Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) Q3 2023 Earnings Call Transcript

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Leonard Schleifer: So just to add a small point to what George’s eloquent explanation of why Dupixent is such a special drug and the prediction that it would be safe because it’s attacking this vestigial part of the immune system, you’re looking at somewhere in the neighborhood of three-quarters of million people on the drug, many more than that so that have demonstrated the safety that is predicted by the science.

George Yancopoulos: Including in children, as we know, as young as six months is approved there where it’s been demonstrating not only incredible safety but incredible efficacy.

Ryan Crowe: Great points. Thank you. Shannon, I think we have time for two more questions, please.

Operator: Our next question comes from the line of Dane Leone with Raymond James. Your line is now open.

Dane Leone: Thanks for taking the questions, and congratulations on a strong quarter. Just actually really two quick ones for me. First one being, can you just comment whether you saw any impact from increased utilization of biosimilar ranibizumab during the quarter on EYLEA sales. A number of high-volume clinics had highlighted favorable margin opportunities from using more biosimilar ranibizumab, which seems to be potentially a transient impact and use of some of the brands, but it would be interested in your commentary there. And then we’ve gotten just a lot of inbounds in terms of ongoing patent litigation of EYLEA. Could you just maybe state for us what your current expectation is for EYLEA patent life? And just any thoughts you have on how the ruling that we’re awaiting could actually impact your base case? Thank you.

Leonard Schleifer: Yes. So I’ll cover the patents and then Marion can cover any additional insight into the marketplace. On the patents, we’re involved in litigation. There’s a couple of key patents that have evolved in this case that both relate to formulation as well as dosing. On the base case is that, for us, assuming that the exclusivity will expire in May, but we will see what happens in the litigation, which could be an upside, obviously, for the franchise.

Marion McCourt: All right. And on the ranibizumab impact, it’s relatively early in their launches, and – but there hasn’t been a notable impact to the category. The Lucentis biosimilar shares in the low single-digit area in the third quarter, and certainly the impact has been seen more relative to Lucentis, which has declining share. But certainly, this is not extended to EYLEA HD.

Ryan Crowe: Thanks Marion. We’ll just take our last question, please, Shannon.

Operator: Our last question is from the line of Brian Skorney with Baird. Your line is now open.

Brian Skorney: Hey, thanks for taking my question. It looks like J&J had a really good first quarter of their myeloma bispecific. So it definitely seems like there’s a good demand there. But also an element of them having control of a lot of offerings for myeloma. So obviously, [indiscernible] would always dominate each in oncology, but with the initial launch of your bispecific next year. I’m just wondering what your strategy is for competing in the initial late line as a third to market? Do you think that there is differentiated enough data here to kind of take share? Or is the focus really on generating data in earlier line of combos to kind of move up market share? Thanks.

George Yancopoulos: Well, of course, it’s both. We do believe that data rules, the best, both efficacy, safety profile, but also convenience profile. And we will be continuing to show our evolving and maturing data, which we believe could result in best-in-class in terms of efficacy, in terms of response rates and complete response rates in terms of safety, in terms of the frequency of Cytokine Release Syndrome and so forth, and in terms of differentiation in terms of mandated hospitalization. So we will be continuing to present our data. Of course, we’ll see exactly ultimately what gets in the label and what the FDA supports but there’s the potential here for best-in-class differentiation in terms of efficacy, safety and convenience and schedule.

And of course, as you said we’re also moving with, we think, an exciting program in earlier lines of therapy. And all of this is also going to be combined with the opportunities for our future combinations. We have a variety of costim bispecifics that we’re excited about combining specifically with this agent in the Plasma Cell Dyscrasias setting. So we think it’s a very exciting opportunity. As you said, unfortunately there’s a large opportunity out there because there’s a lot of patients that are still in need. I think that if you have the best agent for late-stage patients. A lot of people want to use it. And then if we figure out the best program to demonstrate how it can be utilized in earlier-stage patients that can certainly enhance that opportunity let alone if we come up with one of our magic combos that really takes it to the whole next level.

Ryan Crowe: Okay. Thanks George, and thanks to everyone who dialed in today and for your interest in Regeneron. We apologize to those remaining in the queue that we do not have a chance to hear from. But as always, the Investor Relations team here is available to answer any remaining questions you may have. Thank you once again, and have a great day.

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

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