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

All right. I think we'll get started here with our next fireside discussion. Again, my name is Derek Archila. I'm one of the senior biotech analyst here at Wells. For our next fireside, we have Apellis. From the company, we have Tim Sullivan, the Chief Financial Officer; as well as David Acheson, the SVP of North American commercial. Gentlemen, thanks so much for joining us.

Thanks for having us.

Cool. So maybe just to start off, it would be good just to kind of get a state of the business in terms of like SYFOVRE relaunch and kind of commercial aspects there and also kind of the recent data for EMPAVELI and then we can kind of dig into each of those topics a little bit deeper after that.

Perfect. Yes. So by way of background, Apellis is a biopharmaceutical company located in Waltham, Massachusetts. We were founded essentially on the concept of targeting C3, which is a central component of complement. So it blocks all three activation pathways and all downstream pathways. And the premise of this really was that this was the ideal target to bring the best patients, the best effects for patients who are suffering from diseases of complement. And I think we've done a very good job of that. We now have two commercial products. The first one is SYFOVRE, as you mentioned, for geographic atrophy and the second one is EMPAVELI, which was first approved for PNH and we believe will be approved hopefully for another indication in the near future. We'll talk about that in a bit. And both of these drugs, we believe, are blockbuster potential. So the first one is SYFOVRE, which is a drug for geographic atrophy, that is the leading cause of blindness in people over 50. And it is a -- it's a disease that affects roughly 1.5 million people. And so we launched that drug approximately like since in February of 2023 and we've had one of the best launches of -- in recent history, and that has led to approximately 330,000 injections as of the second quarter and a cumulative revenue of around $570 million. So that's been a great launch for us. And turning to the kind of the second next in the U.S. So turning to the second piece of that, which is in Europe, we are in the middle of the CHMP reexamination process, and we expect to hear the results of that later in September. So we are on the docket for this month's CHMP meetings. So we'll know more then. And as we've said before, we think that's something that is an uphill battle. We do have reasons to believe that there is some potential there possibly because we did have some dissenting votes in our original CHMP opinion or I guess, our second first CHMP opinion. But again, we've reiterated that we think that's an uphill battle for us getting approved in Europe. And then turning to EMPAVELI, that drug was approved in May of 2021 for paroxysmal nocturnal hemoglobinuria, PNH, which is a relatively crowded rare disease, and that's been a reasonable launch for us. But really, what that has done is, I should say, what we've seen with EMPAVELI, in the recent -- and in terms of our recent experience is that what our premise in terms of why we chose C3 that it's the most important target and complement seems to have borne fruit. So we have some excellent data in C3G and IC-MPGN, which is a rare disease affecting the kidney. And this is around the epidemiology of this disease is around 5,000 patients in the U.S., we believe and roughly 8,000 ex U.S. And this is a disease that often has onset in the adolescent age group. And it has -- it's characterized by overactivation of complement and deposition of complement breakdown product in the kidney that causes inflammation and ultimately, and roughly 50% of patients leads to kidney failure within 10 years of diagnosis. And the only treatment available -- treatments available right now other than steroids are dialysis and kidney transplantation. So this is extremely severe disease. And then once patients have been transplanted, roughly 90% of those patients relapse and roughly half of those lose the kidney that they -- that were transplanted. So this is a pretty severe disease. And the data that we saw were super exciting. So we had a 68% reduction in proteinuria and very good results across key secondary end points, and we think these are the class-leading -- potentially class-leading results. So those results came from what was called VALIANT study, which is the largest study ever conducted in C3G and IC-MPGN. And the great thing about this study was that it included both C3G, IC-MPGN transplant, nontransplant as well as adolescent and adult. And when you look at the results, those results pretty much cut across evenly across all of these groups, meaning there was no subgroup that looked differently from another subgroup. And so we're really excited about those data, and we plan to file for approval in the first quarter of this coming year. So that's very exciting for us. So we think between SYFOVRE, which is on track to become a blockbuster drug in an exciting category in which we've just sort of scratched the surface of that market, right? It's just a category that just opened up 18 months ago with our approval. We also think we have a blockbuster potential product in EMPAVELI now with C3G and potentially other indications down the road. So between those two, we are really excited about our commercial story, but we also have a pretty interesting pipeline, which we'll talk about at some point in the near future. We may have an R&D Day early next year. We're not sure, but that's -- but we have very good interesting programs there. And then, I guess, probably the other thing to mention as the CFO is that we have line of sight to profitability and cash flow positivity based on the cash we already have. So we ended the second quarter with $360 million in cash. And based on everything we know today, we should be able to achieve that cash flow profitability at some point without having to access the capital markets.

Got it. Great. Well, that's kind of state of the union there [indiscernible] the business. But let's maybe kind of dig in first on SYFOVRE and kind of the commercial aspect. Obviously, kind of the quarter-over-quarter growth in 2Q was a little bit slower than what we had seen earlier in the launch. Maybe kind of just detail some of the factors that occurred there and then, I guess, maybe kind of the more outlook for the second half and whether those factors will abate or what you guys are doing to kind of address the slowdown?

Sure. No problem. Thank you, Derek, for the question, by the way. So look, we've been really happy with the launch. I think we should -- I'll be excited about what's happened in the space. And Tim touched on it. It's been one of the best launches in the biotech space in recent history. So we feel very good about that. But we've had some headwinds that we talked about a little bit even this morning. And with the J-code and some of the reimbursement and contracting work that Astellas has done, there were some things that we had to work through in the last quarter or so. You'll continue to see a little bit of that going into Q3. And I think one of the things that also needs to happen here is this is a very big marketplace, but it's a responsibility of both companies to help grow that market versus get caught up in the quagmire of a conversation that our competition has talked around specifically with safety, which has made it a little bit more difficult, right? We feel very confident and have completely switched our messaging over to efficacy now that we've gotten through ASRS, and we've got the [ risk ] committee behind us in regards to our data. The safety profile has been consistent. And we're very much focused on now growing the market and doing what we can to get patients to SYFOVRE. Specifically, some of the things that we're working on moving forward, I think we'll have -- or hopefully will have the impact is we're trying to grow the market through outreach to ODs or the optometrists, general ophthalmologists through a couple of different channels with some telesales and some contract teams that we've got in place to help pull that through that's getting started now. The reason for that is we estimate that about 50% of all the patients in the market actually sit with a retina specialist. The other 50% estimated sit in those other two office types, right? So we need to make sure that we're growing the market. Our responsibility as a company, it's a big responsibility as a market leader, is to help grow the market as well as make sure patients get to the best treatment. And then our efficacy story is a big part of that discussion as well to make sure those referrals have a discussion as a patient that can go talk to a retina specialist. The other thing that we're doing, and we've been working on throughout the summer is direct-to-consumer, marketing actually to the television as well as multiple other channels. And we're focused on disease state education there as well as branded education to help grow the market as well as educate patients that there is a treatment out there now, and they can go talk to the retina specialist or to their eye care physician. And at the end of the day, we're also looking at just generally how launch metrics and everything has worked. We've got some very good stories out there where we've got great penetration, and there are some spots where we're going to take a look at and we have taken a look at where we need to put some other additional efforts in potentially more headcount. Nothing -- it will be nominal in nature, but some things that will help us get more share of voice in some major marketplaces, say, California or New York, those type of things.

Beyond the retinal specialists, like is the messaging different for like the ODs and the others that you're looking for referrals? Like how are you positioning that SYFOVRE or maybe just kind of GA awareness.

Yes, it's a great question. So a lot of that is disease state education to begin with, and that's where we spend our time initially. And then we want to make sure though that, that transitions to -- there is an option in SYFOVRE, and here's what you can do to have access to that, if you refer to your typical retina specialist. So a lot of disease state education upfront translates into a discussion around the product.

And in terms of the competitor pushing the safety narrative and you guys kind of pushing the efficacy narrative. I guess when you talk to physicians that are either new or even know of SYFOVRE or the class in general, like what part of the data set resonates in those from an efficacy standpoint?

Yes, that's a good question. So for us, we're blessed with the product that has increased effects over time. Every time we have a data readout, we have more effects in the product than what we saw in the last 6 months or in the readouts that we did prior, up to 40% in non-SYFOVRE patients, which is the biggest number that we've seen so far. Our GALE study continues to run. We'll have additional data that comes out of that in the near future. And I think the other thing that's really important here is our product was studied from the very beginning with every month and every other month dosing with efficacy in both dosing regimens. And I think that sets us apart in multiple different situations, and that's why every other month dosing is used the way that it is with the high efficacy that also sits there as well.

Got it. I guess in terms of like adherence to therapy, but also just kind of net patient adds like obviously, the calculation, people drop off and adding patients. So I guess how do you kind of continue to see this evolve over time? And obviously, we only have the drug on the market for pretty short time. But like what's kind of that kind of duration of therapy looking like? And what do you think it will ultimately evolve to?

Yes. I think it's still a little bit early. I think one of the things to just take a look back on. So after Derby and Oaks, our patients that moved into the GALE study, after 12 months, 92% of them were still on product. And that was voluntary move, right? They didn't have to stay on the study. So that's super important to remember because I think they see the value of the potential opportunity to be treated with a product that will help them not go blind. So that's important to keep a note on. For us, it's a little bit early in the data, but I would think as a benchmark or an anchor, you can look at the anti-VEGF data and say that, that's a pretty good place to start. I think what's going to be interesting for us is the real-world evidence and data that will start to come out of some of the big groups that are doing work on that today that will lean into the discussion around efficacy that will help us tell that story to patients for them to understand that the benefit stays there long term, which we're very close to having, by the way. Some additional -- initial looks with that information because we're a year in plus and some of our big accounts are starting to look at that now.

Got it. And in terms of the user base right now, so I know there's been a lot of concentration in some of the private equity-owned practices, but I guess how do you expand out of that? And ultimately, again, is the messaging different for the academic medical centers, let's say, relative to maybe the more private practice?

Yes, sure. That's a great question. So we have a team that's based out there with multiple -- we actually have multiple teams out there, as you would expect, right? But the teams have access to and call on all of the academic centers and every retina specialists that we have in the country. Now the expansion, our strategy originally was to get into the very large influential accounts and penetrate private equity and all the very kind of sophisticated organizations that could help us pull side forward through and drive our messaging early in the launch. And as well as now what we're doing is expanding our efforts into accounts that maybe have waited a little bit longer to jump into the use of SYFOVRE and pull patients into treatment. Academic centers, we were very successful early to bring a number of them on, but there are a few that have held off, in particular, based off of last year and some of the things that happened last year with the safety signals that we had, some of them had slowed down, but we're in the process now of additionally educating them. That process and some of those situations does take a formulary of view and a committee review and some additional work. But we're in the process now of adding some of those accounts that have been a little bit later to adopt. And education in both of those, quite frankly, really is about disease state education, and it goes back to our efficacy messaging and our flexibility in dosing. So it's pretty much the same story. The setting might be a little bit different, but the message about the brand remains the same.

Got it. And also just how -- from a patient perspective, how is the journey in getting treated with SYFOVRE or getting diagnosed with GA, how has that kind of changed since the launch, I guess, again, where are we kind of like innings-wise, is the awareness very high? Or are we still just like inning number 3, like where are we in that perspective?

Yes. No, it's good. So I'm not -- I wouldn't say that the patient journey, especially in the retina offices that know about the product has changed a lot since launch. And I think if you were a patient to go into a retina specialist office today, the first conversation will be, we've diagnosed you and you know you have geographic atrophy. We now have options for you to be treated. Let's talk about that, and then we'll bring you back in for another appointment. We'll do your first injection, and we'll put you on treatment at every month or every other month depending on how that looks for you as a patient, right? I don't know that's changed a lot after there's a disease state education and identification for those patients. I think the patients that sit outside of the retina specialty offices, that education is a little bit different. They maybe don't know as much about what their disease is. They may know they've got something that they need to be educated on and they start to ask questions and that's why we're doing all the work with the ODs and the general ophthalmology offices for that discussion. And then their journey is to go back into or at least start with a retina specialist in those discussions to get on treatment. I think it's also important to note that we estimate, which I think I said a few minutes ago, is about half of the patients are in a retina specialty office and about half of the patients sit outside of that. And that journey to get over to someone who's an injecting physician takes a little bit longer. But we think with our referral work will help us significantly going into next year educating patients so that there's a lot more awareness. So work to be done, but I think it's all part of the process, and I feel really good about where we are in the retina offices as far as the knowledge base for the physicians and the patients have an access to information around the product.

Got it. And you also talked earlier this morning about a new needle and the kits have maybe make the patient experience a little bit better or also the injecting experience from a physician perspective. Can you maybe just talk about that how that's been going and what's coming in the feedback?

So the feedback has been fantastic. For those of you that don't know, we have placed a new needle in our injection kits. There is still a 29-gauge needle, but it's an extra ultra-thin-wall needle, and it increases the inside of needle size by about 25%. So a product like ours, it's a little bit more viscous. It makes the use of that product to be pushed into the eye significantly easier. I've had multiple quotes and information sent to me from our field teams around what that looks like and have had fantastic feedback. So we've also done a few things along the way, including this to help improve the overall process and user ability of the product, make it a little bit easier to use in the [ offices ].

Got it. Just shifting gears again. SYFOVRE in the EU. I know you mentioned a little bit about the reexamination. So -- and it sounds like it's coming pretty soon this month. So I guess again, just bring us back to -- I mean, you did submit some new data around microperimetry in the first go around. But just remind us of the timelines and when that new data went in. And I guess, ultimately, how you're feeling going into the opinion here?

Yes. So what happened was we had the original opinion. And then we got -- because of some administrative stuff got kind of brought back to the 180-day time point and had a second first opinion. And then that second first opinion, we actually had a slightly different outcome from the first one. But because we were brought back to that time point, we were able to include some new data, and we have some new analyses based on our 3-year data on microperimetry. So we were able to submit that. Some of that's been presented since then. So you may have seen that. But basically, what we showed was a reduction in the number of scotomatous points. So these are the points that are in the kind of the more foveal region, sort of more around your central vision, and also that the area that was saved versus placebo was able to see light with microperimetry. So it's pretty powerful to show that you actually -- not only are you saving this portion of the retina, but you're also that, that retina, it sounds logical, right, but that, that retina actually can see, right? So that is function, and it's how you can measure function in geographic atrophy. And the ad hoc expert group for the CHMP did agree unanimously that microperimetry was the best we have today to measure function in geographic atrophy. And the biggest issue, of course, is that everybody anchors to BCVA, and it's natural to do that, but if you have -- and the analogy I use is not a very good one, which is if you have two baseball players and you're looking at a hitter and you're saying, wow, what's your strike out ratio, and it doesn't really [indiscernible] I don't mean strike out, sorry, I meant to say tRA. It doesn't matter because you're not a pitcher, right? So in our case, when you look at anti-VEGF, that's where BCVA matters because it clouds your -- the fluid clouds your entire field of vision, geographic atrophy. For the most part, it's encroaching in your phobia. And so if you can save retina and then show that what you save is functional, that's a functional benefit. And so we think we've shown that. And I think what's also important is we've shown across a number of measures that we -- that function is preserved and that we're saving very important retinal tissue and saving a lot of it. And so from the perspective -- from our perspective, we've done that. Now the question is, will that translate into an approval. And I think the hard truth is that reexaminations are most often not successful, right? It's a very hard thing to overturn. So it's not something -- like I said, it's an uphill battle.

So I guess let's say, it goes again to you, and it's negative. What are your options? I mean, would it just be the [ retinal ] study? Or like what is it? The EU opportunity worth it enough to do that?

Yes. So there's a big finality to that. We -- there may be the opportunity to look at one or two of the access consortium countries or do one-off filings. We're going to have to reevaluate that. What I can say is that we'll take stock at the time and figure out what we will do next and we'll communicate that in due course.

Got it. Maybe on the flip side, if it goes your way, I guess, in terms of like how you think about commercializing in the EU. And I know we were talking about this earlier about pricing in the EU and how that might be different. Like what are kind of your thoughts there?

So first of all, if we do get approved, we would commercialize that on our own. And from a pricing perspective, and that would be more gradual over time than kind of what you saw in the U.S., start with Germany, and then we'd go by country-by-country basis, primarily in Western Europe and then the Nordics, et cetera. But in terms of pricing, typically, we would anchor to what the VEGF, anti-VEGFs have seen. The thing to remember about the market is that we would say there's roughly 1.5 million patients in the U.S. They're roughly 2.5 million in Europe, right? And even though the prices would be lower. If you look at the anti-VEGF, they still represent around 45% of the total revenue for anti-VEGFs. Europe does or ex U.S. does, I should say. And so even though the price may be as much as 70% lower, so the range you see is from 40% to 70% lower. And even though that may be the case in Europe, the volume tends to be quite a bit higher. And so that makes up for it and makes a pretty substantial portion of the revenue for anti-VEGF. And that's probably the best proxy we have. I don't know if you have anything to add.

No. I think I agree with all that.

Let's shift gears to EMPAVELI in terms of you had some data in C3G and IC-MPGN. And very interesting stuff, very nice activity. So maybe just frame up the opportunities there, first just from the commercial aspects.

Sure. Well, I don't know, I'll turn it over to you, David.

Yes, listen, so first of all, we're super excited about it, Derek. And the opportunity to be in that space as early as we will be, is great for patients. And even we were very pleased and probably a little surprised at how great the data was. I think a couple of things to put in mind. First of all, we estimate and we're conservative in our estimation. That's about 5,000 patients in the U.S. They have C3G or IC-MPGN. Now we look at that a little bit differently than other companies in the diagnosis codes, but we're taking a conservative approach to make sure that we're really right about the work that we're doing. We'll learn more, of course, when we get further into next year and we get start to market. But that's where we're at now. The opportunity here is I think we're going into a space where there's nothing to be treated. There's no treatment today. These patients are on steroids. Some of them might be on a C5 treatment that doesn't do a whole lot when you really talk to physicians as far as helping with the disease state management. And everything today is about managing the symptoms, not helping to cure the disease. And we are hopeful that we'll be able to help with that even further when you see our -- in the future, our secondary endpoints. We've met a number of them and feel really good about how we came through with the product on the course of primary. From a commercial perspective, the really nice thing is EMPAVELI is already in the marketplace. We already have a team based on it, already have an internal group that works on it from a marketing perspective and medical affairs perspective, and we will leverage that portion of our organization to also launch in this space and grow it, of course, where it needed, but we've now got a nice portfolio of indications and our EMPAVELI patients tend to be in some of the large centers that are also the large centers that you're going to see a C3G patient go through, be treated and/or post-transplant. So -- and I think the other thing to note and the opportunity is about 20% of the patients -- that are accessible in the disease state are actually post transplant. We'll actually end up probably trying to talk to that physician first because those patients that have made it to that point are starting to see those physicians now. And we'll then have a chance to really grow the market knowledge and the disease state knowledge along the way. So big opportunity. And I'd love to say that we would be first. We might be in there in amongst with somebody else, but I do think it's a huge opportunity for us.

Got it. I guess -- and you guys have decided that you want to file on the 6-month data. Can you just give us a sense of, again, obviously, the confidence of filing on that versus, I guess, the 12 months of one of the competitors that was required to do? And ultimately, the amount of data that you would have amassed, I guess, prior to the filing.

Yes. So what I'll say is that, that's our base case right now. We don't know for sure what FDA will say. Well, as soon as we know something, we'll obviously tell people. But the -- that's our base case for a couple of reasons. First of all, the study was quite large. It had a very -- the full kind of gamut of patients who suffer from this disease. It's IC-MPGN plus C3G, it's transplant and non-transplant and it's adolescent and adult. So it has the whole spectrum. And it's the largest study ever conducted in this area. So we do have that going for us. And since it's a larger study, we also have the fact that it was an unprecedented result. So those two things give us some confidence. I think the backup is that we have -- most of our patients are already at the 12-month time frame, so we can update with what we have. And if it is required for us to have the 12-month data, it won't be that far long after that we'll have that and be able to file with the 12-month data. But again, we can give interim data, not only on how those patients are doing, how the patients have done since they reached 12 months will probably have as much as any other study at a 12-month time point by the time we file for 6 months for all of the patients. And then we also have the placebo patients who have crossed over and we'll be able to show what happens with them. So we have a broad set of data that's not kind of inherently in our 6-month top line so we can also include. So we feel pretty good. I mean, we don't know.

That makes sense. And then maybe just in terms of -- so with this positive data, like what does this open up for other renal diseases? And obviously, there's a bunch out there. It's a hot area. So what's kind of your speed to prioritize that as another area of development?

Well, this -- so we -- I will say the data were somewhat of a surprise to us, too, and we thought these data were going to be good, but we didn't think -- we didn't conceive them being this good. We could have only hoped. And so we're putting pencil to paper on what our strategy is in the kidney area. There are a number of diseases in the kidney that have a strong complement component to them. So a very good example is IgA nephropathy where there's the immunoglobulin component, but there's also a big complement component. And really, when you look at where we are in C3G, that's one bookend where it's purely complement. And then IgA nephropathy is partly both. And we've seen a complement inhibitor have some decent data there. And so we seem to have the best data that we've seen in a purely complement setting. So it stands to reason that we would have potentially an opportunity in that, for example. So that's one of the hypotheses there. So we're going to explore a number of them. And we'll update everyone on what our plans are when we've had a little time to think about it. So it's been pretty quick.

Is that something that you'd probably be more for the R&D Day or is that a separate disclosure?

Yes, it's a good question. I don't know. For sure, that would be discussed in R&D Day, whether it comes before, I don't know.

Got it. And then maybe just in terms of the R&D Day that you are planning, I mean, obviously, beyond just something else which is a newer development. You guys have talked about some of these earlier-stage assets and pipeline programs and complementing different approaches. But maybe just updates on those, and again, just how you're thinking about investing in the early-stage pipeline and also balancing what you were saying earlier in terms of getting the cash flow positive.

Yes. So from a cash flow positive perspective, everything that's in our business plan so far is incorporated. Obviously, we may add a few heads on the commercial side for C3G, for the nephrology area, but it won't be meaningful and it won't change our perspective on that. We do have in that plan, a bucket for doing additional stuff from an R&D perspective, potentially with EMPAVELI. But we also -- so we also have really cool results in xenotransplantation, where we seem to be pretty valuable in the armamentarium against rejection for xenotransplantation as well. So that stuff is very cool. That's all incorporated right now. And then from an early stage perspective, we'll talk a lot more about this at the R&D Day. I think I'm instructed not to talk about anything other than what we're talking about -- but we have the siRNA, which is in the clinic, and we haven't picked an indication that we've gone public with on that. But we also have really cool stuff early on. We've talked about -- we have an oral factor B inhibitor that we've talked about. We've talked about having our beam collaboration, which we're really excited about. So we have some gene editing programs there. And all of those things are moving forward and they're -- there's been a huge priority for us over the past 4 or 5 years to make sure we have something that -- a number of things that are kind of next-generation drugs for us beyond EMPAVELI. I mean, as great as EMPAVELI and SYFOVRE -- pegcetacoplan is we have a pretty robust pipeline that we're excited to talk about when we do our R&D Day.

Got it. And just two questions on EMPAVELI. So one PNH related to, I guess, that seems like a very stable business. But I mean, is there opportunity for growth there? Or should we just kind of assume pretty modest growth on that aspect? And then just going back to the trial in C3G and renal. So that was with the subcu, not like the pump patch, right? Like that's only in PNH right now, is that correct?

I believe that's correct. That's correct. So that's -- but that is something that we plan to incorporate into our filing, the pump. So we want to have that because this isn't -- in large part, I should say in large part, but often an adolescent population. So we want to make sure that the most convenient method of delivery is available for those patients. But in terms of the -- so I'll go back to the PNH question really quickly. So the PNH market, I'll let David talk about. Why don't you talk about it actually?

So you're right, Derek, the PNH market seems to be stable for us, right? We've had some -- with the oral factor B, of course, there's another competitor that's coming out and an oral always entices patients to see if that's something they want to try. I will tell you that the PNH patients that we have continue to tell us how much better they ever felt on C5. And we've seen patients -- we've had a number of patients that left treatment with EMPAVELI went to the oral factor B and have come back to us because their hemoglobins changed, they weren't as stable, they didn't feel as good, those type of things. So I think I'm not going to -- I wouldn't set the tone that there's a massive amount of growth opportunity there based off of us have an additional data with C3G. But I think what it does tell you is that there's potential that we can have a solid story around multiple indications with a product that can be far superior to any other competitor in the space, and we can actually say that because we've studied it that way, and that it will allow us to have growth in spaces that we are already in, potentially. So the power behind EMPAVELI, so if you remember, we did a head-to-head study with the market leader, which was Soliris at the time, and we have a superiority label for that -- for EMPAVELI against that product, and we have a data point now with C3G that's significantly better than the potential competitor that will come in the marketplace. I think the EMPAVELI franchise could be a very big opportunity for us, including potential growth in PNH. But there's more yet to come. We still have work to do, I think, on that.

Got it. And then just beyond like the pump patch, is there any other work being done on EMPAVELI in terms of formulation to -- I don't know, whether it's cut down the frequency of injections or anything like that? Or do you feel like that profile is totally adequate?

I think that's probably where we are on that profile. It's possible we could extend it in certain ways, and we will look into it, but it's not a priority. It doesn't seem to be a gating item. And efficacy is so good with that product that for the patient populations that we're addressing, it doesn't seem to be an issue.

All right. Cool. Well, I think we'll leave it there, gentlemen. Thank you so much.

Thank you. Appreciate it.