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: Michael Schmidt - Guggenheim Securities LLC - Analyst
: Hey, good morning. Thanks for taking my questions. I had a question on Jakafi where PV, as you mentioned is now the most important
growth driver for the product, capturing about one-third of sales. And can you talk a bit more about your expectations for how much
of that is driven going forward by new patients versus continued use of the drug by patients on therapy?
And secondly, there was some recent positive announcement of Phase 3 data of hepcidemimetic in PV as an add on to standard of
care. How do you expect that potential approval to impact potential use of Jakafi going forward? Thanks so much.
Question: David Lebowitz - Citigroup Global Markets, Inc. - Analyst
: Thank you very much for taking my question. In terms of Povo for chronic spontaneous urticaria, ultimately where do you see it
fitting? Is that something that would be before moving to biologics such as XOLAIR and other therapies, but after things like the
antihistamines in montelukast? Or do you see it more competing directly with the post XOLAIR crowd?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Thanks, and congrats on the new Povo HS data. I know the placebo patients crossed over this trial, but what would you have expected
the control arm to do based on historical data? Are you guys going to continue following these patients beyond 18 weeks?
And then you also suggested in the press release that there may be increased activity in naive patients crossing over from placebo.
Was this the data that you shared in the presentation in patients that have received a prior biologic or were these 298 patients?
Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst
: Hi, good morning. Thanks for taking my question. I just wanted to get an update on one of your pipeline assets, namely the CALR
compound. You had guided to data for this calendar year, is that still the plan? And if so, can you just give us a little bit of guidance
on what level of data to expect? Thanks.
Question: Jessica Fye - JPMorgan Securities LLC - Analyst
: Hey, guys. Good morning. Thanks for taking my question. Curious if you could update us on how the company is thinking about
capital allocation and business development. Do you want to see the rest of this year's pipeline readouts play out before making
any moves there and with the stock back in the 50s is another ASR on the table? Thank you.
Question: Marc Frahm - TD Securities (USA) LLC - Analyst
: Hi, thanks for taking my question. Maybe a couple of follow-ups just on some of the earlier topics. On the CALR update, would you
expect to be able to talk about kind of next steps and whether you think there's a pivotal path forward yet or is this data likely to
maybe not quite be that level of maturity?
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And then on the updated HS data, just the potentially better efficacy in the IL-17 experienced patients is obviously provocative. Any
ideas as to how you can kind of prospectively identify these patients that may do very well on a JAK relative to an IL-17 to maybe
help them avoid months of what might be ineffective IL-17 therapy?
Question: Vikram Purohit - Morgan Stanley & Co. LLC - Analyst
: Hi, good morning. Thanks for taking our questions. Just following-up on the mutant-CALR questions, we actually had a similar one
for the JAK2V617Fi program. Just wanted to see what level of update we can expect this year for that program and also kind of what
you might be able to communicate on next steps there once we have that data set?
And then secondly, just revisiting Rux XR, just wanted to get an update on where that program stands, what next steps are and how
you would see that moving forward, assuming positive update from the FDA there? Thank you.
Question: Ash Verma - UBS Securities Inc - Analyst
: Hi, thanks for taking my question. So I had a question on Monjuvi, just on these Phase 3 in the first line and relapsed refractory,
DLBCL, both the B and the front mind studies. Just if you can share what are your expectations here in these studies in terms of the
efficacy, that would be great. Thanks.
Question: James Shin - Deutsche Bank Securities, Inc. - Analyst
: Good morning, guys. Thank you for the question. Maybe one for Steve and Pablo. For the week 18 povorcitinib update, it looks like
about half of the placebo patients crossed over. Did these crossover patients experienced rapid pain reduction from the week like
we saw in week 12?
And if I recall, around 36% to 37% of the placebo patients were post biologic exposed. Can you give us a breakout of pre and post
biologic for these placebo crossovers? Thank you.
Question: Salim Syed - Mizuho Securities USA LLC - Analyst
: Great. Thanks for the question, guys. Just maybe one for me on the Niktimvo actually. So pretty good beat this quarter. Just curious
if you can maybe comment on just some of the dynamics with the $14 million of sales. Was there anything there particularly one
timer that we should just be aware of?
And then kind of related to that with the J-cut going effective for 1, '25. How much of a tailwind has that been kind of through the
month of April? Thank you.
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Question: Gavin Clark-Gartner - Evercore Group LLC - Analyst
: Hi, guys. I just wanted to quickly follow-up on the TAFA first line Phase 3 DLBCL trial. I believe on the slides you noted the data got
moved to the second half of this year. I think, Steven, you may have noted data was still in the first half potentially. I just wanted to
confirm the latest guidance and also clarify if a 0.73 hazard ratio from Polivy's trial is a reasonable benchmark. Thank you.
Question: Jay Olson - Oppenheimer & Co. Inc. - Analyst
: Hey, thanks for taking the question. And congrats on the progress. For your CDK2 inhibitor, what are the key data points we should
be looking out for in your ASCO update? And what are the gating factors to starting the Phase 3 study in ovarian cancer and especially
if you could talk about the companion diagnostic and how that's progressing? Thank you.
Question: Imogen Mansfield - Cantor Fitzgerald & Co. - Analyst
: Hi, this is Imogen on for Eric. Good morning everyone. Two questions from me. A quick one on Axatilimab. Could you comment on
that $14 million of what proportion of that is inventory. It looks like a really strong launch. So congrats.
And then one question on Povo and the HS and the longer-term data after Week 12. Could you talk about how the dropouts were
treated in that later section and whether patients who took rescue medications like antibiotics in the Week 12 control period, we
then kind of added back in because I think that was part of the non-responder criteria. Thanks.
Question: Michael Schmidt - Guggenheim Securities LLC - Analyst
: Hey, thanks guys for taking the follow-up. Just another one on Povorcitinib. This continued increase in HiSCR 50 out to Week 18
obviously looks very interesting. Did you observe a similar trajectory also for the HiSCR 75 outcomes?
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And the other question I had is just on your KRASG12D inhibitor, where I know you've guided to POC data later this year. Just
wondering how you think about differentiation and the competitive landscape there, just given we've seen some data recently at
ACR? Thanks for taking the follow-up.
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