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: Anupam Rama - J.P. Morgan Securities LLC - Analyst
: Thanks, Cedric. I just want to remind everybody, there are a couple of ways to ask a question. (Conference Instructions)
Maybe I'll just start out with, when we spoke on the 3Q call, you indicated in the fourth quarter, maybe something more like flattish growth, but
you did beat consensus pretty handedly this quarter. But maybe you can walk us through some of the dynamics of what you saw in the quarter
Question: Anupam Rama - J.P. Morgan Securities LLC - Analyst
: We have an email question here, which is a quick point of clarification EMPAVELI sNDA for C3G and IC-MPGN, which is early 2025. So, if that's true,
you'd be filing on a 6-month VALIANT data set versus a 12-month VALIANT, a 12-month data set that your competitor at Novartis had to file on.
Do you have regulatory alignment on this sNDA submission and a 6-month enough?
Question: Anupam Rama - J.P. Morgan Securities LLC - Analyst
: Questions from the audience.
You talked a little bit about your updated sort of DTC efforts, but maybe you could talk a little bit more about your actual physician efforts, whether
it's at medical meetings, what -- how is the sales force messaging evolving?
Question: Anupam Rama - J.P. Morgan Securities LLC - Analyst
: Question from the audience.
On C3G and IC-MPGN, just where do you see that product fitting in both indications given kind of the competitive landscape?
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JANUARY 13, 2025 / 5:45PM, APLS.OQ - Apellis Pharmaceuticals Inc at JPMorgan Healthcare Conference
Question: Anupam Rama - J.P. Morgan Securities LLC - Analyst
: Question from the audience.
So you disclosed today a couple of new focus indications for EMPAVELI, FSCS, delayed graft function. When you looked at the white board of
options where you could take EMPAVELI, what really stuck out to you for both of those?
Question: Anupam Rama - J.P. Morgan Securities LLC - Analyst
: So what are going to be the key pre-commercial activities that you're going to be doing for C3G and IC-MPGN in this year, particularly you're going
to be filing soon, so?
Question: Anupam Rama - J.P. Morgan Securities LLC - Analyst
: Questions from the audience. Maybe just thinking about the path to profitability that you mentioned, how do we think about R&D and SGA trends
here because you are moving into some new indications you're also launching -- committing to launch. Yeah.
Question: Anupam Rama - J.P. Morgan Securities LLC - Analyst
: And then I guess, your competitor -- just going back to SYFOVRE in geographic atrophy -- basically did pre-file. How do you think about the range
of scenarios and outcomes there and how it could impact how you think about 2025 SYFOVRE?
Question: Anupam Rama - J.P. Morgan Securities LLC - Analyst
: My understanding is from a Class I filing that they've got 60 days, right? But what kind of pair dynamic shifts have you seen since CRL? And is there
an opportunity to expand on that? Yeah.
Question: Anupam Rama - J.P. Morgan Securities LLC - Analyst
: Do physicians have any sort of hesitation making the switch from IZERVAY to SYFOVRE? If a patient all of a sudden is no longer reimbursed for
IZERVAY or reaches a 12-month duration, and what happens now, do docs hesitate because they are different drugs, right? Their pegs are different.
Question: Anupam Rama - J.P. Morgan Securities LLC - Analyst
: Questions from the audience. Yeah, go ahead.
Unidentified Participant
And you mentioned two initiatives for SYFOVRE. One is to maintain the leadership and two is to grow the market. So I'm wondering if that growing
the market includes ex-US market and wondering if you could talk a little about.
Question: Anupam Rama - J.P. Morgan Securities LLC - Analyst
: Question from the audience. Cedric, you're going to be hosting an R&D day. You said, I think in the early spring, well, maybe final question for me,
like, how much more can we learn about the pipeline than you disclosed a little bit today already? But is it going to be focused on what you disclosed
today or is there going to be a broader unveiling?
Question: Anupam Rama - J.P. Morgan Securities LLC - Analyst
: Okay. Last call. Any final questions? All right. Thank you, Cedric.
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