A Global Leader in Robotic Therapeutic Ultrasound
Transcript of A Global Leader in Robotic Therapeutic Ultrasound
A Global Leader in Robotic Therapeutic Ultrasound
(NASDAQ: EDAP)
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©2021 EDAP TMS S.A. All rights reserved. Confidential.
This presentation has been prepared solely for use at this meeting. The material is given in conjunction with an oral presentation and should not be taken out of
context. Unless the context requires otherwise, references to “EDAP,” “EDAP TMS,” “the Company,” “we,” “us” and “our,” refer to EDAP TMS S.A., Inc.
Any information in this presentation is subject to modification at any time and the Company undertakes no obligation to update you, except to the extent required
by applicable law. If an offer of securities is made by the Company in the future, prospective investors should rely solely on the Prospectus, including the
information incorporated by reference into the Prospectus. No reliance may be placed for any purposes whatsoever on the information contained in this
presentation, or on its completeness, accuracy or fairness. It is the responsibility of each prospective investor to review the Prospectus, including the information
incorporated by reference into the Prospectus, carefully and to make an independent assessment of the risks and merits of any such offering.
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 expectations and are subject to a number of
uncertainties and risks that could cause actual results to differ materially from those described in the forward-looking statements. Factors that may cause such a
difference include, but are not limited to, the clinical status and market acceptance of our HIFU devices, the sustained activity of our lithotripsy and distribution
business, as well as the length and severity of the recent COVID-19 outbreak, including its impacts across our businesses on demand for our devices and
services. Factors are also those described in the Company's filings with the Securities and Exchange Commission, including under “Cautionary Statement on
Forward-Looking Information”, “Risk Factors” and “Operating and Financial Review and Prospects” in the Company’s annual reports on Form 20-F filed with the
SEC.
The opinions and clinical experiences presented herein are specific to the featured physicians and/or the featured patients and are for information purposes only.
Nothing in this material is intended to provide specific medical advice or to take the place of written law or regulations.
This presentation shall not constitute an offer to sell or the solicitation of an offer to buy any securities of the Company, nor shall there be any sale of these
securities in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such
jurisdiction.
The presentation is being furnished to you solely for your information, and may not be copied, reproduced, distributed or passed, directly or indirectly, in whole or
in part, to any other person.
Forward Looking Statements & Disclaimer
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©2021 EDAP TMS S.A. All rights reserved. Confidential.
Innovative minimally-invasive diagnostic and therapeutic robotic platforms using ultrasound-based technologies
Investment Highlights
Global presence in more than 50 countries:
• 5 commercial subsidiaries (USA, Germany, Japan, Malaysia,
South Korea)
• 2 representative offices (Russia, Emirates)
• worldwide network of distributors 5 continents
EDAP Subsidiaries Distributors
EDAP Headquarters EDAP Representative offices
Designs, produces and markets
medical equipment dedicated to
minimally invasive therapies
based on robotic therapeutic
ultrasound
Lead product, Focal One®,
combines the latest technologies
in imaging and treatment
modalities
Global distribution agreement
with Exact Imaging creates the
most complete end-to-end
offering for the management of
prostate cancer
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Investment Highlights – HIFU Expansion
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Robust HIFU Pipeline
Complete offering in
prostate cancer
management …
… from targeted
diagnostic to
treatment
Large & Growing
WW Prostate Cancer
Market Opportunity
Accelerated Market Access Model Focused On
Surgical Market Trends:
Minimally-invasive, Robotic,
Energy-based Ablation,
Quality of Life Preservation Technology
Expanding Private and Public Covered Lives
Investing in Product Innovation to Expand Indications
Growing U.S. Organization and Direct Sales
Building a Robust Clinical Data Compendium
Leveraging Marquee Commercial Relationships
©2021 EDAP TMS S.A. All rights reserved. Confidential.
Endometriosis PancreasBreast Liver
Manufactured by EDAP TMS
Prostate Cancer
Micro-Ultrasound
Diagnostics
BPH and Lithiasis
Holmium and Thulium
Lasers for vaporization /
Enucleation of Prostate
and Urinary Stones
Urodynamics
UroFlow /
PressureFlow and
Filling Cystometry
Minimally-Invasive
HIFU treatment for
Prostate Cancer and HIFU
developments on other
pathologies
HIFU Division ESWL Division
Urinary Stones
(ESWL)
Non-Invasive treatment for
Urinary Stones
DISTRIBUTION Division
Distributed by EDAP TMS
Three Business Divisions
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©2021 EDAP TMS S.A. All rights reserved. Confidential.
HIFU (High Intensity Focused Ultrasound) =
Acoustic pressure or vibrations delivered to targeted cells. Intense immediate tissue
heating at focal point (+85°C) creates cavitation i.e. tissue necrosis and cellular ablation
HIFU strongly addresses
medical needs for tissue ablation
while preserving healthy
surrounding tissue
EDAP’s HIFU platform is a robotic
device with highly precise
mechatronics, providing image
guidance with motion tracking
and real-time treatment planning
What is HIFU
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Superior HIFU Expertise + Strong EDAP IP Portfolio
=
Multi-application HIFU platform vision
HIFU principles are similar to sun beams going through a magnifying glass
©2021 EDAP TMS S.A. All rights reserved. Confidential.
HIFU Management of Prostate Cancer
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+ Localization
MRI and biopsy fusion for
precise targeting
Real time and 3-D imaging
+ Validation
Confirmatory imaging
+ Ablation
Dynamic Focusing patented
technology for conformational
treatment
50,000+ Prostate cancer treatments
performed worldwide
100+ peer-reviewed publications
300+ HIFU centers in the world
Focal One: The Ultimate Robotic HIFU Tool for Focal Ablation
©2021 EDAP TMS S.A. All rights reserved. Confidential.
Prostate Cancer Management: Distinctive Offering
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A Complete End-to-End Urology Solution from Diagnosis to Focal HIFU Treatment
Exclusive WW distribution agreement with
Exact Imaging creates a synergistic
combination
Combined with EDAP’s Focal One, we believe
this is the only end-to-end solution that offers
urologists complete control of the prostate
cancer workflow
Adds screening, diagnostic and active
surveillance capabilities to EDAP’s focal
therapy
ExactVu’s ability to locate more treatable
cancers can drive Focal One sales and
procedure growth
©2021 EDAP TMS S.A. All rights reserved. Confidential.
Prostate cancer in the World
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1 Million biopsies(1)
248,530 new cases diagnosed (#1 cancer in men)(2)
34,130 deaths (#2 cancer in men)(2)
3.1 Million American men living with prostate cancer(2)
Localized PCa Treatment patterns
Active Surveillance
Radiation Therapy
Radical Prostatectomy
US Key market figures (yearly)
©2021 EDAP TMS S.A. All rights reserved. Confidential.
(1) Loeb et al. Complications after prostate biopsy: data from SEER-Medicare. J Urol. 2011 Nov;186(5):1830-4.(2) 2021 estimates from American Cancer Society (https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html)
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G 6 G7 (3+4) G7 (4+3) G8 G9/T3
Active
Surveillance
Wholegland
treatmentSurgery, Radiotherapy, HIFU
Agressive radical
treatmentSurgery+ radiotherapy
Radiotherapy+ hormonal therapyFocal treatment
Focal Therapy represents a strong balance between the stressful “wait-and-see” approach of
Active Surveillance and the morbid radical surgery or radiotherapy
Active Surveillance Whole-gland treatment(Surgery, Radiotherapy, HIFU)
Combined Therapies(Surgery + Radiotherapy,
Radiotherapy + Hormones)
Focal Treatment
(*) Based on Mygatt et al., Prostate Cancer and Prostatic Disease 2013 and Sivaraman et al., European Urology 2016
Apex
20% of cases
Posterior / Lateral
70% of cases
Anterior
10% of cases
Index tumor localization(*)
Transperineal and Transurethral approach:
Cryotherapy, IRE, TULSA, etc.
Transrectal approach:
Focal One HIFU
Precision approach:
Brachytherapy, Focal One
Focal One is ideally positioned for focal treatment in the majority of the cases
(1) Thuroff et al. J. Urol. 2013 Feb; (2) Ganzer et al. – BJUI 2013; (3)Crouzet et al. – 2013 Eur. Urol.; (4)Rischmann et al. – Eur. Urol. 2016;
(5) Donovan et al. – NEJM 2016; (6) Sponsor Executive Summary PMA P13003 (www.fda.gov); (7)Crouzet et al. – 2017 Eur. Urol.
Patient Benefits – Quality of Life
LOW MORBIDITY
97% preservation of continence(4)
78% preservation of erectile function(4)
HIGH EFFICACY
97-99% cancer specific survival at 10 years(1,2,3)
94-95% metastasis-free rate at 10 years(1,2,3)
ALSO AVAILABLE FOR SALVAGE TREATMENT (Recommended by NCCN Guidelines)
82% cancer specific survival(7)
81% metastasis free rate at 7 years(7)
Minimally-invasive therapy that preserves Quality of Life
Clinically-proven
No incision, no scar, no radiation
Typically less time away from work and leisure activities
Low risk of side effects, such as incontinence or erectile dysfunction
Ultra-precise ultrasound technology
The Paradigm shift in the Management of Prostate Cancer
Robotic HIFU for Prostate Cancer
Morbidity comparison at 2 years
©2021 EDAP TMS S.A. All rights reserved. Confidential.
4%
20%
3%
22%
4%
34%
11%
44%
19%
47%
Incontinence Incidence Erectile Dysfunction Incidence
Active Surveillance (ProtecT)
Hemi HIFU (AFU Trial)
Radiotherapy (ProtecT)
Whole Gland HIFU (FDA Trial)
Prostatectomy (ProtecT)
(5)
(5)
(5)
(4)
(6)
0
200 000
400 000
600 000
800 000
1 000 000
1 200 000
1 400 000
1 2 3North America Europe ROW
New
cases:
1,275,000
HIFU
potential:
220,000
Focal One
Potential:
165,000
30%75%
PCa Market and Assumptions
Business Model
Machine Sales Price $650k
Number of cases per machine 40 (US) – 60 (OUS)
Service contract Price$80k (US)
$60k (OUS)
FocalPak single-use disposable Price$1,200 (US)
$1,000 (OUS)
Potential Market in Revenues (US$)
Annual Revenue
Machine Revenue
(10% renewal rate)$205 Million
Service contract Revenue $215 Million
FocalPak single-use disposable Revenue $175 Million
Total Revenue WW $595 Million
US Revenue $250 Million
And when Endometriosis will be available …
3,000 EDAP HIFU devices
is equivalent to
$2 Billion in machine sales20%
10%
North America;
1 322
Europe; 1 125
ROW; 738
TOTAL NUMBER OF EDAP HIFU DEVICES REQUIRED TO COVER THE MARKET
Focus on US HIFU Adoption Plan
©2021 EDAP TMS S.A. All rights reserved. Confidential.
1. Establish Commercial Excellence
– Revamped Capital Sales Structure (1 to 8)
– Build Sustainable Pipeline
– New Pricing Models
– Add Clinical Sales Structure
2. Focus on Reimbursement Roadmap
– Coding
– Payment
– Coverage
• Fund raise of $28 Million done in April to support the Plan
• Recruitment of Top Medtech Industry Veteran Ryan Rhodes as CEO of EDAP’s US
subsidiary to design and execute the Plan
• 4 Key Areas of Priority :
3. Develop & Deliver Marketing Effectiveness
– Updated Messaging to Key Stakeholders (Physician, Patient, Hospital)
– Patient Activation Strategy & Tactics
– Clinical Positioning Beachhead
4. Leverage Education & Training
– Create Focal One Training Centers
– Support Peer to Peer Instruction
– Influence Residents and Fellows
U.S. Reimbursement Strategy - Focal One®
Focal One® Installs at Tier-1 Institutions
HCPCS Code C9747: Temporary C-code awarded by CMS on 7/1/2017
CPT® 55880: Cat. 1 Code effective 1/1/2021
Secured Physician and Hospital Payment levels
Salvage HIFU Coverage: Medicare (10 states) + Aetna, Cigna (nationwide)
Reimbursement Achievements
Individual claims support: HIFU Coverage Hotline
MACs coverage: Medicare nationwide coverage
Commercial Insurances: Nationwide coverage from United Healthcare,
BlueCross/BlueShield, Aetna, Cigna, Humana, etc.
Reimbursement Next steps
Universal HIFU Coverage: Obtain universal coverage
from Medicare and Commercial Payors
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©2021 EDAP TMS S.A. All rights reserved. Confidential.
Treatment Type CPT Code RVUs* Avg. ($)*
Procedure
Time /
Recovery
Cryotherapy 55873 22.28 $777Home
same day
HIFU (FocalOne) 55880 28.57 $997Home
same day
Radical Prostatectomy 55840 34.06 $1,1883 mo.
recovery
Laparoscopic Radical
Prostatectomy55866 41.95 $1,464
2-6 wk.
recovery
Favorable Physician Economics
* Source: CMS, EDAP TMS
Reimbursement Update
Unanimous Vote at HOP Panel recommending upgrade from
APC level 5 to level 6 : if confirmed by CMS final rule this
would bring the average payment of HIFU from $4500 to $8500
Commercial and Clinical Strategy to Address WW Market Opportunity
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Accelerated US Marketing Plan:
Accelerated US Clinical Plan:
• Patient Marketing
• Digital Marketing
• Expand Marketing Team
• Urologists Events
• Clinical Studies / Data
Management
• Expand Clinical Team
• Endometriosis US Clinical
Study Expenses
Accelerated Europe Go-to-Market Strategy:
• Patient Marketing
• Support Level I and initiated Additional Studies
• Support Reimbursement Strategy
• Provide Clinical Guidance and Recommendations
Accelerated Asia Go-to-Market Strategy
• Expand on Regulatory Programs
• Build Awareness of HIFU in the Region
• Increase Sales Support and Initiative (HIFU
Business Developer)
HIFU beyond Prostate Cancer
Phase I study: study to confirm feasibility (20 patients)
Phase II multicentric study: Confirmatory safety and efficacy study (38 patients).Initiated in 09/20.
Phase III randomized study: to be initiated based on Phase II results.
Multi-application platform to treat various conditions requiring soft tissue ablation
Prostate Endometriosis
Pancreas
Breast
LiverProstate
OB/GYN
Pathologies
Today Tomorrow Future
Focal One® HIFU Platform
Focus on Rectal EndometriosisMinimally invasive alternative to invasive rectal surgery
HIFU
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©2021 EDAP TMS S.A. All rights reserved. Confidential.
Stone ManagementA steady Cash generator
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Exclusive and Patented Technologies
Electroconductivity
latest and most efficient
shockwave technology with
Automatic Pressure Regulation
Visio-Track
User-friendly and radiation-free 3D ultrasound,
proprietary, localization system
Strategic pivot of ESWL research and
development resources toward emerging
HIFU opportunities
Will continue to support lithotripsy
installed base
Lithotripsy division generates revenue as
well as steady and predictable cash flow
to fund other corporate strategic
initiatives
60K+ / year procedures
700+ Installed devices
86Countries
Key Financial Data
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Six Months Ended
June 30,
Twelve Months Ended
December 31,
(in €Millions except
per share data)2021 2020 2020 2019 2018
Revenue €20.7 €16.9 €41.7 €44.9 €39.2
Gross Profit 8.6 7.4 18.4 21.0 16.9
Gross Margin 41.6% 43.9% 44.1% 46.8% 43.2%
Operating Profit (Loss) (0.2) (1.2) 0.3 2.2 (1.3)
Net Income (Loss) 0.4 (1.5) (1.7) 1.5 (0.3)
Earnings (Loss) Per
Share0.01 (0.05) (0.06) 0.05 (0.01)
Revenue
Q2 2021: U.S. HIFU treatment volumes increased +79% over same 2020 period
H1 2021: Total Revenue increased by 22.5% vs H1 2020
Q4 2020: Record quarter revenue level with 51% growth in HIFU
FY 2020: Despite Covid-19 adverse impact, €41.7 million revenue and profitable operating result
Full Year
2019
(+15%)
Full Year
2020
(-7%)
€44.9M
€14.1M(+28%)HIFU
€14.2M(-2%)ESWL
€16.6M(+22%)Distribution
€41,7M
€11.4M(-19%)HIFU
€12.9M(-9%)ESWL
€17.3M(+5%)Distribution
€39.2M
€11.0MHIFU
€14.5MESWL
€13.7MDistribution
Full Year
2018
Balance Sheet Highlights
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Robust financial profile
Strong cash position of
€45.0 Million ($53.3 Million)
as of June 30, 2021,
Balance Sheet As Of:
(in €Million)June 30,
2021
December 31,
2020
December 31,
2019
Cash and cash equivalents 45.0 24.7 20.9
Other current assets 20.4 20.7 21.2
Fixed and other non current assets 9.2 9.8 11.0
74.6 55.2 53.1
Current liabilities 15.3 21.5 17.5
Non current liabilities 11.1 7.4 8.2
Shareholders' equity 48.2 26.2 27.4
74.6 55.2 53.1
High Intensity
Focused
Ultrasound
(HIFU)
Robust HIFU
PipelineExact Imaging
Platform offers a
minimally invasive
robotic tool for soft
tissue ablation,
currently approved
for use in the
treatment of prostate
cancer
Opportunities to
expand HIFU
applications to treat
endometriosis, liver
cancer and
pancreatic cancer
Distribution
agreement adds
complementary
capabilities
leveraging the very
latest technologies
Company Summary
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Innovative minimally-invasive diagnostic and therapeutic robotic tools using ultrasound-based technologies