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: Colleen Kusy - Robert W. Baird - Analyst
: Fantastic. So yeah, let's dive into geographic atrophy. So yes, as you said, a year and a half into launch the first drug approved there, how is the
market of GA and similar different to what you expected now that year and a half --
Question: Colleen Kusy - Robert W. Baird - Analyst
: Great. And so you put out some additional functional data in the last number of months, including some that some presentations at ASRS, kind of
what is what are the data shown in And has that impacted physicians' perception of safe ovary and there further use?
Question: Colleen Kusy - Robert W. Baird - Analyst
: And have you seen the physician perception change with this new data? Do you think there's still education that needs to happen in terms of the
functional asset.
Question: Colleen Kusy - Robert W. Baird - Analyst
: Great. And on the safety science, and there is the eventual vasculitis that came out last summer, and we continue to see some rate of that today.
How is does your understanding of the events have that changed and kind of where where do you think the perception of the safety profile is
today?
Question: Colleen Kusy - Robert W. Baird - Analyst
: And have you seen physicians change how they use a [foree] in light of the vasculitis? And How have the kind of use patterns changed?
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SEPTEMBER 11, 2024 / 1:05PM, APLS.OQ - Apellis Pharmaceuticals Inc at Robert W Baird Global Healthcare
Conference
Question: Colleen Kusy - Robert W. Baird - Analyst
: And on that topic, how do you think about the segments of the GA market? Who are the most likely that are on treatment now and how big are
those separate segments?
Question: Colleen Kusy - Robert W. Baird - Analyst
: And have you seen those referrals from outside practices start coming in [yet]?
Question: Colleen Kusy - Robert W. Baird - Analyst
: And so on the more recent side of the launch, you've had a competitor come into the market now with the permanent J-code, can you just kind
of qualify for us the type of headwinds you're seeing in terms of new patient starts with the new competitor?
Question: Colleen Kusy - Robert W. Baird - Analyst
: What's been kind of driving that shift from that over the course of the change of the recent months as that settled in?
Question: Colleen Kusy - Robert W. Baird - Analyst
: Makes sense. In terms of the patients that you have on treatment, can you talk about the compliance that you've seen so far? And has there been
any kind of pickup in the time that patients are hitting the one year mark?
Question: Colleen Kusy - Robert W. Baird - Analyst
: And then over the remainder of the year, how should we think about seasonality and other factors that will impact the launch launch trajectory.
Question: Colleen Kusy - Robert W. Baird - Analyst
: Would you thought you'd be in a position to provide revenue guidance in '25?
Question: Colleen Kusy - Robert W. Baird - Analyst
: Understood. And then on the European side of things, yes, as you mentioned, some hiccups in that review. Now we're nearing the final review
coming this month. Maybe talk about what, what kind of drove the slight shift in time line things originally 4Q now we'll get that decision in
September?
Question: Colleen Kusy - Robert W. Baird - Analyst
: Understand, is there anything we're able to [glean] from rapitories this time around that could inform the outcome?
Question: Colleen Kusy - Robert W. Baird - Analyst
: Understood. And assuming you guys do get approved and yes, I understood uphill battle, but talk about launch readiness in Europe.
Question: Colleen Kusy - Robert W. Baird - Analyst
: And if this were to be, you know, in this decision in Europe, is that kind of the final now, should we how should we think about the finality of this?
Question: Colleen Kusy - Robert W. Baird - Analyst
: And now moving into Valley to systemic pegcetacoplan, which I know, historically, you've been spending lots of time on GAAP. Now we have
another indication and talk about. So you had the Phase 3 value data and C3G, ICMPGN that you referenced before, and I put that into context
versus the other drug that's out there.
Question: Colleen Kusy - Robert W. Baird - Analyst
: Great. And yeah, I think the feedback I've received two as an EGFR, a little surprised that you would even see something so quickly at the six-month
mark, and can you kind of talk about the response you're seeing there and how confident you are that separation will continue?
Question: Colleen Kusy - Robert W. Baird - Analyst
: Okay. As you mentioned the proteinuria as the approval end point kind of how confident are you that the FDA will accept the six month data? And
how do you think the EGFR data will plan to their review?
Question: Colleen Kusy - Robert W. Baird - Analyst
: And as you mentioned, you enrolled a pretty diverse set of patients in the study. Do you feel as though you have enough data to support approval
in both C3G in ICMPG on the study?
Question: Colleen Kusy - Robert W. Baird - Analyst
: And as you mentioned several that is an oral versus a subcu injection for and the value. How would you expect employee to compete against an
oral in this indication.
Question: Colleen Kusy - Robert W. Baird - Analyst
: And what's the guidance on the next interactions with the FDA and the filing timing?
Question: Colleen Kusy - Robert W. Baird - Analyst
: And so based on these data, then how does this change your view of other indications that the value might be a reason?
Question: Colleen Kusy - Robert W. Baird - Analyst
: And on the earlier stage pipeline, you'll have some Phase 1 data later this year for APEL3000 and seven's your SI RNA silencing asset targeting C3.
What can we expect from that Phase 1 readout? And what should what should investors be looking?
Question: Colleen Kusy - Robert W. Baird - Analyst
: And then the in partnership with something you announced a couple of years ago. Any updates that we can be expecting in the future?
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SEPTEMBER 11, 2024 / 1:05PM, APLS.OQ - Apellis Pharmaceuticals Inc at Robert W Baird Global Healthcare
Conference
Question: Colleen Kusy - Robert W. Baird - Analyst
: And is there a certain indication that you think that would be most applicable? And are you keeping things broad at this point?
Question: Colleen Kusy - Robert W. Baird - Analyst
: Understood. And then on the balance sheet, so you've made some strides this year to clean things up. Kind of talk about the current size of the
balance sheet and higher selling your cash position?
Question: Colleen Kusy - Robert W. Baird - Analyst
: And so another kind of region advanced since Adam Townsend role had been expanded from Chief Commercial Officer to include Chief Operating
Officer as well kind of what drove that slight change with the management team.
Question: Colleen Kusy - Robert W. Baird - Analyst
: And then so just in the last minute here, and we've covered a lot today, but if you can kind of summarize for us why investors should be paying
attention to pass over the next 6 to 12 months?
Question: Colleen Kusy - Robert W. Baird - Analyst
: Thank you for that summary. Thanks for being with us today.
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