Exelixis, Inc. (EXEL) May 19, 2026 Conference Transcript

Our second session, we've got Exelixis, and we're really excited to have them here. They're represented by Andrew Peters, the SVP of Strategy. Thanks for being here.

Yeah, thanks for the invite. Glad to be here. Yeah.

So there's a lot going on at the company. I wanted to start maybe on the commercial franchises first. So you guys have given guidance. Cabo had a pretty solid quarter. So, you know, maybe at a high level, I mean, how are you thinking about the balance of the year the future trajectory this year for Cabo across its existing indication?

Happy to get into that before answering. I want to make sure that everyone understands we're going to be making forward-looking statements today, so please see our relevant disclosures in our regulatory filings. As you said, our guide reflects continued growth for the Cabo franchise, kind of specifically where that's going to come from, I think it's really about our organization, our company continuing to be laser focused on Cabo, both on the base business as well as the net launch. It's one of the things that we've done well historically, and it's something that we want to continue to do and make sure that we're not taking our app the ball. We've talked about kind of, you know, over the last several years, continuing to see market share gains, not only in RCC, and in particular frontline RCC, but now as we're kind of launching into that net segment, you know, really driving that NPS, you know, which, you know, from our perspective, is a pretty good forward-looking indicator. They're, as PJ talked about on the earnings call, highest NPS we've ever had during the quarter. And so it's that laser focus on additional market share, finding those patients as we've now kind of expanded our commercial footprint, you know, to focus not only on the net launch and say the community side, but really lay the groundwork ahead of potential Zanza launch as well. So it's really kind of that singular focus on making sure that we're going out every day and talking about Cabo, talking about the data, and that, again, driving market share.

Maybe just to dive in a little deeper on that, there's obviously two major parts that we've investors been focusing on, the RCC side and the NET side. Just on RCC, I mean, there's been some competitive data, particularly in HIF2. I guess, how are you thinking about maybe the balance between first line and growth you have there versus maybe competitive pressures in the second line and how you envision the trajectory?

Yeah, so, I mean, it's still really obvious that oncology is competitive, has always been competitive, will always be competitive. And that's what, you know, we do every day is we kind of go out and fight, you know, to either develop new therapies to establish standard of care or really ensure that, you know, drugs like Cabo are able to be used in the largest number of patients possible. So as it relates to the HIF space, you know, obviously this is an evolving dynamic with the recent LightSpark 12 data, as well as our own, you know, initiations of the O33 and O34 space. So it's certainly a mechanism that we're paying a lot of attention to. As it relates to kind of this, you know, dynamic around front line, second line use, You know, we've seen a lot of speculation that if Len Bells does get adoption, say, from LightSpark 11 in the second line, does that drive incremental use for Cabo in the first line? That certainly would be an outcome that we'd be okay with, given kind of the relative duration dynamics between those. But, you know, I think there's still kind of a lot of additional information that needs to come out around just the, you know, between Lightswark 5, 11, 12, 22. It's just a continuously evolving space. And so, one, we're obviously paying close attention to. But, you know, right now, Cabo's the number one IOTKI. It's the number one I.O. and we want to do everything we can to make sure that that dynamic continues in the future.

And the other side of it, the equation, is the net growth. And, you know, we've done a fair amount of work here as well and found pretty high levels of prescriber enthusiasm. I think on your recent call, you guys mentioned it's the number one prescribed oral agent in the second line, plus NETS. So I guess how do you think about how much more growth there is in NETS? You guys recently had the Salesforce expansion included, the team moving into that space as well. So I guess what are you hearing on the ground?

Yeah, so again, I think we'd agree with your characterization around kind of that level of enthusiasm. You know, we certainly saw a lot of adoption kind of right out of the gate in the academic space, just given the strength of the cabinet data. But again, as we've talked about historically with, you know, our success in RCC, it's really about going in and driving market share gains. And if you think about, say, net, you know, along with RCC, it's not only about penetrating that academic kind of KOL sphere, but then going into that community space as well, where, you know, the vast majority of patients are actually treated. And so what the Salesforce upsizing allows us to do is kind of do both, continue to kind of really hit hard and kind of hammer home the message around Cabo's strength and really the benefit for patients here, but also educate those kind of community, more community-based docs who may not see that same kind of volume either of RCC patients or NET patients. So it's kind of expanding that to drive additional share. You know, we're now kind of a year into the launch, but, you know, one of the dynamics with NET is just understanding that it's a relatively indolent disease. So there's always that NRX, TRX dynamic that's going to start to happen as well, where you're stacking patients not only with new patients, but refills. And kind of that's something that we're going to continue to look for as well. And I think our guidance, which reflects growth not only in the RCC space, but NET as well, kind of takes all of that into consideration.

I want to move on to ZANZ and some of the pipeline updates there. But since we're on the topic of NETs, I just wanted to first touch on 3.11. I guess how you're thinking about that study, you know, the differentiation that ZANSA might provide both in, you know, the paradigm in which is going to fall in NETS as well as, you know, how that handoff might work between Cabo and ZANSA in the future.

So I think it's a dynamic that's really going to go into kind of two key areas. One is just the uniqueness or kind of differences between Cabo and Zanza and kind of the more user-friendly, shorter half-life, potentially more tolerable, you know, all the things that we've started to see earlier on, and then just the differences between 3.11 and cabinet. So cabinet, relatively later-line population, placebo-controlled, reflecting that dynamic, versus 3.11, where it's really kind of defining or hoping to answer the question, what should be that first oral option? And so what that means from a practical perspective is it's an earlier population, and it's also head-to-head against kind of the current standard of care in Everolimus. And so, again, it's going to come down to levels of evidence if we're able to show that ZANSA is statistically better than kind of the current standard against an active comparator. We think that that's a really powerful message that, you know, in the future our reps will be able to go out and market to versus, you know, cabinet, which, again, you know, it's really rare in this business to see HRs with a 0.2 and 0.3 in front of it. But again, you know, for the most part, that was also a relatively later line population for a lot of those, if you look at kind of the breadth of that study.

I guess the nearest term opportunity for prezanzas is obviously from 303 and CRC. So I want to touch on the commercial there as well. But first, you know, there's also going to be a potential data update in the NLM population. I guess, how are you thinking about what you'd like to see there and, you know, maybe what success in NLMs might mean more broadly for the CRC opportunity?

So, again, there's a couple of dynamics there. You know, on the success side, you know, statement of the obvious, P-values, you know, that's really kind of the bread and butter of the industry and what allows our sales force to go out and really hammer that message home that Zanza Tezo should be the new standard of care for these later line colorectal patients. You know, in terms of does it matter, you know, obviously the ITT population, which read out last year and has the PDUFA date in December, is inclusive of both patients with liver mets and non-liver mets. But again, kind of the best-case scenario, so to speak, is really a data set that enables our commercial organization to go out and have conversations with physicians and prescribers to really emphasize and reemphasize that dynamic around why the combination should be kind of the standard for patients, what the inclusion of an I.O. potentially means from the patient's perspective and really just why we think the data are starting to resonate kind of as we do these kind of market research and KOL checks, a lot of those messages that are starting to come out. So the non-LiverMet readout, certainly looking forward to it and hoping to show as strong a data as possible. But, you know, just, again, as a reminder, kind of that ITT population is really inclusive of all patients.

Appreciate there might not be a lot you can say on the next part of this. But, you know, as you mentioned the PDUFA, as you guys move towards that date, I mean, anything to note on the regulatory interactions?

Yeah, I mean, you know, other than we have a great relationship with the agency, you know, from our perspective, the review and the filing has kind of, you know, gone as well as we could hope. You know, it's one of those things that we just, this isn't our first rodeo, so to speak, on the regular side. So, you know, it's glad that we have that experience and kind of those existing relationships. And, you know, it's been a great collegial collaborative process so far.

And then as we look towards, I guess, December and potentially starting that launch, you know, the data you've shown suggested benefits, you know, broadly for CRC patients. And your strategy, as you mentioned, has been, you know, fight for every patient. So is the initial push going to be broad? Is it going to be focused on both community and the academics? How do you think about, you know, the initial stages of that launch and where you're going to position the drug?

Yeah, I mean, kind of as we've shown at RCC, going out and competing commercially is something that we do especially well. And it's really going to be about kind of targeting all of those populations, fighting for, you know, every patient, fighting for every, you know, market share point is something that we want to do. You know, as I mentioned, kind of those dynamics around the messaging that's really resonating with patients, it's, you know, potentially the first I.O. that's going to be available to these patients is something that, you know, we continuously hear, but also kind of that chemo-free dynamic as well as you think about the patient's journey from, you know, diagnosis towards that treatment decision and kind of the third line space, you know, functionally they'll have been on chemo that entire time. So understanding, you know, a IO containing chemo-free regimen that has a clear survival advantage over a prior standard of care really does resonate. Then you also understand, And, you know, say relative differences between our data and, as you mentioned, kind of this robust benefit across all prior subtypes. Whereas if you look at, say, some competitor data, you know, that same dynamic around something like prior Avastin use or prior Bev use and the differences kind of in efficacy there. That's something that I think, given how patients are treated in the U.S., could be especially relevant.

And just to remind everyone, Salesforce there is largely in place.

So I think, again, kind of what we've talked about as a key part of the Salesforce expansion that we completed last quarter was not only kind of to continue to accelerate that net launch, but also lay the foundation for Zanzib potential approval later this year.

You guys have talked about how this could be potentially a $1.5 billion market opportunity. As investors start doing more work on the launch, are there any other metrics that you'd point to, any other launches that we should think about to better understand how the shape of Zanzib and CRC could look?

Yeah, I mean, you know, I think the best way to think about CRC is kind of that billion five opportunity when you apply kind of contemporaneous pricing and duration and all of that is really a reasonably fragmented market. And that's in part driven by, you know, this academic versus KOL dynamic, which is probably more prevalent in CRC than some other tumor types. But it's, you know, kind of a third, a third, a third, you know, a third roughly that sunlight regimen, a third kind of TKIs, and then a third, you know, hodgepodge of, you know, chemotype options. um and so you know our goal our mission our singular focus again is to make sure that we're taking as much share from each of those three buckets as we can and so um can't and you know won't be able to give guidance on what that trajectory looks like other than you know it's going to be our job every day to kind of come in and drive that um adoption i wanted to pivot towards ZANSA in RCC and non-CLEARCELL as well

with the STELLAR 304 trial. We're looking for data from that this year. I guess, can you talk about, given that there's no approved, formally no approved treatment options in this setting, specifically for this, what, you're gonna tell me P-values, but what looks like, like what would be a win for you guys that can help you, you know, get competitive, move into this underserved patient population? I guess, how are you thinking about that?

I mean, I don't want to say it again, but I think that's the honest answer is, you know, grade data. You know, p-values, one of the things that's driven success for Cabo and RCC and why it's the number one IoTKI is that kind of, you know, PFS, response rate, survival, all of those improvements really resonate with patients and physicians. And so it really comes down to kind of what the existing dynamic is in that kind of non-clear cell space and what we're hoping to achieve there. And, you know, it's this relatively unique aspect of the non-clear cell segment where there's really no data kind of across the board. And so, you know, we were having a conversation with an investor earlier, and adoption is really driven somewhat by inference from the ClearShell space and then as well as guideline-driven recommendations based on some really sparse data sets, you know, single-arm, unrandomized data and, you know, potentially selected patient populations. So it can be really hard to kind of understand, well, how is my patient going to respond to individual therapy or combination X? What this study does is it provides kind of robust data really to answer that question. And so that exact dynamic is actually something that I think we've heard continuously from physicians that they're really looking forward to because we're really the leaders here in defining how patients should get treated.

I guess how much of non-clear cell is more of a foothold for Zanza in the space initially versus a large opportunity in itself, given it's 20% and, you know, Cabo is a great drug as well as you get?

I mean, I think 20% of a large market is still relatively, you know, sizable. And so I don't want to underplay that dynamic. But, you know, we'd certainly agree that as we think about, you know, Zanza going forward, one of the things that we often talk about in the way, you know, we think about development is Cabo has been the TKI and RCC of the 2020s. zanza is going to be the tki and rcc of the 2030s it's not only about the non-clear cell segment but how are we approaching kind of that clear cell space as well you know with 033 now 034 and then um you know kind of the next steps the next wave of investment so to speak to continue to to build that out and so um that's one of the kind of overarching themes for us is that 2020s to 2030s dynamic for ZANSA in making sure that we're covering all the bases, so to speak, not only in non-clear cell, but post-adjuvant front line, de novo front line, and then kind of that second line plus segment. And so we can make sure that as patients are treated differently now than they will be in the future, we want to make sure that ZANSA is a central part of that.

Yeah. And you guys clearly have a leadership position in RCC. And, you know, maybe going back to this HIF discussion, there's a number of trials that ZANZA is participating in with these HIF targeting agents. So, you know, are we viewing it too much through a competitive lens where really uptake, you know, growth of these agents is going to be a positive for ZANZA given the potential combination approach here?

Yeah, I mean, again, it's an interesting and relatively unique dynamic where we're now collaborating with functionally our biggest competitor. And we love working with Merck. We announced another clinical collaboration with them this morning for the 316 study. So, you know, it's a relationship that I think reflects, you know, not only our confidence in the uniqueness of Zanza, but that dynamic around understanding, if we fast forward the clock, you know, five years or so, how are patients going to be treated? Our job as drug developers is really to define new standards of care for patients and really ask the question, you know, the way we drive value for patients, for all stakeholders, for shareholders, is really if we can define a new standard of care, if we can help patients live longer, that translates to, you know, higher revenue, kind of more value, all of that dynamic. And so we think that the combination of, you know, a HIF inhibitor like Bell's and ZANZA plays well together and importantly has the potential to answer really important questions from a clinical perspective, such as if more and more patients will get PEMBRO on the adjuvant side, what should they get if their cancer returns? Again, we're going to be the first to define that answer. Similarly, kind of as adoption of all these different agents kind of changes in the future, what should be that kind of second-line-plus segment as well? So, again, that Zanz and Bells combination is something that we're really excited about. So 033, 034, and then kind of I'd say the last piece is stay tuned for that next wave. You know, you talked about we're the leaders in RCC. We want to continue to be the leaders in RCC. We're going to invest there, but importantly, we're going to invest there smartly. I think the lessons not only from our own 313 study, but the recent LightSpark 12 study kind of can certainly help inform what is it going to take to be successful there. You know, orthogonal combinations of orthogonal mechanisms in smart trial design is going to be kind of central to that.

You alluded to 316 earlier. So I wanted to touch on that. It's an adjuvant study in MRD-positive patients. And I guess the focus there right now is on execution as you guys worked to ramp that up. I guess, can you talk about that, you know, how quickly you can get that running? Obviously, there's some unique approaches to that study, looking at, you know, minimum residual disease, the Natera collaboration, Brown and Mark. So just, you know, how should we think about timelines there and how quickly we can start, you know, layering on to the Zanza opportunity?

Yeah, I mean, I think this is a study that, you know, we're particularly proud of because, again, you know, we're involved in defining a new way for patients to get treated. As the recent Invigor approval will show, this is an approach that's really cutting edge and offers an opportunity for patients to really define kind of a new journey for them. Right now in CRC, unfortunately, you know, there's this, the Signatera test can help you define, you know, based on ctDNA positivity or negativity, you know, how your treatment journey will likely go. If you look at the data, the separation of those curves between ctDNA positive and negative is really striking. And it shows that, unfortunately, for that kind of, you know, 15, 20 percent or so of patients, you know, there is a really high degree of relapse. And unfortunately, right now, kind of the current standard is watch and wait. And so from the patient's perspective, that can be particularly challenging. You know, it's coming in and waking up every day and understanding, you know, is the tumor going to come back? What we're now offering is kind of that question of either Zanza alone or Zanza in combination with Keytruda. Can that push out that DFS interval that, unfortunately, for these ctDNA-positive patients is relatively short, in order of six months or so? And so that dynamic, along with working with Natera to help operationalize the study, is something that I think we can build on. because these are patients with a high-end MET need. They're being identified, you know, literally every day. And so that operational advantage from a kind of clinical trial execution perspective, you know, is something that we think we can accelerate.

Unfortunately, we're out of time. There's so much at the company to talk about. We didn't touch on prostate, lung, the early-stage pipeline, business development.

So thanks for being here. Thank you.