$106.5 million cash position as ofDecember 31, 2025 to be further enhanced by$35 million expected from Medtronic and Ligand in Q2 2026 from previously announced transactions, as well as Haemonetics’ Vivasure acquisition proceeds$33.5 million in 2025 non-recurring revenue primarily driven by impact of new Virtue SAB agreement with Terumo that was announced inOctober 2025 - Strong balance sheet supports focused execution of pivotal trials for both AVIM Therapy and Virtue SAB programs
Hochman continued, “As we enter 2026 with two pivotal trials underway, we remain focused on disciplined execution and long-term value creation for patients, clinicians and shareholders. We are encouraged by the accelerated pace of enrollment in the BACKBEAT global pivotal study following protocol amendments implemented in the fourth quarter and we plan to provide a substantive update in our next quarterly report. We are also pleased with the early progress of the Virtue Trial, which we initiated during the fourth quarter of 2025. We expect to provide additional updates on this trial, which is randomizing coronary in-stent restenosis patients to treatment with Virtue SAB versus the AGENT™ paclitaxel-coated balloon, as we gain further visibility into enrollment trends over the course of the year.”
Q4 2025 and Recent Business Highlights:
- Accelerated patient enrollment of the BACKBEAT global pivotal study, in collaboration with Medtronic (NYSE: MDT), evaluating the efficacy and safety of Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) for the treatment of uncontrolled hypertension in patients indicated for a pacemaker.
- Initiated patient enrollments in the Virtue SAB
U.S. pivotal trial, a randomized head-to-head IDE registrational clinical trial comparing Virtue SAB with the commercially available AGENT paclitaxel-coated balloon for the treatment of coronary in-stent restenosis (the “Virtue Trial”). - Entered into an agreement with Terumo (“ROFR Agreement”) pursuant to which we and Terumo terminated our distribution agreement, and
Orchestra BioMed granted Terumo a right of first refusal (the “ROFR”) with respect to certain strategic transactions relating to Virtue® Sirolimus AngioInfusionTM Balloon (“Virtue SAB”) for the treatment of coronary artery disease globally in exchange for a fee of$10.0 million . In connection with the ROFR Agreement, Terumo invested an additional$20.0 million inOrchestra BioMed through a new series of non-voting convertible preferred stock (the “Series A Preferred Stock”), which is convertible into common stock in the future, subject to certain conditions, at a minimum of$12 per share. - Up to
$21 million in total proceeds expected in connection with the acquisition ofVivasure Medical , previously a strategic holding ofOrchestra BioMed , by Haemonetics.Orchestra BioMed expects to receive up to$10.7 million of these proceeds in 2026, including an initial upfront payment of$4.7 million received inJanuary 2026 and the remainder expected later in the year as a first-milestone payment. The Company may receive additional proceeds in the future associated with potential revenue earnouts.
Financial Results for the Year Ended
- Revenue for 2025 was
$33.5 million , compared with$2.6 million for 2024, which represents an increase of 1,539%. The increase is primarily due to recognizing the remainder of the deferred revenue from our prior distribution agreement with Terumo of$15.4 million as a result of the termination of that agreement,$10.0 million in consideration for the ROFR, and$7.4 million associated with the premium paid above the fair market value of the Series A Preferred Stock. - Research and development expenses for 2025 were
$58.2 million , compared with$42.8 million for 2024, which represents an increase of 36%. The increase was primarily due to additional costs associated with the ongoing BACKBEAT global pivotal study and to advance the Virtue SAB program, including the Virtue Trial. - Selling, general and administrative expenses for 2025 were
$26.9 million , compared with$23.9 million for 2024, which represents an increase of 12%. The increase was primarily due to an increase in professional fees. - Net loss attributable to common stockholders for 2025 was
$52.7 million , or ($1.11 ) per share, compared with a net loss attributable to common stockholders of$61.0 million , or ($1.66 ) per share, for 2024 which represents a decrease of 14%. Net loss attributable to common stockholders for the year-ended 2025 included non-cash stock-based compensation expense of$12.0 million , compared with$10.6 million for the same period in 2024, representing an increase of 13%. - Net cash used in operating activities and for the purchase of fixed assets excluding the payment for the ROFR and the Series A Preferred Stock premium, which was recognized as revenue, was
$66.9 million during 2025, compared with$50.8 million for 2024, with the primary driver of this increase being increased cash outflows for research and development, including clinical trial activities, during 2025. - Cash and cash equivalents and Marketable securities totaled
$106 .5 million as ofDecember 31, 2025 . The Company has commitments from Ligand and Medtronic to receive a combined$35.0 million in additional proceeds on or beforeMay 1, 2026 , based on the terms of agreements with those parties and subject to the conditions therein. Additionally, inJanuary 2026 , Haemonetics closed on the acquisition of Vivasure in which we expect to receive up to$10.7 million of proceeds in 2026, consisting of an upfront payment of approximately$4.7 million , which has already been received, and approximately$6.0 million expected to be received in a first milestone payment.
About
Forward-Looking Statements
Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the proceeds expected to be received by the Company pursuant to the achievement of certain milestones in connection with the acquisition of Vivasure by Haemonetics; and the timing of any update on anticipated enrollment completion and potential primary endpoint results with respect to the BACKBEAT global pivotal study as well as the provision of any update on the Virtue Trial. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended
The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law.
Investor Contact:
Snewcomb@orchestrabiomed.com
Media Contact:
kkirkellis@orchestrabiomed.com
Consolidated Balance Sheets (in thousands, except share and per share data) (unaudited) | ||||||||
| 2025 | 2024 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 34,690 | $ | 22,261 | ||||
| Marketable securities | 71,822 | 44,551 | ||||||
| Accounts receivable, net | 95 | 92 | ||||||
| Inventory | 310 | 173 | ||||||
| Prepaid expenses and other current assets | 994 | 2,094 | ||||||
| Total current assets | 107,911 | 69,171 | ||||||
| Property and equipment, net | 1,715 | 1,384 | ||||||
| Right-of-use assets | 1,496 | 2,103 | ||||||
| Strategic investments | 2,495 | 2,495 | ||||||
| Deposits and other assets | 1,240 | 1,020 | ||||||
| TOTAL ASSETS | $ | 114,857 | $ | 76,173 | ||||
| LIABILITIES, SERIES A PREFERRED STOCK AND STOCKHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable | $ | 6,095 | $ | 5,134 | ||||
| Accrued expenses and other liabilities | 9,890 | 6,084 | ||||||
| Operating lease liability, current portion | 751 | 550 | ||||||
| Deferred revenue, current portion | — | 4,439 | ||||||
| Total current liabilities | 16,736 | 16,207 | ||||||
| Deferred revenue, less current portion | — | 10,989 | ||||||
| Royalty purchase agreement | 16,482 | — | ||||||
| Loan payable | 14,268 | 14,292 | ||||||
| Derivative liability | 2,749 | — | ||||||
| Operating lease liability, less current portion | 936 | 1,687 | ||||||
| Other long-term liabilities | 308 | 40 | ||||||
| TOTAL LIABILITIES | 51,479 | 43,215 | ||||||
| Series A Preferred Stock, | 9,808 | — | ||||||
| STOCKHOLDERS’ EQUITY | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 6 | 4 | ||||||
| Additional paid-in capital | 416,083 | 342,780 | ||||||
| Accumulated other comprehensive income | 60 | 52 | ||||||
| Accumulated deficit | (362,579 | ) | (309,878 | ) | ||||
| TOTAL STOCKHOLDERS’ EQUITY | 53,570 | 32,958 | ||||||
| TOTAL LIABILITIES, SERIES A PREFERRED STOCK AND STOCKHOLDERS’ EQUITY | $ | 114,857 | $ | 76,173 | ||||
| ORCHESTRA BIOMED HOLDINGS, INC. Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) (unaudited) | ||||||||
| Year Ended | ||||||||
| 2025 | 2024 | |||||||
| Revenue: | ||||||||
| Partnership revenue | $ | 32,871 | $ | 2,005 | ||||
| Product revenue | 611 | 633 | ||||||
| Total revenue | 33,482 | 2,638 | ||||||
| Expenses: | ||||||||
| Cost of product revenues | 190 | 204 | ||||||
| Research and development | 58,185 | 42,804 | ||||||
| Selling, general and administrative | 26,914 | 23,931 | ||||||
| Total expenses | 85,289 | 66,939 | ||||||
| Loss from operations | (51,807 | ) | (64,301 | ) | ||||
| Other (expense) income: | ||||||||
| Interest (expense) income, net | (1,148 | ) | 3,356 | |||||
| Change in the fair value of derivative liability | 254 | — | ||||||
| Loss on fair value of strategic investments | — | (68 | ) | |||||
| Other expense | — | (11 | ) | |||||
| Total other (expense) income | (894 | ) | 3,277 | |||||
| Net loss | (52,701 | ) | (61,024 | ) | ||||
| Adjustment to carrying value of Series A Preferred Stock | (254 | ) | — | |||||
| Net loss attributable to common stockholders | $ | (52,955 | ) | $ | (61,024 | ) | ||
| Net loss attributable to common stockholders per share | ||||||||
| Basic and diluted | $ | (1.11 | ) | $ | (1.66 | ) | ||
| Weighted-average shares used in computing net loss attributable to common stockholders per share, basic and diluted | 47,747,078 | 36,821,042 | ||||||
| Comprehensive loss | ||||||||
| Net loss | $ | (52,701 | ) | $ | (61,024 | ) | ||
| Unrealized gain on marketable securities | 8 | 62 | ||||||
| Comprehensive loss | $ | (52,693 | ) | $ | (60,962 | ) | ||
