Exelixis Inc at Guggenheim Global Healthcare Conference Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Michael Schmidt - Guggenheim Securities - Analyst : So we'll just jump right into Q&A.

Question: Michael Schmidt - Guggenheim Securities - Analyst : Why don't we start with a discussion on CABOMETYX now that you have visibility on the [IP] runway following the recent US District Court decision. And so in RCC, I think your market penetration is fairly mature at this point. You're still growing, but talk a little bit about how we think about midterm growth opportunities for cabo as we look at the years ahead.

Question: Michael Schmidt - Guggenheim Securities - Analyst : Right. Is Cabo already used for neuroendocrine tumors, you think, at this point? And is there opportunity for early NCCN guideline inclusion?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Right. Okay. And then how are you tracking towards contact OT submission for prostate cancer, and how will you frame the opportunity in that setting? Post-NHT?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Right. Okay. So shifting gears to zanzalintinib, which is becoming an important growth driver in the near to midterm, actually, now with the STELLAR-303 study potentially reading out next year already. So can you discuss, again, sort of the trial itself, what the clinical bar is relative to regorafenib in this particular study and sort of that initial opportunity in colorectal?

Question: Michael Schmidt - Guggenheim Securities - Analyst : So just to clarify that small randomized Phase II is in colorectal specific?

Question: Michael Schmidt - Guggenheim Securities - Analyst : And what is the purpose of that study?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Got you. Okay. And that would come before STELLAR-303 potentially?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Right. Okay. Great. And then for the non-clear cell RCC opportunity, we know that the KEYNOTE-B61 study was recently included in the labor for Lenvima, how does that impact in your view how zanza may play a role in the market once STELLA-304 reads out?

Question: Michael Schmidt - Guggenheim Securities - Analyst : And for 304 in non-clear cell, just remind us of the size of the magnitude of that a commercial opportunity relative to clear cell RCC, perhaps?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Got you. And on 305, as you just mentioned, the head and neck study, which is now -- it's already been open, I think, for almost a year. And there are several other companies being valued in clinical studies. Can you just comment on the pace of enrollment you just touched on it relative to your expectations and how we think about the TKI-IO approach in the face of some of the emerging competitive mechanisms?

Question: Michael Schmidt - Guggenheim Securities - Analyst : And any learnings from the LEAP-010 study, which was, I would say, a close miss perhaps in head and neck?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Right. And then yes, you just touched on the Merck collaboration that was announced not too long ago. And can you just remind us of your planned study of zanza with belzutifan, and will potential Phase III study initiations be gated by additional early data sets coming from ongoing Phase I -- planned Phase I/II studies?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Makes sense. And then you've also talked about expanding your activities in the neuroendocrine tumor setting with the plant STELLA-311 study in first line. And so yeah, talk a bit about those plans and perhaps potential relative to some radio ligands like glutathera that are being used in other therapies?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Got you. Makes sense. And then what else will we learn from the ongoing STELLAR-002 study that you [brought] study and that has a lot of cohorts?

Question: Michael Schmidt - Guggenheim Securities - Analyst : All right. So looking forward to zanza, really reading out data starting next year. As we think about the rest of the pipeline, curious, with clarity now on cabo, IP and visibility on LOE on that front. I think you've sort of highlighted increased focus on BD, if I interpret your comments on the earnings call correctly. But has the approach to expanding the pipeline beyond zanza changed following the patent decision? And if so, how?

Question: Michael Schmidt - Guggenheim Securities - Analyst : Right. So fully understand your focus on GU, GI in terms of BD, obviously, in terms of leveraging synergies with your existing portfolio. But as we think about the earlier pipeline, it's obviously more broadly spread in terms of therapeutic categories and targets. Is there a theme? Or how do you approach thematically target selection as you build your internal pipeline?

Question: Michael Schmidt - Guggenheim Securities - Analyst : And you just mentioned the USP1 is one of the more advanced product candidates. Just maybe briefly, how do you think about that opportunity? And I know there's been some data from a few other molecules out there? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 12, 2024 / 2:00PM, EXEL.OQ - Exelixis Inc at Guggenheim Global Healthcare Conference

Question: Michael Schmidt - Guggenheim Securities - Analyst : Okay. Great. Well, Mike, with that, our time is up. I really appreciate you, thanks.