Core Insights - Exelixis aims to become a top five solid tumor oncology company, supported by its successful drug cabozantinib, which has significantly boosted its stock performance [1][2] Group 1: Company Overview - Exelixis is a small biotech company with a market capitalization of $11 billion and a gross margin of 96.39% [3] - The company's stock has increased over 20% in the past year and over 97% in the last five years [1] Group 2: Product Pipeline - Cabozantinib, marketed as Cabometyx and Cometriq, is the lead drug, approved for multiple cancer types including kidney, thyroid, liver, and advanced pancreatic neuroendocrine tumors [3][4] - The drug is undergoing a phase 3 trial for advanced neuroendocrine tumors and is protected from generic competition until early 2031 [5] Group 3: Financial Performance - In 2025, Exelixis reported a 7% revenue increase to $2.3 billion, primarily from cabozantinib, with earnings per share rising 57.9% to $2.78 [6] Group 4: New Drug Developments - Zanzalintinib received FDA approval for metastatic colorectal cancer and is involved in multiple phase 3 trials for various cancers [7] - The early-stage pipeline includes antibody-drug conjugates targeting cancer cells with high precision [8] Group 5: Strategic Partnerships - Exelixis collaborates with Takeda Pharmaceutical and Ipsen for cabozantinib sales in Japan [9] - An agreement with Natera will utilize its Signatera assay for enrolling colorectal cancer patients in zanzalintinib's phase 3 trial [10] - The company is also partnering with Merck for zanzalintinib trials in head and neck cancer and kidney cancer [11]

Core Viewpoint - Exelixis has been gaining recognition in the biotech sector over the past five years, driven by strong financial performance and growth potential, particularly through its cancer drug Cabometyx [1] Financial Performance - Exelixis has shown solid financial results with increasing revenue, earnings, and free cash flow over the past five years, slightly outperforming the S&P 500 during this period [3] Product Success - The success of Exelixis is largely attributed to Cabometyx, which is the top-prescribed cancer drug for renal cell carcinoma and has received multiple label expansions, including combination treatments with established drugs like Bristol Myers Squibb's Opdivo [2] Future Prospects - Exelixis is preparing for potential challenges as Cabometyx may face generic competition by early 2030, but the drug is expected to maintain its market position until then [4] - In March 2025, Cabometyx received approval for treating previously treated advanced neuroendocrine tumors, expanding its market reach [5] Pipeline Development - To mitigate reliance on Cabometyx, Exelixis is developing zanzalintinib, which has completed a phase 3 study for metastatic colorectal cancer, an area with significant unmet medical needs [6] - The company has requested regulatory approval for zanzalintinib in colorectal cancer and plans to explore additional indications, alongside other pipeline candidates that may progress clinically in the coming years [7]

Core Insights - Exelixis, Inc. (EXEL) reported better-than-expected fourth-quarter results for 2025, with adjusted earnings per share (EPS) of 94 cents, surpassing the Zacks Consensus Estimate of 77 cents and up from 55 cents in the same quarter last year [1][2][6] - The company achieved net revenues of $598.7 million, exceeding the Zacks Consensus Estimate of $585 million, representing a year-over-year increase of 5.6% [2][4] - Despite the positive results, Exelixis' stock experienced a decline in pre-market trading following the earnings announcement [2] Financial Performance - The growth in net revenues was primarily driven by higher product sales, with net product revenues reaching $546.6 million, a 6% increase year over year [4] - Cabometyx (cabozantinib) generated revenues of $544.7 million, slightly missing the Zacks Consensus Estimate of $554 million but marginally exceeding internal estimates [5][6] - Collaboration revenues totaled $52.1 million, reflecting a 1% year-over-year increase, mainly due to higher royalty revenues from cabozantinib sales outside the U.S. [8] Operating Expenses - Research and development expenses, including stock-based compensation, decreased by 14.4% year over year to $213.2 million, attributed to lower clinical trial costs [9] - Selling, general, and administrative expenses fell by 8% year over year to $123 million, primarily due to reductions in stock-based compensation and personnel costs [9] Share Repurchase Program - During the quarter, Exelixis repurchased $264.5 million in shares, completing a $500 million share repurchase program authorized in February 2025 [10] - Since the initiation of its first share repurchase program in March 2023, the company has repurchased a total of $2.16 billion in common stock [10] 2025 Results and 2026 Guidance - For 2025, Exelixis reported revenues of approximately $2.32 billion, a 7% increase from 2024, with adjusted EPS of $3.08, up from $2 in 2024 [11] - The company expects total revenues for 2026 to be between $2.525 billion and $2.625 billion, with net product revenues projected to be in the range of $2.325 billion to $2.425 billion [12] Pipeline and Regulatory Updates - Exelixis is developing zanzalintinib, a next-generation oral investigational tyrosine kinase inhibitor, with an NDA accepted by the FDA for previously treated metastatic colorectal cancer [14][15] - The company is also advancing several phase I assets and has two new investigational new drug filings planned for 2026 [21][22] Market Position and Future Outlook - Cabometyx remains a leading TKI monotherapy for renal cell carcinoma (RCC) and is gaining traction in the neuroendocrine tumor market [23] - The strong uptake of Cabometyx in the newly approved NET indication is expected to drive future sales growth [24] - The potential approval of zanzalintinib is viewed as a significant catalyst for Exelixis' oncology pipeline, with management expanding sales infrastructure to support growth [24][25]

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 [16] - Full year 2025 US CABO franchise net product revenues grew 17% to approximately $2.12 billion compared to 2024 [10] - GAAP net income for Q4 2025 was approximately $244.5 million, or $0.92 per share basic [18] - Non-GAAP net income for Q4 2025 was approximately $259.5 million, or $0.97 per share basic [19] - Total operating expenses for Q4 2025 were approximately $363 million, up from $341 million in Q3 2025 [18] Business Line Data and Key Metrics Changes - CABOMETYX maintained its position as the leading TKI for renal cell carcinoma (RCC) and neuroendocrine tumors, with a TRX volume growth of 15% in Q4 2025 compared to Q4 2024 [21][22] - CABOMETYX's market share in the oral TKI market increased from 43% to 46% from Q4 2024 to Q4 2025 [21] - The company is preparing to launch zanzalintinib, with a focus on accelerating growth in the GI franchise [11][24] Market Data and Key Metrics Changes - CABOMETYX's US net product revenues exceeded $100 million for the neuroendocrine tumor indication in 2025 [10] - The market basket growth rate for oral TKIs was 7% for the same period, while CABOMETYX outpaced this growth [22] - The company anticipates significant growth opportunities in the community setting for CABOMETYX [52] Company Strategy and Development Direction - The company aims to build a multi-franchise business in solid tumor oncology, focusing on cabozantinib and zanzalintinib [8] - The strategy includes expanding leadership in gastrointestinal (GI) indications and enhancing the commercial footprint for both CABOMETYX and ZANZA [9][11] - Business development activities are focused on late-stage assets in GU and GI spaces, with a commitment to disciplined investment in high-value opportunities [14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about 2026 being a transformational year, with expectations to build on the momentum from 2025 [7][36] - The company is focused on maximizing productivity and advancing its early-stage pipeline while preparing for the potential launch of zanzalintinib [27][36] - Management highlighted the importance of addressing unmet medical needs in the colorectal cancer market with the upcoming STELLAR-303 trial results [25][29] Other Important Information - The company repurchased $954 million of its outstanding common stock in 2025, with approximately $590 million remaining under the stock repurchase plan [19][20] - The gross-to-net for the cabozantinib franchise in Q4 2025 was 28.5%, lower than in Q3 2025, primarily due to lower PHS and 340B volume [16] 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 [40] - The company plans to continue share repurchases as long as shares are perceived as undervalued, with a commitment to complete the current authorization [41] 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 [43][44] - The company will design its channel for Zanza to optimize results based on past experiences with CABO [45] Question: STELLAR-316 population size and timeline - The estimated population for STELLAR-316 is approximately 20,000-25,000 patients who are MRD positive after definitive therapy [48] Question: Revenue potential for neuroendocrine tumors - Management expressed confidence in the growth potential for CABOMETYX in neuroendocrine tumors, particularly in the community setting [51][52] Question: Zanza trial design and market expectations - Management emphasized the importance of establishing Zanza as a standard of care in RCC and highlighted ongoing discussions for potential combination trials [56][57] Question: Non-clear cell RCC market size and competition - Non-clear cell RCC represents approximately 20% of the RCC market, and the company sees significant potential for growth in this underserved area [83]

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]

TUESDAY, FEBRUARY 10, 2026 Fourth Quarter & Fiscal Year 2025 Financial Results Nasdaq: EXEL Today's Agenda Introduction Business Update & Highlights Financial Results & Guidance Commercial Update Research & Development Update Andrew Peters SVP, Strategy and Investor Relations Michael M. Morrissey, Ph.D. President and CEO Chris Senner EVP and CFO PJ Haley EVP, Commercial Dana T. Aftab, Ph.D. EVP, Research and Development All Participants 2 Q&A Forward-Looking Statements This presentation, including any oral ...

Core Viewpoint - Exelixis, Inc. is highlighted as a promising healthcare stock under $50, with a recent price target revision by Barclays indicating a positive outlook for the company [1]. Group 1: Financial Updates - Barclays revised the price target for Exelixis, Inc. to $44 from $41 while maintaining an Equal Weight rating [1]. Group 2: Drug Development - Exelixis announced the acceptance of its New Drug Application (NDA) for zanzalintinib in combination with atezolizumab for treating adult patients with metastatic colorectal cancer [2]. - The FDA has assigned a standard review for zanzalintinib, with a target action date of December 3, 2026 [3]. - Dana T. Aftab, Ph.D., emphasized the potential of zanzalintinib to provide a novel mechanism of action for previously treated metastatic colorectal cancer patients if approved [3]. Group 3: Company Overview - Exelixis, Inc. focuses on discovering, developing, and commercializing new medicines for difficult-to-treat cancers, with a product portfolio that includes cabometyx, cometriq, and cotellic [4].

Group 1: Exelixis Overview - Exelixis has seen a stock increase of +30% over the last year, with Q4 sales expected to rise by 3% year over year to $584.68 million and Q4 EPS projected to increase by 40% to $0.77 compared to $0.55 in the prior year quarter [1][4] - The company received FDA acceptance for a New Drug Application for a combination therapy targeting metastatic colorectal cancer, marking its transition from a single-product biotech to a multi-asset oncology company [2][3] - Exelixis has consistently surpassed Zacks EPS Consensus for six consecutive quarters, with an average earnings surprise of 21.39% in its last four quarterly reports [4][5] Group 2: Gilead Sciences Overview - Gilead Sciences' stock has surged nearly +60% in the last year, with Q4 sales expected to be flat at $7.57 billion and quarterly EPS anticipated to dip 3% to $1.83 [1][10] - The company's HIV franchise, particularly Biktarvy, is highlighted as a primary long-term growth driver, contributing to a "wide moat" for the business [8] - Gilead's robust R&D pipeline, including oncology and virology programs, has been noted as the most extensive in the company's history, fueling investor sentiment [9] Group 3: Financial Projections - For fiscal 2025, Exelixis' annual EPS is expected to increase by 48% to $2.96, while Gilead Sciences' EPS is projected to grow by 76% to $8.14 per share [11] - Exelixis trades at an attractive 12X forward earnings multiple, compared to Gilead's 17X, which is still a slight discount to the Zacks Medical-Biomedical and Genetics Industry average [11] Group 4: Investment Ratings - Exelixis holds a Zacks Rank 1 (Strong Buy), while Gilead Sciences has a Zacks Rank 3 (Hold) ahead of their Q4 reports [12]

Company Overview - Natera (NTRA) has submitted a premarket approval (PMA) application to the FDA for its Signatera CDx test, a personalized molecular residual disease (MRD) assay for muscle-invasive bladder cancer (MIBC) [1][6] - The PMA submission is a significant regulatory milestone for Natera, positioning Signatera CDx as a companion diagnostic to guide adjuvant immunotherapy decisions in MIBC [6][8] Clinical Data and Implications - The application is supported by positive phase 3 IMvigor011 trial data, which demonstrated improved survival outcomes in MRD-positive patients treated with Tecentriq, while MRD-negative patients showed a low risk of recurrence without additional therapy [2][9] - The trial results were strong enough to be featured in a Presidential Symposium at the ESMO Congress and published in The New England Journal of Medicine, enhancing credibility within the oncology community [10] Market Position and Growth Potential - If approved, Signatera CDx could serve as a long-term growth catalyst for Natera by expanding its MRD platform's role from monitoring to treatment decision-making [4][11] - The companion diagnostic status is expected to increase adoption among oncologists, strengthen partnerships with pharmaceutical companies, and support broader reimbursement coverage, leading to higher testing volumes and more sustainable revenue streams [4][11] Financial Performance - Natera's stock has surged 69.2% over the past six months, significantly outperforming the industry growth of 18.1% and the S&P 500's rise of 12.4% [3] - The current market capitalization of Natera stands at $31.97 billion [5] Industry Outlook - The global precision oncology market is projected to grow from an estimated $115.80 billion in 2024 to $201.96 billion by 2030, with a compound annual growth rate (CAGR) of 8.05% from 2025 to 2030 [12] - Growth in the market is driven by technological advancements, increasing demand for diagnostic solutions that provide clinically actionable insights, and the ability to reduce treatment-related side effects for cancer patients [13]

Core Insights - The biotech industry is characterized by volatility, with companies like Exelixis and Summit Therapeutics potentially experiencing significant stock price increases due to strong clinical progress in their drug pipelines Exelixis - Exelixis is a small biotech company focused on oncology, primarily driven by its cancer drug Cabometyx, which is facing generic competition expected by early 2030 [2] - The company is advancing its pipeline with the submission of an FDA application for zanzalintinib in metastatic colorectal cancer, in combination with Roche's Tecentriq [3] - Exelixis plans to initiate several phase 3 studies and expects two late-stage data readouts this year, which could positively impact its stock price [5] - If zanzalintinib secures approval and label expansions, Exelixis could see strong stock performance over the next five years, despite the impending patent cliff for Cabometyx [6] Summit Therapeutics - Summit Therapeutics is focused on its leading candidate, ivonescimab, which is undergoing multiple phase 3 clinical trials and has shown promising results against Keytruda in non-small cell lung cancer [7] - The company aims to replicate its success in the U.S. and has data readouts expected this year for ivonescimab in squamous NSCLC [8] - Summit has submitted an FDA application for ivonescimab in patients with EGFR-mutated NSCLC, with potential for significant stock price increases if approved [10] - The drug is being investigated across 42 studies, with analysts estimating peak sales could reach $53 billion, highlighting Summit's growth potential [11]