Exelixis Reports $1.8 Billion in Net Product Revenues for Fiscal Year 2024

Exelixis, Inc. reported net product revenues of $1.8 billion for fiscal year 2024, an 11% increase compared to $1.6 billion in 2023. This increase was primarily driven by an 8.2% rise in CABOMETYX unit sales due to FDA approval of the drug in combination with nivolumab for first-line treatment of advanced renal cell carcinoma (RCC), and a 2.9% increase in the average net selling price. Total revenues for 2024 reached $2.17 billion, an 18% increase year-over-year, reflecting growth in license revenues (96% increase to $349.2 million) and a decrease in collaboration services revenues (-56% to $10.1 million). The company's net income for 2024 was $521.3 million ($1.80 per share), significantly higher than the $207.8 million ($0.65 per share) reported in 2023.

Research and development expenses decreased by 13% to $910.4 million in 2024 compared to $1.04 billion in 2023, primarily due to lower license and collaboration costs and other drug discovery costs. Selling, general, and administrative expenses also decreased by 9% to $492.1 million. The company attributed the decrease in selling, general, and administrative expenses to lower corporate giving, legal fees, and reduced litigation-related activities. A $51.7 million non-cash impairment charge related to leased facilities was recorded in 2024, along with $33.7 million in restructuring expenses resulting from a workforce reduction of approximately 13%, leaving 1,147 employees at the end of 2024.

Significant strategic developments included the initiation of several pivotal phase 3 trials for zanzalintinib, the company's lead investigational asset, in colorectal cancer, non-clear cell RCC, and squamous cell cancers of the head and neck. Exelixis also launched a phase 1 trial for XB010, its first internally-developed antibody-drug conjugate. Furthermore, the company entered into a clinical development collaboration with Merck & Co. to evaluate zanzalintinib in combination with KEYTRUDA and WELIREG in different cancer types. The company also completed a stock repurchase program of $450 million in 2024 and authorized a new program for up to $500 million in 2025.

Exelixis's financial performance was also impacted by several legal proceedings related to ANDA submissions for generic versions of CABOMETYX. The company engaged in litigation with MSN, Teva, Cipla, and Sun, resulting in settlements with Teva and Cipla, while litigation with MSN and Sun continued. The company also noted the impact of the Inflation Reduction Act of 2022 (IRA) on drug pricing and reimbursement, stating that it had qualified for the small biotech exception for its cabozantinib franchise products through 2027.

Looking ahead, Exelixis anticipates continued growth in net product revenues in fiscal year 2025, driven by factors similar to those in 2024. However, the company acknowledges challenges related to maintaining profitability, securing coverage and reimbursement for its products, and navigating the competitive oncology landscape. The company also highlighted the potential impact of generic competition and ongoing legal proceedings on its future financial performance.