The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Phil Nadeau - TD Cowen - Analyst
: Before diving into SYFOVRE's commercialization in a bit more detail, I did want to ask a broader financial question. Tim, the guidance
that you recently issued is for your cash balance to fund operations through profitability. It seems like some investors are either
skeptical of that guidance or they worry it's too dependent on SYFOVRE growth. What are these investors missing? Can you talk a
little bit more about the cash flow?
Question: Phil Nadeau - TD Cowen - Analyst
: Diving into SYFOVRE's commercialization, you had a very strong Q4 with revenue up 10% quarter over quarter, which beat consensus
when it was preannounced back in January. What drove the strength in this quarter? How much of was it organic demand versus
other things like inventory stocking or gross to net?
Question: Phil Nadeau - TD Cowen - Analyst
: Astellas recently had a label update where they had the duration restriction removed. But every other month dosing was not added
to the label. How would you assess SYFOVRE's competitive position today versus IZERVAY?
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MARCH 03, 2025 / 3:30PM, APLS.OQ - Apellis Pharmaceuticals Inc at TD Cowen Healthcare Conference
Question: Phil Nadeau - TD Cowen - Analyst
: We surveyed physicians ahead of the conference asking where they thought share would be in a few years. And as we projected
this morning, the weighted average answer was about a 50-50 share split between SYFOVRE and IZERVAY, which is actually a recovery
from, say, a year ago when it was more 40-60 or even a little bit worse with most of the share going to IZERVAY. So it seems like
concerns over safety issues have really subsided.
Where is your share today? And what's Astellas' goal to where it could be in a few years?
Question: Phil Nadeau - TD Cowen - Analyst
: Can you talk about trends in Q1? I think you had a couple of notable comments on the earnings call. One was there is some seasonality.
And two, there's the issue with the third parties who are helping with co-pays, I guess, talk a bit more about the trends and what
specifically is that issue at the co-pay assistance providers?
Question: Phil Nadeau - TD Cowen - Analyst
: And is this something that all the companies are aware of, so they could accelerate the timeline in providing new funding? Or is the
funding sources -- or are they typically locked into a certain time of year where they make their donations?
Question: Phil Nadeau - TD Cowen - Analyst
: Last question on SYFOVRE before moving to C3G. What is your long-term vision for SYFOVRE? You mentioned the 1.52 million people
with GA in the US. Ultimately, what penetration is possible for complement inhibitors? What share do you think you could achieve?
Question: Phil Nadeau - TD Cowen - Analyst
: Great. Let's turn to C3G and IC-MPGN, recently filed to extend EMPAVELI's label to include those indications based on the VALIANT
data. Can you walk us through the highlights of the VALIANT data? And what in particular do you think will be most persuasive to
physicians?
Question: Phil Nadeau - TD Cowen - Analyst
: Novartis is also filed for approval of Fabhalta in C3G. Can you compare and contrast the profiles of the two drugs as well as the likely
indications for both?
Question: Phil Nadeau - TD Cowen - Analyst
: Skeptical investors suggest that the magnitude of proteinuria reduction isn't important that I think date suggests that if you get to
a certain level of proteinuria reduction, you're stabilized in the kidney and therefore, yes, you get a better one for EMPAVELI than
Fabhalta, but it doesn't really matter. What do you think these investors are missing?
Question: Phil Nadeau - TD Cowen - Analyst
: And in terms of convenience, the skeptics also point out Fabhalta is oral. In a condition like C3G or IC-MPGN, does oral convenience
matter?
Question: Phil Nadeau - TD Cowen - Analyst
: Who do you think will be the early adopters in this market, will it be the most severe patients who are already having a decline in
kidney function? Will it be kids or patients earlier in the course of the disease to preserve their kidneys? How do you see the adoption
progressing?
Question: Phil Nadeau - TD Cowen - Analyst
: TD Cowen projects approximately $675 million in 2030 sales in the US in C3G and IC-MPGN in 2030. It equates to about 30%, 35%
penetration in the market. How does that estimate strike you? Are we being conservative, aggressive?
Question: Phil Nadeau - TD Cowen - Analyst
: We've recently announced two additional Phase 3 trials in kidney indications, one in FSGS and the other in delayed graft function.
Can you talk about those programs and the rationale for EMPAVELI working now?
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MARCH 03, 2025 / 3:30PM, APLS.OQ - Apellis Pharmaceuticals Inc at TD Cowen Healthcare Conference
Question: Phil Nadeau - TD Cowen - Analyst
: Moving on to the pipeline in the last couple of minutes. You referenced 2007 in your opening remarks. What's the goal of that
program? Ideally, when you combine that with SYFOVRE, what do you hope to accomplish?
Question: Phil Nadeau - TD Cowen - Analyst
: Can you give us some idea of the timing of the milestones in that development plan like when could we see the first data? When
could you move into pivotal studies?
Question: Phil Nadeau - TD Cowen - Analyst
: Great. With that, I think we're out of time. Thanks so much for an interesting discussion.
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