Exelixis, Inc. (EXEL) Earnings Call Transcript & Summary

Well, thank you for joining us, and I'm pleased to be introducing our next company presenter, Exelixis, at the Global -- BofA Global Healthcare Conference. My name is Jason Gerberry. I'm a Biotech Analyst. Pleased to be moderating today's discussion with Andrew Peters, SVP of Strategy at Exelixis. So, Andrew, thanks for joining us all the way over here in London.

Thanks for having me.

Yes. Great. So maybe just one question just to get out of the way just from a timing logistics perspective. You're effectively a single product company in the eyes of investors, and that product has a patent litigation matter that's ongoing. I know you can't speak to the litigation matters specifically, so that's not where I'm going with this. But just can you just speak to the timing and if there's -- help us understand, I think it was initially spring because the decision was expected. A few days, it will be fall. So just wondering if you can speak at all to timeline of that legal matter, which is very important in the eyes of the investors.

Yes. So I guess before I begin, just the way I'll be making some forward-looking statements today. So please see relevant risks -- disclosures around risks to the business. So as Mike talked about at the second quarter earnings, no new updates on the ANDA side. As you can imagine, we can't really talk about specifics there. But it remains, kind of, critical to our business, an important milestone for the company to get that resolved. At the very highest level, we're going to continue to vigorously defend our intellectual property. And beyond that, I can't really say around how to [ treat ] this. So yes.

If you could just maybe help frame, I guess, there are scenarios predicated by the IP that you have. So if you could sort of -- at the earliest, right, you have a composition of matter patent and presumably some pediatric extension off of that, that gets you to, what, early '27 for investors thinking through, kind of, the different patents and different, kind of, range of scenarios that's in play.

Yes. I mean I think it's suffice it to say that there are pretty extensive and wide range of scenarios. And I think you're trying to sufficiently [ look ] into, kind of, the earliest and latest. And within that, as a point of practice, we typically haven't gone through each of those other than what the ANDA decision is going to ultimately do is giving us certainty and clarity, sorry about that, and so within that range that you set out. We have settled [with Teva and Cipla for [ 1131 ] and that these are around, kind of, [ through ] generic platform, [Technical Difficulty] the key.

Great. So with cabo on the commercial side, you've got a $2 billion business, give or take, right, in terms of product revenues and royalties. And so as we think about where the product is in its life cycle right now, how would you frame where you're at? What are some of the growth drivers here to forth?

Yes, that's actually a perfect meeting for this week, actually, we're coming off the ESMO meeting where we had a couple of interesting data sets final Phase III data for a couple of studies. But just to, kind of, set the table, so to speak, for those who are less familiar with the story, when we gave guidance at the beginning of this year, it was for a slowing growth year in, kind of, the core RCC franchise. But then we highlighted 2025 and beyond, is really kind of that potential for reacceleration of growth around new indications. And so if you think about most oncology products, and we've done a lot of this kind of analytics, any new indication tends to hit steady state around 5 to 7 quarters post-launch. And so now as we're entering 12, 13, 14 quarter post-9ER and frontline RCC, unsurprisingly, we're starting to see a bit of slowing. So that was, kind of, reflected in the guidance. Now coming back to the ESMO meeting, we had data presented 2 oral presentations: First from the CABINET study, that's cabozantinib in, kind of, a broad later-line heterogeneous neuroendocrine tumor population; and then CONTACT-02, cabo/atezo versus a second NHT in a post-NHT castrate-resistant prostate cancer population as well. And so as we look towards the longevity of that growth profile of cabo, it's really about layering in those new indications. The one thing that I want to say we continue to be surprised by is really the success that P.J. Haley, our Head of the Commercial, has had in that for RCC market. And so as we talked about on the last earnings call, we actually saw a point of market share growth in that RCC market, kind of, despite the competitive landscape and despite the [ matter ], okay? And so it's been something that we're continuing to be pleased and excited about the success of that franchise. So thinking long term, it's really going to be about continued execution on the RCC kind of core approved in-line business and then expanding into mets, prostate potential, all of that. So our focus going forward is really about that. So we announced our submission, and our filing has been accepted by FDA, and that's with the PDUFA in April next year and then plan to file an update.

Yes. Okay. With NET, I know you guys are sort of holding off until you see a label, right, until you kind of talk about maybe what that can be commercially, but it does sound like your tone is a little more bullish about, say, NET then maybe it was with some of the prior label expansions like DTC. And so I'm just kind of curious, am I reading that appropriately that you see that as maybe a more substantial market opportunity than, say, DTC was?

I certainly think that's fair. I mean from my perspective and as -- we as a company have really kind of dug into the data and really dug into the commercial opportunity in neuroendocrine tumors. It's something that we kind of continue to be pleasantly surprised by, almost every update that we see when we're looking at forecast, looking at kind of the market. It's something that continues to have a really high unmet need. But given the dynamics of the disease, the indolent population relatively slow going, things like duration is like incident versus prevalent pool; those are the sorts of dynamics that I have been excited about, yes, excited about that opportunity. You did mention that, obviously, what the label looks like is going to have a huge impact on that total kind of market potential. But suffice it to say that [ NET ] is an indication that we're really excited about, not only with cabo, but on the last earnings call, we also announced a new Phase III study there. I'm sure we'll get into that later. But it is an indication that I think we really feel that as we become market leaders in the RCC space, we can really grow to be kind of the market leaders in that space as well.

Okay. So, how should investors be thinking about you guys? On the one hand, you generate a lot of gross profit off of your sales and royalties on cabo and you've had tighter expense management this year, leading to greater profitability. So a lot of companies in this space, there is this balance, right, between profitability and investing in pipeline. So I guess, how do you guys manage that balance? And how do you think about that in terms of profitability and profitability growth from here versus seeding the pipeline?

Yes. So this is a topic I think Exelixis as a company probably thinks about more than most in the space. And we always joke that we run Exelixis like a business, not a biotech. And I think some of our actions over the past 18 months have really kind of shown that. So on the one hand, kind of obviously, what we want to grow into is a multiproduct [ oncology ] company to have multiple differentiated therapeutics to help patients live longer, better lives. And that's our perspective on through kind of value creation and growth in this industry, is when you layer on kind of the margin expansion, the top line growth from multiple products, you have to balance that with kind of appropriate investment. The reason I say or kind of highlight appropriate investment is, it's been our observation that really to be successful in this business, you need to generate differentiating data. And kind of me-too data or undifferentiated data usually doesn't translate to commercial success. A lot of companies, we tend to observe, tend to view the FDA approval as kind of the finish line. But to us, it's actually the starting line. And so we need to make sure that when we bring products to market, so that P.J. and his team can bring them out to clinicians and patients; it's actually doing something and [ shifting ] kind of that standard of care. And so what that involves with from an investment perspective, making sure we're developing the right products that have that potential to differentiate. A good example of that is, again, on the last earnings call, we announced the discontinuation of XB002, that's our tissue factor targeting ADC. When we looked at the data, ultimately, we came to the conclusion that it wasn't going to be differentiated than Seagen's, now Pfizer, TIVDAK. And so when we thought about continuing to invest in that program, if it wasn't going to be differentiated, that wasn't really the investment we wanted to make. On the flip side, as we've done kind of more work in the area of [ NET ], not only through kind of the cabo lens, but understanding zanza's profile going forward as well; we identified the 311 study, the head-to-head of zanza versus everolimus in kind of that first oral population is something that we actually think is a smart investment here. So we've talked about in the second quarter earnings call was really a reallocation of resource to kind of make sure that we're making smart investments. So ultimately, as we think about capital allocation and how do we invest in the business versus how do we act as appropriate stewards of shareholder capital, that's the sort of dynamic. We've returned about $1 billion in share buybacks over the last 13 months, and we announced another $500 million buyback again on the last earnings call. And so it's really kind of balancing the cash flow generation that we have in the business, investing in our pipeline and then generating data to allow us to...

So if you secure a favorable patent ruling and you get yourself 6, 7 years of product off of what seemingly is a pretty stable RCC-driven business, right, how does that affect the capital allocation strategy, if at all, right, in terms of this level of R&D spend, this periodic share buyback versus perhaps being more aggressive playing offense on BD side? Or maybe having that runway gives you the comfort to just say we're going to play the long game with our internal R&D assets that we have?

Yes. So I think the best way that I would think about it is what the ANDA decision will give us certainty, whereas right now, we have confidence. But on the capital allocation side, I wouldn't say that historically, kind of that's been the biggest or kind of the biggest factor to consider. It's actually around conviction. And so what we mean by conviction is, is this the appropriate investment? Is it the appropriate investment internally? And importantly, is it the appropriate investment externally? This is an area that I spent a good chunk of time looking externally on the kind of beating the M&A side. And historically, we've had an opportunity to bring in many, many, many different assets across all of the kind of in vogue hot targets that you can imagine. But ultimately, as we kind of dug into the data, more importantly, dug into these commercial opportunities, we recognize that we didn't have that conviction to trigger. And what I always say is there's almost no more value-destructive dynamic in this business than kind of doing bad M&A. And so we need to make sure that we have that kind of conviction in the asset. So I wouldn't necessarily link it to the ANDA. I would say when we find it appropriately, when we find that high conviction, either clinical or commercial program; I think that's where we're going to be excited about.

Curious, what are you seeing out there in terms of at a high level? It seems like the oncology space, publicly traded names maybe had a bit of a setback in the past few years. When we look at deal flow, there's a big -- it seems like a big uptick in -- private-held companies are getting bought, and maybe that's a challenge accessing the capital markets. So as you kind of see where you're positioned, do you feel like the opportunity set maybe is more on the private side?

I think the opportunity set has always been small because it really comes down to -- at least for us, it's not about, you don't have a set dynamic of "We're going to do 10, 15, 20 deals a year, hope that 1 or 2 would work." That's just not a game that we want to play. It's we want to be more specific, more selective, focused on high-quality assets where we can get conviction in the target, we can get conviction in the clinical plan, get conviction in the commercial opportunity. And so I don't think that dynamic of the world of oncology of really high-quality assets has always been small and it continues to be small. I think what we always view things through is what we call the cabo. So what we mean by that is we actually got cabo back to us. And so just because something may be out of favor or passed over or whatever, that doesn't necessarily mean that we think it's not a great opportunity. We have to have that differentiated perspective. In the case of cabo, it was mechanism-related, it was data-related and it was market-related. And we can apply that same filter, we do apply that same filter to every kind of asset we look at externally. And so whether it's a public or private company, probably less relevant to us and how does it fit in kind of with our core skill set in the GI, GU oncology space. One of the lenses that I always look through is what does the asset look like right now, but what does it look like in our team's hands because often time, we can go to our clinical team and the current study that the company is running is probably not the ideal one. Here's how we would amendment -- amend it, here's what we would do, we would expand it, this indication, here is how we could potentially combine it with zanza. So those are all of the dynamics that we look externally, really kind of points us in the direction of "This an attractive asset".

And is investing in Exelixis stock still something that like there's -- investors should expect that to continue in the future? Or were those more one-offs in terms of the repurchase programs?

Yes. I mean now that when our third program, it's something that we're quite familiar with. And even before kind of they were first announced, the topic of buybacks has been something that we've discussed internally for years and years and years. Under the -- understanding the dynamic of when, how much to execute, ultimately, that depends on a variety of factors, including our confidence that the stock is undervalued. But I think one of the things that you can think about, in particular, the last 2 buybacks that we've announced; is really been about understanding the dynamic [ account ]. So the one that we recently completed and the one that we've announced, kind of the core there is really about them being funded by cash flow and not being kind of balance sheet dilutive. And so when we started getting additional, say, milestones from the markets in collaboration and our outlook on cabo revenue going forward, that confidence in the cash flow is something that we could look at and say, "Okay, this gets us much more comfortable with kind of the buyback dynamic while saving that kind of balance sheet, strategic asset, should we find something externally to invest in as we also continue to invest internally.

Okay. Maybe just in terms of your ADC ambitions, about 4 years now or so, you've been kind of piecing together a series of partnerships and transactions? And where do you see the company right now in terms of the ADC ambition? Maybe the lead program didn't, maybe, go as quickly as you maybe hoped. And how quickly could you maybe have an asset that's ready for prime time?

Yes. So I mean, ultimately, kind of the short answer to the question is as soon as we can generate data. XB010, 5T4, ADC recently entered the clinic, and we're hoping to bring XB371 into patients next year as well. That's the kind of the next-gen [ trophophase ] tissue factor that we're developing. To kind of take a step back for those in the audience who are maybe less familiar with the dynamic, you go back to, say, 2018 or so when Exelixis functionally restarted our discovery effort, what we kind of had the opportunity to do is almost [ got ] a blank page, but say, okay, where do we want to focus on from a research perspective and what are the modalities, what are the indications, all of that? One of the things that we chose to focus on is ADCs because there was really a great marriage of kind of our cancer biology background, small molecule chemistry and emerging expertise as we were building up in the biotherapeutic space. So if you think about ADCs, it's a combination of the binder, the antibody, the linker, the conjugation part and then the warhead. And so we looked at the landscape of ADC companies and kind of the conclusion that we came to is there wasn't really one company or one platform that we felt can really solved that dynamic. ADCs are a tremendously interesting modality that they're unsurprisingly complicated, cancer is complicated, drug development is complicated. And just because you have a high-affinity antibody with a relatively stable linker and a medium-sized DAR, doesn't mean that, that same combination will fit across every tumor type, every target. And so what we realized is a better approach was to actually develop this kind of network of collaborations where we could mix and match and kind of iterate and optimize on the binder side, on the linker side and on the forehead side. Tissue factor is a great example of that, where we have -- what we think is a differentiated antibody versus any of the other tissue factor ADCs, where unlike TIVDAK, the antibody we use for [ 002, 371 ] is uncompetitive with factor VII, which given its in the coagulation cascade, leading to bleeding risk. And so differentiated there. And then on the linker warhead side, XB371 actually takes a very stable linker that requires 2 different steps to release the warhead and then it has topoisomerase payload. And so if you think about why is that relevant? Well, tissue factor widely expressed across a wide range of tumor types, but some, where tissue factor is highly expressed, maybe less sensitive to more kind of auristatin-based warheads, where they are especially sensitive to topoisomerase-based warheads. So we kind of looked at that key map -- that landscape and developed 371 with that same dynamic. Similarly with 010, the 5T4 that I mentioned before, we kind of looked at n number of differentiation -- iterations of that combination, ultimately came down to what 010 is. And so 5T4, again, a promising target that maybe was interrogated in the past with earlier-gen ADC technologies that may not have really fully explored the opportunity there. So when we think about ADCs, it's certainly part of our core strategy before, but we have to make sure that we're developing what we think are differentiating products. And if we generate data that suggests our hypothesis of differentiation isn't there, we're going to kill them, and I think we've seen the [ numbers ] within that.

Okay. Maybe shifting gears to neuroendocrine tumors, and this is an opportunity both for cabo and for zanza. It's -- our understanding, as you kind of framed, right, it's a very indolent disease. People tend to have a pretty long life span and cycle through a lot of different therapies. So maybe how you think about the size of this, how the prevalence plays into the market sizing, if at all? And then just the sort of the segmentation that you think about that's relevant to -- thinking about the opportunity for first cabo and then eventually for zanza?

Yes. So I guess at the very highest level, I think P.J. talked about this in the last call, in that kind of second-line plus population, there's about 9,000 drug-treated patients annually in the U.S. And as you mentioned, kind of they tend to cycle through multiple different therapies. I mean if you look at the CABINET population, just really kind of the one of the most -- or the most contemporaneous trial, about half the patients in SUTENT and [ Lunithera ], a good number had seen everolimus, a similar number, a good number had also seen SUTENT. And a lot of them have also seen CAPTEM kind of the chemo combination in these patients as well. So they kind of cycle through a lot of different options. One of the things that always has jumped out to us is this is a population that certainly has parallels to kind of RCC in the 2013, 2014 range, where coincidentally, SUTENT and everolimus were kind of the 2 standards of care. So we understand how data can kind of shift that market opportunity. The ESMO meeting was a really positive one for me just to kind of hear the podium kind of the data being presented and the discussion that happened afterwards, kind of Q&A and all the KOL work that we've done, ad boards, et cetera, that really kind of talked about the excitement for bringing a new therapy with cabo. We've done kind of this blinded [ marker ] research of TPPs, target product profiles. The physician KOLs [ we're ] actually excited about the data. And we've [ unblind ] it and say, this is actually cabo. They go, "Oh, okay, I get it." That's because if you look at the prescriber base of [ NEX ], we find that about 75% to 80% of those NET prescribers actually already give cabo in other indications. So there's this high amount of familiarity. There's this understanding of how to give cabo, how to really deal with the AEs on [ NET ] that will pop up, down titrate, how to dose, all of those things. And so kind of that dynamic is something that you hear us, you mentioned it before, kind of our excitement, our focus on enthusiasm about NET, certainly, that gets layered into.

Yes. So one thing I wonder about like -- so you mentioned that 75% are cabo writers. Is this concentrated in GI, GU type of specialists? The reason where I'm going with this is, we've seen in certain like maybe more rare cancers [ where ] this community onc sees 1 or 2 patients sporadically over the year, and these become like more challenging markets to launch into versus, maybe, markets that are maybe better understood and patients are concentrated within certain specialist offices.

Yes, I wouldn't necessarily group it in kind of the more challenging niche oncology space. And coming back to how I was framing it before, kind of the more we've dug into the market opportunity, the patients prescriber basically, the more comfortable we've been with our existing commercial footprint plus some additional investment, but frankly, not a lot should be sufficient to kind of help us launch it in the space. If you think about our business overall, kind of the GU side is certainly kind of our largest component, but as we look ahead to first with CABINET and then potentially with STELLAR-303 or zanza and colorectal study, ultimately, we hope to see our kind of both sides of the GI, GU businesses be more kind of [ aligned ]. And so our commercial organization is really primed and ready to kind of be, again, label-dependent launchable.

So with the CABINET data, imagine the base case is second line plus with treatment irrespective of, I guess, the site of the tumor location. And you've generated a lot of data broadly, right, that the activity in patients irrespective of the site of the tumor location. So is that a fair kind of base case framing?

Yes. Again, I don't really want to get ahead of -- put words in FDA's mouth, but if you look at the CABINET population, it really was a reasonably broad, really heterogeneous group, not only across pancreatic and extrapancreatic [ NET ], but actually 2 different parts of that study, but also included patients, as I mentioned before, who had seen prior Lutathera, prior everolimus, prior CAPTEM, prior SUTENT. And so it really was kind of a mix of a lot of different patient types. And so this question came up during the oral discussion afterwards. And it's certainly going to be one of those things of where does cabo fit in there. Obviously, it's label-dependent of the CABINET data, certainly provide a broad range of patients to help physicians and patients getting help.

Is the right way to think about the primary competition and effectively everolimus or chemo in that sort of post-Lutathera setting or alternatively could even play a second line for people who don't want exposure to the radiation with Lutathera?

Again, it's going to be dependent on the label. So probably a little too soon to think about that.

And I realize the answer to this question leads to the obvious -- well, it depends on the data, right? But I think about zanza versus cabo, right, and what the study that you're running could afford you competitively in that space versus what cabo gives you, having an active comparator is just like the main difference, right?

311?

Yes.

So 311 is a head-to-head study at zanza versus everolimus. We haven't kind of published the details specifically of that study, so stay tuned a little bit there. But really, as Amy and P.J. kind of talked about in the last call, it's really about having generating data being back first [indiscernible]. And so that's the kind of value of that study, is to establish the standard of care there.

As we think about this idea of functional status of the tumor, when we've talked to physicians, at least as it pertains to something like everolimus, what we tend to hear is that our irrespective of functional status, they still use the therapy and that it's very difficult, I think, to distinguish functional, nonfunctional. So I'm not asking you to speak to the label, right, but as it pertains to the sort of a practical market reality and how these clinicians are wrestling with that distinction in treating these types of patients?

Yes. I mean I think, again, I'd point to one of the benefits of the CABINET data, is really kind of the breadth and the heterogeneity of patient population and the consistency of data there. I think one of the things you can [ consider ] is just one spot, but there's not really kind of a patient group that jumps out that's driving all of the benefit, which frankly, you've seen a lot of other data sets just at ESMO and Barcelona. I can't tell you how many presentations I sat through, and that's one of the 4 dynamics. And so one of the benefits and value really jumps out these kind of scalable ad board type things. It's just that it seems to work in a fairly heterogeneous group, and there's not one population that does or doesn't do well.

Okay. And I know you mentioned that the Phase III zanza design hasn't been fully made available yet. But I mean, going head-to-head against something like everolimus, what gives you the confidence that you can win on a PFS endpoint? So I guess we would look at CABINET, we look at the RADIANT trial for everolimus, and is that the right way to think about it? Or is the internal assumption that zanza can generate a more profound PFS in this setting, and that's what underpins confidence that you can ultimately win on a PFS endpoint?

Yes. So I don't want to jump kind of into the specifics there. But speaking broadly, a couple of things to talk about. The first, obviously, it's a different tumor type, different indication, but we look to kind of cabo's experience with METEOR, beating everolimus head-to-head in an RCC population, there's certainly some things that we can point to and kind of get us incrementally more comfortable. This is a drug. This is a mechanism of target that we'd beat head-to-head in another tumor type and the data we've generated with CABINET and the data that we've generated with zanza kind of showing, maybe, the emerging differentiation profile of zanza versus cabo; that's something that gives us confidence as well. So a combination of the fact that everolimus is a standard of care, but I don't think physicians would necessarily describe it as notable. And I think the fact that we're getting increasingly comfortable with the profile of zanza, we're certainly comfortable with how kind of cabo has done either head-to-head or in NETs as something that plays in as well. And so it's a combination of all these factors, and at least at a very high level kind of [indiscernible].

How do you think about -- you're effectively competing against nonpromoted treatment options. And just simplistically having promoted treatment option where physicians are sort of forced to some cross-trial inferences, right, around cabo versus everolimus or chemotherapy, and so have you looked at just the basic premise of how a promoted treatment option may compare against nonpromoted options and sometimes physicians just want the newest more innovative thing?

I certainly think that's something that P.J. and his team think about a lot. I'm probably going to come back to -- we'll see what the label looks like to see everything. But suffice it to say, the thing that always kind of gives me comfort is that the thing that I mentioned before, is when we unblind that TTP with cabo, physicians [ know how ] and they know how to use it. That's a dynamic that has always jumped out.

Yes. Okay. Maybe shifting gears to zanza and frontline nonclear cell RCC opportunity, and realizing that a lot of TKIs are currently used there, so what does the current landscape look like in terms of nonclear cell? Is that a space where cabo derives a lot of utilization because we think ahead to the world that zanza could potentially be launching into if it secures a label in nonclear cell?

Yes. So there are a couple of dynamics that play there. At a very high level, even if you look at kind of guidelines, it's actually speaking, all drugs that have a label for clear-cell RCC, also have a label for nonclear cell. And so you tend to see somewhat fragmented utilization class, each of those therapies. What the STELLAR study is designed to do is really generate that first pivotal randomized data in a population that what we think or we hope kind of to find a standard of care there. Whereas you look at the data sets that have been generated, that are label-enabling, that are guideline enabling for other drugs, again cabo included; they tend to be kind of single-arm Phase II IST-type studies that, frankly, just have to look at different levels of evidence. And so 304 was really designed to just establish a standard of care there. How that plays out competitively will ultimately depend on the data and -- but really kind of the intention with that study is, as we thought about zanza development early on, 303, 304, 305 were kind of those obvious low-hanging fruit studies to run because -- either cabo data that we've generated or something like nonclear cell RCC, where we believe it's especially sensitive tumor type. And so 304 is really that chance to kind of [ plant ] a flag in the ground in that kidney cancer population, establish a standard of care and then layer on additional studies over time.

You've guided, I think, to completing enrollment of the study middle of next year. How quickly could we expect top line with the study?

Yes. So generally, kind of as a point of corporate practice, we talk about timelines once we've completed enrollment. So point to 303 where we recently completed enrollment and have [ guided ] to data next year. Obviously, with any of these studies, they are event-based. So it can be a little tricky to guide specifically when that top line readout will occur just because it's in that phase to predict [indiscernible].

Yes. Yes. Okay. Within the nonclear cell, as you know Merck, with Lenvima has got the label update. They've run a, I should say, like more of a single-arm study. And so, I guess, how do you see that as a competitive interplay? Merck planning has flagged, maybe, in the nonclear cell space with Lenvima. And I imagine you might come back to, hey, look, we've done pretty well against Lenvima in the broader RCC market, and we feel pretty good about how our profile will stack up.

Yes. I mean I think it's -- again, it's about the data and all of the above, pretty simple things. Wait and see what the data looks like. But certainly, cabo has been able to -- we're the #1 TKI opens monotherapy in combination despite that kind of competitive pressure and so a lot of those things.

Okay. So you've got, what, 4 pivotal programs right now, I think, for zanza that have been announced. You've got a Phase I basket trial evaluating zanza, I believe, in multiple combinations, different tumor types. Maybe if you can just talk about the progress that's made on this basket study and when we could expect perhaps new data to emerge.

Yes. So 2025 going to be a big year for us, for zanza, not only kind of with the 303 readout, but we've also talked about data from the early STELLAR studies, RCC, colorectal cancer, kind of combinations in RCC, that sort of data set that you'll expect next year. And frankly, kind of -- if you can see this increased excitement from Exelixis, it's -- we're very happy with how that data continues to progress and mature. And so we're really excited to share it. But stay tuned next year, it's going to be really good.

Okay. And you're just kind of thinking on sort of that in RCC, the HIF-2 kind of PD-1 combination approach. I know competitors are looking at this approach, and you guys have been a leader in RCC. And so is that something that you guys, I imagine, look at and think about as something?

Yes, certainly, I mean, RCC is kind of -- we're a leader in RCC and we certainly want to continue to be that. One of the dynamics that we want to make sure we're getting right is, again, coming back to this concept that we talked about before. We're not in the business of running trials, just too much trials. We want to shift standard of care. So what those combinations are, and how that differentiates is really important and critical. And we got to think about the best combination partners, the best indications within RCC, are really all central to that dynamic. So kind of stay tuned there and what we're doing in RCC. But needless to say, it's an area we [ want ].

Yes. Okay. So more to come, I guess, on the frontline RCC kind of strategy from the company?

Yes.

All right. And then maybe just at ESMO, you have updates in NET and prostate. Maybe what do you feel like are some of the key highlights that you'd emphasize to investors? I feel like from a net perspective, I think you disclosed a lot of the data, maybe previously, but what do you feel like maybe was incremental coming out of ESMO for either of those 2?

Yes. So CABINET, pretty straightforward, kind of the best way to think about it is that's going to be the data that will potentially be in the label, especially the central versus investigator reviewed PFS data. And then a lot of the AEs were kind of cleaned up as well. And so the CABINET data from ESMO is really what I would think of as kind of labeled data. And then CONTACT-02 was the final survival analysis, and it kind of gave the first look at that survival data, not only overall where we again showed no decrement in survival, but also kind of the key subgroups that were pulled out, especially [ even ] discuss it afterwards. The populations like patients with liver mets, patients with bone mets, how cabo/atezo does and really, those are the patient groups of highest unmet need. And so CONTACT-02 data at ESMO just reiterated the point of positive endpoint, co-primary endpoint of PFS. And then that survival data is kind of looking at the different [ subsectors ].

So with prostate, then I guess you're still on track to submit the sNDA later this year for cabo. And then, I guess, the event here is based on some precedents that are out there, the PFS with no [ detriment ] underpins sort of the confidence that you could get and assess the label out of?

Yes. So again, it's ultimately going to depend on the totality of the data. Now, that the overall -- now that this is currently available, really through that dynamic. But yes, we've guided for submission of the sNDA later this year.

All right. Well, we're out of time. But thank you so much for joining us at the conference.

Yes. Thank you.