+ All Categories
Home > Documents > TransEnterix Earnings Slides - $TRXC

TransEnterix Earnings Slides - $TRXC

Date post: 16-Jul-2016
Category:
Upload: medtechy
View: 79 times
Download: 5 times
Share this document with a friend
Description:
TransEnterix Earnings Slides
22
Fourth Quarter and Full Year 2015 Operating Results March 3, 2016
Transcript
Page 1: TransEnterix Earnings Slides - $TRXC

Fourth Quarter and Full Year 2015 Operating ResultsMarch 3, 2016

Page 2: TransEnterix Earnings Slides - $TRXC

Speakers on Today’s Call2

Todd M. PopePresident & CEO

Joe SlatteryEVP/CFO

Page 3: TransEnterix Earnings Slides - $TRXC

Forward Looking Statements

This presentation includes statements relating to our ALF-X® System, SurgiBot System, and our current regulatory and commercialization plans for these products. 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, including whether we will achieve clearance for the SurgiBot System from the FDA in the first quarter of this year. For a discussion of the risks and uncertainties associated with TransEnterix's business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K and our 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 this 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.

3

Page 4: TransEnterix Earnings Slides - $TRXC

2015 - A Transformational Year

Highlights● Acquired ALF-X Surgical Robotic System● Submitted SurgiBot 510(k) application to FDA● Strengthened leadership team

In 2015, TransEnterix transformed into a global surgical robotics company by building a compelling portfolio of technologically and economically innovative surgical robotics platforms

4

Page 5: TransEnterix Earnings Slides - $TRXC

2015 Accomplishments

Anthony FernandoChief Technology Officer

● 15 years healthcare experience

● Stryker● Becton Dickinson● PerkinElmer

5

Key Leadership Team Additions

Paul ZieglerVP Sales

● 13 years healthcare experience

● 9 years surgical robotics

● Intuitive Surgical● J&J (Ethicon)

Steven BoudrezVP Sales, Europe

● 20 years healthcare experience

● 13 years surgical robotics

● MedTech S.A.● Intuitive Surgical

Page 6: TransEnterix Earnings Slides - $TRXC

2015 Accomplishments

● Multi-port & console-based● Mimics laparoscopy● Haptic feedback & enhanced vision● Broad instrument offering● Compelling per-procedure

economics

Acquired the ALF-X Surgical Robotics Platform in Sept 2015

6

Page 7: TransEnterix Earnings Slides - $TRXC

2015 Accomplishments7

● Q2-15 - Filed 510(k) application● Q3-15 - Received FDA feedback● Q1-16 - Completed response to FDA● Built 8 complete systems and over

1,200 instruments in support of submission

Filed SurgiBot FDA 510(k) application

Continue to Expect Q1-16 FDA Clearance

Page 8: TransEnterix Earnings Slides - $TRXC

Financial Review

Page 9: TransEnterix Earnings Slides - $TRXC

Q4 & Full Year 2015 Financial Review9

Expense Items Q4 2014 Q4 2015 FY 2014 FY 2015

Research & development $6.0M $8.6M $27.9M $29.7M

Sales & marketing $0.4M $1.7M $1.7M $2.9M

General & administrative $1.0M $2.2M $5.7M $7.8M

Balance Sheet Items 12/31/14 12/31/15

Cash & cash equivalents $34.8M $38.4M

Notes payable $9.8M $19.7M

Common Stock Q4 2014 Q4 2015 FY 2014 FY 2015

Weighted averages shares o/s 63.2M 100.1M 58.7M 79.6M

Shares issued, end of period 63.2M 100.2M

Page 10: TransEnterix Earnings Slides - $TRXC

ALF-X Update

Page 11: TransEnterix Earnings Slides - $TRXC

ALF-X Integration Complete Post-Acquisition Confirmations● Extremely high market interest● Reliable & robust platform● Scalable manufacturing supports growth● Strong engineering team

Commercial Background● Prior activity focused on clinical experience● Trade-show participation was limited● Inherited no sales & marketing infrastructure

11

Page 12: TransEnterix Earnings Slides - $TRXC

ALF-X Team TodaySales Team (6)● VP Sales, Europe - Steven Boudrez● Director, EU Distribution● Direct sales

○ France/Switzerland○ UK/Benelux (Q2 start)○ Middle East○ Asia

12

Professional Education Team (3)● Surgeon training● Clinical training● Sales training

Field Service (2)

R&D (12)

23 Employees Focused on ALF-X Commercialization and Support

Page 13: TransEnterix Earnings Slides - $TRXC

ALF-X Marketing Efforts

Conferences and Tradeshows● European Colorectal Congress

(Switzerland)○ 115 demo participants

● Arab Health (Dubai)○ 183 ALF-X test-drives

● World Congress of Endourology (UK)

● Four regional society meetings

13

Marketing and Outreach● Digital/print marketing

campaign started Nov 2015

● Contacted over 5,000 surgeons and hospital administrators in EU and Middle East

● Generated hundreds of high-quality leads

Robust ALF-X Marketing Resulting in Meaningful Lead Generation

Page 14: TransEnterix Earnings Slides - $TRXC

ALF-X Demonstration Capability14

● Two clinical sites for case observations○ Milan (general / colorectal)○ Rome (gyn / gyn oncology)

● Company training lab in Milan (wet and dry)● Dedicated professional education team● Capacity 2 visits / week● 8 hospitals / systems completed 2-day program

○ Typical attendees:■ 2-4 surgeons (multi-specialty)■ 1-2 C-level executives

Leveraging Demonstration Capability to Grow Sales

Page 15: TransEnterix Earnings Slides - $TRXC

ALF-X Commercialization EffortsDirect Sales Efforts● 65 sales presentations through February● Continue expanding direct footprint● Expand clinical team as systems are sold

Building Distribution Infrastructure● Italy● Spain/Portugal● Middle East● Asia

15

Rapidly Establishing Sales Channels

Page 16: TransEnterix Earnings Slides - $TRXC

ALF-X Initial Demand Profile● Majority are private hospitals

○ Approved 2016 robotics budget○ Shorter decision cycles

● Public hospital interest, tender process required● Majority of interested surgeons currently utilize or have been trained

on robotics● Interest from hospitals with and without current robotic system● Urologist typically key stakeholder

○ Virtually all current EU robotic use is urology

16

Favorable ALF-X Procedure Economics Driving High Interest

Page 17: TransEnterix Earnings Slides - $TRXC

2016 Priorities and Expectations

Page 18: TransEnterix Earnings Slides - $TRXC

TRXC Commercialization Strategy18

● Continue to expand sales and service infrastructure for the ALF-X System in Europe and the Middle East

● Following SurgiBot FDA clearance, expand U.S. sales and service infrastructure, develop training sites and work with key opinion leaders to gain clinical experience

● Submit 510(k) application to the FDA for the ALF-X System in the fourth quarter of 2016

● Capitalize on U.S. market opportunity in 2017 with dual-platform portfolio

Implementation of a portfolio-wide commercialization strategy that will most effectively leverage our products, infrastructure and capital

Page 19: TransEnterix Earnings Slides - $TRXC

ALF-X Commercial Ramp

● Expand capital & clinical sales team

● Select distribution partners

● Expand demo capability○ Milan training center - Q2○ Leverage early placements to enable

expansion

We will continue to invest significant resources behind the commercial sales ramp of ALF-X

19

Page 20: TransEnterix Earnings Slides - $TRXC

SurgiBot Commercialization20

● Hire 3 area sales managers shortly after clearance

● Establish commercial foundation:○ Develop clinical experience○ Sell SurgiBot into key training sites○ Establish key opinion leader network○ Build customer support infrastructure

Following FDA clearance, SurgiBot commercialization plan is as follows:

Page 21: TransEnterix Earnings Slides - $TRXC

Upcoming Major Surgical Symposia21

Symposia ALF-X SurgiBot

SAGES (Boston, Mar 16-18)

European Association for Endoscopic Surgery (Amsterdam, Jun 15-18)

American College of Surgery (Washington, D.C. Oct 16-20)

Obesity Week (New Orleans, Oct 31- Nov 4)

American Association of Gynecologic Laparoscopists (Orlando, Nov 14-18)

Page 22: TransEnterix Earnings Slides - $TRXC

22

● Surgical Robotics is a significant market○ >$2B today, projected >$10B by 2021

● Less than 5% of surgery today is performed with robotics due to:○ Economics○ Trade-offs

● Our ALF-X and SurgiBot systems are positioned to address these trade-offs

● ALF-X commercialization on track

● SurgiBot FDA decision expected this month

Summary


Recommended