Amylyx Pharmaceuticals Inc Q4 2023 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Neena Bitritto Garg - Deutsche Bank - Analyst : Hey, guys, thanks for taking my question. So I was just wondering if you could talk a little bit more about some of the gross to net dynamics that impacted the numbers specifically in the US. I know you did take a gross price increase in the US. So just wondering if that was offset. And then if you could maybe explain a little bit more about the magnitude of the ex US sales and how that compares to prior quarters and how we should think about that contribution moving forward. Thanks. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 22, 2024 / 1:00PM, AMLX.OQ - Q4 2023 Amylyx Pharmaceuticals Inc Earnings Call

Question: Neena Bitritto Garg - Deutsche Bank - Analyst : Awesome. Thank you so much.

Question: Corinne Jenkins - Goldman Sachs Group, Inc. - Analyst : Thanks and good morning. Maybe, for me, can you just provide an update on the duration of therapy you're seeing in the US and talk to us about some of the specific strategies you're deploying to improve that duration of therapy? And then maybe as a follow-on, like, when do you expect those to potentially translate into real benefit as measured by revenue? Justin Klee - Amylyx Pharmaceuticals, Inc. - Co-CEO & Co-Founder Yes, hi, Corinne, thank you for the question. So our, we've been reporting on our six-month persistence rate and it's held steady. So in the US, we're still seeing approximately 60% of people still on RELYVRIO, six months after initiating treatment. And in Canada, that number is roughly 80% at six months. So I think the first thing is that we're taking learnings from Canada and applying those to the US. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 22, 2024 / 1:00PM, AMLX.OQ - Q4 2023 Amylyx Pharmaceuticals Inc Earnings Call And I think what we found is that when you look doctor by doctor, some doctors have much, much higher persistence rates than others. And I think what we've learned from Canada as well as looking at those individual doctors, is that it comes down to education. If people know that this is, they're being prescribed as treatment because it will slow down their ALS, it will keep them alive longer, then they're much more likely to stay on treatment. There are also very practical strategies for mitigating any potential side effects. Again, we're trying to transform ALS from a disease that has historically focused mostly on symptom management to one that focuses or we're trying to focus on intervention. And so part of that is, as things come up, how do we manage them. And there are very practical ways that we can do that. And so I think in terms of when that will translate to revenue, I think, made these recognitions recently. We've put many initiatives in place. We now have Dan Monahan leading our US commercial efforts as well. So we expect all of these things to build throughout the year.

Question: Michael Cherny - Evercore ISI Institutional Equities - Analyst : Hey, guys, thanks so much for taking my question. Two for me. Number one, how is the campaign of taking learning from Canada and applying it to US prescribers? What's the reception been like so far? I realize it's pretty early. And my follow-up is, any thoughts or any color you could add on when you may lift the restriction on prescription reporting data? When might we expect that to happen? Thank you. Justin Klee - Amylyx Pharmaceuticals, Inc. - Co-CEO & Co-Founder Yes. Thank you and I'll certainly take the first one. So I agree, so it's early, but I think the learnings from Canada, the initiatives now that we're advancing in the US, we've had very positive feedback. I think again, if you try to think about what does it mean to transform a disease that historically is focused on symptom management because that's largely the tools that have been available. I think that, in short, it's education. So for example, saying that, well, this is not a cure, but it may slow down your ALS and keep you alive longer, that's a big deal. And that changes how one even talks about the disease, focusing on mitigation of any potential side effects. Again, in the past, if one has not had to manage side effects, then those things can be uncertain. But again, it just comes down to education. And I think that the doctors and nurses and therapists who care for people with ALS, I mean, first of all, they're just amazing people. And second, I think they're very, very excited at the opportunity to see this sort of transformation. But I think it's important that we and not just we, but all of our partners provide the right education on these things as well. So I would say that I think the reception has been excellent. As I was saying in the previous question, I think that the impact long-term on revenue, we'll see continue to build throughout the year. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 22, 2024 / 1:00PM, AMLX.OQ - Q4 2023 Amylyx Pharmaceuticals Inc Earnings Call

Question: Michael Cherny - Evercore ISI Institutional Equities - Analyst : Thank you.

Question: Graig Suvannavejh - Mizuho Securities USA LLC - Analyst : Thank you. Good morning. Two questions, if I could. One, any insights you could give into how things are progressing early in 2024, given like the changes that you're trying to make from a commercial perspective and whether there's any uptick versus the fourth quarter trends? And then secondly, I'm curious about this novel ALS biomarker panel that you're developing. Also there, could you provide some color on which exact, or what types of biomarkers might be included in that panel, would be appreciated. Thanks. Justin Klee - Amylyx Pharmaceuticals, Inc. - Co-CEO & Co-Founder Yes. Thank you, Graig. So I would say, as I was saying in the previous remarks, I think with the initiatives we've seen, I think, a great reception from the community. And maybe break things out as I did in the opening remarks again into sort of two broad categories, I think first is physicians who specialize in ALS. And I think there, the educational opportunities, we've seen some people who have fundamentally changed their medical practice. Others have not. And so I think there, it's about educating on the benefits of RELYVRIO as well as tools, practical tools to mitigate side effects. And then secondly, there's about half of people with ALS don't make it to a specialist or are not primarily cared for by a specialist. And for them, for many of them, their knowledge and awareness of ALS is what they learned in medical school. I mean it's, it might be 20, 25 years old. So they're very unaware of not just our treatment, but even the general advances that the field has made. So there, I think awareness is really key. And I would highlight as well that I think PHOENIX is a really great opportunity in both of those segments, both to increase confidence for the specialists and the potential benefits of RELYVRIO for their patients as well as the opportunity to increase awareness more generally in the medical community. And on the diagnostics side, I'll definitely pass to Josh. Josh Cohen - Amylyx Pharmaceuticals, Inc. - Co-CEO & Co-Founder Sure. So when we thought about the ALS diagnostic, I think the first thing to note is that when you think about the pathophysiology of ALS, you have the neurons that go from the brain to the spinal cord and then a second set of neurons that go from the spinal cord to the muscle that degenerate in massive quantity over the course of just two or more years. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 22, 2024 / 1:00PM, AMLX.OQ - Q4 2023 Amylyx Pharmaceuticals Inc Earnings Call So it stands to reason that at least something must be released or measured or measurable when that process occurs. So we've collaborated with several experts in biomarkers and clinically in the ALS space. And what we can tell from looking is there has not really been a serious effort thus far in the field to try to develop a diagnostic in the space. There are many markers that seem to be up or down in ALS, but nobody's taken those together towards a kind of serious effort towards making diagnostics. So we're quite excited about that program. I think there's a lot of low-hanging fruit there, but we'll be reporting data on that later this year.

Question: Andrew Fein - H.C. Wainwright & Co., LLC - Analyst : Yes, hi, good morning. First of all, congratulations on reaching the milestone for completing the first year of the launch. It has been great seeing the story evolve from the inception. And being the last, maybe I have two questions. The first one is related to PHOENIX. On the PHOENIX side, the inclusion criteria mentions definite and clinically probable ALS patients. So my question is, how do one define clinically probable ALS patient? What was the rationale behind including that group of patient? And how does it change the way the data is analyzed? Josh Cohen - Amylyx Pharmaceuticals, Inc. - Co-CEO & Co-Founder Yes. So maybe first, I probably will try not to get too in the weeds, but first, in terms of the definition, so the El Escorial criteria of ALS defines many different potential groups, including suspected, possible or probable lab-supported, probable and definite. And the difference between those is essentially how many regions of the body are convincingly affected by ALS with possible being one, probable lab supported being one plus different lab tests, probable, clinically probable being two, and definite being three or four. The body is divided into four regions on the scale. What's been shown over time is that even people with possible ALS on this criteria have ALS, about 98% of them have ALS. So it's not like, it's not actually a scale of certainty. It's much more a scale of diffusion, basically how far across the body ALS has progressed. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 22, 2024 / 1:00PM, AMLX.OQ - Q4 2023 Amylyx Pharmaceuticals Inc Earnings Call When we did statistical modeling, going for the probable and definite patients does give you a more consistent and fast progression group, which is important, and that was one of the rationales for including them in the trial. But I think the most important thing when we compare CENTAUR and PHOENIX on the baseline characteristics is that, at baseline, the two populations look very similar. They're within 1 point on the baseline ALSFRS-R and within one month on the baseline time since symptom onset, which are two of the most important measures when we're thinking about how a cohort is likely to progress and to perform.