Core Viewpoint - Novavax has experienced a significant decline in stock performance, with a return of -10.9% over the past month, contrasting with the S&P 500's +5.2% and the Zacks Medical - Biomedical and Genetics industry's +0.9% [2] Earnings Estimates - For the current quarter, Novavax is projected to report a loss of $0.12 per share, reflecting a -112.1% change year-over-year, with the consensus earnings estimate for the fiscal year at $2.65, indicating a +315.5% change [5][6] - The consensus earnings estimate for the next fiscal year is $0.4, which represents a -84.8% change from the previous year [6] Revenue Growth Forecast - The consensus sales estimate for the current quarter is $130.5 million, indicating a year-over-year decline of -68.6%. For the current fiscal year, the estimate is $1.07 billion (+56.8%), while for the next fiscal year, it is $516.45 million (-51.7%) [11] Last Reported Results and Surprise History - In the last reported quarter, Novavax achieved revenues of $666.66 million, a +610.3% year-over-year increase, with an EPS of $2.93 compared to -$1.05 a year ago. The revenue exceeded the Zacks Consensus Estimate by +215.04%, and the EPS surprise was +312.68% [12][13] Valuation - Novavax is graded B in the Zacks Value Style Score, indicating it is trading at a discount to its peers, which suggests potential undervaluation [17]

Core Insights - Novavax announced positive results from a late-stage study of its COVID-19-influenza combination (CIC) and standalone influenza vaccine candidates, showing robust immune responses in adults aged 65 and older [1][2][8] - The study's findings will guide the design of another late-stage trial that could support regulatory submissions if successful [3][8] - Novavax is seeking strategic collaborations to finance further development and commercialization of both vaccine candidates as part of a strategic shift to expand its pipeline [4][8] Stock Performance - Novavax shares have underperformed the industry year to date [5] Recent Developments - The announcement followed the FDA's approval of Nuvaxovid for older adults, with a narrower label than expected, restricting use in individuals aged 12-64 with high-risk conditions [7][8] - Sanofi has acquired exclusive global marketing rights for Nuvaxovid, part of a multi-billion-dollar deal, and will receive tiered royalties on future sales [10] Competitive Landscape - Other companies like Pfizer and Moderna are also developing COVID-flu combination vaccines, with Moderna ahead in its investigational candidate mRNA-1083, despite a recent setback [11][12] - Pfizer faced challenges in its phase III study for its combination vaccine, missing one of its primary immunogenicity objectives [13] - Sanofi is testing multiple COVID-19/flu combination vaccine candidates, with two receiving fast-track designation from the FDA [14]

Company Overview - Novavax has transitioned from a vertically integrated commercial organization focused on the launch of its COVID-19 vaccine, Nuvaxovid, to a model that emphasizes research and development (R&D) and diversified partnerships [3][4]. Business Model Evolution - From 2020 to 2022, the majority of Novavax's resources were dedicated to the development and introduction of Nuvaxovid, marking a singular focus on this product [4]. - In early 2023, the company began to evolve its business model to prioritize R&D and establish a broader range of partnerships [3]. Leadership and Presentation - The presentation at the Goldman Sachs 46th Annual Global Healthcare Conference featured key executives, including the CEO, CFO, and the head of R&D, indicating a strong leadership presence [1]. - The conference serves as a platform for Novavax to communicate its strategic direction and business evolution to potential investors and stakeholders [1].

Novavax (NVAX) FY Conference Summary Company Overview - **Company**: Novavax, Inc. (NVAX) - **Date of Conference**: June 11, 2025 - **Key Speakers**: John Jacobs (CEO), Jim Kelly (CFO), Dr. Roxandra Draghia (Head of R&D) Core Industry Insights - **Industry**: Biotechnology and Vaccine Development - **Focus**: Transition from a vertically integrated commercial model to a research and development (R&D) and partnership-focused model [3][4] Key Points and Arguments Business Model Evolution - Transitioned from a singular focus on the COVID-19 vaccine (Nuvaxovid) to a diversified R&D strategy [3][4] - Emphasis on long-term growth through R&D and partnerships [5][6] Strategic Priorities for 2025 1. **Optimize Sanofi Partnership**: Focus on maximizing the collaboration with Sanofi, which includes multiple revenue streams from licensing and royalties [6][12] 2. **Leverage Technology Platform**: Expand the utility of the Matrix M adjuvant and develop new formulations [6][11] 3. **Advance Early Stage Pipeline**: Develop high-value assets and explore additional partnerships beyond Sanofi [6][9] Financial Health and Cost Management - Reduced liabilities by over $2 billion and cut annual SG&A and R&D expenses by over $1 billion [6][7] - Plans to reduce headcount by approximately 80% by 2027 without compromising capabilities [7] Partnership Developments - Signed multiple Material Transfer Agreements (MTAs) with top pharmaceutical companies to explore Matrix M in their pipelines [8][9][22] - Collaboration with Sanofi includes licensing for COVID-19 and combination vaccines, with potential for hundreds of millions in milestones and royalties [12][14] Market Opportunities - COVID-19 continues to pose a significant health threat, with hospitalization rates four times higher than flu [15] - Growing consumer preference for combination vaccines, with 83% of individuals willing to adopt a combo vaccine [24][18] Product Differentiation - Novavax's vaccine shows 39% fewer symptoms compared to mRNA vaccines, highlighting better tolerability [19] - Matrix M adjuvant allows for the development of combination vaccines with less antigen, maintaining tolerability [19][11] R&D Pipeline - Launched four new early-stage programs in Q1 2025, including vaccines for RSV, H5N1, varicella zoster virus, and C. difficile [9][27][28] - Focus on using AI and machine learning for antigen design and study models [28] Future Expectations - Targeting non-GAAP profitability by 2027 through revenue growth from partnerships and cost reductions [31][33] - Anticipating significant milestones from the Sanofi partnership and additional collaborations [35][36] Upcoming Milestones - BLA approval received, with a $175 million milestone achieved [35][36] - Sanofi to commercialize the COVID vaccine in the US and Europe in 2025, with additional milestones available [36][37] Additional Important Insights - The malaria vaccine developed in collaboration with Oxford University is expected to save 180,000 children's lives by 2030 [20] - Sanofi is developing two combination products using Novavax's technology, currently in phase one/two studies [21] This summary encapsulates the strategic direction, financial health, partnership developments, and market opportunities for Novavax as discussed in the conference.

Core Insights - The Zacks Premium service provides tools for investors to enhance their stock market strategies and confidence [1] - Zacks Style Scores are designed to help investors select stocks with the highest potential to outperform the market in the short term [2] Zacks Style Scores Overview - The Style Scores consist of four categories: Value Score, Growth Score, Momentum Score, and VGM Score, each focusing on different investment strategies [3][4][5][6] - Value Score identifies undervalued stocks using financial ratios [3] - Growth Score assesses a company's financial health and future growth potential [4] - Momentum Score capitalizes on price trends and earnings outlook changes [5] - VGM Score combines all three styles to provide a comprehensive evaluation of stocks [6] Zacks Rank and Performance - The Zacks Rank is a proprietary model that utilizes earnings estimate revisions to guide investment decisions [7] - Stocks rated 1 (Strong Buy) have historically achieved an average annual return of +25.41%, significantly outperforming the S&P 500 [8] - Investors are encouraged to focus on stocks with a Zacks Rank of 1 or 2 and Style Scores of A or B for optimal returns [10] Stock Highlight: Novavax (NVAX) - Novavax, Inc. is a biotechnology company focused on developing vaccines for infectious diseases and has a Zacks Rank of 3 (Hold) with a VGM Score of B [12] - The company has a Momentum Style Score of B, with shares increasing by 16.3% in the past four weeks [13] - Recent upward revisions in earnings estimates indicate a positive outlook, with the Zacks Consensus Estimate rising from $1.05 to $2.03 per share [13] - Novavax has an impressive average earnings surprise of 77.9%, making it a noteworthy consideration for investors [13]

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]

Core Viewpoint - Novavax, Inc. announced positive results from the initial cohort of its COVID-19-Influenza Combination (CIC) and stand-alone trivalent hemagglutinin nanoparticle seasonal influenza (tNIV) Phase 3 trial, indicating that both vaccine candidates induced immune responses comparable to licensed vaccines Nuvaxovid® and Fluzone HD [1][2][3] Group 1: Trial Results - The Phase 3 trial involved approximately 2,000 adults aged 65 and older, focusing on the safety and immunogenicity of the CIC and tNIV compared to Nuvaxovid and Fluzone HD [3] - Both vaccine candidates demonstrated robust immune responses, with neutralizing antibody responses increasing by 2.4 to 5.7 times over baseline [2][6] - The trial results showed that nearly all solicited adverse events (>98%) were mild or moderate, indicating good tolerability [2][6] Group 2: Future Development - The data from this trial will inform future discussions with potential partners regarding the registrational Phase 3 program for the CIC and tNIV vaccines [2][3] - Novavax continues to seek partnerships to advance the development of these vaccine programs [6]

Company Participation in Investor Conferences - Novavax, Inc. will participate in the Jefferies Global Healthcare Conference on June 4, 2025, from 2:00 to 2:30 p.m. ET in New York, NY [1] - The company will also present at the Goldman Sachs 46th Annual Global Healthcare Conference on June 11, 2025, from 2:00 to 2:35 p.m. ET in Miami Beach, FL [2] - Webcasts of both events will be available on the company's Events & Presentations page, with replays accessible for 30 days [2] Company Overview - Novavax, Inc. focuses on addressing significant global health challenges through its expertise in vaccines and its technology platform, which includes protein-based nanoparticles and the Matrix-M® adjuvant [3] - The company's growth strategy aims to optimize existing partnerships, expand access to its technology platform through research and development, and pursue organic portfolio expansion in infectious diseases and other areas [3]

Group 1 - Zacks Premium offers various tools for investors, including daily updates on Zacks Rank and Industry Rank, access to the Zacks 1 Rank List, Equity Research reports, and Premium stock screens to enhance investment confidence [1][2] - The Zacks Style Scores rate stocks based on value, growth, and momentum characteristics, helping investors identify securities with high potential for market outperformance over the next 30 days [2][3] Group 2 - The Value Score focuses on identifying undervalued stocks using financial ratios such as P/E, PEG, and Price/Sales, appealing to value investors [3] - The Growth Score assesses a company's financial health and future outlook by analyzing projected and historical earnings, sales, and cash flow, targeting growth investors [4] - The Momentum Score helps investors capitalize on price trends by evaluating short-term price changes and earnings estimate revisions [5] Group 3 - The VGM Score combines Value, Growth, and Momentum Scores, serving as a comprehensive indicator for investors seeking stocks with attractive value, strong growth forecasts, and promising momentum [6] - The Zacks Rank, based on earnings estimate revisions, has shown significant success, with 1 (Strong Buy) stocks averaging a +25.41% annual return since 1988, outperforming the S&P 500 [8] Group 4 - Novavax, Inc. is a biotechnology company focused on developing vaccines for serious infectious diseases, currently holding a 3 (Hold) Zacks Rank with a VGM Score of B [12] - Novavax has a Momentum Style Score of A, with shares increasing by 8.7% over the past four weeks, and has seen upward revisions in earnings estimates for fiscal 2025 [13]

Core Viewpoint - The S&P 500 has experienced persistent volatility in 2025, leading to cautious investor sentiment, but this environment may present opportunities for significant gains for those willing to take moderate risks [1]. Group 1: Septerna Inc. - Septerna Inc. is a clinical-stage biotechnology firm focused on developing G protein-coupled receptor (GPCR) oral small molecule drug candidates for various diseases [4][6]. - The company has secured a major partnership with Novo Nordisk, which could enhance its growth potential, with an immediate payment of approximately $200 million and a deal potentially worth over $2 billion [5][6]. - Analysts have a consensus price target of $27 per share for Septerna, indicating a potential upside of 184.81% from the current price of $9.48, despite the stock having fallen by about 58% year-to-date [7][4]. Group 2: Intellia Therapeutics Inc. - Intellia Therapeutics is a genome editing firm developing therapies for conditions such as hemophilia and cancers, with promising trial data reported for its ongoing Phase 1 trial [9][10]. - The company has a strong cash position of $707 million as of March 31, 2025, which is expected to fund operations through early 2027 [10]. - The consensus price target for Intellia shares is $36.90, suggesting a potential quadrupling of the stock's current price, with 14 out of 21 analysts rating the stock as a Buy [11]. Group 3: Novavax Inc. - Novavax has received full FDA approval for its protein-based COVID-19 vaccine, unlocking a $175 million milestone payment from Sanofi, positioning it as a non-mRNA option [12][13]. - Despite the approval, the FDA has imposed significant restrictions that may limit the vaccine's availability, contributing to mixed market reactions [13]. - The consensus price target for Novavax shares is $19, indicating a potential upside of 160.63%, with four out of seven analysts rating the stock as a Buy [12][13].