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

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P.J. Haley: Yes, Jeff, this is P.J. Thanks for the question. Generally, what I would say is as we focus coming out of the gate, given that, as I mentioned, we kind of really have broad inclusion criteria in our study of whether that’s site of origin, SSTR receptor status, what patients have been previously treated with, we really believe we have the opportunity to go right out of the gate. Should we be approved and launched this very broadly. And I think that will be in what we’re hearing in ad boards, et cetera, very much appreciated and adopted well from a physician community perspective because they need new options, for really all of these patients. And in some cases like right now for patients who have been on a variety of therapies. So I think it would be a broad opportunity and we would certainly position it to as such.

Operator: Thank you. Please standby for our next question. Our next question comes from the line of Etzer Darout with BMO Capital Markets. Your line is open.

Lukas Shumway: Hi. This is Lukas Shumway on for Etzer. Thanks for taking my question. For the prostate and NET filings, what are the key factors that are going to influence like the timing of those filings, what are you waiting on for those? And are those only going to be US filings? Are we also looking for ex-US? And are there any other gating factors for filing those?

Amy Peterson: Thanks, Lukas. This is Amy. I’ll take that question. So I can’t comment on what our partners are going to be doing with regard to ex-US. filing. Cabo is in collaboration under a — collaboration agreement with Ipsen for non-US, non-Japan and with Takeda for Japan. What we’re focused on and what I mentioned in the call is that we needed the data by BIRC in order to complete the dossier for a filing. And we have the data, and we’re in discussions, and we really are hoping to be able to submit in the coming months for the CABINET study. For CONTACT, I also mentioned we have final OS, which we’re anticipating in the coming months. The study was a positive study. Statistically significant OS is not required in order for the study to be positive.

We showed a really nice trend favoring Cabo/Atezo, which I will point out, given the — what else is going on in prostate cancer in terms of radioligand to PSME4 assets where initially hazard ratios for OS were above one. Novartis just announced there’s a less than one, probably very close to one, the fact that we had a nice trend, I think, is also supportive of a risk-benefit profile that is — that favors the patients. And so stay tuned. We’ll let you know how conversations and filings progress with the agency.

Operator: Thank you. Please standby for our next question. Our next question comes from the line of Peter Lawson with Barclays. Your line is open.

Peter Lawson: Thanks for taking the questions. Chris, just a question on the share buyback and thoughts on expanding that especially if there’s a negative outcome around IP, would that be something you would expand or accelerate?

Christopher Senner: Hey, Peter, thanks for the questions. It’s Chris. Yes, I’m not going to speculate on what we’re going to do depending on the different variables around outcomes on the MSN trial. We’re — as I mentioned in our prepared remarks, we’re committed to executing on the $450 million, we did $191 million in the first quarter, and we’re committed to getting the rest done this year.

Operator: Thank you. At this time, there are no further questions. And so I would now like to turn the call back over to your host Varant for closing remarks.

Varant Shirvanian: Thank you, Towanda, and thank you all for joining us today. We welcome your follow-up calls with any additional questions you may have that we were unable to address during today’s call. Thank you.

Operator: Ladies and gentlemen, this concludes today’s conference call. Thank you for your participation. You may now disconnect.

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