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: Stephen Willey - Stifel, Nicolaus & Company, Inc. - Analyst
: <_ALACRA_META_ABSTRACT>Yeah. No, it's been a really interesting confluence of events here over the course of the last month. And I think investors seem to be
comfortable with the clarity that they have, if your stock price is any kind of indicator of that.
I guess I'd be interested given you're the BD guy here, what does that clarity around cabo exclusivity now mean for you? And I guess,
to what extent, if at all, was the BD function previously rate limited by these things? And has the opportunity set now expanded
with this clarity in place, both in terms of development stage and the amount of capital that you're maybe looking to deploy?
Question: Stephen Willey - Stifel, Nicolaus & Company, Inc. - Analyst
: So that portfolio is mostly comprised of GU/GI exposure. I know that you've been very specific in terms of that being an arena in
which you want to shop for assets. How would you characterize the breadth of those opportunities right now that you're seeing in
those specific therapeutic indications?
Question: Stephen Willey - Stifel, Nicolaus & Company, Inc. - Analyst
: Okay. So a lot of the BD that we're seeing play out now is being paid to a lot of non-oncology indications, right, whether it's like
obesity, I&I, CNS. Is that a tailwind for you in terms of your freedom to operate or has the competitive density in terms of BD that
you're seeing in oncology right now -- has that not changed?
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NOVEMBER 18, 2024 / 3:20PM, EXEL.OQ - Exelixis Inc at Stifel Healthcare Conference
Question: Stephen Willey - Stifel, Nicolaus & Company, Inc. - Analyst
: Okay. Maybe just a couple of more BD questions, and then we'll get into the rest of the pipeline in the commercial space. But most
of the deals you've done thus far have been in licensing transactions. And I guess, is there an argument to be made versus a structured
asset transaction like that versus something like M&A? Is the latter just too inherently complex and something that you guys want
to stay away from or -- ?
Question: Stephen Willey - Stifel, Nicolaus & Company, Inc. - Analyst
: Okay. And then you've been in this role now, I think, for a few different market cycles. What's your perspective on asset valuations
right now in the oncology space? And given obviously all of the uncertainty that's afoot right now, whether it's interest rate-related,
RFK-related, do you think there's going to be some meaningful impact on the pace of BD that we as an industry are going to see
now until we start to get clarity on some of these things?
Question: Stephen Willey - Stifel, Nicolaus & Company, Inc. - Analyst
: Okay. Maybe we can talk about cabo. So I think as you referenced a really strong quarter. I know you guys talking about the continued
growth that you're seeing in front-line renal. What are some of the levers that have been driving that growth?
I know you're obviously stacking patients here in the model, right, as a function of these long treatment durations. But are you taking
share from competitor IO/TKI regimens? Are you taking share from ipi/nivo within that poor and intermediate risk bucket? Are you
still making inroads into the single-agent TKIs in the favorable risk population? What are you seeing out there in terms of where
you're generating growth?
Question: Stephen Willey - Stifel, Nicolaus & Company, Inc. - Analyst
: Okay. So the CABINET data was just presented at ESMO. I know you guys have filed an April 3 PDUFA. I know you talked about how
you see the neuroendocrine tumor opportunity is maybe looking like what renal cell did, maybe 10 years ago. What are your thoughts
around maybe just what that initial label looks like in terms of the line of therapy that it specifies? And I guess, how does that
broadness of the label impact your perspective of this accessible market opportunity?
Question: Stephen Willey - Stifel, Nicolaus & Company, Inc. - Analyst
: Okay. And then you mentioned the New England Journal of Medicine manuscript that was published in conjunction with the ESMO
presentation. Should we assume that you're going to be leveraging that publication as a means to petition for a compendia listing
pre-approval?
Question: Stephen Willey - Stifel, Nicolaus & Company, Inc. - Analyst
: Yeah. So maybe we can shift gears to zanza. You guys made a pretty big splash on the recent earnings call by guiding to $5 billion
in peak US zanza sales by 2033. I know you have a number of planned and ongoing Phase 3 trials from which you derive that number.
I think we're going to have a diminished amount of time to probably talk about those.
But we still haven't really seen a lot of data for this drug yet, right? I think just that single second-line RCC cohort, maybe 30 patients
or so. So I guess why push that guidance out there now? And when might we begin to see some additional data to help us think
about the longer-term opportunity for this asset in the context of the guidance that you gave?
Question: Stephen Willey - Stifel, Nicolaus & Company, Inc. - Analyst
: Okay. And so yeah, I think if you compare, contrast zanza, cabo, the trials you have ongoing for the former, the sales you generate
with the latter, I mean obviously, 303 gives you this new opportunity in colorectal; 305 gives you this new opportunity you didn't
have with cabo and head and neck.
But how are you thinking about Zanza as a life cycle extender with the $3 billion in cabo sales that you're now guiding to by 2030?
I mean you have STELLAR-311 in neuroendocrine. But I think RCC will obviously be very important to that.
I know you just did the collaboration with Merck. How does the cabo -- the zanza-belzutifan combination. And again, I'm not sure
this is something you can speak to, but two planned Phase 3 trials -- Merck obviously has three ongoing Phase 3 trials with belzutifan
right now, adjuvant, front-line, a second-line trial head-to-head versus cabo. How does your plan with Merck overlap with what
Merck is already doing with that asset in renal care?
Question: Stephen Willey - Stifel, Nicolaus & Company, Inc. - Analyst
: Okay. We are over time. Andrew, I appreciate it very much.
Question: Stephen Willey - Stifel, Nicolaus & Company, Inc. - Analyst
: Good seeing you. Enjoy the rest of your day.
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