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]

Key Takeaways EXEL is collaborating with Natera on the STELLAR-316 study in resected stage II/III colorectal cancer.The trial will test zanzalintinib with or without an immune checkpoint inhibitor in MRD-positive CRC patients.Exelixis plans to start STELLAR-316 in mid-2026, with disease-free survival as the primary endpoint.Exelixis, Inc. (EXEL) announced that it has collaborated with Natera (NTRA) for the STELLAR-316 study.This phase III study is being sponsored by Exelixis.The study will evaluate Exelixis ...

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 reported better-than-expected Q3 2025 earnings, with adjusted earnings of 78 cents per share, surpassing the Zacks Consensus Estimate of 68 cents, and up from 47 cents in the same quarter last year [3][4] - Net revenues reached $598 million, exceeding the Zacks Consensus Estimate of $589 million, and reflecting a year-over-year increase of 10.8% [4] - The growth in revenues was primarily driven by a 13.5% increase in net product revenues, totaling $542.9 million, attributed to higher sales volume [5] Financial Performance - Cabometyx generated revenues of $540 million, slightly above the Zacks Consensus Estimate of $539 million, and Cometriq contributed $3.1 million in net product revenues [6] - Collaboration revenues totaled $54.8 million, down 10.8% from $61.5 million in the previous year, mainly due to lower milestone-related revenues [9] - Research and development expenses decreased by 10.5% year over year to $199.2 million, while selling, general, and administrative expenses rose by 10.6% to $123.7 million [10] Stock Repurchase Program - Exelixis has repurchased $895.3 million of its common stock under its stock repurchase programs, with plans to complete the February 2025 authorization by Q4 2025 [12] - In October, the board authorized an additional $750 million for stock repurchases, to be completed before December 31, 2026 [12] Guidance and Estimates - The company updated its 2025 revenue guidance to a range of $2.30 billion to $2.35 billion, with net product revenues expected between $2.10 billion and $2.15 billion [13] - Research and development expenses are now anticipated to be between $850 million and $900 million, while selling, general, and administrative expenses are expected to be in the range of $500 million to $525 million [14] Pipeline and Regulatory Updates - Exelixis is developing zanzalintinib, with positive results from the STELLAR-303 study, and plans to submit a new drug application for its use in metastatic colorectal cancer by the end of 2025 [15][17] - The company has initiated a phase I study of XB371, its next-generation tissue factor-targeting antibody-drug conjugate [20] Market Performance - Exelixis has seen a 19.65% upward shift in consensus estimates over the past month, indicating positive investor sentiment [21] - The stock has a VGM Score of A, reflecting strong growth and momentum, and is positioned in the top 40% for value [22]

Group 1: Axsome Therapeutics - Axsome Therapeutics has shown strong clinical and regulatory progress, with a 63% year-over-year revenue increase to $171 million in Q3 [3][6] - The company’s main growth driver is Auvelity, approved for major depressive disorder, and it has received approval for Symbravo, a migraine medication [4][3] - Axsome estimates a potential of over $16 billion in peak sales across all its targeted indications, indicating a large addressable market [6][7] - The company has several late-stage pipeline candidates, including AXS-12 for narcolepsy, which could further enhance its growth prospects [6][8] Group 2: Exelixis - Exelixis specializes in cancer medicine, with Cabometyx as its primary product, approved for multiple indications, contributing to a 10.8% year-over-year revenue increase to $597.8 million in Q3 [9][10] - The company successfully won a lawsuit to keep generic competition for Cabometyx off the market until 2030, boosting its medium-term outlook [10] - Exelixis is developing new cancer therapies, including zanzalintinib for metastatic colorectal cancer, which has shown promise in clinical trials [12][13] - The ongoing development of new treatments and the upward sales trajectory of Cabometyx could enhance Exelixis's stock performance in the coming years [13]

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, Inc. (EXEL) reported better-than-expected results for Q3 2025, with adjusted earnings of 78 cents per share, surpassing the Zacks Consensus Estimate of 68 cents and up from 47 cents in the same quarter last year [1][8] - Net revenues reached $598 million, exceeding the Zacks Consensus Estimate of $589 million and reflecting a year-over-year increase of 10.8% [2][8] - The company's stock has increased by 13.9% year-to-date, outperforming the industry gain of 10.9% [4] Financial Performance - The year-over-year revenue growth was driven by higher product sales, with net product revenues of $542.9 million, up 13.5% year over year [5][8] - Cabometyx (cabozantinib) generated revenues of $540 million, slightly above the Zacks Consensus Estimate of $539 million [6][8] - Collaboration revenues totaled $54.8 million, down 10.8% from $61.5 million in the previous year, primarily due to lower milestone-related revenues [10] Expense Management - Research and development expenses amounted to $199.2 million, down 10.5% year over year, attributed to decreased clinical trial costs [11] - Selling, general, and administrative expenses increased to $123.7 million, up 10.6% year over year, mainly due to higher stock-based compensation [11] Stock Repurchase Program - Exelixis has repurchased $895.3 million of its common stock as of September 30, 2025, under its stock repurchase programs [12][13] - The board authorized an additional $750 million for repurchase before December 31, 2026 [13] Updated Guidance - The company narrowed its 2025 revenue outlook to $2.30-$2.35 billion, with net product revenues estimated between $2.10-$2.15 billion [14] - Research and development expenses are now expected to be in the range of $850-$900 million, while selling, general, and administrative expenses are anticipated to be $500-$525 million [15] Pipeline Developments - Exelixis is developing zanzalintinib, a next-generation oral investigational tyrosine kinase inhibitor, with positive results from the STELLAR-303 study [16][17] - The company plans to submit a new drug application for zanzalintinib in combination with atezolizumab for metastatic colorectal cancer by the end of 2025 [19] - Exelixis has initiated several ongoing phase I studies for its pipeline programs, including XB371, a next-generation tissue factor-targeting antibody-drug conjugate [22] Market Position - Overall performance in the quarter was encouraging, with a beat in both earnings and sales, and initial demand for Cabometyx in the newly approved indication is promising [23]

Financial Performance - Total revenues for Q3 2025 increased by 11% year-over-year to $597.8 million[37], and 5% quarter-over-quarter[37] - Cabozantinib net product revenues were $542.9 million in Q3 2025[22] - GAAP net income for Q3 2025 was $193.6 million, a 64% increase year-over-year[37] - GAAP diluted earnings per share increased by 73% year-over-year to $0.69[37] - The company completed $689.6 million in stock repurchases through Q3 2025, with an additional $750 million SRP authorized through 2026[39, 40] - Full year 2025 total revenue guidance is $2.30 billion - $2.35 billion[41] Research and Development - Positive results were presented from the Phase 3 STELLAR-303 trial of zanzalintinib + atezolizumab in metastatic colorectal cancer (mCRC) at ESMO, with a statistically significant improvement in overall survival (OS) in the ITT population[16, 50] - The company intends to submit an NDA for zanzalintinib in CRC in December 2025[16, 50] - Enrollment was completed in Q2 2025 for the Phase 3 STELLAR-304 trial of zanzalintinib + nivolumab in 1L nccRCC, with top-line results anticipated mid-2026[65] - The Phase 3 STELLAR-311 study in advanced NET was initiated in Q2 2025[116] Commercial Performance - Cabometyx TRx market share reached approximately 46% in Q3 2025[88] - NET contributed approximately 6% to overall CABOMETYX Q3 volume[91] - CABOMETYX captured over 40% of new patient share of the small molecule segment in the 2L+ NET market[102, 104]

Core Insights - Exelixis, Inc. has been upgraded to Outperform from Market Perform by Leerink Partners, with a new price target set at $48, up from $38 [1][2] - The upgrade follows the ESMO presentation of the Phase 3 STELLAR-303 trial, which evaluated zanzalintinib plus atezolizumab against regorafenib in 3L non MSI-high metastatic colorectal cancer [2] - Despite a 12% decline in stock price due to initial data pressure, the trial is seen as establishing significant long-term investment potential for Exelixis [2][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 [3] - The STELLAR-303 trial results are expected to pave the way for the approval of zanzalintinib, which could help offset revenue losses from cabometyx after its patent expiry in 2028 [3]

Core Insights - Exelixis, Inc. reported results from its STELLAR-303 trial comparing zanzalintinib plus atezolizumab to regorafenib in metastatic colorectal cancer (mCRC) on October 20 [1] Group 1 - The STELLAR-303 trial results are significant for the company's ongoing research in the oncology sector [1]