Q4 2023 Axsome Therapeutics Inc Earnings Call
Operator: Hello, and welcome to the Axsome Therapeutics fourth quarter and full year 2023 conference call and webcast. If anyone should require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation. You may be placed into the question queue at any time by pressing star 1 on your telephone keypad.
Hello, and welcome to the Axon Therapeutics fourth quarter and full year 2023 conference call and webcast. If anyone should require operator assistance. Please press star zero on your telephone keypad.
Question and answer session will follow the formal presentation.
Can you maybe placed into question shoot anytime by pressing star one on your telephone keypad.
Operator: As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Chief Operating Officer 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.
As a reminder, this conference is being recorded.
Now my pleasure to turn the call over to Chief operating Officer, Mark Jacobson. Please go ahead Sir.
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 2023.
Release crossed the wire a short time ago and is available on our website at <unk> Dot com.
Mark Jacobson: 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 source of future clinical trials, regulatory plans, future research and development plans, our commercial plans regarding CINOZI, 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 statement.
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 non clinical plans our plans for events or report additional data the anticipated conduct and the source of future clinical trials regulatory plans.
Future research and development plans, our commercial claims regarding Sidoti.
And our pipeline products revenue projection 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.
Mark Jacobson: 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. Ariel Tabuto, Chief Executive Officer, Nick Pizzi, Chief Financial Officer, and Ari Maisel, Executive Vice President and Head of Commercial. Dr. Tabuto will provide an overview of the company and progress made in the fourth quarter of 2023, as well as key upcoming milestones. Following Aereo's presentation, Nick will review our financial results, then Ari will provide a commercial update. We will then open the line for questions, and questions will be taken in the order they are received. And with that, I will turn the call over to Aereo. Thank you, Mark. Good morning, everyone.
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, a doctor area can you tell Chief Executive Officer, Nick Peasy, Chief Financial Officer, and Ari <unk>, Zhao Executive Vice President and head of commercial.
Mario will provide an overview of the company on progress made in the fourth quarter of 2023 as well as key upcoming milestones.
In the area of Nick will review our financial results.
Are you will provide a commercial update.
We will then open the line for questions questions will be taken in the order. They are received and with that I will turn the call over an area.
Thank you Mark good morning, everyone and thank you for joining <unk> therapeutics fourth quarter and year end 2023 financial results and business update conference call.
Mark Jacobson: 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 Axsome, 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, Ovelity, our first-in-class oral NMDA receptor antagonist and SIGNL1 receptor agonist for depression, and Sinozzi, with DNRI and colon agonists 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 morbidity and increasing awareness of our differentiated product. Later in the call, Nick will provide details on our quarterly financials, and Ari will provide additional information on our commercial performance.
2023 was another strong year for axon, Melbourne 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.
That was our first in class oral NMDA receptor antagonist and Sigma one receptor agonist for depression.
And so nosy, our DNR I'm, calling agonist for excessive daytime sleepiness Gen.
Generated combined net product revenue of approximately $205 million.
We expect continued revenue growth in 2024 aided by our completed sales force expansion formality.
An increasing awareness of our differentiated products.
Later in the call Nick will provide details on our quarterly financials and Ari will provide additional information on our commercial performance.
Mark Jacobson: During 2023, our innovative development pipeline also progressed and expanded. We made solid progress in the preparation of our NDAs for AXS07 in migraine and AXS14 in fibromyalgia. We advanced our phase three trials of AXS12 in narcolepsy and AXS05 in Alzheimer's disease agitation. We initiated a phase three trial program for sulforamphetol in ADHD and announced three additional new indications for sulforamphetol.
Okay.
During 2023, our innovative development pipeline also progressed and expanded.
We made solid progress in the preparation of our NDA for you because I saw seven in migraine.
That's 14 in fibromyalgia, we advanced our phase three trials of <unk> 12 in narcolepsy in excess of five and old timers disease agitation, we initiated a phase III trial program saw ramps, calling HD and announced three additional new indications for sabra hands at all.
Ariel Tabuto: 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. AXS07 for the acute treatment of migraine is on track for an NDA resubmission in the first half of 2024.
This progress positions us to deliver multiple potentially value driving milestones throughout 2024.
I will provide a brief update on our industry, leading neuroscience pipeline unexpected milestones.
Starting with our two NDA stage products.
Do you expect sort of seven for the acute treatment of migraine is on track for an NDA resubmission in the first half of 2024.
Ariel Tabuto: The NDE submission for AXS14 for the management of fibromyalgia is also tracking for submission in the second quarter of 2024. Now moving on to our late stage clinical program, we have completed enrollment in the Phase 3 symphony trial of AXS 12 for the treatment of narcolepsy.
The NDA submission for <unk> 14 for the management of Fibromyalgia is also tracking towards 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 <unk> 12 for the treatment of narcolepsy and we are on track to report top line results. So something during the first quarter.
Ariel Tabuto: And we are on track to report top-line results to Symfony during the first quarter. For AXS05, the Phase 3 Advanced 2 trial in the treatment of Alzheimer's disease agitation is tracking for completion in the second half of 2024 based on anticipated enrollment trends and recent treatment market dynamics. In December, we held an Investor Day event where physician experts provided the scientific and clinical rationale underlying the exploration of solar re-amphetol in new target indications, including major depressive disorder, binge eating disorder, and shift work disorder. We expect to initiate phase three trials in each of these indications in the first quarter. These new trials complement the ongoing Phase III-focused trial of solarium fetal in adults with ADHD.
For excess sulfide.
Phase three advanced two trial in the treatment of Alzheimers disease agitation is tracking for completion in the second half of 2024 based on anticipated enrollment trends and our recent treatment market dynamics.
Turning to saw reinstall, the active molecule and Sanofi.
In December we held an investor day event, where physician experts provided the scientific and clinical rationale underlying the exploration of solar oriented call in new targeted indications, including major depressive disorder.
Binge eating disorder and shift work disorder.
We expect to initiate phase III trials in each of these indications in the first quarter.
These new trials compliment the ongoing phase III focused trial of salary and vitol in adults with ADHD.
Ariel Tabuto: Focus is tracking 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 neurological conditions. If successfully developed, these investigational medicines have the potential to transform the treatment landscape for serious and difficult-to-treat CNS disorders, which affect more than 150 million people in the U.S. alone.
Focus is tracking for topline 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 for serious and difficult to treat CNS disorders, which affect more than 150 million people in the U S alone.
Nick Pizzi: I will now turn the call over to Nick, who will provide details of our financial performance. Thank you, Ariel, and good morning. Today, we'll discuss our fourth quarter and full year results and provide some funding. 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.
I will now turn the call to Nick who will provide details of our financial performance.
Thank you area and good morning today, we will 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 at $202 5 million for the fourth quarter and full year of 2023 and royalty revenue of 800000, a $2 4 million respectively.
Total product revenues for the comparable periods in 2022, or $24 4 million and $50 million.
Nick Pizzi: Total revenue for the full year of 2023 was $270.6 million, which included licensed revenue of $65.7 million from outlicensing CENOSI in certain ex-U.S. territories. Aveliti 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 Aveliti. Ovality was launched on October 19, 2022, and it had U.S. net sales of $5.2 million for the fourth quarter of 2020. NOSI net product revenues were $22.5 million and $74.8 million for the fourth quarter and full year of 2023, representing 17% and 67% year-over-year growth, respectively. And consisting of $21.7 million and $72.4 million in net product sales and $800,002.4 million in royalty revenue associated with Sunosi sales in outlicensed territories, respectively.
Total revenue for the full year of 2023 was $276 million, which includes license revenue of $65 7 million from out licensing so no seat in certain ex U S territories.
<unk> 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 ability.
<unk> was launched on October 19, 2022, and had U S. Net sales of $5 2 million for the fourth quarter of 2022.
The nosy 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, a $72 $4 million and net product sales and 800.
And $2 4 million in royalty revenue associated with Sanofi sales in our licensed territories respectively.
Nick Pizzi: So noticing that sales for the comparable period in 2022 were $19.2 million and $44.9, total CENOSI revenue for the full year of 2023 was $140.5 million, which includes a licensed revenue of $65.7 million from outlicensing CENOSI in certain ex-U.S. territories. Total cost of revenues was $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.
But now see net sales for the comparable periods in 2022 were $19 2 million and $44 $9 million.
Total Sanofi revenue for the full year of 2023 was $140 5 million, which includes the license revenue of $65 7 million from out licensing Sanofi in certain ex U S 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, or $2 3 million and $5 2 million.
Nick Pizzi: Total cost of revenue for the full year of 2023 included a one-time cost of $5 million associated with the revenue received on out-licensing CENOSI in certain ex-U.S. territories. Research and development expenses were $30.8 million and $97.9 million for the fourth quarter and full year of 2023, respectively, compared to $14.7 million and $57.9 million for the comparable period in 2022. The increase was primarily related to the focused trial of sulrympetol and ADHD, the advancement of ongoing trials of AXS05 and AXS12, manufacturing costs associated with the anticipated NDAs for AXS07 and AXS14, post-marketing commitments for both Aveliti and Synosi, and higher personnel costs, including non-cash stock-based compensation. Selling, general, and administrative expenses were $86.
Total cost of revenue for the full year of 2023 included a one time cost of $5 million associated with the revenue received on out licensing Sanofi in certain ex U S territories.
Research and development expenses were $38 million and $97 $9 million for the fourth quarter and full year of 2023, respectively compared to $14 7 million and $57 9 million for the comparable periods in 2022.
The increase was primarily related to the focused trial OXXO, where you have to call in ADHD. The advancement of ongoing trials of excess of five in excess fault.
Manufacturing costs associated with the anticipated NDA for access to seven and the excess 14.
Post marketing can answer both of that what are the incentives and higher personnel costs, including noncash stock based compensation.
Selling general and administrative expenses were $86 $8 million or 300.
Third and $23 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.
Nick Pizzi: The increase was primarily related to commercialization activities for Ability and Synosy, including sales force and marketing expenses, and higher personnel costs related to organizational growth, including non-cash stock-based compensation. The net loss for the fourth quarter of 2023 was $98.7 million, or $2.08 per share, compared to a net loss of $61.2 million, or $1.41 per share, for the comparable period in 2022. The net loss in the fourth quarter of 2023 includes $63.7 million in non-cash charges, a prize of $43.2 million in acquisition-related contingent consideration expenses, reflecting our updated sales predictions for recently announced new indications for sorghampetol, $18.9 million for non-cash, stock-based compensation expenses, and $1.6 million of non-cash intangible asset amortization. The net loss was $239.2 million, or $5.27 per share, for the full year of 2023 compared to a net loss of $187.1 million, or $4.60 per share, for the full year of 2022. The net loss for the full year includes total non-cash charges of $117.9 million, which includes $62.6 million of stock compensation expense.
The increase was primarily related to commercialization activities for ability and Sanofi, 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 eight per share compared to a net loss of $61 2 million or $1 41 per share for the comparable period in 2022.
The net loss in the fourth quarter of 2023 includes $63 $7 million in non cash charges comprised of $43 $2 million in acquisition related contingent consideration expense, reflecting our updated sales projections for recently announced new indications for Sarnia epitope.
$18 9 million for noncash stock based compensation expense and $1 $6 million of noncash 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 $187 $1 million or $4 60 per share for the full year of 2022.
The net loss for the full year increased 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.
Nick Pizzi: $48.9 million in fair value of contingent consideration expenses and $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. Aveliti and Sanosi's GTN discounts in Q4 of 2023 were both approximately 50%. Q1 typically has a negative seasonality effect on GTN. As a reminder, the GTN discount for Ability in Q1 of 2023 was in the high to upper 50s and in the mid-50s for Synosy due to the seasonal Q1 GTN dynamic. 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 31st of 2022.
Ability and Sanofi G T N discount in Q4 of 2023 were both approximately 50%.
Q1, typically has a negative seasonality effect on GTS as a reminder, the G can't discount for ability in Q1 of 2023 was in the high to upper fifties and in the mid fifties for Sanofi due to the seasonal Q1 G T N dynamics.
Therefore, I expect a similar G 10 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, who will provide a commercial update.
Thank you Mitch axon and 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 84000 prescriptions were written for our ability representing 23% quarter over quarter growth.
Ari Maisel: 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, who will provide a commercial. 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 Aubelity. In the fourth quarter, approximately 84,000 prescriptions were written for Aubelity, representing 23% quarter-over-quarter growth.
This performance contrasts with a decline of 1% for the overall antidepressant market during the same period.
Additionally, nearly 17000, new patients started on <unk> in the quarter, bringing the total number of unique patients treated with <unk> since launch to approximately 71000.
In the fourth quarter more than 30, 501st time mobility prescribers were activated by our sales team increase.
Increasing the cumulative total number of prescribers since launch to nearly 17000.
Ari Maisel: This performance contrasts with a decline of 1% for the overall antidepressant market during the same period. Additionally, nearly 17,000 new patients started Ovelity in the quarter, bringing the total number of unique patients treated with Ovelity since launch to approximately 71,000. In the fourth quarter, more than 3,500 first-time mobility prescribers were activated by our sales, increasing the cumulative total number of prescribers since launch to nearly 17,000. Payer coverage was stable in Q4, as ovality remained accessible to patients representing approximately 70% of covered lives.
Payer coverage was stable in Q4 as mobility remains 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.
<unk> performance in the quarter was primarily driven by specialists in psychiatry practices with both psychiatry M DS and nurse practitioners and physicians assistants, where N. P. P. A 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 those M. D. U N N P. P. A's as the early impact from our recent sales force expansion began to take hold with increased call activity in primary care offices.
Ari Maisel: We continue to progress in conversations with major plans and PBMs across all channels as we pursue access improvements for patients. Ovality performance in the quarter was primarily driven by specialists in psychiatric practices, with both psychiatric MDs and nurse practitioners and physician's assistants, or NPPAs, 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 NPPAs, as the early impact from our recent Salesforce 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 ability prescribing cited by respondents include rapid onset of action and low impact on weight gain and sexual dysfunction.
In a recent survey of providers in psychiatry and primary care to treat a significant proportion of depression patients key drivers of our ability 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 as demonstrated on day to day patient functioning and it's improvements in patient perceptions of quality of life.
Axon has established a strong commercial foundation to support continued ability grows in 2024.
With approximately 260 sales representatives, calling on 44000 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 U S.
Ari Maisel: In addition, doctors note the positive impact Alveoli 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 growth in 2024. With approximately 260 sales representatives calling on 44,000 healthcare 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 U.S. An enhanced brand story for 2024 has been created to augment provider perceptions of Aubelity and is anchored on Ability, a rapid-acting antidepressant that works fast and lasts, with rapid symptom improvement observed Aveliti has a well-established safety and tolerability profile that includes low impact on weight and sexual dysfunction and no risk of movement disorders or extrapyramide symptoms. Furthermore, alveolity is the only oral antidepressant that modulates both glutamatergic and monoaminergic pathways, a key point of consideration as the role of glutamate in depression is increasingly understood and accepted across the clinician landscape.
And enhanced brand story for 2024 has been created to augment provider perceptions of mobility and is anchored on our ability of key attributes.
Our ability as a rapid acting antidepressant that works fast and less with 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.
Ability 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 pyramidal symptoms.
Further ability is the only oral antidepressant that modulates, both glutamatergic and mono amine <unk> pathway is a key point of consideration is the role of glutamate and depression is increasingly understood and accepted across the clinician landscape.
We are very optimistic about <unk> growth prospects in 2024, and its long term blockbuster potential.
Transitioning now to nosy.
Total prescriptions were just over 42000, representing 2% sequential quarterly growth and 18% growth versus Q4 2022.
Approximately 3600, new patient started as soon as the treatment during the quarter, bringing the total number of unique patients treated with the news each of 65000 since launch.
Ari Maisel: We are very optimistic about Aubelity's growth prospect in 2024 and its long-term blockbuster potential. Transitioning now to Cynosis. Total prescriptions were just over 42,000, representing 2% sequential quarterly growth and 18% growth versus Q4 2022. Approximately 3,600 new patients started CINOZI treatment during the quarter, bringing the total number of unique patients treated with CINOZI 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 12000 since launch.
The field team is focused on communicating the needed urgency to treat excessive daytime sleepiness symptoms in obstructive sleep apnea narcolepsy with disproportionate focus on the nearly 2000 active weekly prescribers in the space.
Ari Maisel: 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 symptoms of obstructive sleep apnea and narcolepsy with a disproportionate focus on the nearly 2,000 active weekly prescribers in the space. Payor coverage for CENOSI was consistent in Q4, with a total of 83% of lives covered across all channels.
Payer coverage first another D was consistent in Q4 with a total of 83% of lives covered across all channels.
In a recent survey of Sanofi adopters key attributes driving demand for the product cited by respondents include significant and sustained impact on the epworth sleepiness scale.
Market, leading nine plus hours of wastefulness observed in phase III clinical trials and significant improvement in patient reported outcomes at week 12.
We are very proud of our commercial effort first to nosy and expect continued growth in 2024.
In closing <unk> delivered 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.
Ari Maisel: In a recent survey of Cynosia adopters, key attributes driving demand for the product cited by respondents include significant and sustained impact on the F-word sleepiness scale, a market-leading nine plus hours of wakefulness observed in phase three clinical trials, and significant improvement in patient-reported outcomes at week 12. We are very proud of our commercial effort for Synozi and expect continued growth in 2024. In closing, Axsome delivered 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 ovality and CINOZI are unique and differentiated treatment options in their respective indications and supports our growing confidence that Axsome is reshaping the treatment landscape for CNS conditions.
Anecdotal feedback from providers and patients continues to reinforce our belief that our ability and sanofi are unique and differentiated treatment options in their respective indications and supports our growing confidence that axon is reshaping the treatment landscape for CNS conditions.
I will now turn the call back to Mark for Q&A.
Thank you Ari operator may we please have our first question.
Thank you well 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 you May press star two if you'd like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing star one.
Our first question today is coming from Tim Michel <unk> from RBC capital markets. Your line is now live.
Mark Jacobson: I will now turn the call back to Mark for Q&A. Thank you, Ari. Operator, may we please have our first question?
Hi, 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 timelines 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 of standards.
Operator: Thank you. We will now be conducting a question and answer session. If you would like to be placed in the question queue, please press star 1 on your telephone keypad. You may press star 2 if you would like to remove your question from the queue.
Leonid Timyshev: For participants using speaker equipment, it may be necessary to pick up your handset before pressing star 1. Our first question today is coming from Leonid Timyshev from RBC Capital Markets. Your line is now live. Thanks for taking my question. I guess, can you maybe provide a little bit more color on what drove the slip in timelines?
Care evolves.
Well. Thank you for that question I think.
The second part of your question, which is.
Evolving nature of the standard of care, that's really what is driving this this is an indication that we're really excited about and we didn't want to take into account. The recent launch of brakes peppers old and any potential impact that could have an enrollment.
As a reminder, a bunch of it was 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.
Ariel Tabuto: 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?
So our revised guidance incorporates this new information, having said that we're confident that we should be able to deliver data this year.
Or any further comments about the evolving treatment landscape. It breaks yeah I would just say you know.
Ariel Tabuto: 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. This is an indication that we're really excited about, and we did want to take into account the recent launch of BrexPripResolve and any potential impact that that could have on enrollment. As a reminder, RetroProzol is the first drug that is approved in this syndication. So, our internal analytics team has been monitoring very closely prescribing trends, and what we've seen is a clear inflection in prescribing, which we attribute to that new indication. Therefore, our revised guidance incorporates this new information. Having said that, we're confident that we should be able to deliver data this year. Are there any further comments about the evolving treatment landscape in brex? Yeah, I would just say, related to the brex protozole increase, we're seeing a substantial increase across the Medicare channel, which we tie directly to the ADA indication. But I think this is also really positive news for AFS05.
Related to the Brexit trip, so increase we're seeing a substantial increase across the Medicare channel, which we can tie directly to D indication, but I think this is also really positive news for <unk> clearly there is significant unmet treatment needs and that gives us great confidence.
Sherwood.
Yes.
Got it thank you.
Thank you. Your next question today is coming from Charles Duncan from Cantor Fitzgerald. Your line is now live.
Hey, good morning.
Morning area and team congrats on a great year of commercialization I did want to follow up on a question on access so fight that first with regard to 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 fast and last in terms of activity I'm wondering what you can see in terms of.
Ariel Tabuto: Clearly, there's significant unmet treatment need, and that gives us great confidence for the future with AFS05. Got it. Thank you. Your next question today is coming from Charles Duncan from Canterpitch General. Your line is now live. Morning, Ariel and team.
[noise] refills and Ah patients staying on drug.
Yeah.
Okay. Thanks for the question Charles.
It's still a little too early to share any information on persistent persistency and adherence, but I will say is that the feedback we're receiving from patients and clinicians suggest that the clinical profile from phase III is holding up in the real world.
Charles Duncan: Congratulations on a great year of commercialization. I wanted to follow up on a question about AXS05, but first, with regard to 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, fast and last in terms of activity.
And we expect to generate additional data in the future but for now.
Say that what we're seeing in the real world is reflective of the phase III clinical trial results.
Okay. That's helpful and if I could follow on to the last question regarding.
Ari Maisel: I'm wondering what you can see in terms of refills in patients staying on drugs. Thanks for the question, Charles. It's still a little too early to share any information on persistency and adherence, but what I will say is the feedback we're receiving from patients and clinicians suggests that the clinical profile from Phase 3 is holding up in the real world. So we expect to generate additional data in the future. But for now, I can say that what we're seeing in the real world is reflective of the results of the Phase 3 clinical trial. Okay, that's helpful.
Access so five in advance to I'm wondering if you have any changed our perspective on the probability of success given our suite because 76 data recently.
And then also in terms of the open label extension are our patients enrolling into that and and how does that appear to be going maybe yeah, just kind of broadly.
Ariel Tabuto: And if I could follow on to the last question regarding AXS 05 and ADVANCE 2, I'm wondering if you have any changed perspective on the probability of success given ATSUKA's 786 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, yeah, just kind of broadly.
Yeah, Matt Thanks for the questions Charles with reversing the Otsuka readout, we don't think that that has any meaningful read through to our product now we watch in data readout, we need developments in this space for any potential learnings.
Our clinical development. However, we think that the best data to look at when you're thinking about the potential of excess of a five year old members disease agitation is the data that we've generated with our own product and as a reminder, we have now completed two phase III trials, which were placebo controlled.
Ariel Tabuto: Yeah, thanks for the questions, Charles. With regard to the Otsuka readout, we don't think that that has any meaningful read-through to our product. Now, we watch any data readout or any developments in the space for any potential learnings to help our clinical development. However, we think that the best data to look at when you're thinking about the potential of AXSO5 and Alzheimer's disease agitation is the data that we've generated with our own product. And as a reminder, we have now completed two phase three trials, which were placebo controlled, both of which had positive results. So we think that that is information that is more relevant than information on other molecules. And if you then, you know, take it one step down and actually look at the products themselves, they are different molecules entirely.
Both of which had positive results so.
So we think that that.
He is information, which is more relevant than information.
With other molecules and the.
If you then you know taking one step down and actually look at the.
Products themselves.
They are different.
Entirely so.
ABP steadily fish.
As a reminder.
Deteriorate modified dextromethorphan, whereas the excess oil <unk> gas right now.
Non deuterium modified dextromethorphan.
Dextromethorphan and B inhibitors also are different so we use in immuno Quito and and then they use quantity.
Ariel Tabuto: So, ABP786, as a reminder, is a deuterium-modified dextromethorphan, whereas XSO5 incorporates a non-deuterium-modified dextromethorphan. And the inhibitors are also different. So, we use an amino ketone, and then they use guanidine. So, they are very different.
So a very different and then as it relates to the open label safety extension trial, if that is going well and.
The vast majority of patients who are rolling out of our advanced two trial are opting to go into the open label safety extension.
We think that that is.
A good indicator of how the caregivers who are thinking about the product.
Ariel Tabuto: And as relates to the open-label safety extension trial, that is going well, and the vast majority of patients who are rolling out of our advanced two trial are opting to go into the open-label safety extension. We think that that is a good indicator of how caregivers are thinking about the process. Okay, very good. Thanks for the added color, Ariel.
Okay very good thanks for the added color area I'll hop back in the queue.
Thank you. Your next question is coming from Ashburn MA from UBS. Your line is now live.
I. Thanks for taking our questions I had two bolt on a D education. So maybe just on the the.
Charles Duncan: I'll hop back in the queue. Thank you. Next question is coming from Ash Verma from UBS. Your line is now live. I have two, both on AD agitation. So maybe just in the advanced two study, are you trying to recruit naive patients to treatment and that's why you want to kind of exclude anyone who has started therapy on Rixaldi? That's the first one.
Advance two study are you trying to recruit though.
<unk> patient to treatment and that's why you want to kind of exclude anyone who has started therapy on Saudi.
That's the first one and then second I like.
Ash Verma: And then second, like, just fast forwarding to when you 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 I'd just curious what type of sales footprint that might require versus, I think your DCC platform is kind of more of a footprint. So, thank you for the question. The answer is yes. We are recruiting primarily naive patients, and we wouldn't want to exclude folks who are on Rexalti for obvious reasons. However, our revised guidance does take into account any potential impact on losing patients because now patients do have a treatment option that is approved. And in terms of long-term care facilities, our studies thus far have been conducted in the community setting.
Is just fast forwarding to when you.
I assume that this would come to the market what do you need to primarily focus on the long term care facilities. There a lot of these patients broadening of design and just curious what type of seems footprint that might require a versus b.
BCC platform is kind of more job like footprint.
So thank you for the question.
Yes, we are recruiting primarily naive patients.
And and we wouldn't want to exclude folks who are on <unk> for obvious reasons.
And then.
Our our revised guidance does take into account any potential impact on losing patients could be there's now a patient you have a treatment option, which is approved and in terms of more computer facilities. Our studies. Thus far have been conducted in the community setting we think that that's where the.
Ariel Tabuto: We think that that's where the majority of patients reside who have this indication. And one of the things that we're excited about as it relates to the profile of SSO5 in Alzheimer's 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.
A majority of patients reside who have this syndication.
And one of the things that we're excited about as it relates to the profile of a survive and one timers 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. The next question is coming from June Lee from Truist Securities. Your line is now live. Good morning, this is Axsome. One for June. Thank you for taking the question. I was wondering if you could comment on what the breakdown of patients on Aveliti currently is around what percent are first line.
Thank you next question is coming from Joon Lee from truly Securities. Your line is now live.
Good morning. This is awesome one for joon thanks for taking the question.
I was wondering if you could comment on what the breakdown of patients ability currently is about 1% of our first line.
June Lee: And then also, just want to clarify, is the expanded salesforce fully online now, and can you comment on if you think current TRX trends are reflective of the full 260% salesforce? Great. Well, thanks. I'll turn that over to Ari.
And then also just wanted to clarify.
Is the expanded sales force fully online now and can you comment on if you think current purex trained that Rick talked about the full 260 person sales force. Thank you.
Okay, well, thanks, I'll turn that over to Ari.
Ari Maisel: Thanks for the question. So we are seeing meaningful improvement in terms of earlier line treatment. Over the course of 2023, we saw meaningful increases in first and second line treatment every quarter. So today, roughly 40 to 50 percent of patients are receiving availability in the first or second line setting.
Hi, Thanks for the question. So we are seeing a meaningful improvement in terms of earlier line treatment.
Over the course of 2023, we saw means.
Meaningful increases in the first and second line treatment.
Every every quarter.
So today, there is roughly a 40% to 50% of patients receiving <unk>.
Ability in the first or second line setting, we expect that trend to continue over time.
Ari Maisel: We expect that trend to continue over time. Regarding your Salesforce expansion question, we are fully complete with the expansion. We hired the additional representatives at the end of last year, and completed training in January of this year. We're starting to see meaningful impact in terms of call activity. In particular, we're seeing an increase proportionally in calls to the primary care segment.
Regarding your Salesforce expansion question, we are fully complete with the expansion.
We hired the additional representatives at the end of last year completed training in January of this year, we're starting to see meaningful impact in terms of call activity in.
In particular, we're seeing increase proportionally of calls to the primary care segment, we would expect the T Rx and N B Rx trends to continue to increase over the course of the year and.
Ari Maisel: We would expect the TRX and NBRX trends to continue to increase over the course of the year, and there will be a ramp beginning in Q1. And so, more details to come, but we are very pleased with the increased field force effort post-expansion. Thank you. Thank you. The next question is coming from Jason Gerberi from Bank of America. Your line is now live. Hey, guys.
There will be a ramp beginning in Q1, and so more details to come but we are very pleased with the increased field force effort post expansion.
Thank you.
Oh.
Thank you next question is coming from Jason <unk> from Bank of America. Your line is now live.
Hey, guys. Good morning, Thanks for taking my questions.
Jason Gerberi: Good morning. Thanks for taking my questions. I just wanted to follow up on the ADA enrollment dynamic with Rick Salti. I guess when we look at the growth of this brand on a TRX basis, that inflection doesn't seem obvious. So I'm wondering if we should be looking at a different metric to gauge that inflection.
I wanted to follow up on the 88 enrollment a dynamic with rock salt, Yeah, I guess, when we look at <unk>.
<unk> growth of this brand in a T rx basis that inflection doesn't seem obvious. So I'm wondering if it we should be looking at a different metric do to to gauge that inflection I don't know if its patient enrollment forms or or claims but.
Ariel Tabuto: I don't know if it's patient enrollment forms or claims, but given the massive market, I'm a little surprised that, you know, given the TRX move that we've seen, that it's being characterized as an inflection. And then is the expectation still that you get both long-term safety and efficacy data in the second half, and then you'd be able to file in the second half? Just wondering if the filing timeline is still on track.
Given that the massive market I'm, a little surprised that you know given the T. Rx 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 timeline is still on track. Thanks.
Ariel Tabuto: Thanks. Thanks for the question. 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 game factor there.
Thanks, everyone for the questions.
We have not given guidance on a.
Finally.
So that's going to be determined by the completion of our long term 16th Central trial, that's the gating factor there.
Ari Maisel: And with regard to what we're seeing from our internal analytics team on RECSALTI, I'll turn it over to Ari. Yeah, thanks Jason. My suggestion and what we've been looking at is claims-based data by payer channel, and our observation is that breast strip azole is increasing significantly within the Medicare channel. So that is what we attribute the growth to the ADA indication to. Okay.
And with regards to what we're seeing from our internal analytics team on <unk>, Oh, I'll turn it over to art, yes.
Yes, thanks, Jason.
<unk> and what we've been looking at are the claims based data by payer channel and our observation is that Brookfield resolve is increasing significantly within the Medicare channel.
That is what we attribute the growth to the EBITDA indication too.
Ari Maisel: Thank you. Thank you. Our next question is coming from David Amsellem on behalf of Piper Sandler. Your line is now live. Hey, thanks. So just a couple.
Okay. Thank you.
Thank you. Our next question is coming from David Anderson from Piper Sandler Your line is that life.
Hey, Thanks, So just a couple first.
David A. Amsellem: First, on AD agitation, can you talk about the potential for branding it differently from Ovelity and pricing it differently, just given that it's a Medicare Part D market and obviously different from the depression landscape. So that's number one. Then, number two, a couple of questions just on Roboxetine.
On a D agitation.
Can you talk about the potential for branding it differently from of the LT and pricing it differently.
Just given that it's a Medicare part D market and obviously different.
From the depression landscape. So that's number one.
Number two a couple just on Reboxetine. One can you talk about the timeline to an NDA and gating factors beyond the study.
Ariel Tabuto: One, can you talk about the timeline to an NDA and gating factors beyond the study to an NDA filing in narcolepsy and cataplexy? And then how are you thinking about pricing in that market? You've got on one end of the spectrum, Pitolacin, and on the other end of the spectrum, Solary Amphatol in narcolepsy.
To an NDA filing in narcolepsy cataplexy.
And then how are you thinking about pricing in that market you've got on one end of the spectrum <unk> and on the other end of the spectrum.
So ramp at all and in narcolepsy. So how are you thinking about that thank you.
Ariel Tabuto: So how are you thinking about that? Thank you. Sure. So a couple of questions there around branding and pricing for both products, and, you know, I'll let Ari provide some color on how we're thinking about those two things. I will preview it by saying that, you know, obviously, we're thinking about what we will do there and what our options are. And, you know, we would not be able to comment too much until we make a final determination.
Okay.
Sure.
A couple of questions there around branding and pricing for both products and our you know.
I'll, let already provide some color on how.
How we're thinking about those two things right my world preview it by saying that obviously, where we're thinking about what.
What we will do them, what our options are and we would not be able to comment too much until we make a final determination.
Ari Maisel: And as it relates to AXS-12 in narcolepsy and the NDA timing, the gaining factor there will be our long-term safety extension trial, so we're monitoring that. That is enrolling patients.
And as it relates to a <unk> 12 in narcolepsy and.
And the NDA timing the gaining factor there will be our long term safety extension trial. So we're monitoring that is enrolling and so we need to complete that and have that readout.
Ari Maisel: And so we need to complete that and have that read out. In order to complete our package for the NDA, Yeah, thanks for the question. Regarding the branding and pricing dynamics for AXSO5, 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, you know, ensuring clarity around patient dosing administration, potential halo effect associated with multiple indications, and the fact that there is comorbid depression in roughly 40% of Alzheimer's patients.
In order to complete our package for the NDA.
Yes. Thanks for the question regarding the branding and pricing dynamics for <unk> five 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 insuring clarity around patient dosing administration.
Potential halo effect associated with multiple indications and the fact that there is you know co morbid depression, and roughly 40% of Alzheimers patients. So there are a lot of considerations, we will share more details in the future.
Ari Maisel: So there are a lot of considerations, and we'll share more details in the future. And regarding Rivoxacine pricing, that's another area of analysis that we're currently exploring, and we'll share additional details in the future. Thank you. Thank you. And the next question today is coming from Joseph Comey from TD Cowen. Your line is now live. Good morning, and thank you for taking my questions. Maybe the first one on AXS12.
And regarding the robots and pricing that's another area of analysis that we're currently exploring.
We'll share additional details in the future.
Thank you.
Thank you. Our next question today is coming from Joseph told me from TD Cowen Your line is that life.
Hi, there good morning, and thank you for taking my questions. Maybe the first one on excess 12, I know the extra small studies all they only powered for cataplexy.
Joseph Comey: I know the AXS12 studies are really only empowered for cataplexy, and it's a little unclear if we're going to actually get the sleepiness scores, but can you talk a little bit from a clinician perspective: is it important to also see a signal on sleepiness in addition to cataplexy, or, you know, kind of, can you come in with another therapeutic like Sanosi to address the sleepiness component And then second, on Sanosi in MDD, how should we be thinking about timelines for 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 Sanosi MDD data this year, or what are the main differences between Gemini and this study that would make that potentially not the case? Thank you. Thanks for the questions. With regard to AXS 12, we're very close to a data readout, so we'll refrain from making any comments on that.
Unclear, if we're going to actually get the sleepiness scores, but can you talk a little bit from a convention perspective is it important to also see a signal on sleepiness. In addition to cataplexy or you know kind of keep coming with with another therapeutic like Sanofi that to address the sleepiness component and then second answer.
<unk> see an M D D. How should we be thinking about timelines to data on that if I remember, Jim and I took about six months from first patient dose to actually seen data. So is it possible that we could see Sanofi MTT data this year or what are kind of the main differences between Gemini in this study that would that would make that potentially not.
Yeah. Thank you.
Thanks for the questions with regards to excess 12, we're very close to a data read out so well.
We'll we'll refrain from.
For me, making any comments around that.
Ariel Tabuto: Look, we're so close, and we'll know very soon what the profile is in the phase three trials. Now, we do think that the product should have a favorable placement in the treatment paradigm that complements Sovremetal and other treatment options. And we're looking forward to the data readout because that will provide us with the first phase three data to complement the phase two data that we've generated thus far. And in terms of CINOZI, With regard to MDD, we'll have more to say about that, hopefully, once we announce enrollment of the first patient in that study. That remains on track to start this quarter.
Look we're so close and we'll know very soon with the profile is in the phase III trials now we do think that the product should have a favorable placement in the treatment paradigm that complement celebrity epitope and other treatment options.
And and we're looking forward to the data readout, because that will provide us with the first phase III data to complement the phase two data that we've generated thus far and in terms of so nosy.
With regards to MPD will have more to say about that hopefully once we announced the enrollment of the first patient in that study.
That remains on track to start.
Ariel Tabuto: Great, thank you. Thank you. As a reminder, that's FAR 1 to be placed in the question queue. Our next question is coming from Mark Goodman from Leering Partners. Your line is now live. Good morning.
This quarter.
Okay. Thank you.
Thank you as a reminder, that star one to be placed in the question queue. Our next question is coming from Marc Goodman from Leerink Partners. Your line is now live.
Yes. Good morning, 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 secondly area or are you willing to give us a sense of what percent.
Mark Goodman: 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 secondly, Ariel, are you willing to give us a sense of what percent of the AD agitation study is enrolled? Or are you 50, 60, 70 percent?
Of the 80 Education studies enrolled are you 50, 60, 70%, maybe you could give us a sense of that thanks.
Nick Pizzi: Maybe you can give us a sense of that. Thanks. Sure, yeah. Thanks, Mark. So as for R&D, our expense for the quarter was $31 million, just under $31 million for Q4.
Sure sure Yeah. Thanks, Mark.
So as for as for R&D or expense for the quarter was $31 million just under 31 million for Q4, I ticked up slightly from the previous quarter.
Nick Pizzi: That ticked up slightly from the previous quarter. We expect R&D spend to increase gradually as solar re-empthal phase III trials commence during the year. This increase will also be offset, though, by lower clinical costs as the Symphony, Advanced II, and Focus trials complete in 2024, and also once AXS-14 and AXS-7 NDAs are filed. As for the SG&A line, total expense for the quarter was just under $87
We expect R&D spend to increase gradually sorry, <unk> phase III trials commence during the year. This increase will also be offset though by lower clinical costs as the symphony advanced two and focused trials complete in 2024 and also once a excess 14 in excess of seven NDA file.
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.
Nick Pizzi: That was also a slight increase from the previous quarter. As you know, as we mentioned, the biggest increase in SG&A was due to the Salesforce expansion, which took place throughout Q4. As 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 realize the full burden of that expansion. And then, from a cash flow positivity or profitability standpoint, we are still at the early stages of the ability launch and a bit more than a year removed from the acquisition of Synosy. We've modeled various scenarios, and based on the success that we've had thus far, we feel very confident of our ability to be cash flow positive.
Is that expansion occurred throughout the quarter roughly half of the quarter as expense for that expansion was realized in Q4. So we would expect a slight increase in Q1.
As as we will realize the full burden of that expansion. So and then from a cash flow positivity of profitability. We are still at the early stages of the mentally launch and a bit more than a year removed from the acquisition of Sanofi.
We've modeled various scenarios and based on the success based on the success that we've had thus far we feel very confident of our ability to be cash flow positive.
Nick Pizzi: As you're aware, launches by nature are very volatile, and as such, we haven't provided any guidance on a specific timeline for cash flow positivity. Do you want to take the next question? Yeah, no, thanks, Mark, for the other question. We haven't provided a specific percentage enrollment in our trials lately. However, weigh the agitation.
As you are aware the launches by nature, a very volatile and as such we haven't provided any guidance on specific timeline or cash flow positivity.
Eric do you want to take the next question Yeah no. Thanks.
For the other question, we haven't provided a specific percentage of enrollment in our trials lately. However.
Weighty agitation, we are confident that we should be able to have resolved this year.
Ariel Tabuto: We're confident that we should be able to get results. Thank you. Operator, next question.
Okay.
Yeah.
Yeah.
Thank you operator next question. Our next question is coming from Greg <unk> from Mizuho Securities. Your line is now live.
Greg Sumanich: Yep. Our next question is coming from Greg Sumanich from Missoula Security. Your line is now live. Great. Your line is now live. Perhaps your phone is on me, and others.
Yeah.
Greg Your line is now live perhaps your phone is on mute.
Ari Maisel: Thanks for listening. We'll see you next time. Goodman. Go ahead, Greg. Can you hear me?
Okay.
But.
Yeah.
Go ahead Greg.
Ari Maisel: Yes. Please go ahead. Thank you. Okay. Great. Thanks. So sorry about that.
Yes. Please go ahead.
Okay, great. Thanks, so sorry about that congrats on the quarter just two questions. One just can you comment on the mobility DTC efforts.
Ari Maisel: Congratulations on the quarter. Just two questions. One, 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 context of – as we think about the potential of serine amphetamine and MDD, could you just remind us how we should think about the differential positioning of that product with regard to ovality? Hey Greg,
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.
As we think about the potential of <unk> and M. D. D could you just remind us on how we should think about the differential positioning of that product with <unk>.
Yeah.
Okay great. Thanks. So much this is Ari I. Appreciate the question as you know we do have a DTC effort today are largely focused on digital engagement and we've been very pleased with with that investment so far.
Ari Maisel: Thanks so much. This is Ari. 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. What we observe through market research is that nearly 8 in 10 patients who ask for our assistance receive it.
What we observed.
Through market research is nearly eight in 10 patients you asked for ability to receive it.
Ari Maisel: And so we're very optimistic about continued investment in consumer advertising, and 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. As it relates to sulranthetol and MDD, as you know, 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 and particular symptoms that may be more difficult for some patients than others, there's usually room for multiple treatment options to help these patients.
So we're very optimistic about continued investment in consumer advertising and 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.
As it relates to still ramp is hall, an M D b.
As you know ABB is a highly heterogeneous.
Additionally.
Not all patients respond to the same types of treatments.
And because there are overlapping symptoms with other illnesses.
And 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.
Ari Maisel: And so until we have more data around sulranthetol and MDD, it's a little premature to talk about co-positioning with alveolity. But based on our experience in this space, we do believe that there will be opportunities for both products to help patients achieve meaningful symptom-related treatment. Thank you. Thank you. The next question is coming from David Hong from Citigroup. Your line is now live.
Until we have more data around full ramp on MTBE, it's a little premature to talk about co positioning with mobility, but based on our experience in this space. We do believe that there will be opportunities for both products.
To help patients achieve meaningful symptom relief.
Thank you.
Okay.
Thank you next question is coming from David Holmes from Citigroup. Your line is now live.
David A. Amsellem: Good morning, and thanks for taking the questions. Congratulations on the quarter. So, maybe just two for me.
Hi, good morning, and thanks for taking the questions and congrats on the quarter.
So maybe just two for me.
Ariel Tabuto: First, on Ovelity, could you provide any color around your ongoing payer discussions in the commercial channel and expectations to improve the coverage there above the current, I think, 48% or so of covered lives? And then, regarding sores in ADHD, once the results of the FOCUS study are in hand, what else would be needed to proceed to an SNDA filing there if those results are positive? Thanks so much.
First on <unk> could you provide any color around your ongoing payer discussions and the commercial channel and expectations to improve the coverage. They are above the current I think 48% or so of covered lives.
And then regarding sorry M Thats all in ADHD. Once the result of a focused study are in hand, what else would be needed to.
Proceed to and S. NDA filing there if those results are positive. Thanks, so much.
Sure.
Ari Maisel: Sure, so we'll take the questions in reverse order. For sole re-ampetile, the focus study is in adults, and we will be launching a phase 3 trial in the pediatric population. So both of those studies, both of those patient populations are needed for an end-to-end filing. Yeah, and related to the payer discussions, as you mentioned, we have roughly 40% coverage in commercial channels, and 70% overall across channels. The way we think about payer dynamics is that we are taking a very disciplined approach to contracting to preserve long-term profitability for our products.
So we'll take the questions in reverse order for sole ramp at all.
The focus studies in adults and we will be launching a phase III trial in the pediatric population. So both of those studies both of those patient populations or needed for an NDA filing.
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 Payor dynamics as we are taking a very disciplined approach to contracting to preserve long term.
Profitability for our products.
Miles Minter: However, we do anticipate expanding coverage over time and remain actively engaged with health insurers to improve access. For insured patients, 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, remain 70% of lives for all Valley patients. Thank you. Our next question is coming from Miles Minter on behalf of William Blair. Your line is now active.
We do anticipate expanding coverage over time and remain actively engaged with health insurers to improve access for insured patients.
You mentioned that our current investments in both patient savings programs as well as reimbursement services that will support continued prescription growth at current levels of coverage, which as I mentioned before remains 70% lives for obesity.
Okay.
Thank you. Our next question is coming from Myles Minter from William Blair. Your line is now live.
Ariel Tabuto: Hey, thanks for taking the questions. Just on the Teberanda filings that I know are active, I noticed that you've recently got some new IP listed in the FDA Orange Book with a patent that expires at 2043. Have you got Chapter 4 filings against those patents that we might not be aware of?
Hi, Thanks for taking the questions just on the Tech Aranda filings, but on our active I noticed that you've recently got you.
I paid listed in the FDA Orange book patent expires at 2043, if you kept the full filings against those patents that we might not be aware of and then secondly, just back on the 14th St coverage in the commercial channel that's flat quarter on quarter, yet your conversations are progressing what is sticky.
Hunter Murdoch: 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 Abality at the moment? Is it more about formulary positioning, risk benefits, or is it simply just coming down to price?
<unk> point with some of these major payers that have yet to get online with the ability at the moment is it more about formulary positioning risk benefit or is it simply just coming down to trough. Thanks.
Ari Maisel: Thanks. Yes, thank you for the question. This is Hunter Murdoch.
Yes. Thank you for the question. This is hunter Murdoch I'm, sorry, Yeah, 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 relating to 2043 patent.
Hunter Murdoch: So yeah, we do have patents going out to 2043, and we do have paragraph 4 filings against them, which we filed suit against. So it is public information that we do have those three paragraph 4 certifications relating to 2043 patents. So that's the type of litigation. And this is Ari.
So that's that.
That with the type of litigation.
And this is Ari regarding your comment on the 48%, yes, it is stable quarter over quarter.
Ari Maisel: Regarding your comment on 48%, yes, it is stable quarter over quarter. You know, every payer discussion is different. In some cases, it's related to ultimate price.
Every payer discussion is different in some cases, it's related to ultimate it's priced in some cases, it's related to utilization management parameters.
Ari Maisel: In some cases, it's related to utilization management parameters. And so we are progressing those conversations. We're having meaningful discussions, but it takes time. And there are ongoing negotiations.
And so where we are progressing those conversations we're having meaningful discussions, but it takes time and there are ongoing negotiations and hopefully we'll be able to share some updates next quarter.
Ari Maisel: And hopefully, we'll be able to share some updates next quarter. Thanks for the questions, and congratulations on the year. Thank you. Our next question today is coming from your teams in Asia from Guggenheim Security. Your line is now live. Hey guys, thanks for taking my question. This is Eddie on for yachting this morning.
Okay. Thanks for the questions and congrats on the year.
Okay.
Thank you. Our next question today is coming from your teams in Asia from Guggenheim Securities. Your line is now live.
Hey, guys. Thanks for taking my question. This is Eddie on for yacht and this morning regarding that except Brazil increase in the long term care channel since Theyre 88 approval is that a good comp for how they have already launched could inflect on upon approval or does a different safety profile or black box warnings Mako ability a more attractive option for this population and then what additional commercial infrastructure.
Eddie: Regarding that Brexit result increase in the long term care channel since their 88 approval, is that a good count for how the ability launch could inflect upon approval? Or does this different safety profile or black spot warnings make ability a more attractive option for this population? And then what additional commercial infrastructure would you need to see that kind of inflection like Brexit saw if approved?
Or would you need to see that kind of inflection like Brexit resolved saw if approved.
Ari Maisel: Yeah, thanks for the question. Just one clarification: we don't have data to suggest an increase in brexprasol in long-term care.
Yeah. Thanks for the question just one clarification.
We don't have data to suggest increasing by principal Rx Pet result in long term care is it's in the Medicare channel and so.
Ari Maisel: It's in the Medicare channel. And so, you know, I think additional data would be needed to understand whether it's in the long-term care setting or in outpatient. And I do think it's a little premature to suggest that it's a good analog for AXSO5. These products do have different clinical profiles. AXSO5 is a non-atypical antipsychotic. It has a slightly different profile overall.
I think additional data would be needed to understand whether it's in the long term care setting or an outpatient.
And I do think it's a little premature to suggest that it's a good analogue or access so by.
These products do have different clinical profiles in terms of a buyback is a non atypical anti psychotic.
It has a slightly different profile overall, and we expect there to be a meaningful growth within that indication if approved in both the outpatient settings as well as long term care as <unk> suggested earlier trials, we are focusing on patient settings.
Ari Maisel: And, you know, we expect there to be meaningful growth within that indication if approved in both outpatient settings as well as long-term care. As Ariel suggested earlier in our trials, we are focused on outpatient settings with a hope to delay patients going to long-term care facilities. In terms of commercial infrastructure, we're obviously evaluating our sales force sizing structure relative to the overall pipeline.
With those within a hope to delay Ah patients.
Patients going to long term care facilities in terms of commercial infrastructure. We're obviously evaluating our sales force sizing structure relative to the overall pipeline.
Ari Maisel: 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, which we expect will continue 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 shared call points for most of the indications that exist in our pipeline as well as our on-market products. Great, thanks. Thank you. We have time for questions from two more analysts. Our next question is coming from Matt Kaplan from Lannenburg-Ballman. Your line is now live.
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, which we expect will continue even for a day so more details to come but we feel very confident that we'll be able to have an ambition selling effort based on the share call points or most of the indications are that exist in our pipeline as well as our on market products.
Great Thanks, and congrats again.
Thank you we have time for questions from two more analysts. Our next question is coming from Matt Kaplan from Ladenburg Thalmann. Your line is now live.
Matt Kaplan: Hi, thanks for taking the question and good morning, guys. Just maybe a question for Ari in terms of now that you've completed the Salesforce expansion, when should we start to see an impact of that new sales? I guess over the course of the year, is it. Is it really the first half or second half when we start to see it?
Hi, Thanks for taking the question 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.
That new sales force and I guess over the course of the year is it a is it really first half or second half and when you start to see them gaining traction.
Ari Maisel: Yeah, thank you for the question. We expect to see a ramp-up in terms of impact over the course of the year. Obviously, you know, the majority of the expansion representatives were hired late last year.
Yes. Thank you for the question, we expect to see a ramp in terms of impact over the course of the year.
Be asleep.
The majority of the expansion Representatives were hired late last year, we completed training in January of this year.
Ari Maisel: We 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 bill 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. That's helpful, and then maybe a question for Ariel. You gave some added detail in terms of what is necessary for filing SNDA and ADHD. In terms of the other indications you're pursuing in phase 3 for salvia amyotol, MDD, benzene disorder, and shift work, what would be necessary there? They both, they all include two phase 3 trials, or could some be?
Next time to go through call cycles and to build confidence with the brand stories and messaging and <unk>.
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.
Okay. That's that's helpful. And then maybe a question for Al you gave us some added detail in terms of what is necessary for filing S. N D. I N S ADHD.
In terms of the other indications you're pursuing in phase III for Solvay ample Tau M D D binge eating disorder and shift work.
What what what would be necessary there.
Is it they both they all include a two phase III trials are good somebody with one.
Ariel Tabuto: Sure. Well, with regard to solar amputate in MDP, we anticipate that we will need two phase three trials. So we're launching our first phase three trial, as you know, this quarter for binge eating disorders. Similarly, we anticipate that we will need two phase three trials, and we're also on track to launch the first phase three trial this quarter. For shift work disorder, we only need one phase three trial for the following SMD.
Sure with regards to a.
So we're able to call in and M. D. D. So there we anticipate that we would need two phase III trials and so we're launching our first phase III trial.
As you know this quarter binge eating disorder. Similarly.
Yes, the two phase three trials and we're also on track to launch out in the first phase III trial. This quarter the shift work disorder, we only one phase III trial for the phone is India.
Ariel Tabuto: Well, thanks for taking the time. Thank you. Our final question today is coming from Vikram Purohit from Morgan Stanley. Your line is now live. Vikram, perhaps your phone is on mute.
Yeah.
Alright, well thanks for taking the question guys.
Thank you. Our final question today is coming from Brooklyn forehead from Morgan Stanley. Your line is that life.
Okay.
Perhaps your phone is on mute.
Vikram Purohit: Hi, good morning. Can you hear me? Thank you. Good morning. Thanks for taking our questions. We had two commercial questions, one on ADA and one on MDD. So, for ADA, assuming Advance 2 is positive and AXSO5 is approved for the indication, what would you expect the annual duration of therapy to be in this 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 availability 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?
Hi, Good morning can you hear me.
Please proceed.
Thank you.
Good morning, Thanks for taking our questions. So we had to.
Commercial questions one on H, one and M D D.
So for a day, assuming advance two is positive and the 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 where they do you can experience and then secondly, an M. D. D. Do you think ability sales guidance as a possibility this year and if so what are some of the metrics and aspects of the launch that youre monitoring to.
Gauge, where the guidance is reasonable to provide thanks.
Ariel Tabuto: Thanks. Thanks for the questions. With regard to duration of treatment for Alzheimer's disease agitation, so Alzheimer's disease agitation is viewed as a chronic condition, and that is 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. Some patients have been on drugs now for a fairly long time, so the study is a one-year trial.
But thanks for the questions are with regards to duration of treatment in all timers disease agitation. So the old address disease agitation is viewed as a chronic condition and that's how we've been studying it and and that is also reflective of how the FDA thinks about it from feed.
<unk> gotten from them so.
Do you have as you know a long term open label safety extension trial, which is ongoing so patients have been on drug now for.
Fairly long time so.
It's a one year trial.
Nick Pizzi: Yeah, sure, Vikram. Hey, this is Nick. As it relates to sales guidance, given the relatively short period of time since launch and evolving dynamics, including the increase in salesforce effort, as well as variability with market access, we're not ready to provide forward-looking guidance on sales, which is likely to be the case for the entirety of 2024 at this point. Thank you. Thank you. 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. Well, thank you for taking the time to join us for today's quarterly update. 2023 was a strong year for Axsome.
Yes, sure Vikram hate this is Nick.
As it relates to the sales guidance given the relatively short period of time since launch and evolving dynamics, including the increase in sales force effort as well as variability with market access we're not ready to provide forward looking guidance on sales, which is likely the case for the entirety of 2024 at this point.
Got it thank you.
Thank you we've reached end of our question and answer session I'd like to turn the floor back over to management for any further or closing comments.
Well. Thank you for taking the time to join US for todays quarterly update 2023 was a strong year for axon, we enter 2024 with a growing commercial business and our late stage neuroscience pipeline that encompasses five innovative product candidates in development.
Mark Jacobson: We entered 2024 with a growing commercial business and a late-stage neuroscience pipeline that encompasses five innovative product candidates in development for ten 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. That does conclude today's teleconference webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.
Then 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 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.
Okay.