Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) Q2 2023 Earnings Call Transcript

With our PSP program and our Wolfram program ongoing first that we’re doing. I’d say the watch it around here right now is focus. Now longer term, I think, we have the opportunity with our launch and with the business that we’re in to potentially do some business development over the longer term. But I think that hopefully we’ll be able to grow the top-line, grow our bottom-line and then also invest in a robust pipeline. But we have a pretty high standard here for new programs. And as I said I think right now the watch word is on focus.

Geoff Meacham: Thanks, guys.

Josh Cohen: You bet.

Operator: And the next question comes from Michael DiFiore with Evercore. Please go ahead.

Michael DiFiore: Hi, guys. Congrats on the quarter and thanks so much for taking my question. Two for me. Now with the passage of more time do you have any better sense of the size of the patient bolus at this point? And my follow-up is this I want to press you a little bit on the discontinuation rates. I mean among the early patients to have received commercial drug in 4Q of last year presumably some of these patients are — would have been on drug for at least six months now. Would you be able to provide any color as to what percent of them are still on therapy at this point again just among the patients who started in 4Q?

Margaret Olinger: Yes. Maybe I’ll just start with your question regarding the bolus. We continue to be pleased that the interest in and demand for RELYVRIO, continues to be as at a very strong pace and I think importantly includes a mix of both newly diagnosed patients and people who have been diagnosed and living with ALS for many years. Again at the end of Q2, we had roughly 3,800 net patients on therapy up from roughly 3,000 patients in Q1 and just over 1,300 in Q4. So we really believe that at this point in time RELYVRIO is really starting to become a foundational therapy in ALS and meeting a really high unmet need for this patient community which is obviously our mission and what we’ve been focused on for some time.

to us we see several: And second we have a really large untapped opportunity for growth outside of this group. As I mentioned, we were heavily focused on the key ALS centers at launch. We’re continuing to expand our outreach and educational efforts more broadly because we believe it’s critically important that everybody is aware that RELYVRIO is the first-and-only product to have both function and survival demonstrated in the clinical trial and we believe we can change the paradigm for treatment moving forward. And maybe just to answer your second question on discontinuation, again, we’re only going to be reporting on net patient numbers for a quarter. But indeed, I think it’s important to reflect that the first cohort of patients who started on therapy at launch many of those who have been really fairly progressed early on. So I think we’re going to see the dynamic of the patients change over time. So it’s a little too early to really give any trends there.

Joshua Cohen: Yeah. And one thing, I’ll remind that, I think Margaret shared earlier as well we — in some of central study approximately 70% of people completed that study on study drug. And what we’re seeing in the real world is not so different from that. But again —

Michael DiFiore: Great. Thank you so much.

Operator: The next question comes from Marc Goodman with Leerink Partners. Please go ahead.

Marc Goodman: Yes. Hi. First question is are you willing to make any comment about what kind of trends you’re seeing you saw in July? And then secondly, can you just confirm — you mentioned 10% of the patients are getting free drug. Just to be clear that, 10% is in the numbers that you provide right in the 3,800 patients that you were talking about and it’s all included in your gross-to-net calculation and everything? I just want to be clear on that. Thanks.