Investor Presentation - September 2020 - ConforMIS
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Forward-Looking Statements This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this presentation, including statements regarding our strategy, future operations, projected financial position, future revenues, projected costs, projected profits, projected margins, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “grow,” “improve,” and “trend”, and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. The forward- looking statements contained in this presentation reflect our current views with respect to future events, and apply only as of the date of this presentation. We assume no obligation to update any forward-looking statements. Our business is subject to substantial risks and uncertainties, including those referenced in certain of our filings with the SEC under the heading “Risk Factors.” You are encouraged to read our filings with the SEC, available at www.sec.gov, including our Annual Report or Form 10-K for the year ended December 31, 2019 filed with the SEC on March 3, 2020, as well as our Quarterly Reports on Form 10-Q. You should give careful consideration to these risks and uncertainties. © 2020 Conformis, Inc. Slide 2
Conformis Today Key Statistics • Founded: 2004 Recognized Leader in • Headquartered: Billerica, MA Patient-Specific Expanding Portfolio of Instrumentation and • Ticker: CFMS Personalized Implants Knee & Hip Implants • Global employees: ~275 • International: Products sold in 18 countries Proprietary Technology Comprehensive Dossier • Milestone: Sold >110,000 Platform with Broad of Clinical and Health Patent Portfolio Economic Benefits personalized knees © 2020 Conformis, Inc. Slide 3
A Paradigm Shift in Orthopedics A personalized solution for patients that delivers demonstrated value to physicians and payors 1 CT Scan • Surgeon orders and sends a standard diagnostic CT scan to Conformis 2 Restore the native anatomy using 3D modeling • Convert the imaging data into a 3D model 3 Create the patient-specific implant and instruments • Single-use, patient-specific instruments include guides and instruments necessary to fit our customized implants to the patient 4 Develop patient-specific pre-surgical plan • iView allows the surgeon to visualize preoperative planning, including measurements, orientations and anatomic variants 5 Digitally driven manufacturing • Produce custom implant and patient-specific instruments Patient-Specific Solution Delivered Just-in-Time in a 6 Just-in-time delivery to the customer Convenient Kit • Deliver implant, iJigs and iView within 6 weeks © 2020 Conformis, Inc. Slide 4
iFit Image-to-Implant Platform Technology iFit Design iFit 3D Additive Printing iFit JIT Delivery Intra-Op Economic Clinical Benefits Benefits Benefits 5
Launching a New Investment Thesis Present Situation Our Plan • We are the clear leader in personalized hip & knee implants with a capital-efficient delivery Develop and launch a new ‘ASC’ 1 model knee to expand our product offering • We are an innovator of the single-use kit, sterile delivery model of implants and patient-specific and aggressively target the ASC and instrumentation (PSI) hospital outpatient facilities • We compete in a large and profitable market 2 that is undergoing a transformation Expand hip product adoption to • Procedural shift to outpatient / ambulatory surgery further accelerate sale centers (ASCs) creates significant opportunity • We have experienced adoption challenges Generate value from PSI expertise & • Lead times and lack of intraoperative flexibility have limited new surgeon adoption and compressed 3 intellectual property portfolio margins © 2020 Conformis, Inc. Slide 6
1 ASC Opportunity is Compelling This shift in elective knee procedures to ASC provides significant growth opportunity Notable Drivers U.S. Joint Replacement Procedures in ASC settings • Medicare / Medicaid reimbursement change 60% Partial and Total Knee • Bundled “Episode of Care” 50% Procedures in 2024: ~370,0001 40% • Physician ownership: capital-efficient requirements 30% • Increased pressure on healthcare spending 20% 10% • COVID-19 protocol accelerates trend 0% • Lack of “installed base” for larger players 2016 2018 2020 2022 2024 2026 Procedure Shift to ASC2 1) Company estimates based on projected shift in elective joint procedures. 2) According to Sg2, a Vizient company. © 2020 Conformis, Inc. Slide 7
Common Challenges for Joint Replacement in the ASC Hospitals and other medical facilities face similar challenges Common Challenges Conformis Solution Limited Processing Capability • 5–10 bulky instrumentation • Potential source of costly infections • Substantial manpower costs Limited Space • Tray management • Inventory storage • Supply costs Limited Efficiency • All instrument trays require timely setup, break down, and • Single-use kit, delivered before surgery sterilization • Set of disposable patient-specific guides • Potential source of costly • One reusable tray infections © 2020 Conformis, Inc. Slide 8
Expand Our Portfolio with New ASC Knee New product offering aimed at driving greater surgeon adoption Present Future iTotal: Patient Specific New ASC Knee iTotal: Patient Specific Target U.S. Launch 2H, 2021 Personalized Solution ASC Solution Personalized Solution • Approx. 6-week lead time • Broader anatomical coverage than competitive • Approx. 6-week lead time • 3 patient-specific poly inserts implants1 • 3 patient-specific poly inserts • Premium priced solution • Implant size matched to patient’s knee scan • Premium priced solution • Custom made for each patient • Approx. 3-week lead time • Custom made for each patient • Patient-specific instrumentation • Full range of standardized poly thickness options • Patient-specific instrumentation • Pre-packaged in a single-use, sterile kit with • Product costs allows greater pricing flexibility • Pre-packaged in a single-use, sterile kit with an iView pre-surgical plan • Select patient-specific instrumentation an iView pre-surgical plan • Pre-packaged in a single-use, sterile kit with an iView pre-surgical plan 1) Company sponsored study. © 2020 Conformis, Inc. Slide 9
New ASC Knee Offers Attractive Benefits Target product profile intended to directly address customer feedback Anticipated Benefits: • New Knee with Poly Options • Pre-select implant size to best fit patient’s knee anatomy Same Efficient • Includes iView Pre-Surgical Plan Solution with Better • Full range of polyethylene inserts for each surgery • Leverage iTotal platform1 with clinical outcome data Pricing and Flexibility • Broader anatomical coverage v. competitive Off-the-Shelf (OTS) knees2 • Shorter Lead Times • Pre-packaged solution to be delivered within approx. 3 weeks • Greater Pricing Flexibility • Ability to competitively price the product given new target product costs • Aggressively Target the ASC Opportunity • Leverage unique delivery model to aggressively target the hospital outpatient and ASC spaces 1) Clinical studies on iTotal Total Knee Arthroplasty system. 2). Company sponsor study. © 2020 Conformis, Inc. Slide 10
Product Gross Margin Improvement Select standardization enables lower cost of goods Validated Targeted Production Savings Patient-Specific Knee Planned changes between platforms to reduce COGS ASC Knee Significant cost savings 70%+ opportunities with new ASC knee offering: 45%-50% • Eliminate implant design labor cost • Lower femur casting costs • Less machining time • Improved material costs • Standardize production quantities • Less scrap 2019 2022 - 2024 © 2020 Conformis, Inc. Slide 11
Conformis Uniquely Positioned to Win in the ASC Conformis Advantage: Right Product at the Right Price Conformis is the IDEAL SOLUTION for ASC Capital-Light Delivery Model Customers • Just-in-time delivery addresses sterilization / lack of inventory space Pre-Packaged Procedural Kit with iView • Total knee replacement-in-a-box improves efficiencies Attractive Target Price iView • Lower COGS allows aggressive targeting of the ASC segment Partnership with Stryker® Validates Approach Re-usable Instrumentation © 2020 Conformis, Inc. Slide 12
Clinically Demonstrated Benefits OUTCOME Publications & Conference Proceedings • Reimann, et al. – Journal of Orthopaedics. 2019 • Schroeder, et al. – Orthopaedic Proceedings of Bone & Joint Surgery. 2019 Higher Patient Satisfaction • Katthagen, et al. – ICJR World Arthroplasty Conference. 2015 • Ogura, et al. – Knee Surgery, Sports Traumatology, Arthroscopy. 2018 Safety & Efficacy • Schroeder et al. – The Journal of Knee Surgery. 2018 Better Alignment • Ivie, et al. – The Journal of Arthroplasty. 2014 Demonstrated in: • Levengood, et al. – The Journal of Knee Surgery. 2017 • Arbab, et al. – The Knee. 2018 Better Health Economic Outcomes • • O’Connor, et al. – American Health & Drug Benefits. 2019 Buch, et al. – Reconstructive Review. 2019 50+ Clinical Studies • Culler, et al. – Arthroplasty Today. 2017 • Namin, et al. – Value in Health. 2019 Better Range of Motion • Zeller, et al. – British Association for Surgery of the Knee. 2017 • Buch, et al. – Reconstructive Review. 2019 30+ • Zeller, et al. – ICJR Pan Pacific. 2016 Peer-Reviewed • Zeller, et al. – The Journal of Arthroplasty. 2017 Publications Better Functional Results • Wang, et al. – International Orthopaedics. 2018 • Reimann, et al. – Journal of Orthopaedics. 2019 • Koeck, et al. – The Knee. 2011 • Carpenter, et al. – The Journal of Arthroplasty. 2014 • Demange, et al. – International Orthopaedics. 2015 Better Fit • Schroeder, Lennart, and Gregory Martin (May 25, 2018) • Meier, et al. – Clinical Orthopedics and Related Research. 2019 • Meier, et al. – Knee Surgery, Sports Traumatology, Arthroscopy. 2019 © 2020 Conformis, Inc. Slide 13
Conformis Re-Defining Patient Satisfaction Improve Patient Reported Satisfaction & Overall Quality Measures Grow Referral Base Patients who respond as ‘Extremely Likely’ recommend Conformis 2.1x more than OTS 2.1x Conformis Patients 77% vs Non-Conformis Patients 36% p
2 New Hip Platform Drives Additional Growth Recent hip introduction doubles addressable market opportunity 2019 $8B global hip Similar to knee, life expectancy Full commercial launch market is projected continues to increase, global of the Conformis Hip to grow in the low population is gaining weight, and System commenced in single digits1 individuals desire to live a more November 20193 active lifestyle2 1) 2019 Orthoworld. The Orthopedic Industry Annual Report. 2) U.N. data, 2019. 3) Conformis Hip Systems were implanted in a limited commercial launch in July 2018. © 2020 Conformis, Inc. Slide 15
Conformis Addresses Total Hip Replacement (THR) Challenges Challenges: Notable Drawbacks with THR Solution: Apply Conformis Philosophy • THR Traditionally is an UNGUIDED Operation • Conformis Hip Systems uses 3D imaging • Heavily dependent on training, skill, and experience of technology to provide PRE-SURGICAL navigation of the surgeon the patient’s specific implant for restoration of patient anatomy • 2D-Templating Can Be Inaccurate • Neck angles and offsets can be dramatically affected by • Patient-specific rotation on x-ray instrumentation improves efficiencies • Standard Hips Offer Limited Neck Angles, Offsets • iView surgical • Capital-intensive delivery model, implant & planning tool instrumentation helps guide • Leg length / offset issues after THR surgical procedure • Hip system offers a range of femoral • Patient Dissatisfaction1 and Revision Rates2 neck options Total Hip Replacement-in-a-Box 1) Jones, et al., and Anakwe et al. 2) Labek, et al. © 2020 Conformis, Inc. Slide 16
Developing a Multi-Line Hip Portfolio Capital efficient delivery model remains central to the product offering iView Pre-Surgical Plan Patient-Specific Instrumentation Product Portfolio Proprietary iView Personalized guides and Customer Preference Guides provides a personalized bone models streamline Level of Customization surgical roadmap the surgical procedure © 2020 Conformis, Inc. Slide 17
Anticipated New Product Cadence Robust pipeline drives growth 2020 2021 2022 1st half 2nd half 1st half 2nd half 1st half 2nd half Hip Hip Line Conformis Additions Hip Fit • Total Hip Product Analysis Total Hip 2nd Stem • Hip Line Additions System Software/ (LMR) • Cordera Standard Hip Stem (FMR) Cordera Cordera Standard Match • Hip Fit Analysis Software Stem • 2nd Hip Stem Design Knee Constrained Poly Identity Cementless • Identity CR Identity (FMR) • Identity PS iTotal New ASC (FMR) Knee New ASC • Constrained Poly Options CS/PS Identity (LMR) New ASC Cementless Knee Knee: • Identity Cementless System Cementless (LMR) (FMR) (LMR) • New ASC Knee LMR = Limited Market Release; FMR = Full Market Release © 2020 Conformis, Inc. Slide 18
3 Strategic Partnership: Stryker Collaboration adds another profitable growth driver 1 Conformis will develop, manufacturer, and supply patient-specific instrumentation for use in connection with Stryker’s knee implant offerings, including the market-leading Triathlon Total Knee System Leveraging the strengths of the respective organizations to further expand personalized care into low-cost, site-of-care settings / ASC 1) Stryker is a registered trademark of Stryker Corporation. © 2020 Conformis, Inc. Slide 19
Stryker: Private Label Opportunity Significant revenue and profit potential Collaboration: Leadership Position: ASC Opportunity: Revenue Potential: Capitalizing on Partner’s Strengths U.S. Primary Knees1 Trend in Knee Procedures2,3 Drive Incremental Growth $30M • $14 million upfront ~30% Share • up to $16 million in milestone payments ~240,000 Units 10%–20% • Long-term supply agreement Partnership validates Stryker is a leader in Projected shift in knee Revenue from private Conformis’ expertise in the U.S. primary procedures to ASC label products offers design, development, knee reconstruction offers significant potential to drive 10%– and manufacturing market opportunity 20% of Conformis’ overall excellence of PSI revenue by 2024 1) 2019 Orthoworld. - the Orthopedic Industry Annual Report and management estimates prior to the emergence of COVID19. 2) Management estimates based on projected shift in elective procedures. 3) According to Sg2, a Vizient company. © 2020 Conformis, Inc. Slide 20
We Plan to Create Significant Shareholder Value 2024 Financial Targets $160M - $190M 60%+ $15M - $30M Revenue Gross Margin Profit Committed to double digit Deliver improved Generate meaningful revenue growth gross margins operating income • New product introductions • Growing contribution of • Scale business, leverage • International market expansion higher margin knee and hip operating expense into India, China, and Japan products • Improved cash flow • Supply of private label products • Introduction of profitable • Accelerates time to breakeven private label products © 2020 Conformis, Inc. Slide 21
Conformis New Growth Drivers Create a Compelling Investment Thesis 1 New knee targets ASC procedure growth and drives gross margin expansion 2 Anticipated hip product adoption further accelerates revenue growth 3 Private label products drive additional profitable growth © 2020 Conformis, Inc. Slide 22
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