Amylyx Pharmaceuticals, Inc. Q3 FY2023 Earnings Call

Good morning. My name is Keith, and I will be your conference operator today. At this time, I would like to welcome everyone to the Amylyx Pharmaceuticals Third Quarter 2023 Earnings Conference Call. All participants will be in listen-only mode. Please be advised this call is being recorded at the company's request. I would now like to turn the conference over to Lindsey Allen, Head of Investor Relations and 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 Klee, our Co-CEOs; Margaret Olinger, our Chief Commercial Officer; and Jim Frates, our Chief Financial Officer. Before we begin, I would like to remind everyone that any statements we make or 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 of 1995. These statements include, but are not limited to, our expectations with respect to RELYVRIO and ALBRIOZA, 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 Amylyx 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 ALS, we are proud of what we have accomplished. We are also keenly focused on the work we still need to do to help transform and improve the way that ALS is treated. Our progress with RELYVRIO continues. As of September 30, 2023, there were roughly 3,900 people living with ALS taking RELYVRIO in the U.S. We generated $102.7 million in 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 RELYVRIO has been adopted at key ALS 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 ALS and are likely unaware of the benefits of RELYVRIO. 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 ALS market. We recognize that it may take time and additional data from PHOENIX to reach the many clinicians who have yet to prescribe RELYVRIO as we work towards our goal that at least 10,000 people will be taking RELYVRIO at any given time. Margaret will provide additional details. As an organization, we are 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 top-line data from the 664 participant 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 ALS Consortium meeting last month. He will also review data from CENTAUR that was recently published in a prominent peer-reviewed medical journal that reaffirm the confidence we have in the survival data for RELYVRIO. As a reminder, the CENTAUR study was the basis for the full approval from the FDA that we received for RELYVRIO in late September 2022 and our approval with conditions in Canada. We also remain committed to bringing the benefits of RELYVRIO outside the U.S. and Canada to the more than 200,000 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 and France, and we are engaging with regulators in Japan. RELYVRIO gives us the opportunity to start to transform ALS from symptom management as standard of care to a disease with meaningful interventions, and our team is working hard to accelerate this shift because we know people living with ALS have 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 for 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 3,900 people on RELYVRIO in the U.S., up from roughly 3,800 at the end of the second quarter. With our goal that at least 10,000 people living with ALS will be taking RELYVRIO at any given time, we are working hard to accelerate this growth, and I will detail some of the specific plans shortly. The interest and engagement among our prescribers remain strong, and we saw a steady cadence of new prescriptions written in the third quarter. In addition, fill times were down to about three weeks for people living with ALS enrolling in the quarter. As we think about how our growth has evolved this year, the slowdown in net adds this quarter was primarily driven by increased discontinuations for a variety of reasons. We have already begun implementing new educational initiatives, which 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's results will reinforce 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 RELYVRIO can significantly impact people living with ALS. Turning to the quarter. Prescribing remains concentrated with roughly 80 prescribers mostly at major ALS centers, representing approximately half of all RELYVRIO prescriptions and approximately 300 prescribers representing the vast majority of prescriptions. We are pleased to have a core group of active prescribers at the top centers, just three full quarters into our U.S. launch. And roughly 25% of the people treated at these centers were taking RELYVRIO. There is still a clear opportunity for continued growth, as our research shows that roughly two-thirds of people living with ALS in these centers were on at least one approved ALS drug. And like I said, only 25% of patients in these centers were taking RELYVRIO. The top clinics are actively prescribing RELYVRIO, and we continue to educate, optimize, and reiterate our messaging about RELYVRIO's efficacy, including the data on early use of RELYVRIO and the importance of staying on treatment as well as the safety profile. As Justin mentioned, we have also learned through experience in the field and further market research that roughly half of all people with ALS received care from clinicians that do not specialize in ALS. For the most part, this group is not prescribing RELYVRIO. We are developing and we'll be rolling out new marketing initiatives to reach the group of both potential prescribers and people with ALS, who may be unaware of RELYVRIO and its benefits on both function and survival. These include increasing our digital presence, enhancing our non-personal efforts, and optimizing our field strategy. We view this as a key source of future growth. Circling back to discontinuations, 60% of people taking RELYVRIO remain on therapy six months after initiation in the U.S. We believe some discontinuations are addressable, especially when comparing our discontinuation rate 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., 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 begun to deploy the learnings and messages from Canada in the U.S. We believe the key is to educate clinicians in their offices on the benefits of RELYVRIO and set right expectations with them, so they are prepared to set expectations with their patients. Overall, RELYVRIO 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 ALS centers. Operationally, our team is delivering and 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 ALS 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 and to support persistency. We have more work to do, but we are also pleased to be off to a great start and honored to continue to serve more and more of the approximately 30,000 people living with ALS in the U.S. and approximately 3,000 people living with ALS 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. As you've heard, we have excellent penetration and engagement among the top ALS centers, and we remain optimistic and committed to the potential for RELYVRIO. As we adapt to 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 ALS 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 chargebacks 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 at specialty pharmacies, similar to what we've seen in previous quarters. Cost of sales was $5.2 million for the quarter, roughly 5% of net product revenues. This is within the range of our expectations. 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 participants in our new global Phase 3 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 $20.9 million in 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 has shown the value of and interest in RELYVRIO among the top ALS centers. We're confident in our ability to continue to grow our top line, invest 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.

Thank you, Jim. We believe RELYVRIO, also known as AMX0035, might be useful for other neurodegenerative diseases, and we are actively conducting clinical trials to assess AMX0035 in progressive supranuclear palsy (PSP) and Wolfram syndrome while also progressing an antisense oligonucleotide for ALS. AMX0035 contains sodium phenylbutyrate and Taurursodiol, which work together to help prevent or slow down cell death. We are on schedule to initiate the Phase 3 ORION trial of AMX0035 in PSP this year. We recently shared the ORION study design at the Neuro 2023 Conference and received positive feedback from attendees. We are also making progress with our Phase 2 trial in Wolfram syndrome and anticipate reporting results in 2024. Additionally, we are moving forward with AMX0114, our antisense oligonucleotide targeting Calpain-2, through IND-enabling studies and expect to begin clinical trials in 2024. We shared preclinical data on this candidate at the NEALS conference. Alongside these new therapeutic programs, we are developing a new composite biomarker for earlier diagnosis of ALS. Current data indicates that diagnosis typically takes about a year. The aim of this program is to create a tool for earlier diagnosis of ALS, which could lead to prompt treatment and improved outcomes. We reported on this initiative at NEALS this year and plan to provide comprehensive results from initial experiments in 2024. For several years, we have been working on a new taste-masked formulation of RELYVRIO that may lead to new intellectual property. We plan to file an IND and carry out Phase 1 testing for this innovative formulation in 2024. This quarter, we continued to publish data on RELYVRIO, which is the first and only approved treatment for ALS to show a statistically significant benefit in function in a clinical trial as well as a survival benefit in a longer-term post-hoc analysis. A recent analysis comparing the long-term survival of trial participants to a historical clinical trial control group was published in the Annals of Clinical and Translational Neurology, showing that the median overall survival was 10.4 months longer in the AMX0035 group compared to the historical control group. As we approach the top-line results for PHOENIX, we are focusing on our execution and are confident in our setup for success. First, the trial design is based on the success demonstrated in CENTAUR, which was a randomized, placebo-controlled study that met its pre-specified primary outcome. Second, although we designed the study to allow broader entry criteria, the enrolled population is very similar to CENTAUR, as shown in a poster presented at NEALS. Lastly, we enrolled 664 participants with a three to two randomization, which is roughly five times the size of the CENTAUR trial. There is strong interest among investigators, and we have thus far executed well and enrolled according to our planned timeline. In closing, our launch has started strong, and we have made significant progress toward our goal of making RELYVRIO the most commonly used medicine for ALS. We look forward to the data from PHOENIX, expected in Q2 2024, while also exploring the potential of RELYVRIO to assist individuals with other neurodegenerative diseases, such as PSP and Wolfram syndrome. Overall, we are very satisfied with our accomplishments as an organization to date and see substantial opportunities ahead, both with our commercial launch and our pipeline. We are now ready to take your questions. Please open the call for Q&A.

Yes, thank you. At this time, we will begin the question-and-answer session. And the first question comes from Corinne Jenkins with Goldman Sachs.

Good morning. Can you clarify the reasons behind the discontinuations you're experiencing? Are they mainly due to adverse events, disease progression, or patient mortality? Additionally, are you noticing any changes in the types of patients starting treatment now compared to the early launch, particularly in relation to the time since their diagnosis?

Yes. Thank you very much for the question. This is Margaret. So yes, on the discontinuations, there's a variety of reasons why people discontinue ALS therapies. But it's important to remember that in many ways, it's really connected to the disease state sadly. So as we mentioned, we're deploying tactics designed to help lower the rate of these types of discontinuations, including taking the key learnings from Canada, where we heavily focused on the importance of remaining on therapy because our long-term efficacy is really based on being on therapy for the long term. So that's highly what we're focused on. And the second question regarding the mix of therapies. We continue to see a mix of therapies, a mix of patients coming on therapy with the prevalent 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.

Yes. And maybe the only thing I'll add there as well. Just going to the discontinuation specifically, at six months in the U.S., we're seeing roughly 60% of people remaining on therapy. In 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 going to be trying to do over the coming quarters.

And do we know what kind of the industry standard is for ALS drugs on the whole, like what's sort of the average duration of therapy or discontinuation rates for the broader cost of therapies in that indication?

Yes. 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 Canada and some of the data we're seeing there, we believe this is an area we can continue to see opportunity and continue to grow.

Yes, and I would just like to add that we continue to believe that patients who begin therapy earlier and maintain it for a longer duration will achieve better outcomes, and that is certainly our objective and mission moving forward.

Okay. And then I guess, how quickly can we expect to see you guys toggle this, in particular, given the acceleration in patient growth in the first half of this year? Or 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 as well.

It's probably too early to comment on how the next quarters will turn out. However, we have several initiatives that we believe will make a positive impact. Currently, a portion of patients are on therapy, and about two-thirds of individuals are receiving any ALS treatment. This presents a significant opportunity for us, which we are committed to optimizing. Additionally, we've discovered that about half of ALS patients are not seeing a specialist, suggesting a chance to expand the reach of RELYVRIO beyond the main ALS centers. Lastly, we have observed effective strategies in different regions and plan to implement those in the U.S. as well, with the goal of maintaining growth.

And Corinne, just bringing it back to that big picture, I think in short, we see great near-term growth opportunities and also long-term growth opportunities. I mean, we have 3,900 people on treatment as of the end of the quarter, and there are roughly 30,000 people in the U.S. at any one time who have ALS. 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 that a treatment would have positive results from two studies. 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. And the next question comes from Geoff Meacham with Bank of America.

Good morning everyone. I appreciate the questions. I have a couple to ask. Regarding PHOENIX, is the timeline of mid '24 instead of 2Q based on a quicker event rate, or did you simply want to provide more precise guidance? For my second question, concerning compassionate use in France and potentially other regions, what additional revenue should we anticipate from these efforts? I'm curious about how this relates to the formal approval process in Europe and whether compassionate use could serve as an early indicator of future 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 readout there. And then I'll pass it over to Jim to talk about the compassionate use impact on revenue.

Yes, thanks Geoff. Good morning. We just launched in France late last month, so it will be interesting to see what the demand is there. I believe this could contribute to incremental revenue as we move through 2024 and hopefully obtain ultimate approval. This also provides a significant opportunity for key centers to gain experience with RELYVRIO. Additionally, these centers are more concentrated in Europe than in the United States, making it important for us to access patients. However, considering the size of our revenues in the United States, while it will indeed be incremental, our primary focus remains on achieving 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 a back-and-forth process as of now. But for PHOENIX, do you think you would have to wait for OS to hit? Or do you think you could file theoretically, if you hit on just the functional data set for next year? Thank you.

Yes. So I'll say, ultimately, we can never expect or speak for the regulators. But certainly, our intention is with positive PHOENIX results, especially coming out of the top-line readout, we will want to push forward towards approval as quickly as we possibly can.

Yes. And just adding, I mean, I think further to your questions, too, I think we remain confident in the design and execution of the study. Again, it's a 664 participant study, our team is executing. And I think that those results will be a major milestone for the ALS community, the opportunity to have two positive studies in a disease where there's been so much historical clinical trial failure, I think it's hard to overstate what a big deal that will be for the community.

Thanks guys.

Hi everyone, I appreciate you taking my question. I have two inquiries. To start, I'm curious about how the implementation of data restrictions on IMS and Symphony vendors this summer aligns with the significant slowdown we observed. It confuses me because it seems like the market was prepared based on your previous communications, yet it feels like you restricted the avenues through which the market could be ready for today. Could you elaborate on this? It appears that you might have anticipated an increase in discontinuations around July.

Well, Umer, maybe I'll start. So our intention at launch was always to have the limited distribution model. And so we updated everyone in February that we thought we had identified one of the areas where there is some data coming out, and so we had addressed that. So that was back in February. And I think the most important thing here, though, is that we have huge long-term growth opportunities ahead of us. We're very proud that we're helping 3,900 people as of the end of the quarter. But again, I'll reiterate, there are 30,000 people with ALS at any one time. And the last thing I'll say, too, is that we're really trying to transform the disease space here. As I said in my remarks, ALS historically is focused on symptom management, and we're trying to shift the field to focus on meaningful interventions. 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 to 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 5,500 patients may have started therapy since your launch? And secondly, if I model out on discontinuations, 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 2Q to 3Q. Is that right? Because I feel like you may have had about, I don't know, 750 discontinuations in 3Q. But if that's the case, you might be in for another about 650 to 700 discontinuations in 4Q, which makes it very hard to again put up a very meaningful net add number in 4Q unless your new add picks up very meaningfully versus where it was in 3Q. Am I on the right track there?

Maybe we haven't commented on any of those metrics, but maybe just to circle back. There are roughly 30,000 people living with ALS in the United States. We have 3,900 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 will achieve that.

Yes. And I think that our initiatives are designed at again, transforming ALS. We have initiatives to help in the top centers where we think there's further opportunity in the market, we found that there are far more people in the broader neurology community. And so we think there's great initiatives we can do for further awareness. And as we showed in Canada, we think that we can use our strategies to show that staying on therapy longer matters. And again, that's part of transforming the disease space. So in answer to your question on sort of both growth in terms of new people coming on as well as staying on treatment, we think we have great strategies to address all of those.

Yes. Let me just take number two. I think as you do your calculations, actually, Margaret mentioned in her remarks, we've had actually steady new prescriptions from Q2 into Q3. So while we obviously want to see more growth and accelerated growth in that and we touched a little bit about that in our remarks. There's no real distinctive change in terms of the new adds. Certainly, it slowed down from Q4 and into Q1, and we talked about that on the last call, but we've seen steady new adds. And just another point on the discontinuations, it's not like we've seen a major drop-off here. This has been 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 discontinuations until we get there. So we've been tracking the CENTAUR data through last quarter. It's gotten a little higher than that discontinuation rate over the last couple of months. 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 launch 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. And the next question comes from Marc Goodman with Leerink Partners.

Yes, maybe you can give us a flavor for how October went to give everybody a sense of trends versus what we just talked about?

Yes. We usually don't report month-to-month. But what I'd say is that we're certainly rolling out many of the things that Margaret described. And certainly, there's nothing revolutionary there in terms of things are continuing. We're continuing to see net adds at a steady pace.

Yes. I think just reiterating what Margaret and Jim were saying, the slowdown in net patient adds we saw was primarily driven by discontinuation. And we think we have great things to address there as well as new opportunities for growth.

Yes. I'd say steady is steady. And so I think that what we want to see is a reacceleration of that growth, right, back to the levels that we saw when we were first launching the drug. And I think 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 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 but expand into the next deciles down.

But is it fair to say that steady means steady, like October was steady trends, just like the previous quarter because here's an opportunity to kind of comment on it given what happened this past quarter. I know you don't normally do it, but maybe you could make an exception this time.

Yes, Marc, the issue is that we had an additional 5% of people on free drug. If we had stayed at the 10% range instead of moving to 15%, our sales would have been significantly higher and closer to expectations. Month-to-month performance is important, even at these levels. We're only one month into the quarter, and it's difficult to predict where we'll be by the end of it based on our current situation.

Thank you. And the next question comes from Graig Suvannavejh from Mizuho Partners.

Hey, it's Graig Suvannavejh. Thanks so much. Thanks for taking my question. I've got two, if I could. First, I know a lot of the growth now is going to be focused on the non-ALS 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-ALS center setting? And then my second question just has to do with kind of with PHOENIX, now a second quarter event. And as you think about current usage of the product, whether it's views 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 not being able to capture more patients because of anticipation around PHOENIX? In other words, how much do you think if you do end up getting positive PHOENIX data that, that will really drive growth over and above what you're experiencing right now? Thanks.

Yes. To address your first question, we see our growth coming from three main areas. First, we believe there is continued potential within the leading ALS centers. As mentioned, there are 300 physicians prescribing to this group of patients, and they are prescribing RELYVRIO to about 25% of their patients, while treating two-thirds with any drug for ALS. This presents a 40% growth opportunity that we are intensely focused on. We aim to drive education about our product, which is the first to provide both function and survival benefits. We strongly believe we can be a foundational treatment. Additionally, we have full approval in the U.S. and are confident in our CENTAUR data, which includes studies on both monotherapy and combination therapy. There is significant opportunity in this area where we have concentrated our efforts. The second area is expanding into non-ALS specialists, where we have identified various strategies and tactics to implement. Although it is challenging to predict the timing of our impact, we are confident it will be positive. We've begun implementing some changes, which will take time. As Justin mentioned, we are changing the landscape of ALS treatment, especially since there has been limited options in the past. We believe every ALS patient who could benefit from our treatment should have access to it to improve their function and survival, representing a substantial opportunity for us. The third area involves improving persistency by applying lessons learned from Canada and focusing our educational efforts on both function and survival. Long-term efficacy relies on patients staying on therapies, which is our priority. We anticipate this focus will yield positive results. Regarding the PHOENIX data, we are actively preparing for its readout and are very optimistic about it. We expect successful outcomes, which we believe will create an inflection point for our business in terms of awareness, demand generation, and duration of use.

Yes, good morning everyone. I have two questions. The first is regarding the apparent lack of PHOENIX data, which seems to be a barrier for RELYVRIO's acceptance among specialists. I'm curious about the awareness of non-specialists regarding the CENTAUR data, and what strategies are in place to educate them as we look ahead to the next quarter?

Thank you for your question. To clarify, I believe we have made a strong start, especially with specialists. A year after our launch, approximately 25% of people with ALS at key centers are using RELYVRIO. While we still have more to accomplish, it's significant considering that ALS has traditionally been focused on symptom management. Our aim is to demonstrate that there are meaningful interventions available. Although there's still plenty of work ahead, we have discussed the opportunities for growth at these key centers. As for the non-key centers, it’s important to remember that many practitioners only learned about ALS during their medical training, and it is often a diagnosis that they are reluctant to provide due to the limited options available for patients. We disagree with that notion, as there are both therapeutic and non-therapeutic interventions that can be impactful. This is essential for transforming the landscape of the disease. Additionally, we believe that the results from the PHOENIX trial will be a significant breakthrough for the community, as it would represent the first treatment supported by two positive studies in ALS. This, alongside the CENTAUR results, which is notable for being the first time a treatment has shown benefits in both slowing disease progression and extending lifespan, leads us to feel optimistic about our near-term opportunities both within key centers and the wider neurology community. We anticipate that PHOENIX will further propel this progress.

Yes, thank you for the question. Canada has really emphasized the importance of staying on therapy from the beginning. It's important to note that Canada is a concentrated market with around 17 key centers of excellence. This makes it somewhat easier to communicate our messages to healthcare providers, who in turn relay them to patients, which is crucial. In contrast, the U.S. market is more decentralized. While we are certainly working on communicating these messages, reinforcing treatment expectations and messaging will be vital. The key takeaway is that we know that when this is done effectively, we can achieve better persistence rates.

Thank you, operator, and thank you all for joining us on our call today and for your support. We hope you have a good day.

Thank you. The conference call has now concluded. Thank you for attending today's presentation. You may now disconnect your lines.