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: Geoffrey Meacham - Citi Infrastructure Investments LLC - Analyst
: Morning, guys. Thanks for the question. Chris, you mentioned the upcoming period, which is very data-heavy. I'm just looking at the Phase 3 results
this year. Are there any that you would call out where maybe you can still achieve the objective of either line extensions or label expansion? I know
you probably have to have an FDA discussion, but I just am curious if there maybe is a faster path to achieving some of the line extensions that
you intended to achieve. Thanks.
Question: Geoffrey Meacham - Citi Infrastructure Investments LLC - Analyst
: Thanks, guys.
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Question: Christopher Schott - JPMorgan Chase & Co - Analyst
: Great. Thanks so much. Just a two-parter on COBENFY. Maybe just first on the launch dynamics, I would love just to hear what you see as the primary
hurdles to adoption for physicians at this point, given reimbursement, et cetera, in place.
And the second part was, as we look forward to the Alzheimer's psychosis results coming later this year, maybe just help frame out expectations
in terms of the type -- magnitude of benefit you feel you need to show to see adoption here. And would the study alone be enough to support a
filing? Thanks so much.
Question: Evan Seigerman - Bank of Montreal - Analyst
: Hey, guys. Thank you so much for taking my question. I wanted to touch on some of the rationale for partnering with BioNTech, and specifically
what you saw in their PD-L1 VEGF bispecific. There's a lot of assets out there. What attracted you to the partnership with them? Maybe walk me
through some of the differentiation, and how you can work with them to accelerate this to potentially the early, kind of in the class of assets. Thank
you.
Question: David Risinger - Leerink Partners LLC - Analyst
: Thanks very much, and congrats on the strong financial performance. So Chris, you had highlighted Milvexian first when you discussed major
pipeline candidates to watch in coming years. And since the Street consensus only models 2032 sales of $2.3 billion, that reflects a lot of skepticism.
So if you and maybe Samit could just help us better understand what you think investors underappreciate about Milvexian's likelihood of success
in secondary stroke, ACS, and AF. Thanks so much.
Question: David Risinger - Leerink Partners LLC - Analyst
: Thanks very much.
Question: Asad Haider - Goldman Sachs Group Inc - Analyst
: Great. Thanks for taking the question, and congratulations on the results. Two quick ones. First, just with respect to the cost optimization program,
can you just elaborate on how you're thinking about the pushes and pulls related to capital needs, given that you also have to support expenditures,
like the $40 billion announced CapEx, as well as large and potentially costly development programs related to expediting the PD-L1 VEGF Phase
3 clinical trials in the wake of the BioNTech deal, and then you also have the debt paydown in BD. So any updated thoughts on costs and margins
as it relates to your goals of shortening the depth of earnings, the earnings trough relative to these new investments and the ultimate return to
growth would be helpful.
And then two, just perhaps just very quickly on ADEPT-2. Just given that's imminent, just remind us on how we should be thinking about the view
Question: Carter Gould - Barclays - Analyst
: Hi. Good morning. Thanks for taking the question. A little bit of a change of pace here, but if you'll indulge me, I always appreciate your view on
the policy side, Chris. IP is under attack across the industry from multiple sources, but most notably compounding. While Bristol is not directly
impacted today, it's not unreasonable, if left unchecked, that Bristol could be impacted in the future. Does Bristol share this view? And are there
efforts you've taken either independently with peers, pharma, or in consultation with the administration to more staunchly advocate defensive IP
in the space?
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Question: Akash Tewari - Jefferies LLC - Analyst
: Hey. Thanks so much. So for COBENFY and the EMERGENT schizophrenia trial, you had about 80% of patients get to the high dose. Given there's
a clear issue with dropouts in the original xanomeline study and there's a clear dose response, what percentage of patients do you think for your
upcoming AD psychosis study get to that 150 or 200 mg dose? What dropout rate have you powered for for this upcoming study?
And then maybe stepping back, is Bristol still as bullish on the probability of success in the study as when the original Karuna deal was announced?
And was there something about site conduct in the adjunct trial that made you concerned about it for the upcoming AD psychosis study? Thank
you.
Samit Hirawat - Bristol-Myers Squibb Co - Executive Vice President, Chief Medical Officer, Head of Development, Member of the Leadership Team
I'll start off. And there's a lot of questions in there. I'll try and address as much as I can.
Keeping in mind, we are at a place where we are totally blinded to the data, so cannot comment on the specificities. As you know, the trial is
designed with four dose escalations on week one, two, three, and four. Of course, the fourth one, the 200 milligram of COBENFY or KarXT with 20
of trospium is an optionality, but of course dependent on the tolerability.
Remember, there's a huge difference between AD psychosis trial that we are conducting versus the 30-year-ago xanomeline-only studies that was
conducted because of the tolerability issue where patients did go off treatment much more and the number of completers was limited because
of the toxicity. So I would not necessarily draw true conclusions directly from that trial. Also over there, when we talk about the impact on some
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Question: Steve Scala - Cowen and Company LLC - Analyst
: Hello. Thank you so much. On the Q1 call, Bristol said that they were exploring a path forward for COBENFY ARISE data, but that they needed to
review all the data and talk with regulators. I'm wondering, has this additional analysis occurred and have the discussions already taken place? And
if so, is there a path forward?
And then secondly, on Sotyktu, can you clarify whether it's been filed in psoriatic arthritis? And what is your level of confidence and success for
lupus and Sj÷gren's? Thank you.
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