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Vir Biotechnology, Inc. (VIR)·Q3 2025 Earnings Summary

Executive Summary

  • Vir reported minimal revenue ($0.24M) and a net loss of $163.1M ($1.17 EPS) in Q3, reflecting ongoing R&D investment and limited near-term revenue drivers; results missed Wall Street consensus on revenue, EPS, and EBITDA; cash and investments were $810.7M with runway into mid‑2027 .
  • Operational execution was strong: ECLIPSE 1 (CHD) enrollment completed ~2 months ahead of schedule; ECLIPSE 2/3 maintained robust momentum; first patient dosed in ARPI combination for mCRPC; comprehensive VIR‑5500 update guided for Q1 2026 .
  • Guidance maintained: runway into mid‑2027 and program timelines (ECLIPSE topline for all three studies expected Q1 2027); Q3 saw lower interest income vs. 2024 and significant R&D including a $75M milestone paid from restricted cash (no runway impact) .
  • Near‑term catalysts: AASLD Nov 9 oral presentation of SOLSTICE 48‑week CHD data; Q1 2026 VIR‑5500 data update; ongoing ECLIPSE enrollment/activation; potential U.S. bulevirtide approval in H2 2026 could expand awareness/testing and support future launch dynamics .

What Went Well and What Went Wrong

What Went Well

  • ECLIPSE 1 enrollment finished ~two months early; ECLIPSE 2 and 3 tracking well, establishing a backbone for U.S./EU filings and payer discussions. “Our third quarter demonstrated exceptional execution across our clinical portfolio” — CEO Marianne De Backer .
  • Oncology TCE progress: first patient dosed in ARPI combo (first‑line mCRPC); VIR‑5500 escalation on weekly and Q3‑week schedules with no MTD reached, planning a comprehensive update in Q1 2026 .
  • Liquidity preserved: $810.7M cash/investments; runway into mid‑2027; $75M milestone paid from restricted cash (escrow) with no impact on reported cash or runway—supports continued execution across registrational CHD and oncology programs .

What Went Wrong

  • Revenue remained de minimis ($0.24M) vs. consensus ($1.98M*) and vs. prior year ($2.38M), driving limited gross margin utility and magnifying operating loss optics [GetEstimates Q3 2025 Revenue Consensus Mean*].
  • EPS and EBITDA missed consensus (EPS −$1.17 vs. −$0.86*, EBITDA −$170.4M vs. −$103.5M*), reflecting higher clinical spend and lower interest income YoY [GetEstimates Q3 2025 Primary EPS Consensus Mean*] [GetEstimates Q3 2025 EBITDA Consensus Mean*].
  • Interest income fell YoY ($9.36M vs. $17.53M), tightening other‑income tailwinds; operating cash use and net change in cash/investments were sizable in Q3 (approx. $81.4M decrease), underscoring continued cash burn while advancing programs .

Financial Results

Quarterly Performance (GAAP)

MetricQ1 2025Q2 2025Q3 2025
Revenue ($USD Millions)$3.03 $1.21 $0.24
Net Income ($USD Millions)$(120.97) $(110.96) $(163.14)
Diluted EPS (GAAP)$(0.88) $(0.80) $(1.17)
Total Operating Expenses ($USD Millions)$142.58 $119.63 $173.68
R&D Expense ($USD Millions)$118.65 $97.51 $151.46
SG&A Expense ($USD Millions)$23.94 $22.28 $22.23
Other Income ($USD Millions)$18.60 $7.63 $10.47
Cash & Investments (period-end) ($USD Millions)~$1,020.0 $892.1 $810.7

Q3 Year-over-Year Snapshot

MetricQ3 2024Q3 2025
Revenue ($USD Millions)$2.38 $0.24
R&D Expense ($USD Millions)$195.18 $151.46
SG&A Expense ($USD Millions)$25.74 $22.23
Net Loss ($USD Millions)$(213.72) $(163.14)
Interest Income ($USD Millions)$17.53 $9.36

Margins (not meaningful due to de minimis revenue)

Margin MetricQ1 2025Q2 2025Q3 2025
EBITDA Margin %NM (de minimis revenue)NM (de minimis revenue)NM (de minimis revenue)
EBIT Margin %NM (de minimis revenue)NM (de minimis revenue)NM (de minimis revenue)
Net Income Margin %NM (de minimis revenue)NM (de minimis revenue)NM (de minimis revenue)

Revenue Composition (by source)

Revenue Source ($USD Thousands)Q1 2025Q2 2025Q3 2025
Collaboration$(70) $(495) $(65)
Contract$1,864 $1,526 —
Grant$1,238 $183 $305
Total Revenues$3,032 $1,214 $240

Estimates vs. Actuals (S&P Global consensus)

MetricQ2 2025 EstimateQ2 2025 ActualQ3 2025 EstimateQ3 2025 Actual
Revenue ($USD)$2,722,000*$1,214,000 $1,983,430*$240,000
Primary EPS (GAAP)$(0.7183)*$(0.80) $(0.8604)*$(1.17)
EBITDA ($USD)$(108,775,000)*$(115,672,000)*$(103,450,000)*$(170,445,000)*

Values with asterisk (*) retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayFY 2025+Into mid‑2027 Into mid‑2027 Maintained
ECLIPSE program topline timingCHDN/A (earlier guidance: primary completion Dec 2026 for ECLIPSE 1) Topline for ECLIPSE 1/2/3 expected Q1 2027 Clarified timeline
VIR‑5500 data updateOncologyOngoing dose escalation Comprehensive data update planned Q1 2026 New timing detail

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2025)Previous Mentions (Q2 2025)Current Period (Q3 2025)Trend
CHD ECLIPSE enrollment/timelineFirst patient dosed in ECLIPSE 1; plan for ECLIPSE 2/3; composite endpoints and regulatory designations (BTD, Fast Track, PRIME, Orphan) ECLIPSE 2/3 initiated; ECLIPSE 1 primary completion targeted Dec 2026; U.S./EU filing backbone ECLIPSE 1 enrollment completed ~2 months early; topline all three studies in Q1 2027 Accelerating execution; timeline clarity
VIR‑5500 (PSMA) programDose escalation; early PSA50 signals; Q3‑week dosing potential (8–10 day half‑life) No MTD reached; expanding into earlier lines; IND cleared for ARPI combo First patient in ARPI combo; Q1 2026 comprehensive update guided; weekly and Q3‑week schedules Building toward major data catalyst
VIR‑5818 (HER2)33% confirmed PR in HER2+ CRC at ≥400 µg/kg; durability >18 months Monotherapy escalation completed; analyzing data; continuing pembrolizumab combo Combo dose escalation ongoing; active enrollment; platform validation narrative Continued progression
VIR‑5525 (EGFR)Phase 1 initiation planned Q2 2025 First patient dosed; program advancing Milestone payment triggered by first‑in‑human dosing; enrollment progressing Program initiated; milestone cash dynamics clarified
Competitive landscape (bulevirtide)Target not detected rates vs. bulevirtide (12% at wk48) positioning; chronic suppression strategy Head‑to‑head ECLIPSE 3 designed for payer/HTA; superiority goal Gilead H2 2026 approval viewed as positive for awareness/testing; dosing (10mg vs 2mg) immaterial to differentiation Constructive competitor dynamic
Cash runway and capital discipline~$1.0B; runway into mid‑2027 $892.1M; runway into mid‑2027 $810.7M; runway into mid‑2027; restricted cash payments do not affect runway Runway maintained amid spend

Management Commentary

  • “We completed ECLIPSE 1 enrollment approximately two months ahead of schedule and continue to see strong momentum across ECLIPSE 2 and 3, positioning us well for our hepatitis delta regulatory submissions.” — CEO Marianne De Backer .
  • “We are excited to provide guidance for a comprehensive VIR‑5500 data update in the first quarter of 2026.” — CEO Marianne De Backer .
  • “Based on our current operating plan, we continue to project our cash runway extending into mid‑2027.” — CFO Jason O’Byrne .
  • “We have not reached a maximum tolerated dose [for VIR‑5500], and escalation continues as planned… half‑life of eight to ten days potentially supports our every three‑week dosing evaluation.” — CMO Mark Eisner .
  • “We think [Gilead’s bulevirtide launch] will help drive disease awareness and HDV testing, preparing the landscape for our launch.” — CMO Mark Eisner .

Q&A Highlights

  • PSMA TCE differentiation vs. peers: Dual‑mask PRO‑XTEN approach, steric hindrance masking on both CD3 and target arms; focus on depth/durability of PSA response; Q1 2026 update will include weekly and Q3‑week data across dose levels .
  • HDV addressable market and launch approach: ~61,000 viremic U.S. patients; broad eligibility (high/low viral load; compensated cirrhosis/non‑cirrhotic); KOL/advocacy/diagnostics engagement; Gilead launch seen as awareness driver .
  • Safety/signals in VIR‑5500 escalation: No MTD reached; safety specifics deferred to Q1 2026 update; Q3‑week dosing supported by PK/half‑life .
  • AASLD SOLSTICE 48‑week: Expect deeper responses over time; full update to inform physicians ahead of potential launch .
  • Regulatory strategy: Base‑case U.S./EU filing anchored by ECLIPSE 1 and 2; ECLIPSE 3 supports payer/HTA via head‑to‑head superiority; accelerated approval sought based on virologic/ALT endpoints .

Estimates Context

  • Q3 2025: Revenue $0.24M vs. $1.98M* (miss), EPS −$1.17 vs. −$0.86* (miss), EBITDA −$170.4M* vs. −$103.5M* (miss); analyst count: EPS 7*, Revenue 7* [GetEstimates Q3 2025 Primary EPS Consensus Mean*] [GetEstimates Q3 2025 Revenue Consensus Mean*] [GetEstimates Q3 2025 EBITDA Consensus Mean*] [GetEstimates Q3 2025 Primary EPS - # of Estimates*] [GetEstimates Q3 2025 Revenue - # of Estimates*].
  • Q2 2025 for trend: Revenue $1.21M vs. $2.72M* (miss), EPS −$0.80 vs. −$0.72* (miss), EBITDA −$115.7M* vs. −$108.8M* (miss) [GetEstimates Q2 2025 Revenue Consensus Mean*] [GetEstimates Q2 2025 Primary EPS Consensus Mean*] [GetEstimates Q2 2025 EBITDA Consensus Mean*].
  • Implications: Street may need to adjust near‑term revenue expectations lower given de minimis grant/contract revenues and lack of commercial products; opex/EBITDA trajectories reflect continued investment in registrational CHD and oncology programs, with runway guidance sustained.

Values with asterisk (*) retrieved from S&P Global.

Key Takeaways for Investors

  • Execution over earnings: Clinical milestones (ECLIPSE 1 early completion, ARPI combo start) and clear timelines (Q1 2026 VIR‑5500 update; Q1 2027 topline across ECLIPSE) are the primary stock drivers near term .
  • De minimis revenue likely persists until regulatory/launch events; expect continued misses to Street quarterly estimates absent milestone/partner inflows .
  • Cash runway into mid‑2027 provides sufficient funding to reach CHD pivotal readouts and oncology data catalysts; restricted cash mechanics mitigate headline cash burn optics .
  • Competitive dynamics favorable: Anticipated U.S. bulevirtide approval could expand testing/awareness, potentially enlarging the treatable market for Vir’s combination regimen .
  • Watch AASLD (Nov 9) for 48‑week SOLSTICE data—depth/durability updates may inform payer, physician education, and confidence in ECLIPSE assumptions .
  • VIR‑5500’s Q3‑week dosing potential and dual‑mask platform differentiation are central to mCRPC positioning; Q1 2026 update is a major inflection point .
  • Payer/HTA strategy: ECLIPSE 3 head‑to‑head superiority vs. bulevirtide is designed to support EU access/reimbursement post‑approval .

Notes:

  • Q3 2025 8‑K 2.02 press release and financials: .
  • Q3 2025 earnings call transcripts: and duplicate transcript -.
  • Additional Q3 press release (conference participation): .
  • Prior two quarters: Q2 2025 8‑K/financials and call - -; Q1 2025 8‑K/financials and call - -.
  • Values with asterisk (*) retrieved from S&P Global.