Financial Data and Key Metrics Changes - For Q4 2025, total revenues were approximately $599 million, including cabozantinib franchise net product revenues of $546.6 million [13] - Full year 2025 US CABO franchise net product revenues grew 17% to approximately $2.12 billion compared to 2024 [7] - GAAP net income for Q4 2025 was approximately $244.5 million, or $0.92 per share basic [16] - Non-GAAP net income for Q4 2025 was approximately $259.5 million, or $0.97 per share basic [17] - Cash and marketable securities at the end of 2025 were approximately $1.66 billion [17] Business Line Data and Key Metrics Changes - CABOMETYX maintained its position as the leading TKI for renal cell carcinoma (RCC) and neuroendocrine tumors, with Q4 2025 TRX volume growing 15% compared to Q4 2024 [19][20] - CABOMETYX's gross-to-net for Q4 2025 was 28.5%, lower than the previous quarter due to lower PHS and 340B volume [13] - Zanzalintinib is positioned as the next potential oncology franchise, with seven ongoing pivotal trials [10][24] Market Data and Key Metrics Changes - CABOMETYX's market share in the oral TKI segment grew from 43% to 46% from Q4 2024 to Q4 2025 [19] - The market basket growth rate for oral TKIs was 7% during the same period, indicating CABOMETYX outpaced the market [20] - The neuroendocrine tumor indication for CABOMETYX exceeded $100 million in revenue for 2025 [21] Company Strategy and Development Direction - The company aims to build a multi-franchise business in solid tumor oncology, focusing on cabozantinib and zanzalintinib [5][6] - The strategy includes expanding leadership in gastrointestinal (GI) indications while maintaining a strong position in genitourinary (GU) oncology [5] - Business development activities are focused on late-stage assets in GU and GI spaces, with a priority on pay-for-success transactions [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in building on the momentum from 2025 into 2026, with expectations for continued strong performance from the cabozantinib business [5] - The company is preparing for the potential launch of zanzalintinib, with a PDUFA date set for later in the year [22] - Management highlighted the significant unmet medical need in the third-line plus colorectal cancer setting, which zanzalintinib aims to address [22][26] Other Important Information - The company repurchased $954 million of its common stock in 2025, retiring approximately 24 million shares [17] - The remaining balance under the stock repurchase plan is approximately $590 million [18] Q&A Session Summary Question: How long will the company benefit from the small manufacturer discount for Zanza? - Management indicated that the small manufacturer exemptions are tied to having a single product as the majority revenue source, which is expected to remain the case for the foreseeable future [34][35] Question: Can you comment on recent 340B purchasing behavior? - Management noted variability in 340B purchasing behavior throughout 2025 and expects continued variability in 2026, which could impact gross-to-net [39][40] Question: What is the expected population size for STELLAR-316? - The estimated population for STELLAR-316 is around 20,000-25,000 patients who are MRD positive after definitive therapy [42][43] Question: What is the growth expectation for NET revenues? - Management expressed optimism about the growth potential in the neuroendocrine tumor segment, emphasizing the need to expand outreach in the community setting [45][47] Question: How does the company anticipate positive data impacting commercial strategy? - Positive data from ongoing trials is expected to enhance communication with physicians and clarify the benefits of the treatment for patients [56][58]
Exelixis(EXEL) - 2025 Q4 - Earnings Call Transcript