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spk07: 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 Amelix Pharmaceuticals Third Quarter 2023 Earnings Conference Call. All participants will be in listen-only mode. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then 1 on your telephone keypad. To withdraw your question, please press star, then 2. Please limit yourself to questions 1 and a follow-up. If you have additional questions, you may rejoin the queue. Please be advised this call is being recorded at the company's request. I would now like to turn the conference over to Lindsay Allen, Head of Investor Relations and Communications. Please proceed, ma'am.
spk10: 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 Friedes, 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 Rolivio and Albreoza, 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 AMAX disclaims any obligation to update such statements unless required by law. Now, I will turn the call over to Justin.
spk15: Thank you, Lindsay, and good morning. As we sit here three full quarters into our US 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 Relivrio continues. As of September 30, 2023, there were roughly 3,900 people living with ALS taking Relivrio 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 Relivrio 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 Relivrio. 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 Relivrio as we work towards our goal that at least 10,000 people will be taking Relivrio 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 focus 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 PhenX, 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 reaffirmed the confidence we have in the survival data for Relivio. As a reminder, The Centaur study was the basis for the full approval from the FDA that we received for Relivrio in late September 2022, and our approval with conditions in Canada. We also remain committed to bringing the benefits of Relivrio outside the US 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. Relivrio 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 still 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.
spk11: Thank you. As Justin mentioned, we ended the quarter with roughly 3,900 people on Reliverio 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 Relivrio 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 ads 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 supportive Phoenix 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 Relivio can significantly impact people living with ALS. Turning to the quarter, prescribing remained concentrated with roughly 80 prescribers, mostly at major ALS centers, representing approximately half of all Relivrio prescriptions, and approximately 300 prescribers representing the vast majority of prescriptions. We are pleased to have a core group of active riders 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 Relivrio. There is still a clear opportunity for continued growth, is 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 Relivio. The top clinics are actively prescribing Relivio, and we continue to educate, optimize, and reiterate our messaging about Relivio's efficacy, including the data on early use of Relivio and the importance of staying on treatment. as well as its 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 receive care from clinicians that do not specialize in ALS. For the most part, this group is not prescribing Relivia. We're developing and will be rolling out new marketing initiatives to reach the group of both potential prescribers and people with ALS who may be unaware of Relivio 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 discontinuation, 60% of people taking Relivio remain on therapy six months after initiation in the U.S. We believe some discontinuations are addressable, especially when comparing our discontinued rate in the US 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 US, 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 and their offices on the benefits of Rolivrio and right expectations with them so they are prepared to set expectations with their patients. Overall, Relivrio 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.
spk02: Thanks, Margaret, and good morning. As you've heard, we have an excellent penetration and engagement among the top ALS centers, and we remain optimistic and committed to the potential for Relivrio. 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 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 were $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 to $40 million in the fourth quarter, as we start enrolling 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 $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 remained 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 Relivrio 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.
spk13: Thanks, Jim. We believe Relivrio, also known as AMX0035, may have applicability across other neurodegenerative diseases, and we are actively advancing clinical trials to evaluate AMX35 in progressive supernuclear palsy, or PSP, and Wolfram syndrome, as well as advancing an antisense oligonucleotide in ALS. AMX35 is comprised of sodium phenylbutyrate and turacediol and works synergistically to prevent or slow cell death. We are on track to launch the phase three Orion trial of AMX35 in PSP later this year. We recently presented the Orion study design at the Neuro 2023 conference and received positive feedback from the community there. Additionally, we continue to progress our Phase II trial in Wolfram syndrome and expect to report results in 2024. We are also advancing AMX-114, our antisense oligonucleotide targeting Palpain 2, through IND-enabling studies and expect to enter the clinic in 2024. We recently presented preclinical data at the NEALS conference on this candidate. In addition to advancing these new therapeutic programs, we are also advancing a new composite biomarker to diagnose ALS earlier. Current data suggests that diagnosis takes about a year. The goal of this program is to create a tool that allows for earlier diagnosis of ALS, which may result in earlier treatment and better outcomes. We shared that we are conducting this program at NEALS 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 Relivrio. This formulation may allow for new intellectual property. We are planning to file an IND and conduct Phase I testing for our innovative formulation in 2024. This quarter, we also continued to publish Relivrio data. Relivrio is the first and only approved treatment for ALS to demonstrate a statistically significant benefit in function in a clinical trial, as well as a survival benefit in a longer-term postdoc analysis. Just recently, an 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 postdoc analysis demonstrated that the median overall survival was 10.4 months longer in the AMX 35 group than in the historical clinical trial group. Finally, as we approach the top-line readout for Phoenix, we are focused on our execution and confident in our setup for success. First, trial design is based on the success we saw in Centaur. which was a randomized placebo-controlled study meeting 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 a poster presented at NCALS. Lastly, we enrolled 664 participants in a three-to-two randomization, and so roughly five times the size of Centaur in the study. 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 Relivrio becoming the most commonly used medicine in ALS. We eagerly await the data from Phoenix, now expected in Q2 2024, and are simultaneously exploring if Relivrio 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 and 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.
spk07: Yes, thank you. At this time, we will begin the question and answer session. To ask a question, you may press star then one on your touch-tone phone. If you are using a speaker phone, please pick up your handset before pressing the keys. To try your question, please press star then two. At this time, we will pause momentarily to assemble the roster. And the first question comes from Corrine Jenkins with Goldman Sachs.
spk12: Good morning. So can you just help clarify a little bit on the discontinuations that you're seeing? Are these primarily due to adverse events 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 type of patients coming on to drug now versus during the early launch, particularly with respect to time since diagnosis?
spk11: Yes, thank you very much for the question. This is Margaret. So, yes, on the discontinuations, you know, 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, you know, 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, you know, because, you know, 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 mix of therapies is, 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.
spk13: Yeah, and maybe the only thing I'll add there as well, you know, 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.
spk12: 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 class of therapies in that indication?
spk13: Yeah, you know, it's a little hard to say. You know, obviously we're all kind of pulling different data on different therapies and probably don't talk too much about, you know, 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.
spk11: Yeah, and I would just say that... Sorry, I was just going to add We continue to believe that patients who get on therapy earlier and stay on therapy longer will have better patient outcomes, and that's certainly our objective and mission moving forward.
spk12: 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, 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, it would be helpful as well.
spk13: Yeah, I'd say, you know, it's probably early to comment 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 impact things. You know, in the top centers, while we have 20% of people on therapy, or 25% of people on Relibrio, roughly 66% of people are on any ALS therapy. So we see a big opportunity there, and we're going to continue optimizing that. And then as we share, what we found is... you know, roughly half of people are not actually seen by an ALS specialist. And, you know, so there's a big opportunity to get relivery out broader beyond just the key ALS centers. And then, you know, I think finally, as we touched on too, on the discontinuation side, we've seen tactics that have worked in regions, and we're going to try to use those in the U.S. as well, and hopefully continue to see growth there.
spk15: And Karin, just bringing it back to the picture, you know, 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, you know, 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.
spk03: Thank you.
spk05: Thank you. And the next question comes from Jeff Meakin with Bank of America.
spk16: Morning, guys. Thanks for the questions. Just had a few. So on Phoenix, the first one is, I know it's splitting hairs, but mid-24 versus 2Q, was 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. You know, how much incremental revenue could we expect to see from some of these? Just thinking about, you know, going into formal full approval 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.
spk13: Yeah, 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.
spk02: Yeah, thanks, Jeff. Good morning. You know, we just started up in France late last month, so 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 hopefully ultimate approval. That said, it is going to be an important opportunity to have the key centers get experience with Relivrio. 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. You know, but given the size, frankly, of our revenues in the United States, while it'll be, you know, it'll certainly be incremental, but, you know, the main driver we're looking for is full approval in Europe.
spk16: Gotcha. 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 a functional data set for next year? Thank you.
spk13: Yeah, so I'll say ultimately we can never or speak for the regulators, but certainly our intention is with positive Phoenix results, you know, especially coming out of the top line readout, you know, we will want to, you know, push forward towards approval as quickly as we possibly can.
spk15: Yeah, and just adding, I mean, I think, you know, further to your questions too, I think we, you know, we remain, you know, confident in the design and execution of the study It's, 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.
spk04: Thanks, guys. Thank you.
spk07: And the next question comes from with Evercore ISI.
spk01: Hi, guys. Thanks for taking my question. I have two. 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 coincided with this massive slowdown, it just really puzzles me because I feel like not only was the street ready from communication on your end, but also I feel like you limited the channels through which the street could have been ready for today. Can you expand on that? Because it looks like you may have had a sense for discontinuations really picking up around July timeframe.
spk06: Well, yeah, maybe I'll start.
spk15: So, you know, 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 was 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 that 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 a 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.
spk01: Got it. And let me just follow up. Justin, 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 ad number in 4Q unless your new ad picks up very meaningfully versus where it was in 3Q. Am I on the right track there?
spk13: Maybe, you know, 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.
spk15: Yeah. And I think that our initiatives are designed that, 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, you know, 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.
spk02: Yeah, let me just say one or two. I think, you know, as you do your calculations, actually, Margaret mentioned in her remarks, we've had actually steady new prescriptions from Q2 into Q3. So, You know, while we obviously want to see more growth and accelerated growth in that, and we touched a little bit about that on our 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 ads. And, you know, just another point in the discontinuations. It's not like we've seen a major drop-off here. This has been a, you know, 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, excuse me, the Centaur 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'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.
spk04: Thank you, guys.
spk06: You're welcome.
spk04: Thank you.
spk05: And the next question comes from Mark Goodwin with Learing Partners.
spk08: Yes, hi. Maybe you can give us a flavor for how October went to give everybody a sense of trends versus what we just talked about.
spk13: Yeah, 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 ads. you know, in a steady pace.
spk15: Yeah, I think just reiterating what Margaret and Jim were saying, you know, the slowdown in net patient ads 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.
spk08: So just to be clear on the new patient ads, from second quarter into third quarter, you had a steady increase in new patient ads. 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.
spk02: Yeah, I'd say, you know, steady is steady. And so, you know, 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, you know, into the next deciles down, you know, deciles, say, three through six is where we're going to be focused.
spk08: Mm-hmm. But is it fair to say that steady means steady, like October was steady trends just like the previous quarter? Because, you know, 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.
spk02: Yeah, well, I think, Mark, you know, 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 drug, right? So if those folks, if we remained at the 10% range instead of the 15% range, right, sales would have been a lot higher and closer to people's expectations. So I think, you know, month to month, you know, single months matter still, you know, even at these levels. And so we're only one month into the quarter, and it's very hard to predict where we're going to be at the end of the quarter where we sit today.
spk07: Thank you. And the next question comes from Greg Silvanage from Mizuho Partners.
spk14: Hey, it's Greg Silvanage. 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 Phoenix, now a second quarter event. And as you think about current usage of the product, whether it's 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 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.
spk11: 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 and opportunity within the top ALS centers. You know, as we've already talked about, we you know, have 300 physicians that are prescribing in that bucket of patients. They're prescribing about 25% of all their patients on Relivio treatment, but they are treating, you know, two-thirds of their patients with any patient, any drug available for ALS. 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 to 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 and are sent to our data. And, you know, we were studied in monotherapy and combination therapy. So we believe that just in that bucket alone, where we've been heavily focused and concentrated on, there's a tremendous amount of opportunity. The second bucket, as you mentioned, is really growing into the non-ALS specialist, where we've identified a number of strategies and tactics that we'll be focused on. It's hard to predict exactly how quickly we'll have an impact on that, but we absolutely do think we'll have an impact on that. And we've started to implement some of that. It'll probably take a little bit of time. As Justin mentioned, we're transforming the landscape in ALS treatment. you know, have had a little bit of apathy because they haven't had a lot of twos in their toolbox in the past. And we're trying to change the fact that, you know, literally we believe that every patient living with ALS that can benefit from our treatment should have access to our treatment and, you know, with 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, taking the learnings we have from Canada, taking the learnings we have from the ALS, and really focusing our educational efforts not only on function but survival, but the long-term efficacy comes with being on therapy for the long term. So that's our focus there. We believe that will have an impact on us. And then the second question regarding Phoenix data is we're doing a lot of this in preparation for the Phoenix readout. 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 from an awareness, a demand generation, and a duration of use perspective.
spk04: Thank you. And the next question comes from Ananda Ghosh with AC Rainwright and Company.
spk09: Yeah, hi, and good morning, guys. One of the questions, I have two questions. The first one is based on, looks like the absence of Phoenix data is a kind of hindrance in terms of uptake with the specialists. My question is, what about the non-specialists? How much aware they are with respect to the Centaur data and what's the strategy around kind of educating the non-specialists as you think about the next quarter?
spk15: Well, 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. I mean, a year into launch, we have roughly 25% of people with ALS on Relivrio in those key centers. Now, obviously, there's more to do, but when you think that ALS historically focuses mostly on symptom management, and we're trying to say, no, there are meaningful interventions, I think that that's quite good for a year into launch. 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 I think reminding everyone, for many of these people, they learned about ALS last time in med school. And ALS is a diagnosis that no one wants to give. Because there's very little you can do for those patients. And we obviously think that's not true. There are therapeutic and non-therapeutic interventions 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 be a major milestone for the community. Because again, having 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 a 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.
spk09: Great, thanks. 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 the question is, like, can you be more specific on what, you know, what exactly Canada, like, how exactly Canada is different than U.S. that you see this stark difference in discontinuation rate?
spk11: Yeah, so thanks for the question. Canada really focused from day one on driving the importance of remaining on therapy. And, you know, just to mention, I mentioned it in the comments, but Canada is a really concentrated market. They have about 17 key centers of excellence. So it's a little hard, a little easier to control sort of that, getting that message down to the HCPs 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 been 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.
spk04: Thank you.
spk05: Thank you.
spk07: And this concludes the question session at this time. I'll turn the call back over to Mr. Clay.
spk15: 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.
spk07: Thank you. The conference call has now concluded. Thank you for attending today's presentation. May now disconnect your lines.
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