Great. Thank you so much, everyone, for joining us. Really pleased to have with us for the next panel, Timothy Sullivan, Chief Financial Officer of Apellis, and also on stage is Elizabeth Webster, who's part of the biotechnology team covering Apellis here. To start, Tim, thank you so much for joining us, and can you give us a snapshot of where the company stands today and what your strategic priorities are for 2024?
Yeah, sure. So thank you, Salveen, for having us, and Goldman. So Apellis was really built on the philosophy of controlling complement Factor 3. So complement, as you may know, is the ancient part of our immune system, and really, that's only recently, in the last sort of 20 years, become an area of focus for drug development, starting with Soliris and Alexion for PNH. We always had the philosophy, and this was laid out by Cedric, you know, many years ago, that controlling complement Factor 3 would kind of be the Swiss Army knife of controlling complement, meaning irrespective of the three activation pathways or any of the downstream effects, complement Factor 3, if you control it correctly, can essentially be a litmus test for a complement-mediated disease and control any complement dysregulated complement.
And so that's underpinned pretty much everything we've done. And today we have two commercial products, SYFOVRE for geographic atrophy and EMPAVELI , initially for PNH, and also we have a pipeline of additional technologies. We have an siRNA that's in phase I, targeting also C3, as well as some preclinical work that's very exciting, including our collaboration with Beam. In terms of SYFOVRE, that was the first drug approved for geographic atrophy and was approved in February and is currently the market leader. And that drug was approved on the basis of two very large, well-controlled studies with 24 months of data, both monthly and every other month, so dosing flexibility, and critically, having increased effects over time. This is something that's incredibly unusual for a pharmaceutical.
Typically, you'll see an effect that, you know, maybe continues on or, in some cases, wanes in something called tachyphylaxis, but it's very unusual to see an increased effect over time. You know, we see that, you know, in the third year, so we have those two 24-month studies. We also have an extension study, and in the third year, we see as much as +40% slowing in certain populations of patients with geographic atrophy. And then from a launch perspective, you know, that's been a very, I would say, successful launch. We did have, you know, some unexpected safety events in the summer that gave a little bit of a hiccup to that trajectory.
We did say that that recovered in our third quarter earnings, and that we've had some of our, you know, our best weeks of sales since then. So that's been a very successful launch for us. And, turning to EMPAVELI, that's been, you know, a drug that was approved in May of 2021. It was approved based on a superiority study, head-to-head against Soliris, which was the standard of care C5 inhibitor when we began that study. And, we showed approximately 50% improvement in hemoglobin levels in patients who are either anemic or transfusion-dependent while on Soliris, in many cases, on the highest possible dose of Soliris. So these patients were not doing great on, a C5 inhibitor. And then once approved, we've, we've had that on the market for two and a half years.
We have incredible compliance, so 97% compliance on that drug. And then from a safety perspective, and it's kind of interesting because when we originally set out to be the people who could control C3 and control complement centrally, the biggest question was, "Can you do this safely?" And it turns out the answer is yes. This drug is very well tolerated. We are now at roughly 1,400 patient years, and we have yet to have one meningococcal infection. So one of the things that is an issue with targeting C5 and covering it to the degree you need to with a C5 inhibitor to get that therapeutic effect is that you open the door for encapsulated organisms and meningococcal infections, particularly. And meningococcal infections are very serious, and you'd expect to see one every 100-200 patient years.
We've seen zero, so you would have expected somewhere between 7 and 14 of these events in the time period that we've been treating people with EMPAVELI. So that's great. And then from a recent event perspective, we just got our EMPAVELI Injector approved, which is the on-body device. I didn't mention this, but it's a twice-weekly subcutaneous administration, EMPAVELI is. And so the on-body device is sort of a needle-free experience. It's a little disc you put on your abdomen, you press a button, delivers the drug, button pops out, and you're done. And you know, it has you know, exceptional uptake. So right now, I think we launched that recently in November, and we have more than 50% of patients who've converted to the injector. And then we have our pipeline, right?
So that's progressing nicely, and I think Cedric will talk a little bit more about that in the coming months.
So Tim, you know, you talked about this. It was definitely 2023 was a year with very exciting moments when you look at the approval of SYFOVRE, but also some tumultuous moments, with the vasculitis events and the European approval process.
I remember that. Sorry.
When you stand here today and you look on the board, what do you think the street is missing from the Apellis story at this point, as you kind of move through all these different processes?
Okay, I love that question because, especially because all we've been doing, like you said, for the past six months, is kind of dealing with what's right in front of our face. But the big picture is actually really encouraging for the SYFOVRE story in ways that I don't think are fully appreciated because of, you know, this process of narrowing the error bars over the last five, six months. The first one is that this is a very patient-driven disease, and it's probably a larger market than we originally thought.
So, I think it can be hard sometimes when you're dealing with data and, you know, the various analytics we all do in the investment community and the commercial side, that this is a patient that is being told they're going blind, and there is. Before this, there was nothing that these physicians could do for them. It was the number one thing that retinal physicians said they needed, was a drug for geographic atrophy, because they hated telling patients there was nothing they could do. Today, they have something, right? They have a drug that can slow the disease. It's an FDA-approved drug, and that conversation with the patient is a real conversation that is activating for the patient. They want control of their destiny and their vision, which is really their number one sense.
So I think that part of it is, was maybe not as well understood, and it certainly was the biggest question we had kind of heading into the approval, and I think it's also what's driven us through what was a little bit of that uncertainty this summer. The second, and probably, I think, even less well-appreciated item is, you know, how hard it is to get a geographic atrophy drug approved and how hard it will be that the bar has been raised. I think it's been raised a lot, and I think it's gonna be quite challenging. So getting back to our strategy of targeting C3 and the way we target C3. There are pieces of this that are mechanistic, regulatory, and then data, kind of package related.
The first one is, from a mechanistic perspective, if you are a drug that can control complement and control all three activation pathways and all downstream pathways, you're probably doing more or less as much as you can do in terms of complement, you know, in a disease state, assuming you get proper drug coverage and everything else. Now, at AAO, from a regulatory perspective, FDA made it pretty clear, I think it was said five or six times, that a study done in geographic atrophy, a pivotal program, would need to be, a superiority study. A non-inferiority study would not cut it. So the bulk of drugs that are being developed right now in geographic atrophy are still complement drugs, right?
And so now you're telling me, okay, you have the Swiss Army knife effectively of complement inhibition, and you've got to take a point solution. Let's say it's a classical pathway inhibitor, an alternative pathway inhibitor, which Factor D, you know, obviously didn't work. That was Roche's program, an extremely well-run study. And then you have. Or, you know, a downstream target, such as, you know, C5 inhibitor or whatever. You may. You have to get a superiority result. That's a challenge in and of itself. But let's say the regulatory environment eases on that, and a non-inferiority study passes for whatever reason, which is, again, definitively not the way where the world is, right now. But let's say that is the case, and you get a drug approved based on 12-month data.
We have 24 months in our label with a piecewise linear analysis showing increased effects over time, and then we have as much as 40+% slowing in year 3 in our extension study. What we've seen is that having 12-month data is one thing, but as we saw at AAO, 24-month data is also super important, and people look at it. And so the bar isn't necessarily approval on a 12-month data endpoint. The bar for really taking a big piece of the market and getting uptake is, what are you doing in year 2 and year 3? This is a long-term disease, long-term progression.
I think all of that together kind of pushes innovation maybe in the direction of new modalities, which is exciting and something we're obviously very interested in, and also pushes you in the direction of, you know, is this gonna be something that's a major competition for the drugs that are existing today? And the answer is maybe not. Maybe those are complementary and will be used, together if there is something else that works in a different way. So I think that hurdle is probably something people really haven't thought much about because it's, you know, hasn't been the topic du jour recently, but I think it's really important.
You commented that the U.S. Geographic Atrophy market is larger than you originally believed. Can you walk us through how you're thinking about the total size of this market and what you're working on to drive penetration?
Sure. So the market we originally thought was, we always said about 1 million patients in the U.S. and 2 million patients in the developed European Union, et cetera. The U.S. population, I think what we have come to believe after you know. So that's based on literature, right? So literature when there was no drug out there, and people did their best to try to understand it, but nobody was treating this. So it was really kind of a best guess, and probably a conservative one. We're estimating that it's somewhere between 20% and 40% larger than what we originally thought. From a driving penetration perspective, I think we're really in the early innings, right?
So if you've you know, we announced, I think the last patient count that we actually talked about, you know, a few months back, was that we thought there were roughly 50,000 patients that had been treated at that point, right? And if you think that you're at, you know, 1.2-1.4 million in terms of population, you're, you know, you're well under 5% of, you know, penetration. So there's definitely a lot of opportunity to increase that. And the ways we're doing that are, you know, obviously disease awareness. The DTC campaign is one aspect of that. So we're doing TV, print, radio. We're also leveraging referral networks, making sure patients who are not being seen are being seen.
So, you know, we're also doing physician awareness campaigns and so forth, all that sort of stuff. And then, I guess the next consideration is whether we think about something like a branded campaign. That's certainly a thought, but we haven't decided to do that yet.
Can you speak about the efforts to drive referrals from non-injecting ophthalmologists and what you're seeing in terms of the use there with the injecting versus non-injecting?
Sure. So again, this is one of those situations where it's a very patient-driven market. So if a patient goes to a physician who is a retinal specialist, who, you know, for whatever reason at this point, has decided they're not gonna be injecting, you get a referral. They often will give a referral somewhere else. They'll say, "Okay, if you're intent on it, go to XYZ doctor." So we do have hospital networks that, for example, don't have it on formulary. There are reasons beyond we don't or we do or do not want to, but functionally, they can't. And those referrals go to other physicians who can, because the patients, again, are the activated. They're the people who want this, right? It isn't it's not being pushed necessarily.
It's really the patient-driven component of this market.
And then in Q3, the drug clearly demonstrated a pretty nice run in terms of the launch outlook here and beat street expectations. What should we expect in terms of the launch trajectory in 2024, and what are the levers in place to maintain growth?
Yeah, so I think the. Well, again, like we said, is we're in the early innings, and one of the things we haven't done yet has been through a full first quarter. And one of the things that happens in the first quarter with intravitreal drugs that are these Medicare drugs is that there are patients who switch their Medicare plan and there are recertifications. So at least in the first quarter, you know, we're cautious a little bit on what that will look like, because we haven't been through it yet. But we've seen continued demand through the fourth quarter. We've been very open about that. We've seen some of our best quarters yet, so we'll see what that impact looks like in the first quarter of 2024.
But beyond that, that shouldn't be any issue, of course, after that in 2024. We don't obviously guide, but we have in terms of the levers in place, I think the most important lever, beyond the things we talked about, like DTC, is really getting the message out on the efficacy, because this is an efficacy-driven market. When people come in, they want the drug to do as much as it can do, right? And, you know, we believe we have class-leading efficacy in geographic atrophy, and so getting the word out there about what these increased effects over time can do and, you know, the breadth and depth of our data, which is, you know, I think is one of our strengths.
Is there much focus at this point on the safety? Maybe just speak to your investigations on the underlying cause of vasculitis and whether there's an update on the working hypothesis for causality.
It's a really tough question. The working hypothesis, there is no. It's basically the current thinking is it must be a multitude of things, probably. We've been very open about what our case counts have been and so forth historically. The rate has been consistent at 0.01%. These are extremely rare, but when you have something as rare as this, this 1 in 10,000 or even less, what is, you know, what is the etiology of that? How do you figure it out? Obviously, one component of, you know, we try to get rid of anything that looks like it could be potentially related. We did have the, you know, essentially, the alert related to the filter needle that came out of the market.
That may have been a contributing factor. It's hard to know. We've seen, you know, if anything, we've seen that rate just maintain, be very steady. Yeah, I don't think we'll ever figure out exactly what it is, given the rarity of it, to be honest. There's some speculation that it could be one thing or another, but we won't know.
Let's maybe move over to Europe. You're expecting a negative opinion at the next meeting in January around EU approval. Can you walk us through what happened here and outline the next steps here, the path forward and the timelines for an appeal and reexamination process?
Sure. So we announced in December that we had a negative trend vote from the CHMP. That was, you know, I think we were pretty open about what that was. That's not a final vote. We expect the final vote to come in January, and we should expect that vote to be negative. There's no reason, you know, in that short timeframe, why anything would change. And in the process, what we expect to do is we expect to submit, at that time, a request for reexamination. And the process beyond that is that, you know, the CHMP would then assign new rapporteurs. These are the people who lead that process within the CHMP, and we would expect a new vote to happen in April. That's sort of the optimistic earliest timeframe.
The EC would give a decision in the beginning of July.
What can be done here, with regard to kind of building a case around your belief why the drug should be approved and addressing the questions that were asked, as well as, you know, I guess, with the new set of rapporteurs, how much read-through is there from the old rapporteurs?
Well, I mean, there's obviously going to be some read-through. You know, but what we found is that, look, we didn't necessarily expect this outcome, and we also, you know, the physicians and the patients were, I think, surprised in Europe by this outcome. And, you know, it's, it's something that we're obviously going to do our best to get this decision to be a positive one. But, you know, it will require some activation by the patients and the physicians, which we're seeing already, right? We've seen a lot of some fairly surprised and upset physicians that are in our network.
What we can do, you know, is not a ton other than really focus on the questions that they had, which is really the structure-function relationship, and focus on the microperimetry and how that education, because that education wasn't always that easy a process, and it's something I think we'll have a ability to be more focused on and more involved in. But again, it's gonna be an uphill battle, but it's one we're gonna fight.
Great. I'm gonna turn it over to Elizabeth on some questions, but before I do that, just one on just going back to the launch here, as we think about 4Q and how that launch has progressed. There are databases which monitor these launches. It seems like, as you said, you know, there's a huge untapped opportunity. Can you just speak to maybe the outlook for 4Q versus 3Q, and then also whether there's any seasonality that would be expected from a holiday period?
Sure. Yeah. So, you know, I think you all saw, or anyone who knows about, listened to our earnings, saw the chart. We call it the EKG, with a little bit of a skip in the heartbeat there. But the trajectory was strong, right? And we've continually, I think, in our public calls since then, reiterated that we've seen some of our strongest weeks, and we saw continued demand through the end of the year. Of course, there are a couple of weeks where there is some seasonality, Thanksgiving and Christmas, holiday weeks. And we did see some seasonality there, but again, you know, continued strong growth is what we saw.
Great. So in December, there was a label update for SYFOVRE to include a warning and precaution around retinal vasculitis, with or without retinal vascular occlusion. Curious what the feedback has been like from the patient and physician community and, what you've been hearing from that community broadly?
Well, I think the good news is that we didn't hear almost anything. When you went through what we went through, we had two goals, right? One was to make sure there was no disinformation and misunderstanding around the drug, but the other goal was to be, you know, as credible as possible as a team and to work with physicians because we figured if we won the trust of physicians, that everything else would follow. And so we were super transparent with physicians, and I think none of this was a surprise for them. Patients, I don't think, really know what goes on in the label for the most part.
I actually think the label update for investors was a bigger kind of overhang and what's that really gonna look like than it was for anybody else, because physicians knew what was going on. I think what also helped was, you know, this vasculitis is not something unique to this drug, and it's also extremely rare with this drug, but it also it happens with anti-VEGF. So Vabysmo, three weeks before we got our label update, got very similar language in their label, and now Eylea has that in their label. So, you know, I want to say, given the focus on this, it was more or less a non-event.
And then, on that rate of 0.01, how do you think the community is viewing that? And I guess the general perception of that and the calculus of how both physicians and patients approach that kind of varies based on the patient's kind of risk appetite.
Yeah, look, it's gonna vary by doctor, right? But for the most part, this falls well within what they talk about with their patients typically. So an endophthalmitis risk is one in every 3,000-5,000 injections, right? That's a risk that's consistent, whether it's your first injection or beyond. This is, you know, a 1 in 10,000, maybe 1 in 5,000-10,000 on your first injection only, right? So for the most part, physicians look at this, and they say, "Okay, this is, I accept this risk. This is part of what we do." And they explain that to the patient.
Where I think the perception around this got so big and out of control was the fairly recent history with Beovu, where it started out as 1 in 10,000, but then on examination and over time, it became 1 in 1,000, and then it became 1 in 100, and then it became 1 in 50 when they went back and looked at the HAWK and HARRIER studies. Having that uncertainty as this is gonna get worse is what really threw this into kind of what it became. Definitively now, given what we've seen and the body of evidence we have, not just in the clinic, okay, where we had over 24,000 injections, you didn't see this happen over time, right? It wasn't like an immune-developing event.
You only saw this in first injections, and you saw it on a commercial basis, and extremely rarely. I think most physicians who think about this and who've kind of gotten enough exposure think this is a non-issue. That's what we really. Not a non-issue, but it's an issue they can explain to their patient. If it happens, obviously, it's not a non-issue, but it's well within the bounds of what they're used to.
And when do you think the ASRS Committee will communicate around their findings around the Vasculitis Cases? And what do you anticipate the kind of nature of that communication to be?
Well, coincidentally, I know one of them, which is that they just published a paper last week. And that paper had 14 cases, which aligns perfectly with our case count. It was 13 patients with 14 cases, and it's the same cases we have, right? So there's nothing different there. And I think that's. What that gets to is, you know, the mission of the ASRS is to help physicians understand the risk-benefit of drug, and that's actually our responsibility also. It's part of our responsibilities, and we have, in that regard, a very common goal. I think the overriding message is sort of three parts. One is, this is extremely rare. It's 0.01%. It's also something where the ASRS's case count is the same, basically, as ours.
They do spend a little bit of time in their paper explaining that there's gray area and that this is a not a science, and so that could explain any differences we've had in the past. So they say that. And then the best, sort of the third and sort of most important piece is that we're working closely with them, and we do have a shared goal, so it's. Yeah.
Any kind of updates in the near term, more, additionally from the committee?
Yeah, there's one retinal conference in February where they are going to do a presentation, but I don't think there should be any expectation of anything different than what they published this past week.
Got it. Got it.
Great. Maybe just talking about competitive dynamics here, Astellas has their Izervay that was approved. When you look at the data that was presented at AAO, we saw their 24-month GATHER data, which in our view, looked less favorable from versus SYFOVRE. Just walk us through how KOL sentiment has changed following that data and how you think about or how doctors are thinking about the safety and efficacy differences between these drugs.
Sure. So, the data were confusing to some extent, right? You had a monthly at 12 months, you had a 17% slowing, and it's just a monthly trial at that point, right? And then they bifurcated the study to monthly in the second 12 months for half of the population and every other month for the other half. And, you know, I think the data were they were confusing to a lot of the physicians. And, you know, these physicians, these retinal specialists have about 20 things they're focused on at AAO. And so, you know, coming out of AAO, I think it was there was a digestion period.
But the feedback we're getting is that efficacy, we have an efficacy advantage, and at least in the doctors' feedback that we've gotten, and we believe this is an efficacy-driven marketplace. The other thing is, from a safety perspective, you know, the events that we've had that were, you know, the vasculitis events were super rare, and you really have to have a pretty big, installed base or number of patients on drug to see any kind of frequency of that type of event, super infrequent with us. And so from a safety perspective, I think those that really understand data understand that that's that you're really comparing an apple and orange when you look at the size of the data set. So, ultimately, as I said, I think it's a, it's a, it's an efficacy-driven market, and I think that favors SYFOVRE.
How do you think ultimately the market will be split between the two drugs?
Great question. And nobody knows. But right now, you know, we are the market leader. We estimate we have actually, we, based on the data we have, we have 96% of the market, approximately. And for every new sort of 10 patients, we get somewhere between 8- 8.5 of those. And that, you know, that's a dynamic that's, you know, could shift over time, but that's what it looks like right now. And subject to new information, you know, our job really is to get as many docs to understand, you know, the benefits of our data set, our two large, well-controlled studies, our increased effects over time, our dosing flexibility, you know, and the advantages of that, what we believe to be an efficacy advantage.
Okay.
Thanks.
When with regard to cash runway here, you have cash runway until at least second quarter of 2025, supported by your cost savings of up to $300 million through 2024 as a result of your recent restructuring. Can you walk us through these efforts and what's embedded in the guidance? And if the SYFOVRE relaunch continues to strengthen, is there flexibility here to spend?
Sure. The guidance we gave, that was for our Q3 earnings, and that was the end of October. And coming out of what we were coming out of, we had to be super conservative in terms of our revenue projections. Now, I think we were very fair on our cost assumptions. And so, you know, there is a reasonable world where that gets extended just based on, you know, improvement in assumptions on top line. Also, part of that cash runway guidance is we have an SFJ obligation, which was the company that helped us fund our PNH studies, and we're paying that obligation back.
When we gave that guidance, there were roughly in that time frame that we gave to, you know, the cash runway of at least into the second quarter of 2025. Included in that was $190-ish million of payments to SFJ. So in terms of, you know, ways to kind of change the runway based on, again, those conservative assumptions, would be perhaps refinancing the SFJ debt, or we also have other levers we can pull that are, you know, internal, such as we have something called a cap call that we can unwind, that can give us some capital, approximately $100 million of today's share price, that sort of thing. So we have levers and things we can do.
So any kind of, the idea of any capital raise, I think, at this point would be something that would be opportunistic, not something where we felt we had to do it right now. And those are kind of. I mean, that's, that's sort of the story on the cash runway, in terms of our levers and what we can do.
Can you walk us through your pipeline and the key catalysts for 2024 and where most of your excitement is around, or which program you have the most excitement in?
Sure. The thing we're most excited about is our VALIANT study, which should read out sometime in the middle of this year. That's a study in C3G and IC-MPGN, where we think we'll have a differentiated product for patients. This is for EMPAVELI, obviously. That study, you know, one of the reasons we're really excited about that study is we recently disclosed data on our smaller NOBLE study that was in post-transplantation setting for patients with recurrent C3G and IC-MPGN post-transplantation. And we had great results in that study. I think we, yeah, we showed some scans of biopsies in our earnings, and the data that we showed really was unprecedented, where we had clearing of C3G deposits in these biopsies.
It's something that the physicians, when we presented at ASN, had never seen before. So there's a lot of excitement around this disease. The other thing to note about C3G and IC-MPGN is that the population is roughly 5,000 on a combined basis in the U.S. alone. And you know, right now, we would say that We estimate that the treated population for PNH, for example, is roughly 1,500, and so this is, you know, a materially larger potential population and one where we think we'll have a differentiated product. So we're really excited about that, and we'll see what those results look like sometime in the middle of the year. Sorry, and I should mention we're also really excited about some of our earlier work that we're progressing.
We have our collaboration with Beam, as we mentioned, and also, you know, at some point we'll be releasing results on our C3 siRNA.
Great. Let me turn it over to you, Elizabeth.
Yeah. So, in moving back to GA for a second, so systemic drugs in GA have kind of faced some challenges in showing efficacy, and certain competitors are moving forward with these approaches. Could you just touch on why Apellis kind of feels so strongly about intravitreal injection and how you view these systemic competitor programs?
So yes, I would say that anything in complement, if it's not covering all of the downstream effects of complement alone, just in and of itself, is something that we are not as interested in. Systemic Soliris was tried, but it wasn't a very well, you know, it wasn't a very big study, so I'm not sure how much you can glean from it. But intravitreal administration of drugs for GA is kind of or for anti-VEGFs, for macular degeneration is sort of the standard. It's the standard is how you get the most drug to where it needs to go.
It was also the reason we developed it, in part, was it's an immune-privileged area, and when we had a systemic program with EMPAVELI that, you know, we, we didn't know the safety profile when we first started that, and so we had kind of a risk mitigation approach. So that's one of the reasons we went into intravitreal. I don't know that we ever necessarily personally pivoted. Could it work? I mean, you know, it's interesting to do something systemic, and we'd love to see what those results show. But that's, you know, I don't think we have a strong opinion other than it can be really hard to get an effect in the eye from a systemic administration of a drug. I know, I know that's our internal belief.
Got it. And for your siRNA modality that you're also evaluating in GA, could you speak about how you intend to evaluate that and kind of ultimately where it would fit in the treatment landscape with SYFOVRE?
Yeah. So we haven't announced what we're going to do with that C3 targeting siRNA other than to say that it does have the potential to extend EMPAVELI, right, to a potentially as long as a once every two weeks dosing, maybe more, we don't know for systemic administration. So that's been our, you know, all we've really disclosed of, in terms of what we plan to do with the C3 targeting siRNA. Again, that's something that we're, you know, going to talk more about in the future.
Got it. Got it. Also on EMPAVELI, we've seen the approval of Fabhalta is to come.
Yeah.
It, yeah.
Yeah.
In the U.S., this past December, I guess, where do you see EMPAVELI now that there's this new agent? Kind of, do you think there'll be any impact to EMPAVELI's opportunity, and where you see kind of the commercial niche for EMPAVELI in PNH?
Yes, EMPAVELI in the current PNH patients that are treated with EMPAVELI, you know, our base case is that they're gonna be happy on EMPAVELI. So they're taking, you know, a twice weekly subcutaneous injection. Most of them are now on this injector. It's a painless experience. It's very easy to manage, and they're doing well on the drug, right? We have 97% compliance, so it's hard to imagine a mass exodus from that. But, you know, again, there's probably gonna be some patients who try out an oral. But it will probably be disruptive and maybe even helpful to us over the long haul in other patients, because, you know, new patients probably will be may wanna try an oral.
You know, the conversation around extravascular hemolysis and, you know, the upstream control of complement will probably be more common as a topic. I think Novartis will help with that. And that could play into our hands in terms of some patients who wanna have better control without having to worry about taking a pill twice a day. This isn't a disease where you can, you know, skip a pill or two, and everything's just fine. If you lose your complement control in PNH, you're very likely to have a hemolytic event, and these breakthrough hemolysis are awful.
And so, you know, that's one place where we think we have, we have an advantage, is that idea that if you take EMPAVELI and you get on a plane and you forget your EMPAVELI, you have three or four days, maybe another one, to get your drug, whereas if you have a pill that has a short half-life, you could be in pretty deep trouble. And that's a lot. That's a burden for a patient with an acute disease.
Got it.
Then maybe one last question here. As you look out to 2024 and beyond, you know, what do you see as kind of the key value drivers or events that you have to really execute on? Or is there anything that, you know, we haven't discussed today that you wanna highlight?
Well, I think we have to keep doing what we're doing and execute on the commercial launch of SYFOVRE. You know, obviously, we're gonna do everything we can do in Europe to try to get the drug approved for patients and physicians. But as you go beyond 2024, I think a lot of what that's gonna look like is gonna come out over the next year, potentially in our discussions around some of our earlier programs. But right now, right now, we're laser focused on the commercialization of SYFOVRE, EMPAVELI, and then progressing our earlier stage programs.
Great. Well, with that, thank you so much, Tim. Really appreciate the time today.
Thank you, Salveen. Appreciate it. Thank you, Liz.