Biogen Inc. (NASDAQ:BIIB) Q1 2023 Earnings Call Transcript

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Michael McDonnell: Yes, I’ll take that one. Thank you for the question, Jay. So we ended the quarter with about $6 billion in cash. And as we mentioned, we received the payment from Samsung for roughly $830 million subsequent to the end of the quarter. So we’re approaching $7 billion of cash on hand. Our EBITDA level is roughly $3 billion. And on a gross debt basis, we’ve got roughly two turns. Obviously, net debt is close to zero, it’s actually negative if you pro forma for the Samsung payment. So there is incremental room. I think that just illustratively if you added a turn of leverage, you’d be at three times growth, you’d still be very modest net. And you add that to the cash, that puts you kind of north of or in the ZIP code of about $10 billion that you’ve got of kind of dry powder so to speak.

I wouldn’t suggest that we would add incremental debt just to add it, but for the right opportunity, the right BD opportunity, et cetera, I think we’ve got a lot of flexibility in our capital structure.

Christopher Viehbacher: We know you all have other calls to get to, so operator, can we please take one more question.

Operator: We now take a question from Colin Bristow of UBS.

Colin Bristow: Hey, good morning, and thanks for squeezing me in. And also welcome, Chuck. We’re excited to be working with you again. On subcut LEQEMBI, what does FDA specifically said is required for approval? And then can you just speak to how important the subcut formulation is to the commercial story? What proportion of patients would it allow you access to the infusion or not? And then just a sort of a subpart on the commercial part. The VHA is excluding APOE4 homozygous. Can you just speak to the risk that you see either as a labeling or commercial risk on full approval as access broadens? Thank you.

Priya Singhal: Okay. Thanks, Colin. I can start — yes, I can start with the subcutaneous formulation. So the plan is on track and Eisai has said that they would be filing by Q1 2024. Just to backup, the evaluation is being conducted in the Phase III open-label extension by a subcutaneous sub-study. And Eisai has also stated that they have discussed the requirements for proceeding with this filing and generating the data and then subsequent filing with FDA and other regulators. And they believe that the strategy currently does allow for an evaluation of PK, PD and safety, which would be required. I’ll move to the next aspect. I think that you asked was about the APOE4 homozygous. So Eisai presented some of these data at AD/PD and also made comments on this topic.

And they believe that really the data set was rather small. The number of APOE4 homozygous was quite small. They don’t believe that the overall conclusions are different in terms of CLARITY AD and confidence in the data. The other aspect here to keep in mind is that actually many of the secondary endpoints favoured LEQEMBI. So there could be a component of placebo not declining as much in this comparator group and that was one of the points that they made as well. Now with regards to the commercial view on subcutaneous, I’m going to turn it to either Chris or Mike.

Michael McDonnell: Yes. I mean I think on — go ahead, Chris.

Christopher Viehbacher: Go ahead, Mike.

Michael McDonnell: Yes. No, I was going to say on the commercial view of subcutaneous, this will be kind of ground-breaking and then we’ll have to see how that plays out over time as patients with Alzheimer’s along with their caretakers are maybe moving to more of a maintenance mode for their treatment. This could be something that could be very valuable and particularly for patients who have a distance to travel to get to an infusion center to be able to self-administer at home and something that we think could have a lot of potential. So more to come on that over time. We’ll expect to hear more about it over the next nine or so months and we think it could be an important differentiator if it comes together.

Chuck Triano: Thanks, everybody.

Christopher Viehbacher: I was just going to add, Chuck, we don’t really see that the biweekly infusion as being a limiter right now for that infusion. But it does, as Mike said, as we think about if we are able to get a maintenance indication and we are able to get blood diagnostics, the length of time that a patient will be on drug potentially will change in future and then therefore the subcu would certainly make a difference in that scenario. Back to you, Chuck.

Chuck Triano: Thanks, Chris. So thank you all for your attention this morning. You can always follow up with the Investor Relations team and this will conclude our call.

Operator: This concludes today’s call. Thank you for your participation. You may now disconnect.

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