We will go ahead and, Let's set it- Jump right in. I was- We'll do a hyper speed discussion about- I was joking that Apellis didn't show up. They got caught. Hence, never heard that one before. Okay, excellent. Well, listen, Tim, why don't you kick things off? We'll jump right in. I think we have Jazz coming up in about 15 minutes, but- Sure. Jump right in. Sure. So- Let's start with the latest update. Where are we right now at in commercial launch and in the debates of the day? Sure. So, you know, in the third quarter, we announced that we had $75 million in revenue of SYFOVRE. We had $24 million in revenue with EMPAVELI. So the launch is underway, and as you probably all saw, or most of you saw from our third quarter earnings, we had a nice rebound in our revenue and our vials shipped. So from a commercial perspective, you know, the dip from the vasculitis announcement looks like it's recovered. And we've had some of our best weeks since that quarter was announced. So, you know, growth seems to be back on track. Maybe can you expand on that a little more, Tim? Sure. Because, I know there was a point in time where you guys were adding. Heading into mid-July, there was a certain weekly adds that could be backed out. Mm. It decelerated, it started to pick back up. Do you think you've topped off the levels where we were prior to, you know, when we were entering July? Yeah. So when we announced our quarter, we were absolutely at the levels where we were, yeah, in you know, yeah, in that time period. So we were back to our growth trajectory and pretty much back at that level. Okay, got it. One thing that we obviously spent a lot of time talking about is adjudication on vasculitis cases. I understand you're not giving case-by-case descriptions anymore, totally appreciate that. But can you talk to us a little bit about the process of adjudication and what the delay is from an initial report that might show up on FAERS, for instance, to a fully adjudicated case that'll show up on your accounts? Yeah. Hi, everyone. So thank you so much for inviting us to be here. So the process is, when a physician has a case that, you know, where vasculitis is suspected, they will typically report it to the ReST Committee, to us, and to the FDA, typically in parallel. We then get that case, and we have an independent panel of four retina docs, very well-respected key opinion leaders who have been public about their contribution to this. And they... Sorry, I've been running. They review that case and then make an adjudication on whether they believe this is vasculitis or not, and then it goes from being a suspected case to a confirmed case, or sometimes, you know, gets adjudicated as not being vasculitis as well. All of that, of course, needs to be seen in the context also of: what are the visual outcomes? We communicate very closely with the ASRS ReST Committee, and we are pretty much exactly on the same page as far as it relates to those adjudications and everything else. But what's the timeline of that independent adjudication committee? How delayed is a final adjudication from them relative to the initial report? Yeah. So it can happen very quickly. It depends on how much information we get from the physicians. So when we get the proper information from the physician, typically within a week or two, we make a determination. I guess, Cedric, because one of the easiest, from a research perspective, one of the easiest notes to write on Apellis right now is, do the latest FAERS run or submit an FOI, and just say, "Hey, there's, like, 25 now and not 23." How are you guys actively monitoring those, cases being resent into FDA and adjudication around it? And/or do you ever intend to perhaps put out something a little more definitive, where you speak about what are some of those cases being submitted? Because a lot of them don't technically meet the bar for true vasculitis- Mm-hmm ... to tease the noise out from what actually matters. Yeah. So we cross-reference, obviously, with the FDA and make sure that we don't miss anything. And in that sense, what is really great is that the reporting is very good and robust in this field of the retina. So we have a very clear view on what is going on. It's important to note that on the FAERS, you will typically often get the same patient being reported multiple times, right? I mean, there was a report that came out a few weeks ago where that was not very well understood by the author of that report, that, you know, these are not new cases, these are old cases- Right ... that can get updates in the FAERS. Well, can you remind us the exact case count from the last updated that you guys have mentioned versus what some of the FAERS stuff is showing? Yeah. So I think FAERS and us are pretty much on the same page, right? I mean, that's the- so when a physician reports it, it can be reported on FAERS as vasculitis- Right ... but then it can be adjudicated by us and by the ReST Committee as not being vasculitis as well. Got it. But I think the key thing is ReST Committee and us being in lockstep with each other, and I think we are at 12 confirmed cases. Was that correct? Yeah. Got it. 12 confirmed cases. There was a very interesting slide shown by the ReST Committee at that Seattle conference, where they had this three-by-two table with bunch of different characteristics, which they need to check the box on to call it a vasculitis and/or ROV, depending on whether certain boxes are checked or not. Mm. My understanding is your criteria were generally consistent with that, but is that well understood and well appreciated by clinicians that are self-submitting these reports into FDA or the FAERS database, on whether those criteria are properly being checked? Yeah. No. I mean, so again, it's important to note here that vasculitis is really an imaging finding, right? I mean, it refers to the leakage of blood from the blood vessels in the back of the eye, which can be associated with occlusion, but which is typically a manifestation of something else, either inflammation, sometimes autoimmune disease, whatever it is. I mean, there's many causes behind that, right? So that complexity, you know, is something that needs to be taken into consideration as well. Also, vasculitis is not something that is, you know, that doesn't happen in the absence of drugs being used or not. It happens with anti-VEGF injections. It can happen naturally in people as well. So all of these things are important to put in context. Got it. Is it still a first-dose phenomenon, the vasculitis findings? 'Cause I know there was an 86-year-old second dose reported at the Retina Conference, but generally speaking, my sense has been it's a first-dose phenomenon to the extent it happens. Yes, it's a first-dose phenomenon, in that patient, that was reported as a second injection. Even the ReST Committee is revisiting that, I believe so. Oh, that's also- Yeah. So I think that's, you know, it's very much a first injection phenomenon. Again, etiology is something that we'll look further into. But I think it's important to note here, this is so extremely rare on such a large denominator. It has to be placed in the context of the history, right? The problem was, or if brolucizumab, i.e., Beovu, had not happened a couple of years ago, this would never have been or turned into what it is today. That is just- Right ... a simple fact. What happened back then is it started off being a 1 in 10,000 event, but because patients were getting sensitized against that drug, it became more and more, and in the end, it was 1 in 50 subjects that had this. Now- This is completely different. But Cedric, to that point exactly- Mm-hmm. If this is a first-dose phenomenon and there's no acceleration, is the proper denominator total doses given or not new patients given? No, I think, I think that is an excellent point. So I think from either angle, right, it looks very good for us, right? So we have... On the last time that we updated this, we have more than 50,000 subjects that have at least received one injection, and we have well north of 100,000 injections at this point in time as well. If you take patients with bad visual outcomes, right? There were 5 patients with bad visual outcomes on a total of 50,000 subjects. So if you- Is that, is that counting only those patients adjudicated as vasculitis with bad outcomes, or are you also counting non-vasculitis cases that had some visual exacerbation? No, that is vasculitis cases with bad visual outcomes, right? So that was them. Mm-hmm. And then again, on the denominator of 100,000, there again, you have that very small number of cases as well. So on either way you look at it, it's something very rare, sporadic. Physicians appreciate this now, and I think, have largely moved beyond that and are now focused on efficacy, right? Because- Maybe let's expand on that. So you mentioned clinicians have moved on beyond that. I remember as of July, in the thick of it, there were three groups of doctors. A third that were saying, "You know what? We're going to continue to do this because we're comfortable." And there were a lot of private equity practice in that. Mm-hmm. A third that said, "We're never, ever, ever going to touch it." And there were a third that were saying, "We're on the sides, and we'll revisit." Has that group started dosing now? Is the clinician base expanding meaningfully as we're gaining more commercial experience? The middle segment is the most important one, right? I mean, those were the physicians that said, like: "Okay, we have something new. Let's take a pause on new patients." But as time progressed and as it was clear that this is not a sensitisation problem like Beovu, they are now in large numbers starting to retreat new patients, which is, of course, accountable for the growth that we're seeing right now. Got it. As you think about expansion into Europe, do you think you want to do that yourself, or do you need a strategic pharma partner to help you with Europe? No. Europe is something that we have prepared for for years. We have prepared the physicians, the payers, the regulators. We're very excited about the prospect of commercializing in Europe on our own. Got it. So in one sense, you don't necessarily need any help from a strategic partner for any ex-U.S. territory, too, or maybe certainly not for Europe, but beyond, you may. Correct. Not for Europe. Outside of Europe, we will have a partnering strategy. Got it. And then also, maybe a question for both of you. I know there was a point in the summer where it sounded like people thought this drug could get... There's no commercial future for this. There was a lot of hysteria around it. Things have stabilized quite a bit, certainly from the vials per week you guys are showing there's growth again. Have you sensed that sense of normalcy beyond just your core prescriber base and even expanding into other corporates you guys interact with, that this is now past, like, that zone where there were a lot of question marks and things are stable and growing again? Has that reflected in the types of meetings you guys just do, broadly speaking? Absolutely. I mean, I think... Again, I mean, it was kind of a bit of a panic moment because of the muscle memory of what happened a few years ago with that other drug. That is now beyond us. Yeah. I mean, we felt that for the first time at ASRS in October, then very clearly at AAO as well, and now the focus is squarely on efficacy, right? I mean, you have an ability to slow down by as much as 40%- Right ... the degenerative process in the third year of dosing. I mean, that's something that really resonated with physicians. Also, the functional data is looking really, really good, which is important, of course, for Europe. I mean, we have the extension in GALE, so all of these things are coming together in this, in this complex disease. Yeah. Cedric, I'll tell you why I ask, and it's the elephant in the room- Mm-hmm ... which is, there's a world in which you say, "You know what? The way we see this launch going is very different than, let's say, a typical pharma would be seeing it. And for that reason, there's a big disconnect in how we think about the true intrinsic value of our company." And sometimes that can create a mismatch in the expectations that you have and/or your investors may have versus external partners. I'm just curious, as you think about it, broadly speaking, is this return in growth being reflected broadly, even in many discussions you have beyond Apellis as well? ... Yeah, I don't want to specifically comment on what's what external expectations are versus our own, but what we have seen is by focusing on the patients and focusing on being transparent and having trust with the retina community, that we are seeing this very meaningful pickup again now, similar to what we saw in the spring. We will know very soon, in the next two months, a couple of important points. I mean, first of all, we're going to get more clarity on the European approval process, and we're going to get more clarity on the projections in terms of revenue. And I think once those two elements are clear, we're going to have, you know, much more certainty about what's in front of us. Tim, can you speak to the expectations on 2024 for SYFOVRE and where they stand and- Yeah, we feel- Like, you know, like, nobody really knows right now. I mean, the expectations are... I can't comment on expectations, that constitutes guidance, and I'm going to get in trouble with Meredith if I do that, so. But look, we feel very good about our growth trajectory. Again, as I mentioned, we had, you know, I think, very nice growth under the circumstances for our last quarter. And we continue to see strong uptake, so we've seen some of our best weeks in the last month, so. How do you, from this point forward, I understand you're not giving patient-by-patient updates on vasculitis, but what do you expect to be giving in terms of cadence of updates, both on the rate of vasculitis and on the rate of vial shipment going forward? Oh. Yeah. Well, I think, look, next step for us is to work on that label update, right? I think that's, you know, I think, Label update for U.S.? For the US, yeah. I think we're going to end up with something that's going to be similar to what the Vabysmo update was as well in the label. And after that- Sorry, what was the Vabysmo update on the label? Vabysmo had a label update as well- On? ... for vasculitis events. I think that's, that's important actually. Because, again, vasculitis is something that can occur with intravitreal injections, including drugs like faricimab. So I think we're going to get a label update that's going to be quite similar to that label update. And at that point in time, what we will do with the retina community is probably give another update on kind of reconfirming that the rate case is stable. There will then be a publication at some point by the ReST Committee, which kind of will synchronize with what we have disclosed. And then at that point in time, I mean, you know, I'm not sure that updates are further needed unless there's a change, of course, that's- On the commercial front, it sounds like you're also not guiding to regular updates on vials shipped anymore. I think we'll give some updates- Quarterly, or is it possible that you could give more frequent- You know- updates as you have been over the- Yeah, we're going to keep, we're going to keep you updated, I think, on vials shipped. That's. I wouldn't worry about that. I don't know whether, whether it's quarterly. I think quarterly is probably an expectation, but beyond that, I don't know. Got it. Okay. And the big difference between Beovu's vasculitis mention and the Vabysmo vasculitis mention on label is that it just says, "If you have it, you discontinue." That's all it says on Vabysmo label. Yeah. So it is the... Yeah, the big one with Beovu was, of course, kind of the immunity-related aspect, et cetera. Right. That's not something that I expect to- Okay, excellent ... to be coming. It's- Maybe just as we wrap it up, I know there were peak sales for the drug. There were a lot of numbers out there. Clearly, you guys had a certain number in mind internally as well. How has that evolved over the course of the summer and into fall? Your peak sales expectation. Yeah, I mean, you know, without commenting on the public's view on peak sales- Yeah ... I think our peak sales expectation hasn't changed that much, to be honest with you. Really? Well, certainly not from our initial launch, right? We, I think one of the things that people don't fully appreciate is how big, for example, Europe and ex US can be, right? So think about the anti-VEGFs, right? The anti-VEGFs, more or less for branded anti-VEGFs, that's 45% of revenue, right? If you look at Eylea, it's 40%, Lucentis, it's 60%. It's a gigantic opportunity. It's probably twice the size of the US, both in terms of retina docs that inject, but also patients. So when you think about that, of course, the pricing is less, right? But when you think about that, that opportunity is, I think, underappreciated by- Then why don't you need a pharma partner for ex-US then? Yeah, because it's a very concentrated prescriber base, right? Mm. If you look at, you know, Germany and France, for example, you need. I'm going to say 25, 20-25 reps. And then for the other EU5, you're looking at 10-15, and beyond that- Medics in Belgium? Medics are number one in Belgium, Medical Affairs, head of Medical Affairs. And then, you know, those EU5 represent 80% of the European anti-VEGF use. Got it. So when you think about that, it's like EU5 is a gigantic market, and it's pretty concentrated, something we can do on our own, so. Excellent. Well, listen, we're past time. I was going to ask you time to break even, but we'll save that for another time. Well, it's 2Q 2025 at the earliest. All right. Excellent. Well, thank you guys for being here. Thank you so much. Sorry about the- Oh, that's okay.