Orchestra BioMed Reports Full Year 2024 Financial Results and Provides a Fourth Quarter Business Update
Orchestra BioMed (NASDAQ: OBIO) has reported its full year 2024 financial results, showing a revenue of $2.6 million, down from $2.8 million in 2023. The company's net loss widened to $61.0 million ($1.66 per share) compared to $49.1 million in 2023.
Key financial metrics include cash and marketable securities of $66.8 million as of December 31, 2024. R&D expenses increased to $42.8 million from $33.8 million, primarily due to the BACKBEAT global pivotal study costs. The company raised approximately $30 million through stock sales and credit facility.
Notable developments include continued progress on the BACKBEAT study with Medtronic, submission of a revised design for the Virtue ISR-US pivotal study, and entering mediation with Terumo for partnership restructuring. The company also strengthened its leadership with three new independent directors and appointed Mark Pomeranz as EVP & General Manager of Interventional Therapies.
Orchestra BioMed (NASDAQ: OBIO) ha riportato i risultati finanziari per l'intero anno 2024, mostrando un fatturato di 2,6 milioni di dollari, in calo rispetto ai 2,8 milioni di dollari del 2023. La perdita netta dell'azienda è aumentata a 61,0 milioni di dollari (1,66 dollari per azione) rispetto ai 49,1 milioni di dollari del 2023.
I principali indicatori finanziari includono disponibilità liquide e titoli negoziabili pari a 66,8 milioni di dollari al 31 dicembre 2024. Le spese per ricerca e sviluppo sono aumentate a 42,8 milioni di dollari rispetto ai 33,8 milioni, principalmente a causa dei costi dello studio globale BACKBEAT. L'azienda ha raccolto circa 30 milioni di dollari attraverso vendite di azioni e una linea di credito.
Sviluppi notevoli includono il continuo progresso nello studio BACKBEAT con Medtronic, la presentazione di un design rivisto per lo studio pivotale Virtue ISR-US e l'ingresso in mediazione con Terumo per la ristrutturazione della partnership. L'azienda ha anche rafforzato la propria leadership con tre nuovi direttori indipendenti e ha nominato Mark Pomeranz come EVP e Direttore Generale delle Terapie Interventistiche.
Orchestra BioMed (NASDAQ: OBIO) ha informado sus resultados financieros del año completo 2024, mostrando ingresos de 2,6 millones de dólares, una disminución respecto a los 2,8 millones de dólares en 2023. La pérdida neta de la empresa se amplió a 61,0 millones de dólares (1,66 dólares por acción) en comparación con los 49,1 millones de dólares en 2023.
Los principales indicadores financieros incluyen efectivo y valores negociables de 66,8 millones de dólares al 31 de diciembre de 2024. Los gastos en I+D aumentaron a 42,8 millones de dólares desde 33,8 millones, principalmente debido a los costos del estudio pivotal global BACKBEAT. La empresa recaudó aproximadamente 30 millones de dólares a través de ventas de acciones y una línea de crédito.
Desarrollos notables incluyen el progreso continuo en el estudio BACKBEAT con Medtronic, la presentación de un diseño revisado para el estudio pivotal Virtue ISR-US y la entrada en mediación con Terumo para la reestructuración de la asociación. La empresa también fortaleció su liderazgo con tres nuevos directores independientes y nombró a Mark Pomeranz como EVP y Gerente General de Terapias Intervencionistas.
Orchestra BioMed (NASDAQ: OBIO)는 2024년 전체 연도 재무 결과를 발표했으며, 매출은 260만 달러로 2023년의 280만 달러에서 감소했습니다. 회사의 순손실은 6100만 달러 (주당 1.66달러)로 2023년의 4910만 달러에 비해 확대되었습니다.
주요 재무 지표에는 2024년 12월 31일 기준으로 6680만 달러의 현금 및 유가증권이 포함됩니다. R&D 비용은 4280만 달러로 증가했으며, 이는 주로 BACKBEAT 글로벌 주요 연구 비용 때문입니다. 회사는 주식 판매와 신용 시설을 통해 약 3000만 달러를 모집했습니다.
주목할 만한 발전으로는 Medtronic과의 BACKBEAT 연구에서 지속적인 진전, Virtue ISR-US 주요 연구를 위한 수정된 디자인 제출, 그리고 파트너십 재구성을 위한 Terumo와의 중재 진입이 포함됩니다. 회사는 또한 세 명의 새로운 독립 이사를 영입하고 Mark Pomeranz를 개입 치료의 EVP 및 총괄 관리자로 임명했습니다.
Orchestra BioMed (NASDAQ: OBIO) a publié ses résultats financiers pour l'année complète 2024, affichant un chiffre d'affaires de 2,6 millions de dollars, en baisse par rapport à 2,8 millions de dollars en 2023. La perte nette de l'entreprise a augmenté à 61,0 millions de dollars (1,66 dollar par action) contre 49,1 millions de dollars en 2023.
Les principaux indicateurs financiers comprennent des liquidités et des valeurs mobilières de 66,8 millions de dollars au 31 décembre 2024. Les dépenses de R&D ont augmenté à 42,8 millions de dollars contre 33,8 millions de dollars, principalement en raison des coûts de l'étude pivotale mondiale BACKBEAT. L'entreprise a levé environ 30 millions de dollars par le biais de ventes d'actions et d'une facilité de crédit.
Les développements notables incluent des progrès continus dans l'étude BACKBEAT avec Medtronic, la soumission d'un design révisé pour l'étude pivotale Virtue ISR-US et l'entrée en médiation avec Terumo pour la restructuration du partenariat. L'entreprise a également renforcé sa direction avec trois nouveaux administrateurs indépendants et a nommé Mark Pomeranz en tant que EVP et directeur général des thérapies interventionnelles.
Orchestra BioMed (NASDAQ: OBIO) hat die finanziellen Ergebnisse für das gesamte Jahr 2024 veröffentlicht, mit einem Umsatz von 2,6 Millionen Dollar, ein Rückgang von 2,8 Millionen Dollar im Jahr 2023. Der Nettoverlust des Unternehmens weitete sich auf 61,0 Millionen Dollar (1,66 Dollar pro Aktie) im Vergleich zu 49,1 Millionen Dollar im Jahr 2023 aus.
Wichtige Finanzkennzahlen umfassen Bargeld und handelbare Wertpapiere in Höhe von 66,8 Millionen Dollar zum 31. Dezember 2024. Die F&E-Ausgaben stiegen auf 42,8 Millionen Dollar von 33,8 Millionen Dollar, hauptsächlich aufgrund der Kosten der globalen BACKBEAT-Studie. Das Unternehmen hat etwa 30 Millionen Dollar durch Aktienverkäufe und Kreditfazilitäten eingeworben.
Bemerkenswerte Entwicklungen umfassen den fortgesetzten Fortschritt bei der BACKBEAT-Studie mit Medtronic, die Einreichung eines überarbeiteten Designs für die Virtue ISR-US-Pivotalstudie und den Eintritt in die Mediation mit Terumo zur Umstrukturierung der Partnerschaft. Das Unternehmen hat auch seine Führung mit drei neuen unabhängigen Direktoren gestärkt und Mark Pomeranz als EVP und General Manager für Interventionelle Therapien ernannt.
- Secured $30M in additional funding through stock sales and credit facility
- Strengthened leadership with three experienced independent directors
- Maintained strong cash position of $66.8M as of December 2024
- Progress in BACKBEAT global pivotal study with Medtronic collaboration
- Revenue declined to $2.6M from $2.8M in 2023
- Net loss increased to $61.0M from $49.1M in 2023
- R&D expenses rose 27% to $42.8M
- Cash burn increased to $50.8M from $46.2M in 2023
- Ongoing partnership issues with Terumo requiring mediation
Insights
Orchestra BioMed's full year 2024 results reveal a widening net loss of $61.0 million ($1.66/share), significantly higher than the $49.1 million loss in 2023. This deterioration stems primarily from a 27% increase in R&D expenses to $42.8 million and 18% higher SG&A costs at $23.9 million. Revenue declined slightly to $2.6 million, reflecting decreased recognition from the Terumo partnership, which is now undergoing formal mediation with resolution targeted for Q2 2025.
The company's cash burn accelerated to $50.8 million in 2024 compared to $46.2 million in 2023. While the $66.8 million cash position provides runway, this represents approximately 16 months at current burn rates. The company has bolstered its finances through a $15 million stock sale and a $15 million credit facility draw, but these dilutive and debt financing mechanisms signal potential capital constraints.
From an operational perspective, OBIO remains focused on its BACKBEAT study with Medtronic for AVIM therapy and is preparing for a redesigned Virtue SAB pivotal trial pending FDA approval. However, the Virtue pivotal study won't initiate until H2 2025, pushing potential commercialization further into the future. The strengthened board and executive appointments with Medtronic connections potentially signal strategic alignment with this key partner.
The financial trajectory remains concerning as OBIO's path to profitability extends while partnership uncertainties persist. The Terumo mediation outcome in Q2 2025 will be a critical inflection point that could significantly impact the company's development strategy and financial outlook.
NEW HOPE, Pa., March 31, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today reported its full year 2024 financial results and provided a fourth quarter business update.
"We remain highly focused on execution of the BACKBEAT global pivotal study, which we believe has the potential to deliver landmark results that can establish AVIM therapy as a new standard of care for the treatment of uncontrolled hypertension in patients already indicated for a pacemaker. We also believe it can lay the foundation for expanding use of AVIM-enabled devices to manage blood pressure and improve cardiovascular function for hypertensive patients with high cardiovascular risk,” commented David Hochman, Chairman, Chief Executive Officer and Founder of Orchestra BioMed. “As we age, our arteries naturally lose elasticity and become stiffer, a process that increases the risk of cardiovascular problems and is linked to changes in blood pressure and heart function. One of the characteristics of this process is the development of diastolic dysfunction, a condition where the heart's ventricles cannot relax and fill with blood properly during the diastolic phase of the cardiac cycle. Our late-breaking data in patients with diastolic dysfunction recently presented at THT showed AVIM therapy’s ability to significantly improve ventricular relaxation and passive filling, highlighting its potential to drive better clinical outcomes through blood pressure reduction, as well as improvement of cardiac function."
“In parallel, we are encouraged by the progress of our Virtue SAB program as we actively prepare to initiate a U.S. coronary pivotal study with an updated trial design, currently under FDA review. The study is expected to randomize patients with coronary in-stent restenosis to treatment with Virtue SAB or Boston Scientific’s AGENT drug-coated balloon. We believe this design will optimally highlight the potential advantages of Virtue SAB’s proprietary design advantages which enables protected delivery of extended focal-release sirolimus without the need for a balloon coating,” continued Mr. Hochman. “With regard to our strategic partnership, we and Terumo are moving our negotiations into a formal mediation process. We believe this is the most efficient way to drive our relationship to a resolution, ideally during the second quarter of this year, ahead of potential initiation of the updated Virtue ISR-US pivotal study in the second half of the year.”
Fourth Quarter 2024 and Recent Highlights
- Continued site activation and patient enrollment of the BACKBEAT global pivotal study, in collaboration with Medtronic (NYSE: MDT), evaluating the efficacy and safety of atrioventricular interval modulation (“AVIM”) therapy in hypertensive pacemaker patients.
- Submitted a revised design to the U.S. Food and Drug Administration (“FDA”) for the Virtue ISR-US pivotal study in coronary in-stent restenosis (“ISR”), which will randomize Virtue® Sirolimus AngioInfusion™ Balloon (“SAB”) against Boston Scientific’s AGENT drug-coated balloon; initiation is targeted for the second half of 2025, pending FDA approval of an amended investigational device exemption (“IDE”) which is expected to be secured in the second quarter of 2025.
- To accelerate potential completion of ongoing partnership restructuring negotiations, Orchestra BioMed and Terumo have elected to enter a mediation process and are currently working on a procedural plan that would aim to conclude the mediation process in the second quarter of 2025.
- Enhanced board of directors with the appointment of three highly experienced independent directors:
- Christopher Cleary, former Senior Vice President of Corporate Development at Medtronic, where he played a key role in establishing the strategic collaboration between Orchestra BioMed and Medtronic for AVIM therapy
- John Mack, former President of Cardiac Surgery at Medtronic with extensive operational and strategic experience in the medical device industry
- David Pacitti, Chief Executive Officer of Avanos Medical, former President of Siemens Medical Solutions USA, Inc. and Head of the Americas, Siemens Healthineers, with nearly 30 years of experience in cardiovascular device and procedural imaging
- Strengthened senior leadership team with the appointment of Mark Pomeranz as Executive Vice President & General Manager, Interventional Therapies. Mr. Pomeranz has over two decades of experience in medical devices, with particular emphasis on cardiology and gastrointestinal verticals. He most recently served as Chief Executive Officer of Motus GI Holdings.
Financial Results for the Year Ended December 31, 2024
- Cash and cash equivalents and Marketable securities totaled
$66.8 million as of December 31, 2024. During the year, our cash inflows included approximately$15.0 million in net cash proceeds from the sale of our Common Stock under a market sales agreement and approximately$15.0 million from the initial draw on our credit facility. - Net cash used in operating activities and for the purchase of fixed assets was
$50.8 million during 2024, compared with$46.2 million for 2023, with the primary driver of this increase being increased cash outflows for research and development during 2024. - Revenue for 2024 was
$2.6 million , compared with$2.8 million for 2023. The decrease was primarily due to decreased recognition of partnership revenues earned under the agreement with Terumo. - Research and development expenses for 2024 were
$42.8 million , compared with$33.8 million for 2023. The increase was primarily due to additional costs associated with the ongoing BACKBEAT global pivotal study. - Selling, general and administrative expenses for 2024 were
$23.9 million , compared with$20.3 million for 2023. The increase was primarily due to increased expenses related to stock-based stock compensation. - Net loss for 2024 was
$61.0 million , or ($1.66) per share, compared with a net loss of$49.1 million , or ($1.48) per share, for 2023. Net loss for the year-ended 2024 included non-cash stock-based compensation expense of$10.6 million , compared with$7.6 million for the same period in 2023.
About Orchestra BioMed
Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s lead product candidate is atrioventricular interval modulation (AVIM) therapy (also known as BackBeat Cardiac Neuromodulation Therapy (CNT™)) for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed is also developing the Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn.
References to Websites and Social Media Platforms
References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release.
About AVIM Therapy
AVIM therapy, also known as BackBeat CNT™, is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized, pilot study, showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will further evaluate the safety and efficacy of AVIM therapy in lowering blood pressure in a similar target population of patients who have been indicated for, and recently implanted with, a dual-chamber cardiac pacemaker.
About Virtue SAB
Virtue SAB is a patented drug/device combination product candidate in development for the treatment of certain forms of artery disease that is designed to deliver a proprietary, investigational, extended-release formulation of sirolimus, SirolimusEFR™, to the vessel wall during balloon angioplasty without any coating on the balloon surface or the need to leave a stent or other permanent implant in the artery. Virtue SAB demonstrated positive three-year clinical data in coronary ISR in the SABRE study, a multi-center prospective, independent core lab-adjudicated clinical study conducted in Europe. Virtue SAB has been granted Breakthrough Device designation by the FDA for specific indications relating to coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee. Orchestra BioMed has a strategic partnership with Terumo (Terumo, TSE: 4543), a global leader in medical technology headquartered in Tokyo, Japan, as well as Terumo Medical Corporation, its U.S. subsidiary, to collaborate on the global development and commercialization of Virtue SAB in coronary and peripheral vascular indications.
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 initiation, enrollment, timing, implementation and design of the Company’s planned and ongoing pivotal trials and reporting of top-line results, realizing the clinical and commercial value of BackBeat CNT and Virtue SAB, the Company’s ability to conclude the mediation process with Terumo in the second quarter of 2025, and the potential safety and efficacy of the Company’s product candidates. 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 December 31, 2024, which was filed with the Securities and Exchange Commission (“SEC”) on March 31, 2025, and under the heading “Item1A. Risk Factors” in Part II of the Company’s subsequently filed quarterly reports on Form 10-Q.
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:
Jeremy Feffer
LifeSci Advisors
Jfeffer@lifesciadvisors.com
Media Contact:
Kelsey Kirk-Ellis
Orchestra BioMed
(484) 682-4892
kkirkellis@orchestrabiomed.com
| ORCHESTRA BIOMED HOLDINGS, INC. Consolidated Balance Sheets (in thousands, except share and per share data) | ||||||||
| December 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 22,261 | $ | 30,559 | ||||
| Marketable securities | 44,551 | 56,968 | ||||||
| Strategic investments, current portion | — | 68 | ||||||
| Accounts receivable, net | 92 | 99 | ||||||
| Inventory | 173 | 146 | ||||||
| Prepaid expenses and other current assets | 2,094 | 1,274 | ||||||
| Total current assets | 69,171 | 89,114 | ||||||
| Property and equipment, net | 1,384 | 1,279 | ||||||
| Right-of-use assets | 2,103 | 1,555 | ||||||
| Strategic investments, less current portion | 2,495 | 2,495 | ||||||
| Deposits and other assets | 1,020 | 769 | ||||||
| TOTAL ASSETS | $ | 76,173 | $ | 95,212 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable | $ | 5,134 | $ | 2,900 | ||||
| Accrued expenses and other liabilities | 6,084 | 5,149 | ||||||
| Operating lease liability, current portion | 550 | 649 | ||||||
| Deferred revenue, current portion | 4,439 | 2,510 | ||||||
| Total current liabilities | 16,207 | 11,208 | ||||||
| Deferred revenue, less current portion | 10,989 | 14,923 | ||||||
| Loan payable | 14,292 | — | ||||||
| Operating lease liability, less current portion | 1,687 | 1,038 | ||||||
| Other long-term liabilities | 40 | — | ||||||
| TOTAL LIABILITIES | 43,215 | 27,169 | ||||||
| STOCKHOLDERS’ EQUITY | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 4 | 4 | ||||||
| Additional paid-in capital | 342,780 | 316,903 | ||||||
| Accumulated other comprehensive income (loss) | 52 | (10 | ) | |||||
| Accumulated deficit | (309,878 | ) | (248,854 | ) | ||||
| TOTAL STOCKHOLDERS’ EQUITY | 32,958 | 68,043 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 76,173 | $ | 95,212 | ||||
| ORCHESTRA BIOMED HOLDINGS, INC. Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) | ||||||||
| Year Ended December 31, | ||||||||
| 2024 | 2023 | |||||||
| Revenue: | ||||||||
| Partnership revenue | $ | 2,005 | $ | 2,106 | ||||
| Product revenue | 633 | 654 | ||||||
| Total revenue | 2,638 | 2,760 | ||||||
| Expenses: | ||||||||
| Cost of product revenues | 204 | 186 | ||||||
| Research and development | 42,804 | 33,822 | ||||||
| Selling, general and administrative | 23,931 | 20,258 | ||||||
| Total expenses | 66,939 | 54,266 | ||||||
| Loss from operations | (64,301 | ) | (51,506 | ) | ||||
| Other income (expense): | ||||||||
| Interest income, net | 3,356 | 3,849 | ||||||
| Loss on fair value adjustment of warrant liability | — | (294 | ) | |||||
| Loss on debt extinguishment | — | (1,151 | ) | |||||
| Loss on fair value of strategic investments | (68 | ) | (18 | ) | ||||
| Other expense | (11 | ) | — | |||||
| Total other income | 3,277 | 2,386 | ||||||
| Net loss | $ | (61,024 | ) | $ | (49,120 | ) | ||
| Net loss per share | ||||||||
| Basic and diluted | $ | (1.66 | ) | $ | (1.48 | ) | ||
| Weighted-average shares used in computing net loss per share, basic and diluted | 36,821,042 | 33,225,227 | ||||||
| Comprehensive loss | ||||||||
| Net loss | $ | (61,024 | ) | $ | (49,120 | ) | ||
| Unrealized gain (loss) on marketable securities | 62 | (2 | ) | |||||
| Comprehensive loss | $ | (60,962 | ) | $ | (49,122 | ) | ||
FAQ
What were Orchestra BioMed's (OBIO) key financial results for 2024?
What is the status of Orchestra BioMed's BACKBEAT study in 2024?
When is Orchestra BioMed (OBIO) expecting to initiate the Virtue ISR-US pivotal study?
How much did Orchestra BioMed's R&D expenses increase in 2024?
What is the timeline for Orchestra BioMed's mediation with Terumo?
