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The update to the expected 2024 APA dose delivery schedules reflects the anticipated shift of approximately $ 250 million in contracted doses from 2024 to future periods . 3. Sanofi agreement initial payments include a non - refundable $ 500 million upfront payment to be received within 10 days and an immediate $ 69 million equity investment in Novavax .
This amount excludes deferred revenue associated with the 2023 Canada amendments to forfeit doses . Guidance Notes : Guidance as of May 10 th , 2024. We undertake no obligation to update or revise this guidance in the future. 1. Total Revenue includes product sales, and royalties & other revenue . 2. Full year 2024 guidance reflects APA expected dose delivery schedules of $ 150 million to $ 250 million and non - APA related revenue of $ 25 0 million to $ 35 0 million, subject to updated variant manufacturing and regulatory approvals, from a combination of commercial market product sales plus royalties and other revenue from our partner - related activity .
Seeing a more normal, non - pandemic consumer demand pattern Delivering unit - dose presentation Focusing on key countries driving business : Italy, Spain , France, the U.K., Poland and Germany U.K. activating private market Entering commercial market for first - time Secured NACI recommendation in Canada Preparing for National Immunization Program and retail model in Australia and New Zealand Priority #4 Financial Guidance and Corporate Milestones SECTION 19 2024 NOVAVAX.
HCP - Aided Awareness 3 Priority #2 vs Clinical program has been modified to seek licensure for both CIC and Stand - alone influenza ( tNIV ) in 60 yo Part B: Stand - alone Influenza (tNIV) Designed to achieve accelerated approval endpoints for both products with no change to timelines tIIV Novavax COVID - 19 + CIC Placebo + tNIV Placebo + tIIV Placebo + vs Phase 3a on track for 2H2024 Immunologic non - inferiority/superiority study against age - recommended licensed comparators Adults 60 yo ; N=4,000 Reconfirming FDA concurrence with revised program design Lot - to - Lot manufacturing consistency studies 2H 2024 CIC lot - to - lot in 60 yo (N=~1,650) tNIV lot - to - lot study in 60 yo (N=~1 , 250) Top - line data for decision - making expected 2Q2025 Potential Accelerated Approval filings 2H2025 Potential launch 2026 Phase 3a Study Design Part A: COVID - Influenza - Combination tNIV = Trivalent nanoparticle influenza vaccine tIIV = Trivalent inactivated influenza vaccine 15 2024 NOVAVAX.
Authorized in Ghana, Nigeria, and Burkina Faso; Commercialized by Serum Institute of India; Granted prequalification by the WHO. Disease Product Preclinical Phase 1 Phase 2 Phase 3 Authorized Novavax Coronavirus Novavax COVID - 19 Vaccine 1 COVID / Influenza Combination Vaccine (CIC) Seasonal Influenza Influenza (Older Adults) Partnered Malaria R21/Matrix - M adjuvant 2 Matrix - M Matrix - M Matrix - M Matrix - M Novavax continues to optimize preclinical candidates, including a new approach to H5N1 pandemic bird flu vaccination, and exp and our core technology for novel applications including mucosal vaccination and high - density nanoparticles.
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' 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 .
These risks and uncertainties include, without limitation, Novavax and Sanofi's ability to successfully implement its partnership, including the ability to transition key processes and effect technology transfers, Novavax's and Sanofi's ability to successfully develop or commercialize any vaccines or vaccine candidates, Novavax's ability to successfully manufacture, distribute, or market its updated COVID - 19 vaccine for the 2024 - 2025 vaccination season ; 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 ; our plans to sell our COVID - 19 vaccine for the 2024 - 2025 vaccination season under Emergency Use Authorization ; challenges or delays in obtaining regulatory authorization or policy recommendations for its product candidates, including its updated COVID - 19 vaccine in time for the 2024 - 2025 vaccination season or for future COVID - 19 variant strain changes ; manufacturing, distribution or export delays or challenges ; Novavax's substantial dependence on Serum Life Sciences Limited for supply of Novavax's COVID - 19 vaccines and the impact of any delays or disruptions in their operations on the delivery of customer orders and commercial supply to Sanofi ; difficulty obtaining scarce raw materials and supplies ; resource constraints, including human capital and manufacturing capacity, and constraints on Novavax's ability to pursue planned regulatory pathways, alone or with partners, in multiple jurisdictions simultaneously, leading to staggered regulatory filings, and potential regulatory actions ; 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 COVID - 19 vaccine, NVX - CoV 2373 or any COVID - 19 variant strain - containing formulation ; 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 ; challenges related to the seasonality of vaccinations against COVID - 19 ; and the risks identified under the heading "Risk Factors" in Novavax' 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 .
S . Biologics License Application (BLA) submissions for Nuvaxovid, the availability of its updated COVID - 19 vaccine, the fall 2024 and future global COVID - 19 market opportunities, and the timing of delivery and distribution of its vaccine are forward - looking statements . 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 forward - looking statements address various matters including information relating to the future of Novavax and its products, statements related to Novavax's partnership with Sanofi and receipt of potential royalties and milestones thereunder, its near - term priorities including delivering an updated single - dose pre - filled syringe and unit dose vial COVID - 19 vaccine for the start of the 2024 - 2025 vaccination season, initiating a pivotal Phase 3 trial for CIC and seasonal influenza in the second half of 2024 , a possible combination vaccine and/or seasonal influenza launch in 2026 , reducing rate of spend, managing cash flow and evolving its scale and structure, the amount and impact of Novavax's previously announced global restructuring and cost reduction plan and new cost reduction plan, its operating plans, objectives and prospects, full year 2024 financial guidance, its future financial or business performance, conditions or strategies, its partnerships, including with respect to the launch of R 21 /Matrix - M Malaria vaccine, the ongoing development of its updated COVID - 19 vaccine and COVID - 19 - Influenza Combination (CIC) and seasonal influenza investigational vaccine candidates, the scope, timing and outcome of future and pending regulatory filings and actions, including Novavax's expected U .