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

Good afternoon, everyone. Thank you for joining the 21st Annual Needham Healthcare Conference. My name is Joey Stringer, and I'm one of the biotech analysts at Needham & Company. It's my pleasure to introduce our next presenting company, Apellis Pharmaceuticals. Joining us today from Apellis is Co-Founder, President and CEO, Cedric Francois. For those of you joining on the webcast, if you want to ask a question, please do so at any time. You can submit a question using the chat box at the bottom of your screen. With that, we'll go ahead and get started. I'll turn it over to Cedric for some opening remarks, and then we'll go ahead and start the chat.

Well, thank you, Joey, for inviting us, and it's a pleasure to be at this meeting. Still virtually. Soon, we'll do all of this in-person again, I hope. But a few words about Apellis for those of you are less familiar with our company. We are a company focused on the complement pathways and more specifically on complement factor C3. This factor sits centrally within the complement cascade. And by controlling C3, you can control, we believe, all of the downstream effects of complements regardless of what the source of activation is. The way in which we have built Apellis since our IPO in November of 2017 was to go really broad across therapeutic areas and all the way from preclinical to commercial. And where that got us today is last year in May, we had our first approval for EMPAVELI the drug for paroxysmal nocturnal hemoglobinuria, where in the Phase III PEGASUS study, we showed superiority of 3.8 grams per deciliter of hemoglobin on a baseline of approximately 8, in those patients with PNH above standard of care. And that is a product that is now in full launch. We've been very happy with the numbers that we have seen since that launch in past May. That drug also got approved in Europe in December and is about to now go into commercialization in several countries there via our partner, Sobi. The same products, EMPAVELI is also in registrational developments in 4 additional clinical programs, one on C3 glomerulopathy and immune complex membranoproliferative glomerulonephritis, 2 very important kidney indications, which we consider kind of really the next stalwart for this, what we believe is a product in a drug. That clinical trial is right now screening patients, and we look forward to hopefully enrolling that as quickly as possible and getting the readouts in the next couple of years. A second program for that same drug EMPAVELI is done in cold agglutinin disease as well as in hematopoietic stem cell associated thrombotic microangiopathy. These 2 programs are run by our partner, Sobi, and also in the process of being started right now. And then last but not least, ALS, where we have just -- and this is actually especially for you, Joey, we just completed the enrollment in the ALS trial. The enrollment there picked up really nicely towards the end of the study. And so towards the middle of next year, we will have the data from that clinical trial as well. So that's as far as EMPAVELI is concerned. These days, most of the questions we get, of course, is to the second cornerstone to the company which is our program in geographic atrophy. Geographic atrophy is the advanced dry form of age-related macular degeneration. There are no therapies available for geographic atrophy and it has had a very difficult path of clinical development in the past. In September, we announced the top line from our 2 Phase III clinical trials in DERBY and OAKS. In OAKS, we met with high statistical significance, the primary endpoints, both for the monthly dose of administration as well as every other month administration. And this administration in these patients with GA is done like an anti-VEGF via intravitreal injection. In DERBY, however, we narrowly missed the primary endpoint. And as we, in September, kind of reviewed what would be the cause of that and what we could do from a regulatory perspective, I'd say 3 important elements were important for us. The first one was to look at our Phase II clinical trial, the so-called FILLY trial, which was run with the quality and with all the aspects needed for it to hold registrational value and we got positive feedback from the FDA for them to indeed view this as a registrational study in the beginning of November -- in this past November. The second piece for us was to then go to the FDA and kind of with the crowning piece on a lot of back and forth, our pre-NDA meeting at the end of January to establish with them that we would include not just the 12-month data, but also the data all the way up to 18 months, both for efficacy as well as for safety. And the reason why we did that and why we offered it is because geographic atrophy is not a disease of 1 or 2 years, it's a disease that affects people for many years, often for decades. So very important for us as well. Those data were released a couple of weeks ago. And -- we're again very positive, specifically in DERBY, now at 18 months, when we rerun the analysis that was done at 12, it is indeed with a p-value below 0.05. We also see kind of the continuous compounding effects that we see over time. We see a positive effect with the slope of the progression and the safety was also maintained and very similar at 18 months compared to what we saw at 12. So now we are in the process of preparing for the NDA that will be submitted in this quarter. And we believe -- we're hopeful that we will get priority review, which could lead to an approval as early as before the end of this year. And should all of that happen would be the first approval and there's 3 of this disease. So of course, very important and very exciting for us and hopefully be able to contribute in that way. And then last but not least, we also have 4 important preclinical programs ongoing without diving into details there. In the second half of this year, we believe that we'll have an opportunity to, for the first time, control C3 in this cerebral spinal fluid initially with an intrathecal injection, but we believe that in neurodegeneration, there's an important future ahead of us. We then also have an siRNA program that will go into an IND within the next 9 to 12 months. That is a program where we lower the levels of C3 so that what we currently do with EMPAVELI with twice a week subcutaneous infusions, we may be able to do with as few as a once-a-month subcutaneous infusion. We then also have an oral product where we -- with an alternative pathway inhibitor where we believe we can compete with LNP023, which is currently in development by Novartis and where we believe we can give this drug once per day. And last but not least, then what we call the [ Renyfitins ], which combines anti-VEGF with anti-C3 for the treatment of wet AMD. To bring it all together, then we have, of course, our partnership also with Beam, where through gene-editing, we have the first important collaboration to see what we can do within the complement pathways. And I would say, in the second half of this year, we're going to start to hear more about that as well.

Great. Well, thank you so much, Cedric, for that great overview. Before we dive into the programs and sort of leading off with geographic atrophy. Just wanted to get your high-level thoughts on sort of the current state of the complement drug development. We've been -- the 3 recent approvals, including EMPAVELI within the last year. And do you see this as a positive sign for the space in general and sort of highlight some of the innovation in the complement space?

Yes, absolutely. Thank you, Joey. And I love how you often talk about kind of the space of complement because I don't really believe that we've only started to scratch the surface. Of course, Alexion does a great service with Sobi. It was the first approval now approximately more than 15 years in the past already. But what it did is, I think for the first-time kind of opened up rare diseases, specifically PNH and now others as well for the treatment and developments of novel approaches within complements. I think we had an opportunity to ourselves provide a contribution with EMPAVELI to show that C5 is very different from C3, right? I mean, in the context of PNH, it looks very different in terms of outcomes. And that allows us to really start understanding what are the best clinical outcomes that we can achieve by not necessarily looking at complement as kind of a black box, but a pathway where we really can look for differentiation on many levels as well. I think one of the really important elements of a potential approval in geographic atrophy would be that it opens up for the first time a specialty to complement, right? So should it materialize, and we, of course, certainly hope and believe that it will, will hopefully be the first of many approvals and specialties for complement therapeutics as well.

Great. Now turning to -- I think you said a complement in geographic atrophy here. A lot of questions. Certainly, a lot of focus on this program, but -- so we'll start with this one. Can you review -- you have the NDA submission plan for this quarter. Can you just review what specifically you plan on including in the NDA submission? And can you comment generally again on what type of label you'd be seeking in GA?

Yes. So the NDA will really have 4 cornerstones. The first one is going to be the safety, which I think positively surprised many people, including ourselves to some extent. I mean it was a -- it's a product that looks that from an intravitreal injection perspective has the same kind of side effect profile as anti-VEGF injections, where we have a very small increased level of exudations in the eye, but that we believe is -- and that physicians know is controllable with anti-VEGF injections. That is cornerstone number one, of course. Cornerstone number two is then going to be the biological activity of the product. And that is premised on having 2 positive registrational studies between FILLY and OAKS, with DERBY, of course, being directionally supportive as well. And then what we believe to be the very important fellow eye analysis in patients with bilateral GA when you treat 1 of the 2 eyes, you see that eye slow down in terms of degeneration compared to the untreated fellow eye, another important part of the biological activity chapter. The third one is then what is the effect size at 1 year, right? And there, between the 3 studies that we have, we see effect sizes ranging from 12% to 29%. So what is really kind of the factor there? And one of the things that we learned from DERBY, and I forgot to mention that earlier, but kind of the point behind DERBY, not meeting the primary endpoint at 1 year, we are convinced was caused by the fact that in the monthly dosed patients in DERBY, we had very fast-progressing patients. And those fast progressing patients were impossible to predict because there are too many factors that can drive the rate of degeneration in these patients. So it was kind of a relatively extreme scenario that we could not control for. But that, as we've talked about, over time, you see correct, right? I mean now at 18 months, better than at 12, and we'll see what it will be at 24 months, but we expected there to be better again as well. So a very clear story there. But at the end of the day, you have raised because of that variability between 12% and 29%. And what we do is a covariant analysis. What does that mean? Well, if we see imbalances, whether they favor you or not, right, that is, it doesn't matter. You can adjust for those in modeling. And by doing that, you see a clear effect as, that is, on average, north of 20% at 1 year. And then the fourth cornerstone the very important one goes back to the 18-month analysis, which is what happens, what can you predict after 1-year or 18 months of treatment to know what in the long run will happen to these patients, if they are on dosing with pegcetacoplan. And there, again, the data looking very promising. We believe that we see compounding effects. And out of all of that emerges a profile that gives us maximum flexibility, I think, from 2 angles. On one hand, within our population, we enrolled patients that have both extrafoveal as well as subfoveal lesions. What does that mean? Subfoveal lesions are lesions that affect the central portion of the retina, and are typically the patients that are the furthest advanced that have had the disease for many years. Extrafoveal patients are patients that are typically newly diagnosed or in the early stages of the disease, where the periphery is only affected, not a central vision yet and these lesions tend to progress more quickly as well. So we've done kind of a sub-analysis on these that, that was prespecified at 12 months, and we see kind of a better product profile for those extrafoveal patients. That is very promising and exciting also in combination with the fact that not only for monthly, but for every other month dosing, we saw statistical significance in 2 of the 3 studies. So the product profile that I'm personally very excited about is you are in newly diagnosed patients, which patients with geographic atrophy, you will now make a decade or decades of investment in saving as much vision as you can, and you can do that with every other month injection where you get probably in the range of 80% to 90% of the benefit of what you would get with a monthly injection.

Got it. And this is a regulatory question, Cedric. But in terms of the NDA submission here, are you expecting priority review and potentially that a AdCom meeting? Any comments on that? Yes.

Yes. So we have high hopes, and I would say an expectation that we will get priority review that is premised on the history of reviews for retinal products, which if you go beyond life or death situations, life-saving interventions, I think rightfully received the attention it deserves from the FDA, and there's a lot of historical precedent for that. We will see if COVID has any impact on that or not, but that is at least our expectation. So we will see from a priority review of the AdCom. It is, of course, a potential first therapy for a brand-new indication with a new drug product. So I think it should be no surprise if we end up getting an AdCom. So far, we have not received any feedback in that regard from the FDA, however.

Okay. And you've already mentioned the 18-month data that you announced in March. You touched on sort of the results of that. But just curious, now that you had the 12-month data, the 18-month data here, what's been the feedback from clinicians? I know it's been a relatively short amount of time since you've announced that, but clinicians' KOL feedback on the 18-month results?

Yes. I mean, I'm very happy with that and very satisfying. So after the 18-month data coincidentally, there was the Vitreous and Buckle Society meeting in Vegas 2 weeks ago. Where kind of with the data fresh in hands, right? I mean, retina docs had an opportunity to talk about that and discuss it and overwhelmingly positive feedback. I think everybody understands, especially how these effects seem to compound over time, how at 18 months, DERBY flips to positive where it was in that 12 months. I think also importantly, one of the elements that we always talk about is the real estate in the retina, right? What does that mean? People may say, oh, this is an anatomical endpoint, what does that mean for function, et cetera? But this is not just any anatomical end point. What we measure is the area of retina that is a life and the area of retina that is dead and dying, right? So -- and that is inherently and directly connected to your vision. So that's it actually, I think, a very important point to make. Sometimes I hear analogy as well is this like amyloid beta et cetera? Absolutely not, right? This is dead or alive retina that we measure. So I wanted to make that point. But if you look, for example, in the OAKS trial, at 1 year, I believe it was, we had 0.41 square millimeters of retina that had been protected compared to the sham at 18 months, that was 0.66, right? So that's something else that we will continue to follow, but that is the real estate. And if you put that in the context, the central portion of our vision depends on only 2 square millimeters more or less of retina, right? That's how important these differences are. So after that, we had also coincidentally the so-called GA days in Europe, where we brought the European specialists together and some other ex U.S. specialists. Fantastic meeting. A very different mindset in Europe than in the U.S., of course, and there as well, we saw a lot of enthusiasm around what we have seen so far.

Great. And some more questions on that the 18-month data here Cedric. The 18-month data in GA, did that increase your confidence in potential approval? And I guess to go along with that, since that 18-month data is being included in the NDA, did that influence your decision whether or not to pursue a broad label versus a more restrictive label, for example, foveal versus nonfoveal types of GA patients?

Yes. Definitely, yes, to the former. Of course, more data is better and especially having 18-month data and having, again, kind of 50% more time to understand the long-term ramifications for patients because I don't think I can overemphasize how especially with the FDA, but also, I think with the EMEA kind of that wanting to understand what it means for many years of dosing for patients out of what is relatively speaking, a short clinical trial, right, is important. So absolutely helps tremendously. As it relates to foveal versus extrafoveal, it is a complex story. And let me just very briefly mention something about that. You really have 3 types of patients. You have patients that have pure extrafoveal lesions. Then you have patients who have extrafoveal lesions and subfoveal lesions, right? So where the whole retina is basically affected. And then you have patients that are subfoveal and that may not yet have the extrafoveal involvement, with a question then what do you consider really subfoveal in terms of area or not, right? So all 3 of these categories are different, may even have different -- slightly different mechanisms behind it. We don't really fully understand that. But the trials that we ran were powered and designed to study them as a whole. So that is how we will submit our package. We do not believe that kind of the differences that we see between extrafoveal and foveal, which are in the range of about 5% or so, should necessarily warrant a parsing out of a label. But we will see what the process is going to be, but we are absolutely filing with the intent of getting a label that crosses both phenotypes.

Yes. In terms of the -- some additional data as you sort of progress in the trial here, I believe you plan to present the 24-month data later this year. I think it's 3Q '22. But is your current thinking or at least sort of a base case scenario that we could expect similar effects to -- on vision growth on a relative basis in both of the DERBY and OAKS trial. So for example, the slopes of the lines to sham versus the treatment sort of stays the same. The absolute difference, of course, will be -- will grow. But is that sort of the expectation now that we've seen the 18-month data, progression from 12 to 18, and now the next data point will be to 24. Is that kind of the base case scenario?

Yes, that is absolutely correct, right? So I think that we should not expect to see from month 18 to 24, I don't expect we should see anything different in terms of safety, right? Of course, with more time it's happened, but there's no change in the rates. Similarly to the slope of the efficacy, it will be fascinating to see if there is kind of further compounding that happens, right? I mean, where on a relative basis -- on an absolute basis, of course, we fully intend to continue to see that separation. But where on the derivative value of that, maybe there's something else to find as well, we shall see. And then a question that we very often get is well, what about the functional endpoints? Well, the functional endpoints at 24 months on a statistical basis won't show us anything and that was never the expectation. We may be surprised, right, but it was never the expectation to show something statistical. So even if we see a trend, whether that will not really change how the approval process of the drug will be. So our intent is not to file a major amendment because we don't think it will help us. But instead to just when the data is available, send it over to the FDA and the other regulatory organizations.

Okay. Now, you could have a potential approval decision by the end of this year. So yes, I guess the -- my next question is around commercial prep and strategy in GA. How is the commercial build-out proceeding? And is it sort of a staged process here? And then, can you outline the strategy around -- the commercialization strategy in terms of what types of physicians you would be targeting or things like that?

Yes. So this is a special build, right? I mean in geographic atrophy, where you have a relatively small physician base that makes most of the prescriptions. To give you an example, if we look at the anti-VEGF injections in the United States, approximately 1,000 retina doctors prescribe probably 80% to 85% of all anti-VEGF injections. So between MedAffairs and the commercial team, if we take kind of the analogy of, again, companies that are commercializing anti-VEGF agents, you're looking at between 75 and 125 people across commercial as well as MedAffairs. I think one of the great things about the retina is that this is a very well educated and highly communicative group of specialists, which is why I also make a personal effort to go to all these conferences because these are -- these retina docs love to be educated, loved to learn. And I think, again, it's worth mentioning, they see half of the time the patient with geographic atrophy, either in its primary form or secondary too many years of anti-VEGF treatment and have nothing to offer to these patients. So hopefully, we will be able to change that in the near future.

And how should we think about pricing in GA? Are the approved drugs for wet AMD good comps to consider here?

Yes. So I think -- look, one thing is to think about modeling like we all do, right? I mean from that perspective; I sure think that is a good way to go about. Right now, we are focused on getting the first drug approved for geographic atrophy for these patients, really understanding the clinical benefit that we provide to these patients. And then we will have a discussion around pricing.

And in terms of the commercialization, Cedric, in GA, would you plan to commercialize this on your own globally? Or would you consider partnerships, for example, ex U.S.?

Right now, our plan is absolutely to commercialize this drug by ourselves. Again, we have the great precedent of the anti-VEGFs, where Regeneron, for example, decided to choose a different strategy. I mean, even Genentech/Roche, of course, with Novartis, Lucentis was commercial ex U.S. by Novartis, but we know what it takes to get access to these retina practices, and our intent and our build-out is designed to do both with a focus, of course, on the U.S. and European Union.

All right. Last question on GA, and then we'll move on to the other programs. So we have the time we have left. But this is more of a market question in GA, Cedric. Given that there are no approved drugs in geographic atrophy, do you think -- clearly, you're in the lead here with pegcetacoplan, but is this a winner-take-all market? Or is there room for other therapies in GA? And maybe give us a quick sense for what are the competitive programs in development out there?

Yes. I think that what we believe will be the first approval is going to many more and better options for patients, right? I mean right now, we see something that we believe is highly clinically meaningful with that slowdown north of 20% at 1 year, potentially amplifying from there in year 2 and beyond, but we want to be able to get there faster. We want to be able to have effect sizes that are larger. We want to be able to do it with modalities that may in the future not require monthly or every other month intravitreal injections. There's great room for improvement, right? But for now, we are celebrating the fact that it looks like we will have a first therapy available, right, at the end of 2022 or maybe the beginning of 2023, but for a disease that we have had nothing for before. So that is what we're focused on. In terms of competition, there are other companies with drugs in development. Iveric, of course, has the GATHER2 data coming out this summer. We will see what comes out of that study. There are several others that are further behind, and we'll see what they come up with. But my viewpoint is that we're all in this together. For me, this is a healthy competition to ultimately benefit the patients the most.

Yes. All right. EMPAVELI. So launch has progressed very well so far, and sales have exceeded, a lot of expectations the last couple of quarters. So what's been the key to the success so far for EMPAVELI?

I think 2 things. First of all, the trials that we have run and specifically the PEGASUS trial. So we made a deliberate decision at the time that we decided to take on what we believed was an important unmet need in PNH in the form of extravascular hemolysis and addressing that. We took a deliberate decision to not run a non-inferiority trial against the standard of care, but truly to go for superiority. And to kick it out of the park there, right? I mean, I don't know if you recall at the time, Joey, but we were talking about people had expectations or hopes for 1 gram per deciliter superiority. If we had 2, it would be amazing. And we had 3.8 grams per deciliter superiority, right, I mean that's to put that in context. It makes an enormous difference for patients. And when you speak with payers, I think the boldness that we took in that clinical trial is something that is appreciated as well. I think payers often have to deal with products where the differentiation from the standard of care can be hard to understand and assess. That's not the case here, right? So we have run several efficacy -- or, I should say, benefit analyses with -- sorry, did I lose you -- sorry, here you go -- health economic benefits analysis with these payers, and all of that comes back very positively. So that's aspect number one. Number two is that we have an amazing commercial team. I have to say for all of you who are listening if you're on the call here, thank you for your hard work. Adam has done an amazing job leading that effort. And it's great to watch how, again, with the payers and with the physicians, where in the U.S., the landscape for PNH is much more scattered than it is, for example, in Europe. They've done an amazing job in spite of kind of the COVID situation, which makes access to these clinics difficult. Remember, many of these are hema-oncology practices, Needless to say, in an era of COVID getting open doors for MedAffairs' teams or sales representatives has been quite challenging. But I think at the end of the day, the efficacy of the drug is showing in the real world what we had hoped it would do. I think also from a safety perspective, we are seeing very positive signs. It's worth mentioning that we have crossed now what we believe was kind of an important first barrier of 500 patient years of dosing. We have yet to see a single case of meningococcal infection. If you compare that to C5 inhibitors, for example, at least the ones that are on the market, typically, you would have expected to see probably in the range of approximately 2 by now. So we will continue to monitor that, but that matters. And this year, I think the task ahead for us is, especially again with the hema-oncology physicians to start making the step away from being viewed as a rescue product for patients that don't do well on C5 inhibitors to really appreciating that this is simply what we believe is a better product for PNH compared to C5 inhibitors.

Great. And I guess to that point, Cedric, what are the key growth drivers for EMPAVELI going forward? And sort of how do you see -- what levers do you have to pull to sort of increase uptake in, say, treatment-naive patients or -- and/or patients with sort of near normal or normal hemoglobin levels?

Yes. I think mainly the point that I made earlier, kind of getting that first-line mindset. I think with the hema-oncology clinics specifically, we have a lot of work to do to get access there. A lot of it comes down to education and also creating more of a sense of urgency, right? I think that -- remember, with Soliris or Ultomiris you have life-saving therapies for these patients, right? And the notion that these patients can be better is attractive, but kind of the urgency behind how attractive it is and how much better these patients get that requires education and needs -- the physicians need to understand that and that just takes to work on the road that we are currently doing. But on the flip side, from a patient perspective, we are seeing kind of all of the positive energy that comes with patients that go on dosing and then communicate their experience through social media with other patients. So that is definitely kind of a swell that we see grow gradually.

Yes. So the drug was approved in Europe in December of last year, I believe. Your partner, Sobi, will market there. Just wanted to get your thoughts on the expectations around -- the cadence of sort of country-specific reimbursement? And how long do you think this process will take? And I know you're not giving guidance on revenue, but do you -- what do you think the ex U.S. contribution would be in 2022?

Yes. So without providing numbers and kind of with strong belief and trust in our partner. I mean, Sobi is a wonderful company. That's why we chose them, especially with hematology products. We are launching first in Germany and got a positive opinion from NICE in the U.K. as well. So those are the first 2 countries that will be tackled. And again, as I touched upon earlier, what is really neat there is that, again, I think the payer feedback is very good. The physicians kind of really understand what the need is. It's easier to kind of reach the key opinion leaders that drive adoption there. And we'll see how it goes.

Great. We -- you have a lot of other programs in the pipeline. And certainly, we could spend a lot of time on those. But we'll try and condense it here in the last 5 minutes. You have 2 other Phase III trials ongoing, C3G and IC-MG (sic) [ IC-MPGN ] and also -- excuse me, you have the Valeant trial ongoing. So can you talk about the therapeutic rationale for pegcetacoplan in this indication first, Cedric?

Yes. So in C3 glomerulopathy and immune complex membranoproliferative glomerulonephritis, I had to practice a lot to say it, Joey, I don't feel bad. It's a complex disease. These are rare diseases of the kidney, which between each of these 2 phenotypes of what kind of is a common underpinning disease, represent approximately the same population as PNH. That's the easy way to think about it. There is no therapy approved for this rare disease. And one of the important differences between C3G and IC-MPGN is that C3G is believed to be exclusively driven by the alternative pathway whereas IC-MPGN has an immune complex, in other words, classical pathway of complement contribution to the pathology as well. But the manifestation of this disease in the kidneys is quite similar. So we had a very powerful Phase II clinical trial on which we presented the data now already 2 years ago, and spent the past 2 years kind of really finding harmonization so that we have a clinical trial that can make it across the finish line and where the focus is really on patients that are more advanced, are at risk of end-stage renal failure and then also patients who may have already been transplanted and are at risk of falling back again into the same disease. So a very important clinical trial for us for what we believe is the next big step for EMPAVELI and Aspaveli. ALS is then the other big trial. As I mentioned earlier, we just completed our enrollment. Very excited about that. It's a high-risk trial, of course, right? It's ALS, enormous challenge. It's worth mentioning that 2 C5 inhibition programs have failed in ALS. That was also the case with geographic atrophy, didn't stop us there either because it is a very different target. And it is a program that we really believe in. So hopefully, in the middle of next year, we'll be able to report something positive. But that's, of course, not one where we have the benefit of the Phase II data that we have, for example, in C3G. Cold agglutinin disease has sutimlimab on the market, the Sanofi drug. That is a classical pathway inhibitor, has to be given every 2 weeks intravenously as opposed to our drug, which would be twice a week subcutaneous, self-administered at home. And we'll see what the efficacy profile looks like. And then HSCT-TMA, that is something that is more of a niche opportunity, but where we believe to have a life-saving intervention that could make an enormous difference for patients even if financially may not be as attractive as the others, we thought it was important to do.

Great. And Cedric, we're up on time here. So we appreciate you fitting in those mid-stage programs. Certainly, we can spend more time on that, but we'll have to leave it at that for now. We thank you and the rest of the Apellis team for participating and joining us today. Thanks, everyone else on the webcast for joining us as well. Everyone, have a good day.

Thank you, Joey. Thank you for listening.