Orchestra BioMed (OBIO) Jefferies Global Healthcare Conference 2026 summary

Business model and partnership strategy

• Focuses on biomedical innovation through a partnership model, driving pivotal trial execution and data generation, while partners handle regulatory, manufacturing, and commercialization.

• Concentrates spending on R&D, with potential for significant revenue growth and rapid profitability through royalty interests as partners commercialize products.

• Partnership with Medtronic for the lead program leverages Medtronic’s global reach and expertise in cardiac pacing.

• Partnership with Terumo for the second program is structured as a right of first refusal, providing flexibility to engage other potential partners.

• Model allows for operational and financial flexibility, extending resources of large partners and building core competencies in clinical trial execution.

Lead program: BackBeat AVIM therapy

• AVIM therapy, delivered via pacemaker, targets hypertension and hypertensive heart disease, offering immediate and sustained blood pressure reduction.

• Phase II data showed an average 13.2 mmHg reduction in systolic blood pressure, with consistent double-digit reductions out to four years.

• BackBeat pivotal trial is nearing enrollment completion, with data expected in Q2 next year and potential global commercialization by 2028–2029.

• Partnership structure enables Medtronic to file for approval promptly after data release, aiming for PMA supplement approval by end of 2027.

• Royalty structure includes minimum payments per device, with potential for substantial revenue given the global pacemaker market size.

Second program: Virtue drug delivery platform

• Virtue uses a novel encapsulated sirolimus formulation delivered via a microporous balloon, enabling higher drug uptake and extended release.

• Demonstrated superior outcomes in pilot studies compared to existing drug-coated balloons, with lower target lesion failure rates at one and three years.

• Pivotal trial is underway, designed as a head-to-head non-inferiority study against Boston Scientific’s AGENT balloon, with potential for superiority.

• Partnership with Terumo provides a right of first refusal, but there is significant interest from other global strategics.

• Enrollment for the pivotal study is expected to finish next year, with ongoing site activations and strong physician enthusiasm.