Q3 2023 Axsome Therapeutics Inc Earnings Call
Good morning, and welcome to Axon 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.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad. 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 of Axon Therapeutics. Thank you. Please go ahead 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 third quarter of 2023.
The release crossed the wire, a short time ago and be available on our website at axon Dot com.
During today's call, we will be making certain forward looking statements. These statements may include statements regarding among other things you have ticketing safety and intended utilization of our investigational agents our.
Clinical and non clinical plans.
To prevent the report date.
The anticipated conduct and the source of future clinical trials regulatory plans future research and development plan, our commercial plans regarding thing.
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.
Yeah.
These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports.
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 area, Attributor, Chief Executive Officer, Mike Pizzi, Chief Financial Officer, and Lori Inglebert Executive Vice President product strategy area will provide an overview of the company and progress made in the third quarter of 2023 as well as key upcoming milestones.
Following Ariel Nick will review our financial results.
Lori will provide a commercial update.
We will then open the line for questions.
Questions will be taken in the order they are received.
That I will turn the call over the area.
Thank you Mark good morning, everyone and thank you for joining excellent therapeutics third quarter 2023 financial results and business update conference call.
In the third 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 medicines to patients with serious brain disorders and to the health care providers.
Okay.
Total net product revenue in the quarter was $57 8 million, representing significant year over year and quarter over quarter sequential growth.
The quarters strong showing reflects contributions from both the ability and so nosy.
Well that <unk>, our first in class oral NMDA receptor antagonist and Sigma one receptor agonist has now been on the market for one year.
Its commercial performance to date reflects its fast onset and lasting efficacy as demonstrated in clinical trials.
Later in the call Nick will provide additional details on our quarterly financials and Lori will go into more detail on our commercial performance.
While we are proud of the positive market reception formality to date.
The progress we have made with some nosy do you believe that we have barely scratched the surface of these opportunities.
Look forward to continued commercial execution to realize the tremendous potential for these two differentiated medicines.
Our commercial success to date has been enabled by strong clinical profiles formality, and so nosy and by our efficient effective and innovative digital centric commercialization or D. C. C approach.
We will continue to deploy this platform with our expanded Ovality salesforce to further drive business performance.
In addition, we intend to fully leverage the deep sea platform for the potential commercialization of our broad late stage pipeline.
I will provide a brief update on the pipeline progress, including some anticipated upcoming clinical and regulatory milestones.
Starting without too in the speech products.
Well he excess of 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 excess 14 for the management of Fibromyalgia, which is on track for submission in the first quarter of 2024.
Moving on to a phase III clinical programs.
The phase III simply trial of excess 12 for the treatment of narcolepsy is on track to complete enrollment this year.
With announcement of topline results expected in the first quarter of 2024.
The phase III advance two trial, what makes it so five for the treatment of old English disease agitation is on track for completion in the first half of 2024.
In July we initiated a focused phase III trial of Sabri answer calls in ADHD.
We anticipate completion of this trial in the second half of 'twenty 'twenty four.
We previously announced that we intend to develop so ran for tall for the treatment of binge eating disorder and for the treatment of excessive sleepiness associated with shift work disorder.
These are two new potential indications with significant patient populations.
Limited treatment options.
We are on track to initiate phase III trials in Psoriatic call in binge eating disorder by the end of this year and shift work disorder in the first quarter of 2024.
Further details about these clinical programs will be provided at a solid reemphasize investor day planned to be held before year's end.
Overall, the third quarter 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.
Thank you Ariel and good morning today, I will discuss our third quarter results and provide some financial guidance total.
Total revenue in the third quarter of 2023 was $57.8 million representing year over year growth of 244%.
Revenue consisted of net sales of our two commercialized products <unk>, Sanofi and royalty revenue from Sanofi sales and out license territories.
Revenue for the comparable period was $16 $8 million.
I only have U S. Sanofi sales visibility was not launched until October of 2022.
<unk> net sales in the quarter were $37 $7 million, representing 36% sequential growth with no net sales in the comparable 2022 period due to the timing of launch.
The notes the net revenue for the quarter was $21 million, representing 20% year over year growth.
Sanofi net revenue consisted of net sales of $19 4 million and $7 million in royalty revenue from sales in the out licensed territories.
The notes the net revenue for the comparable period was $16 $8 million.
Cost of revenue was $6 5 million in the quarter compared to $1 9 million in the prior year period. The increase reflects the higher product volumes for both ability and Sanofi in the current year.
Research and development expenses were $28 8 million for the third quarter versus $14 9 million for the comparable period in 2020 to.
The increase was primarily related to the focused trial saw reenter tall in ADHD.
The advancement of ongoing trials of access of five and the access 12.
DMC costs associated with the N V as for access to a seven and a excess 14.
Marketing commitments for a valid and Sanofi.
And higher personnel costs, including noncash stock based compensation.
Selling general and administrative expenses were $83 2 million for the third quarter versus $40 9 million for the comparable period in 2020 to.
The increase was primarily related to commercial activities for ability and Sanofi.
Higher noncash stock based compensation expense due to the build out of both the commercial teams.
Net loss for the third quarter was $62 2 million or $1 32 per share versus a net loss of $44 $8 million or $1 seven per share for the comparable period in 2022.
We ended the quarter with $416 $6 million in cash and cash equivalents compared to 200.8 million as of 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'll now turn the call over to Laurie who will provide a commercial update.
Thank you Nick and good morning, everyone.
In the third quarter that was ability internet delivered strong growth results. Despite typical market seasonality.
Or validated we recently reached an important milestone of being on the market for one full year.
Market reception has been very positive.
Slapping the clinical profile of this new treatment.
Well, the only thing works fast and less with rapid improvement in depression, sometimes starting at one 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.
So Nancy I re launch efforts are resulting in solid growth year over year and quarter over quarter.
Both brands are meaningfully impacting the lives of patients and we expect continued growth in quarter four and beyond.
Q3 represents only the third full quarter personal launch for a reality.
In the quarter approximately 69000 prescriptions were written for our ability.
Representing 30% quarter over quarter Glenn.
This performance is in contrast to a decline of 1% for the overall anti depressant market during the same period due to market seasonality.
In the third quarter Hep's write prescriptions for more than 16000, new patients, bringing the total number of the new person will start a reality since months. So approximately 55000 at the end of Q3.
Prescription growth came from both an increased depth of prescribing with HCP adopters as well as an increase back with new prescribers.
In the third quarter, we added approximately 3200, new first time prescribers.
Increasing the cumulative total prescribers since launch to 13000.
As mentioned during our Q2 earnings call and response to our early launch success and growing demand. We are expanding the ability sales force by about 100 sales representatives.
So 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 first quarter.
The expansion will increase our reach from 26000 prescribers to approximately 44000 subscribers.
These 44000 institutions right approximately 90% of new to brand prescriptions.
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 ability coverage is now at 48% of covered lives.
In the Medicaid and Medicare channels.
100% of lives are covered.
Active discussions with payers continue as coverage expands and evolves.
Turning to Sanofi.
Total prescriptions for some nicely in the U S grew 16% year over year and 5% sequentially.
Likeability Sanofi experienced meaningful demand growth in the third quarter. Despite the expected overall market decline due to summer seasonality.
The steady growth of Sanofi can be attributed to our focus promotional investments and so nicely differentiated clinical profile.
Since Q3 of last year. So nice he has added 14000 unique mutations which represents an increase of 40.
40% and so a lot of questions over the past year.
Our field team continues to work on driving depth within the current prescriber base and Brett by adding new prescribers.
Since Q3 of last year, we had increased unique new writers assume nicely by 23%.
Payer coverage Crystal nicely remains Bob with 95% of commercial lives and 83% quite of lives covered.
Okay.
We expect our promotional efforts to drive continued growth for the product and the current indication.
In addition, Sanofi has significant growth potential in new target indications, including ADHD and eating disorder answer the phone.
Overall, the ability internally to prepare for strong performance in the quarter.
We remain focused on commercial execution to maximize the potential of these clinically differentiated treatments, let's address patient populations with high unmet needs.
I will now turn the call back to Mark to lead the Q&A discussion.
Thank you Laurie operator may we please have our first question.
Thank you. The floor is now opened for questions. If you would like to ask a question. Please press star one on your telephone keypad at this time.
Formation of tone will indicate your line is in the question queue. You May press star two if he would like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up the handset before pressing the star keys.
Our first question today is coming from Charles Duncan of Cantor Fitzgerald. Please go ahead.
Hey, good morning, <unk> and team congratulations on a really nice quarter. Thanks for taking our question.
I had a couple one is commercial one is pipeline, perhaps for Lori or whoever wants to answer it regarding a valid 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 would result in Ah patients staying on the drug longer than you might expect for.
And then a depression.
Hey, Charles I'll take that question.
So it's really a few questions I think thanks for asking it is one that where we're still working through we have just hit our one year Mark So it's still a bit hard to comment on the long term persistence.
Reis for MLD, where we're not seeing anything particularly different than what you would expect it from a therapeutic area.
That no from an anecdotal feedback as well as what we're seeing in refill prescriptions anecdotal feedback and the product is working part of the label early on how we really heard about was the rapid onset of action.
But now now that were you know just take passed the one year Mark we are starting to hear about the durability of effect for the product and the product as fast and it laughs, which is consistent you know anecdotal feedback from both Acp's.
And patient and we're starting to see that through you just didn't have the healthy number of refill prescriptions.
Yeah. That's that's that's evidence that clinicians and patients are seeing a response and a continuing treatment.
Very good.
I think I cannot I'm, sorry, I was just going to ask.
Arriving of mutations we're still very pleased with the number of new patient acquisition that where we're getting on a weekly basis.
Okay. That's a positive I 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 are not yet there.
Yeah, I think we're still a bit early on will you know, we'll continue to ponder that as we get closer towards the end of the year and into 'twenty.
2024.
But there is there is so many variables at this point.
Giving guidance is.
As.
Okay.
It is difficult at this point, so standby but.
Here the question Charles.
Okay. Okay regarding maybe day area regarding the pipeline I had a question about <unk>, you know I'm really intrigued with advance to Alzheimer's.
Alzheimer's disease agitation.
I'm wondering eat 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 samples that you are enrolling on obviously on a blinded basis, thus far.
How are you confirming Alzheimer's disease diagnosis or is a symptom presentation of crash neuro degenerative disease are not all that different and so you don't really need to confirmed diagnosis of Alzheimer's.
Thanks for the question Charles the patient sample that we're enrolling.
Good match or is matching the sample that we enrolled in the advance one trial and the way that we can find diagnose diagnosis or through validated scales for both <unk> disease as well as for agitation.
Well, except it scales in the same ones that we used in the advance one trial.
So that is used in other studies most diverse disease.
Okay, but you're not you're not doing imaging correct.
I'll feel that's necessary.
No why imaging or biomarker studies.
Yeah.
We are not doing imaging.
Okay, or no or by blood based biomarkers.
We are not doing imaging biomarkers for enrolment into the trial and that's pretty standard for studies of old timers disease that look at cognition or behavioral symptoms.
Yeah makes sense.
So a clinical diagnosis, okay. Thanks for taking the questions.
Okay.
Thank you. The next question is coming from Marc Goodman of Leerink Partners. Please go ahead.
Hey morning diesel Judy on the line from Mark since for taking my questions. So just a quick follow up too.
Two other ones. Two question. So can you talk about your expectations for the upcoming Readouts.
What data do you think will be adequate to support an NDA filing for these indications.
So I assume that that question has to do with one of them was that he's agitation.
And in terms of data from upcoming Readouts, We do have the advanced two trial, we expect that to complete and read out in the first half of 2024.
And that along with the results from our prior studies as well as you won't go and open label safety trial will be a little form the basis for the F&B finally.
Yeah.
Okay, but do you still need now.
No.
<unk> grown at once to you would have to file for that indication.
The other three studies, which are or efficacy trials, which will which will be in the package or the advance one trial.
The accord study as well as the ongoing events two trial.
Okay. That's helpful. Thanks.
Thank you. The next question is coming from Vikram, a parent of Morgan Stanley. Please go ahead.
Hi, good morning, Thanks for taking our question too.
From our side one on narcolepsy. It seems like there was a little bit of a slip on.
For expected data readout from our late this year to <unk> of next year, just wanted to get some context on what might have driven that and then secondly for the <unk> launch.
What is your latest sense on the breakup of patients you're seeing across lines of therapy.
Yeah.
Great. Thank.
Thank you I'll take the first question and we'll have Lori take the second question with regards to narcolepsy and the excess 12 study.
The change in terms of when we expect to have top line results is driven purely by enrollment.
We're on track to complete enrollment by the end of the year.
Hey, Vikram. So in terms of the type of patients that where we're seeing right now about 10% to 12% R. R.
First line therapy, but the majority of the overwhelming majority is about 60% of the patients that we're seeing have failed one or two prior therapies. So.
And then all up 70%.
One or two or a brand new to therapy.
Okay.
And I would just add that we are.
We're really pleased that this early on in the launch 40% of patients.
Either or brand new or have failed wound treatment.
Understood. Thank you.
Thank you. The next question is coming from David <unk> of Piper Sandler. Please go ahead.
Yeah.
Hey, Thanks, just a couple so first on.
On.
The S reboxetine.
The filing and an opportunity how are you thinking about the fit of that commercially within the organization. I mean, my understanding is it's a you know 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 one and then number two or.
For Reboxetine is it your expectation that.
You'll be filing on this on this data set or are there any other gating.
Gating items to our filing in the narcolepsy setting.
Thanks.
Yeah, Hi, al I'll take that I'll take the first one on fibromyalgia. So you you're exactly right if I round.
It's an incredibly underserved market 5 million patients in the U S. Only three products are approved to treat right now theyre all generic widespread there hasn't been any promotional dollars in the area for a very long time patience Hep's are all very very frustrated.
With this patient type because they 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 them, but what we are.
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 ACP and patients are educated well on the disease State and then we'll focus our field force on the highest.
Right highest likelihood to prescribe <unk>.
Right.
Uh huh.
Great and I'll, just add that to what more you said one of the things that we've always been mindful of.
In designing our commercial approach is is to make sure that we built 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 center commercialization platform is performing with regards to modality as well as us to nosy and some.
That experience is allowing us to hone it tends to make it even better.
And we will be leveraging that with fibromyalgia March.
With respect to your your question on Remoxy the team and the biggest set for the filing the dataset will consist of.
The Symphony Phase III trial, which is ongoing as well as the concert phase II trial.
In addition, there is an ongoing open label safety.
Safety extension trial that that is also required for the filing so and.
So those three studies.
The basis for the filing.
Okay. That's helpful. Thank you.
Yeah.
Thank you. The next question is coming from Jason <unk> of Bank of America. Please go ahead.
Oh, Hey, 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 four so curious.
Any views on your AD like what what might be going on here, perhaps most of the generics are going paragraph III since they can't get first to file but on the flip side, maybe this trend might be real and maybe there's going to be limited IP challenges given the breadth of your IP and then my second question is just your thoughts specifically to narcolepsy.
I see maybe how the orexin could competitively have.
I have an interplay with Oh five it looks like a drug that's very potent on M. W. T, but may have a tradeoff with insomnia rates.
Sleep disorder tradeoffs. So just curious your thoughts on the emerging profile of Orexin is and how that can competitively interplay with O five thanks.
Jason This is hunter Murdoch. 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.
<unk> ability and we don't have any further comment on it.
Great.
And.
Maybe I'll touch on your question around the Orexin and.
How they might impact the market. So we like our portfolio would you have seen nosy, which was approved to treat excessive daytime sleepiness in patients with narcolepsy and then we have an excess 12.
One is as you know we're waiting with the readout of that phase III trial, and the primary endpoint for that study as cataplexy.
When we think about the market and the need and I'll, let lorie talk about that in one of the.
Aspects of the disease through to be cognizant of is that there are multiple symptoms that these patients.
Spirit so.
No one treatment will address each system, so we like our portfolio, which should be able to address.
More than one of those symptoms.
And as those that are on the market and approved right now patients have to endure a really difficult dosing schedules.
Good off efficacy or tolerability or vice versa. So there is still a high unmet need in this orphan indication for patients.
Yeah.
Thank you. The next question is coming from Joon Lee of <unk> Securities. Please go ahead.
Hey, thanks for taking our questions.
Basically four sorry, as opposed sounds like it could be either a niche or huge opportunity. How are you framing the prevalence and commercial opportunity and Judy and the U S. For so you have to talk.
I have a follow up.
Hey, Dan.
Yeah, where we are also very excited about the potential here for binge eating disorder. It is the most common eating disorder 7 million is the estimated prevalence right now only in a very very limited treatment options.
<unk> are available for patients so again high unmet need and are in a disease that is incredibly prevalent.
Alright.
Looking for tier events on that on the narcolepsy study, what hitting statistical significance on cataplexy, but not on just update time syndrome speaking thats, a good outcome or.
Is it your goal to hit statistical.
Statistical significance on both cataplexy and eds.
For the primary endpoint of the study is as cataplexy.
And.
We're not going to speculate in terms of what versus.
It would be or could be where close so youll know very soon.
Alright, okay.
Looking for thank you.
Thank you. The next question is coming from Ron <unk> of H C. Wainwright. Please go ahead.
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.
And when it might secure label for this indication.
Hey, Ron Yeah happy to Yeah, right now again, there is a I think one product available.
For binge eating disorder generic and is highly prevalent ssris F&I is being prescribed for the disorder.
We think we have a you know an opportunity to really differentiate ourselves clinically in the in the marketplace.
Okay, Great and then can you just.
Refresh my memory regarding you know your timeline with regards 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're already.
We have in the field.
There is an obvious overlap in terms of therapeutic area.
For smoking cessation and the rest of our psychiatry and neurology pipeline. So so we like the concentration and I think you know a lot will depend upon the clinical profile as it evolves from our phase III trials.
Thank you.
Thank you. The next question is coming from Joseph some of TD Cowen. Please go ahead.
Hi, there good morning, and thank you for taking my questions. 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 are the additional specialists that you werent seeing earlier and given that the staff is gonna be hired a group it would be higher by the end of the first quarter should we expect more of like a Q2 impact from that.
Or how are you thinking about that and then second on the core data presented at <unk>. It looks like Disney has popped up as the the largest E <unk> and principally that went to zero.
And the double blind period. So can you just talk a little bit about dizziness with Axa. So five to just go away with time.
And what kind of a grade of of that thank you.
I'm sorry.
Hey, Joseph I'll address the expansion so as we mentioned last quarter and refresh everyone's memory at this.
This readout.
We are expanding our sales force from about 26000, HCP targets to 44000 ACP target.
That will take you know a higher number of P. C piece into to that number but what we have remained focused on is the highest likelihood to prescribe <unk>.
Hcp's of those 44000 HCP.
They are writing 90% of new.
Branded therapies them on a weekly basis. So we felt like we have a great opportunity to.
To tap into.
Optimize the growth of the product.
Great.
Yes.
With regards to the.
Question around dizziness, and the court trial your observations are correct.
The business was a mild transient decreased over time and it did not result in discontinuation.
Great. Thank you very much.
Thank you. The next question is coming from Yadkin nature of Guggenheim. Please go ahead.
Hi, Good morning, Thanks for taking my questions. This is Eddie on for yacht and just just one from us in light of the increasing Salesforce. This quarter, how should we think about the quarter over quarter script increases for ability.
And do you expect.
The increased.
Increased sales force to really show increased cadence then or do you think you'll have to wait until a later than that in 2024 before we see an inflection there. Thanks.
Yeah, Hey, Eddie.
So as we mentioned before we should have the sale of hired and and.
Yeah trained and promoting by Q1, but it does take a little time for new sales reps to.
Establish themselves M N and get out there to produce so.
We don't expect any kind of meaningful uptick until until later in India.
Yeah.
Yeah.
Thank you. The next question is coming from Greg.
She was a navy yard of Mizuho Securities. Please go ahead.
Good morning, Thanks for taking my questions and congratulations on a good quarter.
Just wondering if you could please comment on grub.
Gross to net in the third quarter for both locality and Sanofi and weather third quarter reported sales for both products, reflecting any changes in inventory.
A follow up please thanks.
Sure Greg.
So the gross to net for ability in the quarter was approximately 50%.
Was an improvement from the previous quarter, which had a GCN discount that was in the low to.
Low to mid fifties.
Sanofi as well.
Was in that low 50 is very similar to where we saw in the previous quarter.
As it relates to inventory.
We've always shared that we maintain roughly two weeks of inventory in channels. So there was no.
No inflection as it relates to the sales for <unk>.
Inventory for neither ability north Sanofi.
Great. Thanks, and then.
Okay.
Now see.
It's actually there you've done a nice product.
But.
Given our peak sales that you've put out there of 300 to 500 billion I'm. Just wondering if maybe you could comment on kind of how we should expect kind of the time to peak sales.
What the dynamic might look like between OSA and narcolepsy.
Yeah, Greg I'll I'll answer and then Nick chime in if there's anything else you want to add so right now the split between OSA and narcolepsy is about 70%, let's say, 30% narcolepsy that's to be expected OSA prevalence is about $22 million at.
Ah patients, whereas narcolepsy as you know 185 to 200000.
We do expect let's say to continue to increase right now of those 22 million OSA patients only about 1 million patients are actually treated so are past the peak sales will come with increased efforts in education and understanding of OSA and in treating the disease, which we are very heavily.
Doing and have started doing.
Several quarters ago.
So we are anticipating.
Anticipating that that that promotional effort will continue and and peak sales force team.
Yes, and the other thing I'll, maybe I'll add is that while we're continuing to grow very nicely in the U S market ex U S. There's been a refocus with the farm in earlier transaction that was announced earlier.
And pharma is really ramping up their sales and marketing.
Strategy.
And we would expect to start seeing significant international sales and from our perspective royalty revenue as it relates to the format of the strat.
Strategy.
Okay. Thank you.
Thank you. The next question is coming from Myles Minter with William Blair. Please go ahead.
Hi, Good morning, you've got Sarah on for miles congrats with another great quarter.
Just two quick ones from US do you guys have any internal goals about the ability prescribing between primary care physicians and specialty referrals account.
And then secondly did you.
Is there any read through or learnings from Iraq salty approval in Alzheimers disease agitation and how do you see as differentiating from that recently approved an option.
Hey, Sara I'll take the first one so in terms of goals we.
We don't really we don't we don't typically look at it that way and as I mentioned you know we take a look at the prescribers that are most likely to prescribe <unk>.
Right now, there's about 80% cyc, 20% TCE.
TCP that's to be expected, especially with a novel mechanism of action and a new product come to market.
Consistent with our expansion and as we expand out to broader PCP says, we do expect that to level out a little bit.
Great.
And with regards to <unk> and any learnings from there.
We've been happy with our clinical development plan with regards to excess of 500 disease agitation, we like the clinical profile, thus far from our completed trials, which have been consistent.
And we think that it.
It is and will remain differentiated as it relates to <unk>.
Yeah.
Great. Thanks for taking the question.
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.
Hey, good morning, guys and thanks for taking my question and congrats on a strong quarter.
Just wanted to talk a little bit about the ADHD opportunity.
Personnel theme and what what the potential is there and can you describe the market maybe more for Lori in terms of the unmet need there.
Yeah, Hey, Matt Yeah. We again, we are very excited about ADHD.
First of all we have to tell prevalent for ADHD across you know pediatrics as well as us as adults and adolescents is about 17 million. 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 break it up into stimulant and non stimulant stim.
Stimulants really have rather large effect sizes.
But they do have safety risks that come along with that while you're non stimulants are safer.
But they have less less effect sizes.
So we are we are excited again for the opportunity for personal ramp assortment in ADHD.
Okay.
Okay.
Thanks, Ken.
Thank you at this time I'd like to turn the call back over to <unk> CEO for any concluding remarks.
Well.
Thank you all for joining us on today's call.
I am proud of the efforts made by our outstanding team.
So we're excited by the opportunity ahead of us for both so nosy and mobility 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 fronts over the next 12 months. Our team is working hard to deliver on our goal of having potentially at least five marketed products by 2025, we look forward to updating you on our progress have a great rest of your day.
Ladies and gentlemen, thank you for your participation. This concludes today's event you may disconnect your lines cause log off the webcast at this time and enjoy the rest of your day.
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