Group 1 - Exelixis is the final presenting company at the 44th Annual JPMorgan Healthcare Conference [1] - The presentation will be led by President and CEO Michael Morrissey [1][2]

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 ...

Financial Performance - Exelixis reported preliminary U.S. net product revenues of approximately $2.123 billion for fiscal year 2025[1]. - The company provided fiscal year 2026 net product revenues guidance of $2.325 billion to $2.425 billion[2]. - Total revenues for fiscal year 2025 are estimated at around $2.320 billion, with guidance for 2026 set at $2.525 billion to $2.625 billion[4]. - The effective tax rate for fiscal year 2026 is projected to be between 21% and 23%[4]. - Exelixis' preliminary financial results for FY 2025 are being finalized, with the company cautioning that these results are based on preliminary information and may differ from audited results[22]. Research and Development - Research and development expenses for fiscal year 2025 are approximately $825 million, with guidance for 2026 ranging from $875 million to $925 million[4]. - Exelixis anticipates continued growth in the cabozantinib franchise, which is the leading tyrosine kinase inhibitor in renal cell carcinoma and neuroendocrine tumors[8]. - The company expects to initiate the STELLAR-316 trial in mid-2026, evaluating zanzalintinib in patients with resected stage II/III colorectal cancer[14]. - Exelixis plans to advance two programs into clinical development in 2026, including LITESPARK-033 and STELLAR-201[14]. - The company is progressing XL309, XB010, XB628, and XB371 into full development as part of its strategy to build next-generation oncology franchises[21]. - The company is focused on advancing its pipeline, including the clinical development of XL557 and XB773, contingent on supportive phase 1 data[21]. Commercial Strategy - Exelixis anticipates 2026 to be a significant year for clinical, regulatory, and commercial progress, focusing on expanding its cabozantinib business and developing zanzalintinib[20]. - The company aims to establish lasting franchises in renal cell carcinoma (RCC), neuroendocrine tumors (NET), and colorectal cancer (CRC), while driving sustained growth and returning capital to shareholders[20]. - Exelixis expects continued strong commercial performance of cabozantinib, with anticipated growth in RCC and NET in 2026, including plans to expand its gastrointestinal (GI) sales team[20]. - The regulatory review process for zanzalintinib's NDA for previously metastatic CRC in combination with atezolizumab is underway, with potential first commercial launch planned[20]. - Exelixis plans to initiate several pivotal trials, including STELLAR-316 and STELLAR-301, in 2026, and expects clinical data readouts from STELLAR-303 and STELLAR-304[20]. - The company emphasizes the importance of maintaining adequate sales, marketing, and distribution capabilities for its products to ensure market acceptance[21]. Shareholder Returns - Exelixis has repurchased a total of $2.16 billion of its common stock since March 2023, retiring 76.7 million shares[16].

Core Insights - Exelixis, Inc. (EXEL) reported preliminary unaudited financial results for fiscal year 2025, with revenues of approximately $2.32 billion, slightly below the Zacks Consensus Estimate of $2.33 billion [2][8] - The company provided guidance for fiscal year 2026, projecting total revenues between $2.525 billion and $2.625 billion, driven by continued demand for its lead drug, Cabometyx [5][8] - Despite the positive outlook, the stock experienced a decline in pre-market trading on January 12, 2026 [1] Financial Performance - Preliminary net product revenues for 2025 were about $2.12 billion, with cash and marketable securities totaling $1.65 billion at year-end, indicating strong financial flexibility [4] - Research and development (R&D) expenses for 2025 were approximately $825 million, while selling, general and administrative (SG&A) expenses totaled around $520 million [4] 2026 Guidance - For 2026, net product revenues are expected to be in the range of $2.325 billion to $2.425 billion, reflecting a 3% price increase effective January 2026 [5][6] - Operating expenses are projected to rise, with R&D expenses estimated at $875 million to $925 million and SG&A expenses at $575 million to $625 million [6] Product Developments - Cabometyx continues to be a key growth driver, maintaining its position as the leading tyrosine kinase inhibitor (TKI) in renal cell carcinoma (RCC) [6][7] - The label expansion of Cabometyx to include treatment for pancreatic neuroendocrine tumors (pNET) and extra-pancreatic neuroendocrine tumors (epNET) is expected to boost sales further [3][7] Pipeline Expansion - Exelixis is actively expanding its oncology portfolio, with zanzalintinib being a significant near-term catalyst, currently under review for metastatic colorectal cancer (CRC) [10][11] - The company is also advancing several phase I assets, including XL309, XB010, XB628, and XB371, alongside plans for two new investigational new drug filings in 2026 [14][15] Shareholder Returns - Exelixis has repurchased $2.16 billion of stock since 2023, with an additional $750 million authorization in place through 2026, indicating a commitment to returning capital to shareholders [16] Market Performance - Exelixis shares have increased by 24.7% over the past year, outperforming the industry average gain of 19.6% [17]

Core Viewpoint - Exelixis anticipates significant clinical, regulatory, and commercial progress in 2026, focusing on expanding its cabozantinib business and developing zanzalintinib as a potential second commercial franchise while advancing its earlier-stage pipeline [1][19]. Financial Results and Guidance - Preliminary total revenues for fiscal year 2025 are approximately $2.320 billion, with guidance for fiscal year 2026 set between $2.525 billion and $2.625 billion [3]. - Net product revenues for fiscal year 2025 are approximately $2.123 billion, with guidance for fiscal year 2026 ranging from $2.325 billion to $2.425 billion [3]. - Cost of goods sold as a percentage of net product revenues is approximately 3.7% for 2025, with a projected range of 3.5% to 4.5% for 2026 [3]. - Research and development expenses for 2025 are approximately $825 million, with guidance for 2026 set between $875 million and $925 million [3]. - Selling, general, and administrative expenses for 2025 are approximately $520 million, with guidance for 2026 ranging from $575 million to $625 million [3]. - The effective tax rate for 2026 is projected to be between 21% and 23% [3]. Business Updates - The company is focused on leveraging its diverse pipeline and key clinical collaborations to build next-generation oncology franchises aimed at improving cancer care standards [1][6]. - Exelixis expects continued growth in its cabozantinib franchise, which is the leading tyrosine kinase inhibitor in renal cell carcinoma and neuroendocrine tumors [7]. - The company achieved major milestones with zanzalintinib, including a positive pivotal data readout and a U.S. regulatory filing for its use in metastatic colorectal cancer [6][8]. Regulatory and Clinical Milestones - The FDA is currently reviewing Exelixis' New Drug Application for zanzalintinib in combination with atezolizumab for previously treated metastatic colorectal cancer [2][8]. - The STELLAR-303 trial for zanzalintinib has shown a statistically significant reduction in the risk of death compared to regorafenib, with further analyses expected in mid-2026 [8][9]. - The STELLAR-304 trial is evaluating zanzalintinib in combination with nivolumab versus sunitinib in previously untreated advanced non-clear cell renal cell carcinoma, with results anticipated in mid-2026 [10]. Pipeline Development - Exelixis is advancing several phase 1 clinical trials for new molecules, including XL309, XB010, XB628, and XB371, with plans to progress them into full development if data are supportive [12]. - The company anticipates initiating two new IND applications in 2026, further expanding its oncology pipeline [13]. Stock Repurchase Program - Exelixis has repurchased a total of $2.16 billion of its common stock since March 2023, with an additional $750 million authorized for repurchase before December 31, 2026 [15].

Core Insights - Exelixis, Inc. is a biotechnology company focused on developing cancer treatments, particularly known for its innovative therapy cabozantinib [1] - The company is competing with other biotech firms like Amgen and Gilead Sciences in the oncology sector [1] Stock Performance and Analyst Outlook - Robert Burns from H.C. Wainwright set a price target of $52 for Exelixis, indicating a potential upside of 16.1% from the current trading price of $44.79 [2] - Following the announcement of the collaboration with Natera, Exelixis' stock increased by 6% on January 7, reflecting positive market sentiment [4] - Over the past year, Exelixis' shares have risen by 33.9%, significantly outperforming the industry gain of 17.2% [4][6] Collaboration and Clinical Trials - Exelixis announced a collaboration with Natera for the phase III STELLAR-316 study, focusing on the efficacy of zanzalintinib in patients with resected stage II/III colorectal cancer [3][6] - The trial will evaluate zanzalintinib both with and without an immune checkpoint inhibitor, with the primary endpoint being disease-free survival, expected to start in mid-2026 [3] Current Market Data - Exelixis' current stock price is approximately $44.74, showing a decrease of about 3.14% or $1.45 [5] - The stock has fluctuated between a low of $44.39 and a high of $45.84 during the trading day [5] - The company has a market capitalization of approximately $11.99 billion, with a trading volume of 561,415 shares [5]

Core Insights - Exelixis, Inc. (EXEL) has announced a collaboration with Natera (NTRA) for the STELLAR-316 study, a phase III trial evaluating zanzalintinib in patients with resected stage II/III colorectal cancer (CRC) [1][3] - Following the announcement, Exelixis' stock rose by 6% on January 7, and the shares have increased by 33.9% over the past year, outperforming the industry gain of 17.2% [1] Study Details - The STELLAR-316 study is set to begin in mid-2026 and will assess zanzalintinib, a novel oral kinase inhibitor, both alone and in combination with an immune checkpoint inhibitor [3][7] - Eligible patients for the trial are those with molecular residual disease (MRD)-positive CRC, as determined by Natera's Signatera test, after definitive therapy [3][4] - The primary endpoint of the study is disease-free survival, with a secondary endpoint focusing on the clearance of circulating tumor DNA [4][7] Zanzalintinib Development - Zanzalintinib is also being evaluated for advanced solid tumors, including CRC, kidney cancer, and neuroendocrine tumors [8] - Exelixis has submitted a new drug application (NDA) to the FDA for zanzalintinib in combination with Roche's Tecentriq for previously treated metastatic colorectal cancer, supported by positive results from the STELLAR-303 study [9][10] - The STELLAR-303 trial demonstrated a statistically significant reduction in the risk of death compared to Stivarga, with consistent overall survival benefits across various subgroups [10][11] Future Plans - Exelixis is planning additional pivotal trials for zanzalintinib, including studies in post-chemotherapy adjuvant CRC settings and high-grade recurrent meningiomas [12][13] - The company aims to expand its oncology portfolio beyond its lead drug, Cabometyx, which has recently received label expansion for treating neuroendocrine tumors [14]

Core Insights - The healthcare sector underperformed in 2025, but there are still solid investment opportunities in smaller biotech companies [1] - Axsome Therapeutics and Exelixis are highlighted as promising investment options for 2026 and beyond [2] Axsome Therapeutics - Axsome Therapeutics has made steady clinical and regulatory progress, with approved products including Auvelity for depression, Symbravo for migraines, and Sunosi for narcolepsy [3] - The company is close to earning approval for Auvelity in treating Alzheimer's disease agitation, which could address a significant unmet need, as approximately 5 million patients in the U.S. experience this condition [4] - Axsome's revenue for the first nine months of 2025 reached $442.5 million, marking a 65.8% increase year-over-year [7] - The company has several late-stage pipeline candidates, including AXS-12 for narcolepsy and AXS-14 for fibromyalgia, which could further boost revenue [6][8] Exelixis - Exelixis specializes in oncology, primarily generating revenue from Cabometyx, which is approved for various cancers, including liver and kidney cancer [9] - The company reported $1.7 billion in revenue for the first nine months of 2025, a 7.5% increase compared to the same period in 2024 [10] - Exelixis has successfully defended its patent rights, delaying generic competition until the next decade [10] - The company is developing new products, including Zanzalintinib for metastatic colorectal cancer, which has shown strong phase 3 results and could significantly impact sales [12][14] - Exelixis is expected to submit regulatory applications soon, which will help diversify its portfolio beyond Cabometyx [13]

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