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].

GAITHERSBURG, Md., Aug. 21, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced that it has entered into privately negotiated agreements with certain of the holders of its existing 5.00% Convertible Senior Notes due 2027 (the "2027 Notes") and new investors, pursuant to which the Company will issue $225 million aggregate principal amount of its 4.625% Convertible Senior Notes due 2031 (the "2031 Notes") consisting of (i) approximately $175.3 million principal amount of 2031 Notes issued in exc ...

(相关资料图) 美银将诺瓦瓦克斯医药的目标价从9美元下调至7美元，评级从"中性"下调至"跑输大市"。(格隆汇) 相关事件 美银下调诺瓦瓦克斯医药目标价至7美元花旗首予诺瓦瓦克斯医药"卖出"评级及目标价6美元 标签： ...

美银将诺瓦瓦克斯医药的目标价从9美元下调至7美元，评级从"中性"下调至"跑输大市"。(格隆汇) ...

Core Insights - Novavax (NVAX) reported Q2 2025 earnings per share (EPS) of 62 cents, surpassing the Zacks Consensus Estimate of a loss of seven cents, but down 37% year over year [1] - Quarterly revenues were $239 million, a 42% decline year over year, yet exceeded the Zacks Consensus Estimate of $118 million [1] Revenue Breakdown - Product sales amounted to $11 million, down from $23 million in the previous year, including a net reversal of $2 million in sales of the COVID vaccine Nuvaxovid [2] - Licensing, royalties, and other revenues totaled $228.5 million, which included a $175 million milestone payment from Sanofi following FDA approval of Nuvaxovid, but this figure also declined 42% year over year due to a prior $391 million upfront payment from Sanofi [3] Strategic Developments - Sanofi acquired exclusive global marketing rights for Nuvaxovid, with Novavax transitioning commercial leadership to Sanofi for the 2025-2026 vaccination season [4] - Shares of Novavax rose nearly 13% following this transition, as Sanofi's established distribution network is expected to enhance the marketing of Nuvaxovid [5] Financial Guidance - Novavax raised its 2025 adjusted revenue forecast to $1 billion to $1.05 billion, up from a previous estimate of $0.98 billion to $1.03 billion, largely due to Sanofi cost reimbursements [7][10] - The company also increased its combined R&D and SG&A expense projections to $495 million to $545 million, up from $475 million to $525 million [11] Cost Management - R&D expenses for the quarter were $79 million, down 26% year over year, attributed to reduced expenditures related to COVID vaccine development [8] - SG&A expenses decreased 57% year over year to $44 million, influenced by the transition of commercial activities to Sanofi and ongoing cost reduction efforts [9] Pipeline Updates - Novavax reported promising initial data from a late-stage study on its COVID-influenza combination vaccine and standalone influenza vaccine candidates, showing robust immune responses [12] - The company plans to initiate a post-marketing commitment study later this year, expecting to incur costs of $70 million to $90 million, with 30% reimbursed by Sanofi [14] Collaborations and Agreements - Novavax entered into material transfer agreements with three unnamed pharmaceutical companies to explore the utility of its patented Matrix-M [15]

Group 1 - Novavax reported quarterly earnings of $0.62 per share, exceeding the Zacks Consensus Estimate of a loss of $0.07 per share, representing an earnings surprise of +985.71% [1] - The company posted revenues of $239.24 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 102.74%, compared to year-ago revenues of $415.48 million [2] - Novavax has consistently surpassed consensus EPS estimates over the last four quarters [2] Group 2 - The stock has underperformed the market, losing about 16.3% since the beginning of the year, while the S&P 500 has gained 7.1% [3] - The company's earnings outlook will be crucial for future stock performance, with current consensus EPS estimates at -$0.22 for the coming quarter and $2.54 for the current fiscal year [4][7] - The Zacks Industry Rank indicates that the Medical - Biomedical and Genetics sector is currently in the bottom 42% of over 250 Zacks industries, which may impact stock performance [8]

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]

Financial Performance - Total revenue for Q2 2025 was $239 million, a 42% decrease compared to $415 million in Q2 2024[32] - Licensing, royalties, and other revenue amounted to $229 million in Q2 2025, a 42% decrease from $393 million in Q2 2024[32] - Product sales were $11 million in Q2 2025, a 52% decrease compared to $23 million in Q2 2024[32] - Combined R&D and SG&A expenses decreased by 41% in Q2 2025 compared to Q2 2024[26,39] - SG&A expenses decreased by 57% in Q2 2025 as the company transitions lead global commercial leadership to Sanofi[26,39] - The company had combined cash and accounts receivable of $854 million as of June 30, 2025, including $628 million in cash[28] and $226 million in accounts receivable[28] Strategic Updates - The company is prioritizing the Sanofi partnership and seeking additional partnerships to leverage its technology platform and pipeline[10] - The company anticipates receiving up to $50 million in Sanofi milestones in the fourth quarter of 2025[29] - The company updated its full-year 2025 guidance to incorporate the Nuvaxovid postmarketing commitment (PMC) study[27] Pipeline Development - The company intends to partner both the COVID-Influenza Combination (CIC) vaccine and stand-alone flu vaccine candidates, with ongoing discussions with potential partners[18] - Pre-clinical H5N1 data was published in Nature Communications, highlighting robust immune responses after a single or two-dose administration[19] Financial Outlook - The company expects adjusted total revenue for full year 2025 to be between $1 billion and $105 billion[46] - The company is targeting combined R&D and SG&A expenses less partner reimbursement of approximately $350 million in 2026 and $250 million in 2027[45]

[Q2 2025 Financial Results and Operational Highlights](index=1&type=section&id=Novavax%20Reports%20Second%20Quarter%202025%20Financial%20Results%20and%20Operational%20Highlights) [Operational Highlights and Strategic Priorities](index=1&type=section&id=Second%20Quarter%202025%20and%20Recent%20Highlights) Novavax achieved FDA **BLA approval** for **Nuvaxovid**, triggering a **$175 million Sanofi milestone**, and advanced its vaccine pipeline - Received FDA **Biologics License Application (BLA) approval** for **Nuvaxovid™**, its protein-based, non-mRNA COVID-19 vaccine, for individuals aged 12 and older at high risk[5](index=5&type=chunk)[6](index=6&type=chunk) - The BLA approval triggered a **$175 million milestone payment** from partner Sanofi[5](index=5&type=chunk)[6](index=6&type=chunk) - Completed the **transition of Nuvaxovid™ commercial leadership** in the U.S. to Sanofi for the 2025-2026 vaccination season[5](index=5&type=chunk)[9](index=9&type=chunk) - Reported **robust immune responses** in a **Phase 3 trial** for its COVID-19-Influenza-Combination (CIC) and stand-alone influenza vaccine candidates, with T-cell responses numerically higher than the comparator, Fluzone HD[5](index=5&type=chunk)[9](index=9&type=chunk) - Announced **positive preclinical data** for its **H5N1 avian pandemic influenza vaccine** candidate, which was published in Nature Communications[8](index=8&type=chunk) - The R21/Matrix-M malaria vaccine, developed in partnership, has sold **20 million doses** since its launch in mid-2024[9](index=9&type=chunk) [Second Quarter 2025 Financial Results](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Results) Novavax reported $239 million in Q2 2025 revenue, a 42% decrease, with net income of $107 million and reduced operating expenses Q2 2025 Revenue Breakdown ($ in millions) | Revenue Source | Q2 2025 | Q2 2024 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Product Sales | $11 | $23 | ($12) | (52)% | | Licensing, Royalties and Other | $229 | $393 | ($164) | (42)% | | **Total Revenue** | **$239** | **$415** | **($176)** | **(42)%** | Q2 2025 Key Financial Metrics ($ in millions) | Metric | Q2 2025 | Q2 2024 | % Change | | :--- | :--- | :--- | :--- | | Total Revenue | $239 | $415 | (42)% | | Cost of Sales | $15 | $46 | (67)% | | R&D Expenses | $79 | $107 | (26)% | | SG&A Expenses | $44 | $101 | (57)% | | **Net Income** | **$107** | **$162** | **(34)%** | - Cash, cash equivalents, marketable securities, and restricted cash totaled **$628 million** as of June 30, 2025, compared to **$938 million** at the end of 2024[17](index=17&type=chunk) - The **$175 million milestone payment** from Sanofi, earned in Q2 2025, is expected to be received in Q3 2025[17](index=17&type=chunk) [Condensed Consolidated Statements of Operations](index=12&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) Novavax reported Q2 2025 total revenues of $239.2 million and net income of $106.5 million, or $0.62 per diluted share Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Total Revenue | $239,240 | $415,484 | | Total Expenses | $138,170 | $254,486 | | Income from Operations | $101,070 | $160,998 | | **Net Income** | **$106,508** | **$162,381** | | **Diluted Net Income per Share** | **$0.62** | **$0.99** | [Selected Consolidated Balance Sheet Data](index=13&type=section&id=SELECTED%20CONSOLIDATED%20BALANCE%20SHEET%20DATA) As of June 30, 2025, Novavax's total assets were $1.34 billion, with stockholders' equity turning positive to $37.6 million Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $253,744 | $530,230 | | Total Assets | $1,336,549 | $1,560,418 | | Working Capital | $530,374 | ($25,474) | | Total stockholders' equity (deficit) | $37,625 | ($623,841) | [Full Year 2025 Financial Framework and Guidance](index=5&type=section&id=Full%20Year%202025%20Financial%20Framework) Novavax updated its FY2025 outlook, raising Adjusted Total Revenue guidance to $1.0-$1.05 billion and increasing R&D/SG&A expenses Updated Full Year 2025 Revenue Framework ($ in millions) | Metric | FY 2025 Guidance (Aug 6) | FY 2025 Guidance (May 8) | | :--- | :--- | :--- | | Nuvaxovid Product Sales | $610 | $610 | | Adjusted Supply Sales | $25 - $40 | $20 - $35 | | Adjusted Licensing, Royalties & Other | $365 - $400 | $345 - $380 | | **Adjusted Total Revenue** | **$1,000 - $1,050** | **$975 - $1,025** | Updated Full Year 2025 Expense Guidance ($ in millions) | Metric | FY 2025 Guidance (Aug 6) | FY 2025 Guidance (May 8) | | :--- | :--- | :--- | | Combined R&D and SG&A Expenses | $495 - $545 | $475 - $525 | - The company will conduct a postmarketing commitment (PMC) study for Nuvaxovid at an estimated cost of **$70-$90 million**, of which Sanofi will reimburse approximately 70% (**~$55 million**)[16](index=16&type=chunk) - The revenue framework **excludes potential Sanofi Supply Sales, Royalties** (high teens to low twenties percent), and milestones related to the Influenza-COVID-19 combination product (up to **$350M**) and new Matrix-M vaccines (up to **$200M each**)[22](index=22&type=chunk) [Supplementary Information](index=9&type=section&id=Supplementary%20Information) This section provides conference call details, a corporate overview, and disclaimers on non-GAAP measures and forward-looking statements - Provides details for the **quarterly conference call and webcast** for investors[24](index=24&type=chunk)[25](index=25&type=chunk) - Explains the use of **non-GAAP financial measures** like Adjusted Total Revenue and notes the **inability to reconcile forward-looking guidance to GAAP measures** due to reliance on Sanofi sales forecasts[27](index=27&type=chunk)[28](index=28&type=chunk) - Includes a standard **Forward-Looking Statements section** cautioning investors about **numerous risks and uncertainties** that could cause actual results to differ from those projected[29](index=29&type=chunk)[30](index=30&type=chunk)

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This part presents the company's unaudited financial statements, management's analysis, and key risk disclosures for the period [Item 1. Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Consolidated%20Financial%20Statements) The company reported significant H1 2025 net income driven by APA terminations, leading to a positive shift in stockholders' equity [Consolidated Statements of Operations](index=4&type=section&id=Consolidated%20Statements%20of%20Operations) | Financial Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | H1 2025 (in thousands) | H1 2024 (in thousands) | | :--- | :--- | :--- | :--- | :--- | | **Total Revenue** | $239,240 | $415,484 | $905,895 | $509,339 | | **Total Expenses** | $138,170 | $254,486 | $289,311 | $493,172 | | **Income from Operations** | $101,070 | $160,998 | $616,584 | $16,167 | | **Net Income** | $106,508 | $162,381 | $625,154 | $14,831 | | **Diluted EPS** | $0.62 | $0.99 | $3.55 | $0.10 | - Net income for the first six months of 2025 surged to **$625.2 million**, a substantial increase from **$14.8 million** in the same period of 2024, primarily driven by higher revenue[13](index=13&type=chunk) - Total expenses **decreased significantly** in both the three-month and six-month periods of 2025 compared to 2024, reflecting successful cost control measures[13](index=13&type=chunk) [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) | Balance Sheet Item | June 30, 2025 (in thousands) | Dec 31, 2024 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $253,744 | $530,230 | | Marketable securities | $358,560 | $392,888 | | **Total Current Assets** | $919,512 | $1,128,942 | | **Total Assets** | $1,336,549 | $1,560,418 | | Deferred revenue (Current) | $113,763 | $675,067 | | **Total Liabilities** | $1,298,924 | $2,184,259 | | **Total Stockholders' Equity (Deficit)** | $37,625 | ($623,841) | - The company's financial position improved significantly, with total stockholders' equity becoming positive at **$37.6 million** as of June 30, 2025, compared to a deficit of **$623.8 million** at the end of 2024[17](index=17&type=chunk) - Total liabilities saw a substantial decrease to **$1.30 billion** from **$2.18 billion**, primarily due to a reduction in deferred revenue from **$1.12 billion** to **$0.51 billion**[17](index=17&type=chunk)[48](index=48&type=chunk) [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) | Cash Flow Activity | H1 2025 (in thousands) | H1 2024 (in thousands) | | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | ($312,964) | $230,714 | | Net cash provided by (used in) investing activities | $37,779 | ($379,957) | | Net cash (used in) provided by financing activities | ($8,101) | $264,102 | | **Net (decrease) in cash, cash equivalents, and restricted cash** | **($276,310)** | **$111,748** | - There was a significant negative swing in operating cash flow, with a net cash use of **$313.0 million** in H1 2025 compared to a net cash provision of **$230.7 million** in H1 2024[22](index=22&type=chunk) [Notes to the Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20the%20Consolidated%20Financial%20Statements) Notes detail the strategic focus on the Sanofi partnership, revenue from APA terminations, and the basis for the going concern assumption - The company's three strategic priorities are: focusing on the Sanofi partnership, enhancing existing partnerships and forging new ones, and advancing its technology platform and early-stage pipeline[25](index=25&type=chunk) - Based on its current cash balance and cash flow forecast, management has concluded that the company has **sufficient capital to fund operations for at least one year** from the financial statement issuance date, supporting the going concern assumption[34](index=34&type=chunk) - In H1 2025, the company recognized **$575.7 million** in product sales revenue from the termination of the Canada APA and **$27.3 million** from the termination of the New Zealand APA[60](index=60&type=chunk)[61](index=61&type=chunk) - The company continued its global restructuring plan, recording charges of **$5.1 million** in H1 2025 for severance and asset impairments, as part of its effort to improve operational efficiency[111](index=111&type=chunk)[113](index=113&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes improved H1 2025 results to APA terminations and outlines its strategic focus on the Sanofi partnership and pipeline advancement [Overview and Pipeline](index=33&type=section&id=Overview%20and%20Pipeline) - The company's strategy is centered on three priorities: the Sanofi partnership, leveraging its technology platform for new partnerships, and advancing its early-stage pipeline through a lean operating model[126](index=126&type=chunk) - In May 2025, the FDA approved the Biologics License Application (BLA) for Nuvaxovid, triggering a **$175 million milestone payment** from Sanofi[137](index=137&type=chunk)[158](index=158&type=chunk) - Novavax intends to partner its late-stage COVID-Influenza Combination (CIC) and stand-alone influenza vaccine candidates to advance further development after a Phase 3 trial showed robust immune responses[130](index=130&type=chunk)[151](index=151&type=chunk) - The early-stage pipeline is being advanced with a capital-efficient approach, focusing on RSV combinations, H5N1 avian pandemic influenza, shingles, and C. Diff, with the intent to partner these programs at proof of concept[132](index=132&type=chunk)[142](index=142&type=chunk) [Results of Operations](index=40&type=section&id=Results%20of%20Operations) Three Months Ended June 30, 2025 vs 2024 (in thousands) | Item | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | **Total Revenue** | $239,240 | $415,484 | ($176,244) | | Cost of Sales | $15,325 | $46,242 | ($30,917) | | R&D Expenses | $79,233 | $106,946 | ($27,713) | | SG&A Expenses | $43,612 | $101,298 | ($57,686) | | **Net Income** | $106,508 | $162,381 | ($55,873) | - The decrease in Q2 2025 revenue was primarily due to **lower licensing revenue** from the Sanofi CLA compared to the prior year, which included a large upfront fee recognition[167](index=167&type=chunk)[170](index=170&type=chunk) Six Months Ended June 30, 2025 vs 2024 (in thousands) | Item | H1 2025 | H1 2024 | Change | | :--- | :--- | :--- | :--- | | **Total Revenue** | $905,895 | $509,339 | $396,556 | | Cost of Sales | $29,439 | $105,451 | ($76,012) | | R&D Expenses | $168,170 | $199,625 | ($31,455) | | SG&A Expenses | $91,702 | $188,096 | ($96,394) | | **Net Income** | $625,154 | $14,831 | $610,323 | - The substantial increase in H1 2025 revenue was driven by the recognition of **$603 million** from the termination of the Canada and New Zealand APAs[185](index=185&type=chunk) [Liquidity Matters and Capital Resources](index=49&type=section&id=Liquidity%20Matters%20and%20Capital%20Resources) - As of June 30, 2025, the company had **$627.5 million** in cash, cash equivalents, restricted cash, and marketable securities[215](index=215&type=chunk) - The company expects to receive a **$175.0 million milestone payment** from Sanofi in Q3 2025, which was triggered by the FDA's BLA approval[203](index=203&type=chunk)[215](index=215&type=chunk) - Under the Sanofi CLA, Novavax is eligible for up to **$475 million** in remaining aggregate milestone payments related to COVID-19 and combination vaccine products[203](index=203&type=chunk)[204](index=204&type=chunk) - The company has remaining obligations of **$222.1 million** under various APAs, with a risk that up to **$92.5 million** under the Australia APA may become refundable[212](index=212&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=53&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risks stem from foreign currency fluctuations and interest rate movements on its investment portfolio - The company's operations are subject to foreign currency exchange rate fluctuations, primarily the U.S. dollar against the Euro, Pound Sterling, and Swedish Krona[222](index=222&type=chunk) - A **10% decline in foreign exchange rates** would result in an approximate **$16 million decline** in stockholders' equity as of June 30, 2025[223](index=223&type=chunk) - Interest rate risk is primarily confined to the company's investment portfolio, and the company does not believe it has material exposure from its fixed-rate convertible notes[225](index=225&type=chunk)[227](index=227&type=chunk) [Item 4. Controls and Procedures](index=54&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective and noted no material changes to internal controls - As of June 30, 2025, the CEO and CFO concluded that the company's disclosure controls and procedures were **effective at the reasonable assurance level**[228](index=228&type=chunk) - There were **no material changes** to the company's internal control over financial reporting during the quarter ended June 30, 2025[229](index=229&type=chunk) [PART II. OTHER INFORMATION](index=54&type=section&id=PART%20II.%20OTHER%20INFORMATION) This part details legal proceedings, risk factors, and other required corporate disclosures [Item 1. Legal Proceedings](index=54&type=section&id=Item%201.%20Legal%20Proceedings) The company has resolved significant stockholder class action and derivative lawsuits, resulting in dismissals and a net settlement gain - The Sinnathurai securities class action was settled, and the case was **closed by the court in May 2024**[102](index=102&type=chunk)[231](index=231&type=chunk) - A settlement was reached in the consolidated derivative lawsuits, which was approved by the court in March 2025, including a **$6.8 million payment to Novavax** and the adoption of new governance measures, resulting in a net gain of **$4.8 million**[104](index=104&type=chunk)[233](index=233&type=chunk) - Following the main derivative settlement, the Mesa and Acosta actions in Delaware were dismissed with prejudice in May and July 2025, and the Kirst and Needelman actions in Maryland were dismissed in April 2025[107](index=107&type=chunk)[109](index=109&type=chunk)[236](index=236&type=chunk)[238](index=238&type=chunk) [Item 1A. Risk Factors](index=56&type=section&id=Item%201A.%20Risk%20Factors) Key risks include contractual obligations, the transition to a commercial COVID-19 market, regulatory changes, and vaccine shelf-life approval - The company faces risks in satisfying performance obligations under its Sanofi CLA and APAs, with up to **$92.5 million** of deferred revenue from the Australia APA potentially refundable if regulatory deadlines are not met[241](index=241&type=chunk)[244](index=244&type=chunk) - There is significant uncertainty regarding pricing and reimbursement as the COVID-19 vaccine market **shifts from government purchasing to a commercial model**, which could be adversely affected by changes in recommendations from bodies like the ACIP[245](index=245&type=chunk)[250](index=250&type=chunk) - The company faces regulatory uncertainty due to the **change in presidential administration**, which could lead to adverse changes in vaccine recommendations by the CDC and ACIP, potentially reducing demand for its COVID-19 vaccine[248](index=248&type=chunk)[260](index=260&type=chunk) - A key commercial risk is the pending FDA approval to **extend the shelf life of its COVID-19 vaccine from three to six months**, as the current shelf life is unlikely to be commercially attractive[253](index=253&type=chunk) [Item 5. Other Information](index=61&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during the second quarter of 2025 - No director or officer adopted or terminated a Rule 10b5-1 trading plan during the three months ended June 30, 2025[261](index=261&type=chunk) [Item 6. Exhibits](index=62&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the report, including officer certifications and material agreements