Exelixis Inc Wells Fargo 21st Annual Healthcare Conference
Review the key takeaways and the transcript of this earnings call.
- Exelixis launched the NET indication for Cabo last year and is continuing to penetrate the market for both NET and RCC indications in 2026.
- The company is focused on growing Cabo franchise revenue toward a $3 billion target, considering RCC and NET indications as key growth drivers through 2027 to 2029.
- Second quarter Cabo revenue guidance was reduced due to slower than expected patient treatment kinetics in the NET indication, attributed to longer scan intervals and treatment breaks in indolent disease.
- Exelixis maintains a peak NET opportunity estimate of approximately $1 billion at contemporary pricing and reports new patient market share around 45%.
- The company views 505(b)(2) products like the tentative approval of a Cabo-like therapy in Japan as minimal commercial risk due to lack of clinical data and substitution challenges.
- Exelixis plans for Cabo generic entry in January 2031 based on settlements, with ongoing litigation expected until then.
- Zanza's filing for colorectal cancer (CRC) is based on the ITT population including all-comers, supporting confidence in securing an all-comers label.
- Physician feedback on Zanza's CRC data is enthusiastic, especially due to the chemo-free and checkpoint inhibitor components, with familiarity among community oncologists.
- Exelixis expanded its GI sales team in early 2023 to support NET and prepare for Zanza's CRC launch, which will occur immediately upon approval.
- Pricing for Zanza is expected to be contemporary with recent market trends, though no specific details were provided.
- The ongoing Stellar 304 Phase 3 study aims to establish a standard of care for non-clear cell RCC, a heterogeneous and underserved population currently treated off-label with drugs approved for clear cell RCC.
- Exelixis excludes chromophobe histology from Stellar 304 to improve study success and aims to capture as much of the approximately 20% non-clear cell RCC market as possible.
- Zanza is being studied in combination with Belzutifan in clear cell RCC to address high unmet needs, particularly after failure of frontline therapies, with the goal of establishing a new standard of care.
- Exelixis remains excited about the NET franchise overall, considering it a core franchise alongside RCC, with ongoing development of Zanza and earlier pipeline programs.
- The meningioma Phase 2 study aims to show a robust response rate to support potential accelerated approval, addressing a high unmet need with few effective options.
- Exelixis plans to generate sufficient data on early pipeline programs to make informed go/no-go decisions for late-stage development, with no specific timing announced for R&D updates.
- The company has repurchased approximately $2.9 billion of shares from 2023 to Q2 2026, retiring about 90 million shares, with $600 million remaining on the current authorization.
- Capital allocation priorities include R&D spending under $1 billion annually, business development focused on GI and GU areas, and ongoing share buybacks.
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Transcript
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Great. Welcome to the next session. My name is Eva Fortea. I am one of the biotech analysts here at Wells. We have with us today Andrew Peters, Senior Vice President, Strategy, and Chris J. Senner, CFO of Exelixis. Thanks so much for being with us today.
Yeah, thank you for the invite.
Great. Maybe we can just start our chat with lay of the land, last 12 months, next 12 months for Exelixis.
Yeah, I can start, and Andrew can kick in. We continue to, currently in 2026, we're in the process of. We launched the NET indication last year. We're continuing that process of penetrating the market from a NET indication perspective, and also from an RCC perspective. The development of zanzalintinib continues to be at the forefront of what we do. It's a big part of what the company is, as we look into 2027, it's a big part of what our expectations for the outlook for the company.
Yeah. Just to add on that, and just as a reminder, Chris J. Senner and I are going to be making forward-looking statements today, so please see relevant disclosures around risks to our business. I think Chris said it well in that 2026 is this interesting transition period for the company as we're continuing to execute, grow CABOMETYX, and really use that financial success that we have with our base CABOMETYX business to then invest in zanzalintinib, not only ahead of our potential launch in CRC later this year, but also expand the breadth of that development. So that as we exit the decade, in 2031, the LOE of CABOMETYX, that handoff to not only replace that CABOMETYX revenue, but growing it, is really the focus of the company.
Between our early-stage pipeline or being opportunistic around business development, enable that third, that fourth, that fifth program so that we can really scale as a company. That's really what we're focused on, is maximizing the value of CABOMETYX while really starting to invest at a really important time in the zanzalintinib franchise, and then being opportunistic in investing appropriately within our own internal program, looking externally, and then, again, making sure that we're doing the right thing for our shareholders and looking towards things like share buybacks as well. So, really exciting time at Exelixis.
Great. So maybe let's start talking a little bit about the CABOMETYX franchise. It's been incredibly successful. How should we be thinking about growth from here?
Yeah, from an overall CABOMETYX franchise perspective, we set out a $3 billion what success could look like number, and we still feel like that's an achievable number based on everything we know today. The RCC indication is part of that growth, but also NET is a big part of that growth as we look into 2027, 2028, and 2029.
Got it. Maybe just touching upon what drove the reduction in guidance and the second quarter revenue for CABO.
Yeah. We talked about it on the call to a large degree, but when we looked at the overall pace of the NET indication, we saw that as we drove into the community with our expanded field force, we saw that the kinetics around how some patients move from therapy to therapy, we saw that was a little bit slower than we originally had projected. In a more indolent disease like NET versus other solid tumor malignancies, they do not get scanned as often, right?
For some of the patients in other solid tumor malignancies, they get scanned every three months. From a NET perspective, a neuroendocrine tumor perspective, for some of these patients, it could be a longer period between scans and also sometimes a longer period between therapies. That is what we noticed in the market. We do not see a change in our overall outlook for the total potential, but it is just going to be a slower ramp than we originally projected.
Yeah, I think the best way I think about it is really more of a temporal dynamic than anything. It is that gap between new patient market share and total market share. P.J., our head of commercial, talked about this on the call, with 47% or so new patient market share. As patients, as Chris said, are coming in for scans, if they do need to come onto a new therapy, increasingly they are going onto CABO. But that time course on when that new treatment decision happens is just a little bit slower, especially in the community, because of either the scan interval or is there a treatment break between these. Because again, unlike a lung cancer or most other solid tumors, that slower-growing disease that is just inherent in neuroendocrine tumors makes that decision point or part where the new bottle is dispensed just temporally a little bit slower.
But again, the focus from our perspective, that leading indicator is new patient market share. We're confident that those patients are there. We're increasingly successful in converting those new patients. It's more a temporal dynamic than anything around when that switch occurs.
Got it. Have you shared your assumptions on peak opportunity in the NET space for CABOMETYX, and how has your assumptions on the launch ramp changed?
Yeah, I think we've talked about NET being about a billion-dollar indication from an oral perspective at contemporary pricing, and we still believe that's the case. And as Andrew was talking about, the new patient share that we're picking up is around that 45% range, and that's a good leading indicator of our penetration.
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