Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) Q4 2022 Earnings Call Transcript

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Corinne Jenkins: Okay, thanks.

Operator: The next question is from Marc Goodman with SVB Securities. Please go ahead.

Marc Goodman: Yes. Hi, there’s a lot of conversation about the PHOENIX study. I was just making sure I understand, just to be clear. When you make a decision on whether the PHOENIX study is successful or not, would you be waiting for the survival data to actually make that determination? Thanks.

Josh Cohen: Yes. I think what we’ve said and I think what’s the case is, we’re going to do what’s best for patients. I’m really, really excited about the data that we’re going to unveil. And as the data comes in, we’ll make the appropriate decisions in collaboration with the ALS community. But again, we have a lot of confidence in the trial design and the execution here and we’re really excited to unveil those results next year.

Justin Klee: Yes. And Marc, just going further to your point, too, it’s Justin. So first, we measure function at 48 weeks, and then we will measure survival. These are really key endpoints for people living with ALS. They are really key end points for doctors and the care team who look after people with ALS. It’s also what we saw in the CENTAUR study. So the study design and the data that we’re collecting are based off of both what we saw in the first study as well as what’s important to the ALS community.

Marc Goodman: Right? And what you’re saying is survival is very important to the ALS community. So you’re going to need to see that data to really understand what you don’t have.

Justin Klee: It’s certainly a critical endpoint.

Marc Goodman: Okay, thanks.

Operator: And our last question today comes from Ananda Ghosh with H.C. Wainwright. Please go ahead.

Ananda Ghosh: Hey, hi guys. Thanks and congrats for the quarter. On behalf of Andrew, I just had one question, like even post approval, there were questions on Phase 2 data and potential positive Phase 3 data. Now what has been the feedback as you have been negotiating with the peers, especially in terms of the data?

Josh Cohen: Yes. So I think the question relates to how payers have asked about ongoing studies and ongoing data. I’d say, thus far, we’ve seen broad and really good coverage from the payers. Of course, we’re only third of the way through. It’s only a third of payers have released their policies. But thus far, the engagement has been great, and we’ve been, the vast majority have had broad coverage policies that we’re very happy with.

Margaret Olinger: And I would just add to that, that we have a really strong payer and medical affairs team that are having ongoing discussions with the clinical teams and I think these payers are really understanding just how devastating this disease is and more broadly, our payer interactions today have been highly encouraging.

Ananda Ghosh: Great, thanks.

Operator: Thank you. There are no further questions at this time. I’ll turn the call back to Mr. Klee for final comments.

Justin Klee: Thank you, operator. We are proud of the progress we’ve made to date and encouraged by the early success of our commercial launch. We remain focused on the work ahead to pursue our goal of delivering RELYVRIO to every eligible person living with ALS. Thank you all for joining us and thank you for joining the call. Have a good evening.

Operator: The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.

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