Biogen Inc. (NASDAQ:BIIB) Q3 2023 Earnings Call Transcript

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Operator: And next, we’re going to go to Paul Matteis from Stifel.

Paul Matteis: Chris, you just mentioned getting an appointment with neurologists. And then earlier in the call, you talked about the registry requirement not being as much of a challenge. I wanted to ask about the other components of the infrastructure here with LEQEMBI, IVs, PET scans and MRIs? How would you rank order these components of the equation as it relates to most and least challenging for centers to navigate? And how do you envision this kind of whole infrastructure network looking by saying next summer?

Christopher Viehbacher: The situation is a little heterogeneous. It’s not quite the same situation in every center. But I would say, based on what we know today, I do think there’s clearly, at the moment, the need to get an appointment with a neurologist. The reality is that there weren’t that many patients already in neurology practices. They tend to be in PCP practices. And the neurology practices – neurologists were already busy. And we have quite a volume of patients now to put through those neurology practices and a lot of them are realizing, I may be have to staff up on here. Do I have enough business to justify staffing up and not necessarily with neurologists, but perhaps with nurse practitioners, others who can take on some of the parts of the care pathway.

For some of them, it’s going through their internal governance process and determining which patients, I think, appropriately at this stage. There’s clearly an awful lot of caution around ARIA. My personal belief is that, over time, neurologists will become more accustomed to understanding ARIA. Is there a difference between the asymptomatic and the symptomatic? And they’ll have a lot more experience but they’re looking at making sure that the patients who go through are trying to get to have the least risk of ARIA. I don’t think the infusion center capacity seems to be a big issue for most centers. PET scans, there are enough PET scans as far as we can tell. It’s really been around how do I get reimbursement for it? Is it just one? And it was more the confusion around – so I think the clarity of that will just take one of the factors of discussion and time out of the process.

There is just at each stage – if you send someone out for the PET scan, the scan has got to come back, it’s been interpreted by a PET scan reader there, but sometimes a physician will want to have someone in that practice read that. And it’s just connecting – sending the patient to all these different points, even if you’re an integrated delivery network. So I don’t think it’s necessarily any one thing, although I would say, if we can do a better job of getting patients triaged even before they can get to the neurologist, that could certainly be helpful. But I think it really is – this is changing, the practice paradigm for a lot of clinics. And they’re all having to work through it. And these, of course, are super busy people. They’ve got other needs.

And so trying to fit in the time to actually manage all this is actually a challenge. So I think it’s completely natural and expected that this is progressing slowly. But again, you see some who are racing ahead. And that certainly gives me the confidence that others are going to figure this out, too.

Operator: We can go to our last question. And that’ll be from Phil Nadeau from TD Cowen.

Phil Nadeau: I want to ask about the SKYCLARYS EMA review? Could you give a bit more of an update on what the status of that review is? Has there been a need for a whole explanation? And generally, what’s Biogen confidence that a positive CHMP opinion will be secured in the first half of 2024?

Priya Singhal: Overall, just stepping back during diligence, we reviewed regulatory correspondence. And we had a certain level of understanding of the topics. And subsequent to closing the deal, we have had more regulatory interactions, and nothing has changed our view, as Chris mentioned. We’d still expect to see an outcome in early 2024. So that remains on track. With regard to whether or not there will be an oral explanation, that is really something we don’t comment on because it’s under review. And that’s part of the review details. So I hope that helps.

Chuck Triano : And this will conclude our call. Thanks, everyone, for joining us today. And the IR team will be available later on, of course, for any other follow-up questions.

Operator: Thank you. And ladies and gentlemen, that does conclude today’s conference. We appreciate your participation. Have a wonderful day.

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