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?
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APRIL 30, 2025 / 3:30PM, IONS.OQ - Q1 2025 Ionis Pharmaceuticals Inc Earnings Call
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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