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: Andrew Berens - Leerink Partners LLC - Analyst
: <_ALACRA_META_ABSTRACT>Thank you, gentlemen, for spending some time with us to walk us through the story. Why don't we start, I guess, with a brief overview
of Exelixis. Obviously, you've been around a while, accomplished a lot. You have commercial assets and a lot of stuff the pipeline
will talk about. I think would help to get an overview of the company.
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Yes. And I think that vision of Exelixis 3.0, obviously resonated with investors. I think that's what your stock really broke out of a
trading range you have been in for quite a while, and it's done well even despite the hard times, so a lot of the colleagues in biotech
of experience. So congratulations on that.
Chris, maybe we could talk just a little bit about the guidance, the cabo guidance in 2025. Can you just give us what's behind those
numbers, some of the pushes and pulls?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Right. Why don't we talk a little bit about cabo and the net indication? You originally had an AdCom schedule, the PDUFA date is
April 3, and then it was essentially canceled. And I believe that was before a lot of the government cuts that have come down
subsequently. So any color that you can give to us investors about what drove the initial decision to schedule that and then the
subsequent vision to cancel it.
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. Have those discussions included label negotiations with the FDA?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. You don't have net in your guidance at this point, but if approved, and you will give it. What will you have to do to expand the
infrastructure to repair for potential net?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. The $3 billion number that you pointed to in 2030, does look like consensus is supportive that you'll reach that number. How
much is for CRPC and that guidance number, the $3 billion.
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MARCH 12, 2025 / 2:40PM, EXEL.OQ - Exelixis Inc at Leerink Partners Global Healthcare Conference
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. Why don't we move to zanza? I think, obviously, a big part of fundamental, but also probably strategic value for the company
is going to be a viable tail to continue the success you've had with cabo. Can you just walk us through the profile of zanza versus
cabo? Why don't we start there, and then we'll talk about the development.
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. In terms of differentiation versus cabo, I think some investors were not convinced at some of the updates that there was a
clear differentiation. How important is it that in all these indications, some of which cabo is not approved, that you actually have
that differentiation. I mean, can you -- I mean, obviously, a big part of Exelixis 3.0 is extending the tail on the IP of a very successful
drug, which, like I said, I think, adds both strategic and fundamental value. How important is it that there's a clear benefit for zanza
over cabo to achieve that goal?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Right. I mean it seems to me the most relevant question is, can you get approved? And what the data will look like relative to other
options in those respect therapeutic areas?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. Can we talk -- that's obviously a very big milestone for the company STELLAR-303 in third line plus colorectal cancer. Can we
talk a little bit about the design of that trial? And how it's changed over the number of years?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: How does regorafenib do in liver mets versus non-liver mets?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. Third line plus colorectal cancer, obviously, a late-stage disease and a lot of colons, blood flow and lymphatic strength to the
liver. What percentage of the opportunity do you lose by excluding patients with liver mets, you think?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. What's your sense for investor expectations? Do you think that if you get the non-liver population, and it looks approvable in
that indication, but not in the patients with liver mets. Do you think that would be a (technical difficulty) for investors? Or do you
think that's going to be enough to -- you're positive, cattle's?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. Fair enough. The trial has also altered with RAS mutation versus wild type. Can you talk a little bit about the implications and
the genesis of that?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. Got it. We only have a couple of minutes left, and I want to make sure we talk about the other programs. What -- I guess, before
we move to some of the earlier pipeline, what about STELLAR-304. Can you just give us a rundown of that program and what kind
of achieve?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. And it's going to be the PFS endpoint that comes up?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: How important is OS and the regulatory decision?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Yes. Okay. Maybe just on the head and neck program for zanza, what do you assume as the contribution from head and neck? Because
it's an area we're very interested in. We have a number of companies that developing, and we think it's a pretty large opportunity.
What are your assumptions for zanza's potential there?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. Its risk adjusted or.
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. Yes. We see those multiples beyond that, especially based on the duration of some of these drugs that could expand the
market. We only have a few seconds. What in the early pipeline besides zanza is important to the overall strategy for the company
going forward?
Question: Andrew Berens - Leerink Partners LLC - Analyst
: Okay. Well, we really appreciate the updates. Congrats on all the progress. You've got a big readouts this year, and we'll definitely
be watching.
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