Core Insights - Exelixis reported $598.66 million in revenue for Q4 2025, a 5.6% year-over-year increase, with an EPS of $0.94 compared to $0.55 a year ago, exceeding both revenue and EPS estimates [1][4] Revenue Performance - Net product revenues reached $546.58 million, surpassing the average estimate of $529.04 million by nine analysts, reflecting a 6.1% increase year-over-year [4] - Collaboration revenues were reported at $52.09 million, exceeding the average estimate of $49.91 million, marking a significant year-over-year increase of 2289.3% [4] - CABOMETYX generated $544.7 million in net product revenues, slightly below the average estimate of $554.08 million, but still showing a 6.2% year-over-year growth [4] - COMETRIQ reported net product revenues of $1.8 million, which fell short of the average estimate of $3.15 million, indicating a year-over-year decline of 25.6% [4] - License revenues from collaboration reached $66.36 million, exceeding the average estimate of $48.87 million from five analysts [4] Stock Performance - Exelixis shares have returned -0.3% over the past month, while the Zacks S&P 500 composite remained unchanged [3] - The stock holds a Zacks Rank 2 (Buy), suggesting potential outperformance against the broader market in the near term [3]

Financial Data and Key Metrics Changes - For Q4 2025, total revenues were approximately $599 million, with cabozantinib franchise net product revenues of $546.6 million, and CABOMETYX net product revenues at $544.7 million [15][18] - Gross-to-net for the cabozantinib franchise in Q4 2025 was 28.5%, lower than the previous quarter, primarily due to lower PHS and 340B volume [15][16] - GAAP net income for Q4 2025 was approximately $244.5 million, or $0.92 per share basic, and $0.88 per share diluted [17] - Non-GAAP net income was approximately $259.5 million, or $0.97 per share basic, and $0.94 per share diluted [18] - Cash and marketable securities at year-end 2025 were approximately $1.66 billion, with $954 million spent on share repurchases during the fiscal year [18][19] Business Line Data and Key Metrics Changes - The cabozantinib business maintained strong performance, with U.S. CABO franchise net product revenues growing 17% to approximately $2.12 billion for the full year 2025 [10] - CABOMETYX continued to be the leading TKI for renal cell carcinoma (RCC) and the market leader for neuroendocrine tumors in the oral second-line-plus segment [20] - CABOMETYX TRX volume grew 15% in Q4 2025 compared to Q4 2024, outpacing the market basket growth rate of 7% [21] Market Data and Key Metrics Changes - CABOMETYX's market share in the oral TKI market increased from 43% to 46% from Q4 2024 to Q4 2025 [20] - CABOMETYX revenue in neuroendocrine tumors exceeded $100 million in 2025, indicating strong market demand [23] Company Strategy and Development Direction - The company aims to build a multi-franchise business in solid tumor oncology, focusing on cabozantinib and zanzalintinib, with a strategy that encompasses products, tumor indications, and modalities [8][9] - The company is preparing for the potential launch of zanzalintinib in colorectal cancer (CRC) and has expedited the build-out of its GI sales team to support this initiative [11][23] - Business development activities are focused on late-stage assets in GU and GI spaces, with an emphasis on pay-for-success transactions [13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about 2026 being a transformational year, with expectations for continued growth in cabozantinib and the potential launch of zanzalintinib [35] - The company is actively engaging with regulators regarding the NDA for zanzalintinib, with a PDUFA target action date set for December 3, 2026 [26][28] Other Important Information - The company reported a sequential increase in operating expenses due to higher manufacturing costs, NDA filing fees, and personnel expenses [16][17] - The company has approximately $590 million remaining under its stock repurchase plan authorized in October 2025 [19] Q&A Session Summary Question: Duration of small manufacturer discount for Zanza and share repurchase cadence - Management indicated that the small manufacturer exemptions are tied to having a single product as the majority revenue source, which is expected to remain for the foreseeable future [39] - Share repurchases will continue as long as the company feels undervalued, with a commitment to complete the remaining authorization this year [40] Question: 340B purchasing behavior and Part D redesign impact - Management noted variability in 340B purchasing behavior and expects this to continue, which could impact gross-to-net [42] - The company plans to optimize its channel for Zanza based on experiences from cabozantinib [44] Question: STELLAR-316 population size and timeline - The estimated population for STELLAR-316 is around 20,000-25,000 patients who are MRD positive after definitive therapy [47] Question: Revenue potential for NET and market dynamics - Management expressed confidence in the growth potential for neuroendocrine tumors, emphasizing the importance of community outreach and the expansion of the GI sales team [51] Question: Non-clear cell RCC market size and outcomes - Non-clear cell RCC represents approximately 20% of RCC, and the company is optimistic about the potential benefits of its pivotal study in this underserved population [82]

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]

Group 1 - Exelixis, Inc. is ranked eighth among the Top 10 Oncology Stocks to Buy Now [1] - H.C. Wainwright analyst Robert Burns raised the price target on EXEL to $52 from $49 while maintaining a Buy rating, citing zanzalintinib's commercial potential as a key value driver [2] - Morgan Stanley downgraded Exelixis, Inc. to Equal Weight from Overweight and raised its price target to $48 from $45, noting the stock's recent performance and the anticipated commercial launch of zanzalintinib in 2026 [3] Group 2 - Exelixis reported preliminary 2025 revenues of approximately $2.32 billion and forecasts sales of $2.525–$2.625 billion for 2026, which are significant for analysts' models [4] - The company focuses on developing small molecules for cancer treatment, with primary products CABOMETYX and COMETRIQ targeting multiple tyrosine kinases involved in tumor growth [4]

Summary of Exelixis Conference Call Company Overview - **Company**: Exelixis - **Event**: 44th Annual J.P. Morgan Healthcare Conference - **Presenter**: Michael Morrissey, President and CEO Key Industry Insights - **Focus on Oncology**: Exelixis is dedicated to improving cancer treatment through innovative therapies, particularly in solid tumors, leveraging their expertise in biology, pharmacology, and clinical sciences [4][5][6] - **Franchise Building**: The company emphasizes building multiple blockbuster franchises rather than focusing on single indications, aiming to maximize value for patients and shareholders [4][6][30] Financial Performance - **2025 Preliminary Results**: - Total revenues: $2.32 billion - Net product revenues: $2.123 billion - R&D expenses: approximately $825 million - Cash at year-end: $1.65 billion [13][14] - **2026 Guidance**: - Net product revenue expected between $2.325 billion and $2.425 billion, with a midpoint of $2.375 billion - R&D expenses projected between $875 million and $925 million [14][15] Product Pipeline and Growth Strategy - **Cabozantinib (Cabo)**: - Continues to be the primary revenue driver, maintaining its position as the top TKI in the U.S. for renal cell carcinoma (RCC) [7][13] - Cumulative growth of 30% from 2023 to 2025 [13] - **Zanzalitinib (Zanza)**: - Aiming to establish Zanza as a significant oncology franchise, with ongoing pivotal trials in RCC, colorectal cancer (CRC), and neuroendocrine tumors (NET) [9][10][29] - First regulatory filing for CRC submitted in Q4 2025 [9][15] - **Pipeline Expansion**: - Four molecules currently in clinical trials, with plans for additional investigational new drug (IND) applications [10][12] Market Opportunities - **Colorectal Cancer (CRC)**: - Identified as a fragmented market with a $1.5 billion opportunity, with strategies to position Zanza effectively against competitors [32][33] - **Neuroendocrine Tumors (NET)**: - Projected market growth from $2.5 billion to over $7 billion, with a focus on innovative therapies [29] Strategic Approach - **Combination Therapies**: - Emphasis on developing combination therapies that leverage different mechanisms of action to enhance treatment efficacy [24][25][26] - **Market Leadership**: - Aiming to establish leadership in multiple tumor types, including RCC and CRC, while focusing on improving patient outcomes and standard of care [17][22] Shareholder Returns - **Capital Allocation**: - $2.16 billion returned to shareholders through share repurchase programs since March 2023, with an ongoing $750 million program [12][30] Conclusion - Exelixis is strategically positioned to leverage its strong product pipeline and market insights to drive growth in the oncology sector, focusing on building franchises that enhance patient care and deliver shareholder value. The company is committed to disciplined capital allocation and innovative research to maintain its competitive edge in the market [30][38]

J.P. MORGAN 2026 HEALTHCARE CONFERENCE JANUARY 12, 2026 Building Next-Generation Oncology Franchises Michael M. Morrissey, Ph.D. President and CEO Safe Harbor Statement This presentation, including any oral presentation accompanying it, contains forward-looking statements, including, without limitation, statements related to: Exelixis' strategy to build franchises in key solid tumors; Exelixis' goal to become a leader in oncology R&D and a top 5 solid tumor oncology company, with multiple blockbuster produc ...

Exelixis 2025 R&D Day Summary Company Overview - **Company**: Exelixis (NasdaqGS:EXEL) - **Focus**: Oncology, specifically solid tumor oncology Key Themes and Strategic Focus - **Multi-Compound, Multi-Franchise Strategy**: Exelixis aims to build a diverse pipeline of oncology products rather than focusing on single indications [4][5] - **Franchise Approach**: The company is prioritizing the development of franchise molecules and indications to enhance its market position and revenue potential [5][10] - **Patient-Centric Goals**: The overarching goal is to improve the standard of care for cancer patients, thereby benefiting both patients and shareholders [6][10] Financial Projections and Growth - **CABO Franchise Growth**: Projected cumulative growth of over 30% in CABO product revenues from 2023 to 2025, driven by new indications in the MET space [7] - **Zanza Development**: Zanza is positioned as a key molecule for future growth, with positive results from pivotal trials and an FDA filing based on the STELLAR-303 trial [8][9] Pipeline and Product Development - **Early-Stage Pipeline**: The pipeline includes three IND candidates (XB010, XB628, XB371) and new molecules like XB773 and XL557, which are advancing towards IND status [9] - **Focus Areas**: The company is concentrating on kidney cancer, neuroendocrine tumors, and colorectal cancer as primary targets for its pipeline [14] Clinical Trials and Research - **Ongoing Trials**: Exelixis has multiple ongoing or planned pivotal trials, including STELLAR-304 for non-clear cell renal cell carcinoma (RCC) and LITESPARK-033 for patients progressing after adjuvant Pembrolizumab [35][49] - **Zanza's Mechanism of Action**: Zanza is designed to target multiple pathways (MET, TAM kinases, VEGF) to combat resistance and improve patient outcomes [30][32] Unmet Medical Needs - **Non-Clear Cell RCC**: There is a significant unmet need in treating non-clear cell RCC, which has historically been underrepresented in clinical trials [20][24] - **Adjuvant Treatment Gaps**: The introduction of Pembrolizumab in the adjuvant setting has created a new patient population with unmet needs, which Exelixis aims to address with Zanza and HIF-2 inhibitors [49] Collaboration and Partnerships - **Expert Collaborations**: Exelixis collaborates with leading oncologists and institutions to enhance its research and development efforts, ensuring a strong focus on patient outcomes [60] Conclusion - **Commitment to Oncology**: Exelixis emphasizes its long-term commitment to advancing treatment options in oncology, particularly in renal cell carcinoma, with a focus on innovative therapies and patient care [61]

Strategy and Vision - Exelixis aims to become a top 5 solid tumor oncology company by building next-generation oncology franchises across products, modalities, and tumors[8, 12] - The company plans to maintain focus on solid tumors and select modalities to maximize R&D productivity and build product, modality, and tumor franchises[13] - Exelixis anticipates sustained revenue growth through 2031 and beyond by establishing, expanding, and entrenching leadership in key tumors[5, 13] Financial Performance and Growth - Net product revenues are projected to grow from $1.63 billion in FY 2023 to approximately $2.10-$2.15 billion in FY 2025[9] - The 3L+ mCRC market is approaching $1.5 billion in 2026, representing a significant opportunity for zanzalintinib[102] - The CRC market is expected to grow from approximately $3.4 billion in 2024 to $7 billion in 2035, with a compound annual growth rate (CAGR) of 6.6%[123] Pipeline Development and Clinical Trials - Zanzalintinib's phase 3 trial (STELLAR-303) met its primary endpoint, supporting its first NDA filing[9] - Multiple zanzalintinib pivotal trials have been initiated or are planned, including two phase 3 studies in RCC in collaboration with Merck[5, 9] - STELLAR-303 trial data showed median OS of 10.9 months for Zanzalintinib + Atezolizumab arm vs 9.4 months for Regorafenib arm, with HR of 0.80 (95% CI, 0.69–0.93); P=0.0045[93] Key Product Candidates and Franchises - The company is focusing on RCC, neuroendocrine, and CRC franchises as core to its portfolio strategy[24] - XB628, a novel NKG2A x PD-L1 bispecific antibody, is in Phase 1 clinical trials with potential in IO sensitive and insensitive tumors[10, 65] - XL557, an oral SSTR2 agonist, has the potential to broadly displace SSAs in NET, with branded SSAs generating approximately $1.1 billion in U.S sales in 2024[10, 140]

Core Insights - Exelixis is a midsized commercial stage biotech company focused exclusively on oncology, navigating various challenges over the past 25 years, particularly in the last decade [3]. Company Overview - The company has a commercial story centered around CABOMETYX, alongside recent and upcoming data releases for zanzalintinib, which is a key pipeline product [2]. - Exelixis is preparing to close out 2025 and transition into 2026, indicating a strategic focus on future growth and development [2].

Core Insights - Exelixis reported a revenue of $597.76 million for the quarter ended September 2025, reflecting a year-over-year increase of 10.8% and an EPS of $0.78, up from $0.47 in the same quarter last year [1] - The revenue exceeded the Zacks Consensus Estimate of $589 million by 1.49%, while the EPS surpassed the consensus estimate of $0.68 by 14.71% [1] Revenue Breakdown - Net product revenue was $542.93 million, exceeding the average estimate of $532.38 million by analysts, with a year-over-year increase of 13.6% [4] - Collaboration revenues reached $54.83 million, surpassing the estimated $50.78 million, marking a significant year-over-year increase of 4307.2% [4] - CABOMETYX generated $539.9 million in net product revenue, slightly above the average estimate of $538.89 million, with a year-over-year change of 13.5% [4] - COMETRIQ reported net product revenue of $3.1 million, compared to the average estimate of $3.17 million, reflecting a year-over-year increase of 29.2% [4] - License revenues from collaboration amounted to $56.24 million, exceeding the average estimate of $50.62 million [4] - Collaboration services revenues were reported at -$1.41 million, falling short of the estimated $1.42 million [4] Stock Performance - Exelixis shares have returned -4.9% over the past month, contrasting with the Zacks S&P 500 composite's increase of 2.1% [3] - The stock currently holds a Zacks Rank 4 (Sell), indicating potential underperformance relative to the broader market in the near term [3]