SARS-CoV-2 Spike Protein Vaccine(Recombinant)(Novavax, Inc.)

随着新冠疫苗销量锐减，诺瓦瓦克斯（Novavax）正着眼于其他新型疫苗，这些疫苗将在公司制药合作伙伴的帮助下推向市场。而在 2020 年新冠疫情席卷全球时，该公司并未选择这么做。 对于诺瓦瓦克斯来说，故事本可能大不相同。这家总部位于马里兰州的生物制药公司在不到两年半的时间里研发出新冠疫苗，并获得了美国食品药品监督管理局（FDA）的批准。唯一的问题是什么呢？另外三种疫苗上市速度更快。 通常情况下，研发一种疫苗需要大约 5 到 10 年的时间。由于紧迫性极高、政府资助以及战略合作伙伴关系，辉瑞（Pfizer）和 BioNTech 联合研发的新冠疫苗 Comirnaty 在 2020 年 12 月 11 日赢得了 FDA 的首个紧急使用授权（EUA），距离世界卫生组织于 3 月 11 日正式宣布新冠疫情，恰好过去了 9 个月。莫德纳（Moderna）的 Spikevax 和强生（Johnson & Johnson）的新冠疫苗也迅速获批。诺瓦瓦克斯的 Nuvaxovid 在 2022 年 7 月才获得 FDA 的紧急使用授权。 抢先上市的优势十分显著：辉瑞报告称，2021 年 Comirnaty 的销售额高达 368 亿美元，2022 年又达到 378 亿美元，而诺瓦瓦克斯的 Nuvaxovid 在 2022 年上市期间的销售额仅为 15 亿美元。此后，随着疫情的消退，所有这些疫苗都遭遇了所谓的 “新冠悬崖”，销售额大幅下降。 在世卫组织宣布新冠疫情五周年前夕，BioSpace 采访了诺瓦瓦克斯的执行副总裁兼首席企业事务与倡导官西尔维亚・泰勒（Silvia Taylor），探讨了公司在新冠疫情一线的经历。 泰勒表示：“我想这是我们学到的一点，速度是相对的。这只是一种假设，但如果其他公司花了三年时间，而我们花了两年呢？” 她沉思道，在那种情况下，人们问的可能就不是诺瓦瓦克斯为什么落后了，而是 “是什么让你们如此成功？” 吸取的战略教训 为了更好地说明情况，泰勒将诺瓦瓦克斯与德国的 BioNTech 进行了对比，称两者在全球健康危机中都是 “小型创新者”。 然而，与 BioNTech 不同的是，诺瓦瓦克斯在研发阶段选择了独自行动。泰勒说：“我们有更多的时间来扩大规模、建立商业基础设施和分销能力，所以我们选择了这么做。现在回过头看，我们本可以更快吗？我们不知道。我们不能对没有发生的事情进行推测。” 虽然泰勒指出，诺瓦瓦克斯的技术使其疫苗颇具吸引力，但这也可能延缓了疫苗的研发。诺瓦瓦克斯的 Nuvaxovid 基于蛋白质技术，泰勒认为这项技术 “很棒”，但她也表示，“它（蛋白质技术）就是没有（mRNA 技术）那么快。” 但泰勒强调，速度并非唯一的考量因素。她补充说，在应对具有大流行潜力的传染病时，思考世界真正需要什么非常重要。“拥有多种技术平台极其重要…… 因为我们知道，并非每种技术都适合所有人。” 虽然诺瓦瓦克斯在早期没有与其他制药公司合作，但在疫苗获批后的阶段，它利用了多项合作。泰勒指出，毕竟 Nuvaxovid 是这家拥有 38 年历史的公司首次商业化推出的产品，“我们当时真的处于学习阶段”。 泰勒称，2024 年 5 月，公司与赛诺菲（Sanofi）签署了一项许可协议，赛诺菲在疫苗商业化方面 “发挥主导作用”。此外，诺瓦瓦克斯还与另外两家 “大型制药公司” 签署了材料转移协议，不过泰勒没有透露更多细节。 她说，这些材料转移 “让其他公司能够接触到我们的佐剂基质，使他们能够研究并了解如何将其应用于自己的产品组合以及正在研发的疫苗中”。 合作也是诺瓦瓦克斯未来新冠疫苗战略的关键要素。该公司目前有一种新冠 / 流感联合疫苗正处于三期研发阶段。泰勒表示，对于这款产品，诺瓦瓦克斯决定在没有合作伙伴的情况下，不会进行全面研发或商业化推广。因此，在等待 2025 年年中预计出炉的试验数据时，泰勒称公司 “也在与潜在合作伙伴进行富有成效的对话”。“我们吸取了教训，并决定这就是我们要做的。” 诺瓦瓦克斯还在与 FDA 商讨这款联合疫苗的潜在加速审批途径。如果这一计划得以实现，将使诺瓦瓦克斯在这个竞争激烈的领域获得优势。2024 年 6 月，莫德纳公布了其新冠 / 流感联合疫苗 mRNA-1083 的三期积极数据，同年 8 月，辉瑞和 BioNTech 公布了他们联合疫苗的三期混合数据。莫德纳的产品目前正在接受 FDA 审查，而辉瑞和 BioNTech 的数据让合作伙伴 “评估疫苗的下一步计划”。 然而，诺瓦瓦克斯全资拥有的新冠 - 流感联合疫苗并非其在这一目标上的唯一尝试。泰勒说，与赛诺菲的协议还授权这家大型制药公司将 Nuvaxovid 与赛诺菲一款领先市场的流感疫苗进行组合，“他们决定这么做，而且不止一种候选疫苗，而是两种”。这两款疫苗在 2024 年 12 月都获得了 FDA 的快速通道指定。 泰勒说：“我认为联合疗法，即通过一种疫苗预防两种传染病，这是（新冠疫苗）市场的发展方向。” “备战状态” 在等待这些潜在产品带来收益的同时，诺瓦瓦克斯和同行们一样，面临着 “新冠悬崖” 的困境。 上个月，该公司公布了 2024 年第四季度及全年收益，报告显示，Nuvaxovid 在第四季度的销售额为 5000 万美元，而前一年同期为 2.51 亿美元。2024 年 Nuvaxovid 的总营收为 1.9 亿美元，而 2023 年为 5.31 亿美元。 但诺瓦瓦克斯仍向前看。泰勒说：“（新冠疫苗业务）从来都不是我们的长期战略。我们把能够推出新冠疫苗视为对我们技术平台和创新能力的验证。” 在收益报告中，诺瓦瓦克斯首席执行官约翰・雅各布斯（John Jacobs）列出了三个战略重点：与赛诺菲的合作、利用技术平台和产品线建立更多合作关系，以及推进技术平台和早期产品线的发展。值得一提的是，该公司有一种针对禽流感（H5N1）的实验性疫苗已准备好进入临床开发阶段。 泰勒说：“如果我们能为新冠疫情做到这些，那么举例来说，如果禽流感大流行爆发，会怎么样呢？” 在研发新冠疫苗时，诺瓦瓦克斯获得了流行病防范创新联盟（CEPI）和美国政府 “曲速行动”（Operation Warp Speed）的资助。泰勒表示，虽然 H5N1 疫情仍在持续 —— 据联合国数据，2024 年有 76 人感染了 H5 禽流感毒株，主要是农场工人 —— 诺瓦瓦克斯已经在与提供非稀释性资金的组织进行谈判，“探讨获得资金以推动研发进入下一阶段的可能性。这就是全球、美国的备战状态。我们准备好继续推进研发。” 泰勒表示，从更广泛的层面来看，制药行业在全球疫情期间也在沟通方面学到了很多。“我认为在（新冠疫情）期间，错误信息泛滥，但…… 我觉得与其说它影响了我们的疫苗，不如说它影响了人们对疫苗接种的总体态度。” 事实上，据《对话》（The Conversation）报道，自疫情以来，流感疫苗接种率有所下降，药店和医生诊所的接种剂量比新冠疫情前的平均年份减少了 920 万剂。 泰勒说，展望未来，情况需要改变。“我认为，从政府公共卫生官员、非政府组织到制药公司，我们都必须思考，如何以一种一致且简洁的方式发布信息？” 她说，虽然在新冠疫情期间这一点没有做到，但我们已经吸取了教训，“我们不会再重蹈覆辙”。 参考来源：https://www.biospace.com/business/novavax-applies-lessons-learned-from-turbulent-covid-19-experience 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不本站。

Transitioned lead commercial responsibility of Nuvaxovid™ COVID-19 vaccine to Sanofi beginning with the 2025-2026 season Achieved total revenue of $88 million in the fourth quarter of 2024 and $682 million for the full year 2024 Achieved $50 million milestone under Sanofi agreement associated with the pediatric clinical trial database lock for the first cohort Completed $200 million sale of Czech Republic manufacturing facility to Novo Nordisk; reduces annual costs by approximately $80 million Advanced pipeline programs, based on proven and innovative technology platform Ended full year 2024 with over $1 billion in Cash and accounts receivables Provides 2025 financial guidance and revenue framework Company to host conference call today at 8:30 a.m. ET GAITHERSBURG, Md., Feb. 27, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced its financial results and operational highlights for the fourth quarter and twelve months ended December 31, 2024. "In 2024, we unveiled our new corporate growth strategy, shifting our focus from commercializing our COVID-19 vaccine, to maximizing the value of our cutting-edge technology platform through pipeline expansion and partnerships for our development-stage vaccine candidates and our Matrix-M™ adjuvant," said John C. Jacobs, President and Chief Executive Officer, Novavax. "As we look to 2025 and beyond, we believe we are well positioned to potentially create significant value for all stakeholders." Fourth Quarter 2024 and Recent Highlights Strategic Priority #1: Sanofi Partnership Transitioned lead commercial responsibility of Nuvaxovid™ COVID-19 vaccine beginning with the 2025-2026 vaccination season for the U.S. and other select major markets Achieved $50 million milestone associated with the first pediatric database lock in the fourth quarter of 2024 Prescription Drug User Fee Act target action date of April 2025 for Novavax's COVID-19 vaccine Biologics License Application (BLA) Achievement of BLA approval triggers a $175 million milestone payment from Sanofi Marketing authorization transfers to Sanofi for U.S. and European Union (EU) markets are expected in late 2025 Achievement triggers an additional $50 million in combined milestone payments from Sanofi Sanofi announced it received U.S. Food and Drug Administration (FDA) Fast Track designation for two combination vaccine candidates progressing to Phase 1/2 clinical trials, combining Novavax's proven COVID-19 vaccine with Sanofi's market-leading influenza vaccines Potential for future $350 million development and launch milestone payments associated with Sanofi influenza-COVID-19 combination products Strategic Priority #2: Leverage our technology platform and pipeline to forge additional partnerships In December 2024, initiated an initial cohort of 2,000 participants for the Phase 3 trial for our COVID-19-Influenza Combination (CIC) and stand-alone seasonal influenza vaccine candidates to evaluate immunogenicity and safety in adults aged 65 and older Initial cohort data expected by mid-2025 Intend to partner both vaccine programs to advance all future clinical development, regulatory filing and commercialization activities R21/Matrix-M malaria vaccine launched in additional countries in Africa by Serum Institute of India Pvt. Ltd. (SII) Strategic Priority #3: Advance our technology platform and early-stage pipeline Continued preclinical development of H5N1 avian pandemic influenza program evaluating multiple highly pathogenic avian influenza strains Continued advancement of early-stage preclinical research for respiratory syncytial virus (RSV) combinations, varicella-zoster virus (shingles) and Clostridioides difficile (C. Diff.) colitis vaccine candidates Initiated exploratory preclinical work in areas outside of infectious disease, such as oncology Advancing artificial intelligence capabilities to significantly accelerate predictive modeling, optimize discovery and enhance the precision of vaccine design Initiated work on new potential Matrix formulations intended to enable different regimens and dosing schedules, improve vaccines and enable targeted approaches and advancements in therapeutic areas beyond infectious diseases Fourth Quarter and Full Year 2024 Financial Results Total revenue for the fourth quarter of 2024 was $88 million, compared to $291 million in the same period in 2023. Total revenue for the full year 2024 was $682 million, compared to $984 million in the same period in 2023. Product sales for the fourth quarter of 2024 were $50 million, compared to $251 million in the same period in 2023. Product sales for the full year 2024 were $190 million, compared to $531 million in the same period in 2023. The decrease in both periods was due to lower product sales under our APA agreements. Cost of sales for the fourth quarter of 2024 was $37 million, compared to $155 million in the same period in 2023. Cost of sales for the full year 2024 was $203 million, compared to $344 million in the same period in 2023. Research and development (R&D) expenses for the fourth quarter of 2024 were $104 million, compared to $165 million in the same period in 2023. R&D expenses for the full year 2024 were $391 million, compared to $738 million in the same period in 2023. The decrease in both periods was primarily due to reductions in overall expenditures relating to COVID-19 vaccine development and manufacturing activities. Selling, general and administrative (SG &A) expenses for the fourth quarter of 2024 were $78 million, compared to $155 million for the same period in 2023. SG&A expenses for the full year 2024 were $337 million, compared to $469 million in the same period in 2023. The decrease in both periods was primarily due to decreased COVID-19 vaccine commercialization activities and SG&A cost reduction efforts. Gain on disposition of Czech Republic manufacturing facility of $52 million recorded for the fourth quarter and full year 2024 was the result of the $200 million sale of our vaccine manufacturing facility located in the Czech Republic to Novo Nordisk. $190 million in cash payments were received in 2024 and an additional $10 million is expected in 2025 along with ongoing annual cost reductions of approximately $80 million. Net loss for the fourth quarter of 2024 was $81 million, compared to a net loss of $178 million in the same period in 2023. Net loss for the full year 2024 was $187 million, compared to net loss of $545 million in the same period in 2023. Cash, cash equivalents, marketable securities and restricted cash (Cash) were $938 million as of December 31, 2024, compared to $584 million as of December 31, 2023. Financial Framework Full Year 2025 Financial Guidance Novavax is providing Full Year 2025 Financial Guidance for R&D plus SG&A expenses and expects to achieve the following results: 2025 Revenue Framework Novavax has transitioned lead commercial responsibility of Nuvaxovid beginning with the 2025-2026 vaccination season to Sanofi for select markets. Since Novavax is reliant on Sanofi's sales forecasts for certain revenue components, these will not be included in the 2025 Revenue Framework at this time. For 2025, Novavax expects to achieve Adjusted Licensing, Royalties and Other Revenue of between $300 million to $350 million. $225 million in U.S. BLA & Market Authorizations Milestones. Novavax is eligible to receive from Sanofi a $175 million milestone payment upon the approval of the COVID-19 U.S. BLA and inclusive of JN.1 and pre-filled syringe presentation, and two separate $25 million milestone payments upon the transfer to Sanofi of the Market Authorization for the U.S. and EU markets, respectively. $15 million Database Lock Milestone Amortization. In December 2024, Novavax triggered the achievement of a $50 million milestone from Sanofi related to the COVID-19 pediatric database lock. Revenue recognition will occur over the performance period through 2026. During 2024, $16 million was recorded, and $15 million and $19 million are expected for 2025 and 2026, respectively. Receipt of the $50 million cash payment is expected in the first quarter of 2025. All remaining milestone payments under the Sanofi CLA will be recorded to revenue in the periods when earned. $35 million Upfront Payment Amortization. In 2024, Novavax received a $500 million upfront payment upon signing of the Sanofi CLA. Revenue recognition will occur over the performance period through 2026. During 2024, $424 million was recorded, and $35 million and $41 million are expected for 2025 and 2026, respectively. $25 million to $50 million of R&D Reimbursement. Under the Sanofi CLA, Novavax is eligible to receive reimbursement for costs incurred related to select R&D and technology transfer activities during the transition performance period that is expected to run through the end of 2026. $0 million to $25 million in Other partner revenue. Royalties and adjuvant reimbursement associated with collaborations with the Serum Institute on R21 and collaboration partners for COVID-19 vaccine, including Serum, SK Bio and Takeda. Components of Revenue excluded from the 2025 Revenue Framework are described below. Sanofi Royalties Sanofi will initiate lead commercial responsibility for the 2025-2026 vaccination season in select markets, including the U.S. Novavax is eligible to receive royalties in the high teens to low twenties percent on Sanofi sales. Sanofi CIC and Matrix-M Related Milestones Novavax is eligible to receive up to $350 million in Phase 3 development and commercial launch milestone payments associated with Sanofi influenza-COVID-19 combination products. For each new vaccine using Matrix-M, Novavax is eligible to receive up to $200 million in launch and sales milestones and mid-single digit sales royalties for 20 years. Nuvaxovid Product Sales During the first half of 2025, Novavax will continue to sell Nuvaxovid in the U.S. as it transitions the market to Sanofi beginning with the 2025-2026 vaccination season. These sales are expected to be immaterial. Novavax will sell Nuvaxovid commercial supply to Sanofi for the 2025-2026 vaccination season and the reimbursement for this supply will be recorded as product sales. APAs - Novavax is working to amicably negotiate or deliver doses or when appropriate exit agreements with the goal of these activities to be cash flow neutral or favorable on a go forward basis. Conference Call Novavax will host its quarterly conference call today at 8:30 a.m. ET. To join the call without operator assistance, you may register and enter your phone number at to receive an instant automated call back. You may also dial direct to be entered to the call by an operator. The dial-in numbers for the conference call are (800) 836-8184 (Domestic) or (+1) (646) 357-8785 (International). Participants will be prompted to request to join the Novavax, Inc. call. A replay of the conference call will be available starting at 11:30 a.m. ET on February 27, 2025, until 11:59 p.m. ET on March 6, 2025. To access the replay by telephone, dial (888) 660-6345 (Domestic) or (+1) (646) 517-4150 (International) and use passcode 79349 #. A webcast of the conference call can also be accessed on the Novavax website at ir.novavax.com/events. A replay of the webcast will be available on the Novavax website until March 29, 2025. About Novavax Novavax, Inc. (Nasdaq: NVAX) tackles some of the world's most significant health challenges by leveraging its scientific expertise in vaccines and its cutting-edge technology platform, including a protein-based nanoparticle and Matrix-M™ adjuvant. The Company's growth strategy is focused on building new and diversified partnerships via the out-licensing of its technology platform and vaccine assets earlier in the development process. These strategic collaborations are fueled by smart investments in a growing early-stage pipeline starting with the Company's core expertise in infectious disease and potentially expanding into other disease areas. Please visit novavax.com and LinkedIn for more information. Non-GAAP Financial Measures The Company has used a non-GAAP financial measure in this press release, which is Adjusted Licensing, Royalties and Other Revenue. Non-GAAP financial measures refer to financial information adjusted from financial measures prepared in accordance with accounting principles generally accepted in the United States (GAAP). The Company believes that the presentation of this adjusted financial measure is useful to investors as it provides additional information on comparisons between periods by including certain items that affect overall comparability. The Company uses this non-GAAP financial measure for business planning purposes and to consider underlying trends of its business and believes presenting this measure also provides useful information to investors and others for understanding and evaluating trends in the Company's expenses in the same manner as the Company's management. Non-GAAP financial measures should be considered in addition to, and not as an alternative for, the Company's reported results prepared in accordance with GAAP. The use of this non-GAAP financial measure may differ from similar measures reported by other companies and may not be comparable to other similarly titled measures. The Company is unable to reconcile this forward-looking non-GAAP financial measure to the most directly comparable GAAP measure without unreasonable effort because the Company is reliant on Sanofi sales forecasts for certain revenue categories, which are not available. Forward-Looking Statements Statements herein relating to the future of Novavax, its mission; its corporate strategy and operating plans, objectives and prospects; its value drivers and near-term priorities, its partnerships, including expectations with respect to potential royalties, milestones, and cost reimbursement, and plans for additional potential partnering activities; its expectations regarding manufacturing capacity, timing, production and delivery for its COVID-19 vaccine; the transition of the lead responsibility for commercialization of Novavax's COVID-19 vaccine to Sanofi beginning with the 2025-2026 vaccination season; the development of Novavax's clinical and preclinical product candidates and innovation expansion opportunities, including with respect to new Matrix formulations; the conduct, timing and potential results from clinical trials and other preclinical studies; scope, timing and outcome of future and pending regulatory filings and actions, including the potential BLA approval for Novavax's COVID-19 vaccine; full year 2025 financial guidance and revenue framework; negotiations regarding Novavax's existing advance purchase agreements; and Novavax's future financial or business performance. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges or delays in obtaining regulatory authorization or approval for its COVID-19 vaccine, in particular with respect to its BLA submission to the FDA for approval of its COVID-19 vaccine, or its other product candidates, including for future COVID-19 variant strain changes, its CIC vaccine candidate, its stand-alone influenza vaccine candidate or other product candidates; Novavax's ability to successfully and timely manufacture, market, distribute, or deliver its updated 2024-2025 formula COVID-19 vaccine and the impact of its not having received a BLA from the FDA for the 2024-2025 vaccination season; challenges related to Novavax's partnership with Sanofi and in pursuing additional partnership opportunities; challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification, assay validation and stability testing, necessary to satisfy applicable regulatory authorities; challenges or delays in conducting clinical trials or studies for its product candidates; manufacturing, distribution or export delays or challenges; Novavax's substantial dependence on SII and Serum Life Sciences Limited for co-formulation and filling Novavax's COVID-19 vaccine and the impact of any delays or disruptions in their operations; difficulty obtaining scarce raw materials and supplies including for its proprietary adjuvant; resource constraints, including human capital and manufacturing capacity; constraints on Novavax's ability to pursue planned regulatory pathways, alone or with partners; challenges in implementing its global restructuring and cost reduction plan; Novavax's ability to timely deliver doses; challenges in obtaining commercial adoption and market acceptance of its updated 2024-2025 formula COVID-19 vaccine or any COVID-19 variant strain containing formulation, or for its CIC vaccine candidate and stand-alone influenza vaccine candidate or other product candidates; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities, including requirements to deliver doses that may require Novavax to refund portions of upfront and other payments previously received or result in reduced future payments pursuant to such agreements and challenges in amending or terminating such agreements; challenges related to the seasonality of vaccinations against COVID-19 or influenza; challenges related to the demand for vaccinations against COVID-19 or influenza; challenges in identifying and successfully pursuing innovation expansion opportunities, including with respect to Novavax's Matrix-MTM adjuvant; Novavax's expectations as to expenses and cash needs may prove not to be correct for reasons such as changes in plans or actual events being different than its assumptions; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at and , for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Contacts: Investors Luis Sanay, CFA 240-268-2022 [email protected] Media Giovanna Chandler 202-709-5563 [email protected] SOURCE Novavax, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED