Exelixis Inc. reports developments from its oncology business, including commercial performance for the cabozantinib franchise and clinical and regulatory updates across cancer programs. The company discovers, develops and commercializes cancer medicines, with CABOMETYX® (cabozantinib) as its flagship commercial product and COMETRIQ® also part of its cabozantinib portfolio.
Recurring updates include quarterly financial results, product revenue trends, financial guidance, pipeline milestones and investor conference presentations. Exelixis also discusses zanzalintinib, an investigational oral kinase inhibitor, and a broader pipeline of small molecules and biotherapeutics targeting additional tumor types and indications.
Exelixis, Inc. (NASDAQ: EXEL) responds to a letter from Farallon Capital Management, emphasizing its commitment to driving growth and enhancing shareholder value through a strategic focus on its cabozantinib franchise and a promising clinical pipeline, including the next-generation inhibitor zanzalintinib and the ADC XB002. The company has a robust financial position, with approximately $2.1 billion in cash and investments, enabling continued investments in R&D and a recently announced $550 million share repurchase program.
Despite ongoing engagement with Farallon, Exelixis declined to meet Farallon’s demands for extensive confidential information about its pipeline. The company aims to present its board nominations in its upcoming proxy statement for the 2023 Annual Meeting.
Farallon Capital Management, owning approximately 7.2% of Exelixis (NASDAQ: EXEL), calls for change in the company's board, citing a history of shareholder disappointment. Despite significant revenue from cabozantinib, shareholder returns have been underwhelming, averaging less than 1% annually since the IPO. Farallon plans to nominate three independent directors to bring fresh perspectives, improve R&D efficiency, and communicate a coherent strategy. The firm criticizes Exelixis for undisciplined R&D spending, forecasting over $1 billion in 2023 while managing too many simultaneous trials. Investors seek accountability and a commitment to returning capital to shareholders.
Exelixis, Inc. (Nasdaq: EXEL) has authorized a share repurchase program of up to $550 million of its common stock by the end of 2023. The buyback strategy will consider various factors including capital needs, market conditions, and stock price. The program provides flexibility, allowing Exelixis to make repurchases through multiple methods without the obligation to acquire a specific number of shares. This initiative reflects the company's confidence in its financial position and aims to enhance shareholder value.
Exelixis (NASDAQ: EXEL) will present a corporate overview at the 2023 Guggenheim Healthy Altitudes Summit on March 16, 2023, at 10:00 a.m. ET. Interested parties can access the presentation via a webcast on www.exelixis.com. Attendees should log on 15 minutes early for software downloads. A replay will be available for 30 days post-event. Exelixis focuses on innovative cancer treatments, primarily through its flagship drug, CABOMETYX® (cabozantinib), and is committed to expanding its oncology portfolio.
Exelixis, Inc. (NASDAQ: EXEL) announced that its phase 3 CONTACT-03 study did not achieve its primary endpoint of progression-free survival (PFS) when evaluating cabozantinib (CABOMETYX®) in combination with atezolizumab versus cabozantinib alone in patients with advanced renal cell carcinoma (RCC) post-immune checkpoint therapy. The trial included 522 patients but failed to show clinical benefit for the combination treatment. However, the safety profile remained consistent with known effects of individual agents, with no new safety signals observed. Detailed findings will be revealed in a forthcoming medical meeting.
Exelixis (NASDAQ: EXEL) is scheduled to participate in multiple investor conferences in March 2023. The company will present at the Cowen 43rd Annual Health Care Conference on March 7 at 1:30 PM ET in Boston, and at the Barclays Global Healthcare Conference on March 14 at 1:35 PM ET in Miami. Additionally, Exelixis will present virtually at the Oppenheimer 33rd Annual Healthcare Conference on March 14 at 1:20 PM ET. Investors can access the live webcasts and replays on the company’s website. Exelixis is committed to advancing cancer care through innovative therapies.
Bristol Myers Squibb (NYSE: BMY) and Exelixis (NASDAQ: EXEL) announced three-year follow-up results from the Phase 3 CheckMate -9ER trial, demonstrating significant benefits for the combination of Opdivo® (nivolumab) and CABOMETYX® (cabozantinib) in treating advanced renal cell carcinoma (RCC). With a median follow-up of 44 months, the combination showed a 30% reduction in the risk of death and improved overall survival (49.5 months vs. 35.5 months) compared to sunitinib. Progression-free survival also doubled (16.6 months vs. 8.4 months) while maintaining safety profiles. These results will be presented at the ASCO GU 2023 Symposium.
Exelixis has received FDA clearance for the Investigational New Drug (IND) application of ADU-1805, a monoclonal antibody targeting SIRPα, which is designed to block the SIRPα-CD47 checkpoint in patients with advanced solid tumors. This advancement signifies a critical step in Exelixis’ pipeline, with a phase 1 study set to begin in Q2 2023. The IND clearance activates a $35 million milestone payment to Sairopa. ADU-1805 shows promise due to its potential to treat a wider patient population than existing therapies. This move aligns with Exelixis' broader goal of innovating treatments for cancer patients.
Exelixis reported total revenues of $423.9 million for Q4 2022 and $1.61 billion for the full year, showing a rise in U.S. net product revenues for cabozantinib to $1.4 billion. GAAP EPS was $(0.09) for Q4 2022 but $0.56 for the full year. The non-GAAP EPS was $(0.03) in Q4 2022 compared to $0.82 for the full year. Research and development expenses rose to $336.8 million for Q4 and $891.8 million for the year. Exelixis aims for robust growth in 2023, targeting total revenues of $1.775-$1.875 billion. Upcoming milestones include pivotal trial data readouts and the advancement of its drug pipeline.
Exelixis, Inc. (NASDAQ: EXEL) has announced its participation in two major investor conferences in February 2023. The first is the Guggenheim Healthcare Talks Oncology Day, taking place on February 9 at 11:20 am ET in New York. The second conference is the SVB Securities Global Biopharma Conference, with a virtual presentation scheduled for February 15 at 2:20 pm ET.
Investors can access the webcasts via www.exelixis.com. Replays will be available for 30 days after the event. Exelixis focuses on innovative cancer treatments and aims to bring hope to patients through advanced therapies.