• Total Revenue: Approximately $567 million for Q4 2024.
• Cabozantinib Franchise Net Product Revenue: $515.2 million for Q4 2024.
• CABOMETYX Net Product Revenue: $512.8 million for Q4 2024.
• Gross to Net: 26.8% for Q4 2024, with an estimated 29%-30% for full year 2025.
• Collaboration Revenue: Approximately $51.5 million for Q4 2024.
• Operating Expenses: Approximately $403 million for Q4 2024.
• Provision for Income Taxes: Approximately $44.9 million for Q4 2024.
• GAAP Net Income: Approximately $139.9 million for Q4 2024.
• Non-GAAP Net Income: Approximately $160.3 million for Q4 2024.
• Cash and Marketable Securities: Approximately $1.75 billion as of December 31, 2024.
• Share Repurchase: Approximately $656 million worth of shares repurchased in fiscal year 2024.

• Warning! GuruFocus has detected 5 Warning Signs with EXEL.

Release Date: February 11, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Exelixis Inc (NASDAQ:EXEL) reported strong financial performance with a 20% year-over-year growth in US cabo franchise net product revenues for Q4 2024.
• The company is advancing its oncology pipeline with significant progress in cabozantinib and zanzalintinib, aiming for aspirational revenue goals of $3 billion for cabo by 2030 and $5 billion for zanza by 2033.
• Exelixis Inc (NASDAQ:EXEL) is launch-ready for the CABINET indication, with the FDA having accepted their sNDA for cabozantinib in pNET and epNET indications, with a PDUFA date set for April 3, 2025.
• The company has a robust pipeline with plans to accelerate Phase 3 development of XL309 and initiate several new INDs, showcasing a strong commitment to expanding its oncology portfolio.
• Exelixis Inc (NASDAQ:EXEL) maintains a strong balance sheet with approximately $1.75 billion in cash and marketable securities, supporting its strategic initiatives and share repurchase program.

Negative Points

• Exelixis Inc (NASDAQ:EXEL) faces challenges with higher gross-to-net deductions due to increased co-pay assistance and Medicare Part D expenses, impacting financial metrics.
• The company is experiencing choppy clinical trial sales, which are expected to continue, potentially affecting revenue consistency.
• There is uncertainty regarding the regulatory approval and market uptake of new indications, such as the CABINET indication, which could impact future revenue projections.
• Exelixis Inc (NASDAQ:EXEL) is navigating competitive pressures in the oncology market, particularly with the development of zanzalintinib, which faces comparisons to existing treatments like cabozantinib.
• The company is investing heavily in R&D, with plans to spend about $1 billion in 2025, which could strain resources if expected outcomes are not achieved.

Q & A Highlights

Q: Can you discuss the lack of overlap in the approved indications for cabozantinib (cabo) and where you anticipate zanza will be? Also, have you seen payers force a substitution with a generic of something that is not the actual generic product? A: Michael Morrissey, President and CEO, explained that Exelixis is focused on comparing zanza combinations to individual standards of care in pivotal trials like STELLAR-303 and STELLAR-305. The goal is to generate positive data to push indications forward, rather than speculating on payer behavior regarding generics.

Q: How are you currently thinking about the launch trajectory and expectations for cabo in NET, and can you comment on the emerging safety profile of zanza? A: Patrick Haley, EVP of Commercial, stated that Exelixis is launch-ready for NET, with a significant opportunity in the $1 billion oral market. The CABINET study data supports broad applicability for NET patients. Regarding zanza, Michael Morrissey noted that the safety profile is encouraging, with ongoing trials to further assess dose intensity, especially in combination with checkpoint inhibitors.

Q: With a strong balance sheet, how do you plan to manage capital allocation between buybacks and bolstering the pipeline with M&A? A: Michael Morrissey emphasized the importance of disciplined capital allocation to advance pipeline priorities, buy back shares when appropriate, and invest in new assets. The company plans to spend about $1 billion in R&D this year, focusing on prioritizing successful projects and stopping less promising ones.

Q: Can you provide insights on the recent NET data presented at ASCO-GI and how it might influence clinical practice and labeling? A: Amy Peterson, Chief Medical Officer, highlighted that the CABINET study reflects a broad patient population with consistent benefits across subgroups. The data supports broad applicability, but specific label details are still under discussion with the FDA.

Q: Regarding the STELLAR-303 trial, how should we think about the differences in patient populations and their impact on overall survival for zanza plus atezolizumab? A: Amy Peterson explained that STELLAR-001 was designed to evaluate the contribution of components, showing positive results across efficacy endpoints. The STELLAR-303 trial will provide further insights, with results expected in the second half of 2025.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.