Theraclion Sa · EURONEXT:ALTHE
Theraclion Sa — Investor Presentation (July 2016)
52 slides from Theraclion Sa's investor presentation, July 2016
Slide 1: Investor presentation July 2016
Modifiez le style du titre Sous-titre Investor presentation July 2016
Slide 2: Disclaimer
Modifiez le style du titre Disclaimer Sous-titre • 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 publi
Slide 3: Management Team: Track Record of Success in Healthcare
Management Team:du Modifiez le style Track Record of Success in Healthcare titre Sous-titre Jean-Yves Burel David Caumartin Chairman of the Board of Directors Chief Executive Officer Former GE executive with 26 years of experience at GE 14 years of experience with GE Healthcare Healthcare Experience
Slide 4: Company Profile
Modifiez le Profile Company style du titre Sous-titre Non-invasive technology Our product: the Echopulse® • Differentiated, non-invasive technology using high-intensity ultrasound (HIFU) for treatment of breast fibroadenomas and thyroid nodules • CE marked in 2013; 19 systems placed and growing • Re
Slide 5: Why a capital increase?
Modifiez Why le styleincrease a capital du titre ? Sous-titre • Build a profitable recurrent business in current markets ─ Strengthen German success, first country for Theraclion (9 sites, 1,5 m covered for echotherapy) ─ Accelerate conquest of South Korea, (1 EP sold in 2015, authorization to treat
Slide 6: Terms of the rights issue
Modifiezoflethe Terms style du titre rights issue Sous-titre • €9.63 million capital increase with preferential subscription rights (€11.07 million maximum size in case of execution of Size / Extension Clause) Structure • 1,610,257 new shares issued (which may be increased to a maximum of 1,851,795)
Slide 7: Expected timetable
Modifiez le timetable Expected style du titre Sous-titre 22 July • AMF Visa on the Prospectus 25 July • Press release announcing the terms of the transaction 26 July • Beginning of the subscription period / trading of the preemptive rights 5 August • Closing of the subscription period / end of tradi
Slide 8: Agenda
Modifiez le style du titre Agenda Sous-titre 2015 Highlights and financials Theraclion, a specialist in non-invasive tumor treatment Commercialization and Geographic Expansion Underway 8
Slide 9: 2015 Highlights
Modifiez 2015 Highlights le style du titre Sous-titre 2 x in sales: 1,8M€ vs 800k€ in 2014 3 x more commercial sites : 16 vs 5 in 2014 5 x faster: accelerated treatment with BEAMOTION 6 x more orders signed in 2015: 12 vs 2 in 2014 6 new countries 9 Source: THERACLION.
Slide 10: Demonstrating accelerated purchase order development
Demonstrating accelerated Modifiez le style du titrepurchase order development Sous-titre 9 3 Germany (Heilbronn, Coburg) Germany (Paderborn, Bürgerhospital, Italy (Livorno) Bremen, BORAD), Taiwan, Korea, China (University of Hong-Kong), Switzerland (Belinzona), 4 Spain (Madrid), UK (London), Egypt
Slide 11: Strong clinical adoption confirmed
Strong clinical Modifiez adoption le style confirmed du titre Sous-titre 12 months rolling Treatments 250 200 150 100 50 0 +115% growth in treatment numbers driven by German and Asian thyroid market 11
Slide 12: Establishment of a strong pole of activity in Germany
Modifiez le style Establishment du titre of a strong pole of activity in Germany Sous-titre Echopulse offered in Germany • 9 sites • 1.5m covered • 3 investors Acceleration of the number of patients covered by insurers 1 500 000 1 000 000 Thyroid 500 000 FA 0 12/ 2014 12/2015 03/2016 Strengthened pr
Slide 13: Echopulse with BEAMOTION: significant reduction of treatment duration
Modifiez le style Echopulse duBEAMOTION ® with titre Sous-titre reduction of treatment duration Significant Without BEAMOTION With BEAMOTION H 9 mm Ø 2 mm H 7,3 mm Ø 5 mm HIFU transducer is fixed HIFU transducer moves during the pulse Optimized energy deposition scheme with moving beam With BEAMOTIO
Slide 14: Echopulse with BEAMOTION: significant reduction of treatment duration
Modifiez le style Echopulse duBEAMOTION ® with titre Sous-titre reduction of treatment duration Significant Patient arrival Procedure includes • Positioning • Treatment planning • Treatment delivery • Patient discharge Total procedure duration < 30 min < 30 min Patient discharge [9 – 26 min*] 14
Slide 15: Detailed Consolidated Group Financials
Modifiez Group Detailed le styleConsolidated du titre Financials Sous-titre Profit & Loss Balance Sheet In K€ 31/12/2015 31/12/2014 Var. (%) In K€ 31/12/2015 31/12/2014 Var. (%) Revenues 1 531 800 91% Net fixed assets 1 894 1 426 33% from equipment sales 1 412 774 83% Current assets 7 363 6 858 7% f
Slide 16: Cash Burn Analysis
Modifiez Cash BurnleAnalysis style du titre Sous-titre 14000 Cash burn K€ 12000 1683 10000 904 8000 7746 4639 6000 4000 2000 4272 3753 0 Cash 31.12.14 Private Offering June, Net Subsidies from BPI Cash collections and Spending from Cash at 31.12.15 TEPA and Equity line CIR operations • Since March 1
Slide 17: Agenda
Modifiez le style du titre Agenda Sous-titre 2015 Highlights Theraclion, a specialist in non-invasive tumor treatment Commercialization and Geographic Expansion Underway 17
Slide 18: Echopulse: Mobile Robotic Outpatient Tumor Treatment
Echopulse ®: style Modifiez le MobileduRobotic titre Outpatient Tumor Treatment Sous-titre Echopulse® System Robotized head For Accuracy: Robotized head For Safety & Ease of Use: Cooling and coupling + In-line Ultrasound imaging probe + HIFU transducer Intuitive Touchscreen Wheels interface for mobi
Slide 19: Surgery without surgical procedure
Surgery Modifiezwithout le stylesurgical du titreprocedure Sous-titre Breast Fibroadenomas and Thyroid Nodules Non-Invasive Technology Provides Attractive, Effective Alternative to Surgery and Invasive Ablative Technologies Compact, Mobile and Less Expensive Breast Benign thyroid fibroadenoma nodule
Slide 20: Echopulse System Benefits All Three Major Stakeholders
Modifiez ®leSystem Echopulse Benefits style du titre All Three Major Stakeholders Sous-titre PATIENTS PROVIDERS PAYORS One simple outpatient procedure Attracts new patients No hospitalization costs NO general anesthesia Outpatient day procedure No general anesthesia NO radiation Simp
Slide 21: Echopulse offers substantial benefits versus alternative therapies
Echopulse Modifiez offers substantial le style du titre benefits versus alternative Sous-titre therapies Echopulse Traditional Surgery Min. invasive surgery Metric 3-7 cm 1.3 – 2.5 cm Incision Length NONE Pain after Treatment NONE Moderate to significant Moderate Anesthesia Local or no anesthesia Ge
Slide 22: Clinical Results in Peer-Reviewed Journals
Clinical ModifiezResults le styleindu Peer-Reviewed titre Journals Sous-titre Journal of Therapeutic Ultrasound • Multi-center, international 42-patient ‘Article of the month’ study ─ Significant Breast Fibroadenoma volume reduction at 12 months (unpublished 36 month data, continues trend) ─ No ultr
Slide 23: Theraclion is Focused on Two Large Indications
Modifiez leisstyle Theraclion Focused du titre on Two Large Indications Sous-titre Commercialization efforts will focus on three large markets Surgery Surgery 800 000 1 000 000 700 000 800 000 600 000 500 000 600 000 400 000 300 000 400 000 200 000 200 000 100 000 0 0 EMEA USA CHINA ROW EMEA USA CHI
Slide 24: Agenda
Modifiez le style du titre Agenda Sous-titre 2015 Highlights Theraclion, a specialist in non-invasive tumor treatment Commercialization and Geographic Expansion Underway 24
Slide 25: Commercialization Process is Well Underway
Modifiez le style duProcess Commercialization titre is Well Underway Sous-titre Established Direct Sales in 4 Largest Markets in EMEA: Germany, France, UK, Italy Some Reimbursement in Germany & Italy; French Authorities Studying New French Initiative (“Forfait Innovation”) funds medical innovation;
Slide 26: Echotherapy Centers Worldwide as of June 2016
Echotherapy Modifiez le style Centers du titre Worldwide as of June 2016 Sous-titre UK S Harley Street, London – 2015 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
Slide 27: Theraclion Goal: Establish Echotherapy as a Standard of Care
Theraclion le Modifiez Goal: Establish style Echotherapy as a Standard of Care du titre Sous-titre • Build-out the commercial network • Engage Key Opinion Leaders and medical • Enter the US and societies in order to China markets get specific codes • Generate initial for echotherapy sales with priva
Slide 28: Germany: the biggest thyroid market in Europe
Modifiez leThe Germany: style biggest du titre thyroid market in Europe Sous-titre Annual # of thyroidectomies per country + 50 000 treatments with radioactive iodine Germany • Treatment of hot nodules • Treatment in inpatient settings 28
Slide 29: Germany: A strong year for sales in 2015
Modifiez leAstyle Germany: strong duyear titrefor sales in 2015 Sous-titre All 2015 sites treat thyroid, 4/5 are nuclear medicine Jose Abellan-Martinez Marienhospital, Bottrop – 2013 VP, Germany & Central Helios Klinik, Schkeuditz – 2014 Europe • More than 30 years experience in Drs. Hakman NKM, Pad
Slide 30: Germany: Reimbursement is key
Modifiez leReimbursement Germany: style du titre is key Sous-titre Very successful start via integrated care contracts Integrated care contracts • Offer insurers possibility to differentiate from competition • Offer • « Innovation » • « Patient’s choice » • « Cost-efficiency » Agreements with Insura
Slide 31: Germany: Next Step with global approach to Insurer Market
Germany: Modifiez Next Stepdu le style with global approach to Insurer Market titre Sous-titre Approach with different types of insurers Private insurers Other private DBK Allianz TKK Barmer Small and mid-size DAK public insurers Big public insurers AOK Bayern (ca. 120 independant Other public compa
Slide 32: Germany: A cost effective solution in echotherapy
Modifiez leAstyle Germany: cost du effective titre solution in echotherapy Sous-titre German tarif (DRG) 4 000 € 3 500 € surgery 3 000 € Avg. radioiodine 2 500 € 2 000 € 1 500 € 1 000 € 500 € 0€ radioiodine therapy, complex radioiodine therapy, slightly complex other radioiodine therapy surgery othe
Slide 33: Germany: Strong key opinion leader support
Modifiez leStrong Germany: style du keytitre opinion leader support Sous-titre 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-leade
Slide 34: Germany: Intense media activity
Modifiez leIntense Germany: style du media titre activity Sous-titre 22 Articles in 6months – reaching 20 Mio online and 20 Mio printed press readers 34
Slide 35: Market Access – European Markets
ModifiezAccess Market le style – European du titre Markets Sous-titre France United Kingdom Italy “Forfait Innovation”: new innovation Michael Leach Giuliano Laghi financing decree published in 2015 VP, UK & Northern Europe VP, Italy & Southern Europe • MoH launched tool to facilitate market access
Slide 36: Market Access – Asian Markets
ModifiezAccess Market le style – Asian du titre Markets Sous-titre Asia Surgeries of Thyroid and FA in China Dennis Guo Business Development • Distributors 1 275 VP Asia • Korea 750 • Singapore 630 • Taiwan • … More to come • Based out of the new Asia office Top tier hospitals Average Thyroid Averag
Slide 37: Preparing the ground for successful U.S. market entry
Modifiez lethe Preparing style ground du titre for successful U.S. market entry Sous-titre USA • Investigational Device Exemption – Granted Feb. 2014 Incidence ─ U. of Virginia (UVA) clinical trial for Safety & Efficacy data (on-going) • Specific-Patient Population ─ Hispanic and Afro-American women
Slide 38: Roadmap through FDA clearance to new CPT Code
Modifiez lethrough Roadmap style duFDA titre clearance to new CPT Code Sous-titre 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
Slide 39: Key milestones and roadmap
Modifiez le Business style duKey Strategy: titremilestones and roadmap Sous-titre 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
Slide 40: Investment Thesis
Modifiez le style Investment Thesisdu titre Sous-titre Large Existing Market and Demand for Non-Invasive Ablation Patented Mobile Technology Greatly Increases Ease of Use Excellent Clinical Results with First Two Indications; Many Potential Applications Approved in Europe; Focusing Now on Asia and U
Slide 41: BACK-UP SLIDES
Modifiez le style du titre Sous-titre BACK-UP SLIDES
Slide 42: Shareholding structure and share information
Modifiez le style Shareholding structure du titreand share information Sous-titre Stock information (July 8th, 2016) Shareholder structure (as of July 8th, 2016) • Alternext Paris Truffle Capital 19% 0% Furui • Ticker: ALTHE 55% Deutsche Bank Wealth Management 5% • ISIN code: FR0010120402 Natixis 2%
Slide 43: Theraclion is the only player in both thyroid and breast treatment
Theraclion Modifiez islethe onlydu style player titrein both thyroid and breast Sous-titre treatment Bone Uterine Liver/ Prostate Thyroid Breast PHILIPS Equipment price (k€) metastases fibroid Pancreas INSIGHTEC Maintenance fee (k€) Mr-Guided 1,500 200 HAIFU 600 – 1,200 60 Ultrasound-Guided
Slide 44: Theraclion, the only HIFU player for thyroid and breast
Modifiez lethe Theraclion, style du HIFU* only titre player for thyroid and breast Sous-titre RF**/ Laser/ Cryoablation Vacuum Biopsie Surgery • Novian Health • Bard • AngioDynamics • Hologic • Icecure • Mamotome • Galil Medical • Sanarus Source: THERACLION. 44 Notes: (*) High Intensity Focused Ultr
Slide 45: Publications in leading scientific journals (1/5)
Publications Modifiez leinstyle leading scientific journals (1/5) du titre Sous-titre 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
Slide 46: Publications in leading scientific journals (2/5)
Publications Modifiez leinstyle leading scientific journals (2/5) du titre Sous-titre Senologie* – Breast fibroadenoma Material & Methods • 27 cases Advantages of HIFU • Maximum size 25 mm • Outpatient setting under local analgesia Complete ablation or significant volume reduction in all patients, c
Slide 47: Publications in leading scientific journals (3/5)
Publications Modifiez leinstyle leading scientific journals (3/5) du titre Radiology : A major medical and Sous-titre international publication Radiology* – Thyroid nodules Material & Methods • 20 patients : 24 – 65y • Volume reduction assessed after 3- to 6-month Ablation effectiveness follow-up
Slide 48: Publications in leading scientific journals (4/5)
Publications Modifiez leinstyle leading scientific journals (4/5) du titre Elected article of the month Sous-titre Journal of Therapeutic Ultrasound* – Breast fibroadenoma Material & Methods • 42 patients: 16 – 52y • Follow-up: 2, 6 and 12 months Ablation effectiveness proven by significant breast
Slide 49: Publications in leading scientific journals (5/5)
Publications Modifiez leinstyle leading scientific journals (5/5) du titre Sous-titre Journal of Therapeutic Ultrasound* – Thyroid nodules Material & Methods • 9 patients : 36-80 year • Treatment on an outpatient basis with local or no Median volume reduction of about 50% 3 months after anesthesia
Slide 50: Forfait Innovation Upcoming Submission
Forfait ModifiezInnovation le style du titre Sous-titre Submission Upcoming New tool for the reimbursement of innovation for: – Medical innovation: a key factor in the improvement of the health of French people – French MedTech: a source for innovation and jobs creation Open to submission since Augu
Slide 51: Echopulse as an Exciting Innovation: KOLs
Modifiez KOLs Seele Echopulse style du titre® as an Exciting Innovation Sous-titre “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 Hospit
Slide 52: Board of Directors
Board Modifiez of Directors le style du titre Sous-titre Jean-Yves Burel Dr. Philippe Pouletty Chairman of the Board of Directors Permanent representative of Truffle Capital Former GE executive with 26 years of experience at GE Co-Founder and General Partner of Truffle Capital Healthcare Founder of