CORPORATE PRESENTATION
29TH ANNUAL PIPER JAFFRAY HEALTHCARE CONFERENCE NOVEMBER 28, 2017 DEPLOYING SYSTEM-BASED TECHNOLOGY FOR PERSONALIZED SPINAL CARE
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CORPORATE PRESENTATION 29 TH ANNUAL PIPER JAFFRAY HEALTHCARE - - PowerPoint PPT Presentation
DEPLOYING SYSTEM-BASED TECHNOLOGY FOR PERSONALIZED SPINAL CARE CORPORATE PRESENTATION 29 TH ANNUAL PIPER JAFFRAY HEALTHCARE CONFERENCE NOVEMBER 28, 2017 1 11/27/2017 SAFE HARBOR This document has been prepared by MEDICREA International (the
CORPORATE PRESENTATION
29TH ANNUAL PIPER JAFFRAY HEALTHCARE CONFERENCE NOVEMBER 28, 2017 DEPLOYING SYSTEM-BASED TECHNOLOGY FOR PERSONALIZED SPINAL CARE
11/27/2017
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This document has been prepared by MEDICREA International (the “Company”) whose shares are admitted to trading on the Alternext market of Euronext in Paris, solely for information use as part of a roadshow presentation. By receiving this document and attending this meeting, you acknowledge having read the following restrictions. This document is personal and strictly confidential and is not to be reproduced by any person, nor be distributed to any person other than to investors invited to such presentations and their colleagues. You must comply with all laws applicable to the possession of such information including laws on insider trading, the regulations or recommendations of the French Autorité des marchés financiers (the “AMF”). The distribution of this document in other jurisdictions may be restricted by law and persons, who come to hold it, should inform themselves about the existence of such restrictions and comply with them. This document does not constitute an offer or invitation to purchase or subscribe for any shares and no part of it shall form the basis of, or be relied upon in connection with, any contract, commitment or investment decision in relation thereto. Any decision to purchase or subscribe for securities in connection with any future offer should be taken on the basis
distribution of this document in certain jurisdictions may be restricted by law and persons into whose possession this document comes should inform themselves about, and comply with, any such restrictions. Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The information contained in this document (the “Information”) has not been independently verified and no representation or warranty, express or implied, is made as to the fairness, accuracy or completeness of the information or opinions contained herein. The Information is provided as at the date of this document and may change materially. The Company is under no obligation to keep current the information contained in this document and any opinions expressed in this document are subject to change without notice. Neither of the Company nor any of its affiliates, advisors or representatives shall have any liability whatsoever (in negligence or otherwise) for any loss whatsoever arising from any use of this document or its contents, or otherwise arising in connection with this document. It is not the purpose of this presentation to provide, and you may not rely on this document as providing, a complete or comprehensive analysis of the Company’s financial or commercial position or prospects. This document includes forward-looking statements that involve risks and uncertainties. The forward-looking statements are based on management’s current expectations or beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Given the uncertainty of the forward-looking statements, readers are advised that they do not constitute a guarantee, by the Company or anyone, to achieve the objectives and projects of the
contained in this document apply only to this document. Even if the Company’s financial condition, results of operations and cash flows and the development of the industry in which the Company operates are consistent with the forward-looking statements contained in this document, those results or developments may not be indicative of results or developments in future periods. The Company does not undertake any obligation to review or confirm analysts’ expectations or estimates or to release publicly any revisions to any forward-looking statements to reflect events that occur or circumstances that arise after the date of this document.
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Medicrea’s “Adaptive Spine Intelligence” is the convergence of adaptive healthcare information technology and FDA-cleared
scientifically deliver improved clinical results while providing system-wide cost reductions.
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INNOVATIVE OVATIVE DAT ATA-DRIVEN, DRIVEN, SE SERVICE VICE-ORIENTE ORIENTED D AP APPROACH OACH TO COMPLEX MPLEX SP SPINE NE
3D-PRI PRINTE NTED D PATIENT NT-SPECIF ECIFIC C PLATFO FORM RM IN-HOUSE
YORK CITY
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Denys SOURNAC Founder, Chairman & CEO
Successful entrepreneur in the medical supply and orthopaedics industry with over 30 years’ experience creating, building and managing companies.
Pierre e OLIVIE IER CEO, Medicrea crea USA USA
Over 25 years’ experience in Marketing and Project Management, mainly in the United States, particularly in sales launches of new innovative products. Fabrice abrice KILFI LFIGER GER Chi hief f Fin inancia cial l Offi ficer cer Over 25 years’ experience in finance, including over 10 years heading the finance divisions of listed companies. Dav avid id RYAN Chi hief f Oper erating ting Officer ficer Biomechanical Engineer with more than 11 years’ experience in
Scient’x (Alphatec Spine). 11/27/2017
Thomas MOSNIE IER Chief ef Scient entif ific ic Office cer
PhD with over 15 years’ experience in spinal research beginning at the Biomechanics Laboratory of ENSAM
Richar hard d Washbur urn EVP - UNiD ASI
Over 20 years experience in new product development,
commercialization.
Joseph eph Walland EVP - Sales
Over 15 years’ commercial leadership experience in spine, most recently with Stryker Spine.
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1. 2015 Instrumented Thoracolumbar Procedures annually (409,100). 2013 Millennium Research Group, Inc., Table 87 “Thoracolumbar Fusions, by Indication.”
PATIENT SPECIFIC UNiD 3D INTERBODY DEVICES & VERTEBRAL BODY REPLACEMENT SYNTHETIC BIOACTIVE BONE GRAFT EXTENDER
ANNUAL COMPLEX SPINE CASES1
ANNUAL DEGEN CASES1
AVG REVENUE PER DEGEN CASE
AVG REVENUE PER COMPLEX CASE
PATIENT SPECIFIC DUAL-DIAMETER ROD PATIENT SPECIFIC ROD
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Pre- Operative
Planning
IBDS
Selection and Insertion
SCREWS
Selection and Insertion
RODS
Bending and Insertion
tissue displacement to achieve desired placement
during surgery
surgeon during surgery
various lengths
surgery
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1. Moal B, Schwab F, Ames CP, et al. Radiographic Outcomes of Adult Spinal Deformity Correction: A Critical Analysis of Variability and Failures Across Deformity Patterns. Spine Deform. 2014.
2. Rothenfluh DA, Mueller DA, et al. Pelvic incidence-lumbar lordosis mismatch predisposes to adjacent segment disease after lumbar spinal fusion. Eur Spine J (2015) 24:1251-1258
1978
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INCREASED RISK OF ADJACENT LEVEL DISEASE2
ROD FRACTURE SAGITTAL MALALIGNMENT ADJACENT DISEASE
CURRENT TREATMENT METHODS FAIL TO ACHIEVE QUALITY OUTCOMES
disease
stakeholders
OF REVISIONS FAIL TO ACHIEVE ADEQUA TE LUMBAR LORDISIS
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OF P A TIENTS ARE MALALIGNED POST-OP
1
OF MANUALL Y BENT RODS FRACTURE
3
FRACTURE-RA TE WITH PSO
3
OF P A TIENTS REQUIRE REVISION
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Source: Iyer, Lenke, et al., 2016
Chain of correlation linking alignment of the lower extremities to the pelvis, spine, and occiput as well as global alignment parameters.1
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ALIGNMENT PARAMETERS VARY BASED ON THE PATIENT’S AGE AND COMPENSATORY FACTORS.1
Source: Barrey et al., 2011
COMPENSATORY MECHANISMS FOR SAGITTAL MALALIGNMENT
COMPLEX ALIGNMENT CONSIDERATIONS
10 BONE GRAFT SOLUTIONS SPECIALIZED SYSTEMS FOR COMPLEX SPINE PERSONALIZED SAGITALLY ALIGNED RODS PERSONALIZED INTERBODY DEVICES
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› Surgical planning, analytics, and data visualization software › Integrates surgical planning through machine learning with patient-specific design and manufacturing techniques › Leverages data science to drive improved surgical outcomes and economic efficiencies
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Selected Screws Personalized or Selected Cages
Case Plan Memo
Sagitally-Aligned Personalized Rods
Screws selection Ø & length
› Proprietary process based on routine images (X-rays) › Typical tray includes 400 screws, reduce screws by ~75% › Personalized Caddie for each surgery › Inventory & sterilization costs reduction
Cages selection Footprint, height & lordosis
› Implant selection from a huge range of 3D printed Cages › Planning to design a patient specific interbody device
Rod design and manufacture Shape & positioning
› Patient-specific rod, pre-bent to meet patient’s needs and surgeon’s preference › Laser-marked to indicate optimal implantation position › Eliminate need for intra-operative bending
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Post-Op Fracture Rates Standard Rod UNiD Rod Reduction in Fracture Rate Using UNiD Rod ASD Patients 14.9% 1.8% 88% ASD Patients w/ PSO 22.0% 3.1% 86%
Utilizing patient-specific rods designed and manufactured by Medicrea’s UNiD technology significantly reduces the incidence of rod fracture in complex spine surgery patients
Source: Patient-Specific Rods show a reduction in rod breakage incidence, reviews a cohort of more than 450 Adult Spinal Deformity (ASD) patients with at least 1 year from the surgical implantation of patient-specific UNiD™ Rods, generated by Medicrea’s UNiD A SI™ systems-based technology for personalized spinal care. The above excludes results from cases in which surgeons manually bent UNiD rods. Including those cases, the reduction in fracture rates for ASD patients = 85%, the reduction in fracture rates for ASD patients with PSO = 79%.
MEANINGFUL CLINICAL BENEFIT FROM PATIENT SPECIFIC RODS
Standard rod –bent manually
French Bender Acute Bend Notching
88% reduction 86% reduction
10. McCarthy IM, Hostin RA, Ames CP, et al. Total hospital costs of surgical treatment for adult spinal deformity: an extended follow-up study. Spine J. 2014
SUBSTANTIAL LONG-TERM SAVINGS FOR ALL STAKE- HOLDERS
Increase in the overall average costs of adult spinal deformity surgery for patients requiring revisions and reoperations10
Costs associated with hospital readmission10
REDUCED RISK OF REVISION AND TIME-SAVING TECHNOLOGY
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Room Fees. The American Journal of Cosmetic Surgery, 2005 Vol. 22, No. 1.
ASSOCIATED TIME & COST REDUCTION BENEFITS
US spinal surgeons, on national average, spend 15 minutes manually bending spinal rods in the O.R.13 $100 / minute national average cost in the O.R.14 Potential savings by procedure by minimizing manual rod bending in the O.R.
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Adaptive Spine Intelligence
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IN-HOUSE PATIENT SPECIFIC ROD & IMPLANT MANUFACTURING
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› PATIENT SPECIFIC RODS AND IMPLANTS MANUFACTURED ON CASE-BY-CASE BASIS UTILIZING UNID PLATFORM PREDICTIVE TECHNOLOGIES › UNID RODS – CUSTOM MANUFACTURED FOR U.S. DEGEN & DEFORMITY MARKET › UNID IBDS & VBRS – 3D PRINTED TITANIUM PATIENT SPECIFIC IMPLANTS
CUSTOM SAGITALLY ALIGNED RODS CUSTOM INTERBODY DEVICES
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PATIENT MEDICREA 3RD PARTY PAYER HOSPITAL SURGEON
IM PROVED OUTCOM ES TIM E SAVINGS REDUCED COST OPTIM IZED INVENTORY POSITIVE DIFFERENTIATION PATIENT SELECTION
CONSTITUENTS BENEFITS
INTRA-OP CONFIRM ATION
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UNID RODs UNID IBDs PROPRIETARY BIO-ACTIVE BGE PEDICLE SCREWS
Least commoditized Low conversion sensitivity Most commoditized Higher conversion sensitivity
ENGAGE FULLY CONVERT
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SALES AND MARKETING
› HYB YBRI RID DIRE RECT CT + + DIST STRIBUTO RIBUTOR MOD ODEL EL › DRI RIVE VE RE REVE VENUE NUE GROW ROWTH TH WITH TH INT NTEGR EGRATED ATED PR PROD ODUCT UCT SO SOLUTIO UTIONS NS TH THROUG ROUGH UNi NiD TE TECH CHNOL NOLOGY OGY ADOPTIO PTION › BUILD LD BOD ODY Y OF OF EVI VIDENCE DENCE FOR OR PA PATI TIEN ENT-SPEC SPECIFI IFIC C UNi NiD RO ROD › INC NCRE REASE ASE PR PRESE SENCE NCE WITH TH KO KOLS IN ST N STRA RATEGIC TEGIC HOS OSPI PITALS TALS AND ND CE CENT NTERS ERS › INC NCRE REASE ASE AWAREN RENESS ESS WITH TH UNi NiD WARRA RRANTY NTY PR PROG OGRAM RAM › EXP XPAND ND ON ONLINE NE MARKE RKETI TING NG CA CAMPA PAIGN IGN AIMED ED AT T US PA S PATI TIEN ENTS TS
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4Q-14 1Q-15 2Q-15 3Q-15 4Q-15 1Q-16 2Q-16 3Q-16 4Q-16 1Q-17 2Q-17 3Q-17 US OUS
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FDA
CLEARED 11/27/2017
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Weighted average levels per procedure
Deformity Degen
# of levels per procedure
25 24 23 22 21 20 19 18 17 16 15 14 13 12 11 10 9 8 7 6 5 4 3 2 1
9 10
4Q-14 1Q-15 2Q-15 3Q-15 4Q-15 1Q-16 2Q-16 3Q-16 4Q-16 1Q-17 2Q-17 3Q-17 U.S. O.U.S.
FDA
CLEARED
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UNiD Introduced 4Q14 11/27/2017
UC - Denver
2014
› UNiD introduced Nov. 2014 › 2 active UNiD surgeons
2015
› Total procedure volume +72% YoY › UNiD utilized in 26% of all cases › 2 active UNiD surgeons
2016
› UNiD procedure volume +108% YoY › UNiD utilized in 30% of all cases › 3 active UNiD surgeons
2017 (thru 9/30)
› UNiD procedure volume +78% YoY › UNiD utilized in 47% of all cases › 3 active UNiD surgeons › Commenced Degen UNiD cases
2013 Rev
$0.8m
2017 Rev (thru 9/30)
$2.6m
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21 25 51 47 46 70 97 84 95 98 139 114 23 51 64 51 56 89 68 47 68 86 94 75
44 76 115 98 102 159 165 131 163 184 233 189
4Q-14 1Q-15 2Q-15 3Q-15 4Q-15 1Q-16 2Q-16 3Q-16 4Q-16 1Q-17 2Q-17 3Q-17 US UNiD OUS UNiD
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Q1 ‘18
NEW TECHNOLOGY DEVELOPMENT
DEVICES
AND VERTEBRAL BODY REPLACEMENT DEVICES
Q3 ‘17 Q4 ‘17
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$8.1 $6.4 $8.9 $7.9 $7.5 $7.7 $8.8 $7.5 $8.3 $7.4 $8.6 $7.5 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% $0.0 $1.0 $2.0 $3.0 $4.0 $5.0 $6.0 $7.0 $8.0 $9.0 4Q-14 1Q-15 2Q-15 3Q-15 4Q-15 1Q-16 2Q-16 3Q-16 4Q-16 1Q-17 2Q-17 3Q-17 UNiD $ PENETRATION GLOBAL REVENUE ($ millions) Global UNiD Revenue Global Total Revenue UNiD $ Penetration
FDA
CLEARED
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$4.8 $3.4 $5.5 $5.0 $4.3 $4.4 $5.6 $5.0 $4.5 $4.1 $5.5 $4.7
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% $0.0 $1.0 $2.0 $3.0 $4.0 $5.0 $6.0 4Q-14 1Q-15 2Q-15 3Q-15 4Q-15 1Q-16 2Q-16 3Q-16 4Q-16 1Q-17 2Q-17 3Q-17 UNiD $ Penetration Revenue ($ millions) US UNiD US Other UNiD $ Penetration
FDA
CLEARED
1Q-17 2Q-17 3Q-17 UNiD YoY Revenue Growth +15% +22% +27%
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source of production and manufacturing efficiency
investors and € 13M in June 2017 from French investors
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UNiD : A New Era In Patient Care https://www.youtube.com/watch?v=jRwrDg_bca4 UNiD in the NEWS : New Frontiers https://www.youtube.com/watch?v=OaOccVBrJpk FDA Approved : Medicrea Announces UNiD Cervical Rod https://www.youtube.com/watch?v=Z55zvgtqvVs Patient-facing website www.personalizedspinalimplants.com Medicrea US Website Newsroom http://www.medicrea.com/usa/newsroom-usa/
VIDEOS PATIENT-FACING PRESS RELEASES
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QUOTES
“The patient-specific rod is very much ahead of its time. When we finish the
pain.”
“We now realize how important it is to provide a specific alignment of the spine that is unique to each patient. If we do not achieve the optimal alignment during surgery, then we are too-often revising that patient later. UNiD™ is using precision technology and analysis to solve this clinical issue for patients as well as providing an invaluable support service and feedback loop for surgeons.”
“Understanding and restoring sagittal alignment is key towards providing better patient outcomes and preventing the need for reoperations, a major factor in rising health care costs. By providing rod customization, UNiD™ allows surgeons to precisely execute their preoperative plan and frees them from the antiquated technique of freehand bending, ensuring individual patients receive the most accurate and effective treatment. Having a more precise, personalized rod ready before even stepping foot in the operating room is a game-changer for spine surgery.” – Dr Schwab, HSS, New York
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