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Vaxcyte, Inc. (PCVX)·Q3 2025 Earnings Summary

Executive Summary

  • Vaxcyte reaffirmed timelines to initiate the pivotal VAX-31 adult non-inferiority Phase 3 study in December 2025, with topline data in 2026; infant Phase 2 study advanced to the final stage and remains on track for PD3/PD4 readouts by 1H 2027 .
  • Q3 operating intensity rose as R&D and G&A spending increased with adult Phase 3 preparations and infant Phase 2 activities; net loss widened to $212.8M and EPS was -$1.56, versus -$0.83 in Q3 2024 .
  • Cash, cash equivalents and investments were $2.6706B, and management reiterated runway funding the current operating plan into mid-2028 .
  • U.S. commercial manufacturing expanded with a Thermo Fisher (Greenville, NC) fill-finish agreement (up to $1B commitment) and continued buildout of the dedicated Lonza suite (on track, up to ~$350M total cost) to support potential commercialization .
  • Bold catalyst path for investors: adult Phase 3 first-patient-in (December), comparator disclosure and study design specifics near initiation, infant dose-optimized Phase 2 progress, and continued manufacturing scale-up—each with potential to reshape sentiment and drive estimate revisions .

What Went Well and What Went Wrong

What Went Well

  • “We remain laser-focused on advancing the development of VAX-31…we expect to initiate the VAX-31 pivotal, non-inferiority study in December, with additional Phase 3 study initiations in 2026,” underscoring execution readiness on the adult program .
  • Final VAX-24 infant Phase 2 data were consistent with positive interim data and showed robust, dose-dependent immune responses with little to no carrier suppression—strengthening rationale for higher-dose arms in the ongoing VAX-31 infant Phase 2 .
  • Strategic manufacturing and commercialization build: long-term Thermo Fisher fill-finish in NC (up to $1B), Lonza suite spend continued; appointment of Chief Commercial Officer Mike Mullette adds launch leadership depth .

What Went Wrong

  • Burn increased: R&D rose to $209.9M (from $116.9M YoY), G&A to $32.4M (from $23.0M YoY); total operating expenses climbed to $242.4M (from $139.9M YoY), widening net loss to $212.8M .
  • Cash declined sequentially with program spend ($2.6706B vs. $2.8265B in Q2 2025) despite continued discipline, while other income declined QoQ ($29.6M vs. $59.6M) on lower mark-to-market/other income dynamics .
  • Revenue remains at zero as a clinical-stage company with no product approvals, keeping margin analysis inapplicable and placing emphasis on clinical and regulatory milestones to sustain valuation .

Financial Results

MetricQ3 2024Q1 2025Q2 2025Q3 2025
R&D Expense ($USD Millions)$116.9 $148.1 $194.2 $209.9
G&A Expense ($USD Millions)$23.0 $32.7 $32.0 $32.4
Total Operating Expenses ($USD Millions)$139.9 $180.8 $226.2 $242.4
Other Income, net ($USD Millions)$36.8 $40.1 $59.6 $29.6
Net Loss ($USD Millions)$103.1 $140.7 $166.6 $212.8
EPS ($USD)$(0.83) $(1.04) $(1.22) $(1.56)

KPIs

MetricQ1 2025Q2 2025Q3 2025
Cash, Cash Equivalents & Investments ($USD Millions)$2,950.8 $2,826.5 $2,670.6
Lonza Suite Capex (Quarterly) ($USD Millions)$31.7 $44.6 $23.0
Lonza Suite Cumulative Capex ($USD Millions)$246.0 $290.6 $313.7

Revenue and Margins

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Revenue ($USD Millions)—$0.0 $0.0 $0.0
Gross Margin (%)N/AN/AN/AN/A

Notes: Vaxcyte reports GAAP results; non-GAAP adjustments are not presented. Stock-based compensation was $35.3M in Q3 2025 vs. $21.3M in Q3 2024 .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
VAX-31 Adult Pivotal NI Study StartDec 2025Q4 2025 start; topline 2026 December 2025 start; topline 2026 Clarified timing (month)
VAX-31 Adult Remaining Phase 3 Starts20262025–2026 starts 2026 starts Maintained/updated sequencing
VAX-31 Infant Phase 2 (Optimized Dose)Through 1H 2027Modified study; topline PD3/PD4 by 1H 2027 Final stage; PD3/PD4 either sequentially or together by 1H 2027 Maintained; disclosure approach clarified
Cash RunwayThrough mid-2028Fund plan to mid-2028 Fund plan to mid-2028 Maintained
Lonza Dedicated Suite CompletionEarly 2026Early 2026; ~$300–$350M total Early 2026; up to ~$350M total Maintained
Thermo Fisher Fill-FinishLong-termNew NC agreement; up to $1B (Sept) Up to $1B, 15-year initial term, US-based capacity New detail confirmed

Earnings Call Themes & Trends

TopicQ1 2025 (Prev.)Q2 2025 (Prev.)Q3 2025 (Current)Trend
Adult Phase 3 readinessExpect mid-2025 start; topline 2026 Finalizing Phase 3 post EoP2; start Q4 2025; topline 2026 Start December 2025; topline 2026; no field efficacy or placebo required per FDA dialogues (as described by mgmt.) Firming timelines
Infant program dose optimizationVAX-31 moved to Stage 2; PD3 mid-2026; PD4 up to 9 months later Added Optimized dose; proceed by end Q3 2025 Final stage; PD3/PD4 by 1H 2027; stronger PD4 dose response; minimal carrier suppression Strengthening immunogenicity
Manufacturing scale-upLonza capex plan outlined Streamlining pipeline; Lonza suite on track Thermo Fisher fill-finish (NC) up to $1B; Lonza suite up to ~$350M, early 2026 completion Supply-chain readiness
Market dynamics (adult PCV)—ACIP lowered age to 50; adult growth driver Adult market ~$8B growing to $12–$14B; 50–65 catch-up; boost at 65 when broader valent available Positive structural tailwinds
Regulatory interactions—EoP2 completed; CMC inputs received FDA interactions ongoing; no outsized safety DB; team continuity; “business as usual” Constructive
Competitive landscape——Pfizer/GSK timelines lag; Vaxcyte lead widening per mgmt. view Favorable relative position

Management Commentary

  • CEO: “We remain laser-focused on advancing the development of VAX-31…the final data from our VAX-24 infant Phase 2…show that VAX-24 elicited robust, dose-dependent immune responses, with little to no evidence of carrier suppression observed.”
  • CFO: “With this strong financial position, we are advancing both the VAX-31 adult Phase 3 program and the infant Phase 2 study while investing in activities to help ensure commercial readiness.”
  • Conference remarks: “Expect to start the pivotal non-inferiority study in December…not expecting…a placebo-controlled study, a field efficacy study, or an outsized safety database” .
  • Conference remarks: “Adult market…$8B today, grown to $12–$14B…broader has been better…we’re excited about the profile of this vaccine and the opportunity to hopefully commercialize it soon.” .

Q&A Highlights

  • Adult Phase 3 execution and comparators: Management guided to December start, comparable powering vs PCV20 and Capvaxive with cohort sizes ~850–1,200; comparator specifics to be disclosed near FPI .
  • Infant dose-response: PD4 data showed greater dose-dependent improvements; minimal carrier suppression vs PCV20; decision to add Optimized 4.4/3.3mcg arm reinforced .
  • Market dynamics and ACIP: Lowering adult recommendation to age 50 creates a 63M-person catch-up; potential boost at 65 upon broader-valent approvals could expand addressable market .
  • Manufacturing readiness: Lonza dedicated suite on track and on budget; Thermo Fisher fill-finish provides long-term U.S. capacity ahead of launches .
  • Competitive timing: Management indicated peers have pushed timelines, supporting Vaxcyte’s relative lead .

Estimates Context

MetricQ3 2025 ConsensusQ3 2025 Actual
Primary EPS Consensus Mean$(1.33)*$(1.56)
Revenue Consensus Mean ($USD Millions)$0.0*$0.0 (no product revenue)
Primary EPS – # of Estimates7*—
Revenue – # of Estimates7*—
Target Price Consensus Mean ($)$99.89*$99.89*

Values retrieved from S&P Global.*

Implications: EPS was a miss versus consensus as spending ramped ahead of Phase 3; revenue remains zero, as expected for a clinical-stage profile . As adult Phase 3 specifics (comparator, endpoints) and FPI approach, and infant dose-optimization progresses, we expect models to adjust OpEx cadence and probability-weighted timelines.

Key Takeaways for Investors

  • Adult Phase 3 FPI in December is a near-term trading catalyst; details on comparator(s) and study design could influence sentiment and peer-relative positioning .
  • EPS miss reflects accelerated investment into Phase 3 and commercialization readiness; watch OpEx trajectory and other income normalization as drivers of quarterly EPS variability .
  • Manufacturing scale-up (Lonza + Thermo Fisher NC) reduces supply-chain risk and supports U.S.-centric commercial readiness—a positive for future launch narratives .
  • Infant program’s Optimized dosing and consistent PD3/PD4 immunogenicity trends mitigate carrier suppression concerns and strengthen the best-in-class thesis for broader coverage .
  • Adult market expansion (ACIP 50+, potential boost at 65; international adoption) supports multi-year TAM growth and underpins commercial viability upon approval .
  • Cash runway to mid-2028 enables execution through adult readouts and infant milestones without near-term financing overhang—de-risking program continuity .
  • Monitor upcoming disclosures (adult Phase 3 comparator, infant unblinding strategy) and investor events; each is a potential catalyst for estimate and valuation recalibration .

Additional Press Releases and Prior Quarters (for trend analysis)

  • Q2 2025: Finalizing adult Phase 3 post EoP2; Optimized infant dose added; cash $2.8265B; runway to mid-2028 .
  • Q1 2025: Positive VAX-24 infant Phase 2 topline; adult Phase 3 expected mid-2025; cash $2.9508B .

Cross-References and Notes

  • Vaxcyte remains a clinical-stage company with no product revenue to date .
  • Commercial manufacturing agreement with Thermo Fisher (Greenville, NC) has a 15-year initial term; capacity commitment up to $1B supports long-term U.S. supply .
  • Non-GAAP measures were not presented; stock-based compensation in Q3 2025 totaled $35.3M (vs. $21.3M YoY) .