Joseph Slattery Executive Vice President & CFO. Ladenburg Thalmann Conference September 26, 2017

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Transcription:

Joseph Slattery Executive Vice President & CFO Ladenburg Thalmann Conference September 26, 2017

3 Forward Looking Statements This presentation includes statements relating to TransEnterix s current regulatory and commercialization plans for our products, the Senhance Surgical Robotic System and the SurgiBot System. These statements and other statements regarding our future plans and goals constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, whether the commercialization of the Senhance Surgical Robotics System will be successful, whether and when we will prepare a 510(k) submission for the Senhance Surgical Robotic System, the pace of adoption of our products by surgeons, the success and market opportunity of our products, our current cash reach, the effect on our business of existing and new regulatory requirements and other economic and competitive factors. For a discussion of the most significant risks and uncertainties associated with TransEnterix's business, please review our filings with the Securities and Exchange Commission (SEC), including our including our Annual Report on Form 10-K filed on March 6, 2017 and other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this presentation and speak only as of the origination date of the presentation. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

4 TransEnterix: TRXC Focus: Surgical Robotics Compelling Platform Technology Senhance Surgical Robot Robotic benefits with responsible economics Significant addressable market opportunity Surgical robotics growing but minimally penetrated Recent highlights Completed final FDA response for US submission process Expanded portfolio to include 3mm micro instruments and leading vision systems Sold first unit into Japan

Senhance Robotic System 5

6 Surgical Robotics Poised for Growth Abdominal Robotic Surgery Market Size $2.7 Billion in 2016 $10.5 Billion in 2021 Procedure expansion, geographic expansion and new entrants will grow abdominal robotic surgery market significantly Source: Abdominal Surgical Robots Market Shares, Strategies, and Forecasts, Worldwide, 2015 to 2021 WinterGreen Research, December 2015

7 Benefits of Surgical Robotics Enhanced precision and control Increased surgeon ergonomics Advanced visualization Patient attractiveness Benefits of Surgical Robotics Consolidation of volume & surgeon recruitment

8 Robotic Surgery Landscape Current abdominal robotic surgery 0.6 MM procedures EU & U.S. Open Surgery 4 MM procedures EU & U.S. Laparoscopic Surgery 6 MM procedures EU & U.S. Historical Growth Drivers: Sources: Intuitive Surgical Investor Slides, TRXC Estimates and Millennium Research Group Convert open surgeries to robotics Clinical and patient benefits have come from converting an open procedure to a minimally-invasive surgical approach Offset signficant per-procedure cost increase with length of stay benefit vs. open surgery Conversion of laparoscopy to robotics difficult due to substantial per-procedure cost increase

9 Robotic Surgery Landscape Open Surgery 4 MM procedures EU & U.S. Laparoscopic Surgery 6 MM procedures EU & U.S. Future Growth Drivers: Convert laparoscopic surgeries to robotics Sources: Intuitive Surgical Investor Slides, TRXC Estimates and Millennium Research Group Opportunities to improve laparoscopy: greater precision, surgeon control of vision, better ergonomics, reduced need for assistance Provide meaningful robotic benefits to laparoscopic surgery without significant per-procedure cost increase

11 Trade-offs of Competing Systems Larger incisions Lengthy set up time Disengaged from surgical team No haptic feedback Trade-offs v. Laparoscopy High procedure costs

12 Senhance Surgery Builds on the foundation of laparoscopy: Highly efficient operations with minimal additional docking time or change to technique Robotic precision: Performing precise, complex surgery in a more minimally invasive manner Comfortable ergonomics: Increased comfort and reduced strain for the surgeon The security of haptics: Safe management of the operation by retaining sensing of touch Eye-sensing camera control: Increases surgeon control over vision and multiple instruments Advanced technology with responsible economics: Managing operative costs effectively

Senhance Leveraging Laparoscopic Experience 13 Builds on the foundation of laparoscopy: Highly efficient operations with minimal additional docking time or change to technique Multi-port system Laparoscopic motion Utilizes standard laparoscopic trocars 5mm instruments Force sensing for minimal torque

14 Senhance Robotic Benefits Robotic precision: Performing precise, complex surgery in a more minimally invasive manner Scaled motion Tremor filtration Articulating instrument options HD3D vision Small incisions for minimal trauma (5-mm instruments) Comfortable ergonomics: Increased comfort and reduced strain for the surgeon Seated at console Easy hand repositioning Ability to pause Stable camera Stable instruments

15 Senhance Haptic Feedback The security of haptics: Safe management of the operation by retaining sensing of touch Safe management of the operation by retaining sensing of touch: Provides the surgeon with critical safety awareness of objects in and out of field of view Force-based instrument fulcrum for minimal torque on incision

Senhance Eye-Sensing Camera Control 16 Eye-sensing camera control: Increases surgeon control over vision and multiple instruments Surgeon controls camera by moving eyes & head Allows surgeon to control camera and two instruments simultaneously Improves procedure workflow Up/Down/Left/Right/Zoom in/zoom out

17 Senhance Responsible Economics Advanced technology with responsible economics: Managing operative costs effectively Reusable instruments Minimal disposables/case Fast set up and instrument exchange Leverage existing hospital infrastructure Access to robotics, but with costs similar to laparoscopy

Open Architecture Leverages the True Hospital Ecosystem 18 Advanced technology with responsible economics: Managing operative costs effective Hospitals make major investments in existing OR beds, endoscope systems, imaging technologies Surgeons have developed strong preference for many of these technologies We have enabled interoperability with existing surgical technologies

Reducing Invasiveness Robotic Microlap Introducing the first robotic microlap 3mm system Enabling virtually scarless surgery Using robotic precision, tremor filtration and surgeon camera control with microlaparoscopy

20

Building Clinical Evidence 21 Peer-reviewed published data on procedures for benign and malignant disease and in obese patients Surgeons cite positives of short learning curve & median 7 minute set-up time Feasibility, safety profile and procedural economics similar to lap surgery for procedures investigated Journal Reference Patients Study Findings In process hernia 64 Positive safety & efficacy profile in hernia repaor, short learning curve and docking time In process cholecystectomy 20 Positive safety & efficacy profile in cholecystecomy, Accepted colorectal 47 Positive safety & efficacy profile in colorectal Fanfani F, et al. Surg Endosc. 2015 146 Positive safety & efficacy profeil in a range of gynecologic surgical procedures Fanfani F, et al. J Minim Invasive Gynecol. 2015 80 Similar safety & efficacy profile to laparoscopy in hysterectomy Rossitto C, et al. Int J Med Robot. 2016 81 Robotic benefits with responsbile economics for the laparoscopic hysterectomy Gueli Alletti S, et al. J Minim Invasive Gynecol. 2015 Gueli Alletti S, et al. J Minim Invasive Gynecol. 2015 43 Similar safety & efficacy profile to laparoscopy for early-stage endometrial cancer 10 Positive safety & efficacy profile in ovarian cyst enucleation Rossitto C, et al. J Robot Surg. 2016 10 Positive safety & efficacy profile in obsese hysterectomy patients

Initial Global Clinical Sites Imperial College, St. Mary s London, England St. Marien-Krankenhaus Siegen Siegen, Germany Universitaetsklinikum Hamburg Eppendorf (UKE) Hamburg, Germany C.H.U. ST Etienne Saint-Etienne, France Humanitas University Milan, Italy Policlinico Gemelli Rome, Italy Saitama Medical University Hidaka- City, Japan

23 Commercial Activity Strong foundation established Direct sales team covering Germany, France & UK Distributors and agents covering Australia, New Zealand, Taiwan, Kuwait, UAE, Austria, Switzerland, Italy US sales team hiring begun with 9 field based reps already onboard Sales activities Italian first sale Q3 16 German first sale in Q1 17 Japan first sale Q2 17 Additional systems placed with option to buy 12-18 month sales cycle US FDA clearance expected in 2017

24 2017 Key Priorities Continued focus on commercialization efforts in CE Mark countries Obtain Senhance US 510(k) clearance by year end Continue to demonstrate clinical success across multiple specialties and procedures Prepare for U.S. launch pending FDA clearance with focused market development activities