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Vir Biotechnology, Inc. (VIR)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 results were below Street on revenue and EPS as Vir continues its transition to registrational CHD and early oncology execution: revenue $1.21M vs $2.72M cons. (MISS), EPS −$0.80 vs −$0.72 cons. (MISS), and EBITDA −$116M vs −$109M cons. (MISS).* Actuals reflect de minimis near‑term revenues and ongoing R&D investment .*
  • Cash/investments of $892.1M provide runway into mid‑2027; Q2 cash burn of ~$127.7M included $50.5M of previously expensed ECLIPSE milestones; excluding milestones, net cash used was ~$77.2M .
  • Strategic progress: all three ECLIPSE registrational trials for chronic hepatitis delta (CHD) now enrolling; first patient dosed in Phase 1 EGFR TCE (VIR‑5525); oncology pipeline advancing with HER2 (VIR‑5818) and PSMA (VIR‑5500) dose escalations .
  • Management reiterated mid‑2027 cash runway and highlighted a comprehensive CHD registrational strategy; ECLIPSE 1 primary completion targeted for Dec 2026 (potential filing scenarios include ECLIPSE 1 ± ECLIPSE 2 depending on timing/data) .
  • Stock reaction catalysts: execution on ECLIPSE enrollment and timelines; updated SOLSTICE (48‑wk) data by year‑end 2025; oncology dose‑escalation updates (dose/interval selection, activity signals), and clarity on CHD regulatory path and payer strategy .

What Went Well and What Went Wrong

What Went Well

  • ECLIPSE registrational program fully underway: first patients enrolled in ECLIPSE 2 and 3; ECLIPSE 1 enrolling well, supporting a comprehensive BD/HTA strategy across patient segments .
  • Oncology momentum: first‑in‑human dosing of EGFR TCE VIR‑5525; continued advancement of HER2 (VIR‑5818) and PSMA (VIR‑5500) with IND clearance to combine VIR‑5500 with AR pathway inhibitors in earlier‑line prostate cancer .
  • Cost discipline and opex leverage: R&D and SG&A both down year‑over‑year; restructuring charges immaterial in Q2’25 vs sizable in Q2’24 .

Selected management quotes

  • “All three registrational studies are now actively recruiting patients globally.” — CEO .
  • “VIR‑5525…positions us to potentially address the shortcomings of available treatment options across multiple EGFR‑expressing solid tumors.” — CEO .
  • “Excluding milestone payments, quarterly net cash consumed was approximately $77.2M.” — CFO .

What Went Wrong

  • Revenue/EPS/EBITDA below consensus given limited near‑term revenue drivers: $1.21M vs $2.72M*, EPS −$0.80 vs −$0.72*, EBITDA −$116M vs −$109M*; other income also down YoY on lower interest income .*
  • Cash decreased ~$127.7M in Q2 (inclusive of $50.5M ECLIPSE milestones); restricted cash includes $75M milestone tied to VIR‑5525 FIH dosing (recognized in Q3) — highlighting continuing cash use through development ramp .
  • Minimal top‑line contribution and lower interest income (YoY), keeping losses elevated despite opex savings (net loss −$111.0M) .

Financial Results

Summary P&L and Liquidity (YoY and QoQ)

MetricQ2 2024Q1 2025Q2 2025
Revenue ($M)3.08 3.03 1.21
Net Loss ($M)(138.38) (120.97) (110.96)
Diluted EPS ($)(1.02) (0.88) (0.80)
Total Operating Expenses ($M)161.71 142.58 119.63
LiquidityDec 31, 2024Mar 31, 2025Jun 30, 2025
Cash, Cash Equivalents & Investments ($M)1,100.0 1,020.0 892.1
Restricted Cash & Equivalents ($M)95.7 94.4 95.2

Operating Expense and Other Line Items

Metric ($M)Q2 2024Q1 2025Q2 2025
R&D105.11 118.65 97.51
SG&A30.27 23.94 22.28
Restructuring/Impairment, net26.28 (0.01) (0.17)
Other Income18.74 18.60 7.63

Q2 2025 Actuals vs S&P Global Consensus

MetricActualConsensusBeat/Miss
Revenue ($M)1.21 2.72*MISS
EPS ($)(0.80) (0.72)*MISS
EBITDA ($M)(115.67) (108.78)*MISS

Values marked with * are from S&P Global (consensus). Actuals sourced from company filings.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayFY 2025Into mid‑2027 (Q1’25) Into mid‑2027 (Q2’25) Maintained
ECLIPSE 1 primary completionProgram timelineNot disclosed (Q1’25)Dec 2026 (target) New disclosure
CHD registrational filing approachRegulatory strategyBase case ECLIPSE 1+2 (Q1’25 narrative)Base case ECLIPSE 1+2; if timing diverges, may consider ECLIPSE 1 + SOLSTICE discussion with FDA Clarified

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024)Previous Mentions (Q1 2025)Current Period (Q2 2025)Trend
CHD ECLIPSE program statusPhase 3 program planned to begin 1H25 ECLIPSE 1 first patient enrolled; plans for ECLIPSE 2 First patients now enrolled in ECLIPSE 2 & 3; all three studies enrolling; ECLIPSE 1 primary completion Dec 2026 Execution progressing; timelines firming
Regulatory/filing pathDesignations (BTD, Fast Track, PRIME, Orphan) reiterated Same; partner flexibility outside U.S. (Alnylam opt‑out) Base case uses ECLIPSE 1+2; possible initial filing ECLIPSE 1 + SOLSTICE depending on timing/data Filing optionality clarified
Oncology (TCEs)Positive early Phase 1 signals for HER2/PSMA; plan to start EGFR in 1H25 HER2/PSMA dose escalation continues; EGFR Phase 1 initiation planned Q2 EGFR VIR‑5525 first‑in‑human dosed; IND cleared for earlier‑line PSMA combinations Portfolio broadened; earlier‑line strategy
Commercial strategy (CHD)N/A specificN/A specificConcentrated U.S./EU patient geography; targeted specialty force; payer/HTA supported by ECLIPSE 3 head‑to‑head Increasing commercial color
Financial disciplineCost‑saving initiatives underway Opex control with restructuring benefits YoY opex down; runway reiterated mid‑2027 Stable discipline

Management Commentary

  • Strategic priorities: “Driving enrollment across all three ECLIPSE studies… advancing our clinical stage T cell engager programs… and executing on our business development strategies” — CEO .
  • CHD opportunity and market approach: “Patient population is geographically concentrated… efficient commercial approach… value‑based pricing model… pursuing commercialization partnerships in Europe” — CEO .
  • Oncology platform: “PRO‑XTEN masking technology… designed to minimize systemic toxicity while enabling selective killing of cancer cells” — Press release .
  • Financial posture: “We ended the second quarter with approximately $892M… cash runway extending into mid‑2027” — CFO .

Q&A Highlights

  • ECLIPSE enrollment/timing: Enrollment “going very well” for ECLIPSE 1; first patients enrolled for ECLIPSE 2/3; ECLIPSE 1 primary completion expected Dec 2026; more detailed enrollment updates to come .
  • Filing strategy optionality: Base case uses ECLIPSE 1+2; if timelines diverge, could discuss ECLIPSE 1 + SOLSTICE with FDA; ECLIPSE 2 has 24‑wk primary endpoint and may complete on similar timeline .
  • EGFR (VIR‑5525) dosing rationale: Start at MABEL‑based weekly dose per regulatory norms; potential to move to less‑frequent dosing as supported by preclinical PK/half‑life and experience with other TCEs .
  • Competitive landscape (CHD): Possible U.S. bulevirtide approval could aid education/screening; Vir aims for >60% HDV RNA TND at Wk48 vs ~12% on bulevirtide, with monthly administration convenience .
  • PSMA (VIR‑5500): Q3W dosing under evaluation; IND cleared for earlier‑line combinations; aiming for convenience and to avoid resensitization issues common in TCE step‑up regimens .

Estimates Context

  • Q2 2025 vs S&P Global consensus: revenue $1.21M vs $2.72M*, EPS −$0.80 vs −$0.72*, EBITDA −$115.7M vs −$108.8M* (6 revenue ests, 7 EPS ests).* Actuals reflect negligible near‑term product revenue; losses driven by R&D into registrational CHD and oncology .*
  • Forward look (Street): EPS consensus trends remain negative for the next two quarters (Q3’25 −0.86*, Q4’25 −0.63*); revenue expectations remain de minimis (low single‑million dollars per quarter*), consistent with pre‑commercial profile.* Values marked with * are from S&P Global (consensus).

Key Takeaways for Investors

  • Results underscored the pre‑commercial profile: low revenue and negative EPS/EBITDA, with opex trending down; near‑term stock moves likely tied to clinical/regulatory milestones, not quarterly P&L .
  • Vir executed on critical CHD milestones: all ECLIPSE trials enrolling; clarity on ECLIPSE 1 primary completion (Dec 2026) and filing options improves visibility to regulatory path .
  • Oncology pipeline broadened with EGFR TCE (VIR‑5525) now dosing; platform consistency (HER2/PSMA) supports potential safety/PK advantages and less‑frequent dosing — a potential differentiation lever .
  • Cash runway into mid‑2027 provides adequate time to reach CHD and oncology value inflections; Q3 will include a $75M milestone expense for VIR‑5525 FIH dosing (held in restricted cash), so expect elevated near‑term cash use .
  • Expect additional catalysts: full 48‑week SOLSTICE dataset by YE25; further HER2/PSMA updates (dose/interval decisions, durability/response depth); ECLIPSE enrollment/operational updates — potential drivers for estimate revisions and sentiment .
  • Competitive dynamics in CHD may be net‑positive near term if bulevirtide expands awareness/testing; Vir positions combination as best‑in‑disease on virologic suppression and convenience (monthly) — important for payer/HTA .

Appendix: Additional Detail

  • Q2 financial constructs: Revenue $1.21M (contract/grant mix), R&D $97.5M (incl. $6.9M SBC), SG&A $22.3M (incl. $5.5M SBC), other income $7.6M (lower interest income YoY), net loss −$111.0M (−$0.80/sh) .
  • Liquidity: $892.1M cash/investments at 6/30; $95.2M restricted (incl. $75M Sanofi milestone tied to VIR‑5525, triggered July 2025) .
  • Program notes: ECLIPSE 3 head‑to‑head vs bulevirtide designed to support EU HTA/access; ECLIPSE 2 addresses bulevirtide inadequate responders; ECLIPSE 1 in geographies with limited bulevirtide access .

Values marked with * are from S&P Global.