Establishment Labs Holdings Inc. · NASDAQ:ESTA
Establishment Labs — Investor Day (2023)
107 slides from Establishment Labs's investor day presentation, 2023
Slide 1: Discovery Session
> Discovery Session
Slide 2: Agenda
1. Welcome 2. The Science and Technology Behind The Motiva Standard 3. Global Clinical Evidence Agenda 4. Femtech Solutions 5. Femtech Roadmap 6. Expert panels 7. Q&A
Slide 3: Safe Harbor and Forward-Looking Statement
Safe Harbor and Forward-Looking Statement PROPRIETARY INFORMATION OF ESTABLISHMENT LABS HOLDINGS INC. AND ITS AFFILIATES (“Establishment Labs”) All information contained in this document is owned by, and is the proprietary information of, Establishment Labs and may not be used, captured, published,
Slide 4: Juan José Chacón-Quirós, Founder and CEO
Juan José Chacón-Quirós Founder and CEO
Slide 5: Establishment Labs
Establishment Labs is a first-of-its-kind medical technology company focused in breast aesthetics and breast reconstruction, bringing to market Femtech innovations for women’s health and wellbeing.
Slide 6: Let's go back to 1960's
Lets go back to 1960’s FIRST MODERN 3rd GENERATION BAYWATCH AIRS FDA PLACED A ANDERSON OPTS BREAST IMPLANT, BREAST IMPLANTS: ON TELEVISION TO HAVE HER Introduction of double-lumen And ushers in a new era TEMPORARY (DOW CORNING breast implants (Heyer Schulte). of implants. IMPLANTS MORATORIUM CORPORA
Slide 7: Company history timeline
| 4 " \ , DiurmHss TORY —(o)——(o} {0} —{o} (0) (6) (o}—{9) c (8) (0) oe) 2004 2010 2011 2012 2014 2016 2017 2018 2019 2020 2021 2022 2023 Established the Women’s Health Hub in Barcelona.
Slide 8: The Motiva Standard
The Motiva Standard ® • 12 years in the market. • Post-Market Surveillance (March 2023). ® • Three-million Motiva devices sold. ® • 3-year results from Motiva U.S. IDE study. • Less than 1% device-related complications. • +85 countries where Motiva Implants® have been approved •+25 Inventions (paten
Slide 9: Femtech Solutions
> Femtech Solutions Establishment ee Om Sulayém
Slide 10: Our Femtech Solutions
Our Femtech Solutions Motiva Flora Motiva JOY Mia Femtech TM ® ® ® JOY ® Flora Tissue Expander Motiva Round ® Ergonomix ® Ergonomix2 ® Ergonomix2 Diamond ® SmoothSilk /SilkSurface SmoothSilk /SilkSurface SmoothSilk /SilkSurface SmoothSilk /SilkSurface ® ® ® ® ® ® ® ® SmoothSilk /SilkSurface ® ® Non-
Slide 11: Science-Based Femtech Solutions
Science-Based Femtech Solutions Beyond clinical outcomes, improved aesthetic outcomes: •Breast augmentation: MOTIVA , JOY ® ® •Breast harmonization: Mia Femtech™ •Breast reconstruction: Aesthetic BreastRecon , Flora Tissue Expander ® ® •Custom designed procedures •Safety features: RFID enablement Er
Slide 12: The Motiva Standard all over the world
The Motiva ® Standard all over the world Motiva implants sold in 85+ countries ® Direct Distribution Near-term Opportunities
Slide 13: Delivering Consistent Growth
Delivering Consistent Growth
Slide 14: Beyond 2022
Beyond 2022 Targeting $500M in Annual Revenue in Fiscal 2026 Average rate of growth of 33% per year over the next 4 years, and significant growth beyond Creating positive impact and long- term social, environmental and economic value in all our products, activities and corporate efforts. ~$162 M $50
Slide 15: Roberto de Mezerville
Roberto de Mezerville Head of Research, Development and Innovation
Slide 16: The Science and Technology Behind The Motiva Standard
The Science and Technology Behind The Motiva Standard ® a
Slide 17: The Science and Technology Behind The Motiva Standard
The Science and Technology Behind The Motiva Standard ® a 3-year data from Motiva FDA trial 3 million implants in Less than 1% device-related further confirms our less than 1% market at 12+ years data complications supports best in device-related complication rate. ® on Motiva Implants . ® class saf
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Slide 19: Clinical Complications Most Common User Needs
Clinical Complications Most Common User Needs Re-Operation Rupture BIA-ALCL Firm Implants BII & SCC Malposition Biofilm / “Anatomical Bacteria Shaped” Double Capsular Capsule Contracture
Slide 20: Patient Benefits
Biocompatibility Testing: • Leachable characterization • Cytotoxicity • Sensitization • Regulatory Requirements • Irritation or intracutaneous reactivity • ISO 10993 • Acute systemic toxicity • ISO 14971 Biocompatibility Risk • Subacute toxicity • EU Directive 93/42/EEC • Genotoxicity Patient Benefi
Slide 21: Patient Benefits, Risks and Satisfaction
Biocompatibility Testing: • Leachable characterization • Cytotoxicity • Sensitization • Irritation or intracutaneous reactivity • Acute systemic toxicity • Subacute toxicity • Genotoxicity • Implantation Patient Benefits • Biodegradation • Carcinogenicity • Immunocitoxicity Bio-Tolerable • Regulator
Slide 22: Complications mapped to Motiva technologies
Biofilm / Double Capsular Firm Implants BIA-ALCL “Anatomical Re-Operation Rupture Bacteria Capsule Contracture Malposition BII & SCC Shaped” Surface Characterization Biofilm/ Bacteria Gel diffusion Immune Response SmoothSilk® / Shell BluSeal® Biotribology Qid™ Safety Heavy Metals ProgressiveGel® Tra
Slide 23: Patient-Centric Risk vs. Benefit of Motiva Implants
Patient-Centric Risk vs. Benefit of Motiva Implants ® Patient Risk Benefits High Frequency – Low Risk Patient Less than 1% Capsular Contracture Rate Less than 1% Rupture Rate Satisfaction Low Frequency – High Risk Healthy capsule Lower inflammation Comfort Ergonomy Historical absence of Double Consi
Slide 24: Variables that impact immune response and capsular contracture
Variables that impacts Immune Response and Capsular Contracture Women Lifestyle Filling material (diffusion) Shell materials Surface and particles Immune response Surgical techniques Bacteria colonization & biofilm Implant placement
Slide 25: Innovative Designs
DNPA@O Innovative Designs = —— q
Slide 26: Shell: Consumer Centric Design and Engineering
Shell: Consumer Centric Design and Engineering Patient Risk / Benefit Analysis Minimize Ruptures BluSeal® • Patient-Focused • Risk Assessment of ® • Motiva Implants Surfaces Minimize Folds 100% Filled Minimize Gel Diffusion Geometry
Slide 27: VIDEO
VIDEO 27
Slide 28: Science-Based Design
Science-Based Design Defining Optimal Surface Architecture Cell alignment Cell adhesion/ Focal adhesion formation Cells align to nano-sized features Cells preferentially adhere to small substrate heights, with MORE attachment sites Tissue Tissue Implant Implant 100nn width and 160nm height: Reduces
Slide 29: Science-Based Design
Science-Based Design Defining Optimal Surface Architecture Scientific Theory SmoothSilk / SilkSurface ® ®
Slide 30: Shell Surface: Consumer-Centric Design & Engineering
Shell Surface: Consumer-Centric Design & Engineering Patient Risk / Benefit Analysis Provokes the least amount of inflammation and foreign body response Less bacteria attachment SmoothSilk® Less biofilm Less friction Cell friendly Designed and Controlled Surface
Slide 31: Fill Gel: Consumer-Centric Engineering
Fill Gel: Consumer-Centric Engineering Patient Risk / Benefit Analysis TrueMonobloc® ProgressiveGel® Gel Filling Material
Slide 32: VIDEO
VIDEO
Slide 33: Ergonomix
Ergonomix ® Women’s Life-Style 33
Slide 34: Zen Platform
Zen Platform ® New Generation for the Radio-Frequency platform: • MR Conditional with no artifact effect outside of the implant • Electronic Serial Number traceability feature • Passive device with no internal battery • Will allow Biosensing capabilities in the future
Slide 35: The Science Behind The Motiva Standard
The Science Behind These Motiva Standard ® 50+ peer-reviewed scientific publications
Slide 36: Rosalyn Cole D'Incelli
Rosalyn Cole D’Incelli SVP, Global Clinical, Medical & US Regulatory Affairs
Slide 37: Global Clinical Evidence
Global Clinical Evidence
Slide 38: Disclosure
Disclosure The Motiva Core pivotal study is an ongoing US clinical trial of an investigational medical device under an FDA-approved Investigational Device Exemption. The Motiva device has not been approved by the Food and Drug Administration and is not commercially available in the United States. Th
Slide 39: Safety Our First Priority
Safety Our First Priority
Slide 40: The Motiva Standard
The Motiva Standard ® 3-year data from Motiva 3 million implants in Less than 1% device- FDA trial further confirms market at 12+ years data related complications our less than 1% device- ® supports best in class related complication rate. on Motiva Implants. safety standard. Backed by the power of
Slide 41: US IDE Study Update
US IDE Study Update 33 Study sites: US & EU Study the Safety and Effectiveness of the Motiva Breast Implants in ® Primary Breast Augmentation, Primary Breast Reconstruction, and Revision 834 Subjects • 560 Aug and Rev-Aug Office visit Augmentation • 274 Recon and Rev-Recon Follow-up rate • MRI cohor
Slide 42: Motiva Kaplan-Meier
Motiva Kaplan-Meier (KM) ® KEY COMPLICATIONS 3-YEAR INCLUDING MRI COHORT PRIMARY AUGMENTATION 2-YEAR 3-YEAR (N=451), 95% CI (N=451), 95% CI Capsular contracture (Baker Grade III/IV) 0.5% (N=2) 0.5% (N=2) Rupture, suspected or confirmed (MRI Cohort) 1 0.6% (N=1) 0.6% (N=1) Breast pain 0.5% 0.7% Infec
Slide 43: Post-Market Surveillance
Post-Market Surveillance Motiva Patient Registration and Warranty ® Device Registration and Warranty data provides a valuable framework for evaluating breast implant devices' long-term safety and performance, in addition to protecting surgeons and their patients. 326,700 women registered their impla
Slide 44: Global Clinical Evidence
Global Clinical Evidence PMCF Oval PMCF Flora Sweden ABR Flora Oval Spain PMCF ATF PMCF Flora Mia Poland ABR Flora Retrospective EU Belgium EU PMA MIM US PMCF Oval Transgender Austria Belgium Netherlands Ergo2 Mia Korea PMCF Flora PMCF Flora Flora ABR MCF ATF PMCF ATF Panama Mia MIM+10 Study Thailan
Slide 45: Mia IRB Prospective Study
Mia IRB Prospective Study ® 2-YEAR FOLLOW-UP
Slide 46: Study population
Study population Demographics 100 participants 29 22 age (mean) BMI (mean) 81% 57% 62% Professional College/university Follow up compliance employment graduate
Slide 47: Kaplan-Meier Analysis Key Events
Kaplan-Meier Analysis Key Events Adverse Events by patient 2-year (N=81)95% CI BREAST-Q Scores Capsular contracture (Baker Grade III/IV) 0.0% Rupture, suspected or confirmed 0.0% Pre 41% Breast Satisfaction Breast pain 2.0% 79% Breast Satisfaction Malposition 1.0% Post 2y Implant removal, with/witho
Slide 48: Study Participant
Study PRE-OP Participant Age: 23 Height: 5.2 ft 3 MONTHS Weight: 110 lb BMI: 19.9 Implant: DSM 190 2 YEARS
Slide 49: Slide 49
Slide 50: Flora Studies
Flora Studies ® Flora ABR (Reverse Expansion) EU, LatAm EU, LatAm Flora PMS Flora PMS Retro EU
Slide 51: ABR Reverse Expansion
ABR Reverse Expansion Ergonomix2 Patient of Dr. Filip Stillaert ®
Slide 52: Flora ABR
Flora ABR ® Peer-reviewed Studies • In radiotherapy planning, Motiva Flora®’s RFID port Surgeons reported: First-in-human study confirms Flora’s MRI- showed superior dosimetric results to the heart and Higher satisfaction with the lower pole conditional does not affect the image quality of lungs vs
Slide 53: Flora ABR
Flora ABR ® Designed by women for women. High Satisfaction5 Low Device-Related FemTech. Complications1-4 1.Stillaert F, Lannau B, Van LanduytK, Blondeel P The Prepectoral, Hybrid Breast Reconstruction: The Synergy of Lipofilling and Breast Implants Plastic ReconstructiveJournalGlobal Open 2020 doi:
Slide 54: Motiva USA
Motiva USA ®
Slide 55: US Aesthetic Overview Market
US Aesthetic Overview Market ~365,000 breast augmentations in 2021 (+44% from COVID decline in 2020). $400m - $600m/yr Breast augmentation 148,000 market in the US women reported to implant removal with replacement (+32% from 2020)* $350m/yr Estimated breast reconstruction 310,000 market in the US p
Slide 56: The US Breast Market lacks Product Differentiation
The US Breast Market lacks Product Differentiation • The last PMA approval for a breast implant in the US was Sientra in 2012 • In March 2019, the FDA hosted a General and Plastic Surgery Devices Advisory Panel. • Allergan global textured implants recall in 2019 • FDA issues alert on SCC in 2022 In
Slide 57: An Opportunity to educate and differentiate in a commodity market
An Opportunity to educate and differentiate in a commodity market Market research commissioned in 2022/23 to understand US Market surgeon and patient preference Key Patient Findings (265 interviews) Key Surgeons Findings (100 interviews) Generally unaware of implant brands Surgeons generally view im
Slide 58: Motiva China
Motiva China ®
Slide 59: Breast augmentation market volume in China is recovering
Breast augmentation market volume in China is recovering Breast Augmentation Market Size in Volume 150 155 145 130 110 100 90 44% 12% 7% Market Size in volume, thousand unit 10% YoY growth -33% -18% 2019 2020 2021 2022 2023E 2024E 2025E Forecast overall market will gradually recover to the pre-COVID
Slide 60: Market Segment Opportunity for Motiva
Market Segment Opportunity for Motiva ® Patient Economic Mid-Low Mid-End Premium Luxury Market potential 12% (4%value) 18% (12%value) 42% (43%value) 25% (35%value) 3% (6%+value) Patient Procedure <$3,00 $3,000 -4,500 $4,500- 7,500 $7,500 - 12,500 $12,000+ Price (USD)
Slide 61: JOY by Motiva
JOY by Motiva ® It’s the first program of its kind for women looking for an elevated breast augmentation experience
Slide 62: Innovation
INNOVATION ENHANCED SAFETY | MINIMAL SCAR | SOFTER & NATURAL PREMIUM BREAST AUGMENTATION +20%-30% price increase GOOD BETTER BEST
Slide 63: Safety Woman's Choice Program
Safety Woman’s Choice Program
Slide 64: What generates appeal?
WHAT GENERATES APPEAL? THE NATURAL RESULT | SAFETY | WARRANTY | MINIMAL SCARS Price VS Quality % • JOY appeal: The idea is well liked in all countries and by all patients (9 out of 10 patients liked JOY) 26 1800 WOMEN IN • Women want more natural and 6 DIFFERENT COUNTRIES softer results. BETWEEN AGE
Slide 65: 30 Countries and growing
30 Countries AND GROWING! 2021 2022 2023 – to date DENMARK AUSTRIA FRANCE IRELAND GERMANY NORWAY BELGIUM CROATIA ITALY CZECH REPUBLIC HUNGARY GREECE SEVERAL SPAIN LATVIA POLAND DOMINICAN REPUBLIC COUNTRIES SWEDEN SWITZERLAND SOUTH AFRICA ECUADOR HAVE EXCEEDED UNITED KINGDOM TURKEY MONGOLIA PANAMA 10
Slide 66: The implants that I chose fit me just right
The implants that | chose fit me just right. \ =— 4—r
Slide 67: Aesthetic BreastRecon
Slide 68: Mia is the voice of over 16k women around the globe
Slide 69: FEMTECH
FEMTECH
Slide 70: Get to know their stories!
Get to know their stories!
Slide 71: Value proposition
Value proposition CATEGORY INNOVATION EXPERIENCE OUTCOME COMMUNICATION AND BRAND Breaking taboos Minimal invasive Best-in-class Align with their Arrive at right & breaking down technology experience in expectation. target and create barriers by & technique. collaboration Natural, discreet advocates
Slide 72: Early stage.
Early stage.
Slide 73: Local Landing Pages in each Country
Global Website Top-Tier Local Patient Mia Femtech™ Magazines Aggregators Local Landing Pages in each Country JAPAN SPAIN FRANCE
Slide 74: Spark conversations and build communities
Spark conversations and build communities Engage, connect, influence & encourage UGC
Slide 75: DTC Social Media Campaign B2B2C Strong Communication
DTC Social Media Campaign B2B2C Strong Communication +50 posts & stories
Slide 76: Juno (Social Club)
Juno (Social Club) Private Consultations Communications posts & stories
Slide 77: Early stage.
: periefices “ine ’ ~arecasy to share, DUE hard to copy” ———<——= Mia
Slide 78: Early stage. Clinic set-up
Utoquai & LAC Clinic set- ae
Slide 79: Planas Clinic set-up
Planas Clinic set-up FEWTECH x CUNICAPLANAS
Slide 80: Seishin Roppongi Clinic set-up
Seishin Roppongi Clinic set-up
Slide 81: Demonstrated in just 13 weeks
Demonstrated in just 13 weeks EXPANDING WILLINGNESS TO EXCEEDING THE MARKET PAY PREMIUM EXPECTATIONS Unmet need Minimally invasive Innovative solution & women´s technology with an appealing desire & technique benefit
Slide 82: Initial results
Initial results from • The initial campaign generated over 175 leads to the clinics. • There are ~30 women currently either awaiting a Mia appointment or have one scheduled. • 50% of women were not considering a traditional breast augmentation.
Slide 83: Clinics
Europe Spain Sweden 8 17 Practices Clinics France Switzerland Germany UK 1 America Asia 3 7 Practices Clinics Flagship Japan Costa Rica Clinic *signed clinics
Slide 84: Femtech Roadmap
> Femtech Roadmap Establishment ee Om Sulayém
Slide 85: Minimally Invasive Platform and Tissue Preservation, Minimal Scar, Fast Recovery
Minimally Invasive Platform and Tissue Preservation, Minimal Scar, Fast Recovery
Slide 86: A Superior Technology Platform
A SUPERIOR TECHNOLOGY PLATFORM
Slide 87: Motiva Ergonomix2 Diamond
Motiva® Ergonomix2® Diamond® Implants Motiva Injector ® Motiva® Channel Separator Motiva® Marking Tool Motiva® Inflatable Balloon 87
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Slide 89: Patient Y Two cups size up
Patient “Y“ Two cups size up Pre-op Volume Post-op Volume Left: 326cc Right: 318cc Left: 496cc Right: 473cc Pre-op Post-op 3D Scan
Slide 90: Mia & Mia + Mia
<M’ & Mia’ )3~——__ > Mia®
Slide 91: Joy + Mia & Mia +
Joy*+ —— SOM o> Mit to >
Slide 92: GEM
GEM ®
Slide 93: GEM
GEM ® 93
Slide 94: RFID Sensor Platform
> RFID Sensor Platform Establishment ee Om Sulayém
Slide 95: RFID Sensor Platform
RFID Sensor Platform
Slide 96: RFID Sensor Platform
a RFID Sensor Platform Motiva® launched with Qid® safety technology in 2014 Only Motiva® implants 60% of Motiva® Of all registered provide traceability implants with Qid® in implants, 70% are using RFID technology the market with Qid®
Slide 97: Vision – BioZensor Platform
Vision – BioZensor Platform
Slide 98: Bra development and pressure testing
•Bra development to provide the consumers a better experience and recovery results. •Pressure testing to back-up design decisions. •Preliminary testing before starting study with University of Portsmouth. •Data analysis for future wearable devices development.
Slide 99: RFID Sensor Platform Live Demo
RFID Sensor Platform Live Demo
Slide 100: Publication
Publication MicroTransponder Platform Sensors
Slide 101: Thermography publication references
First Screenshot: Kennedy, D. A., Lee, T., & Seely, D. (2009). A comparative review of Second Screenshot: Ng, E. K. (2009). A review of thermography as promising non-invasive thermography as a breast cancer screening technique. Integrative cancer therapies, 8(1), 9-16. detection modality for breast
Slide 102: Expert Panel Discussion
> Expert Panel Discussion Establishment ee Om Sulayém
Slide 103: Beyond 2022
Beyond 2022 Targeting $500M in Annual Revenue in Fiscal 2026 Average rate of growth of 33% per year over the next 4 years, and significant growth beyond Creating positive impact and long- term social, environmental and economic value in all our products, activities and corporate efforts. ~$162 M $50
Slide 104: Threats to women's health: BIA-ALCL and SCC and other lymphomas
Threats to women’s health in our industry: Expert Update on BIA-ALCL and SCC and other lymphomas - Dr Mark Clemens & Dr Fabio Santanelli
Slide 105: Systemic Symptoms associated with breast implants
Systemic Symptoms associated with breast implants: an Expert review of the evidence. Dr Caroline Glicksman & Dr Pat McGuire
Slide 106: Q&A
Q&A
Slide 107: Thank you
Thank you C) Establishment Labs’ Sulayom