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美国
证券交易委员会
华盛顿特区20549
表格 10-Q

根据13条或15(d)条款的季度报告
证券交易所法案

截至季度结束日期的财务报告2024年9月29日

或者

根据第13条规定的过渡报告
1934年证券交易所法第13或15(d)条款

过渡期从______到______


佣金档案号 1-3619

----

辉瑞制药公司.
(根据其章程规定的注册人准确名称)
特拉华州13-5315170
(拟定公司)(纳税人识别号码)

66 Hudson Boulevard East, 纽约, 纽约  10001-2192
(主要执行办公室的地址)(邮政编码)
(212) 733-2323
(注册人电话号码包括区号)。
在法案第12(b)条的规定下注册的证券:
每一类的名称交易标志在其上注册的交易所的名称
普通股,每股面值0.05美元辉瑞请使用moomoo账号登录查看New York Stock Exchange
到期日为2027年的1.000%票据辉瑞27请使用moomoo账号登录查看New York Stock Exchange
请在检查标记处注明注册人(1)是否已在证券交易法第13或15(d)条所规定的过去12个月(或注册人需要提交此类报告的较短期间)内提交了所有必须提交的报告,并且(2)自过去90天以来一直受到此类提交要求的限制。
x

在检查标记中表明注册人是否已经在过去的12个月内(或者为注册人需要提交这些文件的较短期间)根据S-T法规405规定,递交了每个互动数据文件。
x

请勾选圆圈以表示公司的注册人是否为大型加速报告公司、加速报告公司、非加速报告公司、小型报告公司或新兴成长公司。有关“大型加速报告公司”、“加速报告公司”、“小型报告公司”和“新兴成长公司”的定义,请参见《交易所法规》第120亿.2条。

大型加速申请人 x加速提交者 非加速提交者较小的报告公司新兴成长公司

如果是新兴成长型企业,请勾选此项,表示注册者已选择不使用根据《交易所法》第13(a)条提供的任何新的或修订后的财务会计准则的延长过渡期进行遵守。

请在复选标志处注明公司是否为壳公司(根据交易所法令第12b-2条的定义)。
x

2024年10月30日, 5,666,990,035 股票发行人的表决普通股股份中,尚有5,666,695,064股流通。



目录
 
 
事项二
 
 
 
 
 
 
第3项。 
对优先证券的违约无数据
事项4。 
矿山安全披露无数据
项目5。 
其他信息
 
N/A = 不适用
2


定义条款

除非上下文要求其他,否则本表格10-Q中对辉瑞公司的提及,“公司”,“我们”,“我们”或“我们”的指称均指辉瑞公司及其子公司。辉瑞营运于美国以外的子公司财政季末截至和截至2024年8月25日和2023年8月27日,美国子公司财政季末截至和截至2024年9月29日和2023年10月1日。本表格10-Q中对“附注”的提及是指本表格10-Q中的基本或合并财务报表附注,或我们2023年表格10-k中的附注。我们在本表格10-Q中还使用了其他几个术语,其中大部分在下文已解释或定义。
*
表示计算无意义或结果大于100%
2023年10-K表格
2023年12月31日年度报告表格10-K
艾伯维公司
雅培制药公司
Alexion,即AstraZeneca罕见病部门,是2021年收购Alexion Pharmaceuticals Inc.后创建的集团,专注于治疗罕见病。
阿斯利康PLC子公司赛诺菲国际业务有限公司
ALK间变性淋巴瘤激酶
联盟收入联盟协议下的收入,我们共同促进其他公司或我们自己发现或开发的产品
安斯泰莱安斯泰莱制药(ADR),安斯泰莱美国有限公司和安斯泰莱制药美国有限公司
ATTR-CM甲状腺激素转运蛋白淀粉样心肌病
biohaven
biohaven制药控股有限公司
BioNTechBioNTech SE
生物制药全球生物制药业务
bms系统Bristol-Myers Squibb Company
董事会董事会
CDC美国疾病控制与预防中心
Cerevel或Cerevel Therapeutics
Cerevel Therapeutics控股有限公司
科莫菲蒂疫苗(a)
除非另有说明,均指适用的、经授权或批准的辉瑞-BioNTech COVID-19疫苗;Comirnaty(COVID-19疫苗,mRNA)原始单价配方;辉瑞-BioNTech COVID-19疫苗,二价(原始和奥密克戎BA.4/BA.5);辉瑞-BioNTech COVID-19疫苗(2023-2024配方);Comirnaty(COVID-19疫苗,mRNA)2023-2024配方;Comirnaty(COVID-19疫苗,mRNA) 2024-2025配方;Comirnaty原始/奥密克戎BA.1;Comirnaty原始/奥密克戎BA.4/BA.5;Comirnaty奥密克戎XBb.1.5;Comirnaty JN.1 和 Comirnaty KP.2。
COVID-192019年新型冠状病毒疾病
发达市场
包括但不限于以下市场:西欧、日本、加拿大、中欧、澳大利亚、斯堪的纳维亚、韩国、巴尔干、新西兰和芬兰
DMD
杜兴肌营养不良症
EMA(European Medicines Agency)欧洲药品管理局欧洲药品管理局
新兴市场
包括但不限于以下市场:亚洲(不包括日本和韩国)、拉丁美洲、非洲、中东、某些东欧国家和土耳其
每股收益
每股收益
ESG奖:表彰环境、社会和管治(ESG)策略的杰出实施;
环境、社会和管理方面的问题:
欧盟欧洲联盟
紧急使用授权紧急使用授权
使拥有公司注册证券类别10%以上股权的官员、董事或实际股东代表签署人递交表格3、4和5(包括修正版及有关联合递交协议),符合证券交易法案第16(a)条及其下属规则规定的要求;证券交易所法(1934年修改)第425条规定
FASB财务会计准则委员会
除非董事会书面批准,否则公司或其子公司及附属实体将不提供或致使提供任何关于证券发行和销售的发售材料,包括任何最终发售募集说明书。
《反海外贿赂法》
FDA美国食品药品监督管理局
10-Q表格2024年9月29日结束的本季度报告表格10-Q
通用会计原则(GAAP)公认会计原则
GSKGSk plc
哈利恩海利昂股份有限公司
HIPAA1996年《健康保险移植和责任法》
赫匹善赫匹善股份有限公司
耗尽恢复和复原
同源重组修复
知识产权研发2023
IRA2022年通胀缩减法
美国国家税务局(“IRS”)美国国内税务局
合资公司合资公司
金格King制药有限责任公司(前身为King Pharmaceuticals, Inc.)
每股损失每股亏损
转移性结直肠癌转移性结直肠癌
转移性去势抵抗性前列腺癌
转移性去势抵抗性前列腺癌
转移性去势前列腺癌
转移性去势前列腺癌
MD&A分销计划
MDL多地区诉讼
3


meridianMeridian Medical Technologies, Inc.
Moodys
Moody的评级(前身为Moody's Investors Service)
mRNA信使核糖核酸
MylanMylan N.V.
NDA
新药申请
Nimbus
Nimbus Therapeutics, LLC
nmCRPC
非转移性去势抗原阳性前列腺癌
nmCSPC
非转移性去势敏感前列腺癌
NSCLC是指非小细胞肺癌。非小细胞肺癌
场外交易口腔崩解片
小基站
肿瘤医疗研发
场外交易场外交易和美国的几家交易所上的交易。
Paxlovid(a)
一种口服COVID-19治疗(nirmatrelvir片剂和利托那韦片剂)
PC1辉瑞中心一
制药公司Pharmacia LLC(前身为制药公司)
固定资产
资产、厂房和设备
PRD
Pfizer Research and Development
Prevnar家族
Includes Prevnar 20/Apexxnar (pediatric and adult) and Prevnar 13/Prevenar 13 (pediatric and adult)
PsA银屑病性关节炎
季度 Quarter-to-date or three months ended
RA类风湿性关节炎
RCC肾细胞癌
研发费用研发
RSV呼吸道合胞病毒
标准普尔指数
S&P Global (formerly Standard & Poor’s)
Seagen
Seagen Inc. and its subsidiaries
美国证券交易委员会美国证券交易委员会
SNS
Strategic National Stockpile
武田制药
武田制药公司有限公司
UC溃疡性结肠炎
英国。英国
美国。美国
ViiV维敏健康有限公司
Vyndaqel家族包括Vyndaqel、Vyndamax和Vynmac
全年
截至今年年初或九个月结束
(a)Paxlovid和生物-biontech以及辉瑞的COVID-19疫苗的某些用途尚未获得FDA批准或许可。Paxlovid已获得FDA授权,根据突发事件使用授权(EUA),用于治疗高风险进展为严重COVID-19,包括住院或死亡的12岁及以上孩童(体重至少40公斤)患者的轻至中度COVID-19。Pfizer和生物biontech的COVID-19疫苗的紧急使用,包括Pfizer-biontech COVID-19疫苗(2024-2025配方),已获得FDA根据EUA的授权,以防范6个月及以上个体的COVID-19。紧急使用仅授权在COVID-19大流行期间,在美国联邦食品、药品和化妆品法案第564(b)(1)条下,情况存在,促使对医疗产品授权紧急使用,直到宣言终止或授权被提前撤销。请参阅EUA事实说明书 www.covid19oralrx.com www.cvdvaccine-us.com.

本10-Q表格包括有关各种上市产品和/或产品候选人的某些临床研究的讨论。这些研究通常是某个更大临床数据的一部分,有关讨论应该在更大数据背景下考虑。此外,临床试验数据可能会有不同的财报解读,即使我们认为数据足以支持产品候选人的安全性和/或有效性,或者支持上市产品的新适应症,监管机构可能不认同我们的观点,可能需要额外数据,甚至可能拒绝批准。
在本10-Q表格中,部分数量可能因四舍五入而不相等。所有百分比均是使用未经四舍五入的数量计算得出。所有提及的商标均为其所有者的财产。
本网站、我们的Facebook、Instagram、YouTube和LinkedIn页面,或我们的X(以前称为Twitter)账户上含有的信息,或第三方网站上的信息,并不被纳入参考至这份10-Q表格中。
在本10-Q表中讨论的某些产品和产品候选者正在与其他公司共同进行研究、共同开发和/或共同推广,而辉瑞在不同市场的权利会有所不同,或属于辉瑞在特定市场拥有商业化权利的协议主题。
4


第一部分 财务信息
项目 1. 基本报表
pfizer inc及其附属公司
综合营业损益汇缩陈述
(未经查核)
 结束于三个月的期间九个月结束了
(以百万为单位,除每股数据外)九月29日,
2024
十月一日,
2023
九月29日,
2024
十月一日,
2023
收入:
产品收入(a)
$15,417 $11,587 $38,731 $38,575 
联盟收入(a)
1,900 1,645 6,140 5,672 
版税收入(a)
384 260 992 737 
总收益17,702 13,491 45,864 44,984 
成本及费用:
销货成本(b), (c)
5,263 9,269 11,942 17,391 
销售、资讯和行政费用(b)
3,244 3,281 10,456 10,196 
研究与开发支出(b)
2,598 2,711 7,787 7,864 
在进程中取得的研发费用13 67 20 122 
营业无形资产摊销1,312 1,179 3,927 3,466 
重组费用和某些与收购相关的成本313 155 1,669 377 
其他收入/扣除-净243 181 2,030 381 
继续营运收入/(亏损) 在所得税/(亏损) 费用/(利益)之前4,715 (3,352)8,033 5,187 
所得税/(亏损)费用/(利益)234 (964)393 (320)
营运持续损益4,481 (2,388)7,640 5,507 
停业营运-税后(8)12 4 11 
非控制权益分摊前的净利润/(亏损)4,473 (2,376)7,644 5,518 
减:非控制权益所享有之净利润8 6 23 30 
净利润/(亏损)归属于pfizer inc普通股股东$4,465 $(2,382)$7,621 $5,488 
每股盈利/(亏损)-基本:
    
归属pfizer inc普通股股东的持续营运收入/(亏损)$0.79 $(0.42)$1.35 $0.97 
停业营运-税后    
净利润/(亏损)归属于pfizer inc普通股股东$0.79 $(0.42)$1.35 $0.97 
每股收益/(亏损)-摊薄:
    
属于pfizer inc普通股股东的持续营运利润/(亏损)$0.79 $(0.42)$1.34 $0.96 
停业业务-税后净额    
净利润/(亏损)归属于pfizer inc普通股股东$0.78 $(0.42)$1.34 $0.96 
加权平均股份-基本5,667 5,646 5,663 5,642 
加权平均股份-摊薄5,705 5,646 5,699 5,714 
(a)请参阅 注意事项一 A.
(b)不包括无形资产摊销。
(c)请查看 注释 13A.
请查看附注。
5


辉瑞公司及附属公司
综合损益简明合并财务报表
(未经查核)
 结束于三个月的期间九个月结束了
(百万)九月29日,
2024
十月一日,
2023
九月29日,
2024
十月一日,
2023
净利润/(损失)在分配给非控股利益前$4,473 $(2,376)$7,644 $5,518 
外汇翻译调整,净131 (109)200 234 
金融工具衍生工具公允价值未实现收益/(亏损),净额(303)408 41 519 
重新分类调整包含在净利润/(亏损)中的(收益)/亏损(a)
(175)(67)(334)73 
 (477)341 (293)593 
可供出售证券未实现公允价值盈亏/(亏损),净额59 (83)(17)30 
重新分类调整包含在净利润/(亏损)中的(收益)/亏损(b)
(6)51 80 (442)
 54 (32)63 (411)
与以往服务成本摊销等重新分类调整,净额相关(27)(29)(83)(88)
与以往服务成本摊销和其他,净额相关的减记等重新分类调整(2)(1)(2)(14)
 (29)(30)(85)(102)
其他全面收益/(亏损),税前(322)170 (115)313 
其他综合收入/(损失)的税款提列/(收益)(157)36 (81)(17)
除了分配给非控制权益的其他综合收入/(损失)$(166)$134 $(35)$330 
在分配给非控制权益之前的综合收入/(损失)$4,307 $(2,242)$7,609 $5,848 
减:归属于非控制权益的综合收益/(亏损)(3)4 (2)23 
归属于pfizer inc的综合收入/(损失)$4,310 $(2,247)$7,611 $5,826 
(a)重新分类为 其他收入/扣除-净 销售成本。 请参阅 附注7E.
(b)重新分类为 其他(收入)/扣除-净额。
见附带备注。
6


pfizer inc及其附属公司
缩表合并资产负债表
(百万)九月29日,
2024
2023年12月31日
(未经查核)
资产
现金及现金等价物$1,092 $2,853 
短期投资8,860 9,837 
交易应收帐款,扣除呆帐提存:2024—$465; 2023—$470
14,451 11,566 
存货11,721 10,189 
当前税款资产3,243 3,978 
其他流动资产3,855 4,911 
全部流动资产43,223 43,333 
股权法下之投资8,582 11,637 
长期投资2,180 3,731 
物业、厂房及设备,扣除累积折旧:2024年—$16,675; 2023—$16,045
18,541 18,940 
可识别无形资产59,986 64,900 
商誉68,570 67,783 
非流动递延税资产及其他非流动税资产7,909 3,706 
其他非流动资产10,486 12,471 
资产总额$219,476 $226,501 
负债及股东权益  
短期借款,包括长期负债的当期部分:2024—$3,746; 2023—$2,254
$9,699 $10,350 
交易应付帐款5,314 6,710 
分红派息应付款 2,372 
应纳所得税款2,877 2,349 
应计薪酬及相关项目3,383 2,776 
透过租赁取得的收益2,020 2,700 
其他流动负债19,917 20,537 
流动负债合计43,211 47,794 
长期负债58,002 61,538 
退休金和退休福利义务2,073 2,167 
非流动递延所得税负债2,158 640 
其他税项应付5,905 8,534 
其他非流动负债15,569 16,539 
总负债126,918 137,213 
承诺和条件
普通股票480 478 
资本公积额额外增资93,477 92,631 
库藏股(114,760)(114,487)
保留收益121,059 118,353 
累积其他全面损失(7,971)(7,961)
pfizer inc股东权益总额92,286 89,014 
归属于非控股权益的股本272 274 
总股本92,558 89,288 
负债加股东权益总额$219,476 $226,501 
见附带备注。
7


pfizer inc及其附属公司
综合股权附注表
(未经查核)
PFIZER INC. SHAREHOLDERS
普通股库藏股
(以百万为单位,除每股数据外)股份帐面价值Add’l
资本溢价
股份成本保留收益累计其他综合准备
亏损
股份-
股东权益
非控制股权股东权益总额
2024年6月30日资产负债表9,592 $480 $93,197 (3,925)$(114,757)$116,596 $(7,816)$87,700 $275 $87,975 
净利润/(损失)
4,465 4,465 8 4,473 
其他综合收益/损失(税后)
(155)(155)(10)(166)
每股宣布的现金股息: $
普通股票   
基于股份支付的交易  281  (3)(2)276 276 
其他(1)— —     
2024年9月29日的结余9,592 $480 $93,477 (3,926)$(114,760)$121,059 $(7,971)$92,286 $272 $92,558 
pfizer inc. 股东
普通股库藏股
(以百万为单位,除每股数据外)股份帐面价值额外
资本溢价
股份成本保留收益累计其他综合金额
亏损
股份-
股东权益
非控制股权股东权益总额
2023年7月2日结存9,561 $478 $92,329 (3,916)$(114,482)$128,796 $(8,102)$99,019 $274 $99,293 
净利润/(损失)
(2,382)(2,382)6 (2,376)
其他综合收益/(亏损),税后135 135 (2)134 
宣布的每股现金股息:$
普通股    
非控制权益— (8)(8)
基于股份支付的交易1  167  (4)(2)161 161 
其他 —      
Balance, October 1, 20239,562 $478 $92,496 (3,916)$(114,485)$126,411 $(7,966)$96,934 $270 $97,204 
pfizer inc. 股东
普通股库藏股
(以百万为单位,除每股数据外)股份帐面价值其他
资本溢价
股份成本保留收益其他综合收益累积额。
亏损
股份-
股东权益
非控制股权股东权益总额
2024年1月1日的余额9,562 $478 $92,631 (3,916)$(114,487)$118,353 $(7,961)$89,014 $274 $89,288 
净利润/(损失)
7,621 7,621 23 7,644 
其他综合收益/亏损,税后(10)(10)(25)(35)
每股宣布的现金分红: $0.84
普通股票(4,760)(4,760)(4,760)
基于股份支付的交易30 2 846 (10)(273)(155)420 420 
其他(1)— — — —   
2024年9月29日的结余9,592 $480 $93,477 (3,926)$(114,760)$121,059 $(7,971)$92,286 $272 $92,558 
pfizer inc. 股东
普通股库藏股
(以百万为单位,除每股数据外)股份帐面价值其他
资本溢价
股份成本保留收益累积其他全面准备金。
亏损
股份-
股东权益
非控制股权股东权益总额
2023年1月1日的结余9,519 $476 $91,802 (3,903)$(113,969)$125,656 $(8,304)$95,661 $256 $95,916 
净利润/(损失)
5,488 5,488 30 5,518 
其他综合收益/(损失),税后338 338 (8)330 
每股宣布的现金股息:$0.82
普通股 (4,629)(4,629)(4,629)
非控制权益— (8)(8)
基于股份支付的交易43 2 694 (12)(516)(104)77 77 
其他 — —     
Balance, October 1, 20239,562 $478 $92,496 (3,916)$(114,485)$126,411 $(7,966)$96,934 $270 $97,204 
见附带备注。
8


pfizer inc及其附属公司
简明财务报表现金流量表
(未经查核)
 九个月结束了
(百万)九月29日,
2024
十月一日,
2023
营运活动  
非控股利益份额调整前净利$7,644 $5,518 
已中止业务—税后4 11 
持续营运业务的净利润,未分配给非控制权益7,640 5,507 
调整以将继续营运的净收入调整为分配给非控制权益的净现金  
折旧与摊提5,222 4,620 
资产减值和损耗1,080 499 
递延税(1,706)(1,584)
股份报酬费用700 404 
超出费用/收入的福利计划贡献(466)(467)
与 COVID-19 产品相关的存货减值和相关费用(a)
 5,847 
其他调整,净额(455)(744)
其他资产和负债变动,扣除企业收购和出售(5,992)(10,622)
营运活动提供的净现金/(使用)6,023 3,460 
投资活动  
固定资产购入(1,992)(2,863)
购买短期投资(3,957)(30,138)
卖出/赎回短期投资所得款额2,630 18,018 
三个月或以下原始到期日的短期投资的净(购买/)赎回/出售所得款2,649 (6,102)
长期投资购买(75)(166)
长期投资赎回/销售所得1,541 189 
Haleon投资部分沽出所得(b)
3,491  
收购业务,扣除取得现金净额
 (25)
其他投资活动,净额(13)(193)
投资活动提供的/(使用的)净现金4,275 (21,282)
融资活动  
短期借款收益8,175 14 
短期借款支付(7,774) 
Net (<b>支付/取得)原始到期日少于三个月的短期借款款项</b>
(2,590)(106)
发行长期债务证券所得 30,831 
长期债务付款(2,250)(2,569)
支付的现金股利(7,132)(6,932)
其他筹资活动,净额(455)(613)
筹资活动产生的净现金流量(12,026)20,624 
汇率变动对现金及现金等价物和受限制现金及现金等价物的影响
(37)(39)
现金及现金等价物和受限制现金及现金等价物的净增加/(减少)(1,765)2,764 
现金及现金等价物和受限现金及受限现金等价物,在期初2,917 468 
现金及现金等价物和受限现金及受限现金等价物,在期末$1,152 $3,233 
补充现金流量资讯
期间内支付的现金:  
所得税
$3,172 $2,907 
支付利息
1,833 1,153 
利率对冲31 98 

(a) 请查看 注释 13A.
(b) 请查看 Note 2B.

请参考附注。
9


辉瑞公司及其子公司
压缩合并财务报表注释
(未经审计)

注1报表呈现的基础和重要会计政策
A. 报告范围
我们按照美国通用会计准则(U.S. GAAP)的要求编制了这些简明的合并财务报表,在所有重要方面符合我们2023年10-k表格中所采用的标准。根据SEC关于中期报告的要求,某些注脚或其他财务信息已被压缩或省略。
这些基本报表包括了所有正常且经常性调整,这些调整被认为对呈现中期业绩的公平陈述是必要的。此表格10-Q中包含的信息应与我们2023年表格10-K中包含的合并基本报表和附注一起阅读。. 营收、费用、资产和负债在每个季度可能会有不同。因此,这些中期基本报表中的结果和趋势可能不代表整个年度的情况。
辉瑞在美国境外运营的子公司的财政季度截至日期分别为2024年8月25日至2023年8月27日的三个月和九个月,而在美国的子公司财政季度截至日期分别为2024年9月29日至2023年10月1日的三个月和九个月。
我们通过运营部门来管理商业运营,每个部门都由一位单一的经理领导:生物制药、PC1和辉瑞点燃。生物制药是唯一报告的部门。见 三个业务部门,分别由一名经理领导:生物制药、PC1和辉瑞引领。生物制药是唯一需要报告的部门。见 注13A.
我们对以下内容进行了重新分类和调整,以符合当前的演示方式:
在2024年第一季度,我们将版块资产(几乎全部与生物制药有关)的版税收入重新分类 其他(收入)/扣除——净额 ,并重新分类了我们的关联版税应收账款; 版税收入 我们的合并利润表中的。 总收入 在我们的合并利润表中重新分类,并重新分类相关的版税应收款项 其他资产在我们的综合资产负债表中,交易应收账款减去呆账准备 在我们的综合资产负债表中;
在2023年第四季度,我们开始将其作为独立行项目在我们的综合经营报表中展示; 产品收入和页面。联盟收入 在我们的综合损益表中作为单独的行项目显示; 总收入
与于2024年1月1日生效的商业重组相关的分部报告和地理信息(详见 注释13).
业务发展活动,包括2023年12月收购seagen,影响了所示时期的财务业绩。详情请参见以下链接。 注2 如下,以及 附注1A和页面。2 在我们的2023年第10-k表格中。
B. 2024年采用新会计准则
2024年1月1日,我们采用了一项新的会计准则,澄清契约销售限制不被视为以公允价值衡量权益证券的因素。这项新指引与我们现有的政策一致,因此对我们的合并财务报表没有影响。
C. 营收和交易应收账款
客户——除了2023年的Paxlovid,我们的处方生物制药产品主要销售给批发商,但我们也直接向零售商、医院、诊所、政府机构和药房销售。2023年我们主要将Paxlovid全球销售给政府机构。我们在美国的疫苗主要直接销售给联邦政府(包括CDC)、批发商、个体提供者办公室、零售药店和综合送货系统。我们在美国以外地区的疫苗主要销售给政府和非政府机构。我们组合中的某些产品受到需求季节性变化影响,Paxlovid的收入随感染率趋势变化。
收入扣减--我们针对医疗补助、医疗补助相关的州级计划、绩效合同回扣、折让销售、销售退货和现金折扣进行了计提。
(百万)2023年9月29日
2024
2023年12月31日
保留应收款项 交易应收账款减少应收账款准备
$1,955 $1,770 
其他流动负债:
应计折扣8,252 5,546 
其他应计项目1,068 902 
其他非流动负债
822 796 
总计应计折扣及其他销售相关应计$12,097 $9,014 
10


辉瑞公司及其子公司
压缩合并财务报表注释
(未经审计)
应交易账户应收账款--应交易账户应收账款按其净可变现价值计量。信用损失准备反映了对应收账款组合预期信用损失的最佳估计,该估计基于历史经验、当前信息和未来经济状况预测。在开发预期信用损失的估计时,根据市场(美国与国际)、逾期状态和客户类型(高风险与低风险、政府与非政府),将应交易账款应收账款分成资产池,并为每个应交易账款应收账款资产池设定固定的储备百分比。
在确定每个交易应收账款池的准备金比例时,我们考虑了与某些客户和客户类型的历史经验、监管和法律环境、国家和政治风险以及其他相关的当前和未来预测的宏观经济因素。当管理层意识到某些影响信贷风险的特定客户因素时,将为这些已知的有问题的账户记录特定的拨备。
在截至2024年9月29日和2023年10月1日期间,对信贷损失准备金的增加、坏账核销和应收客户款项的收回均对我们的简明综合财务报表没有重大影响。关于我们的贸易应收账款的更多信息,请参见 注释1G 在我们的2023年10-K表格中。
注2。 收购和权益法投资
A. 收购
seagen––2023年12月14日(收购日期),我们收购了全球生物技术公司seagen,该公司致力于发现、开发和商业化革命性的癌症药物,交易金额为229 每股...美元的现金,我们收购了一家全球生物技术公司seagen,该公司发现、开发和商业化具有变革性的癌症药物。所转移的考虑的总公允价值为...亿美元(扣除已获得的现金)。44.2163.943.4(扣除已收到的现金净额)。辉瑞和seagen的某些实体的组合可能正在各个司法管辖区等待批准,整合取决于完成各种本地法律和监管步骤。
下表总结了2024年前9个月认定的资产和负债,包括在收购日期进行的调整(计量期调整),也影响商誉。估计值尚未最终确定(见下文),可能会发生重大变化。我们将尽快确定认定的金额,但最迟不迟于自收购日期起一年内。
(百万)
已认可的金额
截至收购日期
(如2023年12月31日之前已报告的)已认可金额
(不应计入其他所有项目的除外)(a)
收购日已调整的已认可金额
营运资本,不包括存货
$736 $(114)$622 
存货(b)
4,195 (891)3,304 
资产:固定资产524 (234)290 
可识别无形资产,不包括在研究与开发中的资产(c)
7,970 (575)7,395 
研发中的项目20,800 (50)20,750 
其他非流动资产174 (96)77 
净所得税账户
(6,123)1,332 (4,790)
其他非流动负债(167)(33)(200)
可辨认净资产合计28,108 (661)27,447 
商誉16,126 661 16,787 
获得的净资产/支付的对价总额$44,234 $ $44,234 
(a)预估公允价值的变更主要是为了更好地反映收购日现有的市场参与者对事实和情况的假设。计量期调整并非来自收购日期后的干预事件。.
(b)根据调整,它包括$亿的流动存货和$亿的非流动存货。1.2 当前库存为$亿,非流动库存为$亿。2.1$亿的非流动资产。
(c)经过调整,主要包括价值为$的有限生命科技权利。6.9大约为估算加权平均寿命的有限生命周期开发技术权利价值$十亿。 18.
计量期调整对我们的收益没有重大影响。
下列项目可能会变更:
在基本报表(不包括存货)中,某些余额的金额和某些法律诉讼的金额,在等待收到可能影响已记录的暂定金额的某些信息。我们认为法律诉讼的任何调整不会对我们的合并基本报表产生重大影响。
鉴定无形资产、存货、合同承诺、固定资产及租赁权利资产和负债的金额,暂时待定估值工作的完成及特定实物清点的完成。
11


辉瑞公司及其子公司
压缩合并财务报表注释
(未经审计)
待Seagen完成前收购纳税申报和收到信息,包括但不限于来自税务机关的信息,金额将用于所得税资产、应收账款和负债,可能会改变某些估计和假设。
以下表格提供了未经审计的美国通用会计准则的补充比较信息,假定Seagen的收购发生于2022年1月1日:
未经审计的补充
合并业绩的假设情形
三个月之内结束九个月结束
(百万美元,除每股数据)10月1日2023年(39周)
2023
10月1日2023年(39周)
2023
收入$14,140 $46,756 
归属辉瑞公司普通股股东的净利润/(损失)
(3,338)2,702 
归属于辉瑞股份有限公司普通股股东的每股摊薄收益/(亏损)
(0.59)0.47 
未经审计的补充合并财务数据仅反映了收购事项未在2022年1月1日前完成时的合并公司经营业绩,也不预示合并公司未来的经营业绩或反映与收购相关的任何成本节省的预期实现。由于诸多因素,合并公司的实际经营业绩可能与此处反映的合并公司的补充合并财务调整有显著差异。
未经审计的附加拟形式财务信息包括各种假设,包括与从seagen收购的资产的初步购买价格分配以及从中承担的负债相关的假设。辉瑞和seagen的历史性美国通用会计准则财务信息已进行调整,主要是针对2023年10月1日结束的三个月和九个月的税前调整。
约$的额外摊销费用1421百万美元和427百万,分别与所收购的可辨认无形资产的初步估价相关。
与收购日期库存的公允价值调整初步估计相关的额外费用,估计已售出约$2241百万美元和673百万。
额外估计利息支出约$1141百万美元和905涉及辉瑞发行的债务和商业票据借款,用于部分融资收购,预计将产生约$百万的额外利息支出。
约$利息收入的清除4741百万美元和804分别涉及投资于收购日期前发行债务所得和与货币市场所有基金类型相关的资金,“基金”的假设是其中一部分资金将被清算以部分资助收购。
然后,使用适用的预估加权平均法定税率对适用的预估调整后进行税务调整。
b.权益法投资
Haleon--我们直接拥有 322024年3月,我们通过全球公开发行出售了大约百分之 30万股普通股及通过向Haleon出售 791万股普通股,总对价为 102万普通股,并向Haleon支付了总价值为$3.5 百万美元的收益。在150年第一季度期间 ) 。出售后,我们拥有Haleon流通投票股的大约百分之 (见 注4). 在股份出售后,我们大约拥有 23%的海量投票股份截至2024年9月29日。
2024年9月29日,根据Haleon股票的市场报价,我们对Haleon投资的公允价值为$11.0 亿美元。Haleon是一家外国被投资公司,其报告货币是英镑,因此我们将其财务报表转换为美元,并在我们投资的账面价值和其他综合收益中确认外汇翻译调整的影响。我们按季度滞后一个季度记录来自Haleon的收益。 其他(收入)/扣除——净额.
12


pfizer inc及其附属公司
基本报表注
(未经查核)
以下表格总结了我们在Haleon投资价值的变动。
结束于三个月的期间九个月结束了
(百万)九月29日,
2024
十月一日,
2023
九月29日,
2024
十月一日,
2023
报告的开始携带价值 股权法下之投资
$7,796 $11,228 $11,451 $10,824 
出售股份的携带价值
  (3,312) 
分红派息
(55)(65)(212)(154)
货币翻译调整和其他(a)
471 (446)341 (172)
根据差异调整和摊销(b), (c)
10  (91)(1)
辉瑞在Haleon投资者资本交易中的份额(b),(d)
46  (44) 
辉瑞在Haleon收益中的份额(b)
88 122 224 341 
报告中结束携带价值 股权法下之投资
$8,356 $10,838 $8,356 $10,838 
(a)请查看 附注6.
(b)包括在 其他收入/减项––净额.
(c)2024年9月29日结束的九个月的调整包括:(i)Haleon品牌出售和无形资产减值的影响,以及(ii)Haleon税率变化对无形资产相关递延税项的影响。
(d)2024年9月30日结束的九个月包括(i)在2024年第二季度记录的减少$份红派息91 Pfizer分享Haleon第一季度购买的库藏股票的投资者资金交易的份额的减少$份红派息,这在2024年第三季度调整了$百万46 Pfizer持股比例从约%减少影响了2024年第二季度Haleon基本报表中认可的于2024年第一季度具有记载日的分红派息 32% 23百万美元,这些分红派息在Haleon的2024年第二季度基本报表中确认
Haleon截至2024年6月30日三个月和九个月的汇总财务信息,为最近可得的期间,以及截至2023年6月30日三个月和九个月的财务信息如下:
三个月之内结束九个月结束
(百万)6月30日,
2024
6月30日,
2023
6月30日,
2024
6月30日,
2023
净销售额$3,503 $3,490 $10,636 $10,379 
销售成本(1,346)(1,323)(4,312)(4,211)
毛利润$2,157 $2,167 $6,324 $6,168 
持续经营业务收入400 403 1,019 1,133 
净收入400 403 1,019 1,133 
归属于股东的收益388 382 971 1,066 
注3. 与收购和成本降低/提高生产率计划相关的重组费用和其他成本
A. 调整成本基础计划
在2023年第四季度,我们宣布启动了为期多年、企业范围的成本调整计划,旨在将成本与我们的长期营业收入预期相匹配。我们预计与这项为期多年的努力相关的成本将主要持续到2024年,并总计约 $2.3十亿美元,主要代表裁员和实施成本,其中十亿美元与我们的生物制药板块有关。1.7开启控件该计划至2024年9月29日,我们已经为该计划产生了约 $1.8十亿美元,主要代表裁员和实施成本,其中十亿美元与我们的生物制药板块有关。1.4 开启控件该计划至2024年9月29日,我们已经为该计划产生了约 $1.3 亿美元与我们的生物制药部门相关(其中包括 $
b. 制造业-半导体优化计划
2024年第二季度,我们宣布启动了一个为期多年、分阶段实施的计划,旨在降低成本,其中包括提高经营效率、网络结构变更和产品组合升级。该计划的第一阶段专注于提高经营效率,我们预计该阶段的成本总额约为1.7十多亿美元,主要代表离职和实施成本的现金支出,所有这些费用均与我们的生物医药板块相关。 这些费用将主要记录在2024年,现金支出预计主要在2025年和2026年。 从该项目启动至2024年9月29日,我们针对该项目发生了高达数十亿美元的费用。1.3数十亿美元,其中绝大部分是我们生物医药板块的重组费用。
13


辉瑞公司及其子公司
压缩合并财务报表注释
(未经审计)
C. 关键活动
以下总结了收购、成本削减/提高生产率计划的成本和贷项:
三个月之内结束九个月结束
(百万)2023年9月29日
2024
10月1日2023年(39周)
2023
2023年9月29日
2024
10月1日2023年(39周)
2023
重组费用/(抵免):    
员工解雇$25 $16 $1,009 $77 
资产减值111 40 177 45 
出口成本
82 15 145 44 
重组费用/(贷项)(a)
217 71 1,331 165 
交易费用(b)
 5 5 14 
整合/预整合费用和其他(c)
96 78 333 198 
重组费用和一定收购相关成本313 155 1,669 377 
记入的净期间福利费用/(贷款) 其他(收入)/扣除——净额
2  7 (7)
额外折旧——资产重组 记入我们的简明综合损益表如下(d):
    
销售成本6 5 11 27 
销售、情报和管理费用2  5  
总额外折旧——资产重组
8 5 16 28 
实施成本记录在我们的简明综合损益表如下(e):
    
销售成本30 16 95 43 
销售、情报和管理费用13 71 77 196 
研发费用33 29 66 59 
总实施成本75 116 238 298 
与收购和降低成本/提高生产力计划相关的总成本$398 $276 $1,930 $696 
(a)主要代表成本削减举措。和我们的生物制药业务有关的金额:2024年6月30日三个月和六个月的费用为10亿美元(包括2024年6月30日三个月和六个月的制造优化计划的费用20亿美元和我们成本基础重组计划的3月和6月分别获得的信贷金额分别为1,000万美元和1,400万美元),而2023年7月2日三个月和六个月我们的生物制药业务相关费用不是实质性的。1412024年9月29日结束的三个月,我们主要包括重新调整成本基础计划的费用,以及1.2结束于2024年9月29日的九个月,包括1.3制造业优化计划的10亿美元支出和10亿美元的贷款69我们重新调整成本基础计划的300万美元。 2023年10月1日结束的三个月和九个月与我们的生物制药部门有关的金额不重要。
(b)代表银行、法律、会计和其他类似服务的外部成本。
(c)代表着与整合收购业务直接相关的外部递增成本,以及2023年我们当时拟议的收购seagen,例如用于咨询和系统和流程整合的支出以及某些其他符合条件的费用。截至2023年10月1日的九个月内,整合/预整合成本和其他大部分与我们对biohaven和全球血液疗法公司的收购以及我们当时拟议的对seagen的收购有关。
(d)代表了参与重组行动的资产预计使用寿命变化的影响。
(e)代表与我们的非收购相关的费用削减/生产力提升计划直接相关的增量外部成本。
以下总结了重组应计款项中的元件和变化:
(百万)员工
终止
成本
资产
减值损失
费用
退出费用计提
2023年12月31日的余额(a)
$1,978 $ $11 $1,988 
应计/(贷项)1,009 177 145 1,331 
利用率和其他(b)
(867)(177)(144)(1,187)
2024年9月29日结余(c)
$2,120 $ $12 $2,132 
(a)包括在 其他流动负债 ($1.3 亿元)和 其他非流动负债 ($663 百万)。
(b)其他活动包括对我们简明综合基本报表不重要的外汇换算调整。
(c)包括在 其他流动负债 ($1.1 十亿)和 其他非流动负债 ($1.1 百万美元))。
14


pfizer inc及其附属公司
基本报表注
(未经查核)
注意事项4。 其他收入/扣除-净额
元件的 其他(收益)/ 欠款净额 包括:
 结束于三个月的期间九个月结束了
(百万)九月29日,
2024
十月一日,
2023
九月29日,
2024
十月一日,
2023
利息收入$(116)$(523)$(374)$(1,015)
利息费用783 695 2,352 1,521 
净利息费用(a)
668 173 1,977 505 
股本证券期间内确认的净利损
(446)393 (129)709 
合作收入、外部授权安排和compound/product权利销售收入(1)(10)(25)(84)
除了服务成本之外的净周期福利成本/信用(102)(92)(311)(260)
特定的法律事项,净(b)
45 71 422 246 
特定资产减值(c)
  349 264 
Haleon权益法(收入)/亏损(d)
(150)(131)(102)(354)
其他,净额(e)
228 (222)(153)(645)
其他收入/扣除-净$243 $181 $2,030 $381 
(a)2024年第三季度净利息支出增加反映了 (i) 由于完成了我们在2023年12月收购seagen后投资余额降低导致利息收入减少43.4 100亿美元seagen收购交易致使2023年12月发行的商业票据余额增加导致利息支出增加8 2024年前九个月净利息支出增加反映了 (i) 我们在2023年5月发行的数十亿美元无抵押高级票据导致的利息支出增加,以及2023年第四季度发行的数十亿美元商业票据的余额增加,这两者均是为了我们收购seagen的融资; (ii) 由于完成了我们的100亿美元seagen收购交易后导致的投资余额降低导致利息收入减少31100亿美元seagen收购交易的融资部分,2023年第四季度发行的商业票据余额和2023年5月发行的十亿美元无抵押高级票据导致的利息支出增加8 由于完成了我们的100亿美元seagen收购交易后导致的投资余额降低导致利息收入减少43.4 在2023年12月完成70亿美元Seagen收购后,投资余额下降,导致利息收入下降。
(b)2024年第三季度和前九个月主要包括辉瑞停止销售和/或剥离产品相关的特定产品责任费用。2023年第三季度包括与收购前事项相关的法律义务以及辉瑞停止销售和/或剥离产品相关的特定产品责任费用。2023年前九个月主要包括辉瑞停止销售和/或剥离产品相关的特定产品责任和其他法律费用以及与收购前事项相关的法律义务。
(c)2024年前9个月包括一个价值$的无形资产减值费用240 百万美元的无形资产减值费用,与我们的生物制药业务相关,代表了与DMD治疗第3期研究相关的IPR&D,反映了不利的临床试验结果。2023年前9个月主要代表无形资产减值费用,包括(i)$128 与我们的生物制药业务有关,代表了与DMD治疗的3期研究相关的IPR&D,反映了不利的临床试验结果。2023年前6个月主要涉及无形资产减值损失,其中包括(i)$100万与其他业务活动有关,涉及IPR&D和软件资产的开发技术权利,反映了不利的关键试验结果和更新的商业预测,以及(ii)$100万,与我们的生物制药业务有关,由于终止了与一项用于治疗前列腺癌的转让IPR&D资产相关的研究。120与我们的生物制药业务有关,代表了与DMD治疗的3期研究相关的IPR&D,反映了不利的临床试验结果。2023年前6个月主要涉及无形资产减值损失,其中包括(i)$100万与其他业务活动有关,涉及IPR&D和软件资产的开发技术权利,反映了不利的关键试验结果和更新的商业预测,以及(ii)$100万,与我们的生物制药业务有关,由于终止了与一项用于治疗前列腺癌的转让IPR&D资产相关的研究。
(d)请参阅规则13d-7(b)以获取应抄送副本的其他各方。备注2B.
(e)2024年第三季度和前九个月主要包括,除其他外,收取的费用为美元420 百万美元与预期的销售额有关 我们的设施因我们的DMD计划终止而产生的。除其他外,2024年的前九个月还包括一美元1502024年第一季度出售我们对Haleon的部分投资的收益为百万美元,股息收入为美元183 百万美元来自我们对ViiV的投资。除其他外,2023年第三季度和前九个月包括一美元222 将我们的早期罕见病基因疗法产品组合剥离给Alexion,获得百万美元的收益。2023 年的前九个月我除其他外,包括 股息收入为美元213百万美元来自我们对 ViiV 的投资,以及 $211 数百万美元来自武田收购了Nimbus的口服选择性变构酪氨酸激酶2(TYK2)抑制剂项目子公司对Nimbus的投资。
以下是关于2024年减值的无形资产的额外信息:
九个月结束
公允价值(a)
2024年9月29日
(百万美元)金额一级二级Level 3Impairment
无形资产-知识产权和研发(b)
$ $  $ $240 
无形资产-开发技术权利(b)
102   102 109 
总计
$102 $ $ $102 $349 
(a)净值金额是以减值日期为准呈现的,因为该资产不是按照重复计量净值方式计量的。另请参见 注释1E 在我们的2023年10-K表格中.
(b)反映了2024年无形资产减值至公允价值的情况。 公允价值是使用收益法确定的,具体为多期超额利润法,也称为贴现现金流法。 我们从资产的所有预期净现金流开始预测,然后应用资产特定的贴现率到达净现值金额。此方法中一些更为重要的估计和假设包括:预测的净现金流量的金额和时间,其中包括预期的竞争、法律和/或监管力量对产品的影响;贴现率,它试图反映预期现金流所固有的各种风险;税率,则试图纳入预期现金流的地理多样性。
15


辉瑞公司及其子公司
压缩合并财务报表注释
(未经审计)
注5. 税务事项
A.持续经营利润/(损失)所得税
我们持续经营的有效税率为 5.02024年第三季度相比, 28.82024年第三季度,与2023年相比,为 4.92024年前九个月,相比(6.2)2023年前九个月为。2024年第三季度的有效税率主要是因收入的司法分布以及较小程度的税收利益,与涵盖多个税收年度的IRS审计结束相关。2023年第三季度的正有效税率反映了税前亏损的税收利益。2024年9月29日结束的头九个月的有效税率增加,与2023年10月1日结束的头九个月相比,主要是由于在2023年第二季度涵盖多个税收年度的全球所得税解决方案的税收利益不再发生,部分抵消了IRS审计闭幕涵盖多个税收年度的税收利益。
我们选择了在提交我们的2018年美国联邦综合所得税申报表时,通过2026年的8年时间支付我们的初始预计$XX十亿的汇回税负债。第六年付款应在2024年4月15日到期。第七年的年度分期付款应于2025年4月15日到期,报告当前年度。15 在2026年前的八年内,应对累积的1986年后外国收入进行的数十亿美元的遣返税义务。第六年度分期款已于2024年4月15日前支付。第七年度分期款应于2025年4月15日前支付,并记录在当前余额中。 应付所得税 截至2024年9月29日的报告日期,其余的义务记录在非流动负债中。 其他应付税款。 我们的义务可能因外国税收和其他抵销结转或转回额度的可用性而有所不同。
截至2023年12月31日,我们缴纳的所得税现金净额为$,扣除退还金额。3.1此外,我们与客户合同承诺的履约义务,主要与Google Cloud相关,包括尚未确认为营业收入的未来服务。截至2021年3月31日,这些承诺尚未确认的收入总额为$38.22亿。我们预计在接下来的24个月中会确认其中约一半,并在此后确认剩余部分。然而,收入的金额和时间主要受客户何时使用服务和我们是否能够按照相关合同条款交付的影响,这可能影响我们对未确认履约义务的估计以及我们预计何时确认该收入。1.9 美国缴纳了亿美元。
B. 税务风险
我们在许多司法管辖区都要缴纳所得税,需要对与所得税相关的资产和负债进行一定程度的估计。我们所有的税务立场都会接受每个司法管辖区的当地税务当局审核。这些税务审计可能涉及复杂的问题、财报解读和判断,事项的解决可能需要跨越多年,特别是如果涉及谈判或诉讼。
美国是我们的一个重要税收司法管辖区之一,我们经常接受IRS的审计。在2024年第三季度,我们成功地了结了辉瑞2016年至2018年的联邦所得税申报审计。2019年至2024年的税务年度尚未完成审计。所有其他税务年度均已结案。除了在美国尚未完成审计的年度外,我们在一些重要的国际税收司法管辖区也有从2012年开始的尚未完成审计的年度以及相关的某些审计、上诉和调查。
请参阅规则13d-7(b)以获取应抄送副本的其他各方。请注意5D 在我们的2023年10-k表格中。
C.其他综合收益/损失的税务规定/(利益)
元件的 税款拨备/(受益) 其他全面收益/(损失) 包括:
截至三个月九个月结束
(百万美元)2023年9月29日
2024
10月1日2023年(39周)
2023
2023年9月29日
2024
10月1日2023年(39周)
2023
汇兑差额净额(a)
$(50)$(28)$(7)$(33)
金融衍生工具未实现持有收益/(亏损),净额(65)80 5 108 
主要合并中包括的重新分类调整(收益)/损失
(42)(5)(68)(16)
(107)75 (63)91 
可供出售证券未实现持有损益,净额7 (10)(2)4 
主要合并中包括的重新分类调整(收益)/损失
(1)6 10 (55)
7 (4)8 (51)
与服务成本和其他有关的摊销再分类调整,净额(6)(7)(20)(21)
由于服务成本和其他减少再分类调整,净额 (1)1 (3)
(6)(7)(18)(24)
其他综合收益/(亏损)应纳税款/(税收优惠)$(157)$36 $(81)$(17)
(a)对于我们打算持有的国际子公司的投资所发生的外币翻译调整,不提供税务。
16


辉瑞公司及其子公司
压缩合并财务报表注释
(未经审计)
注释6。累计其他综合损失(不包括非控制权益)
以下总结了税后变化 累计其他综合损失:
 净未实现收益/(损失)利益计划 
(百万美元)
外币翻译调整(a)
衍生金融工具可供出售证券先前服务(成本)/贷项和其他累计其他综合收益/(亏损)
2023年12月31日的余额
$(7,863)$(217)$(9)$128 $(7,961)
其他综合收益/(亏损)(b)
232 (230)55 (67)(10)
2024年9月29日余额$(7,631)$(447)$46 $61 $(7,971)
(a)金额不包括归属于非控制权益的外汇转换调整。
(b)外币翻译调整包括与我们在Haleon的股权投资相关的净收益(见 备注2B)以及与我们的净投资对冲计划的影响相关的净损失。
17


辉瑞公司及其子公司
压缩合并财务报表注释
(未经审计)
注7。金融工具
A.公允价值衡量
按市场方法衡量的经常性重复使用的金融资产和金融负债的公允价值及其公允价值层次:
2024年9月29日2023年12月31日
(百万美元)总计一级二级总计一级二级
金融资产:
短期投资
具有明确可确定公允价值的权益证券:
货币市场基金$1,420 $ $1,420 $5,124 $ $5,124 
可供出售的债务证券:
政府机构—非美国
3,493  3,493 817  817 
政府和机构-美国。
2,120  2,120 2,601  2,601 
公司和其他费用
1,236  1,236 982  982 
6,849  6,849 4,400  4,400 
所有短期投资8,269  8,269 9,524  9,524 
其他资产
衍生资产:
利率合约
1  1    
汇率期货合同
280  280 298  298 
其他流动资产合计281  281 298  298 
所有基金类型投资
具明确定公允价值的权益证券(a)
1,368 1,368  2,779 2,772 7 
可供出售的债务证券:
政府和机构——非美国
   124  124 
公司和其他费用
6  6 26  26 
6  6 150  150 
总的长期投资1,374 1,368 7 2,929 2,772 156 
其他非流动资产
衍生资产:
利率合约
192  192 144  144 
汇率期货合同
160  160 258  258 
衍生工具资产总计352  352 402  402 
保险合同(b)
878  878 790  790 
其他长期资产总额1,231  1,231 1,191  1,191 
总资产$11,154 $1,368 $9,787 $13,943 $2,772 $11,170 
财务负债:
其他流动负债
衍生负债:
利率合约$28 $ $28 $16 $ $16 
汇率期货合同
488  488 404  404 
其他流动负债总额516  516 420  420 
其他非流动负债
衍生负债:
利率合约216  216 275  275 
汇率期货合同
777  777 725  725 
其他非流动负债总额993  993 1,000  1,000 
负债合计$1,508 $ $1,508 $1,420 $ $1,420 
(a)截至2023年12月31日,$ 开多的长期股权证券被保留在美国非合格员工福利计划的受限信托中。127 百万,2024年6月30日为$百万。130 美国非合格员工福利计划的受限信托持有 $ 开多的长期股权证券。
(b)包括为美国非合格员工福利计划持有的受限信托中的人寿保险单。这些合同中的基础投资资产是有市场性的证券,按公允价值计量,公允价值变动确认在 其他收入/扣除—净 (见 注4).
未在重复基础上以公允价值衡量的金融资产和负债长期债务的账面价值,不包括当前部分,截至2024年9月29日为$58十几亿美元,截至2024年9月29日和$62。根据市场方法及二级输入,该债务的预计公允价值为$58十几亿美元,截至2024年9月29日和$61亿,截至2023年12月31日为$。
持有至到期债券、股权证券、长期应收款和未按公允价值计量的短期借款的预估公允价值与账面价值之间的差异,在再发生基础上没有显著影响。
18


辉瑞公司及其子公司
压缩合并财务报表注释
(未经审计)
截至2024年9月29日和2023年12月31日。我们持有至到期债务证券和短期借款的公允价值衡量基于2级输入。我们的长期应收款和股权投资证券的公允价值衡量基于3级输入。
B. 投资
开空期权、开多期权和权益法投资总计
以下总结了我们按分类类型的投资情况:
(百万美元)2023年9月29日
2024
2023年12月31日
短期投资
具明确定公允价值的权益证券(a)
$1,420 $5,124 
可供出售债务证券6,849 4,400 
持有至到期债券591 313 
总短期投资$8,860 $9,837 
所有基金类型投资
具明确定公允价值的权益证券(b)
$1,368 $2,779 
可供出售债务证券6 150 
持有到期日债券47 47 
按成本计量的股权证券(b)
759 755 
总长期投资$2,180 $3,731 
权益法投资8,582 11,637 
总长期投资和权益法投资$10,762 $15,368 
持有至到期的现金等价物$236 $207 
(a)代表主要投资于美国国债和政府债券的货币市场基金。
(b)代表着生命科学行业的投资.
债务证券。
我们的投资组合包括跨多个政府、企业和金融机构发行的投资级别债务证券:
2024年9月29日2023年12月31日
未实现总额合约或估计到期期限(年)未实现总额
(百万美元)摊销成本收益损失公允价值1年内超过1年
1年到5年
超过5年摊销成本收益损失公允价值
可供出售债务证券
政府和机构––非美国
$3,443 $51 $(2)$3,493 $3,493 $ $ $953 $2 $(14)$941 
美国政府和机构
2,120   2,120 2,120   2,601   2,601 
公司和其他费用1,239 4 (1)1,242 1,236 6  1,006 4 (2)1,007 
持有到期日债券
定期存款和其他
759   759 716 23 20 561   561 
政府和机构––非美国
115   115 111 4 1 4   4 
所有债务证券$7,677 $55 $(3)$7,729 $7,676 $33 $21 $5,126 $6 $(16)$5,115 
预期信贷损失对我们的基本报表来说是不重要的。
股票的权益
下面展示的是报告日期持有的除权益法定投资以外的权益证券未实现(损益)的部分计算:
三个月结束九个月结束
(百万美元)2023年9月29日
2024
10月1日2023年(39周)
2023
2023年9月29日
2024
10月1日2023年(39周)
2023
股票的净收益/损失(a)
$(446)$393 $(129)$709 
减:本期出售的权益证券的净(损益)涨跌(914)(1)(1,129)(48)
报告期间对仍在持有的股票的未实现(利润)/损失(b)
$468 $394 $1,000 $757 
19


辉瑞公司及其子公司
压缩合并财务报表注释
(未经审计)
(a)报告在 其他(收入)/扣除––净额。请查看注4.
(b)净未实现(收益)/损失中包含了对股权证券进行的可观察价格变动,而这些股权证券没有明确的公允价值。截至2024年9月29日,累计减值和下调金额为$323 万元,上调金额为$。这些减值、下调和上调对2024年和2023年第二季度和前六个月的运营都没有显著影响。198 减值、下调和上调对我们在2024年第三季度和前9个月,以及2023年的运营不构成重要影响。
C. 开空期借款
短期借款包括:
(百万美元)2023年9月29日
2024
2023年12月31日
商业票据,本金金额
$5,841 $7,965 
长期债务的流动部分,本金金额3,750 2,250 
其他短期借款,本金金额(a)
160 252 
总短期借款,本金金额
9,751 10,467 
与套期保值和购买会计有关的净公允价值调整
 5 
净未摊销贴现、溢价和债务发行成本(52)(121)
所有板块 短期借款,包括长期负债的流动部分,按历史收益计提,经调整
$9,699 $10,350 
(a)主要包括现金担保。参见 附注7F.
D. 长期负债
以下总结了我们的无抵押长期债务的总本金金额,以及进行我们的总长期债务报告的调整:
(百万)九月二十九日,
2024
2033年12月31日
总长期债务,本金金额$57,371 $60,982 
与避险和采购会计相关的净公允价值调整1,083 1,039 
未摊销的折扣、贴现和债券发行成本的净额(453)(483)
总长期债务,按照历史收益计算,经过调整$58,002 $61,538 
E. 金融衍生工具及避险活动
汇率期货风险––我们的收入、获利和在外国联属企业的净投资的重要部分暴露于外汇汇率的变动。当汇率期货风险无法通过其他敞口来抵消时,我们主要通过使用衍生金融工具和外币债务来管理我们的汇率期货风险。这些金融工具有助于减轻因再评估转换为另一货币的净利润所产生的影响,或因将特定以外汇计价的交易转换为美元而产生的影响。
衍生金融工具主要用于对冲或抵销欧元指数、英镑、人民币、日币、加币和瑞典克朗方面的风险,包括我们预计的外汇企业间库存销售部分的汇率期货对冲。 年内。我们可能会寻求保护我们外国业务实体的净投资可能下降。
利率期货风险––我们的利息承受投资和借款受到利率期货的风险。视市场情况,我们可能通过进入利率掉期等衍生财务工具来改变我们未清债务或投资的概况,无论是为了避险或抵消与固定利率的对象的公正价值变动相关的风险,还是将变动利率的债务或投资转换为固定利率。衍生财务工具主要对冲美元固定利率债务。
20


pfizer inc及其附属公司
基本报表注
(未经查核)
以下摘要了衍生金融工具的公平价值和名义金额:
2024年9月29日2023年12月31日
公允价值公允价值
(百万)名义资产责任。名义资产责任。
指定为避险工具的衍生品:
汇率期货合约(a)
$23,870 $305 $1,115 $18,750 $403 $916 
利率合约6,750 193 244 6,750 144 290 
498 1,359 546 1,206 
未指定为避险工具的衍生品:
汇率期货合约$19,245 135 150 $25,609 154 214 
总计$633 $1,508 $700 $1,420 
(a)对冲我们公司预测库存销售的未来外汇合约的名义金额为$5.2十亿美元截至2024年9月29日,以及4.9十亿美元截至2023年12月31日。
21


pfizer inc及其附属公司
基本报表注
(未经查核)
以下概括了用于对冲或抵消操作性汇率或利率风险敞口而产生的收益/(亏损)的信息:
 
收益/(亏损)
认列于OID中的收益/(亏损)
(a)
收益/(亏损)
认列于OCI中的收益/(亏损)
(a)
收益/(亏损)
从OCI重新分类至OID和COS中
从OCI转出至OID和COS中的重新分类收益/(亏损)(a)
结束的三个月份:
(百万)2024年9月29日2023年10月1日2024年9月29日2023年10月1日2024年9月29日2023年10月1日
货币流量避险关系中的衍生金融工具:
汇率期货合约(b)
$— $— $(306)$359 $171 $20 
免于效力测试并摊销至收益的金额(c)
— — 3 49 3 46 
公平值避险关系中的衍生金融工具:
利率合约
332 (213)— — — — 
避险物
(332)195 — — — — 
净投资避险关系中的衍生金融工具:      
汇率期货合约
— — (695)297   
金额不列入有效性测试并在收益中摊销(c)
— — 93 5 40 35 
净投资避险关系中的非衍生金融工具(d):
      
外币长期债务— — (37)22   
未指定为避险的衍生金融工具:
汇率期货合约
64 57 — — — — 
 $64 $39 $(941)$733 $215 $102 
收益/(亏损)
OID(发行折价)中认列的收益
(a)
收益/(亏损)
在其他综合收益中公认
(a)
利得/(损失)
从中重新分类
从其他综合收益转入损益及资本公积(a)
九个月结束
(百万)2024年9月29日2023年10月1日2024年9月29日2023年10月1日2024年9月29日2023年10月1日
现金流量避险关系中的衍生金融工具:      
利率合约$— $— $ $68 $ $ 
汇率期货合约(b)
— — 21 312 313 (210)
从有效性测试中排除并摊销至盈余中的金额(c)
— — 20 139 20 136 
公平价值避险关系中的衍生金融工具:
利率合约
107 (210)— — — — 
已避险项目
(107)192 — — — — 
净投资避险关系中的衍生金融工具:
汇率期货合约
— — (380)14   
从有效性测试中排除的金额并摊销至收入中(c)
— — 145 81 116 102 
净投资避险关系中的非衍生金融工具(d):
外币长期债务— — (11)5   
未指定为避险的衍生金融工具:
汇率期货合约
106 173 — — — — 
$106 $155 $(204)$620 $450 $29 
(a)OID = 其他(收入)/扣除 - 净额,包含于 其他收入/支出-净额 的简明综合损益表中. COS = 销售成本,包含于 销货成本 的简明综合损益表中。OCI = 其他综合收入/(损失),包含于简明综合收入/(损失)表中.
(b)由OCI重新分类至COS的金额为:
22


pfizer inc及其附属公司
基本报表注
(未经查核)
第三季度2024年获得了$百万的净利37 2024年第三季度获得了$百万的净利
在2024年前九个月的纯收益为$106 百万美元;
2023年第三季度纯盈额$49 百万;并且
2023年前九个月的纯利润为$195 百万。
剩余金额已从OCI重新分类为OID。根据随时可能变动的季度结束汇率,我们预期将对一笔税前损失重新分类为$91 百万,预计在接下来的12个月转为收入. 我们对未来外汇现金流量变动的避险期限最长约为 19 年,涉及外币借款。
(c)从OCI重新归类的金额被重新归类为OID。
(d)长期负债包括外货借款,用于净投资避险;截至2024年9月29日和2023年12月31日,相关摊销值为$836 百万美元和$824 百万。
以下摘要了我们对长期负债在公平价值避险方面的累积基础调整:
2024年9月29日2023年12月31日
公平价值避险调整累积金额增加/(减少)至
资产价值
公平价值避险调整累积金额增加/(减少)至
资产价值
(百万)
被避险资产/负债的携带金额(a)
有效避险关系已终止避险关系
被避险资产/负债的携带金额(a)
有效避险关系已终止避险关系
长期负债$7,165 $(24)$908 $7,196 $(131)$957 
(a)携带金额不包括公允价值避险调整的累积金额。
F. 信用风险
我们重要部分的贸易应收账款余额来自批发商和政府。有关我们与重要客户的贸易应收款项的其他信息,请参见下方的部分。 附注13C ,以及 附注17C 在我们2023年度第10-k表格中。
截至2024年9月29日,我们投资组合中最大的投资曝险主要是美国政府货币市场基金,以及美国发行的主权债券。
关于我们与金融机构签订的衍生金融工具协议,我们不预期因任何交易对手的失败而遭受重大损失。衍生金融工具是根据国际掉期和衍生品协会主协议执行的,附有信用支持协议,其中包含零阈值条款,要求根据暴露水平每日交换担保品。因此,与任何个别金融机构都不存在重大的信用风险集中。截至2024年9月29日,这些处于净应付位置的衍生金融工具的累计公允价值为$910百万美元,我们已提供$917 百万担保品,相应金额报告在 短期投资。截至2024年9月29日,我们处于净应收位置的衍生金融工具的累计公允价值为$104百万,收到$129百万担保品,相应金额报告在 短期借款,包括长期负债的流动部分。
Note 8. 其他财务信息
A. 库存
以下总结了元件的 存货:
(百万)9月29日
2024
2023年12月31日
成品$3,280 $3,495 
在制品7,267 5,688 
原材料和用品1,174 1,007 
库存(a)
$11,721 $10,189 
上述未包括的非流动库存(b)
$2,765 $4,568 
(a)2023年12月31日的增加反映特定产品库存水平提高,主要原因是净市场需求变化、供应恢复和网络策略。
(b)包括在 其他非流动资产。截至2023年12月31日,主要是由于购得的seagen库存减少,包括并购会计公平值调升。另请参阅 附注2A. 根据我们目前的估计和假设,这些金额没有可收回性问题。
b. 其他流动负债
其他流动负债 包括支付给biontech的Comirnaty毛利润分成金额,截至2024年9月29日共计美元375百万美元2.0十亿美元截至2023年12月31日。
23


pfizer inc及其附属公司
基本报表注
(未经查核)
C. 供应商融资计划义务
我们与几家参与的金融机构维持自愿供应链金融协议。根据这些协议,参与的供应商可以自愿选择将他们与辉瑞的应收账款出售给这些金融机构。截至2024年9月29日和2023年12月31日,分别有$628百万。791 百万我们与参与这些融资安排的供应商之间的应付贸易款项仍未清偿。
注意 9。 可识别无形资产与商誉
A. 可辨识无形资产
以下总结了元件的各部分 可识别无形资产:
2024年9月29日2023年12月31日
(百万)毛利
携带
金额
累积
摊谢
可识别的
无形
资产,少了
累积
摊谢
毛利
携带
金额
累积
摊谢
可识别的
无形
资产,其他少
累积
摊谢
有限寿命无形资产
开发的科技权(a)
$99,373 $(64,067)$35,306 $99,267 $(60,493)$38,773 
商标(b)
1,749 (961)788 922 (877)45 
授权协议和其他2,720 (1,474)1,246 2,756 (1,458)1,297 
103,842 (66,502)37,340 102,944 (62,828)40,116 
无限期使命能无形资产
商标(b)
  827 827 
研发与知识产权(c)
21,976 21,976 23,193 23,193 
授权协议和其他670 670 763 763 
22,646 22,646 24,784 24,784 
可识别无形资产(d)
$126,488 $(66,502)$59,986 $127,728 $(62,828)$64,900 
(a)毛账面额的增加包括将知识产权和研发转移至发展科技权利的$727 百万美元,用于talazoparib(Talzenna),部分抵消了$385 百万美元的计量期间调整,与我们收购seagen相关(见 附注2A)和$109百万美元的减值(见 附注4).
(b)总携带金额的变动反映了从无限期品牌转移美元。827 百万美元从永久品牌转移到Depo-Medrol有限寿命品牌。
(c)总携带金额下降反映了将IPR&D转让为$发展的科技权利727 达拉佐帕尼(Talzenna)的百万,以及$250 我们收购seagen(详见 注释2A)和$240 百万(请参见 注释4)
(d)这是主要因为摊薄费用减少$3.9 十亿测量期调整,与我们收购seagen有关$625百万(见 注释2A百万的损害(见349 百万 附注4).
b. 商誉
以下总结了运输金额变化。 商誉:
(百万)
总计(a)
2024年1月1日的余额
$67,783 
新增款项(b)
661 
汇率期货的影响
125 
截至2024年9月29日的结余
$68,570 
(a)所有商誉都分配在生物制药的报告范畴内。由于在2024年第一季度生物制药营运部门的商业结构发生了组织变更(请参阅,我们的商誉需要被重新分配至受影响的报告单位。商誉的分配是一个复杂的过程,需要我们判断在旧与新的组织结构下每个报告单位的公平价值,以及转移的部分。因此,我们尚未完成分配,但将在当前年度完成。 注释 13A所有商誉都分配在生物制药的报告范畴内。由于在2024年第一季度生物制药营运部门的商业结构发生了组织变更(请参阅),我们的商誉需要被重新分配至受影响的报告单位。商誉的分配是一个复杂的过程,需要我们判断在旧与新的组织结构下每个报告单位的公平价值,以及转移的部分。因此,我们尚未完成分配,但将在当前年度完成。
(b)补充资料代表与我们收购seagen相关的计量期调整(见 注释2A).
24


pfizer inc及其附属公司
基本报表注
(未经查核)
注10. 退休金和退休福利计划
以下是网络周期性福利成本/(贷项)的元件摘要:
 养老金计划
 美国。国际其他综合损益(在所得税前),不包括重新分类金额
计划
结束的三个月份:
(百万)2024年9月29日2023年10月1日2024年9月29日2023年10月1日2024年9月29日2023年10月1日
服务成本$ $ $21 $21 $4 $3 
利息成本139 147 78 73 6 5 
计划资产预期回报(208)(194)(80)(77)(13)(11)
先前服务成本摊销/(贷方)  1  (28)(29)
精算(收益)/亏损
2 (11)    
特别终止福利  2    
在收入报告中的净周期性福利成本/(赊帐)$(68)$(58)$23 $17 $(31)$(32)
 养老金计划
 美国。国际其他综合损益(在所得税前),不包括重新分类金额
计划
九个月结束
(百万)2024年9月29日2023年10月1日2024年9月29日2023年10月1日2024年9月29日2023年10月1日
服务成本$ $ $65 $65 $11 $9 
利息成本416 442 233 216 17 16 
计划资产预期回报(624)(583)(240)(229)(38)(33)
先前服务成本摊销/(贷项)1 1 3  (87)(90)
精算(收益)/损失
2 4  3   
减少  (2)(1) (12)
特别终止福利 6 9    
报告于收入的净期间福利费用/(信贷)$(206)$(131)$68 $53 $(96)$(109)
净定期福利成本/(信贷)中,除了服务成本元件之外的其他元件主要包括在 其他(收益)/ 欠款净额 (见 附注4).
截至2024年9月29日的九个月,我们从我们的总资产中为美国养老金计划贡献了$百万。96 美国养老金计划和国际养老金计划分别从我们的总资产中资助了$百万和$百万,包括直接雇主福利支付。135 美国养老金计划和国际养老金计划分别从我们的总资产中资助了$百万和$百万,包括直接雇主福利支付。
注意事项11. 归属于pfizer inc普通股股东的每股盈利/(损失)
以下呈现每股盈利/(亏损)的详细计算:
 结束的三个月份:九个月结束
(百万)9月29日
2024
十月一日,
2023
9月29日
2024
十月一日,
2023
每股收益/(每股亏损)分子
属于pfizer inc普通股股东的持续营运利润/(亏损)$4,473 $(2,394)$7,617 $5,477 
停业业务-税后净额(8)12 4 11 
净利润/(亏损)归属于pfizer inc普通股股东$4,465 $(2,382)$7,621 $5,488 
每股收益/(每股亏损)分母
    
加权平均普通股股份-基本5,667 5,646 5,663 5,642 
普通股等值物(a)
39  36 72 
加权平均普通股股份-稀释5,705 5,646 5,699 5,714 
反稀释普通股等价物(b)
25 58 25 2 
(a)截至2023年10月1日的三个月,由于pfizer inc.普通股股东的净亏损,加权平均普通股等值股份为 56百万股未纳入稀释每股盈亏的计算中 因为其纳入将对每股盈亏造成不利影响。
(b)这些普通股等价证券在所述期间持有,但未纳入该期间的摊薄后每股收益/(损失)计算,因为其纳入将会产生抵减效应。
25


pfizer inc及其附属公司
基本报表注
(未经查核)
附注 12. 条款与特定承诺
我们及我们的某些子公司可能面对许多业务常规中出现的情势,包括税务和法律紧急情势、担保和补偿。以下概述了我们的法律紧急情势、担保和补偿。有关我们税务紧急情势的讨论,请参见 附注5B.
A. 法律程序
我们的法律备忘包括但不限于以下:
专利诉讼通常涉及对各种产品、过程或剂型的专利覆盖范围和/或有效性的挑战。不利的结果可能导致产品的专利保护丧失,产品收入的重大损失或相关资产价值的减损。我们是这些诉讼大多数的原告。
与现行或先前产品相关的产品责任和其他产品相关诉讼,可能包括个人受伤、消费、离标推广、证券、反垄断和违约索赔等,通常涉及与医疗因果关系、标签警告和依赖该警告、科学证据和发现、实际、可证明的伤害等高度复杂问题。
商业及其他已主张或未主张的事项,可能包括收购、许可、知识产权、合作或合推广相关的诉讼及产品定价索赔和环保母基索赔及诉讼,其涉及的复杂性会因事项而异。
政府调查通常与美国及其他司法管辖区的国家、州和地方政府机构对药品公司的广泛监管有关。
某些这些偶发情况可能导致支出和/或损失增加,包括损害赔偿、版税支付、罚款和/或民事罚款,这可能是相当大的,以及/或刑事控罪。
我们相信,在我们作为被告的案件中,我们的主张和辩护是充分的,但诉讼本身是不可预测的,且有时会出现过高的裁决。我们不认为这些事项中的任何一项将对我们的财务状况产生实质不利影响。然而,我们可能会被判定败诉,达成和解协议或修订我们对事项结果的预期,这可能会对我们当期已计入或支付的金额对营运结果和/或现金流量产生实质不利影响。
我们已为损失计提赔偿款项,这些损失既可能发生且可以合理估算。基本上,我们的所有不确定事项都存在重大不确定性,因此,确定损失的可能性和/或任何损失的计量都可能相当复杂。因此,我们无法估计超出计提金额的损失区间。我们的评估结果源于对未来事件和不确定性做出的一系列复杂判断,其基于管理层认为合理的估计和假设,但这些估计和假设可能证明是不全面或不准确的,未来可能发生未曾预料的事件和状况,这可能导致我们修改这些估计和假设。
对法律和环保母基的记录金额可能源自于对未来事件和不确定性的一系列复杂判断,并且在很大程度上依赖于估计和假设。对于涉及政府机构的环境法律诉讼,我们采用了$门槛值的披露,以潜在或实际政府金融制裁。1 百万的潜在或实际政府金融制裁金额。
我们所涉及的主要待处理事项如下所述。在确定待处理事项是否为主要事项时,我们考虑量的和质的因素来评估重要性,例如,损害金额和其他所寻求救济的性质,如果有指定的话; 我们对索赔的合理性和我们防御力量的看法; 该诉讼声称或已经是处于集体诉讼的行动,如果没有经认证,我们对法院很可能会认证集体诉讼的看法; 进行诉讼的司法管辖区; 是否将相关行动转移到多地诉讼; 我们或我们所知道的其他公司在类似诉讼中的经验; 该诉讼的披露对于基本报表的读者是否重要,包括披露是否可能改变读者对我们基本报表的判断,考虑读者所能获取的所有信息; 该诉讼对我们声誉的潜在影响; 以及该事项所具有的公众利益。此外,在我们是原告的专利事项中,我们会考虑,除其他事项外,该专利所保护的产品的财务重要性。以下讨论的一些事项包括管理层认为可能超过已提列金额的损失可能性很小的事项。
A1. 法律诉讼--专利诉讼
我们参与与我们的专利(或我们合作/许可合作伙伴的专利,我们拥有许可或共同推广权利),其中包括但不限于以下所述的诉讼。我们面临来自仿制药品制造商的索赔,该等制造商声称
26


pfizer inc及其附属公司
基本报表注
(未经查核)
涵盖我们产品的专利(或我们与之合作/授权合作伙伴具有许可或共同推广权的专利,可能我们可能有或可能没有参与)的过程或剂量形式是无效的和/或不涵盖仿制药品制造商的产品。此外,已提出反诉以及各种独立行动,指控我们对某些产品主张的或试图执行的专利权涉嫌不正当竞争和/或违反反托拉斯法。除了下文讨论的美国专利所面临的挑战之外,我们产品或我们合作/授权合作伙伴的某些产品的专利权在其他各地司法管辖区也受到质疑。我们有些合作或授权合作伙伴在非美国司法管辖区面临专利权有效性的挑战。例如,2022年4月,英国高等法院就一项与Eliquis有关的bms系统专利作出判决,该专利将于2026年到期,裁定该专利无效。2023年5月,上诉法院驳回了bms的上诉,2023年10月,最高法院拒绝了bms的上诉申请。其他司法管辖区还在处于挑战中。同样,2022年7月,CureVac AG(CureVac)在德国地区法院对BioNTech及其某些子公司提起专利侵权诉讼,指控Comirnaty侵犯某些德国实用新型专利和某些到期及未到期的欧洲专利。对Comirnaty专利的其他挑战可能在未来对我们和/或BioNTech在其他司法管辖区提起。这些事项中的不利决定可能对我们的营运结果产生重大不利影响。 我们也在各种司法管辖区参与了专利损害诉讼,根据这些诉讼,仿制药品制造商、支付方、政府或其他方正在寻求向我们索赔,指控我们据称导致仿制进入的延期。
我们也经常参与其他程序,如专利审查程序、发后审查、再审查或反对程序,在美国专利商标局、欧洲专利局或其他外国对应机构,以及涉及我们的知识产权或他人知识产权的法庭程序,包括由我们发起对该等权利的挑战。此外,如果我们的专利(或我们合作/授权伙伴的专利)在这些程序中被判定为无效,可能会导致市场推出通用产品或竞争性产品,进而侵蚀我们现有产品的销售额。例如,我们的肺炎球菌疫苗组合中的几项专利已在美国专利商标局的专利审查程序和发后审查程序,以及国外进行挑战。 我们肺炎球菌疫苗组合中任何一项专利的无效可能会让其他竞争者的疫苗提前进入市场,如果得到批准。如果任何专利被认定为有效并侵权,竞争对手的疫苗(如果获批准)可能被禁止进入市场,或竞争对手可能被要求支付我们的专利费。
我们还可能受到专利诉讼的影响,根据该诉讼,一个或多个第三方寻求赔偿和/或禁令救济,以补偿我们的商业或其他活动被指控侵犯其专利。如果我们营销的产品(或我们具有许可或共同推广权利的合作/许可合作伙伴的产品)被裁定侵犯第三方的有效专利权,该第三方可能被授予重大损害赔偿或版税支付,或者我们可能被禁止再销售该产品。如果我们或我们的子公司被裁定故意侵犯第三方的有效专利权,这些损害可能增加多达三倍。
我们是原告的诉讼行动
Xeljanz(托法替尼)
自2017年开始,我们向几家生产商提起了侵犯专利的诉讼,这些生产商分别向FDA提交了简化新药申请(ANDA),以获得市场上的托法替尼锭剂的5毫克和10毫克剂量或两种剂量的仿制版本的批准,并且主动型和延长型的版本。到目前为止,我们已就一些生产商达成和解,条款对我们并无实质影响。其余的诉讼将如下所述继续在特拉华州地区法院进行。
2021年10月,我们针对荷尔蒙新药品有限公司(Sinotherapeutics)提起了一项单独的侵犯专利诉讼,声称其侵犯了我们对托法替尼布延长释放配方的专利的有效性,这一专利被Sinotherapeutics在其申请批准推出托法替尼布11毫克延长释放片剂的仿制版本的ANDA中提出挑战。2022年11月,我们对Sinotherapeutics提出了一项额外的侵犯专利诉讼,该诉讼涉及其在其ANDA中挑战我们的延长释放配方和治疗方法专利,以获批准推出托法替尼布22毫克延长释放片剂的仿制版本。2024年10月,我们就这些针对Sinotherapeutics的诉讼达成和解,对我们没有实质影响。
2024年6月,我们对Biocon Limited、Biocon Pharma Limited和Biocon Pharma, Inc.(统称为Biocon)提起了单独的侵犯专利诉讼,主张其侵犯了我们的专利,该专利涵盖了一项在其ANDA中挑战的材料组成专利,以获得市场批准来生产备有托法替尼布11毫克和22毫克延长释放片剂的仿制版本。2024年9月,我们与Biocon达成和解,条款对我们不具重要性。
27


pfizer inc及其附属公司
基本报表注
(未经查核)
2024年8月,我们对SpecGx LLC(SpecGX)提起了一项独立的专利侵权诉讼,主张我们的物质组成专利的侵权和有效性,该专利涵盖了托珠单抗的即时释放配方,而SpecGX也在其ANDA中挑战该专利,以获得对托珠单抗5毫克和10毫克即时释放片的市场上市批准。
于2024年10月,我们对Breckenridge Pharmaceutical, Inc.(Breckenridge)提起了一项单独的专利侵权诉讼,声称其侵犯了我们的组合专利的有效性,涵盖Breckenridge在其ANDA中挑战的tofacitinib 10毫克即时解除剂型片剂的即时发行配方。
Mektovi(binimetinib)
自2022年8月起,几家仿制药公司通知我们,他们已向FDA提交了ANDAs,寻求批准上市Mektovi的仿制版本。这些公司声称2030年到期的 两个 用法专利的无效性和不侵权,2031年到期的用法专利, 两个 2033年到期的用法专利,以及2033年到期的制造方法专利。自2022年9月起,我们在美国特拉华州地区法院对仿制药申请者提起了专利侵权诉讼,主张所有 专利的有效性和侵权。
2022年8月,我们收到Teva Pharmaceuticals, Inc. (Teva)的通知,表示他们已提交ANDA,寻求批准推出Mektovi的仿制版本。Teva声称该公司无效和不侵犯专利。 两个 2033年到期的使用方法专利和2033年到期的产品制程专利。在2023年6月,我们在特拉华州地区的美国地方法院对Teva提起了专利侵权诉讼,主张该专利的有效性和侵权。 三个月的普通股东可获得的收入。 专利。
Vyndaqel-Vyndamax(塔法米地/塔法米地甲醇酸庄)
从2023年6月开始,几家仿制药公司通知我们他们已向FDA提交ANDA以取得上市辉瑞蓝本中Vyndamax(褪拉米特)及Vyndaqel(褪拉米特美革胺)的仿制版本的批准,挑战FDA橙皮书中所列载的某些或所有专利。Scripps Research Institute(Scripps)拥有涵盖该产品的物质组成专利和治疗方法专利,而辉瑞是专属许可证持有人。辉瑞另外拥有晶型专利。从2023年8月开始,我们和Scripps在特拉华州地区法院对仿制药扶持者提起了专利侵权诉讼,声称所涉专利的有效性和侵权性。辉瑞是唯一原告在只声称晶型专利的诉讼中。
Oxbryta (voxelotor)
2024年1月,Zydus Pharmaceuticals (美国) Inc.,Zydus Lifesciences Limited和Zydus Worldwide DMCC(统称为Zydus)以及MSN Pharmaceuticals Inc.和MSN Laboratories Private Ltd.(统称为MSN)分别向我们通知,他们已向FDA提交了ANDA,以寻求批准上市voxelotor片剂的通用版本,挑战了FDA橙皮书中Oxbryta(voxelotor片剂300毫克和500毫克剂量和/或口服悬浮液)列出的一些专利,理由是非侵权。2024年3月,我们在特拉华区地方法院对这两家通用药企提起了专利侵权诉讼,主张挑战专利的有效性和侵权性。Zydus和MSN没有挑战我们Oxbryta的物质组成专利或治疗方法专利。
Nurtec (rimegepant)
2024年4月,Rubicon Research Private Limited,Teva Pharmaceuticals, Inc.,常州药厂,Natco Pharma Limited和Natco Pharma, Inc.,MSN,Aurobindo Pharma Limited,Apitoria Pharma Private Limited和Aurobindo Pharma U.S.A. Inc.(统称Aurobindo)以及Apotex Inc.和Apotex Corp.(统称Apotex)通知我们,它们已向FDA提交ANDA,以寻求批准上市rimegepant口崩片的仿制版本,声称不侵权和/或挑战FDA橙皮书中列出的Nurtec(rimegepant口崩片Eq 75毫克基)的部分或全部专利的有效性。2024年5月,我们在特拉华州特拉华区联邦地方法院对所有仿制商提起了专利侵权诉讼。
Xtandi(恩扎鲁胺)
从2024年8月开始,几家仿制药公司通知我们,他们已向美国食品药品监管局提交了ANDA,以寻求批准上市Xtandi的仿制版本,挑战FDA橘皮书中列出的Xtandi的专利中的一些或全部。从2024年8月开始,我们在美国新泽西州联邦地方法院对仿制商提起专利侵权诉讼,主张诉讼中的专利的有效性和侵权性。
我们是被告的情况
科克帝(tozinameran)
Alnylam Pharmaceuticals, Inc.(Alnylam)于2022年3月在美国特拉华地方法院对辉瑞和我们的全资子公司P&U公司提起了诉讼,指控Comirnaty侵犯了2022年2月发行的美国专利,并要求未明示的金钱赔偿。2022年7月,Alnylam提起了一
28


pfizer inc及其附属公司
基本报表注
(未经查核)
对辉瑞、辉瑞和BioNTech Manufacturing GmbH提起第二份投诉,指控Comirnaty侵犯了一项2022年7月颁发的美国专利并寻求未指明的金钱赔偿。2023年5月,Alnylam在特拉华州联邦地方法院对辉瑞和辉瑞提起了另外一起诉讼,指控Comirnaty侵犯了在2023年各个日期发行的其他美国专利,并寻求未指明的金钱赔偿。 2023年发行的其他美国专利并寻求未指明的金钱赔偿。
2022年8月,modernaTX公司(ModernaTX)和Moderna US公司(Moderna)在麻萨诸塞州联邦地区法院对Pfizer、BioNTech、BioNTech制造业公司和BioNTech US公司提起诉讼,指控Comirnaty侵犯美国专利。 三个月的普通股东可获得的收入。 根据其投诉,Moderna表示其寻求赔偿,该侵权发生在2022年3月7日之后。 两个三个月的普通股东可获得的收入。 2024年3月,美国专利局专利审查及上诉委员会就有关专利进行了审查。
在2022年8月,莫德纳TX向德国对辉瑞和某些子公司以及biontech和某些子公司提起了专利侵权诉讼,指控Comirnaty侵权。 两个 在2022年9月,莫德纳TX根据相同的欧洲专利向英国和荷兰对辉瑞和某些子公司以及biontech和某些子公司提起了专利侵权诉讼。 两个 在其投诉中,莫德纳TX表示正在寻求赔偿指称发生在2022年3月7日之后的侵权行为。 在2023年11月,其中一欧洲专利被欧洲专利局撤销。在2023年12月,另一个欧洲专利被荷兰法院宣告无效(无效决定仅限于荷兰)。在2024年7月,英国法院撤销 判定该专利无效,并认定另一专利有效且侵权。 ModernaTX还在某些其他非美国司法管辖区对辉瑞和biontech提起了额外的专利侵权诉讼。
2023年4月,arbutus biopharma corporation(Arbutus)和Genevant Sciences GmbH(Genevant)向新泽西州地方法院对辉瑞和 biontech 提起诉讼,指控Comirnaty及其制造侵犯美国专利。 寻求未指明金额的赔偿。
2024年4月,葛兰素史克生物制剂SA和葛兰素史克LLC在美国特拉华区地方法院对辉瑞、斐乐制药及亚伯公司LLC、biontech、biontech制造业有限公司和biontech美国有限公司提起诉讼,声称Comirnaty侵犯了美国专利,并寻求未指明金额的损害赔偿。 2024年8月,葛兰素史克生物制剂SA和葛兰素史克LLC提交修订控告指称Comirnaty侵犯了额外的美国专利。 三个月的普通股东可获得的收入。 额外的美国专利。
Paxlovid
2022年6月,Enanta Pharmaceuticals, Inc.在美国麻萨诸塞州地方法院对辉瑞提起诉讼,指称Paxlovid的有效成分nirmatrelvir侵犯了2022年6月获得的美国专利。 并要求不明款额的金钱赔偿。
Abrysvo
2023年8月,葛兰素史克生物制品SA和葛兰素史克LLC(简称GSK集团)在美国特拉华州地方法院对辉瑞提起诉讼,指控Abrysvo的有效成分侵权。 此诉讼要求未指明的金钱赔偿,并要求对Abrysvo在60岁以上成年人中使用的销售施行永久禁令。 两个 2023年11月,GSK集团修改其诉讼,宣称侵犯了其他专利。
此外,在包括英国、荷兰、比利时和统一专利法院等境外司法管辖区,我们挑战了葛兰素史克的RSV生物-疫苗专利,而葛兰素史克声称Abrysvo侵犯了这些专利。 2024年10月,英国法院裁定 两个 葛兰素史克的英国专利无效且未侵权。
涉及辉瑞及其合作/授权伙伴的事项
科克帝(tozinameran)
2022年7月,辉瑞、biontech和biontech制造业在美国麻萨诸塞州地方法院对CureVac提起确定性裁定申诉,寻求关于不侵权的判决。 三个月的普通股东可获得的收入。 美国专利与Comirnaty相关的美国专利,于2023年5月,这起案件被转移到维吉尼亚东区联邦地方法院。同样在2023年5月,CureVac主张Comirnaty侵犯了我们所提出的确定性裁定申诉的专利。 三个月的普通股东可获得的收入。 在2023年5月和7月,CureVac声称Comirnaty侵犯了数个额外的美国专利。
在英国,辉瑞和biontech已经起诉curevac,寻求判决其几项专利无效,而curevac已提出某些侵权反诉。2024年9月,英国法院裁定两项curevac专利无效。
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pfizer inc及其附属公司
基本报表注
(未经查核)
A2. 法律诉讼-产品诉讼
我们是许多案件中的被告,包括但不限于以下讨论过的,涉及我们的药品和其他产品。这些案件的原告基于声称的人身伤害和经济损失等各种理由寻求赔偿和其他救济。
石棉
从1967年到1982年,华纳-朗伯特公司(Warner-Lambert)拥有制造和销售呼吸防护装置和石棉安全服饰的美国光学公司(American Optical)。1982年出售美国光学公司时,华纳-朗伯特同意对买家进行偿还某些责任,包括某些与石棉有关及其他索赔。华纳-朗伯特于2000年被辉瑞收购,是辉瑞的全资子公司。华纳-朗伯特积极参与军工股的辩护工作,将继续探索各种解决这些索赔的方式。
针对American Optical、辉瑞及其先前拥有的某些子公司,目前在各个联邦和州法院有众多诉讼案件正在审理,该等案件旨在寻求赔偿,因疑似受到辉瑞及其先前拥有的某些子公司出售的据称含有石棉和其他据称有害物质的产品而导致的声称人身伤害。
此外,在各联邦和州法院还有少量诉讼案例正在进行中,寻求赔偿因据称在辉瑞公司或其子公司拥有或曾拥有的设施中受到石棉暴露。
艾芬来
自2011年开始,针对Wyeth以及在某些诉讼中涉及Wyeth子公司和其他被告的行动,包括所谓的集体诉讼,已在各联邦法院提起,涉及Effexor XR,这是Effexor的延长释放配方。各个集体诉讼的原告寻求代表所有在美国及其领土直接购买、间接购买或为购买Effexor XR或Effexor XR仿制品而对任何被告进行补偿的人群类别。从2008年6月14日起至被告被指控的非法行为结束的时间。所有诉讼中的原告都声称在美国及其领土推迟了Effexor XR仿制品的推出,违反了联邦反垄断法,以及在某些诉讼中,违反了某些州的反垄断、消费者保护和其他各种法律,原因是Wyeth诈取并不当地列出了Effexor XR的某些专利于橙皮书中,+执行了Effexor XR的某些专利并就Effexor XR与一家仿制药厂进行了诉讼和解协议。每位原告都就美国及其领土自2008年6月14日以来的Effexor XR或Effexor XR仿制品的价格虚增要求三倍赔偿金(个别诉讼中为其自身,或在所谓的集体诉讼中代表潜在的集体)。所有这些诉讼都已合并至新泽西州联邦地方法院。
2014年,地方法院驳回了直接购买方原告基于诉讼和解协议提出的诉求,但拒绝驳回其他直接购买方原告的诉求。2015年,地方法院对所有和解协议诉求作出部分终局判决,包括直接购买方和最终支付方原告所提出的诉求,原告将此上诉至美国第三巡回上诉法院。2017年,美国第三巡回上诉法院撤销了地方法院的裁决并将诉求发回地方法院。2024年4月,各方达成了解决诉讼的协议。已获法院批准的这些需要法院批准的和解已经获得批准,此事现已解决。
立普妥
自2011年起,针对立普妥涉及的所谓集体诉讼已在各联邦法院提起,被告包括辉瑞、某些辉瑞联属公司,以及在大部分的诉讼中,Ranbaxy实验室有限公司(Ranbaxy)和某些Ranbaxy联属公司。这些不同诉讼中的原告寻求代表全国、多州或州内的类别,包括直接购买、间接购买或为立普妥(或在某些诉讼中为仿制立普妥)的购买向任何被告支付费用的个人或实体,范围从2010年3月直至被告据称的非法行为停止为止(类别期间)。原告声称延迟推出仿制立普妥,违反联邦反托拉斯法及(或)州反托拉斯、消费者保护以及其他各种法律,原因包括(i)2008年协议,根据该协议,辉瑞和Ranbaxy解决了涉及立普妥的某些专利诉讼,辉瑞授予Ranbaxy在各个市场开始贩卖仿制立普妥的许可证,以及(ii)在某些诉讼中,取得和(或)执行了立普妥的某些专利。这些诉讼之一旨在代表买家提出多倍赔偿,理由是在类别期间,立普妥(或在某些诉讼中,仿制立普妥)的价格被过高收费。此外,对辉瑞、Ranbaxy及其某些联属公司提起了单独诉讼,原告主张并寻求了类似于上述所谓集体诉讼中主张的和请求的救济的索赔。这些不同诉讼已在美国纽泽西州地方法院进行预审程序的联合诉讼中集中。 纽泽西州地方法院是这些不同行动的联同审判所在地。
2013年和2014年9月,地方法院驳回了所有直接购买者的索赔。2014年10月和11月,地方法院驳回了所有其他MDL原告的索赔。所有原告均就地方法院采取驳回其索赔的订单提起上诉,移交至第三巡回上诉法院。此外,
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pfizer inc及其附属公司
基本报表注
(未经查核)
直接购买者代表原告上诉了否定他们修正判决和修改控诉权的订单至上诉法院。2017年,上诉法院推翻地方法院的决议并将索赔提交至地方法院。2024年4月,各方达成了和解诉讼的协议。需要法院批准的和解已获批准,此事现已解决。
同样地,在2013年,西弗吉尼亚州对辉瑞、Ranbaxy等提起诉讼,主张并寻求为西弗吉尼亚州和该州居民提供与上述所述集体诉讼中所主张的要求和所寻求的救济类似的救济。
多西他素
克勒压和辉瑞在各联邦和州法庭面临多起诉讼,原告声称接受多西纳后出现永久脱发。克勒压是我们在2015年9月收购的全资子公司。绝大多数案件还涉及其他被告,包括这个品牌产品的制造商Taxotere。原告寻求赔偿金和惩罚性损害赔偿。亦有其他诉讼声称接受多西纳治疗后出现阻塞性泪囊。
2016年,联邦案件转移到美国路易斯安那州东区联邦地方法院的MDL进行协调的预审程序。2022年,眼部受伤案件被转移到美国路易斯安那州东区联邦地方法院的MDL进行协调的预审程序。
Zantac
辉瑞在各联邦和州法院遭到多项诉讼,原告宣称因服用Zantac而发展出各种类型的癌症,或面临著增加罹患癌症风险的情况。这些案件中绝大多数也指控其他曾历史性生产和/或销售Zantac的被告。自2006年以来,辉瑞已经不再销售Zantac,仅出售一种场外交易版本的产品。2006年,辉瑞将包含Zantac场外交易权利的消费业务出售给强生,并将与Zantac场外交易相关的资产和负债转让给了强生。这些案件的原告寻求赔偿金和惩罚性赔偿。
于2020年2月,联邦行动被转移至美国佛罗里达州南区联邦地方法庭(联邦MDL法庭)进行协调的庭前程序。MDL诉讼中的原告对辉瑞及其他许多被告提起了主个人受伤诉讼,一个整合消费者集体诉讼诉状,涉及所有50个州消费者保护法的索赔,以及一个医疗监控诉状旨在根据13个州法律认证医疗监控类别。2022年12月,联邦MDL法庭准许被告的达柏特(Daubert)提证动议排除原告的专家证言,以及针对一般因果关系的总结判决动议,导致诉讼中所有诉状被驳回。原告已对联邦MDL法庭的裁决提起上诉。
此外,(i) 辉瑞已收到加拿大集体诉讼投诉,将辉瑞和其他被告列为被告,要求赔偿金和惩罚性赔偿金,理据是被告在加拿大销售Zantac产生的个人伤害和经济损失;(ii) 新墨西哥州及巴尔的摩市长和市议会分别在州法院向辉瑞和其他许多被告提起民事诉讼,指控被告涉嫌在各地区销售Zantac,声称与被告在相应司法管辖区内声理上的各种州法和普通法主张有关。2021年4月,在加州阿拉米达县的加州上级法院成立了一个司法委员会协调程序,以协调加州州法院提起的针对辉瑞和其他被告的个人伤害诉讼。其他州法院也已成立协调程序。大多数州法院案件已在新卡斯尔县的特拉华州上级法院提起诉讼。
许多这些与Zantac有关的案件已经悬而未决多年,可能需要更多年才能解决。辉瑞不时地探讨并将继续探讨这些事宜的机会性和解。截至2024年7月,辉瑞已经解决,或者已经达成明确协议或初步协议以解决,在州法院中提交控方声称使用辉瑞产品的大多数案件,但仍有未解决的州法院案件在各州法院进行中。
Chantix
自2021年8月起,一系列侵权集体诉讼已在各个美国联邦法院对辉瑞提起诉讼,因辉瑞自愿召回Chantix药品,其中含有一种亚硝胺N-亚硝基维蓝。原告主张因购买辉瑞出售的Chantix或通用维蓝克药品而遭受经济损害。原告寻求代表全国和特定州的集体诉讼,并寻求各种赔偿,包括损害赔偿和医疗监控。到了2022年12月,这些联邦诉讼被转移到美国纽约南区联邦地方法院的MDL进行协调的庭前程序。类似的侵权集体诉讼也已在加拿大和以色列提起,产品品牌为Champix。
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pfizer inc及其附属公司
基本报表注
(未经查核)
A3. 法律诉讼-商业及其他事项
孟山都相关事项
1997年,蒙萨诺公司(前身为蒙萨诺)将某些化学制造业务和设施捐赠给新成立的公司Solutia Inc.(Solutia),并分拆Solutia的股份。2000年,蒙萨诺与Pharmacia&Upjohn公司合并,组成Pharmacia。Pharmacia随后将其农产品业务转移到一家新成立的子公司,名为蒙萨诺公司(新蒙萨诺),并以完成于2002年的两阶段过程分拆。Pharmacia于2003年被辉瑞收购,并成为辉瑞的全资子公司。
2002年完成的分拆后,新孟山都承担并同意赔偿Far诺公司与Far诺公司以前的农产品业务有关的任何责任。新孟山都已为Far诺公司抵御相关索赔和诉讼,这些索赔和诉讼涉及或与农产品业务有关,并在该等索赔和诉讼的责任被课以或达成和解时赔偿Far诺公司。
1997年分拆时,索利特承担并同意为费尼亚环保母基承担与前孟山都化学业务相关的责任。由于在美国破产法第11章的重新组织下,索利特对于前孟山都化学业务所承担的赔偿义务主要限于索利特曾拥有或营运过的地点。此外,2002年完成的分拆中,新孟山都承担并同意为费尼亚承担主要与前孟山都化学业务相关的任何责任,包括但不仅限于索利特承担的任何此类责任。索利特和新孟山都对费尼亚名为被告的与前孟山都化学业务相关的现有诉讼以及未来诉讼承担并同意为费尼亚提供赔偿,包括但不限于主张环境索赔的诉讼,包括声称暴露于多氯联苯的官司。索利特和/或新孟山都正在为费尼亚辩护,处理因前孟山都化学业务而引起或相关的各种索赔和诉讼,并在对这些索赔和诉讼施加责任或达成和解时为费尼亚提供赔偿。2018年,拜耳(adr)收购了孟山都公司(新孟山都),现已成为拜耳(adr)的子公司。自收购以来,新孟山都一直在为费尼亚辩护并提供对这些责任的赔偿。
环保方面的事宜
2009年,作为我们收购Wyeth的一部分,我们承担了环保母基整治责任,该Wyeth Holdings LLC(原名Wyeth Holdings Corporation和American Cyanamid Company)位于新泽西州邦德布鲁克的停用工业化学设施。从那时起,我们已签署或成为与美国环境保护局、新泽西州环境保护部以及联邦和州自然资源受托人共同执行或签署了一系列行政和解协议、共议命令和/或司法共识裁定,以进行整治设计、清除和整治行动,以及相关的环保母基活动,以解决在邦德布鲁克设施中涉嫌对自然资源造成的损害。我们已提取出对这些活动目前估计成本。
我们也参与了许多根据1980年修订的《全面环保应对、赔偿和责任法》以及其他州、地方或外国法律提起的诉讼中,其中主要所寻求的救济是过去和/或未来的治理成本。
与伊拉克卫生部签订合同
2017年,一些美国军人、平民及其家属在美国哥伦比亚特区地方法院对一些药品和医疗器械公司提起投诉,包括辉瑞及其某些子公司,指控被告违反美国反恐法。投诉声称被告通过与伊拉克卫生部订立的药品和医疗器械合同,透过其销售方式向恐怖组织提供资金支援,并要求经济赔偿。2020年7月,地方法院准许被告的驳回动议,并驳回了所有原告的主张。2022年1月,上诉法院推翻了地方法院的决定。2024年6月,美国最高法院发出了一项许可令,撤销上诉法院的决定,并将案件发回上诉法院。
Allergan提供赔偿申诉
2019年,辉瑞被安力甘财务有限责任公司(安力甘)与金氏共同诉讼,提起补偿索偿,关于Kadian一事,Kadian在2008年短暂由金氏拥有,之后于2010年辉瑞收购金氏前,此案在纽约州最高法院被自愿撤销并不许再起诉。
合同违反-科莫尼特
2023年,辉瑞和biontech制造业在比利时布鲁塞尔第一审法院对波兰共和国、罗马尼亚共和国和匈牙利提起独立的正式诉讼。辉瑞和biontech正在寻求一份订单
32


pfizer inc及其附属公司
基本报表注
(未经查核)
要求法院让这些国家遵守他们在2021年签订的合同中订购COVID-19疫苗的承诺。
A4. 法律诉讼––政府调查
与其他跨国药品公司一样,我们在多个发达市场和新兴市场受到政府机构的广泛监管。在美国和其他经营的管辖区,政府调查可能会导致刑事指控、巨额罚金、民事罚款、限制我们在适用管辖区开展业务的能力、公司诚信或延迟起诉协议、声誉受损、事项引起的公众关注增加等。这些事项通常涉及政府根据自愿或通过传票要求信息,而后政府可能会通过后续要求或附加传票寻求更多信息。此外,在政府拒绝干预的告密者诉讼中,原告仍可代表政府追讨民事损害赔偿和罚款。政府机构的调查包括以下事项。
Greenstone反垄断诉讼
2019年5月,50多个州和地区的总检察长向康涅狄格州地区提起了诉讼,其中包括辉瑞和绿石等多家制药公司。绿石是辉瑞的旧子公司,销售仿制药。此事被转移至美国宾夕法尼亚东区地方法院的多个前审协调诉讼程序中。至于绿石和辉瑞,此诉讼称其违反了联邦和州反托拉斯法以及州消费保护法的反竞争行为。2020年6月,州总检察长对多家公司提起了新的诉讼,包括绿石和辉瑞,对不同的药品提出了类似的指控。这起诉讼于2020年7月转移到MDL。MDL还包括私人原告和州县对辉瑞、绿石和其他被告提起的民事诉讼,声称其所述的指控通常与州总检察长所述的指控重叠。在2024年4月,由州总检察长提起的两起指控绿石和辉瑞的案件被发回康涅狄格州地区。
涉及Tris Pharma/Quillivant XR的传讯
在2018年10月,我们收到了来自纽约南区美国检察官办公室的传票,请求提供与另一家制药公司及其生产和制造药物的记录,包括但不限于Quillivant XR。 我们已根据此请求提供了记录。.
有关Meridian医疗技术的政府查询
2019年2月,我们收到了来自美国南区纽约市司法部门的民事调查需求(CID)。该CID要求提供与在Meridian站制造自动注射器时涉及的所谓质量问题有关的记录和信息。2019年8月,我们收到了由密苏里州东区的美国检察官办公室颁发的HIPAA传票,与此同时,还与美国司法部消费者保护部门协调,寻求类似的记录和信息。我们已经回应了这些请求并提供了相关记录。
多西他赛––密西西比州司法部长政府调查
请参阅规则13d-7(b)以获取应抄送副本的其他各方。法律诉讼––产品诉讼––多西他赛––密西西比州总检察长政府行动 有关Docetaxel营销实践的政府调查信息,请参考上述。
美国司法部有关印度业务的调查
2020年3月,我们收到了美国司法部消费保护分部的一份非正式要求,要求我们提供有关印度制造业务的文件,包括位于印度Irrungattukottai的我们的前工厂。2020年4月,我们收到了美国南区纽约检察官办公室的类似要求,涉及我们在印度工厂的运营的民事调查。我们正在根据这些要求制作记录。
美国司法部/证券交易委员会有关中国业务的调查
2020年6月,我们收到了美国司法部FCPA部门的非正式请求,要求提供我们在中国经营方面的文件。2020年8月,我们收到了SEC的FCPA部门类似的请求。我们已按照这些请求提供了记录。
Zantac-新墨西哥州和巴尔的摩市市长和市议会民事诉讼
请参阅规则13d-7(b)以获取应抄送副本的其他各方。法律诉讼——产品诉讼——赞达克 有关新墨西哥州和巴尔的摩市市长及市议会分别提起的民事诉讼的详细信息,指控被告在这些司法管辖区内销售赞达克,违反了各种州法和普通法诉求。
关于biohaven的政府调查
2022年6月,美国司法部商事诉讼部和纽约西区联邦检察官办公室向biohaven发出了调查令。 调查令寻求与其他事项相关的记录和信息。
33


辉瑞公司及其子公司
压缩合并财务报表注释
(未经审计)
biohaven在辉瑞收购biohaven之前与医疗专业人员的接触和共付优惠券卡。2023年3月,加州保险局发出传票,要求提供与CID请求的记录类似的文件。biohaven是我们在2022年10月收购的全资子公司。我们已针对这些请求提供了相关记录。我们一直在讨论这些事项的潜在解决方案。
美国司法部调查涉墨西哥业务
2023年3月,我们收到了美国司法部FCPA部门的非正式要求,要求我们提供与我们在墨西哥的业务有关的文件。我们已经按照要求提供了记录。
关于Xeljanz的政府调查
2023 年 4 月,我们收到了美国弗吉尼亚西区检察官办公室与司法部商业诉讼处协调发出的HIPAA传票,要求提供与辉瑞在零售药房赞助的与 Xeljanz 有关的计划相关的记录和信息。我们已根据该要求制作了记录。
b. 担保和赔偿
在正常的业务过程中,以及与资产和业务的销售及其他交易相关时,我们通常会对我们的对手方就与交易相关或与交易之前或之后的事件和活动相关的某些责任进行赔偿。如果被赔偿方根据赔偿条款提出成功索赔,我们可能需要偿还损失。这些赔偿通常受到各种限制和条件的约束。历史上,我们在这些条款下并未支付 significant 金额,截至2024年9月29日,这些赔偿义务的估计公允价值对辉瑞来说并不重大。
此外,与我们进入某些协议和其他交易相关,我们的交易对手可能有义务向我们提供赔偿。例如,我们与biontech达成的全球协议,共同开发面向预防COVID-19感染的基于mRNA的冠状病毒疫苗计划,包括某些赔偿条款,根据这些条款,biontech和辉瑞各自同意为某些涉及Comirnaty的第三方索赔可能产生的某些责任提供赔偿。
参见 备注 7D 在我们的 2023 年 10-k 表格中,了解有关辉瑞公司为辉瑞投资企业私人有限公司发行的债务提供担保的信息。有限公司(辉瑞的全资财务子公司)于 2023 年 5 月成立。我们还为我们收购的某些公司的长期债务提供了担保,这些公司现在是辉瑞的子公司。
C. 收购的有条件的考虑
我们可能需要向卖方支付一些对于特定以前的业务组合而言取决于未来事件或结果的费用。请参见 附注1D 在我们的2023年10-k表格中。
附注13.分部、地理及其他营业收入信息
A. 分段信息
我们通过运营部门来管理商业运营,每个部门都由一位单一的经理领导:生物制药、PC1和辉瑞点燃。生物制药是唯一报告的部门。见 我们的业务分为几个运营部门,由单一经理领导:生物制药、PC1和辉瑞Ignite。生物制药专注于全球范围内生物制药产品的发现、开发、制造、营销、销售和分销。PC1是我们的合同开发和制造组织,是特种活性药品成分的领先供应商。辉瑞Ignite是一个提供战略指导和端到端研发服务的产品,针对与辉瑞研发重点领域对齐的创新生物科技公司。在2024年6月之前,PC1和辉瑞Ignite由同一经理一起管理,作为前业务创新运营部门的一部分。生物制药是唯一可报告的部门。我们的商业部门负责营销、分销和卖出我们的产品,全球运营职能负责我们产品的研究、开发、制造和供应。每个运营部门都得到我们全球企业支持职能的支持。我们的首席运营决策者使用运营部门的收入和收益,作为绩效评估和资源分配的因素之一。我们定期审查我们的部门以及管理层用于评估绩效和分配资源的方法。
2024年初,我们对商业组织进行了调整,将seagen纳入,并改善了关注焦点、速度和执行力。具体来说,在我们的生物制药汇报分部内,我们创建了辉瑞肿瘤学部、辉瑞美国商业部和辉瑞国际商业部:
辉瑞肿瘤部门结合了美国肿瘤商业组织、全球肿瘤营销组织以及辉瑞和seagen的全球和美国肿瘤医疗事务。
辉瑞美国商业部门包括美国初级护理和美国专业护理客户群,首席营销办公室,全球首席医疗事务办公室以及全球医疗与价值。
34


辉瑞公司及其子公司
压缩合并财务报表注释
(未经审计)
辉瑞国际商业部门包括覆盖辉瑞在所有国际市场的产品组合的美国以外的商业和医疗事务组织。
自2024年1月1日起,生物制药的收益包括与我们生物制药业务相关产品的研发、医疗与安全、制造与供应、销售和市场活动的成本。在2024年之前,与我们全球ORD和PRD组织管理的研发和医疗与安全活动以及与我们制造业务相关的一般运营成本被视为其他业务活动的一部分。我们已将先前时期的分部信息重新分类以符合当前期的披露要求。
其他业务活动和对账项目——其他业务活动包括PC1和辉瑞点燃的运营结果以及部分未分配到我们营运部门结果的税前成本,例如与公司支持功能和其他公司成本相关的成本以及我们从Haleon获得的收益。对账项目包括以下未分配到我们营运部门的项目、交易和事件:(i)所有无形资产的摊销;(ii)有关收购的项目;和(iii)某些重大项目,代表实质性和/或飞凡的项目,并且在某些情况下是重复性的,这些项目由管理层根据个别情况评估,由于其性质或规模,这些项目不应该预期作为我们正常业务的一部分定期发生。
分段资产––我们以总公司为基础管理我们的资产,而不是按运营分段,因为我们的运营资产是共享或混合的。因此,我们的首席运营决策者并不定期按照运营分段审查任何资产信息,因此我们不按运营分段报告资产信息。总资产为$219 十亿,截至2024年9月29日,以及$227 亿美元。
所选经营报表信息
以下提供按报告分部门选择的信息:
截至三个月截至九个月
 
总收入
收益(a)
总收入
收益(a)
(百万)2024年9月29日2023年10月1日2024年9月29日2023年10月1日2024年9月29日2023年10月1日2024年9月29日2023年10月1日
报告分部门:
生物制药(b)
$17,392 $13,188 $8,319 $(137)$44,987 $44,051 $21,838 $14,422 
其他业务活动(c)
310 303 (1,527)(1,100)877 933 (5,520)(3,325)
调节项目:
无形资产摊销(1,312)(1,179)(3,927)(3,466)
收购相关项目(465)(227)(1,590)(778)
某些重大项目(d)
(299)(708)(2,768)(1,666)
$17,702 $13,491 $4,715 $(3,352)$45,864 $44,984 $8,033 $5,187 
(a)持续经营的收入/(损失)在所得税的准备金/(收益)之前。 如上所述,鉴于2024年第一季度生效的组织变更,与我们的全球ORD和PRD组织管理的研发、医疗和安全活动相关的费用,以及与我们的制造业-半导体运营相关的间接费用现在被纳入生物制药的收益中。我们已将$7.7私人股权和其他投资的金额分别为52.27亿美元和53.98亿美元,截至2023年7月31日和2023年1月31日。11.1 十亿美元的净成本在2023年第三季度和前九个月,分别从其他业务活动重分类到生物制药,以符合当前期间的展示。
(b)2024年前九个月的生物制药收入和利润反映了一项非现金有利产品退还调整,金额为$771 百万,记录在2024年第一季度(详见 请参见下面的Note 13C。). 生物制药的收入还包括我们在ViiV投资中获得的股息收入,分别为2024年第三季度的$48 百万,在2023年第三季度的$30 百万,以及2023年前九个月的$183 2024年前九个月为$213 百万。生物制药2023年第三季度和前九个月的利润中,包括约$5.6亿和美元5.8分别计入了数十亿美元的存货减值准备和相关费用 销售成本 主要是由于我们 COVID-19 产品需求低于预期
(c)其他业务活动包括与PC1和辉瑞Ignite相关的收入和成本,以及我们不分配给经营部门的成本,如上所述。
(d)某些重要项目是实质性的和/或飞凡的,在某些情况下是重复发生的项目(如上所述)。2024年第三季度和前九个月的利润包括,其他项目中,因停止我们的DMD项目而预计出售的, ) 。出售后,我们拥有Haleon流通投票股的大约百分之 员工福利计划420 百万与 一份 我们的一些设施1.52024年前九个月的利润还包括重组费用/(收入)和实施成本,以及额外的折旧——资产重组为$ 十亿美元(主要在 重组费用和一定收购相关成本2023年前九个月的收益包括,飞凡项目的股票证券净亏损$711 百万美元记录在 其他(收入)/扣除––净额。请查看注释34.
35


辉瑞公司及其子公司
压缩合并财务报表注释
(未经审计)
b. 地理信息
以下汇总了按地理区域划分的收入:
 三个月已结束九个月已结束
(百万)九月 29,
2024
10月1日
2023
%
改变
九月 29,
2024
10月1日
2023
%
改变
美国$12,064 $8,064 50 $29,470 $23,233 27 
国际:
发达市场
3,412 3,335 2 9,774 13,094 (25)
新兴市场2,226 2,092 6 6,620 8,656 (24)
总收入
$17,702 $13,491 31 $45,864 $44,984 2 
C.其他营业收入信息
重要客户
2023年10月,我们与美国政府签署了一份修订后的协议,促进了Paxlovid于2023年11月在美国传统商业市场的过渡。有关此协议,我们记录了一笔非现金收入逆转,金额为10亿美元,涉及预计约的100万个有限授权使用(EUA)标记的美国政府库存返回。2024年第一季度,我们记录了一笔非现金有利的最终调整,金额为3500万美元,以反映由2024年2月29日以前归还的700万个EUA标记的治疗疗程,这些疗程被转换为基于成交量的信用,将支持由辉瑞运营的美国政府患者援助计划继续使用Paxlovid。我们还同意在2024年创建一个美国战略国家储备库,以备未来的疫情准备,可提供3500万个治疗疗程至2028年,由辉瑞免费管理和供应给美国政府或纳税人。虽然我们在交付预计的1500万个治疗疗程时认可收入,但这些疗程没有任何剩余的现金考虑。3.5 100万个EUA标记的治疗疗程的预计回报,使2023年第四季度我们记录了10亿美元的非现金收入逆转。 6.5 这是对2024年第一季度的非现金有利的最终调整,金额为3500万美元,以反映前一个月已归还的700万个EUA标记治疗疗程。771 可持续访问Paxlovid的基于成交量的信用的反映,使我们记录了3500万美元的非现金有利的最终调整。 5.1 截至2024年2月29日,共有百万个EUA标签治疗课程被退回,这些课程已转换为基于成交量的信用,用于支持通过辉瑞运营的美国政府患者援助计划继续获取Paxlovid。在2024年第三季度,针对这一修订协议,我们还以免费方式向美国政府或纳税人提供了一批美国SNS,数量为 1.0 百万治疗课程,以便支持未来的疫情准备至2028年,并记录营业收入为$442 百万。虽然我们在交付时确认营业收入,但这些治疗课程并没有现金对价。 6.1
来自美国政府的收入占2024年6月30日和2023年7月2日的总收入的百分之 9截至2024年9月29日的三个月总收入的百分比 7截至2024年9月29日和2023年10月1日的九个月总收入的百分比。来自美国政府的收入在截止2023年10月1日的三个月总收入中所占的比例不重要。有关我们重要的批发客户的信息,请参见 注17C 在我们的2023年10-K表格中。
按产品分类的显著收入
以下为我们几款主要产品的详细营业收入信息:
(百万)三个月已结束九个月已结束
产品主要适应症或等级2024 年 9 月 29 日2023 年 10 月 1 日2024 年 9 月 29 日2023 年 10 月 1 日
总收入$17,702 $13,491 $45,864 $44,984 
全球生物制药业务(生物制药)
$17,392 $13,188 $44,987 $44,051 
初级保健$9,060 $6,310 $21,224 $23,755 
Eliquis(a)
非瓣膜性心房颤动、深静脉血栓形成、肺栓塞1,617 1,498 5,534 5,135 
Paxlovid(b)
某些高危患者的 COVID-192,703 202 4,989 4,414 
Prevnar 家族主动免疫预防肺炎链球菌引起的肺炎、侵入性疾病和中耳炎1,803 1,843 4,853 4,877 
Comirnaty
主动免疫以预防 COVID-19
1,422 1,306 1,970 5,858 
Nurtec odt/Vydura偏头痛的急性治疗和发作性偏头痛的预防337 233 870 646 
Abrysvo
主动免疫预防呼吸道合胞病毒感染
356 375 557 375 
Premarin 家族
更年期的症状
90 92 283 299 
fsme-immun/ticovac
主动免疫预防蜱传脑炎疾病
81 91 246 237 
所有其他初级保健各种各样652 670 1,921 1,914 
专业护理$4,289 $3,763 $12,215 $11,035 
Vyndaqel 家族ATTR-CM 和多发性神经病1,447 892 3,907 2,360 
Xeljanz
RA、psA、UC、活动性多关节病程幼年特发性关节炎、强直性脊柱炎
321 503 818 1,210 
Enbrel(美国和加拿大以外)
RA、幼年特发性关节炎、psA、斑块状银屑病、儿科斑块状银屑病、强直性脊柱炎和非射线照相轴向性脊柱关节炎
169 208 507 627 
Sulperazon细菌感染156 122 468 619 
Zavicefta细菌感染152 130 427 378 
36


辉瑞公司及其子公司
压缩合并财务报表注释
(未经审计)
(百万)截至三个月截至九个月
产品主要适应症或类别2024年9月29日2023年10月1日2024年9月29日2023年10月1日
奥他亚胶体(c)
原发性免疫缺陷,成人慢性免疫性血小板减少性紫癜,成人皮肌炎骨骼肌病
221 53 400 164 
英福替单抗
克罗恩病,儿童克罗恩病,溃疡性结肠炎,儿童溃疡性结肠炎,类风湿关节炎联合甲氨蝶呤,强直性脊柱炎,银屑病关节炎和寻常型银屑病
126 121 382 373 
人类生长激素替代治疗药物吉诺替比119 158 358 379 
齐瑟病细菌感染83 60 357 254 
血友病B治疗药物奥比曲塔88 107 294 321 
欧布利塔(d)
镰状细胞贫血17 85 193 232 
西必利普特松63 37 152 91 
所有其他医院(e)
Various
1,108 1,086 3,296 3,452 
所有其他专科护理Various218 202 658 575 
肿瘤学$4,043 $3,115 $11,549 $9,261 
艾倍洛曲HR阳性/HER2阴性转移性乳腺癌1,087 1,244 3,272 3,635 
扩拓(f)
mCRPC,nmCRPC,mCSPC,nmCSPC561 440 1,474 1,202 
Padcev
局部晚期或转移性膀胱癌409  1,144  
肿瘤生物类似药(g)
Various
285 310 828 1,085 
Adcetris霍奇金淋巴瘤和某些T细胞淋巴瘤268  804  
Inlyta爱文思控股先进晚期肾癌247 252 736 773 
Lorbrena
ALK阳性转移性非小细胞肺癌
206 159 538 393 
Bosulif费城染色体阳性慢性髓性白血病161 160 474 463 
Braftovi/Mektovi
在BRAF V600E/k突变患者中治疗转移性黑色素瘤突变 以及在BRAF患者中治疗转移性非小细胞肺癌V600E 突变;同时,Braftovi与Erbitux(西妥昔单抗)联合使用(h) 用于治疗BRAFV600E-突变mCRC在先前治疗后
173 131 437 346 
Tukysa
无法手术或转移性HER2阳性乳腺癌; RAS野生型、HER2阳性无法手术或转移性结直肠癌124  351  
Tivdak
复发性或转移性宫颈癌34  94  
Talzenna
用于HRR基因突变性mCRPC成人患者与Xtandi(恩扎鲁胺)联合治疗; 用于治疗BRCA基因突变、HER2阴性、无法手术或复发的乳腺癌36 20 91 42 
所有其他肿瘤板块
Various453 399 1,306 1,322 
辉瑞 CENTREONE(i)
$285 $293 $820 $908 
辉瑞点燃
$25 $10 $56 $25 
生物制药
$17,392 $13,188 $44,987 $44,051 
辉瑞美国商业部门(美国初级保健和美国专科护理)
8,938 5,864 20,702 16,679 
辉瑞肿瘤学部
3,026 2,111 8,516 6,260 
辉瑞国际商业部门
5,428 5,214 15,769 21,112 
上述总联盟收入$1,900 $1,645 $6,140 $5,672 
上述总版税收入
$384 $260 $992 $737 
(a)主要反映联盟收入和产品收入。
(b)2024年第三季度和前九个月包括$442 百万的营业收入,记录于创建美国SNS的相关事务中。2024年前九个月还包括$771 2024年上半年包括在2023年第一季度记录的1百万美元有利最终调整,反映出2023年第四季度预计的10亿美元非现金收入逆转。这个调整是基于2024年2月29日之前,美国政府退回了160万EU标记的治疗课程,而原本预计会归还240万治疗课程的情况下做出的。3.5 苹果首席执行官库克大规模抛售股票,获逾3亿港元。 5.1 截至2024年2月29日,美国政府退回了约100万份欧盟批准标签的治疗方案,与预计的相比。 6.5 2024年上半年包括在2023年第一季度记录的1百万美元有利最终调整,反映出2023年第四季度预计的10亿美元非现金收入逆转。这个调整是基于2024年2月29日之前,美国政府退回的治疗课程数为160万,而预计归还240万治疗课程的情况下做出的。
(c)2024年第三季度和前九个月包括$129 与我们的商业化合作伙伴达成的一次性销售结算协议相关的百万美元。
(d)2024年9月,我们宣布自愿撤回在所有批次中批准的市场上用于治疗镰状细胞病的Oxbryta,以及全球范围内所有活跃的voxelotor临床试验和扩展获得计划,基于现在显示Oxbryta的整体临床数据表明,在批准的镰状细胞患者人群中,Oxbryta的总体益处不再超过风险。数据表明在血管闭塞危机和致命事件中存在不平衡,需要进一步评估。
(e)包括医院产品中的所有板块,以前展示的所有其他抗感染剂和Ig组合。
(f)主要反映联盟收入和版税收入。
(g)类生物制品是经过批准和授权的生物药品的高度相似版本。肿瘤学类生物制品主要包括Retacrit、Ruxience、Zirabev、Trazimera和Nivestym。
(h)Erbitux是ImClone LLC的注册商标。
(i)PC1包括我们的制造业-半导体和原料药销售业务的收入,以及与传统辉瑞业务/合作伙伴的制造和供应协议相关的收入。
37


辉瑞公司及其子公司
压缩合并财务报表注释
(未经审计)
剩余履约义务––预计在长期合同中从剩余履约义务中确认的合同收入,来自firm订单用于向我们的客户供应Comirnaty和Paxlovid的总额约为$6亿和美元1 亿,其中包括提前收款和递延金额,以及未来交付这些产品时将开具的发票。在这些金额中,当前合同条款提供了2024年至2028年期间交付产品的预期,具体时间可能会重新协商。剩余履约义务基于2024财政第三季度结束时的汇率,并且不包括原预计合同期限少于一年安排的义务。与其他产品和服务的合同相关的剩余履约义务在2024年9月29日或2023年12月31日时并不显著。
递延收入——我们的递延收入主要涉及从各种政府或政府赞助的客户那里收到或应收的用于供应Paxlovid和Comirnaty的预付款。与Paxlovid和Comirnaty相关的递延收入总额为美元3.5 截至 2024 年 9 月 29 日,已达十亿美元,其中为2.0 十亿和美元1.5 流动负债和非流动负债分别记录了10亿美元。与Paxlovid和Comirnaty相关的递延收入总额为美元5.1 截至 2023 年 12 月 31 日,已达十亿美元,其中为2.6 十亿和美元2.5 流动负债和非流动负债分别记录了10亿美元。2024年前九个月Paxlovid和Comirnaty递延收入的下降主要是由以下方面确认的金额推动的 产品收入 当我们向客户交付产品时(包括 $442 百万美元与美国社交网站(Paxlovid)以及前面提到的美元771 Paxlovid在2024年第一季度记录了数百万美元的最终调整优惠,但部分被2024年前九个月我们签订修订合同时收到的额外预付款所抵消。在2024年第三季度和前九个月中,我们确认的收入约为美元1.1 十亿和美元2.3 截至2023年12月31日,这分别包含在Paxlovid和Comirnaty递延收入余额中。截至2024年9月29日的Paxlovid和Comirnaty递延收入将在以下时间确认 产品收入 当我们将产品控制权移交给客户并履行合同规定的履约义务时,流动负债中包含的金额预计将在以下日期确认 产品收入 在接下来的12个月内,以及预计将确认的非流动负债中包含的金额 产品收入 从 2025 年到 2028 年。截至2024年9月29日或2023年12月31日,与其他产品合同相关的递延收入并不大。
38


第2项 控件 财务状况和经营业绩的管理讨论和分析。
操作。
一般规定
以下的管理层讨论与分析旨在帮助读者理解我们的财务状况和经营业绩,包括对来自经营活动和外部资金来源的现金流量金额和确定性的评估,仅供参考,并应与基本报表及相关附注一起阅读。 项目1. 财务报表 在本第10-Q表格中。
对于业务差异的参考是指与上一时期相比的变化,不包括汇率变化的影响。虽然汇率变化是我们业务的一部分,但它们不在我们的控制范围内,而且因为它们可以掩盖业务中的正面或负面趋势,因此我们认为提供排除了这些汇率变化的业务差异可以提供有用的信息来评估我们的结果。
2024年第一季度,我们重新分类了版税收入(其中绝大部分与我们的生物制药板块相关) 其他(收入)/扣除——净额 ,并重新分类了我们的关联版税应收账款; 权利收入 我们的合并利润表中的。 总收入 在我们的合并利润表中进行了呈现。以往的期间金额已重新调整以符合当前的呈现形式。
我们的业绩概述,经营环境,策略和展望。
我们的业务和策略––辉瑞公司是一家以研究为基础的全球生物制药公司。我们运用科学和全球资源,为人们提供能够延长和显著改善其生活的治疗方案。我们2024年的重点优先事项是:
实现世界级的肿瘤学领导地位
交付下一波管线创新
最大化我们新产品的性能
通过重新调整成本基础来扩大利润率
配置资金以增强股东价值
我们相信通过科技,包括人工智能,能够更高效、更有效地执行这五个战略优先事项。
我们通过一个由三个业务部门组成的全球结构来管理我们的商业运营:生物药品、PC1 和辉瑞Ignite。生物药品是唯一的报告部门。请查看 注13A.
2023年第四季度,我们宣布推出了一个为期多年的企业范围成本重新调整计划(重新调整我们的成本基础计划),旨在将我们的成本与我们的长期营业收入预期调整一致。2024年第二季度,我们宣布启动了一个为期多年的、分阶段的降低销售成本的计划(制造业优化计划),预计将包括运营效率、网络结构变更和产品组合增强。查看 注3。有关这些计划相关的预期节省的描述,请参阅 成本和费用-重组费用及与收购和降低成本/提高生产力举措相关的其他费用 MD&A中的章节.
有关我们业务、策略和运营环境的更多信息,请参见 第1项. 业务 部分和 我们表现、运营环境、策略和展望的概述 在我们2023年10-K表格的MD&A部分。
我们的业务发展计划——我们致力于战略性地利用增长机会,主要通过推动我们自己的产品线并最大化现有产品的价值,同时也通过各种业务发展活动。有关截至2024年2月22日(我们2023年10-K表格的提交日期)的重大近期交易的描述,请参见 备注2 我们2023年10-K表格。请参见 备注2 有关重大近期活动的详细信息。
我们2024年第三季度和2024年前九个月的业绩
总收入––总收入 2024年第三季度,在运营增长31%的情况下,收入从2023年第三季度的$135亿增加了$42亿,达到$177亿,这主要反映了$43亿的运营增长,部分抵消了$13300万的汇率期货不利影响。运营增长主要得益于Paxlovid的增长、2023年12月收购的Seagen传统产品的收入以及Vyndaqel家族的增长,部分抵消了Xeljanz和Ibrance的下降。不包括Paxlovid和Comirnaty的贡献, 总收入 运营增长$17亿,增长14%。
总收入 2024年前九个月汇率期货增加了88000万美元,或2%,从2023年前九个月的450亿美元增至459亿美元,运营增长了13亿美元,或3%,部分抵消了汇率期货影响的不利影响,为41100万美元,或1%。运营增长主要来自传统seagen的营收
39


2023年12月收购的产品,以及Vyndaqel系列、Paxlovid和Eliquis的增长,部分被Comirnaty的下降抵消。排除Paxlovid和Comirnaty的贡献, 总收入 运营上增加了46亿美元,或13%。
详情请参见 地理位置的总营业收入选定产品的总营业收入讨论 更多信息的部分,包括对我们营业收入表现关键驱动因素的讨论。我们的一些疫苗,包括科莫依德,受需求季节性影响,预计营业收入的较大部分集中在秋季和冬季,而帕克索利特的收入则随感染率变化。另请参见 全球货币环境——COVID-19 下面的部分是关于我们的COVID-19产品的信息。有关某些产品的主要适应症或分类的信息,请参见 请参见下面的Note 13C。.
继续经营收入/(损失)在税前的收入/(收益)准备—— 税前的继续经营收入/(收益) 2024年第三季度的收入为47亿美金,比较2023年第三季度的34亿美元亏损,主要由于(i) 收入增加,(ii) 一定减少, 销售成本 以及(iii) 2024年第三季度股票证券的净收益,相对于2023年第三季度股票证券的净亏损,部分抵消了(iv) 更高的净利息支出和(v) 2024年第三季度因 ) 。出售后,我们拥有Haleon流通投票股的大约百分之 结束我们DMD项目而产生的费用。
持续经营收入在税前的增长为28亿,2024年前九个月达到80亿美元,而2023年前九个月为52亿美元,主要是由于(i) 减少了 Cost of sales, (ii) 收入增加以及(iii) 2024年前九个月的股权证券净收益与2023年前九个月的股权证券净损失相比,部分被(iv) 净利息支出增加,(v) 资产增加和(vi) 2024年的费用所抵消 重组费用和一定收购相关成本无形资产摊销 到期 ) 。出售后,我们拥有Haleon流通投票股的大约百分之 与我们DMD项目的终止有关.
查看 汇总合并经营报表的分析 MD&A中的部分以及 注4有关我们的税收准备和有效税率的信息,请参见 所得税/(损失)税收条款内的部分 MD&A中的部分以及 注5.
我们的运营环境——我们和其他行业的企业一样,面临某些特定行业板块的挑战。这些挑战包括以下列出的 话题,以及在 第1项 业务——政府监管和价格限制 第1A项 风险因素 部分, 我们业绩、运营环境、策略和展望概述––我们的运营环境 MD&A部分 我们的2023年10-K表格的内容。
知识产权与合作/许可权知识产权的丧失、到期或无效、专利诉讼和解与判决,以及共同推广和许可权的到期,可能会对我们的收入产生重大不利影响。我们的一些产品在过去几年中经历了基于专利的到期或在某些市场失去了监管专属权,并且我们预计未来几年某些产品将面临增加的仿制药竞争。尽管会继续出现额外的专利到期,但我们预计从2024到2025年,专利到期将对收入产生适度影响。我们预计在2026到2030年,随着我们的多款在售产品遭遇专利到期,收入将受到更显著影响。我们将继续积极维护我们的专利权,打击侵权行为,并将继续支持加强全球专利权认知的努力,同时采取必要措施确保适当的患者获取。
有关我们认为对整体业务最重要的专利权的更多信息,请参见 第1项 业务——专利和其他知识产权 我们2023年10-K表格的部分。有关涉及我们某些产品的专利诉讼的最新进展,请参见 注释12A1.
监管环境/定价与获取——政府和其他支付组织的压力——全球各国政府以及美国的私人第三方支付者可能采用各种措施来控制成本,包括但不限于立法或监管性定价改革、药品目录(包括分级和利用管理工具)、跨国合作和采购、价格削减、强制性回扣、健康技术评估、作为市场准入条件的强制性本地化要求、“国际参考定价”(即一个国家将其调节药价与其他国家挂钩的做法)、质量一致性评估流程和基于成交量的采购。我们预计这些及类似举措将继续在全球增加定价和获取压力。在美国,无论哪个党派在2024年11月之后执政,我们都预计国会和总统行政当局将继续专注于监管药品定价。已于2022年8月签署成为法律的IRA药价规定将在未来几年继续实施。2023年8月,拜登政府公布了首批受医疗保险药品价格协商计划(该计划)约束的十种药品,要求选择药品的制造商与联邦政府开展过程以确定新的医疗保险价格,这些价格将于2026年生效。Eliquis是首批受该计划约束的十种药品之一。2024年8月15日,美国政府公布了Eliquis新的医疗保险价格,从2026年1月1日起,每30天等效供应的价格将为231.00美元。Eliquis医疗保险价格将被纳入我们的长期财务规划,符合我们的标准财务报告和预测规程。未来可能会选择更多我们的产品,这可能会导致
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在知识产权保护到期之前,收入降低。我们继续评估《减税和就业法案》(IRA)对我们业务、运营、财务控件和结果的影响,因为IRA对我们业务和药品行业的全面影响仍不确定。此外,医疗补助药物回扣计划或3400亿药物定价计划(3400亿计划)的变化,包括关于3400亿计划的联邦或州级别的法律或立法进展,可能对我们的业务产生重大影响。请参见 第1项. 业务––定价压力和管理护理组织 和 ––政府监管和价格约束第1A项。风险因素––定价和报销 节及 我们业绩、运营环境、策略和展望的概述——我们的运营环境 我们2023年10-K表格的MD&A部分.
2023年7月在北卡罗来纳州洛基山的龙卷风影响––我们位于北卡罗来纳州洛基山的制造业-半导体设施在2023年7月遭受了龙卷风的损坏。该设施是无菌注射剂的主要生产商,负责制造我们近25%的所有无菌注射剂,包括麻醉、镇痛和微量营养素。药品供应已经从龙卷风的影响中恢复。
我们在2023年和2024年遭受了损失,部分被2023年收到的保险赔付所抵消。我们预计将在2024年第四季度录得额外的保险赔付。
产品供应我们定期遇到供应延迟、中断和短缺,包括由于自愿产品召回、自然或人为灾害。作为对各种监管机构的要求的回应,包括辉瑞在内的药品行业的制造商正在评估其产品组合,以了解亚硝胺的潜在存在或形成。2021年,由于美国尼古丁戒烟药Chantix中存在一种亚硝胺N-亚硝基维兰尼克林的成分达到或超过FDA暂定可接受摄入限值,辉瑞召回了所有批次的Chantix。监管机构已发布了有关亚硝胺可接受摄入水平的更新指导。根据这一指导,包括N-亚硝基维兰尼克林更新的摄入水平,我们已开始提交监管文件,以潜在地使Chantix在美国和某些国际市场重新上市。
除了上面讨论的北卡罗来纳州洛基山的龙卷风影响外,在2024年前九个月及本表格10-Q提交日期之前,我们没有看到显著的供应链中断,全球所有的制造业-半导体站点仍然继续以正常水平或接近正常水平运行。我们继续监测某些元件和原材料的行业板块需求,并实施减缓策略,以减少对产品供应可能造成的风险或影响,包括积极的供应商管理、合格的额外供应商和尽可能的爱文思控股采购。有关与产品制造相关的风险信息,请参阅 项目1A。风险因素——产品制造、销售和市场风险 部分内容在我们2023年的10-K表格中。
自愿退出Oxbryta––详情请参见 产品开发 MD&A中的部分。
全球货币经济环境——除了上述行业板块特定因素外,我们和其他同规模、全球活动范围的企业一样,面临经济周期的影响。请参见 我们业绩、运营环境、策略和展望概述––全球货币经济环境 我们2023年10-k表格的MD&A部分。
COVID-19作为应对COVID-19的一部分,我们开发了Paxlovid并与biontech合作共同开发Comirnaty。作为我们针对COVID-19的策略的一部分,我们将继续在突破性科学方面进行重大投资。这包括继续评估Comirnaty和Paxlovid,包括针对新关注的变体,开发特异变体适应的疫苗候选者,以及开发可能的联合呼吸道疫苗和可能的下一代疫苗和疗法。我们还在评估Paxlovid适用于其他人群。请查看MD&A中的部分。 产品开发 在 MD&A 中的部分。
2023年,我们主要在全球范围内根据政府合同销售新冠 mRNA 疫苗。2023年9月,由于合同到期以及辉瑞和biontech的 COVID-19 疫苗库存耗尽或未使用,Comirnaty 在美国过渡到传统的商业销售模式。这是在引入新变异疫苗后的市场需求改变所致。国际上,2023年 Comirnaty 在发达市场通常是在政府合同下销售的,在新兴市场则是通过私人渠道和政府合同的组合方式销售;在这两种情况下,我们都计划在2024年开始向商业市场过渡。由于商业市场过渡以及预期的 COVID-19 疫苗需求季节性,我们预计2024年 Comirnaty 约60% 的全球收入将记录在第四季度。
In 2023, we principally sold Paxlovid globally to government agencies. On October 13, 2023, we announced an amended agreement with the U.S. government, which facilitated the transition of Paxlovid to traditional commercial markets in the U.S. in November 2023, with minimal uptake of NDA-labeled commercial product before January 1, 2024 (see Note 13C). Internationally, for Paxlovid, most markets have now transitioned to commercial markets, and we are expecting most revenue for Paxlovid to be generated through commercial channels in 2024.
For information on risks associated with our COVID-19 products, including certain assumptions made for purposes of our operational planning and financial projections and the uncertainty of future developments, as well as COVID-19 intellectual property disputes, see the Item 1A. Risk Factors—COVID-19, —Intellectual Property Protection and —Third-Party Intellectual
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Property Claims sections of our 2023 Form 10-K, as well as Notes 12A1 and 13 and the Forward-Looking Information and Factors that May Affect Future Results section of this Form 10-Q.
Israel/Hamas Conflict––Our local operations have been impacted by the armed conflict between Israel and Hamas that began on October 7, 2023. For both the nine months ended September 29, 2024 and the fiscal year ended December 31, 2023, the business of our Israeli subsidiary represented less than 1% of our consolidated revenues and assets. We are closely monitoring developments in this conflict, including evaluating potential impacts to our business, customers, suppliers, employees, and operations in Israel and elsewhere in the Middle East that may impact global operations. At this time, longer term impacts to the Company are uncertain and subject to change.
Russia/Ukraine Conflict––Our local operations have been impacted by the armed conflict between Russia and Ukraine. For both the nine months ended September 29, 2024 and the fiscal year ended December 31, 2023, the business of our Russia and Ukraine subsidiaries represented less than 1% of our consolidated revenues and assets. While we are monitoring the effects of the conflict between Russia and Ukraine, the situation continues to evolve and the long-term implications, including the broader economic consequences of the conflict, potential additional sanctions, and actions by our customers or suppliers (including financial institutions) are difficult to predict at this time.
For information on risks associated with these conflicts, see the Item 1A. Risk Factors—Global Operations section of our 2023 Form 10-K.
SIGNIFICANT ACCOUNTING POLICIES AND APPLICATION OF CRITICAL ACCOUNTING ESTIMATES AND ASSUMPTIONS
For a description of our significant accounting policies, see Note 1 in our 2023 Form 10-K. Of these policies, the following are considered critical to an understanding of our consolidated financial statements as they require the application of the most subjective and the most complex judgments: Acquisitions (Note 1D); Fair Value (Note 1E); Revenues (Note 1G); Asset Impairments (Note 1M); Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives (Note 1N); Tax Assets and Liabilities and Income Tax Contingencies (Note 1Q); Pension and Postretirement Benefit Plans (Note 1R); and Legal and Environmental Contingencies (Note 1S).
For a discussion about the critical accounting estimates and assumptions impacting our consolidated financial statements, see the Significant Accounting Policies and Application of Critical Accounting Estimates and Assumptions section within MD&A of our 2023 Form 10-K. See also Note 1C in our 2023 Form 10-K for a discussion about the risks associated with estimates and assumptions.
For a discussion of a recently adopted accounting standard, see Note 1B.
ANALYSIS OF THE CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Total Revenues by Geography
The following presents worldwide Total revenues by geography:
Three Months Ended
 WorldwideU.S.InternationalWorld-wideU.S.Inter-national
(MILLIONS)Sept. 29, 2024Oct. 1, 2023Sept. 29, 2024Oct. 1, 2023Sept. 29, 2024Oct. 1, 2023% Change
Operating segments:
Biopharma$17,392 $13,188 $11,964 $7,975 $5,428 $5,214 32 50 
Pfizer CentreOne
285 293 76 79 210 214 (3)(5)(2)
Pfizer Ignite
25 10 25 10 — — **— 
Total revenues$17,702 $13,491 $12,064 $8,064 $5,638 $5,427 31 50 
Nine Months Ended
WorldwideU.S.InternationalWorld-wideU.S.Inter-national
(MILLIONS)Sept. 29, 2024Oct. 1, 2023Sept. 29, 2024Oct. 1, 2023Sept. 29, 2024Oct. 1, 2023% Change
Operating segments:
Biopharma$44,987 $44,051 $29,218 $22,939 $15,769 $21,112 27 (25)
Pfizer CentreOne
820 908 195 269 625 639 (10)(27)(2)
Pfizer Ignite
56 25 56 25 — — **— 
Total revenues$45,864 $44,984 $29,470 $23,233 $16,394 $21,750 27 (25)
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The following provides an analysis of the worldwide change in Total revenues by geographic areas in the third quarter of 2024 compared to the third quarter of 2023:
(MILLIONS)WorldwideU.S.International
Operational growth/(decline):
Worldwide growth from Paxlovid
$2,510 $2,313 $197 
Revenues from legacy Seagen, which was acquired in December 2023
854 815 39 
Worldwide growth from the Vyndaqel family, Eliquis, Xtandi and Nurtec ODT/Vydura, partially offset by worldwide declines from Xeljanz, Ibrance, the Prevnar family, Abrysvo and Inlyta
546 435 111 
Worldwide growth from Comirnaty
119 169 (51)
Other operational factors, net315 268 47 
Operational growth/(decline), net4,344 4,000 344 
Unfavorable impact of foreign exchange(133)— (133)
Total revenues increase/(decrease)
$4,211 $4,000 $210 
The following provides an analysis of the worldwide change in Total revenues by geographic areas in the first nine months of 2024 compared to the first nine months of 2023:
(MILLIONS)WorldwideU.S.International
Operational growth/(decline):
Revenues from legacy Seagen, which was acquired in December 2023
$2,440 $2,333 $107 
Worldwide growth from the Vyndaqel family, Eliquis, Xtandi, Nurtec ODT/Vydura and Abrysvo, partially offset by declines from Xeljanz, Ibrance and Inlyta, while the Prevnar family was flat
1,967 1,563 404 
Worldwide growth from Paxlovid
592 2,221 (1,629)
Worldwide decline from Comirnaty
(3,879)— (3,879)
Decline in oncology biosimilars, largely due to lower net price in the U.S.(250)(246)(4)
Other operational factors, net422 366 56 
Operational growth/(decline), net1,292 6,237 (4,945)
Unfavorable impact of foreign exchange(411)— (411)
Total revenues increase/(decrease)
$880 $6,237 $(5,356)
See the Total Revenues––Selected Product Discussion section within MD&A for additional analysis and Note 13C.
Product Revenue Deductions––Our gross product revenues are subject to a variety of deductions, which generally are estimated and recorded in the same period that the revenues are recognized. These deductions represent estimates of the related obligations and, as such, knowledge and judgment are required when estimating the impact of these product revenue deductions on gross sales for a reporting period. Historically, adjustments to these estimates to reflect actual results or updated expectations, have not been material to our overall business and generally have been less than 1% of revenues. Product-specific rebates, however, can have a significant impact on year-over-year individual product revenue growth trends.
The following presents information about product revenue deductions:
 Three Months EndedNine Months Ended
(MILLIONS)September 29,
2024
October 1,
2023
September 29,
2024
October 1,
2023
Medicare rebates$1,801 $286 $3,278 $718 
Medicaid and related state program rebates720 406 1,846 1,228 
Performance-based contract rebates1,836 1,363 4,884 3,784 
Chargebacks3,805 2,627 9,467 7,216 
Sales allowances1,569 1,732 4,654 4,841 
Sales returns and cash discounts
1,123 379 1,474 1,130 
Total(a)
$10,855 $6,793 $25,603 $18,918 
(a)The increase in revenue deductions in the third quarter and first nine months of 2024 is primarily driven by the transition of Paxlovid and Comirnaty to commercial markets, our acquisition of Seagen in December 2023, and higher sales of other recently acquired products, partially offset in the first nine months of 2024 by a $771 million favorable final adjustment recorded in the first quarter of 2024 to the estimated non-cash Paxlovid revenue reversal of $3.5 billion recorded in the fourth quarter of 2023 (see Note 13C).
Product revenue deductions are primarily a function of product sales volume, mix of products sold, contractual or legislative discounts and rebates.
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For information on our accruals for product revenue deductions, including the balance sheet classification of these accruals, see Note 1C.
Total Revenues––Selected Product Discussion
Biopharma
(MILLIONS)Revenue% Change
ProductPeriodGlobal
Revenues
RegionSept. 29, 2024Oct. 1, 2023TotalOper.Operational Results Commentary
EliquisQTD
$1,617

Up 9%

(operationally)
U.S.$1,002 $883 13 
Growth driven primarily by continued oral anti-coagulant adoption and market share gains in the non-valvular atrial fibrillation indication in the U.S. and certain markets in Europe, partially offset by declines due to loss of patent-based exclusivity and generic competition in certain international markets.
Int’l.616 615 
Worldwide$1,617 $1,498 
YTD
$5,534

Up 9%

(operationally)
U.S.$3,677 $3,296 12 
Int’l.1,857 1,838 
Worldwide$5,534 $5,135 
PaxlovidQTD
$2,703

Up *

(operationally)
U.S.$2,313 $— *
QTD growth primarily driven by:
• strong demand, particularly in the U.S., driven by higher utilization during a recent global COVID-19 wave;
• the one-time contractual delivery of treatment courses to the U.S. SNS in the third quarter of 2024; and
• no third quarter 2023 U.S. sales in anticipation of transition to commercial markets in November 2023. See Note 13C.

YTD growth primarily driven by:
• strong demand, particularly in the U.S., driven by higher utilization;
• a $771 million favorable final adjustment recorded in the first quarter of 2024 to the estimated non-cash revenue reversal of $3.5 billion recorded in the fourth quarter of 2023; and
• the one-time contractual delivery of treatment courses to the U.S. SNS in the third quarter of 2024,
partially offset by:
• lower contractual deliveries in most international markets as a result of the transition to traditional commercial market sales; and
• lower demand in China, largely due to the non-recurrent surge in COVID-19 infection during the first quarter of 2023.
Int’l.389 202 93 97 
Worldwide$2,703 $202 **
YTD
$4,989

Up 13%

(operationally)
U.S.$4,181 $1,960 *
Int’l.807 2,454 (67)(66)
Worldwide$4,989 $4,414 13 13 
Prevnar familyQTD
$1,803

Down 2%
(operationally)
U.S.$1,308 $1,299 
QTD decline primarily driven by fewer adult vaccinations in the U.S. and lower pediatric indication sales in most international developed markets and certain emerging markets, partially offset by growth in the pediatric indication in the U.S. reflecting recovered market share as a result of the Prevnar 20 launch in 2023, as well as strong uptake of the adult indication in certain international markets.

YTD performance primarily driven by growth in the pediatric indication in the U.S. reflecting recovered market share as a result of the Prevnar 20 launch in 2023, as well as strong uptake of the adult indication in certain international markets, offset by fewer adult vaccinations in the U.S. and lower pediatric indication sales in most international developed markets and certain emerging markets.
Int’l.495 544 (9)(7)
Worldwide$1,803 $1,843 (2)(2)
YTD
$4,853

Flat
(operationally)
U.S.$3,289 $3,252 
Int’l.1,564 1,624 (4)(1)
Worldwide$4,853 $4,877 
Vyndaqel familyQTD
$1,447

Up 63%

(operationally)
U.S.$960 $511 88 
Growth largely driven by continued strong demand, primarily in the U.S. and international developed markets.
Int’l.486 381 28 31 
Worldwide$1,447 $892 62 63 
YTD
$3,907
Up 67%

(operationally)
U.S.$2,572 $1,329 94 
Int’l.1,334 1,031 29 32 
Worldwide$3,907 $2,360 66 67 
IbranceQTD
$1,087

Down 12%
 
(operationally)
U.S.$717 $838 (14)Declines primarily driven by lower demand due to competitive pressure globally and price decreases in certain international developed markets, partially offset by increased clinical trial supply orders in certain international developed markets versus prior year.
Int’l.371 406 (9)(6)
Worldwide$1,087 $1,244 (13)(12)
YTD
$3,272

Down 9%

(operationally)
U.S.$2,136 $2,438 (12)
Int’l.1,135 1,197 (5)(3)
Worldwide$3,272 $3,635 (10)(9)
Comirnaty
QTD
$1,422

Up 9%

(operationally)
U.S.$1,164 $994 17 
QTD growth largely driven by timing of stocking as a result of earlier approval of the new variant vaccine in the U.S. in 2024 compared to 2023, partially offset by lower contractual deliveries and demand in international markets.
YTD decline largely driven by lower contractual deliveries and demand in international markets, reflecting the anticipated seasonality of demand for vaccinations and as certain markets, including the U.S., transition to traditional commercial market sales.
Int’l.258 312 (17)(16)
Worldwide$1,422 $1,306 
YTD
$1,970

Down 66%

(operationally)
U.S.$1,339 $1,339 
Int’l.631 4,519 (86)(86)
Worldwide$1,970 $5,858 (66)(66)
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(MILLIONS)Revenue% Change
ProductPeriodGlobal
Revenues
RegionSept. 29, 2024Oct. 1, 2023TotalOper.Operational Results Commentary
XtandiQTD
$561

Up 28%

(operationally)
U.S.$561 $440 28 
Growth largely driven by strong demand due to uptake of the nmCSPC indication following approval in the fourth quarter of 2023.
Int’l.— — 
Worldwide$561 $440 28 28 
YTD
$1,474

Up 23%

(operationally)
U.S.$1,474 $1,202 23 
Int’l.— — 
Worldwide$1,474 $1,202 23 23 
PadcevQTD
$409
 
*
U.S.$407 $— *
Growth driven by the acquisition of Seagen in the fourth quarter of 2023 as well as strong demand.
Int’l.— **
Worldwide$409 $— **
YTD
$1,144
 
*
U.S.$1,128 $— *
Int’l.16 — **
Worldwide$1,144 $— **
Nurtec ODT/VyduraQTD
$337

Up 45%

(operationally)
U.S.$314 $227 38 
Growth primarily driven by strong demand in the U.S. and, to a much lesser extent, recent launches in international markets.

YTD growth was partially offset by lower net price in the U.S. due to unfavorable changes in channel mix.
Int’l.23 **
Worldwide$337 $233 45 45 
YTD
$870

Up 35%

(operationally)
U.S.$820 $633 30 
Int’l.50 13 **
Worldwide$870 $646 35 35 
XeljanzQTD
$321

Down 35%

(operationally)
U.S.$203 $371 (45)
Declines driven primarily by decreased prescription volumes globally resulting from ongoing shifts in prescribing patterns related to label changes, as well as lower net price in the U.S. and the impact of regulatory exclusivity expiry in Canada.
Int’l.118 132 (11)(7)
Worldwide$321 $503 (36)(35)
YTD
$818

Down 31%

(operationally)
U.S.$459 $794 (42)
Int’l.360 416 (13)(11)
Worldwide$818 $1,210 (32)(31)
AdcetrisQTD
$268
 
*
U.S.$260 $— *
Growth driven by the acquisition of Seagen in the fourth quarter of 2023.
Int’l.— **
Worldwide$268 $— **
YTD
$804
 
*
U.S.$784 $— *
Int’l.20 — **
Worldwide$804 $— **
InlytaQTD
$247

Down 1%

(operationally)
U.S.$150 $153 (2)
Declines primarily driven by lower demand in the U.S. as well as lower volumes and lower net price in international markets, partially offset by higher demand in China.
Int’l.97 98 (2)
Worldwide$247 $252 (2)(1)
YTD
$736

Down 4%

(operationally)
U.S.$442 $476 (7)
Int’l.294 297 (1)
Worldwide$736 $773 (5)(4)
AbrysvoQTD
$356

Down 5%

(operationally)
U.S.$318 $375 (15)
QTD decline primarily due to a slower start to the RSV season in 2024 in the U.S. as well as higher U.S. sales in the third quarter of 2023 due to launch stocking for the older adult indication, partially offset by launch uptake in certain international markets as well as launch of the maternal indication in the U.S. in December 2023.

YTD growth primarily driven by U.S. launches of the older adult indication in July 2023 and the maternal indication in December 2023, as well as launch uptake in certain international markets.
Int’l.38 — **
Worldwide$356 $375 (5)(5)
YTD
$557
 
Up 48%

(operationally)
U.S.$490 $375 31 
Int’l.66 — **
Worldwide$557 $375 48 48 
Pfizer CentreOne
(MILLIONS)Revenue% Change
Operating SegmentPeriodGlobal
Revenues
RegionSept. 29, 2024Oct. 1, 2023TotalOper.Operational Results Commentary
PC1
QTD
$285

Down 2%

(operationally)
U.S.$76 $79 (5)
Declines primarily driven by lower manufacturing of divested and other third-party products under manufacturing and supply agreements, partially offset by growth in manufacturing-related services.
Int’l.210 214 (2)(1)
Worldwide$285 $293 (3)(2)
YTD
$820

Down 9%

(operationally)
U.S.$195 $269 (27)
Int’l.625 639 (2)(1)
Worldwide$820 $908 (10)(9)
See the Item 1. BusinessPatents and Other Intellectual Property Rights section of our 2023 Form 10-K for information regarding the expiration of various patent rights, Note 12 for a discussion of recent developments concerning patent and product
45


litigation relating to certain of the products discussed above and Note 13C for additional information regarding the primary indications or class of the selected products discussed above.
Costs and Expenses
Costs and expenses follow:
Three Months EndedNine Months Ended
(MILLIONS)September 29,
2024
October 1,
2023
%
 Change
September 29,
2024
October 1,
2023
%
 Change
Cost of sales$5,263 $9,269 (43)$11,942 $17,391 (31)
Percentage of Total revenues
29.7 %68.7 %26.0 %38.7 %
Selling, informational and administrative expenses3,244 3,281 (1)10,456 10,196 
Research and development expenses2,598 2,711 (4)7,787 7,864 (1)
Acquired in-process research and development expenses13 67 (80)20 122 (84)
Amortization of intangible assets1,312 1,179 11 3,927 3,466 13 
Restructuring charges and certain acquisition-related costs313 155 *1,669 377 *
Other (income)/deductions—net243 181 34 2,030 381 *
Third Quarter of 2024 vs. Third Quarter of 2023 and First Nine Months of 2024 vs. First Nine Months of 2023
Cost of Sales
Cost of sales decreased $4.0 billion in the third quarter of 2024, primarily due to:
the non-recurrence of a non-cash charge of $5.6 billion recorded in the third quarter of 2023 for inventory write-offs and related charges ($4.7 billion for Paxlovid and $0.9 billion for Comirnaty),
partially offset by:
an unfavorable change in sales mix of $1.5 billion, primarily driven by higher sales of Paxlovid and Comirnaty, including a charge for the 50% gross profit split with BioNTech and applicable royalty expenses; and
an impact of $490 million from our Seagen acquisition, inclusive of the amortization of the fair value step-up of inventory.
Cost of sales decreased $5.4 billion in the first nine months of 2024, primarily due to:
the non-recurrence of the aforementioned non-cash charge of $5.6 billion recorded in the third quarter of 2023; and
a favorable change in sales mix of $845 million, primarily driven by lower sales of Comirnaty,
partially offset by:
an impact of $1.4 billion from our Seagen acquisition, inclusive of the amortization of the fair value step-up of inventory.
The decrease in Cost of sales as a percentage of revenues in the third quarter and the first nine months of 2024 reflects the non-recurrence of the aforementioned non-cash charge of $5.6 billion recorded in the third quarter of 2023.
Certain of our vaccines, including Comirnaty, are subject to seasonality of demand, with a greater portion of revenues and related cost of sales anticipated in the fall and winter seasons. See also Overview of Our Performance, Operating Environment, Strategy and OutlookThe Global Economic Environment––COVID-19 section for information about our COVID-19 products.
Selling, Informational and Administrative Expenses
Selling, informational and administrative expenses were relatively flat in the third quarter of 2024, primarily due to:
a decrease of $210 million due to lower U.S. healthcare reform fees primarily related to Paxlovid and Comirnaty,
largely offset by:
an increase of $165 million in marketing and promotional expenses for recently launched and acquired products.
Selling, informational and administrative expenses increased $260 million in the first nine months of 2024, primarily due to:
an increase of $600 million in marketing and promotional expenses for recently launched and acquired products,
partially offset by:
a decrease of $310 million for marketing and promotional expenses for Paxlovid.
46


Research and Development Expenses
Research and development expenses decreased $113 million in the third quarter and $77 million in the first nine months of 2024, primarily due to:
lower spending of $430 million in the third quarter and $930 million in the first nine months related to certain ongoing vaccine programs and as a result of our cost realignment program,
partially offset by:
a net increase in spending of $310 million in the third quarter and $850 million in the first nine months mainly to develop certain product candidates acquired from Seagen.
Amortization of Intangible Assets
Amortization of intangible assets increased $133 million in the third quarter of 2024 and $461 million in the first nine months of 2024, primarily driven by:
increases of $140 million in the third quarter and $400 million in the first nine months from our December 2023 acquisition of Seagen; and
increases of $120 million in the third quarter and $360 million in the first nine months related to assets reclassified in 2023 from IPR&D to developed technology rights,
partially offset by:
decreases of $130 million in the third quarter and $350 million in the first nine months related to changes in asset lives and fully amortized assets.
Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives
Realigning our Cost Base Program––This program is expected to deliver net cost savings of at least $4 billion, to be achieved primarily from 2023 through 2024.
Manufacturing Optimization Program––The first phase of this multi-phased program is expected to deliver savings of approximately $1.5 billion by the end of 2027, some of which is expected to begin being realized in 2025.
Certain qualifying costs for these programs in all periods since inception were recorded and reflected as Certain Significant Items and excluded from our non-GAAP measure of Adjusted Income/(Loss). See the Non-GAAP Financial Measure: Adjusted Income/(Loss) section within MD&A.
For a description of our programs, as well as the anticipated and actual costs, see Note 3A. The program savings discussed above may be rounded and represent approximations. In addition to these programs, we continuously monitor our operations for cost reduction and/or productivity opportunities, especially in light of patent-based and regulatory exclusivity expiries as well as the expiration of collaborative arrangements for various products. Improvement of operating margin will continue to be an important focus for the Company.
Seagen acquisition––In connection with our acquisition of Seagen, we are focusing our efforts on achieving an appropriate cost structure for the combined company. We expect to generate approximately $1 billion of annual cost synergies, to be achieved by 2026. The one-time costs to generate these synergies are expected to be approximately $1.5 billion, incurred primarily from 2023 through 2025.
Other (Income)/Deductions—Net
The unfavorable period-over-period changes of $62 million in the third quarter of 2024 and $1.6 billion for the first nine months of 2024 were primarily driven by higher net interest expense and a charge in the third quarter of 2024 related to the expected sale of one of our facilities resulting from the discontinuation of our DMD program, partially offset by net gains on equity securities in 2024 versus net losses on equity securities in 2023. See Note 4.
Provision/(Benefit) for Taxes on Income/(Loss)
 Three Months EndedNine Months Ended
(MILLIONS)September 29,
2024
October 1,
2023
%
Change
September 29,
2024
October 1,
2023
%
Change
Provision/(benefit) for taxes on income/(loss)
$234 $(964)*$393 $(320)*
Effective tax rate on continuing operations5.0 %28.8 %4.9 %(6.2)% 
For information about our effective tax rate and the events and circumstances contributing to the changes between periods, as well as details about discrete elements that impacted our tax provisions, see Note 5.
47


Cash paid for income taxes, net of refunds, consisted of:
Year Ended December 31,
(MILLIONS)202320222021
United States
$1,923 $3,867 $4,455 
International
1,224 4,000 2,972 
Total
$3,147 $7,867 $7,427 
Changes in Tax Laws––Many countries outside the U.S. have enacted legislation for global minimum taxation resulting from the Organization for Economic Co-operation and Development’s (OECD) Base Erosion and Profit Shifting “Pillar 2” project. The EU has approved a directive requiring member states to incorporate the OECD provisions into their respective domestic laws, and countries outside the EU are also enacting the provisions into their domestic law. The provisions are generally effective for Pfizer in 2024, though significant details and guidance around the provisions are still pending. Income tax expense could be adversely affected as the legislation becomes effective in countries in which we do business, and such impact could be material to our results of operations. We continue to monitor pending OECD guidance and legislation enactment and implementation by individual countries.
PRODUCT DEVELOPMENTS
A comprehensive update of Pfizer’s development pipeline was published as of October 29, 2024 and is available at www.pfizer.com/science/drug-product-pipeline. It includes an overview of our research and a list of compounds in development with targeted indication and phase of development, as well as mechanism of action for some candidates in Phase 1 and all candidates from Phase 2 through registration.
This section provides information as of the date of this filing about significant marketing application-related regulatory actions by, and filings pending with, the FDA and regulatory authorities in the EU and Japan.
The table below includes filing and approval milestones for products that have occurred in the last twelve months and generally does not include approvals that may have occurred prior to that time. The table includes filings with regulatory decisions pending (even if the filing occurred outside of the last twelve-month period).
48


Products
PRODUCTINDICATION OR PROPOSED INDICATION
APPROVED/FILED^
U.S.EUJAPAN
Prevnar 20/Prevenar 20
(Vaccine)
Active immunization to prevent invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older.
Approved
June
2021
Approved
February
2022
Approved
August
2024
Active immunization to prevent invasive pneumococcal disease caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes contained in the vaccine in infants and children six weeks through 17 years of age, and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in Prevnar(a).
Approved
April
2023
Approved
March
2024
Approved
March
2024
TicoVac
(Vaccine)
Active immunization to prevent tick-borne encephalitis in individuals 1 year of age and older
Approved
August
2021
Approved
March
2024
Nurtec ODT/Vydura
(rimegepant)
Acute treatment of migraine with or without aura in adults
Approved
February
2020
Approved
April
2022
Prevention of episodic migraine in adults
Approved
May
2021
Approved
April
2022
Penbraya
(Vaccine)
Active immunization to prevent serogroups ABCWY meningococcal infections in adolescents and young adults 10 through 25 years of age
Approved
October
2023
Filed
June
2023
Abrysvo
(Vaccine)
Active immunization of pregnant individuals for the prevention of lower respiratory tract disease caused by RSV in infants from birth through 6 months of age
Approved
August
2023
Approved
August
2023
Approved
January
2024
Active immunization for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years and older
Approved
May
2023
Approved
August
2023
Approved
March
2024
Active immunization for the prevention of lower respiratory tract disease caused by RSV in individuals 18-59 years of age
Approved
October
2024
Filed
June
2024

Velsipity (etrasimod)
Moderately to severely active ulcerative colitis in adults
Approved
October
2023
Approved
February
2024
Filed
June
2024
Braftovi (encorafenib) and Mektovi (binimetinib)(b)
BRAFV600E-mutant metastatic non-small cell lung cancer in adult patients
Approved
October
2023
Approved
August
2024
Elrexfio (elranatamab)
Triple-class relapsed/refractory multiple myeloma in adult patients
Approved
August
2023
Approved
December
2023
Approved
March
2024
Talzenna (talazoparib)
Combination with Xtandi (enzalutamide) for adult patients with HRR gene-mutated mCRPC(c)
Approved
June
2023
Approved
January
2024
Approved
January
2024
Treatment of adult patients with germline breast cancer susceptibility gene (gBRCA)1/2-mutations, who have human epidermal growth factor receptor 2-negative (HER2-) locally advanced (LA) or metastatic breast cancer (MBC)
Approved
October
2018
Approved
June
2019
Approved
January
2024
Beqvez (fidanacogene elaparvovec)(d)
Moderate to severe hemophilia B in adults
Approved
April
2024
Approved
July
2024
Filed
June
2024
Xtandi (enzalutamide)(e)
nmCSPC with biochemical recurrence at high risk for metastasis (high-risk BCR)
Approved
November
2023
Approved
April
2024
Hympavzi
(marstacimab-hncq)
Hemophilia A and B
Approved
October
2024
Filed
October
2023
Filed
February
2024
Emblaveo
(aztreonam-avibactam)(f)
Treatment of infections in adult patients caused by Gram-negative bacteria with limited or no treatment options
Approved
April
2024
Padcev
(enfortumab vedotin-ejfv)(g)
In combination with Keytruda®(h) (pembrolizumab) for locally advanced or metastatic urothelial cancer in adults
Approved
December
2023
Approved
August
2024
Approved
September
2024
Tivdak
(tisotumab vedotin-tftv)(i)
Recurrent or metastatic cervical cancer with disease progression on or after first-line therapy
Approved
April
2024
Filed
February
2024
Filed April 2024
Comirnaty (COVID-19 Vaccine, mRNA) 2024-2025 Formula, Omicron KP.2-adapted(j)
Active immunization to prevent COVID-19 caused by SARS-CoV-2 for individuals 12 years of age and older
Approved August 2024
Approved September 2024

Comirnaty (COVID-19 Vaccine, mRNA) 2024-2025 Formula, Omicron JN.1-adapted
Active immunization to prevent COVID-19 caused by SARS-CoV-2 for individuals 6 months of age and older
Approved
July
2024
Approved
August
2024
Ngenla (somatrogon)(k)
Adult growth hormone deficiency
Filed
June
2024
Adcetris
(brentuximab vedotin)(l)
Relapsed/refractory diffuse large B-cell lymphoma
Filed
July
2024
49


^     For the U.S., the filing date is the date on which the FDA accepted our submission. For the EU, the filing date is the date on which the EMA validated our submission.
(a)Listed indication applies to U.S. only. For the EU, approved indications are pneumococcal invasive disease pneumonia and otitis media. For Japan, approved indication is invasive pneumococcal disease.
(b)Pierre Fabre is the Marketing Authorization Holder for Braftovi (encorafenib) and Mektovi (binimetinib) in the EU. We have exclusive rights to Braftovi and Mektovi in the U.S., Canada and certain emerging markets, and Ono Pharmaceutical Co., Ltd., Medison Pharma and Pierre Fabre Laboratories have exclusive rights in all other markets.
(c)Listed indication applies to U.S. only. EU indication (all comers): mCRPC in whom chemotherapy is not clinically indicated; Japan indication: BRCA gene-mutated mCRPC.
(d)Being developed in collaboration with Spark Therapeutics, Inc. In July 2024, Beqvez (previously Durveqtix) received Conditional Marketing Authorization in the EU.
(e)Being jointly developed and commercialized with Astellas Pharma Inc.
(f)Being developed in collaboration with AbbVie. AbbVie has the exclusive commercialization rights to this investigative therapy in the U.S. and Canada; Pfizer leads the joint development program and has commercialization rights in all other countries.
(g)Being jointly developed and commercialized with Astellas Pharma Inc.
(h)Keytruda® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
(i)Being developed in collaboration with Genmab A/S. The April 2024 approval date in the U.S. refers to the conversion of a prior accelerated approval to full approval.
(j)In September 2024, the European Commission (EC) approved the Pfizer/BioNTech Omicron KP.2-adapted monovalent COVID-19 vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. U.S. approval (August 2024) is for individuals 12 years of age and older, with EUA granted for individuals 6 months through 11 years of age.
(k)Being developed in collaboration with OPKO Health, Inc.
(l)Being developed in collaboration with Takeda. Takeda has ex-U.S./Canada rights.
The following provides information about additional indications and new drug candidates in late-stage development:
PRODUCT/CANDIDATEPROPOSED DISEASE AREA
LATE-STAGE CLINICAL PROGRAMS FOR ADDITIONAL USES AND DOSAGE FORMS
FOR IN-LINE AND IN-REGISTRATION PRODUCTS
Ibrance (palbociclib)(a)
ER+/HER2+ metastatic breast cancer
Talzenna (talazoparib)Combination with Xtandi (enzalutamide) for DNA Damage Repair-deficient mCSPC
Braftovi (encorafenib) and Erbitux® (cetuximab)(b)
First-line BRAFV600E-mutant mCRC
Paxlovid (nirmatrelvir; ritonavir)COVID-19 in high-risk children (6-11 years of age; >88lbs)
Litfulo (ritlecitinib)Vitiligo
Elrexfio (elranatamab)Multiple myeloma double-class exposed
Newly diagnosed multiple myeloma post-transplant maintenance
Newly diagnosed multiple myeloma transplant-ineligible
2nd line + relapsed refractory multiple myeloma
Eliquis (apixaban)(c)
Venous thromboembolism (pediatric)
Padcev (enfortumab vedotin)(d)
Cisplatin-ineligible/decline muscle-invasive bladder cancer
Cisplatin-eligible muscle-invasive bladder cancer
Tukysa (tucatinib)HER2+ adjuvant breast cancer
2nd line/3rd line HER2+ metastatic breast cancer
1st line HER2+ maintenance metastatic breast cancer
1st line HER2+ metastatic colorectal cancer 
NEW DRUG CANDIDATES IN LATE-STAGE DEVELOPMENT
giroctocogene fitelparvovec
(PF-07055480)(e)
Hemophilia A
PF-06425090 (vaccine)
Immunization to prevent primary clostridioides difficile infection
sasanlimab (PF-06801591)Combination with Bacillus Calmette-Guerin for non-muscle-invasive bladder cancer
VLA15 (PF-07307405) vaccine(f)
Immunization to prevent Lyme disease
vepdegestrant (PF-07850327)(g)
Breast cancer metastatic - 2nd line ER+/HER2-
inclacumab (PF-07940370)Sickle cell disease
Ibrance + vepdegestrant(g)
ER+/HER2- metastatic breast cancer
dazukibart (PF-06823859)
Dermatomyositis, polymyositis
disitamab vedotin(h)
1st line HER2 (≥IHC1+) metastatic urothelial cancer
sisunatovir (PF-07923568)Respiratory syncytial virus infection (adults)
PF-07926307 (COVID-19/flu combo vaccine)(i)
Immunization to prevent COVID-19 infection and influenza
sigvotatug vedotin (PF-08046047)
2nd line non-small cell lung cancer
osivelotor (PF-07940367)
Sickle cell disease
atirmociclib (PF-07220060)
2nd line metastatic breast cancer
(a)Being developed in collaboration with The Alliance Foundation Trials, LLC.
(b)Erbitux is a registered trademark of ImClone LLC. In the EU, we are developing in collaboration with the Pierre Fabre Group. In Japan, we are developing in collaboration with Ono Pharmaceutical Co., Ltd. We have exclusive rights to Braftovi and Mektovi in the U.S., Canada and certain emerging markets, and Ono Pharmaceutical Co., Ltd., Medison Pharma and Pierre Fabre Laboratories have exclusive rights in all other markets.
(c)Being developed in collaboration with BMS.
(d)Being jointly developed and commercialized with Astellas Pharma Inc.
50


(e)Being developed in collaboration with Sangamo Therapeutics, Inc.
(f)Being developed in collaboration with Valneva SE.
(g)Vepdegestrant is being developed in collaboration with Arvinas, Inc.
(h)Being developed in collaboration with RemeGen Co., Ltd.
(i)Being developed in collaboration with BioNTech.
The late stage development flu program has been removed from the table above as it represented the first-generation quadrivalent candidate. Pfizer is developing second-generation candidates with the goal of improving immunogenicity and potentially breadth of protection, including new trivalent formulations that match updated recommendations by the World Health Organization and the FDA’s Vaccines and Related Biological Products Advisory Committee. These candidates are currently in Phase 2. Pfizer will continue to evaluate its influenza vaccine program and discuss next steps with health authorities.
In August 2024, Pfizer announced Phase 3 top-line results for Pfizer and BioNTech’s combination mRNA vaccine candidate against influenza and COVID-19 in healthy individuals 18-64 years of age. The trial did not meet one of its primary immunogenicity objectives of non-inferiority against the influenza B strain despite obtaining higher influenza A responses and comparable COVID-19 responses versus the comparator vaccines. The companies are evaluating adjustments to the candidate and are discussing next steps with health authorities.
In September 2024, Pfizer announced that it is voluntarily withdrawing all lots of Oxbryta (voxelotor) for the treatment of sickle cell disease in all markets where it is approved. Pfizer is also discontinuing all active voxelotor clinical trials and expanded access programs worldwide. Pfizer’s decision is based on the totality of clinical data that now indicates the overall benefit of Oxbryta no longer outweighs the risk in the approved sickle cell patient population. The data suggest an imbalance in vaso-occlusive crises and fatal events, which requires further assessment. Pfizer has notified regulatory authorities about these findings and its decision to voluntarily withdraw Oxbryta from the market and discontinue distribution and clinical studies while further reviewing the available data and investigating the findings.
In July 2024, the EMA initiated a referral procedure under Article 20 of Regulation (EC) No 726/2004 for Oxbryta (voxelotor) to review the product’s benefits and risks. In October, the EC suspended the Oxbryta marketing authorization while the EMA’s review of data is ongoing. In addition, the FDA has initiated an evaluation of newly identified safety signals. The FDA also has placed the Oxbryta (voxelotor) investigational new drug application on clinical hold following Pfizer’s market withdrawal. Pfizer is working with the EMA, FDA, and other regulators globally in relation to this matter.
For additional information about our R&D organization, see Note 13 and the Item 1. BusinessResearch and Development section of our 2023 Form 10-K. For additional information regarding certain collaboration arrangements see the Item 1. BusinessCollaboration and Co-Promotion Agreements section of our 2023 Form 10-K.
NON-GAAP FINANCIAL MEASURE: ADJUSTED INCOME/(LOSS)
Adjusted income/(loss) is an alternative measure of performance used by management to evaluate our overall performance as a supplement to our GAAP Reported performance measures. As such, we believe that investors’ understanding of our performance is enhanced by disclosing this measure. We use Adjusted income/(loss), certain components of Adjusted income/(loss) and Adjusted diluted EPS/(LPS) to present the results of our major operations––the discovery, development, manufacture, marketing, sale and distribution of biopharmaceutical products worldwide––prior to considering certain income statement elements as follows:
MeasureDefinitionRelevance of Metrics to Our Business Performance
Adjusted income/(loss)
Net income/(loss) attributable to Pfizer Inc. common shareholders(a) before the impact of amortization of intangible assets, certain acquisition-related items, discontinued operations and certain significant items
Provides investors useful information to:
evaluate the normal recurring operational activities, and their components, on a comparable year-over-year basis
assist in modeling expected future performance on a normalized basis
Provides investors insight into the way we manage our budgeting and forecasting, how we evaluate and manage our recurring operations and how we reward and compensate our senior management(b)
Adjusted cost of sales, Adjusted selling, informational and administrative expenses, Adjusted research and development expenses and Adjusted other (income)/deductions––net
Cost of sales, Selling, informational and administrative expenses, Research and development expenses and Other (income)/deductions––net(a), each before the impact of amortization of intangible assets, certain acquisition-related items, discontinued operations and certain significant items, which are components of the Adjusted income/(loss) measure
Adjusted diluted EPS/(LPS)
EPS/(LPS) attributable to Pfizer Inc. common shareholders––diluted(a) before the impact of amortization of intangible assets, certain acquisition-related items, discontinued operations and certain significant items
(a)Most directly comparable GAAP measure.
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(b)The short-term incentive plans for substantially all non-sales-force employees worldwide are funded from a pool based on our performance, measured in significant part versus three budgeted metrics, one of which is Adjusted diluted EPS (as defined for annual incentive compensation purposes), which is derived from Adjusted income/(loss) and accounts for 40% of the bonus pool funding tied to financial performance. Additionally, the payout for performance share awards is determined in part by Adjusted net income/(loss), which is derived from Adjusted income/(loss). Since 2022, we no longer exclude any expenses for acquired IPR&D from our non-GAAP Adjusted results but we continue to exclude certain of these expenses for our financial results for annual incentive compensation purposes. The bonus pool funding, which is largely based on financial performance, is adjusted by our R&D pipeline performance, as measured by three metrics, and performance against certain of our ESG metrics, and may be further modified by our Compensation Committee’s assessment of other factors.
Adjusted income/(loss) and its components and Adjusted diluted EPS/(LPS) are non-GAAP financial measures that have no standardized meaning prescribed by GAAP and, therefore, are limited in their usefulness to investors. Because of their non-standardized definitions, they may not be comparable to the calculation of similar measures of other companies and are presented to permit investors to more fully understand how management assesses performance. A limitation of these measures is that they provide a view of our operations without including all events during a period, and do not provide a comparable view of our performance to peers. These measures are not, and should not be viewed as, substitutes for their most directly comparable GAAP measures of Net income/(loss) attributable to Pfizer Inc. common shareholders, components of Net income/(loss) attributable to Pfizer Inc. common shareholders and EPS/(LPS) attributable to Pfizer Inc. common shareholders—diluted, respectively.
We also recognize that, as internal measures of performance, these measures have limitations, and we do not restrict our performance-management process solely to these measures. We also use other tools designed to achieve the highest levels of performance. For example, our R&D organization has productivity targets, upon which its effectiveness is measured. In addition, total shareholder return, both on an absolute basis and relative to a publicly traded pharmaceutical index, plays a significant role in determining payouts under certain of our incentive compensation plans.
Adjusted Income/(Loss) and Adjusted Diluted EPS/(LPS)
Amortization of Intangible Assets—Adjusted income/(loss) excludes all amortization of intangible assets.
Acquisition-Related Items—Adjusted income/(loss) excludes certain acquisition-related items, which are composed of transaction, integration, restructuring charges and additional depreciation costs for business combinations because these costs are unique to each transaction and represent costs that were incurred to restructure and integrate businesses as a result of an acquisition. We have made no adjustments for resulting synergies. Acquisition-related items may include purchase accounting impacts such as the incremental charge to cost of sales from the sale of acquired inventory that was written up to fair value, depreciation related to the increase/decrease in fair value of acquired fixed assets, amortization related to the increase in fair value of acquired debt, and the fair value changes for contingent consideration.
Discontinued Operations—Adjusted income/(loss) excludes the results of discontinued operations, as well as any related gains or losses on the disposal of such operations. We believe that this presentation is meaningful to investors because, while we review our product portfolio for strategic fit with our operations, we do not build or run our business with the intent to discontinue parts of our business. Restatements due to discontinued operations do not impact compensation or change the Adjusted income/(loss) measure for the compensation in respect of the restated periods, but are presented for consistency across all periods.
Certain Significant Items—Adjusted income/(loss) excludes certain significant items representing substantive and/or unusual items that are evaluated individually on a quantitative and qualitative basis. Certain significant items may be highly variable and difficult to predict. Furthermore, in some cases it is reasonably possible that they could reoccur in future periods. For example, although major non-acquisition-related cost-reduction programs are specific to an event or goal with a defined term, we may have subsequent programs based on reorganizations of the business, cost productivity or in response to generic or biosimilar entry or economic conditions. Legal charges to resolve litigation are also related to specific cases, which are facts and circumstances specific and, in some cases, may also be the result of litigation matters at acquired companies that were inestimable, not probable or unresolved at the date of acquisition, or legal matters related to divested products or businesses. Gains and losses on equity securities and pension and postretirement actuarial remeasurement gains and losses have a very high degree of inherent market volatility, which we do not control and cannot predict with any level of certainty, and we do not believe including these gains and losses assists investors in understanding our business or is reflective of our core operations and business. Unusual items represent items that are not part of our ongoing business; items that, either as a result of their nature or size, we would not expect to occur as part of our normal business on a regular basis; items that would be non-recurring; or items that relate to products we no longer sell. See the Reconciliations of GAAP Reported to Non-GAAP Adjusted information—Certain Line Items below for a non-inclusive list of certain significant items and the Non-GAAP Financial Measure: Adjusted Income section within MD&A of our 2023 Form 10-K.
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Reconciliations of GAAP Reported to Non-GAAP Adjusted Information––Certain Line Items
Three Months Ended September 29, 2024
Data presented will not (in all cases) aggregate to totals.
(MILLIONS, EXCEPT PER SHARE DATA)
Cost of sales(a)
Selling, informational and administrative expenses(a)
Other (income)/deductions––net(a)
Net income/(loss) attributable to Pfizer Inc. common shareholders(a), (b)
Earnings/(loss) per common share attributable to Pfizer Inc. common shareholders––diluted
GAAP Reported$5,263 $3,244 $243 $4,465 $0.78 
Amortization of intangible assets— — — 1,312 
Acquisition-related items(355)(9)(11)465 
Discontinued operations
— — — 
Certain significant items:
Restructuring charges/(credits) and implementation costs and additional depreciation—asset restructuring(c)
(36)(13)— 304 
(Gains)/losses on equity securities
— — 446 (446)
Actuarial valuation and other pension and postretirement plan (gains)/losses— — (4)
Other(d)
(4)(430)437 
Income tax provision—non-GAAP items(498)
Non-GAAP Adjusted$4,874 $3,219 $243 $6,050 $1.06 
Nine Months Ended September 29, 2024
Data presented will not (in all cases) aggregate to totals.
(MILLIONS, EXCEPT PER SHARE DATA)
Cost of sales(a)
Selling, informational and administrative expenses(a)
Other (income)/deductions––net(a)
Net income/(loss) attributable to Pfizer Inc. common shareholders(a), (b)
Earnings/(loss) per common share attributable to Pfizer Inc. common shareholders––diluted
GAAP Reported$11,942 $10,456 $2,030 $7,621 $1.34 
Amortization of intangible assets— — — 3,927 
Acquisition-related items(1,117)(25)(32)1,590 
Discontinued operations
— — — (14)
Certain significant items:
Restructuring charges/(credits) and implementation costs and additional depreciation—asset restructuring(c)
(106)(77)— 1,502 
Certain asset impairments(e)
— — (349)349 
(Gains)/losses on equity securities
— — 129 (129)
Actuarial valuation and other pension and postretirement plan (gains)/losses— — (9)
Other(d)
(41)(11)(971)1,036 
Income tax provision—non-GAAP items
(1,769)
Non-GAAP Adjusted$10,678 $10,342 $797 $14,124 $2.48 
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Three Months Ended October 1, 2023
Data presented will not (in all cases) aggregate to totals.
(MILLIONS, EXCEPT PER SHARE DATA)
Cost of sales(a)
Selling, informational and administrative expenses(a)
Other (income)/deductions––net(a)
Net income/(loss) attributable to Pfizer Inc. common shareholders(a), (b)
Earnings/(loss) per common share attributable to Pfizer Inc. common shareholders––diluted(f)
GAAP Reported$9,269 $3,281 $181 $(2,382)$(0.42)
Amortization of intangible assets— — — 1,179 
Acquisition-related items(127)(2)(8)227 
Discontinued operations
— — — (13)
Certain significant items:
Restructuring charges/(credits) and implementation costs and additional depreciation—asset restructuring(c)
(20)(71)— 185 
(Gains)/losses on equity securities
— — (393)393 
Actuarial valuation and other pension and postretirement plan (gains)/losses— — (6)
Other(d)
(216)(4)85 137 
Income tax provision—non-GAAP items(687)
Non-GAAP Adjusted$8,906 $3,205 $(128)$(968)$(0.17)
Nine Months Ended October 1, 2023
Data presented will not (in all cases) aggregate to totals.
(MILLIONS, EXCEPT PER SHARE DATA)
Cost of sales(a)
Selling, informational and administrative expenses(a)
Other (income)/deductions––net(a)
Net income/(loss) attributable to Pfizer Inc. common shareholders(a), (b)
Earnings/(loss) per common share attributable to Pfizer Inc. common shareholders––diluted
GAAP Reported$17,391 $10,196 $381 $5,488 $0.96 
Amortization of intangible assets— — — 3,466 
Acquisition-related items(360)(7)(158)778 
Discontinued operations
— — — (11)
Certain significant items:
Restructuring charges/(credits) and implementation costs and additional depreciation—asset restructuring(c)
(70)(196)— 450 
Certain asset impairments(e)
— — (264)264 
(Gains)/losses on equity securities
— — (711)711 
Actuarial valuation and other pension and postretirement plan (gains)/losses— — — — 
Other(d)
(238)(18)21 242 
Income tax provision—non-GAAP items
(1,478)
Non-GAAP Adjusted$16,723 $9,974 $(730)$9,908 $1.73 
(a)Items that reconcile GAAP Reported to non-GAAP Adjusted balances are shown pre-tax. Our effective tax rates for GAAP Reported income/(loss) from continuing operations were: 5.0% and 4.9% in the three and nine months ended September 29, 2024, respectively, and 28.8% and (6.2)% in the three and nine months ended October 1, 2023, respectively. See Note 5. Our effective tax rates for non-GAAP Adjusted income/(loss) were 10.8% and 13.3% in the three and nine months ended September 29, 2024, respectively, and 22.3% and 10.4% in the three and nine months ended October 1, 2023, respectively.
(b)The amounts for the three and nine months ended September 29, 2024 and October 1, 2023 include reconciling amounts for Research and development expenses that are not material to our non-GAAP consolidated results of operations.
(c)Includes employee termination costs, asset impairments and other exit costs related to our cost-reduction and productivity initiatives not associated with acquisitions. See Note 3.
(d)For the third quarter and first nine months of 2024, the total Other (income)/deductions––net adjustments of $430 million and $971 million, respectively, include charges of (i) $420 million related to the expected sale of one of our facilities resulting from the discontinuation of our DMD program and (ii) $45 million for the third quarter and $422 million for the first nine months for certain legal matters, primarily representing certain product liability expenses related to products discontinued and/or divested by Pfizer. For the first nine months of 2024, the total Other (income)/deductions––net adjustment of $971 million also includes charges of $312 million mostly related to (a) our equity-method accounting pro-rata share of intangible asset amortization, impairments and restructuring costs recorded by Haleon, as well as (b) adjustments to our equity-method basis differences and (c) Pfizer's share of investee capital transactions recognized by Haleon (see Note 2B), partially offset by a $150 million gain on the partial sale of our investment in Haleon. For the third quarter and first nine months of 2023, the total Cost of sales adjustments of $216 million and $238 million, respectively, primarily included $209 million in inventory losses, overhead costs related to the period in which the facility could not operate, and incremental costs resulting from tornado damage to our manufacturing facility in Rocky Mount, NC. For the third quarter of 2023, the total Other (income)/deductions––net adjustment of $85 million primarily included a $222 million gain on the divestiture of our early-stage rare disease gene therapy portfolio to Alexion, partially offset by charges of $71 million for certain legal matters, representing legal obligations related to pre-acquisition matters and certain product liability expenses related to products discontinued and/or divested by Pfizer. For the first nine months of 2023, the total Other (income)/deductions––net adjustment of $21 million primarily included (i) the $222 million gain on the divestiture of our early-stage rare disease gene therapy portfolio to Alexion, and (ii) dividend income of $211 million related to our investment in Nimbus resulting from Takeda’s acquisition of Nimbus’s oral, selective allosteric tyrosine kinase 2 (TYK2) inhibitor program subsidiary, partially offset by charges of (i) $246 million for certain legal matters, primarily representing certain product liability and other legal expenses related to
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products discontinued and/or divested by Pfizer and legal obligations related to pre-acquisition matters, and (ii) $92 million mostly related to our equity-method accounting pro-rata share of intangible asset amortization and impairments, costs of separating from GSK and restructuring costs recorded by Haleon.
(e)See Note 4.
(f)For the third quarter of 2023, basic weighted-average shares outstanding of 5,646 million (excluding common share equivalents) were used to calculate GAAP Reported and non-GAAP Adjusted Loss per common share attributable to Pfizer Inc. common shareholders––diluted.

ANALYSIS OF THE CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
 Nine Months Ended
(MILLIONS)September 29,
2024
October 1,
2023
Drivers of change
Cash provided by/(used in):
Operating activities$6,023 $3,460 
The change was primarily driven by the timing of receipts and payments in the ordinary course of business (which includes a decrease in deferred revenue driven by utilization of the U.S. government volume-based credit for Paxlovid), partially offset by a decrease from net income adjusted for non-cash items.
Investing activities$4,275 $(21,282)
The change was driven mainly by $19.5 billion greater net redemptions of short-term investments in 2024, $3.5 billion of proceeds from the partial sale of the Haleon investment in 2024, as well as $1.4 billion greater proceeds from the sale of long-term investments including $1.2 billion in proceeds from our investment in Cerevel.
Financing activities$(12,026)$20,624 
The change was driven mainly by $30.8 billion of proceeds from the issuance of long-term debt in 2023 as well as $2.1 billion greater repayments of commercial paper in 2024.
ANALYSIS OF FINANCIAL CONDITION, LIQUIDITY, CAPITAL RESOURCES AND MARKET RISK
Our historically robust operating cash flows, which we expect to continue over time, is a key strength of our liquidity and capital resources and our primary funding source. We expect operating cash flows to be below typical levels this year largely due to the timing of certain payments and one-time expenses. Additionally, with an anticipated heavy weighting of revenue to the fourth quarter of 2024 due to the expected seasonality of certain products in our portfolio, a potentially higher level of cash collections may carry over into the first quarter of 2025. We continue to believe that with our ongoing operating cash flows, together with our financial assets, access to capital markets, revolving credit agreements, and available lines of credit, we have and will maintain the ability to meet our liquidity needs to support ongoing operations, our capital allocation objectives, and our contractual and other obligations for the foreseeable future. For information about the sources and uses of our funds and capital resources, as well as our operating cash flows, see our Condensed Consolidated Statements of Cash Flows, Condensed Consolidated Balance Sheets, Condensed Consolidated Statements of Equity, and the Analysis of the Condensed Consolidated Statements of Cash Flows section within MD&A. For information on our money market funds, available-for sale-debt securities and long-term debt, see Note 7.
For information about our diverse sources of funds, off-balance sheet arrangements, contractual and other obligations, global economic conditions and market risk, see the Analysis of Financial Condition, Liquidity, Capital Resources and Market Risk section within MD&A of our 2023 Form 10-K. For more information on guarantees and indemnifications, see Note 12B.
Credit Ratings––The cost and availability of financing are influenced by credit ratings, and an increase or decrease in our credit rating could have a beneficial or adverse effect on financing. Our long-term debt is rated high-quality by both S&P and Moody’s.
As of the date of the filing of this Form 10-Q, the following ratings have been assigned to our commercial paper and senior unsecured long-term debt:
NAME OF RATING AGENCYPfizer Short-Term RatingPfizer Long-Term RatingOutlook/Watch
Moody’sP-1
A2
Stable Outlook
S&PA-1
A
Stable Outlook
These ratings are not recommendations to buy, sell or hold securities and the ratings are subject to revision or withdrawal at any time by the rating organizations. Each rating should be evaluated independently of any other rating.
Debt Capacity––Lines of Credit––As of the date of the filing of this Form 10-Q, we had access to a total of $15 billion in committed U.S. revolving credit facilities, consisting of an $8.0 billion facility maturing in October 2025 and a $7.0 billion facility maturing in October 2029, which may be used for general corporate purposes including to support our global commercial paper borrowings. In addition to the U.S. revolving credit facilities, our lenders have provided us an additional
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$281 million in lines of credit, of which $246 million expire within one year. Essentially all lines of credit were unused as of the date of the filing of this Form 10-Q.
Capital Allocation Framework––Our capital allocation framework is primarily devised to enhance shareholder value and is based on three core pillars: maintaining and growing our dividend over time, reinvesting in the business and making share repurchases after de-levering our balance sheet. In October 2024, our BOD declared a dividend of $0.42 per share, payable on December 2, 2024, to shareholders of record at the close of business on November 8, 2024. As of September 29, 2024, our remaining share-purchase authorization was $3.3 billion, with no repurchases in the first nine months of 2024. See Note 12 in our 2023 Form 10-K for more information on our publicly announced share-purchase plans.
In March 2024, we sold a portion of our investment in Haleon for $3.5 billion reducing our ownership interest from 32% to approximately 23% (see Note 2B). In the fourth quarter of 2024, we sold an additional portion of our investment in Haleon for $3.5 billion further reducing our ownership interest to approximately 15%. Pfizer intends to use the proceeds to support its capital allocation priorities. With the reduction of our Haleon ownership percentage, we will no longer apply the equity method to our investment in Haleon. We expect to begin accounting for our remaining investment in Haleon as an equity security with a readily determinable fair value, which is carried at fair value, with changes in fair value reported in Other (income)/deductions––net. We intend to continue to monetize our remaining 15% stake in Haleon in a disciplined fashion, with an objective of maximizing value for Pfizer shareholders.
NEW ACCOUNTING STANDARDS
Recently Adopted Accounting Standard
See Note 1B.
Recently Issued Accounting Standards, Not Adopted as of September 29, 2024
Standard/DescriptionEffective DateEffect on the
Financial Statements
In November 2023, the FASB issued final guidance to improve transparency of segment disclosures. The final guidance requires the disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, other segment items by reportable segment and a description of its composition, and requires all current annual disclosures be provided in interim periods.
2024 for annual reports and 2025 for interim reports. Early adoption is permitted.
This new guidance will result in increased disclosures in the notes to our financial statements.
In December 2023, the FASB issued final guidance to improve income tax disclosures. The final guidance requires enhanced disclosures primarily related to existing rate reconciliation and income taxes paid information.
2025 for annual reports. Early adoption is permitted.
This new guidance will result in increased disclosures in the notes to our financial statements.
FORWARD-LOOKING INFORMATION AND FACTORS THAT MAY AFFECT FUTURE RESULTS
This Form 10-Q contains forward-looking statements. We also provide forward-looking statements in other materials we release to the public, as well as public oral statements. Given their forward-looking nature, these statements involve substantial risks, uncertainties and potentially inaccurate assumptions.
We have tried, wherever possible, to identify such statements by using words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek,” “potential,” “hope” and other words and terms of similar meaning or by using future dates.
We include forward-looking information in our discussion of the following, among other topics:
our anticipated operating and financial performance, including financial guidance and projections;
reorganizations, business plans, strategy, goals and prospects;
expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, launches, clinical trial results and other developing data; revenue contribution and projections; potential pricing and reimbursement; potential market dynamics, including demand, market size and utilization rates; and growth, performance, timing of exclusivity and potential benefits;
strategic reviews, capital allocation objectives, dividends and share repurchases;
plans for and prospects of our acquisitions, dispositions and other business development activities, and our ability to successfully capitalize on growth opportunities and prospects;
sales, expenses, interest rates, foreign exchange rates and the outcome of contingencies, such as legal proceedings;
expectations regarding the impact of or changes to existing or new government regulations or laws;
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our ability to anticipate and respond to and our expectations regarding the impact of macroeconomic, geopolitical, health and industry trends, pandemics, acts of war and other large-scale crises; and
manufacturing and product supply.
In particular, forward-looking information in this Form 10-Q includes statements relating to specific future actions, performance and effects, including, among others, the expected benefits of the organizational changes to our operations; our anticipated operating and financial performance; our ongoing efforts to respond to COVID-19, including our plans and expectations regarding Comirnaty and Paxlovid, and any potential future vaccines or treatments, including anticipated revenue and expectations for the commercial market for Comirnaty and Paxlovid; our expectations regarding the impact of COVID-19 on our business; the expected seasonality of demand for certain of our vaccines, including Comirnaty and the anticipated percentage of Comirnaty revenue to be recorded in the fourth quarter of 2024; expected patent terms; the expected impact of patent expiries and generic and biosimilar competition; the expected pricing pressures on our products and the anticipated impact to our business; the benefits expected from our business development transactions, including our December 2023 acquisition of Seagen; our anticipated cash flows and liquidity position; the anticipated costs, savings and potential benefits from certain of our initiatives, including our enterprise-wide Realigning our Cost Base Program, which we launched in October 2023 and our Manufacturing Optimization Program to reduce our cost of goods sold, which we announced in May 2024; our expectations regarding the impact from the 2023 tornado on our manufacturing facility in Rocky Mount, NC; our planned capital spending; and our capital allocation framework.
Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. Actual outcomes may vary materially from past results and those anticipated, estimated, implied or projected. These forward-looking statements may be affected by underlying assumptions that may prove inaccurate or incomplete, or by known or unknown risks and uncertainties, including those described in this section and in the Item 1A. Risk Factors section in our 2023 Form 10-K.
Therefore, you are cautioned not to unduly rely on forward-looking statements, which speak only as of the date of this Form 10-Q. We undertake no obligation to update forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities law. You are advised, however, to consult any further disclosures we make on related subjects.
Some of the factors that could cause actual results to differ are identified below, as well as those discussed in the Item 1A. Risk Factors section in our 2023 Form 10-K and within MD&A. We note these factors for investors as permitted by the Private Securities Litigation Reform Act of 1995. The occurrence of any of the risks identified below, in the Item 1A. Risk Factors section in our 2023 Form 10-K or within MD&A, or other risks currently unknown, could have a material adverse effect on our business, financial condition or results of operations, or we may be required to increase our accruals for contingencies. It is not possible to predict or identify all such factors. Consequently, you should not consider the following to be a complete discussion of all potential risks or uncertainties:
Risks Related to Our Business, Industry and Operations, and Business Development
the outcome of R&D activities, including the ability to meet anticipated pre-clinical or clinical endpoints, commencement and/or completion dates for our pre-clinical or clinical trials, regulatory submission dates, and/or regulatory approval and/or launch dates; the possibility of unfavorable pre-clinical and clinical trial results, including the possibility of unfavorable new pre-clinical or clinical data and further analyses of existing pre-clinical or clinical data; risks associated with preliminary, early stage or interim data; the risk that pre-clinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; and whether and when additional data from our pipeline programs will be published in scientific journal publications, and if so, when and with what modifications and interpretations; and uncertainties regarding the future development of our product candidates, including whether or when our product candidates will advance to future studies or phases of development or whether or when regulatory applications may be filed for any of our product candidates;
our ability to successfully address comments received from regulatory authorities such as the FDA or the EMA, or obtain approval for new products and indications from regulators on a timely basis or at all;
regulatory decisions impacting labeling, including the scope of indicated patient populations, product dosage, manufacturing processes, safety and/or other matters, including decisions relating to emerging developments regarding potential product impurities; uncertainties regarding the ability to obtain, and the scope of, recommendations by technical or advisory committees, and the timing of, and ability to obtain, pricing approvals and product launches, all of which could impact the availability or commercial potential of our products and product candidates;
claims and concerns that may arise regarding the safety or efficacy of in-line products and product candidates, including claims and concerns that may arise from the conduct or outcome of post-approval clinical trials, pharmacovigilance or Risk Evaluation and Mitigation Strategies, which could impact marketing approval, product labeling, and/or availability or commercial potential;
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the success and impact of external business development activities, such as the December 2023 acquisition of Seagen, including the ability to identify and execute on potential business development opportunities; the ability to satisfy the conditions to closing of announced transactions in the anticipated time frame or at all; the ability to realize the anticipated benefits of any such transactions in the anticipated time frame or at all; the potential need for and impact of additional equity or debt financing to pursue these opportunities, which has in the past and could in the future result in increased leverage and/or a downgrade of our credit ratings and could limit our ability to obtain future financing; challenges integrating the businesses and operations; disruption to business and operations relationships; risks related to growing revenues for certain acquired or partnered products; significant transaction costs; and unknown liabilities;
competition, including from new product entrants, in-line branded products, generic products, private label products, biosimilars and product candidates that treat or prevent diseases and conditions similar to those treated or intended to be prevented by our in-line products and product candidates;
the ability to successfully market both new and existing products, including biosimilars;
difficulties or delays in manufacturing, sales or marketing; supply disruptions, shortages or stock-outs at our facilities or third-party facilities that we rely on; and legal or regulatory actions;
the impact of public health outbreaks, epidemics or pandemics (such as COVID-19) on our business, operations and financial condition and results, including impacts on our employees, manufacturing, supply chain, sales and marketing, R&D and clinical trials;
risks and uncertainties related to our efforts to continue to develop and commercialize Comirnaty and Paxlovid or any potential future COVID-19 vaccines, treatments or combinations, as well as challenges related to their manufacturing, supply and distribution, including, among others, the risk that as the market for COVID-19 products continues to become more endemic and seasonal, demand for our COVID-19 products has and may continue to be reduced or not meet expectations, or may no longer exist, which has and may continue to lead to reduced revenues, excess inventory on-hand and/or in the channel which, for Paxlovid and Comirnaty, resulted in significant inventory write-offs in 2023 and could continue to result in inventory write-offs, or other unanticipated charges; risks related to our ability to develop and commercialize variant adapted vaccines; challenges related to the transition to the commercial market for our COVID-19 products; uncertainties related to the public’s adherence to vaccines, boosters, treatments or combinations; risks related to our ability to accurately predict or achieve our revenue forecasts for Comirnaty and Paxlovid or any potential future COVID-19 vaccines or treatments; and potential third-party royalties or other claims related to Comirnaty or Paxlovid;
trends toward managed care and healthcare cost containment, and our ability to obtain or maintain timely or adequate pricing or favorable formulary placement for our products;
interest rate and foreign currency exchange rate fluctuations, including the impact of currency devaluations and monetary policy actions in countries experiencing high inflation or deflation rates;
any significant issues involving our largest wholesale distributors or government customers, which account for a substantial portion of our revenues;
the impact of the increased presence of counterfeit medicines, vaccines or other products in the pharmaceutical supply chain;
any significant issues related to the outsourcing of certain operational and staff functions to third parties;
any significant issues related to our JVs and other third-party business arrangements, including modifications or disputes related to supply agreements or other contracts with customers including governments or other payors;
uncertainties related to general economic, political, business, industry, regulatory and market conditions including, without limitation, uncertainties related to the impact on us, our customers, suppliers and lenders and counterparties to our foreign-exchange and interest-rate agreements of challenging global economic conditions, such as inflation or interest rate fluctuations, and recent and possible future changes in global financial markets;
the exposure of our operations globally to possible capital and exchange controls, economic conditions, expropriation, sanctions and/or other restrictive government actions, changes in intellectual property legal protections and remedies, unstable governments and legal systems and inter-governmental disputes;
the impact of disruptions related to climate change and natural disasters, including uncertainties related to the impact of the tornado at our manufacturing facility in Rocky Mount, NC in 2023;
any changes in business, political and economic conditions due to actual or threatened terrorist activity, geopolitical instability, political or civil unrest or military action, including the ongoing conflicts between Russia and Ukraine and in the Middle East and the resulting economic or other consequences;
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the impact of product recalls, withdrawals and other unusual items, including uncertainties related to regulator-directed risk evaluations and assessments, such as our ongoing evaluation of our product portfolio for the potential presence or formation of nitrosamines, and our voluntary withdrawal of all lots of Oxbryta in all markets where it is approved and any potential regulatory or other impact on other sickle cell disease assets;
trade buying patterns;
the risk of an impairment charge related to our intangible assets, goodwill or equity-method investments;
the impact of, and risks and uncertainties related to, restructurings and internal reorganizations, as well as any other corporate strategic initiatives and growth strategies, and cost-reduction and productivity initiatives, including any potential future phases, each of which requires upfront costs but may fail to yield anticipated benefits and may result in unexpected costs, organizational disruption, adverse effects on employee morale, retention issues or other unintended consequences;
the ability to successfully achieve our climate goals and progress our environmental sustainability and other ESG priorities;
Risks Related to Government Regulation and Legal Proceedings
the impact of any U.S. healthcare reform or legislation or any significant spending reduction or cost control efforts affecting Medicare, Medicaid or other publicly funded or subsidized health programs, including the IRA, or changes in the tax treatment of employer-sponsored health insurance that may be implemented;
U.S. federal or state legislation or regulatory action and/or policy efforts affecting, among other things, pharmaceutical product pricing, intellectual property, reimbursement or access or restrictions on U.S. direct-to-consumer advertising; limitations on interactions with healthcare professionals and other industry stakeholders; as well as pricing pressures for our products as a result of highly competitive biopharmaceutical markets;
legislation or regulatory action in markets outside of the U.S., such as China or Europe, including, without limitation, laws related to pharmaceutical product pricing, intellectual property, medical regulation, environmental protections, reimbursement or access, including, in particular, continued government-mandated reductions in prices and access restrictions for certain biopharmaceutical products to control costs in those markets;
legal defense costs, insurance expenses, settlement costs and contingencies, including without limitation, those related to legal proceedings and actual or alleged environmental contamination;
the risk and impact of an adverse decision or settlement and risk related to the adequacy of reserves related to legal proceedings;
the risk and impact of tax related litigation and investigations;
governmental laws and regulations affecting our operations, including, without limitation, the IRA, changes in laws and regulations or their interpretation, including, among others, changes in tax laws and regulations internationally and in the U.S., the adoption of global minimum taxation requirements outside the U.S. generally effective in most jurisdictions since January 1, 2024 and potential changes to existing tax laws following the November 2024 U.S. elections;
Risks Related to Intellectual Property, Technology and Security
any significant breakdown or interruption of our information technology systems and infrastructure (including cloud services);
any business disruption, theft of confidential or proprietary information, security threats on facilities or infrastructure, extortion or integrity compromise resulting from a cyber-attack, which may include those using adversarial artificial intelligence techniques, or other malfeasance by, but not limited to, nation states, employees, business partners or others;
risks and challenges related to the use of software and services that include artificial intelligence-based functionality and other emerging technologies;
the risk that our currently pending or future patent applications may not be granted on a timely basis or at all, or any patent-term extensions that we seek may not be granted on a timely basis, if at all; and
risks to our products, patents and other intellectual property, such as: (i) claims of invalidity that could result in patent revocation; (ii) claims of patent infringement, including asserted and/or unasserted intellectual property claims; (iii) claims we may assert against intellectual property rights held by third parties; (iv) challenges faced by our collaboration or licensing partners to the validity of their patent rights; or (v) any pressure, or legal or regulatory action by, various stakeholders or governments that could potentially result in us not seeking intellectual property protection or agreeing not to enforce or being restricted from enforcing intellectual property rights related to our products, including Comirnaty and Paxlovid.
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Information required by this item is incorporated by reference from the discussion in the Analysis of Financial Condition, Liquidity, Capital Resources and Market Risk section within MD&A of our 2023 Form 10-K.
ITEM 4. CONTROLS AND PROCEDURES
As of the end of the period covered by this report, we carried out an evaluation, under the supervision and with the participation of our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Based on this evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures are effective in alerting them in a timely manner to material information required to be disclosed in our periodic reports filed with the SEC.
During our most recent fiscal quarter, there has not been any change in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II.  OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS

Certain legal proceedings in which we are involved are discussed in Note 12A.
ITEM 1A. RISK FACTORS
We refer to the Overview of Our Performance, Operating Environment, Strategy and Outlook—Our Operating Environment and —The Global Economic Environment sections and the Forward-Looking Information and Factors That May Affect Future Results section within MD&A of this Form 10-Q and of our 2023 Form 10-K and to the Item 1A. Risk Factors section of our 2023 Form 10-K.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
The following summarizes purchases of our common stock during the third quarter of 2024:
Period
Total Number of
Shares Purchased(a)
Average Price
Paid per Share(a)
Total Number of Shares Purchased as Part of Publicly Announced Plan
Approximate Value of Shares That May Yet Be Purchased Under the Plan(b)
July 1 through July 28, 2024
14,581 $27.73 — $3,292,882,444 
July 29 through August 25, 2024
22,257 $30.44 — $3,292,882,444 
August 26 through September 29, 2024
57,730 $29.02 — $3,292,882,444 
Total94,568 $29.16 — 
(a)Represents (i) 91,700 shares of common stock surrendered to the Company to satisfy tax withholding obligations in connection with the vesting of awards under our long-term incentive programs and (ii) the open market purchase by the trustee of 2,868 shares of common stock in connection with the reinvestment of dividends paid on common stock held in trust for employees who deferred receipt of performance share awards.
(b)See the Analysis of Financial Condition, Liquidity, Capital Resources and Market Risk—Capital Allocation Framework section within MD&A of this Form 10-Q and Note 12 in our 2023 Form 10-K.
ITEM 5. OTHER INFORMATION
During the three months ended September 29, 2024, none of our directors or officers adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408 of Regulation S-K.
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ITEM 6. EXHIBITS
 Certification by the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
 Certification by the Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
 Certification by the Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
 Certification by the Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
 Exhibit 101:  
EX-101.INSXBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
 EX-101.SCH
EX-101.CAL
EX-101.LAB
EX-101.PRE
EX-101.DEF
 Inline XBRL Taxonomy Extension Schema
Inline XBRL Taxonomy Extension Calculation Linkbase
Inline XBRL Taxonomy Extension Label Linkbase
Inline XBRL Taxonomy Extension Presentation Linkbase
Inline XBRL Taxonomy Extension Definition Document
Exhibit 104Cover Page Interactive Data File––the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
 Pfizer Inc.
 (Registrant)
  
  
Dated:November 4, 2024/s/ Jennifer B. Damico
 Jennifer B. Damico
Senior Vice President and Controller
(Principal Accounting Officer and
Duly Authorized Officer)
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