Capivasertib

CAMBRIDGE, England--(BUSINESS WIRE)--AstraZeneca: Revenue and EPS summary H1 2026 % Change Q2 2026 % Change $m Actual CER1 $m Actual CER - Product Sales 28,896 8 5 14,510 5 4 - Alliance Revenue 1,699 31 29 874 34 33 Product Revenue 30,595 9 6 15,384 6 5 Collaboration Revenue 77 (6) (9) - n/m n/m Total Revenue 30,672 9 6 15,384 6 5 Reported EPS ($) 3.60 4 3 1.61 2 (2) Core2 EPS ($) 5.21 12 11 2.63 21 18 Key performance elements for H1 2026 (Growth numbers at constant exchange rates) Total Revenue up 6%, with double-digit growth in Oncology and Rare Disease offsetting headwinds from Farxiga US loss of exclusivity and China volume-based procurement Core Operating profit and Core EPS increased 11% Interim dividend increased 3 cents to $1.06 per share (79.5 pence, 10.32 SEK) 30 approvals in major regions since Q4 2025 results Pascal Soriot, Chief Executive Officer, AstraZeneca, said: "In the first half we saw strong performance and continued pipeline delivery, including six key positive Phase III programmes and eight first approvals in major markets, including in the US for Baxfendy, our first-in-class medicine for hypertension. While we are disappointed by the CARDIO-TTRansform outcome, we are on track to deliver our $80bn Total Revenue ambition, which assumes successes and setbacks. We remain confident in the strength of our pipeline and have more than twenty high-value readouts due over the next 18 months. We continue to invest at pace in our transformative technologies, and in our commercial execution to bring our innovative medicines to patients around the globe and drive growth beyond 2030." Guidance AstraZeneca reconfirms Total Revenue and Core EPS guidance3 for FY 2026 at CER, based on the average foreign exchange rates through 2025. Total Revenue is expected to increase by a mid-to-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 July 2026 to December 2026 were to remain at the average rates seen in June 2026, it is anticipated that Total Revenue in FY 2026 would benefit from a low single-digit percentage positive impact (unchanged) compared to the performance at CER, and Core EPS growth would be broadly similar (unchanged) to the growth at CER. Results highlights Table 1: Milestones achieved since the prior results announcement Phase III and other registrational data readouts Medicine Trial Indication Event Imfinzi VOLGA MIBC not candidates for cisplatin Primary endpoint met Imfinzi EMERALD-2 Adjuvant HCC Primary endpoint not met Imfinzi NILE 1L bladder cancer Primary endpoint met sone-ve CLARITY-Gastric01 2L+ Cldn18.2+ gastric/GEJ cancer Primary endpoint met Wainua CARDIO-TTRansform ATTR-CM Primary endpoint not met Ultomiris TMA-313 HSCT-TMA (adults) Primary endpoint not met Ultomiris ALXN1210-MG-319 gMG (paediatric) Primary endpoint met Regulatory approvals Medicine Trial Indication Region Calquence AMPLIFY 1L CLL (fixed duration) JP Datroway TROPION-Breast02 1L TNBC for patients where immunotherapy is not an option US Enhertu DESTINY-Breast05 High-risk HER2+ early breast cancer (post-neoadjuvant) US Enhertu DESTINY-Breast11 Neoadjuvant HER2+ Stage II or III breast cancer US Enhertu DESTINY-PanTumor02 / DESTINY-Lung01 / DESTINY-CRC02 HER2-positive solid tumours EU Etcamah (camizestrant) SERENA-6 ESR1m HR+ HER2- 1L locally advanced or metastatic breast cancer EU, JP Imfinzi POTOMAC NMIBC US Imfinzi MATTERHORN Resectable gastric/GEJ cancer JP Orphathys NCT04923932 3L+ MET+ gastric/GEJ cancer CN Truqap CAPItello-281 PTEN-deficient mHSPC US Baxfendy BaxHTN Hypertension US Fasenra NATRON Hypereosinophilic syndrome US, EU, JP, CN Regulatory submissions or acceptances* in major regions Medicine Trial Indication Region Baxfendy BaxHTN / Bax24 / BaxAsia Hypertension JP tozorakimab OBERON / TITANIA / MIRANDA / PROSPERO COPD EU, CN Ultomiris I CAN IgAN US, JP efzimfotase alfa MULBERRY / CHESTNUT / HICKORY HPP JP * US, EU and China regulatory entries in this table denote filing acceptance Other pipeline updates For recent trial starts and anticipated timings of key trial readouts, please refer to the Clinical Trials Appendix document in the financial results section of the AstraZeneca investor relations website: www.astrazeneca.com/investor-relations.html Table 2: Key elements of financial performance: Q2 2026 For the quarter Reported Change Core Change ended 30 June $m Act CER $m Act CER Product Revenue 15,384 6 5 15,384 6 5 * See Tables 3, 7, 23, 24 and 25 for further details of Product Revenue, Product Sales and Alliance Revenue Collaboration Revenue - n/m n/m - n/m n/m * See Tables 4 and 26 for further details of Collaboration Revenue Total Revenue 15,384 6 5 15,384 6 5 * See Tables 5 and 6 for Total Revenue by Therapy Area and by region Gross Margin (%) 84 +1pp - 84 +1pp +1pp + Variations in Gross Margin can be expected between periods due to various factors, including fluctuations in foreign exchange rates, product seasonality and Collaboration Revenue − Pricing headwinds, including those driven by loss of exclusivity and VBP in China R&D expense 4,053 14 13 3,662 6 5 * Core R&D: 24% of Total Revenue + Increasing number of trials, and patients in those trials + Investments in transformative technologies + Addition of R&D projects from business development + Positive data readouts for high value pipeline opportunities that have ungated large late-stage trials SG&A expense 5,651 16 14 4,050 7 4 * Core SG&A: 26% of Total Revenue + Investment to support ongoing and future launches Other operating income and expense4 152 92 93 152 >2x >2x + Various partner milestones Operating profit 3,164 (10) (13) 5,158 12 10 Operating Margin (%) 21 -4pp -4pp 34 +2pp +2pp Net finance expense 355 (4) (8) 340 13 8 + Lower interest income on short-term deposits − Reported Net finance expense benefitted from a lower discount unwind on contingent consideration liabilities Tax rate (%) 10 -11pp -11pp 15 -6pp -6pp − Benefit from adjustments to deferred tax assets, as a result of certain internal legal entity changes. * Variations in the tax rate can be expected between periods EPS ($) 1.61 2 (2) 2.63 21 18 For dollar values in this table, the unit of change is percent. For Gross Margin, Operating Margin and Tax rate, the unit of change is percentage points (pp). In the table above, R&D expense, SG&A expense and Net finance expense are displayed as positive numbers. The plus and minus symbols next to comments denote the directional impact of the item being discussed. For example, a plus symbol next to a comment about an R&D item indicates that the item increased R&D expenditure relative to the prior year period. Corporate and business development Dizal Pharmaceutical Co In July 2026, AstraZeneca entered into an exclusive license agreement with Dizal Pharmaceutical Co (Dizal), Ltd for Zegfrovy (sunvozertinib), a novel oral irreversible EGFR inhibitor for patients with lung cancer. AstraZeneca will acquire worldwide rights to develop and commercialise Zegfrovy, which is approved in the US and China for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. AstraZeneca will make an upfront payment to Dizal of $600m and additional payments of up to $900m upon achievement of specific development, regulatory and sales-related milestones. Additionally, Dizal will receive tiered royalties on the global sales of Zegfrovy. The transaction is expected to close in the second half of 2026, subject to customary closing conditions and regulatory clearances. Sino Biopharmaceutical In July 2026, AstraZeneca and Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ), a subsidiary of Sino Biopharmaceutical Limited, entered into an exclusive licence agreement for the development, manufacturing and commercialisation of CTTQ's PDE3/4 inhibitor, TQC3721, which is being developed for respiratory indications. Sino Biopharmaceutical Limited is eligible to receive an upfront payment of $200m, with additional development, regulatory and sales milestones up to $1.9bn, as well as tiered royalties ranging up to double-digit percentages based on the annual net sales of TQC3721 products. The agreement is subject to customary closing conditions, including regulatory clearances. Sustainability highlights In July 2026, AstraZeneca hosted a call for investors to discuss the latest developments in its Sustainability strategy. A replay of the call is available on astrazeneca.com. Reporting calendar The Company intends to publish its 9M and Q3 2026 results on 30 October 2026. Conference call A conference call and webcast for investors and analysts will begin today, 27 July 2026, at 11:45 UK time. Details can be accessed via astrazeneca.com. Notes Constant exchange rates. The differences between Actual Change and CER Change are due to foreign exchange movements between periods in 2026 vs. 2025. 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. 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 10 and 11 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. 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 H1 & Q2 2026 Financial Results press release in full, read here .

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been recommended for approval in the European Union (EU) for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the DESTINY-Breast09 Phase III trial presented at the 2025 American Society of Clinical Oncology Annual Meeting and subsequently published in The New England Journal of Medicine.1 Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “HER2-positive metastatic breast cancer is an aggressive subtype, so starting patients on an effective HER2-targeted treatment early and continuing it for as long as they benefit can have a meaningful impact on long-term outcomes. DESTINY-Breast09 sets a new benchmark with a median progression-free survival of more than three years, underscoring the potential of Enhertu plus pertuzumab to redefine first-line treatment for patients with HER2-positive metastatic breast cancer.” John Tsai, Global Head, R&D, Daiichi Sankyo, said: “Enhertu in combination with pertuzumab improved progression-free survival by more than one year compared with the current first-line standard of care, representing a meaningful advantage early in the treatment of patients with metastatic HER2-positive disease. Today’s positive CHMP opinion brings us closer to making Enhertu available in the EU as a first-line treatment option for eligible patients with HER2-positive metastatic breast cancer, marking an important milestone in moving this medicine earlier in the treatment pathway.” In DESTINY-Breast09, Enhertu in combination with pertuzumab reduced the risk of disease progression or death by 44% versus a taxane, trastuzumab and pertuzumab (THP) (based on a hazard ratio of 0.56; 95% confidence interval [CI]: 0.44-0.71; p<0.00001) in patients with HER2-positive metastatic breast cancer who had not received prior chemotherapy or HER2-targeted therapy or had received neoadjuvant or adjuvant HER2-targeted therapy more than six months before the diagnosis of advanced or metastatic disease. Median progression-free survival (PFS) was 40.7 months with Enhertu in combination with pertuzumab compared to 26.9 months with THP. The PFS benefit was consistent across subgroups, including for the prespecified stratification factorsof hormone receptor status, de novo or recurrent disease and PIK3CA mutation status. The safety profile of Enhertu plus pertuzumab was consistent with the known profiles of each individual therapy with no new safety concerns identified. Enhertu in combination with pertuzumab is approved in the US, Switzerland and other countries as a 1st-line treatment for patients with metastatic HER2-positive breast cancer based on the results from the DESTINY-Breast09 trial. Enhertu is also under review in the EU for patients with HER2-positive breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment based on data from the DESTINY-Breast05 trial. Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. Notes HER2-positive metastatic breast cancer Breast cancer is the most common cancer in women worldwide and the leading cause of cancer-related death among women.2 Approximately, 2.4 million breast cancer cases were diagnosed in 2024, with more than 690,000 deaths globally.2 In Europe, approximately 540,000 cases of breast cancer are diagnosed annually, with more than 140,000 deaths.3 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or whose disease has progressed to metastatic disease are expected to live five years following diagnosis.4 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast cancer.5 HER2 protein overexpression may occur as a result of HER2 gene amplification.4 Approximately one in five cases of breast cancer is considered HER2-positive.5 HER2-positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 that affects 15% to 20% of patients with metastatic breast cancer.6 While HER2-targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of first-line treatment with THP, which has been the standard of care for more than a decade.6-8 Further, approximately one in three patients do not receive any treatment following first-line therapy due to disease progression or death.10,11 DESTINY-Breast09 DESTINY-Breast09 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg) either alone or in combination with pertuzumab versus standard of care THP as first-line treatment in patients with HER2-positive metastatic breast cancer who had not received prior chemotherapy or HER2-targeted therapy or had received neoadjuvant or adjuvant HER2-targeted therapy more than six months before the diagnosis of advanced or metastatic disease. Patients were randomised 1:1:1 to receive either Enhertu monotherapy with a pertuzumab matching placebo; Enhertu in combination with pertuzumab; or THP. Randomisation was stratified by prior treatment (de novo metastatic disease versus progression from early-stage disease), hormone receptor (HR) status and PIK3CA mutation status. The primary endpoint of DESTINY-Breast09 is PFS as assessed by BICR in both the Enhertu monotherapy and Enhertu combination arms. Secondary endpoints include investigator-assessed PFS, overall survival, ORR, duration of response, pharmacokinetics and safety. The investigational arm assessing Enhertu monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis. DESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov. Enhertu Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Enhertu (5.4mg/kg) followed by THP is approved in the US, China and Singapore as a neoadjuvant treatment for adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer based on the results from the DESTINY-Breast11 trial. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu (5.4mg/kg) is approved in the US as an adjuvant treatment for adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial. Enhertu (5.4mg/kg) in combination with pertuzumab is approved in the US, Switzerland, India, Israel, United Arab Emirates, Saudi Arabia, Korea and Singapore as a 1st-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer based on the results from the DESTINY-Breast09 trial. Enhertu (5.4mg/kg) is approved in more than 100 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial. Enhertu (5.4mg/kg) is approved in more than 75 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally authorised test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial. Enhertu (5.4mg/kg) is approved in more than 100 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial. Enhertu (5.4mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu (6.4mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric04 trials. Enhertu (5.4mg/kg) is approved in more than 45 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and/or HERALD trials. Continued approval in the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu clinical development programme A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu as a monotherapy, in combination or sequentially with other cancer medicines across multiple HER2-targetable cancers. Daiichi Sankyo collaboration AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise Enhertu in March 2019 and Datroway (datopotamab deruxtecan) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and Datroway. AstraZeneca in breast cancer Driven by a growing understanding of breast cancer biology, AstraZeneca is challenging, and redefining, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death. AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. With Enhertu, AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive, HER2-low and HER2-ultralow metastatic breast cancer, and expanding its potential in earlier lines of treatment and in new breast cancer settings. In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines Faslodex and Zoladex (goserelin) and aims to reshape the HR-positive space with first-in-class AKT inhibitor, Truqap (capivasertib), the TROP-2-directed ADC, Datroway (datopotamab deruxtecan) and next-generation oral SERD, Etcamah. PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in these settings. AstraZeneca is also exploring the potential of saruparib, a potent and selective inhibitor of PARP1, in combination with Etcamah in BRCA-mutated, HR-positive, HER2-negative advanced breast cancer. To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is collaborating with Daiichi Sankyo to evaluate the potential of Datroway alone and in combination with immunotherapy Imfinzi (durvalumab). AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References Oncology Corporate and financial