Edap Tms SA · NASDAQ:FOCL
Edap Tms SA — Investor Presentation (January 2006)
46 slides from Edap Tms SA's investor presentation, Jan 17, 2006
Slide 1: EDAP TMS Investor Summary
a edap Ems EDAP TMS Investor Summary The world leader in HIFU for localized prostate cancer Hugues de Bantel: Chief Executive Officer Philippe Chauveau: Chairman of the Board January 2006
Slide 2: Forward Looking Statements
Forward Looking Statements eee This presentation contains, in addition to historical information, forward-looking statements that involve risks and uncertainties. These include statements regarding the Company's growth and expansion plans. Such statements are based on management's current expectatio
Slide 3: Company Overview
Company Overview a. EDAP TMS S.A. is the world leader in High Intensity Focused Ultrasound treatment for prostate cancer. The company develops and markets Ablatherm®-HIFU, a proven minimally invasive and effective treatment option for localized prostate cancer, prese! ig patient quality of life. The
Slide 4: EDAP TMS Global Operations
EDAP TMS Global Operations a edap Ems EDAP is Addressing Two Major Pathologies in Urology: Prostate Cancer & Urinary Stones HIFU Anew advance in the treatment of prostate cancer 50% gross margin* - Approved in Europe, Canada, Russia, Australia, South East Asia + Start of US clinical trials approved
Slide 5: Global Growth Platform
" Global Growth Platform et thine = 2004 operational turnaround demonstrated cash-positive capabil in both divisions = In 2005, market expansion was driven by the following strategy: > Expanded mobile services base and treatments > Continued strong site and treatment growth rates > Launched Ablather
Slide 6: Focus on Ablatherm-HIFU
Focus on Ablatherm®-HIFU et thine The Market Potential for Minimally Invasive Prostate Cancer Treatment Represents EDAP’s High Growth Opportunity
Slide 7: The Ablatherm-HIFU Solution
The Ablatherm®-HIFU Solution et thine EDAP is committed to: + Offer patients the best combination Safety and Efficacy + Full enlightenment of patients about existing treatment options + Preserve patient quality of life Ablatherm-HIFU is The Solution for growing sensitivity and awareness from prostat
Slide 8: Focus on Ablatherm-HIFU
Focus on Ablatherm®-HIFU et thine The New Integrated Imaging Ablatherm: The Most Advanced HIFU Technology with the New Dual Function Probe
Slide 9: Imaging & Treating Simultaneously
® edap Ems Focus on Ablatherm®-HIFU Imaging & Treating Simultaneously Imaging ee / From a transversal real-time image, » the 7.5 MHz electronic ultrasound ’ transducer can provide an accurate 3D reconstruction of the treatment area Firing High-energy ultrasound waves are focused through the rectal w
Slide 10: Focus on Ablatherm-HIFU
Focus on Ablatherm®-HIFU dats Imaging and treating The firing process is visible in real time onthe echographic display Robotized probe placement 5 axis computer controlled movements, avery sophisticated device with fully robotized motion control for precise probe positioning
Slide 11: Market Driving EDAP Forward
HIFU Market et thine Market Driving EDAP Forward = Prostate Cancer: 2"! most common cancer in American and European males: > 231,000 new cases per year in the USA* > 238,000 new cases per year in Europe’* = Dramatic increase in worldwide public awareness: > Increased sensitivity toward Quality of Li
Slide 12: Current market scope for Ablatherm-HIFU
HIFU Market et thine The current market scope for Ablatherm-HIFU is 70% of all prostate cancer cases m11-T2 Other Today, less than 1% of these patients are treated with Ablatherm-HIFU!
Slide 13: Currently Available Therapies for Localized Prostate Cancer
HIFU Market «a. Currently Available Therapies for Localized Prostate Cancer > Current alternatives to HIFU: - Surgery - Radiation -Watchful Waiting - Cryosurgery Europe* usa* s ta a % arora) aro suey jmvewetting | 29 aW.waiting octyo 6 octyo aur |p 3 ° cin Akane cine Aone > Large number of treatment
Slide 14: The Best Solution Available Today
HIFU Market a edap Ems The Best Solution Available Today: Low 4 Side Effects High - Optimal efficacy - Preserving quality of life “| cryosurgery Efficacy Low
Slide 15: Our Proven Efficacy
HIFU Market Our Proven Efficacy* T1-T2 Population (First Choice Therapy) Negative biopsy rates Teor PSA> 20 nal of CI Tab oe 10 < PSA" 20 agin or Ch TieT2a and PSA © 10 ng/ml and Gloason score < 6 °C. Chaussy, S. Thiiroft, 6. Vallancien, W. Wieland, H..l Kiel, A. Le Duc, F. Desgranchamps, J. de la R
Slide 16: Preservation of Quality of Life: Lowest Side Effects
HIFU Market et thine Preservation of Quality of Life : Lowest Side Effects In nce Impotence POR! Literature Fie 2005 -lourna af Uriogy 2003 (2 Geet) 8 ICE Corgress 2008 (CF Oto) Contemporary Uriogy 2008 louma of Uraogy daly @ Py. 2004, Surgeon 2008 Ove Bowral et Endourbogy Juy/Auget 2008
Slide 17: Clinical Benefits: Preservation of Quality of Life
HIFU Market eee Clinical Benefits: Preservation of Quality of Life No port, no seeds, no radiation Precise and definitive necrosis of the targeted area Nadir PSA after only 3 months Minimal side effects Ifneeded at any time during follow up To the physician and the patient's therapeutic goals euti A
Slide 18: Less Expensive than Radiation Therapies
HIFU Market et thine Less Expensive than Radiation Therapies Capital Investment Medium Low 5 10 15 20 25 30 $000 treatment total cost
Slide 19: 2006 Market opportunities
HIFU Market et thine 2006 Market opportunities vv vvvVY Grow 2005 new markets: Canada, UK, Australia & Switzerland Starting US clinical trials through relationship with HTRN Priming the pump through cost-per-procedure (CPP) & mobile model Approval and reimbursement in key markets: - national reimbur
Slide 20: Growth Strategy Road Map
HIFU Market for Prostate Cancer a dns Growth Strategy Road Map » We have successfully met all major market challenges wank Global market ar leadership Market Evaluation imeaaotion Expanslon FDA Development very ct phasos 8 an
Slide 21: FDA Trials Road Map
HIFU Market et thine FDA Trials Road Map 1- FDA approval obtained to start clinical trials in the US to prove efficacy 2- Finalization of contracts with 10 participating clinical institutions, a mix of high profile academic sites and private practices 3- Ablatherm devices are being deployed and clin
Slide 22: Recent Market Expansion
HIFU Market et thine Recent Market Expansion Australia » Launched at St Vincent's Clinic, Sydney, on CPP basis in October 2005 » Utilization for retreatment of brachytherapy and radiation failures United Kingdom » Unit at Stepping Hill Hospital since April 2004 » Set up Royal Marsden Hospital, Londo
Slide 23: CPP Business Model = Growth Opportunity
HIFU Market et thine CPP Business Model = Growth Opportunity >» Cost-per-Procedure (CPP) performed is an easy and profitable way to make this technology available to a larger number of patients as well as hospitals and clinics >» Mobile business facilitates rapid access to Ablatherm HIFU technology
Slide 24: Mobile Through Europe
HIFU Market et thine Mobile Through Europe » Deploy mobile units for France, Germany, Austria, Italy, Spain, UK, Belgium and other locations ® 63 sites using Ablatherm-HIFU on a mobile basis at December 05 end _ 4
Slide 25: Momentum: CPP Growth
HIFU Market Momentum: CPP Growth a edap Ems mA Treatraris| mcrP 2000 rrr ‘80 ‘600 cea 400 20 ‘000 00] ane 500 40 200 0 2003 2004 2008 mos zone 08 CPP Revenues in (€ 000s) Average 2005 selling CPP price : €2,807 Cesimated a Des. end" 06 Number of Treatments / CPPs 6
Slide 26: Growth in HIFU Service Business
Growth in HIFU Service Business et thine Recurring and Very Profitable Maintenance Revenues » Maintenance contracts include supplies, professional services > Average maintenance contract is 10% of the equipment invoice price > Average gross margins on maintenance is 68% ileal 1021 1000 eno: 208 2004
Slide 27: German Mobile CPP Business Model
HIFU Market «a. German Mobile CPP Business Model >» Cumulative estimated 500 >» Revenues related to mobile treatments completed as of CPP business December end 2005 > 21 sites using the Ablatherm ona mobile CPP basis >» Two Ablatherm mobile units 160. 8: a0. 00 20 ee 100. 79 ao ES 20 60: alae 100. 2
Slide 28: Regulatory Approvals
HIFU Market Regulatory Approvals Approvals a edap Ems Reimbursements - CE mark in 2000 C € - Canada (2004) - Positive NICE guidance (April 2005) - FDA approval obtained to start clinical trials - Seeking US and Japan marketing approval for Ablatherm-HIFU - Reimbursement in Germany & Italy (up to €4,
Slide 29: Growth Strategy
HIFU Market et thine Growth Strategy > Leverage awareness using PR & web support > Build-up "centers of excellence” to maintain and strengthen our clinical credibility > Strong relationship with local urology communities and opinion leaders > Encourage urologists to capture the market from radio-onc
Slide 30: Rapidly Accelerating Market Acceptance
HIFU Market «a. Rapidly Accelerating Market Acceptance > 9,000 estimated > Currently 96 sites cumulative treatments as delivering treatment: of December end 2005 , 10000 000: 8000: 7000: 6000: 5000. 4000: 3000: 2000: 1000. 0 cseesseseees 201 202 2008 MNO ao ame 2003 2004 28 lative number of treatmen
Slide 31: edap Ems
® edap Ems a
Slide 32: Lithotripsy Leadership
Lithotripsy Leadership et thine " Satisfied installed base of more than 400 lithotripters worldwide = A Leader in Asia, including Japan, and Europe due to customer proximity and provided services = IP Protection: 17 Lithotripsy Patents = Mature market with pressure on prices and margins; = Highly sk
Slide 33: Lithotripsy Market
Lithotripsy Market et thine LITHOTRIPSY: Worldwide Market Scope = Market Drivers: > Service Capacity, Credibility & Proximity > Technology > Global reach = Current Worldwide Installed Base > 3,000 Units Replacement Market > 300 Units / Year @ average $250,000 (= $75M / Year) = Service & Consumables
Slide 34: Lithotripsy Market: Geographical Distribution
Lithotripsy Market tees Geographical Distribution of Global Lithotripsy Market @ = Ewope @ Asia © Americas @ Others ‘banpend waaaneses’ 4
Slide 35: Lithotripsy Leadership: Installed Base
Lithotripsy Leadership EDAP TMS’s Large Installed Base’ \ “+25 Litho = "183 Litho Total: 416 litho ai - @ Europe: 76 LITHO © Ameticas: 25 LITHO ® Others: 135 LITHO * Company's figues at Dec.‘05 % 183 LITHO
Slide 36: Lithotripsy Strategy
Lithotripsy Strategy et thine LITHOTRIPSY: Provides Momentum for Overall Business = Improved products & marketing = Create key differentiators through services = Strong Project Sales Approach vs. Equipment Sales: > Equipment > Maintenance (on site, online, preventive, corrective maintenance services
Slide 37: Financials
Financials ”
Slide 38: EDAP TMS Financials
EDAP TMS Financials et thine = Profit capable at both operating division levels = Well capitalized for additional investments in growth of new and current markets = Focus on cost controls, prudent investment of capital = Strong, improving margins throughout 2005: 41% Company Gross Margin as of Sept.
Slide 39: Division Performance
Division Performance «a. EDAP -HIFU Division: Euro 000s" First Nine Months Revenue Gross Margin Operating Income (Loss) 2005 5,033, 50% (333) 2004 5,064 45% 164 TMS — UDS (Lithotripsy) Division: Euro 000s* First Nine Months Revenue Gross Margin Operating Income (Loss) 2005 11,686 30% 209 2004 13,214
Slide 40: Strong Balance Sheet
Strong Balance Sheet a edap Ems Sept. 30, June 30, Sept. 30, June 30, All figures in 000s 2005 2005, ane 0S Euros Euros gus gus Balance Sheet and Liquidity Cash and Cash Equivalents 7,463 8,222 8,999 9,947 Total Current Assets Bll4 23,254 26545 28,133 Total Current Liabilities 978 = 10,089 14800 12,
Slide 41: Income Statement
Income Statement et thine For the 12 Months Ending Dec.31, Dee. 31, Dec.31, Dee. 31, Al figures in 000s, 2004 2003 2004 2003 Euros Euros us us Total Revenues wiles 18473 2764 21079 Cost of Sales 13676) (13,094 17,065) (14,942 Gross Profit 84a? 5,379 10589 6,137 Interest, Currency, Taxes, Other Gis)
Slide 42: Income Statement
Income Statement ct tine For the 9 Months Ending Sept.30 Sept. 30 Sept.30 Sept 30 Allfigures in 000s, 2005 2008 2005 2004 Euros Euros gus gus Total Revenues 1460316511 18,955 20,218 Cast of Sales (6.588) 0.158 (10,920) (12,497: Gross Prot Sa15 8383 7435 7,778 Interest, Currency, Taxes, Other 259 50
Slide 43: Investor Highlights
Investor Highlights et thine Focus on continued growth and expansion = Well positioned as the global leader in HIFU installations, treatment technology and clinical data = Compelling clinical benefits, growing market awareness breeding demand = Established successful model to enter and grow new key
Slide 44: Investor Highlights: Committed Management
Investor Highlights et thine Committed Management = Management focus on increasing company valuation = Driving HIFU approval and reimbursement in all key markets with a focus on total number of treatments = Strengthening our marketing team to drive an international marketing campaign to educate doct
Slide 45: Shareholders / Stock Performance
LN Shareholders / Stock Performance edaptEms 7.781.731 Outstanding shares*: -6,715,873 ADRs (floating) - 1,065,858 Ordinary shares (non-floating) Strong Stock Performance late 2005, reflecting HIFU potential high growth and increasing interest. Market Cap: $51.7 million TTM Revenue: Cash: $9.7 milli
Slide 46: EDAP TMS Investor Summary
[LOGO OF EDAP TMS] EDAP TMS Investor Summary The world leader in HIFU for localized prostate cancer Hugues de Bantel: Chief Executive Officer Philippe Chauveau: Chairman of the Board January 2006 Forward Looking Statements [LOGO OF EDAP TMS] This presentation contains, in addition to historical info