Biogen Inc. (NASDAQ:BIIB) Q1 2024 Earnings Call Transcript

But what our outlook is for the year, which I can’t give you a specific number, is that we are going to continue to add every single month. We are able to find those patients in the community, and there are other puts and takes in those numbers. But at the end of the day, we will ensure that we are still leading the rare disease analogs and that we’re going to generate market penetration.

Chris Viehbacher: Yes. And in Europe, we’re booking revenue now for Germany and actually — we’ve actually launched in Austria and the Czech Republic as well. And in some countries, we’re actually able to charge for the early access programs in Europe and some of that revenue will come down too, but you probably see more full EU as a region revenue in 2025, but there will be certainly revenue contributions in 2024 from certain countries in Europe.

Chuck Triano: Great. Thanks, Chris. Let’s go to the next question, please.

Operator: We’ll go next to Colin Bristow with UBS.

Colin Bristow: Good morning and thanks for taking the questions. Maybe one on the LEQEMBI commercial setup. So, one investor concern and important feedback we’ve been hearing from physicians is around, there being less sales and marketing presence than perhaps had been expected. I heard in your prepared remarks you’re saying you expect a 30% increase in the US footprint. Are you able to sort of quantify the current US commercial footprint? And was the 30% increase always planned, or was it based on some review that the current footprint wasn’t adequate? Thank you.

Alisha Alaimo: Thank you very much for the question. If you really take a step back and look at how we strategically looked at this launch, we always said that we were going to do in a stepwise approach. We knew from the beginning that sites were going to take a while to get up and running. We had to wait for several indicators from CMS giving full approval and NCD being overturned for PET. And so with that being said, we didn’t want to go out of the gate with a really huge field force that wasn’t able to actually impact or penetrate the market. So instead, what was decided is we went in with a very focused approach. We focused on really the top accounts that we think handle the majority of the diagnosed patients, especially that are under neurology care.

And we said once the market gets to a place where we think it’s ready for expansion, then we will expand. Now, to your comment about physicians coming back saying they’re not seeing a lot of sales efforts, I think, we also have to have really the context of getting these sites up and running takes a lot of effort. And you also don’t want to have three, four, five different people going into these accounts to support. And so, we’ve been very focused on really getting the large IDNs up and running. Some of these centers that have come forward that really could move quite quickly, we got them up and running. And now as you see the expansion take place with the 30%, we are going to focus mainly on the large IDNs that are now opening up their expand and extend satellite offices, where they’re now going to allow a larger cohort of patients to come through for diagnosis and treatment.

And so, with this next phase of a build, which we believe we’ve done a lot of analytics behind it, and we’ve had a lot of third parties weigh-in on what is the appropriate sizing, we and Eisai believe that this is going to be the right footprint to drive the next acceleration of growth.

Chuck Triano: And let me just turn it to Priya for a clarification back to Mike Yee’s question on subcu.

Priya Singhal: Thank you. Thank you. Just wanted to clarify that it’s the outcome by fiscal year — Eisai’s fiscal year 2025, which is Q1 2026 for the subcutaneous induction. Of course, that — it could be a range because it would involve sBLA, a prior — potentially a priority review and other such aspects, which could shift it, but that is the — that is what Eisai has communicated. I just wanted to reaffirm that. Thank you.

Chuck Triano: So, the outcome and not the filing?

Priya Singhal: Yes.

Chuck Triano: Obviously earlier?

Priya Singhal: Earlier.

Chuck Triano: Yes.

Priya Singhal: Thank you.

Chuck Triano: Thanks, Priya. Let’s move to the next question, please.

Operator: We’ll go next to Brian Abrahams with RBC Capital Markets.

Brian Abrahams: Hi, there. Good morning. Thanks so much for taking my question. With regards to LEQEMBI subcu, on the FDA request for immunogenicity data, I’m curious if you have a sense as to what drove that request. Your level of confidence that the PK will be linear using half the subcu dose? And then, when are you proposing that patients in their course of treatment should transition from an IV to a subcu maintenance? Thanks.

Priya Singhal: Sure. Thanks, Brian. So overall, we — as you know, we had tested the 720 milligrams in the naive patient population that was in the Clarity AD open-label extension sub-study for subcutaneous. Now, from that — in addition to that, we had modeling data and this is what we are proposing for 360 milligrams to be the weekly maintenance, and the FDA is just requiring additional immunogenicity data. We see this as a reasonable request, and we are already in the process of generating it. So overall, we don’t expect that the bioequivalence is going to be in question. This is now really about the immunogenicity and actually generating on patients who would be tested for this. So, that’s what we expect with that. Can you remind me what was the second aspect of your question?

Brian Abrahams: When are you proposing that patients transition from the IV to the subcu maintenance? Is there data supporting what — when in the course of treatment that transition should happen?