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: Peter Welford - Jefferies LLC - Analyst
: Hi, thanks for taking my question. I've got two. So firstly, if we can ask on the C3G data that you've got with iptacopan. Curious, we see other data
for drugs in the complement pathway. I'm curious how you would compare particularly focusing on what a lot of clinicians seem to comment on,
which is the proportion of patients that managed to achieve at least a 50% reduction in proteinuria, where I believe the proportion with an was
relatively modest. So I guess, how important is that as an end point and how do you sort position this in the complement landscape?
And then just a similar one, if you don't mind, but the zigakibart, which is just there's an antibody, I believe that just recently read out similar data
-- similar mechanism, sorry, there's a few years ahead. I wonder if you could sort of contrast how you would compare your approach to theirs,
perhaps both in terms of the patients that you're targeting in Beyond and the mechanism more commute there are differences? Thank you.
Question: Richard Vosser - JPMorgan Chase & Co - Analyst
: Hi, thanks for taking my question. It's just a question on the commercial uptake of (inaudible) in PNH and thinking about the bridge support. So
just -- if you could give us an update on that launch, what proportion of patients are now commercial pay, how the Bridge program is going and
how you expect that proportion on the Bridge program to change over, over time over the next six to nine months? But just an update on the
launch would be great. Thanks.
Question: Richard Vosser - JPMorgan Chase & Co - Analyst
: Thanks very much.
Question: Simon Baker - Redburn (Europe) Limited - Analyst
: Thank you for taking my question. It's on C3G, but from a slightly different angle. Given that there are two genes that are implicated in C3G, and
given Novartis' expertise in June therapy, I was just wondering what your thoughts were on gene therapy options for C3G? And broadening out
that question on the basis that there are about 80 renal genetic diseases and given your heritage with [so Germanspher]. What do you see as the
opportunity? And what are you doing in the renal space with respect to gene therapy? Thanks so much.
Question: Simon Baker - Redburn (Europe) Limited - Analyst
: Thank you, so much.
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OCTOBER 28, 2024 / 12:00PM, NOVN.S - Novartis AG Renal Portfolio Update
Question: Graham Parry - BofA Securities - Analyst
: Great. Thanks for taking questions. So just actually on the Phase III iptacopan data. So the proteinuria reduction was noticeably less in Phase III than
we saw in Phase II. Just if you could sort of talk through any kind of explanation for that why we see, I think it was over 50% although not placebo
adjusted in the Phase III study? And then secondly, what reimbursement, co-pay or compliance issues do you think you may run into with an oral
therapy in C3 glomerular? And how are you planning on addressing those ahead of launch?
Question: Emmanuel Papadakis - Deutsche Bank AG - Analyst
: Thanks for taking question. Perhaps a few follow-ups. So C3G, you've mentioned a couple of times differences in baseline characteristics. Is there
any particular aspect of that you'd mentioned? And then it doesn't seem, on the basis of UPCR any position would choose iptacopan for those
patients. So how many patients do you think would actually prefer an oral versus twice-weekly subcutaneous?
And then maybe a question on overall guidance. I didn't see any update today. I assume the above $3 billion peak guidance is intact. Could you
compliment to what extent that was constituted by C3G versus PNH and IgA nephrology? Thank you.
Question: Emmanuel Papadakis - Deutsche Bank AG - Analyst
: Thanks, and apologies if I was not clear, I was actually referring to differences in the baseline carry sort of between (inaudible) basis? Thank you.
Question: Emmanuel Papadakis - Deutsche Bank AG - Analyst
: Thank you.
Question: Kerry Holford - Joh. Berenberg, Gossler & Co. KG - Analyst
: Hi, thank you for taking my question. I'm just thinking about sort of bigger picture here with regard to the approval process in some of these rare
kidney disease areas accelerated versus full. Do you expect the reduction in personal urea to continue to enable accelerated approval for a number
of these rare diseases? Or is that route like to become more limited as the competition increases?
And then, I guess, associated with that, how confident are you that we (inaudible) will remain the primary focus for the regulators? Is there a risk
that eGFR stabilization or any benefit (technical difficulty) becomes increasingly important to gain that initial approval. Thank you.
Question: Seamus Fernandez - Guggenheim Securities - Analyst
: Thanks very much for the question. So I just had one question on the historical data for Zigakibart. I think there were two cases in the earlier data
set that had some SAEs. Just hoping that you could maybe cover those SAEs and explain to us if it was specific to the patients in those earlier data
sets or perhaps it was reflected with an issue with the product. Thanks.
Question: Seamus Fernandez - Guggenheim Securities - Analyst
: Just to clarify, the (inaudible) cases were deemed not due to study drug?
Question: Seamus Fernandez - Guggenheim Securities - Analyst
: Okay, great. Thank you.
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OCTOBER 28, 2024 / 12:00PM, NOVN.S - Novartis AG Renal Portfolio Update
Question: Stephen Scala - TD Cowen - Analyst
: Thank you. Just one brief question. Industry-wide, how big do you think the GaN market could become, for instance. Do you think it could total
more than $10 billion, more than $20 billion? And what portion of that would Novartis capture? Thank you.
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