Novavax (NVAX) 2025 Conference Summary Company Overview - **Company**: Novavax (NVAX) - **Event**: 2025 Bank of America Healthcare Conference - **Date**: May 14, 2025 Key Points Industry and Company Developments - Novavax has transitioned from a small biotech to a more structured organization post-pandemic, focusing on leveraging its technology platform for growth through partnerships and R&D [3][4] - The company has launched four new R&D programs in the last quarter, indicating a robust pipeline for future growth [3] Financial Guidance and Performance - Novavax raised its revenue guidance based on BLA milestones from its partnership with Sanofi, with expectations of breakeven and profitability as early as 2027 [6][7] - The company anticipates receiving $2.25 billion in cash from BLA approvals and license transfers to Sanofi, which includes a $1.75 billion milestone and two $25 million license transfers [39][40] Regulatory and Approval Pathways - Novavax is in discussions with the FDA regarding post-marketing commitments, which are expected to be less stringent than requirements, allowing for potential approval in the near term [9][10][14] - The company has a robust dataset from a placebo-controlled trial involving 30,000 individuals for its COVID vaccine, Nuvaxavid, supporting its approvability [17][18] Market Dynamics and Vaccine Strategy - The company is observing a shift in consumer choice towards vaccines with better tolerability, which could favor Novavax's offerings [58][59] - The COVID vaccine market is expected to grow significantly, with Novavax aiming to capture a substantial share through its innovative technology and partnerships [77] Partnerships and Collaborations - Novavax has expanded its partnership with Sanofi and signed new agreements with top pharmaceutical companies to explore the utility of its Matrix M adjuvant in various vaccine platforms [4][48][50] - The updated agreement with Takeda includes a $20 million upfront payment and a shift to a traditional royalty model, enhancing the partnership's economic viability [44][46] Future Outlook - The company is focused on reducing liabilities and costs, aiming for an 80-85% reduction in R&D and SG&A expenses by 2027, which will enable a stronger focus on value creation [76][77] - Novavax is positioned to capitalize on the growing vaccine market, projected to increase from $50 billion to $75 billion, leveraging its technology across multiple vaccine categories [77] Additional Insights - The company is actively monitoring the evolving landscape of COVID variants and the need for seasonal vaccine updates, which is critical for maintaining market relevance [26][28] - Novavax's strategy includes developing combination vaccines and exploring new markets, such as oncology, to diversify its product offerings [48][52] Conclusion - Novavax is strategically positioned for growth through innovative partnerships, a strong pipeline, and a focus on cost reduction, aiming to capture a significant share of the expanding vaccine market while ensuring product safety and efficacy.

Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, but may initiate a beneficial Long position through a purchase of the stock, or the purchase of call options or similar derivatives in NVAX over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. Seeking ...

分组1 - Zacks Premium offers various tools for investors to enhance their stock market strategies, including daily updates and access to research reports [1][2] - The Zacks Style Scores categorize stocks into Value, Growth, Momentum, and VGM Scores, helping investors identify stocks with the potential to outperform the market [2][3][6] 分组2 - The Value Score identifies attractive stocks based on valuation ratios like P/E and Price/Sales, appealing to value investors [3] - The Growth Score focuses on a company's future prospects by analyzing earnings, sales, and cash flow, targeting growth investors [4] - The Momentum Score helps investors capitalize on price trends, using metrics like weekly price changes and monthly earnings estimate changes [5] 分组3 - The Zacks Rank is a proprietary model that uses earnings estimate revisions to assist in stock selection, with 1 (Strong Buy) stocks achieving an average annual return of +25.41% since 1988 [7][8] - Investors are encouraged to consider stocks with a Zacks Rank of 1 or 2 and Style Scores of A or B for optimal investment success [10][11] 分组4 - Novavax, Inc. is a biotechnology company focused on developing vaccines for infectious diseases, currently holding a Zacks Rank of 3 (Hold) and a VGM Score of B [12] - The company has seen a 22.7% increase in share price over the past four weeks, with positive earnings estimate revisions for fiscal 2025 [13]

Core Viewpoint - Novavax reported a significant turnaround in its financial performance for Q1 2025, with earnings per share of $2.93, surpassing expectations and showing a substantial increase in revenue driven by product sales, particularly from COVID-19 vaccine agreements [1][2][7]. Financial Performance - Earnings per share for Q1 2025 were $2.93, compared to a loss of $1.05 per share in the same quarter last year [1]. - Quarterly revenues reached $667 million, a significant increase from $94 million in the prior year, exceeding the consensus estimate of $212 million [1]. - Product sales amounted to $622 million, up from $90 million year-over-year, primarily driven by $608 million from the COVID-19 vaccine Nuvaxovid [1][2]. Revenue Drivers - The increase in product sales was largely attributed to $603 million recognized from the termination of advanced purchase agreements (APAs) with Canada and New Zealand [2]. - Licensing, royalties, and other revenues totaled $45 million, up from $4 million in the previous year, mainly due to $40 million from Sanofi related to upfront payments and milestone amortization [3]. Cost Management - Research and development (R&D) expenses were $89 million, down 4% year-over-year, reflecting reduced expenditures on COVID-19 vaccine development [4]. - Selling, general, and administrative (SG&A) expenses decreased by 45% to $48 million, attributed to lower commercialization activities and cost-reduction efforts [4]. Cash Position - As of March 31, 2025, Novavax had $747 million in cash and cash equivalents, down from $938 million at the end of 2024 [5]. Future Guidance - Novavax has raised its adjusted revenue guidance for 2025 to between $975 million and $1.03 billion, significantly higher than the previous estimate of $300-$350 million [7]. - The company reaffirmed its full-year projection for combined R&D and SG&A expenses in the range of $475-$525 million [8]. Pipeline and Regulatory Updates - Novavax expects FDA approval for its COVID-19 vaccine regulatory filing and is in discussions to finalize study parameters for post-marketing commitments [9]. - The transfer of marketing authorization to Sanofi for the U.S. and EU markets is anticipated in Q4 2025, which will trigger additional milestone payments [10]. - The company has improved its partnership terms with Takeda Pharmaceuticals, receiving a $20 million upfront payment and potential future payments tied to vaccine sales [11]. Strategic Collaborations - Novavax has expanded its partnership with a top-tier pharmaceutical company to utilize its Matrix-M adjuvant and entered a preclinical collaboration for cancer vaccine development [12]. - The company initiated a late-stage program for a combination vaccine targeting influenza and COVID-19, with initial data expected in mid-2025 [13].

Core Viewpoint - Novavax Inc. reported significant growth in first-quarter 2025 sales, driven by the termination of Advance Purchase Agreements and increased product sales, indicating a positive turnaround for the company [1][4]. Financial Performance - First-quarter 2025 sales reached $667 million, a substantial increase from $94 million in the same period last year, surpassing the consensus estimate of $343.85 million [1]. - Earnings per share for the quarter were $2.93, a recovery from a loss of $1.05, exceeding Wall Street's estimate of 71 cents [3]. - Nuvaxovid sales amounted to $608 million, up from $82 million a year ago [4]. Revenue Breakdown - Licensing, Royalties, & Other Revenue for the first quarter was $45 million, boosted by $40 million from Sanofi related to upfront payments and milestone amortization [2]. - Cost of sales decreased to $14 million from $59 million year-over-year, while R&D expenses were reduced to $89 million from $93 million [5]. - SG&A expenses fell to $48 million from $87 million, reflecting cost reduction efforts [5]. Cash Position and Guidance - As of March 31, 2025, cash and equivalents stood at $747 million, down from $938 million at the end of 2024 [6]. - For 2025, Novavax anticipates adjusted total revenue between $975 million and $1.025 billion, significantly higher than the previous range of $300 million-$350 million [7]. Strategic Focus - The company is focused on optimizing its partnership with Sanofi, advancing new and existing partnership opportunities, and developing its early-stage organic pipeline [4]. - Novavax has transitioned lead commercial responsibility of Nuvaxovid to Sanofi for select markets starting with the 2025-2026 vaccination season [6]. Regulatory Outlook - Novavax believes its Biologics License Application is approvable based on discussions with the FDA, although there has been a delay in full approval [8]. Market Reaction - Following the earnings report, NVAX stock increased by 16.10%, reaching $6.91 [8].

Financial Performance - Novavax reported quarterly earnings of $2.93 per share, significantly exceeding the Zacks Consensus Estimate of $0.71 per share, and compared to a loss of $1.05 per share a year ago, representing an earnings surprise of 312.68% [1] - The company posted revenues of $666.66 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 215.04%, and compared to year-ago revenues of $93.86 million [2] Market Performance - Novavax shares have declined approximately 26% since the beginning of the year, while the S&P 500 has decreased by 4.3% [3] - The current consensus EPS estimate for the upcoming quarter is $0.07 on revenues of $149.29 million, and for the current fiscal year, it is $0.84 on revenues of $633.26 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Novavax belongs, is currently ranked in the top 33% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Novavax's stock performance [5]

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]

Financial Performance - Total revenue for Q1 2025 reached $667 million[23], a significant increase compared to $94 million in Q1 2024[27] - Nuvaxovid sales contributed $608 million[27] to the total revenue, including $603 million related to the termination of two APAs[30] - The company reported a net income of $519 million[31] in Q1 2025, a substantial turnaround from a net loss of $148 million in Q1 2024[31] - Combined R&D and SG&A expenses decreased by 24% to $137 million in Q1 2025, compared to $180 million in Q1 2024[32] - Current liabilities were reduced by $732 million in Q1 2025[23], resulting in a current liability balance of $0.4 billion[34] Strategic Priorities and Partnerships - The company is prioritizing its partnership with Sanofi[11], expecting up to $225 million in milestones in 2025[25] - Adjusted total revenue for full year 2025 is projected to be between $975 million and $1025 million[42] - Adjusted licensing, royalties, and other revenue are expected to be between $345 million and $380 million[42], including $225 million in U S BLA & Marketing Authorizations Milestones[44] R&D and Pipeline - The company's Matrix-M adjuvant has a favorable reactogenicity profile, supported by over 60 publications[14] - Nuvaxovid recipients experienced approximately 39% fewer symptoms on average compared to mRNA vaccines[18] - The company is diversifying its R&D pipeline, including combination vaccines for COVID-19 and seasonal influenza (CIC)[21]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (State or other jurisdiction of incorporation or organization) Delaware 22-2816046 (I.R.S. Employer Identification No.) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File No. 000-26 ...