EXEL

EXEL is an oncology company that discovers, develops, and commercializes new treatments for hard-to-treat cancers. Its second-quarter 2026 report showed $629 million in quarterly revenue ($573 million from its cabozantinib product alone, a 10% year-over-year rise), GAAP net income of $212 million ($0.82 per diluted share), $1.4 billion in cash, and $312 million in repurchases last quarter. It’s no wonder EXEL shares are up 26% so far this year – and they could rise more. MoneyFlows data shows how Big Money investors are once again betting heavily on the forward picture of the stock. Institutional volumes reveal plenty. In the last year, EXEL has enjoyed strong investor demand, which we believe to be institutional support. Each green bar signals unusually large volumes in EXEL shares. They reflect our proprietary inflow signal, pushing the stock higher: Plenty of health care names are under accumulation right now. But there’s a powerful fundamental story happening with Exelixis. Institutional support and a healthy fundamental backdrop make this company worth investigating. As you can see, EXEL has had strong sales and earnings growth: 3-year sales growth rate (+13%) 3-year EPS growth rate (+83.6%) Source: FactSet Also, EPS is estimated to ramp higher this year by +16%. Now it makes sense why the stock has been generating Big Money interest. EXEL has a track record of strong financial performance. Marrying great fundamentals with our proprietary software has found some big winning stocks over the long term. Exelixis has been a top-rated stock at MoneyFlows. That means the stock has unusual buy pressure and growing fundamentals. We have a ranking process that showcases stocks like this on a weekly basis. It’s made the rare Outlier 20 report 31 times since 2017, rising 134.3% since the first outlier inflow signal. The blue bars below show when EXEL was a top pick in the last year…institutional support keeps flowing: Tracking unusual volumes reveals the power of money flows. This is a trait that most outlier stocks exhibit…the best of the best. Big Money demand drives stocks upward. The EXEL action isn’t new at all. Big Money buying in the shares is signaling to take notice. Given the historical gains in share price and strong fundamentals, this stock could be worth a spot in a diversified portfolio. Disclosure: the author holds no position in EXEL at the time of publication. If you are a Registered Investment Advisor (RIA) or a serious investor, take your investing to the next level. MoneyFlows created 11 Frontiers indexes to help serious investors capture AI-driven themes and learn the leading stocks in each Frontier. Get started here. This article was originally posted on FX Empire USD/CAD Turns Bullish as GBP/USD, AUD/USD Lose Momentum Solana Price Targets $120 as Schwab Adds SOL, ETF Inflows Rise EUR/USD, EUR/JPY and AUD/USD Brace for Jackson Hole Volatility Tesla, Ford and GM Stocks Test Key Technical Boundaries Strong Sales, Earnings Send Exelixis Shares Higher Zcash Price Eyes $1,000 as Social Volumes Flash Buy Signal

Image source: The Motley Fool. Wednesday, Aug. 5, 2026 at 5:00 p.m. ET President - Michael Morrissey Chief Financial Officer - Christopher Senner Executive Vice President of Research and Development - Dana Aftab Executive Vice President of Commercial - P.J. Haley Senior Vice President of Strategy and Investor Relations - Andrew Peters Kathleen: 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: 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 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 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 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. Michael Morrissey: 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 6 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 5 key elements, including: first, execution. Zanza is leading the pack as our next potential franchise opportunity and our highest R&D priority. The EXEL team continues to execute on key objectives across the program, including the STELLAR-303 regulatory review, pivotal trial data readouts, expediting clinical trial enrollment and new study initiations. The second is expansion. 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 cabozantinib 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 with the potential launch of zanza in third-line plus CRC, pending a positive regulatory review later this year. 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, as 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 5 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 zanza towards becoming a major oncology franchise, expand our development portfolio, drive continued growth to the cabozantinib 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. Christopher Senner: 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 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. 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 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 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 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 (sic) [ non-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. As of the end of the second quarter 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. And with that, I'll turn the call over to P.J. P. Haley: 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 9ER data, where we maintain a high market share as the #1 TKI plus IO combination in addition to being the #1 prescribed TKI in renal cell carcinoma. 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 2 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. Sometimes NET patients are scanned less frequently than a standard 3-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 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 second-line plus NET market share. We have 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. 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 are thinking about building on and expanding our GI franchise, we are 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 1 of the big 4 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. 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 #1 TKI and TKI plus IO combination in RCC as well as the #1 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. And with that, I will turn the call over to Dana. Dana Aftab: Thanks, P.J. My update today will be focused mostly on the 7 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 atezo 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. 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 pembro 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, and 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, 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 III trials competing for these patients. In the neuroendocrine tumors indication, STELLAR-311 is our global Phase III trial evaluating zanza 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. 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. 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. 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 zanza. Pivoting now to clear cell RCC, progress continues with regard to the 2 pivotal Phase III studies that Merck is running to evaluate zanzalintinib in combination with belzutifan. The LITESPARK-033 trial is comparing zanza plus belz versus cabo in the frontline setting for patients who received adjuvant treatment with anti-PD-1 or anti-PD-L1 therapy. And LITESPARK-034 is comparing zanza plus belz versus belz 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 III studies in clear cell RCC moving forward and 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, 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-002 study to evaluate zanza in patients with metastatic bladder cancer who have progressed on the combination of enfortumab vedotin or EV plus pembro. 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 pembro in multiple settings, including in the frontline 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-002, evaluating zanza 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 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. 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. 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 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 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-small cell lung cancer since KEYNOTE-407 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 4 molecules currently in clinical development, namely XL309, XB010, XB628 and XB371 continue to progress, and we are also continuing to move new small molecule and ADC 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. Michael Morrissey: 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. 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. Kyuwon Choi: 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? And just any sort of updated precision on data timing that you could offer would be great. Michael Morrissey: Dana, go ahead, please. Dana Aftab: Sure. Thanks for the question, Paul. So 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. Anastasia Parafestas: This is Anastasia on for Akash. So I wanted to ask about your first-line post-adjuvant study. Specifically, I think you guys have made a comment about maybe like a 15,000 patient population. I'm wondering if that changes at all based on the LITESPARK-022 study, the one that had improved PFS. Do you anticipate patients will start switching to an already existing like the pembro plus HIF-2 alpha. And if you do, does that reduce your patient population? How are you viewing that data? P. Haley: Yes. Thanks for the question, Anastasia. This is P.J. I think, obviously, very early days for the LITESPARK-022 combination just getting approved with belz 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 therapy is in that kind of a 20% to 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. 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. Tsan-Yu Hsieh: 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? Michael Morrissey: Yes. P.J., please? P. Haley: Yes. 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. And as Dana said, it's progressing well. So I think to your point, any time you do have a study that is recruiting, it does draw potential patients from the commercial patient pool, so to speak. And it can be a bit exacerbated in a smaller tumor type, for example. So we think that could be having a small impact. But 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. And 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. And I think 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. So 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. So we're excited about that going forward. Sean Laaman: Just with the CRC PDUFA date coming up later this year, what label language would be the most commercially meaningful? And what label limitations, if any, around liver mets prior therapy or subgroup interpretation do you think could be real that may constrain uptake? Michael Morrissey: Yes. Thanks, Sean. Dana, do you want to take that one? Dana Aftab: Yes, sure. So as I mentioned, Sean, earlier, the -- 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 label that is really up to discussions with the agency. Joshua Werman: This is Josh on for Sylvan. Congrats on the update. At the beginning of maybe it was 2025, Exelixis shared their vision for $5 billion in revenue for zanza by 2033. Now I guess, 1.5 years from that point, can you highlight the progress made towards that goal? And if how the makeup of that projection has evolved since then? Michael Morrissey: Yes, Josh, thanks for the question. Yes, 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. The fact that we have launched or are about to launch or one is imminent of the 7 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. 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. Kalpit Patel: Just one on the ANDA's tentative approval. We've been feeling in 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? Michael Morrissey: Yes, Andrew? Andrew Peters: Kalpit, thanks for the question. I 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 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. Yaron Werber: Great. I have maybe kind of a dual-part question. The first one on meningioma, STELLAR-201. So it's really encouraging to see how fast it enrolled. And we've seen in these areas that a single-arm Phase II can lead to approval. How fast can you -- do you think you can generate data? Kind of what's the standard of care historically shown? And then secondly, just 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? Michael Morrissey: Yes. Dana, why don't you start, and then we'll do a quick turnover. Dana Aftab: Sure, sure. So 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. And the excitement on the trial is really being driven in part by the emerging data from a small study with cabozantinib. 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 as you're kind of hinting at, this could be a very fast process, but the details of that really need to evolve over time. So we really can't comment on that at this time. Michael Morrissey: Good. Thank you. Andrew? Andrew Peters: Yes, Yaron. So on the 505(b)(2) dynamics, a couple of things to mention here. As you know, there are pretty big differences between the kind of standard ANDA pathway and the 505(b)(2), things like labeling, therapeutic equivalence, 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 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 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. I guess kind of the key thing from Exelixis's perspective is we're focused on 2 things: patient safety and prioritizing our intellectual property rights, and we're going to continue to focus on those 2 things. But I think as you think about guideline recommendations, that patient safety dynamic is really important. Michelle Boisvert: This is Michelle on for Michael. I just wanted to ask about STELLAR-304. It seems like enrollment ran for about 9 to 10 months longer than the original protocol suggested. So 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? Dana Aftab: Sure. Thanks for the question, Michelle. This is Dana. So 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 how these dynamics are really going to play out. We put our best foot forward. But 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, were -- and actually, I think we mentioned for the first time last quarter at the earnings call that we are 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. Joshua Wolfson: Josh on for Leo. So 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? Michael Morrissey: PJ, do you want to take that one? P. Haley: Yes. So I mean, I think as far as zanza and NET, 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 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 3 high-level modalities. So given the fact that this is the first study -- Phase III 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, I think, very well in the neuroendocrine tumor marketplace. Chi Meng Fong: This is Chi on for Jason. Question is on NET. Given your observation on cabo ramp in the NET indication, do you expect to see similar patient inflow kinetic dynamic for zanza in NET? Or would you expect a different trajectory for zanza if you can secure head-to-head data over everolimus in STELLAR-311? And just quickly, could you provide how much NET contribute to cabo sales this quarter? Michael Morrissey: P.J.? P. Haley: Yes. Thanks for the question, Chi. Again, 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 in 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 will 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 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. When our top physicians are excited about it, that always gives us excitement. So really looking forward to the readout of that study. Luke Sergott: This is Luke on for Etzer. 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? Michael Morrissey: Yes, 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. 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. Ashwani Verma: 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 met subgroup did not achieve static OS benefit? Is it possible some subgroup analysis was like underpowered? Or is it anything to do with atezo that might see some diminishing efficacy? And have you discussed this with the agency as a part of your ongoing review? Michael Morrissey: Dana? Dana Aftab: Sure. Thanks for the question, Ash. So yes, regarding the non-liver mets primary endpoint, as we announced, I think, in June that, 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. 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. Stephen Willey: So 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. So just curious, what can you do in the STELLAR-316 and 202 trials just to make sure that persistency doesn't end up confounding data interpretation? Michael Morrissey: Yes. So let me start and Dana or P.J. 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, 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. So 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. So it's really balancing activity -- short-term activity with long-term duration to be able to give benefit. Obviously, some of the earlier maybe first generation or 2 of TKIs have some challenges there. We feel really good about that with zanza relative to the target inhibition profile, the pharmacodynamics, the short half-life. So with 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. Andrew Peters: 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. Operator: Ladies and gentlemen, that concludes today's call. Thank you, everyone, for joining. You may now disconnect. Before you buy stock in Exelixis, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Exelixis wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $403,337!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,334,946!* That performance is why people listen. With a track record of beating the S&P 500 by 4x, Stock Advisor offers a distinct advantage. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built for the long haul. See the 10 stocks » *Stock Advisor returns as of August 12, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has positions in and recommends Exelixis. The Motley Fool has a disclosure policy. Exelixis (EXEL) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Exelixis, Inc. EXEL reported mixed results for the second quarter of 2026 and lowered its annual outlook. Adjusted earnings per share (EPS) of 82 cents comfortably beat the Zacks Consensus Estimate of 75 cents. The company posted adjusted EPS of 65 cents in the year-ago quarter. Adjusted earnings excluded the impact of stock-based compensation expenses. Including stock-based compensation expense, EPS was 82 cents compared with 65 cents in the year-ago period. The bottom-line growth benefited from higher operating income and a decrease in shares outstanding due to ongoing buybacks. Revenues rose 10.6% year over year to $628.7 million but missed the Zacks Consensus Estimate of $635 million. The stock is trading down in response to the second-quarter results. Year to date, Exelixis’ shares have risen 25.5% compared with the industry’s growth of 3.6%. Image Source: Zacks Investment Research Net product revenues increased to $573.03 million from $520.01 million in the year-ago quarter, primarily due to higher sales volume. Cabometyx (cabozantinib) generated revenues of $570.6 million, which missed the Zacks Consensus Estimate of $578 million and our model estimate of $575 million. The drug is approved for advanced renal cell carcinoma (RCC) and previously treated hepatocellular carcinoma. Cabometyx remained the leading prescribed tyrosine kinase inhibitor (TKI) in RCC. Its total prescription share within the company’s tracked oral TKI market basket increased to 47% from 45% a year earlier, while prescription volume rose 12%, outpacing the market basket’s 6% growth. In March 2025, Exelixis obtained FDA approval for the label expansion of Cabometyx for the treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic and extra-pancreatic neuroendocrine tumors (pNET). The drug was also approved for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic NET (epNET). However, the neuroendocrine tumor indication expanded more gradually than management had projected. Exelixis attributed the slower ramp to the relatively indolent nature of NET, less frequent patient scans and longer transitions between therapies. Cometriq (cabozantinib capsules) generated $2.4 million in net product revenues for treating medullary thyroid cancer. Collaboration revenues rose 15.4% to $55.7 million. The improvement reflected higher royalties on cabozantinib sales outside the United States by partner Ipsen, partly offset by lower development cost reimbursements. Exelixis earned $53.2 million in royalty revenues from partners Ipsen and Takeda during the quarter. Research and development expenses increased 5.8% year over year to $211.99 million due to higher clinical trial, manufacturing and collaboration costs as Exelixis continued investing in zanzalintinib and other pipeline candidates. Selling, general and administrative expenses rose 9.5% to $147.63 million, reflecting higher marketing and personnel costs. Despite the increased spending, operating income climbed 16.3% to $248.41 million, and the operating margin expanded to 39.5% from 37.6%. Management lowered and narrowed its 2026 total revenue guidance to $2.50-$2.55 billion from $2.525-$2.625 billion. Net product revenue guidance was reduced to $2.30-$2.35 billion from $2.325-$2.425 billion, primarily because of the slower-than-expected NET ramp. The revised outlook excludes potential revenues from zanzalintinib in previously treated metastatic colorectal cancer. Exelixis also reduced its R&D expense forecast to $825-$875 million from $875-$925 million. Its SG&A expense projection remained unchanged at $575-$625 million. Exelixis repurchased $311.6 million of the company’s shares in the second quarter, completing the $750 million share repurchase program (SRP) launched in October 2025. The company also began repurchases under a new $750 million SRP authorized in May 2026, which runs through Dec. 31, 2027. Since launching its first SRP in March 2023, Exelixis has repurchased $2.9 billion of stock, retiring 93.3 million shares at an average price of $31.12 per share as of the end of the second quarter of 2026. The FDA is reviewing zanzalintinib in combination with Roche’s RHHBY Tecentriq for previously treated metastatic colorectal cancer, with a target action date of Dec. 3, 2026. Its approval would establish zanzalintinib as Exelixis’ second commercial oncology franchise and broaden its portfolio beyond cabozantinib. In June 2026, Exelixis reported final phase III STELLAR-303 results showing a non-statistically significant overall survival trend favoring zanzalintinib plus Tecentriq over regorafenib in the non-liver metastases (NLM) subgroup of previously treated non-MSI-high metastatic colorectal cancer. The study had previously met its other dual primary endpoint of overall survival in the intent-to-treat population, which included all randomized patients regardless of the presence of active liver metastases, as reported in June 2025. Roche’s Tecentriq is a cancer immunotherapy that is approved around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various types of cancer. EXEL has collaborated with Merck & Co. MRK to evaluate zanzalintinib, in combination with subcutaneous Keytruda Qlex in the planned phase III STELLAR-316 study for resected stage II/III colorectal cancer (CRC). Under the agreement, Exelixis will sponsor the STELLAR-316 study, while Merck will provide Keytruda Qlex for use in the same. Keytruda is approved for several types of cancer. Exelixis expects to initiate STELLAR-316 shortly, which will evaluate zanzalintinib with and without Keytruda Qlex in patients with resected stage II/III CRC who, following definitive therapy, have tested positive for molecular residual disease (MRD+) and have no radiographic evidence of disease — a high-risk population with substantial unmet need. Earlier this year, Exelixis partnered with Natera (NTRA), a global leader in cell-free DNA and precision medicine, for this study.Natera will supply its Signatera assay to identify eligible MRD-positive patients for enrollment, further integrating precision medicine into the program. The Merck partnership extends beyond colorectal cancer. In April 2026, Merck initiated the phase III LITESPARK-034 trial evaluating zanzalintinib plus Welireg versus Welireg and placebo in previously treated advanced RCC patients who progressed after PD-1/L1 and VEGFR-TKI therapies. This marks the second Merck-sponsored phase III study under the collaboration, following LITESPARK-033 (launched in December 2025), which is assessing the combination against cabozantinib in first-line advanced RCC post-adjuvant immunotherapy. In May 2026, Exelixis announced the initiation of STELLAR-201, a phase II study evaluating zanzalintinib in patients with recurrent Grade I/II/III meningioma with relapse or progression following radiation and/or surgery or those who are not candidates for these therapies. While EXEL beat earnings expectations and Cabometyx remains the leading prescribed TKI in RCC, the revenue miss and lowered guidance underscore the company's continued reliance on Cabometyx and uncertainty around the pace of the NET franchise ramp. Exelixis, Inc. price-consensus-eps-surprise-chart | Exelixis, Inc. Quote Zanzalintinib represents the company’s most significant near-term catalyst. A potential approval for the candidate will be a significant boost for EXEL’s oncology pipeline. Exelixis currently carries a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Exelixis, Inc. (EXEL) : Free Stock Analysis Report Roche Holding AG (RHHBY) : Free Stock Analysis Report Merck & Co., Inc. (MRK) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Interested in Exelixis, Inc.? Here are five stocks we like better. Q2 revenue reached approximately $629 million, driven by $573 million in U.S. cabozantinib franchise net product revenue. However, Exelixis lowered its full-year 2026 revenue outlook by reducing the midpoint $50 million, citing a slower-than-expected ramp in the neuroendocrine tumor indication. Zanzalintinib remains central to Exelixis’ growth strategy, with the FDA expected to decide by early December on its colorectal cancer application in combination with atezolizumab. The company is also advancing seven ongoing or imminent pivotal studies across colorectal, renal, neuroendocrine and other cancers. Exelixis reported approximately $212 million in GAAP net income and repurchased $312 million of stock during the quarter. Cash and marketable securities totaled about $1.4 billion at June 30, supporting continued investment in clinical trials and capital returns. Exelixis Reports Solid Earnings—Are New Highs Back on the Table? Exelixis (NASDAQ:EXEL) reported second-quarter 2026 revenue of approximately $629 million, including $573 million in cabozantinib franchise net product revenue, as the company prepared for a potential late-year launch of zanzalintinib in colorectal cancer and advanced a broader development program for the drug candidate. President and Chief Executive Officer Mike Morrissey said the company is entering its next growth phase as it seeks to build a multi-franchise oncology business beyond cabozantinib, marketed as CABOMETYX. Zanzalintinib, or Zanza, is Exelixis’ highest research and development priority and is under FDA review in combination with atezolizumab for previously treated colorectal cancer. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control 3 Stocks to Buy for a Soft Landing, If There Is One The FDA has set a PDUFA date in early December for the Zanza colorectal cancer application, which is supported by results from the STELLAR-303 trial. Morrissey described the potential colorectal cancer approval as an important first step toward establishing Zanza as Exelixis’ second oncology franchise. U.S. cabozantinib franchise net product revenue increased about 10% year over year to $573 million in the second quarter, while global cabozantinib franchise net product revenue, including partner sales, rose about 13% to $806 million, according to Morrissey. → 3 Drone Stocks That Should Soar After the Summer Slump 3 Strong Biotech Performers To Watch As Sector Nears Breakout Chief Financial Officer Chris Senner said CABOMETYX net product revenue totaled $571 million, including approximately $2.7 million in clinical trial sales. The company also recorded about $53 million in royalties from partners Ipsen and Takeda related to their cabozantinib sales. Exelixis lowered and narrowed its full-year 2026 total revenue and net product revenue outlook, reducing the midpoint by $50 million. Senner said the update reflects modestly slower growth due to a more gradual-than-expected ramp in the neuroendocrine tumor, or NET, indication. → The Bitcoin Comeback May Already Be Underway—2 ETFs for Exposure The company also reduced its R&D expense guidance, lowering the midpoint of that range by $50 million. Morrissey said Exelixis expects projected free cash flow to remain essentially unchanged as it balances investment in its pivotal trials with expense discipline. P.J. Haley, executive vice president of commercial, said the slower NET revenue ramp was tied to characteristics of the patient population rather than a change in the company’s long-term view of the market. NET tumors can be more indolent than other solid tumors, and patients may be scanned less frequently, remain on their existing treatment longer, or take treatment breaks before moving to a subsequent therapy. Despite those dynamics, Haley said CABOMETYX achieved more than 45% of oral second-line-plus new-patient market share in NET during the quarter. He said increasing new-patient share should support refills and future demand. CABOMETYX total prescription share in an oral TKI market basket increased to 47% in the second quarter, from 45% a year earlier. CABOMETYX prescription volume rose 12% year over year, compared with 6% growth for the overall market basket cited by the company. Exelixis said CABOMETYX remains the leading prescribed TKI in renal cell carcinoma and the leading TKI-plus-immunotherapy combination in first-line RCC. Exelixis reported GAAP net income of approximately $212 million, or $0.82 per diluted share, for the second quarter. The company reported non-GAAP net income of approximately $237 million, or $0.91 per diluted share, excluding roughly $25 million of stock-based compensation net of related tax effects. Operating expenses totaled approximately $380 million, up from $359 million in the first quarter. Senner attributed the sequential increase primarily to higher clinical trial costs, marketing expenses and stock-based compensation. Cash and marketable securities totaled approximately $1.4 billion as of June 30. During the quarter, Exelixis repurchased approximately $312 million of common stock, retiring about 6.5 million shares at an average price of $47.85 per share. The company completed its October 2025 repurchase program and had approximately $598 million remaining under a $750 million authorization approved in May 2026. Dana Aftab, executive vice president of research and development, said Exelixis has seven ongoing or imminent pivotal studies for Zanza. The company expects top-line results from STELLAR-304, a phase III trial of Zanza plus nivolumab versus sunitinib in locally advanced or metastatic non-clear cell renal cell carcinoma, in the second half of 2026. Exelixis completed enrollment in STELLAR-304 last year. Aftab said the study is the first large, global randomized phase III trial focused on non-clear cell RCC, which represents approximately 20% of RCC cases. Positive results could support the company’s second new drug application for Zanza, she said. The company is also preparing to begin screening patients this month in STELLAR-316, a trial in resected stage II or III colorectal cancer patients who test positive for molecular residual disease after definitive therapy but have no radiographic evidence of disease. The study will evaluate Zanza with and without subcutaneous pembrolizumab. In NET, the STELLAR-311 phase III trial is comparing Zanza with everolimus as an initial oral therapy in pancreatic or extrapancreatic NET. Aftab said enrollment is running months ahead of projections. Other development efforts include Merck-led phase III trials evaluating Zanza plus belzutifan in clear-cell RCC, an expansion cohort in metastatic bladder cancer after progression on enfortumab vedotin plus pembrolizumab, and a cohort studying Zanza with docetaxel in metastatic castration-resistant prostate cancer. Exelixis also said enrollment in its phase II STELLAR-201 study in recurrent meningioma is exceeding initial projections. The trial is enrolling up to 100 patients who have progressed after, or are no longer eligible for, local therapies. The company is designing a confirmatory phase III study while the phase II trial continues. In addition, Exelixis expects to initiate STELLAR-202 in the second half of 2026. The phase II study will evaluate Zanza during maintenance therapy following pembrolizumab plus chemotherapy induction in squamous non-small cell lung cancer. During the question-and-answer session, executives declined to discuss potential label language for the colorectal cancer application while the FDA review remains ongoing. Aftab said the company views the application as potentially significant because, if approved, it would provide an immunotherapy-containing regimen for a broad population of patients with third-line-plus colorectal cancer. Haley estimated the U.S. third-line-plus colorectal cancer setting includes approximately 23,000 patients and represents a $1.5 billion opportunity at contemporary pricing. He said physicians and advisory boards have expressed interest in the STELLAR-303 data and in the potential availability of an immune checkpoint inhibitor-containing regimen for the broader colorectal cancer population. Morrissey said Exelixis continues to evaluate options for partnering Zanza outside the U.S., noting that the company has received interest but has not made a decision. Exelixis, Inc is a biotechnology company specializing in the discovery, development and commercialization of small molecule therapies primarily for the treatment of cancer. Building on a platform that leverages model organism genetics and high-throughput screening, the company focuses its research on kinase inhibitors that modulate critical signaling pathways involved in tumor growth and metastasis. Exelixis's translational research approach aims to advance novel compounds from early-stage discovery through clinical development and regulatory approval. The company's most recognized products include CABOMETYX® (cabozantinib), approved for the treatment of advanced renal cell carcinoma and hepatocellular carcinoma, and COMETRIQ® (cabozantinib) for metastatic medullary thyroid cancer. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Exelixis Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Exelixis (EXEL) reported $628.69 million in revenue for the quarter ended June 2026, representing a year-over-year increase of 10.6%. EPS of $0.91 for the same period compares to $0.75 a year ago. The reported revenue represents a surprise of -0.99% over the Zacks Consensus Estimate of $635 million. With the consensus EPS estimate being $0.86, the EPS surprise was +5.81%. While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to determine their next move, some key metrics always offer a more accurate picture of a company's financial health. Since these metrics play a crucial role in driving the top- and bottom-line numbers, comparing them with the year-ago numbers and what analysts estimated about them helps investors better project a stock's price performance. Here is how Exelixis performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Revenues- Net product revenues: $573.03 million versus the six-analyst average estimate of $582.81 million. The reported number represents a year-over-year change of +10.2%. Revenues- Collaboration revenues: $55.67 million versus $52.17 million estimated by six analysts on average. Compared to the year-ago quarter, this number represents a +15.4% change. Revenues- Net product revenues- CABOMETYX: $570.6 million versus the five-analyst average estimate of $578.01 million. The reported number represents a year-over-year change of +10.2%. Revenues- Net product revenues- COMETRIQ: $2.4 million versus $2.75 million estimated by five analysts on average. Compared to the year-ago quarter, this number represents a +13% change. Revenues- Collaboration revenues- Collaboration services revenues: $-4.15 million compared to the $2.24 million average estimate based on two analysts. The reported number represents a change of +293.3% year over year. Revenues- Collaboration revenues- License revenues: $59.81 million compared to the $52.31 million average estimate based on two analysts. The reported number represents a change of +21.3% year over year. View all Key Company Metrics for Exelixis here>>> Shares of Exelixis have returned -1.9% over the past month versus the Zacks S&P 500 composite's +3.5% change. The stock currently has a Zacks Rank #4 (Sell), indicating that it could underperform the broader market in the near term. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Exelixis, Inc. (EXEL) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

This article first appeared on GuruFocus. Total Revenues: Approximately $629 million for Q2 2026. Cabozantinib Franchise Net Product Revenues (US): $573 million, up approximately 10% year-over-year. Global Cabozantinib Franchise Net Product Revenues (Exelixis and partners): $806 million, up approximately 13% year-over-year. CABOMETYX Net Product Revenues: $571 million, including approximately $2.7 million in clinical trial sales. Royalty Revenues: Approximately $53 million from partners Ipsen and Takeda. Gross to Net: 29.5% for Q2 2026; full-year 2026 guidance updated to between 30% and 31%. Total Operating Expenses: Approximately $380 million in Q2 2026, up from $359 million in Q1 2026. GAAP Net Income: Approximately $212 million, or $0.85 per share basic and $0.82 per share diluted. Non-GAAP Net Income: Approximately $237 million, or $0.95 per share basic and $0.91 per share diluted, excluding approximately $25 million of stock-based compensation. Cash and Marketable Securities: Approximately $1.4 billion as of June 30, 2026. Share Repurchases: Approximately $312 million of common stock repurchased in Q2 2026, retiring approximately 6.5 million shares at an average price of $47.85 per share. Full-Year 2026 Guidance: Total revenues and net product revenue guidance lowered, with the midpoint reduced by $50 million; R&D expense guidance midpoint also reduced by $50 million. Warning! GuruFocus has detected 6 Warning Signs with OSUR. Is EXEL fairly valued? Test your thesis with our free DCF calculator. Release Date: August 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Exelixis Inc (NASDAQ:EXEL) reported strong Q2 2026 financial results with total revenues of approximately $629 million and GAAP net income of $212 million, reflecting solid operational performance. The cabozantinib franchise continues to grow, with US net product revenues up 10% year-over-year to $573 million and global revenues up 13% to $806 million, driven by strong RCC and NET market share gains. Zanzalintinib is advancing well, with the STELLAR-303 NDA under FDA review (PDUFA in December 2026) and six additional pivotal trials progressing, including STELLAR-304 expected to read out in H2 2026. The company is executing on its strategic expansion, with new trials like STELLAR-316 (adjuvant CRC) and STELLAR-202 (squamous NSCLC) set to initiate, and expansion cohorts in bladder and prostate cancer showing early promise. Exelixis Inc (NASDAQ:EXEL) maintains strong financial discipline, reducing R&D expense guidance by $50 million while keeping free cash flow essentially unchanged, and continues to return capital to shareholders via a $750 million buyback program. The NET franchise is gaining traction, with CABOMETYX achieving over 45% new patient market share in the second-line plus setting, positioning it as the leading oral therapy and a key growth driver. Exelixis Inc (NASDAQ:EXEL) lowered its full-year 2026 revenue guidance by $50 million at the midpoint, reflecting a more gradual ramp in the NET indication due to slower patient kinetics and indolent disease characteristics. The STELLAR-303 trial's non-liver metastasis subgroup failed to achieve statistical significance on overall survival, raising potential concerns about the robustness of the overall data despite the ITT population being positive. The NET market ramp is slower than expected, with patients often taking treatment breaks or delaying subsequent therapy, which could limit near-term revenue growth from this indication. The company faces potential competitive and regulatory risks, including the tentative approval of ANDAs for generic versions of cabozantinib, which could impact future market exclusivity despite existing agreements. Enrollment in the STELLAR-304 trial took longer than originally projected, and the company remains cautious about data timing, with results still expected in H2 2026 but subject to event rate variability. The launch of zanzalintinib in CRC is pending FDA approval, and any label restrictions or subgroup limitations could constrain commercial uptake, especially in the third-line plus setting. Q: Regarding the STELLAR-304 trial in non-clear cell renal cell carcinoma, can you provide an update on the timing of the data readout and whether it could be presented at a major medical meeting this year?A: Dana Aftab, EVP of R&D, stated that the trial is expected to achieve the planned number of events in the second half of 2026, but declined to speculate on the exact timing of the data release or presentation at a medical meeting, noting the company will communicate at the appropriate time. Q: Given the recent LITESPARK-022 data showing improved disease-free survival with a pembro plus HIF-2 alpha combination in the adjuvant setting, do you anticipate this will reduce the patient population for your first-line post-adjuvant study (LITESPARK-033)?A: P.J. Haley, EVP of Commercial, responded that it is too early to speculate on the utilization of the new adjuvant combination. He noted that the adjuvant setting is historically sensitive to toxicity, and given the high overall survival bar set by pembro monotherapy, physicians will be cautious about adding another agent with potential toxicity. He does not expect a significant impact on the first-line patient population. Q: Is the ongoing STELLAR-311 trial in neuroendocrine tumors potentially cannibalizing cabo sales, contributing to the more gradual ramp and lowered guidance?A: P.J. Haley acknowledged that any recruiting study can draw patients from the commercial pool, which may have a small impact in a smaller tumor type like NET. However, he emphasized that the primary driver of the slower ramp is the indolent nature of NET, where patients often take more time to initiate subsequent therapy. He remains confident in the long-term opportunity, citing the achievement of over 45% new patient market share in the second-line plus setting. Q: With the upcoming PDUFA date for zanzalintinib in colorectal cancer, what label language would be most commercially meaningful, and what limitations could constrain uptake?A: P.J. Haley stated that the review is ongoing and the company cannot comment on label discussions with the agency. He reiterated the excitement about the potential approval, which would be the first immunotherapy-containing regimen for the vast majority of third-line plus CRC patients and the first launch of the company's next franchise molecule. Q: Can you highlight the progress made towards the aspirational goal of $5 billion in revenue for zanza by 2033, and how has the makeup of that projection evolved?A: Mike Morrissey, President and CEO, noted that the company is executing on its strategy with seven pivotal trials either ongoing or imminent, and a next wave of trials in development. He expressed excitement about the depth and breadth of the opportunity, emphasizing the company's commitment to making zanza a valuable second franchise for patients and shareholders. Q: If the ANDA filers receive full approval, could that accelerate the timing of generic entry before the 2031 timelines in your agreements?A: Andrew Peters, SVP of Strategy and IR, declined to discuss specifics of the agreements but noted that the scenario described is not common in such agreements and should not be expected. Q: Regarding STELLAR-201 in meningioma, how quickly could data be generated, and can a new salt (505(b)(2)) get NCCN guideline placement without clinical data?A: Dana Aftab noted that STELLAR-201 is a single-arm Phase II study with high unmet need and no standard of care, and the company is designing a confirmatory Phase III trial. Andrew Peters added that 505(b)(2) products differ significantly from standard ANDAs in labeling and interchangeability, and successful examples like ABRAXANE were based on large Phase III trials. He emphasized the company's focus on patient safety and IP rights. Q: STELLAR-304 enrollment ran longer than originally projected. Does the extra follow-up time mean the overall survival data will be more mature at the top-line readout?A: Dana Aftab explained that trial timelines are based on projections and actual enrollment can shift. She confirmed the company still expects the readout in the second half of 2026, based on current event rates, but did not comment on the maturity of the OS data. Q: How might zanza play alongside novel agents in NETs, such as ADCs or radiopharmaceuticals?A: P.J. Haley stated that STELLAR-311 is designed to position zanza as potentially the first oral agent in NET. He noted that other modalities like SSAs and radioligand therapies exist, but a positive Phase III readout against an approved oral agent would position zanza very well in the marketplace. Q: Given the observed patient kinetics for cabo in NET, do you expect a similar dynamic for zanza, and can you provide the contribution of NET to cabo sales this quarter?A: P.J. Haley responded that zanza's positioning as a potential first or second-line agent, if approved, could change the patient flow kinetics compared to cabo. He did not provide specific NET sales figures but reiterated excitement about the STELLAR-311 study and the potential for a different trajectory. Q: Are you still looking to partner zanza ex-US, similar to the cabo model, or will you keep it internal globally?A: Mike Morrissey confirmed that the company is still evaluating all options for ex-US partnering, taking into account various factors. He noted there is significant interest and expects it to grow as more pivotal trial data read out positively. Q: What might have driven the lack of statistical significance in the non-liver mets subgroup of STELLAR-303, and has this been discussed with the FDA?A: Dana Aftab explained that the non-liver mets subgroup was a small subpopulation and the treatment effect was similar to the interim results. She emphasized that the ITT population, which includes both liver and non-liver mets patients, is the basis of the NDA submission and remains the most important dataset. Q: How will you ensure patient persistency with oral TKIs in the maintenance setting for STELLAR-316 and STELLAR-202, given historical challenges?A: Mike Morrissey highlighted the importance of dose selection and balancing short-term activity with long-term For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Exelixis (EXEL) came out with quarterly earnings of $0.91 per share, beating the Zacks Consensus Estimate of $0.86 per share. This compares to earnings of $0.75 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +5.81%. A quarter ago, it was expected that this drug developer would post earnings of $0.75 per share when it actually produced earnings of $0.87, delivering a surprise of +16%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Exelixis, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $628.69 million for the quarter ended June 2026, missing the Zacks Consensus Estimate by 0.99%. This compares to year-ago revenues of $568.26 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Exelixis shares have added about 27.8% since the beginning of the year versus the S&P 500's gain of 13%. While Exelixis has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Exelixis was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.87 on $659.3 million in revenues for the coming quarter and $3.53 on $2.59 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 44% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Arcturus Therapeutics (ARCT), another stock in the same industry, has yet to report results for the quarter ended June 2026. The results are expected to be released on August 6. This pharmaceutical company is expected to post quarterly loss of $1.07 per share in its upcoming report, which represents a year-over-year change of -214.7%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Arcturus Therapeutics' revenues are expected to be $2.51 million, down 91.1% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Exelixis, Inc. (EXEL) : Free Stock Analysis Report Arcturus Therapeutics Holdings Inc. (ARCT) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

- Total Revenues of $628.7 million, Cabozantinib Franchise U.S. Net Product Revenues of $573.0 million - - GAAP Diluted EPS of $0.82, Non-GAAP Diluted EPS of $0.91 - - Conference Call and Webcast Today at 5:00 PM ET - ALAMEDA, Calif., August 05, 2026--(BUSINESS WIRE)--Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the second quarter of 2026, provided an update on progress toward achieving key corporate objectives, and outlined its commercial, clinical and pipeline development milestones. "Exelixis continues to execute across the key pillars of our business, positioning the company to deliver on our strategic objectives for 2026 and beyond," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. "For zanzalintinib, our next potential franchise molecule, the R&D organization is executing on our priority goals for pivotal data readouts, clinical trial enrollment and new study initiations, while also laying the foundation for the next wave of development opportunities. Additionally, in the second quarter, we saw the continued growth of the cabozantinib franchise while advancing preparations for the potential launch of zanzalintinib in metastatic colorectal cancer, pending approval from regulatory authorities later this year. We are executing on all these initiatives while maintaining disciplined expense management and capital allocation, with a focus on simultaneously investing in R&D and returning capital to shareholders, as well as pursuing opportunistic business development when appropriate." Second Quarter 2026 Financial Results Total revenues for the quarter ended June 30, 2026 were $628.7 million, as compared to $568.3 million for the comparable period in 2025. Total revenues for the quarter ended June 30, 2026 included net product revenues of $573.0 million, as compared to $520.0 million for the comparable period in 2025. The increase in net product revenues was primarily due to an increase in sales volume. Collaboration revenues, composed of license revenues and collaboration services revenues, were $55.7 million for the quarter ended June 30, 2026, as compared to $48.2 million for the comparable period in 2025. The increase in collaboration revenues was primarily related to higher royalty revenues for the sales of cabozantinib outside the U.S. generated by Exelixis’ collaboration partner Ipsen Pharma SAS (Ipsen), partially offset by lower development cost reimbursements earned. Research and development expenses for the quarter ended June 30, 2026 were $212.0 million, as compared to $200.4 million for the comparable period in 2025. The increase in research and development expenses was primarily related to increases in clinical trial costs, manufacturing costs to support our development candidates, and license and other collaboration costs, partially offset by a decrease in personnel expenses. Selling, general and administrative expenses for the quarter ended June 30, 2026 were $147.6 million, as compared to $134.9 million for the comparable period in 2025. The increase in selling, general and administrative expenses was primarily related to increases in marketing activities and personnel expenses. Provision for income taxes for the quarter ended June 30, 2026 was $50.6 million, as compared to $45.6 million for the comparable period in 2025. GAAP net income for the quarter ended June 30, 2026 was $212.1 million, or $0.85 per share, basic and $0.82 per share, diluted, as compared to GAAP net income of $184.8 million, or $0.68 per share, basic and $0.65 per share, diluted, for the comparable period in 2025. GAAP net income per share for the quarter ended June 30, 2026 was favorably impacted by lower weighted-average common shares outstanding for the quarter ended June 30, 2026, as compared to the comparable period in 2025, as a result of the stock repurchase programs. Non-GAAP net income for the quarter ended June 30, 2026 was $237.1 million, or $0.95 per share, basic and $0.91 per share, diluted, as compared to non-GAAP net income of $212.6 million, or $0.78 per share, basic and $0.75 per share, diluted, for the comparable period in 2025. Non-GAAP Financial Measures To supplement Exelixis’ financial results presented in accordance with U.S. Generally Accepted Accounting Principles (GAAP), Exelixis presents non-GAAP net income (and the related per share measures), which excludes from GAAP net income (and the related per share measures) stock-based compensation, adjusted for the related income tax effect for all periods presented. Exelixis believes that the presentation of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors. In particular, Exelixis believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare Exelixis’ results from period to period, and to identify operating trends in Exelixis’ business. Exelixis has excluded stock-based compensation, adjusted for the related income tax effect, because it is a non-cash item that may vary significantly from period to period as a result of changes not directly or immediately related to the operational performance for the periods presented. Exelixis also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions. These non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. Exelixis encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations, to more fully understand Exelixis’ business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release. 2026 Financial Guidance Exelixis is providing the following updated financial guidance for fiscal year 2026. Net product and total revenues guidance do not currently reflect any revenues resulting from a potential U.S. regulatory approval and commercial launch of zanzalintinib for the treatment of patients with previously treated metastatic colorectal cancer (CRC). The U.S. Food and Drug Administration (FDA) is currently reviewing Exelixis' New Drug Application (NDA) for this proposed indication, when used in combination with atezolizumab (Tecentriq®). Cabozantinib Franchise Highlights Net product revenues generated by the cabozantinib franchise in the U.S. were $573.0 million during the second quarter of 2026, with net product revenues of $570.6 million from CABOMETYX® (cabozantinib) and $2.4 million from COMETRIQ® (cabozantinib). Based upon cabozantinib-related net product revenues generated by Exelixis’ collaboration partners, Ipsen and Takeda Pharmaceutical Company Limited, during the quarter ended June 30, 2026, Exelixis earned $53.2 million in royalty revenues. Zanzalintinib GI Highlights Ongoing Regulatory Review of Zanzalintinib in Combination with Atezolizumab for Previously Treated Metastatic CRC and Update on Results from the Non-Liver Metastases (NLM) Subgroup from STELLAR-303. In June 2026, Exelixis announced results from the final analysis of the dual primary endpoint of overall survival (OS) in the NLM subgroup in the phase 3 STELLAR-303 pivotal trial evaluating zanzalintinib in combination with atezolizumab versus regorafenib in previously treated non-microsatellite instability (non-MSI)-high metastatic CRC. The results showed a non-statistically significant trend in OS favoring the combination in the NLM subgroup. As previously announced in June 2025, STELLAR-303 met its other dual primary endpoint, OS in the intention-to-treat population, which included all randomized patients regardless of the presence of active liver metastases. In February 2026, the U.S. FDA accepted the company’s NDA for zanzalintinib, in combination with atezolizumab, for the treatment of patients with metastatic CRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, and, if RAS wild-type, an anti-epidermal growth factor receptor (EGFR) therapy. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026. Phase 3 STELLAR-316 Pivotal Trial Nearing Initiation, in Collaboration with Merck and Natera. Exelixis remains on track to initiate the planned phase 3 STELLAR-316 pivotal trial of zanzalintinib in mid-2026. This Exelixis-sponsored trial will evaluate zanzalintinib, with and without KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) [KEYTRUDA QLEX is marketed outside the U.S. as KEYTRUDA SC™], in patients with resected stage II/III CRC who, following definitive therapy, have tested positive for molecular residual disease (MRD+) and have no radiographic evidence of disease. Natera, a global leader in cell-free DNA and precision medicine, will provide its Signatera™ assay to identify MRD+ patients for trial enrollment. In May 2026, Exelixis announced a clinical development collaboration in which Merck, known as MSD outside of the United States and Canada, will supply KEYTRUDA QLEX injection for subcutaneous administration in combination with zanzalintinib for the trial. The primary endpoint of STELLAR-316 will be disease-free survival, with secondary endpoints including circulating tumor DNA clearance. Enrollment Progress for Phase 2/3 STELLAR-311 Pivotal Trial. Exelixis is continuing to actively enroll patients in the phase 2/3 STELLAR-311 pivotal trial. STELLAR-311 is evaluating zanzalintinib versus everolimus as a first oral therapy in patients with advanced neuroendocrine tumors (NET), regardless of site of origin, who have received up to one prior line of therapy. The primary endpoint of the trial is progression-free survival (PFS) per RECIST 1.1 as assessed by blinded independent central review. Zanzalintinib GU Highlights Topline Results for Phase 3 STELLAR-304 Pivotal Trial Expected in Second Half of 2026. In May 2026, Exelixis announced that the company expects topline results from the STELLAR-304 trial in the second half of 2026, depending on event rates. STELLAR-304 is a phase 3 pivotal trial evaluating zanzalintinib in combination with nivolumab versus sunitinib in previously untreated patients with advanced non-clear cell renal cell carcinoma (nccRCC). The primary endpoints of the trial are PFS as assessed by blinded independent radiology committee and objective response rate (ORR) per RECIST 1.1, with OS as the secondary endpoint. Initiation of Phase 3 LITESPARK-034 Pivotal Trial as Part of Clinical Development Collaboration with Merck. In April 2026, Exelixis’ collaborator Merck initiated LITESPARK-034, a global phase 3 pivotal trial evaluating zanzalintinib in combination with WELIREG® (belzutifan) versus WELIREG and placebo in second-line or later advanced renal cell carcinoma (RCC) patients who have progressed on or after both programmed death-1/ligand 1 (PD-1/L1) and vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFR-TKI) therapies in sequence or in combination. LITESPARK-034 is the second of two Merck-sponsored phase 3 pivotal trials of zanzalintinib and WELIREG in RCC under the companies’ clinical development collaboration. Merck initiated the first trial, LITESPARK-033, in December 2025. LITESPARK-033 is evaluating the combination of zanzalintinib and WELIREG versus cabozantinib in first-line advanced RCC following an immunotherapy administered in the adjuvant setting. Zanzalintinib Development Program Expansion Opportunities Initiation of Phase 2 STELLAR-201 Trial in Recurrent Meningioma. In May 2026, Exelixis announced the initiation of STELLAR-201, a phase 2 trial evaluating zanzalintinib in patients with recurrent Grade I/II/III meningioma with relapse or progression following radiation and/or surgery or those who are not candidates for these therapies. The primary endpoint of the trial is ORR, with secondary endpoints including PFS, duration of response (DOR) and OS. Enrollment is currently ongoing. Pending favorable results, the trial represents an opportunity for zanzalintinib to become the first and only systemic therapy for this form of meningioma, the most common primary intracranial neoplasm for which there are currently no approved systemic therapies. Expansion of Zanzalintinib Clinical Development Program in Squamous Non-small Cell Lung Cancer (NSCLC), Metastatic Bladder Cancer and Metastatic Castration-Resistant Prostate Cancer (mCRPC). Exelixis has additional planned and ongoing zanzalintinib studies across multiple tumor types. These include STELLAR-202, a planned phase 2 trial evaluating zanzalintinib in combination with pembrolizumab in the maintenance setting in squamous NSCLC, as well as expansion cohorts in the ongoing phase 1b/2 STELLAR-002 study. The STELLAR-002 expansion cohorts are evaluating zanzalintinib monotherapy in patients with metastatic bladder cancer who have progressed following treatment with enfortumab vedotin and pembrolizumab, as well as zanzalintinib in combination with docetaxel in mCRPC patients with measurable disease. Both the bladder cancer and mCRPC expansion cohorts in the STELLAR-002 study have been initiated and enrollment is ongoing. Exelixis expects to initiate STELLAR-202 in the second half of 2026. Corporate Highlights Zanzalintinib and Cabozantinib Data Presentations at the 2026 American Society of Clinical Oncology Annual Meeting (ASCO 2026). Zanzalintinib and cabozantinib were the subject of numerous presentations at ASCO 2026, which was held from May 29 through June 2 in Chicago. Notable posters included an analysis of the contribution of atezolizumab to the efficacy of the combination with zanzalintinib in the phase 3 STELLAR-303 trial and results from a subgroup analysis of the phase 3 CABINET pivotal trial evaluating CABOMETYX in patients with previously treated advanced NET. The STELLAR-303 data support the contribution of atezolizumab to the previously observed survival benefits of zanzalintinib in combination with atezolizumab for patients with metastatic CRC. The presentation demonstrated the importance of generating data around the potential impact of anti-drug antibodies on systemic exposures or neutralization of immune checkpoint inhibitor activity, which Exelixis plans to continue to interrogate across all zanzalintinib development opportunities. The results from the CABINET subgroup analysis showed CABOMETYX provided significant improvements in PFS versus placebo in patients with NET regardless of functional status, highlighting the ability of CABOMETYX to delay disease progression for these patients. Stock Repurchase Program (SRP) Update. In the second quarter of 2026, Exelixis repurchased $311.6 million of the company’s stock, at an average price of $47.85 per share, and completed the SRP authorized in October 2025, fulfilling its commitment to purchase a total of $750 million of the company’s stock under the October 2025 SRP before December 31, 2026. In May 2026, Exelixis’ Board of Directors authorized the repurchase of up to an additional $750 million of the company’s outstanding common stock before December 31, 2027 (May 2026 SRP). Exelixis began executing stock repurchases under the May 2026 SRP in the second quarter of 2026. Since Exelixis’ Board of Directors authorized the first SRP in March 2023, Exelixis has repurchased a total of $2.9 billion of the company’s common stock, retiring 93.3 million shares, at an average price of $31.12 per share, as of the end of the second quarter of 2026. Stock repurchases under the May 2026 SRP may be made from time to time through a variety of methods, which may include open market purchases, in block trades, Rule 10b5-1 trading plans, accelerated share repurchase transactions, exchange transactions or any combination of such methods. The timing and amount of any stock repurchases under the program will be based on a variety of factors, including ongoing assessments of the capital needs of the business, alternative investment opportunities, the market price of the company’s common stock and general market conditions. The program does not obligate Exelixis to acquire any amount of its common stock, and may be modified, suspended or discontinued at any time without prior notice. Basis of Presentation Exelixis has adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31. For convenience, references in this press release as of and for the fiscal periods ended July 3, 2026 and July 4, 2025, are indicated as being as of and for the periods ended June 30, 2026 and June 30, 2025, respectively. Conference Call and Webcast Exelixis management will discuss the company’s financial results for the second quarter of 2026 and provide a general business update during a conference call beginning at 5:00 p.m. ET / 2:00 p.m. PT today, Wednesday, August 5, 2026. To access the conference call, please dial (800) 715-9871 (domestic) or (646) 307-1963 (international). The Exelixis conference call ID number is 5587241. To access the live webcast link, log onto www.exelixis.com and proceed to the Event Calendar page under the Investors & News heading. A webcast replay of the conference call will be archived on www.exelixis.com for one year. About Exelixis Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules and biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our pipeline of franchise molecules, including our novel oral kinase inhibitor zanzalintinib, and to extend the impact of our flagship commercial product, CABOMETYX® (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit www.exelixis.com, follow @ExelixisInc on X (Twitter), like Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis’ plans and ability to execute and deliver on its strategic objectives for 2026 and beyond; Exelixis’ belief in zanzalintinib as its next potential franchise molecule; Exelixis’ focus on investing in R&D, returning capital to shareholders, and pursuing opportunistic business development; Exelixis’ goals and clinical development plans for zanzalintinib, including the anticipated timing for pivotal data milestones for STELLAR-304 and plans to initiate additional zanzalintinib trials, including STELLAR-202 and STELLAR-316; Exelixis’ belief that STELLAR-201 represents an opportunity for zanzalintinib to become the first and only systemic therapy for recurrent Grade I/II/III meningioma; complexities and the unpredictability of the regulatory review and approval process with respect to Exelixis’ NDA for zanzalintinib for the treatment of patients with previously treated metastatic CRC, when used in combination with atezolizumab, including the risk that the FDA may not approve zanzalintinib as a treatment for metastatic CRC in a timely fashion, if at all; Exelixis’ updated FY 2026 financial guidance; the timing, amount, and completion of any stock repurchase programs; Exelixis’ scientific pursuit to create transformational treatments that give more patients hope for the future; and other statements that are not historical facts. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the degree of market acceptance of CABOMETYX and other Exelixis products in the indications for which they are approved and in the territories where they are approved, and Exelixis’ and its partners’ ability to obtain or maintain coverage and reimbursement for these products; the effectiveness of CABOMETYX and other Exelixis products in comparison to competing products; complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere; the level of costs associated with Exelixis’ commercialization, research and development, in-licensing or acquisition of product candidates, and other activities; Exelixis’ ability to maintain and scale adequate sales, marketing, market access and product distribution capabilities for its products or to enter into and maintain agreements with third parties to do so; the availability of data at the referenced times; the potential failure of cabozantinib, zanzalintinib and other Exelixis product candidates, both alone and in combination with other therapies, to demonstrate safety and/or efficacy in clinical testing; uncertainties inherent in the drug discovery and product development process; Exelixis’ dependence on its relationships with its collaboration partners, including their pursuit of regulatory approvals for partnered compounds in new indications, their adherence to their obligations under relevant collaboration agreements and the level of their investment in the resources necessary to complete clinical trials or successfully commercialize partnered compounds in the territories where they are approved; Exelixis’ continuing compliance with applicable legal and regulatory requirements; unexpected concerns that may arise as a result of the occurrence of adverse safety events or additional data analyses of clinical trials evaluating cabozantinib, zanzalintinib and other Exelixis product candidates; Exelixis’ dependence on third-party vendors for the development, manufacture and supply of its products and product candidates; Exelixis’ ability to protect its intellectual property rights; market competition, including the potential for competitors to obtain approval for generic versions of Exelixis’ marketed products; changes in economic and business conditions, including as a result of changing trade policies and tariffs and the related uncertainty thereof; and other factors detailed from time to time under the caption "Risk Factors" in Exelixis’ most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and in Exelixis’ other future filings with the Securities and Exchange Commission. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law. Exelixis, the Exelixis logo, CABOMETYX and COMETRIQ are registered U.S. trademarks of Exelixis, Inc. TECENTRIQ (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group. WELIREG®, KEYTRUDA QLEX™ and KEYTRUDA SC™ are registered trademarks of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA. View source version on businesswire.com: https://www.businesswire.com/news/home/20260804452015/en/ Contacts Chris Senner Chief Financial Officer Exelixis, Inc. 650-837-7240 [email protected] Andrew Peters SVP, Strategy & Investor Relations Exelixis, Inc. 650-837-7248 [email protected]