Orchestra BioMed Holdings, Inc. OBIO
Our vision is to accelerate medical innovation to patients through risk-reward-sharing partnerships with leading medical device companies.
We are a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. We are led by a highly accomplished, multidisciplinary management team and a board of directors with extensive experience in all phases of therapeutic device development. Our business was formed in 2018 by assembling a pipeline of multiple late-stage clinical product candidates originally developed by our founding team.
Our flagship product candidates are Atrioventricular Interval Modulation Therapy ("AVIM Therapy") for the treatment of hypertension ("HTN"), the leading risk factor for death worldwide, and Virtue® Sirolimus AngioInfusion™ Balloon ("Virtue SAB") for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. We have an exclusive license and collaboration agreement with Medtronic, Inc. (an affiliate of Medtronic plc) ("Medtronic") for the development and commercialization of AVIM Therapy for the treatment of uncontrolled HTN in patients indicated for a cardiac pacemaker (as amended, the "Medtronic Agreement"). We are actively conducting a double-blind, randomized, global pivotal study (the "BACKBEAT study"), enrolling up to 500 patients with uncontrolled hypertension who are indicated for a Medtronic dual-chamber pacemaker, with enrollment completion currently planned for mid-2026. We recently initiated patient enrollments in the Virtue SAB in the Treatment of Coronary In-Stent Restenosis ("ISR") Trial (the "Virtue Trial") for our U.S. investigational device exemption ("IDE") pivotal study randomizing Virtue SAB vs. Boston Scientific Corporation's AGENT™ drug-coated balloon. Designed to support regulatory approval of Virtue SAB, the Virtue Trial is expected to enroll 740 patients in the United States with enrollment completion currently planned for mid-2027.
Valuation FY2025 figures against the last close
Annual financial statements
Income statement
| Fiscal year | FY2025 | FY2024 | FY2023 | FY2022 | FY2021 | FY2020 |
|---|---|---|---|---|---|---|
| Revenue | $33.5M | $2.6M | $2.8M | $3.5M | — | — |
| Cost of revenue | $190.0K | $204.0K | $186.0K | $211.0K | — | — |
| Gross profit | $33.3M | $2.4M | $2.6M | $3.3M | — | — |
| R&D | $58.2M | $42.8M | $33.8M | $21.9M | — | — |
| SG&A | $26.9M | $23.9M | $20.3M | $14.0M | $274.8K | — |
| Total operating expenses | $85.3M | $66.9M | $54.3M | $36.2M | — | — |
| Operating income | -$51.8M | -$64.3M | -$51.5M | -$32.7M | -$394.8K | — |
| Interest expense | — | — | $3.8M | $50.0K | — | — |
| Pre-tax income | -$52.7M | — | — | — | — | — |
| Income tax | $0 | — | — | — | — | — |
| Net income | -$52.7M | -$61.0M | -$49.1M | -$33.6M | -$378.8K | — |
| EPS, basic | -1.11 | -1.66 | -1.48 | -2.24 | -0.02 | — |
| EPS, diluted | -1.11 | -1.66 | -1.48 | -2.24 | -0.02 | — |
| Shares, diluted (wtd. avg.) | 47.7M | 36.8M | 33.2M | 15.0M | 20.4M | — |
Balance sheet
| Fiscal year | FY2025 | FY2024 | FY2023 | FY2022 | FY2021 | FY2020 |
|---|---|---|---|---|---|---|
| Cash and equivalents | $34.7M | $22.3M | $30.6M | $19.8M | $9.9M | $2.0M |
| Short-term investments | $71.8M | $44.6M | $57.0M | $63.9M | — | — |
| Receivables | $95.0K | $92.0K | $99.0K | $96.0K | — | — |
| Inventory | $310.0K | $173.0K | $146.0K | $276.0K | — | — |
| Total current assets | $107.9M | $69.2M | $89.1M | $84.7M | $1.8M | $2.1M |
| Property, plant and equipment | $1.7M | $1.4M | $1.3M | $1.5M | — | — |
| Total assets | $114.9M | $76.2M | $95.2M | $95.6M | $161.8M | $162.2M |
| Accounts payable | $6.1M | $5.1M | $2.9M | $4.0M | $1.4K | $13.8K |
| Total current liabilities | $16.7M | $16.2M | $11.2M | $18.6M | $165.5K | $119.0K |
| Long-term debt | $15.0M | $15.0M | — | — | — | — |
| Total liabilities | $51.5M | $43.2M | $27.2M | $43.0M | $5.8M | $5.7M |
| Retained earnings | -$362.6M | -$309.9M | -$248.9M | -$199.7M | -$3.9M | -$3.6M |
| Total equity | $53.6M | $33.0M | $68.0M | $52.5M | -$19.8M | -$3.6M |
Cash flow
| Fiscal year | FY2025 | FY2024 | FY2023 | FY2022 | FY2021 | FY2020 |
|---|---|---|---|---|---|---|
| Operating cash flow | -$49.0M | -$50.6M | -$46.1M | -$29.3M | -$272.4K | — |
| Depreciation and amortisation | $327.0K | $308.0K | $287.0K | $222.0K | — | — |
| Stock-based compensation | $12.0M | $10.6M | $7.6M | $3.4M | — | — |
| Capital expenditure | $489.0K | $289.0K | $78.0K | $591.0K | — | — |
| Investing cash flow | -$26.9M | $13.1M | $10.7M | -$64.1M | — | — |
| Financing cash flow | $88.3M | $29.2M | $46.2M | $103.3M | — | — |
Figures as tagged in each year's own filing, in US dollars. A year restated by a later filing shows the restated figure. Capital expenditure, dividends and buybacks are cash out, shown positive. A line the filer does not report is not listed. Latest from accession 0001104659-26-026754.
Plot the figures US dollars
- Revenue
- Gross profit
- Net income
| Fiscal year | FY2020 | FY2021 | FY2022 | FY2023 | FY2024 | FY2025 |
|---|---|---|---|---|---|---|
| Revenue | — | — | $3.5M | $2.8M | $2.6M | $33.5M |
| Gross profit | — | — | $3.3M | $2.6M | $2.4M | $33.3M |
| Net income | — | -$378.8K | -$33.6M | -$49.1M | -$61.0M | -$52.7M |
Recent filings and events
- Shareholder vote The results of the annual meeting or a special vote. Item 5.07
- Annual report filed A new 10-K. The figures and the business description on this site come from it. Form 10-K
- Officer or director change Someone at the top arrived or left. The item covers everything from a board retirement to a chief executive being removed, and only the filing itself says which. Item 5.02
- Other event The catch-all. The company chose to disclose something that fits no other item, so the content is whatever it says it is. Item 8.01
- Regulation FD disclosure Something the company told the market and had to tell everyone at once - usually a slide deck or a press release. Item 7.01
- Regulation FD disclosure Item 7.01
- Material agreement signed The company entered an agreement outside the ordinary course of business - a large contract, a credit facility, a merger agreement. Item 1.01
- Material agreement terminated An agreement that mattered has ended. Often the other half of a deal that fell through. Item 1.02
- Unregistered share sale Shares issued outside a registered offering. Dilution, and for a small company often the way it is funded. Item 3.02
- Regulation FD disclosure Item 7.01
- Other event Item 8.01
- Material agreement signed Item 1.01
Item numbers are Form 8-K's own, and a filing date is up to four business days after the thing it reports. The same feed across the whole market.
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