Adagio Medical Holdings, Inc · NASDAQ:ADGM
Adagio Medical — SPAC Merger (April 2024)
95 slides from Adagio Medical's SPAC merger presentation, Apr 24, 2024
Slide 1: Adagio Medical Investor Presentation
ADAGIO MEDICAL Investor Presentation | April 2024 1
Slide 2: Disclaimer
DISCLAIMER 2 PRIVATE AND CONFIDENTIAL This investor presentation (together with the oral statements made in connection herewith, this “Presentation”) is for informational purposes only to assist interested parties in making their own evaluation with respect to the proposed business combination and a
Slide 3: Disclaimer (cont.)
DISCLAIMER (CONT.) 3 PRIVATE AND CONFIDENTIAL Combination; (6) delays in obtaining, adverse conditions in, or the inability to obtain regulatory approvals, or delays in completing regulatory reviews, required to complete the Business Combination; (7) the ability to meet stock exchange listing standa
Slide 4: Disclaimer (cont.) Participants in the Solicitation
DISCLAIMER (CONT.) 4 PRIVATE AND CONFIDENTIAL Participants in the Solicitation ARYA, the Company, ListCo and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from ARYA’s shareholders with respect to the Business Combination. A list of
Slide 5: Today's Presenters / Adagio at a Glance
TODAY’S PRESENTERS Olav Bergheim CEO & President 30+ years of experience in life sciences Founder of John Dahldorf Chief Financial Officer 20+ years of corporate finance experience Innovative cardiac ablation medical technology company ✔ Focused on large, underserved market – cardiac arrythmia addre
Slide 6: Why Invest: Adagio Medical Opportunity in a Nutshell
WHY INVEST: ADAGIO MEDICAL OPPORTUNITY IN A NUTSHELL Currently ~$3 billion catheter market; advanced catheter revenue (75% of total) experienced historical double-digit growth1 ✔ Unique near-term opportunity in ~ $300M VT ablation market with potential 2-3x segment growth on improved safety, effecti
Slide 7: Adagio Solution
PRIVATE AND CONFIDENTIAL ADAGIO SOLUTION: PFCA for atrial arrhythmias Cryopulse™ ULTC for atrial arrhythmias iCLAS™ DURABLE, CONTIGUOUS, TRANSMURAL LESIONS …anywhere in the heart ULTC/PFCA for ventricular arrhythmias vCLAS™
Slide 8: ULTC Temperatures and Lesions
ULTC TEMPERATURES AND LESIONS 8 Engineering Model: Catheter in Circulating 370C Water PRIVATE AND CONFIDENTIAL https://vimeo.com/936025754/f221e1388a?share=copy
Slide 9: Invasive Treatments of Cardiac Arrhythmias
INVASIVE TREATMENTS OF CARDIAC ARRHYTHMIAS Normal Electrical Conduction Ventricular Tachycardia (VT) VT is a heart rhythm problem (arrhythmia) caused by irregular electrical signals in the lower chambers of the heart (ventricles). Original Surgical “Cut and Sew” Technique Using surgical cuts or cath
Slide 10: Ventricular Tachycardia Ablations Market: Opportunity, Drivers and Inhibitors
VENTRICULAR TACHYCARDIA ABLATIONS MARKET: OPPORTUNITY, DRIVERS AND INHIBITORS
Slide 11: VT Market: Current Size and Growth Opportunity
150 200 Annual VT Ablations Annual Incidence of "Trigger" VTs Disease Prevalence Cases (thousands) HF / Cardiomyopathy / ICDs Idiopathic VTs VT MARKET: CURRENT SIZE AND GROWTH OPPORTUNITY 2% CAGR 100 7% CAGR 50 0 2-3x3 market growth opportunity with improved ablation effectiveness and reduced risk p
Slide 12: VT Market: Current Risk-Benefit Limits Ablation Therapy Penetration
VT MARKET: CURRENT RISK-BENEFIT LIMITS ABLATION THERAPY PENETRATION 12 Use and Potential Benefits of VT Ablations1-5 Procedural Risks and Complications6 Death 2.7% Perforations/tamponade 2.0% Major Bleeding 5.6% Vascular 1.7% Stroke 0.4% Unspecified 1.8% Any Complication 11.5% 1) 2) 3) 4) 5) 6) 7) 8
Slide 13: Role of ULTC Lesion Depth in Ablation of Scar-Mediated VTs
ROLE OF ULTC LESION DEPTH IN ABLATION OF SCAR-MEDIATED VTs 13 Bourantas CV, Nikitin NP, Loh HP, et al. Prevalence of scarred and dysfunctional myocardium in patients with heart failure of ischaemic origin: A cardiovascular magnetic resonance study. Journal of Cardiovascular Magnetic Resonance 2011,
Slide 14: Adagio Medical VT Cryoablation System
ADAGIO MEDICAL VT CRYOABLATION SYSTEM 14 INDICATIONS FOR USE1: The Adagio Medical Inc. VT Cryoablation System (Catheter and Console) is indicated for the treatment of monomorphic ventricular tachycardia by ablation of arrhythmogenic tissue that drives and maintains these arrhythmias. Titratable lesi
Slide 15: CryoCure-VT Study
CRYOCURE-VT STUDY (NCT # 04893317) Patients 64 patients, Rx-refractory persistent recurring monomorphic VT of both ischemic and non-ischemic etiology Endpoints Procedural safety, acute and chronic effectiveness Sites 9 centers Data Readout Late-Breaking Clinical Trial Presentation at EHRA 2024 CE-Ma
Slide 16: vCLAS CryoCure-VT Clinical Trial: Redefining Risk/Benefit in VT Ablations
vCLAS™ CRYOCURE-VT CLINICAL TRIAL: REDEFINING RISK/BENEFIT IN VT ABLATIONS 16 Exceptional Acute Effectiveness and Safety Excellent Procedural Profile CRYOCURE-VT RF-based Reference Procedure Time 185 min 225-273 min # of lesions 9 24 - 34 Adagio Medical, Inc. CryoCure-VT Interim Clinical Investigati
Slide 17: Highly Concentrated Market Drives Commercial Strategy
17 HIGHLY CONCENTRATED MARKET DRIVES COMMERCIAL STRATEGY 17 US Estimated VT Ablations Penetration in Europe (2016)1 and US (2023)2 Estimated Annual VT Ablations Volumes in 20222 2024 Adagio’s commercial focus: UK and Germany, large volume / key opinion leader accounts Key performance metric: share u
Slide 18: US Market
US MARKET 18 US VT Market Structure1 Top 150 sites perform ~ 50% of VT procedures FULCRUM-VT Early Feasibility IDE Study Vanderbilt University Medical Center Banner University Health Center Mount Sinai Hospital UC San Francisco 19 patients enrolled Based on management's analysis of Medicare FFS data
Slide 19: Near-Term VT Valuation-Driving Milestones
NEAR-TERM VT VALUATION -DRIVING MILESTONES Q1 Q2 Cryocure-VT Primary Endpoints (EHRA 2024) vCLAS™ CE-Mark and EU launch 2024 2025 FULCRUM-VT Pivotal IDE Start Q3 vCLAS™ PMA and US launch Note: Milestones are preliminary and subject to change. Please see Disclaimer – Forward-Looking Statements on sli
Slide 20: Atrial Fibrillation Market: Opportunity, Drivers and Inhibitors
ATRIAL FIBRILLATION MARKET: OPPORTUNITY, DRIVERS AND INHIBITORS
Slide 21: AF Market: Full Upside Requires Improvement in Long-Term Outcomes
AF MARKET: FULL UPSIDE REQUIRES IMPROVEMENT IN LONG-TERM OUTCOMES 0 1 2 3 4 5 6 7 8 9 Annual AF Ablations Annual AF Incidence AF Prevalence Cases (millions) 0.23 1.9 8.6 4% CAGR 4% CAGR 14% CAGR 6-8x upside in ablations if Class I indication as 1st line therapy – not achievable at current rates of r
Slide 22: AF Ablation Modalities: Equivalent Safety and Efficacy Outcomes
AF ABLATION MODALITIES: EQUIVALENT SAFETY AND EFFICACY OUTCOMES Freedom From AF/AT After Single Procedure In Paroxysmal AF Patients . 1) 2) Andrade JG, et al. Cryoballoon or radiofrequency ablation for atrial fibrillation assessed by continuous monitoring: A randomized clinical trial. Circulation 20
Slide 23: Persistently Worse Outcomes in Persistent AF Patients
PERSISTENTLY WORSE OUTCOMES IN PERSISTENT AF PATIENTS 23 25 50 75 100 Freedom from AF of AT/AF at 12 months (%) 68% n=102 Cryoballoon2 Hybrid CONVERGE3 MANIFEST5 2023 51% 58% 69% 71% n=196 n=3,133 n=339 n=7,502 Catheter Ablation RF1 Minimally Invasive Surgical Ablation1 w/o AAD w/ or w/o AAD w/o AAD
Slide 24: Durable, Contiguous, Transmural Lesions for Treatment of AFib
DURABLE, CONTIGUOUS, TRANSMURAL LESIONS FOR TREATEMENT OF AFIB 24 Shaped Stylets Esophageal Warming Balloon iCLAS™ Cryoablation Catheter Same ULTC platform (as vCLAS) Same scientific principles of lesion formation (as vCLAS) Catheter implementation for patient-tailored atrial ablations iCLAS™ Cryoab
Slide 25: CryoCure-2 Clinical Trial
CRYOCURE-2 CLINICAL TRIAL 25 Cryomapping Cohort (n=65) Cryomapping Cohort Phrenic nerve palsy 1 Resolved during procedure 1 Resolved during follow-up 1 Unresolved 0 Total device-related events 1.5% No esophageal fistula, pericarditis, heart block 1.5% T. De Potter, et al. Ultralow Temperature Cryoab
Slide 26: Leveraging VT Penetration into AF Market Share
LEVERAGING VT PENETRATION INTO AF MARKET SHARE US Ablation Market Structure1 AF market is slightly less concentrated compared to VT Access to 50% of VT volumes creates potential pull-through in ~ 40% of AF volumes Top 150 sites perform ~ 50% of VT procedures Based on management's analysis of Medicar
Slide 27: What Is Pulsed Field Cryoablation?
WHAT IS PULSED FIELD CRYOABLATION?
Slide 28: PFCA: Modulating Tissue Impedance to Optimize PFA Energy Delivery
PFCA: MODULATING TISSUE IMPEDANCE TO OPTIMIZE PFA ENERGY DELIVERY Increased impedance of frozen tissue leads to reduced electric current for the same magnitude of electric field or and increased magnitude of electric field for the same magnitude of electric current as compared to normal temperature
Slide 29: PFCA: Combining the Benefits of ULTC and Minimizing Limitations of PFA
PFCA: COMBINING THE BENEFITS OF ULTC AND MINIMIZING THE LIMITATIONS OF PFA PFA Console Cryoablation Console Single catheter with ablation element capable of both ultra-low temperature cryoablation and PFA Connected to standalone or integrated cryoablation and PFA consoles Lesion Formation: Short dur
Slide 30: PFCA vs PFA
PFCA: COMBINING THE BENEFITS OF ULTC AND MINIMIZING THE LIMITATIONS OF PFA PFCA vs PFA2,3: Potentially deeper lesions Consistent tissue contact Contiguity “by design” No phrenic nerve capture No skeletal muscle activation No or minimized microbubbles No or minimized coronary spasm4 Note: Management'
Slide 31: Pre-Clinical Evidence: Shorter Ablations, Deeper Lesions, Enhanced Selectivity
PRE-CLINICAL EVIDENCE1: SHORTER ABLATIONS, DEEPER LESIONS, ENHANCED SELECTIVITY PFCA LESION IN ~ 6mm THICK CTI Lesion depth enhancement due to pulsed field Lesion depth of 30 seconds, single freeze ULTC Blood vessel and surrounding muscle bundle preservation, suggestive of PFA exclusion from the unf
Slide 32: EU PARALELL Trial
EU PARALELL TRIAL (NCT #05408754): Pulsed Field Ablation and Pulsed Field Cryoablation for Persistent Atrial Fibrillation PFA 1) Expectations are preliminary and subject to change. Please see Disclaimer -- Forward-Looking Statements on slide 2. 32 PFCA Patients Projecting 120 PsAF patients (90 PFCA
Slide 33: Near-Term AF Valuation-Driving Milestones
NEAR-TERM AF VALUATION-DRIVING MILESTONES Q3 Q1 2024 2025 iCLAS™ IDE Primary Endpoints PARALELL Primary Endpoints iCLAS™ PMA Approval Cryopulse™ CE-Mark Q1 Note: Milestones are preliminary and subject to change. Please see Disclaimer – Forward-Looking Statements on slide 2. Q4 2026 33 33 PRIVATE AND
Slide 34: Transaction Summary
34 TRANSACTION SUMMARY Assumes (i) price per share of $10, (ii) pro forma closing cash balance of $30 million, including $15 million in cash remaining in ARYA’s trust (assuming additional 50% of redemptions in connection with the Business Combination), (iii) $23 million in bridge financing, (iv) ~$8
Slide 35: Thank You
THE COOLEST CATHETER ABLATION TECHNOLOGY THANK YOU © COPYRIGHT 2023 ADAGIO MEDICAL, INC. COMPANY CONFIDENTIAL 35
Slide 36: Appendix
APPENDIX | # Adagio:
Slide 37: Transaction Overview
37 TRANSACTION OVERVIEW Transaction Summary Adagio Medical, Inc. and ARYA Sciences Acquisition Corp IV (“ARYA”, Nasdaq: ARYD) propose to enter into a definitive business combination agreement ARYA is a special purpose acquisition company sponsored by Perceptive Advisors LLC The Post-Business Combina
Slide 38: Illustrative Pro Forma Ownership
ILLUSTRATIVE PRO FORMA OWNERSHIP1 38 All numbers adjusted for treasury stock method Subject to all assumptions and footnotes set forth on "Transaction Summary" and "Transaction Overview" slides. Illustrative per share price of Post-Business Combination company (to be a newly incorporated Delaware co
Slide 39: Highly Accomplished Executive Team
HIGHLY ACCOMPLISHED EXECUTIVE TEAM 10+ years of experience in medical devices 20+ years of corporate finance experience and Product Management 20+ years of medical device experience Olav Bergheim Hakon Bergheim John Dahldorf Nabil Jubran Tim Glynn Ilya Grigorov Doug Kurschinski CEO & President Chief
Slide 40: Selected Risk Factors
SELECTED RISK FACTORS 40 PRIVATE AND CONFIDENTIAL No representation or warranty (whether express or implied) has been made by ARYA, the Company, ListCo or any of their respective directors, officers, employees, affiliates, agents, advisors or representatives with respect to the proposed PIPE financi
Slide 41: Selected Risk Factors (cont.)
SELECTED RISK FACTORS (CONT.) 41 PRIVATE AND CONFIDENTIAL The consummation of the Business Combination is subject to a number of conditions, and if those conditions are not satisfied or waived, the Business Combination may not be completed; Some of ARYA’s, the Company’s or the
Slide 42: Selected Risk Factors (cont.)
SELECTED RISK FACTORS (CONT.) 42 PRIVATE AND CONFIDENTIAL The proceeds held in ARYA’s trust account could be reduced and the per-share redemption amount received by ARYA shareholders may be less than $10.00 per share; The Nasdaq Stock Market LLC may delist ARYA’s Cl
Slide 43: Selected Risk Factors (cont.)
SELECTED RISK FACTORS (CONT.) 43 PRIVATE AND CONFIDENTIAL Upon executing a definitive agreement with respect to the Business Combination by and among the Company, ARYA and the Post-Business Combination Company, ARYA may be prohibited from entering into certain transactions that might otherwise be
Slide 44: Selected Risk Factors (cont.)
SELECTED RISK FACTORS (CONT.) 44 PRIVATE AND CONFIDENTIAL If the Post-Combination Company estimates or judgments relating to its critical accounting policies are based on assumptions that change or prove to be incorrect, its results of operation could fall below its publicly announced guidance o
Slide 45: Selected Risk Factors (cont.)
SELECTED RISK FACTORS (CONT.) 45 PRIVATE AND CONFIDENTIAL Adagio is subject to regulation by the FDA or other regulatory authorities in the future and would be required to obtain prior approval or clearance by the FDA or other regulatory authorities, which could take significant ti
Slide 46: Appendix II – Market Sources & Analyses
APPENDIX II – MARKET SOURCES & ANALYSES
Slide 47: Atrial Fibrillation
ATRIAL FIBRILLATION # Adagio:
Slide 48: Analysis of Epidemiology (US)
CAGR 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 Prevalence, millions 4.3% 7.9 8.3 8.6 9.0 9.4 9.8 10.2 10.7 11.1 11.6 12.1 Incidence, millions 3.9% 1.8 1.8 1.9 2.0 2.1 2.1 2.2 2.3 2.4 2.5 2.6 ANALYSIS OF EPIDEMIOLOGY (US) AF Epidemiology in the USA1 25% (10-40%) of incident AF may be asy
Slide 49: Analysis of Current Volume of AF Ablations in the USA
PRIVATE AND CONFIDENTIAL ANALYSIS OF CURRENT VOLUME OF AF ABLATIONS IN THE USA Data Sources: Analysis of Medicare FFS Standard Analytical Files using CPT 936561 Limitations: Outpatient sample only Medicare FFS only Changes to coding during period of interest Required adjustments: Inpatient-outpatien
Slide 50: Utilization of PVI vs PVI+ Procedures
UTILIZATION OF PVI vs PVI+ PROCEDURES IN PATIENTS WITH DIFFERENT AF DIAGNOSIS Medicare FFS SAF Claims Add-on code to mark procedures with extra-PVI ablations. Since PVI is always performed, denoted “PVI+” Main AF ablation code inclusive of all PVI ablations Procedures that have PVI but not extra-PVI
Slide 51: Market Opportunity Assessment
MARKET OPPORTUNITY ASSESSMENT 51 Assumptions: Outcomes with Adagio technology are sufficient to establish ablation as a 1st line therapy for symptomatic patients Calculation to be made on incidence basis, larger prevalence representing additional upside Opportunity in 2022-2023: Total incidence / cu
Slide 52: AF Market: Full Upside Requires Improvement in Long-Term Outcomes
AF MARKET: FULL UPSIDE REQUIRES IMPROVEMENT IN LONG-TERM OUTCOMES 0 1 2 3 4 5 6 7 8 9 Annual AF Ablations Annual AF Incidence AF Prevalence Cases (millions) 0.23 1.9 8.6 4% CAGR 4% CAGR 14% CAGR 6-8x upside in ablations if Class I indication as 1st line therapy – not achievable at current rates of r
Slide 53: Monomorphic Ventricular Tachycardia
MONOMORPHIC VENTRICULAR TACHYCARDIA 53
Slide 54: Catheter Ablation Indications in VT
PRIVATE AND CONFIDENTIAL CATHETER ABLATION INDICATIONS IN VT1,2 Highly heterogeneous patient population Complex treatment pathways, combination of ICD and Rx approaches In majority of cases ablation in Class II indication for failed/poorly tolerated Rx and poorly tolerated/deleterious ICD therapies
Slide 55: Epidemiology of VT Ablations
PRIVATE AND CONFIDENTIAL EPIDEMIOLOGY OF VT ABLATIONS Brigham and Women Hospital Cohort1 US Community Medicare Cohort2 German VT Ablation Registry Cohort3 14% 34% 52% 78% 22% 35% 17% + 48% 1) 2) 3) Kumar S, et al. Long-term outcomes after catheter ablation of ventricular tachycardia in patients with
Slide 56: VT Ablations Market by Category and Current Ablation Triggers
VT ABLATIONS MARKET BY CATEGORY AND CURRENT ABLATION TRIGGERS (ICM/NICM ONLY) ~$75M ~$75M $150M TRIGGERS OF ABLATION4 VT ABLATIONS, BY INDICATION1,2,3,4 1) 2) 3) 4) Refer to Sllide #68 for management assessment of total market of VT ablations ($0.3B) and slide #55, Epidemiology of VT ablations Dinov
Slide 57: Analysis of Current Volume of VT Ablations in the USA
PRIVATE AND CONFIDENTIAL ANALYSIS OF CURRENT VOLUME OF VT ABLATIONS IN THE USA Data sources: Analysis of Medicare FFS Standard Analytical Files using CPT 936541 Limitations: Outpatient sample only Medicare FFS only Changes to coding during period of interest Required adjustments: Inpatient-outpatien
Slide 58: The Burden of Incident Idiopathic VTs
PRIVATE AND CONFIDENTIAL THE BURDEN OF INCIDENT IDIOPATHIC VTs Growth assumptions Extrapolation of 2013 observed growth incidence rate per disease state to 2022 Weighted average growth rate VT ablation eligibility assumptions Symptomatic PVCs: those with >20% burden Idiopathic VTs: those with >20% b
Slide 59: Total Burden of VT in ICD Population
PRIVATE AND CONFIDENTIAL TOTAL BURDEN OF VT IN ICD POPULATION ACTUALS CAGR PROJECTIONS ICD Leads 2010 2011 2012 2013 2014 2015 2022 2023 Single Coil 8,123 13,795 17,499 22,705 27,796 35,521 Dual Coil 49,086 56,635 54,926 53,894 50,028 48,764 Total Annual 76,279 70,430 72,425 76,599 77,824 84,285 96,
Slide 60: HF Hospitalizations in US
PRIVATE AND CONFIDENTIAL HF HOSPITALIZATIONS IN US 1) 2) Tsao C, et al. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation 2022;145:e153-e169 Shah KS, Xu H, Matsouaka RA, et al. Heart failure with preserved, borderline and reduced ejection frac
Slide 61: Burden of VT in Hospitalized HF Patients
BURDEN OF VT IN HOSPITALIZED HF PATIENTS Estimated incidence of post-hospitalization VTs in HF patients is ~ 32K, based on 1.35M HF hospitalizations projected in 2022 based on 1.9% annual growth from 1.25M in 20183 1-year incidence - 5.4% 1-year incidence adjusted for ICD eligibility – 2.4%* Inciden
Slide 62: Summary Calculation of Incident Trigger VTs
SUMMARY CALCULATION OF INCIDENT “TRIGGER” VTs PROMPTING CONSIDERATION FOR ABLATION 62 Market growth opportunity: All trigger VTs / Current VT ablations = 3.1x* Trigger VTs due to cardiomyopathy (HF hospitalizations + ICD Implants) / Current VT ablations = 1.9x** 2-3x range represents conservative as
Slide 63: VT Market: Current Risk-Benefit Caps Ablation Therapy Penetration
150 200 Annual VT Ablations Annual Incidence of "Trigger" VTs Disease Prevalence Cases (thousands) HF / Cardiomyopathy / ICDs Idiopathic VTs VT MARKET: CURRENT RISK-BENEFIT CAPS ABLATION THERAPY PENETRATION 2% CAGR 100 7% CAGR 50 0 2-3x market growth opportunity* with improved ablation effectiveness
Slide 64: Overall Market Sizing and Growth
OVERALL MARKET SIZING AND GROWTH
Slide 65: Overall Market Sizing
OVERALL MARKET SIZING JnJ, ABT and BSX report Electrophysiology revenue on quarterly basis using standard annual calendar Prior to 2023 JnJ reported revenue for Interventional Solutions segment, comprising predominantly of Electrophysiology + much smaller Neurovascular products. Starting 2023, Elect
Slide 66: Market Structure by Segment
MARKET STRUCTURE BY SEGMENT Normalization procedure is performed against total revenue of main market players to exclude line items representing non-essential or separately reported lines of business Ablation catheter revenue - $3.1 - $3.2B St Jude % Adagio Model % Revenue, $B Ablation Catheter 31%
Slide 67: Volumes and Growth Considerations
VOLUMES AND GROWTH CONSIDERATIONS Ablations Volumes UK Germany Spain Switzerland US Years Reporting 2020 2020 2019 2019 2022 AF 9,768 34,888 5,194 3,075 230,000 VT 1,310 7,525 1,484 540 32,000 VT (as % of AF) 13% 22% 29% 18% 14% 14% in 2022, considering higher AF Growth Ablations Growth Rates Austra
Slide 68: Segmental Market Revenue
SEGMENTAL MARKET REVENUE Mid-range values for segmental growth Based on prior assumptions and market estimates in slides 63-65 Growth potential per segment: PAF: 6-8x per slide #50 PsAF+VT 6-8x for PsAF (slide #50) 2-3x for VT (slide #60) Weighted potential is ~ 5x, suggest conservative assessment o
Slide 69: Initial Focus on Segments of Highest Need
INITIAL FOCUS ON SEGMENTS OF HIGHEST NEED VT + Persistent AF markets: ~$1B / ~10% CAGR – attractive segment for share taking and market expansion PAROXYSMAL AF (PAF) SVT/AFL PERSISTENT AF (PsAF) V-TACH (VT) $0.8B $0.8B $1.2B $0.3B CLINICAL NEED Total ~$3.2B1 Growth Opportunity 2 – 3x Growth Opportun
Slide 70: Go-to-Market Assessments
GO-TO-MARKET ASSESSMENTS a Adagio:
Slide 71: US Market of VT Ablations (Medicare FFS 2022 Data)
US MARKET OF VT ABLATIONS (MEDICARE FFS 2022 DATA) 71 Top 150 sites perform ~ 50% of VT procedures Per center volume analysis Number of VT ablations is based on the total number of claims CPT/HCPCS 03654 Non-numerical reporting of claims (1-10) is interpolated to achieve reported totals Population-b
Slide 72: EU Market for VT Ablations
72 EU MARKET FOR VT ABLATIONS (MANAGEMENT ESTIMATES) 72 World Population Data 2016. Population Reference Bureau. https://www.prb.org/wp-content/uploads/2016/08/prb-wpds2016.pdf Raatikainen MJP, Arnar DO, Merkely B, et al. A Decade of Information on the Use of Cardiac Implantable Electronic Devices a
Slide 73: Leveraging VT Penetration into AF Market Share
LEVERAGING VT PENETRATION INTO AF MARKET SHARE Management Assessment of US Ablation Market Structure1 AF market is slightly less concentrated compared to VT Access to 50% of VT volumes creates potential pull-through in ~ 40% of AF volumes Top 150 sites perform ~ 50% of VT procedures Based on managem
Slide 74: Competitive Devices and Indications
COMPETITIVE DEVICES AND INDICATIONS
Slide 75: Abbott / St. Jude Medical
ABBOTT / ST. JUDE MEDICAL Product Name US IFU Available Indicated Conditions Energy Source TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ YES PAF, PsAF RF TactiCath™ Quartz Contact Force Ablation Catheter YES PAF RF TactiFlex™ Ablation Catheter, Sensor Enabled™ YES PAF, AFL RF Safire™ A
Slide 76: Expanded Indication for FlexAbility Catheter
PRIVATE AND CONFIDENTIAL EXPANDED INDICATION FOR FLEXABILITY CATHETER Source: company website 76
Slide 77: Boston Scientific
BOSTON SCIENTIFIC Source: product Instructions For Use downloaded from US portion of the website, except FARAWAVE (see reference 1). OUS indications for use may vary. 77 Product Name US IFU Available Indicated Conditions Energy Source Blazer II®, Blazer II HTD® Temperature Ablation Catheters YES Acc
Slide 78: JnJ (Biosense Webster, Inc.)
JnJ (Biosense Webster, Inc.) Source: product Instructions For Use downloaded from US portion of the website. OUS indications for use may vary. 78 Product Name US IFU Available Indicated Conditions Energy Source QDOT MICRO™ Uni-directional Catheter YES AFL, PAF RF QDOT MICRO™ Bi-directional Catheter
Slide 79: Original Indication for Thermocool Catheter
ORIGINAL INDICATION FOR THERMOCOOL CATHETER Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030031 79 PRIVATE AND CONFIDENTIAL
Slide 80: Medtronic
MEDTRONIC 80 Source: product Instructions For Use downloaded from US portion of the website, excluding PulseSelect (see reference 1). OUS indications for use may vary. Product Name US IFU Available Indicated Conditions Energy Source AFFERA Sphere-9™ Mapping and Ablation Catheter YES PAF, PsAF, AFL,
Slide 81: Ablation Modalities Comparison
ABLATION MODALITIES COMPARISON
Slide 82: Using NHS Cost-Effectiveness Model for Technology Comparisons
USING NHS COST-EFFECTIVENESS MODEL FOR TECHNOLOGY COMPARISONS Conversions of data from source inputs into table: 1-year freedom from AF: 1 – 1st year AF recurrence Incremental mortality = Mortality – AAD Mortality For PFA values refer directly to quoted sources 1st year freedom from AF 27% 69% 68% 6
Slide 83: PFA: Comparison of Outcomes in PAF and PsAF Patients
PFA: COMPARISON OF OUTCOMES IN PAF and PsAF PATIENTS FARAPULSE/BSX: MANIFEST-PF REGISTRY1 MDT: PULSED AF TRIAL2 1) 2) 3) Turagam MK, Neuzil P, Schmidt B, et al. Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry. Circulatio
Slide 84: NHS Cost-Effectiveness Model: Complications
USING NHS COST-EFFECTIVENESS MODEL FOR TECHNOLOGY COMPARISONS: COMPLICATIONS AAD RF point-by- point RF Multi- electrode Cryobaloon Laser Ablation Mini- thoracotomy Hybrid Ablation N/A 0.5% 0.5% 0.5% 0.5% N/A N/A N/A 1% 1% N/A 1% N/A N/A N/A N/A N/A 0.4% N/A N/A N/A N/A 1% 1% 1% 1% N/A N/A N/A N/A N/
Slide 85: VT Market: Current Risk-Benefit Caps Ablation Therapy Penetration
150 200 Annual VT Ablations Annual Incidence of "Trigger" VTs Disease Prevalence Cases (thousands) HF / Cardiomyopathy / ICDs Idiopathic VTs VT MARKET: CURRENT RISK-BENEFIT CAPS ABLATION THERAPY PENETRATION 2% CAGR 100 7% CAGR 50 0 2-3x7 market growth opportunity with improved ablation effectiveness
Slide 86: Appendix III – Technical Supplement
Appendix III – TECHNICAL SUPPLEMENT 86
Slide 87: Scaling Graph – Manual Measurements of Reported Data
Scaling Graph – Manual Measurements of Reported Data (to ensure accuracy on slide # 13) 30mm = 1.89” Healthy Depth Scale + Error - Error Scar 1.3mm = 0.08” 3.2mm = 0.2” 10mm = 0.63” 13mm = 0.81” 3.8mm = 0.24” 5.1mm = 0.32” Dewland TA, Higuchi S, Venkateswaran R, Lee C, Gerstenfeld EP. AB-452672-2 Ul
Slide 88: Appendix IV - Older Slides
Appendix IV - OLDER SLIDES a Adagio:
Slide 89: AFib Catheter Ablation Outcomes: In Need of Technology Breakthrough
AFIB CATHETER ABLATION OUTCOMES: IN NEED OF TECHNOLOGY BREAKTHROUGH 89 * mostly from 2016 ESC guidelines, catheter esophageal perforations – 0.5% Note: Management's estimates which are subject to significant uncertainty and may prove to be incorrect. Please see Disclaimer - Management's Estimates on
Slide 90: Acquisitions Have Driven Consolidation Among Competitors
Year Purchase Price ($mm) Target 2008 388 2009 225 2019 316 2022 925 Year Purchase Price ($mm) Target 2001 115 2012 265 2013 275 2018 202 2021 450 2022 1,750 Year Purchase Price ($mm) Target 2004 47 Irvine Biomedical 2005 237 2008 92 2008 250 2013 331 2014 250 Year Purchase Price ($mm) Target 1997 4
Slide 91: Adagio Medical: Outcomes-Focused Technology Differentiation
ADAGIO MEDICAL: OUTCOMES-FOCUSED TECHNOLOGY DIFFERENTIATION Durable, contiguous, transmural lesions… anywhere in the heart to drive long-term ablation effectiveness, therapy adoption and market growth Comprehensive technology solution for advanced EP practice Compatible with commercial mapping syste
Slide 92: Competitive Technology Landscape in Catheter Ablations
92 COMPETITIVE TECHNOLOGY LANDSCAPE IN CATHETER ABLATIONS: STABILITY DESPITE DISRUPTION1 1) Based on management's analysis using internal and third-party estimates and resources, subject to certain assumptions and limitations. Please see Slides 68-73 which are part of Appendix II - Market Sources &
Slide 93: US iCLAS for Persistent AF IDE
US iCLAS FOR PERSISIENT AF IDE (NCT # 04061603) iCLAS™ Catheter 93 Patients 183 PsAF Endpoints Procedural safety and chronic effectiveness Sites 20 (7 OUS) Data Readout Expected in Q2 2024 PMA Expected in Q1 2025 Note: Expectations are preliminary and subject to change. Please see Disclaimer Forward
Slide 94: Initial Focus on Highest Needs and Upsides
INITIAL FOCUS ON HIGHEST NEEDS AND UPSIDES PAROXYSMAL AF (PAF) SVT/AFL PERSISTENT AF (PsAF) V-TACH (VT) 1%-4% CAGR 5%-8% CAGR $0.8B $0.8B $1.2B $0.3B SIMPLE CATHETERS ADVANCED CATHETERS 10%-13% CAGR ~75% of the market is in the “advanced” catheters: irrigated Radiofrequency (RF) ablation with contac
Slide 95: EP Market: Continuing Growth, Perennial Opportunity
48% 54% 14% 11% 33% 26% 6% 8% 2018 2022 JNJ MDT ABT BSX EP MARKET: CONTINUING GROWTH, PERENNIAL OPPORTUNITY Worldwide EP Market (Main Competitors)1 Worldwide $7.3bn EP Market Breakdown3 $5.1B $7.3B2 EP Ablation Catheters (consumables) ~$3.2B ~4% of total J&J revenue ~3% of total Medtronic revenue ~4