Cilgavimab/Tixagevimab

Analysis of secondary endpoint of symptomatic COVID-19 events in CANOPY is unrelated to regulatory filing or review, but may be hypothesis generating for future Invivyd discovery and development work Today’s update on Day 67 and Day 90 event rates is the first of two planned public updates on symptomatic COVID-19 events in CANOPY; Invivyd plans to analyze all future events at Day 180 Further defining the relationship between serum virus neutralizing antibody titers and clinical protection that prospectively builds on published data is an anticipated goal of future clinical trials WALTHAM, Mass., March 22, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced interim exploratory COVID-19 clinical event data for VYD222, an investigational, monoclonal antibody (mAb) in development for the pre-exposure prophylaxis of COVID-19. The data announced today from the ongoing Phase 3 CANOPY clinical trial reflect and add further to the initial potential signal of clinical protection from symptomatic COVID-19 shared in December 2023, and may be useful in updating prior published work that analyzed the relationships between serum virus neutralizing antibody (sVNA) titers and protection in patients who had no prior exposure to vaccination or natural infection.1 “While these interim clinical efficacy data are exploratory and not part of the primary immunobridging endpoint of the CANOPY clinical trial, we believe they further our efforts to understand the relationship between sVNA titers and clinical efficacy in individuals who have some level of vaccine- or infection-induced immunity,” said Dave Hering, Chief Executive Officer. “As we continue to build out our company and advance the science describing monoclonal antibody pre-exposure prophylaxis (PrEP), we believe we can incorporate these findings into future prospectively designed clinical studies that seek to establish formal relationships between neutralizing titers and protection. Exploratory data such as provided in today’s update are important for broad reflection as they represent some of the first data from a clinical trial conducted with a monoclonal antibody in a population that has acquired prior immune exposure from either vaccination or natural infection. By contrast, studies of prior authorized COVID-19 PrEP mAbs largely relied on participants required by protocol to be naïve to vaccination or prior infection2. As such, these people would presumably have no baseline titers. We continue to explore how measured titers compare with calculated titers and look to assess if higher levels of protection in future studies may be possible with lower levels of additional titers conferred from mAbs.” The ongoing CANOPY Phase 3 clinical trial is designed to evaluate the safety and tolerability of VYD222 and to assess immunobridging from VYD222 to certain historical data from the company’s previous Phase 2/3 clinical trial of adintrevimab (ADG20) for the prevention of symptomatic COVID-19 (EVADE). Symptomatic COVID-19 event collection in the CANOPY clinical trial is a secondary exploratory endpoint designed to allow Invivyd to contemplate further discovery and development work only. The CANOPY clinical trial enrolled participants in two cohorts. Cohort A is a single-arm, open-label trial in adults who have moderate-to-severe immune compromise including complex underlying medical conditions (n=306). Cohort B is a randomized, placebo-controlled cohort that enrolled adults without moderate-to-severe immune compromise who are at risk of acquiring SARS-CoV-2 due to regular unmasked face-to-face interactions in indoor settings. All CANOPY Cohort A participants received VYD222 administered via intravenous (IV) infusion. Cohort B participants were randomized 2:1 to receive VYD222 or placebo administered via IV infusion. Updated Findings As previously disclosed by the company in December 2023, a potential early signal of clinical protection from symptomatic COVID-19 confirmed by RT-PCR was observed. Invivyd is now providing an update on the clinical cases of confirmed symptomatic COVID-19 through Day 90. Beyond today’s update, additional cases of COVID-19 have occurred in Cohorts A and B post Day 90. These data are planned to be analyzed at Day 180 and presented when available. Cohort B (Randomized, placebo-controlled cohort without moderate-to-severe immune compromise at risk of acquiring SARS-CoV-2 due to regular unmasked face-to-face interactions) — Proportion of participants with RT-PCR-confirmed symptomatic COVID-19 (exploratory data): As of December 1, 2023 (median 67 days follow-up) Through Day 90 VYD222 0% (0/322) 0.3% (1/314) Placebo 3% (5/162) 5% (8/159) Cohort A (Open-label cohort with moderate-to-severe immune compromise) — Proportion of participants with RT-PCR-confirmed symptomatic COVID-19 (exploratory data): As of December 1, 2023 (median 35 days follow-up) Through Day 90 VYD222 0% (0/306) 1% (3/298) Additional COVID-19 events have occurred in Cohort A (unblinded) and Cohort B (randomized, not yet analyzed) post Day 90, but the company has not yet analyzed the data. Invivyd plans to provide a Day 180 update and a more complete analysis of the observed relationships between sVNA titers, both calculated and measured, and events of confirmed symptomatic COVID-19 when these data are available. About VYD222 VYD222 is a neutralizing, half-life extended monoclonal antibody (mAb) candidate being investigated for the pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised adults and adolescents. VYD222 was designed for broad activity and has demonstrated in vitro neutralizing activity in pseudotyped virus-like particle and authentic virus neutralization assays against various pre-Omicron and Omicron variants, including JN.1. VYD222 was engineered from adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for both the prevention and treatment of COVID-19. About Invivyd Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company on a mission to rapidly and perpetually deliver antibody-based therapies that protect vulnerable people from the devastating consequences of circulating viral threats, beginning with SARS-CoV-2. ​​The company’s proprietary INVYMAB™ platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering. Leveraging its INVYMAB platform approach, the company is generating a robust pipeline of product candidates which could be used in prevention or treatment of serious viral diseases, starting with COVID-19 and expanding into influenza and other high-need indications. Visit to learn more. References Schmidt, Pete et al. “Antibody-mediated protection against symptomatic COVID-19 can be achieved at low serum neutralizing titers.” Sci. Transl. Med.15, eadg2783 (2023); Follmann, Dean et al. “Examining protective effects of SARS-CoV-2 neutralizing antibodies after vaccination or monoclonal antibody administration.” Nature communications vol. 14,1 3605. 17 Jun. 2023. Ison, Michael, et al. “Prevention of COVID-19 Following a Single Intramuscular Administration of Adintrevimab: Results From a Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial (EVADE).” Open Forum Infectious Diseases, Volume 10, Issue 7, July 2023; Levin, Myron J et al. “Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19.” The New England Journal of Medicine vol. 386,23 (2022): 2188-2200. Cautionary Note Regarding Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “could,” “expects,” “estimates,” “intends,” “potential,” “projects,” and “future” or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, the company’s ongoing research and clinical development activities, as well as future potential research and clinical development efforts; the potential of VYD222 for clinical protection from symptomatic COVID-19 based on early signals shown by interim data from the CANOPY clinical trial; the company’s plans to provide any future public updates on symptomatic COVID-19 events in the CANOPY clinical trial, including the timing thereof; the potential for exploratory clinical efficacy data from the CANOPY clinical trial to be hypothesis generating for future discovery and development work of the company, and the possibility of updating prior published work that analyzed the relationships between sVNA titers and protection; the in vitro neutralizing activity of VYD222 against major SARS-CoV-2 variants; the company’s mission to rapidly and perpetually deliver antibody-based therapies that protect vulnerable people from the devastating consequences of circulating viral threats, beginning with SARS-CoV-2; the ability of the company to leverage its INVYMAB platform approach to generate a robust pipeline of product candidates which, if authorized or approved, could be used in prevention or treatment of serious viral diseases, starting with COVID-19 and expanding into influenza and other high-need indications; the company’s business strategies and objectives; and other statements that are not historical fact. The company may not actually achieve the plans, intentions or expectations disclosed in the company’s forward-looking statements and you should not place undue reliance on the company’s forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the company’s actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: the timing and progress of the company’s discovery, preclinical and clinical development activities; the risk that results of preclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further analysis; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the predictability of clinical success of the company’s product candidates based on neutralizing activity in preclinical studies; the company’s reliance on third parties with respect to virus assay creation and product candidate testing and with respect to its clinical trials; variability of results in models used to predict activity against SARS-CoV-2 variants; whether VYD222 or any other product candidate is able to demonstrate and sustain neutralizing activity against major SARS-CoV-2 variants, particularly in the face of viral evolution; the company’s ability to leverage its INVYMAB platform approach to generate a robust pipeline of product candidates which, if authorized or approved, could be used in prevention or treatment of serious viral diseases; the uncertainties and timing of the regulatory authorization or approval process, and available development and regulatory pathways for authorization or approval of the company’s product candidates; changes in the regulatory environment; the company’s ability to continue as a going concern; and whether the company has adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause the company’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the Securities and Exchange Commission (SEC), and in the company’s other filings with the SEC, and in its future reports to be filed with the SEC and available at Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law. This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release. Contacts: Scott Young (781) 208-1747 syoung@invivyd.com Gabriella Linville-Engler (781) 208-0160 gengler@invivyd.com

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: