Welcome to the UBS Virtual Event. I would now like to pass the call over to Eliana Merle. Good morning, everyone. I'm Eli Merle, one of the biotech analysts here at Ophthalmology Day. Very happy to be starting the day off with Apellis. Joining us from Apellis is Tim Sullivan, chief financial officer, and David Acheson, SVP of North American Commercial. Just a quick disclosure statement. As research analysts, we're required to provide certain disclosures relating to the nature of our own relationships at UBS with any company on which we express a view on this call today. You can find these disclosures at UBS.com/disclosures, or reach out to us and we can provide them to you. With that being said, Tim, David, thank you so much for joining us today, and yeah, to jump right in, you know, now we're over a year and a half into the launch of Syfovre in GA. I guess, what are you seeing in terms of the dynamics in the GA market and how the market has changed with approved treatments? Yeah, first of all, thank you for having us today. I appreciate it, and look forward to the conversation for the next 30 minutes or so. Look, I think it's a couple things. As you would suspect, the fact that we've got two products in the space now, in the complement space for GA, we're starting to learn a lot more around the market, the physicians, the patients. One of the things, and you know this, I think, because we've talked about this, the market's definitely bigger than what we anticipated. This is a very big market. Originally, we had thought there was about a million patients that were in the space, and we think now it's a million and a half, and maybe even bigger than that, depending on where everything comes in from patients being referred outside of where the retina specialists are. So I think that's a pleasant surprise for all of us, of course. And I also think the dynamics in the space that we're seeing now is that we are starting to experience a very good momentum on the efficacy message that we have and the product itself, and I think that's a really good move in the right direction for patients. I do think that patients in the space are in tune to what they need for treatment. They ask their physicians regularly about, "Is this something I should be doing?" and I think it's a joint conversation between the two, and our efficacy message is really starting to play out the way that we expected it would. So I think that's been good for us, for sure. And the market, I think, is really starting to understand a little bit more about complement, and how it works, and the space in general, I think, is accepting of the tools that are here. So excited about that, and I look forward to seeing what happens over the next, you know, year or two. All right. Great, and, I mean, you mentioned that the prevalence is, you know, much larger than you initially thought. Maybe just what are you seeing this in the form of? I guess, maybe just are you seeing, you know, an increase in referral rates, like an increase in the number of patients broadly under care with GA? And, you know, specifically, if you can speak to that, like, if, you know, in practices, that's grown by a certain, you know, percentage since- Sure ... you know, the time of launch. Yeah. So I think, like, a couple things to keep in mind, right? So there's about 50% of these patients that sit with an injecting retina specialist in those offices today. About 50% sit outside of that. In the data that we have and some of the work that we're doing to help kind of grow the market, we are specifically focused in the world of GOs, general ophthalmologists, and ODs, because a lot of those patients sit there. What we can see in the data, and what we see now for some of the referral processes coming in, and if you talk to retina specialists that have a referral network already set up, which some of them have a very good referral network already in place, we can start to see some of those patients coming in, and they're telling us that those patients are now coming in as a referral based off the fact that there's treatments in the space, which I think is exactly what we want to do, and we're working specifically to help move those patients over as well, because we know that there are a number of patients that just don't have access to the retina specialist yet or haven't been in that office. That's how we can kind of see through the data and the information we've got from our physicians that are injecting today, that there's a number of patients that just, you know, are starting to come in that we don't have access or haven't had access to in a retina office up until now. Mm-hmm. Makes sense. And now that you have a competitor on the market with a permanent J-code, and you have a better sense of the market share split, I guess, you know, can you speak to the latest that you're seeing in terms of market share for Syfovre? Yeah. So look, overall, and what we've reported up until now, is that we were sitting around that 75% market share coming out of the last quarter. Things have not adjusted drastically there, and we feel really solid going into the last part of the year with the last quarter. And, you know, we're at about a 50-50 split on new starts, which, that's starting to trend up for us as well. So, you know, I think in general, things have not moved significantly on what we've reported up until this point in time. And I'm comfortable that we'll continue to take the leadership role in this space, especially since we're really working to help grow the space and the market, which is gonna be important, you know, long term, making sure patients get access to the product. So, that's where we've been up to this point. Mm-hmm. Great, and so you mentioned that at the latest, you had 75% market share, and things haven't changed much since when you gave that update, and that, you had been seeing a 50-50 split on new starts, and that this is starting to adjust up as well. I guess maybe can you speak to what you expect in terms of market share and how this will evolve over time? Specifically maybe in the near term, it seems like you're seeing a little bit of an uptick. Yeah. So look, I don't- I'm not sure we'll give a whole lot of guidance on where we think the market share will land, but I do... Look, the market's really big, so I think the thing that we've gotta keep in mind here is that having two competitors in the space is not a bad thing. It helps grow the market, bring awareness in, and it gives us the ability to have more patients be treated, both for their sake as well as for the brand. And I think that we can, you know, do very well long term, with the two players that are in the space, knowing that there's not anything else coming behind this for several years, right? So I think that's super important to keep in mind. I also think the thing that will always play out over time is the fact that our efficacy story is super strong and super solid with all our studies were big, right? We've got every month and every other month dosing and efficacy from the very start of those studies, and over time, I think that will continue to drive the lion's share of the market towards Syfovre, and I think we'll continue to be the market leader as a result of that. So, efficacy, at the end of the day, is gonna win the battle, and we're starting to see, you know, that impact in even some of our latest market research, where the recall on efficacy is very, very high, upwards of 75%. You know, a year ago, efficacy was not a conversation that most physicians were really talking about, and it's moved significantly in that direction, so I'm confident we'll continue to lead the market. In terms of the centers that you work with, I guess, are you seeing centers stock both Syfovre and Izervay, or do you find that it tends to be some practices, you know, stock one or the other? Yeah. No, I think it's a great question. All of that's true. Everything you just said is true, right? So some accounts are 100% Syfovre, some accounts are 100% Izervay, some accounts are split between both. That's just gonna happen, right? When you have markets that start to have more than one player in it. I will tell you, the majority of the accounts out there will actually have both products stocked. They'll give a patient conversation around both drugs, have you know a good dialogue with the patient, and help the patient make the decision. I do know that those conversations, especially as we've gotten additional information out on the efficacy story in the last couple of meetings, ASRS and Retina Society, those additional discussions are driving that efficacy discussion a lot more. I think that's where we'll continue to have a leg up as well is with the efficacy story. I think all of... You know, I'm not worried about the fact that someone will have both products in there, and they make a choice for patients to have a good discussion around. I think that's healthy. At the end of the day, I think we will still continue to see more patients coming to Syfovre as a result of the efficacy and what we're seeing with treatment, you know, with patients today. Mm-hmm. And I guess, what's the split maybe or mix that you're seeing in terms of prescribing from some of the private equity backed centers versus the more academic centers, and how we should think about that? Yeah, no, that's good, good, good question. So a couple things to keep in mind. About 30% of the retina specialists today, or 30% of the market, sits in a private equity group, right? So, and for us, we have about 30% of our overall business that sits in private equity or large accounts like that, so it's not overly weighted. I think that's healthy, because we've got a good balance between the very big accounts and then that long tail of accounts that are not a part of private equity, which is good for us and the patients. The other thing is we've got over 2,100 accounts that have used the product, and they've got product stocked, and they've got patients that have been treated, which is also very good. So it's not like we're reliant on just a, you know, very specific subset of offices to drive the lion's share of the business. And the breakdown for that is about in line with what you're gonna see in the marketplace for anti-VEGFs as well. It's not. We've been very deliberate to make sure that we can get into the right offices, have a good relationship, and be able to treat patients in the very big clinics, but also make sure that we've got breadth across the other accounts, including academic centers. I think one of the misnomers is that we don't have a lot of penetration in academic centers. We have a lot of academic centers that have the product available. Those centers don't tend to treat as many patients as maybe some of the private equity groups do, but the ability for that, the patient to have access to that product in the academic centers is good, across the board, and we've got some very good relationships with some very large accounts, like the Kaisers of the world and others that have product available for patients in those centers as well. I know you've mentioned that you have use across a number of different types of centers, but maybe is there one type of center that you find, particularly when you have conversations about the Syfovre efficacy relative to Izervay or about the safety profiles, that you find you have more traction in? I look, I think at this point. The answer to that might have been different when we were going through some of our safety challenges last year, right? I think it's important to remember that the safety challenges that we had have been very stable, right? And we haven't had any additional challenges, all the way through, you know, up until now. So, I think today what you're gonna find is that the penetration is pretty consistent across most of the accounts that we have. Now, the larger accounts that have more patients and more physicians, and they've got, you know, 10 or 15 doctors that are treating patients in there, obviously that's a place for us to have a lot more focus, just based off of the ability to treat more patients. But at the end of the day, I think the uptake across most of those accounts has been fairly consistent. So I think it's, you know, again, we're not overly weighted anywhere, and we've got good consistency across the accounts that we have that have brought product in. So I feel confident that we're gonna continue to do that. Makes sense. And just on the topic of kind of your commercial strategy, particularly as it relates to competition, I mean, economics are a big part of some of these retina practices in driving prescriber decisions. I guess, how should we think about broadly some of maybe your potential contracting decisions or potential for giving discounts to certain practices? Yeah. No, great question. So, look, I think it's important for everyone to know that contracting in the buy and bill space, not just for this product or any product in the eye care space, but generally speaking, is common practice, right? It just happens. It's one of those things that helps drive the business overall. It's one of about 20 levers that you can pull in the commercialization of a product. So I don't think you want to overweight it in your thinking, but I also want to make sure that people know it's just part of what we do. I will tell you that, we've got contracts in place, but they are one of the things we've not done is chased the really big rebates, which is one of the things that our competitor has done. They've really put some big rebates out there, and we've played it where we need to, to be in a fairly good balance, but we haven't gone to a deep discount on certain things that and most companies would react to that and do the same thing. And we've tried very diligently to balance the economics with the efficacy story, as well as the increased effects over time that we have. This product gets better over time for patients, and we know that if we put all of that in one big story, it helps us manage the discussion in a clinic better than just contracting. So I think it's important to keep that balance in mind. We're doing the best we can to manage that. I think we're doing the right things, and I don't think we'll ever chase the biggest, uh... We won't ever chase the biggest rebate number because it's not practical, and it's not the right thing to do long term for the brand. But, you know, again, at the end of the day, it's one of, you know, several levers that we've got to pull, and we do. You know, we have contracts in place because it's the right thing to do for the patients to have access. But that's just part of the business model that we're in. Understood. So maybe just from, you know, our modeling perspective, how should we think about gross to net, you know, going forward, say, in the near term as well as long term relative to the quarters that we've seen reported in the past? Yeah, so I mean, I can rely on Tim to maybe jump in here, too, but I wouldn't put a whole lot of guidance out there on gross to net. We're still early in the launch. There's things that we're working through to get where we need to go and to grow the space here is a big responsibility for the market leader. That's our job. And we hope that Astellas will come on board and do that with us. They haven't yet, but we would like them to, because to grow that market would be healthy, and you gotta do some things in that environment to grow a market that is gonna be a certain amount of spend to get there. So the gross to net is probably not something we're gonna put a lot of guidance behind because it can change up and down as we move forward. I don't know, Tim, if you've got any comments on that. Yeah, I would say the same thing. We don't guide on gross to net. You know, different quarters will have different amounts of degradation or whatever, but typically what you'll see is that over time, gross to net does degrade over time in these buy and bill spaces where you do some contracting, because that's just the nature of the game. But we can't guide on a quarter-to-quarter basis or really over the long term. Okay, makes sense. But fair to say, we shouldn't see, like, a dramatic, you know, uptick in discounts, but maybe slowly over time? I think what you'll see is that we you know, for example, when you talk about, when David talked about our competitor having, you know, being aggressive in a particular quarter, we can't not respond to some extent to make sure there's no disincent you know, sufficiently disincentive, sufficiently sized disincentive, I should say, to use one drug or the other. What we won't do is overcompensate or chase where we don't think it's valuable. I think that's what we have to be judicious, and I think that's what David was saying. Yeah. So, you know, you'll see some degradation. It's just the nature of the business, and you'll see some contracting. Again, it's, like David said, the nature of the business. That's helpful context. Another question that we get a lot from investors is just the long-term patient adherence, particularly since this is the slowing of the growth, not necessarily patients seeing improved vision. I guess, what have you seen in terms of patient adherence, both in terms of showing up to their appointments, you know, at the scheduled frequency, as well as, you know, the rate of potential discontinuation so far? Yeah. Look, I still think it's a little bit early because, you know, if you think about this for a second, Eli, the market penetration in the patient base. Remember that 50% of these patients sit in an injecting office and 50% sit out. In the 50% that sit in an injecting office, 13% penetration has happened, right? So it is very early for us to have the right amount of data to say that we can pinpoint exactly discontinuation rates and, you know, the uptake in certain situations for people to be on adherence for a long time. I will tell you, I think I'm pleasantly surprised with what I hear from physicians on adherence for patients that have started the product. I think what really helps us is the fact that we've got large studies with every other month dosing from the very beginning, so we've got clinical data and efficacy that matches up to every other month dosing... and that's a really good selling point for these patients to continue to come back, because it's, it's as few as six doses a year, right? And they can still get the efficacy out of it, and the real-world data that we're seeing is that those patients continue to wanna stay on product because they know that there is that there's an issue that they, long-term, are gonna go blind from. The other thing to keep in mind is the GALE study. When we moved the GAIL study, when we came out of that, on the back end of that, when we moved those patients, everyone went to product, and the majority of those patients went to treatment. When we went into the GAIL study, after 12 months, 92% of those patients remained on product, right? So they're in. That's, you know, we've got another year of that study still, and 92% is a really good indicator of how these patients believe that they should stay on treatment, and the fact that we've got efficacy in every other month dosing, and some flexibility in dosing, too, 'cause we've got some patients on every-month dosing. I think they believe that it's the right thing to do, and I think the physicians, at least the feedback I've gotten, is that they feel really good that these patients are in for the long haul. You're gonna have some discontinuations, you'll have some fall-off. All that's gonna happen. But what we anticipate, and what we've seen in some early data, it's much like what you'll see in the anti-VEGF space. So it's not surprising, you know, when we see some of that. Yeah, I think that's one of the surprises that some people got, is that there hasn't been much variation versus what we see with anti-VEGFs. And I personally think part of that, and David, you chime in, is it's not just the length of data that we've shown, but the increased effects over time does drive that mentality, that this is something that if you stick with, it's gonna have a greater benefit. Agreed. Ah, that's encouraging. And I think when the clinical data was coming out, a large investor debate was on, you know, the onset of new-onset exudations. Maybe just what are you seeing in the real world in terms of that, and in particular, like, you know, the need for VEGF use with Syfovre? So I think it's in line with what we've seen in, you know, in the studies. I don't. It's not a conversation that has come up that is out of line with what we would expect. So I don't, I don't think, Eli, unless Tim's got any comments on it, I don't, I don't think there's anything there that's surprising, from based off of what we've seen in studies and moving into commercialization of product. I don't know, Tim, if you've got any comments on that. No, the only comment I would make is that that isn't a topic we hear a lot. At least, I go to, I don't know how many conferences I go to, David. I go to about half of the ones David goes to, but I'm around the docs a lot, too, because it's important for all of us to kind of hear what the direct feedback is, and CNV is not, so new-onset CNV while on treatment is not something we hear a lot about. I think one of the counter narratives to this is whether you look at our competitor or us on a monthly basis, you have a certain rate, but it seems to track injections, right, and exposure to injections. So when you have the every-other-month flexibility, you get that decrease in conversion, at least we showed that in our studies. So there's, you know, that is in some cases much, much closer to what you saw in sham. So the every other month does improve that, and I think that's one other thing that drives physicians, the safety of the every-other-month injection, and I think that's another thing that drives physicians to prefer that for a lot of their patients. Yeah, agreed. And just a question from the inbox: "Are you feeling more positive about Q3, given the positive inflection you're seeing with new starts? Great question. So look, I think it's super important to make sure that we set some expectations here, that we have still got to grow the market, right? And that's super important. And the market, you know, has been something that has flattened out a little bit. I think the biggest driver behind that is the fact that we have a competitor that's done nothing but talk about safety. And it's important that we turn the corner as a collective group, both us and them, to talk about treating patients, efficacy, making sure we grow the space. I'm confident that we're gonna, you know, be in a really good place long term, but this is it's a tough corner to turn in regards to when you you know, you think about this for a second. When you've got a competitor that walks into an office and they talk about nothing but safety, that's the only message they've had. It makes my team go in, and the first question they have to answer is a safety discussion, right? And then you gotta get to efficacy, and then you gotta get to other things about the product, and that are more important than the things that we've been through, because it's stabilized, right? So I think, you know, it's taken some time to get there. What we need is some discipline in the marketplace to grow the market and to have the right conversation, so we can continue to see that growth that we expect, and I think it's important for us to keep that in mind. But Tim can comment on it, too, but that's, you know, that's my- Yeah, sure. You know, what I'll just say is that the, you know, the NRXs were, you know, in Q2, were trending down, and that continued in the start of Q3, and it did dip below, slightly below 50%. It stabilized, and we've seen some comeback in that, so we've seen some positive trends in Q3, and I think our biggest effort right now is maintaining that leadership position, growing the market. Those are our two levers right now. It's a gigantic market, and it really is just we've really just scratched the surface on this, so from our perspective, when you're looking at 15 or 14 or 13, whatever the exact% is, of patients that are treated, who are seeing, you know, a retinal physician or an ophthalmologist, that's just a huge market remaining for us. What we really need is just, as David said, to grow the market, and we have a number of things that, you know, David can talk about, that we're implementing, including a DTC campaign that's branded with Henry Winkler, which should be kicking in. That was always a big tailwind for us. Henry seems to be very popular with the demographic. You know, that's our goal, really. Our goal is to grow the market, and, you know, we believe that our competitor has moved to the same mindset, so that's a positive for everybody. Yeah, I agree. I do the other thing is, Eli, I think, to Tim's point, we do have, as part of this market growth, so DTC is a part of it, right? But the other thing that we're doing is we've got a few initiatives outside of the retina specialty offices. So we've got an OD team that is in place to help us get referrals to move into retina specialists. That's a telesales or, you know, kind of a virtual group. Then we've also got an ophthalmology team focused on general ophthalmologists that is in progress now to get finalized, that will help us grow the market. And I think that will certainly help pull patients over into treating offices or injecting offices. I think, you know, our competitor is in a position to do some of the same things, which will help, so to Tim's point, our goal is to grow the market as the market leader, and then make sure that those patients get to Syfovre because of the efficacy and what the product does for patients. Yeah, absolutely makes sense. I mean, there's if only 15% of GA patients are seeing a retina specialist, that's obviously a huge opportunity. Yeah. Maybe just so that we can be clear on, I guess, what the overall GA start volumes are versus what you're seeing in terms of market share. I know you mentioned you're seeing, like, an uptick in your market share recently, but maybe just what are you seeing kind of overall in terms of new starts and volumes in the GA space overall? Is that, you know, a steady number of new starts per month, say, or is that decreasing relative to, say, what you've seen in the past? Yeah, so this goes back to the market size, right? And to the growth that we need to see in the market, and we definitely saw it flatten out. When you go back to the August period, and you guys, you know, have the data as well, but you can go back to the August period, and you kind of saw the market flatten out a little bit. I think that was a direct correlation of, you know, a safety message that was generated by the competition. What we're seeing now is that market starting to uptick, and I think it's a large part of it is because of the discussions that we're having around efficacy. The recall around the attributes of the product and the efficacy behind it is significantly higher than what we would've seen in the front end of the year, which I think is positive, so you're starting to see an uptick in the market, which is very good for everybody, but it's still, you know, we need to push that more. I mean, and there's so many patients out there that we just need to make sure that they have an option to get treated, and they are in the right offices to do that, so I, the specific numbers, I would have to go back and take a look at the very specifics, but the good thing is we're starting to see a few upticks in the market. Also, I would mention that this is our first kind of, sort of semi-normal year, right, since launch. I would certainly not characterize a year ago as a normal anything. So, understanding seasonality and what August looks like in any one year versus another or any one month versus another is sort of something we don't have a normalized experience for yet. So, you know, the more we know, and the more we'll be able to guide on things like that, but that's one of our challenges, is this the first real year we've ever had. Understood. And one last question, since you did mention this, Tim, in your comment just there. What's your philosophy on guidance from here since- Well, you know- Like, will you guide for GA sales next year? Oh, I don't think we'll commit to anything yet, but I certainly think we're you know, the more we know and the more we feel comfortable saying, it's reliable, and you know, we'll try to give you in terms of color. I can't commit yet to revenue guidance. I know everyone wants it, but you know, we don't wanna do it until we feel very comfortable we can give you something that we can stand by. Understood, well, Tim, David, thank you both for joining us. Thank you, Eli. Yeah, thank you very much.