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Vaxcyte, Inc. (PCVX)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 delivered continued execution on the PCV franchise: positive topline VAX-24 infant Phase 2 data, VAX-31 infant Phase 2 advancing to Stage 2, and reaffirmed timing to initiate VAX-31 adult Phase 3 by mid-2025 with topline data in 2026 .
  • Financials tracked higher R&D/G&A as programs scale; net loss was $140.7M and EPS was -$1.04, modestly beating Wall Street consensus EPS of -$1.061 (beat by $0.02) as higher interest/other income offset OpEx growth . Estimates are from S&P Global.*
  • Cash, cash equivalents and investments were $2.951B, down $184M QoQ, with continued capex on the Lonza manufacturing suite ($31.7M in Q1; $300–$350M total expected) supporting commercial readiness .
  • Narrative catalysts: (1) strong VAX-24 infant immunogenicity and memory response signals; (2) adult VAX-31 Phase 3 initiation in mid-2025; (3) platform confidence reinforced by announcement of third-generation candidate VAX-XL .

What Went Well and What Went Wrong

What Went Well

  • Positive VAX-24 infant Phase 2 topline: Mid dose met Phase 2 NI criteria on seroconversion for 20/24 serotypes and met IgG GMR targets on all currently circulating serotypes; robust OPA across all serotypes, with robust memory post-dose 4 interim IgG . “We continue to make meaningful progress…bringing us closer to potentially delivering the broadest-spectrum PCVs” — CEO Grant Pickering .
  • VAX-31 infant Phase 2 advanced to Stage 2; adult Phase 3 initiation reaffirmed for mid-2025 with topline in 2026, underpinning near-term clinical catalysts .
  • Strong liquidity: ~$3.0B cash/investments supporting multiple milestones through 2026–2027; management evaluating capital allocation to further strengthen the balance sheet .

What Went Wrong

  • Elevated OpEx as programs scale: R&D rose to $148.1M (+56% YoY) and G&A to $32.7M (+64% YoY), widening net loss to $140.7M (+48% YoY) .
  • Cash draw QoQ: cash/investments decreased to $2.951B from $3.135B, reflecting higher burn and capex for the Lonza suite; $31.7M incremental Q1 buildout spend, cumulative $246.0M, total expected unchanged at $300–$350M .
  • No standalone Q1 earnings call transcript; management commentary came via press releases and investor conference appearances, limiting direct call Q&A for this quarter .

Financial Results

Income Statement and Liquidity (Quarterly)

MetricQ3 2024Q4 2024Q1 2025
Research & Development ($USD Millions)$116.9 $133.6 $148.1
General & Administrative ($USD Millions)$23.0 $28.5 $32.7
Total Operating Expenses ($USD Millions)$139.9 N/A$180.8
Net Loss ($USD Millions)$103.1 $137.1 $140.7
Net Loss per Share ($USD)$(0.83) $(1.01) $(1.04)
Interest Income ($USD Millions)$28.1 N/A$32.9
Other Income (Expense) ($USD Millions)$0.3 grant; $8.5 FX loss N/A$7.1
Total Other Income ($USD Millions)$36.8 N/A$40.1
Cash, Cash Equivalents & Investments ($USD Millions)$3,273.0 $3,134.7 $2,950.8

Notes: N/A indicates not disclosed in cited document for that specific quarter metric.

Q1 2025 Actual vs Wall Street Consensus (S&P Global)

MetricActualConsensusSurprise
EPS ($USD)$(1.04) $(1.061)*+$0.02
Revenue ($USD Millions)$0.0 $0.0*In line

Values marked with * retrieved from S&P Global.

Manufacturing Capex and Suite Buildout

MetricQ3 2024Q4 2024Q1 2025
Capex on Lonza Suite ($USD Millions)$41.3 $33.0 $31.7
Cumulative Buildout Spend ($USD Millions)$181.3 $214.3 $246.0
Total Expected Cost ($USD Millions)$300–$350 $300–$350 $300–$350

Segment breakdown: Not applicable (pre-revenue).

KPIs (Clinical/Immunogenicity)

KPIQ1 2025 Status
VAX-24 infant Phase 2 NI on seroconversionMid dose met NI criteria for 20/24 serotypes post-dose 3
VAX-24 infant IgG GMR targetsMet on all currently circulating serotypes; 22/24 overall post-dose 3
VAX-24 infant OPA responsesRobust across all serotypes/doses post-dose 3
Post-dose 4 interim IgG memoryRobust memory responses; Mid dose >0.6 GMR on 19/24 serotypes
VAX-31 infant Phase 2Advanced to Stage 2; topline primary series mid-2026
VAX-31 adult Phase 3Initiation by mid-2025; topline 2026

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
VAX-31 adult Phase 3 pivotal initiationMid-2025Mid-2025 Mid-2025 Maintained
VAX-31 adult Phase 3 topline20262026 2026 Maintained
VAX-31 infant Phase 2 topline (primary series)Mid-2026Mid-2026 Mid-2026 Maintained
VAX-24 infant Phase 2 topline (primary series)End Q1 2025End Q1 2025 Announced Mar 31, 2025 Achieved
VAX-24 infant booster toplineEnd 2025End 2025 End 2025 Maintained
Manufacturing suite total cost2026 completion; $300–$350M$300–$350M $300–$350M; completion early 2026 Maintained

Earnings Call Themes & Trends

Note: No standalone Q1 2025 earnings call transcript; themes reflect Q4 2024 call and Q1 2025 investor events.

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q4 2024)Current Period (Q1 2025)Trend
Adult VAX-31 strategy/readinessPhase 1/2 adult data positive; financing bolstered balance sheet Expect Phase 3 mid-2025; BTD granted; OPA NI met/exceeded Phase 3 initiation reaffirmed mid-2025; topline 2026 Consistent progression
Infant programs (VAX-24, VAX-31)VAX-24 Phase 2 enrollment completed VAX-31 infant IND cleared; Stage 1 initiated VAX-24 infant positive topline; VAX-31 infant advanced to Stage 2 Positive momentum
Manufacturing & CMCCapex ramp; suite buildout tracking Cumulative $214.3M; tracking +$31.7M Q1; cumulative $246.0M; total $300–$350M; early 2026 completion Execution continues
Macro/regulatory/public affairs—CFO noted public affairs function establishment, engagement with FDA/CDC/ACIP Monitoring Washington dynamics; mission unaffected; capital allocation evaluation Proactive engagement
Financial discipline/cash runway$3.273B cash; net proceeds from offering $3.135B cash; $2.2B net proceeds ~$3.0B cash; evaluating investment priorities Strong but tightening with spend

Management Commentary

  • “We continue to make meaningful progress across our pneumococcal conjugate vaccine (PCV) candidates…bringing us closer to potentially delivering the broadest-spectrum PCVs” — Grant Pickering, CEO .
  • “With a strong balance sheet totaling approximately $3.0 billion…we are evaluating our investment priorities and allocation of capital to ensure the continued strength of our balance sheet” — Andrew Guggenhime, President & CFO .
  • On 2025 OpEx profile: Expect substantial increase in R&D/G&A, driven by adult launch manufacturing investments, VAX-31 adult Phase 3 initiation, and headcount growth; R&D to fluctuate with manufacturing timing .
  • On macro/policy: “Monitoring closely what is happening in Washington…no potential substantive policy change seen yet…mission unaffected” — CFO at BofA Healthcare Conference .

Q&A Highlights

  • Phase 3 design and uncertainties: Management characterized upcoming adult VAX-31 Phase 3 as “standard blocking and tackling,” reaffirming mid-2025 start and 2026 topline; competitive positioning expected with 31-valent breadth .
  • Manufacturing readiness: Initial adult launch from existing shared-use Lonza facilities; dedicated facility completion early next year; begin stockpiling inventory to support adult and infant launches .
  • Non-inferiority margins and seroconversion (from Q4 call): Company targets 15% delta in Phase 2 guiding Phase 3 design to hit 10% registrational hurdle; confidence on serotype 3 based on adult results and translatability .

Estimates Context

  • EPS modest beat: Actual Q1 EPS -$1.04 vs consensus -$1.061; likely aided by higher interest and other income ($40.1M), partially offsetting OpEx growth . Consensus from S&P Global.*
  • Revenue in line: Pre-revenue company; consensus $0 and actual $0 . S&P Global.*

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • Near-term clinical catalysts: VAX-31 adult Phase 3 initiation by mid-2025; VAX-24 infant full dataset (including booster) by end-2025; VAX-31 infant primary series topline mid-2026 .
  • Platform validation strengthens infant thesis: VAX-24 infant Phase 2 signals (NI on 20/24 serotypes, robust OPA, memory response) support confidence in carrier-sparing approach and potential best-in-class coverage .
  • Cash runway robust but spending elevated: ~$3.0B cash/investments with ongoing evaluation of capital allocation; continued capex into Lonza suite to enable global supply, with total cost maintained at $300–$350M .
  • Expect OpEx volatility tied to manufacturing/activity timing; Q1 showed meaningful increases in R&D/G&A as programs scale toward Phase 3 and commercial readiness .
  • VAX-XL announcement expands long-term coverage ambition and underscores pipeline breadth beyond current PCVs .
  • Regulatory positioning: Adult VAX-31 BTD and proactive engagement with FDA/CDC/ACIP de-risk aspects of development and potential review timelines .
  • Trading implication: Stock narrative likely anchored to execution milestones (adult Phase 3 start, infant data cadence); absence of revenue means EPS beats/misses hinge on OpEx timing and interest income variability rather than operations.

Additional documents read:

  • Q1 2025 press release and 8-K (Item 2.02, EX-99.1, financials) .
  • March 31, 2025 VAX-24 infant topline press release .
  • Q4 2024 press release and 8-K, plus Q4 call transcript excerpts .
  • Q3 2024 press release and 8-K .