Q4 2023 Axsome Therapeutics Inc Earnings Call
Participants
Mark Jacobson; COO & Secretary; Axsome Therapeutics, Inc.
Herriot Tabuteau; Founder, Chairman, CEO & President; Axsome Therapeutics, Inc.
Nick Pizzie; CFO; Axsome Therapeutics, Inc.
Ari Maizel; Executive VP and Head of Commercial; Axsome Therapeutics, Inc.
Charles Duncan; Analyst; Cantor Fitzgerald & Co.
Ash Verma; Analyst; UBS
Jason Gerberry; Analyst; BofA Securities
David Amsellem; Analyst; Piper Sandler & Co.
Joseph Thome; Analyst; TD Cowen
Marc Goodman; Analyst; Leerink Partners
Graig Suvannavejh; Analyst; Mizuho Securities USA LLC
David Holmes; Analyst; Citigroup
Myles Minter; Analyst; William Blair & Company L.L.C.
Matthew Kaplan; Analyst; Ladenburg Thalmann & Co. Inc.
Vikram Purohit; Analyst; Morgan Stanley
Presentation
Operator
Hello, and welcome to the Axsome Therapeutics Fourth Quarter and Full Year 2023 Conference Call and Webcast. (Operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to turn the call over to Chief Operating Officer, Mark Jacobson. Please go ahead, sir.
Mark Jacobson
Good morning and thank you all for joining us on today's conference call. This morning we issued our earnings press release, providing a corporate update and details of the company's financial results for the fourth quarter and full year of 2023.
The release crossed the wire a short time ago and is available on our website at axsome.com. During today's call, we will be making certain forward-looking statements. These statements may include statements regarding, among other things, the efficacy, safety and intended utilization of our investigational agents.
Our clinical and nonclinical plans, our plans to present or report additional data, the anticipated conduct and the source of future clinical trials, regulatory plans, future research and development plans. Our commercial plans regarding Symbility mobility and our pipeline products, revenue projections and possible intended use of cash and investments. These forward-looking statements are based on current information assumptions and expectations 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.
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 place undue reliance on these forward-looking statements, which are only made as of today's date and the Company disclaims any obligation to update such statements.
Joining me on the call today are Dr. Herriot Tabuteau, Chief Executive Officer; Nick Pizzie, Chief Financial Officer; and Ari Maizel, Executive Vice President and Head of Commercial; Herriot will provide an overview of the Company and progress made in the fourth quarter of 2023 as well as key upcoming milestones following Herriot, Nick will review our financial results. Then Ari will provide a commercial update. We will then open the line for questions through questions will be taken in the order they are received.
And with that, I will turn the call over to Herriot.
Herriot Tabuteau
Thank you, Mark. Good morning, everyone, and thank you for joining Axsome Therapeutics Fourth Quarter and Year End 2023 financial results and business update conference call. 2023 was another strong year for Axel built on focused commercial execution for our first in class marketing products and continued advancement and expansion of our industry-leading neuroscience pipeline during our first full year as a commercial company mobility, our first in class oral NMDA receptor antagonist and sigma-1 receptor agonist for depression and Sunosi, our DNRI.s and colon agonist for excessive daytime sleepiness generated combined net product revenue of approximately $205 million. We expect continued revenue growth in 2024, aided by our completed sales force expansion for ABILITY and increasing awareness of our differentiated products. Later in the call, Nick will provide details on our quarterly financials and already will provide additional information on our commercial performance during 2023.
Our innovative development pipeline also progressed and expanded. We made solid progress in the preparation of our NDA for excess of seven in migraine and FS14. In fibromyalgia, we advanced our Phase 3 trials and the excess 12 in narcolepsy in excess of five in Alzheimer's disease agitation. We initiated a Phase three trial program. Solriamfetol in each team announced three additional new indications for solriamfetol.
This progress positions us to deliver on multiple potentially value-driving milestones throughout 2024. I will provide a brief update on our industry leading neuroscience pipeline and expected milestones. Starting with our two NDA stage products. Excess of seven for the acute treatment of migraine is on track for an NDA resubmission in the first half of 2024. The NDA submission for AXS-14 for the management of fibromyalgia is also tracking for submission in the second quarter of 2024.
Now moving on to our late-stage clinical programs. We have completed enrollment in the Phase three Symphony trial of AXS-12 for the treatment of narcolepsy, and we are on track to report top line results for Symphony during the first quarter for Aircastle five Phase 3 advance two trial in the treatment of Alzheimer's disease agitation is tracking for completion in the second half of 2024 based on anticipated enrollment trends in a recent treatment market dynamic.
Turning to solriamfetol, the active molecule in Sunosi in December, we held an Investor Day event where physician experts provided the scientific and clinical rationale underlying the exploration of solriamfetol in new targeted indications, including major depressive disorder, binge eating disorder and shift work disorder we expect to initiate Phase three trials in each of these mutations in the first quarter. These new trials complement the ongoing Phase three FOCUS trial of solriamfetol in adults with ADHD focus tracking for top line results in the second half of 2024.
Overall, our development portfolio encompasses five innovative late-stage patent-protected product candidates for 10 serious psychiatric and neurologic conditions if successfully developed these investigational medicines have the potential to transform the treatment landscape serious and difficult to treat CNS disorders, which affect more than 150 million people in the US alone.
I will now turn the call to Nick. He will provide details of our financial performance.
Nick Pizzie
Thank you, Herriot, and good morning. Today we'll discuss our fourth quarter and full year results and provide some financial guidance. Total product revenues were $71.5 million and $204.9 million for the fourth quarter and full year of 2023, representing year-over-year growth of 193% and 309% respectively.
This consisted of net product sales of $70.7 million and $202.5 million for the fourth quarter and full year of 2023 and royalty revenue of $800,000 and $2.4 million, respectively. Total product revenues for the comparable periods in 2022 were $24.4 million and $50 million total revenue for the full year of 2023 was $270.6 million, which includes license revenue of $65.7 million from out-licensing Sunosi in certain ex-US territories.
Availity net product sales were $49 million and $130.1 million for the fourth quarter and full year of 2023, respectively, representing the first full year of commercialization for Availity. Availity was launched on October 19, 2022, and had US net sales of $5.2 million for the fourth quarter of 2022. Sunosi net product revenues were $22.5 million and $74.8 million for the fourth quarter and full year of 2023, representing 17% at 67% year-over-year growth, respectively, consisting of $21.7 million and $72.4 million in net product sales of $800,000 and $2.4 million in royalty revenue associated with Sunosi sales in our licensed territories, respectively.
Sunosi net sales for the comparable periods in 2022 were $19.2 million and $44.9 million total Sunosi revenue for the full year of 2023 was $140.5 million, which includes license revenue of $65.7 million from out-licensing Sunosi in certain ex-US territories. Total cost of revenues were $7.4 million and $26.1 million for the fourth quarter and full year of 2023.
Total cost of revenue for the comparable periods in 2022 were $2.3 million and $5.2 million total cost of revenue for the full year of 2023 includes a one-time cost of $5 million associated with the revenue received on out-licensing Sunosi in certain ex-US territories.
Research and development expenses were $30.8 million and $97.9 million for the fourth quarter and full year of 2023 prospectively compared to $14.7 million and $57.9 million for the comparable periods in 2022. The increase was primarily related to the focus trial of solriamfetol in ADHD, the advancement of ongoing trials of a excess of five and AXS-12 manufacturing costs associated with the anticipated NDA for AXS-07 AXS-14 post-marketing commitments are both ability and Sunosi and higher personnel costs, including non-cash stock-based compensation.
Selling, general and administrative expenses were $86.8 million and $323.1 million for the fourth quarter and full year of 2023 respectively, compared to $61.5 million and $159.3 million for the comparable periods in 2022. The increase was primarily related to commercialization activities for Availity and Sunosi, including sales force and marketing expenses and higher personnel costs related to organizational growth, including noncash stock-based compensation.
Net loss for the fourth quarter of 2023 was $98.7 million, or $2.8 per share compared to a net loss of $61.2 million or $1.41 per share for the comparable period in 2022 net loss in the fourth quarter of 2023 includes $63.7 million in noncash charges, comprised of $43.2 million in acquisition related contingent consideration expense reflecting our updated sales projections.
We've recently announced new indications for sorry, EBITDA of $18.9 million for non-cash stock-based compensation expense and $1.6 million of non-cash intangible asset amortization, net loss was $239.2 million or $5.27 per share for the full year of 2023, compared to a net loss of one $187.1 million or $4.60 per share for the full year of 2022.
The net loss for the full year includes total noncash charges of $117.9 million, which includes $62.6 million of stock compensation expense, $48.9 million in fair value of contingent consideration expense at $6.4 million in intangible amortization compared to $37.7 million, $3.3 million and $4.1 million, respectively. For the full year of 2022.
Availity and Sunosi GTN discount in Q4 of 2023 were both approximately 50%. Q1 typically has a negative seasonality effect on GTN. As a reminder, the GTN discount for Availity in Q1 of 2023 was in the high to upper 50s and in the mid-50s for Sunosi due to the seasonal Q1 GTN Dynepo. We would therefore expect a similar GTN in Q1 of 2024 for both products. We ended 2023 with $386.2 million in cash and cash equivalents compared to $200.8 million at December 31, 2022. We believe that our current cash balance is sufficient to fund anticipated operations into cash flow positivity based on the current operating plan.
I would now like to turn the call over to Ari, we'll provide a commercial update.
Ari Maizel
Thank you, Nick Axsome completed our first full year as a commercial company by delivering strong performance for both of our on-market products. Starting with mobility in the fourth quarter, approximately 84,000 prescriptions were written for mobility, representing 23% quarter over quarter growth.
This performance contrasts with the decline of 1% for the overall antidepressant market during the same period Additionally, nearly 17,000 new patients started our ability in the quarter, bringing the total number of unique patients treated with mobility since launch to approximately 71,000 in the fourth quarter, more than 3,500 first-time mobility prescribers were activated by our sales team, increasing the cumulative total number of prescribers since launch to nearly 17,000 payer coverage was stable in Q4 as our ability to remain accessible to patients representing approximately 70% of covered lives.
We continue to progress in conversations with major plans and PBMs across all channels. As we pursue access improvements for patients. Our ability performance in the quarter was primarily driven by specialists in psychiatry practices with both psychiatry MDs and nurse practitioners and physicians' assistants or NPPA. is contributing to robust growth in the quarter and over the course of 2023.
In addition, we observed meaningful traction within the primary care segment among both MDs and TPAs as the early impact from our recent sales force expansion began to take hold with increased call activity in primary care offices in a recent survey of providers in psychiatry and primary care who treat a significant proportion of depression patients.
Key drivers of mobility prescribing cited by respondents include rapid onset of action and low impact on weight gain and sexual dysfunction. In addition, adopters note the positive impact our ability has demonstrated on day-to-day patient functioning and its improvements in patient perceptions of quality of life.
Axsome has established a strong commercial foundation to support continued mobility growth in 2024 with approximately 260 sales representatives calling on 44,000 health care providers and continued investment in our industry leading digital centric commercialization platform.
We are well positioned to accelerate our education and awareness objectives across the predominant depression treaters in the US and enhance brand story for 2024 has been created to augment provider perceptions of mobility and is anchored on our ability of key attributes, ability of the rapid-acting antidepressant that works best in class with the rapid symptom improvement observed at week one, substantial symptom improvement observed at week two and both sustained and substantial symptom improvement observed at week six.
Mobility has a well-established safety and tolerability profile that includes a low impact on weight and sexual dysfunction and no risk of movement disorders or extra parameters symptoms further, our ability is the only oral antidepressant that modulates both glutamatergic and mono immunologic pathways.
A key point of consideration as the role of glutamate in depression is increasingly understood and accepted across the clinician landscape. We are very optimistic about our abilities growth prospects in 2024 and its long term blockbuster potential. Transitioning now to denoting. Total prescriptions were just over 42,000, representing 2% sequential quarterly growth and 18% growth versus Q4 2022 to approximately 3,600 new patients started Sunosi treatment during the quarter, bringing the total number of unique patients treated with Sunosi to 65,000 since launch.
Although excessive daytime sleepiness is a smaller market with a more limited prescriber base, we continue to activate new prescribers, including more than 400 during the fourth quarter alone for a total cumulative prescriber base of more than 12,000 since launch.
The field team is focused on communicating the needed urgency to treat excessive daytime sleepiness symptom in obstructive sleep apnea and narcolepsy with disproportionate focus on the nearly 2,000 active weekly prescribers in this space. Payer coverage for Sunosi was consistent in Q4 with a total of 83% of lives covered across all channels in a recent survey of Sunosi adopters. Key attributes driving demand for the product cited by respondents include significant and sustained impact on the Epworth Sleepiness Scale, a market-leading nine plus hours of wakefulness observed in Phase 3 clinical trials and significant improvement in patient reported outcomes at week 12. We are very proud of our commercial effort for Sunosi and expect continued growth in 2024.
In closing, Axsome deliver compelling commercial performance in Q4 2023 as the optimization of our commercial infrastructure took shape, and we completed our first full year as a commercial company. Anecdotal feedback from providers and patients continues to reinforce our belief that our ability and Sunosi our unique and differentiated treatment options in their respective indications and supports our growing confidence that Exxon is reshaping the treatment landscape for CNS conditions.
I will now turn the call back to Mark for Q&A.
Mark Jacobson
Thank you, Ari. Operator, may we please have our first question.
Question and Answer Session
Operator
(Operator Instructions) Leo [Kamenetskiy], RBC Capital Markets.
Thanks for taking my question. Maybe I'll start off with a question on the advanced two readout. I guess, can you maybe provide a little bit more color on what drove the slip in time lines. I guess what's driving the slower recruitment? Is there any reflection on the potential market opportunity from that?
And any risks to trial integrity, especially as standard of care evolves?
Herriot Tabuteau
Well, thank you for that question. I think the second part of your question, which is the evolving nature of the standard of care, that's really what is driving this. And this is an indication that we're really excited about, and we did want to take into account the recent launch of brexpiprazole and any potential impact that could have an enrollment.
As a reminder, brexpiprazole is the first drug that is approved in this indication. So our internal analytics team has been monitoring very closely. The prescription trends and what we've seen is a clear inflection in prescribing, which we attribute to that new indication. So our revised guidance incorporates this new information. Having said that, we're confident that we should be able to deliver data this year are any further comments about the evolving treatment landscape of Embrex?
Yes, I would just say to related to the French protocol increase, we're seeing a substantial increase across the Medicare channel which we tied directly to the MI indication. But I think this is also really positive news ranked us oh five. Clearly, there's significant unmet treatment need, and that gives us great confidence for the future with a sequencer.
Got it. Thanks thank you.
Operator
(Operator Instructions) Charles Duncan, Cantor Fitzgerald.
Charles Duncan
Yeah, morning, Herriot and team, congrats on a great year of commercialization. I did want to follow up on a question on access oh five, but first, with regard to our commercial performance for ability I'm wondering if you can provide any sense of persistence. I know it may be a little bit too long, but you mentioned for the branding, you know, a vast and in terms of activity. I'm wondering what you can see in terms of kind of refills and patients staying on drug.
Herriot Tabuteau
Thanks for the question, Charles.
It's still a little too early to share any information on persistent persistency and adherence. What I will say is the feedback we're receiving from patients and clinicians suggests that clinical profile from Phase three is holding up in the real world. So we expect to generate additional data in the future. But for now, just let me say that what we're seeing in the real world is reflective of the Phase 3 clinical trial results.
Charles Duncan
Okay, that's helpful. And if I could follow on to the last question regarding certain AXS oh five in advance two, I'm wondering if you have any changed our perspective on the probability of success given Otsuka's 76 data recently? And then also in terms of the open-label extension, are patients enrolling into that? And how does that appear to be going? Maybe?
Herriot Tabuteau
Yeah, Thanks for the question, Charles. With regards to the full sugar readout, we don't think that that has a meaningful read through to our products. Now we watch any data readout or any development in the space for any potential learnings to our clinical development.
However, we think that the best data to look at. And when you're thinking about the potential that exists, we'll find in Alzheimer's disease agitation is the data that we've generated with our own product. And as a reminder that we have now completed two Phase three trials, which were placebo-controlled, both of which had positive results. So we think that that is inflammation, which is more relevant than inflammation with other molecules and the and if you view that and try to take it one step down and actually look at the products themselves, they are different molecules entirely. So our EBIT establish.
As a reminder, deuterium modified dextromethorphan, whereas excess alpha gal operates a nonmaterial modified dextromethorphan and the inhibitors also have different. So we used an immune keto and these quality. So what so very different as it relates to the open label safety extension trial that is going well and the vast majority of patients who are rolling out of our advance two trial are opting to go into the open-label safety extension. And we think that that is a good indicator of how the caregivers are thinking about the product.
Charles Duncan
Okay, very good, thanks for the added color area. I'll hop back in the queue.
Operator
(Operator Instructions) Ash Verma, UBS.
Ari Maizel
Your line is now live and thanks for taking our questions.
Mark Jacobson
I had to vote on AD agitation. So maybe just on the of the advance two study, are you trying to recruit, though naive patient to treatment? And that's why you want to kind of exclude anyone who has started therapy on Rexulti? That's the first one.
And then second one is just fast-forwarding to when you I assume that this would come to the market, would you need to primarily focus on the long-term care facilities where a lot of these patients broadly reside? And just curious what type of sales footprint that might require versus I think the DCC platform is kind of more draw like footprint?
Herriot Tabuteau
So thank you for the question. The answer is yes, we are recruiting primarily naive patients and down, and we wouldn't want to exclude folks more on Rexulti for obvious reasons. And then business, our revised guidance does take into account any potential impact on losing patients could because now patients do have a treatment option which is approved. And in terms of bomb long-term care facilities, our studies thus far have been conducted in the community setting. We think that that's where the majority of patients reside who have this indication pending.
One of the things that we're most excited about as it relates to the profile of episode five and while diverse disease agitation is that it could potentially keep patients out of long-term care facilities. In other words, keep them at home with their loved ones.
Ash Verma
Thank you.
Charles Duncan
(Operator Instructions) Joon Lee, Truist Securities.
This is us and one for Joon to entertain the questions. I was wondering if you could comment on what the breakdown of patients on ability currently is around what percent are first line? And then also just want to clarify, is the expanded sales force fully online now and can you comment on if you think current TRx trends are reflective of the full 250 person sales force?
Okay. Thanks.
Herriot Tabuteau
I'll turn it over to Ari.
Ari Maizel
Thanks, for the question and so we are seeing a meaningful improvement in terms of earlier line treatment over the course of 2023, we saw meaningful increases in the first and second line treatment every quarter. And so today, there's roughly a 40% to 50% of patients receiving mobility in the first or second line setting. And we expect that trend to continue over time.
Regarding your sales force expansion question, we are fully complete with the expansion and we hired the additional representatives at the end of last year, completed training in January of this year, and we're starting to see meaningful impact in terms of call activity. In particular, we're seeing increased proportionally of calls to the primary care segment. We would expect the TRx and NBRx trends to continue to increase over the course of the year. And there will be a ramp up beginning in Q1. And so more details to come, but we are very pleased with the increase field force effort post expansion.
Thank you.
Charles Duncan
(Operator Instructions) Jason Gerberry from Bank of America.
Jason Gerberry
Good morning. Thanks for taking my questions. And just wanted to follow up on the EDA enrollment dynamic with Rexulti. I guess when we look at growth of this brand and a TRx basis, that inflection doesn't seem obvious.
So I'm wondering if it we should be looking at a different metric you on to gauge that inflection point as patient enrollment forms or claims, but dumb, given that the massive market, I'm a little surprised that given the TRX move that we've seen that it's been characterized as an inflection and then is the expectation still that you get both long-term safety and efficacy data in second half and then you'd be able to file in second half. Just wondering if the filing time line is still on track? Thanks.
Mark Jacobson
I think thanks for the question. I we have not given guidance on filing. So that's going to be determined by the completion of our long-term safety extension trial. That's the gating factor there. And with regards to what we're seeing from our internal analytics team on Rexulti, I'll alternative or yes, thanks, Jason.
Ari Maizel
And my suggestion and what we've been looking at a claims-based data now by payer channel. And our observation is that our breadth of RESOLVE is increasing significantly within the Medicare channel. So that is what we I attribute the growth to the IDA indication, too.
Jason Gerberry
Okay. Thank you.
Operator
(Operator Instructions) David Amsellem, Piper Sandler.
David Amsellem
I'm a bank So just a couple. First on AD agitation. Can you talk about the potential for branding it differently from Availity and pricing it differently, just given that it's a Medicare Part D market and obviously difference from the depression landscape. So that's number one.
And number two, couple just on reboxetine. One, can you talk about the time line to an NDA and gating factors beyond the study to an NDA filing in narcolepsy cataplexy? And then how are you thinking about pricing in that market? You've done on one end of the spectrum pitolisant and on the other end of the spectrum solriamfetol in narcolepsy. So how are you thinking about that?
Thank you.
Herriot Tabuteau
Sure. So a couple of questions there around branding and pricing for both products. And you know that I'll let Ari provide some color on how we're thinking about those two things, right. I will preview it by saying that obviously we're thinking about it what we will do there and what our options are, and we would not be able to comment too much until we make a final determination.
And as it relates to what if it's the 12 in narcolepsy and the NDA timing, the gating factor there will be our long-term safety extension trial. So we are we're monitoring that, but that is enrolling and so we need to complete that and have that readout. So in order to complete our package for the NDA.
Ari Maizel
Yes. Thanks for the question. Regarding the branding and pricing dynamics for assets so buys, we're currently performing an analysis to better understand the potential impact of having the same brand or different brands. And there are a lot of considerations that will go into it, including ensuring clarity around patient dosing administration and potential halo effect associated with multiple indications. And the fact that there is no co-morbid depression in roughly 40% of Alzheimer's patients. So there are a lot of considerations and we'll share more details in the future.
And regarding the reduction in pricing, that's another area of analysis that we're currently exploring. We'll share additional details in the future.
David Amsellem
Thank you.
Operator
(Operator Instructions) Joseph Thome, TD Cowen.
Joseph Thome
Good morning and thank you for taking my questions. Maybe the first one on AXS-12. I know that a controlled study is really powered for cataplexy, and it's a little unclear if we're going to actually get the sleepiness score is, but can you can you talked a little bit? And from a commission perspective, is it important to also see a signal on sleepiness in addition to cataplexy or kind of can you come in with another therapeutic like Sunosi data to address the sleepiness component?
And then second, on Sunosi in MDD, how should be thinking about it time lines to data on that.
If I remember, Gemini took about six months from first patient dose to actually seeing data.
So is it possible that we could see Sunosi MDD data this year or what are kind of the main differences between Gemini in this study that would that would make that potentially not the case B.
Thank you.
Herriot Tabuteau
Fair enough thanks for the questions. With regards to AXS-12, we're very close to a data readout. So we'll refrain from making any comments around that. Look, we're so close and we'll know very soon what the profile is in the Phase 3 trials.
Now we do think that the product should have a favorable placement in the treatment paradigm that complements solriamfetol and other treatment options and we're looking forward to the data readout because that will provide us in the first Phase three data to complement the Phase two data that we've generated thus far. And in terms of on Sunosi with regards to INDD., we'll have more to say about that. Hopefully, once we announced enrollment of the first patient in that study, that remains on track to start to this quarter.
Joseph Thome
Okay thank you.
Operator
(Operator Instructions) Marc Goodman, Leerink Partners.
Marc Goodman
Good morning. And Nick, can you talk about how we're thinking about spending this year? And then secondly, you talk about how you have enough cash to get to cash flow positivity. Can you give us a sense of when that is?
And then Nam?
Secondly, Aereo, are you willing to give us a sense of what percent of the AD agitation study is enrolled? Are you 50% 60%, 70%? Maybe you can give us a sense of that because.
Herriot Tabuteau
Sure, yes.
Thanks, Marc. As for S R & D expense for the quarter was $31 million, just under $31 million for Q4. It ticked up slightly from the previous quarter. We expect R&D expense to increase gradually as solriamfetol Phase three trials commence during the year. This increase will also be offset though by lower clinical costs as Symphony advanced two and FOCUS trials complete in 2024 and also once AXS-14 in excess of seven ANDAs are filed.
As for the SG&A line, total expense for the quarter was just under $87 million. That was also a slight increase from the previous quarter. As you know, as we as we mentioned, the biggest increase in SG&A was due to the sales force expansion, which took place throughout Q4, Tom had that expansion occurred throughout the quarter. Roughly half of the quarter's expense for that expansion was realized in Q4.
So we would expect a slight increase in Q1 as we will realize the full burden of that expansion. So and then from a cash flow positivity and profitability, where we are still at the early stages of the launch and a bit more than a year removed from the acquisition of Sunosi. We've modeled various scenarios. And based on that, based on the success that we've had thus far, we feel very confident of our ability to be cash flow positive. And as you are aware, the launch is by nature, very volatile. And as such, we haven't provided any guidance on specific time line for cash flow positivity. Ari you do you want to signal Express?
Ari Maizel
Yeah thanks, Mark. For the other question, we haven't provided the specific percentage enrollment in our trials lately. However, well, Ueli agitation, we're confident that we should be able to have results this year.
Marc Goodman
Okay.
Operator
(Operator Instructions) Graig Suvannavejh, Mizuho Securities.
Graig Suvannavejh
Okay, great.
Thanks.
So sorry, but congrats on the quarter. Just two questions. One, just can you comment on the mobility DTC. efforts and any thoughts around how that effort might evolve in 2024 and your level of satisfaction with what you've done so far and what's needed on a go-forward basis?
And then secondly, just in the as we think about the potential of solriamfetol in MDD. Could you just remind us on how we should think about the differential positioning of that product with reality?
Thanks.
Ari Maizel
Great. Thanks so much, Ari, and I appreciate the question. As you know, we do have a DTC effort today, largely focused on digital engagement. We've been very pleased with that investment so far from what we observed through market research is nearly eight in 10 patients who ask for our ability to receive it. And so we're very optimistic about continued investment in consumer advertising, but we are assessing additional investments at the moment.
And so we would expect to share some updates later in the year based on whether we intend to increase the investment around consumer advertising and as it relates to solriamfetol in MPD. As, MDD is a highly heterogeneous condition.
Not all patients respond to the same types of treatments and because there are overlapping symptoms with other illnesses in particular symptoms that may be more difficult for some patients than others. There's usually room for multiple treatment options to help these patients. And so until we have more data around solriamfetol and MTV. It's a little premature to talk about Coke positioning with our ability based on our experience in this space. We do believe that there will be opportunities for both products and two to help patients achieve meaningful symptom relief.
Graig Suvannavejh
Thank you.
Operator
(Operator Instructions) David Holmes, Citigroup.
David Holmes
Thanks.
Good morning, and thanks for taking the questions and congrats on the quarter.
And so maybe just two from me.
First on ABILITY, could you provide any color on your ongoing payer discussions and the commercial channel and expectations to improve the coverage there above the current, I think 48% or so covered lives.
And then regarding solriamfetol in ADHD, once the results of the FOCUS study are in hand, what else would be needed to proceed to an NDA filing there if those results are positive?
Thanks.
Ari Maizel
So we'll take the questions in reverse order for solriamfetol, the focused studies in adults, and we will be launching a Phase three trial in the pediatric populations of both of those studies. Both of those are patient populations are needed for an NDA filing?
Herriot Tabuteau
Yeah and related to that, the payer discussions, as you mentioned, we have roughly 40% coverage in commercial channels, 70% overall across channels. And the way we think about the payer dynamics is we are taking a very disciplined approach to contracting to preserve long-term profitability for our product. However, we do anticipate expanding coverage over time and remain actively engaged with health insurers to improve access for insured patients. And I will mention that our current investments in both patient savings programs as well as reimbursement services will support continued prescription growth at current levels of coverage, which, as I mentioned before, means 70% of lives for mobility.
David Holmes
Thank you.
Operator
(Operator Instructions) Myles Minter, William Blair.
Myles Minter
Just on the tanker and the filings that are active, I noticed that you've recently got some new IP listed in the FDA. Orange Book patent expires at 2043. If you've got Chapter four filings against those patents that we might not be aware of and then secondly, just back on the 48% coverage in the commercial channel that's flat quarter over quarter, yet your conversations are progressing. What is the sticking point with some of these major payers that have yet to get online with the ability at the or is it more about formulary positioning, risk benefit or is it simply just come down to price?
Thanks.
Herriot Tabuteau
Yes, thank you for the question this is Herriot. We do have patents going out to 2043 and we do have a Paragraph four filings against them, which we filed suit against. So it is public information that we do have those three Paragraph four certification of relating to 2043 patent so that that that would be Teva litigation.
Ari Maizel
And Ari, regarding your comment on the 48%, yes, it is stable quarter over quarter. Every payer discussion is different. In some cases, it's related to ultimate price. In some cases, it's related to utilization management parameters. And so where we are progressing those conversations, we're having meaningful discussions, but it takes time and there ongoing negotiations and hopefully we'll be able to share some updates on that next quarter.
Myles Minter
Okay.
Thanks for the questions and congrats on the year.
Operator
(Operator Instructions) Yatin Suneja, Guggenheim Securities.
Hey, guys. Thanks for taking my question. This is Eddie on for Yatin this morning. Regarding that Pexip result increase in the long-term care channel since their FDA approval. Is that a good comp for how the ability launch could inflect on upon approval?
Or does the different safety profile or black box warnings make mobility a more attractive option for this population?
And then what additional commercial infrastructure would you need to see that kind of inflection like Brexit results all in, Bruce?
Ari Maizel
Yeah thanks for the question and just one clarification. We don't have data to suggest increase in breakfast, but they're correct pet result in long-term care in the Medicare channel. And so, I think additional data would be needed to understand whether it's in the long-term care setting or an outpatient.
But I do think it's a little premature to suggest that it's a good analog or access oh five of these products do have different clinical profiles. Excess of five is an anomaly, atypical anti-psychotic. It has a slightly different profile overall, and we expect there to be meaningful growth within that indication, if approved in both the outpatient settings as well as long-term care. As Aereo suggested earlier in our trials, we are focused in outpatient setting and with that within, I hope to delay patient patients go into long-term care facilities.
In terms of commercial infrastructure, we're obviously evaluating our sales force size and structure relative to the overall pipeline, and we do expect to have a meaningful presence in long-term care facilities. However, our existing sales force is primarily focused on outpatient care practices and which we expect will continue even for ADA. So more details to come, but we feel very confident that we'll be able to have an efficient selling effort based on the share call points for most of the indications that exist in our pipeline as well as our on-market products.
Thanks and congrats again.
Thank you.
Operator
(Operator Instructions) Matt Kaplan, Ladenburg Thalmann.
Matthew Kaplan
Thanks for taking the questions and good morning, guys. Just maybe a question for Ari in terms of now that you've completed the sales force expansion, when should we start to see an impact of that of that new sales force? And I guess over the course of the year, is it is it really first half or second half when we start to see them gaining traction?
Ari Maizel
Yes.
Thank you for the question.
And we expect to see a ramp in terms of impact over the course of the year. Obviously, the majority of the expansion representatives were hired late last year. We had completed training in January of this year. It takes time to go through call cycles and to build confidence with the brand stories and messaging and also to expand our reach into the primary care setting. And so we expect the build to occur over the course of the year. We're starting to see some meaningful impact in terms of call activity, and we would expect demand trends to have corresponding increases over the course of the year.
Matthew Kaplan
Okay. That's helpful. And then maybe a question for Aereo. You gave us an added detail in terms of what is necessary for filing SMDANAI ADHD. In terms of the other indications, you're pursuing Phase 3 ramp at all MDD binge eating disorder and shift work and what would be necessary there are they both they all include two Phase 3 trials are good Sunday with one?
Herriot Tabuteau
Sure.
Well, with regards to solriamfetol in MDD, so there we anticipate that we would need two Phase three trials. So we're launching our first Phase three trial. As you know, this quarter binge eating disorder. Similarly, we anticipate that we will have two Phase 3 trials and we're also on track to launch the first Phase 3 trial this quarter for shift work disorder. We only need one Phase 3 trial for the financial year.
Matthew Kaplan
Great.
Well, thanks for taking questions.
Operator
(Operator Instructions) Vikram Purohit, Morgan Stanley.
Vikram Purohit
Hi, good morning. Can you hear me.
Operator
Please proceed.
Vikram Purohit
Yes, thank you.
Good morning.
Thanks for taking our questions. So we had two commercial questions, one on ADA. one and MDD. So for ADA, assuming advanced two is positive and excess of five is approved for the indication, what would you expect annual duration of therapy to be into setting given the potential differences in the number and duration of agitation episodes that patients with AD. can experience? And then secondly, in MDD, do you think ability sales guidance is a possibility this year and if so, what are some of the metrics and aspects of the launch that you're monitoring to gauge whether guidance is reasonable to provide?
Herriot Tabuteau
Thanks. My questions are with regards to duration of treatment in Alzheimer's disease agitation. So although these agitation is viewed as a chronic condition, and that's how we've been studying it. And that is also reflective of how the FDA thinks about it from feedback that we've gotten from them. So we do have, as you know, a long-term open-label safety extension trial, which is ongoing. And so patients have been on drug now for a fairly long time.
So the study it's a one-year trial.
Nick Pizzie
Yes, sure, Vikram.
Hey, this is Nick up. As it relates to sales guidance, given their relatively short period of time since launch and evolving dynamics, including the increase in sales force effort as well as variability with market access were not ready to provide forward-looking guidance on sales which is likely the case for the entirety of 2024 at this point.
Vikram Purohit
Got it. Thank you and thank you.
Operator
We've reached the end of our question-and-answer session. I'd like to turn the floor back over to management for any further or closing comments.
Herriot Tabuteau
We'll thank you for taking the time to join us for today's quarterly update. 2023 was a strong year for Axsome as we enter 2024 with a growing commercial business in a late-stage neuroscience pipeline that encompasses five innovative product candidates in development, the 10 serious neuropsychiatry indications. We look forward to providing multiple updates throughout the year on our progress. Thank you and have a great rest of your day.
Thank you.
Operator
That does conclude today's teleconference. Webcast. You may disconnect your lines at this time and have a wonderful day. We thank you for your participation today.
