Q3 2023 Amylyx Pharmaceuticals Inc Earnings Call
Good morning, My name is Keith and I'll be your conference operator today at this time I would like to welcome everyone to the analytics Pharmaceuticals third quarter 'twenty to 'twenty two earnings conference call.
All participants will be on listen only mode.
After todays presentation, there will be an opportunity to ask questions to ask a question you May Press Star then one on your telephone keypad.
Your question. Please press Star then two.
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Let's turn the conference over to Lindsey Allen head of Investor Relations Communications. Please proceed ma'am.
Good morning, and thank you for joining us today to discuss our third quarter 2023 earnings.
With me on the call are Josh Cohen, and Justin <unk>, our co Ceos.
Margaret Ohlinger, our Chief commercial officer, and Jim Brady, our Chief Financial Officer.
Before we begin I would like to remind everyone that any statements. We make are information presented on this call that are not historical facts are forward looking statements that are made based on our current beliefs plans and expectations and are made pursuant to the safe Harbor provisions of the private Securities Litigation Reform Act.
Act of 1995.
These statements include but are not limited to our expectations with respect to really live here in Alberta is that statements regarding our current and planned clinical trials and regulatory developments and the expected timing thereof, our business and marketing strategy and outlook and our expected financial performance.
Actual events and results could differ materially from those expressed or implied by any forward looking statements as a result of various risks uncertainties and other factors, including those set forth in our most recent filings with the SEC and any other future filings that we may make with the SEC you are cautioned not to place.
Any undue reliance on these forward looking statements and <unk> disclaims any obligation to update such statements unless required by law now I will turn the call over to Justin.
Thank you Lindsey and good morning.
As we sit here three full quarters into our U S launch in AOS, we are proud of what we've accomplished.
We are also keenly focused on the work, we still need to do to help transform and improve the way that Alex is treated.
Our progress with for Liberty O continues.
As of September 30th 2023, there were roughly 3900 people living with ALS, taking delivery in the U S.
We generated $102 $7 million of net product revenues in the third quarter.
And $272 $3 million in the first three full quarters of launch.
We are incredibly pleased with how quickly we're liberal has been adopted at T. A L S centers and with our engagement with clinicians.
While we will continue our efforts to grow within these centers. We are now expanding our focus beyond those top centers based on our experience in the field and new research that points to the fact that roughly half of all people living with ALS receive care from clinicians that do not specialize in AOS and are likely unaware of the benefits of delivery.
A key message that you will hear on our call. Today is that we are continuing to evolve our commercial focus as we look to transform the AOS market.
We recognize that it may take time and additional data from Phoenix to reach the many clinicians who have yet to prescribe the live real as we work towards our goal that at least 10000 people will be taking delivery or at any given time.
Margaret will provide additional details.
As an organization, we're focused on both delivering on our commercial and R&D goals in the near term and investing for the long term with a pipeline focused on treating neurodegenerative diseases.
Importantly, our Phoenix study is progressing well and we now expect to report topline data from the 664 participants study in the second quarter of 2024.
We continue to be confident in the design and execution of the study.
Josh will provide additional details on Phoenix review, our pipeline and share the key conclusions from data we presented at the northeast AOS consortium meeting last month.
He will also review data from Centaur that was recently published in a prominent peer reviewed medical journal that reaffirmed the confidence we have in the survival data for Liberty al.
As a reminder, the Centaur study was the basis for the full approval from the FDA that we received for delivery in late September 2022, and our approval with conditions in Canada.
We also remain committed to bringing the benefits of delivery all outside the U S and Canada to the more than 200000 people living with ALS worldwide.
Assuming the data from Phoenix is supportive we plan to seek approval in the European Union as quickly as possible.
In addition, we continue to interact with key stakeholders around the world to explore opportunities for access like we did in Israel in France.
And we are engaging with regulators in Japan.
For Liberty or gives us the opportunity to start to transform a L. S from symptom management of standard of care to a disease with meaningful interventions.
Our team is working hard to accelerate this shift because we know people living with ALS had no time to wait.
While we are pleased with the progress we've made to date there are so many more thousands of people to help and clear opportunities ahead of us real growth in the U S and Canada and throughout the world.
I will now turn the call over to Margaret to share some additional detail on our commercial launches and plans in the U S and Canada.
Thank you.
As Justin mentioned, we ended the quarter with roughly 3900 people on <unk> in the U S up from roughly 3800 at the end of the second quarter.
With our goal that at least 10000 people living with ALS will be taking delivery of it at any given time, we are working hard to accelerate this growth and I will detail some of the specific plan shortly.
The interest and engagement among our prescribers remains strong and we saw a steady cadence of new prescriptions written in the third quarter.
In addition, several times, we're down to about three weeks for people living with AOS enrolling in the quarter.
As we think about how our growth has evolved this year.
Low down in net adds this quarter was primarily driven by increased discontinuation for a variety of reasons.
We have already begun implementing new educational initiatives.
I will touch on in a few minutes.
In addition, we are developing an updated clinician engagement and marketing program in preparation for Phoenix.
We believe support of Phoenix results reinforced the robust data currently available and help all aspects of our launch with greater awareness demand and greater duration of use.
Our hope is that these data will further demonstrate that were livio can significantly impact people living with a L. S.
Turning to the quarter.
Prescribing remain concentrated with roughly 80 prescribers, mostly as a major E. L. F centers, representing approximately half of all we're living a prescription and approximately 300 prescribers representing the vast majority of prescriptions.
We are pleased to have a core group of active writers at the top centers, just three full quarters into our U S launch.
Roughly 25% of the people treated at these centers were taking where Libya.
There is still a clear opportunity for continued growth is our research shows that roughly two thirds of people living with ALS from the centers. We're on at least one approved a L. S drops.
And like I said, only 25% of patients in these centers.
We're taking real over yet.
The top clinics are actively prescribing reliv Rio and we continue to educate optimized and reiterate our messaging about where liberty is efficacy, including the data on early used to roller Bureau, and the importance of staying on treatment.
As well as the safety profile.
As Justin mentioned, we have also learned your experience in the field and further market research that roughly half of all people with ALS receive care from coordination that did not specialize in E. L F.
For the most part this group is not prescribing where livia.
We are developing and will be rolling out new marketing initiatives to reach the group of both potential prescribers and people with.
Yeah, well, maybe auto wherever liberal and its benefits on both function and survival.
These include increasing our digital presence and enhancing our non personal efforts in optimizing our field strategy.
We view this as a key source of future growth.
Circling back to discontinuation.
60% of people, taking where live real remain on therapy six months after initiation in the U S.
We believe some discontinuation are addressable.
Especially when comparing our discontinued right in the U S to Canada.
In Canada, roughly 80% of insured patients both private and public are still on therapy six months after starting treatment.
Our Canadian team has made substantial efforts to educate on the importance of remaining on therapy.
While the Canadian system is clearly different from the U S <unk>.
Including the fact that it is a more concentrated system. We do believe we can leverage our learnings in Canada in the U S and improve our discontinuation rate.
We have began begun to deploy the learnings and messages from Canada and the U S.
We believe the key is to educate clinicians and their offices on the benefits of our live Rio.
Great expectations with them. So they are prepared to set expectations with their patients.
Overall, we're liberal is a well tolerated drug and we are optimistic that our additional educational efforts in the U S will result in increased prescribing and duration of use.
To summarize we are off to a strong start with significant interest and engagement from the major E. L F centers.
Operationally our team is delivering in people living with ALS are able to start therapy quickly. We are focused on three goals that will drive our commercial strategy going forward.
First we are optimizing our approach to engaging with key clinicians to maintain and continue to grow that segment of the business.
Second we will increase our programs to build awareness among clinicians and people living with al and their caregivers outside of the key centers.
And third we will take the learnings from Canada, and our insights in the U S to educate on appropriate utilization into support persistency.
We have more work to do but.
But we are also pleased to be off to a great start.
Honored to continue to serve more and more of the approximately 30000 people living with a L S and the U F <unk>.
And approximately 3000 people living with a lap in Canada.
I will now turn the call over to Jim to discuss our financial results for the third quarter.
Thanks, Margaret and good morning <unk>.
As you've heard we have an excellent penetration and engagement among the top of outlet centers and we remain optimistic and committed to the potential for liver Ya.
As we adapt our focus and await Phoenix data, we're confident in the long term prospects of our business.
In the meantime, we're profitable and focused on being prepared for success when Phoenix reads out in the second quarter of next year.
Now, let me turn to the financial results for the quarter.
Net product revenues were $102 $7 million for the third quarter compared to net product revenues of $98 $2 million for the second quarter of 2023 with the vast majority of that revenue coming from the United States.
Our results were impacted by a number of factors.
In addition to what Margaret mentioned earlier, there was also a higher number of people living with a less receiving free goods slightly over 15% versus roughly 10% in Q2.
Gross to net adjustments were approximately 8% in the quarter.
This is below our long term expectations and was similar to Q2.
We continued to see lower charge backs and rebates than we had anticipated.
Going forward, we expect our gross to net will settle in the range of 12% to 15%.
Inventory levels at quarter end were as expected with approximately two weeks of inventory in the channel with specialty pharmacies similar to what we've seen in previous quarters.
Cost of sales were $5 $2 million for the quarter, roughly 5% of net product revenues.
It is within the range of our expectations Q.
Q3 was helped by a low rate of scrap and the completion of our royalty obligations in the second quarter.
Going forward, we expect Cogs to be in the range of 5% to 10% of sales.
Research and development expenses were $30 million for the quarter.
You should expect R&D expenses to be in the range of $35 million to $40 million in the fourth quarter as we start enrolling patient participants in our new global Phase III trial in PSP and advance other programs in our portfolio.
Selling general and administrative expenses or SG&A were $48 $7 million for the quarter compared to $43 $4 million in Q2.
The increase was mainly driven by increases in marketing expenses.
Personnel and additional charitable contributions in the quarter.
We expect SG&A expenses to be in this range for the fourth quarter.
These results led to a strong bottom line, we generated $29 million and net income representing our third quarter in a row of profitability.
Finally, we ended the quarter with cash and short term investments of $355 million and zero debt.
Our balance sheet remains strong as our assets increased $13 million in the quarter and we paid down approximately $18 million in payables during Q3.
We're pleased with our strong financial position and we are well situated as we await the completion of the Phoenix trial.
Our launch is show them the value of an interest in religion, Rio among the top eight less centers.
We're confident in our ability to continue to grow our top line.
First in our pipeline to provide much needed additional treatments for neurodegenerative diseases and to deliver on our bottom line.
I'll now turn the call over to Josh to discuss our R&D program updates.
Thanks, Jim.
We believe <unk> also known as Amex zero zero 35, they have applicability across other neurodegenerative diseases, and we are actively advancing clinical trials to evaluate amex 35 in progressive Supranuclear palsy, or PSP and law firm syndrome as well as advance.
<unk>, an antisense oligonucleotide and AOS.
Image 35 is comprised of sodium <unk> and tourists, a dial and work synergistically to prevent or slow cell death.
We are on track to launch the phase III Orion trial with Amex 35 in PSP here this year.
We recently presented the Orion study design that the Neuro 2023 conference and received positive feedback from the community there.
Additionally, we continue to progress our phase two trial and Wolfram syndrome, and expect to report results in 2024.
We are also advancing amex $1 14 for antisense oligonucleotide targeting helping too.
Through R&D, enabling studies and expect to enter the clinic in 2024.
We recently presented preclinical data at the meals conference on this candidate.
In addition to advancing these new therapeutic programs. We are also advancing a new composite biomarker to diagnose a L. S earlier.
Current data suggests the diagnosis takes about a year. The goal of this program is to create a tool that allows for earlier diagnosis of AOS, which may result in earlier treatment and better outcomes.
We shared that we were conducting this program at Neil's this year.
We intend to provide a full set of results from initial experimentation in 2024.
For several years, we have also been working on a new taste masked formulation of <unk>.
This formulation may allow for new intellectual property we.
We are planning to file an IMD and conduct phase one testing for innovative formulation in 2024.
This quarter, we also continued to publish where Liberty O data.
Liberal is the first and only approved treatment for AOS to demonstrate a statistically significant benefit and function in a clinical trial as well as a survival benefit and a longer term post hoc analysis.
Just recently and analysis comparing the long term survival of participants in the trial to a historical clinical trial control group was published in the Annals of clinical and translational neurology.
The results of this post hoc analysis demonstrated that the median overall survival was 10 four months longer than the Amex 35 group than the historical clinical trial group.
Finally, as we approach the topline readout for Phoenix, we're focused on execution and confidence and are set up for success.
First travel design is based on the success, we saw in center, which was a randomized placebo controlled study meet it its pre specified primary outcome.
Second while we designed the study to allow for a broader entry criteria. The population that enrolled are very similar to centaur as shown in the poster presented at <unk> last.
Lastly, we enrolled 664 participants and a $3 three to two randomization.
And serve roughly.
Five times, the size of Centaur and stuff.
Interest among investigators is high and we have so far executed well and enrolled per our planned timeline.
In closing our launch is off to a strong start and we have made great progress towards our goal of a liberal becoming the most commonly used medicine and AOS.
We eagerly await the data from Phoenix now expected in Q2, 'twenty 'twenty four.
And are simultaneously exploring for Liberty can help people with other neurodegenerative diseases, including PSP and Wolfram syndrome.
Overall, we are very pleased with what we have achieved as an organization to date.
With the substantial opportunity ahead of us both with our commercial launch.
And our pipeline.
Now we'd be happy to take your questions. Operator, please open the call up to Q&A.
Yes. Thank you at this time, we will begin the question and answer session plus a question you May Press Star then one on your Touchtone phone.
If you are using a speakerphone. Please pick up your handset before pressing the keys to withdraw your question. Please press Star then two.
At this time, we will pause momentarily to assemble the roster.
And the first question comes from Korean Jenkins with Goldman Sachs.
Hi, good morning so.
So can you just help clarify a little bit on the discontinuation that youre seeing are these primarily due to adverse events no disease progression or kind of patients.
Ultimately dying or are you and then kind of as a follow on from that are you seeing any change in the types of patients coming on to drive now versus during the early launch, particularly with respect to this.
Time since diagnosis.
Oh, yes. Thank you very much for the question. This is Margaret so yes on the discontinuation.
Theres a variety of reasons why people discontinue a L S therapies.
But it's important to remember that in many ways, it's really connected to the disease states sadly so, whereas we mentioned we're deploying tactics designed to help lower their rate of these types of discontinuation, including taken the key learnings from Canada, where we heavily focused on the importance of remaining on therapy.
You know because you know our long term efficacy is really based on being on therapy for the long term. So that's highly while we're focused on.
And the second question regarding mix up therapies, we continue to see a mix up therapy is a mix of patients coming on therapy with the prevalent patient patients, but I would say in the third quarter, we've probably seen a slightly higher mix of patients coming on that were more newly diagnosed patients and we define that as patients that have been.
Diagnosed in the last six months, yeah, maybe only thing I'll add there as well.
Just going through the discontinuation specifically at six months in the U S. We're seeing roughly 60% of people remaining on therapy and Canada. However, we're seeing roughly 80%.
So what this tells US is that we believe that we can impact this and so that's what we're gonna be trying to do over the coming quarters.
And do we know what kind of industry standard is for Alice drugs on the whole like what's sort of the average duration of therapy or discontinuation rates for.
The broader.
The class of therapies in that indication.
Yeah.
It's a little hard to say, obviously, we're all kind of pulling different data on different therapies, and probably don't talk too much about the other therapies on the market, but again I think our goal is to be best in class here and looking at looking at Canada and some of the data we're seeing there.
We believe this is an area. We can we can continue to see opportunity and continue to grow.
Yes, I think the last name.
Mhm.
Alright, and I was just going to add.
We continue to believe that patients who get on therapy earlier and stay on therapy longer we'll have better patient outcomes and that's certainly our objective and our mission forward.
Okay, and then I guess, how quickly can we expect to see you guys toggle that in particular, given the acceleration in patient growth in the first half of this year should we expect this to be a big factor into the fourth quarter and if you could comment on kind of trends you're seeing there would be helpful.
Yeah, I'd say it's.
Probably early to comment on on how the next quarters will land, but what I can say and I think as Margaret mentioned.
We have a number of initiatives that we're rolling out that we hope will will impact things.
And the top centers and while we have percent of people on therapy.
With our 25% of people under Liberal roughly 66% of the people on any AOS therapy. So we see a big opportunity there and we're going to continue optimizing that and then as we share but we've found is.
Roughly half of people are not actually seen by an AOS specialist.
And so there's a big opportunity to get delivery out a broader beyond just the key E. O S centers and then you know I think finally as we touched on two of them. The discontinuation side. We've seen tactics that have worked in regions and we're going to try to try to use those in the U S as well and hopefully continue to see growth there.
And just bringing it back to the picture.
I think in short, we see great near term growth opportunities and also long term growth opportunities I.
I mean, we we have 3900 people on treatment as at the end of the quarter and there are roughly 30000 people in the U S. At any one time, who have they last.
And while we have the growth opportunities as Josh was outlining we also have the Phoenix study results, which we think will be a huge milestone for the ALS community. The first time.
You know that that had treatment would have a.
Positive results from two studies.
Yeah. So I think we have great.
Growth opportunities ahead of US right now and we have the Phoenix trial results, which we think will further accelerate that.
Thank you.
Thank you next question comes from Geoff Meacham with Bank of America.
Good morning, guys. Thanks for the question.
Just had a few so on Phoenix. The first one is I know its splitting hairs, but mid 24 versus two Q is that based on a faster event rate or did you guys just want to get more specific.
With the guidance and the second question is compassionate use in France, and maybe other geographies how much incremental revenue could we expect to see.
From some of these I'm just thinking about you know going into.
Formal full approval and as you think about Europe, but does compassionate use kind of be a is that a leading indicator I guess of ultimate demand. Thank you.
Yes, so maybe on Phoenix first I think we first said mid 24.
Maybe at this point over a year ago or otherwise. So I do think it's just a case of getting more specific as we're getting closer and nearer to the to the REIT out there.
And then I'll pass it over to Jim to talk about the the compassionate use impact on revenue.
Thanks, Jeff Good morning.
Just started up in France.
Late last month, so it'll be it'll be interesting and it remains to be seen the demand that we see there.
I do think this will be incremental revenue if we see it through as we see it through 2024, and then I'll hopefully ultimate approval.
And that said it is going to be an important opportunity to have the key centers get experience with Reliv Rio and you know.
Additionally, you know those centers tend to be more concentrated in Europe than they are in the United States. So it's important for us to get access to patients.
But given the size frankly of our revenues in the United States, while it'll be you know it will certainly be incremental but hum.
Main driver we're looking for is full approval in Europe.
Got you and just a follow up to that real quick when you think about filing in Europe. I know you guys have been through you know a back and forth process as of now but.
For Phoenix do you think you would have to wait for.
Oh EFS to hit or do you think you could file.
Theoretically if you hit you know on just the functional data set for for next year. Thank you.
Yeah, So I'll say ultimately we can never.
Victor or speak for the for the regulators, but certainly our intention is with positive Phoenix results, especially coming out of the top line readout.
We will want to you know.
Push forward towards approval as quickly as we possibly can and it just adding I mean, I think further to your questions too.
Think we you know we're we remain confident in the design and execution of the study. It's again, it's a 664 participants study.
Our team is.
Is is executing and I think that those results will be a major milestone for the analyst community the opportunity to have two positive studies.
In a disease, where there's been.
So much historical clinical trial failure.
It's it's hard to overstate, what a big deal that would be for the community.
Thanks, guys.
Yeah.
Thank you and the next question comes from member of Fat with Evercore ISI.
Yeah.
Hi, guys. Thanks for taking my question I have to let me start with this perhaps if I just look at the fact pattern on how you implemented the data restriction on IMS and Symphony vendors. This summer and how that coincide with this massive slow down it just really puzzled with me because I feel like not only was the street ready from communication on your end, but also I feel like you've limited the channels through which to treat.
Could have been ready for today, how do you can you can you expand on that because it looks like.
It looks like you may have had a sense for discontinuation is really picking up around July time frame.
Well, yeah, maybe it well maybe I'll start. So so you know our intention at launch was was always to have a b a limited distribution model.
And so we updated everyone in February.
We thought we had identified one of the areas, where there is some data coming out and so we had addressed that so that that was back in February and I think the most important thing here, though is that.
We had a huge long term growth opportunities ahead of us.
Very proud that where we're helping <unk> 3900 people as at the end of the quarter, but again I'll reiterate there are 30000 people with a L. S at any one time.
And the last thing I'll say too is that we're really trying to transform a disease space here as I said in my remarks, a L. S. Historically has focused on symptom management and were trying to shift the field to focus on meaningful interventions are that's not going to happen overnight, but we think we've done a great job so far.
But we've also identified even further opportunities.
Just start to transform the landscape.
So we think we have great growth opportunities ahead of us.
Got it and let me just follow up just on a am I right in calculating about 5500 patients may have started therapy since your launch and secondly.
If I model out on discontinuation, what I feel is it's not just the discontinuation. It's also the new starts might have dropped about 35, 40% quarter over quarter from two Q3 Q is that right.
Because I feel like you may have had about I don't know 750, discontinuation and three Q, but if that's the case you might be in for another about 650 to 700 discontinuation in <unk>, which makes it very hard to again put up a very meaningful net adds number in for Q unless your new adds picks up very meaningfully versus where it wasn't three Q am I on the right track there.
Maybe we haven't commented on any of those metrics, but maybe just to circle back there roughly 30000 people living with ALS in the United States. We have 3900 on therapy. So we certainly see an opportunity to continue to grow.
And that's what we're going to be out here trying to do I think we shared several of the tactics that we think we'll achieve that yeah, and I think that our.
Initiatives are designed that again transforming a last we.
We have initiatives to help in the top centers, where we think there's further opportunity.
And the market we found that there are far more people in the in the broader neurology community and so we think theres great initiatives, we can do for a further awareness.
And as we showed in Canada, we think that we can use our strategy is to showed that staying on therapy longer matters and again, that's part of transforming the disease space. So an answer to your question on sort of both growth in terms of new people.
People coming on as well as staying on treatment. We think we have great strategies to address all of those.
Yeah. Let me just say you were to I think as you do your calculations actually Margaret mentioned in our remarks we've.
Actually steady new prescriptions from Q2 into Q3 so.
You know well, we obviously want to see more growth and accelerated growth in that and we've touched a little bit about that on my remarks, there's no real distinctive change in terms of the new ads certainly it's slowed down from you know from Q4 and into Q1, and we talked about that on the last call, but we've seen steady new adds and and you know just another point of the discontinuation.
It's not like we've seen a major drop off here. This has been a you know it's a.
Slightly steady decline as we move through time, we've always cautioned about what the right discontinuation model is right because we can't model six months or nine months discontinuation is until we get there. So we've been tracking fine excuse me the central data.
Through last quarter, you know, it's gotten a little higher than that discontinuation rate over the last couple of months.
You know that that's different in Canada. So we actually think that as we lean into this a little bit more and adjust our tactics here on what has been a very solid launched so far in our first nine months. This is an adjustment of tactics and I think we can hopefully get back to seeing growth again.
Thank you guys.
Youre welcome.
And the next question comes from Marc Goodman with Leerink partners.
Yes.
Yes, Hi, maybe you can give us a flavor for how October went to give everybody a sense of of <unk>.
Trends versus what we just talked about.
Yeah, we usually don't report month to month.
But.
What I'd say is that we're we're certainly rolling out many of the things that Margaret Margaret described and certainly Theres nothing Theres nothing revolutionary there in terms of.
Uh huh.
Things that things are continuing we're continuing to see net adds.
The steady pace, Yeah, I think just reiterating what Margaret and Jim was saying you know that.
The slowdown in net patient adds we saw was primarily driven by discontinuation and we think we have great.
Things to address there and as well as new opportunities for growth as well.
Just to be clear on the new patient adds from second quarter into third quarter, you had a steady increase in new patient adds and so whatever that steady pace was month to month is that what it was October everything's just kind of the same similar slowing down speeding up just give us a sense.
Yeah, I'd say steady a steady.
And so if.
You know what we want to see is a reacceleration of that growth right back to back to the levels that we saw when we were first launching the drug.
And I think it was a very important point to make here is that we're doing exceptionally well in the key centers and one of the things that we're doing right and it was a it was a logical place for us to focus we're going to keep that focus on those key centers, where we've got penetration up to roughly 25% of all patients as Margaret talked about but what we have to do now is continue to grow there.
Expand you know into the next decile is down you know decile say three through six is where we're gonna be focused.
Mhm.
But it's just is it fair to say that steady mean steady like October was steady trends just like the previous quarter, because here's an opportunity to kind of comment on that given what happened this past quarter.
I know you don't normally do it but maybe you could make an exception this time.
Yeah, well I think Mark you know the.
The trouble is right this is not.
You know.
Another factor that's going on here right is we had an additional 5% of the people that were on free drugs right. So if those folks if we remain at the 10% range instead of the 15% range right sales would have been a lot higher and closer to people's expectations. So.
Think.
You know month to month.
Single months matter still even at these levels and so we're only one month into the quarter and it's very hard to predict where we're gonna be at the end of the quarter, where we sit today.
Thank you and the next question comes from Greg Savannah is from Mizuho partners.
Hey, it's Greg salaries. Thanks, so much thanks for taking my question.
Two if I could first.
No a lot of the growth now is going to be focused on the non E. L. F. A center setting and I was wondering if you could just maybe provide additional color around the pace with which you think you can penetrate that non AOS center setting and then my second question just has to do with kind of with Pheno.
Now a second quarter event and as you think about current usage of the product are whether it's V.
He used by physicians or patients I'm wondering if you feel and maybe help us.
Understand this if you feel that there is some element of you're not being able to capture more patients because of anticipation.
Around Phoenix are in other words, how much do you think if you do end up getting positive Phoenix data that that will really drive Ah.
Our growth are over and above what you're experiencing right now thanks.
Yeah, great. So just to answer your first question certainly we see our growth coming in three different buckets. One is we do believe we have continued focus on opportunity within the top of your less centers.
Already talked about we have 300 physicians that are prescribing in that bucket of patient, they're prescribing about 25% of all their patients on <unk> treatment, but they are treating you know two thirds of their patients with any patient any drug available for <unk>. So that's a 40% growth opportunity in front of us that we are.
Heavily focused on driving our education, the first and only product they have function plus survival.
And we really believe that we can be foundational treatment and again just to reiterate we have full approval in the U S. We are confident in our sensor data and you know we we were studied in monotherapy and combination therapy. So we believe that just in that bucket, along where we've been heavily focused and concentrated on there's a tremendous.
My back of opportunity the second bucket as you mentioned is really growing into the non AOS specialist, where we've identified a number of strategies and tactics that will be focused on.
No. It's it's hard to predict exactly how quickly will have an impact on that but we absolutely do we think will have an impact on that and we've started to implement some of that and it'll probably take a little bit of time and as Justin mentioned, Yeah worked we're transforming the landscape in a L. S treatment day.
Have had a little bit of apathy because they haven't had a lot of tools in their toolbox in the past and we're trying to change. The fact that you know literally we believe that every patients living with a laugh that can benefit from our treatments should have access to our treatment.
And you know what function and survival. So we believe that's a tremendous amount of opportunity for us moving forward and the third bucket would be you know really driving the persistency taken the learnings we have from Canada taken the learnings we happened to have a lot and really focusing our educational efforts not only on function about survival, but the long term efficacy.
He comes with being on therapy for the long term. So so that's our focus narrowly but don't believe that we'll have a.
And in fact all of it up.
And then the second question regarding Phoenix data is we're doing a lot of different preparations for their Phoenix readout. We are incredibly bullish on our Phoenix data. We believe we're going to have successful data. That's certainly what we're planning for and we believe it will have an inflection point on our business both.
Both from an awareness of demand generation and a duration of use for stepped up.
Okay.
And the next question comes from we're not negotiate with H C Wainwright and company.
Yeah, Hi, good morning, guys.
One of the questions I have two questions. The first one is based on looks like the central Phoenix data is kind of hindrance in terms of Oh.
It's really fuels up to with the specialists Mike.
My question is what about the non specialists how much they are.
Respect with the St George Utah, and what's the strategy your own kind of educating the nonspecialist guys, who think about the next speaker.
Well I yeah. Thank you for the question and.
Maybe to clarify I mean, I think we're off to a great start with particularly with the specialists. So I mean, a year into launch we have roughly 25% of people with a L. S on delivery O in those key centers now, obviously theres more to do but when you think that Alastair.
Eric We focus is mostly on symptom management and were trying to say I know there are meaningful intervention.
I think that that's that's that's quite good for a year into launched now there's obviously more work to do but again.
We've talked about where we see those opportunities for growth in the key centers.
In terms of the non key centers.
Just you know I think reminding everyone for many of these people. They they learned about AOS last time in Med school and in AOS is the diagnosis that no one wants to get because there's there's a very little you can do for those patients and we obviously think that that's not true their therapeutic and non therapeutic <unk>.
You mentioned that are very meaningful.
But that's what it means to transform a disease landscape.
Now on top of all of those things, we think that the Phoenix trial results will.
It will be a major milestone for the community because again having.
Having the the first treatment with two positive studies in ALS is a really big deal.
On top of of course, the central results, which is the first time in treatment showed a benefit on both slowing disease progression as well as increasing lifespan.
So that's why we feel like we have great near term opportunities in both the key centers as well as the broader neurology community and then we think Phoenix will just further accelerate all of that.
Great. Thanks, and my second question is on the discontinuation rate you know the difference, which you see in Canada and U S. I mean, it's quite prominent and then the question is like can you be more specific on what you know what exactly Canada like how exactly Canada is different than.
Then you is that you see this stock stark difference in discontinuation rate.
Yeah. So so thanks for the question, Canada really focus from day, one on driving the importance of remaining on therapy and yeah, just to mention I mentioned it in the comments, but concentrate Canada isn't really concentrated market. They have about 17 key centers of excellence, so, it's a little harder or easier to come.
Troll sort of that getting that message down to the H D piece, and then having them communicated to the patients which is incredibly important where it's a little bit more decentralized in the U S. So while we certainly have and communicating those messages I think getting those.
Treatment expectations, and just doubling down on that messaging is going to be really important but I think the important point is we know that when done and done well you can achieve better.
Persistency rates.
Got it thank you.
Okay. Thank you and this concludes our question session at this time I'll turn the call back over to Mr. Kelly.
Thank you operator, and thank you all for joining us on our call today and for your support and we hope you have a good day.
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