Financial Data and Key Metrics Changes - Novavax reported total revenue of $239 million for Q2 2025, down from $415 million in Q2 2024, which included a $175 million milestone from Sanofi related to the BLA approval for Nuvaxibid [30][32] - The company achieved a net income of $107 million or 62 cents per diluted share for Q2 2025 [35] - Combined R&D and SG&A expenses were reduced by 41% year-over-year, with SG&A expenses down 57% due to the transition of commercial activities to Sanofi [31][34] Business Line Data and Key Metrics Changes - Product sales for Q2 2025 were $11 million, consisting of $13 million from supply sales and a negative $2 million from Nivaxibid product sales due to market activity closeout [33] - Year-to-date sales of the R21 Matrix M malaria vaccine reached 14 million doses, exceeding the total of 6 million doses sold in 2024 [33] Market Data and Key Metrics Changes - The partnership with Sanofi is expected to enhance commercialization efforts for Nuvaxibid in select global markets, with additional milestone payments anticipated [9][10] - The company is actively pursuing new partnerships to leverage its technology platform and expand its market presence [13] Company Strategy and Development Direction - Novavax's strategy focuses on optimizing partnerships, enhancing existing collaborations, and advancing its technology platform and early-stage pipeline [7][40] - The company aims for potential non-GAAP profitability as early as 2027, driven by its partnerships and technology advancements [7][32] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of combination vaccines and the ongoing discussions with partners, particularly Sanofi [10][45] - The company is committed to maintaining a lean operational model while driving value creation through targeted investments in R&D [37][40] Other Important Information - The company is exploring the utility of its Matrix M adjuvant in oncology and has signed material transfer agreements with three pharmaceutical companies [14][27] - A post-marketing commitment study is planned for 2025 and 2026, with costs expected to be reimbursed by Sanofi [35][36] Q&A Session Summary Question: Will Novavax file for approval for the COVID vaccine for the upcoming season? - Management confirmed that they are working on regulatory filings to improve the shelf life profile of their vaccine for the fall season [43] Question: What is the interest level in the combination vaccine partnership? - Management indicated ongoing discussions with multiple potential partners and noted positive feedback from Sanofi regarding combination assets [45] Question: What is the confidence level in the post-marketing Phase four trial efficacy data? - Management stated that the design and timing of the post-marketing commitment study are being finalized, with expectations to start by the end of the year [72] Question: Is the company open to acquiring or in-licensing clinical stage candidates? - Currently, the focus is on external partnerships and internal development rather than acquiring clinical stage candidates [66] Question: How does the shifting FDA funding landscape impact Novavax? - Management sees continued investment in vaccines by peer companies and believes there is a growing interest in alternative technology platforms like theirs [76][80]

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.

Financial Data and Key Metrics Changes - Novavax reported total revenue of $667 million for Q1 2025, a significant increase from $94 million in Q1 2024, driven by $622 million in product sales [30][31] - The company reduced current liabilities by over 60% compared to year-end 2024 and improved its cost structure by reducing combined R&D and SG&A costs by 24% year-over-year [31][38] - Net income for Q1 2025 was $519 million, or $2.93 per diluted share [37] Business Line Data and Key Metrics Changes - Product sales for Q1 2025 included $603 million from the closeout of the Canada and New Zealand APA agreements, allowing Novavax to retain cash previously received [31][35] - Supply sales of $14 million in Q1 2025 were primarily related to Matrix M adjuvant sales to licensed partners [35] - Licensing royalties and other revenue totaled $45 million, with $40 million from the Sanofi agreement [36] Market Data and Key Metrics Changes - The partnership with Takeda has improved financial terms for Novavax in Japan, enhancing its position in the third-largest healthcare market globally [8][12] - The company anticipates earning an additional $225 million in milestones from Sanofi, assuming BLA approval in the US and Europe [33] Company Strategy and Development Direction - Novavax is focusing on optimizing its partnership with Sanofi, leveraging its technology platform to forge additional partnerships, and advancing its tech platform and early-stage pipeline [9][44] - The company aims for non-GAAP profitability as early as 2027, with a commitment to streamlining operating expenses [30][40] - The strategic priorities include executing on the Sanofi partnership, leveraging technology for new collaborations, and advancing early-stage pipeline programs [9][44] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential approval of the BLA for the COVID vaccine and emphasized the importance of a non-mRNA protein-based vaccine option for US consumers [10][11] - The company is actively seeking additional partnerships and collaborations to create multiple growth opportunities [12][14] - Management highlighted the positive impact of their technology on public health and the potential for significant value creation [14] Other Important Information - The company reiterated its full-year financial guidance for combined R&D and SG&A expenses between $475 million and $525 million, reflecting a 30% reduction compared to 2024 [32][39] - Novavax is working closely with the FDA on the parameters of the requested post-marketing commitment study related to its BLA [32][40] Q&A Session Summary Question: Nature of the post-marketing commitment FDA requested - Management has not publicly commented on the specifics of the study but is working diligently with the FDA to bring the process to a positive conclusion [48][49] Question: Target profile for KIC program and flu - The current study is designed to generate immunogenicity and safety data to inform the design of a phase three trial, not a pivotal trial [51][52] Question: Quality of life data from the Utah Shield study - The Utah study is observational and not part of typical regulatory submissions; it informs consumer understanding rather than regulatory decisions [58] Question: Impact of post-marketing commitment on Sanofi milestone - The milestone based on BLA approval is not impacted by the post-marketing commitment [95] Question: Confidence in receiving FDA approval of the BLA - Management sees a potential pathway forward for approval based on alignment on the post-marketing commitment [103]

Financial Data and Key Metrics Changes - Novavax reported total revenue of $667 million for Q1 2025, a significant increase from $94 million in Q1 2024, driven by $622 million in product sales [28][29] - The company reduced current liabilities by over 60% compared to year-end 2024 and improved its cost structure by reducing combined R&D and SG&A costs by 24% year-over-year [29][36] - Net income for Q1 2025 was $519 million, or $2.93 per diluted share [35] Business Line Data and Key Metrics Changes - Product sales for Q1 2025 included $603 million from the closeout of the Canada and New Zealand APA agreements, allowing Novavax to retain cash previously received [29][33] - Supply sales of $14 million in Q1 2025 were primarily related to Matrix M adjuvant sales to licensed partners [34] Market Data and Key Metrics Changes - The partnership with Takeda has improved financial terms for Novavax in Japan, enhancing its position in the third-largest healthcare market globally [8][12] - Anticipated cash flows from licensed partners include $225 million in milestones from Sanofi and a $20 million upfront payment from Takeda [31][40] Company Strategy and Development Direction - The company is focusing on three strategic priorities: optimizing the partnership with Sanofi, leveraging its technology platform to forge additional partnerships, and advancing its tech platform and early-stage pipeline [9][43] - Novavax aims for non-GAAP profitability as early as 2027, with a disciplined investment strategy in high-potential value opportunities [7][39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential approval of the BLA for the COVID vaccine and emphasized the importance of a non-mRNA protein-based vaccine option for U.S. consumers [10][11] - The company is actively seeking additional partnerships and collaborations to create multiple growth opportunities [12][13] Other Important Information - The company reiterated its full-year financial guidance for combined R&D and SG&A expenses of $475 million to $525 million, reflecting a 30% reduction compared to 2024 [30][38] - Novavax is working closely with the FDA on the parameters of the requested post-marketing commitment study related to its BLA [30][39] Q&A Session Summary Question: Nature of the post-marketing commitment FDA requested - Management has not publicly commented on the specifics of the study but is working diligently with the FDA to bring the process to a positive conclusion [46][47] Question: Target profile for KIC program and flu - The current study is designed to generate immunogenicity and safety data to inform the design of a phase three trial, not a pivotal trial [50][51] Question: Impact of the Utah Shield study on regulatory science - The Utah study is observational and not part of typical regulatory submissions; it informs consumer understanding rather than regulatory decisions [54][57] Question: Cash recognition from APA revenues - The $603 million recognized from Canada and New Zealand is non-cash, as the cash was received in prior years [71][72] Question: Safety profile of the combined vaccine - The study is designed to demonstrate immune response to both pathogens, with safety data to be supplemented from the immunogenicity data [79][80] Question: Confidence in receiving FDA approval of the BLA - Management sees a potential pathway forward for approval based on alignment on the post-marketing commitment [102][103]