Orchestra BioMed (OBIO) Wells Fargo 21st Annual Healthcare Conference summary

Business model and partnerships

• Focuses on innovation, IP, and clinical execution, leveraging risk/reward partnerships with major medical device companies for commercialization and global market access.

• Strategic partners include Medtronic and Terumo, with significant investments and royalty-sharing agreements; Ligand and other healthcare investors also hold stakes.

• Partnerships insulate partners from R&D burdens while providing growth programs and shared upside.

• Over 21% of the company is owned by strategic investors, ensuring alignment and long-term support.

• Near-term catalysts are fully funded through 2027, positioning the company for value creation.

AVIM therapy program

• AVIM therapy targets hypertension in pacemaker patients, leveraging existing devices for immediate and sustained blood pressure reduction.

• The pivotal BACKBEAT trial is nearing enrollment completion, with primary data expected in Q2 next year and potential U.S. commercialization in H1 2028.

• Medtronic partnership includes exclusive rights, regulatory, manufacturing, and sales responsibilities, with uncapped royalties starting at $500 per device.

• Pilot studies show consistent >10 mmHg systolic BP reduction, improved cardiac function, and better compliance due to always-on therapy.

• Two Breakthrough Device designations and a potential $16 billion global market opportunity beyond the pacemaker population.

Virtue SAB program and coronary market

• Virtue SAB delivers sirolimus via a proprietary AngioInfusion Balloon, addressing the shift to leave-nothing-behind coronary interventions.

• Targets a $7.5 billion PCI market, with at least half transitioning to drug-eluting or drug-coated balloons.

• Demonstrates superior drug delivery and retention compared to leading stents and balloons, with promising pilot study results versus Boston Scientific's AGENT balloon.

• IDE pivotal trial underway, aiming for non-inferiority and potential superiority to AGENT; Terumo holds right of first refusal for coronary rights.

• Precedent transactions in the space suggest significant potential value for the program.