Apellis Pharmaceuticals Inc at Citi Global Healthcare Conference Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Yigal Nochomovitz - Citi - Analyst : Yeah. Well, yeah, that was a good meeting with Pascal and the old guard, I guess. Okay. So let's start with the new indication, which -- well, it's not so new for you, but for -- maybe for investors that need to understand it better in kidney disease, C3G, IC-MPGN, you had some very nice data, Phase 3 data recently a few months ago. Tell us about it, tell us about how you believe it could impact patients, and I'm sure we'll have plenty of detailed questions soon?

Question: Yigal Nochomovitz - Citi - Analyst : So I think it would be helpful if you could just -- I think there's still some not confusion, but just help us understand the difference between C3G and IC-MPGN. I mean are they distinct, are they related? And the point being is that your -- you've studied both of those populations. The competitor -- the oral competitors not generated data yet in IC-MPGN and as far as I understand, and it may not be for a few years. So maybe just help us understand that a little bit better?

Question: Yigal Nochomovitz - Citi - Analyst : So since you've covered all year basis in terms of both of the phenotypes and then the pre- and the post-transplant and in terms of pediatrics and adults. So, you have covered everything. And the competitive molecule is oral. So there's some discussion around oral versus subcu, but there's not a parallel there in terms of what's been explored in the clinical setting? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 05, 2024 / 6:00PM, APLS.OQ - Apellis Pharmaceuticals Inc at Citi Global Healthcare Conference

Question: Yigal Nochomovitz - Citi - Analyst : And so just really quickly, just remind everybody when you're filing that's, I guess, an sNDA or how would you characterize it?

Question: Yigal Nochomovitz - Citi - Analyst : Okay. And you have teams in place that you're working on building out that commercial effort?

Question: Yigal Nochomovitz - Citi - Analyst : I mean, we've talked to a number of KOLs, as you know. And they obviously highlighted the very strong efficacy. And I think some of your experts obviously have noted that having the efficacy should be the determining factor over maybe slightly better conveniences with oral. I guess I've kind of summarized it, but anything else you want to add to that statement?

Question: Yigal Nochomovitz - Citi - Analyst : And like in some other areas in development with your pipeline, you've done long-term extension studies. Do you have such a plan for C3G, IC-MPGN to continue to monitor or like to see longitudinal benefits on eGFR beyond the primary endpoint?

Question: Yigal Nochomovitz - Citi - Analyst : Okay. And then what are the plans outside of the United States to develop this indication?

Question: Yigal Nochomovitz - Citi - Analyst : So they have the rights to the glomerulopathy, okay.

Question: Yigal Nochomovitz - Citi - Analyst : Okay. And what about other territories, they have everything outside the United States?

Question: Yigal Nochomovitz - Citi - Analyst : So Asia as well? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 05, 2024 / 6:00PM, APLS.OQ - Apellis Pharmaceuticals Inc at Citi Global Healthcare Conference

Question: Yigal Nochomovitz - Citi - Analyst : Okay. Great. And as far as other conference presentations, I mean, you've given a lot already, but what's the -- is there another data point that we should be looking for outside of the typical regulatory?

Question: Yigal Nochomovitz - Citi - Analyst : Yes, just in terms of other clinical -- I mean, I know, for example, I mean in ophthalmology, you have many studies that beyond the -- go beyond the primary data?

Question: Yigal Nochomovitz - Citi - Analyst : I'm curious, what other settings would you be worth pursuing?

Question: Yigal Nochomovitz - Citi - Analyst : Okay. Well, those -- we follow a lot of those companies as well in IgA and all cards of interesting possible scenarios for combining because those, for example, like Travere, the different, I mean (inaudible) is a steroid, but Travere, that's maybe like an orthogonal MOA, so it could be interesting. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 05, 2024 / 6:00PM, APLS.OQ - Apellis Pharmaceuticals Inc at Citi Global Healthcare Conference Okay. Very good. So maybe we should spend a little bit of time on ophthalmology. So just give us the latest updates as far as how you're seeing -- how you're seeing the launch progress. We're -- you're now almost -- well, I guess, 7.5, 7 quarters in something like that?

Question: Yigal Nochomovitz - Citi - Analyst : Tell us how you've got that -- is it almost five years now? How long -- how much time do you have on that?

Question: Yigal Nochomovitz - Citi - Analyst : Beyond four, okay. That's almost five.

Question: Yigal Nochomovitz - Citi - Analyst : Tell -- I mean, we want everyone to succeed, but still -- I mean, I remember when Adam Townsend made the point about getting the two-year data on the label from the outset and that whole situation back then, which we won't discuss too much. But basically, that clearly was the right decision. And then -- and now, of course, Izervay doesn't have that claim, at least not for a little bit. So how is that -- how are the retina experts thinking about that because that's clearly an important point?

Question: Yigal Nochomovitz - Citi - Analyst : And they can't improvise, right? They can't take, I mean there's no data to support that?

Question: Yigal Nochomovitz - Citi - Analyst : I know, obviously, it's been a tougher road across the pond. Is there anything to say there? Is there another strategy? Is there -- could that come back into more focus with more data, real-world data, more KOLs? I mean both you and Iveric, Astellas have had similar challenges over there? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 05, 2024 / 6:00PM, APLS.OQ - Apellis Pharmaceuticals Inc at Citi Global Healthcare Conference

Question: Yigal Nochomovitz - Citi - Analyst : But it's -- like you've explained to me and others many times, I mean this BCVA, this is an old tool, right? I mean, you put it on the wall, and you read letters. It somehow may not be the most appropriate assay, so to speak, right, for GA because of the nature of GA and the way that the lesions creep around the fovea and so things of that nature?

Question: Yigal Nochomovitz - Citi - Analyst : You're not going to move your head around trying to see every part of the big letter?

Question: Yigal Nochomovitz - Citi - Analyst : Understood. Let's spend a little time on PNH, if we could. It's doing well, but it's sort of trending to -- I don't know what you want to say, but it's decelerating. So talk about where you see that growth if it's really more of a mature product now. Or how should we think about that for going forward? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 05, 2024 / 6:00PM, APLS.OQ - Apellis Pharmaceuticals Inc at Citi Global Healthcare Conference

Question: Yigal Nochomovitz - Citi - Analyst : Okay. Let's talk about pipeline. I mean you've done some enterprising trials, some sort of high risk, high reward, i.e., ALS, which you characterize as a high-risk study. But there's some other programs that are in the earlier pipeline, if you could elaborate. And then you have a program to help with gene therapy, correct?

Question: Yigal Nochomovitz - Citi - Analyst : Those are disclosed programs? Or what -- can you say more there?

Question: Yigal Nochomovitz - Citi - Analyst : So you'll do teaser for the spring, okay.

Question: Yigal Nochomovitz - Citi - Analyst : By the way, are you going to have a different trade name for C3G? Are you going to call it Empaveli or what's the plan there? I'm just curious.

Question: Yigal Nochomovitz - Citi - Analyst : Okay. I do get a lot of questions around the path to profitability and the financing and the cash. So can you just maybe Tim just walk us through how you're thinking about that? I think you've made the point that you can make it to profitability with the growth of the existing business and the current expectations around the OpEx?

Question: Yigal Nochomovitz - Citi - Analyst : And what -- just to remind everyone what was that vehicle that allowed you to limit that risk on the --? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 05, 2024 / 6:00PM, APLS.OQ - Apellis Pharmaceuticals Inc at Citi Global Healthcare Conference

Question: Yigal Nochomovitz - Citi - Analyst : And then the balance sheet. So just to remind everyone, you -- is there -- have you extinguished all the debt? Or is there a piece there that's still existing?

Question: Yigal Nochomovitz - Citi - Analyst : That's a straight debt, not convertible?

Question: Yigal Nochomovitz - Citi - Analyst : When does that mature?

Question: Yigal Nochomovitz - Citi - Analyst : So what's the plan for the $93 million? You're just going to let it convert or you're going to early -- REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 05, 2024 / 6:00PM, APLS.OQ - Apellis Pharmaceuticals Inc at Citi Global Healthcare Conference

Question: Yigal Nochomovitz - Citi - Analyst : Okay. It's only $93 million. All right. Now any other -- what about external activity in BD? Anything -- are you looking at external assets? To what extent is that a relevant part of the business plan?

Question: Yigal Nochomovitz - Citi - Analyst : Okay. Well, we have some more time. So a few other kind of grab baggy questions. So everyone's asking about a few things, AI. Does that feature in any way in your organization, either for efficiency purposes or actually for real drug development or not?

Question: Yigal Nochomovitz - Citi - Analyst : Okay. And then as far as the marketing efforts with the social media and of course, the Henry Winkler and all these other -- so you -- how is that going? And do you expect to leverage that sort of effort for -- I mean, for C3G, maybe it's not really necessary, right? But I just --

Question: Yigal Nochomovitz - Citi - Analyst : Invite him to the next fireside?

Question: Yigal Nochomovitz - Citi - Analyst : Okay. Another new question, which only emerged after November 5 or 6 or whenever the election was. So I mean, on the manufacturing, just remind everybody, where do you source -- how much is sourced internally in the United States versus anything offshore as regards to the potential, more protectionist trade policy that could happen?

Question: Yigal Nochomovitz - Citi - Analyst : Okay. And you don't have to answer this one, but you can if you want. So any thoughts on the potential changes in leadership at the following HHS, CMS and the FDA?

Question: Yigal Nochomovitz - Citi - Analyst : More concrete question. I mean, given the change in leadership specifically at the your division, does that impact you in any meaningful way or, I mean, you're obviously approved. So it's kind of in the past, but I'm just wondering if that has any relevance now for you.

Question: Yigal Nochomovitz - Citi - Analyst : Yeah.

Question: Yigal Nochomovitz - Citi - Analyst : Perfect. Okay. Well, thanks again. We'll have Henry Winkler here next year.