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]

分组1 - Exelixis reported quarterly earnings of $0.78 per share, exceeding the Zacks Consensus Estimate of $0.68 per share, and showing an increase from $0.47 per share a year ago, resulting in an earnings surprise of +14.71% [1] - The company achieved revenues of $597.76 million for the quarter ended September 2025, surpassing the Zacks Consensus Estimate by 1.49%, and up from $539.54 million year-over-year [2] - Exelixis has surpassed consensus EPS estimates in all four of the last quarters and has topped consensus revenue estimates three times during the same period [2] 分组2 - The stock has gained approximately 14.3% since the beginning of the year, while the S&P 500 has increased by 16.5% [3] - The current consensus EPS estimate for the upcoming quarter is $0.64 on revenues of $609.17 million, and for the current fiscal year, it is $2.69 on revenues of $2.32 billion [7] - The Medical - Biomedical and Genetics industry, to which Exelixis belongs, is currently ranked in the top 39% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

Financial Data and Key Metrics Changes - For Q3 2025, the company reported total revenues of 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 [7][13] - Gross-to-net for the Cabozantinib franchise in Q3 2025 was 30.4%, with total operating expenses of approximately $361 million, compared to $355 million in Q2 2025 [13][14] - The company reported GAAP net income of approximately $193.6 million, or $0.72 per share basic, and non-GAAP net income of approximately $217.9 million, or $0.81 per share basic [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 U.S. business showed strong growth, with net product revenues growing to $543 million in Q3 2025, and global revenues from the Cabozantinib franchise reaching approximately $739 million [7][8] - Demand in neuroendocrine tumors grew about 50% and contributed approximately 6% of the third-quarter business, with expectations to exceed $100 million in revenue for this indication in 2025 [8][31] - The Zanzalintinib franchise is advancing with seven ongoing pivotal trials, and the company aims to file for regulatory approval in the CRC indication as soon as possible [9][10] Market Data and Key Metrics Changes - Cabozantinib maintained its leadership position as the top TKI for RCC, with a greater than 40% new patient share in the oral second-line plus net segment [7][8] - The company is expanding its GI sales team to accelerate growth in the Cabo net indication before Zanza's anticipated launch [8][34] - Market research indicates that Cabometyx is viewed as the best-in-class oral therapy in neuroendocrine tumors, which is expected to drive prescribing behavior positively [32][33] Company Strategy and Development Direction - The company is focused on building a best-in-class, multi-franchise oncology business, with a commitment to improving the standard of care for cancer patients [6][9] - There is a strong emphasis on the Zanzalintinib franchise as a potential second oncology franchise that could eclipse the size and impact of the Cabozantinib business [9][10] - The company plans to repurchase shares when undervalued and has been authorized to repurchase an additional $750 million of shares [12][15] 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, particularly following positive trial results [6][9] - The company is optimistic about the upcoming NDA filing for Zanzalintinib and the potential for a broad label in CRC, which could significantly enhance its market position [10][73] - Management highlighted the importance of navigating the competitive landscape effectively, especially with the anticipated launch of Zanzalintinib [9][10] Other Important Information - Susan Hubbard, EVP of Public Affairs and Investor Relations, announced her retirement, with Andrew Peters set to take over her responsibilities [38][39] - The company is preparing for an R&D day on December 10th, where more details on the early-stage pipeline and Zanzalintinib trials will be shared [12][27] Q&A Session Summary Question: Can you summarize the post-ESMO feedback on Zanzalintinib results? - Management noted positive feedback from physicians regarding the overall survival benefit and the potential for Zanzalintinib to capture market share in a fragmented market [42][44] Question: Why is Sunitinib the right control for STELLAR-304? - Management explained that Sunitinib is a standard of care in the setting and has a relevant target profile, making it a suitable comparator for the trial [48][50] Question: How does the STELLAR-303 data set expectations for the NLM cut? - Management indicated that the trial was designed to include both liver and non-liver metastases, with results expected to mature around mid-year 2026 [52][55] Question: What is the strategy regarding potential cannibalization between Cabozantinib and Zanzalintinib? - Management expressed confidence in the distinct positioning of Zanzalintinib in the market, emphasizing the growth potential for both products [67][70] Question: Will the NDA submission for Zanzalintinib include both subgroups? - Management confirmed that the NDA will be filed based on the ITT population, which encompasses the entire trial population, allowing for a broad label [72][73]

Financial Data and Key Metrics Changes - The company reported total revenues of approximately $598 million for Q3 2025, which included Cabozantinib franchise net product revenues of approximately $543 million, reflecting a year-over-year growth of about 14% from $478 million in Q3 2024 [7][13] - Non-GAAP net income for Q3 2025 was approximately $217.9 million, or $0.81 per share basic, compared to $193.6 million GAAP net income, or $0.72 per share basic [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][16] Business Line Data and Key Metrics Changes - The Cabozantinib business maintained its leadership position as the top TKI for RCC, with net product revenues growing to approximately $543 million in Q3 2025 [7][28] - Demand in neuroendocrine tumors grew about 50% quarter-over-quarter, contributing approximately 6% of total demand for Cabozantinib in Q3 2025 [8][31] - The company expects to exceed $100 million in revenue for the neuroendocrine tumor indication in 2025 [8][32] Market Data and Key Metrics Changes - The Cabozantinib franchise net product revenues generated globally were approximately $739 million in Q3 2025, compared to $653 million in Q3 2024 [7] - Cabometyx's TRX volume grew 21% in Q3 2025 relative to Q3 2024, outpacing the market basket growth rate of 13% [29] - Cabometyx achieved a new patient market share of over 40% in the second-line plus neuroendocrine tumors segment [31] 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 [6] - Zanzalintinib is positioned as the next oncology franchise opportunity, with seven ongoing and soon-to-start pivotal trials [9][12] - The company plans to expedite the build-out of its GI sales team to support the growth of the Cabozantinib neuroendocrine tumor indication and prepare for Zanzalintinib's launch [8][35] 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 eclipse it [6][9] - The company is optimistic about the regulatory approval process for Zanzalintinib, especially following positive results from the Stellar-303 trial [10][20] - Management highlighted the importance of capital allocation and plans to repurchase shares when undervalued, with an additional $750 million share repurchase program authorized [12][15] Other Important Information - Susan Hubbard, EVP of Public Affairs and Investor Relations, announced her retirement after more than 35 years in the biopharma industry [38] - Andrew Peters will take over investor relations responsibilities, reflecting a strategic move within the company [39] Q&A Session Summary Question: Can you summarize the post-ESMO feedback on Zanzalintinib results? - Management noted positive feedback from physicians regarding the overall survival benefit and the introduction of an immune checkpoint inhibitor in a significant tumor type [41][43] Question: Why is Sunitinib the right control for the Stellar-304 study? - Management explained that Sunitinib is a standard of care in the setting and has a relevant target profile, making it a suitable comparator [47][49] Question: How does the Stellar-303 initial data set expectations for the NLM cut? - Management indicated that the study's design allowed for a broader analysis, and they expect results for the non-liver metastases subgroup to mature around mid-year 2026 [51][54] Question: What is the clinical trial contribution for Cabozantinib in Q3? - There were no clinical trial sales reported in the quarter [58] Question: Is there a risk to the Stellar-303 trial approval? - Management refrained from commenting on external opinions regarding Cabozantinib's usefulness [62] Question: How is the NET launch performing relative to Lutathera? - Management expressed confidence in the strong performance of Cabozantinib in the NET market, indicating a favorable position compared to Lutathera [85]

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]