Financial Data and Key Metrics Changes - The company reported total revenue of $1.1 billion for the full year 2025, a 65% increase year-over-year, including $625 million from non-cash revenue recognition related to Nuvaxovid agreements [33][34] - For Q4 2025, total revenue was $147 million, reflecting a 67% increase compared to Q4 2024 [34][38] - The company achieved positive income for both the full year and Q4 of 2025, indicating improved financial performance [34][40] - Cash and accounts receivables at year-end 2025 totaled $857 million, with an additional $80 million in non-dilutive cash expected in Q1 2026 [35][36] Business Line Data and Key Metrics Changes - Nuvaxovid product sales for Q4 2025 were $20 million, with additional supply sales of $19 million from Matrix-M adjuvant sales [38] - Sanofi licensing, royalty, and other revenue for Q4 2025 was $98 million, primarily driven by milestone achievements [38] Market Data and Key Metrics Changes - The company noted a 12% market share for Nuvaxovid in Japan, with over 30 million doses of the R21/Matrix-M malaria vaccine distributed [10] - The global vaccine market is projected to exceed $60 billion in the next four to five years, with the immunotherapeutic vaccines subset in oncology expected to reach over $42 billion by 2032 [23] Company Strategy and Development Direction - The company has shifted from a COVID-focused organization to one that emphasizes long-term value through partnerships and R&D, supported by a lean operating model [8][9] - The partnership with Pfizer for Matrix-M is expected to generate significant revenue through milestones and royalties [9][10] - The company aims to leverage its Matrix technology to create a portfolio of adjuvants, expanding its utility beyond infectious diseases [12][30] Management's Comments on Operating Environment and Future Outlook - Management acknowledged uncertainties in the current macro and regulatory environment for vaccine companies but remains optimistic about the long-term need for vaccines [15] - The company anticipates continued progress in 2026, including potential new partnership announcements and advancements in R&D efforts [14][41] Other Important Information - The company has significantly reduced R&D and SG&A expenses, achieving a 42% reduction for Q4 2025 and a 53% reduction for the full year [34][39] - The 2028 guidance for combined R&D and SG&A expenses is set at $200 million or below, representing a 50% decrease compared to 2025 [42][44] Q&A Session Summary Question: Update on Sanofi's vaccine business strategy with new CEO - Management expressed confidence in the ongoing partnership with Sanofi, noting that interactions remain positive despite leadership changes [54] Question: Prioritization of early pipeline programs - The company is advancing multiple early-stage programs, including C. diff, VZV, and RSV, with promising preclinical results [57] Question: Potential for co-promotions in partnerships - The company is currently focused on partnerships rather than building a commercial framework but remains open to co-promotions for significant products in the future [63] Question: Timeline for MTAs to evolve into formal partnerships - The timeline for MTAs to become formal partnerships depends on the partners' development progress, with ongoing discussions and data generation to facilitate these transitions [71][75]

Financial Data and Key Metrics Changes - Total revenue for 2025 reached $1.1 billion, a 65% increase year-over-year, including $625 million from non-cash revenue recognition related to Nuvaxovid agreements [32][33] - Fourth quarter revenue was $147 million, a 67% increase compared to the same period in 2024, with positive income reported for both the full year and fourth quarter [33][35] - Combined R&D and SG&A expenses were reduced by 42% and 53% for the fourth quarter and full year 2025, respectively, while maintaining partnership commitments [33][38] Business Line Data and Key Metrics Changes - Nuvaxovid product sales for the fourth quarter were $20 million, with additional supply sales of $19 million from Matrix-M adjuvant sales [37] - Sanofi's licensing, royalty, and other revenue amounted to $98 million, driven by milestone achievements and R&D reimbursements [37] Market Data and Key Metrics Changes - Takeda achieved over 12% market share for Nuvaxovid in Japan, and more than 30 million doses of the R21 Matrix-M malaria vaccine were distributed [9] - The global vaccine market is projected to exceed $60 billion in the next four to five years, with the immunotherapeutic vaccines subset in oncology expected to reach over $42 billion by 2032 [21][22] Company Strategy and Development Direction - The company has transitioned from a COVID-focused organization to one that emphasizes partnerships and R&D, aiming for long-term value creation through its Matrix technology [6][8] - The growth strategy includes leveraging R&D to expand the utility of Matrix technology beyond infectious diseases and developing new assets for partnerships [10][11] Management's Comments on Operating Environment and Future Outlook - The management acknowledges significant uncertainties in the current macro and regulatory environment for vaccine companies but remains optimistic about the long-term need for vaccines [13] - The company anticipates continued progress in 2026, including potential new partnership announcements and advancements in its R&D pipeline [12][13] Other Important Information - The company ended 2025 with $857 million in cash and accounts receivables, with an additional $80 million in non-dilutive cash expected in early 2026 [34] - A new credit facility of $330 million was established to provide flexibility and access to non-dilutive capital [34] Q&A Session Summary Question: Update on Sanofi's vaccine business with new CEO - Management expressed confidence in the ongoing partnership with Sanofi, noting that interactions remain positive despite the leadership change [51][52] Question: Prioritization of early pipeline programs - The company is advancing multiple early-stage programs, including C. diff, shingles, and RSV, with no specific prioritization disclosed [54] Question: Interest in co-promotions for Matrix-M - The company is currently focused on partnerships rather than building a commercial framework but remains open to co-promotions if a significant opportunity arises [60] Question: Timeline for MTAs to become formal partnerships - The timeline for MTAs to evolve into formal partnerships depends on the partners' development progress, with ongoing discussions and data generation to facilitate these transitions [72][73]

Novavax Conference Call Summary Company Overview - Novavax is recognized for its successful development of a highly efficacious COVID-19 vaccine using subunit protein nanoparticle technology combined with the Matrix-M adjuvant, which has also been utilized in a malaria vaccine developed by Serum Institute of India [4][5] Strategic Focus - The company is transitioning from a pandemic-focused entity to an endemic-based vaccine manufacturer, partnering with Sanofi to integrate its COVID-19 vaccine, Nuvaxovid, into Sanofi's portfolio of vaccines [5][6] - Novavax aims to reduce costs, strengthen its balance sheet, and advance its pipeline through partnerships, with a long-term goal of achieving profitability and diversified revenue streams [6][9] Partnership with Sanofi - The partnership with Sanofi is structured in layers, including commercialization of the COVID-19 vaccine, development of combination vaccines, and leveraging Matrix-M in Sanofi's portfolio [9][10] - The market for combination flu and COVID-19 vaccines could reach $8 billion annually, with Novavax eligible for up to $350 million in milestones and royalties ranging from high single digits to low teens [10][11] - Sanofi's 2026 season is expected to be the full launch year for the COVID-19 vaccine, with 2025 serving as a transition year for learning and marketing efforts [12][13] Financial Highlights - Novavax received a $70 million investment from Sanofi, $500 million upfront, and has the potential for $700 million in milestone payments [22][23] - In the current year, Novavax earned $225 million in milestones, with royalties expected to grow significantly as the partnership matures [23] Matrix-M Adjuvant - Matrix-M is positioned as a critical driver of innovation in the vaccine industry, with potential royalties of mid-single digits for up to 20 years on new vaccines developed using this adjuvant [25][26] - The global vaccine market is projected to grow from $57 billion in 2024 to over $75 billion by 2030, highlighting the significant opportunity for Matrix-M [25] Early Stage Pipeline - Novavax is exploring various early-stage vaccines targeting infectious diseases, including CDIF, shingles, RSV, and pandemic flu, with a focus on addressing unmet medical needs [38][39] - The company is also investigating the use of Matrix-M in oncology vaccines, collaborating with partners to explore its potential in this area [34][41] Market Potential - The oncology vaccine market is valued at over $40 billion, contributing to a combined market potential exceeding $100 billion when combined with the vaccine market [34] - Novavax's approach includes leveraging AI and machine learning to enhance immune responses and develop tailored vaccines for specific needs [33][41] Conclusion - Novavax is strategically positioned to capitalize on its innovative technologies and partnerships, with a clear focus on expanding its vaccine portfolio and driving long-term value creation through diversified revenue streams and cost management [6][23][25]

William Blair 45th Annual Growth Stock Conference Using Proven, Innovative Adjuvant Technology to Help Protect the World Against Infectious Diseases June 2025 Nasdaq: DVAX Forward-Looking Statements Statements contained in this presentation regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about Dynavax's expected financial results and market share as of and for the quarter ended M ...