Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) Q4 2022 Earnings Call Transcript (Corrected)

George Yancopoulos: Well, as you say, the important thing about that aspect of the Alnylam collaboration is together, we were hoping for the first time to see if we could develop technology that would actually allow us to do what’s been done now by Alnylam and others in the liver to bring it to other tissues, particularly to the central nervous system in this case. So this €“ the first study, which is focused on APP is really a proof of concept that can we get this technology to work, we view it as a potential sort of platform enabler, meaning that if we see anything here and obviously these are challenging things to be first and to do something that nobody has ever done before. And it’s obviously very early in the program. But the goal is to establish proof of principle that this type of technology, which looks like it can be pretty effective in the liver, chat and work outside of the liver, particularly in the CNS. So this would be a platform enabler.

Ryan Crowe: Thanks, George. Next question, please.

Operator: Our next question comes from the line of Brian Abrams with RBC Capital Markets. Your line is now open.

Brian Abrams: Hey, guys. Congrats on all the progress and thanks for taking my question. So with the potential approval coming this December, I am curious how we should be thinking about the launch cadence for high-dose aflibercept just considering some elements like the introduction of pre-filled syringe, the J-code and maybe your overall strategy and how you are thinking about converting market segments and where you are initially focused? Thanks.

Leonard Schleifer: Give us a second. We will disconnect all the Roche people on the call, so we can get you our strategy. In all seriousness, obviously, there is a lot of thought that’s going to go in between now and what we hope will be our late August approval on pricing, on rollout, on targeting, on strategy, etcetera, etcetera. But we are working on that. We have to get our label. We have to get it approved, and we will have everything else ready to go. The initial launch will be with a vial and then we hope down the road, not too far with the pre-filled syringe. Marion, I don’t know if you want to give away any of the secrets at this point.

Marion McCourt: I would just say that we have a highly experienced team in commercialization, and we certainly will be ready for the launch. And in the meantime, we are very focused on our participation in the market today with EYLEA. But certainly more to come, and we absolutely look forward to the potential launch of 8 milligrams.

Brian Abrams: Very good.

Leonard Schleifer: Obviously, the Vabysmo launch has not turned the market sideways on us. It’s real competition. But that, I think there is a window that’s sort of closing for them to compete against 2 milligrams, we hope and then 8 milligrams, we hope could become the standard of care. So, lots to look forward to later in the year.

Ryan Crowe: Certainly. Thank you. Next question please.

Operator: Our next question comes from the line of Evan Seigerman with BMO Capital Markets. Your line is now open.

Evan Seigerman: Hi, guys. Thanks for taking the question. Maybe a follow-up to Matt’s question, can you just speak to what you saw in the pre-specified interim efficacy analysis of the BOREAS trial and just any additional color on the level of benefit versus placebo that triggered the initiation of the NOTUS trial? Thank you.

George Yancopoulos: All I can say is that we powered it to deliver would be a clinically significant improvement. There was a combination of measures of exacerbations and lung function improvement, and we haven’t disclosed what those numbers were.

Leonard Schleifer: And we remain blinded to that interim analysis Evan. So, next question please.

Operator: Our next question comes from the line of Salveen Richter with Goldman Sachs. Your line is now open.