Slide 1: Investor Presentation March 2017
Investor Presentation March 2017
Slide 2: Disclaimer
Disclaimer • This document is prepared by THERACLION( the “Company”) only for the purpose of this presentation. The information contained in this document is confidential and may not be reproduced or redistributed, directly or indirectly, to any person, or published, in whole or in part, for any rea
Slide 3: Investment profile
Theraclion Investment profile Company overview Large existing market; strong demand for non-invasive approach Echopulse® system – differentiated and proprietary HIFU technology Development and commercialization strategy – Expanding in Europe and Asia; preparing for U.S. Gaining market traction with
Slide 4: Company profile
Theraclion Company profile Echopulse®: Non-invasive HIFU technology Operations • Non-invasive high-intensity ultrasound (HIFU) for • WW locations: Frankfurt, London, Milan, Hong Kong, treatment of breast fibroadenomas and thyroid nodules based in Malakoff, France • Alternative to 3M invasive surgeri
Slide 5: Management Team: Track Record of Success in Healthcare
Theraclion Management Team: Track Record of Success in Healthcare David Caumartin Chief Executive Officer Sylvain Yon 14 years of experience with GE Healthcare Deputy CEO, VP Research & Development Experience of sales, marketing and development of new Co-Founder of Echosens in 2001 products in the U
Slide 6: Investment profile
Theraclion Investment profile Company overview Large existing market; strong demand for non-invasive approach Echopulse® system – differentiated and proprietary HIFU technology Development and commercialization strategy – Expanding in Europe and Asia; preparing for U.S. Gaining market traction with
Slide 7: Large Global Market
Large Global Market ~3M surgeries performed annually that could be treated non-invasively ~1,4 million procedures for breast fibroadenomas • 10% of women develop benign breast fibroadenomas making them the most common benign breast diseases • Removal is recommended if they cause irritation, are grow
Slide 8: Focused on Two Large Indications
ECHOPULSE® Focused on Two Large Indications Commercialization efforts will focus on three large markets Surgery Surgery 800 000 1 000 000 600 000 800 000 600 000 400 000 400 000 200 000 200 000 0 0 EMEA USA CHINA ROW EMEA USA CHINA ROW Breast Thyroid Sources : Kaufman et al., American Journal of Sur
Slide 9: Investment profile
Theraclion Investment profile Company overview Large existing market; strong demand for non-invasive approach Echopulse® system – differentiated and proprietary HIFU technology Development and commercialization strategy – Expanding in Europe and Asia; preparing for U.S. Gaining market traction with
Slide 10: "Surgery" without Surgery
ECHOPULSE® “Surgery” without Surgery Non-Invasive Technology Provides Effective Alternative to Surgery and Invasive Ablative Technologies Breast Fibroadenomas and Thyroid Nodules Compact, Mobile and Less Expensive Breast Benign thyroid Potential Alternative to Radio-Iodine Therapy fibroadenoma nodul
Slide 11: ECHOPULSE with BEAMOTION
ECHOPULSE® with BEAMOTION Launched 4Q15 With BEAMOTION 7 times fewer pulses required enabling significant reduction of treatment duration: 17 minutes [10-27] vs. H 7,3 mm Ø 5 mm 83 minutes [36-144]* with fixed transducer HIFU transducer moves during the pulse * THC901687-A - Comparison of thyroid no
Slide 12: Substantial Benefits vs. Alternative Therapies
ECHOPULSE® Substantial Benefits vs. Alternative Therapies ECHOPULSE® with Traditional Surgery Min. invasive surgery Metric BEAMOTION 3-7 cm 1.3 – 2.5 cm Incision Length NONE Anesthesia Local or no anesthesia General anesthesia Local or general anesthesia 30 – 45 minutes Duration (breast) of procedur
Slide 13: Unique HIFU Solution for Thyroid and Breast Indications
ECHOPULSE® Unique HIFU Solution for Thyroid and Breast Indications Bone Uterine Liver/ Prostate Thyroid Breast Equipment price (k€) metastases fibroid Pancreas Maintenance fee (k€) THERACLION 350 20 Ultrasound-Guided SONACARE EDAP 400 – 500 30 HAIFU 600 – 1,200 60 PHILIPS INSIGHTEC Mr-Guided 1,500 2
Slide 14: Breast Fibroadenoma: Clinical Results in Peer-Reviewed Journals
ECHOPULSE® Breast Fibroadenoma: Clinical Results in Peer-Reviewed Journals 1 session 2 sessions mean volume reduction at 2Y = 77.32% mean volume reduction at 2Y = 90.47% 20 patients Volume at baseline = 1.82 mL Volume at baseline = 8.14mL • No case of regrowth • High patient satisfaction with excell
Slide 15: Thyroid nodule: Single Session Treatment
Modifiez Thyroid: le stylenodule Large du titre Single Session Treatment Sous-titre HK University publication in American Thyroid Association, Prof. Lang Material & Methods • 73 consecutive patients • Nodule volume monitored • Recruitment in < 1year o 1 week • Single HIFU session o 1 – 3 – 6 months
Slide 16: Investment profile
Theraclion Investment profile Company overview Large existing market; strong demand for non-invasive approach Echopulse® system – differentiated and proprietary HIFU technology Development and commercialization strategy – Expanding in Europe and Asia; preparing for U.S. Gaining market traction with
Slide 17: Establish Echotherapy as Standard of Care
Theraclion Establish Echotherapy as Standard of Care • Build-out commercial network • Engage Key Opinion Leaders and medical • Enter U.S. and China societies to obtain specific codes for • Generate initial sales echotherapy with private “Early Adopters” Echotherapy as • Initiate transitory standard
Slide 18: Synergistic Development Progression
Synergistic Development Progression HIFU NucMed CANCER: Credibility & Research Center Surgery Radiology HIFU Endocrino Gynecolo Endrocrin XYZ-ology Head & Neck gy ology Center Gyneco Neuro BENIGN: Adoption, Market Access, HIFU Clinic Center Experimentation 18
Slide 19: Growth Strategy Beyond Existing Indications
Growth Strategy Beyond Existing Indications Limited or No Early Investment – Early KOL Engagement Product V&V Pivot Trial CE Existing User Idea for Customer Indication New Indication Research Tight collaboration with Site Initiated Development / academic KOL customer. Feasibility R&D & Investigation
Slide 20: Echotherapy Benefits All Three Major Stakeholders
Echotherapy Benefits All Three Major Stakeholders PATIENTS PROVIDERS PAYORS One simple outpatient procedure Attracts new patients No hospitalization costs NO general anesthesia Outpatient day procedure No general anesthesia NO radiation Simple-to-use Avoids post-surgical infections and NO recovery t
Slide 21: Worldwide Presence as of March 2017
Echotherapy Worldwide Presence as of March 2017 UK S Harley Street, London – 2015 S The London Endocrine Center – 2016 GERMANY S Marienhospital Bottrop – 2013 USA S Helios Klinik Schkeuditz – 2014 C University of Virginia – 2014 S Drs. Hakman - Praxis für Nuklearmedizin, Paderborn – 2015 S BORAD, Bo
Slide 22: Large European Opportunity in Thyroid
Echotherapy Large European Opportunity in Thyroid Germany is significant portion of European market <30 surgeries 30-65 surgeries >65 surgeries /100 000 inhabitants / 100 000 inhabitants / 100 000 inhabitants Primary focus is German market which Bulgaria 15 Sweden 32 Germany 105 accounted for ~40% o
Slide 23: Establish Strong Foundation in Germany
Echotherapy in Germany Establish Strong Foundation in Germany Cumulative Placements Germany • Grow placements 12 • Obtain insurance reimbursement 10 • Develop KOL support 8 • Cost-effective solution 6 4 • Grow patient awareness 2 0 2012 2013 2014 2015 2016 2017 TD Leverage German success across EU a
Slide 24: Drive Reimbursement
Echotherapy in Germany Drive Reimbursement Very successful start via integrated care contracts + the first “big” insurers (AOK,TK) Started with integrated care contracts Continued effort to enlarge covering • Offer • « Innovation » • « Patient’s choice » • « Cost-efficiency » Private insurers • Resu
Slide 25: Develop KOL Support
Echotherapy in Germany Develop KOL Support Breast Thyroid Nuclear Medicine • Prof. Hahn, Tübingen University • Prof. Luster, Marburg University • Certified Breast Center • Head of thyroid section endocrine society, Head of thyroid section Nuclear medicine • Co-leader of clinical study • Dr. Kolberg,
Slide 26: Promote Cost-Effective Solution for Thyroid
Echotherapy in Germany Promote Cost-Effective Solution for Thyroid German tarif (DRG) €5 000 €4 500 €4 000 €3 500 €3 000 €2 500 49% 36% €2 000 €1 500 €1 000 €500 €0 Complex Thyroid Surgery Non-Complex Thyroid Echotherapy Surgery Surgery: Use of operating room & 3.3 nights of hospitalisation on avera
Slide 27: Grow Patient Awareness
Echotherapy in Germany Grow Patient Awareness 22 Articles in 6months – reaching 20 Mio online and 20 Mio printed press readers 27
Slide 28: First Forfait Innovation: First Randomized Study
Echotherapy in France First Forfait Innovation : First Randomized Study 3/1/2017 28
Slide 29: Additional European Markets
Market Access Additional European Markets United Kingdom Michael Leach VP, UK, Northern Europe & ME • More than 20 years experience in healthcare BD • NHS Lead radiographer • GE & Nuffield Business developer • Entrepreneur in Managed Equipment Service in UK • First sales in prestegious Harley Street
Slide 30: Asian Markets
Market Access Asian Markets Asia Thyroid and FA Surgeries in China (per hospital) Dennis Guo Business Development • Distributors 1 275 VP Asia • Korea 750 • Singapore 630 • Taiwan • … More to come • Based in Hong Kong since March Top tier hospitals Average Thyroid Average FA Surgeries ’15 Installati
Slide 31: Preparing the Ground for Successful U.S. Market Entry
Market Access Preparing the Ground for Successful U.S. Market entry USA • Investigational Device Exemption – Granted Feb. 2014 ─ U. of Virginia (UVA) clinical trial for Safety & Efficacy data (recruitment fulfilled 20 patients, follow-up ongoing) • Single Clinical Trial Required for FDA Submission ─
Slide 32: Investment profile
Theraclion Investment profile Company overview Large existing market; strong demand for non-invasive approach Echopulse® system – differentiated and proprietary HIFU technology Development and commercialization strategy – Expanding in Europe and Asia; preparing for U.S. Gaining market traction with
Slide 33: Growing Number of Echopulse Worldwide Installed Base
Modifiez Number Growing le style du of titre Echopulse® Sous-titre Worldwide Installed Base Per Indication • Treatments : close to 900 (as of Dec. 7 2016) Germany (Heilbronn, Coburg, Frankfurt) • 19 centers offering thyroid treatments* 10 Italy (Livorno, Roma) UK (London) • 14 centers offering breas
Slide 34: Driving Clinical Adoption
… Driving Clinical Adoption Global Number of Treatments 12 months rolling Treatments 400 350 300 250 200 150 100 Launched 50 First Sale BEAMOTION 0 +138% growth in treatment numbers (1) driven by German and Asian thyroid market (1) Include both clinical trials and commercial treatments 34
Slide 35: Key Milestones
Theraclion Key Milestones 2014 2015 2016 2017 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 China CFDA Regulatory Technical tests certifications USA 513k IDE New contouring procedure Continuous 2 year clinical study at London King’s Echopulse® Treatment College time reduction evolution Fast scanni
Slide 36: FY 2016 Consolidated P&L and BS
FY 2016 –Consolidated P&L and BS Sales up 8%, Net losses up 6% Profit and Loss Balance Sheet In K€ 31/12/2016 31/12/2015 Var. (%) In K€ 31/12/2016 31/12/2015 Revenue 1,889 1,531 23% Net fixed assets 1 793 1 894 Equipment sales 1,580 1,412 12% Current assets 12 633 7 363 Equipment rental 187 75 129%
Slide 37: Cash burn 2016
Cash burn 2016 18250 16250 1 918 -99 14250 -2 053 12250 10250 En K€ 11492 8250 6250 -8 020 4250 6990 2250 3752 250 Cash at 31.12.15 Equity raised Net Sublsidies Cash collections and EP purchase Spending from Cash at 31.12.16 (including Bpi) CIR operations • Equity Raise: €1.8M Furui April 2016, €0.4
Slide 38: Shareholding Structure and Share Information
Shareholding Structure and Share Information Stock information (March 24th, 2017) Shareholder structure (as of August 22nd, 2016) • Alternext Paris 41% Truffle Capital 22% 0% Furui • Ticker: ALTHE Deutsche Bank Wealth Management • ISIN code: FR0010120402 5% Natixis • Stock price: 4,92 € Aviva 1% 19%
Slide 39: Summary
Investor Presentation Summary Echopulse® system – differentiated and proprietary HIFU technology Large existing market; strong demand for non-invasive approach Development and commercialization strategy – Expanding in Europe and Asia; preparing for U.S. Gaining market traction with upcoming catalyst
Slide 40: Thank you
Modifiez le style du titre Sous-titre Thank you
Slide 41: Back-Up Slides
(@). THERACLION Back-Up Slides
Slide 42: Roadmap through FDA clearance to new CPT Code
Roadmap through FDA clearance to new CPT Code Pivotal study preparation Target coverage by private payers: Pivotal study completed • Slightly below surgery:4500 In order to anticipate, USD Academic Society (ASBS, ASR) to be contacted Once FDA cleared after the pre-IDE discussion to have their « bles
Slide 43: Publications in leading scientific journals (1/5)
Publications in leading scientific journals (1/5) Journal of Therapeutic Ultrasound – Thyroid nodules Dr Korkusuz (Frankfurt) Early assessment of HIFU* treatment of benign thyroid nodules by scintigraphic International Journal of Hyperthermia – Thyroid nodules Dr Korkusuz (Frankfurt) Local thyroid t
Slide 44: KOLs See Echopulse as an Exciting Innovation
KOLs See Echopulse® as an Exciting Innovation “In my opinion, it is a very good method. Patients are interested because it allows them to avoid a surgical intervention for this benign pathology.” Roussanka Kovatcheva – Professor of endocrinology University Hospital of Endocrinology of Sofia – Bulgar
Slide 45: Board of Directors
Board of Directors Jean-Yves Burel Samuel Levy Chairman of the Board of Directors Administrator Former GE executive with 26 years of experience at GE Co-founder and President of Allurion Technologies in 2009 Healthcare Graduate from Yale and Harvard Medical School Vice-President Marketing & Commerci