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10-K2026-03-12· grok-4-1-fast-non-reasoning

OBIO · Orchestra BioMed Holdings, Inc.

0001104659-26-026754

SEC filing

Summary

Orchestra BioMed Holdings, Inc. (OBIO) reported FY 2025 total revenue of $33.5M, a 1,169% YoY increase from $2.6M in 2024, driven by $32.9M in partnership revenue from the Terumo Termination and ROFR Agreement, including $10.0M upfront and $7.4M premium on Series A Preferred Stock issuance, plus recognition of remaining $15.4M deferred revenue. Product revenue from FreeHold retractors was stable at $0.6M. Despite revenue growth, net loss narrowed to -$52.7M from -$61.0M, with EPS improving to -$1 from -$1.66 on 47.7M weighted shares. Operating loss improved to -$51.8M from -$64.3M, reflecting higher R&D ($58.2M, +36%) for BACKBEAT and Virtue Trials, and SG&A ($26.9M, +12%). Cash position strengthened to $106.5M ($34.7M cash + $71.8M marketable securities), supporting operations into Q4 2027. Financing included $57.8M from common stock/pre-funded warrants, $20.0M royalty proceeds from Ligand, and $12.6M Series A issuance. Total assets reached $114.9M, with $51.5M liabilities including $16.5M royalty liability and $14.3M loan payable. Focus remains on pivotal trials for AVIM Therapy (enrollment mid-2026) and Virtue SAB (mid-2027), with partnerships enabling commercialization.

Key takeaways

Full analysis

Performance Summary

Orchestra BioMed reported FY 2025 total revenue of $33.5M, up 1,169% YoY from $2.6M, primarily from $32.9M partnership revenue tied to Terumo Termination and ROFR Agreement ($10.0M upfront, $7.4M Series A premium, $15.4M deferred revenue recognition). Product revenue remained flat at $0.6M. Net loss improved to -$52.7M (14% better than -$61.0M), with operating loss at -$51.8M vs. -$64.3M prior year. EPS was -$1 on 47.7M shares vs. -$1.66 prior. R&D rose 36% to $58.2M supporting BACKBEAT (mid-2026 enrollment) and Virtue Trials (mid-2027). Cash flow used $49.0M in operations; balance sheet shows $106.5M liquidity.

Revenue Analysis

Partnership revenue surged to $32.9M (1,539% YoY) from Terumo deal termination, recognizing full deferred revenue and ROFR fee. No Medtronic revenue yet. Product revenue $0.6M from FreeHold retractors, down 3% on lower volume. Single operating segment focused on clinical development. No geographic breakdown disclosed.

Margins & Profitability

Gross profit not directly stated; cost of product revenues $190K (down 7%). Operating margin negative at -155% (improved from -2,437%). Total expenses $85.3M (+27% YoY), driven by R&D (+36%) and SG&A (+12%). Loss from operations -$51.8M. Other expense -$0.9M includes -$1.1M net interest from royalty/debt.

Cash Flow & Balance Sheet

Operating cash use $49.0M (similar to $50.6M prior). Investing -$26.9M (net securities activity). Financing +$88.3M from equity ($57.8M + $1.5M ATM), royalty $20.0M, Series A $12.6M. Cash + equivalents $34.7M, marketable $71.8M (total $106.5M). Total assets $114.9M; liabilities $51.5M (royalty $16.5M, loan $14.3M, derivative $2.7M). Equity $53.6M; accumulated deficit -$362.6M.

Outlook

Liquidity supports operations to Q4 2027. Priorities: BACKBEAT enrollment mid-2026, Virtue Trial mid-2027. Expected inflows: $20.0M Medtronic loan (Apr 2026), $15.0M Ligand (May 2026), up to $10.7M Vivasure (2026). Risks include trial delays, funding needs, partnership execution. No quantitative guidance provided.