EXELIXIS (EXEL)

• Exelixis announced that the U.S. FDA has accepted its New Drug Application (NDA) for zanzalintinib in combination with atezolizumab for the treatment of adult patients with previously treated metastatic colorectal cancer (mCRC).
• The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026, for the review of the application.
• The NDA is based on results from the phase 3 STELLAR-303 pivotal trial, which showed that zanzalintinib in combination with atezolizumab improved median overall survival and significantly reduced the risk of death compared to regorafenib.

• Ellipses Pharma Limited has signed a collaboration and licensing agreement with Innolake Biopharm Co. Ltd to jointly develop a clinical-stage, global-first B7H3-targeted antibody-drug conjugate (ADC).
• Under the agreement, Ellipses obtains the rights to develop the ADC, designated as ILB-3101 (or EP0028), globally outside of Greater China.
• The candidate is currently being advanced through Phase I clinical trials in China by Innolake, and Ellipses plans to initiate Phase I clinical trials in the US and expand to Europe and other regions, pending regulatory approvals.
• This ADC is a significant addition to Ellipses' clinical-stage development pipeline and represents its second asset introduced from a Chinese innovative biotech enterprise.

• Exeltis has signed a binding term sheet with Dilafor for an exclusive semi-global license (excluding China and Japan) for Dilafor's lead candidate drug, tafoxiparin.
• Exeltis will fund the pivotal clinical trials, development, and commercialization of tafoxiparin, which is clinical phase 3 ready for priming of labor.
• The agreement includes sales-based milestone payments and up to double-digit royalties on net sales for Dilafor, along with limited upfront and development-based milestones.

• Exelixis reported preliminary unaudited total revenues of $2.32 billion and net product revenues of $2.123 billion for full year 2025, with R&D expenses around $825 million and $1.65 billion in cash at year-end.
• For 2026, the company provided guidance for net product revenue between $2.325 billion and $2.425 billion (midpoint $2.375 billion) and R&D expenses between $875 million and $925 million, which excludes any contribution from a potential Zanzalitinib approval and launch.
• The company's strategy focuses on building multiple blockbuster franchises, with Cabozantinib continuing as a key driver and Zanzalitinib positioned as the next large oncology franchise, having submitted its first regulatory filing in Q4 2025 for metastatic colorectal cancer.
• Exelixis has returned $2.16 billion in cash to shareholders through share repurchase plans since March 2023 and has an ongoing $750 million share repurchase program authorized in October 2025.

• Exelixis reported preliminary unaudited 2025 Total Revenues of $2.320 billion and Net Product Revenues of $2.123 billion, and provided 2026 financial guidance projecting Total Revenues between $2.525 billion and $2.625 billion and Net Product Revenues between $2.325 billion and $2.425 billion.
• The company's strategic goal is to become a leader in oncology R&D and a top 5 solid tumor oncology company, aiming for sustained revenue growth through 2031 and beyond by building franchises in key solid tumors.
• Zanzalintinib is positioned as the next oncology franchise opportunity, with its first U.S. regulatory filing submitted in Q4 2025 for previously treated mCRC. The company has seven ongoing and planned pivotal studies for zanzalintinib across various indications.
• Exelixis has returned $2.16 billion to shareholders through Stock Repurchase Programs (SRPs) since March 2023, and an ongoing $750 million SRP was authorized in October 2025.

• Exelixis reported preliminary, unaudited total revenues of $2.32 billion and net product revenues of $2.123 billion for 2025, ending the year with $1.65 billion in cash.
• For 2026, the company issued net product revenue guidance of $2.325 billion to $2.425 billion and R&D expense guidance of $875 million to $925 million, which does not include any potential contribution from zanzalitinib approval and launch.
• The company submitted its first regulatory filing for zanzalitinib in Q4 2025 for previously treated metastatic colorectal cancer (CRC) and has seven ongoing or soon-to-begin pivotal trials for the drug.
• Exelixis continues to emphasize the strong performance of its cabozantinib franchise, which was a key driver of 2025 growth and remains a top TKI in the U.S. for RCC.

Exelixis reported preliminary unaudited financial results for FY 2025, including $2.32 billion in total revenues and $1.65 billion in cash at year-end. The company also provided its FY 2026 guidance, projecting net product revenues between $2.325 billion and $2.425 billion and R&D expenses between $875 million and $925 million. This guidance does not include any potential contribution from Zanzalitinib approval and launch.

The company's strategy is focused on building multiple blockbuster franchises, with Cabozantinib continuing as a key driver and Zanzalitinib positioned as the next large oncology franchise. The first regulatory filing for Zanzalitinib, for previously treated metastatic colorectal cancer, was submitted in Q4. Exelixis has returned approximately $2.16 billion in cash to shareholders through share repurchase plans since March 2023 and has an ongoing $750 million share repurchase program authorized in October 2025.

• Exelixis announced preliminary unaudited financial results for fiscal year 2025, with total revenues of approximately $2.320 billion and net product revenues of approximately $2.123 billion.
• The company provided financial guidance for fiscal year 2026, projecting total revenues between $2.525 billion and $2.625 billion and net product revenues between $2.325 billion and $2.425 billion.
• Exelixis expects continued growth for its cabozantinib franchise in 2026 and is preparing for the potential first commercial launch of zanzalintinib, with key clinical trial readouts anticipated in mid-2026.
• As of the end of fiscal year 2025, Exelixis had repurchased $2.16 billion of its common stock, retiring 76.7 million shares, and authorized an additional $750 million stock repurchase program in October 2025.

• Exelixis announced preliminary unaudited Fiscal Year 2025 total revenues of approximately $2.320 billion and net product revenues of approximately $2.123 billion.
• For Fiscal Year 2026, the company provided guidance for total revenues between $2.525 billion and $2.625 billion and net product revenues between $2.325 billion and $2.425 billion.
• Exelixis anticipates 2026 to be a significant year for clinical, regulatory, and commercial progress, including the potential first commercial launch of zanzalintinib for previously treated metastatic colorectal cancer and several key clinical trial readouts.
• As of the end of Fiscal Year 2025, Exelixis had repurchased $2.16 billion of common stock and authorized an additional $750 million stock repurchase program in October 2025.

• Exelixis is strategically building towards becoming a top five solid tumor oncology company, expanding beyond its current position as a top 10 U.S. company, with a focus on developing multi-compound, multi-franchise solutions.
• The company projects more than 30% cumulative growth for its Cabozantinib (Cabo) franchise from full year 2023 to full year 2025, supported by existing and two new MET indications.
• Zanzalitinib (Zanza) is a key next-generation molecule, with a New Drug Application (NDA) filed with the FDA based on positive STELLAR-303 trial results in colorectal cancer, which showed a 20% reduction in the risk of death and a median overall survival of 10.9 months for the Zanza plus atezolizumab combination.
• The third-line plus colorectal cancer market represents an estimated $1.5 billion opportunity in the U.S. for Zanza, which is also being advanced through seven ongoing or planned label-enabling studies across various indications, including renal cell carcinoma and adjuvant colorectal cancer.
• Exelixis maintains a productive early-stage pipeline, including three IND candidates (XB010, XB628, XB371), new molecules like XB773 and XL557 advancing towards IND status, and a novel discovery program targeting KRAS with molecular glues and degraders.