Apellis Pharmaceuticals, Inc. (APLS) Earnings Call Transcript & Summary

Thanks, everyone, for joining us Day 3 of the Goldman Sachs Global Healthcare Conference. And obviously, we're thrilled to be joined by the team from Apellis Pharmaceuticals. I mean, not a lot going on, so it's kind of show time for you all. I think I'll start with the first question, what's with the hat?

Yes, I'm a big Boston Red Sox fan now...

Boston Soccer fan. That's awesome. Thank you.

Amazing. Excellent. All right. So let's start at a very high level, then we'll kind of dive right into it. Walk us through how the launch of SYFOVRE, you're recently approved drug in geographic atrophy is progressing?

Thank you so much, [ Medwin ], and thank you, everyone, for joining. So the launch, obviously, is the combination of many years of work that we prepared very carefully for. Adam Townsend joined us approximately 4 years ago to prepare for this launch. Typically, launching in a specialty for a company our size is something that would be some would call fool's errand, but the retina is a very special place. And there's this very interesting combination of factors that played into this launch, one, of course, being the tremendous unmet need of people losing vision and going blind. Then that combines with a physician corps that is very used to doing these intravitreal injections that also know how to get reimbursed for that, et cetera, as a whole model is there. And that is, quite frankly, these synergistic forces are what we see at work right now, and we couldn't be more thrilled with what we have seen so far.

Great. So kind of following from that, what do you think kind of drove the strong 1Q revenue for SYFOVRE and more practically, I think what the real debate that's out there is, how do you all think that translates into 2 key revenues?

Yes, sure. So it was -- obviously, it was a very nice start to the launch. A couple of things, Robert. First of all, I think there was a lot of work done by the Apellis team, both the med affairs team and to a degree the sales force could interact with the retinal community before. I think there was a great deal of work done there. And that showed up in the unaided awareness. So we had 98% unaided awareness. And that compares to, let's say, VABYSMO, which when it launched, had roughly 2/3, so 66%-ish. So there was a ton of awareness, a ton of presentations at conferences and so forth. So that really helped. And then also, there was some stocking, right? So it wasn't all just straight through demand. There was some stocking in the channel. So -- wasn't a lot, but we talked about how much that was on our call. Typically, that results in, call it, somewhere between 2 and 3 weeks of demand in the channel. So that had to get stocked upfront. So -- but altogether, I think we were super pleased.

Great. So maybe thinking about that a little further, if you think about the 1Q number, now it translates to 2Q, a couple of different levers at play, right? So obviously, there's just a natural ramp in time between 1 month on the street versus 3 months in 2Q because as you mentioned, the stocking multiples, there's the kind of monthly versus every other month treatment. Like how do you balance all of those starting to think about what a 2Q number could look like relative to 1Q?

Yes. So when we think about it, obviously, it's -- we got to be very careful because that first quarter was technically like 4.5 weeks. We call it 5 weeks, but sort of 4.5 weeks. And so we try to look at things on a weekly basis on a pure demand basis. So we did give people the number of vials out to -- the commercial vials out as well as samples. So we -- we had the commercial vials out, that was around 6,000, just slightly over 6,000, and that was true paid commercial demand. And that's really the baseline off of which we sort of think about, what the next 13 weeks look like, and that's the second quarter. And I think building on kind of the earlier discussion and how we think about it, ultimately -- and I guess this gets to partly to your first question as well is, I think one of the things that people didn't fully appreciate was that sort of patient physician interaction. And what it's really like to say, "Hey, I have geographic atrophy," and for a doctor to say, "Hey, I have nothing for you or now I have something for you." And what does that mean in terms of a potential prescription and treatment paradigm. So all of those things kind of factor into how we think about the second quarter. We did say on our first quarter earnings, call that we saw demand continue into April, and we thought there might be a little bit of a let off after that first bolus, but that wasn't the case. And maybe with the idea that there might be a little more every other month dosing or whatever, but it didn't happen, and the demand continued into April.

Okay. Great. So maybe kind of following from that, another question we get a lot is about thinking of a newly approved drug with a temporary J-Code. Obviously, that comes up a lot when thinking about SYFOVRE. And I guess, now that you're pretty well into the launch, not just a couple of weeks, now you're a couple of months in, how would you guys think that temporary J-Code is effective at the early launch? And I guess more importantly, to look ahead to the fourth quarter, how do you think -- what benefit do you think you specifically see from a permanent J-Code come [ October first ]?

Yes, the permanent J-Code is important. We made a big deal about that before the launch for a good reason. And we thought that was going to be more of a broad impediment than it was, but it's more of a kind of a category-specific impediment we're seeing, and it's on a case-by-case basis. So particularly if you're a small retinal practice, it matters a lot, right? For them, they see the risk and effort to get reimbursed as a bigger hurdle. Other kind of really well-oiled machines that larger shops that know how to deal with this, that's -- it's been a little bit less of an issue, but also academia, it's an issue, right? So on a segmented basis, it does represent significant friction. So when you think about the fourth quarter, it really just removes that [ governer ], right? I mean it's -- we have a hard time kind of projecting exactly how that will turn out, but we know that, that does reduce barriers for a reasonable amount of the population.

Okay. Great. So kind of at a high level, following from that, what has been patient and physician feedback on SYFOVRE and its use. And I guess to this point, you mentioned about kind of the hierarchy of users or kind of a raise of users, how do you think it's defined in terms of top prescriber use of the drug versus kind of non-top prescriber use of the drug? I mean maybe I describe it as the people I can search for on Instagram by typing SYFOVRE, [ those ] consumers versus potentially other kind of a broader swath of prescribers for the drug?

Yes. No, it's just -- it's been kind of wonderful to see the -- how the pickup has happened, right? And in the initial phases of a launch of a drug of this magnitude, of course, the first thing you look at is what does the safety look like? And that's been one of the really great things to us. I mean, of course, that's all publicly available, right? I mean with those first injections, what we see is a favorable safety profile that's reflective of what we saw in the clinical trials. I think that's also something very important to a large swath of physicians. It's a new drug. It is very similar to an intravitreal injection with an anti-VEGF, but it is slightly more viscous. So it is not exactly the same thing. And we have heard from physicians that they would -- in patients with bilateral GA, right? They may start with the worst seeing eye instead of the better seeing eye to get the handle of it. But that has been -- has gone tremendously well in the first couple of months. And I think the overall sentiment in the physician population has been wonderful to see how it kind of gravitate towards, okay, we understand how to administer it, how to help slowly, how to get reimbursed by it. There's still a lot of that going on in the J-Code, but also the fact that some physicians are hesitant to make large orders. They make small orders, make sure they get reimbursed and then they start inviting more patients. But in confluence with that, you now have, of course, more and more patient demand, right? I mean it was already there, obviously, from the very beginning in March, it goes back to what Tim was saying, I mean, the unmet need and the fact that you lose vision over time is something that people talk about. These are older individuals. They communicate with each other. They hear about it. We know, of course, our DTC campaign as well with Henry Winkler who is trending very favorably in that regard. So right now, for us, it's kind of riding that wave where we make sure that all the pieces are there to address the demand that already exists and then slowly ramping it up in confidence with the tools that are available to us.

Okay. Great. So kind of maybe moving more to kind of the clinical data side of SYFOVRE. The question that comes up a lot is how to think about how important the full 24 months of data for SYFOVRE was both for its approval and kind of uptake among physicians and patients?

Very important. So the 24-month data is the point in time where the DERBY and OAKS trial become remarkably similar, almost identical, right? I mean you would never guess that 1 year that was different than the primary endpoint readout because in the second year, DERBY outperformed OAKS and essentially ended up more or less exactly at the same place for both dosing regimens. So of course, that was a major factor in the decision to file the major amendment. And the drug got approved fundamentally on 2 important premises from an efficacy perspective, the fact that we have increasing efficacy over time, right, when you go from month 18 to 24. We are talking easily starting to get north of 30% slowdown, both for monthly as well as every other month, and that was key. We know that from direct feedback to the approval of the drug. And then also the fact that we had the efficacy in the treated eye compared to the untreated fellow eye in patients that have bilateral geographic atrophy. So 24 months, very important. Key in all of that, of course, also the every other month dosing the fact that we got into the label. Dosing between 25 and 60 days provides such flexibility to physicians to match their calendars with their patients, all of these things in retrospect make having the full 24 months in the label, a really positive thing for us as a company.

Can I ask a really simplistic question about that. Why do you think that is? Why do -- why do you get an improved activity over time in DERBY and OAKS?

So, look, everything I'm going to say in that regard is speculative, so we have to prove it.

That's what you're here for.

But the easiest explanation, I think, is that when you start treating a patient, definitely in our clinical trials. They all had the baseline lesion. And again, if you take the [ first five ] analogy, right, you have the dead zone and then outside of that, you have the living zone. But it's not like it goes from full death to full alive, right? There is an area around that zone, where cells are already negatively impacted, are already sick. They haven't perished yet, but they will be much harder to rescue. So on day 1, those cells on the periphery are going to see drug for the very first time. A year later, as the lesion has expanded, now you have cells that have already been exposed to a year of drug, that are arguably going to be less sick than those cells that were in that exact same spot a year earlier. So I think that's probably the most plausible explanation to explain what we see.

Okay. So maybe following from that, I guess the question that comes a little bit is kind of tied to the idea of is there anything you would expect to add to the FIFO relabel that isn't there now from GALE, both in terms of expansion of GA lesion growth decline or I think what people are kind of most focused on potential visual acuity or functional vision changes. Is there anything you're thinking on that front? Or there something that could be added from the ongoing trials to kind of provide additional evidence for activity?

Yes. So the label that we got is pretty much the perfect label for us, right. So we, of course, continue to think about what could improve that label, what could potentially be better. But in terms of getting out of the gates, making this drug available to as many patients as possible to as many physicians as possible is quite frankly couldn't have been better. So going back to the GALE data set, what's really going to be exciting there is to see whether these increasing effects that we saw, I mean, more or less 20% slowdown in year 1, 30% slowdown in year 2, what is it going to be in year 3, and we'll have the midway point of the third year presented at the ASRS conference in Seattle at the end of July. So really looking forward to that, and hopefully, we'll show that trend. But then also, to your point, to continue to better understand what the functional story really looks like, we said it many times and retina doctors know this. It's not that there is no functional improvement, its that measuring function in the retina is just very hard to do with a lot of noise. We have ways of looking through that. We presented that recently at ARVO. We also had data on microperimetry, now already several quarters ago at AAO and that work continues and will continue in GALE as well.

Okay. Great. So one last question on the U.S. SYFOVRE launch. How should we think about the drug's potential use in patients with macular atrophy? Maybe for some of us who are not -- like getting up to see what macular atrophy is? And is there a use case for SYFOVRE in that population?

Yes. So first of all, macular atrophy is a term that generally gets used for an OCT imaging of atrophy and generally refers to patients who have wet exudative disease and where in a patient where you keep the eye dry with an anti-VEGF, you will start seeing atrophy appear, which is by any account geographic atrophy, but it's measured with OCT. So for those patients, you can imagine if you have a patient who is on anti-VEGF, initially, the eye dries up, has tremendous benefit. Of course, eyes saving benefits to those patients. But then visual acuity will continue to decline over time as generally visual function would as well. And that loss of visual function over time seems to be related to the development of that atrophy. So there are many, many patients. We think somewhere in the neighborhood of 20% to 30% of patients who are on treatment with anti-VEGF that will have macular atrophy that will be losing vision over time because of that atrophy and where physicians may be inclined to treat those patients with both drugs at the same time, that could theoretically be done the same day. It could also be done on an alternating schedule 1 month anti-VEGF, 1 month SYFOVRE. So we're going to learn much more about what -- whether there are differences there or not, et cetera, but it is included in the label, and there are physicians that are doing this.

Okay. Great. Maybe let's shift gears and think about the European review process for pegcetacoplan. So remind us what's the latest in terms of potential approval for PEG in Europe? And can you comment on any feedback on the functional data that you provided. You discussed before [ dealing with ] that functional data is something different from the U.S. filing?

Yes. So the European regulatory process has gone very well. And most of you know that it's quite different, how that regulatory process happens in Europe compared to the U.S., in the sense that you get 2 rapporteur countries within the European Union that are going to be responsible for the review and that should they give a recommendation at the end for approval that typically gets stepped in by all of the countries of the union. So those 2 rapporteurs are countries that we have been working with. But typically, the -- I'd say, the experience or the knowledge base within those rapporteur countries can be limited, obviously, because they have to handle up. So they rely very heavily on key opinion leaders in Europe. And this is something we're, of course, seeing the kind of the harmonization between the European KOLs and the U.S.-based KOLs and their joint view on what SYFOVRE does in the retina is very important. We organize every year something called the GA Days. Last year, that was in Barcelona. This year in Rome, where we specifically bring those European KOLs together to talk about the drug and that is always an overwhelmingly [ positive ], has been done twice -- has twice been an overwhelmingly positive experience. So we expect that regulatory process in Europe will be smooth to the point of function, it has always been more of a point in the European Union to say, okay, what is the role of -- or how is lesion size reduction related to visual function, right -- which is a natural question. How does that differ with the U.S.? In the U.S., there was a whole workshop that was done with the NIH and the FDA in collaboration where they decided in the end, look, if photoreceptor cells die, they will stop seeing. So because function is so hard to measure, we will assume that function follows the lesion. That's the premise and it was underbuilt by a 3-year very deep investigation with NIH. In Europe, they're like, "We don't understand this very well, explain to us how these 2 are correlated." And we have a lot of data to do that, which is, of course, part of our filing, which we believe will lead to a successful approval.

And I guess, two follow-up questions. The first one is -- is there anything from the FDA review that could be brought to the European review that's important for that consideration? And...

Yes. So look, I think needless to say, I mean, when you have an FDA approval, that is also an important signal to the European regulators, and they talk to each other. It's not like they live inside those, right? That includes inspections, that includes all these things are I'd say much more collaborative than one would assume them to be. So of course, there is cross talk. Our filing in the U.S. as you'll probably know, did not involve the functional measurements as part of the approval process, in Europe it does, and that's the data that we've generated in our trials and have and continue to analyze.

I mean, I guess, more practically where precisely are you in the review process? How should we think about timing?

So we expect to be approved early next year. The next step for us is to talk about the CHMP recommendation.

Okay. Kind of following from that, in a scenario where you get positive recommendation and approval, how should we think about pricing of PEG in Europe versus the U.S.?

Sure. So pricing is not like a 1 number fits all in Europe. It's done on a country-by-country basis, and it depends on those particular analyses. The way to think about it is, at least for the anti-VEGF, it's somewhere between 40% and 70% of the U.S. price. So -- and I think it's important to recognize the market potential there as well. So when you think about the number of GA patients in the U.S., it's roughly 1 million, we talk about 1 million, 1.1 million or something in that order of magnitude. It's double that in Europe, right? So it is a meaningful opportunity and then sort of triangulating the value as well. For the anti-VEGF, it's roughly 45% of revenue. Whereas the U.S. would be 55%, okay? So 45% is Europe and rest of world, but mostly Europe. So it's a substantial opportunity. And again, it's on a case-by-case basis.

Okay. I guess kind of following that, you discussed earlier the idea of European retinal specialists. And I guess, how should we think about them relative to U.S. specialists in their kind of clinical practice? And we obviously all heard there's pretty significant demand among kind of U.S. retinal specialists for a drug for geographic atrophy. Is there that same kind of enthusiasm among some of the big European centers for a drug in the disease?

Yes. I think it's -- at the end of the day, the depreciation for the mechanism and the slowdown of the degenerative process, combined with the safety is shared across the world. What is, of course, different is how these physicians get reimbursed, right? So the buy-and-bill model that we have here in the States does not apply to Europe. So the financial incentives are quite different from a retina perspective. But other than that, on the substance, it's a very small world in the retina. There's not a lot of retina docs around. They all know each other. They talk to each other and they're very quick to pick up new things as well.

Fair enough. So maybe let's step back and think more broadly about the GA landscape. And I'm not going to again ask you to dangerously opine and speculate. On a very simple question, why is it so hard to attack the complement cascade in this disease. In the last year or so, there have been what like 5 drugs that have tried and just massive gap in efficacy. They all kind of do something, but nothing like -- what like a few players have seen in this space? What do you think is the challenge? And what -- how do you think that affects kind of the handful of remaining complement targeting drugs out there in development?

It's an enzymatic system that requires enzymatic control. I think that is the -- it's very important to understand that these are all serine proteases that interact with each other, where if you shut one down and it's not in a central hub, there's going to be bypass and there's going to be overrides. And we always -- I mean, the reason why pegcetacoplan is as efficient as it is at shutting down complement activation is because it sits not just that level of C3, but because our drug binds specifically to the pocket of C3b on that protein. And that means that it binds to C3, prevents C3 from releasing its binder and going on cell surfaces. But once it is bound in the form of C3b, covalent need to cell surface, and tries to assemble convertases and generate that antiemetic activity, that gets controlled by pegcetacoplan as well. So you have control of C3, then you have control of the C3 convertases and both of the C5 convertases. And we always give the analogy in the PNH space, right, of a river with a waterfall. And what we do is we build not one dam trying to stop all the water, but 4 sequential dams. And the reason why that's important is sometimes there's a big rainstorm upstream, right? And there's more complement activation that comes. If you have just one dam, it can be very hard to control. But if you have 4 sequential ones, if each of them is only 90% efficient, ultimately that makes all the difference. So that is what we believe is the magic behind pegcetacoplan, both as we have seen it in PNH as well as in geographic atrophy.

Okay. So kind of in that context, let's convert that kind of science idea into practicality, how big a moat do you think there is for the kind of most advanced drugs in geographic atrophy? Like is this kind of thing where there's going to be like 5 other complement drugs in the next 5 years? Or do you think like this could be it for a good long time?

I mean, to your point, it's a very complex cascade, a very complex target. For example, NGM had a wonderful program. But we were always skeptical, as you know, because the antibody had been evolved to bind specifically to C3 and not C3b, which was kind of the opposite of what we think you needed to do. So it's easy to say, we knew or what we know what's going on, I mean it's more about kind of learning from the failures and using them and looking forward. The beauty of pegcetacoplan is that you sit centrally in the cascade. That all 3 pathways of activation, classical alternatives and mannose-binding lectin are all controlled at that hub of C3. If you go upstream, you're going to take risks, right? If you go downstream, you're going to take risk. So it's hard to tell. But I think if you have a less than comprehensive approach on controlling the convertase activity in DI, you're going to take pharmacology risk.

Okay. Great. So -- now I'm going to step back and ask the question that probably 80% of the people here really want me to ask, which is we all have to live with the world of business development and acquisitions, particularly in GA, right? Obviously, there's been a recent transaction in the space. And so how are you all currently thinking about business development and M&A opportunities for SYFOVRE?

Our focus right now is on the launch, which, again, is going better than we had hoped even and we have a tendency of getting high expectation. So that's really our main focus. I mean we never comment on M&A. We are always open to business development opportunities, has to be the right one for us. But our philosophy has always been to build a company and a program for the long haul, and that is also the best way to generate value in whatever context that may be.

Okay. Great. So maybe let's shift gears from SYFOVRE. We do it -- we always do were just talk about SYFOVRE most of the time. But let's come back to EMPAVELI, [ has almost ] forget you guys have -- this happens to be a pretty good drug in PNH. Can you remind them the latest about EMPAVELI that kind of ramp-up in PNH.

And we get the question sometimes what is the CLX to be commercial now? I've been there a while. EMPAVELI is a wonderful, wonderful drug product. So that is reflected in 98% compliance. I mean there are very few drugs that can claim that type of compliance. And that's, of course, a reflection of how good patients do once they are on treatment with EMPAVELI. We also have now north of 1,100 patient years of dosing. We have yet to see a single case of a Meningococcal infection. I mean had we spoken about that 10 years ago, people would have laughed with it, right? I mean, everybody always thought that C3 was going to be less saved than C5. Well, the real world evidence, certainly does not point in that direction, right? So it's a drug that is in PNH doing really, really well. It's hard to commercialize in the U.S. because it's so spread out. And you have to think of a hematologist with everything that they see, this is something that is going to be 1 or 2 or 3 patients that they see once per year. So finding that point of entry is difficult. But what we see now is we have well north of 200 patients on dosing now with EMPAVELI in the U.S. Patients start talking to each other, sharing notes. And that is momentum that we hope will carry us forward in the months and years to come. We then also, of course, EMPAVELI have the additional indications. Most exciting one there is probably C3G. That one is going to be fully enrolled in the near future and give us a readout next year. Very exciting program for us based on what we have seen in our Phase II clinical trial in C3G and IC-MPGN, combined with what we are seeing on our compassionate use basis. This is a drug that should work very well in these patients. And then we have, of course, these 2 smaller trials that Sobi is running cold agglutinin disease and HSCT-TMA. Those are all opportunities that are at the registrational stage that will come around in the next couple of years. But EMPAVELI's also being explored in other indications, where we think there is great promise. We do that in a smaller fashion. An example, of course, is what we are doing right now, where we combine it with KEYTRUDA, that's going on in Roswell -- in Roswell Clinic in Buffalo. And we have other kind of ways for us to explore what can be done with C3 in the rare disease base.

Okay. So maybe with that in mind, obviously, top of mind in the PNH landscape is the competitive landscape. I think most of our focus for people is Iptacopan from Novartis. So how are you looking at kind of the forward dynamic for EMPAVELI assuming that the attack ends the world kind of hit the scene relatively quickly?

Yes. These oral products are fantastic. I mean they provide a great opportunity for patients to have a very convenient way of treatment. I think the devil is in the details. In the sense that taking a pill twice a day with -- as far as we know, very little flexibility in terms of missing that, right? I mean missing 1 dose for longer than 12 hours may cause issues. I mean, in a clinical trial context, that's easier to control than in the real world. And these are very serious diseases, right? So while it's exciting and where we fully expect this to become an important and very helpful and exciting product for patients, there is some context there to bear in mind where kind of the longevity of having a subcutaneous product where you can forget to take a dose for 1 or 2 or 3 or maybe 4 days without severe consequences is going to matter where we have a lot of experience as well that matters. And so I think what you will see pan out is kind of the patient's phenotype that will gravitate towards one versus the other. And then with subsequent indications. Of course, we need to be cognizant of the fact that there are these other opportunities that we'll have to compete with.

Okay. So beyond -- we've noticed obviously SYFOVRE, EMPAVELI. Beyond these approved products, are there any other pipeline assets that you think investors are underappreciating or things that are coming online that this time next year, you all will be really kind of keyed in on?

Yes. So we have an open clinical trial, still Phase I for siRNA where we lower the levels of C3 in circulation, where we hope to be able to then also reduce the dosing with EMPAVELI. So something that you can -- instead of having to administer it twice a week subcutaneous at home, we hope and believe we'll be able to be done once every 2 weeks, something that then makes the competition with the orals also much more interesting, right? So very excited about that siRNA program. We then also have ways to control both VEGF with an anti-VEGF component in the same molecule with anti-C3 control, something that we look forward to bringing forward in the context of next-generation anti-VEGF opportunity. And then kind of strategically very important to us, the ability, we believe, to control C3 in the vein. So the [indiscernible] 1030 that allows us to do that directly through an intrathecal injection, that's, of course, not very optimal, but for certain indications, is possible, and that's a program that you will hear much more about in the next year with the ultimate vision of having more convenient ways of controlling C3 in the brain, which we believe is going to be the next frontier for complement in many neurodegenerative conditions.

Okay. So maybe stepping back and thinking about balance sheet financial operations, can you remind us where the company's cash position is? And I guess, more practically, how to think about your financial path in the near to medium term?

Sure. Well, we've guided that we have cash into the first quarter of 2025, which sounds nice, and that was -- now we're in a position where we're not raising capital with the gun to our head, which seems like the last 6 years of our existence. So the way we think about cash right now is -- there are two things that allow us to have -- to understand our cash, one is our revenue ramp and the other one is our cost structure, obviously. And right now, we're in a stage where we're kind of still figuring out what our revenue ramp is going to look like. Obviously, we had a great first quarter. We'll see how the second quarter goes. And we're bringing in some expenses as well. I mean we are -- things like our DTC campaign was something we thought we were going to do next year. And we brought it in this year because of the excitement around this launch. So we're still figuring out exactly what the right way to optimize that sort of -- our balance sheet and our capital structure is. But we're coming at it from a very sort of thoughtful perspective and not feeling like we're under the gun to do something. But realistically, I think our -- we feel pretty good about where we are, and we're looking forward to how the next couple of months unfold and we'll figure it out and do the best thing for shareholders.

Okay. Let me kind of -- I'll ask you a little bit on that front on kind of operating costs in out years. As you think about GALE in the next like 3 to so years winding down, how should we think about kind of like the R&D spend on the forward? Is it really going to be governed by, particularly, I think, the VEGF-C3 program, the neuroscience program. Where are we looking at kind of like where cost on that front could be?

Yes. So -- we obviously have ramped down some of it related to the ALS Phase II/III program. And then we have GALE ongoing, but we do seem to be adding a little bit here and there to that only because this is a disease that nobody really understands in years 3 through 5, right? It's something -- and we don't understand -- or should say we don't understand, but we want to understand as much as we can about how our drug performs in that time period. So that started out with a certain scope, and that's crept a little bit. So we expect that to sort of be more or less the same, maybe a tiny bit more expensive over that period of time, but also really making up for that the ALS cost is going to be the new programs coming in from preclinical. So we don't guide on expenses, but I don't see like a seismic shift in our cost structure on the R&D side.

Okay. Great. So finally, the question we ask every company at the conference, especially relevant for you all because of the dividends and why, which means the stock can be moving up, is what is the reason to own Apellis stock in the next 12 months?

No. I mean I think we -- it's a very interesting moment in the history of this company, of course. The SYFOVRE launch is going the way we had hoped it was better than that. And in the next 6 to 12 months, that will be the main focus. But what we are building on right now is what will come after that as well. So the next few months are going to be very exciting from whichever angle you look at it. And, it's a company that is ready for anything that comes next.

Cool. Well, thanks so much for joining us. It's great to have you here, and thanks everyone for joining us today at the Goldman Sachs Global Healthcare Conference.

Thank you, [ Medwin ].

Thanks.