Smallpox (vaccinia) vaccine, live(Sanofi)

摘要:2019冠状病毒病（COVID-19）大流行的出现使我们意识到迅速开发治疗方法和拯救生命的重要性。这场针对这种新型冠状病毒的疫苗研发竞赛在大流行出现之初就开始了。时间是唯一的限制因素。从1796年针对天花的第一种疫苗到最新的COVID-19疫苗，已有多种疫苗减轻了疾病的负担，以及相关的死亡率和发病率。多年来，我们在生物体分离、细胞培养、全基因组测序和重组核技术方面取得了许多新的进展。这些技术极大地促进了疫苗的开发。每种疫苗都有自己的开发故事，通过学习疫苗开发中的突破，我们可以获得很多智慧。 1.背景 尽管接种实践始于500多年前，但“疫苗”这个词是在18世纪由爱德华·詹纳首次描述的。它源自拉丁语“Vacca”，意为牛。1796年，詹纳将挤奶女工手上的牛痘病灶接种给一个八岁的男孩，最终赋予了对天花的免疫力。80年后，路易·巴斯德在开发针对人类的狂犬病活减毒疫苗方面发挥了重要作用，取得了巨大成功。在19世纪，我们见证了通过科赫发现的众多微生物而发展起来的病原体理论。到了20世纪中叶，在引入减毒毒素（类毒素）之后，第一代疫苗得以开发。通过这一发展，人们得以制造出白喉和破伤风疫苗。在1930年代，实验室技术的重大进步使得病毒能够在鸡胚的卵黄囊膜上培养。这促成了流感和黄热病疫苗的开发。15年后，细胞培养的进化促成了脊髓灰质炎疫苗的创造，这标志着疫苗的黄金时代的开始。在这一时期，一系列重要的疫苗如麻疹、腮腺炎、风疹和水痘疫苗被开发出来。重组DNA和全基因组测序技术的引入是疫苗开发的里程碑。它为研究人员提供了开发针对以前不可能的病原体的新疫苗的工具。我们的目标是涵盖上个世纪开发的大多数疫苗的时间线和发展（图1）。 图1：疫苗历史时间线 COVID-19，2019冠状病毒病；FDA，美国食品药品监督管理局；HPV，人乳头瘤病毒 2.综述 2.1.天花 天花是最古老的已知传染病之一。它造成了数亿人死亡。关于这种疾病的最早书面记录可以追溯到4世纪的中国。一些研究表明，在埃及木乃伊上发现了类似天花的皮疹，表明它可能至少可以追溯到3000年前。1980年，世界卫生组织（WHO）宣布天花成为全球首个因积极的免疫努力而被根除的疾病。 最早的关于接种的文献记录是在16世纪的中国和印度。这是通过鼻腔或皮肤途径接种天花脓液或痂皮实现的。在全球天花爆发期间，早期的接种试验于1721年在英国和马萨诸塞殖民地进行。此外，还有来自奥斯曼帝国和北非的接种报告。尽管接种的起源并不确定，无论是起源于亚洲还是非洲，接种的做法最早是由爱德华·詹纳在1796年引入的。他观察到患有牛痘病灶的挤奶女工对天花感染有免疫力。然后他让一个小男孩接触到挤奶女工的病灶，并观察到这个男孩获得了对天花的免疫力。他将这种做法扩展到更多的孩子，并记录了类似的结果。从那时起，人们一直在不断努力开发更安全的疫苗技术。 目前，FDA批准了三种主要的天花疫苗。Dryvax®是20世纪早期根除天花的主要组合之一。它的生产始于19世纪的Wyeth实验室，并在1982年全球根除目标实现后暂停。Dryvax®一直储备到2008年，直到被ACAM2000取代，ACAM2000是第二代疫苗，更安全，但与Dryvax®具有相同的效力概况。最新的天花疫苗是MVA-BN。它于2013年在欧洲和加拿大获得批准，2019年在美国获得批准。与Dryvax®和ACAM2000相比，MVA-BN在患有特应性皮炎和免疫缺陷的患者中有更好的安全性概况。尽管天花已被根除，但卫生感染控制实践咨询委员会和免疫实践咨询委员会推荐在某些高风险群体中采取疫情前措施。 2.2.人乳头瘤病毒 人乳头瘤病毒（HPV）是宫颈癌的最常见原因，也是全球女性第四常见的癌症。HPV最初是在1983年的宫颈癌活检中检测到的。二十年后，关于第一种HPV疫苗临床试验的最早出版物发布。第一种HPV疫苗于2006年获得FDA批准。针对HPV的普遍疫苗接种计划已导致宫颈癌的发病率和死亡率显著降低。 2.3.埃博拉病毒 1976年在西非首次记录了埃博拉病毒病的流行后，发生了多次短期爆发性疫情，严重程度不一。2014年发生的最致命和最近的一次爆发，病死率高达85%。这导致世界卫生组织在2014年8月宣布该流行病为国际公共卫生紧急情况。在此之前，已经进行了多项非人类试验，以开发针对埃博拉病毒家族的疫苗。2015年，开始了一场创造安全有效疫苗的竞赛，并且建立了许多人临床试验来测试多种疫苗候选物。为了快速进行安全性和免疫原性测试，使用了一种表达扎伊尔埃博拉病毒（ZEBOV）糖蛋白的复制型重组水泡性口炎病毒（rVSV）基疫苗。以Ervebo®的品牌名，它在2019年11月获得了欧洲药品管理局（EMA）的授权，并在2019年12月获得了FDA的授权。第二种疫苗是两剂异源Ad26.ZEBOV和MVA-BN-Filo埃博拉疫苗方案，这是两种不同的疫苗，相隔约56天给予。它在2020年7月被EMA批准用于医疗用途。尽管许多疫苗仍在试验中，但这些是唯一获批针对埃博拉病毒家族的疫苗。 2.4.轮状病毒 轮状病毒于1973年首次被发现，被发现是儿童急性胃肠炎的主要病原体。自1981年以来，已经进行了几项I-III期临床试验，以开发针对轮状病毒的安全疫苗。第一个获得FDA批准的疫苗品牌名为Rotashield®，于1998年获得许可，但由于与肠套叠的证实关联，在不到一年的时间里被撤回。又过了八年，直到一种更安全的轮状病毒疫苗才获得许可。2006年，RotaTeq®（RV5：五价）被引入美国的普及疫苗接种计划。然后，Rotarix®（RV1：单价）在2008年获得了FDA的许可。在美国进行的多项病例对照研究的元分析，比较了不同轮状病毒疫苗类型的有效性，没有显示出统计学上的显著差异。 2.5.甲型肝炎病毒 甲型肝炎病毒于1973年在美国首次被检测到。花了三十年时间开发出一种安全有效的疫苗。第一个针对甲型肝炎的疫苗名为Havrix®，于1992年获得许可。随后是疫苗Vaqta®，于1993年获得许可。这些是美国唯一获批的针对甲型肝炎病毒的疫苗。 2.6.流感嗜血杆菌 流感嗜血杆菌于1892年首次被描述。最初，它被错误地认为是流感大流行的病原体，直到1933年揭示了其病毒病因。它负责一系列局部和侵袭性传染病。它被分类为有胶囊和无胶囊变体。有胶囊的被根据胶囊抗原亚分为a-f六个血清型。最有毒和侵袭性的血清型是b型菌株（Hib）。针对Hib开发的第一种疫苗是在20世纪70年代初在芬兰。它由胶囊多糖胶囊多聚核糖核糖磷酸盐（PRP）组成。纯多糖疫苗于1985年在美国首次获得许可，并推荐给超过18个月的人使用。研究表明，由于免疫系统的不成熟，PRP疫苗在18个月以下的年龄段没有效果。它一直使用到1988年，当时显示结合疫苗在诱导婴儿免疫反应方面更好，这被认为是侵袭性Hib感染的高峰年龄。PRP附着在蛋白结合物如破伤风和白喉类毒素上是开发结合疫苗的第一步。目前，获批的产品是与其他疫苗产品的组合，如乙肝和百白破疫苗。 2.7.流感 流感大流行的确切时间尚不清楚。最早的类似流感的疾病由希波克拉底在公元前400年的“流行病学”中提到，然而，并非所有研究人员认为这实际上是流感。第一个肯定符合当前流感描述的大流行是在1580年记录的。从那时起，世界各地发生了多次流感大流行。其中最具破坏性的大流行是1918年的“西班牙流感”，导致数千万人的死亡。直到1931年从感染患者的鼻分泌物中分离出流感病毒，人们错误地认为大流行有细菌病因。20世纪30年代中期进行了首次开发疫苗的试验。1938年，成功进行了一次实验，开发了一种单价灭活疫苗，以保护美国军队免受甲型流感病毒的侵害。该疫苗于1945年在美国获得公共使用许可。不久之后发现了一种新菌株“乙型流感”，几年后，第一种双价疫苗获得许可供公共使用。 抗原的移位和漂移以及病毒成分的持续变化使得有必要建立一个监测循环流感菌株的监测系统。第一次监测是由世界卫生组织在1952年创建的。发现新菌株和不同大流行中不同类型的血凝素和神经氨酸酶抗原导致在20世纪70年代引入了三价疫苗。随后，四价疫苗于2012年获得FDA许可。细胞培养技术、重组DNA和全基因组测序的进步使科学家能够迅速应对不断演变的流感大流行，如1997年的“禽流感”和2009年的“猪流感”，在几个月内创造出安全有效的疫苗。当前的研究重点包括开发能够应对当前和不断演变菌株的通用疫苗。 2.8.COVID-19 2019年12月，中国武汉首次报告了COVID-19病例。一群原因不明的呼吸道感染患者被证明是由一种名为SARS-CoV-2的新型冠状病毒引起的。这种病毒属于冠状病毒科，其中还包括严重急性呼吸综合征冠状病毒-1（SARS-CoV-1）和中东呼吸综合征冠状病毒（MERS-CoV）。2020年3月11日，世界卫生组织（WHO）宣布COVID-19为大流行病。发热、肌肉痛、咳嗽、呼吸困难和类似流感的症状是COVID-19最常见的症状，主要影响呼吸系统。从无症状感染到呼吸衰竭、多器官功能障碍和死亡，COVID-19具有广泛的临床表现。除了呼吸系统外，COVID-19还与其他身体系统的危害有关。尽管与SARS-CoV和MERS-CoV相比，SARS-CoV-2的死亡率较低，但其传播性和扩散性远高于SARS-CoV-1和MERS。2020年初，开发有效安全疫苗的竞赛开始了。很快，全球有200多个候选疫苗处于临床前和临床开发阶段。少数疫苗进入了临床三期试验，到2020年12月，由辉瑞和BioNTech合作开发的第一种COVID-19疫苗获得了批准。COVID-19疫苗的开发被认为是疫苗科学史上最快速的之一。由于疾病的有限传播和需求减少，SARS-CoV-1和MERS疫苗候选物没有超过I期，但它们帮助理解了身体对冠状病毒的反应。2020年12月31日，WHO为辉瑞COVID-19疫苗（mRNA疫苗）发布了紧急使用清单（EUL）。2021年2月15日，WHO为阿斯利康/牛津COVID-19疫苗（腺病毒载体疫苗）发布了EUL。2021年3月12日，WHO为强生COVID-19疫苗（腺病毒载体疫苗）发布了EUL。目前，这些是由EUL发布的唯一疫苗。另一种由Moderna生产的mRNA疫苗于2020年12月18日获得FDA许可，并于2021年1月6日获得EMA许可。虽然其他疫苗如中国国药、科兴、诺瓦瓦克斯和卫星疫苗等正在其他国家分发，但它们并未包含在撰写本文时由WHO发布的紧急使用清单中。不同类型的疫苗、它们的给药途径以及它们的作用机制在表1中进行了总结。 表1：不同类型疫苗的总结。 COVID-19疫苗许可日期基于WHO建议提供。IM，肌肉内注射；HPV，人乳头瘤病毒 3.结论 疫苗在减轻传染病负担方面发挥了至关重要的作用。这一切都始于500年前中国人和印度人的最初接种努力。这种做法的旅程穿越了奥斯曼和非洲，最终传入欧洲和北美。当爱德华·詹纳的理念为疫苗接种奠定了基础时，他希望自己的努力最终能导致天花的根除。从那时起，这是一段充满挑战和失败的漫长旅程，但他的希望最终在1980年世界卫生大会宣布世界摆脱这种疾病时得以实现。疫苗开发的知识体系不断增长，实验室技术的进步挽救了数百万生命。此外，COVID-19疫苗的空前成功为证明疫苗有效性的证据库增添了另一种武器。每种疫苗都有其独特的发展历史，研究它可能提供我们在将来大流行中可能需要的智慧。因此，我们希望利用这个机会分享我们对历史上各种疫苗发展深入调查的结果。 识别微信二维码，添加生物制品圈小编，符合条件者即可加入 生物制品微信群！ 请注明：姓名+研究方向！ 版 权 声 明 本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

Third Quarter 2024 Total Revenues of $293.8 million, increase of 9% versus prior yearThird Quarter 2024 Net Income of $114.8 million, increase of 144% versus prior yearThird Quarter 2024 Adjusted EBITDA of $105.3 million, increase of 432% versus prior yearRaises FY 2024 guidance GAITHERSBURG, Md., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today reported financial results for the third quarter ended September 30, 2024. "Through disciplined execution and steady, measurable progress, Emergent's financial position is the strongest it has been since 2021 as evidenced by our favorable third-quarter results," said CEO Joe Papa. "We have successfully improved efficiencies and refocused our operations related to customer demand, generated value in our core medical countermeasures and NARCAN® Nasal Spray businesses and refinanced our debt leading to increased revenue and cash flow." Papa continued, "Based on the success of our efforts since the beginning of this year, we are officially entering the turnaround phase of our multi-year transformation plan, and we will be focused on driving profitable growth, continued operational improvements and the generation of sustainable value for shareholders. We believe ongoing public health crises like the opioid overdose epidemic and mpox outbreak underscore the need for Emergent's capabilities and expertise. It is not if, but when, the next public health threat emerges, and we believe we are uniquely qualified to help respond to protect, enhance and save lives." FINANCIAL HIGHLIGHTS(1) Q3 2024 vs. Q3 2023 ($ in millions, except per share amounts)Q3 2024Q3 2023% ChangeTotal Revenues$293.8 $270.5 9%Net Income (Loss)$114.8 $(263.4)144%Net Income (Loss) per Diluted Share$2.06 $(5.08)141%Adjusted Net Income (Loss)(2)$76.2 $(56.2)236%Adjusted Net Income (Loss) per Diluted Share(2)$1.37 $(1.09)226%Adjusted EBITDA(2)$105.3 $19.8 432%Total Segment Gross Margin %(2) 57% 33% Total Segment Adjusted Gross Margin %(2) 59% 38% Year to Date (“YTD”) 2024 vs. YTD 2023 ($ in millions, except per share amounts)YTD 2024YTD 2023% ChangeTotal Revenues$848.9 $772.7 10%Net Loss$(159.3)$(711.0)78%Net Loss per Diluted Share$(3.03)$(13.97)78%Adjusted Net Loss(2)$(14.7)$(273.0)95%Adjusted Net Loss per Diluted Share(2)$(0.28)$(5.36)95%Adjusted EBITDA(2)$162.1 $(25.7)731%Total Segment Gross Margin %(2) 32% 31% Total Segment Adjusted Gross Margin %(2) 46% 33% SELECT Q3 2024 BUSINESS UPDATES Secured a new Term Loan for $250 million with OHA Agency, LLC as administrative agent.Closed on a new asset backed loan facility for $100 million with Wells Fargo Bank, National Association.Received $75 million for the sale of our RSDL® (Reactive Skin Decontamination Lotion) product to a subsidiary of SERB Pharmaceuticals ("SERB"), subject to customary adjustments based on inventory value at closingCompleted the sale of the Baltimore-Camden manufacturing site for $35 million, including customary post-closing adjustmentsSold an underutilized warehouse at our Canton, MA facility for $7 millionReceived $50 million in the third quarter related to the resolution of the contractual dispute with Janssen Pharmaceuticals, Inc.Earned $30 million development milestone payments from Bavarian Nordic as part of the sale of the Travel Health Business THIRD QUARTER 2024 FINANCIAL PERFORMANCE(1) Revenues The Company uses the following categories in discussing product/service level revenues: NARCAN® — comprises contributions from NARCAN® Nasal SprayAnthrax MCM — comprises contributions from CYFENDUS®, previously known as AV7909, BioThrax®, Anthrasil® and RaxibacumabSmallpox MCM — comprises contributions from ACAM2000®, VIGIV and TEMBEXA®Other Products — comprises contributions from BAT® and RSDL®Bioservices — comprises service and lease revenues from the Bioservices business ($ in millions)Q3 2024Q3 2023% ChangeProduct sales, net:(3) NARCAN®$95.3$142.1(33)%Anthrax MCM 11.4 32.9(65)%Smallpox MCM 132.7 24.7437%Other Products 30.1 50.1(40)%Total Product sales, net$269.5$249.88% Bioservices: Services$13.9$13.25%Leases 0.4 1.0(60)%Total Bioservices revenues$14.3$14.21% Contracts and grants$10.0$6.554% Total revenues$293.8$270.59% Products Sales, net NARCAN® For Q3 2024, revenues from NARCAN® (naloxone HCl) Nasal Spray decreased $46.8 million, or 33%, as compared with Q3 2023. The decrease was primarily driven by the discontinuation of prescription NARCAN® due to the launch of over-the-counter (“OTC”) NARCAN® in the third quarter of 2023 and lower Canadian retail sales, partially offset by higher sales of OTC NARCAN®. Anthrax MCM For Q3 2024, revenues from Anthrax MCM products decreased $21.5 million, or 65%, as compared with Q3 2023. The decrease reflects the impact of timing of sales related to CYFENDUS® and Anthrasil®, partially offset by an increase in BioThrax® sales, due to timing. Anthrax vaccine product sales are primarily made under annual purchase options exercised by the U.S. government (the “USG”). Fluctuations in revenues result from the timing of the exercise of annual purchase options, the timing of USG purchases, the availability of governmental funding and the Company’s delivery of orders that follow. Smallpox MCM For Q3 2024, revenues from Smallpox MCM products increased $108.0 million, or 437%, as compared with Q3 2023. The increase was primarily due to timing of USG purchases of ACAM2000® and VIGIV. Fluctuations in revenues from Smallpox MCM result from the timing of the exercise of annual purchase options in the existing procurement contracts, the timing of USG purchases, the availability of governmental funding and Company delivery of orders that follow. Other Products For Q3 2024, revenues from Other Product sales decreased $20.0 million, or 40%, as compared with Q3 2023. The decrease was due to lower product sales of BAT®, due to timing of deliveries, and lower product sales of RSDL®, which was sold to SERB during the third quarter of 2024. Bioservices Revenues Services For Q3 2024, revenues from Bioservices services increased $0.7 million, or 5%, as compared with Q3 2023. The increase was primarily attributable to an increase in production at the Company’s Camden facility, prior to the sale of the facility to Bora, partially offset by lower production at the Company’s Canton and Winnipeg facilities. Leases For Q3 2024, revenues from Bioservices leases decreased $0.6 million, or 60%, as compared with Q3 2023. The decrease was related to the completion of a lease for a Bioservices customer at our Canton facility, partially offset by new lease revenue associated with SERB at our Winnipeg facility. Contracts and Grants For Q3 2024, revenues from contracts and grants increased $3.5 million, or 54%, as compared with Q3 2023. The increase was primarily due to timing of funding as well as an increase related to work under the Ebanga™ program. Operating Expenses ($ in millions)Q3 2024Q3 2023% ChangeCost of Commercial product sales$47.2$60.0(21)%Cost of MCM product sales 54.0 72.5(26)%Cost of Bioservices 21.4 44.3(52)%Research and development (“R&D”) 13.8 15.3(10)%Selling, general and administrative (“SG&A”) 76.6 86.0(11)%Amortization of intangible assets 16.3 16.3—%Goodwill impairment — 218.2(100)%Total operating expenses$229.3$512.6(55)% Cost of Commercial Product Sales For Q3 2024, cost of Commercial Product sales decreased $12.8 million, or 21%, as compared with Q3 2023. The decrease was primarily due to lower prescription NARCAN® unit volume, partially offset by higher OTC NARCAN® unit volume. Cost of MCM Product Sales For Q3 2024, cost of MCM Product sales decreased $18.5 million, or 26%, as compared with Q3 2023. The decrease was primarily due to lower sales of BAT® and CYFENDUS®, coupled with lower allocations to Cost of MCM Product sales at our Bayview facility. This decrease was partially offset by higher sales of BioThrax® and ACAM2000®. Cost of Bioservices For Q3 2024, cost of Bioservices decreased $22.9 million, or 52%, as compared with Q3 2023. The decrease was primarily due to lower overhead and remediation costs related to the sale of the Camden facility, coupled with a decrease in overhead costs at our other Maryland facilities as a result of the announced shutdowns and lower costs at our Canton facility. The decrease was partially offset by an increase in production at our Winnipeg facility. Research and Development Expenses For Q3 2024, R&D expenses decreased $1.5 million, or 10%, as compared with Q3 2023. The decrease was driven by a reduction in spend for certain funded and unfunded projects, excluding Ebanga™. The decrease was partially offset by an increase in funded R&D related to Ebanga™. Selling, General and Administrative Expenses For Q3 2024, SG&A expenses decreased $9.4 million, or 11%, as compared with Q3 2023. The decrease was primarily due to lower employee related expenses and compensation as a result of restructuring initiatives during 2023 and 2024, coupled with a decrease in legal services fees for disputes and other corporate initiatives. This decrease was partially offset by the settlement charge related to the stockholder litigation matter, net of expected insurance proceeds. Goodwill Impairment For Q3 2024, Goodwill impairment decreased $218.2 million as compared with Q3 2023. The decrease was due to the Q3 2023 non-cash impairment charge to Goodwill in the MCM Products reporting unit, which reduced the reporting unit’s goodwill balance to zero. ADDITIONAL FINANCIAL INFORMATION(1) Capital Expenditures ($ in millions)Q3 2024Q3 2023% ChangeCapital expenditures$5.8 $12.6 (54)%Capital expenditures as a % of total revenues 2% 5% For Q3 2024, capital expenditures decreased largely due to lower product development activities across the Company’s facilities. SEGMENT INFORMATION The Company manages the business with a focus on three reportable segments: (1) the Commercial Products segment consisting of our NARCAN® and other commercial products that were sold as part of our travel health business in the second quarter of 2023; (2) the MCM Products segment consisting of the Anthrax - MCM, Smallpox - MCM and Other products and (3) the services segment (“Services”) consisting of our Bioservices business. The Company evaluates the performance of these reportable segments based on revenues and segment adjusted gross margin, which is a non-GAAP financial measure. Segment revenue includes external customer sales, but does not include inter-segment services. The Company does not allocate contracts and grants revenue, R&D, SG&A, amortization of intangible assets, interest and other income (expense) or taxes to its evaluation of the performance of these segments. THIRD QUARTER 2024 SEGMENT RESULTS ($ in millions)Commercial ProductsQuarter Ended September 30, 2024 2023 $ Change% ChangeRevenues$95.3 $142.1 $(46.8)(33)%Cost of sales 47.2 60.0 (12.8)(21)%Gross margin**$48.1 $82.1 $(34.0)(41)%Gross margin %** 50% 58% Segment adjusted gross margin(2)$48.1 $82.1 $(34.0)(41)%Segment adjusted gross margin %(2) 50% 58% ** Gross margin is calculated as revenues less cost of sales. Gross margin % is calculated as gross margin divided by revenues. Commercial Products gross margin decreased $34.0 million, or 41%, to $48.1 million in the quarter, as compared with $82.1 million in the prior year quarter. Commercial Products gross margin percentage decreased seven percentage points to 50% for the quarter ended September 30, 2024. The decrease was largely due to an unfavorable price and volume mix in 2024 for NARCAN® products. Commercial Products segment adjusted gross margin is consistent with gross margin. ($ in millions)MCM ProductsQuarter Ended September 30, 2024 2023 $ Change% ChangeRevenues$174.2 $107.7 $66.5 62%Cost of sales 54.0 72.5 (18.5)(26)%Gross margin**$120.2 $35.2 $85.0 241%Gross margin %** 69% 33% Add back: Changes in fair value of financial instruments$— $(1.1)$1.1 100%Restructuring costs 4.9 5.0 (0.1)(2)%Inventory step-up provision 1.2 — 1.2 NMSegment adjusted gross margin(2)$126.3 $39.1 $87.2 223%Segment adjusted gross margin %(2) 73% 36% ** Gross margin is calculated as revenues less cost of sales. Gross margin % is calculated as gross margin divided by revenues.NM - Not Meaningful MCM Products gross margin increased $85.0 million, or 241%, to $120.2 million in the quarter, as compared with $35.2 million in the prior year quarter. MCM Products gross margin percentage increased 36 percentage points to 69% for the quarter ended September 30, 2024. The increase was largely due to overall higher sales volumes with a favorable product mix weighted more heavily to higher margin products coupled with lower allocations to cost of MCM Product sales at our Bayview facility and overall lower shutdown and overhead costs across our facilities. MCM Product segment adjusted gross margin in the current year period excludes the impact of non-cash items related to the impact of restructuring costs of $4.9 million and inventory step-up provision of $1.2 million. ($ in millions)ServicesQuarter Ended September 30, 2024 2023 $ Change% ChangeRevenues$14.3 $14.2 $0.1 1%Cost of services 21.4 44.3 (22.9)(52)%Gross margin**$(7.1)$(30.1)$23.0 76%Gross margin %**(50)%(212)% Add back: Restructuring costs 0.1 8.1 (8.0)(99)%Segment adjusted gross margin(2)$(7.0)$(22.0)$15.0 68%Segment adjusted gross margin %(2)(49)%(155)% ** Gross margin is calculated as revenues less cost of services. Gross margin % is calculated as gross margin divided by revenues. Services gross margin increased $23.0 million, or 76%, to $(7.1) million in the quarter, as compared with $(30.1) million in the prior year quarter. Services gross margin percentage increased 162 percentage points to (50)% for the quarter ended September 30, 2024. The increase was primarily due to lower overhead and remediation costs related to the sale of the Camden facility coupled with lower costs at our Bayview facility. Services segment adjusted gross margin in the current year period excludes the impact of restructuring costs of $0.1 million. YTD 2024 SEGMENT RESULTS Commercial Products Nine Months Ended September 30, 2024 2023 $ Change % Change Revenues$333.8 $386.2 $(52.4)(14)%Cost of sales 152.7 160.2 (7.5)(5)%Gross margin**$181.1 $226.0 $(44.9)(20)%Gross margin %** 54% 59% Segment adjusted gross margin(2)$181.1 $226.0 $(44.9)(20)%Segment adjusted gross margin %(2) 54% 59% ** Gross margin is calculated as revenues less cost of sales. Gross margin % is calculated as gross margin divided by revenues. Commercial Products gross margin decreased $44.9 million, or 20%, to $181.1 million for the nine months ended September 30, 2024, as compared with $226.0 million for the nine months ended September 30, 2023. Commercial Products gross margin percentage decreased five percentage points to 54% in 2024. The decrease was largely due to an unfavorable price and volume mix in 2024 for NARCAN® products, partially offset by the sale of the products associated with our travel health business to Bavarian Nordic. Commercial Products segment adjusted gross margin is consistent with gross margin. ($ in millions)MCM ProductsNine Months Ended September 30, 2024 2023 $ Change% ChangeRevenues$393.0 $309.2 $83.8 27%Cost of sales 147.3 208.4 (61.1)(29)%Gross margin**$245.7 $100.8 $144.9 144%Gross margin %** 63% 33% Add back: Changes in fair value of financial instruments$0.6 $(0.4)$1.0 250%Inventory step-up provision 1.2 1.9 (0.7)(37)%Restructuring costs 7.5 7.0 0.5 7%Segment adjusted gross margin(2)$255.0 $109.3 $145.7 133%Segment adjusted gross margin %(2) 65% 35% ** Gross margin is calculated as revenues less cost of sales. Gross margin % is calculated as gross margin divided by revenues.NM - Not Meaningful MCM Products gross margin increased $144.9 million, or 144%, to $245.7 million for the nine months ended September 30, 2024, as compared with $100.8 million for the nine months ended September 30, 2023. MCM Products gross margin percentage increased 29 percentage points to 63% for the nine months ended September 30, 2024. The increase was largely due to overall higher sales volumes with a favorable product mix weighted more heavily to higher margin products coupled with lower allocations to Cost of MCM Product sales at our Bayview facility and lower shutdown related costs, a reduction in Trobigard® related costs, due to the Trobigard® revocation, and realization of previously adjusted inventory values. MCM Product segment adjusted gross margin excludes the impact of restructuring costs of $7.5 million, inventory step-up provision of $1.2 million and changes in fair value of financial instruments of $0.6 million. ($ in millions)ServicesNine Months Ended September 30, 2024 2023 $ Change% ChangeRevenues$97.5 $57.7 $39.8 69%Cost of services 263.3 151.7 111.6 74%Gross margin**$(165.8)$(94.0)$(71.8)(76)%Gross margin %**(170)%(163)% Add back: Settlement charges, net$110.2 $— $110.2 NMRestructuring costs 0.3 8.1 (7.8)(96)%Segment adjusted gross margin(2)$(55.3)$(85.9)$30.6 36%Segment adjusted gross margin %(2)(57)%(149)% ** Gross margin is calculated as revenues less cost of sales. Gross margin % is calculated as gross margin divided by revenues.NM - Not Meaningful Services gross margin decreased $71.8 million, or 76%, to $(165.8) million for the nine months ended September 30, 2024, as compared with $(94.0) million for the nine months ended September 30, 2023. Services gross margin percentage decreased 7 percentage points to (170)% for the nine months ended September 30, 2024. The decrease was primarily due to the Settlement Agreement with Janssen and resulting revenue and write-down of related assets to net realizable value, coupled with lower production at the Company's Canton facility. This decrease was partially offset by an increase in production at the Camden facility prior to the sale of the facility to Bora and a decrease in overhead costs at our other Maryland facilities. Services segment adjusted gross margin in the current year period excludes the impact of segment settlement charge, net of $110.2 million and restructuring costs of $0.3 million. 2024 FINANCIAL FORECAST The Company provides the following updated financial forecast for full year 2024, reflecting management's expectations based on the most current information available. Full Year 2024 METRIC($ in millions)Updated Range(as of 11/6/2024)Previous Range(as of 08/06/2024)Previous Range(as of 05/01/2024)Previous Range(as of 03/06/2024)Total revenues$1,065 - $1,125$1,050 - $1,125$1,000 - $1,100$900 - $1,100Net loss$(203) - $(183)$(314) - $(274)$(148) - $(98)$(183) - $(133)Adjusted net loss(2)$(50) - $(30)$(115) - $(75)$(65) - $(15)$(130) - $(80)Adjusted EBITDA(2)$180 - $200$140 - $180$125 - $175$50 - $100Total segment adjusted gross margin %(2)43% - 45%42% - 45%44% - 47%40% - 45% Segment Level Revenue(4) Commercial Products$420 - $430$450 - $480$460 - $500$460 - $500MCM Products$510 - $550$455 - $490$440 - $490$340 - $490Services(5)$105 - $110$120 - $130$70 - $80$70 - $80 Key Assumptions($ and shares in millions)Updated Range(as of 11/6/2024) Interest expense~$75 R&D~7% of Revenue Weighted avg. fully diluted share count~53 Capex~$25 Depreciation & amortization~$109 FOOTNOTES (1) All financial information included in this release is unaudited. (2) See “Non-GAAP Financial Measures” and the "Reconciliation of Non-GAAP Financial Measures" tables for the definitions and reconciliations of these non-GAAP financial measures to the most closely related GAAP financial measures. (3) Product sales, net are reported net of variable consideration including returns, rebates, wholesaler fees and prompt pay discounts in accordance with U.S. generally accepted accounting principles. (4) Our Commercial Products forecast consists solely of NARCAN® Nasal Spray, as our Other Commercial Products, including Vivotif® and Vaxchora®, were sold to Bavarian Nordic as part of our travel health business in May 2023. (5) Our Services revenue forecast includes $50.0 million related to the Settlement Agreement with Janssen and excludes revenues related to the Baltimore-Camden Facility after August 20, 2024. CONFERENCE CALL, PRESENTATION SUPPLEMENT AND WEBCAST INFORMATION Company management will host a conference call at 5:00 pm eastern time today, November 6, 2024, to discuss these financial results. The conference call and presentation supplement can be accessed from the Company's website or through the following: By phoneTo join via telephone, please use the following dial-in details:U.S. / New York: +1-646-968-2525U.S. & Canada (Toll Free): +1-888-596-4144Conference ID: 5259189 By webcast Visit https://edge.media-server.com/mmc/p/nm3oj8g9A replay of the call can be accessed from the Emergent website. ABOUT EMERGENT BIOSOLUTIONS INC. At Emergent, our mission is to protect and enhance life. We develop, manufacture, and deliver protections against public health threats through a pipeline of innovative vaccines and therapeutics. For over 25 years, we have been at work defending people from things we hope will never happen—so that we are prepared just in case they ever do. We do what we do because we see the opportunity to create a better, more secure world. One where preparedness empowers protection from the threats we face. And peace of mind prevails. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information, visit our website and follow us on LinkedIn, Twitter, and Instagram. NON-GAAP FINANCIAL MEASURES In the accompanying analysis of financial information, we sometimes use information derived from consolidated and segment financial information that may not be presented in our financial statements or prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). Certain of these financial measures are considered not in conformity with GAAP (“non-GAAP financial measures”) under the United States Securities and Exchange Commission (“SEC”) rules. Specifically, we have referred to the following non-GAAP financial measures: Adjusted Net Income (Loss)Adjusted Net Income (Loss) per Diluted ShareAdjusted EBITDATotal Segment RevenuesTotal Segment Gross MarginTotal Segment Gross Margin %Total Segment Adjusted Gross MarginTotal Segment Adjusted Gross Margin %Segment Adjusted Gross MarginSegment Adjusted Gross Margin % We define Adjusted Net Income (Loss) and Adjusted Net Income (Loss) per Diluted Share, which are non-GAAP financial measures, as net income (loss) and net income (loss) per diluted share, respectively, excluding the impact of changes in fair value of financial instruments, acquisition and divestiture-related costs, severance and restructuring costs, settlement charges, net, exit and disposal costs, impairment charges, gain (loss) on sale of business, non-cash amortization charges, contingent consideration milestones, and other income (expense) items. We use Adjusted Net Income (Loss) for the purpose of calculating Adjusted Net Income (Loss) per Diluted Share. Management uses Adjusted Net Income (Loss) per Diluted Share to assess total Company operating performance on a consistent basis. We believe that these non-GAAP financial measures, when considered together with our GAAP financial results and GAAP financial measures, provide management and investors with an additional understanding of our business operating results, including underlying trends. We define Adjusted EBITDA, which is a non-GAAP financial measure, as consolidated net income (loss) before income tax provision (benefit), interest expense, net, depreciation, amortization of intangible assets, excluding the impact of changes in fair value of financial instruments, acquisition and divestiture-related costs, severance and restructuring costs, settlement charges, net, exit and disposal costs, impairment charges, gain (loss) on sale of business, non-cash amortization charges, contingent consideration milestones and other income (expense) items. We believe that this non-GAAP financial measure, when considered together with our GAAP financial results and GAAP financial measures, provides management and investors with a more complete understanding of our operating results, including underlying trends. In addition, EBITDA is a common alternative measure of operating performance used by many of our competitors. It is used by investors, financial analysts, rating agencies and others to value and compare the financial performance of companies in our industry, although it may be defined differently by different companies. Therefore, we also believe that this non-GAAP financial measure, considered along with corresponding GAAP financial measures, provides management and investors with additional information for comparison of our operating results with the operating results of other companies. We have included the definitions of Segment Gross Margin and Segment Gross Margin %, which are GAAP financial measures, below in order to more fully define the components of certain non-GAAP financial measures presented in this press release. We define Segment Gross Margin, as a segment's revenues, less a segment's cost of sales or services. We define Segment Gross Margin %, as Segment Gross Margin as a percentage of a segments revenues. We define Segment Adjusted Gross Margin, which is a non-GAAP financial measure as Segment Gross Margin excluding the impact of restructuring costs, changes in the fair value of financial instruments, settlement charges, net and inventory step-up provision. We define Segment Adjusted Gross Margin %, which is a non-GAAP financial measure, as Segment Adjusted Gross Margin as a percentage of a segment's revenues. We define Total Segment Revenues, which is a non-GAAP financial measure, as our Total Revenues, less contracts and grants revenue, which is also equal to the sum of the revenues of our reportable operating segments. We define Total Segment Gross Margin, which is a non-GAAP financial measure, as Total Segment Revenues less our aggregate cost of sales or services. We define Total Segment Gross Margin %, which is a non-GAAP financial measure, as Total Segment Gross Margin as a percentage of Total Segment Revenues. We define Total Segment Adjusted Gross Margin, which is a non-GAAP financial measure, as Total Segment Gross Margin, excluding the impact of restructuring costs, settlement charges, net, changes in the fair value of financial instruments and inventory step-up provision. We define Total Segment Adjusted Gross Margin %, which is a non-GAAP financial measure, as Total Segment Adjusted Gross Margin as a percentage of Total Segment Revenues. Non-GAAP financial measures are not defined in the same manner by all companies and may not be comparable with other similarly titled measures of other companies. The determination of the amounts that are excluded from these non-GAAP financial measures are a matter of management judgment and depend upon, among other factors, the nature of the underlying expense or income amounts. Non-GAAP financial measures should be considered in addition to, but not as a substitute for or superior to, the information contained in our Consolidated Statements of Operations and Consolidated Statements of Cash Flows. Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the financial tables accompanying this press release. SAFE HARBOR STATEMENT This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including statements regarding the future performance of the Company or any of our businesses, our business strategy, future operations, future financial position, future revenues and earnings, our ability to achieve the objectives of our restructuring initiatives and divestitures, including our future results, projected costs, prospects, plans and objectives of management, are forward-looking statements. We generally identify forward-looking statements by using words like “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “future,” “goal,” “intend,” “may,” “plan,” “position,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” and similar expressions or variations thereof, or the negative thereof, but these terms are not the exclusive means of identifying such statements. Forward-looking statements are based on our current intentions, beliefs, assumptions and expectations regarding future events based on information that is currently available. Readers should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Readers are, therefore, cautioned not to place undue reliance on any forward-looking statement contained herein. Any such forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake any obligation to update any forward-looking statement to reflect new information, events or circumstances. There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements, including, among others, the availability of USG funding for contracts related to procurement of our medical countermeasure ("MCM") products, including CYFENDUS® (Anthrax Vaccine Adsorbed (AVA) Adjuvanted), previously known as AV7909, BioThrax® (Anthrax Vaccine Adsorbed), and ACAM2000® (Smallpox (Vaccinia) Vaccine, Live) among others, as well as contracts related to development of medical countermeasures; the availability of government funding for our other commercialized products, including Ebanga™ (ansuvimab-zykl) and BAT® (Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine)); our ability to meet our commitments to quality and compliance in all of our manufacturing operations; our ability to negotiate additional USG procurement or follow-on contracts for our MCM products that have expired or will be expiring; the commercial availability and acceptance of over-the-counter NARCAN® (naloxone HCl) Nasal Spray; the impact of a generic and competitive marketplace on NARCAN® Nasal Spray and future NARCAN® Nasal Spray sales; our ability to perform under our contracts with the USG, including the timing of and specifications relating to deliveries; our ability to provide Bioservices (as defined below) for the development and/or manufacture of product and/or product candidates of our customers at required levels and on required timelines; the ability of our contractors and suppliers to maintain compliance with current good manufacturing practices and other regulatory obligations; our ability to negotiate further commitments related to the collaboration and deployment of capacity toward future commercial manufacturing under our existing Bioservices contracts; our ability to collect reimbursement for raw materials and payment of service fees from our Bioservices customers; the results of pending government investigations and their potential impact on our business; our ability to obtain final court approval of the proposed settlement agreement relating to the stockholder litigation, including our ability to satisfy the conditions of the proposed settlement, and the source of funds to be used to resolve the litigation, and the potential impact of the settlement agreement, if approved, on our business; our ability to comply with the operating and financial covenants required by our term loan facility under a credit agreement, dated August 30, 2024, our revolving credit facility under a credit agreement, dated September 30, 2024, and our 3.875% Senior Unsecured Notes due 2028; our ability to maintain adequate internal control over financial reporting and to prepare accurate financial statements in a timely manner; our ability to successfully manage our liquidity in order to continue as a going concern; the procurement of our product candidates by USG entities under regulatory authorities that permit government procurement of certain medical products prior to FDA marketing authorization, and corresponding procurement by government entities outside the United States; our ability to realize the expected benefits of the sale of our travel health business to Bavarian Nordic, the sale of RSDL® to SERB Pharmaceuticals and the sale of our drug product facility in Baltimore-Camden to Bora Pharmaceuticals Injectables Inc.; the impact of the organizational changes we announced in January 2023, August 2023, May 2024 and August 2024; our ability to identify and acquire companies, businesses, products or product candidates that satisfy our selection criteria; the impact of cyber security incidents, including the risks from the unauthorized access, interruption, failure or compromise of our information systems or those of our business partners, collaborators or other third parties; the success of our commercialization, marketing and manufacturing capabilities and strategy; and the accuracy of our estimates regarding future revenues, expenses, capital requirements and need for additional financing. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Readers should consider this cautionary statement, as well as the risks identified in our periodic reports filed with the Securities and Exchange Commission, when evaluating our forward-looking statements. Trademarks Emergent®, BioThrax®, BaciThrax®, BAT®, Trobigard®, Anthrasil®, CNJ-016®, ACAM2000®, ​NARCAN®, CYFENDUS®, TEMBEXA® and any and all Emergent BioSolutions Inc. brands, products, services and feature names, logos and slogans are trademarks or registered trademarks of Emergent BioSolutions Inc. or its subsidiaries in the United States or other countries. All other brands, products, services and feature names or trademarks are the property of their respective owners, including RSDL® (Reactive Skin Decontamination Lotion), which was acquired by SERB on July 31, 2024. Investor ContactRich LindahlExecutive Vice President, Chief Financial Officerlindahlr@ebsi.comMedia ContactAssal HellmerVice President, Communicationsmediarelations@ebsi.com Emergent BioSolutions Inc. Consolidated Balance Sheets(unaudited, in millions, except per share data) September 30, December 31, 2024 2023 ASSETS Current assets: Cash and cash equivalents$149.9 $111.7 Restricted cash 6.5 — Accounts receivable, net 121.3 191.0 Inventories, net 322.7 328.9 Prepaid expenses and other current assets 61.0 47.9 Total current assets 661.4 679.5 Property, plant and equipment, net 278.1 382.8 Intangible assets, net 517.8 566.6 Other assets 20.5 194.3 Total assets$1,477.8 $1,823.2 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable$82.1 $112.2 Accrued expenses 16.1 18.6 Accrued compensation 63.3 74.1 Debt, current portion 0.8 413.7 Other current liabilities 67.6 32.7 Total current liabilities 229.9 651.3 Debt, net of current portion 661.8 446.5 Deferred tax liability 41.9 47.2 Other liabilities 35.8 28.9 Total liabilities$969.4 $1,173.9 Stockholders’ equity: Preferred stock, $0.001 par value per share; 15.0 shares authorized, no shares issued and outstanding — — Common stock, $0.001 par value per share; 200.0 shares authorized, 59.7 and 57.8 shares issued; 54.1 and 52.2 shares outstanding, respectively. 0.1 0.1 Treasury stock, at cost, 5.6 and 5.6 common shares, respectively (227.7) (227.7)Additional paid-in capital 924.4 904.4 Accumulated other comprehensive loss, net (7.3) (5.7)Accumulated deficit (181.1) (21.8)Total stockholders’ equity$508.4 $649.3 Total liabilities and stockholders’ equity$1,477.8 $1,823.2 Emergent BioSolutions Inc. Consolidated Statements of Operations(unaudited, in millions, except per share data) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Revenues: Commercial Product sales$95.3 $142.1 $333.8 $386.2 MCM Product sales 174.2 107.7 393.0 309.2 Total Product sales, net 269.5 249.8 726.8 695.4 Bioservices: Services 13.9 13.2 96.7 52.2 Leases 0.4 1.0 0.8 5.5 Total Bioservices revenues 14.3 14.2 97.5 57.7 Contracts and grants 10.0 6.5 24.6 19.6 Total revenues 293.8 270.5 848.9 772.7 Operating expenses: Cost of Commercial Product sales 47.2 60.0 152.7 160.2 Cost of MCM Product sales 54.0 72.5 147.3 208.4 Cost of Bioservices 21.4 44.3 263.3 151.7 Research and development 13.8 15.3 61.6 82.0 Selling, general and administrative 76.6 86.0 247.2 278.7 Amortization of intangible assets 16.3 16.3 48.8 49.4 Goodwill impairment — 218.2 — 218.2 Impairment of long-lived assets — — 27.2 306.7 Total operating expenses 229.3 512.6 948.1 1,455.3 Income (loss) from operations 64.5 (242.1) (99.2) (682.6) Other income (expense): Interest expense (8.3) (19.7) (56.2) (66.2)Gain (loss) on sale of business 64.3 (0.7) 24.3 74.2 Other, net 21.9 (3.4) 15.8 (2.1)Total other income (expense), net 77.9 (23.8) (16.1) 5.9 Income (loss) before income taxes 142.4 (265.9) (115.3) (676.7)Income tax provision (benefit) 27.6 (2.5) 44.0 34.3 Net income (loss)$114.8 $(263.4) $(159.3) $(711.0) Earnings (loss) per common share Basic$2.16 $(5.08) $(3.03) $(13.97)Diluted$2.06 $(5.08) $(3.03) $(13.97) Shares used in computing earnings (loss) per common share Basic 53.1 51.8 52.6 50.9 Diluted 55.6 51.8 52.6 50.9 Nine Months Ended September 30, 2024 2023 Operating Activities Net loss$(159.3) $(711.0)Adjustments to reconcile net loss to net cash provided by (used in) operating activities: Share-based compensation expense 13.7 19.1 Depreciation and amortization 82.8 95.5 Change in fair value of contingent obligations, net 0.6 (0.4)Amortization of deferred financing costs 5.2 15.6 Deferred income taxes (5.1) (3.7)Noncash gain on sale of business (32.2) (74.2)Change in fair value of warrant and forward liabilities (1.1) — Goodwill impairment — 218.2 Impairment of long-lived assets 27.2 306.7 Loss on disposal of assets 28.9 13.9 Other 3.9 (5.0)Changes in operating assets and liabilities: Accounts receivable 52.7 (58.5)Inventories (35.5) (25.0)Prepaid expenses and other assets 146.3 (18.3)Accounts payable (22.8) 17.7 Accrued expenses and other liabilities 32.9 (30.2)Long-term incentive plan accrual 2.5 3.7 Accrued compensation (9.9) (0.8)Income taxes receivable and payable, net 26.6 (3.5)Contract liabilities (18.8) 1.8 Net cash provided by (used in) operating activities 138.6 (238.4)Investing Activities Purchases of property, plant and equipment (21.2) (40.2)Proceeds from sale of property, plant and equipment 7.6 — Milestone payment from prior asset acquisition — (6.3)Proceeds from sale of business 110.2 270.2 Net cash provided by investing activities 96.6 223.7 Financing Activities Proceeds from the issuance of debt, net of lender fees 219.0 — Proceeds allocated to warrants issued in conjunction with debt 13.4 — Proceeds allocated to common stock issued in conjunction with debt 9.3 — Principal payments on term loan facility (198.2) (160.7)Proceeds from revolving credit facility 65.0 — Principal payments on revolving credit facility (284.2) (386.8)Debt issuance costs (14.6) — Proceeds from share-based compensation activity 0.7 1.3 Taxes paid for share-based compensation activity (0.9) (2.4)Proceeds from at-the-market sale of stock, net of commissions and expenses — 8.2 Net cash used in financing activities: (190.5) (540.4)Effect of exchange rate changes on cash, cash equivalents and restricted cash — 0.3 Net change in cash, cash equivalents and restricted cash 44.7 (554.8)Cash, cash equivalents and restricted cash, beginning of period 111.7 642.6 Cash, cash equivalents and restricted cash, end of period$156.4 $87.8 Supplemental cash flow disclosures: Cash paid for interest$55.8 $56.5 Cash paid for income taxes$35.5 $38.3 Non-cash investing and financing activities: Purchases of property, plant and equipment unpaid at period end$1.6 $9.2 Gain on extinguishments of debt$0.6 $— Issuance of common stock in conjunction with debt 7.7 — Reconciliation of cash and cash equivalents and restricted cash: Cash and cash equivalents$149.9 $87.8 Restricted cash 6.5 — Total$156.4 $87.8 Emergent BioSolutions, Inc.Reconciliation of Non-GAAP Financial MeasuresReconciliation of Net Income (Loss) and Net Income (Loss) per Diluted Share to Adjusted Net Income (Loss) and Adjusted Net Income (Loss) per Diluted Share(1) ($ in millions, except per share data)Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 SourceNet income (loss)$114.8 $(263.4) $(159.3)$(711.0) Adjustments: Non-cash amortization charges$9.7 $21.9 $54.0 $65.0 Amortization of intangible assets (IA), Other IncomeImpairments — 218.2 27.2 524.9 Impairment of long-lived assets and goodwillSeverance and restructuring costs 6.3 20.6 22.9 34.5 Cost of MCM Products, Cost of Services, SG&A and R&DInventory step-up provision 1.2 — 1.2 1.9 Cost of MCM ProductsAcquisition and divestiture costs — — — 2.8 SG&AExit and disposal costs — — 13.3 6.1 R&DLoss (gain) on sale of business (64.3) 0.7 (24.3) (74.2)Other Income (Expense)Settlement charges, net 10.0 — 120.2 — Cost of Services and SG&AContingent consideration milestones (30.0) — (30.0) — Other Income (Expense)Changes in fair value of financial instruments (1.1) (1.1) (0.5) (0.4)Cost of MCM Products and Other Income (Expense)Other expense (income), net items 6.7 — 9.8 — Other Income (Expense)Tax effect 22.9 (53.1) (49.2) (122.6) Total adjustments:$(38.6)$207.2 $144.6 $438.0 Adjusted net income (loss)$76.2 $(56.2) $(14.7)$(273.0) Net income (loss) per diluted share$2.06 $(5.08) $(3.03)$(13.97) Adjustments: Non-cash amortization charges$0.17 $0.42 $1.03 $1.28 Amortization of IA, Other Income (Expense)Impairments — 4.21 0.52 10.31 Impairment of long-lived assetsSeverance and restructuring costs 0.12 0.40 0.44 0.68 Cost of MCM Products, Cost of Services, SG&A and R&DInventory step-up provision 0.02 — 0.02 0.04 Cost of MCM ProductsAcquisition and divestiture costs — — — 0.06 SG&AExit and disposal costs — — 0.25 0.12 R&DLoss (gain) on sale of business (1.16) 0.01 (0.46) (1.46)Other Income (Expense)Settlement charges, net 0.18 — 2.29 — Cost of Services and SG&AContingent consideration milestones (0.54) — (0.57) — Other Income (Expense)Changes in fair value of financial instruments (0.02) (0.02) (0.01) (0.01)Cost of MCM Products and Other Income (Expense)Other expense (income), net items 0.12 — 0.19 — Other Income (Expense)Tax effect 0.42 (1.03) (0.95) (2.41) Total adjustments:$(0.69)$3.99 $2.75 $8.61 Adjusted net income (loss) per diluted share$1.37 $(1.09) $(0.28)$(5.36) Diluted shares used in computing Adjusted net income (loss) per diluted share 55.6 51.8 52.6 50.9 Emergent BioSolutions, Inc.Reconciliation of Net Income (Loss) to Adjusted EBITDA(1) ($ in millions)Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Net income (loss)$114.8 $(263.4) $(159.3)$(711.0)Adjustments: Depreciation & amortization$26.4 $27.9 $82.8 $95.5 Income taxes 27.6 (2.5) 44.0 34.3 Total interest expense, net 7.7 19.4 54.8 59.9 Impairments — 218.2 27.2 524.9 Inventory step-up provision 1.2 — 1.2 1.9 Changes in fair value of financial instruments (1.1) (1.1) (0.5) (0.4)Severance and restructuring costs 6.3 20.6 22.9 34.5 Exit and disposal costs — — 13.3 6.1 Acquisition and divestiture costs — — — 2.8 Loss (gain) on sale of business (64.3) 0.7 (24.3) (74.2)Settlement charges, net 10.0 — 120.2 — Contingent consideration milestones (30.0) — (30.0) — Other expense (income), net items 6.7 — 9.8 — Total adjustments$(9.5)$283.2 $321.4 $685.3 Adjusted EBITDA$105.3 $19.8 $162.1 $(25.7) Emergent BioSolutions, Inc.Reconciliations of Total Revenues to Total Segment Revenues and of Segment and Total Segment Gross Margin and Gross Margin % to Segment and Total Segment Adjusted Gross Margin and Adjusted Gross Margin %(1) Three Months Ended September 30, 2024(unaudited, in millions)Commercial ProductsMCM ProductsServices Total Segment Contracts & Grants Total RevenuesRevenues$95.3 $174.2 $14.3 $283.8 $10.0$293.8 Cost of sales or services 47.2 54.0 21.4 122.6 Gross margin$48.1 $120.2 $(7.1) $161.2 Gross margin % 50% 69%(50)% 57% Add back: Inventory step-up provision$— $1.2 $— $1.2 Restructuring costs — 4.9 0.1 5.0 Adjusted gross margin$48.1 $126.3 $(7.0) $167.4 Adjusted gross margin % 50% 73%(49)% 59% Three Months Ended September 30, 2023(unaudited, in millions)Commercial ProductsMCM ProductsServices Total SegmentContracts & Grants Total RevenuesRevenues$142.1 $107.7 $14.2 $264.0 $6.5$270.5 Cost of sales or services 60.0 72.5 44.3 176.8 Gross margin$82.1 $35.2 $(30.1) $87.2 Gross margin % 58% 33%(212)% 33% Add back: Changes in fair value of financial instruments$— $(1.1)$— $(1.1) Restructuring costs — 5.0 8.1 13.1 Adjusted gross margin$82.1 $39.1 $(22.0) $99.2 Adjusted gross margin % 58% 36%(155)% 38% Emergent BioSolutions, Inc.Reconciliations of Total Revenues to Total Segment Revenues and of Segment and Total Segment Gross Margin and Gross Margin % to Segment and Total Segment Adjusted Gross Margin and Adjusted Gross Margin %(1) Nine Months Ended September 30, 2024(unaudited, in millions)Commercial ProductsMCM ProductsServices1 Total SegmentContracts & Grants Total RevenuesRevenues$333.8 $393.0 $97.5 $824.3 $24.6$848.9 Cost of sales or services 152.7 147.3 263.3 563.3 Gross margin$181.1 $245.7 $(165.8) $261.0 Gross margin % 54% 63%(170)% 32% Add back: Changes in fair value of financial instruments$— $0.6 $— $0.6 Inventory step-up provision — 1.2 — 1.2 Settlement charges, net — — 110.2 110.2 Restructuring costs — 7.5 0.3 7.8 Adjusted gross margin$181.1 $255.0 $(55.3) $380.8 Adjusted gross margin %(1) 54% 65%(57)% 46% (1) Total Segment results for the nine months ended September 30, 2024 includes $50.0 million attributable to the Settlement Agreement with Janssen. The revenue and cost of services is related to raw materials purchased for the Janssen Agreement which Janssen had not reimbursed. Excluding the impacts of the Settlement Agreement, Total Segment Adjusted Gross Margin % would have been 3% higher for the nine months ended September 30, 2024. Nine Months Ended September 30, 2023(in millions)Commercial ProductsMCM ProductsServices Total SegmentContracts & Grants Total RevenuesRevenues$386.2 $309.2 $57.7 $753.1 $19.6$772.7 Cost of sales or services 160.2 208.4 151.7 520.3 Gross margin$226.0 $100.8 $(94.0) $232.8 Gross margin % 59% 33%(163)% 31% Add back: Changes in fair value of financial instruments$— $(0.4)$— $(0.4) Inventory step-up provision — 1.9 — 1.9 Restructuring costs — 7.0 8.1 15.1 Adjusted gross margin$226.0 $109.3 $(85.9) $249.4 Adjusted gross margin % 59% 35%(149)% 33% Emergent BioSolutions, Inc.Reconciliation of Net Loss Forecast to Adjusted Net Income (Loss) Forecast ($ in millions)2024 Full Year ForecastSourceNet loss$(203) - $(183) Adjustments: Non-cash amortization charges$65Amortization of intangible assets and Other Income (Expense)Changes in fair value of financial instruments(1)Other Income (Expense)Impairments27Impairment of long-lived assetsSeverance and restructuring costs23Cost of MCM Products, Cost of Services, SG&A and R&DInventory step-up provision1Cost of MCM ProductsExit and disposal costs13R&DLoss (gain) on sale of business(24)Other Income (Expense)Settlement charges, net120Cost of Services and SG&AContingent consideration milestones(30)Other Income (Expense)Other expense (income), net items10Other Income (Expense)Tax effect(51) Total adjustments:$153 Adjusted net loss$(50) - $(30) Reconciliation of Net Loss Forecast to Adjusted EBITDA Forecast ($ in millions)2024 Full Year ForecastNet loss$(203) - $(183)Adjustments: Depreciation & amortization$109Income taxes60Total interest expense, net75Impairments27Inventory step-up provision1Changes in fair value of financial instruments(1)Severance and restructuring costs23Exit and disposal costs13Loss (gain) on sale of business(24)Settlement charges, net120Contingent consideration milestones(30)Other expense (income), net items10Total adjustments$383Adjusted EBITDA$180 - $200 Reconciliations of Forecasted Total Revenues to Forecasted Total Segment Revenues and of Forecasted Segment and Total Segment Gross Margin and Gross Margin % to Forecasted Segment and Total Segment Adjusted Gross Margin and Adjusted Gross Margin %(1) (in millions)2024 Full Year Forecast Total revenues$1,065 - $1,125Contracts & Grants(30) - (35)Total segment revenues$1,035 - $1,090 Cost of sales or services$710 - $719Total segment gross margin$325 - $371Total segment gross margin %31% - 34%Add back: Changes in fair value of financial instruments$1Inventory step-up provision1Settlement charges, net110Restructuring costs8Total segment adjusted gross margin$445 - $491Total segment adjusted gross margin %43% - 45%