Anifrolumab-FNIA

2025年全球制药TOP10已经重新洗牌：辉瑞重回第一，AZ超越常年霸榜前几名的罗氏，艾伯维成研发费用增速最高MNC。 撰文| Erin 诚如此前预测，2025年全球制药TOP10的格局果然重新洗牌。 辉瑞在万众瞩目中重回了制药业务营收第一的位置，其肿瘤业务收入更表现出进击肿瘤五霸的潜质。 由于在第三季度就显露增长趋势，这并非最令人惊喜的消息。让人更加意想不到的是，AZ凭借21%的超高增长，在营收排名上超越了罗氏、诺华。不出意外，它也将一举挺进营收TOP5俱乐部，成为年度最大“黑马”。 比“黑马”横空出世剧情更刺激的则是逆袭。 谁能想到，过去10年时间，研发费用都在最后几名的艾伯维，其2024年竟然逆势增长66.66%到127.91亿美元，还一举冲进了MNC研发费用率（研发费用/总营收）TOP5的位置。 数据来源：公司财报 当然，也有让人惋惜者。罗氏、诺华两家排名下滑背后的研发投入难得回报的困境，GSK即将被新贵挤出前十的无奈…… 不过，无论是宇宙大药厂辉瑞重回制药业务第一，艾伯维跳出修美乐专利断崖困境实现逆袭，还是GSK增速不及无奈落榜，归根结底还是跨国药企的赚钱逻辑发生了变化：共同之处在于，单打独斗的速度已经难以赶上抱团取暖；独到之处则是，如今赚到的钱，来自何时的布局，是如何布局的？ 辉瑞重回第一，AZ超越罗氏、诺华成“黑马” 从目前发布2024年财报的跨国药企情况来看，全球制药巨头的格局已经发生了巨变。最大的两个变化是，辉瑞经历一年多的沉寂以及成本削减、裁员等调整后，再度重回制药业务营收第一；AZ的2024年业绩以21%的高增速，超越了罗氏、诺华两大营收TOP5常客，成为2025年最大“黑马”。 其实从收入结构来看，辉瑞的调整成果显而易见，来自Seagen的ADC产品带来了收入增长新动能。 值得一提的是，伴随Seagen新产品带来的数十亿美元收入，辉瑞的肿瘤业务在2024年全年收入超过150亿美元，几乎已经能冲击肿瘤“五霸”格局。 当然，距离肿瘤产品总收入超过300亿美元的默沙东，以及超过220亿美元的AZ两大肿瘤巨头，辉瑞仍然有一些距离。 AZ能够取得21%的空前增长，成为2024年收入增速最高的跨国药企，探究其背后的原因，自然离不开产品的增长。 从财报数字来看，AZ的肿瘤、心血管/肾脏/代谢疾病(CVRM)、呼吸与免疫(R&I)三大核心业务皆实现了超过20%的高速增长。除了大部分产品的增速为两位数之外，还有包括HER2 ADC Enhertu（德曲妥珠单抗）、AKT抑制剂Truqap、慢阻肺病三联复方Breztri、TSLP单抗Tezspire、同类首创红斑狼疮药物Saphnelo等新产品实现超过50%的增速。 有意思的是，这些新产品几乎都带有FIC或是BIC的标签，也直接验证了AZ的BD与立项眼光。而AZ也在财报新闻稿中指出，2024年的收入高增长成为其“在2030年底实现800亿美元的总收入”目标的重要一步。 不过，AZ的高速增长反衬出罗氏、诺华难以回避的业绩疲软困境。例如对于罗氏而言，肿瘤是其最核心的业务，2024年收入占比高达51.4%，然而增速却仅为7%。不过好消息是，罗氏的血液肿瘤仍然取得了79.09亿瑞士法郎（约为87.73亿美元），同比增长保持在两位数17.1%。 此外，罗氏的眼科业务增速也高达44%，主要为VEGF-A/Ang2双抗产品Vabysmo（法瑞西单抗）所带来，该产品在2024年（上市的第三年）取得38.64亿瑞士法郎销售额。 Vabysmo也继承了罗氏以往“All in”一个疾病领域所有适应证的风格，被称为眼科王牌产品阿柏西普的“最强挑战者”，几乎包揽了视网膜疾病相关的所有核心适应证。 在跨国药企的肿瘤、自免两大广阔赛道的竞争之外，全球疫苗市场的乏力也在跨国药企的业绩中体现出来。一方面，默沙东、辉瑞、阿斯利康三位TOP10成员的疫苗业务都呈现不同程度的下滑，其中辉瑞全球知名的肺炎疫苗Prevnar下滑1%；阿斯利康的疫苗和免疫疗法（V&I）业务核心产品几乎都在下滑，仅有用于婴儿预防和治疗呼吸道合胞病毒(RSV)感染的单抗Beyfortus呈现超200%的的增长，达7.22亿美元。 默沙东的HPV疫苗Gardasil/Gardasil 9全年销售额为85.83亿美元，同比下降3%。甚至由于需求的下滑，默沙东在近期宣布了暂停向中国市场供应HPV疫苗。默沙东的中国市场收入，也遗憾得在HPV疫苗的负面影响下，下滑20%至53.94亿美元。 同样面临增长乏力的还有GSK的带状孢疹疫苗，2024年销售额为33.64亿英镑，与上一年同期相比几乎没有增长。 不过好在，GSK的肿瘤业务似乎为公司带来了新的增长动能，2024年收入14.1亿英镑，增速高达98%。这部分业务的增长主要来自于其PARP抑制剂 Zejula、PD-1单抗Jemperli、JAK1/JAK2抑制剂Ojjaara 和 ACVR1 抑制剂Omjjara等产品的增长。 从业绩数字上来看，不出意外，GSK或将在今年无缘营收TOP10榜单。其总营收仅为313.76亿英镑（约为392.32亿美元），增速约为7%。  推荐阅读  * 辉瑞再回第一？礼来跻身前十，GSK无奈落榜，全球制药营收TOP10格局生变 * 辉瑞“硬刚”肿瘤五霸，BMS大裁员，罗氏再砍管线，Q1营收TOP10药企仍在阵痛中… 默沙东研发费用下降40%后仍为第一；艾伯维开启逆袭 如果对比2023年的情况来看，2024年更让人意外的一个现象是，艾伯维研发投入逆势增长，不仅相较于前一年增长66.66%到127.91亿美元，还一举冲进了营收TOP10 MNC中研发费用率（研发费用/总营收）TOP5的位置。 增长半数的研发投入背后，其实是艾伯维广阔的研发管线布局。 在自免领域，艾伯维的重磅白介素产品Skyrizi和JAK1抑制剂Rinvoq，接棒修美乐，成为收入支柱。2024年全年销售额分别达117.18亿美元和59.71亿美元，增长都超过50%。 同时，艾伯维还在持续开发这两大产品的新潜力。据其披露的最新研发进展，Skyrizi还在开发针对银屑病关节炎、溃疡性结肠炎、炎症性肠病等多种新适应证；Rinvoq的潜力空间更是巨大，目前进行的III期临床就有4项，主要针对斑秃、遗传性球形红细胞增多症、系统性红斑狼疮等疾病。艾伯维在去年还在全球多地提交了Rinvoq用于治疗成人巨细胞动脉炎 (GCA) 的新适应证申请。 从这点就可以看到，艾伯维能够在修美乐遭遇专利断崖后短时间内就恢复“元气”的秘籍就是，源源不断的新产品/新适应证接续。后续，艾伯维的自免双抗Lutikizumab、NLRX1激动剂ABBV-113、全新 IL-2突变蛋白产品CUG-252都在I、II期临床开发中，未来也将有望延续艾伯维在自免领域的强势地位。 除此之外，艾伯维也仍然是一员BD猛将，2024年共计达成了16项BD/并购交易，除了自免之外，神经科学也是其重点关注的领域。 MNC中另一家BD“狂人”默沙东，尽管全年研发费用下滑了超40%，但其仍然是目前披露财报的MNC营收TOP10中，研发费用和研发费用率最高的公司之一。具体而言，默沙东全年投入了179.38亿美元进行研发，费用率高达31%。 默沙东高昂的研发费用，其实主要为两大方向——拓展K药版图，寻找肿瘤领域下一个超级重磅炸弹。 据悉，K药在2024年取得了294.82亿美元的销售额，增速高达18%，占据公司制药业务总营收的接近一半。E药经理人不完全统计，截至目前K药在全球获批了将近50个适应证，也就是说其上市10年，接近每年就能获批5个新适应证。而根据默沙东官网，以K药为核心的临床试验就高达10余项。 此外，研发投入增长达到24%的阿斯利康，也坐稳了全球肿瘤五霸之一的地位，尤其是在ADC领域。据悉，上个月阿斯利康与第一三共合作的德曲妥珠单抗获批治疗HER2超低表达乳腺癌后，德曲妥珠单抗完成了HER2乳腺癌的全覆盖；也在同月，阿斯利康与第一三共合作的另一款TROP2靶向ADC Dato-DXd在FDA获批，阿斯利康再次在全球TROP2 ADC赛道占据了“C位”。 相较于艾伯维、默沙东两位超高研发费用率，重回第一的宇宙大药厂辉瑞其实仍在突破研发回报难题的过程中。与其630多亿美元总收入相对应的却是仅108亿美元的研发费用，相对应的研发费用率也仅约为17.01%。 值得一提的是，在本周辉瑞的财报电话会上，其宣布了计提29亿美元无形资产减值，其中就包括一款B7-H4 ADC的研发管线被砍掉。主要原因是，虽然取得了预期之内的早期临床数据，但未来并不具备超越标准疗法潜力。 几乎在去年同期，辉瑞还砍掉了一款B7H4/CD3双抗，转而将资源更加集中在来自Seagen的ADC产品。 除了辉瑞，面临专利悬崖带来的“青黄不接”困境的BMS，其2024年财报也暗示出探索“开源节流”的苦心。一方面，去年研发投入达111.59亿美元，同比增长20%；另一方面，BMS在今天财报发布的同时又宣布了新的成本削减计划——“计划在未来三年内额外节省 20 亿美元。”该计划包括了一部分裁员，还有营销、临床试验和供应链项目等运营成本的削减。 一审| 黄佳 二审| 李芳晨 三审| 李静芝 精彩推荐 CM10 | 集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化 ｜ 猎药人系列专题 | 出海 启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册 创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖 ｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 |  荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药 ｜再鼎医药｜亚虹医药 跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

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 .