3 unchanged sentences
Such forward-looking statements include, without limitation, statements about our capabilities, goals, expectations regarding future revenue and expense levels, and capital raising activities;
+Added: our corporate growth strategy and key value drivers;
+Added: our technology platform;
+Added: our COVID-19 program (which currently includes our Nuvaxovid™ prototype COVID-19 vaccine ("NVX-CoV2373” or “prototype COVID-19 vaccine”), our Nuvaxovid™ COVID-19 vaccine for the 2023-2024 vaccination season (“XBB COVID-19 Vaccine”) and our Nuvaxovid™ updated COVID-19 vaccine for the 2024-2025 vaccination season (“NVX-CoV2705” or “updated COVID-19 vaccine”) collectively referred to as our (“COVID-19 Vaccine”));
our operating plans and prospects, including our ability to continue as a going concern through one year from the date of Novavax’ audited financial statements for the year ended December 31, 2024;
−Removed: our global restructuring and cost reduction plan (“Restructuring Plan”), which includes a more focused investment in our COVID-19 commercial program (which currently includes Nuvaxovid™ prototype COVID-19 vaccine ("NVX-CoV2373” or “prototype vaccine”) and Nuvaxovid™ updated COVID-19 vaccine (“NVX-CoV2601” or “updated vaccine”) collectively referred to as our (“COVID-19 Vaccine”)), potential market sizes and demand for our product candidates;
−Removed: the efficacy, safety, and intended utilization of our product candidates;
+Added: our global restructuring and cost reduction plan (“Restructuring Plan”), which includes a more focused investment in our COVID-19 vaccine;
+Added: our cash flow forecast and project revenue, including potential royalties and milestones pursuant to our collaboration and license agreement (the “Sanofi CLA”) with Sanofi Pasteur Inc.
+Added: potential market sizes and demand for our products and product candidates;
+Added: the efficacy, safety, and intended utilization of our products and product candidates;
the development of our clinical-stage product candidates and our recombinant vaccine and adjuvant technologies;
the development of our preclinical product candidates;
+Added: our research and development investment strategy;
+Added: the potential expansion of our pipeline beyond infections diseases into other therapeutic areas;
our expectations related to enrollment in our clinical trials;
2 unchanged sentences
our expectation of manufacturing capacity, timing, production, distribution, and delivery for our COVID-19 Vaccine by us and our partners;
−Removed: our estimate of the number of individuals who may potentially be reached by our COVID-19 Vaccine;
−Removed: our expectations with respect to the anticipated ongoing development and commercialization or licensure of the COVID-19 Vaccine, ongoing development of COVID-19 variant strain-containing monovalent or bivalent formulation, efforts to expand our COVID-19 Vaccine label worldwide as a booster, and to various age groups and geographic locations;
+Added: our expectations with respect to the anticipated ongoing development and commercialization or licensure of the COVID-19 Vaccine;
+Added: our expectations with respect to the anticipated ongoing development of COVID-19 variant strain-containing formulations, including the Phase 2b/3 Hummingbird™ trial, our CIC vaccine candidate and our stand-alone influenza vaccine candidate;
+Added: our partnership efforts for our COVID-19-Influenza (“CIC”) vaccine candidate and stand-alone influenza vaccine candidate to advance towards a Biologics License Application (“BLA”) filing and commercialization;
+Added: efforts to expand our COVID-19 Vaccine label worldwide as a booster, and to various age groups and geographic locations;
the expected timing, content, and outcomes of regulatory actions;
−Removed: funding from the U.S.
−Removed: government partnership formerly known as Operation Warp Speed under the USG Agreement, the U.S.
−Removed: Department of Defense (“DoD”), and CEPI;
−Removed: funding under our APAs and supply agreements and amendments to, termination of, discussion regarding, or legal disputes relating to any such agreement;
+Added: funding under our advance purchase agreements ("APAs") and supply agreements and amendments to, termination of, discussion regarding, or legal disputes relating to any such agreement;
our available cash resources and usage and the availability of financing generally;
plans regarding partnering activities and business development initiatives;
+Added: plans regarding APA amendments;
and other matters referenced herein.
Generally, forward-looking statements can be identified through the use of words or phrases such as “believe,” “may,” “could,” “will,” “would,” “possible,” “can,” “estimate,” “continue,” “ongoing,” “consider,” “anticipate,” “intend,” “seek,” “plan,” “project,” “expect,” “should,” “would,” “aim,” or “assume,” the negative of these terms, or other comparable terminology, although not all forward-looking statements contain these words.
+Added: Table o f Contents
Forward-looking statements are neither historical facts nor assurances of future performance.
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Forward-looking statements involve estimates, assumptions, risks, and uncertainties that could cause actual results or outcomes to differ materially from those expressed or implied in any forward-looking statements, and, therefore, you should not place considerable reliance on any such forward-looking statements.
−Removed: Such risks and uncertainties include, without limitation, our ability to successfully manufacture, distribute, or market our updated COVID-19 vaccine in a single dose vial or pre-filled syringe product presentation for the 2024-2025 vaccination season;
−Removed: challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization
−Removed: requirements, including those related to process qualification, assay validation, and stability testing, necessary to satisfy applicable regulatory authorities;
−Removed: challenges or delays in conducting clinical trials;
−Removed: challenges or delays in obtaining regulatory authorization for our product candidates, including our updated COVID-19 vaccine in time for the 2024-2025 vaccination season or for future COVID-19 variant strain changes;
+Added: Such risks and uncertainties include, without limitation, our ability to successfully and timely manufacture, market, distribute, or deliver our updated COVID-19 vaccine and the impact of our not having received a BLA from the U.S.
+Added: Food and Drug Administration (U.S.
+Added: FDA”) for the 2024-2025 vaccination season;
+Added: challenges related to our partnership with Sanofi and in pursuing additional partnership opportunities;
+Added: 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;
+Added: challenges or delays in conducting clinical trials, or studies for our product candidates;
+Added: challenges or delays in obtaining regulatory authorization for our product candidates, including for future COVID-19 variant strain changes, our CIC vaccine candidate, our stand-alone influenza vaccine candidate or other product candidates, including as a result of resource constraints at regulatory authorities including the U.S.
+Added: FDA and the WHO;
manufacturing, distribution or export delays or challenges;
our substantial dependence on Serum Institute of India Pvt.
−Removed: and Serum Life Sciences Limited for co-formulation and filling and PCI Pharma Services for finishing our COVID-19 vaccines and the impact of any delays or disruptions in their operations on the delivery of customer orders;
−Removed: difficulty obtaining scarce raw materials and supplies;
−Removed: resource constraints, including human capital and manufacturing capacity, constraints on the ability of Novavax to pursue planned regulatory pathways, alone or with partners, in multiple jurisdictions simultaneously, leading to staggering of regulatory filings, and potential regulatory actions;
−Removed: challenges in implementing our global restructuring and cost reduction plan;
+Added: (“SII”) and Serum Life Sciences Limited (“SLS” and together with SII, “Serum”) for co-formulation and filling our COVID-19 vaccine and the impact of any delays or disruptions in their operations;
+Added: difficulty obtaining scarce raw materials and supplies, including for our proprietary adjuvant;
+Added: resource constraints, including human capital and manufacturing capacity, constraints on our ability to pursue planned regulatory pathways, alone or with partners;
+Added: challenges in implementing the Restructuring Plan;
our ability to timely deliver doses;
−Removed: challenges in obtaining commercial adoption and market acceptance of our updated COVID-19 vaccine or any COVID-19 variant strain-containing formulation;
−Removed: 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;
+Added: challenges in obtaining commercial adoption and market acceptance of our COVID-19 vaccine, any COVID-19 variant strain-containing formulation, our CIC vaccine candidate, our stand-alone influenza vaccine candidate or our other product candidates;
+Added: challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities, including requirements to deliver doses that may require us to refund portions of upfront and other payments previously received or result in reduced future payments pursuant to such agreements;
challenges related to the seasonality of vaccinations against COVID-19;
+Added: challenges related to the demand for vaccinations against COVID-19 or influenza;
+Added: challenges in identifying and successfully pursuing innovation expansion opportunities;
+Added: our 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 our assumptions;
and other risks and uncertainties identified in Part I, Item 1A “Risk Factors” of this Annual Report on Form 10-K, which may be detailed and modified or updated in other documents filed with the SEC from time to time, and are available at www.sec.gov and at www.novavax.com.
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Any non-GAAP financial measures presented are not, and should not be viewed as, substitutes for financial measures required by GAAP, have no standardized meaning prescribed by GAAP, and may not be comparable to the calculation of similar measures of other companies.
−Removed: We are a biotechnology company that promotes improved global health through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.
−Removed: Our proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticle vaccines designed to address urgent global health needs.
−Removed: Our vaccine candidates are nanostructures of conformationally correct recombinant proteins that mimic those found on pathogens.
−Removed: This technology enables the immune system to recognize target proteins and develop protective immune responses.
−Removed: We believe that our vaccine technology may lead to the induction of a differentiated immune response that may be more efficacious than naturally occurring immunity or some other vaccine approaches.
−Removed: Our vaccine candidates also incorporate our proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response, stimulate higher levels of functional antibodies, and induce a cellular immune response.
−Removed: We have developed an updated COVID-19 vaccine for the 2023-2024 vaccination season.
−Removed: In October 2023, the U.S.
−Removed: FDA granted emergency use authorization (“EUA”) for our updated vaccine for active immunization to prevent COVID-19.
−Removed: The updated vaccine is authorized as (1) a single dose in individuals 12 years and older who have been vaccinated with any COVID-19 vaccine at least 2 months after receipt of the last previous dose of COVID-19 vaccine, and (2) a series of 2 doses administered 3 weeks apart to individuals 12 years and older who were not previously vaccinated with any COVID-19 vaccine.
−Removed: Our updated vaccine is available within the U.S.
−Removed: at many major pharmacy retailers.
−Removed: Outside the U.S.
−Removed: for our updated vaccine, in January 2024, we were granted marketing authorization by the United Kingdom’s (“UK”) Medicines and Healthcare products
−Removed: Regulatory Agency (“MHRA”), in December 2023, we were granted expanded authorization by Health Canada, and in October 2023, we were granted approval by the European Commission (“EC”).
−Removed: We are committed to meeting the full supply of our key target markets through advance purchase agreements (“APAs”) covering such markets.
−Removed: We continue to work closely with regulatory authorities globally for authorization of our updated vaccine.
−Removed: We previously developed a prototype COVID-19 vaccine, which has received full marketing authorization (“MA”), marketing approval, interim authorization, provisional approval, conditional marketing authorization (“CMA”), from multiple regulatory authorities in over 40 countries globally.
−Removed: We continue to progress our regulatory authorizations for our prototype vaccine in select territories, as we believe these may facilitate authorization of our vaccine candidates for updated strains in the future.
−Removed: Additionally, we are developing a CIC vaccine candidate.
−Removed: In addition to COVID-19, our other areas of focus include providing Matrix-M™ adjuvant for collaborations, including in R21/Matrix-M™ adjuvant malaria vaccine, which recently received authorization in several countries, as well as other preclinical vaccine research with our Matrix-M™ adjuvant, including through a partnership with the Bill & Melinda Gates Medical Research Institute.
−Removed: We intend to focus the organization to align our investments and activities with our top priority of delivering our updated vaccine for the 2023-2024 vaccination season.
−Removed: To maximize our opportunities and mitigate the significant risks and uncertainties of the COVID-19 market, we have progressed our cost restructuring measures to reduce spend, extend our cash runway, and operate efficiently to seek to best position the Company to deliver longer-term growth.
−Removed: We discuss these cost restructuring strategies in greater detail in Note 2 to our consolidated financial statements in this Annual Report.
+Added: We are a company tackling global health challenges through scientific innovation that seeks to maximize our deep scientific expertise in vaccines and our cutting-edge technology platform.
+Added: The differentiated platform features our recombinant protein-based nanoparticle technology and unique Matrix-M ™ adjuvant.
+Added: Our three strategic priorities are:
+Added: focusing on our partnership with Sanofi announced in May 2024, leveraging our technology platform and pipeline to forge additional partnerships, and advancing our proven technology platform and early-stage pipeline.
+Added: Our corporate growth strategy is supported by a lean and focused operating model.
+Added: Table o f Contents
+Added: Our technology platform combined with our deep vaccine expertise, is the fuel for innovation and partnerships and we believe it has the potential to create significant value.
+Added: Our proprietary Matrix-M ™ adjuvant when added to vaccines, has been shown to help induce a stronger and longer-lasting immune response.
+Added: Our recombinant protein-based nanoparticle technology has been shown to be highly immunogenetic.
+Added: Together, we believe that our technology platform can induce potent, durable and broad immune responses, with the potential to be antigen-sparing.
+Added: Our Matrix-M ™ adjuvant can increase both antibody and cell-mediated immune responses to the vaccine and it has demonstrated a favorable tolerability profile in clinical trials.
+Added: Our technology platform is used in our authorized COVID-19 vaccine and the R21/Matrix-M ™ adjuvant malaria vaccine.
+Added: We have developed and manufactured our updated COVID-19 vaccine for the 2024-2025 vaccination season for use in individuals aged 12 and older.
+Added: Our updated vaccine received Emergency Use Authorization (“EUA”) from the U.S.
+Added: FDA in August 2024, along with several additional global regulatory authorizations for use in the 2024-2025 vaccination season.
+Added: In the U.S., our BLA for our prototype COVID-19 vaccine and for our XBB COVID-19 vaccine is currently under U.S.
+Added: FDA review with a Prescription Drug User Fee Act (“PDUFA”) date of April 2025.
+Added: In May 2024, we entered into a Collaboration and License Agreement with Sanofi, to co-commercialize our COVID-19 vaccine, including future updated versions that address seasonal COVID-19 variants.
+Added: Under the terms of the agreement, we will continue to commercialize our updated COVID-19 vaccine through the end of the 2024-2025 vaccination season and beginning in 2025 and continuing during the term of the Sanofi CLA, we and Sanofi will commercialize the COVID-19 vaccine worldwide in accordance with a commercialization plan agreed by us and Sanofi, under which we will continue to supply certain of our existing APA customers and strategic partners, including Takeda Pharmaceutical Company Limited (“Takeda”) and SII.
+Added: Upon completion of the existing APAs, we and Sanofi will jointly agree on commercialization activities of each party in each jurisdiction.
+Added: Additionally, Sanofi has the right to develop novel influenza-COVID-19 combination vaccines utilizing our COVID-19 vaccine and Sanofi’s seasonal influenza vaccine, combination products containing our COVID-19 vaccine and one or more non-influenza vaccines, and multiple new vaccines utilizing our Matrix-M ™ adjuvant.
+Added: In December 2024, Sanofi announced that the U.S.
+Added: FDA granted Fast Track designation to two Sanofi combination vaccine candidates:
+Added: the first combination consists of Fluzone High-Dose combined with our COVID-19 vaccine, and the second combination consists of Flublok with our COVID-19 vaccine.
+Added: Sanofi is evaluating the safety and immunogenicity of both combination vaccine candidates in two separate Phase 1/2 trials.
+Added: We are eligible to receive royalties and milestones associated with the ongoing sales of our COVID-19 vaccine and Sanofi’s influenza-COVID-19 combination vaccines and any other combination vaccines Sanofi may develop, as well as ongoing product royalties for vaccines developed with our Matrix-M ™ adjuvant.
+Added: We discuss this agreement in further detail in Note 4 to our accompanying consolidated financial statements.
+Added: Additionally, we are advancing our pipeline of both late- and early-stage programs with a focus on potentially high-value assets in areas with unmet medical need, compelling scientific rationale and strong commercial opportunity.
+Added: Our late-stage programs include a CIC vaccine candidate, as well as a stand-alone influenza vaccine candidate.
+Added: In December 2024, we initiated the initial cohort of a Phase 3 trial comparing our CIC vaccine and stand-alone influenza vaccine to our updated COVID-19 vaccine and a licensed seasonal influenza vaccine comparator in adults aged 65 and older.
+Added: We intend to partner these vaccine candidates in order to advance to BLA filing and commercialization.
+Added: Furthermore, we provide our Matrix-M™ adjuvant for use in collaborations.
+Added: These include the R21/Matrix-M™ adjuvant malaria vaccine, a malaria vaccine developed by our partner, the Jenner Institute, University of Oxford (“R21/Matrix-M™ adjuvant malaria vaccine”) and manufactured by SII.
+Added: R21/Matrix-M™ adjuvant malaria vaccine is authorized in several countries.
+Added: Additionally, we provide Matrix-M ™ adjuvant for use in various programs in preclinical and clinical stage, as well as preclinical investigations.
+Added: Examples include, an agreement with the Gates Foundation, and in a related master transfer agreement with a leading pharmaceutical company for exploration of Matrix-M™ adjuvant used as a potential advancement in their pipeline.
+Added: We continue to advance our strategic assessment of our emerging, early-stage pipeline.
+Added: We intend to develop our early-stage pipeline using a disciplined and capital-efficient approach.
+Added: Our R&D investment strategy seeks to place smart, lower-cost investments on the programs with the highest potential value, both within infectious disease and beyond, with the
+Added: Table o f Contents
+Added: intent of partnering these assets at proof of concept and shifting late-stage development costs to our partners to finalize clinical development.
+Added: We are pursuing early-stage research in diseases such as, respiratory syncytial virus (“RSV”) combinations, varicella-zoster virus (shingles) and Clostridioides difficile (C.
+Added: Diff.) colitis.
+Added: We are actively working to evaluate several RSV combination candidates to progress forward toward an Investigational New Drug (“IND”).
+Added: We are actively developing an H5N1 avian pandemic influenza vaccine candidate and the toxicology study is underway.
+Added: We are actively monitoring the emerging public health situation and are pursuing funding opportunities to join preparedness options.
+Added: Additionally, we are evaluating potential expansion beyond infectious diseases including therapeutic areas such as oncology, where we believe our technology could augment and improve upon current therapies.
Business Highlights
Fourth Quarter 2024 and Recent Highlights
−Removed: Demonstrated ability to update COVID-19 vaccine and deliver the only protein-based non-mRNA option to market.
−Removed: • Gained commercial experience in the U.S.
−Removed: after receiving EUA with future efforts to focus on a recalibration of U.S.
−Removed: field teams to focus on the retail segment
−Removed: • Progressed efforts to position Novavax for a stronger performance in 2024-2025 COVID-19 vaccination season with focus on a single-dose product presentation for delivery at the start of the season and planned BLA approval to enable marketing and promotion for Nuvaxovid™ during season
−Removed: • Progressed efforts to streamline manufacturing and to advance strain selection at risk while advocating for more timely identification of strains by regulatory authorities
−Removed: • Continued advancement of discussions for 2024-2025 COVID-19 vaccination season with major retailers who have driven 90% of the pharmacy business
−Removed: Global Markets:
−Removed: Delivered on 2023 APA obligations in Europe, Canada, Australia, New Zealand, Singapore and Taiwan.
−Removed: • For 2024, made strategic decision to prioritize and focus commercial effort in Europe on select key countries including Italy, Spain, France and the UK.
−Removed: • Spring 2024 U.K.
−Removed: private market launch expected for Novavax’s COVID-19 vaccine as enabled by the recent Green Book addition by the UK Health Security Agency
−Removed: Novavax has made significant progress on its commitment to improve its financial position while maintaining the capabilities that support long-term value creation.
−Removed: • Reduced full year 2023 operating expenses by $1.1 billion, or 41%, as compared to 2022
−Removed: • Reduced workforce by a total of 30% compared to first quarter of 2023
−Removed: • Delivered fourth quarter 2023 doses under the Canada APA agreement and received $175 million contingent payment in January 2024
−Removed: • Settled arbitration with Gavi, removing financial uncertainty and enabling focus on shared public health mission
−Removed: Novavax remains focused on leveraging its technology platform, including its proprietary Matrix-M™ adjuvant, to drive long-term growth and protect global public health.
−Removed: • Expect to initiate a pivotal Phase 3 trial for CIC vaccine candidate in the second half of 2024, with potential for accelerated approval and anticipated launch in 2026
−Removed: • R21/Matrix-M™ adjuvant malaria vaccine received prequalification by the WHO based on Phase 3 efficacy trial results, which were recently published in The Lancet, enabling global rollout of the vaccine in eligible United Nation countries
+Added: Strategic Priority #1:
+Added: Sanofi Partnership
+Added: • Transitioned lead commercial responsibility of Nuvaxovid™ COVID-19 vaccine beginning with the 2025-2026 vaccination season for the U.S.
+Added: and other select major markets.
+Added: • Achieved $50 million milestone associated with the first pediatric database lock in the fourth quarter of 2024.
+Added: • Prescription Drug User Fee Act target action date of April 2025 for our COVID-19 vaccine BLA.
+Added: ◦ Achievement of BLA approval triggers a $175 million milestone payment from Sanofi.
+Added: • Marketing authorization transfers to Sanofi for U.S.
+Added: and European Union markets are expected in late 2025.
+Added: ◦ Achievement triggers an additional $50 million in combined milestone payments from Sanofi.
+Added: • Sanofi announced it received U.S.
+Added: 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.
+Added: ◦ Potential for future $350 million development and launch milestone payments associated with Sanofi influenza-COVID-19 combination products.
+Added: Strategic Priority #2:
+Added: Leverage our technology platform and pipeline to forge additional partnerships
+Added: • In December 2024, initiated an initial cohort of 2,000 participants for the Phase 3 trial for our CIC and stand-alone seasonal influenza vaccine candidates to evaluate immunogenicity and safety in adults aged 65 and older.
+Added: ◦ Initial cohort data expected by mid-2025.
+Added: ◦ Intend to partner both vaccine programs to advance all future clinical development, regulatory filing and commercialization activities.
+Added: • R21/Matrix-M™ adjuvant malaria vaccine launched in additional countries in Africa by SII.
+Added: Strategic Priority #3:
+Added: Advance our technology platform and early-stage pipeline
+Added: • Continued preclinical development of H5N1 avian pandemic influenza program evaluating multiple highly pathogenic avian influenza strains.
+Added: • Continued advancement of early-stage preclinical research for RSV combinations, varicella-zoster virus (shingles) and C.
+Added: colitis vaccine candidates.
+Added: • Initiated exploratory preclinical work in areas outside of infectious disease, such as oncology.
+Added: • Advancing artificial intelligence capabilities to significantly accelerate predictive modeling, optimize discovery and enhance the precision of vaccine design.
+Added: • 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.
+Added: Table o f Contents
Financing Transactions
In August 2023, we entered into an At Market Issuance Sales Agreement (the “August 2023 Sales Agreement”), which allows us to issue and sell up to $500 million in gross proceeds of shares of our common stock, and terminated our then-existing At Market Issuance Sales Agreement entered in June 2021 (the “June 2021 Sales Agreement”).
−Removed: During the year ended December 31, 2023, we sold 38.3 million shares of our common stock under our August 2023 Sales Agreement and 7.9 million shares of our common stock under our June 2021 Sales Agreement, resulting in net proceeds of approximately $321 million, of which $6.9 million was included in Prepaid expenses and other current assets as of December 31, 2023 and received in cash in January 2024.
+Added: During the year ended December 31, 2024, we sold 12.2 million shares of our common stock under our August 2023 Sales Agreement, resulting in net proceeds of approximately $188 million.
As of December 31, 2024, the remaining balance available under the August 2023 Sales Agreement was approximately $51 million.
−Removed: During the year ended December 31, 2022, we sold 2.2 million shares of our common stock resulting in net proceeds of approximately $179 million , under our June 2021 Sales Agreement.
−Removed: In August 2023, pursuant to the Securities Subscription Agreement with SK, we agreed to sell and issue to SK 6.5 million shares of our common stock at a price of $13.00 per share (the “Shares”) in a Private Placement for aggregate gross proceeds to us of approximately $84.5 million.
−Removed: We recognized the Shares at the settlement date fair value of $46.5 million (see Note 4 to our consolidated financial statements for additional discussion of the Securities Subscription Agreement with SK).
+Added: In May 2024, we also entered into a securities subscription agreement (the "Sanofi Subscription Agreement") with Sanofi, pursuant to which we sold and issued to Sanofi, in a private placement, 6.9 million shares of our common stock, at a price of $10.00 per share, for aggregate gross proceeds to us of $68.8 million.
+Added: During the year ended December 31, 2023, we sold 38.3 million shares of our common stock under our August 2023 Sales Agreement and 7.9 million shares of our common stock under our June 2021 Sales Agreement, resulting in net proceeds of approximately $321 million, of which $6.9 million was included in Prepaid expenses and other current assets as of December 31, 2023 and received in cash in January 2024.
+Added: In August 2023, we also entered into a Securities Subscription Agreement (the "SK Subscription Agreement") with SK bioscience Co., Ltd.
+Added: ("SK"), pursuant to which we agreed to sell and issue to SK, in a private placement (the "Private Placement"), 6.5 million shares of our common stock at a price of $13.00 per share (the “SK Shares”) for aggregate gross proceeds to us of approximately $84.5 million.
The closing of the Private Placement occurred on August 10, 2023.
−Removed: In December 2022, we completed a public offering of 7,475,000 shares of our common stock, including 975,000 shares of common stock that were issued upon the exercise in full of the option to purchase additional shares granted to the underwriters, at a price of $10.00 per share resulting in net proceeds, net of offering costs of $4.9 million, of approximately $70 million.
−Removed: We completed this public offering concurrent with the issuance of the 2027 Notes (see Note 10 to our consolidated financial statements).
Critical Accounting Policies and Use of Estimates
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The preparation of our consolidated financial statements requires us to make estimates, assumptions, and judgments that affect the reported amounts of assets, liabilities, and equity and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenue and expenses during the reporting period.
−Removed: These estimates, particularly estimates relating to accounting for product sales revenue, pre-launch inventory, inventory realizability, and research and development expenses have a material impact on our consolidated financial statements and are discussed in detail throughout our analysis of the results of operations discussed below.
+Added: These estimates, particularly estimates relating to accounting for product sales revenue, licensing and transition services revenue, inventory realizability, and research and development expenses have a material impact on our consolidated financial statements and are discussed in detail throughout our analysis of the results of operations discussed below.
We base our estimates on historical experience and various other assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets, liabilities, and equity that are not readily apparent from other sources.
1 unchanged sentence
For an in-depth discussion of each of our significant accounting policies, including our critical accounting policies and further information regarding estimates and assumptions involved in their application, see Note 2 to the accompanying consolidated financial statements included in Part II, Item 8, “Financial Statements and Supplementary Data” of this Annual Report on Form 10-K.
−Removed: Revenue Recognition, Product Sales - Advance Purchase Agreements
−Removed: Product sales include sales associated with COVID-19 Vaccine supply agreements, sometimes referred to as advance purchase agreements (“APAs”), with various international governments.
−Removed: We recognize revenue from product sales related to these APA’s based on the transaction price per dose calculated in accordance with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers, at the point in time when control of the product transfers to the customer and customer acceptance has occurred, unless such acceptance provisions are deemed perfunctory.
+Added: Revenue Recognition, Product Sales - Advance Purchase Agreements (“APAs”)
+Added: Product sales include sales associated with COVID-19 Vaccine supply agreements, sometimes referred to as APAs, with various international governments.
+Added: We recognize revenue from product sales related to these APA’s based on the transaction price per dose calculated in accordance with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”), at the point in time when control of the product transfers to the customer and customer acceptance has occurred, unless such acceptance provisions are deemed perfunctory.
The APAs typically contain terms that include upfront payments, which are reflected in Deferred revenue.
We constrain the transaction price for APA’s until it is probable that a significant reversal in revenue recognized will not occur.
−Removed: Specifically, if an APA includes a provision whereby the customer may request a discount, return, or refund, or includes a term that may have the effect of decreasing the price per dose of previously delivered shipments, revenue is constrained based on an estimate of the impact of the transaction price until it is probable that a significant reversal in revenue recognized will not occur.
+Added: Specifically, if an APA includes a provision whereby the customer may request a discount, return, or refund, or includes a term that may have the effect of decreasing the price per
+Added: Table o f Contents
+Added: dose of previously delivered shipments, revenue is constrained based on an estimate of the impact of the transaction price until it is probable that a significant reversal in revenue recognized will not occur.
Revenue Recognition, Product Sales - U.S.
−Removed: In the fourth quarter of 2023, we commenced sales of COVID-19 Vaccine to the U.S.
−Removed: commercial market.
Product sales in the U.S.
14 unchanged sentences
• Product returns:
−Removed: We offer U.S.
−Removed: customers the right to return COVID-19 Vaccine.
−Removed: These return rights include the right of wholesale distributors to return unsold and expired doses and the right of indirect customers to return any partial or unused vials upon expiry.
+Added: We offer wholesale distributors and indirect customers the right to return expired doses.
Estimated returns for COVID-19 Vaccine are determined considering levels of inventory in the distribution channel, projected market demand, utilization data, returns claims received, and product shelf life.
5 unchanged sentences
commercial product sales of $120.3 million for product returns and $105.8 million for wholesale distributor fees, discounts and chargebacks.
−Removed: As of December 31, 2023, $82.5 million related to product returns and $20.6 million related to wholesale distributor fees, discounts,
−Removed: and chargebacks were included in Other current liabilities and $2.6 million was included in Accounts receivable on our consolidated balance sheet.
−Removed: Pre-Launch Inventory
−Removed: We capitalize raw materials and production costs as inventory when we determine that commercialization of a product is probable and have a present right to the economic benefit associated with the product.
−Removed: Our estimate of when commercialization is probable is based primarily on our experience with obtaining regulatory approval of comparable products.
−Removed: We began to capitalize inventory in 2022.
+Added: As of December 31, 2024, $77.1 million and $10.1 million related to product returns, wholesale distributor fees, discounts, and chargebacks were included in Accrued expenses and Accounts payable, respectively, and $50.6 million was included in and reduced Accounts receivable on our consolidated balance sheet.
+Added: During the year ended December 31, 2023, we recognized gross-to-net deductions against U.S.
+Added: commercial product sales of $84.7 million for product returns and $47.0 million for wholesale distributor fees, discounts and chargebacks.
+Added: As of December 31, 2023, $82.5 million related to product returns and $20.6 million related to wholesale distributor fees, discounts, and chargebacks were included in Accrued expenses and $2.6 million was included in and reduced Accounts receivable on our consolidated balance sheet.
+Added: Revenue Recognition, Licensing, Royalties, and Other - Licensing and Transition Services
+Added: The terms of licensing agreements may contain multiple performance obligations, which may include licenses and transition services.
+Added: We evaluate licensing agreements under ASC 606, to determine the distinct performance obligations.
+Added: Prior to recognizing revenue, we estimate the transaction price, including variable consideration that is subject to a constraint.
+Added: Variable consideration is included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur and when the uncertainty associated with the variable consideration is subsequently resolved.
+Added: Total consideration may include nonrefundable upfront license fees, transition service fees, other
+Added: Table o f Contents
+Added: payments based upon the achievement of specified milestones, and royalty payments based on product sales from licensed products.
+Added: For multiple performance obligation arrangements, we allocate the transaction price to each distinct performance obligation based on its relative stand-alone selling price.
+Added: The stand-alone selling price is generally determined for each performance obligation based on the prices charged to customers, discounted cash flows, or using expected cost-plus margin.
+Added: For stand-alone selling prices determined using discounted cash flows, we consider discounted, probability-weighted cash flows related to the performance obligation transferred.
+Added: In developing such estimates, we apply judgment in determining the forecasted revenue, expected margins, and the discount rate.
+Added: These estimates are subjective and require us to make assumptions about future cash flows.
+Added: Revenue related to performance obligations satisfied at a point in time is recognized when the customer obtains control of the promised asset.
+Added: For performance obligations recognized over time, we recognize revenue using an input method to measure progress by utilizing costs incurred to-date relative to total expected costs.
+Added: Under this process, we consider the costs that have been incurred to-date, as well as projections to completion using various inputs and assumptions, including, but not limited to, progress towards completion, labor costs and level of effort, material and subcontractor costs, indirect administrative costs, and other identified risks.
+Added: Estimating the total cost at completion of our performance obligation under a contract is subjective and requires us to make assumptions about future activity and cost drivers.
+Added: Changes in these estimates can occur for a variety of reasons and may impact the timing of revenue recognition on our contracts.
+Added: Changes in estimates related to the process are recognized in the period when such changes are made on a cumulative catch-up basis.
+Added: We have not experienced any material adjustments as a result of changes in estimates arising from this process.
Inventory Realizability
2 unchanged sentences
Our assumptions about expected future demand are inherently uncertain and if we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of inventory write down that we report in a particular period.
−Removed: We began to capitalize inventory in 2022.
−Removed: Subsequently, for the year ended, December 31, 2022 we recorded inventory write-downs of $447.6 million and losses on firm purchase commitments of inventory of $155.9 million to the extent the cost cannot be recovered based on estimates about future demand.
For the year ended December 31, 2024, we recorded inventory write-downs of $21.0 million and losses on firm purchase commitments of inventory of $7.4 million.
In addition, for the year ended December 31, 2024, we recorded recoveries on firm purchase commitments of $0.7 million related primarily to negotiated reductions to previously recognized firm purchase commitments.
+Added: For the year ended December 31, 2023, we recorded inventory write-downs of $72.4 million and losses on firm purchase commitments of inventory of $73.5 million.
+Added: In addition, for the year ended December 31, 2023, we recorded recoveries on firm purchase commitments of $40.2 million related primarily to negotiated reductions to previously recognized firm purchase commitments.
Accounting for Research and Development Expenses
2 unchanged sentences
• expenses incurred under agreements with contract research organizations (“CROs”) that conduct our clinical trials and third party consultants;
−Removed: • the cost of developing and manufacturing vaccine components under third-party CMOs and contract development and manufacturing organizations (“CDMOs”) agreements, including expenses incurred for the procurement of raw materials, laboratory supplies and equipment.
+Added: • the cost of developing and manufacturing vaccine components under third-party contract manufacturing organizations (“CMOs”) and contract development and manufacturing organizations (“CDMOs”) agreements, including expenses incurred for the procurement of raw materials, laboratory supplies and equipment.
We base our expenses on our estimates of the services provided and efforts expended pursuant to contracts, statements of work and related change orders with the service provider, and discussion with internal personnel and external service providers as to the progress of the services and the agreed-upon fee to be paid for such services.
2 unchanged sentences
Additionally, invoicing from third-party service providers may not coincide with actual work performed and can result in a prepaid or an accrual position at the end of the period.
−Removed: The estimation process requires us to make significant judgments and estimates in determining the services incurred as of the balance sheet date, which may result in either a prepaid or an accrual balance.
+Added: The estimation process requires us to make
+Added: Table o f Contents
+Added: significant judgments and estimates in determining the services incurred as of the balance sheet date, which may result in either a prepaid or an accrual balance.
As actual costs become known, we adjust our estimates.
13 unchanged sentences
Product sales $ 190,212 $ 531,389 $ (341,177)
+Added: Licensing, royalties, and other
+Added: 491,950 24,993 466,957
Grants — 427,323 (427,323)
−Removed: Royalties and other 24,993 43,990 (18,997)
Total revenue $ 682,162 $ 983,705 $ (301,543)
−Removed: Revenue for the year ended December 31, 2023 was $983.7 million as compared to $2.0 billion for the year ended December 31, 2022, a decrease of $1.0 billion.
−Removed: Revenue for the years ended December 31, 2023 and 2022 was primarily comprised of revenue from product sales of COVID-19 Vaccine and services performed under our U.S.
−Removed: government agreement with Advanced Technology International (“USG Agreement”), the Consortium Management Firm acting on behalf of the Medical CBRN Defense Consortium in connection with the partnership formerly known as Operation Warp Speed.
−Removed: The decrease in revenue is primarily due to a decreased quantity of dose sales of COVID-19 Vaccine.
+Added: Revenue for the year ended December 31, 2024 was $682.2 million as compared to $983.7 million for the year ended December 31, 2023, a decrease of $301.5 million.
+Added: Revenue for the year ended December 31, 2024, was primarily comprised of revenue from licensing and product sales of COVID-19 Vaccine.
+Added: Revenue for the year ended December 31, 2023, was primarily comprised of revenue from product sales of COVID-19 Vaccine and services performed under our USG Agreement.
+Added: The decrease in revenue is due to a decrease in revenue under the USG Agreement and in the quantity of dose sales of COVID-19 Vaccine, partially offset by licensing, royalties, and other revenue from the Sanofi CLA.
Product sales
−Removed: Product sales for 2023 were $531.4 million as compared to $1.6 billion for 2022, a decrease of $1.0 billion.
−Removed: The decrease in product sales is primarily due to a decreased quantity of dose sales of COVID-19 Vaccine during the year ended December 31, 2023 as compared to 2022.
−Removed: Product sales for 2023 related to revenue from commercial sales of COVID-19 Vaccine, which commenced in 2022.
−Removed: The geographic distribution of product sales in 2023 was as follows:
+Added: Product sales for 2024 were $190.2 million as compared to $531.4 million for 2023, a decrease of $341.2 million.
+Added: The decrease in product sales is primarily due to a decreased quantity of dose sales of COVID-19 Vaccine under our APA agreements during the year ended December 31, 2024 as compared to 2023.
+Added: The geographic distribution of product sales was as follows:
2024 2023 Change
7 unchanged sentences
$ 190,212 $ 531,389 $ (341,177)
−Removed: We recognized grant revenue as follows:
+Added: Table o f Contents
+Added: Licensing, royalties, and other
+Added: Licensing, royalties, and other revenues for 2024 were $492.0 million as compared to $25.0 million for 2023, an increase of $467.0 million.
+Added: The increase was primarily due to revenue from the Sanofi CLA.
2024 2023 Change
−Removed: Grant Revenue (in thousands)
−Removed: USG Agreement
+Added: Licensing, royalties, and other (in thousands)
$ 389,642 $ 8,500 $ 381,142
+Added: Sales-based royalties
8,579 — 8,579
−Removed: Total grant revenue $ 427,323 $ 382,921 $ 44,402
−Removed: Grant revenue for 2023 was $427.3 million compared to $382.9 million for 2022, an increase of $44.4 million.
−Removed: Grant revenue comprised revenue for services performed under our USG Agreement.
−Removed: The increase was primarily due to increased support activities under the USG Agreement during 2023.
−Removed: As of December 31, 2023, the Company has recognized the full contract funding under the USG Agreement in revenue.
−Removed: Royalties and Other
−Removed: Royalties and other includes royalty milestone payments, sales-based royalties, and Matrix-M™ adjuvant sales.
−Removed: Royalties and other revenue for 2023 was $25.0 million as compared to $44.0 million for 2022, a decrease of $19.0 million.
−Removed: The decrease was primarily due to decreased revenue related to milestone payments, partially offset by an increase in Matrix-M™ adjuvant sales.
+Added: Transition services and technology transfer
+Added: 69,733 — 69,733
+Added: Matrix-M™ adjuvant
+Added: 20,459 16,493 3,966
+Added: 3,537 — 3,537
+Added: Total licensing, royalties, and other revenue
+Added: $ 491,950 $ 24,993 $ 466,957
+Added: We did not have any Grants revenue during the year ended December 31, 2024, as compared to $427.3 million during the year ended December 31, 2023, a decrease of $427.3 million.
+Added: Grant revenue for the year ended December 31, 2023 was comprised of revenue for services performed under our USG Agreement.
+Added: As of December 31, 2023, we had recognized the full contract funding under the USG Agreement in revenue.
2024 2023 Change
5 unchanged sentences
Cost of Sales
−Removed: Cost of sales was $343.8 million, or 65% of product sales, for the year ended December 31, 2023, including expense of $145.9 million related to excess, obsolete, or expired inventory and losses on certain firm purchase commitments, $6.1 million ROU asset impairment charges for CMO manufacturing capacity of excess quantities, $64.0 million related to unutilized manufacturing capacity, and a credit of $40.2 million related to negotiated reductions to certain previously recognized firm purchase commitments.
−Removed: Cost of sales was $902.6 million, or 58% of product sales, for 2022, including expense of $603.5 million related to excess, obsolete, or expired inventory and losses on firm purchase commitments.
−Removed: Prior to receiving approval, we expensed manufacturing costs as research and development expenses.
−Removed: After receiving approval, we capitalize the costs of production for a particular supply chain when we determine that we have a present right to the economic benefit associated with the product.
−Removed: While we tracked the quantities of our manufactured vaccine product and components, we did not track pre-approval manufacturing costs and therefore the manufacturing cost of our pre-launch inventory produced prior to approval is not reasonably determinable.
−Removed: If inventory sold during 2023 was valued at expected standard cost, including expenses related to excess and obsolete inventory, adjusted cost of sales for the year would have been $382.8 million, an adjustment of $39.0 million as compared to cost of sales recognized.
−Removed: If inventory sold during 2022 was valued at expected standard cost, adjusted cost of sales for the year would have been approximately $1.1 billion, an adjustment of $164.8 million.
−Removed: The cost of sales as a percentage of product sales may fluctuate in the future as a result of changes to our customer mix or standard costs.
+Added: Cost of sales decreased to $202.7 million for 2024 as compared to $343.8 million for 2023, a decrease of $141.0 million.
+Added: The decrease was primarily due to a decrease in the quantity of dose sales of COVID-19 Vaccine and a decrease in excess, obsolete, or expired inventory and losses on certain firm purchase commitments.
+Added: Cost of sales for 2024 included expense of $28.4 million related to excess, obsolete, or expired inventory and losses on certain firm purchase commitments, $3.8 million ROU asset impairment charges for CMO manufacturing capacity of excess quantities, $44.9 million related to unutilized manufacturing capacity, and a credit of $0.7 million related to negotiated reductions to certain previously recognized firm purchase commitments.
+Added: Cost of sales for 2023 included expense of $145.9 million related to excess, obsolete, or expired inventory and losses on firm purchase commitments, $6.1 million ROU asset impairment charges for CMO manufacturing capacity of excess quantities, $64.0 million related to unutilized manufacturing capacity, and a credit of $40.2 million related to negotiated reductions to certain previously recognized firm purchase commitments.
+Added: The cost of sales as a percentage of product sales may fluctuate in the future as a result of changes to our customer mix, quantity of dose sales, or standard costs.
Research and Development Expenses
−Removed: Research and development expenses decreased to $737.5 million for 2023 as compared to $1.2 billion for 2022, a decrease of $497.8 million.
+Added: Research and development expenses decreased to $391.2 million for 2024 as compared to $737.5 million for 2023, a decrease of $346.3 million.
The decrease was primarily due to a reduction in overall expenditures relating to development
+Added: Table o f Contents
activities on coronavirus vaccines, including our COVID-19 Vaccine and CIC, as summarized in the table below (in thousands):
8 unchanged sentences
Total research and development expenses $ 391,169 $ 737,502
−Removed: Research and development expenses for coronavirus vaccines for the year ended December 31, 2023 and 2022 decreased to $413.4 million from $848.0 million primarily as a result of a reduction in manufacturing and support costs due, in part, to a reduction in our global manufacturing footprint consistent with our contractual obligations to supply, and anticipated demand for, COVID-19 Vaccine, including under manufacturing supply agreements with CMOs and CDMOs, and a reduction in clinical study costs and the commercialization of internal manufacturing capabilities.
−Removed: The decrease was also due to a benefit of $57.7 million during the year ended December 31, 2023 resulting from our settlement agreement and Private Placement with SK (see Note 4 to our consolidated financial statements).
−Removed: The decrease was partially offset by a benefit of $35.2 million and $201.4 million for the years ended December 31, 2023 and 2022, respectively, related to previously accelerated manufacturing costs for leases that we determined were embedded in manufacturing supply agreements with CMOs and CDMOs.
+Added: Research and development expenses for coronavirus vaccines for the year ended December 31, 2024 and 2023 decreased to $122.4 million from $413.4 million primarily as a result of a reduction in coronavirus vaccines clinical and support costs.
+Added: The decrease was also the result of a reduction in manufacturing and support costs due, in part, to a reduction in our global manufacturing footprint consistent with our contractual obligations to supply, and anticipated demand for, COVID-19 Vaccine, including embedded lease costs, under manufacturing supply agreements with CMOs and CDMOs.
We do not provide forward-looking estimates of costs and time to complete our research programs due to the many uncertainties associated with vaccine development.
10 unchanged sentences
As a result of these uncertainties, we are unable to determine the duration and completion costs of our research and development projects or when, and to what extent, we will generate future cash flows from our research projects.
−Removed: For 2024, we expect research and development expenses to decrease as compared to 2023 as we continue to assess our manufacturing needs and modify our global manufacturing footprint consistent with our contractual obligations to supply, and anticipated demand for, COVID-19 Vaccine and as additional manufacturing activities that were previously recognized as research and development expenses begin to meet the criteria for capitalization as inventory.
+Added: For 2025, we expect research and development expenses to decrease as compared to 2024 as we continue to right-size our operating expenses as part of our cost reduction initiative.
Selling, General, and Administrative Expenses
Selling, general, and administrative expenses decreased to $337.2 million for 2024 from $468.9 million for 2023, a decrease of $131.8 million.
−Removed: The decrease in selling, general, and administrative expenses is primarily due to cost containment measures to reduce our operating spend including a decrease in professional fees and advertising and promotion costs in support of our COVID-19 commercial program, partially offset by restructuring expenses.
−Removed: Other Expense, Net:
+Added: The decrease in selling, general, and administrative expenses is primarily due to cost containment measures to reduce our operating spend, including a decrease in advertising and promotion costs in support of our COVID-19 commercial program, employee expenses, and professional fees, partially offset by restructuring expenses.
+Added: Table o f Contents
+Added: Other Income (Expense), Net:
2024 2023 Change
1 unchanged sentence
Interest expense $ (20,075) $ (14,416) $ (5,659)
−Removed: Other income (expense) 37,896 10,969 26,927
+Added: Gain on disposition of Novavax CZ assets
+Added: 51,949 — 51,949
+Added: 40,442 37,896 2,546
Total other income (expense), net
$ 72,316 $ 23,480 $ 48,836
−Removed: We had total net other income of $23.5 million for 2023 compared to total net other expense of $8.9 million for 2022, an increase of $32.4 million.
−Removed: During 2023, other income, net increased primarily due to the favorable impact in 2023 as compared to 2022 of exchange rates on foreign currency denominated balances, including an intercompany loan with Novavax CZ, and an increase in investment income due to higher interest rates.
+Added: We had total net other income of $72.3 million for 2024 compared to total net other income of $23.5 million for 2023, an increase of $48.8 million.
+Added: The increase in other income (expense), net is primarily due to the gain on the disposition of Novavax CZ assets, the favorable impact in 2024 as compared to 2023, of exchange rates on foreign currency denominated balances, including an intercompany loan with Novavax CZ, and additional interest income on Cash and cash equivalents and Marketable securities balances, partially offset by additional interest expense.
Income Tax Expense:
6 unchanged sentences
Net loss for 2024 was $187.5 million, or $1.23 per share, as compared to $545.1 million, or $5.41 per share, for 2023, a decrease of $357.6 million, or $4.18 per share.
−Removed: The decrease in net loss was primarily due to the decline in cost of sales and research and development expenses associated with our COVID-19 Vaccine, partially offset by a decrease in revenue from product sales.
+Added: The decrease in net loss during the years ended December 31, 2024, was primarily due to a decrease in total expenses, partially offset by a decrease in total revenue.
The increase in weighted average shares outstanding for 2024 is primarily a result of sales of our common stock.
Liquidity Matters and Capital Resources
−Removed: Our future capital requirements depend on numerous factors including, but not limited to, revenue from our product sales and royalties under licensing arrangements with our strategic partners;
−Removed: repayments under our grant agreements;
−Removed: our projected activities related to the development and commercial support of our COVID-19 Vaccine and our CIC vaccine candidate, including significant commitments under various CRO, CMO, and CDMO agreements;
+Added: Our future capital requirements depend on numerous factors including, but not limited to, revenue from our product sales, milestone payments, royalties and reimbursements under licensing arrangements with our strategic partners;
+Added: our projected activities related to the development and commercial support of our COVID-19 Vaccine and our CIC and stand-alone influenza vaccine candidates, including significant commitments under various CRO, CMO, and CDMO agreements;
the progress of preclinical studies and clinical trials;
2 unchanged sentences
and other manufacturing, sales, and distribution costs.
−Removed: We plan to continue developing other vaccines and product candidates, such as our potential combination vaccines candidates, which are in various stages of development.
−Removed: We have entered into supply agreements, sometimes referred to as APAs, with the EC and various countries globally.
−Removed: We also have license agreements.
−Removed: As of December 31, 2023, the aggregate amount of the transaction price allocated to performance obligations that were unsatisfied (or partially unsatisfied), excluding amounts related to sales-based royalties under the licensing agreements, was approximately $2 billion, of which $863.5 million is included in Deferred revenue on our
−Removed: consolidated balance sheet.
−Removed: Failure to timely meet regulatory milestones, or achieve product volume or delivery timing obligations under our APAs may require us to refund portions of upfront or other payments or result in reduced future payments, which could adversely impact our ability to realize revenue from our unsatisfied performance obligations.
−Removed: The timing to fulfill performance obligations related to supply agreements will depend on timing of product manufacturing, receipt of marketing authorizations for additional indications, delivery of doses based on customer demand, and the ability of the customer to request variant vaccine in place of the prototype vaccine under certain of our APAs.
−Removed: The supply agreements typically contain terms that include upfront payments intended to assist us in funding investments related to building out and operating our manufacturing and distribution network, among other expenses, in support of our global supply commitment, and are applied to billings upon delivery of COVID-19 Vaccine.
+Added: We plan to continue developing other vaccines and product candidates, such as our potential combination vaccine and stand-alone influenza vaccine candidates, which are in various stages of development.
+Added: Our ability to generate revenue from product sales is subject to uncertainty specifically as it relates to our ability to successfully develop, manufacture, distribute, and market our updated vaccine and to successfully execute on our APAs, as discussed below.
+Added: Additionally, our plans include our ongoing restructuring and cost reduction measures (see Note 18 to our accompanying consolidated financial statements), and may also include raising additional capital through a combination of additional equity and debt financing, collaborations, strategic alliances, asset sales, and marketing, distribution, or licensing arrangements.
+Added: New financings may not be available to us on commercially acceptable terms, or at all.
+Added: If we are unable to obtain additional capital, we will assess our capital resources and may be required to delay, reduce the scope of, or eliminate some or all of our operations, or further downsize our organization, any of which may have a material adverse effect on our business, financial condition, results of operations.
+Added: In May 2024, we entered into the Sanofi CLA pursuant to which Sanofi received:
+Added: Table o f Contents
+Added: i) A co-exclusive license to commercialize our current stand-alone COVID-19 Vaccine, including our prototype vaccine and updated vaccines, that address seasonal variants throughout the world (the “COVID-19 Vaccine Products”);
+Added: ii) A sole license to develop and commercialize combination products containing a potential combination of our COVID-19 Vaccine and Sanofi’s seasonal influenza vaccine (“COVID-19 and influenza Combination Products” or “CIC Products”);
+Added: iii) A non-exclusive license to develop and commercialize combination products containing both our COVID-19 Vaccine and one or more non-influenza vaccines (“Other Combination Products” and together with the COVID-19 Vaccine Products, CIC Products, and Other Combination Products, “Licensed COVID-19 Products”) and
+Added: iv) A non-exclusive license to develop and commercialize other vaccine products selected by Sanofi that include our Matrix-M™ adjuvant.
+Added: Under the Sanofi CLA, we received a non-refundable upfront payment of $500 million.
+Added: We also achieved a $50.0 million milestone, which is included in Accounts receivable on the Consolidated balance sheet as of December 31, 2024.
+Added: We are eligible to receive development, technology transfer, launch, and sales milestone payments totaling up to an additional $650.0 million in the aggregate with respect to the Licensed COVID-19 Products and royalty payments on Sanofi’s sales of such licensed products.
+Added: In addition, we are also eligible to receive development, launch, and sales milestone payments of up to $200 million for each of the first four Adjuvant Products and $210 million for each Adjuvant Product thereafter, and royalty payments on Sanofi’s sales of all such licensed products.
+Added: Commencing shortly after the effective date of the Sanofi CLA, we commenced activities related to the technology transfer of our manufacturing process for the COVID-19 Vaccine Products and Matrix-M™ components to Sanofi.
+Added: Until the successful completion of such transfer, we will supply Sanofi with both COVID-19 Vaccine Products and Matrix-M™ intermediary components for Sanofi’s use and are eligible for reimbursement of such costs from Sanofi.
+Added: Additionally, Sanofi will reimburse us for our research and development and medical affairs costs related to the COVID-19 Vaccine Products in accordance with agreed upon plans and budgets.
+Added: Under the Sanofi CLA, we will continue to commercialize the updated vaccine through the end of the 2024-2025 vaccination season.
+Added: Beginning in 2025 and continuing during the term of the Sanofi CLA, we and Sanofi will commercialize the COVID-19 Vaccine Products worldwide in accordance with a commercialization plan agreed by us and Sanofi, under which we will continue to supply our existing APA customers and strategic partners, including Takeda and SII.
+Added: Upon completion of the existing APAs, we and Sanofi will jointly agree on commercialization activities of each party in each jurisdiction.
+Added: In May 2024, we also entered into the Sanofi Subscription Agreement, pursuant to which we sold and issued to Sanofi, in a private placement, 6.9 million shares of our common stock at a price of $10.00 per share for aggregate gross proceeds to us of $68.8 million.
+Added: We have also entered into supply agreements, sometimes referred to as APAs, with various countries globally.
+Added: As of December 31, 2024, the aggregate amount of the transaction price allocated to performance obligations that were unsatisfied (or partially unsatisfied), excluding amounts related to sales-based royalties under the licensing agreements, was approximately $1.3 billion, of which $1.1 billion is included in Deferred revenue on our consolidated balance sheet.
+Added: Failure to timely meet regulatory milestones, obtain timely supportive recommendations from governmental advisory committees, or achieve product volume or delivery timing obligations under our APAs may require us to refund portions of upfront or other payments or result in reduced future payments, which could adversely impact our ability to realize revenue from our unsatisfied performance obligations or result in the reversal of previously recognized revenue.
+Added: In the first quarter of 2025, we received written notice of a $23 million claim related to certain performance obligations under an APA agreement with a customer.
+Added: We believe we have fulfilled the requirements related to this matter and are evaluating the merits of the claim.
+Added: The timing to fulfill performance obligations related to APAs will depend on timing of product manufacturing, receipt of marketing authorizations for additional indications, delivery of doses based on customer demand, and the ability of the customer to request variant vaccine under certain of our APAs.
+Added: The APAs typically contain terms that include upfront payments intended to assist us in funding investments related to building out and operating our manufacturing and distribution network, among other expenses, in support of our global supply commitment, and are applied to billings upon delivery of COVID-19 Vaccine.
Such upfront payments generally become non-refundable upon our achievement of certain development, regulatory, and commercial milestones.
−Removed: On October 3, 2023, our updated vaccine received EUA from the U.S.
+Added: Additionally, for the remaining APA agreements, our intent is to deliver doses or when appropriate, amicably negotiate and exit
+Added: Table o f Contents
+Added: The timing to fulfill performance obligations related to the Sanofi CLA will depend on the timing of costs incurred relative to total expected costs.
+Added: In August 2024, our updated COVID-19 vaccine received EUA from the U.S.
FDA for active immunization to prevent COVID-19 in individuals aged 12 and older.
−Removed: Immediately upon authorization, our updated vaccine has also been included in the recommendations issued by the CDC in September 2023.
Doses became available within the U.S.
1 unchanged sentence
We have established reserves for gross-to-net deductions for amounts that we expect to return to our customers.
−Removed: As of December 31, 2023, gross-to-net reserve balances are $84.6 million related to product returns and $21.1 million related to wholesale distributor fees, discounts, and chargebacks, of which $103.1 million is included in Accrued expenses and $2.6 million is included in Accounts receivable on our consolidated balance sheet.
−Removed: Pursuant to the Fujifilm Settlement Agreement (see Note 4 to our consolidated financial statements), we agreed to pay up to $185.0 million (the “Settlement Payment”) to Fujifilm in connection with the cancellation of manufacturing activity at FDBT under the Fujifilm CSA, of which (i) $47.8 million, constituting the initial reservation fee under the CSA, was credited against the Settlement Payment on September 30, 2022 and (ii) the remaining balance was to be paid in four equal quarterly installments of $34.3 million each, which began on March 31, 2023.
−Removed: Under the Fujifilm Settlement Agreement, the final two quarterly installments due to Fujifilm were subject to Fujifilm’s obligation to use commercially reasonable efforts to mitigate losses associated with the vacant manufacturing capacity caused by the termination of manufacturing activities at FDBT under the CSA.
−Removed: Any replacement revenue achieved by Fujifilm’s mitigation efforts between July 1, 2023 and December 31, 2023 would offset the final two settlement payments owed by the Company.
−Removed: On October 2, 2023, we sent a notice of breach under the Fujifilm Settlement Agreement to Fujifilm setting forth the Company’s position that Fujifilm had not used commercially reasonable efforts to mitigate losses.
−Removed: We withheld two installments of $34.3 million due to Fujifilm on September 30, 2023 and December 31, 2023, pending resolution of the issues identified in the notice of breach.
−Removed: We paid the first two installments totaling $68.6 million during the twelve months ended December 31, 2023, and the remaining balance of $68.6 million is reflected in Accrued expenses on our consolidated balance sheet.
−Removed: On October 30, 2023, FDBT filed a demand for arbitration with Judicial Arbitration and Mediation Services (“JAMS”) seeking payment of the third quarter installment of the Settlement Payment.
−Removed: In August 2023, we entered into a Settlement Agreement and General Release (the “Settlement Agreement”) with SK regarding the mutual release by the parties of all claims arising from or in relation to certain statements of work (“SOWs”) under the Development and Supply Agreement entered into in August 2020 and the Collaboration and License Agreement, entered into in February 2021 as amended in December 2021 and July 2022 in connection with the cessation of all drug substance and drug product manufacturing activity at SK for supply to us.
−Removed: Pursuant to the Settlement Agreement, we agreed to pay $149.8 million, of which (i) $130.4 million was paid in August 2023 and (ii) the remaining balance was paid in November 2023.
−Removed: Under the Settlement Agreement, we also agreed with SK to a wind down plan with respect to the remaining products, materials and equipment under the SOWs (see Note 4 to our consolidated financial statements).
−Removed: In August 2023, we entered into a Securities Subscription Agreement (the “Subscription Agreement”) with SK, pursuant to which we agreed to sell and issue to SK, in a private placement (the “Private Placement”), 6.5 million shares of our common stock, par value $0.01 per share at a price of $13.00 per share for aggregate gross proceeds to us of approximately $84.5 million.
−Removed: The closing of the Private Placement occurred on August 10, 2023 (see Note 4 to our consolidated financial statements).
−Removed: We have an APA with the Commonwealth of Australia for the purchase of doses of COVID-19 Vaccine (the “Australia APA”).
−Removed: In April 2023, we amended the Australia APA to reduce the number of doses to be delivered with a commensurate increase in the per-dose price, such that the total contract value of the Australia APA is maintained with doses to be delivered through 2024.
−Removed: In May 2023, we extended a credit for certain doses delivered in 2022 to Australia that qualified for replacement under the Australia APA.
−Removed: This credit is the result of a single lot sold to the Australian government that upon pre-
−Removed: planned 6-month stability testing was found to have fallen below the defined specifications and the lot therefore was removed from the market.
−Removed: The credit will be applied against the future sale of doses to Australia.
−Removed: In July 2023, we amended the Australia APA to provide for replacement doses and to extend the delivery schedule through 2025.
−Removed: As of February 2024, we had not yet received TGA authorization or delivered doses as contemplated in the July 2023 amendment and are in active discussions with the Australian government on both the TGA authorization and delivery of the doses previously scheduled for the fourth quarter of 2023.
−Removed: In February 2024, we received notice from the Australian government purporting to cancel its order for such prototype vaccine doses.
−Removed: We believe the cancellation was not proper under the amended Australia APA.
−Removed: However, if such a cancellation were determined to be allowable, $6.0 million of the deferred revenue would become a credit towards future deliveries of doses and approximately $48 million of the contract value related to future deliverables would no longer be available.
−Removed: In April 2023, we amended the Canada APA, pursuant to which the Canadian government forfeited certain doses originally scheduled for delivery in 2022 for a payment of $100.4 million, which we received in the second quarter of 2023.
−Removed: In June 2023, we entered into an additional amendment (the “June 2023 Amendment”) to the Canada APA.
−Removed: Pursuant to the June 2023 Amendment, (i) the Canadian government forfeited certain doses of COVID-19 Vaccine previously scheduled for delivery and agreed to pay a total amount of $349.6 million to us in two equal installments, which total amount equaled the remaining balance owed by the Canadian government with respect to such forfeited vaccine doses, (ii) the amount of doses of COVID-19 Vaccine due for delivery was reduced, (iii) the delivery schedule for the remaining doses of COVID-19 Vaccine to be delivered was revised, and (iv) the parties agreed Novavax would use the Biologics Manufacturing Centre (“BMC”) Inc.
−Removed: to produce bulk antigen for doses in 2024 and 2025.
−Removed: The June 2023 Amendment maintained the total contract value of the original Canada APA.
−Removed: The first Installment of $174.8 million was payable upon execution of the June 2023 Amendment and received by Novavax in July 2023, and the second installment of $174.8 million was contingent and payable upon the delivery of vaccine doses in the second half of 2023 and received by Novavax in January 2024.
−Removed: The Canadian government may terminate the Canada APA, as amended, if we fail to receive regulatory approval for our COVID-19 Vaccine using bulk antigen produced at BMC on or before December 31, 2024.
−Removed: Our 2024 plans do not currently anticipate the submission for regulatory approval of our COVID-19 Vaccine using bulk antigen produced at BMC, and we plan to work with the Canadian government on an amendment that addresses possible alternatives, which may not be achievable.
−Removed: As of December 31, 2023, $102.8 million was classified as short-term Deferred revenue and $485.3 million was classified as long-term Deferred revenue with respect to the Canadian APA on our consolidated balance sheet.
−Removed: If the Canadian government terminates the Canada APA, $28.0 million of the deferred revenue would become refundable and approximately $224 million of the contract value related to future deliverables would no longer be available (see Note 3 to our consolidated financial statements).
−Removed: In the event that the contract is terminated, we would consider competing in the Canadian commercial market.
−Removed: Pursuant to the June 2023 Amendment, we and the Canadian government will endeavor to expand our previously agreed in-country commitment to Canada and to partner to provide health, economic, and future pandemic preparedness benefits to Canada, which value may be provided through a number of activities, including without limitation, capital investments, the performance of activities or services, or the provision of technology or intellectual property licenses.
−Removed: Further, the parties will endeavor to enter into a memorandum of understanding (the “MOU”) to illustrate our ability to deliver such benefits over a 15-year period with an aggregate value of not less than 100% of the amount remaining to be paid under the June 2023 Amendment and ultimately received by us.
−Removed: As of December 31, 2023, discussions regarding the MOU were ongoing.
−Removed: We agreed to hold $20.0 million of the second installment payment received in January 2024 in escrow for the benefit of the Canadian government, which amount is the sole recourse available to the Canadian government in the event of non-performance under the MOU.
−Removed: In September 2022, we entered into an Amended and Restated SARS-CoV-2 Vaccine Supply Agreement (the “Amended and Restated UK Supply Agreement”) with the Authority.
−Removed: Under the terms of the Amended and Restated UK Supply Agreement, the Authority agreed to purchase a minimum of 1 million doses and up to an additional 15 million doses (the “Conditional Doses”) of our prototype vaccine, with the number of Conditional Doses contingent on, and subject to reduction based on, our timely achievement of supportive recommendations from the JCVI that is approved by the UK Secretary of State for Health.
−Removed: If the Authority did not purchase the Conditional Doses or the number of such Conditional Doses was reduced below 15 million doses of our prototype vaccine, we would have to repay up to $225.0 million related to the upfront payment previously received from the Authority under the Original UK Supply Agreement.
−Removed: Under the Amended and Restated UK Supply Agreement, the Authority also has the option to purchase up to an additional 44 million doses, in one or more tranches, through 2024.
−Removed: As of November 30, 2022, the JCVI had not made a supportive recommendation with respect to our prototype vaccine, thereby triggering, under the terms of the Amended and Restated UK Supply Agreement, (i) a reduction of the number of Conditional Doses from 15 million doses to 7.5 million doses, which reduced number of Conditional Doses are contingent on, and subject to further reduction based on, our timely achievement by November 30, 2023 of a supportive recommendation from JCVI that is approved by the UK Secretary of State for Health as described in the paragraph above, and (ii) an obligation for us
−Removed: to repay $112.5 million related to the upfront payment previously received from the Authority under the Original UK Supply Agreement.
−Removed: In April 2023, we repaid the $112.5 million related to the November 30, 2022 triggering event.
−Removed: As of November 30, 2023, the JCVI had not made a supportive recommendation with respect to the prototype vaccine, thereby triggering a reduction in the number of Conditional Doses from 7.5 million doses to zero.
−Removed: As of February 2024, the Company is in discussions with the Authority regarding the treatment of the remaining upfront amount previously received of $112.5 million, which is reflected in Other current liabilities on our consolidated balance sheet.
−Removed: Under the terms of the Gavi APA, we received an upfront payment of $350.0 million from Gavi in 2021 and an additional payment of $350.0 million in 2022 related to our achieving EUL for our prototype vaccine by the WHO (the “Advance Payment Amount”).
−Removed: On November 18, 2022, we delivered written notice to Gavi to terminate the Gavi APA on the basis of Gavi’s failure to procure the purchase of 350 million doses of our prototype vaccine from us as required by the Gavi APA.
−Removed: As of November 18, 2022, we had only received orders under the Gavi APA for approximately 2 million doses.
−Removed: On December 2, 2022, Gavi issued a written notice purporting to terminate the Gavi APA based on Gavi’s contention that the Company repudiated the agreement and, therefore, materially breached the Gavi APA.
−Removed: Gavi also contended that, based on its purported termination of the Gavi APA, it was entitled to a refund of the Advance Payment Amount less any amounts that have been credited against the purchase price for binding orders placed by a buyer participating in the COVAX Facility.
−Removed: As of December 31, 2023, the remaining Gavi Advance Payment Amount of $696.4 million, pending resolution of the dispute with Gavi related to a return of the remaining Advance Payment Amount, was reclassified from Deferred revenue to Other current liabilities on our consolidated balance sheet.
−Removed: On January 24, 2023, Gavi filed a demand for arbitration with the International Court of Arbitration based on the claims described above.
−Removed: We filed our Answer and Counterclaims on March 2, 2023.
−Removed: On April 5, 2023, Gavi filed its Reply to our Counterclaims.
−Removed: On February 16, 2024, we and Gavi entered into a Termination and Settlement Agreement (the “Gavi Settlement Agreement”) terminating the Gavi APA, settling the arbitration proceedings, and releasing both parties of all claims arising from, under or otherwise in connection with the Gavi APA.
−Removed: Pursuant to the Gavi Settlement Agreement, we are responsible for payment to Gavi of (i) an initial settlement payment of $75 million, which we paid on February 20, 2024, and (ii) deferred payments, in equal annual amounts of $80 million payable each calendar year through a deferred payment term ending December 31, 2028.
−Removed: The deferred payments are due in variable quarterly installments beginning in the first quarter of 2024 and total $400 million during the deferred payment term.
+Added: As of December 31, 2024, gross-to-net deduction balances were $116.7 million related to product returns and $21.1 million related to wholesale distributor fees, discounts, and chargebacks.
+Added: As of December 31, 2024, $77.1 million of gross-to-net deductions were included in Accrued expenses, $10.1 million were included Accounts payable, and $50.6 million were included in and reduced Accounts receivable on the consolidated balance sheet.
+Added: Pursuant to the Settlement Agreement with Fujifilm (see Note 4 to our accompanying consolidated financial statements), in March 2024, we paid $42.0 million to Fujifilm, the parties agreed to a mutual release of claims arising from, under or otherwise in connection with the prior confidential settlement agreement and release effective September 30, 2022, and Fujifilm agreed to dismiss its demand for arbitration with the Judicial Arbitration and Mediation Services (“JAMS”).
+Added: This payment is less than amounts previously recognized as embedded lease expense and reflected in Research and development expenses from Fujifilm manufacturing activity and accordingly, during the year ended December 31, 2024, we recorded a benefit of $26.6 million as Research and development expenses.
+Added: We have an APA with the Commonwealth of Australia (“Australia”) for the purchase of doses of COVID-19 Vaccine (the “Australia APA”).
+Added: In December 2024, we entered into an amendment to the Australia APA with Australia.
+Added: Pursuant to the amendment, we acknowledged the cancellation by Australia of the delivery of certain doses of our COVID-19 Vaccine scheduled for delivery between the fourth quarter of 2023 and the fourth quarter of 2025 and we agreed to credit approximately $31 million of the advanced payment paid by Australia to us against outstanding invoices and invoices for the future delivery of approximately 3 million doses of COVID-19 Vaccine without requiring additional cash payments.
+Added: We also agreed to an updated delivery schedule providing for the potential delivery of COVID-19 Vaccine or future variant COVID-19 Vaccine through the end of 2029.
+Added: The amendment further provides for certain remedies for Australia, including return of unused credit, cancellation of doses, or termination of the Australia APA, in the event we miss or under deliver doses to Australia or fail to receive regulatory approval of a variant COVID-19 vaccine.
+Added: The amendment also provides Australia with the right to cancel doses if we fail to timely notify Australia of changes to our commercialization plans.
+Added: As of December 31, 2024, $15.6 million was classified as current Deferred revenue and $118.2 million was classified as non-current Deferred revenue with respect to the Australia APA in our consolidated balance sheet, which will be recognized in product revenue as doses are delivered to Australia.
+Added: We have an APA with the Pharmaceutical Management Agency (“Pharmac”), a New Zealand Crown entity, for the purchase of doses of COVID-19 Vaccine (the “New Zealand APA”).
+Added: In July 2024, Pharmac provided notice of its termination of the New Zealand APA.
+Added: Pharmac has requested a refund of certain advanced payments, and we are in discussion with Pharmac regarding whether a refund of the advanced payments is appropriate under the New Zealand APA.
+Added: As of December 31, 2024 , $31.3 million was classified as Other current liabilities with respect to the New Zealand APA in our consolidated balance sheet.
+Added: Approximately $125 million of the contract value related to future deliverables may no longer be available if the New Zealand APA is terminated.
+Added: We responded to Pharmac in September 2024 indicating we do not believe Pharmac has the right to unilaterally terminate the contract or receive a refund of any part of the remaining upfront payment.
+Added: We are in ongoing discussions with Pharmac to resolve this matter, which may not be achievable on acceptable terms or at all.
+Added: We have an APA with His Majesty the King in Right of Canada as represented by the Minister of Public Works and Government Services, as successor in interest to Her Majesty the Queen in Right of Canada, as represented by the Minister of Public Works and Government Services (the “Canadian government”), for the purchase of doses of COVID-19 Vaccine (the “Canada APA”).
+Added: The Canadian government may terminate the Canada APA, as amended, as we failed to receive regulatory approval for our COVID-19 Vaccine using bulk antigen produced at Biologics Manufacturing Centre Inc.
+Added: (“BMC”) on or before December 31, 2024.
+Added: Therefore, we are in discussions with Canada regarding a potential amendment to the Canada APA to address possible alternatives, which may not be achievable on acceptable terms or at all.
+Added: As of December 31, 2024, $555.7 million was classified as current Deferred revenue with respect to the Canada APA in our consolidated balance sheet.
+Added: If the Canadian government terminates the Canada APA, $28.0 million of advanced payments previously received would become refundable, which was classified as Other current liabilities in our consolidated balance sheet, and approximately $224 million of the contract value related to future deliverables would no longer be available.
+Added: Table o f Contents
+Added: In November 2024, we and The Secretary of State for Business, Energy and Industrial Strategy (as assigned to the UK Health Security Agency), acting on behalf of the government of the United Kingdom of Great Britain and Northern Ireland (the “Authority”) entered into a Termination and Settlement Agreement (the “Settlement Agreement”) and a Letter of Amendment to the Settlement Agreement (the “Settlement Agreement Amendment”), relating to the Amended and Restated SARS-CoV-2 Vaccine Supply Agreement (the “Amended and Restated UK Supply Agreement”) and the SARS-CoV-2 Vaccine Supply Agreement, dated October 22, 2020 (the “Original UK Supply Agreement”).
+Added: The Settlement Agreement resolved the disputes regarding the Amended and Restated Supply Agreement and released both parties of all claims arising out of or connected with the Amended and Restated Supply Agreement.
+Added: Under the terms of the Settlement Agreement and Settlement Agreement Amendment, we and the Authority agreed to terminate the Amended and Restated Supply Agreement and to fully settle the outstanding amount under dispute related to upfront payments of $112.5 million previously received by us from the Authority under the Amended and Restated Supply Agreement.
+Added: Pursuant to the Settlement Agreement, we agreed to pay a refund of $123.8 million (the “Settlement Payment”) to the Authority in equal quarterly installments of $10.3 million over a three year period, ending in June 2027.
+Added: The Settlement Payment amount includes an $11.3 million provision for interest over the period and may be avoided if we choose to accelerate payments.
+Added: As of December 31, 2024, the remaining upfront payment previously received from the authority is classified as $36.4 million of other current liabilities and $58.8 million of Other non-current liabilities on our consolidated balance sheet.
+Added: We entered into an APA with the Vaccine Alliance (“Gavi”) in May 2021 (the “Gavi APA”), pursuant to which we received upfront payments of $700 million from Gavi (the “Advance Payment Amount”) to be applied against purchases of our prototype vaccine by certain countries participating in the COVAX Facility.
+Added: As of December 31, 2023, the remaining Gavi Advance Payment Amount was $696.4 million.
+Added: In February 2024, we and Gavi entered into a Termination and Settlement Agreement (the “Gavi Settlement Agreement”) terminating the Gavi APA, settling the arbitration proceedings, and releasing both parties of all claims arising from, under, or otherwise in connection with the Gavi APA.
+Added: Pursuant to the Gavi Settlement Agreement, we are responsible for payment to Gavi of (i) an initial settlement payment of $75 million, which we paid in February 2024, and (ii) deferred payments, in equal annual amounts of $80 million payable each calendar year through a deferred payment term ending December 31, 2028.
+Added: The deferred payments are due in variable quarterly installments beginning in the second quarter of 2024 and total $400 million during the deferred payment term.
Such deferred payments may be reduced through Gavi’s use of an annual vaccine credit equivalent to the unpaid balance of such deferred payments each year, which may be applied to qualifying sales of any of our vaccines funded by Gavi for supply to certain low-income and lower-middle income countries.
−Removed: We have the right to price the vaccines offered to such low-income and lower-middle income countries at our discretion, and, when utilized by Gavi, we will credit the actual price per vaccine paid against the applicable credit.
+Added: We have the right to price the vaccines offered to such low-income and lower-middle income countries in our discretion, and, when utilized by Gavi, we will credit the actual price per vaccine paid against the applicable credit.
We intend to price vaccines offered via the tender process, consistent with our shared goal with Gavi to provide equitable access to those countries.
−Removed: Also in the Gavi Settlement Agreement, we grant Gavi an additional credit of up to $225 million, which may be applied against any additional qualifying sales, exceeding the $80 million deferred payment amount in any calendar year, of our vaccines in such countries during such deferred payment term.
−Removed: In addition, we and Gavi entered into a security agreement pursuant to which we granted Gavi a security interest in accounts receivable from SIIPL under the SIIPL R21 Agreement (see Note 4 to our consolidated financial statements for more details on SIIPL R21 Agreement), which will continue for the deferred payment term of the Gavi Settlement Agreement.
+Added: Also, pursuant to the Gavi Settlement Agreement, we granted Gavi an additional credit of up to $225 million that may be applied against qualifying sales of any of our vaccines for supply to such low-income and lower-middle income countries that exceed the $80 million deferred payment amount in any calendar year during the deferred payment term.
+Added: In total, the Gavi settlement agreement is comprised of $700 million of potential consideration, consisting of the $75 million initial settlement payment, deferred payments of up to $400 million that may be reduced through annual vaccine credits, and the additional credit of up to $225 million that may be applied for certain qualifying sales.
+Added: We recorded the $3.6 million difference between the refund liability recorded as of December 31, 2023 of $696.4 million and the $700 million of total consideration under the arrangement as a revenue adjustment during the year ended December 31, 2024.
+Added: As of December 31, 2024, the remaining amounts included on our consolidated balance sheet are classified as $225.0 million in non-current Deferred revenue for the additional credit that may be applied against future qualifying sales, $85.0 million in Other current liabilities, and $275.0 million in other non-current liabilities.
+Added: In addition, we and Gavi entered into a security agreement pursuant to which we granted Gavi a security interest in accounts receivable from SII under the SII R21 Agreement (see Note 3 to our accompanying consolidated financial statements), which will continue for the deferred payment term of the Gavi Settlement Agreement.
On February 22, 2024, the claims and counterclaims were dismissed with prejudice.
−Removed: Our funding agreements currently include funding from CEPI in the form of one or more forgivable no interest term loans (“CEPI Forgivable Loan Funding”).
−Removed: Payments received under the CEPI Forgivable Loan Funding are only repayable if project vaccine, as defined under the CEPI funding agreement, manufactured by the CMO network funded by CEPI is sold to one or more third parties (which could include sales credited under the Gavi Settlement Agreement), and such sales cover our costs of manufacturing such vaccine, not including manufacturing costs funded by CEPI.
−Removed: The timing and amount of any loan repayments is currently uncertain.
We continue to assess our manufacturing needs and modify our global manufacturing footprint consistent with our contractual obligations to supply, and anticipated demand for, COVID-19 Vaccine, and in doing so recognize that significant costs may be incurred.
−Removed: For the 2023-2024 vaccination season, we depend exclusively on SIIPL and SLS for co-formulation and filling (other than in Europe), and PCI Pharma Services for finishing COVID-19 Vaccine in Europe.
−Removed: For the 2024-2025 vaccination season, we are seeking to expand our supply chain network and introduce new single-dose vial or pre-filled syringe product presentations in certain markets.
+Added: For the 2023-2024 vaccination season, we depended exclusively on Serum for co-formulation and filling and finishing.
+Added: For the 2024-2025 vaccination season, we expanded our supply chain network and introduced new single-dose vial and pre-filled syringe product presentations in certain markets.
+Added: In May 2024, we and SLS entered into a supply agreement (the “SLS Supply Agreement”) under which SLS will supply us antigen drug substance and finished COVID-19 Vaccine doses.
+Added: The SLS Supply Agreement includes the general terms and conditions of supply orders between us and SLS.
+Added: Table o f Contents
+Added: execute firm purchase orders to include specific quantities to be delivered under the SLS Supply Agreement.
+Added: Pursuant to the SLS Supply Agreement, SLS or its authorized manufacturer is responsible for obtaining and maintaining all necessary permits or other regulatory approvals to manufacture drug substance and drug product.
+Added: Unless otherwise earlier terminated, the SLS Supply Agreement will expire on the later of June 30, 2028 or two years after the expiration or termination of the last firm purchase order under the SLS Supply Agreement.
+Added: Either party may terminate the SLS Supply Agreement if the other party commits a material breach of the SLS Supply Agreement that is not timely cured or is not curable.
+Added: The SLS Supply Agreement contains certain customary representations and warranties of the parties along with certain customary covenants, including confidentiality and indemnity provisions.
Any delays or disruptions in these suppliers’ operations could prevent or delay the delivery of customer orders.
−Removed: As of December 31, 2023, we had $583.8 million in cash and cash equivalents and restricted cash as compared to $1.3 billion as of December 31, 2022.
−Removed: We funded our operations in 2023 primarily with cash and cash equivalents, upfront payments under APAs, revenue from product sales, royalties under licensing arrangements with our strategic partners, and proceeds from the sale of common stock, together with revenue under the USG Agreement that support our COVID-19 Vaccine development activities.
+Added: As of December 31, 2024, we had $545.3 million in cash and cash equivalents and restricted cash and $392.9 million in marketable securities as compared to $583.8 million in cash and cash equivalents and restricted cash as of December 31, 2023.
+Added: We funded our operations in 2024 primarily with cash and cash equivalents, marketable securities, non-refundable upfront payment under the Sanofi CLA and Sanofi Subscription Agreement, proceeds from the sale of securities under our August 2023 Sales Agreement, upfront payments under APAs, and revenue from product sales.
In May 2023, we announced our plan to restructure our global footprint to reduce our planned expenditures and in January 2024, we announced further reductions in our global workforce.
−Removed: We anticipate our future operations to be funded primarily by revenue from product sales, our cash and cash equivalents, and other potential funding sources including equity financings, which may include at the market offerings under our August 2023 Sales Agreement, debt financings, collaborations, strategic alliances, asset sales, and marketing, distribution or licensing arrangements.
+Added: We anticipate our future operations to be funded primarily by milestone payments, royalties, transition services and technology transfer under the Sanofi CLA, revenue and/or royalties from product sales, our cash and cash equivalents and investments in marketable securities, and other potential funding sources including equity financings, which may include at the market offerings, debt financings, collaborations, strategic alliances, asset sales, and marketing, distribution or licensing arrangements.
The following table summarizes cash flows for 2024 and 2023:
4 unchanged sentences
Effect on exchange rate on cash, cash equivalents, and restricted cash (7,800) 3,272 (11,072)
−Removed: Net increase in cash, cash equivalents, and restricted cash (765,035) (179,414) (585,621)
+Added: Net decrease in cash, cash equivalents, and restricted cash
+Added: (38,518) (765,035) 726,517
Cash, cash equivalents, and restricted cash at beginning of year 583,810 1,348,845 (765,035)
1 unchanged sentence
Net cash used in operating activities was $87.3 million for 2024, as compared to cash used in operating activities of $714.0 million in 2023.
−Removed: The increase in cash used in operating activities is primarily due to the timing of payments to vendors and cash receipts from customers, primarily APAs.
+Added: The decrease in cash used in operating activities is primarily due to the non-refundable upfront payment under the Sanofi CLA and an overall decrease in operating expenses period-over-period, partially offset by the timing of payments to vendors.
Net cash used in investing activities was $204.0 million for 2024, as compared to $58.8 million in 2023.
−Removed: The decrease in cash used in investing activities is primarily due to lower expenditures on equipment and leasehold improvements.
+Added: The increase in cash used in investing activities is primarily due to our investment in marketable securities, partially offset by proceeds on the disposition of Novavax CZ assets of 192.6 million and lower expenditures on equipment and leasehold improvements.
Capital expenditures for the years ended December 31, 2024 and 2023 were $13.1 million and $53.8 million, respectively.
Net cash provided by financing activities was $260.6 million for 2024, as compared to $4.5 million in 2023.
−Removed: The decrease in cash provided by financing activities is primarily due to the repayment of our 3.75% Convertible notes of $325.0 million in 2023 as compared to gross proceeds of $175.3 million through the issuance of our 2027 Notes in 2022, partially offset by an increase in net proceeds from the sales of our common stock under our June 2021 and August 2023 Sales Agreements and the Private Placement with SK in 2023.
+Added: The increase in cash provided by financing activities is primarily as a result of the 2023 repayment of $325.0 million of our 3.75% Convertible notes in 2023, partially offset by lower proceeds from the sale of shares under our August 2023 Sales Agreement and Sanofi Subscription Agreement, totaling $263.3 million in 2024, as compared with proceeds from the sale of shares under our June 2021 Sales Agreement and August 2023 Sales Agreement and the sale of SK Shares, totaling $360.2 million in 2023.
+Added: Table o f Contents
Going Concern
The accompanying consolidated financial statements in Part II, Item 8, “Financial Statements and Supplementary Data,” of this Annual Report on Form 10-K have been prepared assuming that we will continue as a going concern within one year after the date that the financial statements are issued and contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business.
−Removed: The consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainty described below.
−Removed: At December 31, 2023, we had $568.5 million in cash and cash equivalents and had a working capital deficiency.
+Added: At December 31, 2024, we had $530.2 million in cash and cash equivalents, $392.9 million in marketable securities, and had negative working capital of $25.5 million.
During 2024, we incurred a net loss of $187.5 million and had net cash flows used in operating activities of $87.3 million.
−Removed: In accordance with ASC Topic 205-40, Presentation of Financial Statements - Going Concern, we evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date that these consolidated financial statements are issued.
−Removed: While our current cash flow forecast for the one-year going concern look forward period estimates that we have sufficient capital available to fund operations, this forecast is subject to significant uncertainty, including as it relates to revenue for the next twelve months and our ability to execute on certain cost-reduction initiatives.
−Removed: Our revenue projections depend on our ability to successfully develop, manufacture, distribute, or market our COVID-19 Vaccine for the 2024-2025 vaccination season, which is inherently uncertain and subject to a number of risks, including our ability to obtain regulatory authorizations, introduce a single-dose vial or pre-filled syringe product presentation for the U.S.
−Removed: commercial and certain other markets, the incidence of COVID-19 during
−Removed: the 2024-2025 vaccination season, our ability to timely deliver doses and commercial adoption and market acceptance of our updated vaccine.
−Removed: Further, failure to meet regulatory milestones or achieve product volume or delivery timing obligations under our advance purchase agreements may require us to refund portions of upfront and other payments or result in reduced future payments which could adversely affect our ability to continue as a going concern.
−Removed: Management believes that, given our history of recurring losses, negative working capital and accumulated deficit, conditions or events exist that raise substantial doubt about our ability to continue as a going concern through one year from the date that these financial statements are issued.
−Removed: Our plans to alleviate the conditions that exist include restructuring and cost reduction measures and successful execution of its commercial plans.
−Removed: In May 2023, we announced our Restructuring Plan, which includes a more focused investment in our COVID-19 Vaccine, reduction to our pipeline spending, the continued rationalization of our manufacturing network, a reduction to our global workforce, as well as the consolidation of facilities, and infrastructure.
−Removed: In our May 2023 announcement, the workforce reduction plan included an approximately 25% reduction in the Company’s global workforce, comprised of an approximately 20% reduction in full-time Company employees and the remainder comprised of contractors and consultants.
−Removed: We incurred one time restructuring expenses of $14.6 million during the twelve months ended December 31, 2023.
−Removed: See Note 17 to our consolidated financial statements for more details on restructuring.
−Removed: We expect the full annual impact of the cost savings to be realized in 2024 due to timing of implementing the measures, and the applicable laws, regulations, and other factors in the jurisdictions in which we operate.
−Removed: In November 2023, we announced that we anticipated further reducing our research and development and selling, general and administrative expenses and our supply network costs.
−Removed: We intend to prioritize improvements to our long-term supply chain efficiency.
−Removed: In January 2024, as part of reducing combined research and development and selling.
−Removed: general and administrative expenses, we announced an approximately 12% reduction of our global workforce, comprised of an approximately 9% reduction in our full-time employees and the remainder comprised of contractors and consultants.
−Removed: We expect the full annual impact of the cost savings to be realized in 2025 and approximately 85% of the annual impact, excluding one-time charges, to be realized in 2024 due to the timing of implementing the measures and the applicable laws, regulations and other factors in the jurisdictions in which it operates.
−Removed: We expect to record a charge of approximately $4 million to $7 million related to one-time employee severance and benefit costs, the majority of which is expected to be incurred in the first quarter of 2024.
−Removed: Upon completion, our resulting workforce is expected to be approximately 30% lower as compared to the end of the first quarter of 2023.
−Removed: Our plans may include raising additional capital through a combination of equity financings, which may include at the market offerings under our August 2023 Sales Agreement, debt financings, collaborations, strategic alliances, asset sales and marketing, distribution, or licensing arrangements.
−Removed: New financings may not be available to us on commercially acceptable terms, or at all.
−Removed: Also, any collaborations, strategic alliances, asset sales and marketing, distribution, or licensing arrangements may require us to give up some or all of our rights to a product or technology, which in some cases may be at less than the full potential value of such rights.
−Removed: If we are unable to obtain additional capital, we will assess our capital resources and may be required to delay, reduce the scope of, or eliminate some or all of our operations, or further downsize our organization, any of which may have a material adverse effect on our business, financial condition, results of operations, and ability to operate as a going concern.
−Removed: Due to the uncertainties associated with our plans, there is substantial doubt about our ability to continue as a going concern for at least one year from the date that these financial statements are issued.
+Added: In accordance with Accounting Standards Codification (“ASC”) Topic 205-40, Presentation of Financial Statements - Going Concern , we evaluated our ability to continue as a going concern within one year after the date that the accompanying consolidated financial statements are issued.
+Added: Based on our current cash, cash equivalents and marketable securities balances and our current cash flow forecast for the one-year going concern look forward period, we concluded that we expect to have sufficient capital available to fund our operations for the one-year period from the date that these financial statements are issued.
+Added: As of December 31, 2023, we had concluded that there was substantial doubt about our ability to continue as a going concern primarily due to significant uncertainty related to our ability to successfully develop, manufacture, distribute, and market our COVID-19 Vaccine and execute on certain cost-reduction initiatives.
+Added: The Sanofi CLA, combined with proceeds from the disposition of assets held by Novavax CZ, cost reductions and the settlement of certain liabilities, alleviated the substantial doubt.
Contractual Obligations
6 unchanged sentences
Finance leases obligation 98,019 12,187 15,306 15,501 55,025
−Removed: Convertible notes (1)
+Added: Convertible notes payable (1)
175,250 — 175,250 — —
5 unchanged sentences
(1) In 2022, we issued $175.3 million of 5.00% convertible senior unsecured notes due in 2027.
−Removed: See “Note 10—Long-term Debt” included in our Notes to Consolidated Financial Statements for additional information related to our convertible notes.
(2) Purchase commitments primarily represent our non-cancelable fixed payment obligations under certain CMO, CDMO, and laboratory supply agreements that we are not contractually able to terminate for convenience.
8 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.