Exelixis, Inc. (NASDAQ:EXEL) Q1 2024 Earnings Call Transcript

Operator: Thank you. Please standby for our next question. Our next question comes from the line of Gregory Renza with RBC Capital Markets. Your line is open.

Gregory Renza: Great. Good afternoon, Mike and team. Thanks for the updates and thanks for taking the question. Mike maybe just to ask a little bit building on the neuroendocrine tumor opportunity certainly nicely in context with respect to Cabo. But as you do think about Zanza and the combo optionality there and the white space that you have. I’m wondering if you could just comment a bit about Zanza in this indication. I mean is there opportunity? And what are the potential development pass as you think about combos would potentially Zanza and Luta therapy be something to explore? Thanks again.

Michael Morrissey: Yes, Greg, thanks for the question. It’s a great one. I can punt over to Amy and P.J. to opine upon, Amy?

Amy Peterson: Yes, sure. As I mentioned during the call, we’re always assessing what is the next best thing to think about for Zanzalintinib. We look at all things that are strategic in our assessment. So I talked about the probability of technical success. That’s a big one for us to consider as well as the time it takes to conduct the study and the competitive and evolving landscape and the value proposition. And I would say that neuroendocrine tumor is high on the list for Zanza and we are very interested in it. I’ll let P.J. comment a little bit on the commercial.

P.J. Haley: Yes. I mean I think just at a high level, if I go back to kind of the opportunity here, certainly, a large unmet medical need, as I mentioned, with not many new therapies, really any oral therapy is being approved since 2016. So I think there’s a lot of room to maneuver in this tumor type, in particular. The orals, as I mentioned, in my remarks and on the slide account for approximately 50% of the second line plus population. So if you think about Lutathera, for example, which is doing over $400 million in revenue annually. Basically a second line-plus population, they have the NETTER-2 data at ASCO GI this year, but those revenue kind of predate that. So that’s a pretty significant opportunity in less than 50% of that market. So I think this is a big space that’s really there’s a high appetite for new therapies, for new trials and really an opportunity for this market to grow over time. So I see it as very exciting.

Michael Morrissey: Yes, that’s great, P.J. I would just add. I think the way we talked about NET here, and we’re really excited about certainly the CABINET data and the opportunities to go forward with Zanza, we think NET is similar to what we saw with RCC back in the 2014, 2015, 2016 time. And there’s lots of similarities between the two, even though they’re obviously different — very different indications. So we’re excited about this. We hope to invest more as we go forward. Lots of opportunities with Zanza and other potential combinations. So stay tuned. As that evolves, we’ll keep you in the loop.

Operator: Thank you. Please standby for our next question. Our next question comes from the line of Yaron Werber with TD Cowen. Your line is open.

Joyce Zhou: Hey, guys. This is Joyce on for Yaron. Thanks for taking the question. Maybe just another follow-up on the NET market opportunity. I think you guys have previously said that the prevalent population is about five times the size of the second-line plus incident population or about 40,000 patients. Just wondering how much of that market you think you can capture or pull into this opportunity with Cabo and/or Zanza? Thank you.

P.J. Haley: Yes. Hi, Joyce. This is P.J. Thanks for the question. I think as I mentioned, the 8,000 patients, those are kind of new incident patients in a given year. And as you mentioned, the prevalent population is much larger. I think I wouldn’t want to speculate before we get to a label on the potential upside or where it might play out in the marketplace, but I think when we think about the 8-K patients, et cetera, that’s kind of the baseline, and there certainly could be many more patients given that this is an indolent disease where patients receive many lines of therapy that might be kind of out there. But again, I think we need to wait until we get in the market to really get a good sense of that. But we’re very confident and comfortable in the 8,000 patients as it is being a really significant potential opportunity for Cabo.

Operator: Thank you. Please standby for our next question. Our next question comes from the line of Andy Hsieh with William Blair. Your line is open.

Andy Hsieh: Great. Thanks for taking our questions. Two quick one, if you don’t mind. One financial one, scientific. In terms of Medicare D exposure, Chris, do you mind reminding us your exposure there for the Cabo franchise? Several companies like Gilead kind of called out the potential impact next year stemming from the Medicare Part D redesign, so that’s part one. Part two, very provocative differential partitioning data, Cabo versus Zanza. I am curious, one, how was that determines? Would it be based on kind of radio labeling experiments? And then perhaps from a hypothesis perspective, do you have any sort of initial working in terms of why that is? Is that kind of a difference in passive diffusion or maybe transporters are involved? So those are the two questions. Thank you.

Michael Morrissey: Yes. Thanks, Andy. It’s Mike. Dana, why don’t you take that second question first, and then we’ll punt it over to P.J. for the Medicare Part D question.