Exelixis Q2 2026 Earnings Call Transcript

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Provided by Quartr
August 5, 2026

Key Takeaways

  • Positive Sentiment: Second-quarter cabozantinib franchise revenue rose 10% year over year in the U.S. to $573 million, while global franchise revenue increased 13% to $806 million. CABOMETYX reached more than 45% new-patient share in second-line-plus NET and maintained leading positions in RCC.
  • Negative Sentiment: Exelixis lowered and narrowed its 2026 revenue and net product revenue guidance, reducing the midpoint by $50 million, as NET adoption is ramping more gradually than expected. Management attributed the slower trajectory to the indolent nature and treatment patterns of NET patients, while maintaining confidence in the long-term opportunity.
  • Positive Sentiment: Zanzalintinib remains the company’s top R&D and commercial priority, with an FDA decision expected in early December for third-line-plus colorectal cancer. Exelixis is preparing for a potential launch and advancing pivotal programs in NET, non-clear cell RCC, early-stage CRC, and other tumor types that could support a multi-franchise oncology business.
  • Positive Sentiment: The company repurchased approximately $312 million of stock during the quarter and ended June with $598 million remaining under its current $750 million authorization. Cash and marketable securities totaled approximately $1.4 billion, supporting continued investment in the pipeline and shareholder returns.
AI Generated. May Contain Errors.
Earnings Conference Call
Exelixis Q2 2026
00:00 / 00:00

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Operator

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.

Andrew Peters
Andrew Peters
SVP of Strategy and Investor Relations at Exelixis

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 Chief Executive Officer, Chris Senner, our Chief Financial Officer, Dana Aftab, our Executive Vice President of Research and Development, and P.J. Haley, our Executive Vice President of Commercial, who will review our progress for the second quarter 2026, ended June 30th, 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.

Andrew Peters
Andrew Peters
SVP of Strategy and Investor Relations at Exelixis

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 could cause actual results to differ materially from those expressed by the company verbally and in writing today, including, without limitation, risks 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 costs associated with the discovery, product development, business development, and commercialization activities. With that, I'll turn the call over to Mike.

Mike Morrissey
Mike Morrissey
President and CEO at Exelixis

All right. Thank you, Andrew, and thanks to everyone for joining us on the call today. 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. zanzalintinib 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.

Mike Morrissey
Mike Morrissey
President and CEO at Exelixis

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. Zanza 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.

Mike Morrissey
Mike Morrissey
President and CEO at Exelixis

We are building the foundation for the next wave of growth opportunities for Zanza. Beyond our current pivotal trials, we are actively evaluating new development opportunities that could further expand the scope, reach, and long-term value of Zanza 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 zanzalintinib 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.

Mike Morrissey
Mike Morrissey
President and CEO at Exelixis

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 Zanza in third line plus CRC, pending a positive regulatory review later this year.

Mike Morrissey
Mike Morrissey
President and CEO at Exelixis

We believe the CRC opportunity represents an important first step towards establishing Zanza 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. Taken together, these five strategic elements working in tandem underscore the strength of our strategy and the progress we are making across the business.

Mike Morrissey
Mike Morrissey
President and CEO at Exelixis

We believe we are well-positioned to advance Zanza towards becoming a major oncology franchise, expand our development portfolio, drive continued growth through the cabozantinib franchise, and deploy capital in a disciplined manner to maximize shareholder value. 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. With that, I'll turn the call over to Chris.

Chris Senner
Chris Senner
EVP and CFO at Exelixis

Thanks, Mike. For the second quarter of 2026, the company reported total revenues of approximately $629 million, which included cabozantinib franchise net product revenues of $573 million. CABOMETYX 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 cabozantinib 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 co-pay assistance for commercial patients, which is partially offset by a modest increase in 340B utilization when compared to the first quarter of 2026.

Chris Senner
Chris Senner
EVP and CFO at Exelixis

Additionally, we're updating our estimate for full year 2026 gross-to-net deductions, and we are now projecting that it'll be between 30%-31%. Our CABOMETYX trade inventory was flat at 2.1 weeks on hand at the end of the second quarter 2026 when compared to the first quarter of 2026. Total revenues in the second quarter of 2026 also includes approximately $53 million in royalties earned from our partners, Ipsen and Takeda, on their sales of cabozantinib. Our total operating expenses for the second quarter 2026 were approximately $380 million compared to $359 million in the first quarter of 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 2026 was approximately $50.6 million, compared to a provision for income taxes of approximately $57.2 million for the first quarter of 2026.

Chris Senner
Chris Senner
EVP and CFO at Exelixis

Company reported GAAP 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 GAAP net income of approximately $237 million, or $0.95 per share basic, and $0.91 per share fully diluted. Non-GAAP net income excludes the impact of approximately $25 million of stock-based compensation, net of the related income tax effect. Cash and marketable securities for the quarter ended June 30, 2026, were 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.

Chris Senner
Chris Senner
EVP and CFO at Exelixis

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. 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 P.J.

P.J. Haley
P.J. Haley
EVP of Commercial at Exelixis

Thank you, Chris. CABOMETYX 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 CheckMate 9ER 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.

P.J. Haley
P.J. Haley
EVP of Commercial at Exelixis

The prescription data in the oral TKI market basket of CABO, lenvatinib, axitinib, sunitinib, and pazopanib convey the strength of CABO relative to the competition. Looking at the TRx comparison of Q2 2025 to Q2 2026, CABOMETYX grew two share points from 45% to 47%. Additionally, CABOMETYX 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. CABOMETYX 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.

P.J. Haley
P.J. Haley
EVP of Commercial at Exelixis

Sometimes NET patients are scanned less frequently than a standard three-month interval, and often a patient's disease may be relatively slow-growing. 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 CABOMETYX second-line plus oral new patient market share grew substantially in the second quarter to over 45%, extending the brand's leadership position in the space. We have begun to see the benefit of more patients on therapy as refills are driving more demand. Given the increased new patient market share, we expect refills to continue to increase going forward.

P.J. Haley
P.J. Haley
EVP of Commercial at Exelixis

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 second-line plus 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. The data highlight the potential for CABO growth in NET, and we remain confident that as patients seek treatment after progression, CABOMETYX 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.

P.J. Haley
P.J. Haley
EVP of Commercial at Exelixis

The expanded sales team will gain valuable experience selling CABO before we turn our focus to the potential launch of zanzalintinib in colorectal cancer. As we're thinking about building on and expanding our GI franchise, we're thrilled with the results of STELLAR-303 and a PDUFA 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.

P.J. Haley
P.J. Haley
EVP of Commercial at Exelixis

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. CABOMETYX 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.

P.J. Haley
P.J. Haley
EVP of Commercial at Exelixis

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.

Dana Aftab
Dana Aftab
EVP of Research and Development at Exelixis

Thanks, P.J. 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 Zanza as a multidimensional solid tumor oncology franchise molecule. Starting with our NDA for Zanza plus atezolizumab in 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.

Dana Aftab
Dana Aftab
EVP of Research and Development at Exelixis

In the early colorectal space, our team has been highly focused on launching the STELLAR-316 trial, which will investigate Zanza with and without subcutaneous pembrolizumab in patients with resected stage II or III 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. We've gotten a lot of positive feedback on the study from KOLs in the GI oncology community. Activation of the first site in this trial is imminent, with many more lined up behind it. 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.

Dana Aftab
Dana Aftab
EVP of Research and Development at Exelixis

We're confident this approach will translate to a steep enrollment curve, especially since there are no other ongoing phase III trials competing for these patients. In the neuroendocrine tumor indication, STELLAR-311 is our global phase III trial evaluating Zanza compared to everolimus as an initial oral therapy in patients with pancreatic or extrapancreatic neuroendocrine tumors. That study was initiated last year. 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, STELLAR-304 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.

Dana Aftab
Dana Aftab
EVP of Research and Development at Exelixis

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 II studies, the majority of which are single-arm, non-randomized trials, have shown activity with a range of treatments in this 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 III 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.

Dana Aftab
Dana Aftab
EVP of Research and Development at Exelixis

We completed enrollment in STELLAR-304 last year, 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 Zanza. Pivoting now to clear cell RCC, progress continues with regard to the two pivotal phase III studies that Merck is running to evaluate zanzalintinib in combination with belzutifan. The LITESPARK-033 trial is comparing Zanza plus belzutifan versus CABO in the frontline setting for patients who received adjuvant treatment with anti-PD-1 or anti-PD-L1 therapy. LITESPARK-034 is comparing Zanza plus belzutifan versus belzutifan plus placebo in the second-line plus setting after both anti-PD-1 or L1 and VEGFR-TKI therapies.

Dana Aftab
Dana Aftab
EVP of Research and Development at Exelixis

We're excited to see these phase III studies in clear cell RCC moving forward, we believe there are other important opportunities to explore in this space, pairing Zanza with other modalities and orthogonal mechanisms in first-line RCC, especially immunotherapies, given the demonstrated clinical differentiation we've observed with Zanza and its potential to be the TKI of choice for combinations with immunotherapies as well as other mechanisms of action. Our discussions with potential collaborators have been advancing well, 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-002 study to evaluate Zanza in patients with metastatic bladder cancer who have progressed on the combination of enfortumab vedotin, or EV, plus pembrolizumab.

Dana Aftab
Dana Aftab
EVP of Research and Development at Exelixis

The rationale for this cohort is based on a significant body of data generated with CABO 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 pembrolizumab in multiple settings, including in the frontline for patients with metastatic disease. This resulted in an important new standard of care for these patients, 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-002 evaluating Zanza as a single agent in patients who progressed on EV plus pembrolizumab. We're already seeing encouraging signs of clinical activity.

Dana Aftab
Dana Aftab
EVP of Research and Development at Exelixis

It's early days, 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 Zanza in the STELLAR-002 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 CABO, where a small phase II study showed favorable outcomes when CABO 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.

Dana Aftab
Dana Aftab
EVP of Research and Development at Exelixis

Sites for this expansion cohort in STELLAR-002 are now activated and open for enrollment. Moving on now to STELLAR-201. This is our phase II trial evaluating Zanza 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. This indication represents a very high unmet need in neuro-oncology.

Dana Aftab
Dana Aftab
EVP of Research and Development at Exelixis

Pending favorable results and given the absence of any approved systemic therapies in this setting, the STELLAR-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 STELLAR-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 pembrolizumab 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 appeared to derive substantial benefit from the combination of CABO plus atezo compared to chemo.

Dana Aftab
Dana Aftab
EVP of Research and Development at Exelixis

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-small cell lung cancer since KEYNOTE-407 established the current standard of care with pembrolizumab plus chemo. We expect to initiate STELLAR-202 in the second half of this year. 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 ADCs programs toward IND filings and development candidate nominations. I look forward to sharing more details as these programs advance. With that, I'll turn the call back over to Mike.

Mike Morrissey
Mike Morrissey
President and CEO at Exelixis

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. 2026 continues to be a potentially transformational year for the company, and everyone at Exelixis is working together as one team with a single focus: to improve outcomes for cancer patients and build value for all our shareholders. Advancing Zanza as our second potential franchise opportunity remains our top priority, while we use the revenues from CABO's growing business to invest in the pipeline while returning value to shareholders through our share repurchase program. I want to thank everyone at Exelixis for their individual and collective efforts, incredible focus, and hard work as we work day in and day out on our mission to help cancer patients recover stronger and live longer.

Mike Morrissey
Mike Morrissey
President and CEO at Exelixis

We look forward to updating you on our progress in the future. Thank you for your continued support and interest in Exelixis. We're happy to now open the call for questions.

Operator

Thank you. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star one on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press the star one again. If you're called upon to ask a question and listening via loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question. Also, please note to limit yourself with one question to accommodate others. Again, please press star one to join the queue. Our first question comes from the line of Paul Choi of Goldman Sachs. Please go ahead.

Paul Choi
Paul Choi
Analyst at Goldman Sachs

Hi. Thanks. Good afternoon, and thank you for taking the question. I want to ask on STELLAR-304 and timing. Do you think this is something that might be able to make a major medical meeting this year? Just any sort of updated precision on data timing that you could offer would be great. Thank you.

Mike Morrissey
Mike Morrissey
President and CEO at Exelixis

Dana, go ahead, please.

Dana Aftab
Dana Aftab
EVP of Research and Development at Exelixis

Sure. Thanks for the question, Paul. 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 data will be available at a medical meeting. What I can say is that we will message on that at the appropriate time.

Operator

Your next question comes from the line of Akash Tewari of Jefferies. Please go ahead.

Analyst at Jefferies

Hi, this is Anastasia on for Akash. Thanks for taking the question. I wanted to ask about your first-line post-adjuvant study. Specifically, I think you guys have made a comment about maybe like a 15K patient population. I'm wondering if that changes at all based on the LITESPARK-022 study, the one that had improved DFS. Do you anticipate patients will start switching to an already existing like the pembro plus HIF-2 alpha? If you do, does that reduce your patient population? How are you viewing that data? Thanks.

P.J. Haley
P.J. Haley
EVP of Commercial at Exelixis

Yeah. Thanks for the question, Anastasia. This is P.J. I think obviously very early days for the, The LITESPARK-022 combination just getting approved with belzutifan in the adjuvant setting. I think what we see in the first line setting in terms of patients overall coming off of previously treated adjuvant therapies in that kind of the 20%-25% range of first line patients. 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 that setting is one that's very sensitive to toxicity. This is 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 pembro monotherapy has set there, it's a very high bar to beat.

P.J. Haley
P.J. Haley
EVP of Commercial at Exelixis

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.

Operator

Your next question comes from the line of Andy Hsieh of William Blair. Please go ahead.

Andy Hsieh
Andy Hsieh
Analyst at William Blair

Great. Thanks for taking my question. Sorry about the background noise. 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 resulting in a more gradual ramp. Thank you.

Mike Morrissey
Mike Morrissey
President and CEO at Exelixis

Yeah, P.J, please.

P.J. Haley
P.J. Haley
EVP of Commercial at Exelixis

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. I'll just say, they're very excited about that study. As Dana says, it's progressing well. I think, 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. We think that could be having a small impact. I'd say, certainly what I mentioned in terms of patient kinetics, in terms of just patients 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.

P.J. Haley
P.J. Haley
EVP of Commercial at Exelixis

Fortunately, these patients, many of them may have the luxury of a little more time before going on to that therapy. 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. I'm sure you'll recall that we always talked about the TAM in this setting as being about $1 billion for the oral therapy market in the second-line plus setting. We're excited about that market share, and eventually those patients we believe when they do have a therapy selection, it will be CABO, in most of those cases. We're excited about that going forward.

Operator

Your next question comes from the line of Sean Laaman of Morgan Stanley. Your line is now open.

Sean Laaman
Sean Laaman
Analyst at Morgan Stanley

Hi, Mike and team. Hope everyone's well, and thanks for taking my question. Just with the CRC PDUFA date coming up later this year, what label language would be the most commercially meaningful? What label limitations, if any, around liver mets, prior therapy or subgroup interpretation do you think could be real that may constrain uptake? Thanks, Mike.

Mike Morrissey
Mike Morrissey
President and CEO at Exelixis

Yeah. Thanks, Sean. Dana, want to take that one?

Dana Aftab
Dana Aftab
EVP of Research and Development at Exelixis

Yeah, sure. 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. Also it would be the first launch of our next franchise molecule. It means a lot for patients and for the company. 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.

Operator

Your next question comes from the line of Silvan Türkcan of Citizens. Please go ahead.

Analyst at Citizens

Hey, this is Josh on for Silvan. Congrats on the update, and thanks for taking my question. At the beginning of, maybe it was 2025, Exelixis shared their vision for $5 billion in revenue for Zanza by 2033. Now, I guess a year and a half from that point, can you highlight the progress made towards that goal and if, how the makeup of that projection has evolved since then?

Mike Morrissey
Mike Morrissey
President and CEO at Exelixis

Josh, thanks for the question. That number was given, I would say late 2024, around our view on what success. Aspirational view on what success could look like relative to our second franchise molecule. 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. 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. Obviously we have a lot of work to do.

Mike Morrissey
Mike Morrissey
President and CEO at Exelixis

We're in the execution business, we're committed to making this second franchise as valuable for patients and for shareholders as possible.

Analyst at Citizens

Great, thank you.

Operator

Your next question comes from the line of Kalpit Patel of Wolfe Research. Please go ahead.

Kalpit Patel
Kalpit Patel
Analyst at Wolfe Research

Yeah. Hey, good afternoon, and thanks for taking the question. Just one on the ANDA's tentative approval. We've been fielding questions on that, and my question is: if they do get the conversion, or they get the full approval, does that, in any sense, accelerate the timing of the generic developers, the agreements that you have in place before the 2031 timelines? Thank you.

Mike Morrissey
Mike Morrissey
President and CEO at Exelixis

Yeah. Andrew?

Andrew Peters
Andrew Peters
SVP of Strategy and Investor Relations at Exelixis

Yeah. Hey, Kalpit. Thanks for the question. Can't really get into the specifics of the agreements that we've had with the other true ANDA generic filers. I would note that 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 something to expect.

Operator

Your next question comes from the line of Yaron Werber of TD Cowen. Please go ahead.

Yaron Werber
Yaron Werber
Analyst at TD Cowen

Great. Thanks so much. I have maybe it's kind of a dual part question. The first one on meningioma, STELLAR-201. It's really encouraging to see how fast it enrolled. We've seen in these areas that a single-arm phase II can lead to approval. How fast do you think you can generate data? Kind of what's the standard of care historically shown? Then secondly, maybe just on ANDA, can you maybe walk us through some of the precedences on whether a new sort of salt can actually get NCCN guideline placement without generating clinical data? Thank you.

Mike Morrissey
Mike Morrissey
President and CEO at Exelixis

Dana, why don't you start and then we'll do a quick turnover to.

Dana Aftab
Dana Aftab
EVP of Research and Development at Exelixis

Sure

Mike Morrissey
Mike Morrissey
President and CEO at Exelixis

Yeah.

Dana Aftab
Dana Aftab
EVP of Research and Development at Exelixis

Sure. Thanks for the question, Yaron. Regarding STELLAR-201, this is a single-arm phase II study designed to enroll 100 patients with meningioma who have progressed on or are no longer candidates for local therapies. As I mentioned, it's a very high unmet need. There's no standard of care for these patients. The excitement on the trial is really being driven in part by the emerging data from a small study with cabozantinib. Our intention is to bring the appropriate data to regulatory authorities at the appropriate time. In the meantime, we're also in the process of designing a confirmatory phase III trial. As you're kind of hinting at, this could be a very fast process. The details of that really need to evolve over time. We really can't comment on that at this time.

Mike Morrissey
Mike Morrissey
President and CEO at Exelixis

Good. Thank you. Andrew?

Andrew Peters
Andrew Peters
SVP of Strategy and Investor Relations at Exelixis

Yeah, Yaron. On the 505(b)(2) dynamics, a couple of things to mention here is, there are pretty big differences between the kind of standard ANDA pathway and the 505(b)(2). Things like labeling, therapeutic equivalents, interchangeability, those are all very different for 505(b)(2) products. You correctly pointed out the new 505(b)(2) is a different salt with very different properties around PK and some other things as we outline in our citizens petition. As NCCN considers all of those dynamics and the real lack of clinical data, it kind of contrasts with other 505(b)(2) examples like ABRAXANE that have been successful in their adoption, but that has largely been based on large phase III trials, large randomized phase III trials, established efficacy.

Andrew Peters
Andrew Peters
SVP of Strategy and Investor Relations at Exelixis

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. I think as you think about guideline recommendations, that patient safety dynamic is really important.

Operator

Your next question comes from the line of Michael Schmidt of Guggenheim Securities. Please go ahead.

Analyst at Guggenheim Securities

Hi, guys. This is Michelle on for Michael. Thanks for taking my question. I just wanted to ask about STELLAR-304. It seems like enrollment ran for about nine to 10 months longer than the original protocol suggested. I was just wondering if you could speak a little to what drove that enrollment delay, and if you think that this extra time and follow-up means that the OS will be more mature at top line than you had originally expected. Thank you.

Dana Aftab
Dana Aftab
EVP of Research and Development at Exelixis

Sure. Thanks for the question, Michelle. This is Dana. You're commenting on trial dynamics, right? Where the numbers that you see in trials and progress posters company slides, clinicaltrials.gov listings are all based on projections. At the end of the day, enrollment happens as it happens, and we don't have a perfect crystal ball to understand how these dynamics are really going to play out. We put our best foot forward, there's always some shift in these timelines, not just in enrollment timelines, but also in how the event rates come in. 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. We're still planning for the second half of this year.

Dana Aftab
Dana Aftab
EVP of Research and Development at Exelixis

Again, that's our best estimate based on our event rates that are coming in currently.

Operator

Your next question comes from the line of Leonid Timashev of RBC. Please go ahead.

Analyst at RBC

Hey, guys. Josh on for Leo. Thanks for taking my question. I was wondering how you might be thinking about Zanza playing alongside novel agents in NETs like ADCs or some radiopharma programs that are out there. Thanks.

Mike Morrissey
Mike Morrissey
President and CEO at Exelixis

Thanks. P.J, you want to take that one?

P.J. Haley
P.J. Haley
EVP of Commercial at Exelixis

Yeah. I think as far as Zanza and NET, the study is designed, and as Dana mentioned, and I kind of reiterated earlier, there's a lot of excitement around this study, is designed to really position Zanza to be potentially the first oral agent in neuroendocrine tumors. Other modalities are there. Obviously, you have the SSAs, you have the radioligand therapies, and then kind of the orals. I'd say overall, as you think about the space, those are the three high-level modalities. Given the fact that this is the first phase III randomized study to have the potential to read out positive relative to an approved oral agent, success in this study would position Zanza, I think, very well in the neuroendocrine tumor marketplace.

Operator

Okay. Once again, if you wish to ask a question, please press star one on your telephone keypad. Our next question comes from the line of Jason Gerberry of Bank of America. Please go ahead.

Analyst at Bank of America

Hey, guys. This is Qi on for Jason. Thanks for taking our question. Question is on NET. Given your observation on CABOMETYX in the NET indication, do you expect to see similar patient inflow kinetic dynamic for Zanza in NET? Or will you expect a different trajectory for Zanza if you can secure head-to-head data over everolimus in STELLAR-311? Just quickly, could you provide how much NET contribute to cabo sales this quarter? Thanks so much.

Mike Morrissey
Mike Morrissey
President and CEO at Exelixis

P.J?

P.J. Haley
P.J. Haley
EVP of Commercial at Exelixis

Thanks for the question, Qi. I think when you think about Zanza and NET, some of the things I've already spoken to here that position it really potentially well, obviously given a positive study, regulatory approval projecting here into the future, the fact that it is head-to-head, as you point out, with everolimus. A few things. Patient eligibility in the study, it'll be positioned really as potentially a first or second-line agent. I think when you think about that will change the potential for the kinetics of the patient flow in that setting. 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. I think suffice it to say, as I mentioned, the KOLs are very excited about the study.

P.J. Haley
P.J. Haley
EVP of Commercial at Exelixis

When our top physicians are excited about it, that always gives us excitement. Really looking forward to the readout of that study.

Operator

Your next question comes from the line of Etzer Zarrugh of Barclays. Please go ahead.

Analyst at Barclays

Hi, this is Luke on for Etzer. Thanks for taking our question. You've previously talked about potentially partnering Zanza in the same way that you did CABO. Are you still looking to pursue that, or are you going to try and keep Zanza internal globally?

Mike Morrissey
Mike Morrissey
President and CEO at Exelixis

Yeah, it's 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 ex-U.S. 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. Stay tuned.

Analyst at Barclays

Thanks.

Operator

Your next question comes from the line of Ash Verma of UBS. Please go ahead.

Ash Verma
Ash Verma
Analyst at UBS

Thanks for taking my question. Just going back to the STELLAR-303 study in CRC. What is your best guess in terms of what might have driven this recent update that the non-liver NET subgroup did not achieve statistical OS benefit? Is it possible some subgroup analysis was underpowered, or is it anything to do with atezo that might see some diminishing efficacy? Have you discussed this with the FDA as a part of your ongoing review? Thanks.

Mike Morrissey
Mike Morrissey
President and CEO at Exelixis

Dana?

Dana Aftab
Dana Aftab
EVP of Research and Development at Exelixis

Sure. Thanks for the question, Ash. 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 that 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. Basically, over time, we really didn't see the data evolve to a point where it became significant. As you mentioned, you pointed to one potential factor there, that this was 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 in 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.

Operator

Your next question comes from the line of Stephen Willey, Stifel. Please go ahead.

Stephen Willey
Stephen Willey
Analyst at Stifel

Good afternoon. Thanks for taking the questions. I guess persistency with oral TKIs as maintenance therapy has historically been somewhat challenging across a number of different tumor types for various agents, I think mostly related to reasons that P.J. cited when he was talking about adjuvant RCC. Just curious, what can you do in these STELLAR-316 and STELLAR-202 trials to make sure that persistency doesn't end up confounding data interpretation? Thank you.

Mike Morrissey
Mike Morrissey
President and CEO at Exelixis

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

Mike Morrissey
Mike Morrissey
President and CEO at Exelixis

Some of the earlier maybe First Generation or Two of TKIs had some challenges there. We feel really good about that with zanzalintinib relative to the target inhibition profile, the pharmacodynamics, the short half-life. With, whether it be STELLAR-316 or STELLAR-202 or even STELLAR-201, we feel like we've got pretty good insight to be able to maximize that opportunity.

Operator

Thank you. At this time, there are no further questions, I will turn the call back over to today's host, Mr. Andrew Peters. Mr. Peters?

Andrew Peters
Andrew Peters
SVP of Strategy and Investor Relations at Exelixis

Thank you, Kathleen, 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.

Operator

Ladies and gentlemen, that concludes today's call. Thank you everyone for joining. You may now disconnect.

Executives
    • Andrew Peters
      Andrew Peters
      SVP of Strategy and Investor Relations
    • Mike Morrissey
      Mike Morrissey
      President and CEO
    • Chris Senner
      Chris Senner
      EVP and CFO
    • P.J. Haley
      P.J. Haley
      EVP of Commercial
    • Dana Aftab
      Dana Aftab
      EVP of Research and Development
Analysts
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