Novavax (NASDAQ:NVAX) said that it has officially transferred the marketing authorization for its COVID-19 vaccine, Nuvaxovid, to Sanofi (NASDAQ:SNY) within the European Union. As a result of this transfer, Novavax received a milestone payment of $25M. This move allows Sanofi ...

, /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) has completed the transfer of the marketing authorization for its COVID-19 vaccine, Nuvaxovid® to Sanofi, in the European Union (EU) enabling Sanofi to take full responsibility for commercial and regulatory activities in the EU. The transfer triggered a milestone payment of $25 million to Novavax and further progresses the collaboration and license agreement (CLA) between both companies. "Novavax continues to steadily advance our corporate growth strategy while ...

Accessibility StatementSkip Navigation GAITHERSBURG, Md., Sept. 30, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced progress on its collaboration and license agreement (CLA) with Sanofi regarding Novavax's Matrix- M adjuvant. The companies have amended their CLA to expand Sanofi's license to include use of Novavax's Matrix-M adjuvant in Sanofi's pandemic influenza vaccine candidate program. Sanofi recently received funding from the Biomedical Advanced Research and Development Author ...

Group 1 - The article discusses the performance and outlook of Novavax, Inc. (NASDAQ: NVAX), highlighting three consecutive Sell recommendations made by the author in October 2024, February 2025, and most recently [1] - The investing group Haggerston BioHealth provides insights into the biotech, pharma, and healthcare sectors, offering catalysts, buy and sell ratings, and detailed financial analyses for major pharmaceutical companies [1] - The author, Edmund Ingham, has extensive experience in the biotech sector, having covered over 1,000 companies and providing detailed reports for investors [1]

Core Insights - Shares of major COVID-19 vaccine manufacturers, including Moderna, BioNTech, Pfizer, and Novavax, experienced declines following reports linking COVID-19 vaccines to the deaths of 25 children [1][6][10] Regulatory Developments - Health officials are reportedly using data from the Vaccine Adverse Event Reporting System (VAERS) to establish a connection between COVID-19 vaccines and pediatric deaths, although VAERS data does not confirm causation [2][3] - The CDC advisory committee is set to meet on September 18-19, 2025, to review vaccine safety, effectiveness, and clinical necessity, which may influence future vaccine recommendations and insurance coverage [5][10] Market Impact - Following the news, Moderna and BioNTech shares fell over 7%, while Pfizer and Novavax saw declines of nearly 4%, indicating investor concerns over regulatory scrutiny and its potential impact on vaccine demand [6][10] Leadership and Policy Changes - The current leadership at the Department of Health and Human Services, particularly Secretary Robert F. Kennedy Jr., known for his vaccine skepticism, has raised concerns about the influence of political factors on public health decisions [7][8] - Recent changes in the CDC advisory committee and the resignation of a senior FDA vaccine official have further fueled worries regarding the independence of public health decision-making [8] Long-term Challenges - Companies like Moderna, Pfizer, BioNTech, and Novavax are already facing declining COVID-19 revenues, and the potential narrowing of vaccine coverage recommendations poses additional long-term challenges [9]

Core Viewpoint - The Trump administration's health officials plan to present claims linking COVID-19 vaccines to 25 child deaths to a key vaccine advisory committee, impacting biotech stocks negatively [1] Group 1: Impact on Biotech Stocks - Following the news, U.S. biotech stocks experienced significant declines, with BioNTech down 7.26%, Pfizer down 3.98%, Moderna down 7.40%, and Novavax down 3.62% [1] - Citigroup highlighted the volatility risk for biotech companies due to the news, emphasizing the robust research supporting COVID-19 vaccines and billions of doses administered [1] Group 2: Company Ratings by Citigroup - **BioNTech**: Rated "Buy" with a target price of $140, but considered "high risk" due to typical volatility in biotech stocks and uncertainties in clinical trials [3] - **Moderna**: Rated "Neutral" with a target price of $30, also deemed "high risk" with potential down risks related to market stability and product effectiveness [4] - **Novavax**: Rated "Sell" with a target price of $6, facing risks but with potential upside if the COVID-19 vaccine market recovers unexpectedly [5] - **Pfizer**: Target price set at $26, with both upside and downside risks related to new drug sales and competitive pressures [6]

Core Insights - Novavax is an innovative biotech company focused on vaccine development, having undergone significant transformation post-pandemic to enhance its technology and create value [2][3] - The company has shifted from a single product focus during the pandemic to a more diversified approach, aiming to strengthen its financial position while exploring multiple value creation opportunities [3] Company Overview - Novavax has developed a vertically integrated structure that initially incurred high expenses but also presented substantial opportunities [3] - The leadership team has worked on reducing the expense base, improving the balance sheet, and extending the cash runway while maintaining operational capabilities [3]

Summary of Novavax Conference Call Company Overview - **Company**: Novavax - **Industry**: Biotechnology, specifically vaccine development Key Points and Arguments 1. **Company Transformation**: Novavax has transitioned from a single-product company focused on COVID-19 vaccines to a more diversified biotech firm, reducing expenses and strengthening its balance sheet while maintaining capabilities for future growth [8][78]. 2. **Vaccine Approval**: The company received full approval for its COVID-19 vaccine for individuals aged 65 and older, supported by data from clinical trials involving nearly 30,000 individuals and a safety database of over 5 million vaccinated individuals [11][12]. 3. **Partnership with Sanofi**: Novavax has partnered with Sanofi for the commercialization of its COVID-19 vaccine, with Sanofi taking over responsibilities and expected to drive significant growth in the vaccine market [22][28]. 4. **Financial Milestones**: The transition to Sanofi will trigger milestone payments of $50 million and an additional $75 million upon successful tech transfer, highlighting the financial benefits of the partnership [23][24]. 5. **Market Potential**: The global vaccine market is projected to grow from $57 billion in 2023 to over $75 billion by 2030, with Novavax positioned to benefit from this growth through its partnerships and innovative technology [36][48]. 6. **Combination Vaccines**: There is a strong consumer and physician preference for combination vaccines, which Novavax aims to develop in collaboration with Sanofi, leveraging their expertise in flu vaccines [45][47]. 7. **Royalties and Cash Flow**: For every billion dollars in sales of the COVID vaccine, Novavax expects to receive approximately $200 million in royalties, with additional opportunities from combination vaccines [52][54]. 8. **Research and Development Pipeline**: Novavax is expanding its R&D pipeline, focusing on multiple assets, including oncology, RSV, and pandemic flu vaccines, with the potential for significant market opportunities [34][70]. 9. **Cost Management**: The company has made significant strides in cost-cutting and debt management, targeting non-GAAP profitability by 2027, with a projected reduction in operating costs by 85% from peak levels [78][79]. 10. **Matrix M Adjuvant**: Novavax's proprietary Matrix M adjuvant is expected to facilitate the development of combination vaccines and enhance immune responses while reducing the required antigen amount [59][60]. Additional Important Content - **Post-Marketing Commitments**: Novavax is committed to ongoing studies to evaluate the safety and efficacy of its vaccines post-approval, which is standard for vaccine manufacturers [20][21]. - **Regulatory Landscape**: The company is actively preparing for future clinical trials and regulatory submissions, emphasizing the importance of safety and immunogenicity data [61][62]. - **Public Health Impact**: Novavax aims to address significant unmet medical needs, particularly in areas like C. diff and shingles, which could provide substantial public health benefits [72][74]. This summary encapsulates the critical insights from the Novavax conference call, highlighting the company's strategic direction, financial outlook, and market opportunities in the evolving vaccine landscape.

Core Viewpoint - Novavax's Nuvaxovid™ has been approved by the U.S. FDA for the 2025-2026 vaccination season, making it the only protein-based, non-mRNA COVID-19 vaccine available in the U.S. for high-risk adults aged 12 to 64 and seniors aged 65 and older [1][4]. Group 1: Vaccine Approval and Target Population - The FDA approval allows Nuvaxovid to be administered to adults 65 years and older, or individuals aged 12 to 64 with at least one underlying condition that increases their risk for severe COVID-19 outcomes [1][4]. - Novavax plans to collaborate with Sanofi to ensure access to the vaccine for eligible individuals this fall [2]. Group 2: Clinical Data and Efficacy - Clinical and preclinical data indicate that Nuvaxovid is safe and effective against COVID-19, particularly the JN.1 strain, which is responsible for the majority of global infections as of July 2025 [3]. - The vaccine induces immunity across various circulating strains within the JN.1 lineage, including NB.1.8.1, LP.8.1, XFG, XFC, LF.7, and XEC [3]. Group 3: Commercialization and Royalties - Sanofi is leading the commercialization efforts for Nuvaxovid, while Novavax is set to receive ongoing tiered royalties from the vaccine sales [3]. Group 4: Vaccine Composition and Technology - Nuvaxovid is a protein-based vaccine that targets the JN.1 variant, utilizing Novavax's recombinant nanoparticle technology to create copies of the SARS-CoV-2 spike protein [8][9]. - The Matrix-M® adjuvant enhances the immune response and allows for a lower dose of the antigen while maintaining effectiveness [10]. Group 5: Company Overview - Novavax, Inc. focuses on addressing significant health challenges through its expertise in vaccines and technology platforms, including protein-based nanoparticles and the Matrix-M adjuvant [11]. - The company's growth strategy includes optimizing existing partnerships, expanding access to its technology, and pursuing research and development innovations [11].

Group 1 - Novavax has entered into agreements to issue $225 million of 4.625% Convertible Senior Notes due 2031, which includes approximately $175.3 million in exchange for existing 5.00% Convertible Senior Notes due 2027 and approximately $49.7 million for cash [1][2][9] - The conversion price of the 2031 Notes is set at $11.14 per share, representing a 27.5% premium over the closing price on August 20, 2025 [2] - After the transactions, approximately $26.5 million of the 2027 Notes will remain outstanding, while the total principal amount of the 2031 Notes will be $225 million [2][3] Group 2 - The refinancing extends the maturity date of most existing debt to 2031, improving the capital structure of Novavax [3][9] - The company aims to optimize existing partnerships and expand access to its technology platform through R&D innovation and new collaborations [6]