EXEL - NASDAQ
Exelixis, Inc.
EXEL·NASDAQ
$51.60
+6.3%HealthcareBiotechnology
Exelixis, Inc., an oncology-focused biotechnology company, focuses on the discovery, development, and commercialization of new medicines to treat cancers in the United States. The company's products include CABOMETYX tablets for the treatment of patients with advanced renal cell carcinoma who received prior anti-angiogenic therapy; and COMETRIQ capsules for the treatment of patients with progressive and metastatic medullary thyroid cancer. Its CABOMETYX and COMETRIQ are derived from cabozantinib, an inhibitor of multiple tyrosine kinases, including MET, AXL, RET, and VEGF receptors. The company also offers COTELLIC, an inhibitor of MEK as a combination regimen to treat advanced melanoma; and MINNEBRO, an oral non-steroidal selective blocker of the mineralocorticoid receptor for the treatment of hypertension in Japan. In addition, it is developing XL092, an oral tyrosine kinase inhibitor that targets VEGF receptors, MET, AXL, MER, and other kinases implicated in growth and spread of cancer; XB002, an antibody-drug conjugate composed of human mAb against tissue factor (TF) for the treatment of advanced solid tumors; XL102, an orally bioavailable cyclin-dependent kinase 7 (CDK7) inhibitor for the treatment of advanced or metastatic solid tumors; and XB002 for the treatment of non-hodgkin's lymphoma. Exelixis, Inc. has research collaborations and license agreements with Ipsen Pharma SAS; Takeda Pharmaceutical Company Ltd.; F. Hoffmann-La Roche Ltd.; Redwood Bioscience, Inc.; R.P. Scherer Technologies, LLC; Catalent Pharma Solutions, Inc.; NBE Therapeutics AG; Aurigene Discovery Technologies Limited; Iconic Therapeutics, Inc.; Invenra, Inc.; StemSynergy Therapeutics, Inc.; Genentech, Inc.; Bristol-Myers Squibb Company; and Daiichi Sankyo Company, Limited. The company was formerly known as Exelixis Pharmaceuticals, Inc. and changed its name to Exelixis, Inc. in February 2000. Exelixis, Inc. was incorporated in 1994 and is headquartered in Alameda, California.
At a Glance
Live SnapshotMarket Cap$12.97B
EPS2.8800
P/E Ratio17.92
Earnings Date07/27/2026
Earnings Call Transcript
EXEL • 2026 • Q1
Operator
Day, ladies and gentlemen, welcome to the Exelixis First Quarter 2026 Financial Results Conference Call. My name is Sheree, and I'll 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, Sheree, and thank you all for joining us for the Exelixis First Quarter 2026 Financial Results Conference Call. Joining me on today's call are Mike Morrissey, our President and CEO, Chris Senner, our Chief Financial Officer, Dana Aftab, our Executive Vice President of Research and Development, and P.J. Haley, our Executive Vice President, Commercial, who will review our progress for the first quarter 2026 ended March 31st, 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.
Andrew Peters
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.
Andrew Peters
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 discovery, product development, business development, and commercialization activities. With that, I'll turn the call over to Mike.
Mike Morrissey
All right. Thank you, Andrew, and thanks to everyone for joining us on the call today. Exelixis is off to a strong start in 2026 with meaningful progress across our discovery, development, and commercial activities. Our strategy has a singular focus to build a multi-franchise business in solid tumor oncology focused on GU and GI histologies based on the depth of the cabozantinib business, the potential breadth of the zanzalintinib opportunity, and the scope of our early-stage pipeline. Key highlights for the quarter include, first, we saw continued strong performance of the cabozantinib business in the first quarter of 2026. CABOMETYX continued to grow in revenue, demand, and market share as the leading TKI for RCC and the market leader for neuroendocrine tumors in the oral second-line plus segment.
Mike Morrissey
Importantly, we expedited the build-out of our GI sales team in the first quarter to accelerate the growth of the CABOMETYX net opportunity before
Mike Morrissey
The NDA for the
Mike Morrissey
Fourth, finally, we remain committed to running the business at the highest level of efficiency as we advance our R&D priorities and at the same time generate substantial free cash to invest in the pipeline through the right targeted BD at the right price to access external sources of innovation and to continue our share repurchase program, including an additional $750 million that was just authorized by the Exelixis board. With that, see our press release issued an hour ago for our first quarter 2026 financial results and an extensive list of key corporate milestones achieved in the quarter. I'll now turn the call over to Chris.
Chris Senner
Thanks, Mike. For the first quarter 2026, the company reported total revenues of approximately $611 million, which included cabozantinib franchise net product revenues of $555 million. CABOMETYX net product revenues were $552.8 million and included approximately $3.6 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 first quarter of 2026 was 30.2%, which is higher than the gross to net we experienced in the fourth quarter of 2025.
Chris Senner
This increase in gross to net deductions in the first quarter of 2026 is primarily related to higher 340B volume, higher Medicare Part D discounts and rebates, and higher co-pay assistance when compared to the fourth quarter of 2025. Our CABOMETYX trade inventory was slightly lower at 2.1 weeks on hand at the end of the first quarter of 2026 when compared to the fourth quarter of 2025. Total revenues in the first quarter of 2026 also includes approximately $45.9 million in royalties earned from our partners, Ipsen and Takeda, on their sales of cabozantinib. Our total operating expenses for the first quarter of 2026 were approximately $359 million compared to $363 million in the fourth quarter of 2025.
Chris Senner
The sequential decrease in these operating expenses was primarily driven by lower clinical trial costs, offset by higher FT-related costs and stock-based compensation expense. Provision for income taxes for the first quarter of 2026 was approximately $57.2 million, compared to a provision for income taxes of approximately $8.2 million for the fourth quarter of 2025. This increase in tax provision was related to certain items that were recognized in the fourth quarter of 2025. Company reported GAAP net income of approximately $210.5 million, or $0.81 per share basic and $0.79 per share diluted for the first quarter of 2026. The company also reported a non-GAAP net income of approximately $232.8 million, or $0.90 per share basic and $0.87 per share diluted.
Chris Senner
Non-GAAP net income excludes the impact of approximately $22.3 million of stock-based compensation expense net of the related income tax effect. Cash and marketable securities for the quarter ended March 31, 2026 was approximately $1.4 billion. During the first quarter of 2026, we repurchased approximately $430.8 million of the company's outstanding common stock, resulting in the retirement of approximately 10 million shares of the company's outstanding common stock at an average price per share of $42.99. As of the end of the first quarter of 2026, we had approximately $159.4 million remaining under the $750 million stock repurchase plan authorized by the company's board in October 2025.
Chris Senner
We expect to complete the October 2025 stock repurchase plan this month. Additionally, in May 2026, the company's board authorized a new $750 million stock repurchase plan that expires on December 31, 2027. Finally, we are reiterating our full-year 2026 financial guidance, which is detailed on slide 16 of our earnings presentation. With that, I'll turn the call over to P.J.
P.J. Haley
Thank you, Chris. The CABOMETYX business continued to grow in the first quarter of 2026. The team is executing at an extremely high level, with CABOMETYX continuing to be the number one prescribed TKI in renal cell carcinoma, the number one TKI plus IO combination in first line RCC, and the number one oral agent in second line plus neuroendocrine tumors. Importantly, Q1 had the highest number of new patient starts in a quarter ever for CABOMETYX, representing strong momentum in the business. At the same time, CABOMETYX plus nivolumab had the highest quarterly first-line RCC market share to date. This is an exciting time for the team with zanzalintinib on the horizon as we prepare to launch our next franchise molecule, which would also expand the Exelixis GI franchise.
P.J. Haley
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 Q1 2025 to Q1 2026, CABOMETYX grew 3 share points from 44% to 47%. Additionally, CABOMETYX TRX volume grew 14% in Q1 2026 compared to Q1 2025, outpacing the growth rate of the market basket, which was 7% for the same period.
P.J. Haley
Physicians are responding positively to the broad net label and the contemporary trial design and perceive the efficacy and tolerability of CABO as favorable relative to other small molecule therapies in the space. Academic and community prescribers are using CABO broadly across patient and tumor characteristics, including patients with neuroendocrine tumors arising in the pancreas, GI tract, and lung, across all tumor grades, functional and SSTR status, and those who have received prior treatment with LUTATHERA. Turning to new patient market share for second-line plus neuroendocrine tumors in the first quarter, we are pleased that CABOMETYX remains the market leader in the oral therapy segment. Additionally, our research indicates that there is opportunity to continue to grow market share, particularly in the community.
P.J. Haley
For that reason, we expedited the expansion of our GI sales team in Q1. The team was in the field providing greater reach into the community in order to continue to grow net market share for CABOMETYX. Our new representatives joined us with significant oncology sales experience, particularly colorectal cancer and GI oncology. Importantly, the expanded team will be able to 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 the PDUFA date set for later this year. Pending regulatory approval, we believe that these data would provide Exelixis with a compelling commercial opportunity in one of the big four tumors.
P.J. Haley
The third-line plus CRC setting consists of approximately 23,000 patients in the U.S. and represents an overall market opportunity of approximately $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 medical need for patients in the third-line plus CRC setting and are excited for the potential to have an ICI option available for the broader population of CRC patients. In closing, we are pleased with the growth of the CABO business both in RCC and NETS. In neuroendocrine tumors, prescribers see CABOMETYX as a more favorable choice versus other previously approved generic small molecule therapies. Simultaneously, our internal team is in full launch preparation for
P.J. Haley
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
Dana Aftab
Thanks, P.J. Our strategy in R&D continues to focus on developing
Dana Aftab
From our standpoint, the review has been proceeding on schedule toward the PDUFA date in early December. As a quick reminder, the trial has dual primary endpoints designed to assess overall survival, both in the broad intention to treat or ITT population, which includes patients both with and without liver metastases, as well as more specifically in the population of patients without liver metastases, which we refer to as the NLM patients or population. The study met one of its dual primary endpoints, demonstrating a 20% reduction in the risk of death with the combination in the broad ITT population at the final analysis. While data pertaining to the other dual primary endpoint of overall survival in the NLM population showed a trend in overall survival favoring the combination.
Dana Aftab
The NLM data were immature at the data cutoff. The trial has been proceeding to the planned final analysis for this endpoint. We continue to expect to have those top-line results around the middle of this year, depending on event rates. The level of excitement here is really high right now about what a potential approval would mean for this large and underserved patient population. As you heard from P.J., our preparations for launch are in full swing. We'll be ready to go the moment we receive a positive decision. As we've discussed since late last year, we believe there is significant additional franchise potential for
Dana Aftab
To realize that potential, our team has been highly focused on launching the STELLAR-316 trial, which will investigate
Dana Aftab
As we've communicated in the past, MRD in STELLAR-316 will be determined with the Signatera circulating tumor DNA test with Natera as our diagnostic partner. Their database, built from testing thousands of patients each year, has been incredibly helpful to us in terms of prioritizing activation of clinical trial sites that are already known to have the highest cadence of testing and the highest numbers of eligible patients. We're quite pleased with the level of enthusiastic feedback on STELLAR-316 that we've gotten from key opinion leaders and other stakeholders, and we are on track for initiating the trial around mid-year. Moving on to kidney cancer,
Dana Aftab
STELLAR-304 is our first pivotal trial for
Dana Aftab
In terms of opportunities in the clear cell RCC space, progress continues with regard to the two pivotal studies that Merck is running in clear cell RCC, evaluating
Dana Aftab
As we've mentioned previously, we continue to have discussions with potential collaborators to investigate novel combinations pairing
Dana Aftab
That study was initiated last year. We have been quite pleased by the speed of enrollment in the trial. In fact, we are now far ahead of our initial enrollment projections. The sites and investigators are very enthusiastic about the trial, given their growing experience with CABO in later-line disease and the opportunity presented by STELLAR-311 to improve on the current treatment landscape in earlier lines, which hasn't seen anything new for over a decade. That enthusiasm appears to be driving the very strong momentum we're seeing in the trial. Another opportunity for
Dana Aftab
Importantly, there are no approved systemic therapies for meningioma that's refractory to local therapies, so this represents a very high unmet need in neuro-oncology. Today, we announced that we have now initiated STELLAR-201, our phase II trial evaluating
Dana Aftab
Today, we also announced two additional studies exploring
Dana Aftab
We're also planning an additional expansion cohort in the ongoing STELLAR-002 study to evaluate
Dana Aftab
Shifting to our early clinical pipeline, we have four molecules in this space that are currently in clinical development, namely XL309, XB010, XB628, and XB371. The phase I studies for these early molecules are progressing well. In terms of earlier stage development candidates, we are continuing to advance exciting new small molecule and ADC programs, I look forward to sharing more details as these early pipeline programs advance. Our strategy with the early pipeline is focused on identifying the next potential franchise molecules beyond CABO and
Mike Morrissey
All right. Thanks, Dana. I will wrap up here by thanking the entire Exelixis team for their outstanding efforts in the first months of 2026. We think 2026 could be a potentially transformational year for the company, and everyone at Exelixis is working together to move the needle for cancer patients and continue building value for all our stakeholders. We are focused on growing the CABO business, at the same time advancing
Mike Morrissey
As always, I wanna thank everyone at Exelixis for their individual and collective efforts, great teamwork, and positive energy as you work every day to exceed expectations 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. We're happy to now open the call for questions.
Operator
Our first question will come from the line of Paul Choi with Goldman Sachs. Your line is open.
Paul Choi
Thank you. Good afternoon, and thanks for taking the question. My question is for Dana, in light of the recent miss from the LITESPARK-012 study, can you maybe just comment on your thoughts on updated thoughts or learnings from that trial result for your belzutifan plus
Dana Aftab
Sure. Thanks for the question, Paul. First of all, you know, our strategy with
Dana Aftab
We have the STELLAR-304 data coming out hopefully soon in non-clear cell renal cell carcinoma. As I mentioned earlier, we're evaluating another number of other potential novel and innovative combinations to further explore the clear cell RCC space. That includes molecules from our own early pipeline. If XB628, which is our novel and innovative bispecific with multiple IO arms on it, pans out, that could be a very interesting combination to explore in these patients. It would be very innovative and nothing in that space has been explored so far. As Mike said earlier, we have multiple shots on goal to really establish and drive the
Operator
One moment for our next question. That will come from the line of Yaron Werber with TD Cowen. Your line is open.
Yaron Werber
Hi, team. Congrats on the quarter, thanks so much for the question. Just two quick questions from us. One, if you could please provide some color on the contribution in renal cell carcinoma versus NET for CABO. Second, I recall that CABO failed as a monotherapy in advanced unselected non-small cell lung cancer and also on OS in phase III for pancreatic, even though it showed a response in PFS. You touched on some of the combo regimens that have shown early data, but could you maybe expand on the rationale for testing combo therapies in STELLAR-202 and STELLAR-002? Thank you.
Mike Morrissey
Yeah, Dana, why don't you take that second question first? I think she was talking about prostate cancer. What's the rationale for going into phase II in non-small cell and then prostate cancer?
Dana Aftab
Sure. You know, as I mentioned, the data that support our hypothesis for testing zanzalintinib in patients with non-small cell lung cancer comes from the CONTACT-01 study, which I think you're referring to. This is the phase III study evaluating cabozantinib plus atezolizumab versus docetaxel in a broad population of non-small cell lung cancer patients. In that study, the subpopulation of patients with squamous histology actually did quite well, appeared to have a favorable benefit compared to the control arm in the study. For that reason, the STELLAR-202 trial is focused 100% on the squamous patient population with non-small cell lung cancer.
Dana Aftab
In this population, the current standard of care is platinum-based chemotherapy plus pembrolizumab during induction, which is up to four cycles of chemotherapy or 12 weeks, and then they go on pembrolizumab maintenance. We are looking to add zanzalintinib onto the maintenance arm of pembrolizumab. We've already shown that
Dana Aftab
In the small phase I, however, we saw very, I'd say favorable outcomes in the patients that were treated in this small study. Based on the results from that, we believe there is rationale to pursue that combination in the phase I STELLAR-002 trial. Once we get data showing safety and potentially activity of that combination, that opens up a lot of different avenues of exploration, either in castration-resistant prostate cancer, potentially in lung cancer, and potentially in other indications where either chemo or chemo-based therapies, including ADCs, might be standard of care.
Operator
Thank you. One moment for our next question. That will come from the line of Sudan Loganathan with Stephens. Your line is open.
Sudan Loganathan
Hi. Thank you for taking my question. My first one, I wanted to get your comments on the quantifiable metrics regarding CABO sales in NET and how the maybe sales team has grown over this time and how it will continue to. Secondly, on
Mike Morrissey
Great. Thanks. P.J., you wanna take that one?
P.J. Haley
Yeah, thanks for the question. You know, with regards to NET, we are really pleased with how the business is going. As I mentioned, you know, overall in the first quarter, we had our highest new patient starts ever for CABOMETYX in a quarter. That's certainly, you know, a really strong sign of the health of the business now. As those new patient starts, you know, ultimately translate to refills going forward, puts us in a really good position. Our business in NET is broad, as I mentioned in the prepared remarks, really across all segments, and is viewed very favorably by physicians. Importantly, you know, we are the market leader in the second-line plus oral segment.
P.J. Haley
Our research and feedback really indicate that we have opportunity to continue to grow, particularly in the community setting, which is why we expedited the build-out of our GI sales force, so we could really have that deeper reach into the community and drive further business there. I'm really pleased to say that, you know, as I mentioned, we brought in a very strong team with GI and CRC experience in sales, and we're really already seeing impact from that team. We're very, very pleased with that. You know, importantly, you know, that team gets here and gets a chance to know the customers in the GI segment.
P.J. Haley
Gets experience selling CABO and a TKI, which is fantastic. As we think about looking forward, you know, to the potential approval of
P.J. Haley
Really, the way we're thinking about
Dana Aftab
Sure. Thanks for the question, Catherine. Regarding 304, again, this is our phase III study comparing zanzalintinib combined with nivolumab versus sunitinib. As such, it really is the first phase III trial to address this high unmet need patient population. Currently, there is no level one evidence supporting a standard of care in these patients. We see a huge opportunity here for the combination of
Operator
One moment for our next question. That will come from the line of Andy Hsieh with William Blair. Your line is open.
Andy Hsieh
Oh, great. Thanks for taking our question. Talking about STELLAR-316 for a little bit, there's an ad comm recently that kind of talks about a progression, definition of progression or change of therapy that's based on non-radiographic progression. For the adjuvant CRC study, I'm just curious about the back and forth with the FDA agreeing on an MRD positivity as a way to change therapy. To educate us on what the dialogue was and then, and how you come to the conclusion that this is actually a regulatory approvable approach. Thank you.
Mike Morrissey
Thanks, Andy. Dana, wanna take that one?
Dana Aftab
Thanks for the question, Andy. You know, we've discussed the STELLAR-316 trial, I think, since December last year. We're super excited about this study because it really addresses a high unmet need population. This is the population of patients who are resected stage II or III colorectal cancer, have completed definitive therapy and now are in a watch and wait game, to wait and see if they develop late-stage disease. The Signatera test has shown in a number of different studies with a high degree of accuracy predict rapid progression of patients. The patients who are positive for the test typically have a median disease-free survival of around six months. It's a very high unmet need population.
Dana Aftab
The trial has been well-designed with, I'd say a large degree of input from key opinion leaders, other stakeholders, as well as the Agency. We're very confident in our design, and we're really excited to release more details as we get closer to launch. When we do, you'll see a lot more design characteristics of the study, especially when it gets posted to clinicaltrials.gov. Just stay tuned for more information.
Operator
One moment for our next question. That will come from the line of Michael Schmidt with Guggenheim. Your line is open.
Michael Schmidt
Hey, guys. Thanks for taking my question. I had a question on RCC and just wanted to understand the size of the opportunity for the LITESPARK-033 study. You know, what percent of patients would be qualified for this? You know, beyond LITESPARK-033 and LITESPARK-034, are there any other studies you're considering for RCC specifically with zanzalintinib? Thanks so much.
Mike Morrissey
Thanks, Michael. P.J.?
P.J. Haley
Sure. Thanks for the question. You know, with regards to, you know, LITESPARK-033, as we've talked about here, we're really thinking about RCC broadly as establishing
P.J. Haley
Kind of drawing off our experience from CABO, how we did multiple studies in RCC to really establish ourselves as, you know, the leader, the leading TKI, in the 20s here. We're building towards our vision of establishing
Operator
One moment for our next question. That will come from the line of Sylvan Turcan with Citizens. Your line is open.
Sylvan Turcan
Yeah, good afternoon, and thanks for taking my question. I just want to ask a little bit broader around your strategy around resource allocation. You're running one of the broadest development strategies for an unapproved drug at this moment, and you even expanded now. Obviously you're sitting on a lot of data that, you know, we don't see, but that clearly make you very excited on
Mike Morrissey
Yeah. Sylvan, thanks for the question. Chris, want to take that one?
Chris Senner
Yeah. Sylvan, thanks for the question. You know, from a capital allocation perspective, and that's how we look at it, is, you know, how do we allocate capital against R&D? How do we allocate capital against BD opportunities, and how do we allocate capital against share repurchases? You know, we're a financially strong company. We have significant cash flows. You know, we're prioritizing our R&D spend on a constant basis so that we're understanding what, you know, what projects are kind of sticking their heads up and saying, you know, "Fund us." We'll continue to do that. You know, Andrew and Steph on the team are continuing to look at BD opportunities. You know, we do have access to capital also.
Chris Senner
We have a lot of things going on here that allows us to, you know, to execute on all those three elements of R&D investments, BD investments, and share buybacks. From a share buyback perspective, we believe that
Mike Morrissey
Yeah. Dana, go ahead.
Dana Aftab
Sure. You know, LITESPARK-034 is Merck's study. As you mentioned, it's evaluating
Dana Aftab
Regarding the population, you know, this study as well as many other studies that are ongoing now or planned for the future really anticipate multiple potential treatment landscapes for patients. This is really in the landscape of patients who are really gonna be candidates for belzutifan alone, or belzutifan in combination with a TKI. These are, you know, typically, again, patients who have already progressed on a TKI-containing regimen and an IO-containing regimen. That really should be an important opportunity, important unmet need when this trial reads out.
Operator
One moment for our next question. That will come from the line of Leonid Timashev with RBC. Your line is open.
Leonid Timashev
Hey, guys. Thanks for taking my question. I want to stick with the franchise approach by 2030 that you've been talking about. I mean, you've mentioned CRC. I wanted to focus on NET and how you're thinking about the franchise there in the future. I mean, you're running STELLAR-311, but are there any other combinations that you're looking at, especially as that treatment landscape evolves with radiopharmaceuticals, ADCs? I mean, how are you envisioning building out
Mike Morrissey
Yeah, thanks for the question. Why don't we tag team this? P.J., why don't you go first, and then Dana can add some commentary.
P.J. Haley
Thanks for the question, Leonid. You know, with regards to kind of the way we're thinking about STELLAR-311, I guess, in the marketplace, you know, as I mentioned, CABO's off to a really strong start in terms of kind of the second-line plus setting. That study is designed specifically to go head-to-head with everolimus as an active comparator, which is kind of a first in the setting. Really positioning that patient population in the first or second line setting, so earlier lines of therapy. Obviously, you know, then a larger patient population, and really, you know, potential to beat an active comparator head-to-head. A lot of excitement around the study design, as Dana mentioned in his prepared remarks. We're excited about that
Dana Aftab
Yeah. Beyond that, I'd say that we are, you know, I think we've mentioned this before. We're very committed to this patient population. We've seen how much benefit CABO is bringing to the table for these patients. We've seen the excitement around STELLAR-311, we're really focused on how else we can really address this patient population. I think as we discussed at R&D Day, we're also looking at a number of other potential opportunities earlier in the discovery pipeline to either address the, specifically the neuroendocrine tumor patients who require treatment also with an SSTR2 agonist. These are mainly patients with functional tumors, but any other patients who express the receptor and are known to be potentially sensitive to that type of treatment.
Dana Aftab
We're developing a small molecule that we hope to file an IND on later this year. That could be a novel approach to offer in combination with
Dana Aftab
It's a very small format with a topoisomerase inhibitor payload that we think is differentiated versus the other competitive molecules that are in the space right now. That molecule can be quite exciting once we generate some data. If it does stand up and show some interesting activity, there we can also explore combinations with
Operator
One moment for our next question. Our next question will come from the line of Kalpit Patel with Wolfe Research. Your line is open.
Kalpit Patel
Yeah. Hey, good afternoon, and thanks for taking the questions. Maybe one on the LITESPARK-012 trial. There was no benefit of the triplet there, compared to the doublets in that first line setting. I guess for your, and Merck's strategy, would you ever entertain a triplet in that exact same first line setting or, you know, what would that future study look like in ccRCC?
Mike Morrissey
Go ahead.
Dana Aftab
Yeah, I'll take the question, Kalpit. Thanks, thanks for the question. You know, as you know, we are collaborating with Merck on LITESPARK-033, which is evaluating
Dana Aftab
As I mentioned in my prepared remarks, we have been looking at a lot of orthogonal MOAs to pair with zanzalintinib in this space, as well as, you know, we're actually going to be investigating the combination of
Mike Morrissey
Dana, go ahead.
Dana Aftab
Sure. Thanks for the question. Regarding the STELLAR-303 trial, as I mentioned, we are on track to see those results of the non-liver metastasis subgroup, the primary endpoint that's focused on that subgroup, around mid-year this year. We're still on track for that. You know, regarding the data and sharing with the FDA, you know, we certainly plan to share those data as well as any other data that the agency might ask for as part of the ongoing review. Again, as I mentioned from our standpoint, that review is progressing on schedule toward the PDUFA date in early December.
Operator
One moment for our next question. That will come from the line of Ashish Verma with UBS. Your line is open.
Ashish Verma
Oh, hi. Yeah, I wanted to just get the latest thoughts on CABOMETYX competitiveness in RCC. Just given the we saw earlier the LITESPARK-022 study that had a PFS positive. Do you think it's unlikely to show OS separation because there isn't enough sample attributed to that analysis? Thanks.
Mike Morrissey
P.J.?
P.J. Haley
Yeah, thanks for the question. You know, I think we're really pleased with where we are competitively in RCC. Generally, I wouldn't wanna speculate on, you know, how other trials continue to read out their data. What I'll say is, you know, kinda as we talked about earlier, building a franchise, we've done so many studies in RCC that we have strength of the business really in every segment.
P.J. Haley
We saw this quarter the highest frontline market share for CABOMETYX plus nivolumab in the first line setting, which we're very pleased with. We continue to see strong momentum there in the first line setting, given the just sort of the breadth and depth of the data and also the experience that prescribers have using this combination now for so many years. We see potential to continue, growing in RCC and particularly in the first line setting.
Operator
At this time, there are no further questions. I will turn the call over to today's host, Andrew Peters. Mr. Peters?
Andrew Peters
Yeah, thank you, Sheree, 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. Thank you all again, and have a great rest of your week.
Transcript from May 5, 2026
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Related Guides
Continue your EXEL research with focused valuation guides.
Research Paths
1
Snapshot
Start with context, operating signals, and key market metrics.
2
Value Model
Stress test fair value across bear, base, and bull assumptions.
3
Statements
Validate revenue quality, margins, and balance sheet durability.
4
Earnings Call
Read management commentary and compare it with reported outcomes.
5
Dividends
Check payout sustainability and long-term distribution behavior.
6
Analyst Expectations
Review consensus spread and where estimate risk is concentrated.