Sodium Zirconium Cyclosilicate

CAMBRIDGE, United Kingdom--( BUSINESS WIRE )--AstraZeneca: Revenue and EPS summary H1 2024 % Change Q2 2024 % Change $m Actual CER $m Actual CER - Product Sales 24,629 15 18 12,452 14 18 - Alliance Revenue 939 50 50 482 42 42 - Collaboration Revenue 49 (78) (78) 4 (98) (98) Total Revenue 25,617 15 18 12,938 13 17 Reported EPS $2.65 13 23 $1.24 6 15 Core 2 EPS $4.03 (1) 5 $1.98 (8) (3) Financial performance for H1 2024 (Growth numbers at constant exchange rates) Total Revenue up 18% to $25,617m, driven by an 18% increase in Product Sales and continued growth in Alliance Revenue from partnered medicines Total Revenue growth from Oncology was 22%, CVRM 22%, R&I 22%, and Rare Disease 15% Core Product Sales Gross Margin 3 of 82% Core Operating Margin of 33% Core Tax Rate of 20% Core EPS increased 5% to $4.03. The increase in Core EPS was lower than Total Revenue growth principally due to gains recognised in the prior year, specifically a $241m gain on the disposal of Pulmicort Flexhaler US rights (Q1 2023), and a $712m gain relating to updates to contractual arrangements for Beyfortus (Q2 2023) Interim dividend increased 7c to $1.00 (77.6 pence, 10.79 SEK) has been declared Guidance for FY 2024 increased, with Total Revenue and Core EPS anticipated to grow by a mid teens percentage at CER (previously a low double-digit to low teens percentage). An increase in Collaboration Revenue is not assumed in the upgraded guidance Pascal Soriot, Chief Executive Officer, AstraZeneca, said: “ Building on our strong growth in the first half of the year and continued underlying demand for our medicines we are upgrading our FY 2024 guidance for both Total Revenue and Core EPS. At our Investor Day in May we set out a new revenue ambition to deliver $80 billion of Total Revenue by 2030. This is a clear reflection of the substantial growth potential we see from both our approved medicines and those in our late-stage pipeline. Already this year we have announced five positive, potentially practice-changing Phase III studies that are anticipated to meaningfully contribute to our growth. In the year to date we have continued to make encouraging progress with several disruptive technologies, including antibody drug conjugates, bispecifics, cell and gene therapies, radioconjugates, and weight management medicines, all of which have the potential to drive our growth beyond 2030.” Key milestones achieved since the prior results announcement Positive read-outs for Imfinzi in combination with chemotherapy in muscle-invasive bladder cancer (NIAGARA), Calquence in untreated mantle cell lymphoma (ECHO), Enhertu in HR-positive, HER2-low metastatic breast cancer (DESTINY-Breast06) US approvals for Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy for primary advanced or recurrent endometrial cancer that is mismatch repair deficient (DUO-E). EU approvals for Truqap in combination with Faslodex for biomarker-positive estrogen receptor-positive, HER2‑negative advanced breast cancer (CAPItello-291), Tagrisso with the addition of chemotherapy for 1st‑line EGFR m NSCLC (FLAURA2). Japan and China approvals for Tagrisso with the addition of chemotherapy for the 1st­­‑line EGFR m NSCLC (FLAURA2) Guidance Due to strong underlying growth in Product Sales and Alliance Revenue, the Company raises its Total Revenue and Core EPS guidance for FY 2024 at CER, based on the average foreign exchange rates through 2023. Total Revenue is expected to increase by a mid teens percentage (previously a low double-digit to low teens percentage) Core EPS is expected to increase by a mid teens percentage (previously a low double-digit to low teens percentage) An increase in Collaboration Revenue is not assumed in the upgraded guidance (previously assumed a substantial increase) Other operating income is expected to decrease substantially (FY 2023 included a $241m gain on the disposal of Pulmicort Flexhaler US rights, and a $712m one-time gain relating to updates to contractual arrangements for Beyfortus ) The Core Tax rate is expected to be between 18-22% 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. Currency impact If foreign exchange rates for July 2024 to December 2024 were to remain at the average rates seen in June 2024, it is anticipated that FY 2024 Total Revenue would incur a low single-digit percentage adverse impact compared to the performance at CER, and Core EPS would incur a mid single-digit percentage adverse impact. The Company’s foreign exchange rate sensitivity analysis is provided in Table 17. Table 1: Key elements of Total Revenue performance in Q2 2024 % Change Revenue type $m Actual % CER % Product Sales 12,452 14 18 Alliance Revenue 482 42 42 • $344m Enhertu (Q2 2023: $255m) • $104m Tezspire (Q2 2023: $62m) Collaboration Revenue 4 (98) (98) • Q2 2023 included $180m for COVID-19 mAbs Total Revenue 12,938 13 17 Therapy areas $m Actual % CER % Oncology 5,331 15 19 • Tagrisso up 8% (12% at CER) due to strong global demand, Calquence up 21% (22% at CER) with sustained leadership in 1L CLL. Enhertu Total Revenue up 46% (49% at CER) CVRM 3,160 18 22 • Farxiga up 29% (32% at CER) , Lokelma up 36% (41% at CER) R&I 1,905 23 26 • Breztri up 44% (47% at CER). Saphnelo up 65%, Tezspire up 97% (>2x at CER), Symbicort up 20% (25% CER) V&I 119 (57) (53) • The drop in V&I revenue was primarily driven by lower Collaboration Revenue from COVID-19 mAbs • Beyfortus revenue was $35m (Q2 2023: $2m), which more than offset a $6m decline in Synagis Rare Disease 2,147 10 14 • Ultomiris up 33% (36% at CER), partially offset by decline in Soliris of 14% (8% at CER) • Strensiq up 13% (14% at CER) and Koselugo up 43% (45% at CER) Other Medicines 276 (11) (5) Total Revenue 12,938 13 17 Regions $m Actual % CER % US 5,571 17 17 Emerging Markets 3,386 9 18 - China 1,630 13 18 - Ex-China Emerging Markets 1,756 5 18 Europe 2,732 24 24 Established RoW 1,249 (5) 6 Total Revenue 12,938 13 17 Key partnered medicines Combined sales of Enhertu , recorded by Daiichi Sankyo Company Limited (Daiichi Sankyo) and AstraZeneca, amounted $1,772m in H1 2024 (H1 2023: $1,169m). Combined sales of Tezspire , recorded by Amgen and AstraZeneca, amounted to $507m in H1 2024 (H1 2023: $257m). Table 2: Key elements of financial performance in Q2 2024 Metric Reported Reported change Core Core change Comments 4 Total Revenue $12,938m 13% Actual 17% CER $12,938m 13% Actual 17% CER • See Table 1 and the Total Revenue section of this document for further details Product Sales Gross Margin 82% Stable Actual Stable CER 83% Stable Actual Stable CER • Variations in Product Sales Gross Margin can be expected between periods due to product seasonality (e.g. FluMist and Beyfortus in H2), foreign exchange fluctuations and other effects R&D expense $3,008m 13% Actual 13% CER $2,872m 12% Actual 13% CER + Increased investment in the pipeline • Core R&D-to-Total Revenue ratio of 22% (Q2 2023: 22%) SG&A expense $4,929m -1% Actual 1% CER $3,735m 13% Actual 16% CER + Market development for recent launches and pre-launch activities • Core SG&A-to-Total Revenue ratio of 29% (Q2 2023: 29%) Other operating income and expense 5 $60m -92% Actual -92% CER $60m -92% Actual -92% CER ‒The prior year quarter included a $712m gain relating to updates to contractual arrangements for Beyfortus Operating Margin 21% Stable Actual +1pp CER 32% -6pp Actual -5pp CER • See commentary above on Gross Margin, R&D, SG&A and Other operating income and expense Net finance expense $343m -7% Actual -7% CER $285m 10% Actual 10% CER + Higher level of Net debt Tax rate 20% +7pp Actual +7pp CER 19% +2pp Actual +2pp CER • Variations in the tax rate can be expected between periods EPS $1.24 6% Actual 15% CER $1.98 -8% Actual -3% CER • Further details of differences between Reported and Core are shown in Table 12 Table 3: Pipeline highlights since prior results announcement Event Medicine Indication / Trial Event Regulatory approvals and other regulatory actions Imfinzi Primary advanced or recurrent endometrial cancer with mismatch repair deficiency (DUO-E) Regulatory approval (US), CHMP positive opinion (EU) Imfinzi + Lynparza Primary advanced or recurrent endometrial cancer with mismatch repair proficiency (DUO-E) CHMP positive opinion (EU) Tagrisso EGFR m NSCLC (1st-line) (FLAURA2) Regulatory approval (EU, JP, CN) Truqap Biomarker-positive ER-positive HER2-negative locally advanced or metastatic breast cancer (CAPItello-291) Regulatory approval (EU) Regulatory submissions or acceptances* Tagrisso EGFR m NSCLC (Stage III unresectable) (LAURA) sNDA acceptance and Priority Review (US) Dato-DXd Non-squamous NSCLC (2nd- and 3rd-line) (TROPION-Lung01) Regulatory submission (EU) sipavibart Prevention of COVID-19 (SUPERNOVA) Regulatory submission (EU) Major Phase III data readouts and other developments Calquence Mantle cell lymphoma (1st‑line) (ECHO) Primary endpoint met Dato-DXd Locally advanced or metastatic NSCLC (TROPION-Lung01) Dual primary endpoint OS not met in the intention to treat population Enhertu HER2-low breast cancer (2nd-line) (DESTINY-Breast-06) Primary endpoint met Imfinzi Muscle-invasive bladder cancer (NIAGARA) Primary endpoint met Imfinzi Adjuvant use in early-stage PD-L1 ≥25% NSCLC (Adjuvant BR.31) Primary endpoint not met Truqap Locally advanced or metastatic TNBC (CAPItello-290) Primary endpoint not met sipavibart Prevention of COVID-19 (SUPERNOVA) Primary endpoint met *US, EU and China regulatory submission denotes filing acceptance Upcoming pipeline catalysts 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 . Corporate and business development In May 2024, AstraZeneca announced its intention to build a $1.5 billion manufacturing facility in Singapore for antibody drug conjugates (ADCs), enhancing global supply of its ADC portfolio. ADCs are next-generation treatments that deliver highly potent cancer-killing agents directly to cancer cells through a targeted antibody. The planned greenfield facility, supported by the Singapore Economic Development Board, will be AstraZeneca’s first end-to-end ADC production site, fully incorporating all steps of the manufacturing process at a commercial scale. Manufacturing of ADCs is a multi-step process that comprises antibody production, synthesis of chemotherapy drug and linker, conjugation of drug-linker to the antibody, and filling of the completed ADC substance. In May 2024, AstraZeneca completed an additional $140m equity investment in Cellectis, a clinical-stage biotechnology company. The equity investment and a research collaboration agreement, announced in November 2023, will leverage the Cellectis proprietary gene editing technologies and manufacturing capabilities, to design up to 10 novel cell and gene therapy products for areas of high unmet need, including oncology, immunology and rare diseases. In Q4 2023, Cellectis received an initial payment of $105m from AstraZeneca, which comprised a $25m upfront cash payment under the terms of a research collaboration agreement and an $80m equity investment. Now that the additional $140m equity investment has closed, AstraZeneca holds a total equity stake of c.44% in Cellectis and AstraZeneca continues to treat its investment in Cellectis as an associate. In June 2024, AstraZeneca completed the acquisition of Fusion Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing next-generation radioconjugates. The acquisition marks a major step forward in AstraZeneca delivering on its ambition to transform cancer treatment and outcomes for patients by replacing traditional regimens like chemotherapy and radiotherapy with more targeted treatments. The acquisition complements AstraZeneca’s leading oncology portfolio with the addition of the Fusion pipeline of radioconjugates, including FPI-2265, a potential new treatment for patients with mCRPC, and brings new expertise and pioneering R&D, manufacturing and supply chain capabilities in actinium-based radioconjugates to AstraZeneca. See Note 5 for further information. In July 2024, AstraZeneca completed the acquisition of Amolyt Pharma, a clinical-stage biotechnology company focused on developing novel treatments for rare endocrine diseases. The acquisition bolsters the Alexion, AstraZeneca Rare Disease late-stage pipeline and expands on its bone metabolism franchise with the notable addition of eneboparatide (AZP-3601), a Phase III investigational therapeutic peptide with a novel mechanism of action designed to meet key therapeutic goals for hypoparathyroidism. In patients with hypoparathyroidism, a deficiency in parathyroid hormone production results in significant dysregulation of calcium and phosphate, which can lead to life-altering symptoms and complications, including chronic kidney disease. See Note 7 for further information. Sustainability highlights At the 77th World Health Assembly in Geneva, Switzerland in May, AstraZeneca convened Ministers of Health, industry, civil society and patient groups. Areas of focus for engagement, led by Ruud Dobber, EVP BioPharmaceuticals, included the need to increase early action to prevent, diagnose and treat disease and to accelerate collaboration to build resilient, equitable and net zero health systems. Conference call A conference call and webcast for investors and analysts will begin today, 25 July 2024, at 11:45 UK time. Details can be accessed via astrazeneca.com . Reporting calendar The Company intends to publish its 9M and Q3 2024 results on 12 November 2024. To read AstraZeneca's H1 and Q2 2024 Financial Results press release in full including the glossary, please click here . 1 Constant exchange rates. The differences between Actual Change and CER Change are due to foreign exchange movements between periods in 2024 vs. 2023. 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. 2 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 Table 11 and Table 12 in the Financial performance section of this document. 3 The calculations for Reported and Core Product Sales Gross Margin exclude the impact of Alliance Revenue and Collaboration Revenue. 4 In Table 2, the plus and minus symbols denote the directional impact of the item being discussed, e.g. a ‘+’ symbol next to a comment related to the R&D expense indicates that the item resulted in an increase in the R&D spend relative to the prior year. 5 Income from disposals of assets and businesses, where the Group does not retain a significant ongoing economic interest, continue to be recorded in Other operating income and expense in the Company’s financial statements.

Strong growth and pipeline momentum with three new medicines approved since the third quarter CAMBRIDGE, United Kingdom--(BUSINESS WIRE)-- AstraZeneca: Revenue and EPS summary FY 2023 Q4 2023 % Change % Change $m Actual CER1 $m Actual CER - Product Sales 43,789 2 4 11,323 5 5 - Alliance Revenue2 1,428 89 89 424 69 67 - Collaboration Revenue2 594 (1 ) (1 ) 277 75 74 Total Revenue 45,811 3 6 12,024 7 8 Total Revenue ex COVID-19 45,488 13 15 12,036 16 16 Reported EPS $3.84 81 96 $0.62 7 5 Core3 EPS $7.26 9 15 $1.45 5 7 Financial performance for full year 2023 (Growth numbers at CER) Total Revenue $45,811m, up 6% despite a decline of $3,736m from COVID-19 medicines4 Excluding COVID-19 medicines, Total Revenue increased 15% and Product Sales increased 14% Double-digit Total Revenue growth from Oncology 21%, CVRM 18%, R&I 10%, and Rare Disease 12% Core Product Sales Gross Margin5 of 82%, up two percentage points, reflecting the decline in sales of lower margin COVID‑19 medicines Core Operating Margin of 32% increased by two percentage points including the previously announced gain from an update to the contractual relationships for Beyfortus, totalling $712m and recorded as Core Other operating income. In the quarter, higher SG&A expense drove lower operating margins, partly due to phasing of expenses and increased investment in launches for Airsupra, Wainua and Truqap The Core Tax Rate for the year was 17%. In the fourth quarter, the tax rate was negatively impacted by reviews by tax authorities, administrative appeal processes and other adjustments, offset by a routine intragroup reorganisation of IP, leading to a tax rate of 10% in the quarter Core EPS increased 15% to $7.26 Second interim dividend declared of $1.97 per share, making a total dividend declared for FY 2023 of $2.90 per share Total Revenue and Core EPS in FY 2024 are each expected to increase by a low double-digit to low teens percentage at CER Pascal Soriot, Chief Executive Officer, AstraZeneca, said: "As AstraZeneca celebrates its 25th anniversary, we are pleased to report another year of strong financial performance and scientific progress, with double-digit earnings growth, and investment in exciting areas of science, including antibody drug conjugates and cell therapies, that lay the foundations for long-term success. We expect another year of strong growth in 2024, driven by continued adoption of our medicines across geographies. Our differentiated and growing portfolio of approved medicines, global reach and rich R&D pipeline give us confidence that we will continue to deliver industry-leading growth." Key milestones achieved since the prior results announcement Three first approvals for new molecular entities: Truqap (capivasertib), Wainua (eplontersen), Voydeya (danicopan) US approvals for Truqap plus Faslodex in HR-positive, HER2-negative advanced breast cancer with biomarker alterations (CAPItello-291), and Wainua for ATTRv-PN (NEURO-TTRansform). China approvals for Imfinzi in mBTC (TOPAZ-1) and Beyfortus for prevention of RSV in infants (MEDLEY/MELODY). First approval, in Japan, for Voydeya, as an add-on therapy to Ultomiris or Soliris for PNH with EVH (ALPHA) Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours Guidance The Company issues its Total Revenue and Core EPS guidance for FY 2024 at CER, based on the average foreign exchange rates through 2023. Total Revenue is expected to increase by a low double-digit to low teens percentage Core EPS is expected to increase by a low double-digit to low teens percentage Collaboration Revenue is expected to increase substantially, driven by success-based milestones and certain anticipated transactions Other operating income is expected to decrease substantially (FY 2023 included a $241m gain on the disposal of Pulmicort Flexhaler US rights, and a $712m one-time gain relating to updates to contractual arrangements for Beyfortus) The Core Tax rate is expected to be between 18-22% 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. Currency impact If foreign exchange rates for February 2024 to December 2024 were to remain at the average rates seen in January 2024, it is anticipated that both FY 2024 Total Revenue and Core EPS would incur a low single-digit adverse impact versus the performance at CER. The Company's foreign exchange rate sensitivity analysis is provided in Table 19. Investor Day AstraZeneca will host an Investor Day on 21 May 2024. For more information, see . Table 1: Key elements of Total Revenue performance in Q4 2023 % Change Revenue type $m Actual % CER % Product Sales 11,323 5 5 * Excluding COVID-19 medicines, Q4 2023 Product Sales increased by 14% Alliance Revenue 424 69 67 * $281m for Enhertu (Q4 2022: $188m) * $80m for Tezspire (Q4 2022: $37m) * $41m for Beyfortus (Q4 2022: $nil) Collaboration Revenue 277 75 74 * $245m Lynparza regulatory milestone (Q4 2022: $105m) * $27m Beyfortus sales milestone (Q4 2022: $nil) Total Revenue 12,024 7 8 * Excluding COVID-19 medicines, Q4 2023 Total Revenue increased by 16% Therapy areas $m Actual % CER % Oncology 4,989 23 24 * Strong performance across all key medicines and regions CVRM 2,702 18 18 * Farxiga up 36% (35% at CER), Lokelma up 38%, roxadustat up 27%, Brilinta declined 5% (4% at CER) R&I 1,675 13 13 * Fasenra up 10% (9% CER), Breztri up 72%. Saphnelo and Tezspire also continue to grow rapidly, partially offset by a 16% decline in Symbicort following entry of a generic competitor in the US in the third quarter V&I 413 (64 ) (66 ) * $6m revenue from COVID-19 mAbs and ‑$17m for Vaxzevria, both resulting from historic contracts (Q4 2022: $734m and $95m respectively) * Beyfortus $122m, including $41m of Alliance Revenue for AstraZeneca's share of gross profits outside US, $27m of Collaboration Revenue for a sales milestone and $54m of Product Sales from product supplied to Sanofi Rare Disease 1,971 9 9 * Ultomiris up 39% (38% at CER), partially offset by decline in Soliris of 15% (13% at CER) * Strensiq up 12% (13% at CER) and Koselugo up 46% (48% at CER) reflecting strong patient demand Other Medicines 274 (33 ) (32 ) * Nexium generic competition in Japan Total Revenue 12,024 7 8 Regions inc. COVID-19 $m Actual % CER % US 5,101 7 6 Emerging Markets 2,783 2 8 - China 1,382 16 16 - Ex-China Emerging Markets 1,401 (9 ) 2 Europe 2,880 25 17 Established RoW 1,259 (9 ) (6 ) Total Revenue inc. COVID-19 12,024 7 8 * Growth rates impacted by lower sales of COVID-19 medicines (see table below) Regions ex. COVID-19 $m Actual % CER % US 5,101 12 12 Emerging Markets 2,791 15 22 - China 1,382 16 16 - Ex-China Emerging Markets 1,409 14 27 Europe 2,884 33 25 Established RoW 1,259 4 8 Total Revenue ex. COVID-19 12,036 16 16 Table 2: Key elements of financial performance in Q4 2023 Metric Reported Reported change Core Core change Comments6 Total Revenue $12,024m 7% Actual 8% CER $12,024m 7% Actual 8% CER * Excluding COVID-19 medicines, Q4 2023 Total Revenue increased by 16% * See Table 1 and the Total Revenue section of this document for further details Product Sales Gross Margin 80% +6pp Actual +6pp CER 80% +3pp Actual +2pp CER + In the prior year period, gross margins were reduced due to inventory write-downs and manufacturing contract terminations for Evusheld * Variations in Product Sales Gross Margin can be expected between periods due to product seasonality, foreign exchange fluctuations and other effects R&D expense $3,073m 17% Actual 15% CER $2,914m 15% Actual 14% CER + Increased investment in the pipeline * Core R&D-to-Total Revenue ratio of 24% (Q4 2022: 23%) + Quarterly phasing impact SG&A expense $5,371m 16% Actual 16% CER $4,034m 13% Actual 12% CER + Market development for recent launches and pre-launch activities * Core SG&A-to-Total Revenue ratio of 34% (Q4 2022: 32%) + Quarterly phasing impact Other operating income and expense7 $107m -43% Actual -42% CER $107m -17% Actual -15% CER ‒ Discontinuation of brazikumab development Operating Margin 10% +1pp Actual +1pp CER 23% Stable * See Product Sales Gross Margin, expenses and Other operating income and expense commentary above Net finance expense $337m 7% Actual 3% CER $259m 5% Actual 1% CER + Higher rates on floating debt and bond issuances + Increased Interest expense on income tax balances ‒ Higher interest received on cash and short-term investments Tax rate -7% +9pp Actual +13pp CER 10% Stable ‒ Intragroup purchase of intellectual property + Reviews by tax authorities, administrative appeals and changes to certain deferred tax balances * Variations in the tax rate can be expected between periods EPS $0.62 7% Actual 5% CER $1.45 5% Actual 7% CER * Further details of differences between Reported and Core are shown in Table 14 Table 3: Pipeline highlights since prior results announcement Event Medicine Indication / Trial Event Regulatory approvals and other regulatory actions Truqap HR-positive HER2-negative advanced breast cancer with biomarker alterations (CAPItello-291) Regulatory approval (US) Imfinzi Biliary tract cancer (TOPAZ-1) Regulatory approval (CN) Wainua ATTRv-PN (NEURO-TTRansform) Regulatory approval (US) Beyfortus RSV (MELODY-MEDLEY) Regulatory approval (CN) Voydeya PNH with EVH (ALPHA) Regulatory approval (JP) Regulatory submissions or acceptances* Lynparza gBRCA breast cancer (adjuvant) (OlympiA) Regulatory submission (CN) Lynparza + Imfinzi Endometrial cancer (1st-line) (DUO-E) Regulatory submission (US, EU, JP) Enhertu HER2-expressing tumours (DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02) Regulatory submission (US), Priority Review (US) Enhertu HER2+/HER2-low gastric (1st-line) (DESTINY-Gastric01) Regulatory submission (CN) Imfinzi + Imjudo NSCLC (neoadjuvant) (AEGEAN) Regulatory submission (EU) Wainua ATTRv-PN (NEURO-TTRansform) Regulatory submission (EU) Fasenra EGPA (MANDARA) Regulatory submission (US, EU, JP) Ultomiris NMOSD (CHAMPION-NMOSD) Regulatory submission (US) Ultomiris gMG Regulatory submission (CN) Major Phase III data readouts and other developments Imfinzi NSCLC (unresectable, Stg. III) (PACIFIC-2) Primary endpoint not met acoramidis 8 ATTR-CM Primary endpoint met *US, EU and China regulatory submission denotes filing acceptance Upcoming pipeline catalysts For a table of anticipated timings of key trial readouts, please refer to page 3 of the Clinical Trials Appendix, available on . Table 4: Phase III trials started since 1 January 2023 Medicine Trial name Indication datopotamab deruxtecan AVANZAR NSCLC (1st-line) TROPION-Lung07 Non-squamous NSCLC (1st-line) TROPION-Breast04 Neoadjuvant/adjuvant triple-negative or HR-low/HER2-negative breast cancer TROPION-Breast05 PD-L1-positive locally recurrent inoperable or metastatic TNBC camizestrant CAMBRIA-1 HR-positive/HER2-negative adjuvant breast cancer CAMBRIA-2 HR-positive/HER2-negative adjuvant breast cancer Truqap CAPItello-292 HR-positive/HER2-negative advanced breast cancer volrustomig eVOLVE-Cervical High-risk locally advanced cervical cancer eVOLVE-Lung02 mNSCLC (1st-line) with PD-L1 <50% eVOLVE-Meso Unresectable malignant pleural mesothelioma (1st-line) eVOLVE-HNSCC Unresected, locally advanced HNSCC rilvegostomig ARTEMIDE-Biliary01 BTC with curative intent saruparib EvoPAR-PR01 HRRm and Non-HRRm mCSPC zibo/dapa ZENITH High Proteinuria CKD with high proteinuria Saphnelo DAISY Systemic sclerosis baxdrostat BaxHTN Uncontrolled, including treatment-resistant, hypertension Tezspire CROSSING Eosinophilic oesophagitis Breztri LITHOS Mild to moderate asthma ATHLOS COPD pMDI portfolio HFO1234ze + Breztri COPD HFO1234ze Mucociliary clearance in healthy volunteers HFO1234ze Asthma tozorakimab MIRANDA COPD ipavibart (AZD3152) SUPERNOVA COVID-19 prophylaxis Ultomiris ARTEMIS Cardiac surgery-associated acute kidney injury ALXN2220 DepleTTR-CM Transthyretin amyloid cardiomyopathy efzimfotase alfa (ALXN1850) HICKORY Hypophosphatasia Corporate and business development In November 2023, AstraZeneca launched Evinova, with an ambition to become a leading provider of digital health solutions to better meet the needs of healthcare professionals, regulators and patients. Evinova will prioritise bringing to market established and scaled digital technology solutions already being used globally by AstraZeneca to optimise clinical trial design and delivery. Globally-leading clinical research organisations Parexel and Fortrea have entered into agreements to offer Evinova digital health solutions to their wide customer base. In December 2023, AstraZeneca entered into a definitive agreement to acquire Icosavax, Inc (Icosavax). The acquisition strengthens AstraZeneca's late-stage pipeline with Icosavax's lead investigational vaccine candidate, IVX-A12, a potential first-in-class, Phase III-ready, combination VLP vaccine that targets both RSV and hMPV. RSV and hMPV are both leading causes of severe respiratory infection and hospitalisation in adults 60 years of age and older and those with chronic conditions such as cardiovascular, renal and respiratory disease. Subject to the satisfaction of the conditions in the merger agreement, the acquisition is expected to close in the first quarter of 2024. In December 2023, AstraZeneca entered into a definitive agreement to acquire Gracell Biotechnologies Inc. (Gracell), a global clinical-stage biopharmaceutical company developing innovative cell therapies for the treatment of cancer and autoimmune diseases. The proposed acquisition will enrich AstraZeneca's growing pipeline of cell therapies with GC012F, a novel, clinical-stage FasTCAR-enabled BCMA and CD19 dual-targeting CAR-T therapy, a potential new treatment for multiple myeloma, as well as other haematologic malignancies and autoimmune diseases including systemic lupus erythematosus. The transaction is expected to close in the first quarter of 2024, subject to customary closing conditions, including regulatory clearances, and Gracell shareholder approval. In February 2024, AstraZeneca announced that it is investing $300 million in a state-of-the-art facility in Rockville, Maryland to establish life-saving cell therapy platforms for critical cancer trials and future commercial supply. To align with clinical trial timelines, the site will initially focus on pivotal clinical trial manufacturing of CAR-T cell therapies to meet current clinical supply demand. More than 150 new highly skilled jobs will be created to initially focus on manufacturing T-cell therapies to enable clinical trials to be conducted around the world. Over time, the site may expand its focus to support other therapy areas. Sustainability highlights Through the Sustainable Markets Initiative Health Systems Task Force, AstraZeneca announced an industry-first renewable power agreement in China together with four global healthcare leaders and renewable energy company Envision Energy, resulting in potential annual emissions savings of approximately 120,000 tonnes, the equivalent of taking 25,000 cars off the road. See the Sustainability section in this document for further details. Conference call A conference call and webcast for investors and analysts will begin today, 8 February 2024, at 11:45 UK time. Details can be accessed via astrazeneca.com. Reporting calendar The Company intends to publish its Q1 2024 results on 25 April 2024. To read AstraZeneca's Full Year and Q4 2023 Financial Results press release in full, click here. ______________________________ 1 Constant exchange rates. The differences between Actual Change and CER Change are due to foreign exchange movements between periods in 2023 vs. 2022. 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. 2 Effective 1 January 2023, the Group has updated the presentation of Total Revenue. For further details of the presentation of Alliance Revenue and Collaboration Revenue, see the Basis of preparation and accounting policies section of the Notes to the Condensed consolidated financial statements section. 3 Core financial measures are adjusted to exclude certain items. The differences between Reported and Core measures are primarily due to costs relating to the acquisition of Alexion, amortisation of intangibles, impairments, legal settlements and restructuring charges. A full reconciliation between Reported EPS and Core EPS is provided in Table 13 and Table 14 in the Financial performance section of this document. 4 The COVID-19 medicines are Vaxzevria, Evusheld, and sipavibart (AZD3152) – the COVID-19 antibody currently in development. 5 The calculation of Reported and Core Product Sales Gross Margin (formerly termed as Gross Margin) excludes the impact of Alliance Revenue and Collaboration Revenue. 6 In Table 2, the plus and minus symbols denote the directional impact of the item being discussed, e.g. a ‘+’ symbol next to an R&D expense comment indicates that the item increased the R&D expense relative to the prior year. 7 Income from disposals of assets and businesses, where the Group does not retain a significant ongoing economic interest, continue to be recorded in Other operating income and expense in the Company’s financial statements. 8 Partnered with BridgeBio Pharma Inc (BridgeBio) – AstraZeneca has rights to commercialise acamoridis in Japan View source version on businesswire.com: Contacts US Media Inquiries Brendan McEvoy, +1 302 885 2677 US Media Mailbox: usmediateam@astrazeneca.com Source: AstraZeneca View this news release online at: