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: Graham Parry - BofA Global Research - Analyst
: Thank you, so Graham Parry from Bank of America. Just wanted to kick off on remibrutinib in CSU, which doesn't actually get that much airtime,
but obviously, a very large patient population you're talking about with 400,000 in the US, 4 million in your kind of commercial markets. Just perhaps
talk us through potential launch strategy and then also just remind everybody the reason for the filing delay into 2025. But when you get into
launch strategy, how do you commercializing this target patient population? And is it the existing patients on high decisive antihistamine above
approved doses. There's the core target market and so perhaps quantify how big that market is for the early easy win, if you like.
Question: Graham Parry - BofA Global Research - Analyst
: So I'll start and I'll finish as well. Graham Parry, Bank of America. So I'm just going to follow up on the AD actually. So just where do you see the
unmet need there in atopic dermatitis. So -- or do you think that Dupixent will always be sort of the go-to first-line biologic just given safety, breadth
of indications, rebate wall, et cetera.
And actually, what you're looking for is the DP failure market there. And then going back to ianalumab, just -- can you just help us understand the
proportion of patients commercially that you think is that target population who don't just have the (inaudible) issues that actually have all the
systemic problems as well. And then last one on that 1 is if you look at the Phase II, you failed on the secondary endpoint of Asbury, just comparing
contrast why is (inaudible) more important than Asbury in Sj÷gren's disease. Thanks.
Question: Graham Parry - BofA Global Research - Analyst
: Thanks. It's Graham Parry from Bank of America. Just starting remibrutinib in MS. Obviously, after we've seen the BTK inhibitors using relapse rates
as a primary point that's clearly challenging. I think Vas was alluding earlier this year, the potential to do sort of hard stock futility with a high hurdle
on remibrutinib, so just wondering if that thought process would progress further and what the timing of that would be so we know if that's actually
continuing or not? That's the first question.
Second question is on iptacopan, you got a program running in myasthenia gravis. Just interested why you didn't run a program in MS.
And then on [YTB], just perhaps help us understand like commercial strategy I know it's early days at Phase II, but given that most MS therapies are
oral or, I guess, easily subcu injectable or infused just talk us through distribution? How do you envisage that fitting into the marketplace? Thanks.
Fiona Marshall - Novartis AG - President - Novartis Institutes for BioMedical Research (NIBR), Member of the Executive Committee
Okay. So quite a few questions there. Norman and the Remy.
Question: Graham Parry - BofA Global Research - Analyst
: Just two follow-ups, actually, just on the first one was on Remibrutinjust confirmed. So when you're saying you think that if you -- the drug performs
as you would expect it to, you would be able to hit the relapse rate reduction. So you have absolute relapse rate data in-house that's showing you
well below the 0.1 level that you'd expect the control arm to be with (inaudible) So that's the first follow-up.
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
NOVEMBER 21, 2024 / 8:00AM, NOVN.S - Novartis AG Meet the Management
And the second 1 is on DLX 313. So in terms of what would warrant a successful Phase IIa readout for you, so I think based on what we've seen with
prasinezumab, you probably missed the primary endpoint in that study but may be a motor symptom secondary end point and if you do that,
were you suggesting you could go straight to Phase III because Roche went to a Phase IIb because they -- I think they need to expand the patient
-- the population size, et cetera, so just two follow-ups. Thanks.
Fiona Marshall - Novartis AG - President - Novartis Institutes for BioMedical Research (NIBR), Member of the Executive Committee
So maybe just a go at (inaudible) very much in your area.
Question: Graham Parry - BofA Global Research - Analyst
: Hi. It's Graham Parry from Bank of America. Just wanted to kick off on the -- Matthew's got his hand up. I just wanted to kick off on the initial launch
directory on Kisqali, the adjuvant setting, so there's some interesting stats earlier. Just when you look at the patient populations that you're
addressing there, are you starting to see that this is more coming from the intermediate risk group and the negative? And are you getting any
traction at all in the high-risk patient population that [Servicio] has already indicated for? So initial thoughts on penetration into the different
populations would be useful. Thanks.
Shreeram Aradhye - Novartis AG - President - Global Drug Development and Chief Medical Officer, Member of the Executive Committee
Reshema, do you want to take that?
Question: Graham Parry - BofA Global Research - Analyst
: Just a question about your post-2029 mid-single-digit growth aspiration. Just I think last time we talked about the sort of post guide, it was post
'27 and you said you're guiding five-year income and so you could clarify. Is that a post 29 mid-single digits for five years? And the reason for asking
is you included Kisqali and Kesimpta in the slide on some of the drivers there, and they lose exclusivity over that time frame. So just wanted to
make sure that whether they're included or not in as growth drivers there.
Similarly, should we think about the margin over that time frame is once you've reached the peak 40% in the guide. Is that really a flat margin we
should be thinking about over that time frame. I think that was the implication from comments this morning.
And then secondly, just on the main litigations that you've got going on at the moment. We had the Kisqali patent litigation trial in February and
Entresto hearings in November, the 13th. Just your best guess on timings of outcomes for those and how they might impact your -- how you guide
for 2025 in January 31. Thank you.
Question: Graham Parry - BofA Global Research - Analyst
: Yes. So a couple of follow-ups (inaudible). So you talked about your growth in 2029 or you gave the guidance this morning. It's actually about 2%
above the Street. So we're also focusing on flat margins, but you're actually guiding to sales that are above the street at the moment.
So just what would you pick out as being when you look across sell-side models or buy side expectations? Where do you think your expectations
are higher. So what are people missing there?
And then secondly, just following on Entresto. If you win both the [Pretium injunction] hearing and the 659 and you have a ruling before the
year-end, that will be before you guide for next year. So could at that point, if you want on both of those, would that give you enough confidence
to guide to 2026 launch of Entresto rather mid-'25?
|