Executive Summary

Q1 2025 was a headline beat driven by one-time APA closeouts: revenue was $666.7M vs S&P Global consensus $343.9M*, and diluted EPS was $2.93 vs $1.41*; the upside primarily reflected $603M of non‑cash revenue recognized from terminating Canada/New Zealand APAs, while underlying commercial sales were modest .
Management raised the FY2025 revenue framework to $975M–$1,025M (Adjusted Total Revenue), and reiterated combined R&D+SG&A guidance of $475M–$525M, citing added Nuvaxovid product sales, higher Matrix‑M supply demand, Takeda upfront, and Sanofi amortization timing .
Strategic execution advanced: FDA feedback suggested a pathway to BLA approval contingent on alignment around a post‑marketing commitment (PMC) during the quarter; subsequently, on May 19 the FDA approved the BLA, triggering a $175M Sanofi milestone (post‑quarter catalyst) .
Cost discipline continued: combined R&D+SG&A fell 24% YoY in Q1; management reiterated a multiyear path toward potential non‑GAAP profitability as early as 2027, with quarterly net spend expected to decline over time .

What Went Well and What Went Wrong

What Went Well

Raised FY2025 revenue framework to $975M–$1,025M driven by APA resolutions, supply sales, partner revenues (incl. $20M Takeda upfront), and amortization timing; maintained opex guidance, demonstrating operating discipline .
Clear regulatory progress and future monetization: management said “FDA feedback on our BLA suggests a pathway to approval upon alignment on study parameters for the postmarketing commitment,” with $175M BLA milestone at approval; BLA approval subsequently arrived May 19 (post‑quarter) .
Cost structure improvement: SG&A down 45% YoY and combined R&D+SG&A down 24% YoY; CFO emphasized streamlining and a path to potential non‑GAAP profitability by 2027 .

What Went Wrong

Quality of revenue: $603M of Q1 product revenue stemmed from non‑cash APA terminations (Canada/New Zealand), masking modest underlying commercial sales ($5M U.S./Germany); Street models will likely adjust for non‑recurring items .
Cash trended lower sequentially: cash, equivalents, marketable securities and restricted cash fell to $747M from $938M at YE’24 as liabilities were reduced and settlements paid; working capital improved but cash burn remains a focal point .
Continued dependency on partners and regulatory timing: the 2025 revenue framework excludes Sanofi royalties and certain milestones due to reliance on Sanofi forecasts; a new PMC trial was anticipated around approval, potentially adding cost/complexity .

Financial Results

Headline P&L vs prior periods and estimates (USD)

Metric	Q3 2024	Q4 2024	Q1 2025	Vs. S&P Global Consensus (Q1 2025)*
Total Revenue ($M)	$84.5	$88.3	$666.7	$343.9 estimate; beat by ~$322.8M
Product Sales ($M)	$38.2	$49.8	$621.7 (incl. $603M APA)	N/A
Licensing, Royalties & Other ($M)	$46.3	$38.5	$45.0 (incl. $40M Sanofi)	N/A
Cost of Sales ($M)	$60.6	$36.7	$14.1	N/A
R&D Expense ($M)	$87.2	$104.4	$88.9	N/A
SG&A Expense ($M)	$70.7	$78.3	$48.1	N/A
Net Income (Loss) ($M)	$(121.3)	$(81.0)	$518.6	N/A
Diluted EPS ($)	N/A	$(0.51)	$2.93	$1.41 estimate; beat by ~$1.52

Note on Q1 revenue quality: $603M of product sales were recognized from closing APAs (non‑cash) with $28M and $4M cash payments to Canada and New Zealand, respectively; remaining $5M came from U.S./Germany sales .
S&P Global disclaimer: *Values retrieved from S&P Global.

Revenue composition (Q1 2025 vs Q1 2024)

Revenue Component ($M)	Q1 2024	Q1 2025
Nuvaxovid Sales	$82	$608
Supply Sales	$8	$14
Product Sales (Subtotal)	$90	$622
Sanofi	$0	$40
Other Partners	$4	$5
Licensing, Royalties & Other	$4	$45
Total Revenue	$94	$667

Balance sheet and liquidity KPIs

KPI ($M)	Dec 31, 2024	Mar 31, 2025
Cash & Cash Equivalents	$530.2	$263.3
Marketable Securities	$392.9	$468.1
Restricted Cash	$15.1	$15.1
Cash + Mkt Sec + Restricted	$938.1	$747.0
Working Capital	$(25.5)	$445.9
Convertible Notes Payable	$169.7	$170.1
Total Stockholders’ Deficit	$(623.8)	$(75.6)

Guidance Changes

Metric	Period	Previous Guidance (Feb 27, 2025)	Current Guidance (May 8, 2025)	Change
Adjusted Total Revenue	FY 2025	$300–$350M	$975–$1,025M	Raised
Nuvaxovid Product Sales	FY 2025	No guidance	$610M (incl. $603M APA recognition)	Introduced
Adjusted Supply Sales	FY 2025	$0–$25M	$20–$35M	Raised
Adjusted Licensing, Royalties & Other	FY 2025	$300–$325M	$345–$380M	Raised
Combined R&D + SG&A	FY 2025	$475–$525M	$475–$525M	Maintained
Sanofi Supply Sales	FY 2025	No guidance	No guidance	Maintained
Sanofi Royalties	FY 2025	No guidance	No guidance	Maintained
Sanofi CIC/Matrix‑M Milestones	FY 2025	No guidance	No guidance	Maintained

Notes: Adjusted Total Revenue excludes Sanofi Supply Sales, Sanofi Royalties, and Sanofi CIC/Matrix‑M milestones; 2025 Adjusted LRO includes $225M of U.S. BLA and Marketing Authorization milestones .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q3’24, Q4’24)	Current Period (Q1’25)	Trend
FDA BLA/PMC	PDUFA April 2025; pathway highlighted	“Pathway to approval upon alignment on PMC” (post‑quarter, BLA approved May 19)	Improving clarity; approval achieved post‑quarter
Sanofi partnership monetization	$50M pediatric DB lock milestone; Fast Track on combos	$40M revenue in Q1 (amortization + R&D reimbursement); 2025 revenue framework excludes Sanofi royalties/milestones	Ongoing, more tangible amortization
Cost structure/opex trajectory	Target ~$500M FY’25 R&D+SG&A	Q1 combined R&D+SG&A down 24% YoY; reiterated $475–$525M FY’25	Execution progressing
CIC/Flu program	Phase 3 cohort initiation (2,000 pts)	Mid‑year immunogenicity/safety data; intent to partner for pivotal path	Data inflection approaching; partner‑led path
Reactogenicity/SHIELD‑Utah	n/a	Real‑world study shows fewer/less severe symptoms vs mRNA	Differentiation messaging building
Partnering beyond Sanofi	New Matrix‑M MTA in Q3’24	Expanded MTAs incl. viral pathogens; preclinical IO collaboration; improved Takeda terms	Broadening BD funnel

Management Commentary

Strategy and regulatory pathway: “FDA feedback on our BLA suggests a pathway to approval upon alignment on study parameters for the post‑marketing commitment requested” — John C. Jacobs, CEO .
Operating leverage: “First quarter 2025 combined R&D and SG&A expenses were $137 million… SG&A… is 45% lower… driven by… closeout of our global sales and marketing capabilities plus strong execution on our broader cost reduction plan” — James Kelly, CFO .
Revenue quality clarification: “The $603 million from Canada and New Zealand is noncash… we had received that cash in prior years” — James Kelly, CFO (Q&A) .
CIC/Flu development intent: “This is not a pivotal trial… our intention [is] to partner both our late‑stage CIC and Flu assets” — John C. Jacobs / Ruxandra Draghia‑Akli .
Post‑quarter catalyst: “FDA has approved the BLA for Nuvaxovid… triggers a $175 million milestone payment from Sanofi” — Company press release, May 19, 2025 .

Q&A Highlights

PMC scope/timing: Management reiterated the PMC is post‑marketing by definition and not a pre‑approval requirement; they’re working urgently with FDA on study parameters .
Revenue recognition mechanics: $603M APA revenue was non‑cash recognition with settlements paid; clarifies sustainability concerns around Q1 revenue composition .
CIC/Flu: Current 2,000‑patient cohort is for immunogenicity/safety to inform a future pivotal study with a partner; not designed for registration; safety profile expected to be “reasonable” .
SHIELD‑Utah: Observational, more consumer‑informing than regulatory‑determinative; supports tolerability narrative vs mRNA .
Milestone resilience: BLA approval milestone is not impacted by PMC requirements; still payable upon approval .

Estimates Context

Q1 2025 results vs S&P Global consensus: Revenue $666.7M vs $343.9M estimate*; Diluted EPS $2.93 vs $1.41 estimate*; Estimates based on 4 revenue and 3 EPS contributors* ; S&P Global disclaimer: *Values retrieved from S&P Global.
Implication: The large beat stems from APA non‑recurring recognition; we expect Street models to adjust core run‑rate revenue and re‑anchor 2025 forecasts to management’s Adjusted Total Revenue, partner cash flows (Takeda upfront, Sanofi amortization), and potential royalty ramps post‑Sanofi commercialization .

Estimate vs Actual Detail (Q1 2025)

Metric	Consensus Estimate*	Actual	Surprise
Revenue ($M)	$343.9*	$666.7	+$322.8*
Diluted EPS ($)	$1.41*	$2.93	+$1.52*
EPS – # of Estimates	3*	—	—
Revenue – # of Estimates	4*	—	—

S&P Global disclaimer: *Values retrieved from S&P Global.

Key Takeaways for Investors

The quarter’s beat was principally driven by non‑cash APA resolution; focus on sustainability of underlying demand and partner‑driven cash flows (Sanofi royalties/milestones not guided, but BLA approval on May 19 triggered $175M) .
FY2025 Adjusted Total Revenue raised sharply to $975M–$1,025M, with explicit components (Nuvaxovid $610M including APA, supply $20–$35M, adjusted LRO $345–$380M); opex discipline maintained ($475–$525M) .
Balance sheet improved on working capital and stockholders’ deficit, but aggregate cash+securities declined vs YE’24; watch cash conversion of milestones/upfronts and cadence of partner reimbursements .
Regulatory overhang eased post‑quarter with U.S. BLA approval; a PMC Phase 4 study will add execution complexity but does not affect the $175M approval milestone .
CIC/Flu mid‑year cohort readout is a partnering catalyst; strategy remains partner‑led for late‑stage development to limit capital intensity .
Tolerability differentiation is a messaging edge (SHIELD‑Utah); commercial translation will depend on Sanofi’s execution and market segment preferences (older/high‑risk populations) .
Near‑term trading lens: positive momentum from BLA approval/milestone and raised framework vs likely model normalization for one‑time APA revenue; medium‑term thesis shifts to partner monetization (Sanofi royalties/milestones), opex glidepath, and pipeline/BD optionality .

Appendix: Additional Data Points

Q1 2025 Sanofi revenue: $40M (amortization of upfront and DB‑lock milestone plus R&D reimbursements) .
Takeda (Japan) agreement: significantly improved terms, including $20M upfront in Q2 and seasonal milestones/royalties .
Liquidity disclosures: reduced current liabilities by >60% vs YE’24; quarterly net spend targeted at $140–$160M and declining .

NOVAVAX INC (NVAX)·Q1 2025 Earnings Summary