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spk03: I think that we gave you some transparency on the overall item related to inventory, overall competitive pressures, and then our preparation for our next launch in the category coming up shortly, we hope, following FDA approval.
spk04: Obviously, as Marion mentioned, on the sequential basis, demand was modestly up, so obviously we were offset by the factors that Marion referred to.
spk02: All right. Next question, please.
spk07: Thank you. Our next question comes from Chris Schott with J.P. Morgan. You may proceed.
spk06: Great. Thanks so much. I have a question on the IL-33 and COPD. I guess is the success you've had with your kind of study design and results with Dupixent increase at all your confidence in that program? And just, I guess, maybe just elaborate a little bit on how you see kind of those two agents kind of interacting as we think about the space overall. Thank you.
spk08: Yeah, we are more optimistic, obviously, that all of our decisions, all of the data that led us to do the particular study and the particular population of patients in COPD with Dupixent was made based on a lot of factors. And we also had, from our Regeneron Genetic Center, very strong human genetic evidence suggesting that it would have activity particularly where we actually saw activity. And so all of that gives us confidence, since we used the same criteria, the same approaches, and so forth, to plan and design our IL-33 study, certainly the fact that everything that went into one, and it all worked so remarkably well, gives us confidence that the same approaches will lead to success with the IL-33. The results with Dupixin were really outstanding, as we've already mentioned. Not only a clinically meaningful reduction in exacerbations, but we hit all these other important endpoints. Most importantly, improvement in lung function, as well as you rarely hit these quality of life improvements unless you have a really active agent that the patients can really feel the difference for their function and for their quality of life. With IL-33, The genetics is very strong. We have a phase two study in the subgroup that we're doing the phase three study in. It was in that group we had demonstrated a 42% reduction in exacerbations in the phase two study. This will be an overlapping population with our Dupixen population. We think we already have a chance to really make a huge difference for this high unmet need population that really has had no new mechanism of action of drugs brought to help these patients for a very, very long time. We have one with dupixin, and we're hoping to hit another one with IL-33, and this could make such a huge difference for these patients who have been suffering for so long without much hope. It could really make a big difference for this population.
spk04: I just wanted to repeat, maybe George said it probably two or three times, but maybe it's even worth saying a fourth time. In yesteryear, the way you did drug development is you identified a target based on some biology or what have you. You did your phase one and phase two, and you hoped your phase two was an indicator for how your phase three was going to turn out. And obviously, that's how it is still done today. But what George mentioned is that we can layer on top of it in sort of a unique way our genetic insights and look and validate and say, is it reasonable to expect that if you block a certain target that you're going to have a beneficial effect? Is that target associated with the disease you're treating? And I know George said it three times, but I think it's worth saying a fourth time. That really gives you added confidence that's uniquely Regeneron in many respects. how we can get this genetic information. People ask us a lot, you know, if you think about the number of people that have been sequenced in the world, George can comment on, I know we've sequenced a large part of them and coupled that with all this medical, anonymized medical information. We use that in so many ways, not only to identify targets, but to validate the work we're doing in specific targets, specific diseases. George, how much have we done?
spk08: We've sequenced about half of all the humans who have been sequenced.
spk04: So, I mean, that's a large database of millions, and I think that that is what you're hearing, is that that's why we had more confidence, perhaps, than others did with Vixen and now with anti-IL-33.
spk08: Since Glenn, you know, expands it just a little bit, just to let you know how it works, what we do is we identify genetic variations that mimic... the blocking of a drug, or exacerbation of this type 2 pathway. And what we showed for dupixin, for the genetic variations that mimic dupixin, those people were protected from COPD, particularly the type 2 COPD patients, whereas increased activity of the IL-413 pathway was associated with more disease. And obviously, you know, that turned out to be the case. I mean, human genetics is a very, very powerful predictor. And we've done the same thing, as Len said, with IL-33, where we have genetic variation that mimics blocking the pathway or exacerbating the pathway. And as Len said, this is one of the secrets to our ability to have high success rates in our studies is we use that as a criteria to make our decisions going forward.
spk02: Okay, thank you. Next question, please, Josh.
spk07: Thank you. Our next question comes from Yatin Suneo with Guggenheim Securities. You may proceed.
spk01: Hi, this is Eddie Hickman on for Yatin. Thanks for taking our question this morning. I was wondering if you could talk about the draft guidance from the FDA on the anti-VEGF trial designs and if that impacts your outlook on the high-dose program at all. Thank you.
spk04: I don't think that has any impact on us, on our program.
spk02: Thank you, Len. Next question, please.
spk07: Thank you. Our next question comes from David Risinger with SEB Securities. You may proceed.
spk10: Yes, thanks very much. I guess I'll just go straight to the question. Len, you had mentioned in your opening remarks the ongoing diversification of the company's revenues away from ILEA. Could you please discuss your expectations for ILEA U.S. sales growth in the near term, including the total ILEA franchise prospects after Regeneron launches the HD? Thank you.
spk04: Well, let me go right to the answer since you went right to the question. we don't give future guidance on specific quantitative measures of our sales. On a qualitative basis, Marion has said that we're anticipating that the combination of ILEA and 8 milligrams of Flibercept will be a growth franchise over time for the company.
spk02: Okay, thank you. Next question, please.
spk07: Thank you. Our next question comes from with Oppenheimer. You may proceed.
spk05: Great. Thank you. And just a quick question on linmo-seltumab. You know, at ASH you presented a Phase I data, and these were your dose rating, I guess, data, really interesting data you presented at ASH. At ASCO, what should we expect to see? Will it be dose expansion data? And then any duration also on the patients, you know, from ASH? What would FDA like to see, you know, before you can go ahead and submit the application? Thank you.
spk08: Well, I think you're going to actually see an update on our pivotal Phase II data, the actual data that was a little bit more maturing. With the further update, we will be hoping to submit to the FDA for our BLA. The data will be very close. We think the data will even get better as it matures, because as we all know, response rates and so forth get better with time as you follow these patients. But these data are going to show what we believe are the potential to have best-in-class efficacy, as well as safety in a favorable dosing schedule, based on the results that we'll show from our physical study at the upcoming ASCO.
spk02: All right. Thank you, George. I think we have time for two more questions.
spk07: Thank you. Our next question comes from Carter Gold with Barclays. You may proceed.
spk00: Good morning. Thanks for taking the question. Sorry to belabor. Ilya, I guess just simply, was the pricing pressure that you guys highlighted in Q1, was that a seasonal dynamic, or would you characterize it as that, or something more permanent around that market landscape going forward? Thank you.
spk04: Before Marion answers that, I just want to come back to the BCMA story a little bit because it's one that I'm particularly excited about. The biospecific field, which was initiated by Regeneron in terms of using biospecifics, I think we were the first to put the biospecific into patients, has obviously become a very crowded space, and it's sometimes hard to differentiate what you've got compared to what the competition has you look at somebody claiming one thing and then you're claiming another and so on and so forth but if you take a dispassionate view i think for the bcma by cd3 program you can really see a differentiated uh and molecules and a potential to be best in class antibodies are not all created equal by specifics are not all created equally you do see differences Clinical trial programs are not all created equally. This is one I really encourage you to take a very careful look at and compare. Now there was some question on Ileah, Mary, and you're going to answer that.
spk03: Sure. And Carter, getting back to your question on the competitive dynamic and pricing pressure, you know, I think if we look at the anti-VEGF category and look at it over time, go back multiple quarters, there has been increasing competitive pressure, and that does then have a corollary to some extent on pricing dynamic, and that would go forward. But I just want to share and remind all that in the category, in the VEGF category, what really is rewarded is product profile. And, you know, as we look at a product like ILEA that launched and was a game changer in the category, that was its profile not being the least costly, right? There's been a low-cost alternative, very low-cost alternative for a very, very long time, but it was the product profile that made the difference for prescribers and patients. So that will always be a very important dynamic to look at going forward and certainly has you know, strong interest for prescribers as we bring a new product into the marketplace following FDA approval with a filibuster of eight milligrams. But to your point, pricing pressure will continue in this category. But what's most important is product profile and the clinical attributes that the patient experiences.
spk02: Thanks. Last question, please.
spk07: Thank you. Our last question comes from Evan Ziegerman with BMO. You may proceed.
spk09: Hi, guys. Thank you for squeezing me in. I'd love to have you expand on some of the feedback you've been hearing from physicians regarding the 8-milligram dose, maybe some color to how they plan on using and assuming approval come June. Thank you.
spk03: So, of course, the updates on actual prescribing will you know, be even more important as the product comes into the marketplace and physicians have an opportunity to use it and select patients. We obviously have done a lot of work with our medical team, looked at the clinical data with specialists, and to give you an early answer to your question, I think there's opportunity for a variety of patients that are deemed to be appropriate candidates. And there's a range. Certainly when physicians are considering new patient starts, it's very attractive. We obviously have a, you know, a strong portion of patients that are naive to ILEA today, but in the future, the question becomes why wouldn't you start a new patient with the product that gives you all the visual acuity benefits and safety of ILEA, but it also gives you that durability and duration because, you know, obviously physicians know their patients are anxious and, you know, don't like to have more injections in the eye than they need to. Similarly, you might have a patient that's very well-controlled on another product, maybe ILEA, maybe another product in the anti-VEGF category, but you'd like to give them that opportunity for duration and maybe in some cases if the product is in another area of the anti-VEGF category, improve visual acuity and duration. So I would say it's the combination of interest for patients who might be broadly anti-VEGF category switch patients or the potential for new patients as well. I hope that helps. and look forward to the day when we can give you specifics for market experience.
spk02: Thank you, Marion, and thanks to everybody who dialed in and for your interest in Regenron. We apologize to those remaining in the queue that we did not have a chance to get to. As always, the IR team is available to answer any remaining questions that anyone may have. Thank you once again, and have a great day, everyone.
spk07: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.
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