Carvolix · EURONEXT:CVX
Carvolix — Affluent Medical — IPO Roadshow (May 2021)
49 slides from Carvolix's IPO roadshow presentation, May 2021
Slide 1: Initial Public Offering Project on Euronext Paris Regulated Market
SAVE AND IMPROVE PATIENTS’ LIVES WITH DISRUPTIVE PROSTHESES INITIAL PUBLIC OFFERING PROJECT ON EURONEXT PARIS REGULATED MARKET
Slide 2: Disclaimer
Disclaimer IMPORTANT NOTICE - YOU MUST READ THE FOLLOWING BEFORE CONTINUING The following applies to this document, the oral presentation of the information in this such information or statistics should not be interpreted as having been adopted or endorsed clients, or for advising any such person in
Slide 3: Management team
INTRODUCTION Management team Michel Finance Jérôme Geoffroy CEO CFO Selected previous experience Selected previous experience 3 Confidential - do not duplicate or distribute without permission from Affluent Medical
Slide 4: Affluent Medical at a glance
INTRODUCTION Affluent Medical at glance 2011 ~50 Founded Employees ARTUS First moderate to severe incontinence device with remote control Q4 2023 Urology €10bn 31 EPYGON Next generation mitral valve replicating the human physiology H2 2025 Addressable markets Patent families by 2027(1) KALIOS Only m
Slide 5: Our mission: save and improve patients' lives with disruptive prostheses
INTRODUCTION Our mission: save and improve patients’ lives with a range of disruptive prostheses Urology Structural heart ARTUS KALIOS EPYGON Large unmet medical needs Improving patient Physiological design Minimally invasive care and surgeon usage Source(s): (1) Irwin DE, Milsom I, Hunskaar S, et a
Slide 6: Key strengths
INTRODUCTION Key strengths Addressing large and fast growing markets 1 with critical unmet needs Unique disruptive prostheses 2 to improve patients’ lives and surgeon care Solid IP portfolio endorsed by respected leaders 3 in the medical community Fully engaged in clinical studies and clear market a
Slide 7: Urology
DISRUPTIVE PROSTHESES ADDRESSING UNMET NEEDS UROLOGY ARTUS First moderate to severe incontinence device with remote control
Slide 8: ARTUS Urinary incontinence at a glance
UROLOGY ARTUS Urinary incontinence at a glance If urinary incontinence was a country, it would be the 3rd largest in the world Prevalence of urinary incontinence Age 40 - 70 Age 70+ 5% - 15% of population >15% of population affected by daily UI(2) affected by daily UI(2) ~423m Increasing risk of UI
Slide 9: Endorsement from Professor Véronique Phé, Urologist
UROLOGY Endorsement from Professor Véronique Phé, Urologist PROFESSOR VÉRONIQUE PHÉ PROFESSOR OF UROLOGY, PITIÉ-SALPÊTRIÈRE, PARIS 9 Confidential - do not duplicate or distribute without permission from Affluent Medical
Slide 10: ARTUS Fast growing urinary incontinence market with unmet needs
UROLOGY ARTUS Fast growing urinary incontinence market with unmet needs Global urinary incontinence device market(5) Over 423m people(1) suffers from urinary incontinence(2) $4.3bn 11% CAGR We focus on moderate to severe urinary 1.4m incontinence, which affects 107m people(3) / 25% of the population
Slide 11: ARTUS First moderate to severe incontinence device with remote control
UROLOGY ARTUS First moderate to severe incontinence device with remote control ✓ ✓ Easy to Improved patient implant life Electro-mechanical Contains ✓ ✓ Device for artificial sphincter software, battery Invisible women and men D-shape and engine Asymmetric Better clinical results ✓ Can be activated
Slide 12: ARTUS Procedure overview
UROLOGY ARTUS Procedure overview 1 Minimally invasive prosthesis The adjustable cuff is positioned around and procedure known by the bladder neck and locked surgeons Reduction of hospitalisation time 2 The cuff is connected to the remotely-controlled Easy to implant by surgeons actuator which drives
Slide 13: Endorsement from Professor Nicolas Barry Delongchamps, Urologist
UROLOGY Endorsement from Professor Nicolas Barry Delongchamps, Urologist PROFESSOR NICOLAS BARRY DELONGCHAMPS PROFESSOR OF UROLOGY, COCHIN HOSPITAL, PARIS 13 Confidential - do not duplicate or distribute without permission from Affluent Medical
Slide 14: ARTUS Competition landscape
UROLOGY ARTUS Competition landscape Electronic artificial Product offering ZSI 375 AMS 800™ urinary sphincter ARTUS™ CE Approval ✓ ✓ Q4 2023(1) FDA Approval ✓ Q4 2024(1) Launch date - - 1987 2024(1) User friendly ✓ ✓✓✓ Efficiency - - ✓ ✓✓✓ Targets men and women ✓ ✓ Surgery type - ✓ ✓ ✓
Slide 15: Structural Heart
DISRUPTIVE PROSTHESES ADDRESSING UNMET NEEDS STRUCTURAL HEART KALIOS Mitral valve repair EPYGON Mitral valve replacement
Slide 16: Two ways of treating mitral insufficiency
KALIOS STRUCTURAL HEART Two ways of treating mitral insufficiency EPYGON Mitral regurgitation occurs Anatomy of the heart and heart valves when the mitral valve no longer closes properly Normal Regurgitation Pulmonary valve Mitral valve Tricuspid valve Aortic valve ~2% of whole population Age 75+ af
Slide 17: Addressing the mitral valve market with complementary solutions
KALIOS STRUCTURAL HEART Addressing the mitral valve market with complementary solutions EPYGON Global Transcatheter Mitral Valve Repair and Implantation(5) market Global TAVI(6) market Cardiovascular diseases are the number one Transcatheter Mitral Valve Transcatheter Aortic Valve cause of death glo
Slide 18: KALIOS Only mitral valve ring that can be adjusted multiple times
STRUCTURAL HEART KALIOS Only mitral valve ring that can be adjusted multiple times post surgery ✓ ✓ Better Transcatheter immediate adjustment on Mitral valve repair surgical results beating heart Adjustable ✓ Adjustable ✓ Minimally Adaptable to the shape through invasive multiple times evolution of
Slide 19: KALIOS Procedure overview
STRUCTURAL HEART KALIOS Procedure overview 1 Implanted as a conventional ‘Carpentier’ ring to perform a normal annuloplasty procedure Minimally invasive procedure Easy to implant for surgeons 2 During implantation, the end of the connection line is routed to a subclavian position to facilitate post
Slide 20: EPYGON Next generation mitral valve replicating the human physiology
STRUCTURAL HEART EPYGON Next generation mitral valve replicating the human physiology ✓ ✓ Mitral valve replacement Easy Adapting valve to implantation the physiology D-shape Asymmetric (native) ✓ ✓ D-shape Decreases Asymmetric Restoring native- Better clinical left ventricle results like blood flow
Slide 21: Endorsement from Professor Christian Latremouille, Cardiac Surgeon
STRUCTURAL HEART Endorsement from Professor Christian Latremouille, Cardiac Surgeon PROFESSOR CHRISTIAN LATREMOUILLE CHIEF SURGICAL OFFICER, CARMAT FORMER PROF. OF CARDIAC SURGERY, EUROPEAN HOSPITAL GEORGES POMPIDOU, PARIS 21 Confidential - do not duplicate or distribute without permission from Affl
Slide 22: EPYGON Physiological blood vortex is key to improving left ventricle recovery
STRUCTURAL HEART EPYGON Physiological blood vortex is key to improving left ventricle recovery EPYGON vs. tri-leaflet mitral valve - Total Normal EPYGON Others energy loss (% ventricular work) in pre-clinical test At 3.5 l/min and 100 mmHg mean aortic pressure 34% reduction 3.5 l/min 1 2 3 Physiolog
Slide 23: EPYGON Procedure overview
STRUCTURAL HEART EPYGON Procedure overview 23 Confidential - do not duplicate or distribute without permission from Affluent Medical
Slide 24: EPYGON Procedure overview
STRUCTURAL HEART EPYGON Procedure overview Transapical& transseptal(1) access 1 The delivery system is advanced to ensure optimal central placing inside the native mitral valve 2 The atrial portion of the device is gradually released; petals Mitral are deployed to obtain the desired D-shaped positio
Slide 25: EPYGON Competition landscape
STRUCTURAL HEART EPYGON Competition landscape Product offering Highlife Saturn INTREPID CARDIAQ TIARA TENDYNE™ EPYGON™ CE Approval ✓ H2 2025(1) FDA Approval Early feasibility Clinical study Q4 2025(1) Few patients Finished 50 patient Ongoing pilot CE-marked InitiatingFirst-in- Stat
Slide 26: Patented technologies backed by key opinion leaders
PATENTED TECHNOLOGIES BACKED BY KEY OPINION LEADERS
Slide 27: 31 patent families: secured IP protection to create value
PATENTED TECHNOLOGIES BACKED BY KEY Secured IP protection to create value OPINION LEADERS Annuloplasty ring AMLL paddle KALIOS Actuator for annuloplasty ring Stent with enhanced grip EPYGON Ring with changeable element Delivery system Cage Elastic chain Valve leaflet with variable Flow sensor thickn
Slide 28: Kardiozis: disruptive technology for abdominal aortic aneurysm with licensing opportunity
PATENTED TECHNOLOGIES BACKED BY KEY Disruptive technology to treat abdominal aortic aneurysm with licensing opportunity OPINION LEADERS Current issues with aortic aneurysm 2 million people suffer from AAA Type II endoleaks occur in 10-47% Patients exposed with high mortality risk, but only of cases
Slide 29: A top tier scientific board
PATENTED TECHNOLOGIES BACKED BY KEY A top tier scientific board OPINION LEADERS Prof. Christian Prof. Alain Berrebi Prof. Alain Carpentier Prof. Theodor Fischlein MD MD, PhD MD Latremouille MD, PhD Interventional Head of Echo-Lab of Prof. of Cardiac Surgery Co-founder of Prof. of Cardiac Surgery, Nu
Slide 30: Key milestones and strategy
KEY MILESTONES AND STRATEGY
Slide 31: Important milestones have been achieved so far
KEY MILESTONES AND STRATEGY Important milestones have been achieved so far Preclinical studies First-in-human study Pilot and pivotal trial Other 15 patients implanted Of whom 3 patients KALIOS had their valve ring adjusted Partnership with local partners to accelerate clinical studies 9 centers and
Slide 32: Roadmap ensures products coming to market every 12 months
KEY MILESTONES AND STRATEGY Roadmap ensures products coming to market every 12 months 2022 2023 2024 2025 2026 KALIOS $ ARTUS EPYGON $ Note(s): Timeline subject to evolution of the COVID pandemic and obtaining financing (IPO and additional financing if necessary) 32 Confidential - do not duplicate o
Slide 33: Next steps and roadmap for future growth
KEY MILESTONES AND STRATEGY Next steps and roadmap for future growth Next steps 2021 2022 2023 2024 2025 2026 KALIOS • ~62 patients Interim results for pivotal trial • Implantations until S2 2021 Pilot / Pivotal trial 15 patients recruited Reimbursement Commercialisation ARTUS discussions Interim re
Slide 34: Detailed newsflow expected over the next 18 months
KEY MILESTONES AND STRATEGY Detailed newsflow expected over the next 18 months S2 2021 S1 2022 S2 2022 KALIOS • Interim results for first 15 patients • Pharma-economy study and pricing • CE Mark • End of inclusion of all patients in pivotal discussion with direct sales countries • Sales & Marketing
Slide 35: Highly specialised production capabilities with clear path to expansion
KEY MILESTONES AND STRATEGY Highly specialised production capabilities with clear path to expansion Production Seamless expansion with low capex needs KALIOS Mainly outsourced Lean and agile outsourced design ARTUS Enough capacity for commercial launch, which Mixed, with in-house cleanroom assembly
Slide 36: Commercialisation strategy built around three building blocks
KEY MILESTONES AND STRATEGY Commercialisation strategy built around three building blocks Partnerships Direct and indirect sales Pricing / reimbursement Potential partnerships Launch in Europe via Premium pricing offering A A A with key US players direct1 and indirect sales vs. competing products Es
Slide 37: Team of experienced leadership experts in MedTech
TEAM OF EXPERIENCED LEADERSHIP EXPERTS IN MEDTECH
Slide 38: Experienced MedTech leadership team
GOVERNANCE Experienced MedTech leadership team Michel Finance Olivier Pierron Jérôme Geoffroy Prof. François Laborde, MD Chairman & Chief Chief Operating Chief Financial Chief Medical Executive Officer Officer Officer Officer Extensive experience with several management Deputy Sales General CEO >15k
Slide 39: Overview of financials
OVERVIEW OF FINANCIALS 9 affluent MEDI
Slide 40: Profit & Loss snapshot
FINANCIALS Profit & Loss snapshot R&D spend as % of 2020 op. expenses Profit & Loss snapshot (in €k) 31 Dec 2020 31 Dec 2019 Sales - - Other operating income 824 1,429 Operating expenses (13,418) (15,269) Operating Income (12,594) (13,841) Share of income from equity affiliates (398) (1,190) Operati
Slide 41: Cash flow snapshot
FINANCIALS Cash flow snapshot Cash flow snapshot (in €k) 31 Dec 2020 31 Dec 2019 Net income/loss (14,319) (16,589) P&L non cash items 5,383 5,177 Cash flow from operating activities (8,936) (11,412) Cash flow from investing activities (304) (185) Cash flow from financing activities 12,762 10,386 Fre
Slide 42: Use of proceeds
FINANCIALS Use of proceeds Clinical - Clinical development plan in the EU for the completion of Kalios / Artus pivotal studies and initiation of Debt repayment large pivotal studies for Epygon 15% R&D - Continuous improvement of Affluent Medical Clinical product portfolio: new version, optimisation,
Slide 43: Why invest in Affluent Medical?
WHY INVEST IN AFFLUENT MEDICAL?
Slide 44: Why invest in Affluent Medical?
CONCLUSION Why invest in Affluent Medical? >€10bn Market opportunity by 2027, growing fast First sales in 2023 31 Patent families protected until 2041 for the Disruptive latest solutions improving patients’ lives 44 Confidential - do not duplicate or distribute without permission from Affluent Medic
Slide 45: Transaction terms
TRANSACTION TERMS
Slide 46: Key terms of the transaction
TRANSACTION TERMS Key terms of the transaction Issuer Affluent Medical SA – ISIN code: FR0013333077 - Ticker : AFME Listing Euronext Paris Regulated Market A public offering in France in the form of an Open Price Offering intended mainly for retail investors (“OPO”) Offering structure A glob
Slide 47: Indicative timeline
TRANSACTION TERMS Indicative timeline 26 May 2021 AMF approval on the Prospectus 27 May 2021 Opening of the French Public Offer and the Global Placement Closing of the French Public Offering at 5:00 p.m. (Paris time) for subscriptions over the counter and at 8:00 p.m. (Paris time) for 8 June 2
Slide 48: Shareholder structure
TRANSACTION TERMS Shareholder structure Pre-IPO1 Post-IPO1 Post-IPO1 Fully diluted basis Fully diluted basis Fully diluted basis Based on a capital composed of 23,939,796 Based on a capital composed of Based on a capital composed of 22,702,297 shares shares 18,865,087 shares Before the exercise of e
Slide 49: Partners of the operation
TRANSACTION TERMS Partners of the operation Global Coordinators, Lead Managers and Bookrunners Legal advisor Auditors Auditors IFRS support Financial communication Corporate communication advisory advisory 49 Confidential - do not duplicate or distribute without permission from Affluent Medical