Apellis Pharmaceuticals Inc at Jefferies London Healthcare Conference Transcript

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

Question: Akash Tewari - Jefferies - Analyst : Awesome. Let's get started. And obviously, news this morning from Astellas CRL on the every-other-month dosing profile, now, it seems like it's not having to do with safety. It does seem to be a statistical analysis that the FDA kind of has an issue with. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 19, 2024 / 8:30AM, APLS.OQ - Apellis Pharmaceuticals Inc at Jefferies London Healthcare Conference I know, obviously, we're looking from the outside in. But Cedric, do you have any early thoughts on what could be the issue with that clinical profile and the stat analysis that the FDA is looking at?

Question: Akash Tewari - Jefferies - Analyst : Understood. And my early suspicion is it might have to do with the nominal p-value with the every-other-month dosing. Let's put it this way. If you were CEO of Astellas right now, I mean, I feel like the option would have to be -- I think if you were going to have data to rectify the concerns with the FDA, they probably would have submitted it by now. I would think you would have to run another clinical trial in order to get that type of language on the label. What's your take? I mean, is this probably

Question: Akash Tewari - Jefferies - Analyst : And let's just think more practically. Because I think if you go to AAO, they certainly talk about the importance of every-other-month. Our survey work suggests it's about 80% to 90% of dosing. But I think the pushback some people might say is, okay, they don't have it on the label. But doctors are going to use that anyway for IZERVAY. How does that calculus change when you actually don't get it on the label and you receive a CRL from a payer perspective and also from a physician perspective?

Question: Akash Tewari - Jefferies - Analyst : Understood. Now I think there were certain aspects of the IZERVAY launch that surprised me as an analyst but then, I think, may have also surprised your team, A, their aggressive discounting out of the gate. B, I think their language around safety was a bit -- they led with that more than just the clinical profile. Now that you have every-other-month dosing, you have a significant, at least, near-term benefit versus your peer. What does that change in terms of your commercial strategy, A, in terms of willingness to pay price; B, in terms of your aggressiveness in investing in the launch over the next year?

Question: Akash Tewari - Jefferies - Analyst : Understood. Now, you've gotten the question on, hey, can Cedric guide? It's a tough question because you have to deal with the J-code, their new pricing strategy, the evolving safety landscape. It's a tough ask. Especially, it's also kind of two of your own launch. But as we go into 2025, it does seem like you have a better handle on what's going on with retinal vasculitis. You have a better handle on what your competitor has from a label perspective. And then you are seeing volume growth, but sales maybe hasn't inflected as much. What is the appetite to potentially start guiding for 2025? What visibility have you been able to get in the back half of the year?

Question: Akash Tewari - Jefferies - Analyst : Okay. Under consideration, but not necessarily committed. Understood. When we think about retinal vasculitis, I mean, if you're covering Apellis or if you're investing, it's kind of a ritual to file your FOIA request at the right time every month. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 19, 2024 / 8:30AM, APLS.OQ - Apellis Pharmaceuticals Inc at Jefferies London Healthcare Conference We are starting to see -- but they're low -- cases spatteringly for IZERVAY. When you had interactions with the FDA -- and the calculus for the agency of including a warning on retinal vasculitis on the label, it seems like you would lean more towards caution, simply from a safety perspective. Is there a threshold of retinal vasculitis cases that you would have to see in the class where you would think that the FDA would look at it more from a class label perspective and not necessarily just your product? Any color there would be helpful.

Question: Akash Tewari - Jefferies - Analyst : Now, I think over the last year and as investors have started to understand the retinal vasculitis cases, I think the question that's been put to your team is, hey, you're at a rate where it's not increasing. You've removed the Beovu option, but there is still that perception on safety. And there were two ideas that, I think, have been posited by investors, and you've talked about it as well: A, potentially developing a blood-based biomarker to prospectively identify patients that might have, let's say, a PEG allergy. And then number two, hey, why not run a trial with, let's say, RCA, where it's like, hey, I'm going to give half a dose of SYFOVRE and then a full dose. So -- because maybe it's -- you're priming the patients, giving a lower dose. And you'll have -- even if you do have vasculitis cases, they're going to be less severe. What is the appetite within Apellis right now to do some of these kind of safety studies or to develop this type of blood-based biomarker versus, hey, I really need to spend on EMPAVELI and look at label expansion into other indications outside of C3G?

Question: Akash Tewari - Jefferies - Analyst : Understood. Now, I think the question we often get from investors is like, okay, PE-backed practices, there's going to be strong uptake out of the gate. But in a community center setting, will this market ever grow to the extent that people really want -- and I feel like in order for this to really

Question: Akash Tewari - Jefferies - Analyst : Understood. Now, I cover Regeneron as well. And it's funny to kind of see the game of telephone between Roche's commentary on Vabysmo and then high-dose Eylea. If you talk to Regeneron, they're like, oh, we're getting a lot of patients who are coming off Vabysmo. And then I'm sure when Peter Welford will talk, with Roche, they'll say we're getting high-dose Eylea patients. But I think the point here is that in wet AMD, patients try everything, right? And I don't know if that paradigm has existed yet in GA. But it seems like, logically, that should be where this is headed, where it's not a binary outcome. You're going to end up having a lot of patients who end up trying both drugs. In terms of your patient starts for SYFOVRE right now, how many of them are patients who have maybe previously tried IZERVAY? And how do you think that dynamic of re-treatment with another product evolves over time? Should we be thinking about this from a binary view?

Question: Akash Tewari - Jefferies - Analyst : Okay. Understood. Now, obviously, sales maybe didn't increase as much in Q3. But you did see volume growth, right? So talk to me about that dichotomy, right? What's going on that's leading to reduction in revenues, but then you're still seeing volume uptake? And how should we think about that calculus for 4Q? Are we going to see volumes uptake and revenues uptake together, or are we still going to have kind of this disconnect?

Question: Akash Tewari - Jefferies - Analyst : Right.

Question: Akash Tewari - Jefferies - Analyst : Now, in terms of pricing generally, I know when IZERVAY kind of initially came out with a discounting strategy, you said, look, we have a better product. We have a better efficacy profile. We don't necessarily want to pay price. I think as we got towards the middle and back half of the year, it's like, okay, there is still some discounting that's occurring. As we go into 2025 and beyond -- and now you do have visibility on maybe the clinical profile of your competitor -- what are your thoughts on pricing dynamics evolving from a gross-to-net perspective? I mean, are we going to continue to see secular declines on ASP or maybe more stability?

Question: Akash Tewari - Jefferies - Analyst : Okay. Well -- and obviously, you can't give guidance, but let's put it this way. You'll often hear from investors that, gosh, I've never seen a launch flatten out and then return to growth. And there are some examples there, but they're rarer, right? It's rare to see a launch flatten out and then actually return to growth. I think Neurocrine is a good example during the pandemic. With what you know right now, are you confident that, let's say, SYFOVRE can return to meaningful growth in 2025? Let's just put it that way.

Question: Akash Tewari - Jefferies - Analyst : Right.

Question: Akash Tewari - Jefferies - Analyst : Understood. I hosted the Madrigal team last week, and they made a comment that was kind of interesting to me. They can really -- they're like, you're not going to get ads for Rezdiffra unless you're coded to have MASH. With AI and technology in identifying patients, I don't think investors realize how much you can prospectively identify the patients who might have MASH or let's say C3G. Obviously, it's a very rare disease, but there should be pretty high unmet need, particularly, in that adolescent patient population. What work are you doing right now to identify patients out of the gate that would need this drug? And given the data is public now, what are you seeing from physicians coming to you and saying, hey, I'm interested in your clinical profile, I'd love to get my patient on that drug? Any comments we offer? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 19, 2024 / 8:30AM, APLS.OQ - Apellis Pharmaceuticals Inc at Jefferies London Healthcare Conference

Question: Akash Tewari - Jefferies - Analyst : Would you agree that there might be a bolus of demand for certain patients who are early stage, who haven't necessarily gotten on dialysis yet? Or it's like, no, this is such a rare disease. It's going to take time for us to identify that. That shouldn't be necessarily the expectation.

Question: Akash Tewari - Jefferies - Analyst : Understood. Now, on EMPAVELI, I think you'll hear from investors who might be more skeptical, they're like, look, the dosing profile is maybe not optimal. But I tend to think, you just talked about the C3 siRNA drug. And I feel like where this is headed is you establish the commercial infrastructure with EMPAVELI. And then if the siRNA drug ends up working -- and I wouldn't be surprised if that ends up having a better dosing profile -- there's a very natural switch to occur. Is that the way we should be thinking about it? It's kind of this one-two punch with EMPAVELI with a mAb approach, higher dosing, but then an siRNA with a much better dosing profile over time. And that's why you guys are invested so much in expanding C3G indications.

Question: Akash Tewari - Jefferies - Analyst : Understood. I know we're out of time. I'm getting the look. (multiple speakers) end it here. It's great hosting you. Thanks so much.