Exelixis(US:EXEL)2025-11-04 23:02Financial Data and Key Metrics Changes - For Q3 2025, the company reported total revenues of approximately $598 million, including Cabozantinib franchise net product revenues of approximately $543 million, which represents a year-over-year growth of about 14% from $478 million in Q3 2024 [7][13] - Gross-to-net for the Cabozantinib franchise in Q3 2025 was 30.4%, with total operating expenses of approximately $361 million, compared to $355 million in Q2 2025 [13][14] - The company reported GAAP net income of approximately $193.6 million, or $0.72 per share basic, and non-GAAP net income of approximately $217.9 million, or $0.81 per share basic [14][15] - Cash and marketable securities at the end of Q3 2025 were approximately $1.6 billion, with share repurchases totaling approximately $99 million during the quarter [15] Business Line Data and Key Metrics Changes - The Cabozantinib U.S. business showed strong growth, with net product revenues growing to $543 million in Q3 2025, and global revenues from the Cabozantinib franchise reaching approximately $739 million [7][8] - Demand in neuroendocrine tumors grew about 50% and contributed approximately 6% of the third-quarter business, with expectations to exceed $100 million in revenue for this indication in 2025 [8][31] - The Zanzalintinib franchise is advancing with seven ongoing pivotal trials, and the company aims to file for regulatory approval in the CRC indication as soon as possible [9][10] Market Data and Key Metrics Changes - Cabozantinib maintained its leadership position as the top TKI for RCC, with a greater than 40% new patient share in the oral second-line plus net segment [7][8] - The company is expanding its GI sales team to accelerate growth in the Cabo net indication before Zanza's anticipated launch [8][34] - Market research indicates that Cabometyx is viewed as the best-in-class oral therapy in neuroendocrine tumors, which is expected to drive prescribing behavior positively [32][33] Company Strategy and Development Direction - The company is focused on building a best-in-class, multi-franchise oncology business, with a commitment to improving the standard of care for cancer patients [6][9] - There is a strong emphasis on the Zanzalintinib franchise as a potential second oncology franchise that could eclipse the size and impact of the Cabozantinib business [9][10] - The company plans to repurchase shares when undervalued and has been authorized to repurchase an additional $750 million of shares [12][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong performance of the Cabozantinib business and the potential of Zanzalintinib, particularly following positive trial results [6][9] - The company is optimistic about the upcoming NDA filing for Zanzalintinib and the potential for a broad label in CRC, which could significantly enhance its market position [10][73] - Management highlighted the importance of navigating the competitive landscape effectively, especially with the anticipated launch of Zanzalintinib [9][10] Other Important Information - Susan Hubbard, EVP of Public Affairs and Investor Relations, announced her retirement, with Andrew Peters set to take over her responsibilities [38][39] - The company is preparing for an R&D day on December 10th, where more details on the early-stage pipeline and Zanzalintinib trials will be shared [12][27] Q&A Session Summary Question: Can you summarize the post-ESMO feedback on Zanzalintinib results? - Management noted positive feedback from physicians regarding the overall survival benefit and the potential for Zanzalintinib to capture market share in a fragmented market [42][44] Question: Why is Sunitinib the right control for STELLAR-304? - Management explained that Sunitinib is a standard of care in the setting and has a relevant target profile, making it a suitable comparator for the trial [48][50] Question: How does the STELLAR-303 data set expectations for the NLM cut? - Management indicated that the trial was designed to include both liver and non-liver metastases, with results expected to mature around mid-year 2026 [52][55] Question: What is the strategy regarding potential cannibalization between Cabozantinib and Zanzalintinib? - Management expressed confidence in the distinct positioning of Zanzalintinib in the market, emphasizing the growth potential for both products [67][70] Question: Will the NDA submission for Zanzalintinib include both subgroups? - Management confirmed that the NDA will be filed based on the ITT population, which encompasses the entire trial population, allowing for a broad label [72][73]