Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) Q3 2023 Earnings Call Transcript

Marc Goodman: 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.

James Frates: Yes. Well, I think, Marc, the trouble is, right, this is not 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 remain at the 10% range instead of the 15% range, right, sales would have been a lot higher and closer to people’s expectations. So I think month-to-month, single months matter still even at these levels. And so we’re only one month into the quarter, and it’s very hard to predict where we’re going to be at the end of the quarter where we sit today.

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

Graig Suvannavejh: Hey, it’s Graig Suvannavejh. Thanks so much. Thanks for taking my question. I’ve got two, if I could. First, I know a lot of the growth now is going to be focused on the non-ALS center setting. And I was wondering if you could just maybe provide additional color around the pace with which you think you can penetrate that non-ALS center setting? And then my second question just has to do with kind of with PHOENIX, now a second quarter event. And as you think about current usage of the product, whether it’s views by physicians or patients, I’m wondering if you feel and maybe help us understand this, if you feel that there is some element of you not being able to capture more patients because of anticipation around PHOENIX? In other words, how much do you think if you do end up getting positive PHOENIX data that, that will really drive growth over and above what you’re experiencing right now? Thanks.

Margaret Olinger: Yes. 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. As we’ve already talked about, we have 300 physicians that are prescribing in that bucket of patients. They’re prescribing about 25% of all their patients on RELYVRIO treatment but they are treating 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 in our CENTAUR data, and 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 specialists 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. And as Justin mentioned, we’re transforming the landscape in ALS treatment. They have had a little bit of appetite because they haven’t had a lot of tools in their toolbox in the past, and we’re trying to change that. Literally, we believe that every patient living with ALS, they can benefit from our treatment should have access to our treatment and work function and survival.

So we believe that’s a tremendous amount of opportunity for us moving forward. And the third bucket would be really driving the persistency, 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 therapies 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 our PHOENIX readout. We are incredibly bullish on our PHOENIX data. We believe we’re going to have successful data. That’s certainly what we’re planning for. And we believe it will have an inflection point on our business both from an awareness and demand generation and a duration of use perspective.

Operator: Thank you. And the next question comes from Ananda Ghosh with H.C. Wainwright & Co.

Ananda Ghosh: 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 the RELYVRIO’s uptake with the specialists. My question is what about the nonspecialists, how much aware they are with respect to the CENTAUR data? And what’s the strategy around kind of educating the nonspecialists as you think about the next quarter?

Josh Cohen: 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 into launch, we have roughly 25% people with ALS on RELYVRIO 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, 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’s not true. There are therapeutic and nontherapeutic 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 CENTAUR results, which is the first time the 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.

Ananda Ghosh: 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.S. that you see the top difference in discontinuation rate?

Margaret Olinger: 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. 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 in 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.