Q1 2023 Axsome Therapeutics Inc Earnings Call
Yeah.
[music].
Hello, and welcome to the Axon Therapeutics first quarter 2023 financial results conference call and webcast. If anyone should require operator assistance. Please press star zero on your telephone keypad.
<unk> and answer session will follow the formal presentation.
You May ask a question at any time by typing them into the ask a question feature on your screen. As a reminder, this conference is being recorded its now my pleasure to turn the call over to Mark Jacobson. Please go ahead Marc.
Thank you operator, 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 first quarter of 2023 release crossed the wire a short time ago and is available on our website at axon dotcom.
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.
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 some nosy mobility and our pipeline chronic revenue projections and possible intended use of cash and investments needs.
These forward looking statements are based on current information assumptions and expectations that are subject to change and involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward looking statements.
These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports you are.
And 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. Arie Youtube Youtube, Chief Executive Officer, Nick PV, Chief Financial Officer, and Lori Inglebert Executive Vice President of commercial and business development.
Area will provide an overview of the company and progress made in the first quarter of 2023 as well as upcoming milestones following Ariel Nick will review our financial results and then Lori 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.
Ariel.
Thank you Mark good morning, everyone and thank you for joining axle therapeutics first quarter 2023 financial results and business update conference call.
We saw strong performance in all areas of our business in the first quarter, which included advancing the commercialization of mortality and Sanofi.
Progressing our late stage product pipeline.
Out licensing ex U S rights for some nosy and strengthening our financial position.
Total net product sales in the quarter were $28 8 million driven by strong performance of LT and solid performance for some of that was the.
Based on the current prescription trends, we are pleased that our two marketed products are now, helping a growing number of patients living with depression.
And with excessive daytime sleepiness.
Later on the call we will provide further details on our commercial performance.
And so nosy.
The first quarter was an important milestone for axle as it was the first full quarter of sales formality.
We have also had control of the U S right Tusa nosy for about one year.
Earlier in the quarter, we announced the out licensing our ex U S marketing rights for <unk> in Europe , the Middle East and North Africa to former Nokia.
Former novia shares our excitement and commitment to maximize the potential of some of it was easy for patients worldwide.
We continue to see significant potential for some nosy both from the current indications as well as in potential new indications.
With regards to new indications, we remain on track to initiate a phase three trial of Psoriatic at all the active molecule in Sanofi in ADHD in adults in the second quarter.
In addition.
And it's all really amphenol for ADHD.
One of our leading CNS pipeline includes <unk> for migraine, the excess 12 for narcolepsy excess 14 for fibromyalgia in excess so five all timers disease agitation and smoking cessation.
Well actually so seven our developmental candidate for the acute treatment of migraine.
Manufacturing activities are moving forward to enable the resubmission of the San Diego, which is slated for the second half of this year.
With the excess 12 hour product candidate for the treatment of narcolepsy. We continue to expect top line results from the pivotal phase three symphony trial in the first half of this year.
With excess 14, our product candidate for the treatment of fibromyalgia manufacturing and other activities related to preparation for the planned submission of an NDA are continuing and we expect to be in a position to submit the NDA for this product candidate in the second half of this year.
With regards to access so five.
For the treatment of old timers disease agitation enrollment in the phase III advance two trial is progressing and we anticipate completing this trial in the first half of 'twenty 'twenty four and <unk>.
We plan to initiate a phase two three trial are being accessed so five in smoking cessation in the fourth quarter of 2023.
In sum, we expect the next 12 to 18 months to be eventful, because we drive the commercialization of mobility and some nosy.
And as we advance our research and development pipeline.
I will now turn the call over to Nick who will provide details of our financial performance.
Thank you Ariel and good morning today, I will discuss our first quarter results and provide some financial guidance.
Total revenue in the first quarter of 2023 was $94 $6 million consisting of net sales of our two commercialized products of LD and Sanofi.
The revenue from the Sanofi Europe , and Mena out licensing agreement signed with Pharmacopeia and royalty revenue from Sanofi sales recorded Biopharma novia.
<unk> net sales in the first quarter were $15 $7 million there were no net sales in the comparable period.
To know see revenue for the quarter was $13 $2 million.
U S. Sanofi sales were 11.2 million.
International revenue was $2 million, including approximately 300000 in royalty revenue from Sanofi sales, India out license markets.
As a reminder, there was a change in the distribution model during the quarter, which negatively impacted net sales by an estimated $3.3 million.
There were no net revenues in the comparable period for citizens.
Cost of revenue was $7.6 million in the first quarter compared to none in the prior year.
In addition to the manufacturing costs were a validated sanofi cost of revenue includes a one time charge of $5 million in licensing sharing fees from the upfront payment received in the first quarter.
Therefore cost of revenue excluding this one time charge was approximately $2 $6 million.
Research and development expenses were $17 $8 million for the first quarter versus $12 6 million for the comparable period in 2022.
The increase was primarily related to higher personnel costs associated with supporting the ongoing clinical trials.
Those marketing commitments for sustainability and non cash stock compensation expense.
Selling general and administrative expenses were $74 $2 million for the first quarter versus $25 7 million for the comparable period in 2022.
The increase was primarily related to commercial activities for mobility and Sanofi.
And higher noncash stock compensation expense due to the build out of both the commercial teams.
Net loss for the first quarter was $11 $2 million or 26 cents per share compared to a net loss of 39 6 million or $1 <unk> per share for the comparable period in 2022.
The decrease in net loss for the first quarter versus the comparable period was primarily due to product sales from modality, and Sanofi offset by higher selling general and administrative expenses related to these commercial activities and license revenue received from Pharmacopeia.
We ended the quarter with $246 $5 million in cash and cash equivalents compared to $208 million as of year end.
During the first quarter, we did not utilize our ATM facility.
In January of 2023, we amended our loan agreement with Hercules capital to increase the size of the facility to $350 million to reduce the interest rate and to extend the maturity and interest only periods, while accessing a $55 million tranche.
We believe that our current cash balance along with the remaining committed capital from the $350 million term loan facility with Hercules capital is sufficient to fund anticipated operations and the cash flow positivity based on our current operating plan.
I will now turn the call over to Laurie who will provide a commercial update.
Thank you Nick and good morning, everyone.
We are off to a great start for 2023 in Q1 marks another exciting quarter for axon with continued commercial growth how about ability and pharmacy.
We are pleased with the early metrics on a reality, which I'll point to a strong launch with significant long term potential.
And what how the relaunch efforts are progressing.
I will say, our key metrics and our commercial efforts for both brands starting with ability followed by Sanofi.
The end of Q1 represents the first full quarter of sales for ability and only five full months post launch.
We are still early in the launch but remain highly encouraged by that.
We'll be back on the question.
Approximately 31000 prescriptions are recorded in Q1 for Valerie.
Representing a growth of 298% in Q1 versus Q4.
We saw prescription growth accelerate through increased depth, but our early H C. P adopters as well as increase the breadth of prescribers.
At the end of Q1, our valleys prescriber base grew to over 6000 unique H C. P writers Boston 2200.
Okay.
Q4.
A T P for prescriptions for over 15000, new patients in Q1, bringing the total number of unique patients onto Valerie to over 21000 at the end of Q1 versus 6000, Oklahoma Court.
Our highly experienced sales force continues to drive adoption by educating ACP on the product profile of Gabelli.
Two high impact engagement.
Detailing on peer to peer speaker programs.
Force has now reached over 22008 he wants.
With regard to payer coverage coverage for <unk> across all channels is currently approximately 65% of all covered lives.
In the commercial channel, which is expected to be the primary channel for ability coverage is now at approximately 40% of covered lives and we look forward to additional formulary decisions in the coming months.
In the Medicaid and Medicare channels, approximately 100% of lives are now covered.
Overall payer coverage for identity is proceeding as expected during the standards six to nine months post launch period, when we expect additional formulary decisions.
Sure.
We remain pleased and extremely encouraged by the initial progress and are steadfast in our commitment to our focus of driving ATP adoption empowering patients and enabling quality access.
Major depressive disorder or N D. D is highly prevalent and a major public health concern with mental health crisis.
Apparently thankful.
21 million U S. Adults are diagnosed in 2020 and there was a report a significant increase in prevalence as a result of a claim dental.
<unk> is an important new therapeutic option for patients living with this chronic and devastating condition and we are proud of our efforts to make are already available to patients living with ADT and their physicians.
Turning to Sanofi.
In the first quarter total prescriptions for Sanofi in the U S grew 13% year over year and 4% quarter over quarter.
So no see generated this growth despite a flat overall market and typical Q1 challenges.
Payer coverage for skilled nursing her name is broad with 96% of commercial lives.
3% of total lives covered.
The growth potential for some nicely in the current approved indications remains substantial.
As a reminder, the first and only DNR I for excessive daytime sleepiness, and obstructive sleep apnea, and narcolepsy and the person only wake promoting agent proven to improve wakefulness grew nine hours.
Sanofi is the only branded therapy available for patients who suffer from eds, and OSA and we expect our increased and enhanced promotional and disease education efforts to drive continued growth for the product.
One in 'twenty three.
We recently launched our new all day or campaign for Sanofi.
New campaign increased updated creative content, additional HCP and patient support tool and new educational resources.
Launching this new campaign is an important next step in the relaunch that's a nice one and I look forward to updating you on our commercial efforts and results related to the C V launch in the coming quarters.
Our key commercial products ability and Sanofi address serious highly prevalent condition.
Bring meaningful innovation to millions of potential patients.
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 if you'd like to be placed in the question queue. Please press star one at this time one moment. Please while we poll for questions. Our first question is coming from Charles Duncan from Cantor Fitzgerald. Your line is now live.
Yeah, Good morning, Ariel and team congratulations on yeah, great quarter for ability nice to see out of the gates.
And a couple of questions one commercial one one development.
Our pipeline regarding the commercial question on Valerie I'm wondering it's Laurie can provide any more granular feedback on what she has heard from prescribers hearing from patients in terms of those patients been on other drugs in the past and how the.
This differentiated mechanism is helping them feel and the potential for persistence. Thanks.
Hey, Charles Good morning, and thanks, Thanks for the question.
So you know I think the best way to answer that is to want to take a look at script trends and how many patients we actually added in Q1.
Yeah, we added over 15000 patients in Q1, and so physicians are clearly seeing a benefit of the product, but we're also seeing a really healthy refill rate right now.
That that's really going to.
Speak to the persistence and compliance it's still a little bit too early not into Q1 with only five months into launch still a little bit too early to see the see through trends on persistency and compliance with the refill rate is really sure.
And I guess I can assume can we assume that now almost halfway through the second quarter, you feel pretty good about tone of business.
Absolutely.
As I mentioned in the prepared remarks, we are we are really heavily investing in optimization of the product in terms of all the omnichannel approach, we're taking from a marketing standpoint strategic media Congresses Speaker program, our salesforce with high impact engagements and I quote.
Hi engagements with.
Either detailing the physician <unk> speaker programs, they've reached over 22000, HCP and that's definitely not a b C pieces.
Yeah.
And moving to the pipeline I struggled as I ask just one question, but I will ask just one question for Ariel.
Because he's got a lot of things going on I guess on Oh, five let's talk about that you mentioned advanced to enrollment is proceeding well I'm wondering if you on a blinded basis feel good about the phenotype of the patient that you're enrolling in if you can provide us any color.
And then if you've learned anything from their recent rate consult the AD com in terms of the Alzheimer's agitation, how does that impact.
Impact change or not your strategy with regard totaled five in Alzheimer's agitation.
Thanks Charles.
The questions with regards to where the types of patients that we're enrolling in advance to think where we feel comfortable that we are enrolling well.
Very similar type of patient is when as we enrolled in advance one.
The protocols are very similar the entry criteria or very similar I think the team is executing.
On enrolling the study and making sure that we have the right patients and then we have a quality trial again.
With regards to a in.
Any learnings from the recent panel.
Yeah.
There are a few observations one is it became clear or it's been clear to us but now.
Thank God.
It's been made publicly clearing at the FDA as well as experts.
Really feel like this is a high unmet medical need so.
What's kind of highlighted was which was the seriousness of the condition and the quandary frankly that physicians find themselves in with no drugs that are approved and are the only drugs that are used off label broadly or.
For anti Psychotics withdraw problematic so <unk>.
It was gratifying to want to be able to share that more broadly that awareness.
The other learning from from a panel.
Is that the the.
The way that that we are going about developing the product.
Consistent with how the FDA views that it should be developed in terms of endpoints.
And again this is not anything with which is new to us because we've always worked very closely with the FDA.
Breakthrough therapy designation.
Our product candidate, but it's it's nice to see those points discussed in a public forum.
Very good.
Consistent with our past diligence so I appreciate the added color.
And good luck with it.
With all the stuff going on on the pipeline and I'll hop back in the queue.
Thank you. Our next question is coming from Jason Goldberg from Bank of America. Your line is now live.
Hi, Good morning. This is Dana on for Jason Congrats.
Congrats on the progress this quarter and thank you for taking our question.
Just a couple on a variety here how much did a valid or you want to benefit from inventory stocking and do you have a firmer handle on the full year gross to net pricing dynamics or is that still more of a second half of.
Of the year, even when you get to more normal normalized rate. Thank you very much.
Hey, Janet it's Nick Thanks for the question the performance variability was not impacted by changes in inventory levels. As we've stated previously our normal inventory levels are at around two weeks during the quarter. It was actually a modest decrease in days on hand of X, although the LD.
On the two distributors so overall.
It was not impactful at all to the net sales in contrast, with Nokia as we mentioned there was an impact of $3 3 million due to the change of title.
<unk> sales would have been $3 three high $3 3 billion.
Additional has there been no change on that and I think your second question.
It related to how do we think about <unk> for the remainder of the year.
We're still not currently in a in a position to give specific guidance.
Around GTS is it's going to be volatile in the short term obviously there is coverage.
Mix, that's going to be so there's there's mixing channel throughout the year, but we're gonna have a distribution coverage is going to be dynamic and coming online as we've seen it is going to continue to come on line throughout the year and then also the utilization of the co pay card. So while we are pleased with the GTA and this quarter, we don't expect it to improve.
In the near term.
Great. Thank you so much and congrats again on the progress this quarter.
Yeah.
Thank you. Our next question is coming from Marc Goodman from SVP Securities. Your line is now live.
Yeah could you give us a sense of commercial coverage, how you're planning that I know that it's been kind of a slow process at the beginning on purpose I was wondering if it's just going to speed up as the year progresses.
And you know how much of an impact did you know volumes get helped by the one contract that you've talked about already and then second question is just the SG&A run rate in the quarter just give us a sense of is that the run rate going forward should we expect that to kind of ramp from there or does that include some upfront costs.
For the year. Thanks.
Yeah, Hey, Mark.
Hum I'll address the first question Passover or not.
So you know and we said it before we have expected you know access to start coming online around six to nine months.
Johnson and Kevin.
We are barely at six months when we're at 65% of lives covered we're feeling pretty good about.
Where we're at with <unk>.
It's covered and we do expect that to continue to evolve over that over the course of the next few months to the rest of the year.
And I wanted to talk about.
Volumes in terms of the contracts that we had in place we don't necessarily.
Look at it that way I'll give you some some numbers to think through and that is 90% of patients who've been prescribed ability our first line.
Sales first line therapy.
60% of patients are our second and third line.
And this is exactly where we would expect patients to be right. Now one out there is an urgent unmet need out in the marketplace, but to you as they work through formulary access and so we are seeing.
A healthy amount of patients.
Using the product later line obviously.
Nice success and the continued improvement in terms of moving the line of therapy.
Part of that is helped by the fact that we have a robust patient support services program.
And the patient support services program Israeli in place to make sure that patients that want to be.
You are able to go there.
So mark I'll take the second part of your question on the SG&A.
And actually Q1, we did have some onetime charges as it related to the farm Adobe out license.
While we're not offering specific guidance for the rest of the year I would point you to taking a look at what we spent in Q4 as well as Q1 as a ballpark of where we would expect to be in.
In future quarters for 2023.
Yeah.
Yeah.
Thank you. Our next question is coming from David Anderson from Piper Sandler Your line is now live.
Thanks, So a couple from me on an ability can you just talk to qualitatively the kinds of patients who are getting the drug and you know in terms of you know how many prior treatments.
Seeing prior exposure to ssris or <unk> program.
Et cetera.
And then secondly on Unrwa box with team I'm trying to tease out how are you thinking about.
The product and in the context of.
The current treatment landscape and in particular, given that there's some mechanistic overlap with Sanofi as you think about narcolepsy, you know where do you see reboxetine fitting and commercially of course, assuming that.
Theres clinical success. Thank you.
Hey, David I'll take that I'll take the first one is coming to the area.
As I just mentioned them tomorrow.
Right now we're seeing you know 90% of patients have failed one therapy, but that's not unusual for exactly.
Exactly as we had expected 60% to 65% in second and third line therapies. Prior and so we are seeing later line use which is exactly as we would expect coming out of the gates again. This is consistent with the unmet need in the patient population and we.
We are seeing obviously success.
Objective evidence shows from refill rates.
As well as what we're hearing from the field and as we access opens up and physicians get clinical experience we can anticipate.
The woman.
Yes.
Great.
And with regards to them to access the 12 or Reboxetine.
You mentioned mechanistic overlap with <unk>.
And how would we think about the two products.
So robotics team is being developed for narcolepsy.
Primarily for cataplexy, so what we saw in the phase II trial was that there was a robust effect on when cataplexy and also on our backbone excessive daytime sleepiness as reminders, who knows he has robust effects on excessive daytime sleepiness, but it is not approved to treat cataplexy. So two products that would be complementary.
Now.
We we.
We like the profile that we saw in the phase two trial for our inks is 12, and we're looking forward to just to see what the results of the phase three trial and that's going to inform us.
In terms of.
The full profile of the product.
That's helpful. If I may just thinking if at all do you think reboxetine cataplexy has to be markedly better than you know what we typically see for off label uses of.
Do a re uptake inhibitor like venlafaxine and Duloxetine because I know there was some off label use how do you think about that.
Okay.
That's a hard question to answer because there have been no controlled trials with any of those agents. So a lot of it is is anecdotal and what we can speak to is the profile of our product.
And we think that that.
Mobile is very attractive.
Which is.
Which has an effect on both cataplexy as well as excessive daytime sleepiness, which is dose during the day, which does not have a lot of the scheduling.
<unk>.
A lot of a lot of you know frankly, the side effect concerns of the agents that are currently marketed.
Okay. That's helpful.
Okay.
Thank you next question is coming from Joon Lee from <unk> Securities. Your line is now live.
Hey, Thanks for taking our questions have put the updates.
If I misheard, but I.
I think I heard Laurie just say that 90% of our patients have failed at least one therapy before getting on our balance sheet.
Does that mean that there are 10%, who get all forget ability as first line therapy and sort of.
Make sure I heard that correctly and I have a follow up.
Yeah. Thanks, Thanks for the question and Theres always going to be some some earlier line use it could be data reporting or it could just be ah patients were paying out of pocket potentially.
Potentially it could also be you know medical necessity grinding for getting through.
Outline this as just reported data that we're seeing and we're seeing either 90% or have failed one prior therapy, which is exactly what we would expect.
<unk>.
But has that sheriff first line use gone up overtime.
It's actually gone down.
Okay got it.
And at high level ability gross to net for first quarter looks like around 50% is that is that in the ballpark and if so can we expect further improvement in that gross net or are you already at that more or less steady state kosta. Thank you.
The agent, Yes, I think I think what I actually said is the GCN is in the high upper fifties as where it was for Q1, and we wouldn't expect that to materially change or improve.
Future orders.
Thank you.
Okay.
Yes.
Thank you next question today is coming from brick and pour it from Morgan Stanley . Your line is now live.
Hi, good morning, Thanks for taking our questions.
First just a quick clarification question for a D. A.
Just remind us exactly which data sets you plan to include an eventual filing for a T. A assuming your dataset with.
Two matures positively and then.
Secondly for excess 12 and.
Narcolepsy from Symphony data read out do you expect to end up in the coming months.
Can you remind us what the study is powered to demonstrate to them.
What you would consider a strong clinically meaningful outcome here. Thanks.
Mhm.
Listen thanks for the questions.
With regards to a one time this disease agitation in the filings.
Indias F&B filing we would include the results from all the studies that we conducted as a reminder, we've completed the event one trial, which is in.
Our pivotal trial.
The advance two trial.
Those data will also be included so that mirrors. The advance one trial also data from the trial will be included as.
As well as data from the open label safety extension trial, so the long term.
Open label safety extension trial so.
So it'll be up a briefing package.
And we look forward to reading out the advanced two trial.
And if that's positive and filing the S N D a.
And.
With regards to.
To access 12 in terms of the.
Powering of the study so the study is 90% powered to detect.
A change in.
On the Capex, the endpoints of efficacy as the primary endpoint.
So we've not disclosed what that Delta is that we were expecting but when we can point you to are the results from the concert trial, the phase II trial and.
It was based upon those results that we powered our site.
Yeah.
Thank you next question is coming from your teams from Asia from Guggenheim Partners. Your line is now live.
Thank you a couple of questions for me I don't know if you articulated what the exact gross to net was or what the approximate gross to net loss for Q1. So that's one.
Any thoughts on providing guidance for sales for real reality, when you might do that.
And if you can articulate for us the cadence of patients.
It's a weekly cadence sort of monthly kit is what it is how do you expect that to change over time.
Hey.
Gross to net for ability in the quarter was in the high upper fifties. This was an improvement from the sixties in Q4 and.
It was due to a higher proportion of refills of scripts versus versus new scripts again, we're very pleased obviously with the GTS this quarter, but we don't anticipate it to improve it.
In the near term and then as for as it relates to the sales guidance. We're in a very very early stages of the launch of ability along with acquiring Sanofi just up to a year now as soon as we find it just really premature to provide any such guidance as there's multiple variables that can affect.
This number.
Do you want to answer the last question Yeah Yeah.
Thanks Sharon.
You know what you mean by the question, but you know the scripts are written on a monthly basis.
Ah patients and we are tracking monthly prescription.
Yeah.
Thank you next question is coming from Joseph Thome from TD Cowen. Your line is now live.
Hi, there good morning, congrats on the quarter and thank you for taking my question maybe.
Maybe the first one on on X is 12.
I know you said, that's okay as long as you're going to be on the cataplexy endpoint, but do you anticipate releasing sleepiness scores as well when you report the full data and then just as you think about the filing package. If these data are positive here can you comment on the safety database and sort of see them see metrics are you ready to file.
The submission if the data are positive or kind of where where do you fall on that thank you.
Sure. Thanks for the question. So when we report top line results historically, we've reported a number of different endpoints. So we don't expect.
We don't expect.
Simply read out to be any different so we'll try and provide as much information as we can given the constraints of reporting topline results from March datasets.
And with regards to our to the.
Finally package in.
Terms of the safety database.
We still need to finalize with the FDA what would be included in the safety database for preliminarily. We are we have a lot of safety data. So we're conducting where we're collecting safety data not only from the studies that we have conducted but also as a reminder, we did.
In license very large patients each database.
For remarks, a team through our Pfizer agreement.
And on the CMC front things are progressing well there. So we we do manufacture we do synthesize that Upi.
Our ourselves so.
Right now that's been going smoothly and everything's going smoothly on the CMC side, and then with regards to you know when we would actually be able to file an NDA a gating factor will be the completion of the long term safety study.
So assuming that we do have success with the Symphony trial, we would expect being able to file an NDA likely in 2024.
Great. That's very helpful. Thank you.
Then maybe more of a definitely helpful on the prescriber base and sort of unique writers can you go into a little bit more detail in terms of how physicians are prescribing this or are they trying it person one patient and then if that goes well you know they they go another patients once you get a writer did they write a lot of prescriptions kind of kind of how how is it getting these physicians onboard and.
How would I trade kind of for the duration of the year do you think.
Thank you yeah, Yeah, that's a great question, so consistent with our expectations.
Expectations of launch you have early adopters that come out of the gate prescribing when does if they have clinical success.
Have tremendous depth and we are seeing exactly that.
The writers that have written they have they have really yeah.
Travel market share in terms of their use of ability so they're seeing a positive clinical experience.
And then you know as you as you move further along in the launch and you're trying to increase your breath and then you start seeing you know writers that are that are on an adoption curve that you may need a little bit more.
Time and market understanding peer influence.
Or they may need clinical experience from one.
But when you write more so we're starting to get into that and is not in our breakfast starting to grow.
As I mentioned.
In Q1, we added 3800, new unique HCP riders and so yes, we definitely expect that to continue to grow just as is the normal adoption curve with regret.
Perfect. Thank you very much.
Thank you next question today is coming from Greg <unk> from Mizuho Securities. Your line is now live.
Okay. Thanks, so much congrats on the quarter had a couple of questions just wanted to get a sense of maybe philosophically speaking where you are in terms of your commercial.
Infrastructure.
And whether given the opportunity your content to keep its size the way it is right now or do.
Do you feel that perhaps you can be opportunistic in and further drive even perhaps better uptake of ability in particular.
And then secondly.
Just wanted to get a sense of just going back to the gross to net and maybe just for clarification on my end just can you tell us how exactly you would go about calculating your gross and I just wanted to make sure that I'm thinking about the same way you are thinking about it. Thank you.
[laughter] Technical Center first Oh.
Greg.
So GTS.
Basically it's the way everybody else would essentially calculate.
Gross to net.
Based on demand in the quarter and.
The utilization of co pay card any type of Rebase any additional.
<unk> as well that all goes into the G. T and we would also accrue for anything that was sold in the quarter. That's that's sitting in the channel.
Has not been distributed to the pharmacy to at that point. So that would also be considered part of the GTS adjustment for the period.
Where do you want answered.
So it yeah.
I'm not sure if you're meaning the ability salesforce it isn't that the sales force that I'll try and answer both the interest rate applicable.
Uh huh.
Just to give you some perspective on the annuity side. There are about 50000 HCP are prescribed really the lion's share of branded therapies.
We are calling on 'twenty, five 'twenty 6000, HCP and of those 50 and photos.
25000 that were calling on day rate almost 70% of the branded therapies.
Our D C C platform.
Intentionally structure, so that we could.
We maintain a share of voice you either through reach or with our Omnichannel marketing of sales forces.
In some cases two times the size of what we have.
Remember our DCT platform is really set up so that we can optimize productivity through effective and efficient engagements and right. Now we are seeing that with our ACP targets.
[laughter] as we're able to reach them as many targets.
Again, so for us that are somewhat upwards of two times the size that we have right now.
So you know as we are continuing to invest in in both ability and Sanofi through Omnichannel marketing strategic media.
Congress spending speaker programs as I've mentioned before we will obviously continue to make sure that we're maximizing the opportunity for both products.
Yeah, and what I would just add to what more you said is that right now.
Our marketing efforts and the yield from that is going exactly as we had expected exactly as we had planned.
We've said before that our field force sizing.
And targeting was based upon.
All of the data and information that we move that through our DTC platform.
And so we feel that we are more than adequately resource right now we're reacting to the way the launch is going.
Obviously anything can change and we are an organization that can.
Be flexible, but for now we're adequately resourced.
Mhm.
Thank you. Your next question is coming from Myles Minter from William Blair. Your line is now live.
Thanks for taking my questions. Congrats on the quarter can you just comment on the proportion of those 31000 scripts for valley that are being reinvested or taking reimbursement through the commercial versus government channels and does that differ materially from the broader branded antidepressant market, which I think is true to its commercial one third government.
Yeah, Hey miles, we are seeing exactly almost almost exactly what we see in Nevada, and depress that category, so that a broader anti depressant category at about 60% to 65% commercial and the remaining are in the government channel and that is spot on we maybe skewing a little bit heavier to commercial I think were around 70.
Uh huh.
Right now but.
It's exactly as expected.
Okay Cool and then the second one is just on the Symphony trial, you made mention that powering assumption.
In concert does that mean that the baseline cataplexy rights over the way you can kind of be similar between those two trials when they're right out.
The entry criteria.
Citerior are similar and whether or not.
Whether or not.
In actual numbers or or or the same that remains to be seen but the entry criteria are similar there's a lot of variability with regards to cataplexy in in patients.
And you know part of the reason for that is.
That.
Cataplexy, although it is a symptom that everybody has it has triggered so so there will be variability from amongst individual patients based on their social situations.
Yeah.
Beautiful thanks for the question.
Yeah.
Thank you we have time for two more questions. Our next question is coming from Matt Kaplan from Ladenburg Thalmann. Your line is now live.
Hi, good morning, and congrats on the results for the quarter.
Just wanted to zero in a little bit on on on Sanofi Sacramento saw.
The ADHD indication and your plans for the Phase III program can you talk about a little bit about the the the indication a need there and then your phase III program initial study without a potentially sufficient for filing as possible.
Okay.
Thanks, Matt for the.
For the question. So ADC is it's a very large market.
Or roughly 12 million patients in the U S.
Who have ADHD and and right now they were treated either with the stimulants, which are which have.
Issues with regards to that.
Version and because they are highly controlled.
These are drugs that are very effective that have a very large effect size, but then they are the downside from a safety perspective.
And then there are the non stimulant medications.
Yeah.
Hmm.
Non stimulant medications.
What they suffer from or more effect sizes. So so there is that there is a very large need still for effective drugs.
They were both effective and also that they have a very good safety profile.
We like so nosy.
Based on the comparison, let's say in other indications, though in excessive daytime sleepiness for example, where the clinical trial results show that.
It appears to be a superior agent to two other drugs. So two other wake promoting agents for example.
And we also very much like the results from the sharp study, which recently read out when we look specifically at cognition.
In patients with OSA, so its not directly analogous, but we like the clinical profile of the drug in other indications.
Like the mechanism of action of the drug also you know, we recently announced that.
It it hits Tar, one which in preclinical models have been shown to be pro cognitive.
So.
There's a lot there.
To.
The test in the upcoming trial, which we expect to start.
This quarter.
And then with regards to you know what would be needed in order to file so.
So to file an.
An NDA or an S. Lee for drug in ADHD. You also do you need to demonstrate efficacy in a pediatric population. So the study that we're about to launch that is a study in adults and we will be also looking to list.
Ah study in pediatric patients to enable a filing.
Okay. That's helpful. And then a quick question Uh huh, so boring in terms of Oh, yeah. Some near term M. D. E filings can you talk about the launch prep and have underway for access on staffing and potentially 14 as well.
The timing of those NDA filings.
Yeah. Thanks. Thanks for the question. So it was seven if you if you remember we got online and start to the finish line. So launch pathway was pretty.
Pretty heavily done there so in terms of marketing materials in preparation for the market and understanding that's all just we know we need to do a refresh.
Based on timing for both 714 will be willing to sign size structure thoughts.
Sales force sizing. So once we have a little bit more understanding on exact timing and date demo well share what that looks like.
Great. Thanks for taking my questions.
Thank you. Our final question is coming from right around several Roger from H C. Wainwright. Your line is now live.
Hi, This is Bob Allen dialing in for Rumsfeld, Rajiv and thanks for taking our questions a couple from us. So firstly I'd love to get your thoughts on intra cellular therapeutics luma tapped her on the study is positive topline data as monotherapy in patients with M. D. D on bipolar depression, but are there any take.
With respect to future clinical directions are.
Oh, I and just recently reported data.
Oh, thanks for the question.
With regards to <unk>.
<unk> are one and the data in in mood disorders.
It's not surprising that our anti psychotic would work in in depression.
It's well known that.
Atypical antipsychotics are used as adjunctive treatment so.
And and <unk>.
Any time any company.
Generates a data in depression or in bipolar depression.
Which is positive we think that that's.
Because there is the need is so large and the patient population is still large.
And there's.
Such a.
A large amount of had a heterogeneity in terms of response from patients. So.
So yes, that's great.
Yeah.
More of that.
Alright. Thanks.
Okay.
Thank you we 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 again for joining us from our call today, and we saw strong performance in all areas of our business in the first quarter.
We are executing on the commercialization of mobility, and so nosy and we are advancing our late stage pipeline to key milestones in multiple indications.
Our marketed and development portfolio positions us to have potentially at least five marketed products by 2025 targeting brain disorders that affect tens of millions of people.
And also these are conditions, where there's still a great unmet medical need.
So we look forward to updating you on our progress during the rest of the year have a great rest of your day. Thank you.
Thank you that does conclude today's teleconference and webcast you may disconnect. Your line at this time and have a wonderful day, we thank you for your participation today.