Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) Q1 2024 Earnings Call Transcript

Francois Brisebois: Thank you. And then just quickly, in terms of the readout here, mid-year VALIANT readout, can you just help remind us, what would you consider a successful readout here?

Cedric Francois: Thank you so much for that question as well. We are very excited about the VALIANT readout. We believe that in C3G and IC-MPGN, there is a very high and unmet medical need that will be associated with an important new market for EMPAVELI. In the VALIANT trial, we have enrolled 124 subjects. A very large trial across both IC-MPGN and C3G, pre-transplant as well as post-transplant. And the primary endpoint is a logarithmic transformation in proteinuria, reduction powered to show approximately 30%, but a significant reduction in proteinuria is what we are looking for and will be placed in the context with some of the secondary endpoints as well.

Francois Brisebois: Thank you.

Operator: Thank you. One moment for our next question. Our next question comes from Adam Vogel with Wells Fargo. Your line is now open.

Adam Vogel: Great. Thank you for taking my call. I’m on for Derek today. Maybe just a little bit more on the VALIANT readout. How granular will you report this data out across each indication and setting? And then within those, is there like one that’s clearly the largest opportunity for you, or are they fairly similar across syndication and settings?

Cedric Francois: Thank you so much, Adam. So this is, again, a very large market opportunity and something that we’re really looking forward to reading out. I didn’t exactly hear a question because it was breaking up a little bit. Could you repeat that, please?

Adam Vogel: Sorry. Yes. So just across the indications, how granular are you going to be reporting out, like, each indication across, like, pre and post kidney transplant? And is there a market opportunity among these that is kind of like the largest opportunity for you guys, or is it fairly similar across each indication and setting?

Cedric Francois: Yeah. Thank you so much. C3G is the larger market and the larger opportunity in terms of patients compared to IC-MPGN. But I think it’s important here to point out as well that correctly differentiating between those two indications is also not straightforward. You have to look at histopath and make the determination there. I think for us, the purpose was to really go very broad, again, not just between the two indications, but also in the pre and the post-transplant setting. And especially in the post-transplant setting, we think we have a really unique opportunity to stand out as a best-in-class opportunity.

Adam Vogel: Got you. And then maybe just one follow-up on the SFJ loan repayment, is there any new color you can provide us on loan repayment strategies?

Cedric Francois: Thank you, Tim.

Tim Sullivan: Sure. Thank you, Adam. So — look, one of the things we look at carefully is our cash management. So ultimately, when you look at our SFJ payments, they amount to approximately $200 million over the next, call it 20 months. And that along with our increase in the receivables that we extend. So the credit we extend to the channel that represents a fairly large cash use for us. So obviously, we spend a good amount of time thinking about the best way to perform balance sheet management. And we have a number of options available to us. Tactical options, non-dilutive options are — there are several of those. So, we evaluate those all the time. We’ll update you if we plan to do anything there.

Adam Vogel: Great. Thank you.

Operator: Thank you. One moment for our next question. Our next question comes from Joseph Stringer with Needham & Company. Your line is now open.

Joseph Stringer: Hi. Thanks for taking our question. Just to follow up on a prior question on the switching between SYFOVRE and Izervay. Understand you haven’t provided quantitative metrics on this, but maybe I’ll ask a different way. Could you give us any color into perhaps the most common reasons why patients would switch between the two drugs?

Cedric Francois: Thank you so much, Joey, for the question. So, look, I think switchers, quite frankly, is not something that I think is an easy conversation between physicians and patients. When you are on either of the two drugs and you want to switch that patient over, you’re going to have a conversation around that. Again, we are mostly focused on the new patients and as they come on board and as we’ve mentioned, we have, of course, our differentiated efficacy profile work from. And again, it’s an enormous market and an enormous number of patients who are in dire need. Adam, Caroline, do you want to add something?

Caroline Baumal: I think it’s uncommon for physicians to be switching now. The majority of physicians are really very happy with our transparency, with our messaging, and with our efficacy. And in the long term, this is an elderly patient population. They want to have this true every other month dosing, which shows enormous efficacy for us into year three and beyond. And I think that really speaks to the doctors and they sort of understand the safety messaging, and — which has also been associated with intravitreal injections as a whole, understand that are able to inform their patients and have moved on from that.

Adam Townsend: And, Joey, just to add. It’s Adam. Yeah. So I think the switching dynamic did occur during the late summer months of last year. We have also seen some patients anecdotally switch back to SYFOVRE. And as Caroline says, our assumption there is that this is an efficacy-driven market. And these are incredibly well-educated patients and physicians. So we continue to see the strong majority of new starts start on SYFOVRE, and I think that’s a very positive indicator.

Joseph Stringer: Great. Thank you so much for taking our questions.

Cedric Francois: Thank you.

Operator: Thank you. One moment for our next question. Our next question comes from Douglas Tsao with H.C. Wainwright. Your line is now open.

Douglas Tsao: Hi. Good morning, and thanks for taking the questions, and congrats on the progress. Just, you’ve noted that this — that’s the way that seems to be a first injection phenomenon. I’m just curious, is there anything that you can do to lower the rate from the one in 4,000, which is already rare, but to minimize it even further? And I guess I’d just be curious if there are efforts both in the near term or perhaps longer term work that could be done. Thank you.

Cedric Francois: Thank you so much, Doug. Look, we are looking into ways to potentially predict the at risk patients that are there. But again, kind of placing things into context here. Right? I mean, the rate that we have here is similar to what you have with — for an infectious endophthalmitis, which is a risk that happens at every single injection that is done. Right. So most importantly, last year when we went into this, the question was, is this a problem that is just the beginning of much more? And it is not. So right now, we are in a period of stabilization. Physicians understand the risk. We’ve been incredibly, I think, good and transparent at communicating it. And now the dialogue is shifting towards efficacy.

Douglas Tsao: And I’m just curious, as a follow-up, to the extent that there are practices using both SYFOVRE as well as Izervay, do you get a sense whether the physician — sort of how has ultimately decided which drug a patient will get? Is it being left up to the patient, do you get the sense or is it sort of, are physicians choosing patients by any number of different reasons?

Cedric Francois: Yeah. Thank you. Caroline. Do you want to…