Apellis at Wells Fargo Conference: Strategic Growth and Confidence

On Wednesday, 03 September 2025, Apellis Pharmaceuticals (NASDAQ:APLS) presented at the Wells Fargo 20th Annual Healthcare Conference 2025. The company highlighted its strategic initiatives, focusing on the successful launch of Empaveli and market stabilization of Cyfovri. While the company expressed confidence in its growth prospects, it also acknowledged the competitive landscape and pricing challenges.

Key Takeaways

• Apellis emphasized the successful launch of Empaveli for C3G and ICMPGN, with promising early results.
• The company highlighted Cyfovri’s market stabilization and modest growth, backed by positive real-world data.
• Apellis is confident in its product portfolio and pipeline, with plans for future growth and innovation.
• Financially, Apellis bolstered its balance sheet by adding $275 million through a royalty monetization deal.
• The company is optimistic about Empaveli’s potential blockbuster status across multiple indications.

Financial Results

• Apellis added $275 million to its balance sheet through a royalty monetization deal with Sobe.
• The balance sheet is described as "very strong" by the company’s executives.

Operational Updates

• The Empaveli launch for C3G and ICMPGN is progressing well, with 50 patients transitioning to the commercial product by the end of Q4.
• Empaveli targets a total addressable market of around 5,000 patients, with initial growth expected to be bolus followed by steady growth.
• For Cyfovri, Apellis has achieved market stabilization, focusing on low to mid-single-digit growth and maintaining market leadership.
• Apellis is developing new technologies to enhance patient and physician understanding of treatment value.

Future Outlook

• Apellis believes Empaveli has blockbuster potential, especially in PNH, C3G, and ICMPGN, with more than 5,000 undiagnosed patients.
• Cyfovri’s growth strategies include physician education, patient activation, and direct-to-consumer advertising.
• The company is committed to innovation, with plans to develop siRNA in combination with Cyfovri and algorithms for understanding functional vision over time.

Q&A Highlights

• Apellis emphasized its competitive advantage with a broad patient label and superior efficacy data for Empaveli.
• The wearable device for Empaveli offers a unique delivery system, which physicians find appealing.
• Apellis took 20 years to achieve the first global GA treatment approval, with the best lesion slowing of any drug tested so far.

In conclusion, Apellis Pharmaceuticals is poised for growth with a strong product portfolio and strategic initiatives. For more detailed insights, please refer to the full conference call transcript.

Full transcript - Wells Fargo 20th Annual Healthcare Conference 2025:

Derek Archila, Senior Biotech Analyst, Wells: Right, everyone. Think we’ll get started with our next session. My name is Derek Archila. I’m one of the senior biotech analysts here at Wells. Very excited to have Appellis with us here for our next fireside discussion.

We got Tim Sullivan, the Chief Financial Officer as well as David Acheson, Chief the Commercial Officer. Gentlemen, thank you so much for coming and looking forward to the discussion here.

David Acheson, Chief Commercial Officer, Apellis: Thanks, Derek. You, Derek.

Derek Archila, Senior Biotech Analyst, Wells: Awesome. Well, maybe let’s just kick things off in terms of just kind of state of affairs. Maybe Tim or David, do you guys want to just kind of give a sense of where the business is today? And then we can start delving into some of

Tim Sullivan, Chief Financial Officer, Apellis: the key questions here. Perfect. So for those who are not familiar with Apellet, it’s a commercial biopharmaceutical company that’s focused on the complement biology system. And you know, for those of you who are not familiar, complement is part of your innate immune system. It’s sort of your original old immune system.

And when it’s dysregulated, it can cause a number of serious diseases. And so Appellis was founded with the idea of targeting diseases within the complement system, doing so at the center of the complement system, a target called C3. And this is the central point of the complement system in the way our drugs so we have two commercial drugs. One is called Cyprivory, which targets geographic atrophy in the eye or treats geographic atrophy in the eye and then also Empiveli, which is for a number of rare diseases we’ll discuss in a minute. But both of those drugs have the same active ingredient, which is pegzetacoplin, which central component of the complement system.

And as a result, it sort of acts as the either the Swiss Army knife or the NVIDIA chip or whatever. Who like that? Exactly, the complement system And it’s really, as far as we know, almost a litmus test for whether a disease is a complement related disease. So there are tons of drugs being developed in the complement system. And we believe pegziotocoplin is sort of the most effective in the sense that it can treat pretty much all diseases within complement because it’s centrally located right below all three of the activation pathways.

So that’s what makes pegzetacoplin different and what makes our two products unique. And so we obviously, as I mentioned, we have these two commercial products. And in terms of where we stand today, we have three approvals, three approvals in the last few years, which is a great accomplishment. We have, again, for Cyphovri. This is a product that was approved for geographic atrophy.

It was the first product approved for geographic atrophy and is also the market leader in the geographic atrophy market. And then we have Empiveli, which was approved for PNH in May 2021 and has subsequently, as of this year, been approved for two other diseases of the kidney two diseases of the kidney, excuse me. First one is C3G or C3 glomerulopathy and then ICMPGN, which is a related disease, which expands our market by approximately 5,000 patients. These are rare diseases. It’s a rare disease drug.

Both PNH as well as C3G and ICMPGN are rare disease opportunities. And then of course, in our pipeline, we have we’re developing a drug called APL-three thousand and seven, which is an siRNA, which is being used to also improve the characteristics of CyFovri in combination. So we have a kind of a combination geographic atrophy targeting approach, which we’re hoping to kind of increase the durability and effectiveness of CyFovri. And then we have some other earlier stage programs, which we’ll talk about at some point in the future. And then very recently, we just did a financing deal.

It was a royalty deal with our partner, Sobe. They have the ex U. S. Rights to Empovelli. And we did a royalty deal, really royalty monetization with them where we added $275,000,000 to our balance sheet.

So we come into this conversation with a very strong balance sheet with two commercial products that are strong and growing. And we feel very good about where we are. I don’t if you have anything else.

David Acheson, Chief Commercial Officer, Apellis: No, Ted.

Tim Sullivan, Chief Financial Officer, Apellis: Great. All

Derek Archila, Senior Biotech Analyst, Wells: right. Well, thanks, Tim. Well, maybe let’s discuss the recent launch of Empivalli in C3G and ICMPGN. Obviously, you stated it’s a rare disease market. So maybe either if you guys want to start just in terms of what are we seeing in the early innings since approval?

And how do you guys think that launch will ramp over the couple of quarters?

David Acheson, Chief Commercial Officer, Apellis: Yes. Yes, it sounds good. Thank you, Derek. First of all, we’re super excited about what we’ve seen for a label from the FDA for both C3G and iCMPGN. It’s a very broad label, and it gives us both pediatric as well as adults in both disease states, which is really, really good.

Also, there’s post transplant data in the label for patients that have gone through transplant. They could also C3G patients, in particular, could be utilized for those patients as well. So it’s a very broad label, which is positive. We’re four which is a little over four weeks into the launch of those two indications. And I can tell you, I think things are going extremely well, at least from a connection to the right customers, the KOLs.

And there’s a lot of interest because of the broad label and what we’ve seen in our data. I think it’s important to remember that we hit what we call the trifecta. So proteinuria reduction of seventy percent, which is the lead endpoint in the studies. We also showed that seventy one percent of the patients after the studies actually had zero C3 staining left in the kidney. So that’s a very big number and hugely impressive.

And we were able to show stabilization of eGFR. And if you talk to a nephrologist, proteinuria is key, but it’s not the only factor they’re looking for. We cover off on the other two, which is staining as well as eGFR stabilization. So it’s exciting. I can tell you that we are as soon as we got the label, we were in the process of trying to move our EAP patients over, which is going to take until the end of the year.

And we’re in the process now of getting folks REMS certified and putting our opportunities for patients to get start forms in and get on the product. So it’s still very, very early, as you can imagine, but the news is exciting in the space, and we’re excited to be able to help patients in the two disease states.

Derek Archila, Senior Biotech Analyst, Wells: Can you just remind us in terms of the number of EAP patients? And I guess, again, you said by the end of the year, what are some of the factors that would dictate that being

David Acheson, Chief Commercial Officer, Apellis: faster Yes. That’s great. So in our EAP program, we have 50 patients that are in the process of moving over. The program obviously was one of those things that was available for patients because there was a high unmet need. So now what we’re working on is making sure that those patients move over to the commercial product.

It takes a little bit of time to do that. In general, once a patient’s identified and they go through vaccinations and the process for start forms and all of the prior auth work and those type of things that happen in rare disease, it takes about four to six weeks to move most patients over. We anticipate it will take to get those 50 patients moved over, it will take some time into Q4. And at the same time, we’ve got new patients that are coming into the process as well. So excited to see it, and we’ll see how things continue to move.

Derek Archila, Senior Biotech Analyst, Wells: Can you discuss the REMS certification? And like how long is that mostly just kind of like paperwork? Or like what’s that actually entail for some of these centers?

David Acheson, Chief Commercial Officer, Apellis: Yes. REMS certification for a physician is actually it’s by doctor, And it’s actually a fairly simple attestation. They need to read through what needs to happen from a labeling perspective, in particular the vaccinations for these patients, which there’s three. And then you need to attest to the fact that the patient is indicated in the process of the label and that they’re being vaccinated or have been vaccinated, and then they sign off on it. So it takes fifteen to twenty minutes.

It’s actually not that hard. The work really comes into start forms and work with the payer and the specialty pharmacy and all of the logistics with the patients. So that’s really where the work is.

Derek Archila, Senior Biotech Analyst, Wells: Got you. And can you just remind us in terms of that vaccine requirement? Obviously, this is something that Empivalli had prior with PNH as well. But typically, what’s the length in terms of getting those vaccines? And I guess, I think a lot of people are trying to understand, is there going be a bolus of patients that just come on beyond the EAP?

And is there really kind of a slight waiting period because of the vaccination requirement here?

David Acheson, Chief Commercial Officer, Apellis: Yes. No worries. Let me address the vaccination process first. So there’s three vaccinations that every patient needs to have, one of which is meningitis that has two vaccinations that have to occur. We in our label, as long as you’ve been vaccinated for influenza B, strep pneumo, and the first meningitis injection or vaccination, two weeks post those injections or those vaccinations, a patient can start product.

And they can also go on prophylactic oral antibiotics if that’s what’s needed, especially for the distance between the first and second injection for meningitis. So that in a nutshell is kind of how that works, right? And that is that’s super important because we obviously it’s a safety event that we want to keep from happening. And that process takes a little bit of time, and we can help facilitate that through our specialty pharmacy and through processes that we have in place so we can speed that process up if a patient is having a hard time finding a way to get vaccinated. And we can work with their offices and their physicians to do that.

And once that’s done, then the start forms go in, all the information is sent into the specialty pharmacy, and then it just takes time with the payers and what processes and logistics to make sure we get the patients the product within the window of time that and is paid for by a payer, okay? From a bolus perspective or what we see for patient uptake, I definitely, I think, Derek, one of the things that you’re going to find in any space like this that hasn’t had a lot of options until recently, they had no options, right? These patients are being are they’re waiting. We’ve got some patient advocates that we work with to help educate our internal teams as well as some work that they do externally for us, and they’ve been anxiously waiting for a product like this to come through that will keep them from actually going to dialysis or post potentially transplant. So it’s super important to them.

So I and do anticipate, like any disease like that, that you’re going to have some bolus of patients that come through in the front end of the launch. But we anticipate that it’s going to be a typical ultra rare disease launch. After that, we are going to see nice, good, steady growth. There’s about 5,000 patients that we see in The U. S.

And all of them, for the most part, should qualify for treatment. It depends on where they are in their treatment kind of processes in the disease state, but at some point, they should all be educated at least on the product and the availability of it. And would you see any like centers of

Derek Archila, Senior Biotech Analyst, Wells: excellence or kind of KOLs start to vaccinate and prepare these patients prior to approval? Like just assuming that it would get approved because of the data?

David Acheson, Chief Commercial Officer, Apellis: Sure. Yes. We actually had we had a number of REMS enrollments that came through from physicians before we actually had approval. All of our EAP patients, for the most part, were vaccinated because they were on product. And we had some patients that were already starting to go through the process to be able to get connected to the physician and to education on the product before the label was actually available.

So all of that started to happen early on, and it continues as now that we’re launching as well.

Derek Archila, Senior Biotech Analyst, Wells: Got you. I guess, do you think of the two opportunities different like pre, post transplant, obviously, like adult, children like pediatric? How do you think about kind of all these opportunities and ultimately like where physicians see kind of the greatest unmet need?

David Acheson, Chief Commercial Officer, Apellis: Yes. It’s interesting you asked that because if you go through our label, you can see pediatric patients for C3G, you can see adult patients for C3G, ICMPGN, you can see post transplant patients for C3G for adults. You’ve got the whole gamut, right? Probably the most the two areas of the highest unmet need that we’re interested in and have concerted efforts around is to make sure that the pediatric patient nephrologists are well educated and know about this product early because that’s a super high unmet need with kids, right, that are potentially in a situation where over their lifetime they’ll end up having to have a transplant or certainly go to dialysis if this thing is not taken care of. So that’s one.

And then post transplant patients, because one of the things that we know is that in a post transplant patient, ninety percent of these patients within thirty days see recurrence of staining of C3 in the new kidney, which because it’s a genetic disease, it’s always going to reoccur, right? So those patients should be high unmet need patients and they hire high unmet need patients with some urgency to make sure that that group of physicians is also well trained on the product, they know how to identify when and how to put patients through the process to get to product and treatment. And then the rest of it is C3G patients that are adults, which are super important, but a little better understood on how to manage because they’ve been adults with the disease for quite some time. And now they have options to be treated that they didn’t have before.

Derek Archila, Senior Biotech Analyst, Wells: Now that you’re in the market, like what are you seeing from Novartis in terms of Iptacopan? Like any sort of counter detailing? Obviously, you have a more extensive label. So like maybe you could just give us some of the dynamics as you see it a couple of weeks in the launch.

David Acheson, Chief Commercial Officer, Apellis: Yes. So look, I think one of the biggest advantages we have is our label because of the broad spectrum number of patients and the age range that we can treat, right, for both indications, which is really separates us. What we get told by physicians and by the KOLs is what will separate us from there is the efficacy that goes along with those broad indications, which we can see in those three areas I talked about, which is proteinuria, C3 staining reduction and eGFR stabilization. And they’re super tuned in to the fact that we can bring them all three, and that’s not necessarily the case in other situations, right? I think the other thing that’s super important is most people would say, We’ve got an oral versus what would be a subcu injectable product.

We have a very easy to use wearable device that goes on when the patients use it. They get dosed twice a week. They put the device on, they hit the button, they never see a needle, and the product delivers the device delivers the product over a window of time of about thirty minutes, right? Oral has to be taken twice a day. And so there’s areas there where the physicians are saying two things: efficacy will always outweigh the path that the patients will take the product.

And the second thing is they’re very intrigued with the fact that we’ve got something that’s so simple to use for these patients with the product that can treat these diseases. How important is compliance? I mean,

Derek Archila, Senior Biotech Analyst, Wells: you just kind of maybe outline that a little bit, but maybe just in terms of both of those, like if you miss a dose of ipnikopan, is that a major issue relative to for this type of disease?

David Acheson, Chief Commercial Officer, Apellis: Look, I think in these disease states, these patients have been living with these situations in the nephrology space for their lives, right, at least since they’ve been diagnosed. Obviously, the best thing to do is to stay on treatment and make sure that they can continuously be treated. If they happen to miss a dose actually in these disease states, they can go right back to treatment. For us, though, the good thing is, is that we’ve got we know that it’s a lot fewer times that they have to take this product. And twice a week is significantly different than what you’ll see patient compliance when you have to take it twice a day.

Got you.

Derek Archila, Senior Biotech Analyst, Wells: So maybe just a higher level question in terms of just the market opportunity here. I think there’s debate whether this is very niche and small, a couple of 100,000,000 to could this be $1,000,000,000 plus. I guess, how do you guys think about this market opportunity? And what peak penetration could really look like across C3G and ICMPGN? So I think if

David Acheson, Chief Commercial Officer, Apellis: you take I’m actually going to add PNH into it too, Sure. You add in PNH, you have C3G and ICMPGN, we absolutely believe we have a blockbuster product. If you take a look at the 5,000 patients that are out there, they’re diagnosed through all of them are diagnosed through a biopsy. So we know that those patients exist, especially on C3G because the ICD-ten code exists for us to be able to track. ICNPGN is actually an epi model to get to that.

And so we’ve got some learning to do, right, on the number of patients that exist. Now that there’s a treatment out there like this that can actually modify the disease versus treat the symptoms, we actually think there’s probably more patients that could surface as diagnosed moving forward, which is typical in most rare disease situations where there haven’t been options before. So we’re very confident in the 5,000 patients. We think there’s probably more out there that could come to the table at some point in time as a result of a product that can treat what their needs are that wasn’t there until recently. Got you.

Derek Archila, Senior Biotech Analyst, Wells: And how do you think about Empivalli just broader across the three indications in terms of IP, life cycle management? Is this something that’s kind of on the radar? I think the patents are up in like, I don’t know, it’s late 20s or early 30s, but finite life nonetheless. But how do you kind of think about that given that want to continue to expand in some other renal locations based on the data we’ve seen?

Tim Sullivan, Chief Financial Officer, Apellis: Sure. So from a patent perspective, the composition matters, depending on the geography, it’s 02/1932, 02/1933, but with customary extensions, thousand and thirty four, February. So we feel very good about the patent life. We also when we started our next two clinical studies, our pivotal studies Empivalli, we looked at patent life and said, okay, we want to have these things be ready for approval by 02/1930. So that was sort of the impetus for us when we were looking at FSGS and DGF.

So we thought that was the appropriate time frame, and we’re continuing to look at life cycle management opportunities.

Derek Archila, Senior Biotech Analyst, Wells: Got you. Okay. Maybe just shift gears to Cyphovri for a bit. Just where are we in terms of like kind of stabilization? Last quarter, it seems like, again, some modest growth there and maybe the business is stabilizing.

Do you feel like we finally kind of done that? Or do we still need to kind of look out a couple more quarters before we feel like that business is kind of starting to grow off that pace modestly?

David Acheson, Chief Commercial Officer, Apellis: Yes. So look, I’m excited about Cyphovri. I think one of the things that we’ve been through is a bit of a roller coaster ride with the brand, right, in the last couple of years. And I think we’re through a big part of that. We came out of ASRS, and I felt really positive that the storyline there was about efficacy, it’s about real world data, it’s about the things that patients and physicians are seeing with the product because we’ve got patients today now, Derek, have been on product for four years, right?

So the amount of tissue that can actually be saved in that four year period of time after they started patients early and they’ve kept them on for a long period of time is very substantial. So that’s a great story for us. And I’m excited about what the brand can do for patients. I think at the end of the day, it’s still important for us to know that this is a space that we’re still continuing to build out. There’s lots of room for growth.

It takes a lot of disease state education still. There’s a lot of work that needs to happen in offices where patients currently exist, not to mention the referral processes. And I think what we’ve put out for guidance is that low to mid single digit growth is something that can get us where we want to go and can hopefully be consistent on the injection side is what we’re So looking but I will tell you, think coming out of the last couple of meetings, in particular, ASRS, I’m excited about the brand and I’m excited about what we’re starting to see for some really positive real world data that I think can help us long term. And I would echo that. I would

Tim Sullivan, Chief Financial Officer, Apellis: say that the franchise has finally hit sort of that stabilization after that tumultuous period. We feel very good about that stabilization. But in terms of the things that are going to kind of push growth to that next level, those are kind of in the next kind of the twelve month timeframe. Those things include like the prefilled syringe and some of the technologies that we use to help we’re going use to help patients, physicians and caregivers understand the value of treating the disease, which I think is missing piece of that dialogue right now because as you know, it isn’t one of those things where you see the effect right away. It’s one of those things you have to have a little bit of faith in, and it’s much easier when you can apply certain technologies to help people see the benefit over time and what it means to treat or not treat.

And once people can really understand that, the decision is very easy to treat.

Derek Archila, Senior Biotech Analyst, Wells: What have you seen like tangibly from maybe ASRS or some of these meetings where you guys are highlighting some additional data with some physicians or groups of physicians that has it really started to change their prescribing or increase it? Or I guess, again, give us some maybe anecdotes in terms of like what you’re seeing on the ground from that’s a result of some of this up or more recent data?

David Acheson, Chief Commercial Officer, Apellis: Yes. No, I think it’s great. So look, let me just make sure everyone remembers where we sit in the marketplace. We are definitely the market leader. And in every market or every metric that we look at and all the markers, we lead the market in market share, new to brand, revenue, all of those all of the things that you can look at as far as metrics we lead.

I think it’s important to know that when we left Q2, we were running in the 55% range on new to brand prescriptions, and we own over 60% in regards to TRxs. So as a market leader, I think we should feel good about that. I think what you’re starting to hear now is when you and I’ll go I’ll reflect back on ASRS. It is clear when you talk to physicians, they know that we have high efficacious product and in comparison to the competitor, they know that our product has robust data that can help them make decisions for their patients and do the right things. And that four years, that forty eight months of data from the Gale study helps them understand what can happen after someone’s been on product for a period of time in regards to tissue preservation.

Nobody else can talk about that data. And our competition will never have that. So I think it’s important for us to really highlight those things. And I think the general sentiment is from the physicians is we see lots of opportunity to help patients, but they also tell us, look, it takes time and education and work. That’s why we settled in on the kind of growth factors that we put out for guidance, at least at this point in time.

Derek Archila, Senior Biotech Analyst, Wells: I guess based on your trajectory as well as what we’re seeing from the sales of IZERVY, like how has that informed or changed your view of like the overall opportunity for GA? I mean do you still I mean, I think the idea was that this could be multibillion, there’s million plus patients. Is that has

David Acheson, Chief Commercial Officer, Apellis: that changed at all? Look, I think the market is there, right? So there’s 1,000,000 patients that we know of that exist in the space. Actually, can give you a quick example. One of our largest accounts has several thousand patients that sit inside their current retina offices and maybe 10% of them are treated, right?

So you’re talking in a group that maybe has 40,000 total patients that are GA identified, you’re talking five thousand to 10,000 have been treated, right? The opportunity alone in some of these accounts without referrals coming in is quite big. And then the opportunity for patients that are identified that are not in the treating offices, the process to move them over is super important because then they can see someone who can actually do an injection for them. So the market itself, I think, is large, and it’s now it’s an effort to make sure education and getting to the patients and then getting the patients into the right places to be treated is what we’re focused on.

Derek Archila, Senior Biotech Analyst, Wells: Like what’s the most important thing that physicians do to activate those patients that again like that are just apparently just sitting there? And is it just the fact that they don’t like injections or they don’t see value and maybe slow learning the progression versus like reversing some of the vision loss? Like what are the things that physicians really need to do?

David Acheson, Chief Commercial Officer, Apellis: Yeah. So look, I think that the patients that sit inside a retina specialty office already, those physicians are working to activate that patient because they already know that they have the disease. They’ve already had these conversations, right? It’s a little easier than someone that might be coming in from on the outside that’s newly diagnosed. It takes a little less time for the office staff.

They don’t have to go through all the new workup, that kind of thing. There’s the education that takes some time, right? And it’s a dedication by the patient to make sure they spend the time talking with the physician about potential treatments. But at the end of the day, I think it’s a we help supply the tools and the information for them that have that dialogue. On many cases, you’ll see them talking to Z State Education with things that we provided.

And we’re also doing everything that we can to help educate patients so they’ll go in and ask for it. And that information is available in multiple different areas for them to find online and through other channels in DTC and that kind of thing.

Derek Archila, Senior Biotech Analyst, Wells: Yes. I was going to ask on DTC. Like do you feel like I guess, have you been ramping that over the last six to twelve months? And how does that evolve as you kind of try to break into some of these additional patients, whether it be

David Acheson, Chief Commercial Officer, Apellis: those types of practices or new practices? Yes. So we have so DTC remember is not just about television. Everyone remembers the television, but there’s a lot

Derek Archila, Senior Biotech Analyst, Wells: I hear more on the radio but I still listen on the radio.

David Acheson, Chief Commercial Officer, Apellis: Yes, on the radio too. But there’s a lot that happens to make sure patients have access to really understand what their challenge or their disease state is and how to go ask their physician on what the next steps might be. We’re continuing to use our work in DTC. We know it has impact. We know that we’re connected to somebody with Henry Winkler that helps us kind of capture the attention of this patient base.

And then they listen and get educated on the things that they need to ask questions about. So we’re dedicated to it, and it works, and we see lots of good feedback that comes out of it. And then

Derek Archila, Senior Biotech Analyst, Wells: maybe just another question in terms of like so how this market evolves and just the competitive landscape. So obviously, we’ve got some other drugs in the clinic, probably get some data next year. How do you guys kind of feel about those programs? And if they were to show some sort of benefit on vision or BCVA? Like how does that kind of change the way people might view Cyphovri?

David Acheson, Chief Commercial Officer, Apellis: Yes. So I think there’s a couple of things to put in perspective here. I don’t think everyone may understand that it’s quite a while before anything else comes, right, several years probably. And if you take a look at where we started, it took us twenty years to get across the line with the FDA with the first approved GA treatment in the actually globally, right? So there it takes a lot of work.

And what we’re more focused on, quite honestly, is that what’s that next step for us to be able to treat patients that have GA, which is what Tim talked about, which is our siRNA and our 3,007 molecule, because you can actually treat the level of CD3 systemically and bring that level down and then treat patients with an IVT and do kind of a double whammy to make sure that you’re helping that patient manage the complement. And that is where we’re really focused is on what’s next for us because we think we’ve got a really good opportunity in that space and to continue to be the leaders in GA treatment as well as somebody that can bring new products to this space for patients.

Tim Sullivan, Chief Financial Officer, Apellis: I would also say that it would be it’s a fundamental misinterpretation of understanding GA to think that in a year or a two year study you can materially impact BCVA. I mean, the idea of how to structure a trial to do that effectively is really hard for us to understand. We have the best slowing of GA lesions of any drug tested so far. And yet we still can’t get a BCBA signal that is significant in a two year timeframe, and that would be a high expectation for a GA study. So if a GA study is positive in the one to two year timeframe with the sample size under, I don’t know, 5,000 or 10,000 for BCVA, then it’s probably luck, right?

And that’s what we saw for our competitor product for IZERVAY. They had a signal in the 15 letter loss for BCBA over the first year of the study and then the second year it disappeared entirely. It was random walk, right? And that’s because to understand GA, you have to understand that the disease is a slow growing disease, right? And it typically affects the peripheral vision more than it does the central vision, at least initially, and eventually comes into the central vision.

And until it crosses into that zone and you have to get a ton of patients who are in that exact spot to then have a, you know, a drug that flows 30%, 40% to change that BCVA outcome, right, materially. And also, we as humans have the ability, at least temporarily, to adjust a little bit, right, when something encroaches in the fovea, when the disease encroaches in the fovea. So it’s way too noisy to expect that to be a significant thing to understand in a two year study. So from our perspective, lesion slowing is the biomarker you need to look at, and what you really should be looking at is that functional vision by using microperimetry, which is what we do, right? And that’s the measure we use to figure out for each kind of which for each photoreceptor, what it looks like, how well it sees and so forth and be able to extrapolate that using AI to understand the functional impact of GA over time in shorter periods of time.

You truly can’t do that with BCVA. So I don’t think we’re worried specifically about BCVA being a material measure of disease for any of these drugs. And also, again, as David said, these are pretty far away.

Derek Archila, Senior Biotech Analyst, Wells: Got you. And just maybe just as we kind of get more experience with these drugs, there’s more data longer term data. Does that at all put the EU back on the table at all? Like is that or is that completely just put for now?

Tim Sullivan, Chief Financial Officer, Apellis: We’ll see. We keep generating data. And again, BCBA is something everybody anchors to because it’s something they understand, right? It’s easy to understand, but it is not the correct measure for GA. We’re adamant about that.

I think we know more honestly, I think we know more about GA than really anybody because of our studies and particularly our understanding of microperimetry, four years of data with people who have microperimetry to understand what happens to their vision over time. Again, microperimetry for those of you who don’t have the background is a way of shining light on these points in the retina and understanding what they can see. And over time, as the retina dies off, you can see what happens to each one of these little pixels and understand how well each one of them sees. And over time we have hundreds of thousands of these data points. But we can now really tell you what’s happening on a functional basis in the retina from GA.

And just using a central ability to read a chart is way too noisy over that period of time. So we’re the ones who have those data. And I think we can bring that to bear for a general understanding that really isn’t there even among regulatory authorities. We’ll see what happens.

Derek Archila, Senior Biotech Analyst, Wells: Got you. Maybe the last couple of minutes. So just kind of how we think about Apellis evolving as a company with obviously Empivatly as a base, Cypovri as a base and then also kind of future pipeline programs. I mean, hinted that obviously seven, but I guess, where do you think the investment goes after kind of getting through some

Tim Sullivan, Chief Financial Officer, Apellis: of these

Derek Archila, Senior Biotech Analyst, Wells: launches in terms of the pipeline? And like where do you want to be in like five years? Yes.

Tim Sullivan, Chief Financial Officer, Apellis: I mean, we have dreams of building a great company, right? We’re already there in terms of the basis. I think what fundamentally, I don’t want to say it’s a misunderstanding, but there’s we have history, right, over the past six, seven years as a public company. But if you look at us today, we have these two approved products, three approvals, both with exceptional growth opportunity, we have a strong balance sheet and we have we are an innovative company. So as an integrated biopharmaceutical company that is independent, I think that may be slightly underappreciated that we’re in a pretty good spot.

And there’s another two other pieces of this. One is that we are highly differentiated in both of our markets, right? Our C3G and ICMPGN markets, we have highly, highly differentiated data. I know David has talked about the trifecta. We have the double the proteinuria of the competitive product pretty much.

We have this C3C staining, which nobody’s seen before in any product. And then we have the stabilization of EGFR. That’s highly differentiated. It’s hard to underscore that enough. In terms of Cifovri, we have what we believe is obviously the best lesion slowing.

We think we have highly, highly differentiated product there as well, and we are the market leader. And so from that perspective, we feel really good about the existing products. What’s also probably not super well understood is that targeting C3 the way we do really is the most effective way, we believe, to target complement in general. And while there are are hundreds of programs out there, I mean, hundreds being developed in complement, we have yet to see one of them outperform the effect of pegzetacoplin in targeting a complement related disease. So we really have that fundamental technology.

And I guess the last thing I would say is that we’re committed to innovation over time, right? We have Cyphovri where this is a perfect example, right? We have Cyphovri where we keep generating data beyond two years, three years, four years, we keep presenting more and more data. We’re developing these algorithms to try to understand functional vision over time. We’re putting you know, we’re developing this siRNA in combination with CyFovri.

We’re not leaving these GA patients behind, right? We’re fundamentally committed to these GA patients into the retina. Similarly in the kidney, we’re just sort of launching there, but we have that same innovative mindset as well. And we’re obviously, as you know, developing Empiveli in DGF and FSGS. So we’re committed to that innovation over time in the key markets where we’re focused right now.

And then obviously, as we talked about, 03/2007, and we have other pipeline products that are emerging over time, which we’ll talk about more. Okay.

Derek Archila, Senior Biotech Analyst, Wells: Cool. Well, gentlemen, we’ll leave it there. Tim, David, great to see you.

David Acheson, Chief Commercial Officer, Apellis: Thanks All Thank you. Thanks, Greg. Appreciate it.

Derek Archila, Senior Biotech Analyst, Wells: Well, guys, good to see you.

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