Full Press Release Details
We undertake no obligation to update or revise this guidance in the future. 1. Full year 2024 product sales guidance reflects approximately $ 100 million in APA dose deliveries in 1 H 2024 and $ 75 million to $ 125 million of commercial market sales in 2 H 2024 . 2. Full year 2024 Licensing, royalties and other revenue guidance includes $ 450 million of revenue recognition from the $ 500 million Sanofi agreement upfront payment and $ 25 million in royalty and other revenue from partner - related activities . 2025 NOVAVAX.
FLUAD is a registered trademark of Seqirus UK Limited; Fluzone High - Dose Quadrivalent is a registered trademark of Sanofi Pasteur Inc. Influenza (65+) 44 - 89% higher HAI* responses for A strains compared to Fluzone HD; non - inferior B - strains 31 - 56% higher for all four strains compared to FLUAD 105 - 113% higher MN response to Fluzone HD and 67 - 86% higher than FLUAD for A strains Substantially higher polyfunctional* CD4+ to Fluzone HD or FLUAD Comparable reactogenicity to Fluzone HD and FLUAD Phase 2 Data Phase 2 Data 2025 NOVAVAX.
Palm, Behdad Zarnegar , Berit Carow , Carolina Lunderius Andersson, Sofia E. Magnusson, Cecilia Carnrot , Vivek Shinde, Gale Smith, Gregory Glenn, Louis Fries & Karin L vgren Bengtsson (2023) The Matrix - M adjuvant: A critical component of vaccines for the 21st century, Human Vaccines & Immunotherapeutics, 19:1, DOI: 10.1080/21645515.2023.2189885 7.Datoo MS, Natama HM, Som A, Bellamy D, Traor O, Rouamba T, Tahita MC, Ido NFA, Yameogo P, Valia D, Millogo A, Ouedraogo F, Soma R, Sawadogo S, Sorgho F, Derra K, Rouamba E, Ramos - Lopez F, Cairns M, Provstgaard - Morys S, Aboagye J, Lawrie A, Roberts R, Val a I, Sorgho H, Williams N, Glenn G, Fries L, Reimer J, Ewer KJ, Shaligram U, Hill AVS, Tinto H.
Comparison of the safety and immunogenicity of a novel Matrix - M - adjuvanted nanoparticl e influenza vaccine with a quadrivalent seasonal influenza vaccine in older adults: a phase 3 randomised controlled trial. Lancet Infect Dis. 2022 Jan;22(1):73 - 84. doi : 10.1016/S1473 - 3099(21)00192 - 4. Epub 2021 Sep 23. PMID: 34563277. 6.Linda Stertman , Anna - Karin E.
Induction of Cross - Reactive Hemagglutination Inhibiting Antibody and Polyfunctional CD4+ T - Cell Responses by a Recombinant Matrix - M - Adjuvanted Hemagglutinin Nanoparticle Influenza Vaccine. Clin Infect Dis. 2021 Dec 6;73(11):e4278 - e4287. doi : 10.1093/ cid /ciaa1673. PMID: 33146720; PMCID: PMC8664440. 5.Shinde V, Cho I, Plested JS, Agrawal S, Fiske J, Cai R, Zhou H, Pham X, Zhu M, Cloney - Clark S, Wang N, Zhou B, Lewis M, Price - Abbott P, Patel N, Massare MJ, Smith G, Keech C, Fries L, Glenn GM.
Safety, Immunogenicity, and Efficacy of the NVX - CoV2373 COVID - 19 Vaccine in Adolescents. JAMA Netw Open. Published April 26, 2023. doi:10.1001/jamanetworkopen.2023.9135 4.Shinde V, Cai R, Plested J, Cho I, Fiske J, Pham X, Zhu M, Cloney - Clark S, Wang N, Zhou H, Zhou B, Patel N, Massare MJ, Fix A, Spindler M, Thomas DN, Smith G, Fries L, Glenn GM.
Efficacy and Safety of NVX - CoV2373 in Adults in the United States and Mexico. New England Journal of Medicine , 386(6), 531 - 543 (2022). 2.Heath PT, Galiza EP, Baxter DN et al. Safety and Efficacy of the NVX - CoV2373 COVID - 19 Vaccine at Completion of the Placebo - Controlled Phase of a Randomized Controlle d Trial. Clinical Infectious Diseases , (2022) 3. ez.
The use of this non - GAAP financial measure may differ from similar measures reported by other companies and may not be comparable to other similarly titled measures . Table of Contents Corporate Overview and Growth Strategy Corporate strategy Novavax technology Value drivers + impact Pipeline Value Drivers Sanofi and additional future partnerships Late - stage pipeline Leveraging our technology Emerging, early - stage pipeline Establishing a Lean Operating Model to Drive Shareholder Value Lean and agile organization Financial guidance 2025: Year Ahead What to expect in 2025 and beyond 4 2025 NOVAVAX.
The Company uses this non - GAAP financial measure for business planning purposes and to consider underlying trends of its business and believes presenting this measure also provides useful information to investors and others for understanding and evaluating trends in the Company's expenses in the same manner as the Company's management . Non - GAAP financial measures should be considered in addition to, and not as an alternative for, the Company's reported results prepared in accordance with GAAP .
Non - GAAP financial measures refer to financial information adjusted from financial measures prepared in accordance with accounting principles generally accepted in the United States (GAAP) . The Company believes that the presentation of this adjusted financial measure is useful to investors as it provides additional information on comparisons between periods by including certain items that affect overall comparability .
S . generally accepted accounting standards . Additional information that will be material to investors will be provided in these financial statements, and, accordingly, investors should not place undue reliance on the limited preliminary information being provided herein . Non - GAAP financial measures The Company has used a non - GAAP financial measure in this presentation, which is adjusted combined R&D and SG&A expenses, net of Sanofi reimbursement costs under the Sanofi Agreement .
Accordingly, Ernst & Young LLP does not express an opinion or any other form of assurance with respect thereto . Novavax's actual results for this period may differ from the foregoing preliminary financial data and such changes could be material . In addition, this preliminary financial data should not be viewed as a substitute for full financial statements for the year ended December 31 , 2024 prepared in accordance with U .
This financial data for the year ended December 31 , 2024 is preliminary and may change . This preliminary financial data has been prepared by, and is the responsibility of, Novavax's management . Ernst & Young LLP, Novavax's independent registered public accounting firm, has not audited, reviewed, compiled or performed any procedures with respect to this preliminary financial data, nor have any other independent accountants .
The forward - looking statements in this presentation speak only as of the date of this presentation, and we undertake no obligation to update or revise any of these statements . Our business is subject to substantial risks and uncertainties, including those referenced above . Investors, potential investors, and others should give careful consideration to these risks and uncertainties .
Novavax cautions investors not to place considerable reliance on the forward - looking statements contained in this presentation . Investors are encouraged to read Novavax's filings with the Securities and Exchange Commission, available at www . sec . gov and on our website at www . novavax . com , for a discussion of these and other risks and uncertainties .
Ltd . and Serum Life Sciences Limited for co - formulation and filling Novavax's COVID - 19 vaccine and the impact of any delays or disruptions in their operations ; difficulty obtaining scarce raw materials and supplies including for its proprietary adjuvant ; resource constraints, including human capital and manufacturing capacity ; constraints on Novavax's ability to pursue planned regulatory pathways, alone or with partners ; challenges in implementing its global restructuring and cost reduction plan ; challenges in obtaining commercial adoption and market acceptance of its updated 2024 - 2025 formula COVID - 19 vaccine or any COVID - 19 variant strain containing formulation, or for its CIC vaccine candidate and stand - alone influenza vaccine candidate or other product candidates ; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities, including requirements to deliver doses that may require Novavax to refund portions of upfront and other payments previously received or result in reduced future payments pursuant to such agreements and challenges in amending or terminating such agreements ; challenges related to the seasonality of vaccinations against COVID - 19 ; challenges related to the demand for vaccinations against COVID - 19 or influenza ; challenges in identifying and successfully pursuing innovation expansion opportunities ; Novavax's expectations as to expenses and cash needs may prove not to be correct for reasons such as changes in plans or actual events being different than its assumptions ; and the risks identified under the heading "Risk Factors" in Novavax's most recent Annual Report on Form 10 - K and subsequent Quarterly Reports on Form 10 - Q, as well as subsequent filings with the Securities and Exchange Commission .
Novavax cautions that these forward - looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements . These risks and uncertainties include, without limitation, Novavax's ability to successfully and timely manufacture, market, distribute, or deliver its updated 2024 - 2025 formula COVID - 19 vaccine and the impact of its not having received a BLA from the FDA for the 2024 - 2025 vaccination season ; challenges related to Novavax's partnership with Sanofi and in pursuing additional partnership opportunities ; challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification, assay validation and stability testing, necessary to satisfy applicable regulatory authorities ; challenges or delays in conducting clinical trials or studies for its product candidates, including increased costs associated with the Phase 3 trial for our CIC and stand - alone influenza vaccine candidates ; challenges or delays in obtaining regulatory authorization for its product candidates, including for future COVID - 19 variant strain changes, its CIC vaccine candidate, its stand - alone influenza vaccine candidate or other product candidates ; manufacturing, distribution or export delays or challenges ; Novavax's substantial dependence on Serum Institute of India Pvt .
These forward - looking statements address various matters including Novavax's corporate strategy and operating plans, objectives and prospects ; its value drivers and near - term priorities ; its partnerships, including expectations with respect to potential royalties, milestones, and cost reimbursement, and plans for additional potential partnering activities ; the potential for its CIC and stand - alone influenza study to be used for accelerated approval and the timing of updates related thereto its expectations regarding manufacturing capacity, timing, production and delivery for its COVID - 19 vaccine ; the development of Novavax's clinical and preclinical product candidates and innovation expansion opportunities ; the conduct, timing and potential results from clinical trials and other preclinical studies ; scope, timing and outcome of future and pending regulatory filings and actions ; potential market sizes and demand for its COVID - 19 vaccine and product candidates ; full year 2024 financial guidance ; expected combined annual R&D and SG&A expenses for 2025 and 2026 ; the amount and impact of Novavax's cost reduction plans ; Novavax's future financial or business performance ; and plans with respect to Novavax's existing advanced purchase agreements .