EXELIXIS Q1 FY26 earnings call EXEL

The CABOMETYX business demonstrated continued strong growth in Q1 FY26, with U.S. net product revenues reaching $555 million, an 8% year-over-year increase. Globally, the CABO franchise generated $764 million, up 12.5% year-over-year. CABOMETYX maintained its position as the #1 prescribed TKI in renal cell carcinoma (RCC) and the #1 TKI plus IO combination in first-line RCC. The quarter saw the highest number of new patient starts ever for CABOMETYX, and CABOMETYX plus nivolumab achieved its highest quarterly first-line RCC market share to date. The company also expanded its GI sales team to further grow the neuroendocrine tumor (NET) market share, where CABOMETYX is the market leader in the second-line plus oral segment.

ZANZA is positioned as Exelixis's next potential oncology franchise, with an NDA for the ZANZA/atezolizumab combination in third-line plus colorectal cancer (CRC) currently under review. This NDA, based on STELLAR-303 data, is a top priority, with a PDUFA date in early December. The ZANZA development program is rapidly expanding, with seven ongoing or soon-to-start pivotal trials, alongside additional Phase II trials planned in prostate and lung cancer. The company aims to establish ZANZA as the TKI of choice in the 2030s for RCC and other indications, potentially surpassing CABO's impact.

The STELLAR-303 trial met one of its dual primary endpoints, demonstrating a 20% reduction in the risk of death in the broad ITT population. While the non-liver metastases (NLM) data were immature, a trend favoring the combination was observed, with final NLM results expected around mid-year. Building on this, the company is initiating STELLAR-316, a Phase III trial investigating ZANZA in resected Stage II or III CRC patients who are molecular residual disease (MRD) positive. This trial addresses a significant unmet need, as these patients typically have poor prognosis and no approved therapeutic options to prevent metastatic progression.

ZANZA's target profile positions it for success in kidney cancer. STELLAR-304, evaluating ZANZA plus nivolumab in non-clear cell RCC, completed enrollment last year, with top-line results now expected in the second half of 2026. If positive, this could establish the first standard of care for this underserved population. Merck is also running two pivotal studies, LITESPARK-033 and LITESPARK-034, evaluating ZANZA plus belzutifan in clear cell RCC. Exelixis is actively discussing with collaborators to investigate novel combinations with orthogonal mechanisms to further advance ZANZA in clear cell RCC.

The Phase III STELLAR-311 trial, evaluating ZANZA versus everolimus as initial oral therapy in pancreatic or extra-pancreatic NETs, has seen rapid enrollment, significantly ahead of projections. This reflects high investigator enthusiasm for improving the treatment landscape in earlier lines of NET. Additionally, Exelixis initiated STELLAR-201, a Phase II trial evaluating ZANZA in patients with recurrent meningioma, a central nervous system tumor with no approved systemic therapies. Given the high unmet need, brisk enrollment is anticipated for this trial.

Exelixis's early clinical pipeline includes four molecules in Phase I development: XL309, XB010, XB628, and XB371, all progressing well. The company is also planning two new Phase II studies for ZANZA: STELLAR-202 in squamous non-small cell lung cancer (NSCLC) in combination with pembrolizumab maintenance, and an expansion cohort in STELLAR-002 evaluating ZANZA with docetaxel in metastatic castration-resistant prostate cancer (mCRPC). These studies aim to explore ZANZA's potential in new tumor types and combination strategies, leveraging insights from previous cabozantinib data.

Exelixis remains committed to running the business efficiently, generating substantial free cash flow to invest in its pipeline, pursue targeted business development, and continue its share repurchase program. The company repurchased approximately $430.8 million of common stock in Q1 FY26, retiring 10 million shares. With the completion of the October 2025 repurchase plan expected in May 2026, the board authorized a new $750 million stock repurchase plan, reflecting confidence in the company's valuation and future prospects.