Exelixis Stifel 2026 Healthcare Conference

Hey, Steve. Thanks for having us.

Thanks for the invite. Great meetings today. Been really fun engaging with investors. As always, going to be making some forward-looking statements today, so please see relevant disclosures around risks in our business in SEC filings. Right now is a really exciting time for Exelixis. We're at that transition point as our next franchise, our second franchise, zanzalintinib, we have a PDUFA date in March of next year, early March of next year. We're seeing that transition from single-product company with Cabo to multi-franchise company with Cabo and Zanza, and then off to the races from there. Just really excited, full speed ahead on just the commercial execution, clinical execution, and then everything we're doing from both an early pipeline perspective.

Really the last thing I would say that is surprising to some is this dynamic or through line that always is at Exelixis is we run the company like a business and not a biotech. It is about execution, it is about discipline, it is about prioritization. All of that just is really good time at Exelixis right now.

Yeah. Simply put, we are tracking events as they come in real time, and as we see the accumulation of events moving towards certain number of events, provide clinical cutoff, clean the data, top line. When we saw a clinical cutoff based on the event rates going to happen closer to year end, that is why we guided to Okay first quarter.

Simple as event rates coming in a little slower as we triangulated what that was expecting, that is what drove the timing. In terms of the press release, what is not going to be in there, honestly, I do not know. I have not written the press release yet. In the past, we have included a lot of data. In the past, we have included just some top line. There is a lot of sausage-making, as you can appreciate, in terms of what gets shared and how around medical conferences and all of that. But our goal, our hope is to generate as robust of a dataset as we can, get that filed, and get into patients as soon as we can.

Yeah. That's the eternal debate, isn't it, in biotech, is how do you compare apples and oranges, single arm, single center phase II to large global randomized phase IIIs? That's really the challenge and is really actually the reason why we started 304 in the first place, is for variety of reasons, all drugs with labels in RCC have those inclusive or exclusive of non-clear cells, so clear cell and non-clear cell. There's actually never been a large global randomized study in this space. We thought what we had a chance to do with 304 is really plant a flag in the ground and define with level 1 evidence a standard of care.

What that does is, right now patients are treated really in a hodgepodge of different therapies, and so use is somewhat driven by guidelines, which again, are driven by single arm unrandomized data, which are complicated in the single center or the sort of patients that are enrolled. There's just a lot of dynamics that go into it. What we have a chance to do is establish with level 1 evidence, with large randomized phase III data, to go in and define the standard of care. I think it's probably less useful to look at small-end datasets or datasets where perhaps a skew of patients, favorable, intermediate, all of those sorts of dynamics. It's just hard to compare smaller studies to large global randomized studies.

Yeah. Honestly, it is probably too early to speculate on something like that. We will have to see the data first and really let the data kind of show us what we are looking at.