Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was reported at $70 million, a decrease from $85 million in Q3 2024 [23][25] - The company recorded a net loss of $202 million, or $1.25 per diluted share, for the third quarter of 2025 [27] - Cash and accounts receivable at the end of Q3 2025 stood at $812 million, prior to factoring in additional earnings from recent transactions [25] Business Line Data and Key Metrics Changes - Product sales for Q3 2025 amounted to $13 million, primarily from COVID-19 vaccine and Matrix-M supply sales [25] - Licensing royalties and other revenue reached $57 million, mainly from the Sanofi agreement, including $46 million in R&D reimbursement [26] Market Data and Key Metrics Changes - Sanofi recorded $23 million in Nuvaxovid sales in Q3 2025, with Novavax earning $4 million in royalties from these sales [23][25] - The company anticipates a significant increase in royalties from Sanofi in 2026 as they prepare for a full commercial launch [32] Company Strategy and Development Direction - The company is transitioning from a focus on COVID-19 vaccine sales to a diversified pipeline and partnerships, aiming for long-term growth and profitability [5][7] - Key priorities for 2025 include optimizing the partnership with Sanofi, enhancing existing partnerships, and advancing the technology platform and early-stage pipeline [10][36] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about achieving non-GAAP profitability as early as 2028, contingent on successful partnerships and product developments [10][54] - The company is focused on reducing costs and improving financial strength while navigating a transition year with Sanofi [24][54] Other Important Information - The company has secured $1.4 billion in new cash while reducing its cost structure and liabilities, with 78% of this cash coming from non-dilutive sources [30] - A significant milestone of $225 million from Sanofi has been achieved, consistent with the 2025 revenue framework [25][30] Q&A Session Summary Question: How does the company see the 2025 COVID season compared to last year? - Management noted a 20% decrease in prescriptions compared to last year, attributing this to a more restrictive policy in the U.S. [41] Question: Can you provide more details on the BARDA grant? - The BARDA grant awarded to Sanofi is for early-stage work on a pandemic influenza vaccine that includes Novavax's Matrix-M adjuvant [43] Question: What are the next steps for the Sanofi collaboration? - Management is excited about the positive data from Sanofi's combination programs and is awaiting further updates on regulatory engagement [46] Question: What is the clinical bar for success for the shingles vaccine? - The company is confident in its data and is conducting experiments with positive controls to ensure comparability with existing vaccines [74][75]

Financial Performance & Strategy - Total revenue for Q3 2025 was $70 million, a decrease of 18% compared to $85 million in Q3 2024[25] - The company achieved $1.1 billion in non-dilutive funding over the past 8 quarters[14] - Novavax is aiming for Non-GAAP profitability as early as 2028, driven by diversified revenue streams[15] - Combined R&D and SG&A expenses for Q3 2025 decreased by 18% compared to Q3 2024[22] - The company anticipates combined R&D and SG&A expenses less partner reimbursement of approximately $350 million for FY 2026 and $250 million for FY 2027[35] Sanofi Partnership - Sanofi revenue in Q3 2025 was $48 million, including $4 million in COVID-19 royalties[23, 28] - Novavax expects $60 million in cash from Sanofi by Q1 2026 related to the COVID-19 commercial role transition[23] - The Sanofi partnership is projected to result in $230 million in operating cost savings over 11 years[23] 2025 Financial Outlook - Adjusted Total Revenue for full year 2025 is projected to be between $1040 million and $1060 million[39] - Nuvaxovid product sales are expected to be $610 million for full year 2025, including $603 million from the termination of the Canada and New Zealand Advance Purchase Agreements[39] Pipeline Development - The company is advancing an early-stage pipeline focused on diseases with high unmet medical needs, including Varicella Zoster Virus (Shingles), C difficile, RSV combinations, and Pandemic Flu[14, 19]

Financial Data and Key Metrics Changes - Novavax reported total revenue of $239 million for Q2 2025, down from $415 million in Q2 2024, which included a $175 million milestone from Sanofi related to the BLA approval for Nuvaxibid [30][32] - The company achieved a net income of $107 million or 62 cents per diluted share for Q2 2025 [35] - Combined R&D and SG&A expenses were reduced by 41% year-over-year, with SG&A expenses down 57% due to the transition of commercial activities to Sanofi [31][34] Business Line Data and Key Metrics Changes - Product sales for Q2 2025 were $11 million, consisting of $13 million from supply sales and a negative $2 million from Nivaxibid product sales due to market activity closeout [33] - Year-to-date sales of the R21 Matrix M malaria vaccine reached 14 million doses, exceeding the total of 6 million doses sold in 2024 [33] Market Data and Key Metrics Changes - The partnership with Sanofi is expected to enhance commercialization efforts for Nuvaxibid in select global markets, with additional milestone payments anticipated [9][10] - The company is actively pursuing new partnerships to leverage its technology platform and expand its market presence [13] Company Strategy and Development Direction - Novavax's strategy focuses on optimizing partnerships, enhancing existing collaborations, and advancing its technology platform and early-stage pipeline [7][40] - The company aims for potential non-GAAP profitability as early as 2027, driven by its partnerships and technology advancements [7][32] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of combination vaccines and the ongoing discussions with partners, particularly Sanofi [10][45] - The company is committed to maintaining a lean operational model while driving value creation through targeted investments in R&D [37][40] Other Important Information - The company is exploring the utility of its Matrix M adjuvant in oncology and has signed material transfer agreements with three pharmaceutical companies [14][27] - A post-marketing commitment study is planned for 2025 and 2026, with costs expected to be reimbursed by Sanofi [35][36] Q&A Session Summary Question: Will Novavax file for approval for the COVID vaccine for the upcoming season? - Management confirmed that they are working on regulatory filings to improve the shelf life profile of their vaccine for the fall season [43] Question: What is the interest level in the combination vaccine partnership? - Management indicated ongoing discussions with multiple potential partners and noted positive feedback from Sanofi regarding combination assets [45] Question: What is the confidence level in the post-marketing Phase four trial efficacy data? - Management stated that the design and timing of the post-marketing commitment study are being finalized, with expectations to start by the end of the year [72] Question: Is the company open to acquiring or in-licensing clinical stage candidates? - Currently, the focus is on external partnerships and internal development rather than acquiring clinical stage candidates [66] Question: How does the shifting FDA funding landscape impact Novavax? - Management sees continued investment in vaccines by peer companies and believes there is a growing interest in alternative technology platforms like theirs [76][80]

Novavax's Corporate Strategy - Novavax is shifting its business model to focus on R&D and diversified partnerships[7, 8] - The company aims to drive value through in-house early-stage R&D and strategic partnerships[6, 9] - Novavax is establishing a lean operating model to drive shareholder value[59] Sanofi Partnership - Sanofi made a minority equity investment (less than 5%) in Novavax[16] - Novavax received a $500 million upfront payment from Sanofi in Q2 2024, with $424 million recognized in 2024 and $76 million amortized through 2026[18] - Novavax is eligible for up to $700 million in milestones from Sanofi[18] COVID-19 and Influenza Vaccines - COVID-19 hospitalization rates are approximately 4 times higher than those for influenza[20] - COVID-19 vaccine coverage rates are less than half of influenza vaccine rates among US adults 18+ in the 2023-24 season (22% vs 45%)[22, 23] - Nuvaxovid recipients experienced approximately 39% fewer symptoms compared to mRNA vaccine recipients[25] Matrix-M Adjuvant and Partnerships - Novavax is eligible to receive up to $200 million in launch and sales milestones plus mid-single digit royalties under the Matrix-M license agreement[19] - Novavax's COVID-Influenza Combination (CIC) vaccine and stand-alone flu vaccines are in Phase 3 trials, with initial cohort data showing robust immune responses and good tolerability[45, 54]