Tyler Van Buren: Great. Thanks guys. And congrats on the tremendous quarterly results. It’s great to see the early EYLEA HD sales, of course, and you mentioned that naive and switch patients are being treated. But are you seeing switches from VABYSMO specifically, and to what extent are you guys sending samples out as we think about assessing additional demand beyond sales?
Marion McCourt: Thanks, Tyler. So let me address the first part and the positive anecdotal case reports we’re getting back really carry across the theme of better vision, better drying than they’ve seen with other anti-VEGF products. They also comment on very frequently the tremendous confidence that they have in the safety of EYLEA and the experience over many, many years. In terms of the switches, it’s early days. We are seeing switches from EYLEA, as you would expect, and of course, we’re the category leaders. So there are more potential patients to consider as well. But we are also hearing switches from faricimab. We’re hearing also switches from Avastin and other products in the category. And the early reports have been quite encouraging.
To your other part of your question related to sampling. We do have a sampling program for EYLEA HD. It’s intended to give physicians experience with EYLEA HD in an appropriate way. The program is constructed on an on demand basis. We don’t disclose the number of samples or things of that sort. And certainly that’s not what you were asking. But I can share with you that we have seen a high conversion rate from practices ordering EYLEA HD samples and then subsequently placing orders of commercial product through commercial channels.
Ryan Crowe: Thank you, Marion. Next question, please?
Operator: Our next question comes from the line of Terence Flynn of Morgan Stanley. Your line is now open.
Unidentified Analyst: Great. Thank you. This is [indiscernible] on for Terence Flynn. Thank you for taking our question. Quick one from us. Could you provide an update on the timing or relative implications of the biosimilar EYLEA litigation with Mylan? Thank you.
Leonard Schleifer: Yes. So we had a trial in West Virginia, a bench trial, and we are waiting for a decision from the Judge. It’s out of our control, and as soon as it comes, it’ll come. It’s been several months. So it could come soon or not. It’s one of those things where it’s really beyond our ability to predict and control.
Ryan Crowe: Thanks, Len. Next question, Shannon.
Operator: Our next question is from the line of Carter Gould with Barclays. Your line is now open.
Carter Gould: Great. Good morning and congrats on all the progress. Maybe a follow up for Marion. Thanks for all the color on the commercial dynamics for high dose EYLEA. One thing you didn’t touch on as much, though, is sort of how maybe some of the step edit language has evolved. Is that sort of tracking in line with what you were seeing with standard dose EYLEA or any broader commentary on how that’s tracking relative to your expectations? Thank you.
Marion McCourt: Sure. So, as a quick reminder, as we get into payer mix, I’ll remind everybody that these are approximates based on typical patterns in the category. It’s a little bit different when you look at a product that just launched, but about 45% of our overall business is in Medicare fee for service. And as I mentioned to you in the call today, we’ve made great progress there, not only in coverage, which is the first step to get coverage, but then taking the extra step to make sure that claims are being paid. So we’re seeing now that 100% of Medicare fee for service jurisdictions have coverage and demonstrated paid claims. When we go over to Medicare Advantage, which is roughly about 25% of anti-VEGF category business, and commercial, which is about 20, what we’re seeing so far.
And we are making good progress with payers. We’re seeing that EYLEA HD is being positioned consistently with EYLEA and other brands in the category. And there are plans, as you know, that have a step edit or utilization management. The good news is that EYLEA HD is being positioned consistently with EYLEA and other brands. We don’t see a differentiation there.
Ryan Crowe: Okay, Marion. Thank you. Next question, Shannon, please.
Operator: Our next question comes from the line of Robyn Karnauskas with Truist Securities. Your line is now open.
Robyn Karnauskas: Hi, guys. Thanks for the question. Question on CSU. I know it’s a big opportunity. Many patients are not controlled well with antihistamines, and you have a CRL. Is Study C sufficient anything in particular you think the FDA is looking for? Is there a disconnect or they’re changing what they view for the bar for approval? What’s your thoughts there? Thanks.
George Yancopoulos: Yes. Well, as you know, we had one very positive study. We had a second study that actually had a P of 0.049, but for various statistical purposes, just missed meeting its predetermined statistical hurdle. But it’s certainly all the indicators were going in the right direction. And what the FDA indicated that they wanted to see the results of our ongoing Study C, as we call it, to make their decision. And so what we’re hoping is that that study, which is in the same population of the very positive initial study, remember the second study was in these recalcitrant patients who had failed [indiscernible], among other therapies. But Study C is in the same population as our very first Study A, the very positive study. And we’re hoping that if we get consistent data in that study, that the FDA will consider and look favorably upon it.
Ryan Crowe: Okay. Thanks George. Next question Shannon.
Operator: Our next question comes from the line of Salveen Richter with Goldman Sachs. Your line is now open.
Salveen Richter: Good morning. Thanks for taking my question. With regard to your cancer portfolio, as we look to additional data coming out at ASH and the proof of concept we’ve seen so far, but combination data that we’re looking to with Libtayo. Can you just talk to us about the optimization still required here and how you’re thinking about positioning it in the context of emerging targets and competitive dynamics? Thank you.
George Yancopoulos: Yes. We have a very large collection of combination opportunities that we’re very excited about. The first one that we hope has a chance of really crossing the finish line in a very significant way, in a very seen population, is our combination of Libtayo in combination with fianlimab, putting together these two checkpoints, the anti-PD-1 and the anti-LAG-3. And I think in this case, we believe we have evidence that we have the best-in-class type of activity with both agents separately. And as you’ve hopefully seen in our earlier stage clinical trials, the data suggests that when we put them together, we really can make a remarkable advance for patients in terms of the number of patients who respond and the extent of their progression-free survival.