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Vaxcyte, Inc. (PCVX)·Q2 2025 Earnings Summary

Executive Summary

  • Vaxcyte reported a wider net loss and higher operating spend as it advanced VAX-31 toward Phase 3 and optimized the infant VAX-31 Phase 2 design; Q2 GAAP EPS was -$1.22 vs S&P Global consensus -$1.18, a miss, driven by higher R&D and G&A supporting late-stage readiness and manufacturing scale-up . Values marked with an asterisk are retrieved from S&P Global.
  • FDA interactions, including an End-of-Phase 2 meeting, set the Phase 3 path for the adult VAX-31 program; pivotal non-inferiority study now expected to initiate in Q4 2025 (later than prior mid-2025 guide), with topline in 2026 (unchanged) .
  • Cash, cash equivalents and investments were $2.83B at quarter-end, and management extended runway guidance to mid-2028; Lonza commercial manufacturing suite capex continues on plan for early 2026 completion and $300–$350M total cost .
  • FDA expanded Breakthrough Therapy Designation for adult VAX-31 to include pneumonia in addition to IPD, strengthening the regulatory positioning and potential label .

What Went Well and What Went Wrong

  • What Went Well

    • FDA alignment on VAX-31 adult Phase 3 design and CMC licensure requirements; management reiterated topline Phase 3 adult data in 2026. CEO: “We are finalizing the Phase 3 program… initiate [the pivotal] in the fourth quarter of this year with topline data expected in 2026” .
    • Adult BTD expanded to include pneumonia (in addition to IPD), supporting a broader potential indication .
    • Strong balance sheet and extended cash runway to mid-2028, enabling late-stage execution and U.S. commercialization prep .

  • What Went Wrong

    • Timing: Adult Phase 3 pivotal start moved from “mid-2025” (prior) to “Q4 2025,” reflecting a schedule slip despite unchanged topline data timing .
    • Higher operating spend: R&D rose to $194.2M (from $131.5M YoY), G&A to $32.0M (from $21.5M YoY), widening net loss to $166.6M (from $128.7M YoY) as programs scale .
    • EBITDA loss deeper than consensus: Q2 EBITDA actual -$223.34M vs S&P Global consensus -$130.63M, reflecting heavier program and manufacturing readiness spend (miss). Values retrieved from S&P Global.*

Financial Results

MetricQ4 2024Q1 2025Q2 2025
Revenue (Reported)Not reported (no revenue line in statements) Not reported (no revenue line in statements) Not reported (no revenue line in statements)
EPS (GAAP, $/sh)-1.018*-1.04 -1.22
Net Loss ($MM)-$137.1 -$140.7 -$166.6
R&D Expense ($MM)$133.6 $148.1 $194.2
G&A Expense ($MM)$28.5 $32.7 $32.0
Cash, Cash Equivalents & Investments ($MM)$3,134.7 $2,950.8 $2,826.5
EBITDA ($MM)-$159.31*-$177.84*-$223.34*

Values marked with an asterisk are retrieved from S&P Global.

Q2 vs Estimates (S&P Global):

MetricQ2 2025 ActualQ2 2025 ConsensusSurprise
EPS (GAAP)-$1.22 -$1.178*Miss
Revenue ($MM)Not reported $0.0*n/a
EBITDA ($MM)-$223.34*-$130.63*Miss

Values marked with an asterisk are retrieved from S&P Global.

KPIs and Program Execution:

KPIQ4 2024Q1 2025Q2 2025
Lonza Suite Quarterly Capex ($MM)$33.0 $31.7 $44.6
Lonza Suite Cumulative Capex ($MM)$214.3 $246.0 $290.6
Runway Guidancen/an/aMid-2028

Segment breakdown: Not applicable (no commercial revenues reported) .

Guidance Changes

Metric/ItemPeriodPrevious GuidanceCurrent GuidanceChange
VAX-31 Adult Pivotal Phase 3 StartStudy startMid-2025 Q4 2025 Delayed
VAX-31 Adult Pivotal ToplineData timing2026 2026 Maintained
VAX-31 Adult BTD ScopeIndicationIPD IPD + Pneumonia (May 2025) Expanded
VAX-31 Infant Phase 2 ReadoutPrimary + BoosterPrimary mid-2026; booster ~9 months later Both by end H1 2027; “minor extension” Slightly delayed
Cash RunwayCorporateNot specified priorTo mid-2028 New/Extended
Lonza Suite Total CostProject$300–$350M $300–$350M; early 2026 completion Maintained

Earnings Call Themes & Trends

Note: We did not locate a published Q2 2025 earnings call transcript; analysis is based on the 8-K and press release .

TopicPrevious Mentions (Q4 2024 & Q1 2025)Current Period (Q2 2025)Trend
Regulatory momentumAdult VAX-31 Phase 1/2 positive; BTD for IPD (Nov-24); on track for Phase 3 mid-2025 start Phase 3 design finalized with FDA input; BTD expanded to pneumonia Positive; label breadth improved
Phase 3 adult timingPivotal study by mid-2025; topline 2026 Pivotal now Q4 2025; topline 2026 maintained Slight delay to initiation
Pediatric strategyVAX-31 infant Phase 2 progressed; VAX-24 infant data by end-2025 Add optimized VAX-31 infant dose; combined primary+booster topline by H1 2027 Optimization with minor timeline extension
Manufacturing readinessLonza suite project advancing; cumulative capex $214.3M (YE24) Additional $44.6M in Q2; cumulative $290.6M; completion early 2026 Execution ongoing; ramping spend
Capital allocationLarge 2024 equity raises; strong cash Streamlining early-stage pipeline; extend runway to mid-2028 Focus to PCV, longer runway

Management Commentary

  • CEO (Grant Pickering): “We are finalizing the Phase 3 program, the results of which we believe could validate the best-in-class potential of VAX-31… initiate in the fourth quarter of this year with topline data expected in 2026” .
  • CFO (Andrew Guggenhime): “We remain focused on advancing VAX-31… directing resources to further extend our cash runway and fully support the continued progress of our PCV programs, including preparation for our planned VAX-31 adult Phase 3 program and pursuit of potential U.S. commercialization” .
  • On pediatric optimization: “Modified the ongoing VAX-31 infant Phase 2 randomized, dose-finding study to add a new Optimized dose… enrollment expected to proceed by end of Q3 2025… topline data from both the primary immunization series and booster by end of H1 2027” .

Q&A Highlights

  • A published Q2 2025 earnings call transcript was not found in our document set; the 8-K references the press release but no transcript was available to review . As a result, no Q&A highlights or clarifications beyond the press release could be extracted.

Estimates Context

  • EPS: Q2 2025 actual -$1.22 vs consensus -$1.178 (miss); Q1 2025 actual -$1.04 vs consensus -$1.061; Q4 2024 actual -$1.018 vs consensus -$1.213 (beat). Values retrieved from S&P Global.*
  • Revenue: Consensus expected $0.0 in Q2 2025 (no product revenue), consistent across recent quarters. Values retrieved from S&P Global.*
  • EBITDA: Q2 2025 actual -$223.34M vs consensus -$130.63M (miss). Values retrieved from S&P Global.*
  • Target Price: Consensus target price ~$99.89 persisted through recent quarters. Values retrieved from S&P Global.*

Where estimates may need to adjust:

  • Near-term, street models may lift operating expense and EBITDA loss assumptions to reflect the pace of Phase 3 readiness and manufacturing buildout evidenced in Q2 .
  • Timing assumptions should reflect adult pivotal start in Q4 2025 (vs mid-2025 prior), with topline in 2026 unchanged; pediatric VAX-31 readout now combined to H1 2027 .

Key Takeaways for Investors

  • The adult VAX-31 regulatory trajectory strengthened (BTD expansion; FDA-aligned Phase 3 design), but pivotal start slides to Q4 2025; topline in 2026 remains the key catalyst .
  • Operating intensity is rising with late-stage execution and CMC readiness; expect elevated R&D through 2026 as Phase 3 initiates and manufacturing scales .
  • Cash runway to mid-2028 and focused capital allocation (pipeline streamlining) reduce financing overhang and support commercialization groundwork .
  • Infant programs advance with a more robust dose strategy; timeline modestly extended to deliver combined primary+booster topline by H1 2027, potentially de-risking immunogenicity targets .
  • Near-term stock drivers: Phase 3 adult initiation in Q4 2025, ongoing updates on manufacturing readiness, and incremental pediatric data cadence; medium-term, the 2026 adult Phase 3 topline readout is the central value inflection .

References:

  • Q2 2025 press release and financials
  • Q2 2025 8-K and exhibit
  • Q1 2025 press release and 8-K
  • Q4 2024 press release

Values marked with an asterisk are retrieved from S&P Global.