Exelixis, Inc. (NASDAQ:EXEL) Q2 2023 Earnings Call Transcript

Vicki Goodman: Yes, so in terms of 303 enrollment, that’s been going well. We’re still in — still have a number of sites to activate. So we’re confident that once we have those sites up and running, we’ll be able to enroll even the additional roughly 50% increase in patients relatively quickly. All of the patients that have already been enrolled, they are certainly relevant to the patient population. So we don’t have any concerns there about any kind of skewing the patient population. The increase is driven by the fact again coming back to the incidents of patients with liver metastases being quite high. So in order to have a representative, patient population that looks somewhere near the incident of liver mets, we have to enroll a substantial fraction of patients with liver mets in addition to those without.

So again, the primary analysis will be in that smaller population. But again, to show a benefit in a smaller population, while preserving the possibility of showing a benefit in the overall population, we have to enroll somewhat higher number, but again, we think we can make-up some time given how well we’ve been recruiting to the study.

Stephen Willey: Great. Thanks for taking the question.

Vicki Goodman: You bet, Steve.

Operator: Thank you. Please standby for our next question. Our next question comes from the line of Chris Shibutani with Goldman Sachs. Your line is open.

Chris Shibutani: Great, thank you. Can I just clarify on 303 with the answer to Stephen’s question. Does the amendment have any implications or effect on potential timelines? And then just more broadly, I guess you have the R&D Day planned in December, but could you just give us a sense for your plans for disclosing additional data across the zenza program and across the Phase III studies. This is pretty much going to wait for December Analyst Day or help us out a little bit when we can get more data. It seems there lot of the responses are, we’ll have to wait-and see.

Michael Morrissey: Okay. So you want to take the first part of the preferred that question. I will take the second.

Vicki Goodman: Yeah. I mean, so we’ve increased the sample size by 50%, so of course, we do expect that it will take longer to enroll. Again, the patients that we’ve already enrolled are remained relevant to the patient population under study, and we’ve had a robust recruitment, again, but still some sites that we’re still bringing on-board, lots of investigator enthusiasm. So we think that we can ultimately make-up some time there.

Michael Morrissey: Yeah, Chris, in terms of the R&D Day agenda and content, I don’t want to get too far ahead of ourselves. That’s in December. It’s barely August. So we’ve got some time to figure that out. Obviously, we’re committed as we have historically, to presenting mature data when it’s available across not only the cabo spectrum, but the entire pipeline. So we’re on-track to do that this year with zanza and certainly it’s the — we have the opportunity with mature data later in the year, we’ll find a way to get that out and certainly that will be the case as this data matures, which it — somebody has designed its own course relative to how that data matures, but when appropriate. So, appreciate your patience. You understand you have been in this business for a long-time, so you understand that some of these things just take a longer than you’d like.

But I think we’re very comfortable with the depth of R&D that we’ve gotten across discovery and development and collaborations and other stuff that we’re working on right now that will have a very fulsome morning in New York, the sheer, the latest and greatest data with — when we are there.

Vicki Goodman: Yeah. Next question?

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