US Market News
3日前
Agilent Receives FDA Approval for Expanded Use of PD-L1 IHC 22C3 pharmDx on Dako Omnis in Esophageal Squamous Cell Carcinoma, Triple-Negative Breast Cancer, Cervical Cancer, and Gastric or Gastroesophageal Junction AdenocarcinomaJune 2, 2026 4:15 PM
Business Wire Approval expands PD-L1 testing onto an automated workflow to support treatment decisions with KEYTRUDA® (pembrolizumab)¹,² Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration (FDA) has approved the expanded use of PD-L1 IHC 22C3 pharmDx, Code GE006, for use on the Dako Omnis platform to aid in identifying patients in the United States with esophageal squamous cell carcinoma (ESCC)3, triple-negative breast cancer (TNBC)4, cervical cancer5, and gastric or gastroesophageal junction (GEJ) adenocarcinoma6, who may be eligible for treatment with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy. This approval expands access to PD-L1 testing across four additional tumor types beyond the previously approved non-small cell lung cancer (NSCLC)7 and head and neck squamous cell carcinoma (HNSCC)8. Until now, these FDA-approved PD-L1 IHC 22C3 pharmDx indications have been available on Autostainer Link 48 (ASL48) as the only platform and are now also approved for the Dako Omnis platform. This enables pathology laboratories to consolidate PD-L1 testing across more tumor types within a single automated Dako Omnis workflow, supporting increased automation and operational efficiency. Majken Nielsen, vice president and general manager of Agilent’s Clinical Diagnostics Division, stated: “Pathology laboratories are increasingly looking to standardize testing on automated platforms that fit seamlessly into daily workflow. By expanding PD-L1 IHC 22C3 pharmDx on Dako Omnis for additional FDA-approved indications, we’re helping labs deliver PD-L1 results more conveniently and efficiently, supporting clinicians as they identify patients who may be eligible for immunotherapy.” To support expanded use of PD-L1 IHC 22C3 pharmDx on Dako Omnis, Agilent conducted a multisite external platform performance comparison study evaluating concordance of PD-L1 IHC 22C3 pharmDx results across staining platforms (Code SK006 on the ASL48 platform and Code GE006 on Dako Omnis) for the four additional indication specimens. Study results met acceptance criteria to demonstrate inter-platform concordance for these specimens when assessed at the appropriate CPS cutoffs. PD-L1 IHC 22C3 pharmDx, Code SK006, was developed by Agilent in partnership with Merck & Co. (known as MSD outside the United States and Canada) as a companion diagnostic for KEYTRUDA. KEYTRUDA ® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Footnotes: PD-L1 IHC 22C3 pharmDx, Code GE006 [Instructions for Use]. Santa Clara, CA: Agilent Technologies, Inc.; 2026. KEYTRUDA® (pembrolizumab) Merck Sharp & Dohme LLC, Rahway, NJ, USA; 2026. For the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 [Combined Positive Score (CPS)≥10] as determined by an FDA-authorized test. In combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. As a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test. In combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test. As a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. As a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. As a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test. About Agilent Technologies Agilent Technologies, Inc. (NYSE: A) is a global leader in analytical and clinical laboratory technologies, delivering insights and innovation that help our customers bring great science to life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of $6.95 billion in fiscal year 2025 and employs approximately 18,000 people worldwide. Information about Agilent is available at www.agilent.com. To receive the latest Agilent news, subscribe to the Agilent Newsroom. Follow Agilent on LinkedIn and Facebook. View source version on businesswire.com: https://www.businesswire.com/news/home/20260602060341/en/ MEDIA CONTACT:
Kate Coyle
Agilent Technologies Inc.
+1 302-633-7490
kate.coyle@agilent.com Original: Agilent Receives FDA Approval for Expanded Use of PD-L1 IHC 22C3 pharmDx on Dako Omnis in Esophageal Squamous Cell Carcinoma, Triple-Negative Breast Cancer, Cervical Cancer, and Gastric or Gastroesophageal Junction Adenocarcinoma
US Market News
1週前
Agilent Reports Second-Quarter Fiscal Year 2026 Financial ResultsMay 27, 2026 4:05 PM
Business Wire Delivers strong Q2 results and raises FY26 revenue growth, margin expansion, and non-GAAP EPS(4) guidance on continued operational momentum Second-quarter fiscal year 2026 Revenue of $1.83 billion for the second quarter ended April 30, 2026, representing growth of 10.0% reported and up 6.3% core(1) compared with the second quarter of 2025. GAAP operating margin of 21.7%; non-GAAP operating margin(2) of 26.4% expanded by 130 basis points year-over-year and 180 basis points sequentially. GAAP net income of $339 million; earnings per share (EPS) of $1.20, an increase of 60% from the second quarter of 2025. Non-GAAP net income(3) of $423 million; non-GAAP EPS(3) of $1.49, an increase of 14% from the second quarter of 2025. Fiscal year 2026 improved outlook and third-quarter guidance Fiscal year 2026 revenue is now expected in the range of $7.39 billion to $7.49 billion, representing a range of up 6.3% to 7.8% reported and up 4.5% to 6.0% core,(1)(5) an increase of 30 basis points at the midpoint. Non-GAAP fiscal year 2026 operating margin expansion(2) at the midpoint of core revenue growth guidance is now expected to be 85 basis points, an increase of 10 basis points. Non-GAAP EPS(4) is now expected in the range of $6.00 to $6.10, an increase of 8 cents at the midpoint. Fiscal third-quarter 2026 revenue is expected in the range of $1.83 billion to $1.85 billion, growth of 5.0% to 6.5% reported and up 4.4% to 5.9% core(1)(5). Non-GAAP EPS(4) is expected in the range of $1.48 to $1.50 per share. Agilent Technologies Inc. (NYSE: A) today reported revenue of $1.83 billion for the second quarter ended April 30, 2026, representing growth of 10.0% reported and up 6.3% core(1) compared with the second quarter of 2025. Second-quarter GAAP net income was $339 million, or $1.20 per share. This compares with $215 million, or $0.75 per share, in the second quarter of 2025. Non-GAAP net income(3) was $423 million, or $1.49 per share, during the quarter, compared with $373 million, or $1.31 per share, during the year-ago quarter. “It was an excellent second quarter for Agilent, with broad-based strength across key end markets, exceptional operational execution and strong margin performance,” said Padraig McDonnell, president and CEO of Agilent Technologies. “The continued momentum we are seeing across the business reflects the strength of our customer-focused strategy, healthy underlying demand, and the increasing impact of the Ignite Operating System across the organization, supported by the resilience of our diversified portfolio. Innovation remains a key driver of our long-term growth. The introduction of solutions such as our new 9500 ICP-MS platform demonstrates our ability to anticipate evolving customer needs and translate those insights into differentiated technologies that improve laboratory productivity and performance. Combined with the continued progress of Ignite, replacement-cycle momentum, and a strong innovation pipeline, we remain well positioned to deliver sustainable growth and long-term value for our customers and shareholders.” Financial Highlights Life Sciences and Diagnostics Markets Group The Life Sciences and Diagnostics Markets Group (LDG) reported second-quarter revenue of $732 million, growth of 12% reported and 9% core(1) year-over-year. LDG’s operating margin for the quarter was 22.0%. Agilent CrossLab Group The Agilent CrossLab Group (ACG) reported second-quarter revenue of $759 million, growth of 6% reported and 2% core(1) year-over-year. ACG’s operating margin for the quarter was 32.0%. Applied Markets Group The Applied Markets Group (AMG) reported second-quarter revenue of $344 million, growth of 14% reported and 11% core(1) year-over-year. AMG’s operating margin for the quarter was 23.3%. Conference Call Agilent’s management will present additional details regarding the company’s second-quarter 2026 financial results on a conference call with investors today at 1:30 p.m. PT. This event will be broadcast live online in listen-only mode. To listen to the webcast, select the “Q2 2026 Agilent Technologies, Inc. Earnings Conference Call” link on the Agilent Investor Relations website. The replay of the call will remain on the company website for 90 days. About Agilent Technologies Agilent Technologies, Inc. (NYSE: A) is a global leader in analytical and clinical laboratory technologies, delivering insights and innovation that help our customers bring great science to life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of $6.95 billion in fiscal year 2025 and employs approximately 18,000 people worldwide. Information about Agilent is available at www.agilent.com. To receive the latest Agilent news, subscribe to the Agilent Newsroom. Follow Agilent on LinkedIn and Facebook. Forward-Looking Statements This news release contains forward-looking statements as defined in the Securities Exchange Act of 1934 and is subject to the safe harbors created therein. The forward-looking statements contained herein include, but are not limited to, information regarding Agilent’s growth prospects, business, financial results, revenue, non-GAAP earnings guidance for fiscal year and third-quarter 2026, and the effects of its operational transformation and customer and market-focused strategy. These forward-looking statements involve risks and uncertainties that could cause Agilent’s results to differ materially from management’s current expectations. Such risks and uncertainties include, but are not limited to, unforeseen changes in the strength of Agilent’s customers’ businesses; unforeseen changes in the demand for current and new products, technologies, and services; unforeseen changes in the currency markets; customer purchasing decisions and timing; and the risk that Agilent is not able to realize the savings expected from integration and restructuring activities. In addition, other risks that Agilent faces in running its operations include the ability to execute successfully through business cycles; the ability to meet and achieve the benefits of its operational transformation, customer and market-focused strategy and cost-reduction goals and otherwise successfully adapt its cost structures to continuing changes in business conditions; ongoing competitive, pricing and gross-margin pressures; the risk that its cost-cutting initiatives will impair its ability to develop products and remain competitive and to operate effectively; the impact of geopolitical uncertainties and global economic conditions on its operations, its markets and its ability to conduct business; the ability to improve asset performance to adapt to changes in demand; the impact relating to or arising from changes to tariffs, import/export or trade policies; the ability of its supply chain to adapt to changes in demand; the ability to successfully introduce new products at the right time, price and mix; the ability of Agilent to successfully integrate recent acquisitions; the ability of Agilent to successfully comply with certain complex regulations; and other risks detailed in Agilent’s filings with the Securities and Exchange Commission, including its quarterly report on Form 10-Q for the fiscal quarter ended January 31, 2026. Forward-looking statements are based on the beliefs and assumptions of Agilent’s management and on currently available information. Agilent undertakes no responsibility to publicly update or revise any forward-looking statement. (1) Core or organic constant currency revenue growth excludes the impact of currency and acquisitions and divestitures within the past 12 months. Core or organic constant currency revenue is a non-GAAP measure. Reconciliations between GAAP revenue and core or organic constant currency revenue for second quarter 2026 are set forth on page 7 of the attached tables along with additional information regarding the use of this non-GAAP measure. Core or organic constant currency revenue growth rate as projected for third quarter 2026 and full fiscal year 2026 excludes the impact of currency and acquisitions and divestitures within the past 12 months. Most of the excluded amounts pertain to events that have not yet occurred and are not currently possible to estimate with a reasonable degree of accuracy and could differ materially. Therefore, no reconciliation to GAAP amounts has been provided for the projection. (2) Non-GAAP operating margin excludes the impacts of restructuring and other related costs, intangibles amortization, transformation initiatives, acquisition and integration costs and net (gain) loss on equity securities. A reconciliation between non-GAAP operating margin and GAAP operating margin is set forth on page 5 of the attached tables along with additional information regarding the use of this non-GAAP measure. Non-GAAP operating margin as projected for full fiscal year 2026 excludes primarily the impacts of restructuring and other related costs, intangible amortization, transformation initiatives and acquisition and integration costs. Most of these excluded amounts pertain to events that have not yet occurred and are not currently possible to estimate with a reasonable degree of accuracy and could differ materially. Therefore, no reconciliation to GAAP amounts has been provided. (3) Non-GAAP net income and non-GAAP EPS exclude the impacts of restructuring and other related costs, intangibles amortization, transformational initiatives, acquisition and integration costs and net (gain) loss on equity securities. Agilent also excludes any tax benefits or expenses that are not directly related to ongoing operations, and which are either isolated or are not expected to occur again with any regularity or predictability. A reconciliation between non-GAAP net income and GAAP net income and a reconciliation between non-GAAP EPS and GAAP EPS is set forth on page 4 of the attached tables along with additional information regarding the use of this non-GAAP measure. (4) Non-GAAP EPS as projected for third quarter 2026 and full fiscal year 2026 exclude primarily the estimated impacts of non-cash intangibles amortization, transformational initiatives, and acquisition and integration costs. Agilent also excludes any tax benefits or expenses that are not directly related to ongoing operations, and which are either isolated or are not expected to occur again with any regularity or predictability. Most of these excluded amounts pertain to events that have not yet occurred and are not currently possible to estimate with a reasonable degree of accuracy and could differ materially. Therefore, no reconciliation to GAAP amounts has been provided. Future amortization of intangibles is expected to be approximately $18 million per quarter. (5) Core or organic constant currency revenue growth outlook is based on forecasted currency exchange rates. AGILENT TECHNOLOGIES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In millions, except per share data) (Unaudited) PRELIMINARY Three Months Ended Six Months Ended April 30, April 30, 2026 2025 2026 2025 Net revenue $ 1,835 $ 1,668 $ 3,633 $ 3,349 Costs and expenses: Cost of products and services 845 802 1,697 1,584 Research and development 126 112 243 225 Selling, general and administrative 465 454 941 864 Total costs and expenses 1,436 1,368 2,881 2,673 Income from operations 399 300 752 676 Interest income 13 14 28 29 Interest expense (25 ) (29 ) (50 ) (57 ) Other income (expense), net 21 (25 ) 42 (21 ) Income before taxes 408 260 772 627 Provision for income taxes 69 45 128 94 Net income $ 339 $ 215 $ 644 $ 533 Net income per share: Basic $ 1.20 $ 0.75 $ 2.28 $ 1.87 Diluted $ 1.20 $ 0.75 $ 2.27 $ 1.86 Weighted average shares used in computing net income per share: Basic 282 285 283 285 Diluted 283 285 284 286 The preliminary income statement is estimated based on our current information. Page 1 AGILENT TECHNOLOGIES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In millions, except par value and share data) (Unaudited) PRELIMINARY April 30, October 31, 2026 2025 ASSETS Current assets: Cash and cash equivalents $ 1,807 $ 1,789 Accounts receivable, net 1,498 1,487 Inventory 1,089 1,025 Other current assets 369 293 Total current assets 4,763 4,594 Property, plant and equipment, net 2,099 2,023 Goodwill 4,484 4,473 Other intangible assets, net 407 445 Long-term investments 136 133 Other assets 1,176 1,059 Total assets $ 13,065 $ 12,727 LIABILITIES AND EQUITY Current liabilities: Accounts payable $ 615 $ 570 Employee compensation and benefits 387 443 Deferred revenue 665 624 Short-term debt 304 304 Other accrued liabilities 298 406 Total current liabilities 2,269 2,347 Long-term debt 3,051 3,050 Retirement and post-retirement benefits 127 126 Other long-term liabilities 496 463 Total liabilities 5,943 5,986 Total Equity: Stockholders' equity: Preferred stock; $0.01 par value; 125,000,000 shares authorized; none issued and outstanding — — Common stock; $0.01 par value, 2,000,000,000 shares authorized; 282,218,158 shares at April 30, 2026 and 283,054,377 shares at October 31, 2025, issued and outstanding 3 3 Additional paid-in-capital 5,629 5,575 Retained earnings 1,692 1,389 Accumulated other comprehensive loss (202 ) (226 ) Total stockholders' equity 7,122 6,741 Total liabilities and stockholders' equity $ 13,065 $ 12,727 The preliminary balance sheet is estimated based on our current information. Page 2 AGILENT TECHNOLOGIES, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (In millions) (Unaudited) PRELIMINARY Six Months Ended April 30, April 30, 2026 2025 Cash flows from operating activities: Net income $ 644 $ 533 Adjustments to reconcile net income to net cash provided by operating activities: Depreciation and amortization 134 145 Share-based compensation 73 70 Deferred taxes expense (benefit) 57 (28 ) Excess and obsolete inventory related charges 25 22 Net (gain) loss on equity securities (1 ) 27 Asset impairment charges — 15 Other non-cash (income) expense, net 4 2 Changes in assets and liabilities: Accounts receivable, net (6 ) (27 ) Inventory (85 ) (41 ) Accounts payable 54 (27 ) Employee compensation and benefits (59 ) (25 ) Other assets and liabilities (295 ) (14 ) Net cash provided by operating activities (a) 545 652 Cash flows from investing activities: Payments to acquire property, plant and equipment (169 ) (211 ) Payments in exchange for convertible note (1 ) (1 ) Payments to acquire businesses and intangible assets, net of cash acquired — 4 Net cash used in investing activities (170 ) (208 ) Cash flows from financing activities: Proceeds from issuance of common stock under employee stock plans 32 31 Payment of taxes related to net share settlement of equity awards (29 ) (24 ) Payments for repurchase of common stock (217 ) (255 ) Payment of excise taxes related to repurchases of common stock (3 ) (10 ) Payments of dividends (144 ) (141 ) Proceeds from issuance of long-term debt — 4 Repayments of long-term debt (3 ) (1 ) Net proceeds from (repayment of) short-term debt — 100 Payments of finance lease (2 ) — Net cash used in financing activities (366 ) (296 ) Effect of exchange rate movements 9 9 Net increase (decrease) in cash, cash equivalents and restricted cash 18 157 Cash, cash equivalents and restricted cash at beginning of period 1,791 1,332 Cash, cash equivalents and restricted cash at end of period $ 1,809 $ 1,489 Reconciliation of cash, cash equivalents and restricted cash to the condensed consolidated balance sheet: Cash and cash equivalents $ 1,807 $ 1,486 Restricted cash, included in other assets 2 3 Total cash, cash equivalents and restricted cash $ 1,809 $ 1,489 (a) Cash payments included in operating activities: Income tax payments, net of refunds received $ 320 $ 248 Interest payments, net of capitalized interest $ 45 $ 51 Net change in property, plant and equipment included in accounts payable and accrued liabilities-increase (decrease) $ (11 ) — Excise tax on share repurchases, accrued but not paid $ 1 $ 2 The preliminary cash flow is estimated based on our current information. Page 3 AGILENT TECHNOLOGIES, INC. NON-GAAP NET INCOME AND DILUTED EPS RECONCILIATIONS (In millions, except per share data) (Unaudited) PRELIMINARY Three Months Ended Six Months Ended April 30, April 30, 2026 2025 2026 2025 Net Income Diluted EPS Net Income Diluted EPS Net Income Diluted EPS Net Income Diluted EPS GAAP net income $ 339 $ 1.20 $ 215 $ 0.75 $ 644 $ 2.27 $ 533 $ 1.86 Non-GAAP adjustments: Restructuring and other related costs 8 0.03 56 0.20 28 0.10 57 0.20 Asset impairments — — 15 0.05 — — 15 0.05 Intangible amortization 19 0.07 27 0.10 38 0.13 55 0.19 Transformational initiatives 39 0.14 24 0.08 58 0.21 30 0.10 Acquisition and integration costs 12 0.04 3 0.01 15 0.05 12 0.04 Net (gain) loss on equity securities 1 — 27 0.10 1 — 27 0.10 Pension settlement loss — — — — — — 14 0.05 Other 7 0.02 9 0.03 34 0.12 15 0.05 Adjustment for taxes (a) (2 ) (0.01 ) (3 ) (0.01 ) (9 ) (0.03 ) (8 ) (0.02 ) Non-GAAP net income $ 423 $ 1.49 $ 373 $ 1.31 $ 809 $ 2.85 $ 750 $ 2.62 (a) The adjustment for taxes excludes tax expense (benefits) that management believes are not directly related to on-going operations and which are either isolated, temporary or cannot be expected to occur again with any regularity or predictability such as the realized gain/loss due to sale of a business, windfall benefits on stock compensation, and the impact of R&D capitalization under section 174 of the Tax Cuts and Jobs Act of 2017 which does not apply for fiscal year 2026 due to the enactment of the One Big Beautiful Bill Act (OBBBA). For the three and six months ended April 30, 2026, management used a non-GAAP effective tax rate of 14.50%. For the three months ended April 30, 2025, management used a non-GAAP effective tax rate of 11.50%. For the six months ended April 30, 2025, management used a non-GAAP effective tax rate of 12.00%. We provide non-GAAP net income and non-GAAP net income per share amounts in order to provide meaningful supplemental information regarding our operational performance and our prospects for the future. These supplemental measures exclude, among other things, charges related to restructuring and other related costs, asset impairments, amortization of intangibles, transformational initiatives, acquisition and integration costs, net (gain) loss on equity securities and pension settlement loss. Restructuring and other related costs include incremental expenses incurred in the period associated with restructuring programs, usually aimed at changes in business and/or cost structure. Such costs may include one-time termination benefits including acceleration of stock-based compensation expense, facility-related costs and contract termination fees. Asset impairments include assets that have been written down to their fair value. Transformational initiatives include expenses associated with targeted cost reduction activities such as manufacturing transfers including costs to move manufacturing, site consolidations, legal entity and other business reorganizations, insourcing or outsourcing of activities. Such costs may include move and relocation costs, one-time termination benefits and other one-time reorganization costs. Included in this category are also expenses associated with company programs to transform our product lifecycle management (PLM) system and human resources and financial systems. Acquisition and integration costs include all incremental expenses incurred to effect a business combination. Such acquisition costs may include advisory, legal, tax, accounting, valuation, and other professional or consulting fees. Such integration costs may include expenses directly related to integration of business and facility operations, the transfer of assets and intellectual property, information technology systems and infrastructure and other employee-related costs. Net (gain) loss on equity securities relates to the realized and unrealized mark-to-market adjustments for our marketable and non-marketable equity securities. Pension settlement loss resulted from the transfer of the Netherlands defined benefit plan to an unaffiliated insurance company. Other includes certain legal costs and settlements, consulting costs, special compliance costs, acceleration of stock-based compensation expense and other miscellaneous adjustments. Our management uses non-GAAP measures to evaluate the performance of our core businesses, to estimate future core performance and to compensate employees. Since management finds this measure to be useful, we believe that our investors benefit from seeing our results “through the eyes” of management in addition to seeing our GAAP results. This information facilitates our management’s internal comparisons to our historical operating results as well as to the operating results of our competitors. Our management recognizes that items such as amortization of intangibles can have a material impact on our cash flows and/or our net income. Our GAAP financial statements including our statement of cash flows portray those effects. Although we believe it is useful for investors to see core performance free of special items, investors should understand that the excluded items are actual expenses that may impact the cash available to us for other uses. To gain a complete picture of all effects on the company’s profit and loss from any and all events, management does (and investors should) rely upon the GAAP income statement. The non-GAAP numbers focus instead upon the core business of the company, which is only a subset, albeit a critical one, of the company’s performance. Readers are reminded that non-GAAP numbers are merely a supplement to, and not a replacement for, GAAP financial measures. They should be read in conjunction with the GAAP financial measures. It should be noted as well that our non-GAAP information may be different from the non-GAAP information provided by other companies. The preliminary non-GAAP net income and diluted EPS reconciliation is estimated based on our current information. Page 4 AGILENT TECHNOLOGIES, INC. RECONCILIATION OF NON-GAAP INCOME FROM OPERATIONS AND OPERATING MARGIN (In millions, except margin data) (Unaudited) PRELIMINARY Year Over Year Operating Operating Percent Pts Q2'26 Margin % Q2'25 Margin % Inc/(Dec) GAAP revenue: $ 1,835 $ 1,668 Income from operations: GAAP Income from operations $ 399 21.7 % $ 300 18.0 % Non-GAAP adjustments: Restructuring and other related costs 8 56 Intangible amortization 19 27 Transformational initiatives 39 24 Acquisition and integration costs 12 3 Net (gain) loss on equity securities — 1 Other 6 8 Non-GAAP income from operations $ 483 26.4 % $ 419 25.1 % 1.3 % We provide non-GAAP income from operations and non-GAAP operating margin amounts in order to provide meaningful supplemental information regarding our operational performance and our prospects for the future. These supplemental measures exclude, among other things, charges related to restructuring and other related costs, amortization of intangibles, transformational initiatives, acquisition and integration costs and net (gain) loss on equity securities. Our management recognizes that items such as amortization of intangibles can have a material impact on our cash flows and/or our net income. Our GAAP financial statements including our statement of cash flows portray those effects. Although we believe it is useful for investors to see core performance free of special items, investors should understand that the excluded items are actual expenses that may impact the cash available to us for other uses. To gain a complete picture of all effects on the company’s profit and loss from any and all events, management does (and investors should) rely upon the GAAP income statement. The non-GAAP numbers focus instead upon the core business of the company, which is only a subset, albeit a critical one, of the company’s performance. Readers are reminded that non-GAAP numbers are merely a supplement to, and not a replacement for, GAAP financial measures. They should be read in conjunction with the GAAP financial measures. It should be noted as well that our non-GAAP information may be different from the non-GAAP information provided by other companies. The preliminary reconciliation of income from operations and operating margins is estimated based on our current information. Page 5 AGILENT TECHNOLOGIES, INC. SEGMENT INFORMATION (In millions, except where noted) (Unaudited) PRELIMINARY Quarter-over-Quarter Life Sciences and Diagnostics Markets Segment Q2'26 Q2'25 Revenue $ 732 $ 654 Gross Margin, % 54.1 % 52.8 % Income from Operations $ 161 $ 129 Operating margin, % 22.0 % 19.7 % Agilent CrossLab Segment Q2'26 Q2'25 Revenue $ 759 $ 713 Gross Margin, % 55.5 % 55.5 % Income from Operations $ 242 $ 231 Operating margin, % 32.0 % 32.4 % Applied Markets Segment Q2'26 Q2'25 Revenue $ 344 $ 301 Gross Margin, % 55.8 % 53.5 % Income from Operations $ 80 $ 59 Operating margin, % 23.3 % 19.5 % Income from operations reflect the results of our reportable segments under Agilent's management reporting system which are not necessarily in conformity with GAAP financial measures. Income from operations of our reporting segments exclude, among other things, charges related to restructuring and other related costs, amortization of intangibles, transformational initiatives, acquisition and integration costs and net (gain) loss on equity securities. Readers are reminded that non-GAAP numbers are merely a supplement to, and not a replacement for, GAAP financial measures. They should be read in conjunction with the GAAP financial measures. It should be noted as well that our non-GAAP information may be different from the non-GAAP information provided by other companies. The preliminary segment information is estimated based on our current information. Page 6 AGILENT TECHNOLOGIES, INC. RECONCILIATIONS OF REVENUE BY SEGMENT EXCLUDING ACQUISITIONS, DIVESTITURES AND THE IMPACT OF CURRENCY ADJUSTMENTS (CORE) (In millions) (Unaudited) PRELIMINARY Year-over-Year GAAP Year-over-Year GAAP Revenue by Segment Q2'26 Q2'25 % Change Life Sciences and Diagnostics Markets Segment $ 732 $ 654 12% Agilent CrossLab Segment 759 713 6% Applied Markets Segment 344 301 14% Agilent $ 1,835 $ 1,668 10% Non-GAAP
(excluding Acquisitions & Divestitures) Year-over-Year
at Constant Currency (a) Year-over-Year Year-over-Year Percentage Point Impact from Currency Current Quarter Currency Impact (b) Non-GAAP Revenue by Segment Q2'26 Q2'25 % Change % Change Life Sciences and Diagnostics Markets Segment $ 732 $ 654 12% 9% 3 ppts $ 22 Agilent CrossLab Segment 759 713 6% 2% 4 ppts 29 Applied Markets Segment 344 301 14% 11% 3 ppts 10 Agilent (Core) $ 1,835 $ 1,668 10% 6% 4 ppts $ 61 We compare the year-over-year change in revenue excluding the effect of recent acquisitions and divestitures and foreign currency rate fluctuations to assess the performance of our underlying business. (a) The constant currency year-over-year growth percentage is calculated by recalculating all periods in the comparison period at the foreign currency exchange rates used for accounting during the last month of the current quarter and then using those revised values to calculate the year-over-year percentage change. (b) The dollar impact from the current quarter currency impact is equal to the total year-over-year dollar change less the constant currency year-over-year change. The preliminary reconciliation of GAAP revenue adjusted for recent acquisitions and divestitures and impact of currency is estimated based on our current information. Page 7 View source version on businesswire.com: https://www.businesswire.com/news/home/20260527246387/en/ INVESTOR CONTACT:
Tejas Savant
+1 917-574-4018
tejas.savant @NINAVEST-7490
kate.coyle@agilent.com Original: Agilent Reports Second-Quarter Fiscal Year 2026 Financial Results
US Market News
3月前
Agilent to Acquire Biocare Medical, a Global Leader in Clinical and Research Pathology SolutionsMarch 9, 2026 3:00 AM
Business Wire
Expands Agilent’s pathology portfolio through addition of highly complementary antibody, reagent and instrument business with annual double-digit revenue and profit growth since 2021
Expected to be accretive to Agilent’s top-line growth rate, margin profile and non-instrument revenue mix in Year 1
Agilent Technologies Inc. (NYSE: A) today announced it has entered into a definitive agreement to acquire Biocare Medical, a global leader in clinical pathology, from an investor group led by Excellere Partners and GHO Capital Partners LLP, in an all-cash transaction valued at $950 million.
Biocare is a high-growth global pathology antibody leader, serving customers with a complementary portfolio of immunohistochemistry (IHC), in situ hybridization (ISH) and fluorescence in situ hybridization (FISH) solutions designed to support improved patient health outcomes across oncology and broader clinical pathology. With more than 300 specialized antibodies and a proven R&D capability, Biocare has achieved annual double-digit revenue and profit growth since 2021 and generated over $90 million in revenue in 2025.
“The acquisition of Biocare enhances Agilent’s pathology portfolio and reflects our strategy to drive long-term growth through customer-centric innovation and disciplined capital allocation,” said Agilent President and CEO Padraig McDonnell. “Together, this complementary combination will enable us to better serve our valued pathology customers across clinical and research settings, accelerate innovation and support long-term value creation for our shareholders.”
“The acquisition by Agilent is an exciting milestone for Biocare,” said Luis de Luzuriaga, CEO of Biocare. “By joining Agilent and combining our complementary capabilities in cancer diagnostics, we will expand our operational scale, accelerate innovation and enhance the level of service we provide to customers and partners – ultimately benefiting the patients we serve. After years of significant progress, this is the right time to move forward with new ownership aligned with our commitment to product quality, clinical impact and value creation. I would like to thank our investors, Excellere Partners and GHO Capital, whose support and counsel have been instrumental in building Biocare into the company it is today.”
In a joint statement, Ryan Glaws and Mike Mortimer, Managing Partners at Excellere Partners and GHO Capital, respectively, said, “Working closely with Luis and the Biocare management team, we have been proud to support their significant growth and success by applying our tried and tested growth playbook and leveraging our deep expertise and network in life science tools and diagnostics to build the company into the successful global business it is today. With its exceptional team and strengthened capabilities, Biocare has developed into a recognized leading innovator in IHC solutions, improving the diagnosis and treatment of patients. As Biocare continues its growth trajectory, we are pleased to have found the right partner in Agilent – one that can utilize its global reach and resources to unlock even greater market access, enhanced customer support and accelerated innovation for Biocare’s customers worldwide.”
Strategic and Financial Benefits of the Transaction
Expands Agilent’s Pathology Portfolio with a Highly Complementary Platform and Leading Innovation Capabilities: The addition of Biocare’s complementary IHC antibody, reagent and instrument portfolio enhances Agilent’s immunohistochemistry offering and expands its ability to serve a broad range of pathology labs across clinical and research settings. Biocare has grown robustly in the IHC market and brings proven, efficient new-product innovation capabilities that strengthen Agilent’s capability to develop and commercialize new IVD antibodies.
Unlocks Growth Through Complementary Commercial Attributes and Geographic Footprints, While Accelerating Menu Development: By combining Agilent’s global operations with Biocare’s strong U.S. commercial presence, the transaction creates a stronger platform to better serve a broader base of research and clinical customers. The combined company will be well positioned to meet diverse testing and throughput needs while accelerating the expansion of Biocare’s antibody portfolio through Agilent’s resources and capabilities.
Delivers Attractive Financial Benefits: The deal is expected to be accretive to Agilent’s top-line growth rate, margin profile and non-instrument revenue mix in the first year. The transaction is expected to become accretive to Agilent’s EPS approximately 12 months following close. The accretive long-term growth, strategic fit and commercial synergy make the financial returns on the transaction highly attractive.
The transaction is subject to customary closing conditions, including receipt of regulatory approvals, and is expected to close by no later than Agilent's fourth fiscal quarter of 2026. Upon close, Biocare will become part of the Agilent Life Sciences and Diagnostics Markets Group.
Advisers
Barclays is serving as financial adviser, Sullivan & Cromwell LLP is serving as legal adviser and Joele Frank is serving as strategic communications adviser to Agilent.
Jefferies is serving as exclusive financial adviser, Ropes & Gray LLP is serving as legal adviser and ICR Healthcare is serving as strategic communications adviser to Biocare.
About Agilent Technologies
Agilent Technologies, Inc. (NYSE: A) is a global leader in analytical and clinical laboratory technologies, delivering insights and innovation that help our customers bring great science to life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of $6.95 billion in fiscal year 2025 and employs approximately 18,000 people worldwide. Information about Agilent is available at www.agilent.com. To receive the latest Agilent news, subscribe to the Agilent Newsroom. Follow Agilent on LinkedIn and Facebook.
About Biocare Medical
Biocare Medical is a global leader in immunohistochemistry (IHC) and molecular pathology solutions, offering automated instrumentation, high-quality reagents, and simultaneous multiplexing to advance cancer diagnostics and research. Biocare’s mission is to deliver advanced staining solutions designed to produce the highest-quality image on every slide, driving diagnostic accuracy and creating a digital-ready platform for the future of pathology.
Forward-Looking Statements
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that constitute “forward-looking statements” within the meaning of applicable U.S. securities laws. All statements herein other than historical facts, including, without limitation, statements regarding Agilent management’s current expectations, assumptions, estimates and projections regarding the industry in which Agilent operates, general economic conditions, Agilent’s businesses and its financial performance or condition, and future events, including the proposed transaction with Biocare referred to in this press release, are forward-looking statements. Such forward-looking statements rely on the safe harbor provisions of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. Because such forward-looking statements are subject to risks and uncertainties, actual results and future trends may differ materially from those expressed in or implied by such forward-looking statements. Accordingly, potential investors and Agilent securityholders should not place undue reliance on such forward-looking statements. Words and phrases such as “anticipate,” “believe,” “combined company,” “could,” “consider,” “create,” “drive,” “expect,” “forecast,” “future,” “growth,” “hope,” “intend,” “opportunity,” “plan,” “potential,” “projected,” “proposal,” “result in,” “synergies,” “unlock,” “upside,” “will,” “would,” and similar words and phrases are intended to identify forward-looking statements. Among the risks and uncertainties that could cause actual results to differ from those described in forward-looking statements are the following: the risk that the transaction with Biocare may not be consummated; the risk that any conditions to the completion of the transaction with Biocare, including the receipt of all required regulatory approvals, may not be satisfied; risks relating to the future performance, results of operations, liquidity and financial position of each of Agilent, Biocare and the combined company resulting from the consummation of the transaction with Biocare; the possibility that the combined company following consummation of the transaction with Biocare may not achieve expected synergies and operating efficiencies within the expected timeframes, or at all; the risk that consummating the transaction with Biocare may be less accretive than expected, or may be dilutive, to Agilent’s earnings per share, which may negatively affect the market price of Agilent’s common stock; the risk that the integration of Biocare’s operations with those of Agilent may be more difficult, time-consuming and costly than expected, or that operating costs and business disruption may be greater than expected; the risk that any announcements relating to, or the completion of, the transaction with Biocare could have an adverse effect on the market price of Agilent’s common stock; the risk that Agilent and Biocare may incur significant transaction and other costs in connection with the transaction, and that those costs may exceed those anticipated by Agilent; and risks related to any unforeseen liabilities of, and future capital expenditures required by, Agilent following consummation of the transaction with Biocare.
Additional risks and uncertainties relating to forward-looking statements in respect of Agilent’s businesses, operations, prospects and financial performance and condition can be found in Agilent’s filings with the Securities and Exchange Commission (the “SEC”), including the risks, uncertainties and other factors discussed in the sections entitled “Risk Factors” and “Forward-Looking Statements” in Agilent’s Annual Report on Form 10-K for the fiscal year ended October 31, 2025, filed with the SEC on December 19, 2025, and the other filings Agilent has made or will make with the SEC after such date, copies of which may be obtained from the SEC’s website at www.sec.gov. All forward-looking statements contained herein and in the exhibits hereto are made only as of the date hereof, and Agilent disclaims any intention or obligation to update or revise any such forward-looking statements to reflect events or circumstances that subsequently occur, or of which Agilent hereafter becomes aware, except as required by applicable law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260309348109/en/
Agilent
INVESTOR CONTACT
Tejas Savant
+1 917-574-4018
tejas.savant@agilent.com
MEDIA CONTACT
Kate Coyle
+1 302-633-7490
kate.coyle@agilent.com
Biocare
MEDIA CONTACT
ICR Healthcare
Amber Fennell, Angela Gray, Kris Lam
biocare@icrhealthcare.com
Original: Agilent to Acquire Biocare Medical, a Global Leader in Clinical and Research Pathology Solutions
US Market News
4月前
Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma (EOC)February 11, 2026 8:22 PM
Business Wire
Approval expands PD-L1 testing to support treatment decisions with KEYTRUDA® (pembrolizumab)1, 2
Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration (FDA) has approved PD-L1 IHC 22C3 pharmDx, Code SK006, as the only FDA-approved companion diagnostic indicated to aid in identifying patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC), whose tumors express PD-L1 and who may be eligible for treatment with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy.
PD-L1 IHC 22C3 pharmDx, Code SK006, enables pathologists to assess PD-L1 expression at the time of diagnosis, supporting informed treatment decisions in a disease where therapeutic options remain limited for many patients. This approval marks the seventh FDA approved companion diagnostic indication currently available for PD-L1 IHC 22C3 pharmDx, Code SK006, for use with KEYTRUDA.
Nina Green, vice president and general manager of Agilent’s Clinical Diagnostics Division, stated: “Delivering effective precision oncology requires close collaboration between diagnostics and therapeutics, and this FDA approval reflects Agilent’s long-standing industry partnership in companion diagnostics. We are proud to enable pathologists to identify patients with EOC who may benefit from immunotherapy. As the first immuno-oncology approval for this disease, this milestone underscores our commitment to advancing precision medicine and expanding access to innovative cancer treatments worldwide.”
PD-L1 expression in EOC was evaluated using PD-L1 IHC 22C3 pharmDx, Code SK006, in the KEYNOTE-B96 clinical trial supporting its use in identifying patients who may benefit from KEYTRUDA.
In the U.S., ovarian cancer caused approximately 12,730 deaths in 2025 and has a 5-year survival rate of 51.6% between 2015 to 20213.
In addition to EOC, PD-L1 IHC 22C3 pharmDx, Code SK006, is indicated in the U.S. to help physicians identify patients with non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), cervical cancer, head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), and gastric or gastroesophageal junction (GEJ) adenocarcinoma who may benefit from treatment with KEYTRUDA.
PD-L1 IHC 22C3 pharmDx, Code SK006, was developed by Agilent in partnership with Merck & Co. (known as MSD outside the United States and Canada) as a companion diagnostic for KEYTRUDA.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Corrected on Feb. 11, 2026: Amended press release to align with FDA-approved KEYTRUDA indication language. See KEYTRUDA full prescribing information.
About Agilent Technologies
Agilent Technologies, Inc. (NYSE: A) is a global leader in analytical and clinical laboratory technologies, delivering insights and innovation that help our customers bring great science to life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of $6.95 billion in fiscal year 2025 and employs approximately 18,000 people worldwide. Information about Agilent is available at www.agilent.com. To receive the latest Agilent news, subscribe to the Agilent Newsroom. Follow Agilent on LinkedIn and Facebook.
References:
PD-L1 IHC 22C3 pharmDx, Code SK006 [Instructions for Use]. Santa Clara, CA: Agilent Technologies, Inc.; 2026.
KEYTRUDA® (pembrolizumab) Merck Sharp & Dohme LLC, Rahway, NJ, USA; 2026.
National Cancer Institute. https://seer.cancer.gov/statfacts/html/ovary.html, accessed 8 January 2026.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260210235592/en/
MEDIA CONTACT:
Kate Coyle
+1 302-633-7490
kate.coyle@agilent.com
Original: Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma (EOC)
US Market News
4月前
Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma (EOC)February 11, 2026 6:45 AM
Business Wire
Approval expands first-line PD-L1 testing to support treatment decisions with KEYTRUDA® (pembrolizumab)1, 2
Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration (FDA) has approved PD-L1 IHC 22C3 pharmDx, Code SK006, as the only FDA-approved companion diagnostic indicated to aid in identifying first-line patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC), whose tumors express PD-L1 and who may be eligible for treatment with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy.
PD-L1 IHC 22C3 pharmDx, Code SK006, enables pathologists to assess PD-L1 expression at the time of diagnosis, supporting informed treatment decisions in a disease where therapeutic options remain limited for many patients. This approval marks the seventh FDA approved companion diagnostic indication currently available for PD-L1 IHC 22C3 pharmDx, Code SK006, for use with KEYTRUDA.
Nina Green, vice president and general manager of Agilent’s Clinical Diagnostics Division, stated: “Delivering effective precision oncology requires close collaboration between diagnostics and therapeutics, and this FDA approval reflects Agilent’s long-standing industry partnership in companion diagnostics. We are proud to enable pathologists to identify patients with EOC who may benefit from immunotherapy in the first-line setting. As the first immuno-oncology approval for this disease, this milestone underscores our commitment to advancing precision medicine and expanding access to innovative cancer treatments worldwide.”
PD-L1 expression in EOC was evaluated using PD-L1 IHC 22C3 pharmDx, Code SK006, in the KEYNOTE-B96 clinical trial supporting its use in identifying patients who may benefit from KEYTRUDA in the first-line setting.
In the U.S., ovarian cancer caused approximately 12,730 deaths in 2025 and has a 5-year survival rate of 51.6% between 2015 to 20213.
In addition to EOC, PD-L1 IHC 22C3 pharmDx, Code SK006, is indicated in the U.S. to help physicians identify patients with non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), cervical cancer, head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), and gastric or gastroesophageal junction (GEJ) adenocarcinoma who may benefit from treatment with KEYTRUDA.
PD-L1 IHC 22C3 pharmDx, Code SK006, was developed by Agilent in partnership with Merck & Co. (known as MSD outside the United States and Canada) as a companion diagnostic for KEYTRUDA.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About Agilent Technologies
Agilent Technologies, Inc. (NYSE: A) is a global leader in analytical and clinical laboratory technologies, delivering insights and innovation that help our customers bring great science to life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of $6.95 billion in fiscal year 2025 and employs approximately 18,000 people worldwide. Information about Agilent is available at www.agilent.com. To receive the latest Agilent news, subscribe to the Agilent Newsroom. Follow Agilent on LinkedIn and Facebook.
References:
PD-L1 IHC 22C3 pharmDx, Code SK006 [Instructions for Use]. Santa Clara, CA: Agilent Technologies, Inc.; 2026.
KEYTRUDA® (pembrolizumab) Merck Sharp & Dohme LLC, Rahway, NJ, USA; 2026.
National Cancer Institute. https://seer.cancer.gov/statfacts/html/ovary.html, accessed 8 January 2026.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260210235592/en/
MEDIA CONTACT:
Kate Coyle
+1 302-633-7490
kate.coyle@agilent.com
Original: Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma (EOC)