Axsome Therapeutics Q3 2023 Earnings Call Transcript

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Provided by Quartr
November 6, 2023

There are 16 speakers on the call.

Operator

And welcome to Axsome Therapeutics Third Quarter 2023 Financial Results Conference Call. Currently, all participants are in a listen only mode. Later, there will be a question and answer session and instructions will follow at that time. As a reminder, today's conference is being recorded. I would now like to turn the conference over to your host, Mark Jacobson, Chief Operating Officer, Axsome Therapeutics.

Operator

Thank you. Please go ahead.

Speaker 1

Good morning and thank you all for joining us on today's conference call. This morning, we issued our earnings press release providing corporate update and details of the company's financial results For the Q3 of 2023. The release crossed the wire a short time ago and is available on our website at axon.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 non clinical 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 Finovee, Ovelity and our pipeline products, Revenue projections and possible intended use of cash and investments.

Speaker 1

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 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 Doctor. Herriot Tabuteau, Chief Executive Officer Nick Peasey, Chief Financial Officer and Lori Engelbert, Executive Vice President of Product Strategy. Ariel will provide an overview of the company And progress made in the Q3 of 2023 as well as key upcoming milestones.

Speaker 1

Following Ariel, Nick will review our financial results, Then Laurie 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 to Herriot.

Speaker 2

Thank you, Mark. Good morning, everyone, and thank you for joining Axsome Therapeutics' 3rd Quarter 2023 Financial Results and Business Update Conference Call. In the 3rd quarter, We advanced our differentiated commercial products as well as our broad late stage neuroscience pipeline. The strong progress in the quarter positions us well to continue delivering potentially life changing new medicines to patients with serious brain disorders And to the healthcare providers, total net product revenue in the quarter was $57,800,000 representing significant year over year and quarter over quarter sequential growth. The quarter's strong showing reflects contributions from both Avelity And Sunosi.

Speaker 2

Avelity, our 1st in class oral NMDA receptor antagonist and Sigma-one receptor agonist Has now been on the market for 1 year. Its commercial performance to date reflects its fast onset and lasting efficacy As demonstrated in the clinical trials. Later in the call, Nick will provide additional details on our quarterly financials, And Laurie will go into more detail on our commercial performance. While we are proud of the positive market reception for velodity to date And the progress we have made with Sunosi, we believe that we have barely scratched the surface of these opportunities. We look forward to continued commercial execution to realize the tremendous potential for these 2 differentiated medicines.

Speaker 2

Our commercial success to date has been enabled by strong clinical profiles for Velody and Sunosi and by our efficient, Effective and innovative digital centric commercialization or DCC approach. We will continue to deploy this platform with our I will provide a brief update on the pipeline progress, including Some anticipated upcoming clinical and regulatory milestones. Starting with our 2 NDA stage products, For AXS-seven, for the acute treatment of migraine, we are on track to resubmit the NDA for this product candidate in the first half of twenty twenty four. In parallel, we are also working on the NDA submission for AXS-fourteen for the management of fibromyalgia, Which is on track for submission in the Q1 of 2024. Moving on to our Phase III clinical programs.

Speaker 2

The Phase 3 SINFONI trial of AXS-twelve for the treatment of narcolepsy is on track to complete enrollment this year, With announcing of top line results expected in the Q1 of 2024. The Phase 3 ADVANCE II trial of AXS-five for The treatment of Alzheimer's disease agitation is on track for completion in the first half of twenty twenty four. In July, we initiated the FOCUS Phase 3 trial of solriamfetol in ADHD, and we anticipate We previously announced that we intend to develop solriamfetol for the treatment of binge eating disorder And for the treatment of excessive sleepiness associated with shift work disorder. These are 2 new potential indications with significant patient populations And limited treatment options. We are on track to initiate Phase III trials of solriamfetol in binge eating disorder by the end of this year And in shift work disorder in the Q1 of 2024.

Speaker 2

Further details about these clinical programs will be provided at a Sol Reinventol Investor Day planned to be held before year's end. Overall, the Q3 saw us make significant progress with our commercial performance and development pipeline. We expect to close out this year with continued strong execution, setting the stage for productive 2024. I will now turn the call to Nick, who will provide details of our financial performance.

Speaker 3

Thank you, Herriot, and good morning. Today, I will discuss our Q3 results and provide some financial guidance. Total revenue in the Q3 of 2023 was $57,800,000 representing year over year growth of 2 44%. Revenue consisted of net sales of our 2 commercialized products of Eldene Sunosi and royalty revenue from Sunosi sales in out licensed territories. Revenue for the comparable period was $16,800,000 comprised only of U.

Speaker 3

S. Sunosi sales since Avelity was not launched until October of 2022. Aveltean net sales in the quarter were $37,700,000 representing 36 percent sequential growth with no net sales in the comparable 2022 period due to the timing of launch. Sunosi net revenue for the quarter was $20,100,000 representing 20% year over year growth. Sunosi net revenue consisted of net sales of $19,400,000 $700,000 in royalty revenue from sales in the out licensed territories.

Speaker 3

Sunosi net revenue for the comparable period was $16,800,000 Cost of revenue was $6,500,000 in the quarter Compared to $1,900,000 in the prior year period, the increase reflects the higher product volumes for both Avelity and Sunosi in the current year. Research and development expenses were $28,800,000 for the 3rd quarter versus $14,900,000 for the comparable period in 2022. The increase was primarily related to the FOCUS trial of sorghienpotal in ADHD, the advancement of ongoing trials of AXS-five and AXS-twelve, CMC costs associated with the NDAs for AXS-seven and AXS-fourteen, post marketing commitments for Avelity and Sunosi And higher personnel costs, including non cash stock based compensation. Selling, general and administrative $83,200,000 for the Q3 versus $40,900,000 for the comparable period in 2022. The increase was primarily related to commercial activities Net loss for the Q3 was $62,200,000 or $1.32 per share versus a net loss of $44,800,000 or $1.07 per share for the comparable period in 2022.

Speaker 3

We ended the quarter with 416 point $6,000,000 in cash and cash equivalents compared to $200,800,000

Speaker 4

Avelity works fast and lasts With rapid improvement in depression symptoms starting at 1 week and durable treatment effects that are sustained up to 12 months, All with a favorable tolerability profile. We remain focused on accelerating demand growth And we expect continued growth in Q4 and beyond. Q3 represents only the 3rd full In the quarter, approximately 69,000 prescriptions were written for Avelity, representing 30% quarter over quarter growth. This performance is in contrast to a decline of 1% for the overall antidepressant market during the same period due to market seasonality. In the Q3, HCPs wrote prescriptions for more than 16,000 new patients, bringing the total number of unique patients to start Avelity Since launch to approximately 55,000 at the end of Q3.

Speaker 4

Prescription growth came from both an increased depth of with HCP adopters as well as an increased breadth of new prescribers. In the Q3, we added approximately 3,200 new source time prescribers of Avelity, increasing the cumulative total of prescribers since launch to 13,000. As mentioned during our Q2 earnings call, in response to our early launch success and growing demand, We are expanding the Avelity field force by about 100 sales representatives to a total of approximately 260. We are on track to complete the hiring of the expanded team by the end of Q4 with completed training and full deployment in the Q1. The expansion will increase our reach from 26,000 prescribers to approximately 44,000 prescribers.

Speaker 4

These 44,000 ACTs write approximately 90% of new to brand prescriptions and will substantially increase our potential to reach And help more patients. With regards to payer coverage, we currently have coverage established for 70% of all covered lives. In the commercial channel, which represents the greatest source of volume for Avelity, coverage is now at 48% of covered lives. In the Medicaid and Medicare channels, approximately 100% of lives are covered. Active discussions with payers continue as coverage expands and evolves.

Speaker 4

Turning to Sunosi. Total prescriptions for Sunosi in the U. S. Grew 16% year over year and 5% sequentially. Like Avelity, Sunosi experienced meaningful demand growth in the Q3 despite the expected overall market decline due to summer seasonality.

Speaker 4

The steady growth of Sunosi can be attributed to our focused promotional investments and Sunosi's differentiated clinical profile. Since Q3 of last year, Sunosi has added 14,000 unique new patients, which represents an increase of 30% in cumulative unique patients over the past year. The field team continues to work on driving both depth within the current subscriber base And breadth by adding new prescribers. Since Q3 of last year, we have increased unique new writers of Synosi by 23%. Payer coverage for Synosi remains broad with 95% of commercial lives and 83% of total lives covered.

Speaker 4

We expect our promotional efforts to drive continued growth for the product in the current indication. In addition, Sunosi has significant growth potential in new target indications, including ADHD, binge eating disorder and shift work disorder. Overall, both Avelity and Sunosi delivered strong performance in the quarter. We remain focused on commercial execution to maximize the potential of these I will now turn the call back to Mark to lead the Q and A discussion.

Speaker 1

Thank you, Laurie. Operator, may we please have our first question?

Operator

Thank you. Our first question today is coming from Charles Duncan of Cantor Fitzgerald. Please go ahead.

Speaker 5

Hey, good morning, Herriot and team. Congratulations on a really nice quarter. Thanks for taking our question. I had a couple. One is commercial, one is pipeline.

Speaker 5

Perhaps for Laurie or whoever wants to answer it. Regarding Avelity, I'm wondering about the drivers of demand In terms of well, I'm wondering about the drivers of revenue. Are you seeing are you still seeing more new patient adds versus persistence? Or are you starting to see persistence because it would seem to me that the product profile would result in patients being on the drug longer than You might expect for an antidepressant.

Speaker 6

Hey, Charles. I'll take that question. So it's a really astute question. So thanks for asking. It is one that we're still working through.

Speaker 6

We have just hit our 1 year mark. So it's Still a bit hard to comment on the long term persistence rates for Avelity. We're not seeing anything particularly different than what you would expect it from the therapeutic Feedback though, from an anecdotal feedback as well as what we're seeing in refill prescriptions, anecdotal feedback, The product is working per the label. Early on, all we really heard about was the rapid onset of action. But now that we're just Take past the 1 year mark, we are starting to hear about the durability of the effect.

Speaker 6

So the product is fast and it lasts, Which is consistent anecdotal feedback from both HCPs and patients. And we're starting to see that through just the healthy number of refill prescriptions. That's evidence that clinicians and patients are seeing a response and are continuing treatment.

Speaker 5

Very good.

Speaker 6

But I know, maybe. I can ask sorry, I was just going to answer the driving of new patients. We're still very pleased with the number of new patients Acquisition that we're getting on a weekly basis.

Speaker 5

Okay. That's a positive. Appreciate it. For Nick, now that you're through a year, are you contemplating giving guidance Next year or is that not yet do you feel like you're not yet there?

Speaker 3

Yes. I think we're still a bit early on. We'll continue to ponder that as we get closer towards the end of the year and into 2024. But there's so many variables at this point that giving guidance It's difficult at this point. So Standby, but I hear the question, Charles.

Speaker 5

Okay. Regarding Maybe, Diario, regarding the pipeline, I had a question about 5. I'm really intrigued with ADVANCE-two in Alzheimer's disease agitation. I'm wondering, you sound pretty bullish about being able to read that out in the first half. And I'm wondering if you could characterize the Patient sample that you're enrolling on, obviously, on a blinded basis thus far, how are you confirming Alzheimer's disease diagnosis or Is the symptom presentation across neurodegenerative disease not all that different and so you don't really need to confirm diagnosis with Sabarral Centers.

Speaker 5

Thanks.

Speaker 2

Thanks for the question Charles. The patient sample that we're enrolling Should match or is matching the patient sample that we enrolled in the ADVANCE-one trial and the way that we confirm Diagnosis are through validated scales for both Alzheimer's disease as well as for agitation. Well accepted scales and the same ones that we used in the ADVANCE-one trial and also that is used in other studies in Alzheimer's disease.

Speaker 5

Okay. But you're not doing imaging, correct? You don't feel that's necessary?

Speaker 2

No. Imaging and Or biomarker. We are not doing imaging.

Speaker 5

Okay. No blood based biomarkers?

Speaker 2

We are not doing imaging or biomarkers for enrollment into the trial and that's pretty standard for studies Of Alzheimer's disease that look at cognition or behavioral symptoms.

Speaker 5

Yes. Thanks, and so clinical diagnosis. Okay. Thanks for taking the questions.

Operator

Thank you. The next question is coming from Mark Goodman of Leerink Partners. Please go ahead.

Speaker 7

Good morning. This is Rudy on the line for Mark. Thanks for taking my questions. So just a quick follow-up Two questions. So can you talk about your expectations for the upcoming readouts?

Speaker 7

And what data do you think will be adequate to

Speaker 2

So I assume that that Question has to do with Alzheimer's disease agitation. And in terms of data from upcoming readouts, we do have the ADVANCE-two trial. We expect that to complete and read out in the first half of twenty twenty four. And that along with The results from our prior studies as well as the ongoing open label safety trial will be will form the basis for the SMDA filing.

Speaker 7

But do you still need like additional efficacy data from ADVANCE-two in order to file for that indication?

Speaker 2

The 3 studies which are efficacy trials, which will be in the package For the ADVANCE-one trial, the ACORD study, as well as the ongoing ADVANCE-two trial.

Speaker 7

Okay. That's helpful. Thanks.

Operator

Thank you. The next question is coming from Vikram Puritan of Morgan Stanley, please go ahead.

Speaker 8

Hi, good morning. Thanks for taking our questions. 2 from our side. 1 on narcolepsy, it seems like there was a little bit of a slip on timing for expected data readout from Late this year to 1Q of next year, just wanted to get some context on what might have driven that? And then secondly, for the Avelity launch, What is your latest sense on the breakup of patients you're seeing across lines of therapy?

Speaker 8

Thanks.

Speaker 2

Great. Thank you. I'll take the first question and we'll have Laurie take the second question. With regards to narcolepsy and the AXS-twelve study, the change in terms of when we expect To have top line results is driven purely by enrollment and we're on track to complete enrollment by the end of the year.

Speaker 6

Hey, Vikram. So in terms of the type of patients that we're seeing, right now about 10% to 12% are First line therapy, but the majority and the overwhelming majority is about 60% of the patients that we're seeing have failed 1 or 2 prior therapies. So sum it all up, 70% have failed 1 or 2 or brand new to therapy.

Speaker 2

And I would just add that we're really pleased that this early on in the launch 40% of patients either are brand new or have failed one treatment.

Speaker 8

Understood. Thank you.

Operator

Thank you. The next Question is coming from David Amsellem of Piper Sandler. Please go ahead.

Speaker 9

Hey, thanks. Just a couple. So first, On the Esterboxitine filing and opportunity, how are you thinking about the fit of that Commercially within the organization, I mean, my understanding is it's a large sort of GP focused Indications, so where does that fit exactly in terms of just where you're taking the organization? That's number 1. Then number 2 for reboxetine, is it your expectation that You'll be filing on this data set or are there any other gating items to Filing in the narcolepsy setting for that drug.

Speaker 9

Thanks.

Speaker 6

Yes. Hi. I'll take the first one on Fibromyalgia. So you're exactly right. Fibromyalgia is an incredibly underserved market, 5,000,000 patients in the U.

Speaker 6

S, Only 3 products approved to treat right now. They're all generic, widespread. There hasn't been any promotional dollars in the area for a very long time. Patients, HCPs are all very, very frustrated with this patient type because they don't have effective products to treat. So in terms of where we're taking the market, it's way too premature for us to speculate on how we will structure our sales force.

Speaker 6

But What we're focusing on right now is really making sure that we understand the marketplace, make sure that we have really strong disease state educational Efforts to make sure that HCPs and patients are educated well on the disease state and then we'll focus our field force

Speaker 10

on the highest

Speaker 6

to prescribe highest likelihood to prescribe HCPs.

Speaker 2

Great. And then just to add that to What Laurie said, I think one of the things that we've always been mindful of in designing our commercial approach To make sure that we build a commercial infrastructure and platform to enable us to leverage the pipeline. So we're ready. We're really happy with the way our DCC or digital centric commercialization platform is performing with regards to Avelity As well as the Sunosi. And so that experience is allowing us to hone it to make it even better.

Speaker 2

And we will be leveraging that with the fibromyalgia launch. With respect to Your question on reboxetine and the data set for the filing, the data set will consist of The SYMPHONY Phase 3 trial, which is ongoing, as well as the CONCERT Phase 2 trial, in addition, there is an ongoing open label Safety extension trial that is also required for the filing. So those three studies will form The basis for the year finally.

Speaker 9

Okay. That's helpful. Thank you.

Operator

Thank you. The next question is coming from Jason Gerberry of Bank of America. Please go ahead.

Speaker 11

Hi, guys. Good morning. Thanks for taking my questions. I guess, firstly, just on the patent front, a little surprising, we're about a year post Launch with only a single paragraph for us. So curious, any views on your end like what might be going on here, Perhaps most of the generics are going paragraph 3 since they can't get first to file.

Speaker 11

But on the flip side, maybe this trend might be real and maybe there's going to be limited IP challenges, just giving the breadth of your IP. And then my second question is just your thoughts, specifically to narcolepsy. Maybe how the Orexins could competitively have an interplay with 5. It looks like a drug that's Very potent on MWT, but may have a trade off with insomnia rates as a sleep disorder trade off. So just curious Your thoughts on the emerging profile of Oraxans and how that could competitively interplay with 5.

Speaker 11

Thanks.

Speaker 3

Jason, this is Hunter Murdock. Thanks for the question. As a matter of practice, we really can't comment On ongoing legal proceedings, but I can tell you we're very proud of our extensive portfolio on Avelity and we don't have any further comment on it.

Speaker 2

And maybe I'll touch on your question around the Orexanes and How they might impact the market. So we like our portfolio. We do have Sunilzi, which is approved to treat effective daytime sleepiness In patients with narcolepsy and then we have AXS-twelve and as you know, we're waiting with the readout of that Phase 3 trial And the primary endpoint for that study is cataplexy. So when we think about the market and the need and I'll let Laurie Talk about that. One of the aspects of the disease to be cognizant of is that There are multiple symptoms that these patients experience.

Speaker 2

So no one treatment will address each symptom. So we like our portfolio, which should be able to address more than one of those symptoms. Laurie?

Speaker 6

Yes. And of those that are on the market and approved right now, Patients have to endure really difficult dosing schedules. They trade off efficacy for tolerability or vice versa. So there is still a high unmet need

Operator

Thank you. The next question is coming from Joon Lee of Truist Securities. Please go ahead.

Speaker 12

Hey, thanks for taking our questions. Binge eating for psoriatico sounds like it could be either a niche Or a huge opportunity. How are you framing the prevalence and commercial opportunity of vingenine in the U. S. For psoriamphetil?

Speaker 12

And I have a follow-up.

Speaker 6

Hey, Jean. Yes, we are also very excited about the potential here for binge eating disorder. It is the most common eating disorder. $7,000,000 is the estimated prevalence right now. Only very, very limited treatment options are available for patients.

Speaker 6

So again, high unmet need in a disease that is incredibly prevalent.

Speaker 12

All right. Looking forward to your event on that. On the narcolepsy study, would hitting statistical significance on cataplexy, but not on excessive The time syndrome is keeping us a good outcome or is it your goal to hit statistical significance on both cataplexy and EBS?

Speaker 2

So the primary endpoint of the study is cataplexy. And We're not going to speculate in terms of what the results would be or could be. We're close. So you'll know very soon.

Speaker 12

All right. Looking forward. Thank you.

Operator

Thank you. The next question is coming from Ram Selvaraju of H. C. Wainwright. Please go ahead.

Speaker 8

Hi, thanks for taking my questions. First one is on binge eating disorder. Can you maybe clarify for us what you expect the competitive landscape, if any, To be for your drug candidate as and when it might secure a label for this indication?

Speaker 6

Hey, Ram. Yes, happy to. Right now, again, there is, I think one product available for binge eating disorder, Generic, it is highly prevalent SSRIs, SNRIs being prescribed for the disorder. So we think we have an opportunity to really differentiate ourselves clinically in the marketplace.

Speaker 8

Okay, great. And then can you just refresh my memory regarding your timeline with regard to smoking cessation? And ultimately, If you could just kind of sketch out for us strategically, assuming a label in that indication, ultimately, how you expect Promotion activities, sales and marketing activities for that indication to dovetail with what you already have in the field?

Speaker 2

There is an obvious overlap in terms of therapeutic area for smoking cessation and the rest of our psychiatry And neurology pipeline, so we like the concentration. And I think a lot It will depend upon the clinical profile as it evolves from our Phase III trials.

Speaker 8

Thank you.

Operator

Thank you. The next question is coming from Joseph Fome of TD

Speaker 13

Maybe the first one on the additional 100 person sales force. Can you go into a little bit more detail on the incremental call points? Are these primary care physicians or are they additional specialists that you weren't Seeing earlier and given that the staff is going to be hired, the group is going to be hired by the end of the Q1, should we expect more of like a Q2 impact from that or how are you thinking about that? And then 2nd, on the core data presented at CTAD, it looked like dizziness popped up as the largest TEAE, but then impressively that went to 0 In a double blind period. So can you just talk a little bit about dizziness with AXS-five?

Speaker 13

Does this go away with time? And what kind of the grade of that AE? Thank you.

Speaker 6

Hey, Joseph. I'll address the expansion. So as we mentioned last quarter And refresh everyone's memory at this readout. We are expanding our sales force from about 26,000 TTP targets to 44,000 HCP targets. That will take a higher number of PCPs into that number.

Speaker 6

But what we Have remained focused on is the highest likelihood to prescribe HCPs. Of those 44,000 HCPs, They are writing 90% of new branded therapies on a weekly basis. So we feel like we have a great opportunity to tap into optimize the growth by the product.

Speaker 2

Great. And with regards to the question around dizziness in the ACORE trial, your observations are correct. The dizziness was mild. It was transient. It decreased over time and it did not result in discontinuations.

Speaker 11

Great. Thank you very much.

Operator

Thank you. The next question is coming from Yatin Suneja of Guggenheim. Please go ahead.

Speaker 8

Hi, good morning. Thanks for taking our questions. This is Eddie on Priyat. And just one from us. In light of the increasing sales This quarter, how should we think about the quarter over quarter script increases for Avelity?

Speaker 8

And do you expect the Increased sales force to really show increased cadence then or

Speaker 1

do you think we'll have

Speaker 8

to wait until later in 2024 before we see an inflection there?

Speaker 6

Yes. Hey, Eddie. So as we mentioned before, we should have the field hired and trained and Promoting by Q1, but it does take a little time for new sales reps to establish themselves and get out there to produce. So We don't expect any kind of meaningful uptick until later in the year.

Operator

Thank you. The next question is coming from Greg Souvannavejhaya of Mizuho Securities, please go ahead.

Speaker 14

Good morning. Thanks for taking my questions and congratulations on Good quarter. Just wondering if you could please comment on gross to net in the Q3 for both Vodality and Sunosi And whether Q3 reported sales for both products reflected any changes in inventory? And I have a follow-up please. Thanks.

Speaker 3

Sure, Greg. So the growth in that for Avelity in the quarter was approximately 50%. That was an improvement from the previous quarter, which had a GTN discount that was in the low to low to mid-50s. Sunosi as well Was in that low 50s, very similar to where we saw in the previous quarter. As it relates to inventory, We've always shared that we maintain roughly 2 weeks of inventory in channel.

Speaker 3

So there was no inflection as it relates to the sales for Inventory for neither Avelity nor Sunosi.

Speaker 14

Great. Thanks. And then So, thanks, Steve. From there, you've done a nice product. But given peak sales that you put out there of $300,000,000 to $500,000,000 I'm just wondering if maybe you can comment on kind of how we should Expect kind of the time to peak sales and what the dynamic might look like between OSA and narcolepsy mix?

Speaker 6

Yes, Greg, I'll answer and then Nick, don't forget to chime in if there's anything else you want to add. So right now, the split between OSA narcolepsy is about 70% OSA, 30% narcolepsy. That's to be expected. OSA prevalence is about 22,000,000 patients, Whereas narcolepsy is 185,000 to 200,000. So we do expect OSA to continue to increase.

Speaker 6

Right now, of those 22,000,000 OSA patients, only about a 1,000,000 patients are actually drug treated. So our path to peak sales will come with increased Efforts and education and understanding of OSA and treating the disease, which we are very heavily doing and have started doing Several quarters ago. So we are anticipating that that promotional effort will continue And Peak Sales will stay in follow-up.

Speaker 3

Yes. And the other thing I'll maybe add is that while we're continuing to grow very nicely in the U. S. Market, Ex U. S, there has been a refocus with the Pharmanovia transaction that was announced earlier.

Speaker 3

And Pharmanovia is really ramping up Their sales and marketing strategy and we would expect to start seeing Significant international sales and on from our perspective royalty revenue as it relates to the Pharmanovia strategy.

Speaker 14

Okay. Thank you.

Operator

Thank you. The next question is coming from Myles Rose Mittner of William Blair, please go ahead.

Speaker 6

Hi, good morning. You've got Sarah on

Speaker 15

for Miles. Congrats on another great quarter. So two quick ones from us. Do you guys have any internal goals about the Avelity prescribing mix between primary care physicians and specialty Referrals account referral accounts? And then secondly, do you is there any read through or learnings from the Rexalte approval in Harmar's disease agitation and how do you see AXS-five differentiating from that recently approved option?

Speaker 15

Thanks.

Speaker 6

Hey, Sarah. I'll take the first one. So in terms of goals, We don't really we don't typically look at it that way. As mentioned, we take a look at the prescribers that are most likely to prescribe. Right now, there's about 80% psych, 20% PCP.

Speaker 15

That's to

Speaker 6

be expected, Especially with a novel mechanism of action and our new product coming to market, consistent with our expansion and as we expand out to broader PCP sets, We do expect that to level out a little bit.

Speaker 3

Great.

Speaker 2

And with regards to RYXALTI and any learnings from there, We've been happy with our clinical development plan with regards to AXS-five and Alzheimer's disease agitation. We like the clinical profile thus far from our completed trials, which have been consistent. And we think that it is and will remain differentiated as it relates to As it relates to Rexalte.

Speaker 15

Great. Thanks for taking the question.

Operator

Thank you. We're showing time for one final question today. The last question is coming from Matt Kaplan of Ladenburg Thalmann. Please go ahead.

Speaker 10

Hey, good morning guys and thanks for taking the question and congrats on the strong quarter. Just wanted to Talk a little bit about the ADHD opportunity for Sanofi and what the potential And can you describe the market maybe more for Lori in terms of the unmet need there?

Speaker 6

Yes. Hey, Matt. Yes, we again, we are very excited about ADHD for solriamfetol. Prevalence for ADHD across pediatrics as well as adults and adolescents is about 17,000,000 so highly prevalent Condition, it's a very large market, right now, lots of prescriptions on a monthly basis. The way that you can take a look at the market and think about the market now and the way that we're evaluating is really you break it up into stimulants and non stimulants.

Speaker 6

Stimulants really have Rather large effect sizes, but they do have safety risks that come along with that, while your non stimulants are safer, But they have less effect sizes. So we are excited again for the opportunity for spironiprazole in ADHD.

Speaker 10

Thanks again.

Operator

Thank you. At this time, I'd like to turn the call back over to Axsome's CEO for any concluding remarks.

Speaker 2

Well, we thank you all for joining us on today's call. I am proud of the efforts made by our outstanding team At Axsome, we're excited by the opportunity ahead of us for both Sunosi and Avelity as we continue to progress our industry leading CNS pipeline. As we close out 2023, we are on track to deliver on multiple potentially value driving milestones on the clinical and regulatory front over the next 12 months. Our team is working hard to deliver on our goal of having potentially at least 5 marketed products by 2025. We look forward to updating you on our progress.

Speaker 2

Have a great rest of your day.

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Key Takeaways

  • Axsome reported Q3 net product revenue of $57.8 million, up 244% year-over-year, driven by Avelity ($37.7 M; 36% sequential growth) and Sunosi ($20.1 M; 20% year-over-year growth).
  • The late-stage pipeline remains active, with NDA resubmissions for AXS-7 (acute migraine) expected in H1 2024 and AXS-14 (fibromyalgia) in Q1 2024; Phase III readouts for AXS-12 (narcolepsy) and AXS-5 (Alzheimer’s agitation) are slated for early 2024, and solriamfetol trials in ADHD, binge eating disorder, and shift work disorder will begin by year-end/Q1 2024.
  • Avelity achieved ~69,000 prescriptions in Q3 (30% sequential growth) with ~55,000 unique patients since launch; Axsome is expanding its field force by ~100 reps to reach ~44,000 prescribers and has secured coverage for ~70% of all lives (48% commercial; ~100% Medicare/Medicaid).
  • Q3 net loss was $62.2 million ($1.32/share) versus $44.8 million ($1.07/share) in Q3 2022, with R&D expenses of $28.8 million, SG&A expenses of $83.2 million, and a cash balance of $416.6 million at quarter-end.
A.I. generated. May contain errors.
Earnings Conference Call
Axsome Therapeutics Q3 2023
00:00 / 00:00