Exelixis Inc Q2 2025 Earnings Call Transcript

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

Question: David Lebowitz - Citi Infrastructure Investments LLC - Analyst : Thank you very much for taking my question. I know it's early, and we haven't really seen the data yet, but any particular takeaways that we have from head and neck that can be extrapolated or not extrapolated to future studies?

Question: Sean Laaman - Morgan Stanley - Analyst : Thank you. Hi, Mike and team. Hope everyone's well. Just thinking a little bit longer term, the $3 billion peak revenue guidance for CABO, it looks like, I think, looking at guidance for this year, probably do around about 2.1 ex-NET and other revenue opportunities. Just looking at the market share gains you had, I'm just wondering sort of how enduring do you think such share gains can be? And the second part would be, do you think you can achieve the same market share in NET as what you've seen in RCC?

Question: Michael Schmidt - Guggenheim Securities LLC - Analyst : Yeah, hey guys, thanks for taking my questions. Yeah, a question on STELLAR-303. Obviously, great positive announcement here earlier on hitting OS in the ITT analysis. And yeah, I think some of us are just curious how you think zanza may be positioned in the broader colorectal cancer landscape, perhaps relative to other new treatment options, including Fruquintinib which we hear is making some inroads in the market? And then question number two, obviously, the trial hit the ITT analysis. So at this point, how important is succeeding on the NLM subset later on in terms of regulatory approvals or commercial marketing ability down the road? Thanks so much.

Question: Asthika Goonewardene - Truist Securities - Analyst : Hi guys, thanks for taking my questions. I want to layer on to Michael's previous question. It sounds like we're having similar thoughts about this too off in our investor discussions. Maybe if you can tell us, with STELLAR-303, the language in the press release was a little bit maybe on the conservative side. So could you maybe tell us if you have a view whether the data in the ITT population is clinically meaningful? I think that's been a debate point here in our discussions with investors. And secondly, do you have plans to advance zanza in combinations in earlier lines in CRC? And could you just maybe tell us what looks most attractive to you? Thanks, guys.

Question: Silvan Tuerkcan - Citizens JMP Securities LLC - Analyst : Thank you. Thanks so much for taking my question, and congrats on the execution this quarter. I just wanted to see if you could comment, please, on the pricing dynamics with cabozantinib, especially with respect to the 340B volume and the reimbursement there in the near future and post- the Big Beautiful Bill? Thank you.

Question: Yaron Werber - TD Cowen - Analyst : Right. Thanks for taking that. I have a couple of interrelated questions. Maybe the first one on 304, the primary endpoint is PFS and ORR. Do you have to hit them both? Or is it one that it's a dual where one of them can over-sway the other? Because I imagine ORR might be earlier than PFS. And then maybe secondly, just on 303 against STIVARGA. In the past did like six months, 10 years ago and then nine months more recently, how would you expect that control to sort of perform given that Avastin does about 10.8 months. So how, historically, is a bit relevant? Thank you.

Question: Akash Tewari - Jefferies LLC - Analyst : Hey, thanks so much. So Mike, I think when we had caught up at ASCO, you had described the head and neck go-no-go decision to be a relatively low bar to proceed. And your team was confident you could have a competitive profile despite some of the emerging single-arm data from bi-specifics. I think CABO/NIVO has shown historically a response rate over 50% in that setting. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JULY 28, 2025 / 9:00PM, EXEL.OQ - Q2 2025 Exelixis Inc Earnings Call Can we affirm that the zanza data looks similar or worse to cabo, and that's what drove your decision to not move that forward? And what were you expecting from a clinical profile there relative to what was shown from an event-rates perspective? Thank you.

Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst : Hey, guys, thanks for taking my questions. So just want another follow-up on STELLAR-303 and the extent that you could comment on the enrollment demographics and maybe if there are any variables that help lead to a different outcome than LEAP-017. I believe that you could have enrolled up to 40% of patients with non-liver met, so pretty much highly similar to LEAP-017, but potentially that could have gone a little bit higher. So I don't know if you're able to comment on directionally the enrollment skew with patients with non-liver met. And the opportunity with 303 in the adjuvant CRC setting, do you have a rough sense of what the US patient number is for that market? I imagine there's some proprietary market-segmentation data that maybe goes into sizing that. But any idea on if you can give us a sense on sizing there?

Question: Andrew Berens - Leerink Partners LLC - Analyst : Okay, thanks. A couple more questions on the CRC program and STELLAR-303. The FDA has made demonstrating contribution of parts of a priority. Just wondering if you think that STELLAR-303 has met that bar. And then some concerns I've heard from investors are that the intent to treat OS benefit may have been driven by an improvement in the non-liver met patients that are part of the cohort and the impact on checkpoint inhibitor efficacy. I know the NMOS analysis is not read out yet, which is probably contributing to this concern. But is there anything you can say to address this? How important is it that you demonstrate a definitive benefit in the patients that have liver mets? Thanks.

Question: Derek Archila - Wells Fargo Securities LLC - Analyst : Hey, thanks for taking the questions. Just one on NET in terms of how should we be thinking about the revenue trajectory post second quarter? And the next couple of quarters have launched more bolus-like before steadying off as you need to roll over these indolent patients become candidates for therapy. And then just a follow-up, just can you discuss the breadth of prescribing that you're seeing among the target positions so far? Thanks.

Question: Peter Lawson - Barclays Services Corp - Analyst : Hey, Chris, just following up around the details around the guidance. Is there any way we should think about clinical trial revenues in the second half? Thank you.