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NOVAVAX INC (NVAX)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 revenue was $70.4M and diluted EPS was -$1.25; revenue beat consensus by ~$28.9M while EPS missed by ~$0.12 as non-cash charges (asset impairment and debt extinguishment) weighed on GAAP results . Consensus EPS -$1.13*, revenue $41.6M*.
  • Licensing/royalty revenue ($57.0M) was driven by Sanofi R&D reimbursement ($46M) and nascent royalties ($4M) as Sanofi recorded $23M in Nuvaxovid sales; product sales were $13.4M (supply to partners) as commercial lead shifted to Sanofi .
  • Raised FY2025 Adjusted Total Revenue to $1.04–$1.06B and tightened cost guidance; affirmed non-GAAP combined R&D+SG&A ~$450M midpoint net of partner reimbursements .
  • Strategic catalysts: $50M MAH transfer milestones achieved in Q4; $75M tech-transfer milestone expected in Q4 2026; Sanofi’s positive Phase 1/2 KICK data and regulatory interactions; site consolidation adds $60M cash and ~$230M expected savings over 11 years .
  • Management now targets potential non-GAAP profitability as early as 2028 (from 2027) given partner timelines; royalties expected to grow materially in the 2026–2027 season under Sanofi .

What Went Well and What Went Wrong

  • What Went Well

    • Execution on Sanofi partnership: all 2025 milestones achieved ($225M YTD), including $50M for U.S. and EU marketing authorization transfers; early positive Phase 1/2 KICK data reported by Sanofi .
    • Cost discipline and footprint optimization: SG&A down 55% YoY; Maryland site consolidation drives $60M cash and ~$230M future savings; CFO highlighted transition to lean model .
    • Pipeline momentum: R&D updates on shingles, C. diff, RSV combo, pandemic flu; T-cell data for CIC and stand-alone flu numerically higher vs Fluzone HD in initial cohort; BARDA support for Sanofi’s pandemic flu program using Matrix‑M .
  • What Went Wrong

    • GAAP loss driven by non-cash charges: $97M impairment (site consolidation) and $29M loss on debt extinguishment; net loss widened to -$202.4M vs -$121.3M YoY .
    • Product sales down YoY as Sanofi assumed lead commercial role; Novavax Nuvaxovid Sales were $0 vs $38M YoY; overall revenue down 18% YoY .
    • U.S. COVID market headwinds: more restrictive label for <65 as season reset; prescriptions down ~20% YoY; EPS missed consensus .

Financial Results

MetricQ1 2025Q2 2025Q3 2025
Revenue ($USD)$666.7M $239.2M $70.4M
Net Income ($USD)$518.6M $106.5M -$202.4M
Diluted EPS ($USD)$2.93 $0.62 -$1.25
Revenue Consensus Mean ($USD)*$343.9M$165.0M$41.6M
Primary EPS Consensus Mean ($USD)*$1.41$0.06-$1.13
Primary EPS - # of Estimates*334
Revenue - # of Estimates*457
  • Q3 vs estimates: Revenue beat by ~+$28.9M; EPS missed by ~-$0.12. Q2 beat on both; Q1 beat on both. Values with asterisks retrieved from S&P Global.
Margin MetricQ1 2025Q2 2025Q3 2025
Gross Profit Margin %*84.54%66.44%-47.21%
EBIT Margin %*77.40%44.17%-112.68%
Net Income Margin %*77.80%44.52%-287.29%
  • Values with asterisks retrieved from S&P Global.

Segment revenue breakdown (YoY):

Segment ($ in millions)Q3 2024Q3 2025
Nuvaxovid Sales$38 $0
Supply Sales$3 $14
Product Sales$41 $13
Sanofi$36 $48
Takeda$5 $6
Other Partners$2 $2
Licensing, Royalties & Other$43 $57
Total Revenue$85 $70

KPIs (YoY):

KPI ($ in millions unless noted)Q3 2024Q3 2025
Cost of Sales$61 $21
R&D Expense$87 $98
R&D Reimbursed by SanofiN/A$46 (≈47% of R&D)
SG&A Expense$71 $32
Non-cash Charges (impairment + debt)N/A$126
Net Loss-$121 -$202
Cash, Cash Equivalents, Marketable Securities, Restricted CashN/A$778
Cash and Cash Equivalents$268.0
Marketable Securities$494.9
Restricted Cash$15.3

Guidance Changes

MetricPeriodPrevious Guidance (Aug 6, 2025)Current Guidance (Nov 6, 2025)Change
Combined R&D and SG&A Expenses ($M)FY 2025$495–$545 $505–$535 Narrowed/Tightened
Less: R&D Reimbursements ($M)FY 2025($45–$70) ($65–$75) Raised reimbursements
Non-GAAP Combined R&D and SG&A ($M)FY 2025$450–$475 $440–$460 Lowered
Adjusted Supply Sales ($M)FY 2025$25–$40 $35–$45 Raised
Adjusted Licensing, Royalties & Other ($M)FY 2025$365–$400 $395–$405 Raised
Nuvaxovid Product Sales ($M)FY 2025$610 $610 Maintained
Adjusted Total Revenue ($M)FY 2025$1,000–$1,050 $1,040–$1,060 Raised
Sanofi Supply Sales, Royalties, KICK/Matrix‑M MilestonesFY 2025No guidance No guidance Maintained

Note: “Adjusted Total Revenue” excludes Sanofi supply sales, royalties, and KICK/Matrix‑M milestones .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
Sanofi partnership: milestones, royalties, commercializationQ1: BLA milestone anticipated, MAH transfers and tech transfer milestones outlined . Q2: BLA approved; transition to Sanofi; PMC cost reimbursement; positive KICK cohort data; partner focus .All 2025 milestones achieved ($175M BLA + $50M MAH transfers); $4M royalties; Sanofi recorded $23M Nuvaxovid; 2026 tech transfer $75M milestone preview; royalties expected to grow in 2026–27 .Strengthening; royalty ramp expected
COVID market dynamics/policyQ1: BLA path; strain selection process noted . Q2: Shelf-life improvement filings and season readiness .U.S. label more restrictive for <65; RXs down ~20% YoY; transition year; building base for 2026–27 .Reset; cautious near term
R&D execution (shingles, C. diff, RSV combo, pandemic flu; AI/ML)Q1: Initiated 4 programs; AI/ML; tolerability data (SHIELD-Utah) . Q2: T-cell data numerically higher vs Fluzone HD; H5N1 NHP data .Continued preclinical progress; exploring Matrix‑M in oncology; government funding pursuit for pandemic flu; Fast Track combo programs at Sanofi .Building momentum
Cost structure & liquidityQ1: Combined R&D+SG&A cut; strong liquidity and liability reduction . Q2: SG&A -57% YoY .Site consolidation: $60M proceeds and ~$230M savings; convertible refinancing extends majority of 2027 notes to 2031 .Leaner, strengthened
Profitability timelineQ1: potential non-GAAP profitability as early as 2027 .Updated target to as early as 2028 given KICK timeline .Pushed out modestly

Management Commentary

  • “We have continued the steady transformation of Novavax and are proud of our progress this quarter… relaunched the Company with a focus on R&D and partnerships intended to position us well for long-term growth and profitability.” – CEO John C. Jacobs .
  • “Sanofi recorded $23 million in Nuvaxovid sales in the third quarter of 2025… Novavax has recorded $4 million in royalties related to these sales in the quarter.” – CFO Jim Kelly .
  • “In both the stand-alone flu and KICK arms, increases from baseline in influenza-specific polyfunctionally expressing CD4+ T cells were numerically higher than in the comparator Fluzone High-Dose arm.” – Head of R&D Ruxandra Draghia .
  • “We are executing toward a future for Novavax in which we have the potential to achieve non-GAAP profitability as early as 2028.” – CFO Jim Kelly .

Q&A Highlights

  • COVID season dynamics: U.S. label changes led to ~20% YoY RX decline; expectation to rebuild from reset base; Sanofi optimizing contracting and marketing for 2026 season .
  • BARDA and pandemic flu: Sanofi received BARDA grant for pandemic influenza candidate using Matrix‑M; Novavax seeking funding for its own pandemic influenza program .
  • KICK program and timelines: Positive Phase 1/2 data; Sanofi engaging regulators; KICK Phase 3 initiation timing influences profitability timeline to 2028 .
  • Tech-transfer milestone and supply sales: $75M milestone expected in Q4 2026 on manufacturing tech transfer; supply sales (COVID and Matrix‑M) intended near break-even margin to support partners and scale .
  • Shingles and tolerability: Opportunity to differentiate on reactogenicity vs Shingrix while meeting efficacy bar; preclinical comparators used; investors should watch upcoming data .

Estimates Context

  • Q3 2025: Revenue $70.4M vs consensus $41.6M* (beat); EPS -$1.25 vs -$1.13* (miss) . Values with asterisks retrieved from S&P Global.
  • Q2 2025: Revenue $239.2M vs $165.0M* (beat); EPS $0.62 vs $0.06* (beat) .
  • Q1 2025: Revenue $666.7M vs $343.9M* (beat); EPS $2.93 vs $1.41* (beat) .

Implications: Consensus likely to adjust upward on partner reimbursements and supply sales visibility but may temper near-term EPS given non-cash charges and transition-year royalties. Values with asterisks retrieved from S&P Global.

Key Takeaways for Investors

  • Near-term trading: Revenue beat driven by partner reimbursements and supply sales; EPS miss was driven by non-cash items—consider normalizing for impairment/debt extinguishment in valuation frameworks .
  • Partnership economics: Royalty streams are starting ($4M in Q3) and expected to grow materially in the 2026–2027 season; $75M tech-transfer milestone in Q4 2026 is a key catalyst .
  • Guidance tightening: FY2025 adjusted revenue raised to $1.04–$1.06B; non-GAAP combined R&D+SG&A lowered to $440–$460M, demonstrating cost control while leveraging reimbursements .
  • Structural improvements: Site consolidation delivers $60M cash and ~$230M savings; convertible refinancing extends maturities to 2031, supporting runway through transition .
  • Pipeline optionality: Multiple preclinical programs (shingles, C. diff, RSV combo, pandemic flu) plus oncology exploration may create future partnering and royalty opportunities; watch upcoming data readouts and potential deals .
  • Profitability path: Target shifted to as early as 2028, contingent on partner progress (KICK Phase 3/launch) and royalty ramp; monitor Sanofi regulatory milestones and U.S./EU commercialization updates .
  • Narrative drivers: Evidence of improved tolerability (SHIELD-Utah, T-cell data) supports positioning vs mRNA in select segments; market reset in U.S. may be a base-building year before broader royalty expansion .

Bolded surprises:

  • Revenue beat vs consensus in Q3 despite transition-year dynamics .
  • EPS miss driven by $126M non-cash charges linked to site consolidation and refinancing .

Notes: Adjusted revenue framework excludes Sanofi supply/royalties/KICK milestones; licensing revenue includes R&D reimbursements recognized as revenue (clarified on call) .