Q1 2025 Axsome Therapeutics Inc Earnings Call

May 5, 2025

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Darren Open: Now my pleasure to turn the call over to your host Darren Open director of corporate communications at excellent Therapeutics.

Leonid Timashev: Our first question today is coming from Leonid Timashev from RBC Capital Markets. Your line is now live. Hey guys, thanks for taking my question and congratulations on the quarter, so maybe a multi-part one.

Please go ahead.

Speaker Change: Thank you good morning, and thank you all for joining us on today's conference call.

Mark Goodman: You've got a number of developmental agents in front of the FDA right now, so I wanted to focus on that. What has your sense been from the FDA on recent interactions? Has there been any changes to the review teams or agency responsiveness? Or I guess in particular, any evolution on the messaging of what may be required for approval, especially for AXS05 and Alzheimer's? And then I guess, given that you have breakthrough designation for that agent, I guess, how confident are you that you'll be able to get a priority review here? Thanks.

Speaker Change: This morning, we issued our earnings press release, providing a business update and details of the company's financial results for the first quarter of 2025.

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.

Speaker Change: Those joining via webcast may advance through the slides at anytime during the discussion.

Take care.

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, our clinical and non clinical plans our plans to present or report additional data the anticipated conduct and the source of future clinical trials.

Mark Jacobson: Hey, Leo, it's Mark. Good morning. So right now, engagement and dialogue with FDA is status quo for us remains status quo. And then with respect to ASS05 and AD Agitation, no changes there versus what we've discussed and the feedback we've received from FDA with respect to our planned SNDA submission. And I think you did mention that that it does have breakthrough therapy designation and it is eligible for prior review. And that's something that that determination is made by the agency at the time of filing.

Have a Great Week!

Speaker Change: <unk> regulatory plans future research and development plans commercial plans and possible intended use of cash and investments.

Speaker Change: Greetings and welcome to the actual Therapeutics first quarter 2025 conference call and webcast. At this time all participants are in a listen only mode. If anyone should require operator assistance. Please press star zero on your telephone keypad.

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.

A question and answer session will follow the formal presentation.

Speaker Change: Can you may be placed in the question queue at any time by pressing star one on your telephone keypad and we ask you. Please ask one question and one follow up then return to the queue. As a reminder, this conference is being recorded.

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.

Mark Goodman: Your next question is coming from Mark Goodman from Leering Partners, your line is now live. Yeah, two questions, really. One is, can you just give us a sense of when you're going to kick in the DTC advertising for O'Dellity? I know that's supposed to happen sometime this year.

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 obligation to update such statements.

Speaker Change: My pleasure to turn the call over to your host Darren Open director of corporate Communications at Axon Therapeutics. Sir. Please go ahead.

Mark Goodman: And then second, the question is really about just the erections coming in to the narcolepsy class and just, you know, how you think about your products getting in as the erections come in.

Speaker Change: Turning to today's agenda Doctor area of <unk>, Our CEO will open today's discussion with an overview of our performance and key upcoming catalysts Nick.

Speaker Change: Thank you good morning, and thank you all for joining us on today's conference call.

Speaker Change: This morning, we issued our earnings press release, providing a business update and details of the company's financial results for the first quarter of 2025.

Mark Goodman: Thank you.

Nick <unk>, our Chief Financial Officer, who will review our financial results for the quarter.

Ari Maizel: Hey Mark, it's Ari. Thanks for the question. Regarding DTC, we expect to launch a national campaign later this year. If you visit our website, you'll see that we have a new creative campaign, but the national campaign launch will be a little bit later this year.

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.

Speaker Change: Already made though our chief commercial officer will then provide a commercial update.

Speaker Change: Mark Jacobson, our Chief operating officer, and Hunter Murdock, our general counsel will be joining us for Q&A.

Speaker Change: Joining via webcast may advance through the slides at any time during the discussion.

Ari Maizel: Regarding orexins and AXS12, you know, we're very optimistic about AXS12. The feedback we got, in particular, most recently at AAN when we shared the symphony data in an oral presentation, that it's a compelling option, you know, daytime dosing, strong impact, not just on cataplexy, but other symptoms of interest. And, you know, the orexins, I think, as enthusiastic as folks are, there's still questions just about the safety tolerability, and it remains to be seen how those drugs will perform in sort of their late stage products. So, you know, we're keeping an eye on it, but we think that there's a real market for AXS12 in the short term, and we look forward to getting it into the hands of providers and patients.

Speaker Change: And with that I'll turn the call over to area.

Speaker Change: Thank you Darin and good morning, everyone.

Speaker Change: Actual named her 2025 with strong momentum across the business in.

Speaker Change: In the first quarter, we delivered year over year total revenue growth of 62% driven.

Speaker Change: Driven by robust underlying demand formality and Sanofi.

Speaker Change: Regulatory plans future research and development plans commercial plans and possible intended use of cash and investments.

Speaker Change: In addition, the recent FDA approval of some Bravo, our second internally developed product reflects <unk> commitment to delivering innovative medicines with the potential to meaningfully improve upon the standards of care for patients living with serious CNS conditions.

Speaker Change: Our portfolio today is distinctively diversified and strategically positioned to drive durable growth.

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 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 obligation to update such statements.

Speaker Change: Earlier this year I outlined key priorities related to our pipeline.

Ari Maizel: Thank you.

Andrew Sly: Next question is coming from Andrew Sly from Jefferies. Your line is now live. Hey, good morning. Congrats on the execution. And thanks for taking my question. It's around audility with your recent settlement with Teva for 2028 to 2030 to 2039 timeframe. Can you confirm if this is the absolute earliest that any generic out there can enter at this juncture?

Speaker Change: The first was to advance our three novel, India stage product candidates toward regulatory filings. These.

Speaker Change: These include <unk> 14 for the management of fibromyalgia in excess of five and old timers disease agitation and the excess 12 for the treatment of cataplexy and narcolepsy.

Speaker Change: Turning to today's agenda Doctor area of capital our CEO will open today's discussion with an overview of our performance and key upcoming catalysts.

Speaker Change: The second was to successfully execute across our multiple phase three clinical programs that broaden the potential of our current products and product candidates, including <unk>. So five sorry, if at all and some Bravo.

Andrew Sly: And does this settlement embolden you to pursue other opportunities outside of smoking cessation and agitation, assuming that you do have guaranteed run for at least 13 years? Can we expect more follow-on indications soon? Thank you.

Speaker Change: Nick Peasy, our Chief Financial Officer will review, our financial results for the quarter.

Speaker Change: <unk> already made though our chief commercial officer will then provide a commercial update.

Speaker Change: Since just the beginning of this year, we've made significant progress on both fronts, which underscores the agility and operational excellence of our organization.

Speaker Change: Mark Jacobson, our Chief operating officer, and Hunter Murdock, our general counsel will be joining us for Q&A.

Hunter Murdock: Hey, thanks for the question. This is Hunter.

Hunter Murdock: I'll answer the first part and then I'll turn it over to Ari for the second part. For the first part, so TEVA has 180-day regulatory accessibility. So regardless of what happens, TEVA will be the first generic to launch. So other generics in file, they would come in after TEVA.

Speaker Change: And with that I'll turn the call over to area.

Speaker Change: Starting with access 14 for the treatment of fibromyalgia.

Speaker Change: Thank you Darin and good morning, everyone.

Speaker Change: We have submitted our NDA to the FDA for excess 14th and anticipate a decision on the acceptance of the filing in the second quarter.

area: XOMA into 2025 with strong momentum across the business.

area: In the first quarter, we delivered year over year total revenue growth of 62%.

Ari Maizel: And now I'll turn it over to Ari. Yeah, and in terms of whether it emboldens us to pursue other indications, we have always planned to pursue other indications with AXS05, given the pharmacology, so the nearest term new opportunity is Alzheimer's disease agitation, and we're on track to file the S&E for that in the third quarter, and following that, we also have sputum cessation, and we are on track to initiate a phased retrial for sputum cessation this year. Thank you.

Speaker Change: Fibromyalgia easy chronic and often debilitating condition characterized by widespread pain.

area: Driven by robust underlying demand formality and Sanofi.

Speaker Change: Key sleep disturbance and cognitive impairment.

area: In addition, the recent FDA approval of <unk> Bravo, our second internally developed product reflects axons commitment to delivering innovative medicines with the potential to meaningfully improve upon the standards of care for patients living with serious CNS conditions.

Speaker Change: Recent research suggests that there are over 17 million people in the U S who are living with fibromyalgia.

Speaker Change: Despite this prevalence there has been no meaningful therapeutic innovation and more than 15 years, while currently available treatment options offer variable efficacy and do not address all key symptoms of this condition.

area: Our portfolio today is distinctively diversified and strategically positioned to drive durable growth.

Speaker Change: The excess 14 has the potential to address this unmet medical need in the treatment of fibromyalgia if approved.

area: Earlier this year I outlined key priorities related to our pipeline.

area: The first was to advance our three novel N E stage product candidates toward regulatory filings.

Speaker Change: Turning now to access to five for the treatment of all timers disease agitation.

Ash Verma: Next question today is coming from Ash Verma from UBS. Your line is now live. Hi, great, thanks for taking my question.

area: Include excess 14 for the management of fibromyalgia.

Speaker Change: In March we announced positive F D. A pre NDA meeting minutes regarding our planned supplemental NDA submission for excess or five in this indication.

Ash Verma: For AD agitation, so thanks for providing the clarity that you'll be an SMDA, just curious, how does that impact the commercial potential here? I would imagine that you would have been more favorably positioned on GTN if it was its own NDA, as opposed to getting lumped into depression, which now you're on rating at like 55, mid 55, mid 50 gross to net.

So five in Alzheimers disease agitation and the excess 12 for the treatment of cataplexy and narcolepsy.

Speaker Change: Which reinforced our key assumptions related to our data package and filing timeline.

area: The second was to successfully execute across our multiple phase three clinical programs that broaden the potential of our current products and product candidates, including <unk>. So five so let me answer call again some bravo.

Speaker Change: We continue to make steady progress here and anticipate submitting the NDA to the FDA in the third quarter of this year with a potential FDA decision and launch in 2026 if approved.

area: Yeah.

area: Since just the beginning of this year, we've made significant progress on both fronts, which underscores the agility and operational excellence of our organization.

Ari Maizel: Thanks, Ash, for the question. I think the FNDA does provide some clarity regarding, you know, promotion of AXS05. It will, you know, share the authority name as it relates to, you know, your question on GTN. I think that that's one way of thinking about it. The other is that we expect, you know, based on our existing payer contracts and the ongoing negotiation, their familiarity with the product and sort of the clinical profile overall has been very positive. So we think of this as being ultimately beneficial to helping secure access for the new indication. And so, you know, the GTN component, I'm not sure that we see it necessarily the same way, but ultimately we need to get an approval for this indication and, you know, expand our existing contracts.

Speaker Change: The successful five has been granted breakthrough therapy designation by the FDA.

Speaker Change: If approved it would address the serious and debilitating unmet medical need which is estimated to impact over 4 million people in the U S alone.

area: Starting with excess 14 for the treatment of fibromyalgia we.

area: We have submitted our NDA to the FDA for excess 14th.

area: And anticipate a decision on the acceptance of the filing in the second quarter.

Speaker Change: Separately, we are also making progress on our development plans for <unk> five for the treatment of smoking cessation.

area: Fibromyalgia is a chronic and often debilitating condition characterized by widespread pain fatigue sleep disturbance and cognitive impairment.

Speaker Change: And anticipate initiating a phase two three trial of excess or five in this indication this year.

area: Recent research suggests that there are over 17 million people in the U S who are living with fibromyalgia.

Speaker Change: Moving on to excess 12, our novel product candidate for the treatment of narcolepsy with cataplexy.

area: Despite this prevalence there has been no meaningful therapeutic innovation and more than 15 years, while currently available treatment options offer variable efficacy and do not address all key symptoms of this condition.

Speaker Change: We previously announced the completion of our registration program, which consists of three controlled phase two and phase III efficacy trials and a long term safety trial.

Speaker Change: We continue to work toward our plan in the submission, which we anticipate in the second half of this year.

area: The excess 14 has the potential to address this unmet medical need in the treatment of fibromyalgia if approved.

Despite the currently available treatment options many patients with narcolepsy remains inadequately manage due to the heterogeneity of the condition and variable response and Tolerability. The currently approved agents.

Ari Maizel: In order to secure access for the new patients. So, you know, we're feeling pretty good about the FNDA. We think there's some really nice advantages from a commercial standpoint, and we'll look forward to sharing some more in the future.

area: Yeah.

area: Turning now to access so five for the treatment of Alzheimers disease agitation.

In March we announced a positive F T. A pre NDA meeting minutes regarding our planned supplemental NDA submission for excess so five into syndication.

Speaker Change: Based on the clinical data to date excess 12 has the potential to deliver rapid and durable improvements in cataplexy, while also demonstrating potential across other key symptom areas.

Rahm Selvaraju: Next question is coming from Rahm Selvaraju from H.T. Wainwright. Your line is now live. Thanks very much for taking my questions.

area: Which reinforced our key assumptions related to our data package and filing timeline.

area: We continue to make steady progress here and anticipate submitting the NDA to the FDA in the third quarter of this year with a potential FDA decision and launch in 2026 if approved.

Rahm Selvaraju: Firstly, I was wondering if you could comment on your expected cadence of coverage for Simbravo following the launch rollout next month, in terms of how quickly you expect Simbravo to reach, you know, qualitatively the same level of access that you currently have secured for Auxility. And then secondly, I was wondering, with respect to the additional indications for sol-re-amsetol, would you say that at this point, given the information you currently have, that binge eating disorder represents the most attractive opportunity from a competitive positioning standpoint? Or is one of the other indications still likely to be more attractive in terms of overall commercial value?

Speaker Change: Shifting now to our ongoing phase III clinical development programs postal ramp at all which is being evaluated in ADHD.

Speaker Change: D D D.

Speaker Change: Binge eating disorder, and excessive sleepiness associated with shift work disorder.

area: Okay. So five has been granted breakthrough therapy designation by the FDA.

area: If approved it would address the serious and debilitating unmet medical need which is estimated to impact over 4 million people in the U S alone.

Speaker Change: In the first quarter, we announced positive topline results from the focused phase III trial of Solvay and Vitol in adults with ADHD.

Speaker Change: With these promising results in hand, we plan to initiate a phase three pediatric trial forceful reenter tall in ADHD later this year.

area: Separately, we are also making progress on our development plans for excess to five for the treatment of smoking cessation.

area: And anticipate initiating a phase two three trial of extra so five in this indication this year.

Speaker Change: We also reported top line results for the paradigm study, which was a phase three proof of concept trial evaluating the efficacy and safety so ramp adult M D D with and without excessive daytime sleepiness or eds.

Rahm Selvaraju: Thank you.

area: Moving on to access 12.

Rahm Selvaraju: Thanks, Raul, for the question.

Rahm Selvaraju: Regarding coverage for Simbravo and the cadence, obviously, we're focused right now on negotiations for Simbravo. I think it's premature to say exactly what the cadence would be, but we are focused on securing access, you know, as quickly as we can. We understand this is a highly competitive market, but there's still significant unmet need, and Simbravo's unique clinical profile, we believe, has significant advantages for patients, and payers are seeing that clinical value.

area: Our novel product candidate for the treatment of narcolepsy with cataplexy.

area: We previously announced the completion of our registration program, which consists of three controlled phase II and phase III efficacy trials any long term safety trial.

Speaker Change: And the pre specified subgroup of patients with severe eds treatment with Sabra Amphenol resulted in numerically greater improvements in depressive symptoms.

area: We continue to work toward our planned NDA submission, which we anticipate in the second half of this year.

Speaker Change: Based on these results.

Speaker Change: To initiate a phase III trial, what are your inventories in MPD patients with eds later this year.

area: Despite the currently available treatment options many patients with narcolepsy remains inadequately manage due to the heterogeneity of the condition and variable response and Tolerability to currently approved agents.

Speaker Change: In parallel we remain focused on advancing our additional phase III trials.

Rahm Selvaraju: So I would say stay tuned for additional updates regarding market access on Simbravo. Great.

Speaker Change: Oriental and binge eating disorder, and excessive sleepiness associated with shift work disorder with topline results from both studies anticipated in 2026.

area: Based on the clinical data to date excess 12 has the potential to deliver rapid and durable improvements in cataplexy, while also demonstrating potential across other key symptom areas.

Ari Maizel: Hi, everyone. This is Ariel. With regards to the second question on sole re-invertol and the additional indications in how we see the product positioned versus competitors, we really like the profile list for sole re-invertol. We've announced positive results in ADHD, and while you can't make cross-trial comparisons, and we should always be careful about that because different trials are run in different patient populations, it was encouraging that the improvement from baseline in terms of the primary endpoint, the AISRS, was on par with what is seen with currently approved stimulant agents. So we really like that, and obviously, there will be further characterization of the clinical profile in ADHD.

Speaker Change: Lastly in February we announced positive topline results from the emerging phase III trial of some Bravo in migraine patients experiencing inadequate response to oral seed European inhibitors.

area: Okay.

area: Shifting now to our ongoing phase III clinical development programs plus oriented call, which is being evaluated in ADHD.

Speaker Change: Results of this study reinforces the unique clinical profile and potential some bravo to provide meaningful efficacy to patients living with migraine.

area: And D D.

area: <unk> disorder, and excessive sleepiness associated with shift work disorder.

area: In the first quarter, we announced positive topline results from the focused phase III trial of soldiering epitope in adults with ADHD.

Speaker Change: As demonstrated by these important milestones we have achieved across our commercial and pipeline programs.

area: With these promising results in hand, we plan to initiate a phase three pediatric trial for silver anti Tau in ADHD later this year.

Speaker Change: XOMA continues to execute with discipline and focus.

Speaker Change: We are closely monitoring trade policy developments, including proposed pharmaceutical tariffs, we believe that any potential impact to our business would be immaterial.

area: We also reported topline results for the paradigm study, which was a phase three proof of concept trial evaluating the efficacy and safety, so reinstall and MPD with and without excessive daytime sleepiness or eds.

Ari Maizel: As it relates to end-human disorder, It's too early to make any pronouncements there. Obviously, there's only one other product which is approved for binging disorder. So if Soyavtol were to be successful, it would be the second product. So from a competitive perspective, that is a very nice dynamic to have. However, we have to wait to see what the results of the phase three trial are. Thank you.

Speaker Change: In particular, the vast majority of our commercial manufacturing takes place in the U S and Canada, including our primary production facilities for ability and some Bravo.

area: And the pre specified subgroup of patients with severe ETS treatment with salt reinstall resulted in numerically greater improvements in depressive symptoms.

Speaker Change: And we do not commercialize these products outside the U S.

Speaker Change: Additionally, all intellectual property related to mobility and access.

area: Based on these results we plan to initiate a phase III trials for Amphenol in MPT patients with Eds later this year.

Speaker Change: So five anthem Bravo are doomed filed in the U S.

Speaker Change: We appreciate that this is a key focus area for investors.

area: In parallel we remain focused on advancing our additional phase III trials are solely amatol, mbank eating disorder and accessories to weakness associated with shift work disorder with topline results from both studies anticipated in 2026.

Speaker Change: And it is challenging environments like today's that truly underscore the deaths resilience and adaptability of our business.

Charles Duncan: Our next question today is coming from Charles Duncan from Cantor Fitzgerald. Your line is now live. Hey, morning, Ariel and team. Congrats on a good quarter. Thanks for taking our question.

Speaker Change: We look forward to providing more updates on our progress as we expect 2025 could be another catalyst rich year.

Charles Duncan: My first question is on Simbravo. I think Ari mentioned Simbravo launch coming up here in terms of building out the sales team. Could you give us any idea of kind of what that means in terms of number of persons or focus? Would you perhaps focus on sites that are treating migraine and therefore helpful to the rest of the portfolio? And then when do you anticipate being able to present some of the recent data on Simbravo including responsive CGRPs? Could that be at the American Headache Society meeting later in June?

Speaker Change: With potentially five marketed products across six indications by 2026, where you are in a strong position to continue delivering innovation to patients and significant value to shareholders.

area: Lastly in February we announced positive topline results from the emerge phase III trial of some Bravo in migraine patients experiencing inadequate response to oral seed European visitors.

Speaker Change: With that I'll hand, the call over to Nick will provide details about our financial performance.

area: Results of this study reinforce the unique clinical profile and potential of some bravo to provide meaningful efficacy to patients living with migraine.

Nick: Thank you Ariel and good morning, everyone.

Nick: Today, I will discuss our first quarter results and provide some financial guidance.

area: As demonstrated by these important milestones we have achieved across our commercial and pipeline programs XOMA continues to execute with discipline.

Nick: Total product revenues were $121 5 million for the first quarter representing year over year growth of 62%.

Nick: This consisted of net product sales of $120 4 million and royalty revenue of $1 1 million.

area: And focus.

Charles Duncan: Hey, Charles, thanks for the question. So regarding some Bravo selling efforts, we are close to completion of the build out of that sales team. We expect to have approximately 100 sales representatives focused primarily on a highly concentrated group of acute migraine treaters and headache centers and large neurology practices. You know, your point about synergy with the existing portfolio is something that we are taking a close look at. You know, there is some utilization in the psychiatry space. I'd say the synergy is more pronounced in the primary care space. That's something that we'll continue to evaluate for future promotional efforts.

Speaker Change: While we are closely monitoring trade policy developments, including proposed pharmaceutical tariffs do you believe that any potential impact to our business would be immaterial.

Nick: Total product revenue for the comparable period in 2024 was $75 million.

Nick: <unk> net product sales were $96 2 million for the first quarter of 2025, representing 80% year over year growth of LD net product sales for the comparable period in 2024 were $53 4 million.

Speaker Change: In particular, the vast majority of our commercial manufacturing takes place in the U S and Canada, including our primary production facilities for ability and some Bravo.

Nick: The notes the net product revenues were $25 2 million for the first quarter of 2025, representing 17% year over year growth and consisting of $24 1 million in net product sales and $1 1 million in royalty revenue associated with Sanofi sales and out license territories.

Speaker Change: And we do not commercialize these products outside the U S.

Speaker Change: Additionally, all intellectual property related to ability, except so five and some Bravo art films filed in the U S.

Speaker Change: We appreciate that this is a key focus area for investors.

Sanofi net product revenue for the comparable period in 24 was $21 6 million consisting of net sales of $20 7 million and 900000 in royalty revenue.

Speaker Change: And it is challenging environments like today's that truly underscore the deaths resilience and adaptability of our business.

Charles Duncan: And then David, the last question. So, as you can imagine, AHS will be a very important scientific meeting for us, and we do expect their presence there. Okay, great. Thanks.

Speaker Change: We look forward to providing more updates on our progress as we expect 2025 could be another catalyst rich year.

Nick: <unk> <unk> discount for the first quarter were both in the mid 50% range and we anticipate GTS to remain in this range for the balance of the year.

Speaker Change: With potentially five marketed products across six indications by 2026.

Speaker Change: You are in a strong position to continue delivering innovation to patients and significant value to shareholders.

David Amsellem: Next question is coming from David Amsellem from Pepper Sandler. Your line is now live. Hey, thanks. Wanted to drill down more on estroboxytene and fibromyalgia. I know you talked about it. I'm wondering, number one, how are you thinking about the sales opportunity? At one point, over a decade ago, Pfizer was prioritizing Lyrica and Fibro, Lilly was prioritizing Cymbalta and Fibro saw it as a big opportunity. Lots of DTC, of course, those products are generic now. So how do you think about the underlying opportunity given, on one hand, the size of the market and on the other hand, the fact that there are generics of these products?

Nick: Total cost of revenue were $9 8 million for the first quarter of 2025, and $6 3 million with comparable period in 2024.

Nick Peasy: With that I'll hand, the call over to Nick will provide details about our financial performance.

Research and development expenses were $44 8 million for the first quarter of 2025 compared to $36 8 million for the comparable period in 'twenty for the.

Nick Peasy: Thank you Ariel and good morning, everyone today, I will discuss our first quarter results and provide some financial guidance total.

Nick: The increase was primarily related to the company's four phase III trials in salary amphenol.

Nick Peasy: Total product revenues were $121 5 million for the first quarter representing year over year growth of 62%. This.

Nick: <unk> costs for the planned launch of some Bravo and higher personnel costs, including noncash stock based compensation associated with organizational growth.

Nick Peasy: This consisted of net product sales of $120 4 million and royalty revenue of 1.1 million.

Nick Peasy: Total product revenue for the comparable period in 2024 was $75 million.

Nick: Selling general and administrative expenses were $128 million for the first quarter of 2025 compared to $99 million for the comparable period in 2024.

David Amsellem: So that's number one. And then number two, what's the extent to which you're going to expand the sales force to support estroboxytene? Thanks.

Nick Peasy: <unk> net product sales were $96 2 million for the first quarter of 2025, representing 80% year over year growth of LD net product sales for the comparable period in 2024 were $53 4 million.

Nick: The increase was primarily related to commercialization activities for ability, including the expansion of the sales force and higher marketing expenses prelaunch activities for some Bravo and higher personnel costs, including noncash stock based compensation associated with the organizational growth.

Ari Maizel: Yeah, thanks, David. You know, we're very enthusiastic about the SS14 and the potential impact. Fibromyalgia, as you mentioned, it's a large market. There are about 17 million people in the U.S. diagnosed with fibromyalgia. And so when you think about promotional efforts, the indication is treated by a diverse group of ACTs in rheumatology, primary care, pain, neurology, and psychiatry. When we look at, you know, the key focus is the concentration specifically in rheumatology and primary care markets. We're continually evaluating the appropriate size and structure for the SS14 sales team, but we do believe there will likely be a mix of utilizing existing sales teams, as well as adding additional sales efforts, particularly for the rheumatology space.

Nick Peasy: The notes the net product revenues were $25 2 million for the first quarter of 2025, representing 17% year over year growth and consisting of $24 1 million in net product sales and $1 1 million in royalty revenue associated with Sanofi sales in out license territories.

Nick: Net loss for the first quarter of 2025 was $59 4 million or $1 22 per share compared to a net loss of $68 4 million or $1 44 per share for the comparable period in 2024.

Nick Peasy: The notes the net product revenue for the comparable period in 24 was $21 6 million consisting of net sales of $20 7 million and 900000 in royalty revenue.

Nick: The net loss in the first quarter of 2025 includes $26 2 million in non cash charges.

Nick Peasy: [noise] ability and Sanofi GTS discount for the first quarter were both in the mid 50% range and we anticipate G. T N to remain in this range for the balance of the year.

Nick: It's primarily of $23 3 million in stock based compensation expense $1 5 million in acquisition related contingent consideration expense and $1 6 million in intangible asset amortization.

Nick Peasy: Total cost of revenue were $9 8 million for the first quarter of 2025, and $6 3 million for the comparable period in 2024.

Nick: We ended Q1, 2025 with $309 million in cash and cash equivalents compared to $315 $4 million as of year end.

David Amsellem: And as it relates to consumer advertising, you know, stay tuned for more information. We're evaluating the most effective way of engaging with patients. As you know, this is a long, dormant market from a promotional standpoint, so we're looking at novel ways of engaging with patients in the future. Okay, thanks.

Nick Peasy: Okay.

Nick Peasy: Research and development expenses were $44 8 million for the first quarter of 2025 compared to $36 8 million for the comparable period in 'twenty for the.

Nick: We believe that our current cash balance is sufficient to fund anticipated operations into cash flow positivity based on the current operating plan.

Nick Peasy: The increase was primarily related to the Companys four phase III trials in salary amphenol.

Ari: I'll now turn the call over to Ari, who will provide a commercial update.

Nick Peasy: <unk> costs for the planned launch of some Bravo and higher personnel costs, including noncash stock based compensation associated with organizational growth.

Ari: Thank you Nick.

Ari: Exome delivered solid commercial performance for our ability and Sanofi in the first quarter of 2025, despite market seasonality headwinds at the beginning of the calendar year.

David Hoang: Thank you. Next question today is coming from David Hoang from Deutsche Bank. Your line is now live. Hi there. Good morning. Congrats on the quarter. And thanks for taking my questions.

Nick Peasy: Selling general and administrative expenses were $128 million for the first quarter of 2025 compared to $99 million for the comparable period in 2024.

Ari: <unk> led the market in Trs growth in Q1, with approximately 167000 prescriptions, representing 76% year over year growth compared to the first quarter of 2024, and 5% sequential quarter over quarter growth.

David Hoang: So first, I wanted to ask on Ovelity, could you just give a little bit more color on your expectations for how payer coverage might evolve for the product over the course of this year? I think you have two major GPOs under contract. So just wondering if getting the third one would be, you know, key in your efforts to get the coverage you want.

Nick Peasy: The increase was primarily related to commercialization activities for ability, including the expansion of the sales force and higher marketing expenses prelaunch activities for some Bravo and higher personnel costs, including noncash stock based compensation associated with organizational growth.

Ari: <unk> was one of only two branded mbd agents with sequential brand growth in Q1.

Ari: By comparison, the antidepressant market was flat compared to the first quarter of 2024 and declined by 2% sequentially.

Ari Maizel: And then on Sanosi, could you give a little bit, just any color you might have on how you're seeing the growth in the EDS for narcolepsy versus OSA indications? Thanks. Yeah, thanks, David. So regarding authority, you know, our team is focused on two primary objectives, increase the number of covered lives and reduce utilization management, such as prior authorization and step edits. We're pleased with the progress the team has made in negotiations across channels, and we do expect access to further expand and evolve this year and beyond. As it relates to Sanofi, we have seen really nice growth in both indications, but, you know, faster growth in the OSA indication.

Nick Peasy: Net loss for the first quarter of 2025 was $59 4 million or $1 22 per share compared to a net loss of $68 4 million or $1 44 per share for the comparable period in 2024.

Ari: Nearly 26000, new patients were prescribed <unk> in the quarter, bringing the total number of new patients started on <unk> since launch to more than 190000.

Ari: <unk> already used in first line or first fit setting is approximately 50% in the quarter, reflecting balanced utilization of <unk> for patients regardless of prior treatment experience.

Nick Peasy: The net loss in the first quarter of 2025 includes $26 2 million in non cash charges.

Nick Peasy: It's primarily a $23 3 million in stock based compensation expense $1 5 million in acquisition related contingent consideration expense and one 6 million and intangible asset amortization.

Ari: Our sales team successfully activated 4100, new prescribers in Q1 with continued growth across both psychiatry and primary care settings.

Ari: We're beginning to see the initial impact of our most recent sales force expansion on overall scripts and new patient starts and we expect continued impact from the expanded sales team throughout the year.

Nick Peasy: We ended Q1, 2025 with $309 million in cash and cash equivalents compared to $315 $4 million as of year end.

Ari Maizel: This is obviously a larger patient population, and, you know, based on our interactions with HCPs, we've seen, you know, significant unmet need, particularly in this area where, you know, the majority of our growth is coming from. Thank you.

Nick Peasy: We believe that our current cash balance is sufficient to fund anticipated operations into cash flow positivity.

Ari: <unk> coverage remains stable in Q1 with 78% of all lives covered across channels and 63% of lives in the commercial segment.

Nick Peasy: The current operating plan.

Ari: I'll now turn the call over to Ari, who will provide a commercial update.

Ari: Based on ongoing negotiations, we expect coverage for <unk> to expand and improve in 2025.

Thank you Nick.

Ari: <unk> delivered solid commercial performance for our ability and Sanofi in the first quarter of 2025, despite market seasonality headwinds at the beginning of the calendar year.

Speaker Change: Turning to Sanofi.

Speaker Change: Total prescriptions were over 46000, representing 12% growth versus Q1, 2024, and a decline of four 8% sequentially.

Joon Lee: Next question is coming from Joon Lee from Truist Securities. Your line is now live. Thanks for taking our questions. It's great to hear that you had the meeting minutes from the ADA, pre-NDA meeting. Any color you can share on how the meeting went and any notable surprises, if any? And do you plan to have any other meeting before the actual submission is requeued? And just a quick follow up. You're now in your third year of availability launch.

Ari: Ability to lead the market in Trs growth in Q1, with approximately 167000 prescriptions, representing 76% year over year growth compared to the first quarter of 2024, and 5% sequential quarter over quarter growth.

Speaker Change: By comparison, the weight promoting agent market increased by 4% compared to the first quarter of 2024 and declined 5% sequentially.

Speaker Change: Approximately 3800, new patient start as soon as the end of the quarter, bringing the total number of new patients started on Sanofi to approximately 85000 since launch.

Ari: <unk> was one of only two branded NBD agents with sequential brand growth in Q1.

Ari: By comparison, the antidepressant market was flat compared to the first quarter of 2024 and declined by 2% sequentially.

Speaker Change: Nearly 440 writers were activated in Q1, resulting in a total cumulative prescriber base of more than 14000 health care providers since launch.

Joon Lee: When do you think you'll be in a position to provide guidance? Ability, Fran Didi.

Ari: Nearly 26000, new patients were prescribed <unk> in the quarter, bringing the total number of new patients started on <unk> since launch to more than 190000.

Speaker Change: Payer coverage for Sanofi in Q1 was stable with 83% of lives covered across channels.

Ari Maizel: Hey, Joon. I don't know that we have any additional color with respect to the engagements with FDA besides what we disclosed and that we're excited about the data we have and our progress towards the SNDA submission. That remains on track. In terms of additional meetings and things like that, right now, the gating steps between today and the submission are completing build-out of the package. And so that's writing and compiling the modules. So we feel good about the work ahead of us. We'll keep you posted.

Speaker Change: Finally, our launch preparations for some Bravo are progressing as planned including the build out of our sales team in the development of marketing messages materials and programs.

Ari: <unk> used in the first line or first fit setting is approximately 50% in the quarter, reflecting balanced utilization of mobility for patients regardless of prior treatment experience.

Feedback from health care providers since approval has been very positive due to the large unmet need that still exists in the acute migraine space.

Ari: Our sales team successfully activated 4100, new prescribers in Q1 with continued growth across both psychiatry and primary care settings.

Speaker Change: There has been a strong positive reaction just in Bravo clinical profile with rapid and durable migraine pain relief that is safe and tolerable, it's multi mechanistic approach that our tax migraine pain in a unique way relative to other approved agents and some bravos novel Mosaiq technology.

Nick Pizzie: Yeah, and June, it's Nick. As it relates to sales guidance, yes, we are in our third year, I would say still pretty fluid situation as Ari spoke about earlier about payer coverage continuing to evolve. We just launched a field force expansion in Q1. We have the DTC campaign that's going to be occurring later this year. So all of these items will have material impact.

Ari: <unk> coverage remains stable in Q1 with 78% of all lives covered across channels and 63% of lives in the commercial segment.

Speaker Change: We look forward to sharing additional details of our commercial launch soon.

Speaker Change: In closing Q1 was a solid quarter that sets up axiom for another successful year.

Ari: Based on ongoing negotiations, we expect coverage for <unk> to expand and improve in 2025.

Speaker Change: <unk> advancement of our commercial execution capabilities will support ongoing performance for mobility into nosy, while enabling a potentially strong launch for some Bravo next month I.

Ari: Turning to Sanofi.

Ari: Total prescriptions were over 46000, representing 12% growth versus Q1, 2024, and a decline of four 8% sequentially.

Darren Open: I will now turn the call back to Darren for Q&A.

Nick Pizzie: So understood the question on sales guidance, but still think it's a bit premature. We'll We'll direct you to our corporate website where we speak to the range of one to three billion for peak sales for NDD alone, and then larger than that for ADA.

Darren Open: Thanks, Laurie operator May we please open the line for questions.

Ari: By comparison, the weight promoting agent market increased by 4% compared to the first quarter of 2024 and declined 5% sequentially.

Speaker Change: Certainly it will now be conducting a question and answer session if you'd like to be placed in the question queue. Please press star one on your telephone keypad as a reminder, we ask you. Please ask one question and one follow up then return to the queue, if you'd like to remove yourself from the queue. Please press star two.

Ari: Approximately 3800, new patient start as soon as the end of the quarter, bringing the total number of new patients started on <unk> to approximately 85000 since launch.

Ari: Nearly 440 writers were activated in Q1, resulting in a total cumulative prescriber base of more than 14000 health care providers since launch.

Serena Chen: Next question today is coming from Serena Chen from Wells Fargo. Your line is now live. Hi, thanks for taking my question and congrats on all the positive readouts so far. I wanted to ask more about the strategic direction of the pipeline. As you have several assets pending regulatory review, how are you thinking about next steps? Would you say the focus is more on expansion opportunities or are there any plans for new molecular entities?

Speaker Change: One moment, please while we poll for questions. Our first question today is coming from the United Simachev from RBC capital markets. Your line is now live.

Ari: Payer coverage for Sanofi in Q1 was stable with 83% of lives covered across channels.

United Simachev: Hey, guys. Thanks for taking my question and congratulations on the quarter. So maybe a multipart one you've got a number of developmental agents in front of the FDA right now so I wanted to focus on that I guess, what is your sense spin from the FDA on recent interactions there've been any changes to the review teams or agency responsiveness or I guess in particular any.

Ari: Finally, our launch preparations for <unk> Bravo are progressing as planned including the build out of our sales team in the development of marketing messages materials and programs.

Ari: Feedback from health care providers since approval has been very positive due to the large unmet need that still exists in the acute migraine space.

Ari Maizel: Thanks for the question. Right now, given the breadth of the pipeline, and the number of assets that we have that are in late stage development, in any stage products Our focus is to make sure that we execute crisply. So we want to make sure that we execute on these opportunities, which if you look at all the opportunities, given the stage of development in the patient population has the potential to deliver peak sales of north of 16 billion dollars. So we want to make sure that we execute and take those over the finish line.

Speaker Change: Evolution on the messaging of what may be required for approval, especially for excess of five in Alzheimers agitation.

Ari: There has been a strong positive reaction and Bravo clinical profile with rapid and durable migraine pain relief that is safe and tolerable, it's multi mechanistic approach that our tax migraine pain in a unique way relative to other approved agents and some bravos novel Mosaiq technology.

Speaker Change: And I guess given that you have breakthrough designation for that agent I guess, how confident are you that you'll be able to get a priority review here, thanks, and I'll hop back in queue.

Mark Jacobson: Hey, Mark.

Mark Jacobson: So right now engagements dialog with FDA and status quo for us remains status quo.

Ari: We look forward to sharing additional details of our commercial launch soon.

Ari: In closing Q1 was a solid quarter that sets up exome for another successful year.

Mark Jacobson: And then with respect to.

Speaker Change: Hey, <unk>.

<unk> advancement of our commercial execution capabilities will support ongoing performance for mobility, and Sanofi, while enabling a potentially strong launch for some Bravo next month.

Speaker Change: And then any agitation no changes there versus what we've discussed and the feedback we received from FDA with respect to our plan.

Operator: Having said that. There are other opportunities which are always being presented to us, as well as other opportunities currently internally, which we have not disclosed. And, you know, stay tuned for those and we will disclose them as they mature or as they become appropriate. Thank you. As a reminder, that's star one to be placed at the question.

Darren Open: I will now turn the call back to Darren for Q&A.

San Diego mission.

And I think you did mention that.

Darren Open: Thanks, Sorry, operator may we please open the line for questions.

Speaker Change: It does have breakthrough therapy designation and is eligible for priority review.

Speaker Change: Certainly well now be conducting a question and answer session if you'd like to be placed into question in queue. Please press star one on your telephone keypad. As a reminder, we ask you. Please ask one question and one follow up then return to the queue, if you'd like to remove yourself from the queue. Please press star two.

Speaker Change: That's something that that determination is made by the agency at the time of filing.

Speaker Change: Thank you. Our next question is coming from Marc Goodman from Leerink Partners. Your line is now live.

Vikram Purohit: Our next question is coming from Vikram Purohit from Morgan Stanley. Your line is now live. Hi, guys. Thanks for taking our question.

Speaker Change: Yeah.

Speaker Change: Two questions really one is can you just give us a sense of when you are going to kick in the DTC advertising for Valerie I know that's supposed to happen sometime this year and then second the question is really about just the erections coming in to the narcolepsy class and just how you think about your products getting again as the erections Kevin.

Speaker Change: One moment, please while we poll for questions. Our first question today is coming from the Internet to Michelle <unk> from RBC capital markets. Your line is that life.

Vikram Purohit: This is Parthan from Vikram. Could you comment on your intended design of the phase 3 study plan to initiate later this year for solar mescal and MDD with EDS? Like, how large of a study population do you anticipate and what do you see as the key endpoints here? And lastly, would this be the only additional trial required for potential approval?

Michelle <unk>: Hey, guys. Thanks for taking my question and congratulations on the quarter. So maybe a multipart one you've got a number of developmental agents in front of the FDA right now so I wanted to focus on that I guess, what is your sense spin from the FDA on recent interactions there've been any changes to the review teams or agency responsiveness or I guess in particular.

Speaker Change: Thank you.

Mark Jacobson: Hey, Mark it's already thanks for the question regarding DTC, we expect to launch a national campaign later this year.

Ari Maizel: Thank you for the question. What we've done historically is disclose the exact design of the studies once we've launched them. Now, we really like what we saw in terms of the signal in this patient population, that is patients with MVD and excessive sleepiness. As a reminder, that represents probably around 50% of patients who have MVD. We will take all the learnings from the study which we've completed as well as the learnings from other depression trials which we've conducted with our other products as we think about the design of this next study. Thank you.

Michelle <unk>: Evolution on the messaging of what may be required for approval, especially for excess of five in Alzheimers agitation.

Mark Jacobson: If you visit our website youll see that we have a new creative campaign, but the national campaign launch will be a little bit later this year.

Michelle <unk>: And I guess given that you have breakthrough designation for that.

Mark Jacobson: Regarding our reps in excess of 12.

Michelle <unk>: I guess, how confident are you that you'll be able to get a priority review here and then I'll hop back in queue.

Mark Jacobson: We're very optimistic about <unk> 12 of the feedback we got in particular, most recently at AAN when we when we shared the symphony data in an oral presentation.

Speaker Change: Hey, Mark good morning, So right now engagements dialogue with MTA and the status quo for us remains status quo.

Mark Jacobson: It's a compelling option daytime dosing strong impact.

Michelle <unk>: And then with respect to.

Michelle <unk>: And if there's a five and EDI agitation no changes there versus what we've discussed and the feedback we received from FDA with respect to our plan that San.

Mark Jacobson: Just on cataplexy, but other symptoms of the interest.

Mark Jacobson: <unk> I think as enthusiastic as folks are theres no questions just about the safety and Tolerability.

Jason Gerberry: Our next question today is coming from Jason Gerberry from Bank of America. Your line is now live. Hey, good morning. Thanks for taking my questions.

Michelle <unk>: San Diego mission.

Mark Jacobson: And it remains to be seen how those drugs will perform and sort of their late stage products. So we're keeping an eye on it but we think that there is a real market for instance, 12 in the short term and we look forward to getting it into the hands of providers and patients.

Michelle <unk>: I think you did mention that it does have breakthrough therapy designation and is eligible for priority review and that's something that that determination is made by the agency at the time of filing.

Jason Gerberry: Follow-up on the MDD-EDS opportunity, just trying to get a sense of how confident you are that that really is half the MDD population. Given the subgroup was only 15% of the study population, was there anything specific in the enrollment criteria that maybe restricted the enrollment of EDS comorbid patients? And then with respect to your MDD peak sales, one to three billion, when do you think you'll be in a position to narrow that guide? I'm just kind of wondering, as you guys think about where you sit today, maybe what are some of the key variables that push you to the high end of three versus maybe the one billion peak sales range?

Mark Jacobson: Thanks.

Michelle <unk>: Okay.

Marc Goodman: Thank you. Our next question is coming from Marc Goodman from Leerink Partners. Your line is now live.

Speaker Change: Thank you next question is coming from Andrew Tsai from Jefferies. Your line is now live.

Michelle <unk>: Yeah.

Andrew Tsai: Hey, good morning, Congrats on the execution and thanks for taking my question. It's around <unk> with your recent settlement with Teva for 2000 2038 to 2000 2039 timeframe can you confirm if this is the absolute earliest that any generic out there can enter at this juncture.

Michelle <unk>: Two questions really one is can you just give us a sense of when you are going to kick in the DTC advertising for Valerie I know that's supposed to happen sometime this year and then second the question is really about just the Iraq since coming in.

Michelle <unk>: The dark Phillip C class and just how you think about your products fit again as the erections Kevin. Thank you.

Speaker Change: And.

Speaker Change: Does this settlement embolden you to pursue other opportunities outside of smoking cessation and agitation assuming that you do have guaranteed run for at least 13 years can we expect more follow on indications here. Thank you.

Ari Maizel: Thanks. Sure. As it relates to the NVD and EDS indication, in the study which we completed, we wanted to see if there was a signal, and to ensure that we had great sensitivity as well as specificity, but importantly specificity, we defined the subgroup as patients with severe EDS. Now, if you look at patients who have EDS with NVD, it is about 50% of the population. And in terms of the MDD peak sales potential of $1 to $3 billion, that does incorporate a lot of different variables. One of the things to watch is what the trajectory is of our current sales.

Speaker Change: Hey, Mark it's already thanks for the question regarding DTC, we expect to launch a national campaign later this year.

Speaker Change: If you visit our website youll see that we have a new creative campaign, but the national campaign, while it will be a little bit later this year.

Hunter Murdock: Hey, Thanks for the question. This is Hunter I'll answer the first part and then I'll turn it over to Ian for the second part.

Speaker Change: Regarding our rep sends an excess 12.

Hunter Murdock: For the first parts and Teva had the 180 day regulatory exclusivity so regardless of what happens Teva will be the first generic launch so other generic file.

Speaker Change: We're very optimistic about <unk> 12 of the feedback we got in particular, most recently at AAN when we when we shared the symphony data in an oral presentation.

Hunter Murdock: It would come in after Teva and now I'll turn it over to Harry.

Speaker Change: It's a compelling option daytime dosing strong impact.

Harry: Yes, and in terms of.

Harry: Whether it's <unk> us to pursue other indications.

Speaker Change: Just on cataplexy, but other symptoms of the interest and the rest and I think as enthusiastic as folks are theres no questions just about the safety Tolerability.

Hunter Murdock: <unk> always planned to pursue other indications with <unk>.

Harry: Makes sense, we'll find given the pharmacology so.

Ari Maizel: And, you know, as we continue the launch, and as other aspects... evolve, we might be in a position to narrow guidance. But right now we feel that that is a very achievable range. And certainly the low end of that is very cheap.

Harry: The nearest term.

Speaker Change: And it remains to be seen how this drug will perform in sort of their late stage products. So we're keeping an eye on it but we think that theres a real market for instance, 12 in the short term and we look forward to getting it into the hands of providers and patients.

Harry: New opportunities garments disease agitation and we're on track to file the <unk> for that.

Harry: The third quarter and following that.

Harry: We also have spoken sensation and we are on track to initiate a phase III trial.

Speaker Change: Thanks.

Harry: Presentation this year.

Speaker Change: Thank you next question is coming from Andrew Tsai from Jefferies. Your line is now live.

Harry: Thanks.

Joel Beatty: Our next question today is coming from Joel Beatty from Barrier Line as an ally. Hello. Good morning.

Speaker Change: Thank you. Your next question today is coming from Ash Birla from UBS. Your line is now live.

Ash Birla: Hi, great. Thanks for taking my question for Eddie observation. So thanks for providing the clarity that can be an SMB.

Chris: This is Chris on for Joel. Just a couple questions on Simbravo. How are you thinking about that CGRP data in February in terms of, you know, are you going to pursue that in a new indication or a label expansion? And then is the plan still to pursue Simbravo, expand the label as well in adolescence? Thanks.

Ash Birla: Just curious how does that impact the commercial potentially had I would imagine that you would have been more favorably position on GDN. If it was its own NDA as opposed to getting lumped into depression, which now you're run rating at like 50% mix of if I may <unk> gross to net.

Speaker Change: And.

Speaker Change: Does this settlement embolden you to pursue other opportunities outside of smoking cessation and agitation assuming that you do have guaranteed around for at least 13 years can we expect more of a follow on indications here. Thank you.

Ash Birla: Thanks.

Ari Maizel: Yeah, thanks, Chris, for the question. From the CGRP data in the eMERGE study, which we read out earlier this year, obviously, it's very compelling data. We've been able to share it in the market since we received it. And it is very clear that clinicians are motivated by that data as it gives them an additional place to try Simbravo once it's commercially available. At this time, we are not seeking to add it to the label as a new indication, but we'll look to promote it through CFL guidance that the FDA puts forth and obviously through a medical affairs team and medical education.

Speaker Change: Okay. Thanks for the question.

Hunter Murdock: Hey, Thanks for the question. This is Hunter I'll answer the first part and then I'll turn it over to Gary for the second quarter.

Speaker Change: I think the SMB agents provide some clarity regarding promotion access so five equal share the <unk> name.

Speaker Change: Sure.

Speaker Change: For the first parts and Teva has 100 DVD regulatory exclusivity, so regardless of what happens Tampa will be the first generic launch so other generic file.

Speaker Change: As it relates to your question on <unk> I think that's one way of thinking about and the other is bad.

Eric: They would come in after Tampa and now I'll turn it over to Eric.

Speaker Change: Based on our existing payer contracts and the ongoing negotiation as their familiarity with the product.

Eric: Yeah and in terms of.

Eric: Whether it's bold moves us to pursue other indications.

Speaker Change: And sort of the clinical profile overall has been very positive.

Eric: We have always planned to pursue other indications with <unk>.

Eric: So five given the pharmacology so.

Speaker Change: So we think the business is being ultimately beneficial to helping.

Eric: The nearest term.

Eric: New opportunities disease agitation and we're on track to file the <unk> for that.

Speaker Change: Secure access from the new indication.

Speaker Change: So the GCN component I'm not sure that we see necessarily the same way, but ultimately we need to get to get an approval for this indication.

Eric: The third quarter and following that.

Ari Maizel: I can take the last part on pediatric development. That work is underway, you know, as agreed to with the FDA. So stay tuned for updates there. Thank you.

Eric: We also have spoken cessation and we're on track to initiate a phase <unk> trial.

Speaker Change: Expand our existing contracts in order to secure access for new patients. So.

Eric: Presentation this year.

Eric: Thanks.

Speaker Change: Thank you next question today is coming from Ash Birla from UBS. Your line is now live.

Speaker Change: We're feeling pretty good about the us NDA, we think there's some really nice advantages from a commercial standpoint, and look forward to sharing some more in the future.

Graig Suvannavejh: The next question today is coming from Graig Suvannavejh from Missoula Security. Your line is now live. Good morning. Congrats on the progress. Thanks for taking my question.

Ash Birla: Hi, great. Thanks for taking my question for Eddie observation. So thanks for providing the clarity that it'll be an S. N D. A.

Speaker Change: Thank you next question is coming from Ron <unk> from H C. Wainwright. Your line is now live.

Ash Birla: Just curious how does that impact the commercial potential here I would imagine that you would have been more favorably position on GDN. If it was its own NDA as opposed to getting lumped into depression, which now you're run rating at like 55 mixed up if I may 50 gross to net.

Nick Pizzie: Maybe just a bigger picture question on profitability or tantalizingly close to being a profitable company, given where you are in cash and kind of where cash has evolved over the last several quarters. Just any comments on whether you do think that profitability can be achieved in 2025, at least on a quarter basis? Thanks. Thanks, Greg. As you know, we haven't provided any guidance around timing, but we do remain confident we'll get the cash flow positivity with our current cash that is on hand. We expect to see, in 2025, leverage in our P&L. It's all a bit in Q1 already as sales growth is outpacing our operating expenses.

Speaker Change: Thanks, very much for taking my questions. Firstly I was wondering if you could comment on your expected cadence of coverage for <unk> Bravo. Following the launch rollout next months in terms of how quickly you expect some bravo to reach.

Speaker Change: Thanks, Greg.

Speaker Change: For the question.

Speaker Change: Qualitatively the same level of access that you currently have secured for OLED and Sanofi and then secondly, I was wondering with respect to the additional indications for solar ramp the call would you.

Speaker Change: I think the NBA does provide some clarity regarding promotion excess survived Ebola shared.

Speaker Change: Sure the <unk> name.

Speaker Change: You say that at this point given the information you currently have that binge eating disorder represents the most attractive opportunity from a competitive positioning standpoint or is one of the other indications still likely to be more attractive in terms of overall commercial value. Thank you.

Speaker Change: As it relates to your question on D C and I think that's one way of thinking about and the other is that we expect based on our existing payer contracts and the ongoing negotiation as their familiarity with the product.

Nick Pizzie: And I think it's important we build Axsome on a very disciplined approach in how we're investing in our operations and how we allocate across our portfolio. On the R&D side, the vast majority of our investment today is in our late-stage pipeline, late-stage programs, and where we expect a high rate of return on that investment. And on the SG&A side, we've built a significant infrastructure over the past three years. Initially, it supports Adozi and NetAbility and now providing operating leverage as we launch the Bravo and will support future product launches. So we believe that we kind of summarize that the current cash will take us to cash flow positivity.

Speaker Change: And sort of the clinical profile overall has been very positive.

Speaker Change: Thanks, Ron My question regarding coverage first and Bravo and the cadence obviously, we're focused right now on negotiations for some brown, though I think it's premature to say exactly what the cadence would be but we are focused on securing access.

Speaker Change: We think that business is being ultimately beneficial to helping <unk>.

Speaker Change: <unk> access for the new indication.

Speaker Change: And so the GTS component I'm not sure that we see necessarily the same way, but ultimately we need to get it get an approval for this indication.

Speaker Change: As quickly as we can understand this is a highly competitive market, but there's still significant unmet need in some bravos unique clinical profile. We believe has significant advantages for patients and payers are foreseeing that clinical value. So I would say stay tuned for additional updates regarding mark.

Speaker Change: Expand our existing contracts in order to secure access for new patients. So.

Speaker Change: We're feeling pretty good about the San Diego, we think there's some really nice advantages from a commercial standpoint, and look forward to sharing some more in the future.

Nick Pizzie: We haven't given any specific guidance around profitability, but we feel like we're on the right course.

Speaker Change: Access on Sept Bravo.

Speaker Change: Oh.

Speaker Change: Great.

Speaker Change: This is Jerry.

Speaker Change: Thank you next question is coming from Rob Suraj, you from H C. Wainwright. Your line is now live.

Nick Pizzie: And then maybe just as a quick follow-up, Nick, just on the evolution of your R&D and SG&A. R&D did come down relative to the fourth quarter. I don't know if you expect that to be sustained in terms of where R&D is right now. I would assume SG&A would tend to tick up higher, but just if you could provide your comments there would be appreciated. Sure, Greg. Yeah, sure. Yeah, you're right. R&D did tick down a bit from Q4. Three ADA trials were completed in Q4, and then the ADHD and MDD trials were completed mid-quarter in Q1.

Speaker Change: With regards to the second question on <unk>.

Speaker Change: The additional indications and how we see the product positioned versus competitors, we really like the profile and that's for a summary of the call.

Rob Suraj: Thanks, very much for taking my questions. Firstly I was wondering if you could comment on your expected cadence of coverage horse and Bravo. Following the launch rollout next month in terms of how quickly you expect some bravo to reach.

Speaker Change: We've announced positive results in ADHD.

Speaker Change: While we can't make cross trial comparisons and.

Rob Suraj: Qualitatively the same level of access that you currently have secured for OLED and Sanofi and then secondly, I was wondering with respect to the additional indications for solar ramp the call would you say that at this point given the information you currently have that binge eating disorder represents the most attractive opportunity from a competitive positioning standpoint.

Speaker Change: Jones.

Speaker Change: Our full amount back because different trials are run in different patient populations. It was encouraging that.

Speaker Change: The improvement from baseline in terms of the primary endpoint.

Nick Pizzie: We would anticipate R&D spend to increase from the Q1 level as we initiate our second phase threes for sovereign infantile and impede ADHD and MDD with EDS. Additionally, as a reminder, we did file the The NDA for AXS 14 in Q2, so we will have that filing fee in Q2. And then as for SG&A, we do expect to see an increase for Q1 as we complete our hiring for the Sombravo field team. We did have in Q1 a partial quarter of leadership team hired, and Q2 will also include a partial quarter of the sales team for Sombravo.

Speaker Change: <unk> is Rs.

Speaker Change: One core what is seen with currently approved stimulant agents. So.

Rob Suraj: Or is one of the other indications still likely to be more attractive in terms of overall commercial value. Thank you.

Speaker Change: We really like that and obviously there'll be further characterization of the clinical profile and ADHD and as it relates to.

Speaker Change: Disorder.

Speaker Change: It's too early to maybe pronouncements there.

Speaker Change: Obviously, there is only one other product, which is approved for binge eating disorder. So if.

Speaker Change: Paul we're to be.

Speaker Change: Be successful it will be the second product so from a competitive perspective that is in very nice dynamic to have however, we have to wait to see what the results of the phase III trial.

Nick Pizzie: So we would anticipate that to tick higher in Q2, and then as Ari talked about, the DTC campaign later in the year, that will further increase SG&A. Thank you.

Speaker Change: Thank you.

Speaker Change: Thank you. Our next question today is coming from Charles Duncan from Cantor Fitzgerald. Your line is now live.

Yatin Suneja: Our next question today is coming from Yatin Suneja from Guggenheim Partners. Your line is now live. is on the ADHD study that you had recently announced.

Speaker Change: Hey, good morning, <unk> and team congrats on a good quarter. Thanks for taking my question. My first question is on some Bravo I think are already mentioned since <unk> launch coming up here in terms of building out the sales team could you give us any any idea of.

Speaker Change: On Sept Bravo.

Speaker Change: Great Hi.

Speaker Change: This is Eric.

Speaker Change: With regards to the second question on <unk>.

Speaker Change: The additional indications and how we see the product.

Yatin Suneja: Could you just talk about, you know, the path forward Also, I think at that time, when you announced the data, there were some questions around the 300 milligram dose that was If you can just talk a little bit about, you know, why was that due? So that's one.

Speaker Change: <unk> versus our competitors, we really like the profile of this for a summary of the call.

Speaker Change: Kind of what that means in terms of number of persons or focus would you perhaps focus on sites that are treating migraine and therefore are helpful to the rest of the portfolio and then when do you anticipate being able to.

Speaker Change: We've announced positive results in ADHD.

Speaker Change: Well you can't make cross trial comparisons.

Speaker Change: <unk> always be careful about that because different trials are run in different patient populations. It was encouraging that.

Ari Maizel: And then the second one is on auxility in terms of the coverage there. I think it seems like there is some plateau in terms of the coverage. Yeah, we'll start with the second question. We were having some difficulty hearing you on the first one, so you may need to just clarify, but the Regarding coverage, obviously, you know, we've had this coverage has been stable over the last couple of quarters, but we have been actively negotiating and in communication with payers. And so we expect, we expect the access to expand and evolve this year. In terms of, you know, ideal percent of covered lives, obviously, we want to secure as many covered lives as possible.

Speaker Change: Present, some of the recent data on <unk>, including responses <unk> could that be at the American Headache Society meeting later in June.

Speaker Change: The improvement from baseline in terms of the primary endpoint.

Speaker Change: It is Rs.

Speaker Change: One four with what is seen with currently approved stimulant agents. So.

Charles Duncan: Hey, Charles Thanks for the question so regarding some bravo selling efforts.

Speaker Change: We really like that and obviously there'll be further characterization of the clinical profile in ADHD and as it relates to binge eating disorder.

Speaker Change: We are.

Speaker Change: Close to completion of the build out of that sales team. We expect to have approximately a 100 sales representatives focused primarily on highly concentrated group of acute migraine treaters and headache centers and large neurology practices.

Speaker Change: It's too early to make any pronouncements there.

Speaker Change: Obviously, there's only one other product which is approved for binge eating disorder. So if.

Speaker Change: Your point about synergy with the existing portfolio is something that we are taking a close look at.

Speaker Change: Paul we're to be.

Speaker Change: To be successful it would be the second product. So from a competitive perspective that is being very nice dynamic. However, you have to wait to see what the results of the phase III trial or.

Speaker Change: There is some utilization in the psychiatry space I'd say, the synergy is more pronounced than the primary care space.

Speaker Change: It's something that we will continue to evaluate for future promotional efforts.

Speaker Change: Thank you.

Ari Maizel: There's not a specific number that we have in mind, just ultimately really focused on improving access for patients so that more patients have the opportunity for coverage with their health insurance plans. Great.

Speaker Change: Thank you. Our next question today is coming from Charles Duncan from Cantor Fitzgerald. Your line is now live.

Speaker Change: And data from last question.

Speaker Change: Yes.

Speaker Change: Hey morning area and team congrats on a good quarter. Thanks for taking my question. My first question is on some Bravo I think are already mentioned some bravo launch coming up here in terms of building out the sales team could you give us any any idea of.

Speaker Change: So as you can imagine IHS will be very important.

Speaker Change: Scientific meeting for Us and we do it.

Ari Maizel: And as it relates to the first question for ADHD, the path forward is to initiate and complete the phase three trial in pediatric patients. With regards to the adult study. And the 300 milligram dose, as a reminder, the top dose, which is approved for sodium butyl is 150 milligrams per day. Given that this was the first study that we're conducting in ADHD, we did want to look at a higher dose just to make sure that we defined what the dose response was. Now, the 150 milligram dose, that was primary dose of focus, since that was the highest approved dose.

Speaker Change: Presence there.

Speaker Change: Okay, great. Thanks.

Speaker Change: Thank you. Your next question is coming from David <unk> from Piper Sandler Your line is now live.

Speaker Change: Hey, Thanks wanted to drill down more on escrow box attained in fibromyalgia I know you talked about it I'm wondering number one.

David: How are you thinking about the sales opportunity at one point.

Speaker Change: Over a decade ago, Pfizer was prioritizing lyrica on fiber Lilly was prioritizing cymbalta.

Speaker Change: Present, some of the recent data on Sim Bravo, including rich responsive <unk> could that be at the American Headache Society meeting later in June.

Speaker Change: Cymbalta and fiber side is a big opportunity lots of DTC of course those products are generic now so how do you think about the underlying opportunity given.

Charles: Hey, Charles Thanks for the question so regarding some bravo selling efforts.

Myles Minter: And we're very happy with the results of the study, which showed a very clear treatment effect for that dose. Sorry, thank you. You addressed both my questions. Thanks. Thank you.

Speaker Change: On one hand, the size of the market and on the other hand.

Speaker Change: We are.

Speaker Change: Close to completion of the build out of that sales team. We expect to have approximately 100 sales representatives focused primarily on highly concentrated group of acute migraine treaters and headache centers and large neurology practices.

Speaker Change: The fact that there are generic so these products. So that's number one and then number two what's the extent to which youre going to expand the sales force to.

Speaker Change: To support S robots, Tim Thanks.

Myles Minter: Next question is coming from Myles Minter from William Blair. Your line is now live. Hey, thanks for the questions, congrats on the quarter.

Speaker Change: Yes, Thanks, David.

Speaker Change: Yes, we're very.

Speaker Change: Louisiana think about NSS fourteens potential impact fiber miles as you mentioned.

Speaker Change: Your point about synergy with the existing portfolio is something that we arent, taking a close look at.

Myles Minter: I think on May 24th, we're expecting the Make America Healthy Again Commission to release an initial report on prevalence and threat of SSRIs, antipsychotic mood stabilizers, stimulants, kind of a catch-all, and I think it's actually maybe focused on childhood disease, but the question is, have you had sort of any interaction with the commission on that report as it pertains to Evalutio Sinose, and I think they're going to finalize it in August, so do you expect to be able to comment on that one? That's the first question.

Speaker Change: Large market of about 17 million people in the U S.

Speaker Change: There is some utilization in the psychiatry space.

Speaker Change: Diagnosed with viral myalgia.

Speaker Change: So the synergy is more pronounced than the primary care space.

And so when you think about promotional efforts.

Speaker Change: It's something that we will continue to evaluate for future promotional efforts.

Speaker Change: The indication is treated by a diverse group of <unk> been rheumatology and primary care pain neurology and psychiatry.

Speaker Change: And David the last question.

David: Got it.

Speaker Change: We look at.

Speaker Change: The key focus is the concentration specifically in rheumatology and primary care markets.

Speaker Change: So as you can imagine the Hs will be very important.

Ari Maizel: The second's just on narcolepsy, I think a few of the KOLs we've talked to are like, look, the efficacy for AXS12 looks great on cataplexy, there's some other symptoms that it looks interesting on as well, but in terms of the stimulant effects, they're looking for like maintenance of wakefulness tests, and I'm wondering whether you're going to have that data in the open label extension. Thanks very much. With regards to the first question, we have not had any interactions with the commission, and we're going to stay tuned, just like everybody else, to see what the outcomes are as we state.

Speaker Change: Scientific meeting for Us and we.

Speaker Change: We're continually evaluating the appropriate size and structure for the excess 14 sales team, but we do believe there will be likely be a mix of utilizing existing sales team as well as adding additional sales efforts, particularly for the rheumatology space.

Speaker Change: We do expect our presence there.

Speaker Change: Okay, great. Thanks.

David: Thank you next question is coming from David <unk> from Piper Sandler Your line is now live.

David: Hey, Thanks wanted to drill down more on escrow box attained in fibromyalgia I know you talked about it I'm wondering number one.

Speaker Change: And as it relates to consumer advertising.

Speaker Change: Stay tuned for more information, we're evaluating the most effective way of engaging with patients.

Speaker Change: How are you thinking about the sales opportunity at one point.

Speaker Change: Over a decade ago, Pfizer was prioritizing lyrica on fibro Lilly was prioritizing.

Speaker Change: This is a long dormant market from a promotional standpoint, so we're looking at novel ways of engaging with patients in the future.

Speaker Change: Cymbalta and fiber side is a big opportunity lots of DTC of course, those products or generic now so how do you think about the underlying opportunity given on one hand, the size of the market on the other hand the.

Ari Maizel: as we make sure that we keep an eye out and keep an ear out for anything that comes out that might affect the sector.

Speaker Change: Okay. Thanks.

Speaker Change: Thank you. Your next question today is coming from David Ho from Deutsche Bank. Your line is now live.

David Ho: Hi, there good morning, congrats on the quarter and thanks for taking my questions. So first I wanted to ask on mobility.

Ari Maizel: As it relates to AXS 12, so with regards to the MWT, you know, we have not incorporated the MWT in our open-label trial. So, however, you know, we have looked at excessive sleepiness, as you know, using other measures, including the clinical global impression of severity. Great, thank you. Thank you.

Speaker Change: The fact that there are generic so these products. So that's number one and then number two what's the extent to which youre going to expand the sales force.

Speaker Change: To support S robots, Tim Thanks.

Speaker Change: Could you just give a little bit more color on your expectations for how payer coverage might evolve for the product over the course of this year I think you have two major GPO is under contract. That's so just wondering if getting the third one would.

Speaker Change: Yes, Thanks, David.

Speaker Change: Yes, we're very.

Speaker Change: <unk> thinks about access fourteens potential impact fiber miles as you mentioned.

Speaker Change: A large market of about 17 million people in the U S.

David Ho: It would be key in your efforts to get the coverage you want and then on <unk> could you give a little bit.

Diagnosed with fibromyalgia.

Speaker Change: And so when you think about promotional efforts.

David Ho: Just any color you might have on how youre seeing the growth in the Etfs for narcolepsy versus OSA indications. Thanks a lot.

Troy Langford: Next question today is coming from Troy Langford from TD Calendar. Your line is now live. Hi guys, thanks for taking our questions and congrats on all the progress this quarter. Just one on Sanosi and ADHD.

Speaker Change: The indication is treated by a diverse group of the keys in rheumatology and primary care and pain neurology and psychiatry.

Speaker Change: Yeah. Thanks, David So regarding mobility. Our team is focused on two primary objectives increased the number of covered lives and reduce utilization management, such as prior authorizations and step edits.

Troy Langford: Just given the level of efficacy that we saw on the Phase 3 ADHD study not too long ago, do you have any reason to believe that the Phase 3 pediatric study will show a substantially different level of benefit? And then just to follow on to that, do you all have any expectations for approximately how long that pediatric study could last? What we know is that historically there's been a correlation between efficacy for ADHD in adults as well as ADHD in pediatric subjects, so we like the fact that we have now seen a clear effect in the adult population.

Speaker Change: We look at.

Speaker Change: The key focus is the concentration specifically in rheumatology and primary care markets.

Pleased with the progress the team has made in negotiations across channels and we do expect that.

Speaker Change: We're continually evaluating the appropriate size and structure for the excess 14 sales team now, but we do believe there'll be likely to be a mix of utilizing existing sales team as well as adding additional sales efforts, particularly for the rheumatology space.

Speaker Change: Weather expand and evolve this year and beyond.

Speaker Change: As it relates to this node b, we've seen really nice growth in both indications.

Speaker Change: And as it relates to consumer advertising.

Speaker Change: Faster growth in the OSA indication.

Speaker Change: Stay tuned for more information, we're evaluating the most effective way of engaging with patients.

Speaker Change: This is obviously a larger patient population.

Speaker Change: And based on our interactions with Hcp's we've.

Speaker Change: This is a long dormant market from a promotional standpoint, so we're looking at novel ways of engaging with patients in the future.

Speaker Change: We've seen significant unmet need particularly.

Ari Maizel: However, we need to conduct a study in pediatric patients. And then in terms of the How long it would take to enroll that study and conduct it is premature.

Speaker Change: Particularly in this area where.

Speaker Change: The majority of our growth is coming from.

Speaker Change: Okay.

Speaker Change: Okay. Thanks.

Speaker Change: Thank you. Your next question today is coming from David Ho from Deutsche Bank. Your line is now live.

Speaker Change: Thank you. Your next question is coming from Joon Lee from <unk> Securities. Your line is now live.

David Ho: Hi, there good morning, congrats on the quarter and thanks for taking my questions. So first I wanted to ask on a reality.

Ari Maizel: So what we'll do is we'll provide some guidance, generally speaking, once we launch the study and talk about the exact design. Thank you.

Joon Lee: Congrats on the strong quarter and thanks for taking our questions. It's great to hear that you had the meeting minutes from the pre NDA meeting any color you can share on how to meeting went and any notable.

Ami Fadia: Our final question today is coming from Ami Fadia from Needham & Company. Your line is now live. I thanks for taking me and taking my question.

Apprises, if any and do you plan to have any other meeting.

Joon Lee: Before the actual submission of <unk> and just a quick follow up.

David Ho: It would be key in your efforts to get the coverage you want and then on <unk> could you give a little bit.

Ami Fadia: Just maybe stepping back with A lot of your assets in late stage or in market, can you talk about how you're managing the business in terms of operating margins and investing across these various assets relative to also exploring potentially bringing in any additional assets and how do we think about what would be sort of that return on investment decision that you make, you know, Thank you. Sure, thanks. Thanks, Ami. You know, as I mentioned earlier in my comments, you know, a lot of our focus, a lot of the R&D spend is on late stage programs, and that has a high POS and a high rate of return.

Joon Lee: You are now in your third year of a battle relaunch when.

Joon Lee: Do you think you'll be in a position to provide guidance on the ability for NTT. Thank you.

David Ho: Just any color you have on how youre seeing the growth in the.

David Ho: Eds for narcolepsy versus OSA indications, thanks, a lot.

Speaker Change: Hey, Jude.

Speaker Change: Yeah. Thanks, Steve So regarding mobility and our team is focused on two primary objectives increased the number of covered lives and reduce utilization management such as prior authorization step edits.

Speaker Change: I don't know that we have any additional color with respect to the engagements with FDA. Besides what we disclosed in that.

Speaker Change: We're excited about the data, we have and our progress towards the NDA submission that remains on track.

Speaker Change: I'm pleased with the progress the team has made in negotiations across channels and we do expect that further.

Speaker Change: In terms of additional meetings and things like that right now the gating steps between today and the submission or completing the build out of the package and so.

Speaker Change: Further expand and evolve this year and beyond.

Speaker Change: As it relates to this node.

Speaker Change: Seating.

Speaker Change: Really nice growth in both indications.

Speaker Change: That's riding in compiling the module so we feel.

Speaker Change: Faster growth in the OSA indication. This is obviously a larger patient population.

Speaker Change: We feel good about the work ahead of us and we'll keep you posted.

Nick: Yes June it's Nick.

Speaker Change: And based on our interactions with the PS.

Speaker Change: Relates to sales guidance, yes, we are.

Ari Maizel: So, we continue to invest in that. As I mentioned, R&D was slightly down for the quarter versus Q4, but continue to invest in developing those late stage programs. And the infrastructure that we have built over the last three years, specifically starting with CENOSI, and then with the launch of Availability, we're able to leverage that infrastructure on all of our future programs. So, we believe that from that perspective, that those programs will have a higher R&D. Thank you.

Speaker Change: Year, I would say, it's still pretty fluid situation is already spoke about earlier about payer coverage continues to evolve we just.

Speaker Change: We've seen significant unmet need particularly.

Speaker Change: Particularly in the area where.

Speaker Change: The majority of our growth is coming from.

Speaker Change: Launch the field force expansion in Q1, we had the DTC campaign.

Speaker Change: Thank you. Your next question is coming from Joon Lee from <unk> Securities. Your line is now live.

Speaker Change: I was going to be occurring later this year. So all of these items will have material impact. So understood. The question on sales guidance, but still think it's a bit premature but will.

Joon Lee: Hey, congrats on the strong quarter and thanks for taking our questions. It's great to hear that you had the meeting minutes from the FDA pre NDA meeting any color you can share on how to meeting went and any notable.

Speaker Change: We will direct you to our corporate website, where we speak to the range of $1 3 billion for peak sales for <unk> alone.

Speaker Change: Apprises, if any and do you plan to have any other meeting.

Then larger than that for <unk>.

Darren Opland: We've reached the end of our question and answer session. I'd like to turn the floor back over for any further closing comments. Well, thank you all for taking the time to join today's call. As you've heard today, Axsome has accomplished a great deal in the first quarter. We are poised to deliver another impactful year, driven by strong commercial execution, a rapidly expanding portfolio, and multiple upcoming milestones. We appreciate your continued interest and support as we continue our work to bring innovative new treatment options to patients and create long-term value for our shareholders. Thank you very much.

Speaker Change: Before the actual submission of <unk> and just a quick follow up here.

Speaker Change: Now in your third year of our February launch went.

Speaker Change: Thank you. Your next question today is coming from Serena Chen from Wells Fargo. Your line is now live.

Speaker Change: Do you think you'll be in a position to provide guidance on <unk>. Thank you.

Speaker Change: Hi, Thanks for taking my question and congrats on all the positive readout so far.

Speaker Change: Hey, Dude.

Serena Chen: Wanted to ask more about the strategic direction of the pipeline as you have several assets pending regulatory review how are you thinking about next steps would you say the focus is more on expansion opportunities or are there any plans for new molecular entities.

Speaker Change: I don't know that we have any additional color with respect to the engagements with F. D. A besides what we disclosed in that that we're in.

Speaker Change: Cited about the data, we have and our progress towards an NDA submission.

Speaker Change: Remains on track.

Speaker Change: Okay.

Speaker Change: In terms of additional meetings and things like that right now the gating steps between today and the submission are completing build out of the package and so that's that's.

Speaker Change: Thanks for the question.

Speaker Change: Right now given the breadth of the pipeline and the number of assets that we have.

Operator: Thank you.

Operator: That does conclude today's teleconference and webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.

Speaker Change: In late stage development and NDA.

Speaker Change: Stage products.

Speaker Change: Our focus is to make sure that we execute crystal so.

Speaker Change: That's riding in compiling the month, but we feel we feel good about the work ahead of us.

Speaker Change: We want to make sure of that.

Speaker Change: Keep you posted.

Speaker Change: These opportunities which.

Speaker Change: Yeah in June it's Nick as it relates to sales guidance yet.

Speaker Change: If you look at all the opportunities given the stage of development in the patient populations has the potential to deliver peak sales.

Speaker Change: Here I would say, it's still pretty fluid situation is already spoke about earlier about payer coverage continues to evolve we just.

Speaker Change: North of $16 billion.

Speaker Change: So we want to make sure that we execute and take those over the finish line.

Speaker Change: <unk> launched the field force expansion in Q1, we had the DTC campaign.

Speaker Change: Seven.

Speaker Change: Going to be occurring later this year. So all of these items will have material impact. So understood. The question on sales guidance, but still think it's a bit premature but will.

Speaker Change: They or other opportunities, which for always being presented to us as well as the other opportunities currently in currently which we have not disclosed and.

Speaker Change: Stay tuned for those two we will disclose them.

Speaker Change:

We will direct you to our corporate website, where we speak to the range of $1 billion to $3 billion for peak sales for <unk> alone.

Speaker Change: As they mature will be more as they become appropriate.

Speaker Change: Thank you.

Speaker Change: And then larger than that for <unk>.

Speaker Change: Thank you as a reminder, thats star one to be placed into the question queue. Our next question is coming from Vikram <unk> from.

Speaker Change: Thank you. Your next question today is coming from Serena Chen from Wells Fargo. Your line is now live.

Speaker Change: Morgan Stanley Your line is now live.

Speaker Change: Hey, guys. Thanks for taking our question. This is park on for Vikram could you comment on your intended design of the Phase III study planned to initiate later this year for solar in this call and MDT with eds like how large of a study population do you anticipate and what do you see as the key endpoints here and lastly, with this being the only additional.

Serena Chen: Hi, Thanks for taking my question and congrats on all the positive readout so far.

Speaker Change: Trial required for potential approval.

Serena Chen: Okay.

Serena Chen: Thanks for the question.

Serena Chen: Right now given the breadth of the pipeline and the number of assets that we have been in late stage development and NDA stage.

Speaker Change: Thank you for the question.

Speaker Change: What we've done historically is disclosed the exact design of the studies once we launch them.

Serena Chen: Stage products.

Speaker Change: Now.

Serena Chen: Our focus is to make sure that execute crisply. So.

Speaker Change: We really like will be songs from EBA signal in this patient population that is patients with IBD and excessive sleepiness as a reminder, that represents probably around 50% of patients who have mbd, we would take all the learnings from the study, which we completed as well as the learnings from other depression trials.

I want to make sure that we execute on these opportunities which.

Serena Chen: If you look at all the opportunities given the stage of development in the patient populations has the potential to deliver peak sales of north of $16 billion. So we want to make sure that we execute and take those over the finish line having said.

Speaker Change: Which we've conducted with our other products.

Speaker Change: As we think about the design of the.

Speaker Change: This next study.

Serena Chen: Or other opportunities, which for always being presented to us as well.

Speaker Change: Thank you. Our next question today is coming from Jason <unk> from Bank of America. Your line is now live.

Serena Chen: <unk> currently and currently we have not disclosed and.

Jason: Hey, good morning, Thanks for taking my questions.

Serena Chen: Stay tuned for those we will disclose them.

Speaker Change: Just to follow up on the MDT Etfs opportunity just trying to get a sense of how confident you are that that really is half the <unk> population.

As they mature as they become appropriate.

Serena Chen: Thank you.

Given the subgroup was only 15% of the study population was there anything specific in the enrollment criteria that may be restricted the enrolment of EES comorbid patient and then with respect your MDT peak sales, 1% to $3 billion.

Speaker Change: Thank you as a reminder, thats star one to be placed into the question queue. Our next question is coming from Vikram <unk> from Morgan Stanley. Your line is now live.

Speaker Change: Hey, guys. Thanks for taking our question. This is on for Vikram could you comment on your intended design of the Phase III study planned to initiate later this year for solar in this call and MDT with Etfs like how large of a study population do you anticipate and what do you see as the key endpoints here and lastly would this be the only additional.

Speaker Change: Thank you will be in a position to narrow that guide I'm just kind of wondering as you guys think about where you sit today.

Speaker Change: Maybe what are some of the key variables that push you to the high end of three versus maybe.

Speaker Change: The $1 billion peak sales range. Thanks.

Speaker Change: Trial required for potential approval.

Speaker Change: Sure as it relates to the MTV in eds indication.

Speaker Change: Thank you for the question.

Speaker Change: What we've done historically is disclosed the exact design of the studies once we launch them.

Speaker Change: In the study, which we completed we wanted to see if there was a signal and to ensure that.

Speaker Change: Now.

Speaker Change: We really like will be songs from EBA signal in this patient population that is patients with IBD and excessive sleepiness as a reminder, that represents probably around 50% of patients who have in BD. We will take all the learnings from the study will be completed as well as the learnings from other depression trials.

Speaker Change: We had great sensitivity as well as specificity, but importantly specificity, we defined the subgroup of patients with severe EES.

Speaker Change: Now if you look at patients who have eds with NPD is about 50% of the population.

Speaker Change: And in terms of the MDT peak sales potential of one to 3 billion that doesn't incorporate a lot of different variables on one of the things to watch is what the trajectory is of our current sales.

Speaker Change: Which we've conducted with our other products as we think about the design of this next study.

Speaker Change: And as we as we continue.

Speaker Change: Thank you. Our next question today is coming from Jason <unk> from Bank of America. Your line is now live.

Speaker Change: And as other aspects.

Speaker Change: Hey, good morning, Thanks for taking my questions.

Speaker Change: <unk>.

Speaker Change: We might be in a position to narrow guidance, but right now we feel that that is a very achievable.

Speaker Change: Just to follow up on the MDT Etfs opportunity just trying to get a sense of how confident you are that that really is half the MVD population.

Speaker Change: The range and certainly the low end of that.

Speaker Change: Given the subgroup was only 15% of the study population was there anything specific in the enrollment criteria that may be restricted the enrollment of ETS comorbid patient and then with respect your MDT peak sales, 1% to $3 billion. When you think you'll be in a position to narrow that guide I'm just kind of.

Speaker Change: He is very achievable.

Speaker Change: Thank you. Our next question today is coming from Joel Beatty from Baird. Your line is now live.

Yeah.

Speaker Change: Hello. Good morning. This is Chris on for Joe just a couple of questions on some Bravo how are you thinking about.

Speaker Change: About the <unk> data in February in terms of are you going to pursue that in a new indication of our label expansion and then is.

Speaker Change: Wondering as you guys think about where you sit today.

Speaker Change: Maybe what are some of the key variables that push you to the high end of three versus maybe.

Speaker Change: The $1 billion peak sales range. Thanks.

Speaker Change: Is the plan still to pursue some bravo.

Speaker Change: Sure as it relates to the MTV in eds indication.

Speaker Change: Expand the label as well in adolescence.

Speaker Change: In the study, which we completed we wanted to see if there was a signal and to ensure that we had great sensitivity specificity, but importantly specificity.

Speaker Change: Yes, thanks for the question.

The <unk> data in the emerge study, which we read out earlier this year, obviously very compelling data, we've been able to share in the market since since we.

Speaker Change: We define the subgroup of patients with severe EES.

Speaker Change: Now if you look at patients who have Etfs with NPD is about 50% of the population.

We received it and it is very clear that clinicians are motivated by that data as it gives them an additional phase two trials and Bravo once it is commercially available at this time.

And in terms of the <unk> peak sales potential of $1 billion to $3 billion that doesn't incorporate a lot of different variables on one of the things to watch is what the trajectory is of our current sales.

Speaker Change: Not.

Speaker Change: <unk> added to the label is a new indication, but we'll look to promoted through CFL guidance that the FDA puts for an obvious III, obviously through our medical affairs team in medical education.

And as.

Speaker Change: As we as we continue.

Speaker Change: Launch and as other aspects.

Speaker Change: <unk>.

Speaker Change: Might be in a position to narrow guidance, but right now we feel that that is a very achievable.

Speaker Change: I can take that last part on pediatric development that that work is underway.

Speaker Change: The range and certainly the low end of that.

As agreed to with the FDA, so stay tuned for updates there.

Speaker Change: <unk> is very achievable.

Joel Beatty: Thank you. Our next question today is coming from Joel Beatty from Baird. Your line is now live.

Speaker Change: Okay.

Speaker Change: Thanks.

Speaker Change: Okay.

Speaker Change: Thank you. Our next question today is coming from Greg <unk> from Mizuho Securities. Your line is now live.

Speaker Change: Hello. Good morning. This is Chris on for Joe just a couple of questions on some Bravo how are you thinking about.

Speaker Change: Hey, good morning, Congrats on the progress. Thanks for taking my question, maybe just a bigger picture question.

Speaker Change: About the <unk> data in February in terms of.

Speaker Change: Are you going to pursue that in a new indication of our label expansion and then is.

Speaker Change: On.

Speaker Change: Profitability or tantalizingly close to being a profitable company, given where you are in cash and kind of where cash has evolved over the last several quarters. Just any comments on whether you do think that profitability can be achieved in 2025 at least on a on a quarter basis. Thanks.

Speaker Change: Is the plan still to pursue some bravo.

Speaker Change: Expand the label as well in adolescence.

Speaker Change: Yeah, Thanks, Chris for the question.

Speaker Change: The <unk> data in the emerge study, which we read out earlier this year, obviously very compelling data, we've been able to share in the market since since we receive.

Speaker Change: Alright, Thanks, Greg.

Speaker Change: We haven't provided any guidance around timing, but we do remain confident that we'll get to cash flow positivity.

Speaker Change: With our current cash that is on hand.

Speaker Change: We received it and it is very clear that clinicians are motivated by that data as it gives them an additional place to to try and Bravo. Once it is commercially available at this time.

Speaker Change: We expect to see in 2025, leveraging our P&L.

Speaker Change: <unk> a bit in Q1 already as sales growth is outpacing our operating expenses and I think it's important we.

Speaker Change: Not <unk>.

Speaker Change: Bill asked though on a very disciplined approach in how we are investing in our operations and how we allocate across our portfolio on the R&D side. The vast majority of our investments today is in early stage pipeline late stage programs and where we expect the high rate of return on that investment and on the SG&A side.

Speaker Change: <unk> added to the label is a new indication, but we'll look to promote it through CFL guidance that the FDA puts for an obvious three obviously through our medical affairs team in medical education.

Speaker Change: I can take that last part on pediatric development that that work is underway.

Speaker Change: We built significant infrastructure over the past three years.

Initially sports are those and then ability and now providing operating leverage as we launch the Bravo sport.

Speaker Change: As agreed to with the FDA, so stay tuned for updates there.

Speaker Change: <unk> product launches so we.

Speaker Change: Okay.

Speaker Change: We believe that we kind of summarize that the current cash will take us to cash flow positivity, we haven't given any specific guidance around profitability Budd.

Speaker Change: Okay.

Speaker Change: Thank you. Our next question today is coming from Greg <unk> from Mizuho Securities. Your line is now live.

Speaker Change: We feel like we're on the on the right course.

Speaker Change: Hey, good morning, Congrats on the progress. Thanks for taking my question, maybe just a bigger picture question.

Speaker Change: And then maybe just as a quick follow up Nick.

Just on the evolution of your R&D and SG&A R&D did come down relative to the fourth quarter I don't know if do you expect that to be sustained in terms of where R&D is right now I would assume SG&A would tend to tick up higher but just if you could provide your comments there would be appreciated. Thanks.

Speaker Change: On.

Speaker Change: Yes sure.

Speaker Change: Yes, Youre right R&D did tick down a bit from Q4 388 trials were completed in Q4, and then the ADHD and NPV trials were completed mid quarter in Q1.

Speaker Change: Sure. Thanks, Thanks, Greg.

Speaker Change: We haven't provided any guidance around timing, but we do remain confident that we'll get to cash flow positivity.

Speaker Change: We would anticipate R&D spend to increase from the Q1 level as we initiate our second phase III for self installed and Pete ADHD and MPD with Etfs. Additionally, as a reminder, we did file the.

Speaker Change: With our current cash that is on hand were.

Speaker Change: We expect to see in 2025, leveraging our P&L.

Speaker Change: <unk> a bit in Q1 already as sales growth is outpacing our operating expenses and I think it's it's important we will act on a very disciplined approach in how we are investing in our operations and how we allocate across our portfolio on the R&D side. The vast majority of our investments today is in early stage pipeline.

Speaker Change: Yes.

Speaker Change: The NDA for <unk>.

Speaker Change: <unk> 14 in Q2, so we will have that filing fee.

Speaker Change: In Q2.

Speaker Change: And then as for as for SG&A, We do expect to see an increase versus Q1 as we complete our hiring for some Bravo team. The <unk> team. We did have in Q1, a partial quarter of leadership team.

Speaker Change: Stage programs, and where we expect the high rate of return on that investment and on the SG&A side we.

Speaker Change: Hired in Q2, we will also include a partial quarter of the sales team offers a bravo. So we would anticipate that to tick higher in Q2, and then as already talked about the DTC campaign later in the year.

Speaker Change: We built significant infrastructure over the past three years.

Speaker Change: Initially sports are those and then ability now providing operating leverage as we launch the Bravo for future product launches. So we.

Speaker Change: That will.

Speaker Change: We believe that.

Speaker Change: Further increase SG&A.

Speaker Change: We can.

Speaker Change: To summarize that the current cash will take us to cash flow positivity, we haven't given any specific guidance around profitability Budd.

Speaker Change: Thank you. Our next question today is coming from your teams from Asia from Guggenheim Partners. Your line is now live.

Speaker Change: We feel like we're on the on the right course.

Hey, guys. Thank you for taking my question.

Speaker Change: And then maybe just as a quick follow up Nick.

Speaker Change: Question is on the ADHD study that you had recently announced could you just talk about.

Speaker Change: Just on the evolution of your R&D and SG&A R&D did come down relative to the fourth quarter I don't know if do you expect that to be sustained in terms of where R&D is right now I would assume SG&A would tend to tick up higher but just if you could provide your comments there would be appreciated. Thanks.

Speaker Change: And the path forward there.

Speaker Change: Also I think at that time, and you know that there was some questions around that.

Speaker Change: Does that go.

Speaker Change: If you can just talk a little bit about why was that.

Speaker Change: Let me come back on the milligram dose.

Speaker Change: Yes sure.

Speaker Change: Yes, Youre right R&D did tick down a bit from Q4 388 trials were completed in Q <unk> Q4, and then the ADHD and MTV trials were completed mid quarter in Q1.

Speaker Change: Going forward.

Speaker Change: So that's one and then this one is on <unk>.

Speaker Change: That would be in terms of the covenant.

Speaker Change: So in terms of the coverage.

Speaker Change: The commercial side could you just talk about what is in Idaho.

Speaker Change: We would anticipate R&D spend to increase from the Q1 level as we initiate our second phase III for self installed and Pete ADHD and MPD with Eds. Additionally, as a reminder, we did file the.

Speaker Change: Thank you.

Speaker Change: I appreciate it thank you.

Speaker Change: Yes.

Speaker Change: The second question.

Speaker Change: Yeah.

Speaker Change: The NDA for <unk>.

Speaker Change: We were having some difficulty hearing you on the first one so maybe to just clarify.

Speaker Change: <unk> 14 in Q2, so we will have that filing fee.

Speaker Change: In Q2.

Speaker Change: And then as for as for SG&A, We do expect to see an increase versus Q1 as we complete our hiring for this and Bravo team. The <unk> team. We did have in Q1, a partial quarter of leadership team.

Speaker Change: B.

Speaker Change: Regarding coverage obviously, we've had this coverage has been stable over the last couple of quarters, but we have been actively negotiating and in communication with payers and so we expect we expect.

Speaker Change: Higher in Q2 will also include a partial quarter of the sales team offers a bravo. So we would anticipate that to tick higher in Q2, and then as already talked about the DTC campaign later in the year.

Speaker Change: The access to expand and evolve this year in terms of <unk>.

Speaker Change: Deal percent of covered lives, obviously, we want to secure as many covered lives as possible theres not a specific number that we have in mind, just ultimately really focused on improving access for patients. So that more patients have the opportunity for for coverage with their their health insurance plans.

Speaker Change: That will.

Speaker Change: Further increase SG&A.

Speaker Change: Thank you. Our next question today is coming from your teams from Asia from Guggenheim Partners. Your line is now live.

Speaker Change: Hey, guys. Thank you for taking my question.

Speaker Change: Question is on the ADHD study that you had recently announced could you just talk about you know what.

Speaker Change: As it relates to the first question for ADHD. The path forward is to initiate and complete the phase III trial in pediatric patients.

Speaker Change: The path forward.

Also at that time, and you know that there was some questions around the two of them.

Speaker Change: With regards to the adult study.

Speaker Change: Does that work.

Speaker Change: If you can just talk a little bit about.

Speaker Change: And the 300 milligram dose as a reminder.

Speaker Change: Why was that.

Speaker Change: <unk>, which is approved for <unk> in the 150 milligrams per day.

Speaker Change: And then come back on that number that goes.

Given that this was the first study that we're conducting in ADHD.

Speaker Change: Going forward.

Speaker Change: So that's one and then this one is.

Speaker Change: That would be in terms of the coverage.

Speaker Change: Did want to look at a higher dose just to make sure that we define what the dose response was.

Speaker Change: Thanks, Mike.

Speaker Change: And it comes with the coverage.

Speaker Change: The side could you just talk about what is and I don't know mark to reach at.

Speaker Change: Now the 150 milligram dose that was.

Primary dose of focus since that was the highest approved dose.

Speaker Change: Like a box or something to that.

Speaker Change: Thank you.

Speaker Change: Yeah.

Speaker Change: The results of the study, which showed a very clear treatment effect.

Speaker Change: Okay, Boston, Yes, I will start with the.

Speaker Change: The second question.

Speaker Change: For that dose.

Speaker Change: We were having some difficulty hearing you on the first one so maybe to just clarify but.

Speaker Change: Alright, thank you.

Speaker Change: My questions. Thanks.

Speaker Change: Thank you next question is coming from Myles Minter from William Blair. Your line is now live.

Speaker Change: The.

Regarding coverage obviously, we've had this coverage has been stable over the last couple of quarters, but we have been actively negotiating and in communication with payers and so we expect we expect to.

Speaker Change: Hey, Thanks for the questions. Congrats on the quarter I think on May 24th were expecting the Mac America healthy again commissions are released an initial report on prevalence and threat of Ssris antipsychotic Marine stabilizes stimulant, it's kind of a capsule and I think it's actually.

Speaker Change: The access to expand and evolve this year in terms of ideal percent of covered lives. Obviously, we want to secure as many covered lives as possible theres not a specific number that we have in mind, just ultimately really focused on improving access for patients so that more patients.

Speaker Change: <unk> focused on childhood diseases, but question is have you had sort of any interaction with the commission on that report as it pertains to validate a scenario.

Speaker Change: They kind of finalize it in August or do you expect to be able to comment on that one.

Speaker Change: And the opportunity for for coverage with their their health insurance plans right.

Speaker Change: First question. The second just on Narcolepsy I think a few of the Kols, who I've talked to are like look the efficacy for access 12 looks great on cataplexy. There's some other symptoms that looks interesting on as well, but in terms of the stimulant effects.

Speaker Change: As it relates to the first question for ADHD. The path forward is to initiate and complete the phase III trial in pediatric patients.

Speaker Change: With regards to the adult study.

Speaker Change: They're looking for like maintenance of Wakefulness test and I'm wondering whether you're going to have that data in the open label extension.

Speaker Change: And the 300 milligram dose in my mind was the top dose which is approved for <unk> in the 150 milligrams per day.

Speaker Change: Very much.

Speaker Change: Sure.

Speaker Change: Given that this was the first study that we're conducting in ADHD. We did want to look at a higher dose just to make sure that we define what the dose response was.

Speaker Change: With regard to the first question, we have not had any interactions with the commission.

Speaker Change: We're going to stay tuned just like everybody else to see what the outcomes are.

Speaker Change: Restate.

Speaker Change: Now the 150 milligram dose that was.

Speaker Change: As we make sure that we.

Speaker Change: Primary dose of focus since that was the highest approved dose we're very happy with the results of the study which showed a very clear treatment effect.

Speaker Change: Keep it up now and keeping your eye out for anything that comes out.

Speaker Change: Might affect the sector as it relates to.

Speaker Change: For that dose.

Speaker Change: Alright, Thank you my questions. Thanks.

Speaker Change: It is 12.

Speaker Change: So with regards to the <unk>, we have not incorporated BMW in our open label trial. So however, we have looked at excessive sleepiness as you know.

Speaker Change: Thank you next question is coming from Myles Minter from William Blair. Your line is now live.

Speaker Change: Yeah.

Myles Minter: Hey, thanks for the questions congrats on the quarter.

Speaker Change: So using other measures, including the clinical global impression of severity.

Speaker Change: On may 24th were expecting the Mac America healthy again Commission, Sir relates to an initial report on prevalence and Fred of Ssris antipsychotic Marine stabilizes stimulant, it's kind of a catch all and I think it's actually maybe focused on childhood.

Speaker Change: Alright, thank you.

Speaker Change: Thank you next question today is coming from Cory Lankford from TD Cowen. Your line is now live.

Cory Lankford: Hi, guys. Thanks for taking our questions and congrats on all the progress this quarter just one on Sanofi in ADHD just.

Speaker Change: But question is have you had sort of any interaction with the commission on that report as it pertains to <unk> and I think they are going to finalize it in August sorry, do you expect to be able to comment on that one.

Cory Lankford: Just given the level of efficacy that we saw on the phase three agencies say not too long ago. Do you have any reason to believe that the phase III pediatric study will show a substantially different level of benefit and then just a follow on to that do you all have any expectations for approximately how long that pediatric study could take.

Speaker Change: First question. The second just on Narcolepsy I think a few of the Kols have talked to I like look the efficacy.

Speaker Change: That's 12 looks great on cataplexy, there's some other symptoms that looks interesting on as well, but in terms of the stimulant effects that theyre looking for like maintenance of wakefulness test and I'm wondering whether you're going to have that data in the open label extension. Thanks very much.

Cory Lankford: What we know is that historically there has been a correlation between efficacy for ADHD.

Speaker Change: Sure.

Cory Lankford: In adults as well as <unk> in pediatric subjects. So we like the fact that we have now seen a clear effect you don't population.

Speaker Change: With regard to the first question, we have not had any interactions with the commission.

Speaker Change: We're going to stay tune just like everybody else to see what the outcomes are.

Cory Lankford: However.

Cory Lankford: We need to conduct the study in pediatric patients.

Speaker Change: Right.

Speaker Change: Hum.

Speaker Change: As we make sure that we.

Cory Lankford: And then in terms of the.

Speaker Change: Keeping up and keeping your eye out for anything that comes out that might affect the sector as it relates to.

Cory Lankford:

Cory Lankford: How long it would take too.

Cory Lankford: To enroll that study and conducted its premature so what we'll do is we'll provide some guidance generally speaking once we launch the study and talk about the exact design.

Speaker Change: <unk> 12.

Speaker Change: So with regards to the BMW <unk>.

Speaker Change: Have not incorporated.

Speaker Change: WT in our open label trial. So however, we have looked at excessive sleepiness as you know using other measures, including the clinical global impression of severity.

Speaker Change: Thank you. Our final question today is coming from Amit <unk> from Needham <unk> Company. Your line is now live.

Amit: Hi, Thanks for taking me and taking my question, just maybe stepping back with.

Speaker Change: Yeah.

Speaker Change: Alright, thank you.

Amit: A lot of your assets in late stage or in market.

Speaker Change: Thank you next question today is coming from Cory Lankford from TD Cowen. Your line is now live.

Amit: Can you talk about how you're managing the business in terms of.

Cory Lankford: Hi, guys. Thanks for taking our questions and congrats on all the progress this quarter just one on Sanofi in ADHD.

Amit: Operating margins and investing across these various assets relative to also exploring potentially.

Speaker Change: The level of efficacy that we saw in the phase III ADHD study not too long ago do you have any reason to believe that the phase III pediatric study will show a substantially different level of benefit and then just a follow on to that do you all have any expectations for approximately how long that pediatric study could take.

Amit: Digging in any additional assets and.

Amit: How do we think about what would be sort of that return on investment decision that you make.

Amit: And then driving into kind of that box to profitability. Thank you.

Amit: Sure. Thanks, Thanks Tommy.

Speaker Change: What we know is that historically there has been a correlation between efficacy for ADHD.

Amit: As I mentioned earlier in my comments.

Amit: Out of our focus.

Amit: A lot of the R&D spend is on late stage <unk>.

Amit: Programs and that has a high pass and a high rate of return.

Speaker Change: In adults as well as <unk> in pediatric subjects. So we like the fact that we have now seen a clear effect.

Amit: So we continue to invest in that.

Speaker Change: Don't population however.

Amit: As I mentioned R&D was slightly down for the quarter versus Q4, both continue to invest in.

Speaker Change: We need to conduct the study in pediatric patients.

Amit: In developing those late stage programs and the infrastructure that we have built over the last three years, specifically, starting with Sanofi and.

Speaker Change: And then in terms of the.

Speaker Change: <unk>.

Speaker Change: How long it would take too.

Speaker Change: To enroll that study and conducted its premature so what we do is we will provide some guidance generally speaking once we launched the study and talk about the exact design.

Amit: Then with the launch of ability, we are able to leverage that infrastructure.

Amit: All of our future programs.

Amit: <unk>.

Amit: We believe that from that perspective.

Speaker Change: Thank you. Our final question today is coming from Amit <unk> from Needham <unk> Company. Your line is now live.

Amit: These programs will have a higher ROI.

Amit: Thank you we've reached end of our question and answer session I'd like to turn the floor back over for any further or closing comments.

Speaker Change: Hi, Thanks for taking me and taking my question, just maybe stepping back with.

Speaker Change: Okay, well. Thank you all for taking the time to join today's call.

Speaker Change: A lot of your assets in late stage or in market.

Speaker Change: As you've heard today axon has accomplished a great deal in the first quarter.

Speaker Change: Can you talk about how you're managing the business in terms of.

Speaker Change: We are poised to deliver another impactful year, driven by strong commercial execution with rapidly expanding portfolio and multiple upcoming milestones.

Speaker Change: Operating margins and investing across these various assets relative to also exploring potentially.

Speaker Change: Thinking in any additional assets and.

Speaker Change: Received your continued interest and support as we continue our work to bring innovative new treatment options to patients.

How do we think about what would be sort of that return on investment decision that you make.

Speaker Change: <unk> long term value for our shareholders. Thank you very much.

Speaker Change: And then driving into kind of that box to profitability. Thank you.

Speaker Change: Thank you that does conclude today's teleconference and webcast you may disconnect. Your lines at this time and have a wonderful day, we thank you for your participation today.

Speaker Change: Sure. Thanks, Thanks Tommy.

Speaker Change: As I mentioned earlier in my comments.

Speaker Change: Lot of our focus.

Speaker Change: The R&D spend is on late stage.

Speaker Change: Programs and that has a high pass and a high rate of return.

Speaker Change: So we continue to invest in that.

Speaker Change: You mentioned R&D was slightly down for the quarter versus Q4, both continue to invest in developing those late stage programs and the infrastructure that we have built over the last three years, specifically, starting with Sanofi and.

Speaker Change: And then with the launch of Fidelity, we're able to leverage that infrastructure.

Speaker Change: All of our future programs.

Speaker Change: We believe that from that perspective that those programs will have a higher rmi.

Speaker Change: Thank you we've reached end of our question and answer session I'd like to turn the floor back over for any further or closing comments.

Speaker Change: Okay, well. Thank you all for taking the time to join today's call as you've heard today axon has accomplished a great deal in the first quarter.

Speaker Change: We are poised to deliver another impactful year, driven by strong commercial execution with rapidly expanding portfolio and multiple upcoming milestones. We appreciate your continued interest and support as we continue our work to bring innovative new treatment options to patients.

<unk> long term value for our shareholders. Thank you very much.

Speaker Change: Thank you that does conclude today's teleconference and webcast you may disconnect. Your line at this time and have a wonderful day.

Speaker Change: Thank you for your participation today.

Speaker Change: Yeah.

Q1 2025 Axsome Therapeutics Inc Earnings Call

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