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NOVAVAX INC (NVAX)·Q2 2025 Earnings Summary
Executive Summary
- Q2 2025 revenue of $239.2M and diluted EPS of $0.62 materially beat S&P Global consensus of $165.0M revenue and $0.06 EPS, driven by a $175M BLA-triggered Sanofi milestone and lower OpEx; management reiterated majority of remaining FY25 adjusted revenue will land in Q4 . Revenue*, EPS*
- Full-year revenue framework raised to $1.00–$1.05B (from $975M–$1.025B) and combined R&D+SG&A guidance increased to $495–$545M (from $475–$525M) to incorporate the FDA postmarketing commitment (PMC) study with 70% Sanofi reimbursement offset .
- BLA approval for Nuvaxovid (U.S.)—the only recombinant protein, non‑mRNA COVID vaccine—triggered the $175M milestone; U.S./EU marketing authorization transfers in Q4 are expected to add $50M in milestones; cash/marketable securities/restricted cash were $628M at 6/30 (pre-collection of the $175M cash) .
- Stock reaction catalysts: visible beat vs. estimates*, raised revenue framework, confirmation of PMC cost coverage by Sanofi, and later in the quarter a debt maturity extension via convertible refinancing announced Aug 21 (reduces near‑term refinancing risk) .
What Went Well and What Went Wrong
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What Went Well
- Regulatory and partnership execution: U.S. BLA approved, triggering $175M milestone; U.S./EU authorization transfers expected in Q4 for another $50M; Sanofi assumes U.S. commercial lead for 2025–2026 season .
- Late‑stage pipeline signal: Phase 3 initial cohort for CIC and stand‑alone flu showed robust immune responses and favorable T‑cell data vs. Fluzone HD; >98% AEs mild/moderate—supportive for partnering .
- Expense discipline: SG&A down 57% YoY and combined R&D+SG&A down 41% YoY as commercialization transitioned to Sanofi and cost actions took hold; net income of $106.5M despite 42% YoY revenue decline, reflecting mix and lower OpEx .
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What Went Wrong
- Underlying product sales weak: Nuvaxovid product sales were negative ($2M) in Q2 due to U.S. closeout/returns; product sales fell 52% YoY to $11M, increasing reliance on milestone/licensing .
- Elevated FY25 OpEx guide: Combined R&D+SG&A raised by ~$20M midpoint to include PMC—while reimbursed at ~70%, gross spend still higher in-year, introducing execution and timing risk on reimbursements .
- Visibility on royalties limited: Company cannot guide Sanofi royalties or combo milestones; FY25 framework excludes these components, constraining investor visibility on sustainable revenue beyond milestones .
Financial Results
Headline vs. S&P Global Consensus (Q2 2025)
Values marked with * are from S&P Global consensus estimates.
Quarterly Trend – Revenue and Diluted EPS
YoY and Key Line Items (Q2 2025 vs Q2 2024)
Revenue Breakdown (Q2 2025 vs Q2 2024)
KPI Snapshot
Notes: Receipt of the $175M BLA milestone earned in Q2 is expected in Q3, affecting quarter-end cash timing .
Guidance Changes
PMC Study (context): 2025–2026 total cost $70–$90M, ~70% reimbursed by Sanofi; FY25 impact is +$20M revenue (reimbursement) and +$20M OpEx .
Earnings Call Themes & Trends
Management Commentary
- “This quarter we continued to progress our growth strategy with key achievements including BLA approval for our COVID-19 vaccine, positive data from our COVID-19‑Influenza‑Combination and stand‑alone influenza programs, advancement of our early-stage pipeline, and progression of our partnership strategy.” — John C. Jacobs, CEO .
- “We ended the second quarter with over $850 million in cash and receivables, including the $175 million milestone payment from Sanofi… We are raising our prior revenue framework and now expect to achieve adjusted total revenue of between $1,000,000,000 and $1,050,000,000.” — Jim Kelly, CFO .
- “The PMC study is anticipated to occur during 2025 and 2026 with a total cost of between 70 and 90 million. Novavax will conduct this study on behalf of Sanofi, and Novavax will be reimbursed 70% of total cost.” — Jim Kelly, CFO .
- “We’re applying AI‑driven insights to accelerate candidate development… exploring new formulations and additional ideas to unlock Matrix‑M’s full value.” — John C. Jacobs, CEO .
Q&A Highlights
- Fall readiness: BLA approved for JN.1; filings focused on improving shelf‑life (aiming ≥6 months) for the season; Sanofi leads commercialization .
- CIC/Flu partnering: Active discussions with multiple potential partners; descriptive Phase 3 cohort data (immunogenicity/safety) intended to inform registrational design with partner .
- PMC details and financials: Size ~$70–$90M over 2025–2026; ~70% reimbursed; no anticipated impact on 2025–2026 operating profit profile per management .
- Profitability path: Potential non‑GAAP profitability as early as 2027; CFO outlined breakeven math under Sanofi royalty rates and/or combo launch milestone ($225M) .
- Platform optionality: Oncology MTAs progressing; goal is partnering/royalty model rather than internal heavy spend .
Estimates Context
- Q2 2025 results vs S&P Global: Revenue $239.24M vs $165.01M*; diluted EPS $0.62 vs $0.056*—both beats, driven by $175M Sanofi milestone and lower OpEx .
- Prior quarter context: Q1 2025 revenue $666.66M vs $343.85M*; EPS $2.93 vs $1.41*—both beats, largely due to APA terminations ($603M recognized) .
- FY 2025/2026 consensus: FY25 revenue $1.0627B*, EPS $2.04*; FY26 revenue $441.94M*, EPS $(0.45)*—FY25 aligns with raised framework ($1.00–$1.05B), FY26 reflects uncertainty on sustainable royalties/milestones .
Values marked with * are from S&P Global consensus estimates.
Key Takeaways for Investors
- Q2 beat on both revenue and EPS vs consensus*, underpinned by milestone recognition; momentum sustained by raised FY25 revenue framework .
- BLA approval de‑risks U.S. commercial path and unlocks milestones/royalties; Sanofi leadership should reduce OpEx volatility and improve execution .
- Near‑term revenue composition remains milestone‑heavy (e.g., $225M BLA/MAH milestones in FY25) with limited visibility on royalties, but PMC reimbursements mitigate gross OpEx uptick .
- CIC/Flu immunogenicity/T‑cell data are supportive for a partner‑funded registrational path—an upside option on medium‑term milestone/royalty streams .
- Capital structure improved post‑quarter with convert maturity extension to 2031 and ~$50M new cash, reducing refinancing risk .
- Trading lens: Positive estimate revisions likely for Q2 actuals and FY25 framework; watch for Q4 revenue weighting, Q3 cash inflow from $175M milestone, and Q4 MAH milestones ($50M) as catalysts .
Appendix: Additional Relevant Press Releases in/around Q2 2025
- U.S. BLA approval (May 19): $175M milestone; PMC requested; readiness for 2025–2026 season .
- CIC/Flu Phase 3 initial cohort (June 11): Robust immunogenicity; well tolerated; informs registrational design .
- Takeda agreement (May 5): Improved Japan terms incl. upfront, annual milestones, royalties .
Values marked with * are from S&P Global.