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: Sean Laaman - Morgan Stanley & Co Ltd - Analyst
: Wonderful. Thank you, Mike. Just before we get into the detail around the company, I've got some macro questions here that we're asking all our
companies. So the first one is with China's rising biotech innovation, how are you thinking about Exelixis' competitive position here? And will it
influence your R&D and business development?
Question: Sean Laaman - Morgan Stanley & Co Ltd - Analyst
: Thank you, Mike. And on to AI. So are you currently leveraging AI? How do you think about AI's disruptive potential?
Question: Sean Laaman - Morgan Stanley & Co Ltd - Analyst
: Wonderful, Mike. And on the regulatory side, what's been the most impactful for Exelixis? Has it been FDA? Has it been (multiple speakers)
Question: Sean Laaman - Morgan Stanley & Co Ltd - Analyst
: For sure, for sure. More to Exelixis specific and just starting with cabo. So you're a couple of quarters into the NET launch. Maybe you could just
frame out the opportunity that you see in NET, how has the launch gone versus expectations? And I think you're at 4% of the business in the last
quarter.
And I guess, what's factored in, if anything, to fiscal '25 guidance on cabo and NET?
Question: Sean Laaman - Morgan Stanley & Co Ltd - Analyst
: Sure. Thanks, Mike. And I guess sort of still on cabo, you've got long-term sales guidance out there, I think, almost to $3 billion by the end of the
decade. How important the plank is net of that? And just to gauge your confidence of getting to that near $3 billion. I think consensus still has a
significant haircut on that number.
Question: Sean Laaman - Morgan Stanley & Co Ltd - Analyst
: Awesome. And maybe I've got a bunch of questions on zanza and some of the readouts that may be coming out some of the events. But maybe
just for those that are less familiar with the Exelixis story, what is zanza? How does it compare to cabo? And what's your vision for the program with
zanza?
Question: Sean Laaman - Morgan Stanley & Co Ltd - Analyst
: Wonderful. And more recently, we saw the mCRC STELLAR-303 data, and you announced positive top line results and start seeing OS improvement
versus rego in the ITT population. The trial is proceeding to plan final analysis for the other dual OS primary endpoint in patients without liver mets.
Can you remind us of the biological differences between the two patient populations and how your study design has evolved since the first iteration?
Question: Sean Laaman - Morgan Stanley & Co Ltd - Analyst
: Got you. And how do your OS expectations for patients with liver mets versus non-liver mets versus the blended ITT population?
Question: Sean Laaman - Morgan Stanley & Co Ltd - Analyst
: Yes, please.
Question: Sean Laaman - Morgan Stanley & Co Ltd - Analyst
: Okay. Okay. Looking at the available mCRC therapies and what's considered standard of care, how are you thinking about rego versus zanza in
terms of the competitive bar in this patient population?
Question: Sean Laaman - Morgan Stanley & Co Ltd - Analyst
: Sure. Next question I get a lot of inbound on. So you indicated that you plan to file for approval in this indication as quickly as possible. When might
we be able to hear an update?
Question: Sean Laaman - Morgan Stanley & Co Ltd - Analyst
: Okay. You mentioned going to early lines of CRC with a focus on the post-adjuvant setting based on the 303 data. Can you talk about how you're
thinking about the patient opportunity and market?
Question: Sean Laaman - Morgan Stanley & Co Ltd - Analyst
: Wonderful. Thank you, Mike. And moving over to 304 and non-clear cell CC. So I think you've updated the timeline pushed out to '26. So how would
you frame the way investors should think about that changing?
Question: Sean Laaman - Morgan Stanley & Co Ltd - Analyst
: Sure. And STELLAR-311 in advanced NET has begun. Is this complete overlap with the current cabo approval? And how are you thinking about
potential cannibalization?
Question: Sean Laaman - Morgan Stanley & Co Ltd - Analyst
: Sure, sure. Still laying out the landscape for zanza and you announced the discontinuation in head and neck and if you could frame out sort of the
reasons why I think you said emerging competition and there are bigger opportunities elsewhere for zanza. So maybe just a bit more measure on
the (inaudible)
Question: Sean Laaman - Morgan Stanley & Co Ltd - Analyst
: Sure, of course. And you mentioned earlier on cabo that you've got the peak revenue guidance out there before the end of the decade, but consensus
is somewhat shy of that. And that's even more true for zanza where you've got, I think it's a $5 billion peak revenue forecast in 2034, if I remember
correctly.
Question: Sean Laaman - Morgan Stanley & Co Ltd - Analyst
: And consensus is probably about half that number. But just, I guess, sort of the feedback from investors, what are you hearing? What are the proving
points that you think are going to get a more optimistic view from Street?
Question: Sean Laaman - Morgan Stanley & Co Ltd - Analyst
: Awesome, Mike. And on the four early-stage programs in Phase 1, is the one that gets you excited the most?
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SEPTEMBER 09, 2025 / 12:30PM, EXEL.OQ - Exelixis Inc at Morgan Stanley Global Healthcare Conference
Question: Sean Laaman - Morgan Stanley & Co Ltd - Analyst
: Sure, sure. Wonderful. And I guess, I don't get a lot of inbound on this, but just lastly, maybe -- and what I find fascinating is that the balance sheet
the company has and the cash flow that you're generating. I don't think it gets like a lot of attention, but I think it should.
Question: Sean Laaman - Morgan Stanley & Co Ltd - Analyst
: So just sort of your thoughts around OpEx going forward.
Question: Sean Laaman - Morgan Stanley & Co Ltd - Analyst
: Awesome. Well, we're fresh out of time, but it's been wonderful to talk to you, Mike.
Question: Sean Laaman - Morgan Stanley & Co Ltd - Analyst
: Thanks for attending. I really appreciate it.
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