Budesonide/Formoterol fumarate/Glycopyrronium Bromide

CAMBRIDGE, England--( BUSINESS WIRE )--AstraZeneca: Revenue and EPS summary FY 2024 % Change Q4 2024 % Change $m Actual CER i $m Actual CER - Product Sales 50,938 16 19 13,362 18 19 - Alliance Revenue 2,212 55 55 714 68 69 - Collaboration Revenue 923 56 54 815 >2x >2x Total Revenue 54,073 18 21 14,891 24 25 Reported EPS $4.54 18 29 $0.97 56 71 Core ii EPS $8.21 13 19 $2.09 44 49 Financial performance for FY 2024 (Growth numbers at constant exchange rates) Total Revenue up 21% to $54,073m, driven by a 19% increase in Product Sales, continued growth of partnered medicines (Alliance Revenue) and the achievement of sales-based milestones (Collaboration Revenue) Total Revenue growth from Oncology was 24%, CVRM 20%, R&I 25%, V&I 8% and Rare Disease 16% Core EPS increased 19% to $8.21 Second interim dividend declared of $2.10 per share, making a total annual dividend declared for FY 2024 of $3.10 per share, an increase of 7%. Dividend to be further increased in FY 2025 Guidance for FY 2025: Total Revenue is expected to increase by a high single-digit percentage and Core EPS is expected to increase by a low double-digit percentage, both at CER Pascal Soriot, Chief Executive Officer, AstraZeneca, said: “ Our company delivered a very strong performance in 2024 with Total Revenue and Core EPS up 21% and 19% respectively. We also delivered nine positive high value Phase III studies in the year, which coupled with increasing demand for our medicines in all key regions, will help sustain our growth momentum into 2025. This year marks the beginning of an unprecedented, catalyst-rich period for our company, an important step on our Ambition 2030 journey to deliver $80 billion Total Revenue by the end of the decade. In 2025 alone, we anticipate the first Phase III data for seven new medicines, along with several important new indication opportunities for our existing medicines. We are also investing in and making significant progress with transformative technologies that have the potential to drive our growth well beyond 2030, many of which have now entered pivotal trials.” Key milestones achieved since the prior results announcement Positive read-outs for Truqap in combination with abiraterone and androgen deprivation therapy in PTEN -deficient de novo metastatic hormone-sensitive prostate cancer (CAPItello-281) and Tagrisso with or without chemotherapy in resectable early-stage EGFR m NSCLC (NeoADAURA) US approvals for Imfinzi in limited-stage small cell lung cancer (ADRIATIC), Calquence in combination with bendamustine and rituximab in mantle cell lymphoma (ECHO), Datroway (datopotamab deruxtecan) in HR+ HER2- metastatic breast cancer (TROPION-Breast01) and Enhertu in chemotherapy-naïve HER2-low and -ultralow metastatic breast cancer (DESTINY-Breast06). EU approvals for Tagrisso in unresectable EGFR m NSCLC (LAURA) and Kavigale for prevention of COVID-19 (SUPERNOVA). Japan approvals for Imfinzi in endometrial cancer (DUO-E), Lynparza plus Imfinzi in pMMR endometrial cancer (DUO-E), Calquence tablet formulation in chronic / small lymphocytic leukaemia, Datroway in HR+ HER2- metastatic breast cancer, Fasenra in EGPA (MANDARA) and Kavigale for prevention of COVID-19. China approvals for Lynparza in gBRCAm HER2- early breast cancer (OlympiA), Orpathys in locally advanced or metastatic MET Exon 14 NSCLC (NCT04923945) Guidance The Company issues its Total Revenue and Core EPS guidance 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% 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 2025 to December 2025 were to remain at the average rates seen in January 2025, it is anticipated that Total Revenue in FY 2025 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. Capital allocation In FY 2025, the Company intends to increase the annual dividend declared to $3.20 per share. The Company also expects to increase capital expenditure iii by approximately 50%, driven by manufacturing expansion projects and investment in IT systems, to support portfolio growth and build capacity for transformative technologies. China In relation to the illegal drug importation allegations, in January 2025, AstraZeneca received a Notice of Transfer to the Prosecutor and an Appraisal Opinion from the Shenzhen City Customs Office regarding suspected unpaid importation taxes amounting to $0.9 million. To the best of AstraZeneca’s knowledge, the importation taxes referred to in the Appraisal Opinion relate to Imfinzi and Imjudo . A fine of between one and five times the amount of unpaid importation taxes may also be levied if AstraZeneca is found liable. AstraZeneca continues to fully cooperate with the Chinese authorities. In December 2024 AstraZeneca announced the appointment of Iskra Reic as Executive Vice President, International, which encompasses China, Asian and Eurasian markets, Middle East & Africa, Latin America, Australia & New Zealand. Iskra succeeds Leon Wang who is on extended leave from the Company while under investigation in China. Table 1: Key elements of Total Revenue performance in Q4 2024 % Change Revenue type $m Actual % CER % Product Sales 13,362 18 19 Alliance Revenue 714 68 69 $392m Enhertu (Q4 2023: $281m) $133m Tezspire (Q4 2023: $80m) $161m Beyfortus (Q4 2023: $41m) Collaboration Revenue 815 >2x >2x $600m Lynparza (Q4 2023: $245m) $111m Beyfortus (Q4 2023: $27m) $100m Koselugo (Q4 2023: nil) Total Revenue 14,891 24 25 Therapy areas $m Actual % CER % Oncology 6,344 27 29 Tagrisso up 20% (21% at CER), Calquence up 20%, Enhertu up 48% (54% at CER) CVRM 3,138 16 17 Farxiga up 21% (22% at CER) , Lokelma up 35% R&I 2,127 27 28 Breztri up 29%. Saphnelo up 65%, Tezspire up 86% (85% at CER), Symbicort up 31% (33% CER) V&I 651 58 55 Beyfortus Total Revenue up >3x Rare Disease 2,377 21 22 Ultomiris up 32% (33% at CER), partially offset by decline in Soliris of 24% (22% at CER), Strensiq up 38% (37% at CER) and Koselugo up >3x Other Medicines 254 (7) (6) Total Revenue 14,891 24 25 Regions $m Actual % CER % US 6,532 28 28 Product Sales up 25% Emerging Markets 3,134 13 19 - China 1,364 (1) (3) Decline primarily due to low rates of seasonal respiratory viral infections, and impact from year-end hospital budget dynamics - Ex-China Emerging Markets 1,770 26 42 Europe 3,948 37 35 Product Sales up 20% (18% at CER) Established RoW 1,277 1 2 Total Revenue 14,891 24 25 Key alliance medicines Combined sales of Enhertu , recorded by Daiichi Sankyo Company Limited (Daiichi Sankyo) and AstraZeneca, amounted to $3,754m in FY 2024 (FY 2023: $2,566m) Combined sales of Tezspire , recorded by Amgen and AstraZeneca, amounted to $1,219m in FY 2024 (FY 2023: $653m) Table 2: Key elements of financial performance in Q4 2024 Metric Reported Reported change Core Core change Comments iv Total Revenue $14,891m 24% Actual 25% CER $14,891m 24% Actual 25% CER See Table 1 and the Total Revenue section of this document for further details Product Sales Gross Margin 80% Stable Actual +1pp CER 79% -1pp Actual Stable CER Variations in Product Sales Gross Margin can be expected between periods, due to product seasonality, foreign exchange fluctuations and other effects R&D expense $4,677m 52% Actual 52% CER $3,573m 23% Actual 22% CER Increased investment in the pipeline Core R&D-to-Total Revenue ratio of 24% (Q4 2023: 24%) Reported R&D includes $753m impairment recorded against the vemircopan (ALXN2050) intangible asset SG&A expense $5,410m 1% Actual 1% CER $4,275m 6% Actual 7% CER Market development for recent launches and pre-launch activities Core SG&A-to-Total Revenue ratio of 29% (Q4 2023: 34%) Other operating income and expense v $100m -7% Actual -6% CER $101m -7% Actual -6% CER Operating Margin 14% +3pp Actual +4pp CER 28% +5pp Actual +6pp CER See commentary above on Gross Margin, R&D, SG&A and Other operating income and expense Net finance expense $365m 9% Actual 8% CER $310m 20% Actual 20% CER Recent debt issued at higher interest rates Decrease in interest income Higher level of Net debt Tax rate 10% +17pp Actual +15pp CER 16% +7pp Actual +7pp CER Variations in the tax rate can be expected between periods EPS $0.97 56% Actual 71% CER $2.09 44% Actual 49% 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 Tagrisso EGFR m NSCLC (Stage III unresectable) (LAURA) Regulatory approval (EU, CN) Imfinzi Limited-stage SCLC (ADRIATIC) Regulatory approval (EU) Imfinzi Advanced endometrial cancer Regulatory approval (JP) Calquence Tablets for chronic lymphocytic leukaemia Regulatory approval (JP) Calquence Mantle cell lymphoma (1st-line) (ECHO) Regulatory approval (US) Lynparza + Imfinzi Advanced endometrial cancer with mismatch repair proficiency (DUO-E) Regulatory approval (JP) Lynparza gBRCAm HER2- eBC (OlympiA) Regulatory approval (CN) Enhertu HR+ HER2-low and -ultralow mBC (DESTINY-Breast06) Regulatory approval (US) Datroway HR+ HER2- mBC (TROPION-Breast01) Regulatory approval (JP, US) Orpathys MET exon 14 skipping altered NSCLC (NCT04923945) Regulatory approval (CN) Fasenra EGPA (MANDARA) Regulatory approval (JP) Kavigale Prevention of COVID-19 (SUPERNOVA) Regulatory approval (EU, JP) Regulatory submissions or acceptances* Imfinzi Muscle-invasive bladder cancer (NIAGARA) Regulatory submission (US, JP) Imfinzi + Imjudo NSCLC (1st-line) (POSEIDON) Regulatory submission (CN) Calquence Chronic lymphocytic leukaemia (1st-line) (AMPLIFY) Regulatory submission (EU) Datroway EGFR m NSCLC (later line) (TROPION-Lung05) Regulatory submission (US) Tezspire Severe uncontrolled asthma (NAVIGATOR/ DIRECTION) Regulatory submission (CN) Koselugo Neurofibromatosis type 1 adult (KOMET) Regulatory submission (EU, JP) Phase III / registrational data readouts and other developments Tagrisso Resectable early-stage EGFR m NSCLC (NeoADAURA) Primary endpoint met Truqap PTEN -deficient de novo metastatic hormone-sensitive prostate cancer (CAPItello-281) Primary endpoint met *US, EU and China regulatory submission denotes filing acceptance Other pipeline updates In January 2025, the vemircopan (ALXN2050) Phase II development programme was terminated. The decision was based on safety and efficacy data from Phase II trials. 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 . Sustainability highlights The Company convened an event on health equity for investors and analysts in November that detailed AstraZeneca’s health equity strategy, which is embedded from the Company’s science through to healthcare delivery and community engagement. At the end of 2024, the Company’s cumulative reduction in Scope 1 and 2 greenhouse gas (GHG) emissions was 77.5% from the 2015 baseline. Conference call A conference call and webcast for investors and analysts will begin today, 6 February 2025, at 11:00 UK time. Details can be accessed via astrazeneca.com . Reporting calendar The Company intends to publish its Q1 2025 results on 29 April 2025. To read AstraZeneca's Full Year and Q4 2024 Financial Results press release in full, click here .

作者 | 颜色 来源 | 赛柏蓝 01 26省明确药事会召开时间 31省双通道药品目录发布 据赛柏蓝不完全统计，截至目前，已经有26地明确召开药事会： （1）1个月内召开药事会（4地）：上海、浙江、江苏、天津； （2）2025年2月底前召开药事会（21地）：安徽、湖南、北京、广东、新疆、宁夏、青海、甘肃、陕西、贵州、四川、重庆、海南、河南、山东、黑龙江、吉林、辽宁、内蒙古、湖北、西藏。 注：完整名单见文末 国谈药品进院情况一直是业内关注的重点，国家医保局通过及时召开药事会、建立完善谈判药品“双通道”保障机制等保障国谈药品落地。 日前，国家医保局、人力资源社会保障部发布《国家基本医疗保险、工伤保险和生育保险药品目录（2024年）》的通知提到，积极推进新增药品进院。 即医保定点医疗机构、工伤保险协议医疗机构和工伤康复协议机构原则上应于2025年2月底前召开药事会，根据《2024年药品目录》及时调整本机构用药目录，保证临床诊疗需求和参保患者合理用药权益。不得以医保总额限制、医疗机构用药目录数量、药占比为由影响药品进院。 与去年相比，今年目前公布召开药事会的省份相较于往年均有所提前，药事会加速召开，国谈药品有望更快进院。 从地方来看，2024年浙江省医保局已经公布了4次三级医疗机构国谈药品配备情况，部分国谈药品的进院数量排名发生了变化。 02 浙江国谈药品三级医疗机构进院情况公布 Top 10生变 1月17日，浙江省医保局发布全省三级医疗机构谈判药品配备情况一览表（2024年第四季度），国谈药品进院数量、各地市配备情况公布。 赛柏蓝对比浙江省2024年四季度国谈药品的进院数量排名，沙库巴曲缬沙坦钠片、醋酸戈舍瑞林缓释植入剂、司美格鲁肽注射液一直保持在2024年浙江省三级医疗机构谈判药品配备情况前三名。 并且，沙库巴曲缬沙坦钠片每季度进院数量递增，1-4季度分别是151、153、154、156。 与第三季度相比，不少药品的排名发生了明显的变化。第四季度的Top 4-10药品分别是德谷门冬双胰岛素注射液、布地格福吸入气雾剂、丁苯酞氯化钠注射液、丁苯酞软胶囊、注射用阿替普酶、重组人血小板生成素注射液、百令胶囊。 具体如下： 浙江省一到四季度的药品进院超过100家的品种数呈较大幅度增长，第一季度进院超过100家药品有17个，第二季度进院超过100家药品有19个、第三季度进院超过100家药品有23个、第四季度进院超过100家药品有24个。 一直处于进院Top 1的沙库巴曲缬沙坦钠片，是由诺华研发的全球首款血管紧张素受体-脑啡肽酶抑制剂（ARNI），用于射血分数降低的慢性心力衰竭和原发性高血压。米内网数据显示，2023年中国公立医疗机构终端沙库巴曲缬沙坦钠片销售额大涨62.80%，突破30亿元。 Top 2的醋酸戈舍瑞林缓释植入剂，用于前列腺、乳腺癌等疾病治疗，2021年在中国公立医疗机构终端的销售额超过30亿元。 Top 3的司美格鲁肽注射液是明星药物，2023年在中国三大终端六大市场，原研的司美格鲁肽注射液（生物制品）销售额超过54亿元。 附： 1.各地召开“药事会”时限及具体要求 2.双通道、单独支付、特殊药品目录等相关信息 制图：颜色 制图：陈芋 END 内容沟通：郑瑶（13810174402） 左下角「关注账号」，右下角「在看」，防止失联