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Vir Biotechnology, Inc. (VIR)·Q4 2024 Earnings Summary
Executive Summary
- Q4 2024 revenue was $12.374M, down year over year versus $16.787M, with EPS of $(0.76) improving from $(0.86); sequential revenue rose sharply from Q3’s $2.380M as collaboration and contract revenue increased .
- Operating discipline drove year-over-year reductions in R&D ($106.083M vs $109.089M) and SG&A ($26.701M vs $41.217M) despite portfolio expansion via Sanofi’s PRO-XTEN platform; net loss narrowed to $(104.589)K from $(115.973)K .
- 2025 financial guidance: cash runway into mid-2027, supported by $1.10B cash, cash equivalents and investments at year-end, with Q4 cash burn of ~$90.6M and FY decline of ~$532.3M largely reflecting Sanofi transaction impacts .
- Catalysts: Phase 3 ECLIPSE (CHD) FPI targeted H1 2025; additional Phase 1 dose-escalation data for HER2 (VIR-5818) and PSMA (VIR-5500), and Phase 1 start for EGFR (VIR-5525) in H1 2025; management emphasized strong early oncology signals and regulatory momentum in hepatitis programs .
What Went Well and What Went Wrong
What Went Well
- Early oncology efficacy and safety: VIR-5818 showed tumor shrinkage in 50% (10/20) at ≥400 µg/kg with 33% confirmed partial responses in HER2+ CRC; VIR-5500 achieved PSA declines in 100% (12/12) mCRPC patients (58% PSA50), with no high-grade CRS and no prophylactic steroids needed .
- Regulatory momentum in CHD: Combination tobevibart + elebsiran received FDA Breakthrough and Fast Track, plus EMA PRIME/Orphan; Phase 3 ECLIPSE advancing to FPI in H1 2025 .
- Cost discipline: 28% YoY reduction in operating expense excluding Sanofi upfront; SG&A down to $26.7M in Q4 (vs $41.2M); FY R&D down despite $102.8M Sanofi upfront recognized as in-process R&D .
Management quotes:
- “2024 was a year of transformation… focusing our resources on our most promising programs…” — CEO Marianne De Backer .
- “We enter 2025 with… $1.10 billion… and a cash runway into mid-2027.” — CFO Jason O’Byrne .
What Went Wrong
- Revenue pressure YoY: Q4 revenue declined to $12.374M from $16.787M primarily due to lower grant revenue (BARDA, Gates), and lower collaboration revenue for FY driven by GSK profit-share releases, partially offset by deferred revenue recognition .
- Interest income down: Other income for Q4 fell to $12.475M from $18.259M on lower interest income, modestly offset by smaller equity investment losses .
- CHB program dependency: Advancement contingent on securing a global partner ex-China; company will proceed only with a development/commercialization partner, increasing execution risk/timing uncertainty .
Financial Results
Quarterly P&L and Cash Trend
Year-over-Year (Q4 2024 vs Q4 2023)
Commentary on Drivers
- Sequential revenue growth to Q4 was driven by collaboration and contract revenue, while YoY declines reflect lower grant revenue and changes in GSK-related collaboration accounting (profit-sharing release and deferred revenue recognition mechanics) .
- Operating expenses fell YoY on personnel and program deprioritizations; FY R&D still reflects $102.8M Sanofi upfront classified as in-process R&D .
- Cash declined ~$90.6M in Q4 and ~$532.3M in FY24, including Sanofi upfront and $75M escrowed milestone reclassified to restricted cash tied to VIR-5525 first-in-human by 2026 .
Guidance Changes
Earnings Call Themes & Trends
Management Commentary
- CEO prepared remarks: “We are poised for significant advancement with the initiation of our Phase 3 registrational program in chronic hepatitis delta and further clinical progression of our dual-masked T-cell engagers in solid tumors.” — Marianne De Backer .
- CMO on CHD efficacy: “At week 60, 80% achieved target not detected levels… unprecedented levels of viral suppression.” — Mark Eisner .
- CMO on HER2: “33% confirmed partial response in colorectal cancer at ≥400 µg/kg… efficacy in MSS tumors resistant to immunotherapies.” — Mark Eisner .
- CFO on cost discipline: “R&D expenses… $507M vs $580M… despite ~$103M Sanofi transaction expenses… net loss improved to $522M.” — Jason O’Byrne .
Q&A Highlights
- PRO-XTEN cleavage efficacy: Dual masks with protease linkers efficiently cleaved in tumor microenvironments; clinical activity with minimal CRS supports tumor-specific activation; ALTUVIIIO cited as clinical validation of XTEN masking .
- ECLIPSE initiation/enrollment: Team targeting H1 2025 FPI; confident in efficient recruitment given unmet need and compelling SOLSTICE data .
- EGFR Phase 1 design: First-in-human basket with patients exhausting standard of care; enrich for EGFR-relevant tumors (NSCLC, H&N, pancreas, CRC); weekly and Q3W dosing considered .
- CHB go/no-go: Functional cure thresholds set at 30% (triplet) and 20% (doublet) based on KOL input; program to advance only with a partner .
- Dose response concerns (PSMA): Early-stage dose escalation; expect deeper and more durable responses at higher doses; HER2 case example showed deepening response with dose increase .
- Alnylam arrangement: Financial-only; option to profit-share or take milestones/royalties; runway assumes short-term opt-out; either path compatible with future CHB partner .
Estimates Context
- Wall Street consensus (S&P Global) for Q4 2024 revenue and EPS was unavailable at time of analysis due to provider request limits; therefore, explicit beat/miss vs estimates cannot be determined here. Values would normally be retrieved from S&P Global; please refresh to incorporate consensus in trading models.*
Key Takeaways for Investors
- CHD is approaching a pivotal Phase 3 start with strong Phase 2 suppression data and multiple expedited designations, positioning the program as a near-term registrational asset .
- Early oncology signals across HER2 and PSMA with favorable safety and no prophylactic steroids suggest PRO-XTEN may expand the therapeutic index, supporting higher, less frequent dosing and combination strategies (e.g., pembro) .
- Fiscal discipline is intact: YoY OpEx reductions and narrowed net loss despite portfolio expansion; runway into mid-2027 provides flexibility to reach clinical inflection points without near-term financing .
- CHB remains a swing factor: functional cure data in Q2 2025 and partnering are prerequisites; outcomes and deal structure will materially affect OpEx trajectory and valuation .
- Near-term catalysts: ECLIPSE FPI (H1 2025), additional HER2/PSMA dose-escalation updates, EGFR Phase 1 initiation—each could drive sentiment and re-rate platform value .
- Revenue remains modest and variable (grants/collaboration), with YoY declines tied to grants and collaboration accounting; stock likely trades on clinical/regulatory milestones rather than near-term P&L .
- Watch Alnylam option and CHB partnership dynamics; either could improve cash profile versus current runway assumptions, providing upside to capital plan .
Footnote: *S&P Global consensus data was unavailable at the time of drafting due to provider limits; please update with the latest consensus before trading decisions.