Orchestra Biomed Holdings, Inc. · NASDAQ:OBIO

Orchestra Biomed — Investor Presentation (June 2023)

26 slides from Orchestra Biomed's investor presentation, Jun 8, 2023

  1. Slide 1: Orchestra BioMed Corporate Presentation Q2 2023

    Bringing medical inn vation to life Bringing medical inn vation to life Orchestra BioMed Corporate Presentation Q2 2023

  2. Slide 2: Forward-Looking Statements

    Forward - Looking Statements 2 This presentation has been prepared for informational purposes only from information supplied by Orchestra BioMed Holdings, I nc. , referred to herein as “we,” “our,” “Orchestra BioMed,” and “the Company,” and from third - party sources indicated herein. Such third - p

  3. Slide 3: Orchestra BioMed Executive Summary

    Orchestra BioMed Executive Summary Strategic collaboration Double - digit revenue share Strong balance sheet and outstanding investors Partnership - enabled business model designed to accelerate innovation to patients, drive strong partner and shareholder value and yield exceptional future profitabi

  4. Slide 4: Orchestra BioMed's Partnership-enabled Model Benefits All

    Enable new growth opportunities Outsource development Minimize P&L dilution 4 Orchestra BioMed’s Partnership - enabled Model Benefits All Development Strategic Partners Commercialization /ŵƉƌŽǀĞƉĂƚŝĞŶƚůŝǀĞƐ ĐĐĞůĞƌĂƚĞĚĞǀĞůŽƉŵĞŶƚ >ĞǀĞƌĂŐĞĞdžƉĞƌƚŝƐĞΘƌĞƐŽƵƌĐĞƐ Secure substantial long - term royalties Out

  5. Slide 5: Highly Accomplished Executive Team & Board

    Avi Fischer, M.D. SVP, Medical Affairs & Innovation J.C. Simeon SVP, Quality Inessa R. Wheeler VP, Marketing Bob Laughner VP, Regulatory Affairs Stephen A. Zielinski VP, Product Dev., Bioelectronic Therapies Ziv Belsky VP, Research, Bioelectronic Therapies Juan Lorenzo VP, Product Dev., Focal Therap

  6. Slide 6: Advancing High-Impact Pipeline

    Product Platforms Target Indications Preclinical Clinical Feasibility Clinical Pivotal Partner Study Sponsor BackBeat Cardiac Neuromodulation Therapy (CNT Ρ ) Hypertension (HTN) (pacing patients; HTN+P) High - Risk HTN (non - pacing patients) ROFN CNT - HF Heart Failure Virtue® Sirolimus AngioInfusi

  7. Slide 7: Strong Collaborations Position Us for Long-term Success

    • Sponsor for BackBeat CNT HTN + Pacemaker global pivotal study • $500 - $1,600 per BackBeat CNT - enabled device sold 1 under existing reimbursement codes Medtronic • Global market leader in pacemakers: >$1.5B in annual revenues • Providing leading device plus clinical & regulatory resources • Excl

  8. Slide 8: BackBeat Cardiac Neuromodulation Therapy (CNT)

    8 BackBeat Cardiac Neuromodulation Therapy Ρ (CNT Ρ )

  9. Slide 9: BackBeat CNT Overview

    BackBeat CNT Ρ Overview 9 Unmet Need • Hypertension is the leading global risk factor for death and #1 comorbidity in pacemaker population , affecting over 70% of patients 1 • Older population at increased risk for major events & challenges with drug compliance • Additional opportunity to treat high

  10. Slide 10: Large Global Opportunity for Treating Hypertension in Target Populations

    Large Global Opportunity for Treating Hypertension in Target Populations *Total addressable market in 2025 based on company estimates; 1 Company estimates based on published sources, including National Inpatient Survey (NIS) and National Health and Nutrition Examination Survey (NHANES); 2 Known and

  11. Slide 11: Designed to Substantially Lower BP & Maintain Reduction

    • Bioelectronic therapy designed to leverage standard dual - chamber pacemaker - Same implant procedure and lead positions - Large trained physician pool that already implant pacemakers - Same target patient population that already need pacemakers - Leverageable existing reimbursement with robust pa

  12. Slide 12: MODERATO II Double-Blind, Randomized Results

    MODERATO II Double - Blind, Randomized Results ĂĐŬĞĂƚEd Ρ ƐŚŽǁĞĚĞŶĐŽƵƌĂŐŝŶŐƌĞƐƵůƚƐŝŶ DKZdK//͕ĂƉƌŽƐƉĞĐƚŝǀĞ͕ŵƵůƚŝ Ͳ ĐĞŶƚĞƌ͕ ƌĂŶĚŽŵŝnjĞĚ͕;ĂĐŬĞĂƚEdнDĞĚŝĐĂůdŚĞƌĂƉLJǀƐ͘ ŽŶƚŝŶƵĞĚDĞĚŝĐĂůdŚĞƌĂƉLJͿ͕ĚŽƵďůĞ Ͳ ďůŝŶĚ͕ƉŝůŽƚƐƚƵĚLJ ŽĨƉĂĐĞŵĂŬĞƌƉĂƚŝĞŶƚƐǁŝƚŚƉĞƌƐŝƐƚĞŶƚŚLJƉĞƌƚĞŶƐŝŽŶ 1 Kalaras et al. Journal of the American He

  13. Slide 13: BackBeat CNT Pivotal Trial Design

    BackBeat CNT Ρ Pivotal Trial Design 13 Current anticipated trial design: • Prospective, multi - center, double - blind study investigating the efficacy of BackBeat CNT Ρ in patients with uncontrolled hypertension (HTN) despite the use of antihypertensive medications, who are indicated for a dual - c

  14. Slide 14: Virtue Sirolimus AngioInfusion Balloon (SAB)

    14 sŝƌƚƵĞΠ^ŝƌŽůŝŵƵƐ ŶŐŝŽ/ŶĨƵƐŝŽŶ Ρ ĂůůŽŽŶ;^Ϳ

  15. Slide 15: Virtue SAB Overview

    Virtue® SAB Overview 15 Unmet Need • Artery disease is the leading cause of death in the U.S. and worldwide • Significant paradigm shift toward “leave nothing behind” treatment for coronary and peripheral indications representing an > $3B global market opportunity 1 • Current treatment options are s

  16. Slide 16: Large Opportunity for Leave Nothing Behind Solution

    Large Opportunity for Leave Nothing Behind Solution 16 >$3 Billion Annual Global CAD & PAD Market Opportunity * ‡ ƌƚĞƌLJĚŝƐĞĂƐĞŝƐƚŚĞƉƌŝŵĂƌLJ ĐĂƵƐĞŽĨĚĞĂƚŚǁŽƌůĚǁŝĚĞ ‡ >ĂƌŐĞŵĂƚƵƌĞŵĂƌŬĞƚǁŝƚŚ ƐŝŐŶŝĨŝĐĂŶƚƵŶŵĞƚŶĞĞĚ Ă ^ƵďŽƉƚŝŵĂůƚƌĞĂƚŵĞŶƚƐĨŽƌ ĐŽƌŽŶĂƌLJ/^Z͕ĐŽƌŽŶĂƌLJ^s ĚĞ ŶŽǀŽ ĂŶĚd< ‡ ĞƐŝŐŶĞĚƚŽůĞǀĞƌĂŐĞĞdžŝƐƚŝŶŐ ƚƌĞ

  17. Slide 17: Virtue SAB Designed to Enable Angioplasty with Protected Sirolimus Delivery

    sŝƌƚƵĞΠ^ ŶŐŝŽ/ŶĨƵƐŝŽŶ Ρ ĂůůŽŽŶ ĚĞƐŝŐŶĞĚƚŽĞŶĂďůĞĂŶŐŝŽƉůĂƐƚLJ ǁŝƚŚƉƌŽƚĞĐƚĞĚĚƌƵŐĚĞůŝǀĞƌLJƚŽĚŝůĂƚĞǀĞƐƐĞů͕ƚŽĐŽŶƐŝƐƚĞŶƚůLJ ĚĞůŝǀĞƌŝŶƚĞŶĚĞĚĚŽƐĞĂŶĚƚŽůĞĂǀĞŶŽŵĞƚĂůďĞŚŝŶĚ Designed to Enable Angioplasty with Protected Sirolimus Delivery while Leaving No Metal Behind 17 1 Granada et al. EuroIntervention 2016;12:740

  18. Slide 18: Compelling SABRE Trial Results in Coronary ISR Patients

    Compelling SABRE Trial Results in Coronary ISR Patients ϭ sĞƌŚĞLJĞĞƚĂů͘:ĂƌĚŝŽǀĂƐĐ/ŶƚĞƌǀ ϮϬϭϳ KĐƚ Ϯϯ ͖ ϭϬ ; ϮϬ Ϳ͗ ϮϬϮϵ Ͳ ϮϬϯϳ ͘K/͗ ϭϬ͘ϭϬϭϲ ͬũ͘ũĐŝŶ͘ ϮϬϭϳ͘Ϭϲ͘ϬϮϭ ͘ Ϯ 'ƌĂŶĂĚĂ ϯ Ͳ zĞĂƌůŝŶŝĐĂůZĞƐƵůƚƐdd ϮϬϭϴ ͘ ϯ Ͳ zĞĂƌ^ZdƌŝĂůůŝŶŝĐĂůZĞƉŽƌƚŽŶĨŝůĞ͘ ĞĨŝŶŝƚŝŽŶƐ͗ dĂƌŐĞƚůĞƐŝŽŶĨĂŝůƵƌĞ;d>&Ϳ͕ůĂƚĞůƵŵĞŶůŽƐƐ;>>>Ϳ͕ƚĂƌŐĞƚ

  19. Slide 19: Virtue SAB Coronary ISR US Pivotal Trial

    Virtue® SAB Coronary ISR US Pivotal Trial 19 ŽƵďůĞ Ͳ ďůŝŶĚ͕ŵƵůƚŝ Ͳ ĐĞŶƚĞƌ͕ƉƌŽƐƉĞĐƚŝǀĞ͕ ƌĂŶĚŽŵŝnjĞĚ ĐŽŶƚƌŽůůĞĚƐƚƵĚLJ ŝŶƉĂƚŝĞŶƚƐǁŝƚŚ ƐŝŶŐůĞ Ͳ ůĂLJĞƌĐŽƌŽŶĂƌLJ /^Z sŝƌƚƵĞΠ^ Eс ϮϬϬ R Target Lesion Failure (CD, TV - MI and TLR) at 12 months Primary Endpoint Statistical Assumption 90% powered for superiority V

  20. Slide 20: 2023 Anticipated Milestones

    2023 - Anticipated Milestones Planned Regulatory Milestones Planned Clinical Milestones 20 1 Timing estimated and subject to Terumo execution since Terumo controls development of Virtue SAB for SV indication and for IS R i n Japan ‡ ĂĐŬĞĂƚEd ,dEнW ϭ Ɛƚ Wƚ͘ŶƌŽůůŵĞŶƚ ‡ sŝƌƚƵĞ^ ŽƌŽŶĂƌLJ/^Z ϭ ƐƚWƚ͘ŶƌŽůůŵ

  21. Slide 21: Two Programs Targeting Large Markets Entering Pivotal Trials

    21 Two Programs Targeting Large Markets Supported by Promising Trial Data Entering Pivotal Trials – BackBeat CNT Ρ • >$10 billion annual market • R andomized, controlled study shows efficacy potential • Collaboration with – V irtue® SAB • ∼ $3 billion annual market • 3 - year pilot study results sho

  22. Slide 22: Partnership-Enabled Business Model

    Partnership - Enabled Business Model 22

  23. Slide 23: Significant Barriers Prevent Innovation From Reaching Patients

    Significant Barriers Prevent Innovation From Reaching Patients 23 Startups often struggle for resources to reach commercial value inflection Large companies’ constrained R&D budgets limit innovation & acquisitions /ŶĐƌĞĂƐŝŶŐďƵƌĚĞŶŽĨĐŽƐƚ͕ƚŝŵĞ͕ĂŶĚǁŽƌŬ ƚŽďƌŝŶŐŵĞĚŝĐĂůŝŶŶŽǀĂƚŝŽŶƚŽƉĂƚŝĞŶƚƐ WƌŽĚƵĐƚĞǀĞůŽƉŵĞ

  24. Slide 24: Orchestra BioMed Can Accelerate Innovation to Patients

    Orchestra BioMed Can Accelerate Innovation to Patients 24 ZŝƐŬ Ͳ ZĞǁĂƌĚ^ŚĂƌŝŶŐ WĂƌƚŶĞƌƐŚŝƉƐ ĂŶKǀĞƌĐŽŵĞƚŚĞĂƌƌŝĞƌƐƚŽ/ŶŶŽǀĂƚŝŽŶ

  25. Slide 25: Selecting Optimal Opportunities: Key Pipeline Criteria

    Ϯϱ Large Market with Unmet Needs Potential for High Impact Favorable for Partnering Key Pipeline Criteria Large market, significant unmet needs, established distribution channels Designed to improve standard of care, fit existing treatment paradigm, disrupt market dynamics ^ŝŐŶŝĨŝĐĂŶƚĚŝĨĨĞƌĞŶƚŝĂƚŝŽŶ

  26. Slide 26: Orchestrating Innovation

    Orchestrating Inn vation 26 ƌĞĂƚĞĚWŝƉĞůŝŶĞ͕WŝŽŶĞĞƌĞĚƵƐŝŶĞƐƐDŽĚĞůĂŶĚƐƚĂďůŝƐŚĞĚWĂƌƚŶĞƌƐŚŝƉƐ ŽŵďŝŶĞĚ͕ŽƵƌůĞĂĚĞƌƐŚŝƉƚĞĂŵŚĂƐ Years of experience Average years of experience each New product approvals/clearances Authored patents 250 + 25 ϭϬϬ н ϲϬϬ н Accomplished Leadership Team

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