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NVAX Internal estimates for season average using two data sources from CDC FluVaxView: a) NIS - Flu data for 6 months - 17 years of age and b) Weekly Cumulative Estimated Influenza Vaccinations Administered for adults 18+ via IQVIA LRx and Dx data. 2. Jefferies, Global Vaccines Deep Dive, Equity Research Report, May 30, 2023. 3. NVAX Internal projected estimate based on current total retail vaccinations as of 12/22 per IQVIA Rx Rapid weekly data. 2023 - 2024 season from September 2023 to March 2024. 4.
Retail channel ~90% of market opportunity 2 Market Access Anticipate broader coverage and access to Novavax's vaccine 0 20 40 60 80 1 0 0 1 2 0 1 4 0 1 6 0 Flu COVID - 19 Millions of doses 2019 - 2022 Average 130M - 140M Significant future U.S. market opportunity expected for combination respiratory vaccines High unmet need and preference for a combination Flu & COVID - 19 vaccine o Potential for increased COVID - 19 vaccination rates as a result of combination Flu represents a significant opportunity o U.S. flu season doses administered 2019 - 2022 average: 130M - 140M 1 o Annual U.S. flu market opportunity: $4B+ 2 30M - 35M 3 17 1.
Developed by University of Oxford and manufactured and commercialized by Serum Institute of India. 2. Datoo, MS et al., 2023. DO I . 3. WHO press release published 10/2/2023. 4. Ourworldindata.org. 5. WHO.int. Photo credit: University of Oxford "As a malaria researcher, I used to dream of the day we would have a safe and effective vaccine against malaria.
Authorized in the U.S. under trade name Novavax COVID - 19 Vaccine, Adjuvanted (2023 - 2024 Formula); Ongoing post - authorization Phase 3 strain - change trial. 3. 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 Clinical - Stage Coronavirus NVX - CoV2373 1 Matrix - M Matrix - M Monovalent XBB.1.5 NVX - CoV2601 2 COVID / Influenza Combination Vaccine (CIC) Matrix - M Seasonal Influenza Influenza (Older Adults) Matrix - M Partnered Clinical - Stage Malaria R21/Matrix - M adjuvant 3 Matrix - M R21/Matrix - M vaccine against malaria approved to help address dire global public health need 12 2024 NOVAVAX.
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 .
S . government ; the potential for an unfavorable outcome in disputes, including the pending arbitration with Gavi ; challenges in implementing its global restructuring and cost reduction plan ; challenges in obtaining commercial adoption, market access and market acceptance for its vaccines or vaccine 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 ; challenges related to the seasonality of vaccinations against COVID - 19 , seasonal influenza or other diseases ; 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 .
Ltd . and Serum Life Sciences Limited for co - formulation and filling and PCI Pharma Services for finishing Novavax's COVID - 19 vaccines and the impact of any delays or disruptions in their operations on the delivery of customer orders ; 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 ; the loss of future funding from the U .
These risks and uncertainties include, without limitation, Novavax's ability to successfully manufacture, distribute or market its updated COVID - 19 vaccine for the 2023 - 2024 and future vaccination seasons ; 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 ; challenges or delays in obtaining regulatory authorization for its product candidates, including future COVID - 19 variant strain changes ; the size of the COVID - 19 , influenza and combination market ; potential developments during the 2023 - 2024 and 2024 - 2025 vaccination season ; manufacturing, distribution or export delays or challenges ; Novavax's exclusive dependence on Serum Institute of India Pvt .
S . Biologics License Application (BLA) for its updated COVID - 19 vaccine, the timing for advancing CIC vaccine candidate to Phase 3 and for its potential commercial launch, anticipated label expansion and market access, and the 2024 and future global COVID - 19 , influenza and combination market opportunities, 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, its near term priorities including reducing rate of spend, managing cash flow and evolving its scale and structure, the amount and impact of its global restructuring and cost reduction plans, its operating plans, objectives and prospects, full year 2023 and 2024 financial guidance, its future financial or business performance, conditions or strategies, the potential sale of the CZ manufacturing facility, the Company's partnerships, including with respect to the launch of R 21 /Matrix - M Malaria vaccine, the ongoing development of its updated COVID - 19 vaccine, COVID - 19 - Influenza Combination (CIC) investigational vaccine candidate and influenza vaccine candidate, the timing of delivery and distribution of its vaccine, the scope, timing and outcome of future and pending regulatory filings and actions, including expected U .