Exelixis Q1 Earnings Call Highlights

Key Points

• CABOMETYX commercial momentum accelerated in Q1 with record new patient starts, TRx share rising from 44% to 47% year‑over‑year and an expanded GI sales force to support a potential zanzalitinib colorectal cancer launch.
• Exelixis reported approximately $611 million in Q1 revenue (cabozantinib franchise net product revenues ~$555 million), ended the quarter with ~$1.4 billion in cash and marketable securities, repurchased ~$430.8 million of stock, and authorized a new $750 million buyback program.
• The zanzalitinib NDA for third‑line‑plus CRC is under FDA review with a PDUFA in early December after STELLAR‑303 showed a 20% reduction in risk of death in the ITT population, and multiple pivotal trials across CRC, RCC, NETs and other indications are advancing.

Exelixis NASDAQ: EXEL executives highlighted continued momentum for its cabozantinib franchise and provided updates on the expanding development program for zanzalitinib during the company’s first-quarter 2026 earnings call.

Cabozantinib revenue grows as Exelixis expands GI commercial footprint

President and CEO Mike Morrissey said the company is “off to a strong start in 2026,” pointing to “continued strong performance of the cabozantinib business” and progress toward building a multi-franchise oncology company focused on genitourinary (GU) and gastrointestinal (GI) cancers.

Morrissey said CABOMETYX continued to grow in “revenue, demand, and market share” and described it as the leading tyrosine kinase inhibitor (TKI) for renal cell carcinoma (RCC) and the market leader in oral second-line-plus neuroendocrine tumors (NETs). He also said Exelixis expedited the build-out of its GI sales team during the quarter to “accelerate the growth of the CABOMETYX net opportunity” ahead of a potential zanzalitinib colorectal cancer (CRC) launch later in 2026.

EVP of Commercial P.J. Haley said the first quarter delivered the “highest number of new patient starts in a quarter ever for CABOMETYX.” He added that CABOMETYX plus nivolumab posted its highest quarterly first-line RCC market share to date. Haley also cited prescription trends across an oral TKI “market basket” (cabozantinib, lenvatinib, axitinib, sunitinib, and pazopanib), saying CABOMETYX total prescriptions (TRx) share rose from 44% to 47% year-over-year, while TRx volume increased 14% compared to 7% growth for the overall market basket.

In NETs, Haley said CABOMETYX is being used broadly across tumor origins and characteristics, including pancreatic, GI tract, and lung NETs, and in patients previously treated with LUTATHERA. He said Exelixis sees additional opportunity to grow share, “particularly in the community,” which drove the accelerated GI sales force expansion. Haley noted the new representatives brought oncology sales experience, “particularly colorectal cancer and GI oncology,” and the team will gain experience selling CABOMETYX ahead of a potential zanzalitinib launch.

Financial results: $611M in revenue, $1.4B in cash and marketable securities

EVP and CFO Chris Senner reported total first-quarter 2026 revenues of approximately $611 million, including cabozantinib franchise net product revenues of $555 million. CABOMETYX net product revenues were $552.8 million, including about $3.6 million in clinical trial sales, which Senner said have “historically been choppy between quarters.”

Senner said gross-to-net for the cabozantinib franchise was 30.2%, higher than the fourth quarter of 2025, driven primarily by higher 340B volume, higher Medicare Part D discounts and rebates, and higher co-pay assistance. Trade inventory ended the quarter at 2.1 weeks on hand, slightly lower than the prior quarter. Exelixis also recorded approximately $45.9 million in royalties from partners Ipsen and Takeda on their cabozantinib sales.

Total operating expenses were approximately $359 million, compared to $363 million in the fourth quarter of 2025, with Senner attributing the sequential decline primarily to lower clinical trial costs, offset by higher full-time related costs and stock-based compensation. The company posted GAAP net income of approximately $210.5 million, or $0.81 per basic share and $0.79 per diluted share. Non-GAAP net income was approximately $232.8 million, or $0.90 per basic share and $0.87 per diluted share, excluding about $22.3 million of stock-based compensation expense net of tax effects.

Exelixis ended the quarter with approximately $1.4 billion in cash and marketable securities. The company repurchased approximately $430.8 million of common stock in the quarter, retiring about 10 million shares at an average price of $42.99. Senner said Exelixis expects to complete its October 2025 $750 million buyback plan in May and that the board has authorized a new $750 million repurchase plan expiring December 31, 2027. Senner also reiterated full-year 2026 guidance, referring listeners to slide 16 of the earnings presentation.

Zanzalitinib NDA in CRC under FDA review; additional pivotal trials advance

Morrissey described zanzalitinib (“ZANZA”) as Exelixis’ next potential oncology franchise, noting the NDA for zanzalitinib plus atezolizumab in third-line-plus CRC based on STELLAR-303 is under review and “the top priority for the entire Exelixis organization.”

EVP of Research and Development Dana Aftab said the review is proceeding on schedule toward a PDUFA date in early December. He explained STELLAR-303 has dual primary overall survival endpoints: one in the broad intention-to-treat (ITT) population and one in patients without liver metastases (NLM). Aftab said the study met one dual primary endpoint, showing a 20% reduction in risk of death in the ITT population at the final analysis. The NLM endpoint showed a trend favoring the combination, but the data were “immature” at the cutoff; Exelixis expects top-line results for the planned final analysis around mid-year, depending on event rates. In response to an analyst question, Aftab said the company plans to share NLM results with the FDA as part of the ongoing review.

Haley framed the third-line-plus CRC setting as about 23,000 patients in the U.S. and an estimated $1.5 billion market opportunity “in terms of contemporary pricing,” adding that market research and advisory boards showed positive physician feedback and highlighted unmet need for broader ICI options in CRC.

Pipeline expansion: RCC, NETs, meningioma, and exploratory lung and prostate studies

Executives emphasized the breadth of the zanzalitinib development effort, with Morrissey saying the company aims to establish it as “the TKI of choice in the 2030s for RCC and other important indications.” He cautioned that improving on existing first-line RCC regimens is difficult and requires careful selection of combination partners to manage efficacy and tolerability.

Aftab provided updates across multiple programs:

• STELLAR-316 (adjuvant-style CRC trial): Exelixis plans to initiate this phase III study around mid-year in resected stage 2 or 3 CRC patients who are molecular residual disease (MRD) positive using Natera’s Signatera ctDNA test. Aftab said roughly 20% of patients are MRD positive after definitive therapy and have poor prognosis, with median disease-free survival “in the 6 to 8-month time frame,” and that there are no therapies proven in phase III to prevent or delay metastatic progression in this setting.
• STELLAR-304 (non-clear cell RCC): A phase III trial evaluating zanzalitinib plus nivolumab versus sunitinib in locally advanced or metastatic non-clear cell RCC. Aftab said enrollment was completed last year and, based on event rates, the company now expects top-line results in the second half of 2026. In Q&A, Aftab declined to speculate on what is driving event timing.
• Merck-led clear cell RCC studies: Aftab said Merck initiated LITESPARK-033 last year (zanzalitinib plus belzutifan versus cabozantinib in first-line patients previously treated with adjuvant anti-PD-1/PD-L1 therapy) and recently initiated LITESPARK-034 (zanzalitinib plus belzutifan versus belzutifan plus placebo in second- or third-line advanced RCC). Aftab noted overall survival has become a “gold standard” in clear cell RCC and that interpretation of dual primary endpoints is “data dependent.”
• STELLAR-311 (NETs): A phase III study comparing zanzalitinib to everolimus as initial oral therapy in pancreatic or extra-pancreatic NETs. Aftab said enrollment has been faster than expected and “far ahead” of projections.
• STELLAR-201 (meningioma): Exelixis has initiated this phase II trial in recurrent meningioma patients refractory to or ineligible for local therapies. Aftab said the study will enroll up to 100 patients and is designed with objective response rate as the primary endpoint.
• STELLAR-202 (squamous NSCLC) and STELLAR-002 (mCRPC expansion cohort): Aftab said STELLAR-202 is planned to explore adding zanzalitinib to pembrolizumab maintenance in squamous NSCLC, citing a squamous subgroup signal from CONTACT-01 (cabozantinib plus atezolizumab). He also said an additional STELLAR-002 cohort will evaluate zanzalitinib plus docetaxel in metastatic castration-resistant prostate cancer patients with measurable disease, based on favorable outcomes observed in a small phase I cabozantinib-plus-docetaxel study. Both are expected to initiate in the second half of the year.

Aftab also said Exelixis has four early clinical pipeline molecules in development—XL309, XB010, XB628, and XB371—and discussed additional discovery efforts in neuroendocrine cancers, including a small molecule targeting SSTR2 and an investigational DLL3-targeted antibody-drug conjugate (XB773) for neuroendocrine carcinomas.

Capital allocation: balancing R&D, business development, and buybacks

In response to a question about resource allocation amid a broad zanzalitinib development strategy, Senner said Exelixis evaluates capital allocation across R&D, business development, and repurchases. He said the company is “financially strong” with significant cash flows and access to capital, allowing it to execute across those priorities. Senner added Exelixis believes the zanzalitinib opportunity is “not really being appreciated” and that the company is undervalued, supporting continued buybacks.

Morrissey closed by calling 2026 a “potentially transformational year,” with efforts focused on growing the cabozantinib business, advancing zanzalitinib as a second franchise opportunity, and continuing to build the early-stage pipeline.

About Exelixis NASDAQ: EXEL

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 contact@marketbeat.com.