Amylyx Pharmaceuticals Q3 2023 Earnings Call Transcript

Quartr
Provided by Quartr
November 9, 2023

There are 12 speakers on the call.

Operator

Good morning.

Speaker 1

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. Please limit yourself to questions, 1 and a follow-up.

Speaker 1

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 Lindsey Allen, Head of Investor Relations and Communications. Please proceed, ma'am.

Speaker 2

Good morning, and thank you for joining us today to discuss our Q3 2023 earnings. With me on the call are Josh Cohen and Justin Klee, our Co CEOs Margaret Uhlinger, our Chief Commercial Officer and Jim Freitas, 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 However, provisions of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, our Expectations with respect to Relivio and Albriosa, 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.

Speaker 2

You are cautioned not to place any undue reliance on these forward looking statements, and Amlyx disclaims any obligation to update such statements unless required by law. Now, I will turn the call over to Justin.

Speaker 3

Thank you, Lindsay, and good morning. As we sit here 3 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 We'll need to do to help transform and improve the way that ALS is treated.

Speaker 3

Our progress with Relibrio continues. As of September 30, 2023, there were roughly 3,900 people living with ALS taking RELIBRIO in the U. S. We generated $102,700,000 in net product revenues in the 3rd quarter and $272,300,000 in the first 3 full quarters of launch. We are incredibly pleased with how quickly RELIBRIO has been adopted at key ALS centers and with our engagement with clinicians.

Speaker 3

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 Relibrio. 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 Pfenex to reach the many clinicians who have yet to prescribe BOLIBRIO As we work towards our goal that at least 10,000 people will be taking Relivio at any given time. Margaret will provide additional details. As an organization, we are focused on both delivering on our commercial and R and D goals in the near term and investing for the long term with a pipeline focused on treating neurodegenerative diseases.

Speaker 3

Importantly, our PHOENIX study is progressing well And we now expect to report top line data from the 664 participant study in the Q2 of 2024. We continue to be confident in the design and execution of the study. Josh will provide additional details on Pfenex, 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 As a reminder, the Centaur study was the basis for the full approval from the FDA that we received for RELIBRIO in late September 2022 and our approval with conditions in Canada. We also remain committed to bringing the benefits of Relivio outside the U.

Speaker 3

S. And Canada to the more than 200,000 people living with ALS worldwide. Assuming the data from Pfenex 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 intervention.

Speaker 3

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. 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.

Speaker 4

Thank you. As Justin mentioned, we ended the quarter with roughly 3,900 people on Relivio 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 remains strong and we saw a steady cadence of new prescriptions written in the 3rd quarter.

Speaker 4

In addition, fill times were down to about 3 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 Pfenex. We believe support of Pfenex results will reinforce the robust data currently available and help all aspects of our launch with greater awareness, Turning to the quarter, prescribing remained concentrated With roughly 80 prescribers, mostly at major ALS centers, representing approximately half of all Relivio prescriptions and approximately 300 prescribers representing the vast majority of prescriptions.

Speaker 4

We are pleased to have a core group of active writers at Top centers, just 3 full quarters into our U. S. Launch. And roughly 25% of the people treated at these centers were taking RELIBRIO. There is still a clear opportunity for continued growth as our research shows that roughly 2 thirds of people living with ALS in these centers We're on at least one approved ALS drug.

Speaker 4

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 Rolivio 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 ROLIVIA. We are developing and will be rolling out new marketing initiatives to reach the group of both potential prescribers and people with left You may be unaware of Relibrio and its benefits on both function and survival.

Speaker 4

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 WILIBRIO remain on therapy 6 months after initiation in the U. S. We believe some discontinuations are addressable, especially when comparing our discontinued rate in the U.

Speaker 4

S. To Canada. In Canada, roughly 80% of insured patients, both private and public, are still on therapy 6 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.

Speaker 4

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.

Speaker 4

We believe the key is to educate clinicians and their offices on the benefits of Alivrio and provide expectations with them, so they are prepared to set expectations with their patients. Overall, Relibrio 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.

Speaker 4

Operationally, our team is delivering and people living with ALS are able to start therapy quickly. We are focused on 3 goals that will drive our commercial strategy going forward. 1st, we are optimizing our approach to engaging with key clinicians to maintain and continue to grow that segment of the business. 2nd, 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.

Speaker 4

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.

Speaker 4

I will now turn the call over to Jim to discuss our financial results for the Q3.

Operator

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 Pfenex 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 Pfenex reads out in the Q2 of next year. Now let me turn to the financial results for the quarter.

Operator

Net product revenues were $102,700,000 for the Q3 compared to net product revenues of $98,200,000 for the Q2 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.

Operator

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 2 weeks of inventory in the channel at specialty pharmacies, similar to what we've seen in previous quarters. Cost of sales were $5,200,000 for the quarter, roughly 5% of net product revenues. This is within the range of our expectations.

Operator

Q3 was helped by a low rate of scrap and the completion of our royalty obligations in the Q2. Going forward, we expect COGS to be in the range of 5% to 10% Research and development expenses were $30,000,000 for the quarter. You should expect R and D expenses to be in the range of $35,000,000 to and advance other programs in our portfolio. Selling, general and administrative expenses or SG and A were $48,700,000 for the quarter compared to $43,400,000 in Q2. The increase was mainly driven by increases in marketing expenses, Personnel and additional charitable contributions in the quarter.

Operator

We expect SG and A expenses to be in this range for the Q4. These results led to a strong bottom line. We generated $20,900,000 in net income, representing our 3rd quarter in a row of profitability. Finally, we ended the quarter with cash and short term investments of $355,000,000 and 0 debt. Our balance sheet remains strong as our assets increased $13,000,000 in the quarter and we paid down approximately $18,000,000 in payables during Q3.

Operator

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 and D program updates.

Speaker 5

Thanks, Jim. We believe RELIBRIO, Also known as AMX-thirty five, they have applicability across other neurodegenerative diseases, And we are actively advancing clinical trials to evaluate AMX-thirty five in progressive supranuclear palsy or PST and Wolfram syndrome, as well as advancing an antisense oligonucleotide in ALS. AMX-thirty five It's comprised of sodium phenylbutyrate and turicidiol and works synergistically to prevent or slow cell death. We are on track to launch the Phase 3 ORION trial of AMX-thirty five in PSP during this year. We recently presented the ORION study design at the neuro 2023 conference and received positive feedback from the community there.

Speaker 5

Additionally, we continue to progress our Phase 2 trial in Wolfram syndrome and expect to report results in 2024. We are also advancing AMX-one hundred and fourteen, our antisense oligonucleotide targeting PALPAIN-two 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.

Speaker 5

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 mask formulation of RILIBRIA. This formulation may allow for new intellectual property. We are planning to file an IND and conduct Phase 1 testing for innovative formulation in 2024.

Speaker 5

This quarter, we also continued to publish RELIBRIO data. RELIBRIO is the first The only approved treatment for ALS to demonstrate a statistically significant benefit in function in a clinical trial as well as a survival benefit and a longer term post doc analysis. Just recently, an analysis comparing the long term survival 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 10.4 months longer in the AMX35 group than in the historical clinical trial group. As we finally, as we approach the top line readout for Pfenex, We are focused on our execution and confident in our setup for success.

Speaker 5

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. 2nd, while we designed this study to allow for a broader entry criteria, the population that enrolled are very similar to Centaur, as shown in a poster presented at N CALLS. Lastly, we enrolled 664 participants in a 3 to 2 randomization and so roughly 5 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.

Speaker 5

We eagerly await the data from Pfenex now expected in Q2 2024 and are simultaneously exploring if OLIVIO 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 and A.

Speaker 1

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

Speaker 6

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.

Speaker 4

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 we're 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.

Speaker 4

So that's highly well we're focused on. And the second question regarding mix of therapies, we continue to see a mix of therapies, A mix of patients coming on therapy with the prevalent patient and patients. But I would say in the Q3, we 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 6 months.

Speaker 5

Yes. And maybe only thing I'll add there as well, just going to the discontinuation specifically, at 6 months in the U. S, 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.

Speaker 6

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

Speaker 5

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.

Speaker 4

Yes. And I will just say

Speaker 3

All right.

Speaker 4

And I was just going to add that 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 And mission moving forward.

Speaker 6

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 This year, should we expect this to be a big factor into the Q4? And if you could comment on kind of trends you're seeing there would be helpful as well.

Speaker 5

Yes, I'd say 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. In the top centers, while we have percent of people on therapy, With or 25 percent of people on Relibrio, roughly 66% of people are in 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 roughly half of people are not actually seen by an ALS specialist.

Speaker 5

And so there's a big opportunity to get Relibrio broader beyond just the key ALS centers. And then 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.

Speaker 3

And Karim, just bringing it back to the 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.

Speaker 3

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 2 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.

Speaker 6

Thank you.

Speaker 1

Thank you. And the next question comes from Jeff Meakim with Bank of America. Good morning, guys. Thanks for the questions.

Speaker 7

Just had a few. So on Pfenex, the first I know it's splitting hairs, but mid-twenty 4 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. How much incremental revenue could we expect to see from some of these?

Speaker 7

Just thinking about 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.

Speaker 5

Yes. So maybe on Pfenex first, I think we first said mid-twenty 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?

Operator

Yes. Thanks, Jeff. Good morning. We just started up in France Late last month, so it will 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.

Operator

And That said, it is going to be an important opportunity to have the key centers get experience with Relivrio. And Additionally, 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 will be it will certainly be incremental, but The main driver we're looking for is full approval in Europe.

Speaker 7

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 Pfenex, 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 for next year. Thank you.

Speaker 5

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

Speaker 3

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. 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.

Speaker 3

The opportunity to have 2 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.

Speaker 7

Thanks, guys.

Speaker 1

Thank you.

Speaker 8

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 Could have been ready for today. How do you can you expand on that? Because it looks like you may have had a sense for discontinuations really picking up around July timeframe?

Speaker 3

Well, yes, maybe I'll start. So our intention at launch It 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.

Speaker 3

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 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.

Speaker 3

So we think we have great growth opportunities ahead of us.

Speaker 8

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 add number in 4Q Unless your new ad picks up very meaningfully versus where it was in 3Q.

Speaker 8

Am I on the right track there?

Speaker 5

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 we'll achieve that.

Speaker 3

Yes. 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.

Speaker 3

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 coming As well as staying on treatment, we think we have great strategies to address all of those. Yes.

Operator

Let me just say, number 2, I think as you do your calculations, actually, Margaret mentioned in her remarks, we've had actually steady new prescriptions from Q2 into Q3. Well, 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.

Operator

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 6 months or 9 months discontinuations until we get there. So we've been tracking excuse me, 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.

Operator

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 1st 9 months, This is an adjustment to tactics and I think we can hopefully get back to seeing growth again.

Speaker 3

You bet. You're welcome.

Speaker 1

Thank you. And the next question comes from Marc Goodman with Leerink Partners.

Speaker 9

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.

Speaker 5

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.

Speaker 3

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

Speaker 9

So just to be clear on the new patient adds, From Q2 into Q3, 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.

Operator

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.

Operator

Deciles say 3 through 6 is where we're going to be focused.

Speaker 9

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.

Operator

Yes. Well, I think, Mark, the trouble is, right, this is not another That's going on here, right, as 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 month to month, Single months matter still even at these levels.

Operator

And so we're only 1 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.

Speaker 1

Thank you. And the next question comes from Greg Savage from Mizuho Partners.

Speaker 10

Hey, it's Greg Spiner. Thanks so much. Thanks for taking my question. I've got 2, 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?

Speaker 10

And then, my second question just has to do with kind of with Pfenex, 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 Pfenex, in other words, how much do you think if you do end up getting positive Pfenex data that that will really drive Is growth over and above what you're experiencing right now? Thanks.

Speaker 4

Yes, great. So, just to answer your first question, certainly, we see our growth coming in 3 different buckets. One is, We do believe we have continued focus and opportunity within the top ALS centers. As we've already talked about, we We 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 2 thirds of their patients with any patient, any drug available for ALS.

Speaker 4

So That's a 40% growth opportunity in front of us that we are heavily focused on driving our education, the 1st 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 in our Centaur data and we were studied in monotherapy and combination therapy.

Speaker 4

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 will probably take a little bit of time. As Justin mentioned, we're transforming the landscape in ALS treatment.

Speaker 4

They have had a Forming the landscape in ALS treatment, they have had a little bit of apathy because they haven't had

Speaker 8

a lot of twos

Speaker 4

in their toolbox in the past. And we're trying to change the fact that literally we believe that every patient within with ALS that can benefit from our treatment should have access to our treatment And with function and survival, so we believe that's a tremendous amount of opportunity for us moving forward. And the 3rd bucket would be really driving the

Speaker 9

persistency, taking the learnings we have from

Speaker 4

Canada, taking the learnings we have in the Taking the learnings we have from Canada, taking the learnings we have in 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 Pfenex data is we're doing a lot of this in preparation for the Pfenex readout. We are incredibly Bullish on our Pfenex data, we believe we're going to have successful data.

Speaker 4

That's certainly what we're planning for. And we believe it will have an inflection point on our business, Both from an awareness of demand generation and a duration of use perspective.

Speaker 1

Thank you. And the next question comes from Ananda Ghosh with H. C. Wainwright and Company.

Speaker 11

Yes. Hi. 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 Relivior's uptake with the specialist.

Speaker 11

My question is what about the non specialists? How much aware they are with respect to the center data? And what's the strategy around kind of educating the non specialists

Speaker 3

Well, yes, 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 end to launch, we have roughly 25 Percent 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, they're meaningful interventions. I think that That's quite good for a year into launch.

Speaker 3

Now there's obviously more work to do, but again, that's 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 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 2 positive studies in ALS is a really big deal, on top of, of course, the Centaur results, which is the first time a treatment showed A benefit on both slowing disease progression as well as increasing lifespan.

Speaker 3

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 Pfenex will just further accelerate all of that.

Speaker 11

Great. Thanks. My second question is on the discontinuation rate. 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 exactly Canada like how exactly Canada is different Than U.

Speaker 11

S. That you see the stock difference in discontinuation rate?

Speaker 4

Yes. So thanks for the question. Canada really focused from day 1 on driving the importance of remaining on therapy. And just to mention, I mentioned it in the comments, but Concentrate Canada is a really concentrated market. They have about 17 key centers of excellence.

Speaker 4

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 communicate it 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.

Speaker 11

Got it. Thank you.

Speaker 1

Thank you. And this concludes the question session at this time. I'll turn the call back over to Mr. Klee.

Speaker 3

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.

Speaker 1

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

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Earnings Conference Call
Amylyx Pharmaceuticals Q3 2023
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