Capivasertib

GUANGZHOU, China, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”), a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, today reported financial results for the three months ended September 30, 2025. Recent Business Updates Therapy Selection Presented study results at the Cell Reports Medicine on esophageal squamous cell carcinoma in September 2025. “Integrating ctDNA with clinical response evaluation improves residual disease detection post-neoadjuvant chemoradiotherapy to support organsparing strategies and that postoperative ctDNA stratifies recurrence risk beyond pathological response to inform adjuvant immunotherapy decisions”. Early Detection PROMISE study test results presented at The Innovation in September 2025. “The PROMISE study was conducted to investigate the feasibility of a multi-omics integration strategy in multi-cancer detection blood tests across nine types of cancers in head and neck (excluding nasopharynx), esophagus, lung, stomach, liver, biliary tract, pancreas, colorectum, and ovary……Compared to the methylation-based classifier, the multimodal classifier combining methylation and protein features, exhibited an improved sensitivity of 75.1% (95% 75 confidence interval [CI], 69.3%–80.3%) at the same specificity of 98.8% with the accuracy of top predicted origin (TPO1) of 73.1% (95% CI, 66.2%–79.2%)”. Pharma Services The OncoGuide™ OncoScreen™ Plus CDx System based on OncoScreen™ Plus to be used as a companion diagnostic for AstraZeneca’s capivasertib has received Manufacturing and Marketing Approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) in September, 2025. Third Quarter 2025 Financial Results Total revenues were RMB131.6 million (US$18.5 million) for the three months ended September 30, 2025, representing a 2.3% increase from RMB128.6 million for the same period in 2024. Revenue generated from in-hospital business was RMB52.8 million (US$7.4 million) for the three months ended September 30, 2025, representing a 17.1% decrease from RMB63.8 million for the same period in 2024, driven by a decrease in sales volume. Revenue generated from central laboratory business was RMB36.8 million (US$5.2 million) for the three months ended September 30, 2025, representing a 7.9% decrease from RMB40.0 million for the same period in 2024, primarily attributable to a decrease in the number of tests, as we continued our transition towards in-hospital testing.Revenue generated from pharma research and development services was RMB42.0 million (US$5.9 million) for the three months ended September 30, 2025, representing a 68.6% increase from RMB24.9 million for the same period in 2024, primarily attributable to an increased development and testing services performed for our pharma customers. Cost of revenues was RMB32.8 million (US$4.6 million) for the three months ended September 30, 2025, representing an 10.9% decrease from RMB36.8 million for the same period in 2024. Gross profit was RMB98.8 million (US$13.9 million) for the three months ended September 30, 2025, representing a 7.6% increase from RMB91.8 million for the same period in 2024. Gross margin was 75.1% for the three months ended September 30, 2025, compared to 71.4% for the same period in 2024. By channel, gross margin of central laboratory business and in-hospital business were 81.8% and 71.8% for the three months ended September 30, 2025, compared to 83.2% and 73.0% during the same period in 2024, primarily due to the cost reduction caused by the rent subsidy for the headquarter building in the third quarter of 2024; gross margin of pharma research and development services was 73.4% for the three months ended September 30, 2025, compared to 48.2% during the same period of 2024, primarily due to the significant increase in revenue from high-margin companion diagnostic (CDx) projects. Non-GAAP gross profit, which excludes depreciation and amortization expenses, was RMB100.9 million (US$14.2million) for the three months ended September 30, 2025, representing a 3.2% increase from RMB97.8 million for the same period in 2024. Non-GAAP gross margin was 76.7% for the three months ended September 30, 2025, compared to 76.0% for the same period in 2024. Operating expenses were RMB115.0 million (US$16.2 million) for the three months ended September 30, 2025, representing a 11.9% decrease from RMB130.4 million for the same period in 2024. The decrease was primarily driven by decreases in amortized expense on share-based compensation, budget control measures and headcount reduction to improve the Company’s operating efficiency. Research and development expenses were RMB41.5 million (US$5.8 million) for the three months ended September 30, 2025, representing a 15.6% decrease from RMB49.2 million for the same period in 2024, primarily due to (i) a decrease in the expenditure for research projects; (iii) a decrease in amortized expense on share-based compensation; and (iv) a decrease in amortized expenses for office building decoration.Selling and marketing expenses were RMB41.8 million (US$5.9 million) for the three months ended September 30, 2025, representing a 13.6% decrease from RMB48.4 million for the same period in 2024, primarily due to (i) a decrease in staff cost resulted from the reorganization of the sales department and improvement in operating efficiency; (ii) a decrease in amortized expense on share-based compensation; and (iii) a decrease in amortized expenses for office building decoration.General and administrative expenses were RMB31.7 million (US$4.5 million) for the three months ended September 30, 2025, representing a 3.6% decrease from RMB32.9 million for the same period in 2024, primarily due to (i) a decrease in the general and administrative personnel’s staff cost; (ii) a decrease in amortized expense on share-based compensation; and partially offset by (i) an increase in impairment expenses for accounts receivables and contract assets; (iii) an increase in operating lease. Net loss was RMB16.8 million (US$2.4 million) for the three months ended September 30, 2025, compared to RMB35.7 million for the same period in 2024. Cash, cash equivalents and restricted cash were RMB467.0 million (US$65.6 million) as of September 30, 2025. About Burning Rock Burning Rock Biotech Limited (NASDAQ: BNR), whose mission is to guard life via science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of i) NGS-based therapy selection testing for late-stage cancer patients, and ii) cancer early detection, which has moved beyond proof-of-concept R&D into the clinical validation stage. For more information about Burning Rock, please visit: ir.brbiotech.com. Safe Harbor Statement This press release contains forward-looking statements. These statements constitute “forward-looking” statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “target,” “confident” and similar statements. Burning Rock may also make written or oral forward-looking statements in its periodic reports to the SEC, in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about Burning Rock’s beliefs and expectations, are forward-looking statements. Such statements are based upon management’s current expectations and current market and operating conditions, and relate to events that involve known or unknown risks, uncertainties and other factors, all of which are difficult to predict and many of which are beyond Burning Rock’s control. Forward-looking statements involve risks, uncertainties and other factors that could cause actual results to differ materially from those contained in any such statements. All information provided in this press release is as of the date of this press release, and Burning Rock does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law. Non-GAAP Measures In evaluating the business, the Company considers and uses non-GAAP measures, such as non-GAAP gross profit and non-GAAP gross margin, as supplemental measures to review and assess operating performance. The presentation of these non-GAAP financial measures is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The company defines non-GAAP gross profit as gross profit excluding depreciation and amortization. The company defines non-GAAP gross margin as gross margin excluding depreciation and amortization. The company presents these non-GAAP financial measures because they are used by management to evaluate operating performance and formulate business plans. The company believe non-GAAP gross profit and non-GAAP gross margin excluding non-cash impact of depreciation and amortization reflect the company’s ongoing business operations in a manner that allows more meaningful period-to-period comparisons. Contact: IR@brbiotech.com Selected Operating Data As of September 30,2024December 31,2024March 31,2025June 30,2025September 30,2025In-hospital Channel: Pipeline partner hospitals(1)3029303031Contracted partner hospitals(2)6163636363Total number of partnerhospitals6992939394 (1)Refers to hospitals that are in the process of establishing in-hospital laboratories, laboratory equipment procurement or installation, staff training or pilot testing using the Company’s products.(2)Refers to hospitals that have entered into contracts to purchase the Company’s products for use on a recurring basis in their respective in-hospital laboratories the Company helped them establish. Kit revenue is generated from contracted hospitals. Selected Financial Data For the three months ended For the nine months endedRevenues September 30,2024 September 30,2025 September 30,2024 September 30,2025 (RMB in thousands) (RMB in thousands)Central laboratory channel 39,984 36,811 136,371 115,968In-hospital channel 63,769 52,847 181,028 173,030Pharma research and development channel 24,891 41,959 72,401 124,255Total revenues 128,644 131,617 389,800 413,253 For the three months ended For the nine months endedRevenues by location of customer September 30,2024 September 30,2025 September 30,2024 September 30,2025 (RMB in thousands) (RMB in thousands)Overseas 25,840 17,214 59,553 79,079Mainland China 102,804 114,403 330,247 334,174Total Revenues 128,644 131,617 389,800 413,253 For the three months ended For the nine months endedGross profit September 30, 2024 September 30, 2025 September 30, 2024 September 30, 2025 (RMB in thousands) (RMB in thousands)Central laboratory channel 33,262 30,126 108,688 98,254In-hospital channel 46,580 37,925 129,830 128,310Pharma research and development channel 12,004 30,793 34,460 77,784Total gross profit 91,846 98,844 272,978 304,348 For the three months ended For the nine months endedShare-based compensation expenses September 30,2024 September 30, 2025 September 30,2024 September 30, 2025 (RMB in thousands) (RMB in thousands)Cost of revenues 289 301 1,349 889Research and development expenses 3,180 73 27,475 1,603Selling and marketing expenses 1,917 624 3,657 2,013General and administrative expenses 4,732 2,831 115,129 6,249Total share-based compensation expenses 10,118 3,829 147,610 10,754 Burning Rock Biotech LimitedUnaudited Condensed Statements of Comprehensive Loss(in thousands, except for number of shares and per share data) For the three months ended September 30,2024 December 31,2024 March 31,2025 June 30,2025 September 30,2025 September 30,2025 RMB RMB RMB RMB RMB US$ Revenues128,644 126,022 133,082 148,554 131,617 18,488 Cost of revenues(36,798)(36,600)(35,681)(40,451)(32,773)(4,604)Gross profit91,846 89,422 97,401 108,103 98,844 13,884 Operating expenses: Research and development expenses(49,150)(52,203)(40,389)(49,770)(41,469)(5,825)Selling and marketing expenses(48,411)(46,730)(40,888)(38,413)(41,808)(5,873)General and administrative expenses(32,874)(37,289)(31,303)(31,417)(31,698)(4,453)Impairment loss on long-lived assets- (35,127)- - - - Total operating expenses(130,435)(171,349)(112,580)(119,600)(114,975)(16,151)Loss from operations(38,589)(81,927)(15,179)(11,497)(16,131)(2,267)Interest income3,173 1,814 2,581 2,226 1,744 245 Interest expense- - - - (15)(2)Other income (expense), net1 4,353 (652)387 7 1 Foreign exchange loss, net(129)(220)(26)(574)(2,151)(302)Loss before income tax(35,544)(75,980)(13,276)(9,458)(16,546)(2,325)Income tax expenses(201)(5,314)(224)(244)(212)(30)Net loss(35,745)(81,294)(13,500)(9,702)(16,758)(2,355)Net loss attributable to Burning Rock Biotech Limited’s shareholders(35,745)(81,294)(13,500)(9,702)(16,758)(2,355)Net loss attributable to ordinary shareholders(35,745)(81,294)(13,500)(9,702)(16,758)(2,355)Loss per share for class A and class B ordinary shares: Class A ordinary shares - basic and diluted(0.35)(0.79)(0.13)(0.09)(0.16)(0.02)Class B ordinary shares - basic and diluted(0.35)(0.79)(0.13)(0.09)(0.16)(0.02)Weighted average shares outstanding used in loss per share computation: Class A ordinary shares - basic and diluted85,902,670 86,036,286 90,291,658 90,357,970 90,416,619 90,416,619 Class B ordinary shares - basic and diluted17,324,848 17,324,848 17,324,848 17,324,848 17,324,848 17,324,848 Other comprehensive (loss) income, net of tax of nil: Foreign currency translation adjustments(4,054)6,009 (72)(243)(1,724)(242)Total comprehensive loss(39,799)(75,285)(13,572)(9,945)(18,482)(2,597)Total comprehensive loss attributable to Burning Rock Biotech Limited’s shareholders(39,799)(75,285)(13,572)(9,945)(18,482)(2,597) Burning Rock Biotech LimitedUnaudited Condensed Statements of Comprehensive Loss(in thousands, except for number of shares and per share data) For the nine months ended September 30,2024 September 30,2025 September 30,2025 RMBRMBUS$Revenues389,800 413,253 58,049 Cost of revenues(116,822)(108,905)(15,299)Gross profit272,978 304,348 42,750 Operating expenses: Research and development expenses(180,087)(131,628)(18,490)Selling and marketing expenses(144,174)(121,109)(17,012)General and administrative expenses(224,349)(94,418)(13,263)Total operating expenses(548,610)(347,155)(48,765)Loss from operations(275,632)(42,807)(6,015)Interest income10,398 6,551 920 Interest expense- (15)(2)Other income, net353 (258)(36)Foreign exchange gain (loss), net120 (2,751)(386)Loss before income tax(264,761)(39,280)(5,519)Income tax expenses(571)(680)(96)Net loss(265,332)(39,960)(5,615)Net loss attributable to Burning Rock Biotech Limited’s shareholders(265,332)(39,960)(5,615)Net loss attributable to ordinary shareholders(265,332)(39,960)(5,615)Loss per share for class A and class B ordinary shares: Class A ordinary shares - basic and diluted(2.58)(0.37)(0.05)Class B ordinary shares - basic and diluted(2.58)(0.37)(0.05)Weighted average shares outstanding used in loss per share computation: Class A ordinary shares - basic and diluted85,467,131 90,332,672 90,332,672 Class B ordinary shares - basic and diluted17,324,848 17,324,848 17,324,848 Other comprehensive loss, net of tax of nil: Foreign currency translation adjustments(2,524)(2,039)(286)Total comprehensive loss(267,856)(41,999)(5,901)Total comprehensive loss attributable to Burning Rock Biotech Limited’s shareholders(267,856)(41,999)(5,901) Burning Rock Biotech LimitedUnaudited Condensed Consolidated Balance Sheets(In thousands) As of December 31,2024 September 30,2025 September 30,2025 RMB RMB US$ASSETS Current assets: Cash and cash equivalents519,849 463,994 65,177Restricted cash2,313 2,985 419Accounts receivable, net152,013 183,841 25,824Contract assets, net13,855 13,049 1,833Inventories, net62,625 54,469 7,651Prepayments and other current assets, net25,963 20,985 2,950Total current assets776,618 739,323 103,854Non-current assets: Property and equipment, net47,152 33,755 4,742Operating right-of-use assets53,188 32,281 4,534Intangible assets, net421 316 44Other non-current assets7,926 6,493 912Total non-current assets108,687 72,845 10,232TOTAL ASSETS885,305 812,168 114,086 Burning Rock Biotech LimitedUnaudited Condensed Consolidated Balance Sheets (Continued)(in thousands) As of December 31, 2024 September 30, 2025 September 30, 2025 RMBRMBUS$LIABILITIES AND SHAREHOLDERS’ EQUITY Current liabilities: Accounts payable33,747 34,277 4,815 Deferred revenue117,895 106,448 14,953 Accrued liabilities and other current liabilities89,498 76,992 10,816 Customer deposits592 592 83 Short-term borrowings- 200 28 Current portion of operating lease liabilities24,567 16,603 2,332 Total current liabilities266,299 235,112 33,027 Non-current liabilities: Long-term borrowings- 1,800 253 Non-current portion of operating lease liabilities27,754 14,577 2,048 Other non-current liabilities10,425 11,102 1,559 Total non-current liabilities38,179 27,479 3,860 TOTAL LIABILITIES304,478 262,591 36,887 Shareholders’ equity: Class A ordinary shares124 120 17 Class B ordinary shares21 21 3 Additional paid-in capital5,002,255 5,006,937 703,320 Treasury stock(63,264)(57,193)(8,034)Accumulated deficits(4,200,261)(4,240,221)(595,620)Accumulated other comprehensive loss(158,048)(160,087)(22,487)Total shareholders’ equity580,827 549,577 77,199 TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY885,305 812,168 114,086 Burning Rock Biotech LimitedUnaudited Condensed Statements of Cash Flows(in thousands) For the three months ended September30,2024 September30,2025 September 30,2025 RMBRMBUS$Net cash used in operating activities(30,278)16,394 2,303 Net cash used in investing activities(987)(2,747)(386)Net cash generated from financing activities2 - - Effect of exchange rate on cash, cash equivalents and restricted cash(3,537)(1,692)(237)Net decrease in cash, cash equivalents and restricted cash(34,800)11,955 1,680 Cash, cash equivalents and restricted cash at the beginning of period533,047 455,024 63,916 Cash, cash equivalents and restricted cash at the end of period498,247 466,979 65,596 For the nine months ended September30,2024 September30,2025 September30,2025 RMBRMBUS$Net cash used in operating activities(111,323)(51,482)(7,232)Net cash used in investing activities(3,600)(4,071)(572)Net cash generated from financing activities2 2,000 281 Effect of exchange rate on cash, cash equivalents and restricted cash(2,048)(1,630)(229)Net decrease in cash, cash equivalents and restricted cash(116,969)(55,183)(7,752)Cash, cash equivalents and restricted cash at the beginning of period615,216 522,162 73,348 Cash, cash equivalents and restricted cash at the end of period498,247 466,979 65,596 Burning Rock Biotech LimitedReconciliations of GAAP and Non-GAAP Results For the three months ended September 30,2024 December 31,2024 March 31,2025 June 30,2025 September 30,2025 (RMB in thousands)Gross profit: Central laboratory channel33,262 33,153 32,191 35,937 30,126 In-hospital channel46,580 29,563 43,895 46,490 37,925 Pharma research and development channel12,004 26,706 21,315 25,676 30,793 Total gross profit91,846 89,422 97,401 108,103 98,844 Add: depreciation and amortization: Central laboratory channel1,277 1,010 562 456 231 In-hospital channel798 623 290 389 372 Pharma research and development channel3,846 2,534 2,412 1,528 1,491 Total depreciation and amortization included in cost of revenues5,921 4,167 3,264 2,373 2,094 Non-GAAP gross profit： Central laboratory channel34,539 34,163 32,753 36,393 30,357 In-hospital channel47,378 30,186 44,185 46,879 38,297 Pharma research and development channel15,850 29,240 23,727 27,204 32,284 Total non-GAAP gross profit97,767 93,589 100,665 110,476 100,938 Non-GAAP gross margin： Central laboratory channel86.4% 87.0% 85.5% 89.1% 82.5% In-hospital channel74.3% 69.5% 76.6% 75.0% 72.5% Pharma research and development channel63.7% 67.6% 64.0% 60.2% 76.9% Total non-GAAP gross margin76.0% 74.3% 75.6% 74.4% 76.7%

CAMBRIDGE, England--(BUSINESS WIRE)--AstraZeneca: Revenue and EPS summary 9M 2025 % Change Q3 2025 % Change $m Actual CER1 $m Actual CER - Product Sales 41,035 9 9 14,365 11 9 - Alliance Revenue 2,108 41 41 815 46 44 Product Revenue2 43,143 10 11 15,180 12 11 Collaboration Revenue 93 (14 ) (15 ) 11 (81 ) (82 ) Total Revenue 43,236 10 11 15,191 12 10 Reported EPS ($) 5.10 43 42 1.64 77 70 Core3 EPS ($) 7.04 15 15 2.38 14 12 Key performance elements for 9M 2025 (Growth numbers at constant exchange rates) Total Revenue up 11% to $43,236m, driven by growth in all Therapy Areas, including 16% growth in Oncology and 13% growth in R&I Growth in Total Revenue across all major geographic regions Core Operating profit increased 13% Core EPS increased 15% to $7.04 16 positive Phase III readouts and 31 approvals in major regions Pascal Soriot, Chief Executive Officer, AstraZeneca, said: "The strong underlying momentum across our business through the first nine months of the year sets us up well to sustain growth through 2026 and has us on track to deliver our 2030 ambition. Across our pipeline we have announced an unprecedented 16 positive Phase III trials this year, with four since our previous results including high-impact readouts for baxdrostat in hypertension and Enhertu and Datroway in breast cancer. We are also delivering on our strategy to strengthen our operations in the United States to power our growth. This includes a historic agreement with the US government to lower the cost of medicines for American patients, and broadening our US manufacturing footprint having broken ground at our new $4.5bn Virginia manufacturing facility in October." Guidance AstraZeneca reiterates its Total Revenue and Core EPS guidance4 for FY 2025 at CER, based on the average foreign exchange rates through 2024. Total Revenue is expected to increase by a high single-digit percentage Core EPS is expected to increase by a low double-digit percentage The Core Tax rate is expected to be between 18-22% If foreign exchange rates for October 2025 to December 2025 were to remain at the average rates seen in September 2025, it is anticipated that FY 2025 Total Revenue growth and Core EPS growth would be broadly similar to the growth at CER (unchanged from the previous guidance). Results highlights Table 1. Milestones achieved since the prior results announcement Phase III and other registrational data readouts Medicine Trial Indication Event Enhertu DESTINY-Breast05 High-risk HER2+ early breast cancer (post-neoadjuvant) Primary endpoint met Datroway TROPION-Breast02 1L TNBC for patients where IO is not an option Dual primary endpoints met Imfinzi MATTERHORN Resectable gastric/GEJ cancer Secondary endpoint met (OS) baxdrostat Bax24 Treatment resistant hypertension Primary endpoint met Fasenra RESOLUTE COPD Primary endpoint not met Saphnelo TULIP-SC SLE (subcutaneous) Primary endpoint met Regulatory approvals Medicine Trial Indication Region Calquence ECHO 1L MCL JP Calquence ACE-LY-004 Relapsed/refractory MCL JP Datroway TROPION-Breast01 HR+ HER2- mBC CN Enhertu DESTINY-Breast06 CTx naïve HER2-low and -ultralow mBC JP Imfinzi NIAGARA Bladder cancer JP Imfinzi AEGEAN Resectable NSCLC JP Lynparza PROpel BRCAm mCRPC CN Tezspire WAYPOINT Chronic rhinosinusitis with nasal polyps US, EU Koselugo KOMET Adult neurofibromatosis type 1 JP, EU Ultomiris CHAMPION-NMOSD NMOSD CN Regulatory submissions or acceptances* in major regions Medicine Trial Indication Region Enhertu DESTINY-PanTumour02 Previously treated HER2+ solid tumours EU Enhertu DESTINY-Gastric04 2L HER2+ gastric/GEJ cancer EU Enhertu DESTINY-Breast09 1L HER2+ mBC US, JP, CN Enhertu DESTINY-Breast11 Neoadjuvant HER2+ Stage II or III breast cancer US, CN Imfinzi MATTERHORN Resectable early-stage gastric and GEJ cancers EU, JP Imfinzi POTOMAC High-risk non-muscle invasive bladder cancer US, EU, JP Truqap CAPItello-281 PTEN-deficient metastatic hormone-sensitive prostate cancer US, EU Breztri KALOS/LOGOS Uncontrolled asthma US, EU, JP, CN Fasenra NATRON HES US, EU, JP, CN Saphnelo TULIP-SC SLE (subcutaneous) US, EU, JP Saphnelo TULIP-1/2, AZALEA SLE CN gefurulimab PREVAIL Generalised myasthenia gravis JP * US, EU and China regulatory submissions denotes filing acceptance Other pipeline updates For recent trial starts and anticipated timings of key trial readouts, please refer to the Clinical Trials Appendix, available on www.astrazeneca.com/investor-relations.html. Table 2: Key elements of financial performance: Q3 2025 For the quarter Reported Change Core Change ended 30 September $m Act CER $m Act CER Product Revenue 15,180 12 11 15,180 12 11 * See Tables 3, 27 and 28 for medicine details of Product Revenue, Product Sales and Alliance Revenue Collaboration Revenue 11 (81) (82) 11 (81) (82) * See Tables 4 and 29 for details of Collaboration Revenue Total Revenue 15,191 12 10 15,191 12 10 * See Tables 5 and 6 for Total Revenue by Therapy Area and by region Gross Margin (%) 82 +4pp +4pp 82 - - * Variations in Gross Margin can be expected between periods due to various factors, including fluctuations in foreign exchange rates, product seasonality and Collaboration Revenue * See 'Reporting changes' below for the definition of Gross Margin5 R&D expense 3,663 18 16 3,550 16 14 * Core R&D: 23% of Total Revenue + Accelerated recruitment year-to-date in ongoing trials + Investments in transformative technologies such as IO bispecifics, cell therapy and radioconjugates + Positive data read-outs for high-value pipeline opportunities that have ungated large late-stage trials + Addition of R&D projects from business development SG&A expense 5,085 (1) (3) 3,822 6 4 * Core SG&A: 25% of Total Revenue Other operating income and expense6 89 >3x >3x 96 >3x >3x Operating Profit 3,583 70 64 4,993 16 13 Operating Margin (%) 24 +8pp +8pp 33 +1pp +1pp Net finance expense 349 27 25 305 (7) (9) − Reduction in Core driven by lower short-term borrowing during the quarter + Reported expense in Q3 2024 included a favourable fair value adjustment Tax rate (%) 22 - - 21 +2pp +2pp * Variations in the tax rate can be expected between periods EPS ($) 1.64 77 70 2.38 14 12 For monetary values the unit of change is percent. For Gross Margin, Operating Margin and Tax rate, the unit of change is percentage points (pp). In the expense commentary above, the plus and minus symbols denote the directional impact of the item being discussed, e.g. a '+' symbol beside an R&D expense comment indicates that the item increased R&D expenditure relative to the prior year period. Corporate and business development Listing harmonisation As announced on 29 September 2025 and approved by shareholders on 3 November 2025, AstraZeneca will harmonise its share listing structure to deliver a global listing for global investors in a global company. It is expected that AstraZeneca shareholders will be able to trade their interests in AstraZeneca ordinary shares across the London Stock Exchange, Nasdaq Stockholm and the New York Stock Exchange from 2 February 2026. For further details, see the Circular containing details of the Harmonised Listing Structure. US investment plans In October 2025, AstraZeneca announced having broken ground on its $4.5bn manufacturing facility in Rivanna Futures, Albemarle County, Virginia. This is part of the Company's plans to invest $50bn in US manufacturing and R&D by 2030, announced in July 2025. The Virginia plant is expected to create approximately 3,600 direct and indirect jobs. It will produce drug substance for AstraZeneca's weight management and metabolic portfolio, including oral GLP-1 (AZD5004), baxdrostat, oral PCSK9 (laroprovstat) and combination small molecule products, and also antibody drug conjugates for the Oncology portfolio. Agreement with US Government In October 2025, AstraZeneca announced a historic agreement with the US administration to lower the cost of prescription medicines for American patients. The Company voluntarily agreed to a range of measures which will enable American patients to access medicines at prices that are equalised with those available in wealthy countries. As part of the agreement, AstraZeneca will provide Direct-to-Consumer sales to eligible patients with prescriptions for select products for chronic diseases. AstraZeneca has also reached an agreement with the US Department of Commerce to delay Section 232 tariffs for three years, enabling the Company to fully onshore medicines manufacturing so that all of its medicines sold in America are made in America. SixPeaks On 22 October 2025, AstraZeneca, by exercise of an option, completed the acquisition of the remaining share capital of SixPeaks Bio AG (SixPeaks), following an initial investment of $15m made in Q2 2024. $170m was paid on closing, $30m to be paid after two years and up to a further $100m is payable on achievement of regulatory milestones. SixPeaks is investigating potential therapies for weight-management with the aim of preserving lean muscle mass. Agreement with Merck on Koselugo In August 2025, the contractual arrangements between AstraZeneca and Merck & Co., Inc., (Merck; known as MSD outside of the US and Canada) were updated and simplified relating to the global development and commercialisation of Koselugo, an oral, selective MEK inhibitor. Under the updated arrangements AstraZeneca will fully recognise the costs, revenues and profits of Koselugo globally. Merck received an upfront payment of $150 million and will receive deferred payments totalling up to $400m. In addition, Merck is eligible to receive up to $175m in potential approval milestones and up to $235m in sales milestone payments, plus single-digit royalties based on net sales. Prior to the updated arrangements, AstraZeneca fully recognised the revenues of Koselugo but shared equally pre-tax profits and losses of the product with Merck. Sustainability highlights For the third consecutive year, TIME Magazine recognised AstraZeneca as one of the World's Best Companies with the Company ranking at 43 out of 1,000 global companies and as the top pharmaceutical company in terms of sustainability transparency. Reporting calendar The Company intends to publish its FY and Q4 2025 results on 10 February 2026. Conference call A conference call and webcast for investors and analysts will begin today, 6 November 2025, at 13:00 UK time. Details can be accessed via astrazeneca.com. Reporting changes since FY 2024 Product Revenue Effective 1 January 2025, the Group has updated the presentation of Total Revenue on the face of the Statement of Comprehensive Income to include a new subtotal 'Product Revenue' representing the summation of Product Sales and Alliance Revenue. Product Revenue and Collaboration Revenue form Total Revenue. Product Sales and Alliance Revenue will continue to be presented separately, with the new subtotal providing additional aggregation of revenue types with similar characteristics, reflecting the growing importance of Alliance Revenue. Full descriptions of Product Sales, Alliance Revenue and Collaboration Revenue are included from page 152 of the Group's Annual Report and Form 20-F Information 2024. Gross Margin Effective 1 January 2025, the Group has replaced the measure of 'Product Sales Gross Margin' with the measure of 'Gross Margin'. Previously, the measure excluded margin related to Alliance Revenue and Collaboration Revenue. The new measure is calculated using Gross profit as a percentage of Total Revenue, thereby encompassing all revenue categories, and is intended to provide a more comprehensive measure of total performance. Notes Constant exchange rates. The differences between Actual Change and CER Change are due to foreign exchange movements between periods in 2025 vs. 2024. CER financial measures are not accounted for according to generally accepted accounting principles (GAAP) because they remove the effects of currency movements from Reported results. Effective 1 January 2025, the Group has updated its presentation of Total Revenue, adding a new subtotal of Product Revenue, the sum of Product Sales and Alliance Revenue. For further details, see Note 1: 'Basis of preparation and accounting policies' in the Notes to the Interim Financial Statements. Core financial measures are adjusted to exclude certain items. The differences between Reported and Core measures are primarily due to costs relating to the amortisation of intangibles, impairments, legal settlements and restructuring charges. A full reconciliation between Reported EPS and Core EPS is provided in Tables 9 and 10 in the Financial Performance section of this document. The Company is unable to provide guidance on a Reported basis because it cannot reliably forecast material elements of the Reported results, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal settlement provisions. Please refer to the cautionary statements section regarding forward-looking statements at the end of this announcement. Effective 1 January 2025, the Group has updated its presentation of Gross Margin. For further details, see Note 1: 'Basis of preparation and accounting policies' in the Notes to the Interim Financial Statements. Income from disposals of assets and businesses, where the Group does not retain a significant ongoing economic interest, is recorded in Other operating income and expense in the Group's financial statements. To read AstraZeneca's 9M and Q3 2025 Financial Results press release in full, click here