Biogen Inc at Morgan Stanley Global Healthcare Conference Transcript

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

Question: Terence Flynn - Morgan Stanley - Analyst : Okay. Got it. Maybe just dig in, high level touched on this a little bit, but maybe first, Mike, you could kind of start in terms of the kind of outlook for M&A and BD right now. Obviously you're delevering from some of the prior deals, but how do you think about kind of the forward cadence? And then Priya, from your seat, just what are the areas that you're most focused on right now? I think you touched on these. Maybe you could just delve in a little deeper on some of those.

Question: Terence Flynn - Morgan Stanley - Analyst : Right now, would you say again, is it more of a buyer's market or seller's market in terms of the assets that you guys are seeing come in through the vetting process?

Question: Terence Flynn - Morgan Stanley - Analyst : Yeah. Okay, great. I want to touch on LEQEMBI and the launch. Obviously, that's one of the important launches here. You touched on that a little bit, Mike, and then had some follow-up for Priya as well. But maybe just give us the latest perspective on kind of launch progress. And your partner Eisai has provided some guidance for kind of a next 12-month basis of about $390million on a worldwide basis. So maybe just help us think about kind of the framework on the guidance side that they provided.

Question: Terence Flynn - Morgan Stanley - Analyst : Yeah. I know you talked about the priority, 100 IDNs that you guys are focused on, but obviously you and Eisai are kind of broadening that footprint with some additional sales representatives. So as you think about that target prescriber base, can you just remind us kind of like what that looks like here and with the achievement? When do you think that that breadth would be sufficient where you find kind of fully blanketed that prescriber base?

Question: Terence Flynn - Morgan Stanley - Analyst : Yeah. As we think about kind of the US the other kind of new wrinkle is Lilly's Kisunla was recently approved. And so as you think about that dynamic back half of the year, anything early on the launch, you're hearing in terms of, from the sales force, in terms of how physicians are choosing between these options? I mean, is that a rising tide lifts all boats, or is this a situation where new starts are now going to be split between these assets? What are you guys hearing from the kind of early days there? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 04, 2024 / 2:00PM, BIIB.OQ - Biogen Inc at Morgan Stanley Global Healthcare Conference

Question: Terence Flynn - Morgan Stanley - Analyst : Okay, great. Maybe a couple follow ups on those points. I guess on the protocol development, when you look back at LEQEMBI, like I know there were the reimbursement dynamics in the background going on, but how long did the protocol development take for you guys to kind of roll that out fully across the sites as we think about Kisunla and how long that might take for Lilly to do?

Question: Terence Flynn - Morgan Stanley - Analyst : Okay. But is that like, was it months? Is that fair? Was it weeks?

Question: Terence Flynn - Morgan Stanley - Analyst : Okay, got it. And the other, feedback we've gotten is just that every other week dosing versus once monthly dosing. It sounds like that's been somewhat of a hurdle for some patients who maybe live further from an infusion center. And so maybe that gives Kisunla somewhat of an advantage. You talked about subcutaneous, so maybe just what are the next steps on subcutaneous from a regulatory perspective? What are the kind of milestones that we should be focused on, both on the maintenance side and the induction side? Because I know those are two different pieces.

Question: Terence Flynn - Morgan Stanley - Analyst : Okay. On the subq induction, can you give us any sense of like, how much more data, like patient numbers, duration? I know you gave the kind of bookend in terms of regulatory outcome by 1Q 2026, so you'd have to file sometime kind of probably by mid 2025. But any more insight in terms of like, how much data you're generating for that question?

Question: Terence Flynn - Morgan Stanley - Analyst : And then the final target profile would be a once weekly self-administered auto injector. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 04, 2024 / 2:00PM, BIIB.OQ - Biogen Inc at Morgan Stanley Global Healthcare Conference

Question: Terence Flynn - Morgan Stanley - Analyst : Okay. And what any market feedback in terms of, like, what percentage of patients might prefer that versus going in to see their physician, like you said, like kind of more the high touch, like.

Question: Terence Flynn - Morgan Stanley - Analyst : Okay, great. I'll come back to the pre-symptomatic in a minute. But the other question is just the EU CHMP re-examination. So maybe just remind us why you're optimistic here, because again, I think, when we looked at some of the precedents, it looks like it's a high bar when companies go back for a re-examination. So why, what gives you confidence? I guess going back to the CHMP.

Question: Terence Flynn - Morgan Stanley - Analyst : Yeah. Do you have the rapporteurs yet, or they haven't been assigned the new rapporteur? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 04, 2024 / 2:00PM, BIIB.OQ - Biogen Inc at Morgan Stanley Global Healthcare Conference

Question: Terence Flynn - Morgan Stanley - Analyst : Okay. Okay. Understood. The maybe question for Mike follow up there is just the infrastructure, rest of world infrastructure. If you don't get the positive CHMP decision, ultimately, are there investments that have already been made that would be scaled back in some of those geographies? Or is that something that you guys were waiting on for the decision to pull the trigger on those investments? Probably a little bit more the latter, but when you look at the size of the company, in totality, not a material needle mover. What I would say is that, in the hopeful event that we're successful on re-examination, we'll be ready. That's the most important thing. And what outside of Japan, what are some of the other key geographies we should think about for the kind of ramp of the ex-US side? Because I know, obviously, Japan was a big part of that second quarter sales result. You mentioned ex-US. But as we think about kind of like the expansion beyond Japan, what are some of the other geographies?

Question: Terence Flynn - Morgan Stanley - Analyst : Okay, maybe just to round out the LEQEMBI discussion, Priya, you referenced the head Phase 3 trial in prevention setting. Maybe just what gives you confidence here in a positive outcome? And, I mean, the other debate, which, again, I know goes back to some of the early aducanumab data, is just like clinical benefit here in Alzheimer's, across the board. So how are you defining clinical meaningfulness, clinical benefit in the context of prevention? Like, what's good enough to really drive commercial uptake?

Question: Terence Flynn - Morgan Stanley - Analyst : Okay, great.

Question: Terence Flynn - Morgan Stanley - Analyst : And that 1Q 2026, would be for enrollment completion. And so when would be the earliest that we could see data potential?

Question: Terence Flynn - Morgan Stanley - Analyst : Yeah, that would include, like, an interim potentially.

Question: Terence Flynn - Morgan Stanley - Analyst : Okay, great. Maybe just in the interest of time, just moving on to, the other one I wanted to cover is Felzartamab, which I can't pronounce. Felza, the high bio asset. Obviously one of the higher profile BD deals, aside from Reata, that you guys have done here, maybe just, one debate out there is the pros and cons of going after CD38 versus BAF in April, such as the vertex alpine asset. So why? Why do you have confidence that this approach is maybe, going to be the better approach here? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 04, 2024 / 2:00PM, BIIB.OQ - Biogen Inc at Morgan Stanley Global Healthcare Conference

Question: Terence Flynn - Morgan Stanley - Analyst : Yeah. Okay, great. Maybe just in the last minute, because I know it that was out this morning, the SPINRAZA high dose data, just any comments on how to think about that relative to low dose? And then is that likely going to convert the market over to high dose, or are both options going to co-exist?

Question: Terence Flynn - Morgan Stanley - Analyst : Okay, well, I think we're up against time, but Mike, Priya thank you so much for joining us. Really appreciate the comments.