Core Insights - Novavax has shifted its strategic focus and aims to leverage its unique technology to differentiate itself in the market [1] Company Overview - Novavax is recognized for developing a highly effective COVID vaccine during the pandemic, a feat not achieved by many larger pharmaceutical companies [1] - The company's success is attributed to its core technology, which utilizes subunit protein nano-based technology for antigen creation, combined with the effective adjuvant Matrix-M [1][2]

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]

Core Viewpoint - Shah Capital, the second-largest shareholder of Novavax, is urging the biotechnology company to make strategic adjustments, including a potential sale, due to dissatisfaction with the weak sales of its COVID-19 vaccine [1] Group 1: Shareholder Actions - Shah Capital has increased its stake in Novavax from 7.2% in October to approximately 8.3% [1] - The shareholder has warned that if there is no progress within the next four months, it may initiate a proxy fight [1]

Core Viewpoint - Shah Capital, the second-largest shareholder of Novavax, is urging the company's board to consider strategic changes, including a potential sale, and has indicated the possibility of initiating a proxy fight if no progress is made [1] Group 1 - Shah Capital is pressing for strategic changes at Novavax [1] - The potential sale of Novavax is being considered as part of the strategic changes [1] - A proxy fight may be launched by Shah Capital if the board does not take action [1]

Core Viewpoint - The article discusses the importance of enabling Javascript and cookies in browsers to ensure proper functionality and access to content [1] Group 1 - The article highlights that users may be blocked from proceeding if an ad-blocker is enabled [1]

Core Insights - Novavax reported a narrower loss of 62 cents per share in Q3 2025, compared to the Zacks Consensus Estimate of a loss of $1.08 per share and a loss of 79 cents per share in the same quarter last year [1][7] - Quarterly revenues reached $70 million, down 18% year-over-year, but exceeded the Zacks Consensus Estimate of $40 million [2][7] - The company raised its 2025 revenue guidance to between $1.04 billion and $1.06 billion, up from the previous estimate of $1.00 billion to $1.05 billion [10] Financial Performance - Novavax's product sales were $13 million, a significant decrease from $41.5 million in the prior year, with no revenue generated from its COVID vaccine Nuvaxovid during the quarter [3] - Licensing, royalties, and other revenues totaled $57 million, including a $48 million milestone payment from Sanofi, marking a 33% increase year-over-year [4] - Research and development (R&D) expenses were $98 million, up 12.6% year-over-year, while selling, general, and administrative (SG&A) expenses decreased by 55% to $32 million [8] Cash Position - As of September 30, 2025, Novavax had $778 million in cash and cash equivalents, an increase from $628 million as of June 30, 2025 [9] Strategic Developments - Novavax completed the transition of the COVID vaccine's commercial leadership to Sanofi for the 2025-2026 vaccination season [4] - The company amended its collaboration and license agreement with Sanofi to expand the use of its Matrix-M adjuvant in pandemic influenza vaccine candidates [11][12] - Novavax received an additional $50 million in milestone payments due to the transfer of marketing authorization for Nuvaxovid to Sanofi in the U.S. and EU [13][14] Market Performance - Shares of Novavax have declined by 5.6% year-to-date, contrasting with an 11.4% rise in the industry [5]

Core Insights - Novavax reported a quarterly loss of $0.62 per share, which was better than the Zacks Consensus Estimate of a loss of $1.08, representing an earnings surprise of +42.59% [1] - The company generated revenues of $70.45 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 77.85%, although this was a decline from $84.51 million in the same quarter last year [2] - Novavax has consistently surpassed consensus EPS and revenue estimates over the last four quarters [2] Financial Performance - The earnings surprise of +42.59% indicates a significant improvement compared to the previous year's loss of $0.76 per share [1] - The company has shown a strong performance in revenue estimates, topping consensus expectations four times in the last four quarters [2] Stock Performance - Novavax shares have declined approximately 4.4% since the beginning of the year, contrasting with the S&P 500's gain of 15.6% [3] - The current Zacks Rank for Novavax is 3 (Hold), suggesting that the stock is expected to perform in line with the market in the near future [6] Future Outlook - The consensus EPS estimate for the upcoming quarter is -$0.33 on revenues of $125.59 million, while for the current fiscal year, it is $2.23 on revenues of $1.07 billion [7] - The outlook for the Medical - Biomedical and Genetics industry, where Novavax operates, is currently in the top 41% of Zacks industries, indicating a favorable environment for potential stock performance [8]

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]

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]