MAKO Surgical Corp. January 2013

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1 MAKO Surgical Corp. January 2013

2 Forward Looking Statements This presentation contains forward-looking statements regarding, among other things, statements related to expectations, goals, plans, objectives and future events. MAKO intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Reform Act of In some cases, forward-looking statements can be identified by the following words: may, will, could, would, should, expect, intend, plan, anticipate, believe, estimate, predict, project, potential, continue, ongoing or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements are based on the current estimates and assumptions of our management as of the date of this presentation and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause actual results to differ materially from those indicated by forward-looking statements, many of which are beyond MAKO s ability to control or predict. Such factors, among others, may have a material adverse effect on MAKO s business, financial condition and results of operations and may include the potentially significant impact of a continued economic downturn or delayed economic recovery on the ability of MAKO s customers to secure adequate funding, including access to credit, for the purchase of MAKO s products or cause MAKO s customers to delay a purchasing decision, unanticipated changes in the timing of the sales cycle for MAKO s products or the vetting process undertaken by prospective customers, changes in competitive conditions and prices in MAKO s markets, delays in MAKO s product development cycles, unanticipated issues relating to intended product launches, decreases in sales of MAKO s principal product lines, decreases in utilization of MAKO s principal product lines or in procedure volume, the effects of Hurricane Sandy, increases in expenditures related to increased or changing governmental regulation or taxation of MAKO s business, both nationally and internationally, unanticipated issues in complying with domestic or foreign regulatory requirements related to MAKO s current products, including Medical Device Reporting requirements and other required reporting to the United States Food and Drug Administration, or securing regulatory clearance or approvals for new products or upgrades or changes to MAKO s current products, the impact of the United States healthcare reform legislation enacted in March 2010 on hospital spending, reimbursement, and the taxing of medical device companies, any unanticipated impact arising out of the securities class action or any other litigation, inquiry or investigation brought against MAKO, loss of key management and other personnel or inability to attract such management and other personnel and unanticipated intellectual property expenditures required to develop, market, protect and defend MAKO s products. These and other risks are described in greater detail under Item 1A, Risk Factors in MAKO s periodic filings with the Securities and Exchange Commission, including MAKO s annual report on Form 10-K for the year ended December 31, 2011 and Form 424B5-Prospectus Supplement, filed November 15, Given these uncertainties, undue reliance should not be placed on these forward-looking statements. MAKO does not undertake any obligation to release any revisions to these forward-looking statements publicly to reflect events or circumstances after the date of this presentation or to reflect the occurrence of unanticipated events. 2

3 Investment Highlights Orthopedics MAKOplasty Large and growing Orthopedic Reconstruction market Need for consistent, reproducible precision Robotic surgical technology platform Proprietary minimally invasive implant systems Demonstrated value propositions for patients, physicians, and hospitals Significant commercial experience proving positive clinical outcomes New product launches expand clinical versatility of technology platform Direct sales forces focused on growing installed base and driving higher utilization Strong financial performance with compelling growth opportunities 3

4 MAKOplasty Experience Through Q RIO systems sold in Q4 2012; total of 45 in RIO system commercial installed base Over 900 surgeons trained 2,904 procedures in Q4 2012; total of 10, 204 in monthly utilization per system in Q Over 23,000 procedures cumulative to date Commercial release of the RIO 2.5 software and Hip 2.0 application software in September 2012 Commercial launch of the RESTORIS PST Cup and Tapered Stem hip implant system in October

5 Implant Revenues ($B) Orthopedic Market Overview Arthroscopy / Soft Tissue Repair 9% Orthobiologics 10% Fracture Repair 14% Other Products 13% Spinal Implants / Instrumentation 19% Reconstructive Devices 35% 2009 Global Revenues $37.75B Shoulders 1% Knees 18% Hips 15% Other Joints 1% Demographic trends are driving continued growth Aging Population $10 $8 $6 $4 $2 $0 U.S. Hip and Knee Implant Forecast Increasing Obesity Rates Hips Knees Sources: Millennium Research Group(2011); ORTHOWORLD (2010) Orthopedic Network News (2008); CDC & US Census 5

6 Needs in the Orthopedic Marketplace Orthopedic Marketplace Patients Shorter recovery Natural movement Restoring quality of life Less pain Minimal incision Reduced length of stay Bone preserving Surgeons Reproducible precision Optimal implant orientation Practice enhancement Patients Hospitals Competitive differentiator ROI model Attract patients Reduced length of stay Surgeon recruitment Robotic technology can address these needs 6

7 The MAKOplasty Solution Robotic Arm Patient Specific Visualization Implants RIO Robotic Arm Interactive Orthopedic System RESTORIS Implant Systems Tissue Sparing, Minimal Incision, Shorter Recovery, Precise, Reproducible 7

8 Platform Technology End-to-End Solution for the Reconstructive Surgeon MAKO RIO System Knees Total Hips Partial Knees Uni-Knees Posterior Approach Direct Anterior Approach Three Implant Systems 8

9 MAKOplasty: Surgical Workflow Please view video located on our website at: MAKO Surgical Corp

10 MAKOplasty Knee Opportunity

11 $ in Billions US Knee Market The US Knee market is large and growing However, the market is still under-penetrated US Knee Implant Market Over 15 Million US Osteoarthritis Knee Sufferers 6 $4.3 $ ,000 Implants ,000 knee implants sold in % expected annual growth rate due to Aging population Obesity rates are rising Sources: Millennium Research Group (2011), CDC & US Census 11

12 Volume x 1000 Late stage Mid stage Early stage MAKO Market Opportunity Robotics Expand Addressable Patient Population for UKA Primary Knee Arthroplasty U.S. Market bi-compartmental MAKOplasty Market Expansion Therapy Disease Act. Est. Est. Est. Est. Est. TKA UKA UKA Potential Market Expansion Source: Millennium Research Group (2011) 12

13 The Progression of OA of the Knee OA Causes Early to Mid Stage OA Late Stage OA Physiology Sports injuries Wear and tear Arthroscopy Reduced quality of life Moderate to substantial pain Reduced mobility Watchful Waiting Further reduced quality of life Substantial pain Further reduced mobility Total Knee Implant 13

14 Current OA Treatments: Tale of Two Procedures Total Knee Arthroplasty (TKA) For late stage OA all 3 compartments Invasive procedure Painful recovery Limited patient adoption Duke University survey (January 2006): ~92% of men and 87% of women say No to TKA or THA Partial Knee Arthroplasty For early stage OA 1 or 2 compartments Technically challenging - alignment Inconsistent results Limited surgeon adoption 14

15 Knee MAKOplasty RESTORIS MCK Multicompartmental Knee System Patellofemoral & Patella Medial Femoral Lateral Femoral MAKO RESTORIS MCK: Medial UKA + PF Configuration Metal-Backed Onlay Poly Inlay 15

16 Recent Product Introductions: Knee Platform RIO 2.5 Software Commercially Launched in Q Improves the efficiency of the MAKOplasty partial knee application Speeds up the registration process Generally improves ease of use 16

17 MAKOplasty Hip Opportunity

18 $ in Billions US Hip Market US Hip Implant Market 4 $2.9 $ ,000 hip implants sold in % expected annual growth rate due to Aging population Obesity rates are rising Recent industry focus on accuracy of cup placement RIO an enabling technology for improved accuracy in minimally invasive approaches Sources: Millennium Research Group (2011) 18

19 OA of the Hip 19

20 Total Hip Implant 20

21 Impingement Leads to Dislocation Malpositioning of the acetabular component in THA Increased rate of dislocation Liner fracture Increased wear Adverse soft tissue reactions in metal-on-metal bearings. However, precursor to dislocation and initiating event for liner wear (both rim and backside) is impingement 21

22 Liner and Backside Wear Caused by Impingement Acetabular insert displaying both severe backside wear and an impingement scar of moderate severity. 22

23 MAKOplasty Total Hip Arthroplasty Accurate Reaming and Cup Impaction Initial Reaming Tip of Reamer Constrained Trajectory Unconstrained Final Reaming Tip of Reamer Constrained Trajectory Constrained Implant Placement Cup Position Constrained Trajectory Constrained 23

24 Cup Version (degrees) MAKOplasty Hip Opportunity Per Machau Mass. General Study (2010): Population % Aligned Within Target Range Traditional procedure can lead to inaccurate cup placement Inaccurate placement can lead to dislocations and surface wear All Patients (N=1,823) 50.0% Low volume Surgeons (N=264) 34.1% Worst Approach (MIS) (N=91) 19.8% 60 All Patients, N=1823 Challenges compounded with low volume surgeons (1.5x) and MIS (2.5x) Source: Dr. Malchau et al (2010) % Cup Abduction (degrees) 24

25 Recent Product Introductions: Hip Platform Commercially launched THA Software 2.0 in Q3 Enables the direct anterior approach for MAKOplasty total hip Launch of MAKO RESTORIS PST Cup and Tapered Stem implant Designed in collaboration with Pipeline Orthopedics 60% of systems upgraded Pipeline Strategic Partnership MAKO s partner in advanced implant development $7 million MAKO commitment to Pipeline 25

26 Growth Strategy

27 Growth Strategy RESULT Sustainable Long Term Growth Clinical Build clinical and economic value propositions Sales Expand direct sales and marketing programs Technology Enhance customer experience IP Protect technology leadership position through strong IP portfolio 27

28 Key Results To Date Clinical and Economic Value Propositions Procedure Value MAKO Focus Value Drivers Clinical Accuracy/Reproducibility Patient 1. Decreased pain 2. Return to function/ short hosp stay/rehab 3. Implant longevity Tissue Preservation Clinical Efficiency Surgeon/Hospital 1. Implant longevity 2. Procedural ease of use 3. Excellent clinical outcomes MAKOplasty Economic Procedural Efficiency Business Growth Implant/Robot Cost Surgeon Hospital/Payer 1. Marketing value 2. OR Time 3. Reimbursement 1. Cost effectiveness 2. OR time/number of cases 3. Procedure growth Abstracts 179 accepted Peer-Reviewed Manuscripts 28 published Whitepapers 15 completed Studies 70+ ongoing studies Book Chapters 4 published 3 in press 28

29 RESTORIS MCK Medial Onlay: 0.4% Revision Rate at 2yr 2 Year Survivorship of Robotically Guided Medial MCK Onlay Principal Investigators: Drs. Roche, Coon, Pearle, Dounchis Methodology: 201 patients (224 knees) from 4 surgeons were enrolled in the study, with follow up at a minimum of 2 years (Average follow up = 32 ± 5 months) Enrollment began with the release date of the RESTORIS MCK medial onlay UKA (March 2009) Patients included initial and consecutive series for each surgeon, starting from the release date of the RESTORIS MCK onlay medial UKA the surgeons learning curves are included in the data Key Result: 0.4% revision rate at 2 years 1. ZUK: Zimmer Unicompartmental High Flex Knee Oxford is a registered trademark of BioMet UK Ltd. n=224 29

30 Using Robotic Arm Guidance for THA Results in Superior Acetabular Cup Positioning When Compared to Manual THA A Multicentric Evaluation of Acetabular Cup Positioning in Robotic-Assisted THA Principal Investigators: Drs. Malchau, Padgett, Dounchis, Illgen, Marchand Methodology: 77 MAKOplasty THA cases from 4 surgeons were evaluated for acetabular cup positioning Post-op A/P pelvis and lateral X-rays were evaluated using Martell hip analysis software Results were compared to data from Callanan et al. (MGH) 2011 CORR Charnley Award paper 1 Manual Cup Positioning at a Teaching Hospital 47% inside MGH safe zone 1. The John Charnley Award: Risk factors for cup malpositioning: Quality improvement through a joint registry at a tertiary hospital. Clin Orthop Relat Res Feb;469(2):

31 Using Robotic Arm Guidance for THA Results in Superior Acetabular Cup Positioning When Compared to Manual THA A Multicentric Evaluation of Acetabular Cup Positioning in Robotic-Assisted THA Key Results: Based on RIO data (3-D), 96% of robotic arm THA cases were inside the MGH safe zone (30-45 inclination and 5-25 version) The Martell reading (2-D) indicated 84% of robotic arm THA cases were inside the MGH safe zone compared to 47% of cases reported in the CORR article The difference between the RIO data and Martell readings (96% vs 84%) was cited by the investigators as possibly due to the fact that the Martell software: makes 3-D measurements using 2-D X-rays does not take pelvic tilt into account when measuring angles Presenter conclusion: Robotic arm assistance improves acetabular cup positioning. MAKOplasty Cup Positioning 84% inside MGH Safe Zone 31

32 Commercialization Strategy: Two Direct Sales Forces RIO Sale Profile surgeons High volume surgeons Knee - Early stage OA focus Target hospitals Technology savvy Leading in orthopedics High volume orthopedic facilities MAKOplasty Implant Sales Support surgeons MAKO rep in every MAKOplasty Support hospitals Center of Excellence 24 Person RIO Sales Force 94 Person MAKOplasty Sales Force 16 Person Marketing Support Team 32

33 Extensive Marketing Programs 33

34 Broad and Deep Intellectual Property Portfolio 115 Issued US Patents Technical Elements Instrumentation Implants 26 Issued OUS Patents Navigation Haptics Robotics Imaging 103 Pending US Applications MIS Procedures Software 101 Pending OUS Applications 34

35 Financial Overview

36 MAKO Revenue Model RIO Sale MAKO Implant Recurring Revenue Service Revenue UKA Inlay UKA Onlay MCK Bicompartmental Modular Knee Total Hip Arthroplasty ASP Blended: $1,000,000 ASP Blended: $5,000 Approx.10% of RIO ASP 36

37 Procedure Ramp 2,904 2,413 2,590 2,297 2,256 1,813 Procedures Year-To-Date Procedures 1,557 1,304 1, , Q10 2Q10 3Q10 4Q10 1Q11 2Q11 3Q11 4Q11 1Q12 2Q12 3Q12 4Q , ,524 2,339 3,485 1,304 2,861 4,674 6,930 2,297 4,887 7,300 10,204 Cumulative Procedures New Sites* Cumulative Sites* ,384 3,115 3,908 4,723 5,869 7,173 8,730 10,543 12,799 15,096 17,686 20, , Avg. Monthly Utilization* * Not including international demo or research and evaluation sites 62% of installed base with Hip Application 37

38 Key Operating Results (In Thousands) Financial Results Years Ended Dec Months Ended Sept Months Ended Sept. 30 (Audited) (Audited) (Unaudited) (Unaudited) Balance Sheet Sept (Unaudited) Revenue: Procedures $17,620 $34,638 $12,042 $36,622 Systems 24,928 43,927 14,413 28,467 Service 1,748 5,942 2,722 7,402 Total Revenue 44,296 84,507 29,177 72,491 Revenue Growth 93% 91% 46% 40% Gross Margin 59% 68% 59% 67% Cash and Equivalents $28,443 Total Assets 114,429 Total Debt 0 Total SH Equity $93,447 Net Loss ($38,687) ($36,143) ($6,554) ($26,819) $43M net proceeds Nov Equity Financing 38

39 Investment Highlights Orthopedics MAKOplasty Large and growing Orthopedic Reconstruction market Need for consistent, reproducible precision Robotic surgical technology platform Proprietary minimally invasive implant systems Demonstrated value propositions for patients, physicians, and hospitals Significant commercial experience proving positive clinical outcomes New product launches expand clinical versatility of technology platform Direct sales forces focused on growing installed base and driving higher utilization Strong financial performance with compelling growth opportunities 39

40 MAKO Surgical Corp Thank You.

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