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: Joe Catanzaro - Piper Sandler - Analyst
: So maybe to start, I'm going to ask you to sort of elaborate a little bit on it and maybe keep LOE question number one. Now with LOE sort of behind
us, right, what changes are made to the overall business pipeline development strategy that maybe you weren't doing before LOE was resolved?
Question: Joe Catanzaro - Piper Sandler - Analyst
: So maybe before we get to cabo and zanza, I want to ask about the early pipeline internal versus external. I think historically, you guys have spoken
of rightsizing the pipeline for your revenue base. Now speaking to 2030, 2033 revenue base that's there, how do you go about rightsizing that
internal versus external?
And I think one thing you guys have been really good at is making very quick go, no-go decisions on early-stage assets. Now do you take on a little
bit more risk there and take things maybe a little bit further and see how things mature? Or are you still quick to make those go/no-go and sort of
Phase I/II stages of development?
Question: Joe Catanzaro - Piper Sandler - Analyst
: Perfect. So maybe with that, we could dig a little deeper and maybe start with cabo. So I think you maybe alluded to on the 3Q call, you provided
2030 guidance in US revenues for cabo at just around $3 billion. Maybe talk through how you get there -- to that number versus where you are
today? What proportion of that is coming from current label indications versus maybe some future expected label expansion?
Question: Joe Catanzaro - Piper Sandler - Analyst
: So you alluded it to a little bit in terms of cabo's momentum. I think it was up 12% year over year in 3Q, still growing at a very healthy clip. You
mentioned sort of patient stacking, taking market share. Maybe speak to that a little bit more, how much more we could expect from that moving
into 2025 and beyond? Again, it sounds like that's a key contributor to getting to that $3 billion number.
Question: Joe Catanzaro - Piper Sandler - Analyst
: So moving to potential label expansion, maybe starting with NET. You guys announced recently that there's going to be an ODAC in the spring
around that NDA. I'm not sure how much you can say, but maybe any insights into what maybe some key questions the FDA has around that
package and its approvability.
Question: Joe Catanzaro - Piper Sandler - Analyst
: So maybe quickly sticking with NET. I think you've sort of positioned maybe the cabo/zanza franchise as a NET play. I guess I'm trying to figure out
how much of the NET opportunity for cabo is a stand-alone real opportunity relative more so priming the market for a future potential zanza launch?
Question: Joe Catanzaro - Piper Sandler - Analyst
: Last question on cabo, and then I do want to speak to zanza a bit more. So you mentioned the prostate cancer opportunity. How should we think
about that, the likelihood, what the biggest risk there is to a potential approval? Maybe you could just speak to that a little bit.
Question: Joe Catanzaro - Piper Sandler - Analyst
: Great. So maybe moving to zanza, again, referencing sort of 3Q call, there, you provided 2033 unadjusted U.S. revenues for zanza of around $5
billion. I think that took a lot of people by surprise, stood out. Maybe at a high level, talk us through sort of what needs to happen for you to get
to that number.
Question: Joe Catanzaro - Piper Sandler - Analyst
: So the first pivotal trial that will read out will be a GI indication in STELLAR-303 with CRC. I think many people point to the LEAP-017 trial and its
negative outcome there. How much sort of read-through is from that trial to STELLAR-303? Is it a fair comp or an unfair comp? And then how much
Question: Joe Catanzaro - Piper Sandler - Analyst
: Perfect. Well, with that, we're right on time here. So thanks, Andrew, for your time and thoughts. And thanks, everybody, for joining. Thank you.
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