Orchestra BioMed (OBIO) Piper Sandler 36th Annual Healthcare Conference summary

Strategic partnerships and business model

• Focuses on strategic partnerships with leading med device companies to drive product development and commercialization, leveraging partners' established commercial infrastructure and sharing revenue over the long term.

• Partnerships with Medtronic and Terumo enable access to large markets and allow for significant revenue shares without the need to build costly sales organizations.

• The model is designed to be capital efficient, with a small, specialized team focused on R&D and clinical execution, while partners handle commercialization.

• Economic structures include substantial per-device payments and royalties, aligning incentives for both parties and supporting profitability.

• The approach is positioned as a potential industry model, aiming for impactful programs in large markets.

Technology and product innovation

• Two flagship programs: AVIM (Atrioventricular Interval Modulation) for hypertension in pacemaker patients, and Virtue, a sirolimus-based drug-eluting balloon for coronary and peripheral artery disease.

• AVIM integrates as firmware into dual-chamber pacemakers, targeting the high prevalence of hypertension in this population.

• Virtue uses a novel bioabsorbable encapsulation for sirolimus, enabling extended focal release and eliminating the need for a surface coating, which improves drug delivery and procedural efficiency.

• Device innovation includes delivering the drug via the inflation medium through engineered holes, allowing precise, high-pressure angioplasty.

• The technology is designed to be adaptable for future indications and applications.

Clinical development and trial progress

• AVIM is in a pivotal trial with a target completion in 2025, aiming to address the hypertensive pacemaker market with a 500-patient, randomized study.

• The trial design has been adapted to improve enrollment, including a longer window for patient inclusion.

• Consistent double-digit reductions in ambulatory systolic blood pressure have been observed, with durable effects and a strong safety profile.

• Virtue is expected to enter a pivotal trial next year, with pilot data showing a low target lesion failure rate compared to competitors.

• Clinical results and data-driven adoption are emphasized as key drivers for market success.