Phil Nadeau: That’s very helpful. Thank you
Operator: One moment for our next question. Our next question comes from Akash Tewari from Jefferies. Your line is open.
Unidentified Analyst : Hey morning, this is Ivy on for Akash. Thanks for taking our questions. We just have two quick ones on SYFOVRE. So when we spoke to our team heading the train, you had felt confident that the long-term split between SYFOVRE and IZERVAY could be somewhere around like 70% and 30%. So given competitor has commented on their call that IZERVAY is currently taking 20% market share after five months of launch. How do you feel comfortable that you can maintain this 70/30 split in the long term? And then secondly just quickly, why hasn’t you guided for SYFOVRE for ’24 and do you plan to guide in later quarters? Thanks
Cedric Francois : Thank you so much for that question. Adam?
Adam Townsend : Sure. Hi, Ivy, it’s Adam. So yeah, Astellas has said they have a 20% market share but as I discussed previously, there are multiple ways you can estimate market share. Our assumption is that Astellas is using total vials shipped for a specific time period. So their last quarter versus our last quarter? What we do is we use real-world ECP injection data which is a snapshot of the current market where physicians are, ordering vials and using vials. And we think this is actually a better way of analyzing market share. It actually counts injections rather than looking at vials shipped or revenue and obviously, there’s a total market analysis that we would do. So we’re confident that we are the number one GA drug out there.
We also did a time-adjusted analysis of our launch versus the competitor’s launch. And if you time adjust so that you assume they both launch on the same day, ECP or physician demand for SYFOVRE was three times greater than that of IZERVAY in the first four months of launch. So that’s an incredibly positive metric. We also see that the majority of new patients starts continue to be on SYFOVRE and just another point, right, keep in mind that this market is much larger than we believed, from 1 million patients to 1.5 million. I think it can accommodate more than one product but we truly believe that we are the number one product and we expect to maintain that leadership over time. So hopefully that answers your question, Ivy. I think I’ll hand to Tim.
Tim Sullivan : Yeah, I’ll take the guidance question, so obviously after the past year we felt we needed a little more time before we could guide effectively and you know case in point. We’ve never been through a first quarter where we have recertifications or the like. So, we’re just going to take our time and make sure we understand the dynamics over the course of a full year and we’ll get back to you on when we plan to guide. Thanks.
Operator: One moment for our next question. Our next question comes from Ellie Merle with UBS. Your line is open.
Ellie Merle : Hey guys, thanks for taking the question and congrats on all the progress. I just want to follow up on the quarter-over-quarter gross question asked earlier. You said you’re seeing January and February as two of the strongest months since launch and the sampling rate did not increase. So shouldn’t 1Q be higher than 4Q? I guess how do we balance that with the seasonality commentary? I just want to clarify on that point. And then just a second question, in terms of compliance and dosing frequency, are you seeing any trends and differences in compliance or dosing frequency at different types of sites such as private equity owned versus academic? Thanks.
Adam Townsend : Hi, Ellie, it’s Adam. So, yeah, so we’ve been — seasonality does impact drugs within this market. As I said, I use the analogs that we found from the anti-VEGF and we do see recertifications happen a lot in January and leak into February and impacted on the weather. We do believe that January and February are likely to be two of our largest months. So we’re executing flawlessly and pushing to make Q1 as big as it possibly can be by being incredibly thoughtful in how we interact with the physicians. So, the team is flawlessly executing, I’m incredibly proud of them and we’re pushing incredibly hard as you would expect us to. We believe we have the number one GA drug, moving forward Compliance, as I said, it’s a touch early for compliance.
We tend to see the vast majority of patients being six to eight weeks and they seem to be very comfortable with that. We have not noticed any difference that I’m aware of between compliance at PE backed practices versus non-PE backed practices. We have a nice wide range of business, right? So PE backed practices are about 30% of our business and the rest, the remaining 70% are independent practices and academic practices. To my knowledge, we haven’t seen any differences in terms of compliance from those groups. As I said, we’ve just exited the first year. I think as we get into years two and three of treatment with this drug, that’s when you know physicians will have to have a conversation with their patients about compliance, but it’s too early for them.
Ellie Merle : Great, thanks.
Operator: One moment for our next question. Our next question comes from Francois Brisebois with Oppenheimer. Your line is open
Unidentified Analyst : Hi, this is Dan on for Frank, please. Well, thanks for taking our questions. Related to a question regarding the physician segments from the market research, now with the permanent J-code effective and the GALE extension read out, are you starting to see an impact within that 1/3 segment of physicians who are on the sidelines?
Adam Townsend: Yes, thanks for the question so yes, obviously, we haven’t redone that market research, but we are starting to see an impact for physicians who are on the sideline, the J-code unlocked all of that. We continue, it’s my favorite metric. We continue to see double-digit new accounts sign up to use SYFOVRE every week since launch. That has continued. That tells you that these physicians are no longer on the sidelines. They keep starting to and want to start patients. I think that’s an incredibly positive metric for us. So yeah, whilst we haven’t done them the research anecdotally, we’re hearing that those physicians who are on the sidelines have started to go. We do have some upside opportunity too, right? So, we have about 1,800 sites of care across the U.S. that’s about 50% of our potential target list.
So there’s still an opportunity for growth for us to target that other half of the market and we have some good plans to go and execute that which we started in the first quarter and expect to move into the — for the rest of the year. So hopefully that answers your question
Unidentified Analyst : And just, congrats on the quarter.
Adam Townsend : Thank you.
Cedric Francois : Thank you.
Operator: One moment for our next question. Our next question comes from Joseph Stringer with Needham. Your line is open.
Joseph Stringer : Hi, good morning and thanks for taking our question. Just a quick one on potential switching dynamics, just curious if you could provide any metrics or data or even qualitative feedback that you’re hearing so far on any switching dynamics between SYFOVRE and IZERVAY?
Cedric Francois : Yeah, I think thank you so much are we great to hear you look that that is a place where I think we are very well positioned as well. At the end of the day where the metrics will stand out is the comparator between on efficacy as well as on safety, right. So and on the efficacy, quite frankly the difference is quite stark, right? I mean as mentioned before on ex-subfoveal patients up to 42% slow down versus what has so far been reported as 14%, even though we don’t know what it is exactly in the second year for our competing product. And then maybe briefly on the safety, right, that risk that exists on the first injection of developing vasculitis, which is very rare, is something that we now firmly believe is caused by a pre-existing allergy towards polyethylene glycol, something that is shared between the products.
And we have every reason to expect that both products in the future will have that risk, rare risk associated with it. That will then have to be discussed with the patient when a treatment is planned. Adam, do you want to add something to that?
Adam Townsend : Yeah, hey, Joe, it’s Adam. So yes, no surprise, right, during the rare cases of vasculitis last year, we did see some accounts switch. They switched primarily for safety. And we know where those accounts are. Now, again, anecdotally, I have actually seen some physicians switch patients back. So I have seen and heard from my field teams that, physicians switched from SYFOVRE to the competitor, and then some of those patients were switched back. So switching does happen in this market. It definitely happened. It definitely happened during the rare cases of vasculitis. But we believe in the profile, the efficacy and the safety and the benefit-risk of this drug. And we truly will be focused on making sure we communicate that profile to every physician in this market.
Joseph Stringer : Great. Thanks so much for the color.
Operator: One moment for our next question. Our next question comes from Derek Archilla with Wells Fargo. Your line is open.
Derek Archila : Hey, good morning. Thanks for taking the questions. Just two on EMPAVELI, I guess first, have you seen any impact from the launch of Iptocopan in PNH? And I guess, how much upside do you think there is in the first line setting from the 10% you discussed today? And then just overall kind of commercial strategy for EMPAVELI and C3G and MPGN? Thanks.
Cedric Francois: Thank you so much, Derek. And great to hear you. Look, in PNH, we now have a very competitive situation, of course. And our expectations should be commensurate with that competitive situation. So while we don’t guide, certainly there will be pressure from this world product. I think in general, though, that it is a great thing that there are now two products available to address the problem of extravascular hemolysis in these patients. If we go back a couple of years, as you may recall, because you were already covering us, there was a notion that this was something affecting 7% of patients. That is not true. This is something that affects the overwhelming majority of these patients. And a big segment of patients can and will benefit from this.
And in that sense, raising the awareness around that, having the overtures by our side, will be helpful. As we’ve mentioned before, we’re incredibly excited about what we can do in the kidney to the readout of the VALIANT trial this summer and what we will be able to do for the 5,000 patients with C3G and IC-MPGN that are in need. Adam, do you want to add something to that?
Adam Townsend : Yeah, you said it really well, Cedric, but just to add a few extra bits, right? So Derek, a twice a day oral will be appealing to PNH patients, for sure. We should expect that. In fact, we’ve seen one or two patients switch from EMPAVELI to the twice a day oral, as you would expect. The vast majority of our patients are really committed to EMPAVELI. They see the benefits of the efficacy, they see the benefits of the safety profile. And with the auto injector, the EMPAVELI Injector, we’re really improving that convenience aspect of the drug. So we’re going to be strongly competitive in the market, but an oral will have an impact. You asked about the first line segment, right? So I do expect we have 10%. I do expect that the oral will be used nicely within that first line segment, but I’ve been around the blocker a little bit and every time there’s a new entrant into the market and a conversation is had between a physician and a patient, it’s an opportunity for EMPAVELI.
So if a patient has a conversation with a physician about starting on an oral or switching from ULTOMIRIS or SOLIRIS to an oral, that is an opportunity for us to make sure that EMPAVELI was in that consideration set, so switching opportunities become particularly important for us during this phase and just an execution perspective on nephrology. So we obviously have a great medical affairs EMPAVELI team. We’re starting to send that medical affairs team to the nephrology conferences and that will be the face of the nephrology discussions that we have based on these conferences, etc., until we see some data mid-2024.
Derek Archila : Got it. Thank you.
Operator: One moment for our next question. Our next question comes from Douglas Tsao with H.C. Wainwright. Your line is open.
Douglas Tsao : Hi. Good morning. Thanks for taking the questions. Just maybe as a follow up on bilateral treatments, presumably there is a slowdown during the vasculitis phase. So should we think that relative to your sort of original expectations in terms of how big a part of the business it was, it is smaller? And are we starting to see sort of some of that catch up? And so should we think about that as sort of some amount of pent up demand of patients who are on SYFOVRE but only getting one eye treated but eventually should most likely convert to bilateral treatment? Thank you.
Caroline Baumal : I think that it’s likely that physicians will once they are comfortable and patients have got past the first injection or so, then they will be using bilateral for patients just out of convenience for these patients, they only have to come in once. So, now that we have such a large number of vials that have been used and the robust patient experience to-date, I think that we’re approaching that.
Adam Townsend : Yeah, Doug, it’s Adam. Just to add, you know, I think the bilateral usage was definitely impacted as you said. I expect that to come back but it’s going to be time delayed, right, as we start to communicate with all of these physicians. They’ve changed their practice on how they do bilateral injections, how the — process of how they do it is different based on what happened last year. I don’t think it impacts the opportunity. I think that’s just the time delay as physicians get more comfortable.
Douglas Tsao : No, no, and I think my sort of question was is that when we think about a certain number of patients on SYFOVRE today, presumably a higher proportion are just having a single eye treated than you might have originally anticipated, but we should expect those to eventually catch up. So, we should see vials per patient increase relative to where we are?
Adam Townsend : I think you should expect to see bilateral increase, yes, moving forward.
Douglas Tsao : Okay, great. Thank you.
Operator: One moment for our next question. Our next question comes from Graig Suvannavejh with Mizuho Securities.
Graig Suvannavejh : Good morning. Thank you for taking my questions and congratulations on the quarter. Just two, please. One, I might have missed this before, but just on the European re-examination process, could you just clarify for me whether as a company during this re-examination period, whether you are able to submit additional data or new analyses, or is it that the two new rapporteurs provide just a fresh view of the previous data that was included in the original dossier? So, that’s my first question. And then my second question, please, just a reminder on the safety profile on SYFOVRE and has the rate of vasculitis changed in terms of either increasing or potentially decreasing, or is it essentially the same? Thank you.
Cedric Francois: Thank you so much, Graig, great to hear you. First of all, on the European Union, so you are not allowed to include new data, but you are allowed to include new analyses, right? So, that is something that our team has really done well. And again, especially the microperimetry data is really compelling. So, we will see what is going to happen, as we mentioned, it’s an uphill battle, but one that we are excited to take on. Then as it relates to the safety, the rate continues to be at 0.01%, where it has been since July. And of course, that stability provides a very good context for physicians to disclose to their patients when they speak with them as to what the risk in front of them is versus the benefit that they can get from being untreated. So, unchanged, again, these cases are so rare that for a rate change to become manifest, we are going to have to wait quite a bit.
Graig Suvannavejh : Thank you.
Operator: And I am not showing any further questions at this time. I would like to turn the call back over to Cedric for any closing remarks.
Cedric Francois: Thank you so much everyone for joining. It is a great start to the year for us, and we look forward to sharing much more with all of you as the months come by. And for those of you available later today, we will be here to take questions and answer any further inquiries that you may have. Thank you.
Operator: Ladies and gentlemen, that does conclude today’s presentation, you may now disconnect. And have a wonderful day.
