Implanet€¦ · 5 Value chain, international developments and partnerships 6 Strategic priorities...
Transcript of Implanet€¦ · 5 Value chain, international developments and partnerships 6 Strategic priorities...
Implanet
European Large and Midcap event
Paris I October 14th, 2019
www.implanet.com
1 Implanet presentation
4JAZZ®, a disruptive technology embedded in spine surgery
2 Markets and trends
3MADISON®, a comprehensive total knee prosthesis range
Agenda
5Value chain, international developments and partnerships
6 Strategic priorities
7 Appendices
Implanet presentation1
◼ Market: listed on
— Euronext Growth Paris
— OTCQX – New York
◼ Offices : Bordeaux, London, Frankfurt & Boston
◼ 2018 revenue: €6.7M 2019 revenue: Third straight quarter of growth(+2% on Q1, +8% on Q2 and +12% on Q3) Jazz activity +10% on Q3 YTD
Business overview
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◼ A medical technology company specialized in vertebraland knee-surgery implants.
About Implanet
A disruptive technology and a strong historical
expertise
Commercial presence in 17 countries around the world
39 employees 37 patents
JAZZ® Platform MADISON® TKP
✓ Exhaustive total knee prosthesis range
Knee revenue: €2.6M of which 69% in France
✓ Exhaustive product range to address 100% of fusion pathologies
Spine revenue: €4.1M of which 39% in France
and 47% in the United States of America
Market and trends2
◼ The spinal implants market is expected to reach $14.6bn in 2019 with a GAGR of 5.5 % on the 2015-2019 period3
IMPLANET is positioned in a promising market
Knee prosthesis and spinal implants market = 49% of the global market for orthopedic IMD1
◼ The knee prosthesis market is estimated at $8bn in 2017 and is expected to reach $10bn in 2024 with a GAGR of 3.7%2
Sources :(1) Xerfi (% over a revenue of 40.5 billions in 2016)(2) Global Market Insights(3) Technavio
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1) Ageing population
2) Changing lifestyles
Key market drivers
3) Improving access to healthcare in emerging countries
4) Medicine progress
22% of the global market for orthopedic IMD1
27% of the global market for orthopedic IMD1
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MADISON®, a comprehensive Total Knee
Prosthesis range
MADISON® a new generation of knee prosthesis
▪ Exhaustive Total Knee Prosthesis range
▪ Bone preservation
▪ 17,000+ Madison implanted since 2010
▪ 2% market share in France / Fourth French player
▪ 7+ years of follow up and clinical evidence
Presentation PartnershipsWorldwide marking
Est. Q4 2019
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TGA Australia
Worldwide recognition of MADISON® TKP’s clinical value
▪ Partnership agreement with KICO KNEE INNOVATION COMPANY PTY LTD signed in November 2018(Australia, New Zealand and United States)
▪ OEM Partnership under discussion for the United States
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JAZZ®, a disruptive technology embedded
in spine surgery
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JAZZ ®, a standard of care in fusion technics
for complex spine surgeries
▪ Pediatric deformity
▪ Degen adult
▪ Trauma
▪ Degenerative diseases
✓ Exhaustive product range to address 100% of fusion pathologies
✓ Significantly better proven clinical results
✓ Security strengthened through this solution
✓ Cost-effectiveness
▪ Quantity of metal
▪ Screw misplacement
▪ Screw fixation
▪ X-ray exposure
▪ Cost of instrumentsets
CURRENT STANDARD OF CARE= ALL SCREW CONSTRUCTION
TOMORROW SOLUTION= JAZZ® PLATFORM
DISADVANTAGES OF SCREW CONSTRUCTIONS
+40,000JAZZ® sold since 2014
+7,500PatientsJAZZ® as of H1 2019 :
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JAZZ®
FRAME
Additional
diameters(3.5 – 6.35
mm)
Compatible
with 100% of
fixation
systems
Launch of
JAZZ® implant
in France and
the US
2014 2015 2016 2017
JAZZ®
LOCK
JAZZ® CLAW
JAZZ ®, an enlarged & established technological platform…
Steady pace of new product launches since inception
JAZZ® range
completion in
scoliosis
JAZZ® solutions less invasive and
dedicated to the degenerative market
JAZZ®
PASSER
JAZZ® EVO
2018
JAZZ®
CAP
JAZZ®
PASSER
BAND
29 granted International Patents
Regulatory clearance in 80% of the global commercial market: United States, Europe…
…positioned to fully address spinal fusion indications
Capitalizing on JAZZ® success to accelerate the development in
degenerative bone disorders
Major growth opportunity for Implanet
Paediatric+
Adolescent
(Elderly patients)
VERTEBRAL FUSION 860,000 operations a year worldwide(1)(2)
Major deformities
Degenerative bone disorders
$480m1
$1.6bn2
x3
Aging population
Prevalence of chronic back pain
Poor bone quality negatively impacts surgical outcomes
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(1): sources i-Data 2010; Company(2): sources i-Data 2010; D. K. Chin and al. Osteoporos Int (2007) 18:1219–1224.; Company
1. Securing screws
(1) : source : 2015 Health Advances study(2) : cf Sung Bae Park, M.D.1 and Chun Kee Chung, M.D. 2 Strategies of Spinal Fusion on Osteoporotic Spine. J Korean Neurosurg Soc. 2011 Jun; 49(6): 317–322. )(3) : sources i-Data 2010(4) : sources D. K. Chin et al. Osteoporos Int (2007) 18:1219–1224 13
2. Proximal Junctional Kyphosis
JAZZ® Band
JAZZ® connector
Screws
Adjacent disks
Degenerative bone disorders : JAZZ®, a complementary solution to screws
▪ Between 10 and 30% of cases classified as high risk (poor bone quality)(1) …
▪ …20 to 25% of which have osteoporosis as co-morbidity(2)
▪ 25% of cases involve complications associated with kyphosis or proximal junctional level following a spine fusion(1)
700,000 cases / year(3) = $1.6bn(4)
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Value chain, international developments
and partnerships
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A well-structured orthopedic company on quality, regulation and logistics
A proven regulatory platform
Operations & Quality processes
▪ ISO 13485 : 2016 certification, critical step to the MDR 2017/745 effective in May 2020
▪ CE marking valid until 2024
▪ Regulatory marking and authorizations on all targeted markets*:
510 (K) USA*
ANVISA Brazil
93/42/CE Europe
ISO 13485TGA Australia*
* En cours pour la gamme MADISON
Outsourcing
◼ Material control
◼ Casting, machining, sanding, plasma spay
◼ Laser marking
ValidationAssembly & sterilization
Certification & final control
Distribution
◼ Quality control team
◼ Sampling and control procedures
Total control over product traceability
Research & Development
Manufacturing
Outsourcing
◼ Assembly
◼ Final cleaning
◼ Packaging
◼ C
◼ C
◼ c
◼ Batch record
◼ Labeling
◼ Traceability
◼ Design
◼ Patents
◼ Biomechanical tests
International commercial strategy: replicating a proven direct sales model
and execution of strategic partnerships
▪ 48% of its revenue coming from abroad since 2016
▪ Replication of a proven direct sales model (already inplace in France and the United States) for Europewith the recent opening of:
— A branch in the UK
— A subsidiary in Germany
▪ For the rest of the world, particularly Brazil, IMPLANEThas forged strong alliances with local distributors
▪ Setting up of strategic partnerships with internationalplayers to accelerate its geographical reach :
SeaSpine: partnerchip for the sale of the JAZZ®
platform in the United States
KICo: partnership for the sale of the kneeprosthesis in the United States and Australia
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International strategyCountries where Implanet has a commercial coverage
Direct sales Distributors
Brazil
PeruAustralia
United States
Belgium
Greece
Italy
Ireland
Lithuania
Morocco
Netherlands
Portugal
Spain
Switzerland
France
Germany
United Kingdom
Active in 17 countries
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KICo: a structuring knee partnership to accelerate international
development
▪ In November 2018, IMPLANET has forged adistribution agreement with KICo (Knee InnovationCompany) in order to market its MADISON® kneeprosthesis firstly in the United States and Australia
▪ KICo benefits from exclusive rights for the MADISON®
knee prosthesis when the threshold of1,000 MADISON® implants are sold over 12 months
▪ KICo will then have an option for a manufacturinglicencse
United States Australia
▪ KICo, founded in 2015, is specialized in theconception, development and sale ot total kneeprosthesis. KICo offers very personalized productadapted to each patient.
▪ The company sales its product mainly inAustralia, in New-Zealand and the UnitedStates.
Strategic partnership(Distribution agreement)
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SeaSpine: a Spine partnership to accelerate our development in the
United States
€143M (+9%)2018 revenue
327 Employees
▪ SeaSpine is specialized in the conception,development and sale of medical technologies forspinal surgery.
▪ The company realizes 90% of its sales in theUSA:
#6 the top US ranking
#7 the top global ranking
▪ SeaSpine has 327 employees of which 105 insales and marketing.
United States
▪ JAZZ® Private Label Distribution agreement with SeaSpine in the US, the world’s largest market for the treatment of spinal pathologies(current Implanet America accounts will continue to be directly managed by our subsidiary)
▪ Capitalize on SeaSpine’s Salesforce and training & education capabilities in the US
— 10 Area Managers
— Training & Education Specialists
— +200 Agents (1099 Reps)
▪ 6 years initial agreement with guaranteed annual minimum sales for Implanet
▪ SeaSpine & Implanet: same vision with a strong culture of innovation and education
▪ JAZZ Cap®: offering a unique and proprietary solution for securing pedicle screws in poor-quality bone. JAZZ Cap®
technology strengthens the offering of JAZZ® productsin the US to address a larger ‘mass market’.
Strategic Partnership (Private Label Distribution agreement)
6Strategic priorities
PROMOTING
▪ Ongoing innovation to JAZZ® platform
▪ Financing new co-developed products with OEM partners
CONTINUING TO DEMONSTRATE
▪ JAZZ ® : clinical studies in degenerative pathologies (Ohio State University)
▪ Madison: PMS follow up
▪ Reinforcing the Scientific Committee & clinical
SEEKING
▪ Developing direct sales in Europe
▪ Reinforcing JAZZ training academy
▪ Executing new strategic partnerships
FINANCING
▪ Financing working capital
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innovation and enlarge certifications
proven medical value based on clinical trials
efficient commercial expansion
Strategic priorities
Clear and focused growth levers
7Appendices
Latest financials
Revenue of €5.6 million for the 9-months to end-September, 2019,
up 7%
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Revenue (€ thousands - IFRS*) 2019 2018 Variation
1st quarter revenue 1,904 1,867 +2%
2nd quarter revenue 1,915 1,765 +8%
Spine (JAZZ®) 1,189 1,056 + 13%
Knee 550 491 +12%
3rd quarter revenue 1,739 1,548 +12%
Spine (JAZZ®) 3,573 3,254 +10%
Knee 1,984 1,926 +3%
Total 9-months revenue 5,557 5,179 +7%
▪ Signature of a strategic partnership withSeaSpine, Inc. to market the JAZZ® range in theUSA
▪ JAZZ Cap® FDA clearance, offering a unique andproprietary solution for securing pedicle screwsin poor-quality bone
▪ Successful first JAZZ Cap® surgeries in theUnited States
▪ Recording of the first orders originating from thepartnerships established with Kico Knee andSeaSpine, Inc. (€0,3M to be delivered in thesecond half of 2019)
HighlightsEnd Sept. 2019
(*) Unaudited data
€1,867 €1,765€1,548
€1,904 €1,915 €1,739
2%8% 12%
1st quarter revenue 2nd quarter revenue 3rd quarter revenue
2018 2019 Variance (%)
H1 2019 results
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▪ Proprietary implants range generating high gross margin
▪ Controlled operating costs to improve EBIT (reduced by €0.9M over H1’19)
▪ Operations restructured late 2018 which should enable a further saving of €0.8M on expenses over H2’19
Maintaining gross margin and operating result
trends improvements
(€ thousands - IFRS) H1 2019 (6 months)
H1 2018 (6 months)
Revenue 3,818 3,632
Gross margin 2,177 2,023
Gross margin as a % of revenue 57.0% 55.7%
Operating expenses -3,898 -4,772
Operating loss before non recurring items
-1,721 -2,750
Operating loss -1,550 -2,750
Net loss -1,825 -2,772
P&L statement
€4.1€3.7 €3.6
€3.1€3.8
€2.1 €1.8 €2.0 €1.7 €2.2
51%
49%
56%55%
57%
H1'17 H2'17 H1'18 H2'18 H1'19
Revenue Gross margin (€M) Gross margin (%)
Revenue and gross margin Operating costs and EBIT
€(5.6)
€(4.5)€(4.8)
€(4.3)€(3.7)
€(3.5)
€(2.7) €(2.7) €(2.6)
€(1.6)
H1'17 H2'17 H1'18 H2'18 H1'19
Operating expenses Operrating income
-€(2.9)M-€(2.3)M
-€(3.1)M
-€(1.9)M-€(1.4)M
H1'17 H2'17 H1'18 H2'18 H1'19
Flux de trésorerie (M€)
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(€ thousands - IFRS) H1 2019(6 months)
H1 2018 (6 months)
Free Cash Flows (1,352) (3,102)
o/w cash flow (1,754) (2,420)
o/w change in WCR (-) (657) 422
o/w Capex (-) 255 260
Cash flow from investment activities 1,853 1,113
o/w Equity 1,937 1,000
o/w Loans & interests (332) 284
o/w other (factor and placements) 248 (170)
Changes in currency rates 32 4
Change in the cash position 533 (1,985)
Free Cash Flows
Cash flow statement▪ Improvement in WCR and not capital
intensive (limited JAZZ instrument costs)
▪ Decrease of cash needs from €3.1M in first half of 2018 to €1.4M in first half of 2019
▪ Cash and cash equivalents of €1.1M at June 30, 2019, no significant LT debts
▪ Stabilized cash position
▪ €3.0M convertible bond financing
arranged with Nice & Green on April 2019 (12 tranches of €250k)
▪ Loans from BPI for a total of €0,6M
Sufficient working capital for the next 12 months
to focus on operations
Free Cash Flows (€M)
Cash position as of 06/30/2019
Team
FranceÉtats-UnisRégis LE COUEDIC
R&D & RAQA Director 26 years of experience
Zimmer, Stryker Corporation,Spine Next, Abbott Spine
Ludovic LASTENNETCEOBoard Director25 years of experienceStryker Corporation, Kavo Dental (Danaher Corp. group)
Laurent PENISSON Knee BU Director23 years of experienceStryker Corporation, Arthrex
Shane DOYLEVP US Sales & Marketing20 years of experienceEtex Corporation, Stryker Corporation
Georges LEGALLOISBusiness Development EMEA Spine15 years of experienceZimmer, Stryker Corporation
David DIEUMEGARDCFO
23 years of experienceKot, Musiwave, ActivIdentity
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Nicolas MARINMarketing Director
20 years of experience Stryker Corporation
A company led by a highly experienced team
With strong international expertise
History
History
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2007
▪ Creation of IMPLANET
2010
▪ Obtaining CE approval
▪ First placement of the MADISON®Implant
2012
▪ First FDA approval 510(k) for the JAZZ® implant
2013 (Nov.)
▪ Initial public offering on Euronext Paris
2014
▪ End of the commercialization of hip prostheses
▪ First publication of “white papers” in favor of the JAZZ® implant
2015
▪ Obtaining regulatory approval from the Brazilian health authority
▪ Definitive intellectual property protection for JAZZ® technology
2017
▪ Obtaining CE and FDA 510(k) approval for the new products
▪ New patents granted in Europe and the United States
2019
▪ Strategic partnership with SeaSpine for distribution of JAZZ® platform in the United States
2013
▪ JAZZ® deployment in France and Europe
▪ Opening of a subsidiary in the United States and first surgery with JAZZ® in the United States
2016
▪ First surgery with JAZZ® in Brazil
▪ Marketing of the JAZZ® Lock implant
▪ Patent granted in the United States for the JAZZ® platform
2018
▪ Development of the direct sales strategy in Europe (opening of subsidiaries in UK and Germany)
▪ Strategic partnership with KICofor the distribution of MADISON®prosthesis
▪ Progressive stop of arthroscopic activity
Strategic refocusing on JAZZ® and MADISON products
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www.implanet.com
IMPLANET
Ludovic Lastennet
CEO
Tel. : +33 (0) 5 57 99 55 55
NEWCAP
Investor Relations
Sandrine Boussard-Gallien /
Pierre Laurent
Tel. : +33 (0)1 44 71 94 94
David Dieumegard
CFO
Tel.: +33(0) 5 57 99 55 76