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Keech C, et al. N Engl J Med. 2020 Dec 10;383(24):2320-2332. 2. Yadav P, et al. Vaccine Insight 2023; 02:59-66. 3. Stertman L, et al. Hum Vaccin Immunoter. 2023 Dec 31;19(1):2189885. 4. Sang S, et al. Welcome Open Res. 2023; 8:450. 5. Carnrot C, et al. Front Drug Deliv. 2023. 3:1279710. 6. Rousculp MD, et al. Vaccines (Basel) 2024 12(7):802. 7. Chung KY, et al.
The Company uses these non-GAAP financial measures for business planning purposes and to consider underlying trends of its business. 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. Our use of non-GAAP financial measures may differ from similar measures reported by other companies and may not be comparable to other similarly titled measures.
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 these adjusted financial measures is useful to investors as they provide additional information on comparisons between periods by including certain items that affect overall comparability.
Novavax cautions investors not to place considerable reliance on forward-looking statements contained in this presentation. Investors are encouraged to read Novavax's filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. 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.
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; the impact of potential legislative, regulatory, or policy changes under the current presidential administration, including any adverse impact funding for vaccine research and development, reimbursement for vaccines and their administration, vaccine mandates and recommendations, and public perception of vaccine importance; uncertainty with respect to pricing, third-party reimbursement and healthcare reform; uncertainty in the regulatory pathway for our COVID -19 vaccine; the impact of any new or changes in interpretations of existing trade measures, including tariffs, embargoes, sanctions, import restrictions, and export licensing requirements; difficulty obtaining scarce raw materials and supplies, including for Novavax's proprietary adjuvant; resource constraints, including human capital and manufacturing capacity, constraints on Novavax's ability to pursue planned regulatory pathways, alone or with partners, in multiple jurisdictions simultaneously, leading to staggering of regulatory filings, and potential regulatory actions; Novavax's ability to timely deliver doses; challenges in obtaining commercial adoption and market acceptance of Novavax's COVID-19 vaccine or any COVID-19 variant strain containing formulation, or Novavax's CIC vaccine candidates, stand-alone influenza vaccine candidates or other 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 negotiating, 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; Novavax's expectation 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 Novavax's assumptions, and other risks and uncertainties identified the Risk Factors and Management's Discussion and Analysis of Financial Condition and Results of Operations sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC).
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 obtain and maintain full U.S. FDA licensure or foreign regulatory approvals necessary to manufacture, market, distribute, or deliver its COVID-19 vaccine; the impact of delays in obtaining regulatory approval, including regulatory decisions impacting labeling, approval or authorization, including the scope of the indicated population, product dosage, manufacturing processes, shelf life, safety, for Novavax's product candidates; challenges in conducting the PMC study, Novavax's ability to obtain adequate additional funding to maintain its current level of operations and fund the further development of its vaccine candidates; challenges related to Novavax's partnership with Sanofi, including collaboration on the PMC, 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 Novavax's product candidates; manufacturing, distribution or export delays or challenges; Novavax's substantial dependence on Serum Institute of India Pvt.
FDA following the U.S. FDA's approval of the BLA for our COVID-19 Vaccine and the expected costs and timing associated with the PMC study; full year 2025 financial guidance and revenue framework; expected combined annual R&D and SG&A expenses for 2025, 2026 and 2027; the amount and impact of Novavax's cost reduction plans; Novavax's future financial or business performance; and plans and negotiations with respect to Novavax's existing advanced purchase agreements.
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; 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 pipeline advancement; the conduct, timing and potential results from clinical trials and other preclinical and postmarketing studies; scope, timing and outcome of future and pending regulatory filings and actions; potential future market sizes and demand for its COVID-19 vaccine and product candidates; the conduct of our post marketing commitment ( PMC ) study requested by the U.S.