Financial Data and Key Metrics Changes - For Q3 2025, total revenues were 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 [5][12] - Gross-to-net for the Cabozantinib franchise was 30.4%, with expectations to maintain around 30% for the year [12] - GAAP net income for Q3 2025 was approximately $193.6 million, or $0.72 per share basic, and $0.69 per share diluted, while non-GAAP net income was approximately $217.9 million, or $0.81 per share basic, and $0.78 per share diluted [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 business showed strong performance, with net product revenues growing to approximately $543 million in Q3 2025, driven by robust demand and revenue growth [5][12] - The demand for Cabozantinib in neuroendocrine tumors grew about 50%, contributing approximately 6% of total business in Q3 2025, with expectations to exceed $100 million in revenue for this indication in 2025 [6][32] - Zanzalintinib is advancing with seven ongoing pivotal trials, focusing on expanding its indications and combinations, with positive results from the Stellar-303 trial in colorectal cancer [8][10] Market Data and Key Metrics Changes - Cabozantinib maintained its leadership position as the top TKI for renal cell carcinoma (RCC), with a greater than 40% new patient share in the oral second-line plus segment [5][6] - The Cabometyx business continued to grow, with TRX volume increasing by 21% in Q3 2025 compared to Q3 2024, outpacing the market basket growth rate of 13% [29] - The market for neuroendocrine tumors is viewed positively, with Cabometyx rapidly becoming the market leader in this segment, achieving over 40% new patient share for oral therapies [32] Company Strategy and Development Direction - The company aims to build a best-in-class, multi-franchise oncology business, focusing on improving the standard of care for cancer patients [4] - There is a strong emphasis on expanding the GI sales team to accelerate growth in the Cabozantinib neuroendocrine tumor indication and prepare for the Zanzalintinib launch [6][37] - The company is committed to managing capital allocation effectively while advancing R&D and commercial priorities, with plans to repurchase shares when undervalued [11] 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 to become a significant oncology franchise [4][8] - The company is optimistic about the regulatory approval process for Zanzalintinib, particularly following the positive results from the Stellar-303 trial [10][24] - Management highlighted the importance of the upcoming R&D day for sharing further details on pipeline developments and strategic initiatives [11][27] Other Important Information - The company announced a new share repurchase program totaling $750 million, authorized by the board, which will expire at the end of 2026 [15] - Susan Hubbard, EVP of Public Affairs and Investor Relations, announced her retirement, with Andrew Peters taking over her responsibilities [39][40] Q&A Session Summary Question: Summary of post-ESMO feedback on Zanzalintinib results - Management noted positive feedback from physicians regarding the overall survival benefit and the potential of Zanzalintinib as a chemo-free option in a fragmented market [42][44] Question: Rationale for using Sunitinib as a control in Stellar-304 - Management explained that Sunitinib is a standard of care in the setting and provides a relevant comparator due to its extensive use [49][50] Question: Expectations for the NLM cut from Stellar-303 - Management indicated that the study design allowed for a combined analysis, and results for the non-liver metastases subgroup are expected around mid-2026 [52][56] Question: Impact of Merck's LITESPARK-011 on Zanzalintinib - Management expressed confidence that ongoing trials with Merck will continue and emphasized the collaboration's potential [59][62] Question: Concerns regarding Stellar-303 trial approval - Management refrained from commenting on external opinions but maintained confidence in the trial's outcomes [64] Question: Strategy for NET population and potential cannibalization with Zanzalintinib - Management highlighted the distinct positioning of Zanzalintinib and the ongoing growth potential for Cabozantinib in the NET space [67][69]

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]

Financial Performance - Total revenues for Q3 2025 were $597.8 million, up from $539.5 million in Q3 2024, representing an increase of approximately 10.5%[3] - U.S. net product revenues from the cabozantinib franchise were $542.9 million, compared to $478.1 million in the same period last year, reflecting a growth of about 13.5%[3] - GAAP net income for Q3 2025 was $193.6 million, or $0.69 per diluted share, compared to $118.0 million, or $0.40 per diluted share in Q3 2024, marking a year-over-year increase of 64%[9] - Non-GAAP net income for Q3 2025 was $217.9 million, or $0.78 per diluted share, compared to $135.7 million, or $0.47 per diluted share in Q3 2024, indicating a growth of approximately 60.6%[10] - Total revenues for the nine months ended September 30, 2025, reached $1.72 billion, compared to $1.60 billion for the same period in 2024, reflecting a 7.5% growth[34] - The company’s net income for Q3 2025 was $193.58 million, up 64.2% from $117.97 million in Q3 2024[34] Expenses - Research and development expenses decreased to $199.2 million in Q3 2025 from $222.6 million in Q3 2024, a reduction of about 10.5%[5] - Selling, general and administrative expenses increased to $123.7 million in Q3 2025 from $111.8 million in Q3 2024, an increase of approximately 10.5%[6] - The company’s operating expenses for Q3 2025 totaled $361.22 million, a decrease from $403.47 million in Q3 2024[34] Stock and Shareholder Returns - Exelixis announced an additional stock repurchase program for up to $750 million by the end of 2026[1] - Exelixis has repurchased $895.3 million of its common stock at an average price of $37.18 per share as of September 30, 2025, returning $1.9 billion to shareholders since March 2023[24] - The weighted-average diluted common shares outstanding decreased from 326.3 million to 278.5 million shares since the first stock repurchase program in March 2023[24] Future Plans and Guidance - Exelixis is providing updated financial guidance for 2025, projecting total revenues between $2.30 billion and $2.35 billion[15] - The company plans to submit a New Drug Application for zanzalintinib in combination with atezolizumab for advanced colorectal cancer by the end of 2025[18] - Exelixis plans to submit a New Drug Application for zanzalintinib in combination with atezolizumab by the end of 2025, pending government service availability[30] Pipeline Development - The cabozantinib franchise generated $542.9 million in net product revenues, with $46.3 million earned in royalty revenues from collaboration partners[16] - Exelixis initiated a phase 1 study of XB371 in August 2025, expanding its early-stage pipeline programs to four ongoing phase 1 trials[23] - Exelixis estimates a federal cash tax benefit of $147 million from the repeal of the requirement to capitalize domestic R&E expenditures, effective for taxable years beginning after December 31, 2024[25]

Group 1: Institutional Investment Activity - Belpointe Asset Management LLC purchased a new stake in Exelixis worth approximately $572,000 during the first quarter [1] - Envestnet Asset Management Inc. increased its position in Exelixis by 23.9%, now owning 248,073 shares valued at $9,159,000 after purchasing an additional 47,845 shares [1] - Intech Investment Management LLC increased its position by 46.4%, now holding 392,022 shares worth $14,473,000 after acquiring an additional 124,297 shares [1] - 85.27% of Exelixis stock is currently owned by hedge funds and other institutional investors [1] Group 2: Analyst Ratings and Price Targets - Truist Financial lowered its price target on Exelixis from $56.00 to $49.00 while maintaining a "buy" rating [2] - Morgan Stanley reduced its price target from $50.00 to $44.00, assigning an "overweight" rating [2] - Guggenheim reiterated a "buy" rating with a price target of $45.00 [2] - Leerink Partners upgraded Exelixis from "market perform" to "outperform" with a price target of $48.00 [2] - The average rating for Exelixis is "Moderate Buy" with a consensus price target of $44.53 [2] Group 3: Stock Performance and Financial Metrics - Exelixis shares opened at $38.67, with a market cap of $10.41 billion [3] - The stock has a P/E ratio of 18.59 and a PEG ratio of 0.79 [3] - Exelixis has a 52-week low of $31.90 and a high of $49.62 [3] Group 4: Company Overview - Exelixis, Inc. focuses on the discovery, development, and commercialization of new medicines for difficult-to-treat cancers in the U.S. [4] - The company offers CABOMETYX for advanced renal cell carcinoma and COMETRIQ for progressive and metastatic medullary thyroid cancer [4]

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]

Upgrades - BofA upgraded Eversource (ES) to Buy from Neutral with a price target of $85, up from $73, citing an "improving regulatory tone" and a projected 6% EPS growth through 2029 [2] - Leerink upgraded Exelixis (EXEL) to Outperform from Market Perform with a price target of $48, up from $38, following the Phase 3 STELLAR-303 trial results, which established important levers for long-term investment despite a 12% stock decline [3] - Citi upgraded Nextracker (NXT) to Buy from Neutral with a price target of $114, up from $66, highlighting its dominant position in tracker sales and potential revenue contributions from acquired businesses by FY30 [4] - Citi upgraded Sunrun (RUN) to Buy from Neutral with a price target of $26, up from $11, noting benefits from rising electricity rates and increased leverage over suppliers due to market shifts [5] - Raymond James upgraded Capri Holdings (CPRI) to Outperform from Market Perform with a price target of $25, indicating a favorable turnaround position supported by improving demand and conservative guidance [6] Downgrades - JPMorgan downgraded Goldman Sachs (GS) to Neutral from Overweight with a price target of $750, up from $625, citing high current valuations compared to European investment banks [7] - BNP Paribas Exane downgraded Verizon (VZ) to Neutral from Outperform with a price target of $44, raising concerns about strategic direction following a recent CEO change [7] - BNP Paribas Exane downgraded NuScale Power (SMR) to Underperform from Neutral with a price target of $25, down from $41, due to concerns over cumulative shipments and financial commitments [7] - Citi downgraded NuScale to Sell from Neutral with a price target of $37.50, down from $46, highlighting potential sales by Fluor and stretched valuations [7] - TD Cowen downgraded Tempus AI (TEM) to Hold from Buy with a price target of $88, up from $72, viewing the stock as fairly valued after a significant rally [7] - Wells Fargo downgraded Cleveland-Cliffs (CLF) to Underweight from Equal Weight with an unchanged price target of $11, describing the recent stock rally as "excess exuberance" [7]

Core Viewpoint - Top Wall Street analysts have revised their outlook on several prominent stocks, indicating potential shifts in investment sentiment and opportunities in the market [1] Group 1: Analyst Ratings Changes - The article highlights changes in analyst ratings, including upgrades, downgrades, and initiations for various stocks [1] - Specific mention of NXT stock suggests it is under consideration for purchase based on analysts' opinions [1]

Core Insights - Exelixis Inc. stock is experiencing a decline following the release of detailed results from the STELLAR-303 Phase 3 trial, which evaluated zanzalintinib in combination with Roche's Tecentriq against Bayer's Stivarga for metastatic colorectal cancer [1][6] Group 1: Trial Results - The STELLAR-303 trial met one of its dual primary endpoints, showing a 20% reduction in the risk of death in the intention-to-treat population at the final analysis [2] - At a median follow-up of 18 months, median overall survival was 10.9 months for the zanzalintinib and atezolizumab combination compared to 9.4 months for regorafenib [2] - The 12- and 24-month landmark overall survival estimates were 46% and 20% for the combination, versus 38% and 10% for regorafenib [4] Group 2: Additional Findings - An interim analysis indicated a trend favoring the combination with overall survival of 15.9 months compared to 12.8 months at a median follow-up of 16.8 months [5] - A trend for improvement in progression-free survival (PFS) was also observed, although statistical superiority cannot be claimed at this time due to the prespecified hierarchical testing strategy [5][6] - The trend for PFS improvement was consistent across subgroups [6]

Market Overview - U.S. stock futures are higher, with Dow futures gaining approximately 0.2% on Monday [1] Company-Specific Movements - Olema Pharmaceuticals Inc (NASDAQ:OLMA) shares fell 18.3% to $7.64 in pre-market trading following the announcement of new data from the Phase 1b/2 trial of palazestrant plus ribociclib in ER+/HER2- metastatic breast cancer at ESMO 2025 [1] - Concord Medical Services Hldgs Ltd (NYSE:CCM) experienced a decline of 24.4% to $4.15 in pre-market trading after a 6% drop on Friday [3] - Addex Therapeutics Ltd – ADR (NASDAQ:ADXN) dipped 15.6% to $9.23 in pre-market trading after a significant gain of 28% on Friday [3] - Exelixis Inc (NASDAQ:EXEL) shares fell 8.3% to $36.00 after announcing detailed results from the Phase 3 STELLAR-303 pivotal trial evaluating zanzalintinib in combination with an immune checkpoint inhibitor in metastatic colorectal cancer, presented at ESMO 2025 and published in The Lancet [3] - Cellectis SA (NASDAQ:CLLS) shares declined 7.3% to $3.69 in pre-market trading [3] - Alumis Inc (NASDAQ:ALMS) saw a decline of 6.7% to $4.19 in pre-market trading [3] - Nanobiotix SA – ADR (NASDAQ:NBTX) fell 6.3% to $23.98 in pre-market trading after a 4% decline on Friday [3] - Genmab A/S – ADR (NASDAQ:GMAB) declined 4.1% to $31.81 in pre-market trading, with Rinatabart Sesutecan achieving a 50% objective response rate and two complete responses in advanced endometrial cancer [3] - Taysha Gene Therapies Inc (NASDAQ:TSHA) fell 4% to $4.53 in pre-market trading [3]