCGRP's launch with significant free goods in the market. And so we've been able to study the dynamics of those launches to formulate our
Speaker Change: our strategy and plan for engagement with payers. We feel very, very confident in the clinical profile of Simbravo. The fact that we have data across pain intensities, very compelling data providing relief.
Speaker Change: or pain freedom and freedom from both bothersome symptoms at two hours extended to 24 hours. There's a very strong clinical rationale for Zimbravo and in our early discussions with payers.
Speaker Change: We do see the potential to engage in access discussions for the brand. So, we'll be able to share more as we get closer to the launch, but we are very mindful of, you know,
Speaker Change: building access while also maintaining long-term profitability for the brand, and that's one of our key areas of focus.
Thank you for watching. See you next time.
Speaker Change: The next question is from the line of Aimee Sadia with Needham & Company. Please receive your question.
Aimee Sadia: Thanks for taking my question. With several assets in late stage, can you maybe just talk about...
Aimee Sadia: your philosophy or how should we think about operating margin evolution over the next two, three years and specifically just for this year as well with the launch of Sombravo. Maybe if you can give us a more grander color on how to think about operating expenses, that would be helpful. Thank you.
Speaker Change: Sure, I'll handle this. I'll start with the second question first. You know, just as we successfully launched Labelady, we're going to take a strategic approach in launching some Bravo and plan to continue to assess the investment over time.
Speaker Change: First and Bravo, we're confident in our ability to execute with an efficient SG&A spend in 2025 by leveraging our DCC approach and we'll invest as needed to build consistent growth trajectory over the long term.
Speaker Change: The approval, suspend, and launch of SEMBRADA has always been factored into our cash flow on the way, and as a reminder, current cash does take us into cash flow positivity.
as we think about
Speaker Change: operating margin over the next couple years. You know, we have the same strategy that we've always had with Ability as well as Tenosi, very focused on ROI and being mindful of how we invest in each dollar within the SG&A as well as in the R&D function to ensure that we get the ROI top line.
Speaker Change: The next question is from the line of Eaton Suneja with Guggenheim Partners. We'll just use your questions.
Hey guys, thank you for taking my question.
Speaker Change: Congrats on all the progress. Just a question on AXS-12 or Robuxetine. Curious to hear how you are thinking about the narcolepsy market in general. I mean we have gotten mixed feedback from the from the QO specifically given that it is an SNRI.
Speaker Change: but you definitely have very interesting data that you have generated across multiple phase three programs. So how should you, how are you thinking about that program, the opportunity there and any impact from our actions that could have on this sort of indication?
70% of those suffer from cataplexy and dissatisfaction, inadequate response.
Speaker Change: with existing treatments is very, very high. So we see a real opportunity for AXS 12 in this marketplace. And we'll share some more details on our thinking on the approach that we'll take as we get a little bit closer to the filing.
Speaker Change: The next question comes from the line of Miles Minter with William Blair. Please proceed with your question.
Miles Minter: Hey, thanks for taking the question. Maybe one for Nick. Is there any material impact of the Medicare Part D restructure that took effect Jan 1st?
Miles Minter: on Evality revenues and I'm also wondering what the mix is of patients that are getting access to Evality through the Medicare system versus commercial payment and if that ratio is going to change over the next few years. Thanks.
Miles Minter: Sure, sure Miles. As it relates to Part D, we don't expect a significant impact. There might be just a little bit of a change in how GTN evolves throughout the year, but overall we don't we don't anticipate an impact at this point.
Speaker Change: Yeah, and related to the mix, so currently Aubelity is roughly 15% Medicare, our TRX volume is 15%. We don't expect any significant changes to that.
Speaker Change: Obviously, with the potential for AXS 05 and Alzheimer's disease agitation, there will be a much heavier focus on Medicare for that product.
Speaker Change: that indication. And so we'll have to share some more as we finalize our plans around NDA, SMDA.
Thank you.
Cool, thanks.
Thank you for watching. We'll see you next time.
Speaker Change: Thank you. Our final question is from the line of Joel Beattie with Baird. Please receive your question.
Good morning, this is Chris Chen on for Joel.
not in ADA, but in smoking cessation.
Speaker Change: Just wondering if you could add a little more color on maybe a potential you know timeline in 2025 and then Just more specifically. Are you incorporating you know the difference any differences between You know users of traditional cigarettes versus e-cigarettes. Thank you
Thank you. Thank you.
Thank you.
Thanks for the question. So we're
Speaker Change: Right now where we are in terms of the plans for the Phase 3 trial, we're very confident that this study will start this year. So we're looking forward to sharing with you more of the details of the study design. The initial trial will look at patients who smoke cigarettes.
Speaker Change: and in terms of your patients to use other forms of nicotine that will come at a later date but for our registration trial it will be in the smokers.
Thank you.
Speaker Change: Thank you. At this time there are no additional questions and I'll hand the floor back to management for closing remarks.
Speaker Change: Thank you for taking the time to join today's call. 2024 was a busy year for the company with the continued success across all aspects of our portfolio. As we sit here today, on February 18th, our business reflects an expanding commercial enterprise.
Speaker Change: and rapidly advancing late-stage neuroscience pipeline poised to deliver potentially five innovative products in ten serious neuropsychiatry conditions that collectively impact the lives of more than 150 million people in the U.S. alone.
Speaker Change: We look forward to updating you on our continued progress throughout the year. Thank you, and have a great rest of your day.
Speaker Change: This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.
Thank you.