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These sales are expected to be immaterial . Novavax will sell Nuvaxovid commercial supply to Sanofi for the 2025 and 2026 seasons and the reimbursement for this supply will be recorded as product sales . For APA agreements, Novavax is working to amicably negotiate or deliver doses or when appropriate exit agreements with the goal of these activities to be cash flow neutral or favorable on a go forward basis .
For each n ew vaccine using Matrix - M, Novavax is eligible to receive up to $ 200 million in launch and sales milestones and mid - single digit royalties for 20 years . 3. Nuvaxovid Product Sales . During the first half of 2025 , Novavax will continue to sell Nuvaxovid in the U . S . as it transitions the market to Sanofi beginning with the 2025 - 2026 vaccination season .
Novavax is reliant on Sanofi's sales forecast to estimate royalties and therefore these will not be included in full year 2025 guidance at this time . 2. Sanofi CIC and Matrix - M related milestones . Novavax is eligible to receive up to $ 350 million in Phase 3 development and commercial launch milestone payments associated with Sanofi influenza - COVID - 19 combination products .
Royalties and adjuvant reimbursement associated with collaborations with the Serum Institute on R 21 and collaboration partners for COVID - 19 vaccine including Serum, SK Bio and Takeda . Contribution to 2025 Adjusted Licensing, Royalties and Other Revenue Components of Total Revenue Significant Value Creation Potential from Sanofi Related Revenue 38 2025 NOVAVAX.
In 2024 , Novavax received a $ 500 million upfront payment upon signing of the Sanofi CLA . Revenue recognition will occur over the performance period through 2026 . During 2024 , $ 424 million was recorded , and $ 35 million and $ 41 million are expected for 2025 and 2026 , respectively . 4. $ 25 M to $ 50 M R&D Reimbursement . Under the Sanofi CLA, Novavax is eligible to receive reimbursement for costs incurred related to select R&D and technology transfer activities during the transition performance period that is expected to run through the end of 2026 . 5. $ 0 M to $ 25 M in Other partner revenue .
In December 2024 , Novavax triggered the payment for a $ 50 million milestone from Sanofi related to the COVID - 19 pediatric database lock and payment is expected in Q 1 2025 . Revenue recognition will occur over the performance period through 2026 . During 2024 , $ 16 million was recorded, and $ 15 million and $ 19 million are expected for 2025 and 2026 , respectively . 3. $ 35 M Upfront Payment Amortization .
Novavax is eligible to receive from Sanofi a $ 175 million milestone payment upon the approval of the COVID - 19 U . S . BLA and inclusive of JN 1 and pre - filled syringe presentation, and two separate $ 25 million milestone payments upon the transfer to Sanofi of the Market Authorization for the U . S . and EU markets, respectively . 2. $ 15 M Database Lock Milestone Amortization .
Focus on key value producing R&D programs and Eliminate the cost and complexity associated with commercialization activities Increase emphasis on licensing and royalty revenue from partners and pursue grant revenue opportunities and Decrease emphasis on product sales Operating expenses are expected to decrease significantly in 2025 & 2026 as we o Sanofi commercialization, U.S.
Timing of the Sanofi CIC launch is a primary contributor to the timing of future Novavax profitability 2. Profitability defined as GAAP operating profit less SBC and depreciation C D 34 2025 is an Important Transition Year for Novavax Change to How Our Financials Will Look What Investors Should Expect During 2025 Revenue changes as we Track our progress on .
Source: USASpending.gov ; CDC; Company Websites and Press Releases. 2. Source: Bhasin. J Hosp Med. 2024; Falsey . Open Forum ID. 2021; Philippot . Heliyon . 2024; Company Financial Reports. 3. Source: Company Financial Reports; GlobalData ; Evaluate Pharma. 4. Source: Feurerstadt . JAMDA. 2022; Guh . N Engl J Med. 2020; Song; GlobalData ; Evaluate Pharma. 31 Establishing a Lean Operating Model to Drive Shareholder Value 2025 NOVAVAX.
No RSV combinations available ; opportunity to develop differentiated combination with broader coverage Building on our expertise and extensive history in this area Our technology has the potential to improve on the current standard of care by enabling a more tolerable, less reactogenic, equally efficacious vaccine Significant market opportunity Significant unmet need, with no approved vaccine Our technology has the potential to facilitate the development of a multivalent adjuvanted vaccine with enhanced activity ~$1B in H5N1 government contracts awarded since 2024 1 $1.5B+ U.S. market with ~ 400K hospitalizations annually for respiratory illness (excluding flu + COVID) 2 More tolerable entrant could substantially grow current ~$2B U.S. market and ~ $4.5B global market 3 $5B - $6B U.S. healthcare costs and ~500K hospitalizations annually; multi - billion market opportunity 4 Market Opportunity 1.
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.
FDA to assess the potential feasibility accelerated approval for CIC Continued market need: >60% consumer preference for all - in - one option 1 Commercial Flu Vaccine CIC Novavax's COVID - 19 Vaccine Novavax's Flu Vaccine Participants to be randomized to one of four arms: Immunogenicity comparisons Immunogenicity comparisons Intend to partner to advance to filing and commercialization 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.
Table of Contents Corporate Overview and Growth Strategy Corporate strategy Novavax technology Strategic priorities + impact Pipeline Strategic Priorities Executing on our Sanofi partnership Leveraging our technology and pipeline to forge additional partnerships Advancing our technology platform and early - stage pipeline Establishing a Lean Operating Model to Drive Shareholder Value Lean and agile organization Financial guidance and revenue framework 2025: Year Ahead What to expect in 2025 and beyond 4 2025 NOVAVAX.
Non - GAAP financial measures should be considered in addition to, and not as an alternative for, the Company's reported results prepared in accordance with GAAP . The use of this non - GAAP financial measure may differ from similar measures reported by other companies and may not be comparable to other similarly titled measures . The Company is unable to reconcile this forward - looking non - GAAP financial measure to the most directly comparable GAAP measure without unreasonable effort because the Company is reliant on Sanofi sales forecasts for certain revenue categories, which are not available .
The Company believes that the presentation of this adjusted financial measure is useful to investors as it provides additional information on comparisons between periods by including certain items that affect overall comparability . The Company uses this non - GAAP financial measure for business planning purposes and to consider underlying trends of its business and believes presenting this measure also provides useful information to investors and others for understanding and evaluating trends in the Company's expenses in the same manner as the Company's management .
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 ; Novavax's ability to timely deliver doses ; challenges in obtaining commercial adoption and market acceptance of its updated 2024 - 2025 formula COVID - 19 vaccine or any COVID - 19 variant strain containing formulation, or for its CIC vaccine candidate and stand - alone influenza vaccine candidate or other product candidates ; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities, including requirements to deliver doses that may require Novavax to refund portions of upfront and other payments previously received or result in reduced future payments pursuant to such agreements and challenges in amending or terminating such agreements ; challenges related to the seasonality of vaccinations against COVID - 19 or influenza ; challenges related to the demand for vaccinations against COVID - 19 or influenza ; challenges in identifying and successfully pursuing innovation expansion opportunities, including with respect to Novavax's Matrix - M TM adjuvant ; Novavax's expectations as to expenses and cash needs may prove not to be correct for reasons such as changes in plans or actual events being different than its assumptions ; and 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, challenges or delays in obtaining regulatory authorization for its COVID - 19 vaccine, in particular with respect to its BLA submission to the FDA for approval of its COVID - 19 vaccine, or its product candidates, including for future COVID - 19 variant strain changes, its CIC vaccine candidate, its stand - alone influenza vaccine candidate or other product candidates ; Novavax's ability to successfully and timely manufacture, market, distribute, or deliver its updated 2024 - 2025 formula COVID - 19 vaccine and the impact of its not having received a BLA from the FDA for the 2024 - 2025 vaccination season ; challenges related to Novavax's partnership with Sanofi and in pursuing additional partnership opportunities ; challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification, assay validation and stability testing, necessary to satisfy applicable regulatory authorities ; challenges or delays in conducting clinical trials or studies for its product candidates ; manufacturing, distribution or export delays or challenges ; Novavax's substantial dependence on Serum Institute of India Pvt .
These forward - looking statements address various matters including Novavax's corporate strategy and operating plans, objectives and prospects ; its strategic priorities and near - term priorities ; its partnerships, including expectations with respect to potential royalties, milestones, and cost reimbursement, and plans for additional potential partnering activities ; its expectations regarding manufacturing capacity, timing, production and delivery for its COVID - 19 vaccine ; the transition of the lead responsibility for commercialization of Novavax's COVID - 19 vaccine to Sanofi beginning with the 2025 - 2026 vaccination season ; the development of Novavax's clinical and preclinical product candidates and innovation expansion opportunities, including with respect to new Matrix formulations ; the conduct, timing and potential results from clinical trials and other preclinical studies ; scope, timing and outcome of future and pending regulatory filings and actions, including the potential BLA approval for Novavax's COVID - 19 vaccine ; full year 2025 financial guidance and revenue framework ; expected combined annual R&D and SG&A expenses for 2025 and 2026 ; negotiations regarding Novavax's existing advance purchase agreements ; and Novavax's future financial or business performance .