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Wave Life Sciences Ltd. (WVE)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 revenue was $9.2M and diluted EPS was $(0.29), reflecting lower collaboration revenue timing; Street consensus looked for ~$11.34M revenue and $(0.256) EPS, implying a revenue miss and slightly wider loss per share. Bold miss: Revenue –$2.16M (–19.1%) vs consensus; EPS –$0.034 vs consensus . Consensus values retrieved from S&P Global.*
  • Operating expenses rose YoY on R&D (to $40.6M) and G&A (to $18.4M), driven by obesity (INHBE), RNA editing programs and compensation; net loss widened to $(46.9M) .
  • Clinical catalysts: initial obesity (WVE-007, INHBE siRNA) data in 2H 2025; AATD (WVE-006) multi-dose and higher single-dose data in Q3/fall 2025; DMD (WVE‑N531) 48-week data showed functional benefit and muscle health improvements; NDA targeted for 2026 on accelerated pathway using dystrophin as surrogate .
  • Cash of $243.1M funds operations into 2027; collaboration milestones from GSK are excluded from runway, maintaining financial flexibility .

What Went Well and What Went Wrong

  • What Went Well

    • DMD (WVE‑N531): 48-week Phase 2 results delivered a statistically significant and clinically meaningful 3.8s Time-to-Rise improvement vs natural history, plus reductions in fibrosis, CK and inflammatory markers; dystrophin averaged 7.8% with 88% of boys ≥5% and safe/tolerated profile .
    • Regulatory clarity: FDA confirmed accelerated approval pathway using dystrophin expression remains open; Wave plans an NDA in 2026 and monthly dosing at launch .
    • Pipeline momentum: Obesity (WVE‑007) completed dosing in first two single-dose cohorts; initial clinical data expected 2H 2025; RNA editing (WVE‑006) multi-dose (200mg Q2W) and single-dose (400mg) cohorts ongoing with comprehensive updates slated for Q3/fall 2025 .

  • What Went Wrong

    • Revenue miss vs Street due to collaboration timing: Q1 revenue of $9.2M fell short of ~$11.34M consensus, and YoY declined from $12.5M; management cited GSK collaboration timing as driver . Consensus values retrieved from S&P Global.*
    • Higher operating costs: R&D increased to $40.6M and G&A to $18.4M YoY, expanding net loss to $(46.9M) .
    • No financial guidance: Company maintains milestone/operational timelines and cash runway commentary, but does not provide revenue/EPS guidance—reduces near-term visibility .

Financial Results

MetricQ1 2024Q4 2024Q1 2025
Revenue ($USD Millions)$12.538 $83.748 $9.175
Diluted EPS ($USD)$(0.24) $0.17 $(0.29)
Net Income (Loss) ($USD Millions)$(31.558) $29.253 $(46.878)
R&D Expense ($USD Millions)$33.447 $44.645 $40.622
G&A Expense ($USD Millions)$13.549 $16.136 $18.357
Total Operating Expenses ($USD Millions)$46.996 $60.781 $58.979
KPIQ4 2024Q1 2025
Cash and Cash Equivalents ($USD Millions)$302.078 $243.075
Current Deferred Revenue ($USD Millions)$65.972 $57.312
Weighted-Avg Diluted Shares (Units)172,290,361 162,527,026
Estimates vs Actuals (Q1 2025)ActualS&P ConsensusSurprise# of Estimates
Revenue ($USD Millions)$9.175 $11.34*–$2.16 (–19.1%)*11*
Diluted EPS ($USD)$(0.29) $(0.256)*–$0.034*9*
Consensus values retrieved from S&P Global.*

Segment breakdown: not applicable; Wave reports collaboration/other revenue with no segment disclosure .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayThrough 2027“Runway into 2027” (FY/Q4 update) “Runway into 2027” (Q1 reiteration) Maintained
Obesity – WVE‑007 INLIGHT initial data2H 2025“2H 2025 initial data” (Q4 update) “2H 2025 initial data; first two single-dose cohorts dosed” Maintained; execution progress
AATD – WVE‑006 RestorAATion‑2Q3/Fall 2025“Multi‑dose data in 2025” (Q4 update) “Complete 200mg multi-dose & single-dose cohorts in Q3; complete 400mg single-dose cohort in fall” Timing specified/updated
DMD – WVE‑N531 NDA2026“Regulatory feedback and 48-week data in Q1 2025” “NDA filing planned in 2026; monthly dosing at launch; accelerated pathway confirmed” Raised clarity (NDA timing and dosing)
HD – WVE‑003 IND2H 2025“IND in 2H 2025” “IND in 2H 2025; FDA supportive of biomarker path (caudate atrophy)” Maintained; supportive feedback reiterated

Earnings Call Themes & Trends

TopicQ3 2024 (Nov)Q4 2024 (Mar)Q1 2025 (May)Trend
Obesity (WVE‑007, INHBE siRNA)Preparing for 1Q25 trial; strong human genetics support and muscle-sparing profile First single-dose cohort fully enrolled; initial data 2H 2025 First two single-dose cohorts dosed; initial data in 2H 2025 Execution progressing toward 2H25 readout
AATD (WVE‑006, RNA editing)First-ever human RNA editing; multi-dose and higher single-dose cohorts planned 200mg Q2W multi-dose initiated; 400mg single-dose initiated; comprehensive 2025 updates 200mg multi-dose and 400mg single-dose dosing underway; Q3/fall updates Building to pivotal dose-interval insights
DMD (WVE‑N531)24-week data: ~9% dystrophin, stem-cell uptake; 48-week data and FDA feedback in Q1 2025 48-week data imminent (March), monthly extension dosing 48-week data show 3.8s TTR benefit, fibrosis reduction; FDA confirmed accelerated pathway; NDA 2026 Strengthened efficacy narrative; regulatory path crystallized
HD (WVE‑003)FDA open to biomarker path (caudate atrophy); IND 2H 2025 SELECT-HD correlation mHTT↓ to caudate; IND 2H 2025; discussions with partners Prepared to submit IND 2H 2025; continued biomarker emphasis and partner engagement Consistent regulatory engagement; partnering optionality
Financials/MacroCash >$310.9M incl. raise; revenue adjusted under collaborations Cash $302.1M YE; Q4 net income from revenue recognition Cash $243.1M; runway into 2027; revenue down on GSK timing Runway intact; quarterly revenue variable

Management Commentary

  • “We have completed dosing in the first 2 single-dose cohorts of our INLIGHT trial… on track to deliver initial data… in the second half of this year” — Paul Bolno, CEO .
  • “We initiated multi-dosing in the first cohort of RestorAATion‑2 (200 mg every other week)… dosing is also underway in our second single-dose cohort at 400 mg… data from complete 200 mg cohorts expected in Q3 and 400 mg single-dose in the fall” — Paul Bolno, CEO .
  • “Our revenue for the first quarter of 2025 was $9.2 million… R&D expenses were $40.6 million… G&A expenses were $18.4 million… net loss was $46.9 million… cash and cash equivalents [were] $243.1 million… sufficient to fund operations into 2027” — Kyle Moran, CFO .
  • “The FDA confirmed… the accelerated approval pathway using dystrophin expression as a surrogate endpoint remains open” — Company press release .

Q&A Highlights

  • INHBE disclosure timing: Company will cut data at predefined time points (1, 3, 6 months); not viewing blinded data; expects biomarkers and weight signals at those intervals .
  • Regulatory divisions: Programs under CDER (not CBER); cadence of communication consistent; comprehensive data package (biomarkers + function) emphasized for DMD and HD .
  • HD imaging: Management defended caudate MRI consistency based on TRACK/PREDICT‑HD and external analyses; continues to pursue allele-selective strategy with robust mHTT lowering and wtHTT sparing .
  • AATD biology: Focus on edited M‑AAT protein levels (functional), with observed serum Z‑protein increases interpreted as liver aggregate breakdown; multi-dose expected to push M‑AAT toward heterozygous levels .
  • DMD label and dosing: Plan to include monthly dosing data in NDA and label; build comprehensive differentiation (dystrophin, muscle health, function, safety) .

Estimates Context

  • Q1 2025 results vs consensus: Revenue $9.175M vs ~$11.34M consensus (miss); diluted EPS $(0.29) vs $(0.256) consensus (miss). Bold miss above; Street may trim near-term collaboration revenue assumptions given timing commentary while awaiting 2H 2025 clinical catalysts . Consensus values retrieved from S&P Global.*

Key Takeaways for Investors

  • DMD thesis strengthening: Functional benefit (TTR), muscle health reversal, and consistent dystrophin underpin an accelerated path; NDA targeted 2026 with monthly dosing—a potential commercial inflection next year .
  • Multiple 2H 2025 catalysts: Obesity (INHBE) initial human data and AATD multi-/higher-dose results are stock-moving events; strong human genetics and differentiated mechanisms (muscle-sparing, durable RNA editing) frame upside scenarios .
  • Revenue volatility expected: Collaboration revenue timing (GSK) drove the Q1 miss; focus should remain on pipeline execution rather than quarterly revenue prints .
  • Cash runway supports execution: $243.1M cash funds operations into 2027 without assuming future milestones—de-risks near-term development timelines .
  • HD program optionality: FDA openness to biomarker path (caudate atrophy) and partner interest create strategic flexibility; IND planned 2H 2025 .
  • Risk management: Regulatory path relies on confirmatory studies post-accelerated approvals; management is engaging proactively on study designs to satisfy endpoints and timing .
  • Trading setup: Near-term sentiment likely tied to obesity readout cadence (1/3/6-months) and AATD durability; DMD regulatory updates can catalyze re-rating ahead of 2026 NDA .