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: Derek Archila - Wells Fargo Securities, LLC - Analyst
: Great deal of pleasure a the state of the union there and some of the business. But I do need to dig in first on SYFOVRE and the commercial aspects
of obviously, the quarter-over-quarter growth in Q2 was a little bit slower than what we had seen earlier in the launch and maybe just detail some
of the factors that occurred there. And then I guess, maybe a bit more outlook for the second half and whether those factors will abate or what
you guys are doing to address the slowdown?
Question: Derek Archila - Wells Fargo Securities, LLC - Analyst
: Beyond the retinol specialists, like how is the messaging different like the ODs and the others that you're looking for referrals? Like how are you
positioning that are SYFOVRE maybe just GA awareness?
Question: Derek Archila - Wells Fargo Securities, LLC - Analyst
: In terms of the competitor, pushing safety, safety narrative and you guys pushing the efficacy narrative. I guess when you talk to physicians that
are either new or even I know of SYFOVRE or the class in general like what part of the dataset resonates most from an efficacy standpoint?
Question: Derek Archila - Wells Fargo Securities, LLC - Analyst
: Got it. I guess in terms of like adherence to therapy, but also just net patient adds like obviously, the calculation people drop off and adding patients.
So I guess, how do you continue to see this evolve over time? And obviously, we only have the drug on the market for a short time yet but like
what's that duration of therapy looking like? And what do you think it will ultimately evolve to?
Question: Derek Archila - Wells Fargo Securities, LLC - Analyst
: And I guess in terms of the user base right now, so I know there's been a lot of concentration of some of the private equity owned practices. But I
guess how do you expand out of that? And ultimately, again, is the messaging different for the academic medical centers, let's say, relative to
maybe the more private practice?
Question: Derek Archila - Wells Fargo Securities, LLC - Analyst
: Got it. And also just how it from a patient perspective, how the journey in getting treated with SYFOVRE you're getting diagnosed with GA. How
is that changed since the launch? And I guess, again, where are we in like innings like awareness very high? Are we still just like inning number
three like where are we in that perspective?
Question: Derek Archila - Wells Fargo Securities, LLC - Analyst
: And you also talked earlier this morning about a new needle in the kit to maybe make the patient experience will be better also the injecting
experienced physicians, respect. Can you maybe just talk about that here, how that's been going and with the feedback?
Question: Derek Archila - Wells Fargo Securities, LLC - Analyst
: Got it. And just shifting gears again to SYFOVRE. I know you mentioned a little bit about the reexamination, so then it sounds like it's coming pretty
soon this month. So I guess, again, bring us back to I mean, you did submit some new data around microperimetry in the first I'll go around, but
just remind us of the timelines and when that new data went in and I guess, ultimately how you're feeling going into the opinion here?
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SEPTEMBER 05, 2024 / 1:30PM, APLS.OQ - Apellis Pharmaceuticals Inc at Wells Fargo Healthcare Conference
Question: Derek Archila - Wells Fargo Securities, LLC - Analyst
: So I guess if let's say it goes against you as negative, what are your options? I mean, would it just be to run another study or like what is the EU
opportunity worth it enough to do that?
Question: Derek Archila - Wells Fargo Securities, LLC - Analyst
: Got it. Maybe on the flip side as it goes your way, I guess in terms of like how you think about commercializing and EU ad I know we were talking
about this earlier about pricing and even how that might be different? Like what are your thoughts there?
Question: Derek Archila - Wells Fargo Securities, LLC - Analyst
: Well, let's shift gears to EMPAVELI in terms of you had some data in C3G and IC-MPGN and very interesting stuff, very nice activity. So maybe just
frame up the opportunities there versus from a commercial aspect?
Question: Derek Archila - Wells Fargo Securities, LLC - Analyst
: Got it. I guess you guys have decided that you want to file on the six month data. Can you just give us a sense of, again, obviously, the confidence
of filing on that versus, I guess, the 12 months, one of the competitors, that's what was required to do and ultimately the amount of data that you
would have amassed, I guess prior to the filing?
Question: Derek Archila - Wells Fargo Securities, LLC - Analyst
: That makes sense. And then maybe just in terms of so with this positive data like what does this open up for other renal diseases? And obviously,
as a bunch out there it's a hot area. So from what's your of speeds and prioritize that as another area of development?
Question: Derek Archila - Wells Fargo Securities, LLC - Analyst
: Is that something that you probably more for the R&D Day or that's a separate disclosure?
Question: Derek Archila - Wells Fargo Securities, LLC - Analyst
: And then maybe just in terms of the R&D Day that you are planning. I mean, obviously beyond just the I mean, all this is a new newer development.
Do you guys have talked about some of these earlier stage assets and pipeline programs and complement and different approaches, but maybe
just updates on those. And I guess just how you're thinking about investing in the early-stage pipeline and also balancing what you're saying earlier
in terms of getting the cash flow positive?
Question: Derek Archila - Wells Fargo Securities, LLC - Analyst
: Got it. So just two questions on emphasize EMPAVELI. One PNH related. So I guess that seems like a very stable business. But I mean, is there
opportunity for growth there? Or should we just assume we have pretty modest growth on that aspect and then just going back to the trial in C3G
and renal. So that was with the subcu, not like the pump patch, right, that's only in PNH right now? Is that correct? I believe that's correct.
Question: Derek Archila - Wells Fargo Securities, LLC - Analyst
: And then just beyond like the pump, is there any other work being done on EMPAVELI in terms of formulation to you? I don't know whether it's
cut down the frequency of injections or anything like that or you feel like that profile is totally adequate?
Question: Derek Archila - Wells Fargo Securities, LLC - Analyst
: All right. Cool. I think we'll leave it there, gentlemen. Thank you so much.
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