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: Jay Olson - Oppenheimer & Co. Inc. - Analyst
: We're curious about olezarsen and any overlap between physician prescribers for FCS and sHTG and how you plan to leverage that? And then
related to that, would approximately 20% pancreatitis history for the patients enrolled in your pivotal sHTG studies provide sufficient power to
show AP reduction and what level of AP reduction are you targeting?
Question: Gary Nachman - Raymond James - Analyst
: So on donidalorsen, just talk a bit more about what you're doing ahead of the PDUFA date internally to prepare for that launch. For patients that
are going to be switching, how you're thinking about that transition, I guess, in the first year of launch?
And just in terms of access, how long do you think that process is going to take? And then just as a follow-up [here], Brett, on the macro dynamics.
You just highlighted it briefly, but just talk a bit more what you think the expected impact from tariffs is going to be to the overall business just
based on the current trade policy?
And just in terms of your conversations with FDA, if you're seeing any sort of signs of potential delays, whether with PDUFA dates or starting clinical
studies?
Question: Debjit Chattopadhyay - Guggenheim - Analyst
: On the FCS launch, how confident is the team on the 2,000-plus FCS patient estimate and how quickly can you convert these patients to commercial
therapy before you have significant price erosion with the launch in sHTG?
Question: Jessica Fye - JPMorgan Chase & Co - Analyst
: I just had a couple. Forgive me if I missed this, but was there any channel stocking for TRYNGOLZA captured in that 1Q number? And if so, can you
quantify that? Second one, can you just elaborate a little bit more on the sources of upside to the revenue guidance and how much of that is driven
by commercial product performance versus the licensing deal.
And lastly, you kind of touched on this, but maybe just a little more specific. Can you just talk about the manufacturing footprint for TRYNGOLZA,
donidalorsen and how you think about possible exposure to tariffs?
Question: Yaron Werber - TD Cowen - Analyst
: Maybe just a couple of questions from me. This one's on WAINUA, can you give us a little bit of a sense, the Part D redesign, now that it's in effect
and it's capping patients to $2,000 out of pocket. How does that going to -- do you think sort of impact uptake under Part D?
And then on TRYNGOLZA, do you have any sense -- I mean, the $6 million is really a great number. That sounds like it's a good baseline from here
onwards. From here on, do you already have patients who you think are going to come on board pretty quickly that are diagnosed? Or as we kind
of think ahead about growth in patient identification, maybe give us some qualitative view on how fast that can be?
Question: David Lebowitz - Citigroup Inc - Analyst
: When you look at the core trials and the baseline AP data, I'm curious as to how the analysis in the trials will actually be carried out. Is it going to
be strictly based on baseline for the overall population relative to reductions, whether it be additional studies or analysis on patients that actually
had baseline AP events to reduce but over the smaller denominator.
I'm curious to what's prespecified and what could possibly be accepted by the FDA for labeling consideration?
Question: Mike Ulz - Morgan Stanley & Co LLC - Analyst
: Maybe just a follow-up on olezarsen and sHTG. It looks like you narrowed the timing of that data slightly for the CORE and CORE2 studies, the 3Q
from the second half previously. Just curious. Any reason behind that? And then secondly, maybe just clarify, will that initial update from those
studies include the 12-month AP data?
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