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]

Revenue Performance - Total revenue for Q3 2025 was $70 million, down 18% from $85 million in Q3 2024[12] - Total revenue for Q3 2025 was $70.445 million, a decrease of 16.6% compared to $84.512 million in Q3 2024[30] - Product sales in Q3 2025 were $13.442 million, down from $41.528 million in Q3 2024, representing a decline of 67.6%[30] - Licensing, royalties, and other revenue increased to $57.003 million in Q3 2025 from $42.984 million in Q3 2024, a growth of 32.5%[30] - Full Year 2025 revenue guidance is projected between $1,040 million and $1,060 million[18] Expenses and Losses - Research and development (R&D) expenses for Q3 2025 were $98 million, up from $87 million in Q3 2024[16] - Selling, general, and administrative (SG&A) expenses decreased by 55% to $32 million in Q3 2025, compared to $71 million in Q3 2024[16] - Total expenses for Q3 2025 were $248.463 million, up from $218.530 million in Q3 2024, an increase of 13.7%[30] - Net loss for Q3 2025 was $202 million, compared to a net loss of $121 million in Q3 2024[16] - Net loss for Q3 2025 was $202.379 million, compared to a net loss of $121.300 million in Q3 2024, reflecting a worsening of 66.9%[30] Cash and Assets - Cash and cash equivalents were $778 million as of September 30, 2025, down from $938 million as of December 31, 2024[16] - Cash and cash equivalents decreased to $268.023 million as of September 30, 2025, from $530.230 million at the end of 2024[32] - Total assets decreased to $1.179 billion as of September 30, 2025, down from $1.560 billion at the end of 2024[32] - Working capital improved to $544.721 million as of September 30, 2025, compared to a deficit of $25.474 million at the end of 2024[32] - The company reported an impairment of assets held for sale amounting to $97.038 million in Q3 2025[30] Partnerships and Future Outlook - Sanofi partnership milestones achieved year-to-date totaled $225 million, including $50 million earned in Q4 2025[4] - The company expects approximately $230 million in future cost savings from Maryland site consolidation transactions[4] - The FDA approved the Nuvaxovid 2025-2026 Formula for COVID-19 prevention in high-risk individuals in August 2025[8] - Novavax is focusing on expanding its clinical pipeline and expects to advance its product candidates, including new Matrix formulations[29] Nuvaxovid Sales - Nuvaxovid sales were $0 million in Q3 2025, a decrease of $38 million compared to $38 million in Q3 2024[9]

Core Insights - Novavax reported a total revenue of $70 million for Q3 2025, a decrease of 18% compared to $85 million in Q3 2024, primarily due to a significant drop in Nuvaxovid sales [3][7][23] - The company is focusing on optimizing partnerships, particularly with Sanofi, and enhancing its technology platform to drive long-term growth and profitability [2][5][20] Financial Performance - Nuvaxovid sales were $0 in Q3 2025, down from $38 million in Q3 2024, while supply sales increased to $14 million from $3 million [3][7] - Product sales decreased by 68% to $13 million from $41 million year-over-year [3][7] - Sanofi partnership revenue increased by 33% to $48 million from $36 million [3][7] - Total expenses for Q3 2025 were $248 million, compared to $219 million in Q3 2024, with R&D expenses rising to $98 million from $87 million [7][23] Strategic Initiatives - The company achieved $225 million in milestones from its partnership with Sanofi year-to-date, including $50 million from marketing authorization transfers [5][6] - Sanofi reported positive Phase 1/2 data for Nuvaxovid in combination with its influenza vaccines, which received Fast Track designation from the FDA [6][20] - Novavax is pursuing government funding for a pandemic influenza vaccine candidate and exploring its Matrix-M platform technology in oncology [6][20] Future Guidance - Novavax raised its full-year 2025 revenue framework, expecting adjusted total revenue between $1,040 million and $1,060 million [9][10] - The company anticipates combined R&D and SG&A expenses of $505 million to $535 million for the full year 2025 [8][10] - The transition of lead commercial responsibility for Nuvaxovid to Sanofi is expected to impact revenue forecasts, which are not included in the full-year guidance [9][15]

Core Viewpoint - Novavax has raised its annual revenue forecast for the third time this year, driven by milestone payments from vaccine supply and licensing agreements, particularly with Takeda Pharmaceuticals in Japan [1] Group 1 - The company has increased its revenue outlook, indicating strong performance and confidence in its vaccine-related business [1] - The adjustments in revenue forecast are attributed to successful partnerships and agreements in the vaccine sector [1]

Vaccine Development and Approvals - Novavax's COVID-19 Vaccine, Nuvaxovid, received BLA approval from the U.S. FDA for adults 65 and older and individuals aged 12-64 with underlying conditions, triggering a $175 million milestone payment under the Sanofi CLA[137]. - The company entered into a collaboration and license agreement (CLA) with Sanofi in May 2024 to co-commercialize the COVID-19 Vaccine and develop combination vaccines, including seasonal variants[127]. - The U.S. FDA granted Fast Track designation to two Sanofi combination vaccine candidates that include Novavax's COVID-19 Vaccine, currently in Phase 1/2 trials[127]. - In August 2025, the U.S. FDA approved the Nuvaxovid™ 2025-2026 Formula for individuals aged 65 and older, or 12 to 64 years with high-risk conditions[138]. - Sanofi received Fast Track designation from the U.S. FDA for the combination of Nuvaxovid with Fluzone High-Dose and Flublok vaccines[145]. Financial Performance - Total revenue for the three months ended September 30, 2025, was $70.4 million, a decrease of $14.1 million from $84.5 million in the same period in 2024, primarily due to a decline in product sales of COVID-19 Vaccine[169]. - Product sales decreased to $13.4 million in Q3 2025 from $41.5 million in Q3 2024, a decline of $28.1 million, attributed to the transition of commercial lead for sales and distribution to Sanofi[170]. - Licensing, royalties, and other revenue increased to $57.0 million in Q3 2025 from $43.0 million in Q3 2024, an increase of $14.0 million, driven by higher revenue from transition services and technology transfer[172]. - Total revenue for the nine months ended September 30, 2025, was $976.3 million, an increase of $382.5 million from $593.9 million in the same period in 2024[190]. - Product sales for the nine months ended September 30, 2025, were $645.8 million, up $491.9 million from $153.9 million in the same period in 2024[192]. Research and Development - Novavax's late-stage programs include a COVID-19-Influenza combination vaccine candidate and a stand-alone influenza vaccine candidate, both showing robust immune responses in a Phase 3 trial[130]. - The proprietary Matrix-M adjuvant enhances immune responses and allows for lower antigen doses, contributing to increased vaccine supply and manufacturing capacity[135]. - The company is advancing its early-stage pipeline with a focus on high-value assets, including candidates for respiratory syncytial virus (RSV) and pandemic influenza[132]. - The company is actively developing a pandemic influenza vaccine candidate and pursuing funding opportunities for preparedness[143]. - The Phase 3 immunogenicity and safety trial for the COVID-Influenza Combination vaccine completed enrollment with approximately 2,000 participants[153]. Expenses and Losses - Research and development expenses rose to $98.3 million in Q3 2025 from $87.2 million in Q3 2024, an increase of $11.1 million, mainly due to increased expenditures on coronavirus vaccine development[179]. - Selling, general, and administrative expenses decreased to $31.7 million in Q3 2025 from $70.7 million in Q3 2024, a reduction of $39.1 million, due to cost containment measures[181]. - Total expenses for Q3 2025 were $248.5 million, an increase of $29.9 million from $218.5 million in Q3 2024, primarily driven by impairment of assets held for sale[177]. - Net loss for the three months ended September 30, 2025, was $202.4 million, or $1.25 per share, compared to a net loss of $121.3 million, or $0.76 per share, for the same period in 2024, representing an increase of $81.1 million[188]. Cash Flow and Financing - Net cash used in operating activities was $205.2 million for the nine months ended September 30, 2025, compared to a cash inflow of $85.9 million for the same period in 2024, representing a change of $291.1 million[226]. - Net cash used in investing activities decreased to $98.8 million in 2025 from $348.0 million in 2024, a reduction of $249.3 million, primarily due to lower investment in marketable securities[227]. - Net cash provided by financing activities was $34.3 million for the nine months ended September 30, 2025, down from $264.0 million in 2024, a decrease of $229.7 million, mainly due to reduced net proceeds from common stock sales[228]. - The company completed a convertible debt refinancing in August 2025, extending the maturity of existing 2027 Notes to 2031, which supports its long-term growth strategy[168]. - The company anticipates future operations to be funded primarily by milestone payments, royalties, and revenue from product sales[225]. Strategic Partnerships and Collaborations - The company is pursuing partnerships to leverage its technology platform and enhance its pipeline, aiming for a disciplined and capital-efficient R&D investment strategy[125]. - The company has entered into material transfer agreements with three pharmaceutical companies to explore the utility of Matrix-M in new vaccine development[160]. - The company has a sole license agreement with Sanofi for the independent development of a COVID-19 and influenza combination product[145]. - The company received a non-refundable upfront payment of $500 million from the Sanofi collaboration agreement and additional milestone payments totaling $225 million during the nine months ended September 30, 2025[212]. Market and Operational Outlook - The company is focused on expanding the COVID-19 Vaccine label worldwide and exploring new markets and age groups for its products[126]. - The company expects a reduction in annual combined research and development, and selling, general, and administrative spend for the remainder of 2025 due to its Restructuring Plan[183]. - The planned consolidation of Maryland-based facilities is expected to result in $60 million in payments and approximately $230 million in future cost savings over 11 years[168]. - The company evaluated its ability to continue as a going concern and concluded it has sufficient capital to fund operations for at least one year from the date the financial statements were issued[229].

Core Insights - Novavax, Inc. will report its third quarter 2025 financial results and operational highlights on November 6, 2025, at 8:30 a.m. ET [1] - The company is focused on tackling global health challenges through its vaccine technology and aims to optimize partnerships and expand its research and development efforts [2] Conference Call Details - The conference call is scheduled for November 6, 2025, at 8:30 a.m. ET, with a registration link provided for participants [1] - Dial-in numbers are available for both U.S. and international participants [1] - A replay of the call will be available starting at 11:30 a.m. ET on November 6, 2025, until November 13, 2025 [2] Company Overview - Novavax specializes in vaccine development, utilizing protein-based nanoparticles and the Matrix-M adjuvant [2] - The company's growth strategy includes optimizing existing partnerships and expanding its technology platform through innovation and collaborations [2]

Core Viewpoint - Novavax, Inc. is recognized as a promising long-term biotechnology investment, with Cantor Fitzgerald initiating coverage with an Overweight rating and a price target of $18 [1] Group 1: Company Strategy and Developments - Novavax is transitioning from direct commercialization to a licensing model, focusing on revenue generation through partnerships related to its Matrix-M adjuvant and vaccine portfolio [2] - The company has transferred its COVID-19 vaccine, Nuvaxoid, to Sanofi, granting Sanofi full responsibility for commercial and regulatory activities in the EU, and is set to receive a $25 million milestone payment [2][3] - Novavax is entitled to additional future milestone payments, including a $75 million payment upon Sanofi's technology transfer of its manufacturing process, and could receive up to an additional $350 million in future milestone payments [3] Group 2: Product and Technology - Novavax develops innovative vaccines using protein-based technology, specifically recombinant nanoparticle technology and its proprietary Matrix-M adjuvant to enhance immune response [3]

Group 1 - Novavax has announced an agreement to assign its Gaithersburg, Maryland facility and certain assets to AstraZeneca [3] - The deals are valued at nearly $60 million [3]

Core Insights - Novavax, Inc. has signed definitive agreements for site consolidation in Maryland, aiming to transform into a leaner and more agile organization, which is part of its corporate growth strategy [1][2] - The agreements are expected to generate $60 million in upfront payments and lead to future cost savings of $230 million over 11 years, primarily from lease expenses and facility operating costs [1][2] Financial Impact - The consolidation will result in $40 million from the assignment of the lease and sale of related assets, expected to close in January 2026 [2] - An additional $20 million is anticipated from the sale of adjacent property, expected to close in Q4 2025 [2] Strategic Focus - The company aims to enhance its focus on research and development (R&D) and partnerships, optimizing its existing capabilities while reducing costs [1][2] - Novavax's growth strategy includes expanding access to its technology platform through R&D innovation and new collaborations [3]

Core Viewpoint - Novavax's stock has shown mixed performance recently, with a notable decline in the latest trading session, while it has experienced a rise over the past month, indicating volatility in investor sentiment [1][2]. Company Performance - Novavax closed at $8.48, reflecting a -4.83% change from the previous day, underperforming compared to the S&P 500, Dow, and Nasdaq [1]. - The company is expected to report an EPS of -$0.44, which represents a 42.11% growth year-over-year, while revenue is anticipated to be $67 million, down 20.72% from the same quarter last year [2]. - For the full year, earnings are projected at $2.53 per share and revenue at $1.03 billion, showing significant increases of +305.69% and +51.52% respectively compared to the previous year [3]. Analyst Estimates - Recent changes in analyst estimates for Novavax are crucial, as positive revisions often indicate favorable business trends [3][4]. - The Zacks Rank system, which evaluates these estimate changes, currently ranks Novavax as 3 (Hold), with a recent decline of 5.67% in the consensus EPS estimate [5]. Valuation Metrics - Novavax's Forward P/E ratio stands at 3.52, significantly lower than the industry average of 19.89, suggesting a potential undervaluation [6]. - The company has a PEG ratio of 0.12, indicating a favorable growth outlook compared to the industry average PEG ratio of 1.84 [7]. Industry Context - The Medical - Biomedical and Genetics industry, which includes Novavax, holds a Zacks Industry Rank of 84, placing it in the top 35% of over 250 industries, suggesting strong overall performance potential [8].