NOVAVAX INC (NVAX)·Q4 2024 Earnings Summary

Executive Summary

• Q4 2024 revenue was $88.3M, down 69.7% y/y on lower APA product sales; net loss improved to $81.0M vs $178.4M y/y, aided by a $51.9M gain on the Czech facility sale and lower OpEx . Product sales were $49.8M and licensing/other revenue $38.5M, with no grant revenue in the quarter .
• Novavax transitioned lead commercial responsibility for Nuvaxovid to Sanofi beginning with the 2025–2026 season and achieved a $50M pediatric database lock milestone in Q4; BLA PDUFA date in April 2025 would trigger a $175M milestone, with U.S./EU MA transfers later in 2025 adding two $25M milestones (total $225M) .
• 2025 guidance: Combined R&D+SG&A of $475–$525M; 2025 “Adjusted Licensing, Royalties and Other Revenue” framework of $300–$350M (excludes Sanofi royalties/CIC milestones/product sales given reliance on Sanofi forecasts) .
• Balance sheet: year-end cash, cash equivalents, marketable securities and restricted cash of $938M; Czech facility sale reduces annual costs by ~ $80M .
• Wall Street consensus (S&P Global) was unavailable at time of writing; we could not compare results to consensus estimates (S&P Global request limit reached).

What Went Well and What Went Wrong

• What Went Well

  • Strategic de-risking via Sanofi: transition of lead commercial responsibility, progress on combination vaccines, and milestone mechanics set up multiple 2025 catalysts. “Achievement of BLA approval triggers a $175 million milestone… Marketing authorization transfers… an additional $50 million” .
  • Operating cost trajectory: sale of Czech facility (gain $51.9M) and reduced R&D/SG&A drove improved quarterly loss; annual cost base expected to decline meaningfully into 2025 and beyond .
  • Pipeline advancement: initiation of Phase 3 initial cohort (~2,000 participants) for CIC and stand-alone influenza; data expected mid-2025. Sanofi’s two CIC programs received FDA Fast Track .

• What Went Wrong

  • Revenue compression: Q4 revenue fell to $88.3M from $291.3M y/y as APA product sales rolled off; product sales declined to $49.8M vs $251.5M y/y .
  • Continued operating losses: Operating loss was $131.1M with R&D at $104.4M and SG&A at $78.3M; though improved vs prior year, the business remains loss-making pending execution of Sanofi-related revenue streams .
  • Limited 2025 visibility on product/royalty revenue: Company did not provide guidance for Sanofi royalties, CIC/Matrix milestones, or product sales, citing reliance on Sanofi forecasts; near-term 2025 Nuvaxovid product sales expected to be “immaterial” in 1H25 .

Financial Results

YoY Snapshot – Q4 2024 vs Q4 2023

Income Statement Trends (oldest → newest)

Revenue Components (oldest → newest)

KPIs and Balance Sheet (period-end; oldest → newest)

Notes:

• Q4 2024 included a $51.9M gain from the sale of the Czech facility (also tied to ~ $80M of annual cost reductions) .
• Q2 2024 licensing revenue was elevated by recognition of the Sanofi upfront payment .

Guidance Changes

Non-GAAP note: Adjusted Licensing, Royalties and Other Revenue is a non-GAAP forward-looking measure; the company cannot reconcile it to GAAP due to reliance on Sanofi sales forecasts .

Earnings Call Themes & Trends

Management Commentary

• CEO on strategy: “In 2024, we unveiled our new corporate growth strategy, shifting our focus from commercializing our COVID-19 vaccine, to maximizing the value of our cutting-edge technology platform through pipeline expansion and partnerships…” .
• CFO on profitability path: “Our business plan is designed to deliver profitability, supported by a potential Sanofi CIC launch as early as 2027… Our expected breakeven revenue for 2027 is approximately $225 million… The CIC launch milestone is $225 million” .
• COO on Sanofi commercialization: “Sanofi has stated they will use 2025 as a learning year… we believe there remains a continued demand for COVID-19 vaccines… [and] Sanofi… will be able to drive additional market share in 2025 and beyond” .
• Head of R&D on H5N1: “Non-human primate studies have shown our candidate pandemic vaccine can produce protective levels of immunity after a single dose” .
• Head of R&D on RSV: Not “a redo” of prior RSV efforts; leveraging lessons learned and AI/ML for improved constructs and combinations .

Q&A Highlights

• BLA status and label: Interactions with FDA are “very positive and productive”; label specifics (e.g., myocarditis/pericarditis warnings) not discussed ahead of BLA decision .
• CIC/Flu regulatory path and partnering: Initial Phase 3 cohort provides immunogenicity/safety to inform design; expectation is to partner before further Phase 3 investment; discussions ongoing on whether immunogenicity could be sufficient for approval .
• H5N1 preparedness: Positive NHP data supporting a one-dose protein-based candidate; company seeking USG funding and partnerships .
• Sanofi commercialization visibility: Sanofi not projecting public 2025 sales; royalties expected high-teens to low-20% on Sanofi sales per agreement .

Estimates Context

• We attempted to retrieve S&P Global consensus for Q4 2024 EPS and Revenue, but the request could not be completed due to a data access limit at the time (S&P Global API daily limit). As a result, comparisons to Wall Street consensus are not shown here.
• Management noted Q4 total revenue was in line with internal expectations but did not quantify versus Street expectations .

Key Takeaways for Investors

• 2025 is a transition year: revenue mix shifts from product sales toward licensing, milestones and eventual royalties; management withheld guidance on Sanofi-driven components due to reliance on partner forecasts, focusing investors on April BLA and MA transfers ($225M potential) as near-term catalysts .
• Cost structure is inflecting: Czech facility sale and Sanofi transition materially reduce operating costs; management targets ~ $250M core R&D+SG&A by 2027 with profitability as early as 2027 contingent on CIC launch and royalty ramp .
• Pipeline catalysts: mid-2025 data readout from CIC/Flu Phase 3 initial cohort; Sanofi’s Fast Track CICs advancing; potential for additional Matrix-M partnerships and early-stage readouts (RSV combos, shingles, C. diff., H5N1) in 2H25 .
• Near-term commercial risk is outsourced: limited 1H25 product sales and no 2025 royalty guidance increase dependence on milestone timing; Sanofi’s 2025 “learning year” may delay meaningful royalty contribution to late-2025/2026 .
• Balance sheet supports runway: $938M cash/securities at year-end provides time to execute on partner-led strategy and catalysts while OpEx declines .
• APA liabilities being managed: intent to negotiate/deliver/exit to be cash-neutral or favorable reduces tail risk from legacy contracts .
• Trading lens: Stock likely sensitive to April PDUFA (binary $175M milestone), updates on U.S./EU MA transfers, and mid-2025 CIC/Flu immunogenicity/safety readout; lack of near-term sales/royalty guidance increases event-driven volatility .

Sources: Q4/FY2024 press release and attached financials ; 8-K referencing Exhibit 99.1 and including forward-looking and financial tables ; Q4 2024 earnings call transcript prepared remarks and Q&A ; Q3 2024 press release ; Q2 2024 press release ; additional Q4 2024 press releases on CIC Phase 3 initiation and Sanofi milestone .