Exelixis (EXEL) Q2 2026 earnings call transcript

Good day, ladies and gentlemen, and welcome to the EXELIXIS second quarter, 2026 Financial Results Conference Call. My name is Kathleen, and I will be your operator for today. As a reminder, this call is being recorded for replay purposes.

I would now like to turn the call over to your host for today, Mr. Andrew Peters, Senior Vice President of Strategy and Investor Relations. Please proceed. Thank you, Kathleen, and thank you all for joining us for the EXELIXIS Second Quarter 2026 Financial Results Conference Call. Joining me on today's call are Mike Morrissey, our President and CEO, Chris Senner, our Chief Financial Officer, Dana Aftab, our Executive Vice President of Research and Development, and PJ Haley, our Executive Vice President of Commercial, who will review our progress for the second quarter 2026 ended June 30, 2026.

During the call today, we will refer to financial measures not calculated according to generally accepted accounting principles. Please refer to today's press release, which is posted on our website, for an explanation of our reasons for using such non-GAAP measures, as well as tables deriving these measures from our GAAP results. During the course of this presentation, we will be making forward-looking statements regarding future events and the future performance of the company. This includes statements about possible developments regarding discovery, product development, regulatory, commercial, financial, and strategic matters, potential growth opportunities, and government drug pricing policies and initiatives. Actual events or results could, of course, differ materially. We refer you to the documents we file from time to time with the Securities and Exchange Commission, which, under the heading Risk Factors, identify important factors that can cause actual results to differ materially from those expressed by the company verbally and in writing today, including, without limitation, risk and uncertainties related to product commercial success, market competition, regulatory review and approval processes, conducting clinical trials, compliance with applicable regulatory requirements, our dependence on collaboration partners, and the level of cost associated with the discovery, product development, business development, and commercialization activities.

With that, I'll turn the call over to Mike.

All right. Thank you, Andrew, and thanks to everyone for joining us on the call today. Okay. EXELIXIS continues to execute across the key elements of our business, positioning the company to deliver on our strategic objectives for 2026 and beyond. We are in the early innings of our next phase of growth as we deliver on our strategy to evolve from a single compound company to one with a pipeline of potential oncology franchise opportunities.

Zanzilintinib is poised to transform EXELIXIS as our next franchise molecule, potentially first with a third-line-plus CRC filing that's currently under review, followed by accelerating progress on the next six pivotal trials that we've highlighted recently. Importantly, a second wave of trials is lining up nicely to initiate, potentially as early as 2027. Our confidence in Cabo's long-term revenue growth trajectory remains unchanged. The updated financial guidance reflects modestly slower growth in 2026 due to a more gradual ramp for the net indication, which reflects the unique characteristics of the net patient population and histology. We remain confident in the long-term potential of the Cabo net indication and view the net franchise as an important growth driver for Cabo, Zanza, and other molecules in our pipeline.

We continue to see meaningful opportunities to expand our impact for patients, strengthen our commercial position, and create value for shareholders. Our strategy to build a multi-franchise oncology business contains five key elements, including first, execution. ZANSA is leading the pack as our next potential franchise opportunity and our highest R&D priority. The EXELIXIS team continues to execute on key objectives across the program, including the stellar 303 regulatory review, pivotal trial data readouts, expediting clinical trial enrollments, and new study initiations. The second is expansion. We are building the foundation for the next wave of growth opportunities for ZANZO. Beyond our current pivotal trials, we are actively evaluating new development opportunities that could further expand the scope, reach, and long-term value of ZANSA in GU, GI, and other indications.

Our goal is to build a durable franchise with stacking capabilities that could drive growth for years to come. Third key element is commercial performance. We continue to see substantial growth from the Cabo Zantanif franchise. Cabo remains the leading TKI for RCC, the market leader for the oral second-line-plus net segment, and a key player in the treatment of patients with liver and thyroid cancers.

Second quarter 2026, U. S. Cabo franchise net product revenues grew approximately 10% year-over-year to $573 million, Continuing its role as a worldwide leading TKI, global Cabo franchise, net product revenues generated by EXELIXIS and its partners, grew approximately 13% year-over-year to $806 million in the second quarter, 2026. Fourth is preparation. We continue to prioritize our commercial readiness for the potential launch of ZANSA and Third Line Plus CRC, pending a positive regulatory review later this year. We believe the CRC opportunity represents an important first step towards establishing ZANSA as our second oncology franchise and a significant driver of future growth.

We see this element of our strategy as especially timely as we pursue new GU and GI indications, specifically in tandem, early and late-stage opportunities in CRC with Stellar 303 and Stellar 316. Fifth and finally, discipline. We remain committed to rigorous expense management and capital allocation. This can be seen by trimming expense guidance while we invest in our mission-critical R&D priorities and keeping our projected free cash flow essentially unchanged. We believe this balanced approach remains an important differentiator and positions us to create long-term value while maintaining strategic flexibility. Taking together these five strategic elements, working in tandem, underscore the strength of our strategy and the progress we are making across the business. We believe we are well positioned to advance ZANSA towards becoming a major oncology franchise, expand our development portfolio, drive continued growth to the Cabo Zantanet franchise, and deploy capital in a disciplined manner to maximize shareholder value.

So, with that, please see our press release issued an hour ago for our quarterly financial results and a comprehensive summary of key corporate milestones achieved during the period. And with that, I'll turn the call over to Chris.

Thanks, Mike. For the second quarter, 2026, the company reported total revenues of approximately $629 million, which included Cabo's Antinib franchise net product revenues of $573 million. CoboMedx net product revenues were $571 million and included approximately $2.7 million in clinical trial sales. As a continued reminder, clinical trial sales have historically been choppy between quarters, and we expect this to continue into the future.

Gross to net for the Cabo Xanthia franchise in the second quarter of 2026 was 29.5%, which is lower than the gross to net we experienced in the first quarter of 2026. This decrease in gross-to-net deductions in the second quarter of 2026 is primarily due to lower copay assistance for commercial patients, which is partially offset by a modest increase in 340B utilization when compared to the first quarter of 2026.

Additionally, we're updating our estimate for full year 2026 gross-to-net deductions, and we are now projecting that it will be between 30% and 31%. Our Cabo Medics trade inventory was flat at 2.1 weeks on hand the end of the second quarter, 2026, when compared to the first quarter, 2026. Total revenues in the second quarter, 2026, also includes approximately $53 million in royalties earned from our partners, Ipsen and Takeda, on their sales of Cabo Sanctit.

Our total operating expenses for the second quarter, 2026, were approximately $380 million, compared to $359 million in the first quarter, 2026. The sequential increase in these operating expenses was primarily driven by higher clinical trial costs, marketing expenses, and stock-based compensation. Provision for income taxes for the second quarter of 2026 was approximately $50.6 million, compared to a provision for income taxes of approximately $57.2 million for the first quarter of 2026.

The company reported gap net income of approximately $212 million, or $0.85 per share basic and $0.82 per share diluted for the second quarter of 2026. The company also reported gap net income of approximately $237 million, or $0.95 per share, basic, and $0.91 per share, fully diluted. Non-gap net income excludes the impact of approximately $25 million to stock-based compensation net of the related income tax effect.

Cash and marketable securities for the quarter ended June 30, 2026, for approximately $1.4 billion. During the second quarter of 2026, we repurchased approximately $312 million of the company's outstanding common stock, resulting in the retirement of approximately 6.5 million shares of the company's outstanding common stock at an average price per share of $47.85. During the second quarter, we completed the October 2025 stock repurchase program. As of the end of the second quarter of 2026, we had approximately $598 million remaining under the $750 million stock repurchase plan authorized by the company's board in May of 2026.

And finally, we're updating our full year 2026 financial guidance. We are lowering and narrowing our total revenues and net product revenue guidance, which lowers the midpoint by $50 million when compared to our previous guidance. This updated financial guidance reflects modestly slower growth in 2026 due to a more gradual ramp for the net indication than the original projection.

Additionally, we are reducing R&D expense guidance, lowering the midpoint of our R&D expense guidance range by $50 million when compared to the previous guidance. Details of our full year guidance can be found on slide 14 of our earnings presentation.

With that, I'll turn the call over to PJ.

Thank you, Chris. Cabo Medics' net product revenue grew 10% year-over-year for Q2-2026 relative to Q2-2025. The revenue growth for the first half of 2026 was modestly slower than we had anticipated due to a more gradual ramp in the growth of net in the second-line-plus setting due to patient kinetics. Importantly, we are pleased that Cabo has achieved second-line-plus oral class new patient market share greater than 45%, and we believe this is a leading indicator for future growth of the net business. The RCC business continues to grow as we have a strong promotional focus on our first-line 90-yard data, where we maintain a high market share as the number one TKI plus IO combination, in addition to being the number one prescribed TKI in renal cell carcinoma.

The prescription data in the oral TKI market basket of Cabo, Lumbatinib, Exitinib, Sunitinib, and Pazapinib convey the strength of Cabo relative to the competition.

Looking at the TRX comparison of Q2 2025 to Q2 2026, CaboMedix grew two share points from 45% to 47%. Additionally, CoboMedx TRX volume grew 12% in Q2-2026 compared to Q2-2025, outpacing the growth rate of the market basket, which was 6% for the same period.

CoboMedx was approved for NET about a year ago, and we have many learnings regarding this unique tumor type. NET is heterogeneous and generally more indolent than many more aggressive solid tumor malignancies. As we have been in the market speaking with physicians and conducting advisory boards we have learned that this may lead to differences in management of these patients Sometimes net patients are scanned less frequently than a standard three interval and often a patient disease may be relatively slow Furthermore, the initiation of subsequent therapy could be less urgent for some patients, resulting in attenuation of a current treatment or sometimes a treatment break.

Hence, the patient kinetics of NET in the Second Line Plus setting can be more gradual than other solid tumors. That said, we continue to be pleased with the market dynamics as the CoboMedic Second Line Plus oral new patient market share grew substantially in the second quarter to over 45%, We have begun to see the benefit of more patients on therapy as refills are driving more demand, and given the increased new patient market share, we expect refills to continue to increase going forward.

Market research indicates that there is opportunity to continue to grow market share, particularly in the community setting. Our expanded GI sales team was in the field, providing greater reach into the community in Q2, and we believe this contributed to an increase in our SecondLinePlus net market share.

We've also acquired and implemented more granular utilization data that gives us greater resolution on the net business at the prescriber level for certain segments of the market. These data are giving us the ability to optimize our promotional efforts through refined targeting.

Data highlight the potential for Cabo growth in net, and we remain confident that as patients seek treatment after progression, CaboMedics will be the leading choice, which will translate into a robust long-term opportunity. Our new representatives joined us with significant oncology sales experience, particularly in colorectal cancer and GI oncology. The expanded sales team will gain valuable experience, selling Cabo before we turn our focus to the potential launch of zanzolitinib in colorectal cancer. As we are thinking about building on and expanding our GI franchise, we are thrilled with the results of Stellar 303 and a Vidufa date set for later this year.

Pending regulatory approval, we believe that these data would provide EXELIXIS with a compelling commercial opportunity in one of the big four tumors. Third line plus CRC setting consists of approximately 23,000 patients in the U. S. and represents an overall opportunity of $1.5 billion in terms of contemporary pricing. Our market research and advisory boards demonstrate positive feedback and excitement for the stellar 303 data. Physicians reiterate the significant unmet need for patients in the third-line CRC setting and are excited for the potential to have a regimen that includes an immune checkpoint inhibitor available for the broader population of CRC patients. Cabo Medics' business remains strong, with growth being driven by both RCC and NET, as our team's sole focus is maximizing the impact of our promotional efforts across all customers and tactics.

Cabo remains well-positioned as the number one TKI and TKI plus IO combination in RCC, as well as the number one oral therapy in second line plus NET. Looking forward to ZANZA, our internal team is in full launch preparation, and the excitement around these efforts is palpable. We look forward to the opportunity to launch the next EXELIXIS franchise later in the year to be able to help appropriate patients with colorectal cancer.

Beyond Stellar 303, we are enthusiastic about the significant development plan for ZANZA, which could position the ZANZA franchise to far exceed CABO in terms of the number of patients that could be impacted across tumor types and settings.

With that, I will turn the call over to Dana.

Thanks, PJ. My update today will be focused mostly on the seven ongoing or imminent pivotal trials for ZANZA, as well as some updates on additional exploratory studies and plans to continue driving the breadth of development of ZANZA, All of which is aligned with our strategy in R&D, which prioritizes developing ZANSA as a multidimensional solid tumor oncology franchise molecule.

Starting with our NDA for ZANSA plus atezo and colorectal cancer, which is based on the results from the STELLAR 303 trial, this continues to be our top priority as we work toward the PDUFA date in early December. Our team continues to focus on the ongoing review and is fully engaged in launch preparations. Alongside those activities, we've also been steadily moving forward on our strategy to realize ZANZA's franchise potential by continuing to drive the breadth of development of ZANZA in key tumor landscapes and indications. In the early colorectal space, our team has been highly focused on launching the STELR 316 trial, which will investigate ZANSA with and without subcutaneous PEMBRO in patients with resected stage 2 or 3 CRC who, following definitive therapy, have tested positive for molecular residual disease, or MRD, and have no radiographic evidence of disease.

The unmet need is high for these patients, and we've gotten a lot of positive feedback on the study from KOLs and the GI oncology community. Activation of the first site in this trial is imminent, with many more lined up behind it, and we anticipate patient screening to begin this month. With Natera as our collaborator, we've been able to select sites based on actual test metrics, prioritizing those with the highest numbers of MRD-positive patients. So we're confident this approach will translate to a steep enrollment curve, especially since there are no other ongoing phase 3 trials competing for these patients.

In the neuroendocrine simulation, STELR311 is our global phase 3 trial evaluating ZANSA compared to Everolimus as an initial oral therapy in patients with pancreatic or extra-pancreatic neuroendocrine tumors. That study was initiated last year, and we continue to see robust enrollment that is months ahead of projections, reflecting both investigator and patient enthusiasm for the study.

Moving on to genitourinary tumors and kidney cancer specifically, STELAR304 is our first pivotal trial for ZANZA in kidney cancer, evaluating the combination of ZANZA plus nivolumab versus sunitinib in patients with locally advanced or metastatic non-clear cell renal cell carcinoma. I'd like to emphasize that the non-clear cell RCC space is underserved, with no positive readouts from a Phase III study specifically focused on these patients, despite them representing approximately 20% of all RCC cases. A handful of phase 2 studies, the majority of which are single-arm, non-randomized trials, have shown activity with a range of treatments in the setting, with wide variations in response rates and durations of PFS for sunitinib and other agents that are currently used for these patients.

Such variations are to be expected when comparing data across trials, especially when those trials are small and geographically restricted. Given the fact that Stellar 304 is the first large randomized controlled phase 3 trial for these patients and is also enrolling globally, we expect that, if positive, the trial could establish the first ever level 1 evidence for benefit and a new standard of care for these patients.

We completed enrollment in Stellar 304 last year, and given current event rates, we continue to expect top line results from the study in the second half of 2026. If positive, those results could lead to our second NDA filing for ZANSA.

Pivoting now to ClearCell RCC, progress continues with regard to the two pivotal phase 3 studies that Merck is running to evaluate zanzolitinib in combination with belzudafam. The LightSpark 033 trial is comparing ZANSA plus BELS versus CAVO in the frontline setting for patients who received adjuvant treatment with anti-PD-1 or anti-PD-L1 therapy. And LightSpark034 is comparing ZANSA plus BELLS versus BELLS plus placebo in the second-line plus setting after both anti-PD-1 or L1 and VEGFR TKI therapies. We're excited to see these phase 3 studies in clear-cell RCC moving forward, and we believe there are other important opportunities to explore in this space, pairing ZANSA with other modalities and orthogonal mechanisms in first-line RCC, especially immunotherapies, given the demonstrated clinical differentiation we've observed with ZANSA and its potential to be the TCAV choice for combinations with immunotherapies, as well as other mechanisms of action.

Our discussions with potential collaborators have been advancing well, and we plan to give further updates on these activities as we get closer to launching the trials. Moving on now to other indications in the GU space, we're excited to advance an expansion cohort in the ongoing Stellar OO2 study to evaluate ZANSA in patients with metastatic bladder cancer who have progressed on the combination of Enfortumab-Vidotin, or EV, plus Pembro. The rationale for this cohort is based on a significant body of data generated with CAVO showing encouraging activity in bladder cancer.

Bladder was not prioritized for pivotal development with Cabo due to the rapidly changing landscape at that time. What's changed since then is the approval of the combination of EV plus Pembro in multiple settings, including in the front line for patients with metastatic disease. This resulted in an important new standard of care for these patients, but very quickly a new unmet need emerged, with essentially no established standard of care for patients after they progress on the combination.

We're enrolling a cohort in Stellar OO2, evaluating ZANSA as a single agent in patients who progressed on EV plus Pembro, and we're already seeing encouraging signs of clinical activity. It's early days, but if the data continue to develop in this way, we plan to move quickly toward launching a pivotal study in this indication. Another expansion cohort for ZANSA in the Stellar OO2 study is in combination with docetaxel in patients with metastatic castration-resistant prostate cancer, or CRPC, who have measurable disease. The rationale for this cohort is based on data with CAVO, where a small phase 2 study showed favorable outcomes when CAVO was combined with docetaxel in patients with metastatic CRPC. We're particularly excited about this cohort because if ZANZA in combination with docetaxel is shown to be safe and active, that could open up a number of opportunities across a range of solid tumors where docetaxel, other chemotherapies, or ADCs carrying cytotoxic payloads, Remain the standard of care, such as in second-line non-small-cell lung cancer.

Sites for this expansion cohort in Stellar-002 are now activated and open for enrollment. Moving on now to Stellar-001, this is our Phase II trial evaluating ZANSA in patients with recurrent meningioma who are no longer responsive to or eligible for local therapies. The primary endpoint of this trial is objective response rate with secondary efficacy endpoints, including duration of response, progression-free survival and overall survival. The trial will enroll up to 100 patients, and our enrollment in this trial so far is exceeding our initial projections, which we believe reflects the high level of interest and enthusiasm for the trial among neuro-oncologists. One factor driving excitement for this study is the fact that there are no approved systemic therapies for meningioma that's refractory to local therapies, so this indication represents a very high unmet need in neuro-oncology.

Pending favorable results and given the absence of any approved systemic therapies in this setting, the STELR-201 trial could be an important opportunity for ZANZA to become the first systemic therapy that could improve outcomes for these patients.

Lastly, we've been making steady progress toward initiation of STELR-202, our planned Phase II trial in squamous non-small cell lung cancer that will explore the addition of ZANZA in the maintenance phase after induction with PEMBRO plus chemotherapy. The rationale for this trial is partly based on data from the CONTACT-01 trial, where the subgroup of non-small cell lung cancer patients with squamous histology appear to derive substantial benefit from the combination of Cabo plus Atezo compared to chemo. This is an important opportunity given the relatively short PFS in the maintenance setting and the lack of any new approvals in frontline squamous non cell lung cancer since Keno established the current standard of care with PEMBRO plus chemo We expect to initiate Stellar 202 in the second half of this year Now shifting to our early clinical pipeline, our four molecules currently in clinical development, namely XL309, XB010, XB628, and XB371, continue to progress.

And we are also continuing to move new small molecule NADC programs toward IND filings and development candidate nominations. And I look forward to sharing more details as these programs advance.

So with that, I'll turn the call back over to Mike.

All right. Thanks, Dana. To close today's call, I'll start by thanking the entire EXELIXIS team for their great efforts during the first half of the year. Thank you. for their individual and collective efforts, incredible focus, and work as we work day in and day out on our mission to help cancer patients recover stronger and live longer. We look forward to updating you on our progress in the future. Thank you for your continued support and interest in EXELIXIS, and we're happy to now open the call for questions.

Dana, go ahead, please. Sure, thanks for the question, Paul. So, you know, as I said in my prior remarks, we are expecting to achieve the planned number of events in the second half of this year. Beyond that, it wouldn't really be appropriate for me to speculate on when exactly that's going to happen or even when the day will be available at a medical meeting. What I can say is that we will message on that at the appropriate time.

Yeah, thanks for the question, Anastasia. This is PJ. Okay. You know, I think, obviously, very early days for the LightSpark 22 combination just getting approved with Bells in the adjuvant setting. You know, I think what we see in the first-line setting in terms of patients overall coming off of previously treated adjuvant therapy is in that kind of a 20% to 25% range of first-line patients. You know, I wouldn't want to speculate with regards to how much utilization the combination will be used in the adjuvant setting, but I will say historically, you know, that setting is one that's very sensitive to toxicity.

This is, you know, I think a reason that agents with positive studies such as sunitinib really didn't get uptake in that in the past. And I think with the overall survival bar that Pembrol monotherapy is set there, you know, it's a very high bar to beat. So I think physicians will think very carefully as to whether or not they want to add toxicity in terms of another agent in this setting.

I'm just curious about your take on the ongoing Stellar 311 study against the backdrop of the guidance lowering, whether there's a chance that it's cannibalizing Cabo sales, you know, resulting in a more gradual ramp. Thank you. Yeah, PJ, please. Yeah, hi, Andy. Thanks for the question. As Dana said, we're really excited, first and foremost, about the Stellar 311 study. I've had the opportunity to speak to a lot of KOLs, obviously, in the NET space, and I'll just say they're very excited about that study, as Dana says, is progressing well. So I think, you know, to your point, anytime you do have a study that is recruiting, it does draw potential patients from the commercial patient pool, so to speak.

It can be a bit exacerbated in a smaller tumor type, for example. You know, so we think that could be having a small impact, but I'd say, you know, certainly what I mentioned in terms of patient kinetics, in terms of just patients, you know, taking a bit more time to go from therapy in subsequent settings is really the driving factor, as it is a more indolent tumor type. And fortunately, these patients, many of them may have the luxury of a little more time before going on to that therapy. You know, that said, I think it's really important just to reiterate that I remain really excited about the opportunity in net. We're not really changing the outlook at all.

As you mentioned, it's just kind of the ramp is a little more gradual, but we're excited that we achieved a new patient market share over 45% this quarter. And, you know, I think I'm sure you'll recall that we always talked about the TAM in this setting as being about a billion dollars for the oral therapy market in the second line plus setting.

So, you know, we're excited about that market share. And eventually those patients, you know, we believe when they do have a therapy selection, it will be Cabo in most of those cases. So we're excited about that going forward.

Dan, do you want to take that one? Yeah, sure. So as I mentioned, Sean, earlier, this is an ongoing review. Our team is highly focused and extremely excited, in fact, about what this can mean for the company, especially given the fact that if approved, this would be the first immunotherapy-containing regimen for the vast majority of patients with this disease.

And also, it would be the first launch of our next franchise molecule. So it means a lot for patients and for the company. So there's a lot of excitement around this. Beyond that, we really can't comment on an ongoing review, and especially on a label that is really up to discussions with the agency.

Yeah, Josh, thanks for the question. Yeah, that number was given, I would say, late 24, around our view on what success, aspirational view on what success could look like relative to our second franchise molecule. So the fact that we have launched or are about to launch or one is imminent of the seven pivotal trials with the next wave on the way, I think, speaks to the depth and breadth of the opportunity going forward. I'm super excited about what's already in the oven, if you will, and then the next wave, as you heard Dana talk about today, potentially involving other GU and GI indications we think is potentially super valuable for patients as well as driving value for shareholders.

So obviously we have a lot of work to do. We're in the execution business, but we're committed to making this second franchise as valuable for patients and for shareholders as possible. Great. Thank you.

Yeah. Hey, Kalpet. Thanks for the question. And, you know, can't really get into the specifics of the agreements that we've had with the other true ANDA generic filers, but I would note that, you know, the sort of scenario that you're describing isn't particularly common in these sorts of agreements, and so I wouldn't think it's, you know, something to expect.

Thank you Yeah Dana why don you start and then we do a quick turnover Sure sure So thanks for the question Yaron Regarding Stellar 201 this is a single phase two study designed to enroll 100 patients with meningioma who have progressed on or are no longer candidates for local therapies As I mentioned it a very high need There no standard of care for these patients And the excitement on the trial is really being driven in part by the emerging data from a small study with cobazantinib So, our intention is to bring the appropriate data to regulatory authorities at the appropriate time. But in the meantime, we're also in the process of designing a confirmatory Phase III trial.

So, you know, as you're kind of hinting at, this could be a very fast process. But, you know, the details of that really need to evolve over time. So, we really can't comment on that at this time. Good. Thank you.

Andrew? Yeah, you were on say. So on the 505B2 dynamics, you know, a couple of things to mention here. As you know, there are pretty big differences between the kind of standard and a pathway in the 505B2. Things like labeling, therapeutic equivalence, interchangeability, those are all, you know, very different for 505B2 products. You correctly pointed out the new 505b2 is a different salt with very different properties around PK and some other things that we outlined in our citizens petition. And so as NCCN considers all of those dynamics and the real lack of clinical data, it kind of contrasts with other 505b2 examples, like Abraxane, that have been successful in their adoption. But that has largely been based on large phase three trials, large randomized phase three trials, established efficacy.

I guess kind of the key thing from EXELIXIS perspective is we're focused on two things, patient safety and prioritizing our intellectual property rights. And we're going to continue to focus on those two things. But I think as you think about guideline recommendations, that patient safety dynamic is really important.

This is Dana. So, you know, you're commenting on trial dynamics, right, where the numbers that you see in trials in progress posters, company slides, clinicaltrials. gov listings are all based on projections, right? But at the end of the day, enrollment happens as it happens. And we don't have a perfect crystal ball to understand, you know, how these dynamics are really going to play out. We put our best foot forward. But, you know, there's always some shift in these timelines, not just in enrollment timelines, but also in how the event rates come in. So, as I mentioned in my prepared remarks, and actually I think we mentioned for the first time last quarter at the earnings call that we're expecting the trial to read out in the second half of the year.

It's still that now, right? We're still planning for the second half of this year. And again, that's our best estimate based on our event rates that are coming in currently.

PJ, want to take that one? Yeah. So, I mean, I think as far as ZANSA and NETS, you know, the study is designed, and as Dana mentioned and I kind of reiterated earlier, a lot of excitement around this study is designed to really position ZANSA to be potentially the first oral agent in neuroendocrine tumors. You know, other modalities are there. Obviously, you have the SSAs, you have the radioligand therapies, and then kind of the orals, let's say. Overall, as you think about the space, those are the three, you know, high-level modalities. So, given the fact that this is the first study, you know, phase three randomized study to go to have the potential to read out positive relative to an approved oral agent, success in this study would position ZANZA, you know, I think very well in the neuroendocrine tumor marketplace.

Yeah, thanks for the question, Chi. You know, again, I think when you think about ZANSA and NET, some of the things I've already spoken to here, the position it really potentially well, obviously given, you know, a positive study, regulatory approval projecting here into the future, the fact that it is head-to-head, as you point out, with Everolimus. So a few things. Patient eligibility in the study, it'll be positioned really as potentially a first or second line agent. So I think when you think about that, that will change the potential for the kinetics of the patient flow in that setting. So, you know, we would expect it to potentially be different. Obviously, very hard to project given so many variables before we see the data out in the future.

But I think, suffice it to say, as I mentioned, the KOLs are very excited about the study. You know, when our top physicians are excited about it, that always gives us excitement. So, you know, really looking forward to the readout of that study.

Yes, Mike, thanks for the question. I think what we said previously is that we're looking at all options there very carefully and very thoughtfully, taking into account all the different levers and, if you will, pulls and puts that are involved in potentially partnering something, you know, ex-US. So still under evaluation. We have lots of options, lots of interest. Certainly, we expect that to continue to grow as we turn over more cards, hopefully positive in terms of pivotal trials. So stay tuned.

Thanks.

Dana? Sure. Thanks for the question, Ash. So, yeah, regarding the non-liver METS primary endpoint, as we announced, I think in June, That endpoint essentially did not meet statistical significance, although I'd say the treatment effect was very similar to when we announced the interim results of that endpoint last year when we released the data on the ITT population. So basically, over time, we really didn't see the data evolve to a point where it became significant. And as you mentioned, you pointed to one potential factor there, that this is a very small subpopulation of the study.

The most important thing to us is that the ITT population is the overall population, the entire population of the study. It includes both liver mets patients and non-liver mets patients, and those are the data that were the subject of the NDA that we submitted to the regulatory agency.

Yeah, so let me start, and Dana or PJ can opine if needed. So I think the key there, and thanks for the question, Steve, is really around picking the right dose and taking into account the patient population, you know, their kind of general performance status, and, you know, what they're progressing from or after their last treatment to be able to maximize, you know, any potential clinical benefit and therapeutic ratio. So we feel like we've got a really good handle on that. Obviously, we have a lot of experience there with CAVO from the standpoint of, you know, picking a lower dose with 9ER and really kind of looking at the, you know, the temporal aspect of clinical benefit as opposed to an early response rate, which then you pay for later with potentially more tox.

So it's really balancing, you know, activity, short-term activity with long-term duration to be able to give benefit. Obviously, some of the earlier, maybe first-generation or two of TKIs had some challenges there. You know, we feel really good about that with Zanza relative to the target inhibition profile, the pharmacodynamics, the short half-life. So, whether it be 316 or 202 or even 201, we feel like we've got pretty good insight to be able to maximize that opportunity.

Thank you.

Thank you, Kathleen, and thank you all for joining us today. We welcome your follow-up calls with any additional questions you may have that we were unable to address during today's call. Have a good rest of your day.