Novavax(NVAX) - 2025 Q2 - Quarterly Results

Q2 2025 Financial Results and Operational Highlights Operational Highlights and Strategic Priorities Novavax achieved FDA BLA approval for Nuvaxovid, triggering a $175 million Sanofi milestone, and advanced its vaccine pipeline - Received FDA Biologics License Application (BLA) approval for Nuvaxovid™, its protein-based, non-mRNA COVID-19 vaccine, for individuals aged 12 and older at high risk[5][6] - The BLA approval triggered a $175 million milestone payment from partner Sanofi[5][6] - Completed the transition of Nuvaxovid™ commercial leadership in the U.S. to Sanofi for the 2025-2026 vaccination season[5][9] - Reported robust immune responses in a Phase 3 trial for its COVID-19-Influenza-Combination (CIC) and stand-alone influenza vaccine candidates, with T-cell responses numerically higher than the comparator, Fluzone HD[5][9] - Announced positive preclinical data for its H5N1 avian pandemic influenza vaccine candidate, which was published in Nature Communications[8] - The R21/Matrix-M malaria vaccine, developed in partnership, has sold 20 million doses since its launch in mid-2024[9] Second Quarter 2025 Financial Results Novavax reported $239 million in Q2 2025 revenue, a 42% decrease, with net income of $107 million and reduced operating expenses Q2 2025 Revenue Breakdown ($ in millions) | Revenue Source | Q2 2025 | Q2 2024 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Product Sales | $11 | $23 | ($12) | (52)% | | Licensing, Royalties and Other | $229 | $393 | ($164) | (42)% | | Total Revenue | $239 | $415 | ($176) | (42)% | Q2 2025 Key Financial Metrics ($ in millions) | Metric | Q2 2025 | Q2 2024 | % Change | | :--- | :--- | :--- | :--- | | Total Revenue | $239 | $415 | (42)% | | Cost of Sales | $15 | $46 | (67)% | | R&D Expenses | $79 | $107 | (26)% | | SG&A Expenses | $44 | $101 | (57)% | | Net Income | $107 | $162 | (34)% | - Cash, cash equivalents, marketable securities, and restricted cash totaled $628 million as of June 30, 2025, compared to $938 million at the end of 2024[17] - The $175 million milestone payment from Sanofi, earned in Q2 2025, is expected to be received in Q3 2025[17] Condensed Consolidated Statements of Operations Novavax reported Q2 2025 total revenues of $239.2 million and net income of $106.5 million, or $0.62 per diluted share Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Total Revenue | $239,240 | $415,484 | | Total Expenses | $138,170 | $254,486 | | Income from Operations | $101,070 | $160,998 | | Net Income | $106,508 | $162,381 | | Diluted Net Income per Share | $0.62 | $0.99 | Selected Consolidated Balance Sheet Data As of June 30, 2025, Novavax's total assets were $1.34 billion, with stockholders' equity turning positive to $37.6 million Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $253,744 | $530,230 | | Total Assets | $1,336,549 | $1,560,418 | | Working Capital | $530,374 | ($25,474) | | Total stockholders' equity (deficit) | $37,625 | ($623,841) | Full Year 2025 Financial Framework and Guidance Novavax updated its FY2025 outlook, raising Adjusted Total Revenue guidance to $1.0-$1.05 billion and increasing R&D/SG&A expenses Updated Full Year 2025 Revenue Framework ($ in millions) | Metric | FY 2025 Guidance (Aug 6) | FY 2025 Guidance (May 8) | | :--- | :--- | :--- | | Nuvaxovid Product Sales | $610 | $610 | | Adjusted Supply Sales | $25 - $40 | $20 - $35 | | Adjusted Licensing, Royalties & Other | $365 - $400 | $345 - $380 | | Adjusted Total Revenue | $1,000 - $1,050 | $975 - $1,025 | Updated Full Year 2025 Expense Guidance ($ in millions) | Metric | FY 2025 Guidance (Aug 6) | FY 2025 Guidance (May 8) | | :--- | :--- | :--- | | Combined R&D and SG&A Expenses | $495 - $545 | $475 - $525 | - The company will conduct a postmarketing commitment (PMC) study for Nuvaxovid at an estimated cost of $70-$90 million, of which Sanofi will reimburse approximately 70% (~$55 million)[16] - The revenue framework excludes potential Sanofi Supply Sales, Royalties (high teens to low twenties percent), and milestones related to the Influenza-COVID-19 combination product (up to $350M) and new Matrix-M vaccines (up to $200M each)[22] Supplementary Information This section provides conference call details, a corporate overview, and disclaimers on non-GAAP measures and forward-looking statements - Provides details for the quarterly conference call and webcast for investors[24][25] - Explains the use of non-GAAP financial measures like Adjusted Total Revenue and notes the inability to reconcile forward-looking guidance to GAAP measures due to reliance on Sanofi sales forecasts[27][28] - Includes a standard Forward-Looking Statements section cautioning investors about numerous risks and uncertainties that could cause actual results to differ from those projected[29][30]