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]

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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]

Exelixis (EXEL) came out with quarterly earnings of $0.78 per share, beating the Zacks Consensus Estimate of $0.68 per share. This compares to earnings of $0.47 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of +14.71%. A quarter ago, it was expected that this drug developer would post earnings of $0.65 per share when it actually produced earnings of $0.75, delivering a surprise of +15.38%.Over the last four quarters, the compan ...

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]

TUESDAY, NOVEMBER 4, 2025 Third Quarter 2025 Financial Results Nasdaq: EXEL Today's Agenda | Introduction | Susan Hubbard | | --- | --- | | | EVP, Public Affairs and Investor Relations | | Third Quarter 2025 Highlights | Michael M. Morrissey, Ph.D. | | | President and CEO | | Financial Results & Guidance | Chris Senner | | | EVP and CFO | | Research & Development Update | Dana T. Aftab, Ph.D. | | | EVP, Research and Development | | Commercial Update | PJ Haley | | | EVP, Commercial | Q&A All Participants 2 ...

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]