Exelixis, Inc. (Nasdaq: EXEL) released its third-quarter financial results for 2024 and highlighted recent progress across key commercial, clinical, and pipeline milestones.
Key Developments and Corporate Updates
- Intellectual Property and Partnerships: Exelixis recently received a favorable ruling on its cabozantinib intellectual property, strengthening its patent position. The company also announced a collaboration with Merck to develop zanzalintinib, which is now undergoing six pivotal phase 3 trials, including two new studies in renal cell carcinoma.
- Financial Performance: Exelixis reported total Q3 revenue of $539.5 million, an increase from $471.9 million year-over-year. Net product revenues rose to $478.1 million, driven by higher sales volume and pricing for cabozantinib products. Collaboration revenues also grew, with milestone-related income and royalties from Ipsen and Takeda sales of cabozantinib outside the U.S.
- Expense Management: Research and development expenses decreased from $332.6 million to $222.6 million year-over-year, due to lower collaboration costs. General and administrative expenses also fell to $111.8 million, with reduced corporate giving, stock-based compensation, and legal fees. Exelixis recorded a $51.7 million non-cash impairment for unused leased facilities.
- Earnings Performance: GAAP net income for Q3 was $118.0 million, or $0.41 per share (basic), compared to $1.0 million the previous year. Non-GAAP net income was $135.7 million, or $0.47 per share, driven by stock repurchase programs that lowered outstanding shares.
- Updated 2024 Financial Guidance: Exelixis raised its full-year revenue outlook, now anticipating total revenues of $2.150-$2.200 billion, with net product revenues between $1.775 billion and $1.825 billion.
Pipeline and Clinical Trials
- Cabozantinib Developments: Exelixis is progressing potential label expansions for cabozantinib, with positive phase 3 CABINET results in neuroendocrine tumors published in The New England Journal of Medicine. The FDA has granted orphan drug status to cabozantinib for pancreatic neuroendocrine tumors, with a review target date of April 3, 2025. Additionally, Exelixis is preparing a regulatory submission for cabozantinib in combination with atezolizumab for metastatic castration-resistant prostate cancer.
- Emerging Therapies: Exelixis’s pipeline includes early-phase trials for XL309, XB010, and XL495 in advanced solid tumors. The company recently completed enrollment for its phase 3 STELLAR-303 study of zanzalintinib in colorectal cancer and announced plans for the STELLAR-311 trial in neuroendocrine tumors, which is expected to begin in early 2025.
- Clinical Collaborations with Merck: Exelixis and Merck are partnering on trials exploring zanzalintinib combinations with KEYTRUDA® in head and neck cancer and with WELIREG® in renal cell carcinoma.
Cabozantinib Franchise Revenue: The cabozantinib franchise generated $478.1 million in U.S. net product revenue, with royalties of $41.8 million from international sales through Exelixis’s partners, Ipsen and Takeda.
Stock Repurchase Program: Exelixis’s $500 million stock repurchase program, launched in August, has seen $12.4 million of shares repurchased at an average price of $25.61 as of September 30, 2024.
Exelixis’s performance and pipeline advancements reflect its strategic focus on strengthening the cabozantinib franchise, expanding its oncology pipeline, and driving future growth through key clinical partnerships and trials.
