UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
April 2, 2014
Date of Report (date of earliest event reported)
TransEnterix, Inc.
(Exact name of Registrant as specified in its charter)
| Delaware | 0-19437 | 11-2962080 | ||
| (State or other jurisdiction of incorporation or organization) |
(Commission File Number) |
(I.R.S. Employer Identification Number) |
635 Davis Drive, Suite 300
Morrisville, North Carolina
(Address of principal executive offices)
919-765-8400
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01 Other Events.
TransEnterix, Inc. (the “Company”) updated its Company presentation (the “Presentation”) on April 2, 2014. A copy of the Presentation is attached hereto as Exhibit 99.1 and is incorporated herein by reference. The Presentation will be used during investor meetings beginning on April 2, 2014.
Item 9.01 Financial Statements and Exhibits.
| Exhibit |
Description | |
| 99.1 | TransEnterix, Inc. Company presentation dated April 2, 2014 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| TRANSENTERIX, INC. | ||||||
| Date: April 2, 2014 | /s/ Joseph P. Slattery | |||||
| Joseph P. Slattery | ||||||
| Executive Vice President and Chief Financial Officer | ||||||
 Todd M. Pope,
President & CEO Joe Slattery, EVP & CFO
April 2, 2014
Exhibit 99.1 |
 Any
statements contained in this presentation that do not describe historical facts, including
statements about the beliefs and expectations of TransEnterix, Inc.
(“TransEnterix,” "we" or "our"),
may constitute forward-looking statements as that term is defined by the United
States Private Securities Litigation Reform Act of 1995. These
forward-looking statements can be identified by terminology such as
"will," "expect," "anticipate," "future," "intend," "plan," "believe," "estimate,"
"confident" and similar statements. Any forward-looking statements
contained herein are based on current expectations, but are subject to a
number of risks and uncertainties that may cause actual results to differ
materially from expectations. Potential risks and uncertainties include the
risks outlined in this presentation and TransEnterix’ filings with the
U.S. Securities and Exchange Commission, including the benefits and opportunities
of surgical robotics, whether the combined company formed as a result of the Sept.
2013 merger of TransEnterix and SafeStitch Medical, Inc. will be successful
in 2014 and beyond, the success and market opportunity of our continuing and
new product development efforts, including the SurgiBot
system, the pace of adoption of our product technology by surgeons, the effect on
our business of existing and new regulatory requirements, the outcome of
coverage and reimbursement decisions by the government and third party
payors, and other economic and competitive factors. We caution
readers not to place undue reliance upon any forward-looking statements, which
speak only as of the date made. We do not undertake or accept any obligation
or undertaking to release publicly any updates or revisions to any
forward-looking statement to reflect any change in our expectations or
any change in events, conditions or circumstances on which any such statement is
based. 2
Cautionary Statement |
 Advancing Surgery
Through Innovation |
 4
Issuer:
TransEnterix, Inc.
Ticker (Exchange):
TRXC (NYSE MKT)
(1)
Amount Offered:
$50 million
Over-Allotment Option:
15%
Lock-up Provision:
90 days
Expected Pricing:
April 10, 2014
Bookrunners:
Stifel / RBC Capital Markets
Use of Proceeds:
For research and development, sales and
marketing, and commercialization related to our
SurgiBot™
System, working capital and other
general corporate purposes.
(1)
Authorized
for
listing
upon
completion
of
offering.
Currently
listed
as
“TRXCD”
on
OTC:BB
Transaction Overview
TM |
 Investment Highlights
5
The SurgiBot System is currently under development
•
Surgical robotics
•
Developing patient-side robotic platform: SurgiBot
•
Addresses unmet needs in today’s robotic offerings
•
Cost effective
•
Broad procedure applicability
•
Large addressable market –
~2M US procedures
•
Strong management team
Technology
Focus
Solution
Market
Experience |
 6
•
TransEnterix
founded
•
FDA 510(K) clearance for
Spider Surgical System
•
CE Mark clearance and release
of Spider Surgical System
•
>3,500 SPIDER cumulative
procedures performed to date
•
Began SurgiBot development
•
SurgiBot preclinical labs
2006
2009
2010
2012
2013
Company History |
 7
Surgical Progress = Less Invasive
Open
Surgery
Rigid
Laparoscopy
(1989)
Flexible
Laparoscopy
(2010) |
 •
Internal (intra-abdominal)
triangulation
•
Flexible, articulating instruments
for dissection and retraction
•
True left/right instrumentation
•
Lower profile port of access
•
Over 3,500 procedures
performed
•
Broad procedural mix
8
Spider Surgical System
Enabling Flexible Laparoscopy |
 SurgiBot
Powered and Robotically-enabled
Next-generation Platform*
*The SurgiBot System is currently under development
TM |
 10
Benefits of Surgical Robotics
Improved
dissection and
retraction strength
Enhanced precision
and control
Improved surgeon
ergonomics
Advanced
visualization
Benefits of
Surgical
Robotics |
 Source: ISRG Investor Presentation, 2/21/2014
11
Worldwide daVinci Procedures |
 12
(2)
ISRG investor call, 1/23/2014
The SurgiBot System is currently under development
(1)
(1)
Multi-Port
Surgeon scrubbed-in
Multi-quadrant utility
Reduced incisions
Internal triangulation
Articulating instruments
Space for assistant
Cost
~$1.5M
(2)
~$500K
“Single-site” upgrade reduces incisions, with added
cost and loss of articulating instruments
(1)
SurgiBot
Purpose Built for Abdominal Surgery |
 13
The SurgiBot System is currently under development
Surgeon scrubbed-in
Easily repositioned for multi-
quadrant surgery
Flexible, articulating channels &
instruments
Steerable 3DHD
Small, mobile platform
Cost effective platform
SurgiBot
First Patient-side Robotic Platform |
 14
3DHD
Optics/Cart
SurgiBot
The SurgiBot System is currently under development
SurgiBot
First Patient-side Robotic Platform |
 15
The SurgiBot System is currently under development
[Video of SurgiBot System Prototype]
SurgiBot
First Patient-side Robotic Platform |
 16
Targeted US
Procedures
160K
1,140K
363K
230K
~2M US
Laparoscopic
Procedures
Procedure Market Opportunity
Bariatric Surgery
Cholecystectomy
Colorectal
Gynecology/Urology
Source: Millennium Research Group US Markets Laparoscopic Devices 2014 |
 Large Addressable Market
17
Source: CDC
Over 5,000 Hospitals in the United States
# of Beds
1,566
2,054
930
458
Under 50
50-200
200
-
400
Over 400 |
 18
Hospitals without
Robotic Capability
Hospitals with
Robotic Capability
•
Invested in the strategic
and competitive value of
robotic surgery
•
ROI expectations
changing/under pressure
•
Potential for
diversification of robotic
solutions
•
Procedures
•
Price
•
Facilities
Hospital Market Opportunity
•
Current robotic offerings
are not cost effective
•
System price
•
Limited procedure volume
•
Surgery centers –
untapped market for
robotics
•
Losing market share to
robotic facilities
•
Large underpenetrated
OUS opportunity |
 Significant Base of Underserved Hospitals
19
•
>3,000 w/ <300
beds
•
>80% lack robotic
offering
•
Losing market share
to robotic facilities
•
Represent >800K
target annual
procedures •
~5,000 in US
•
Economics driving
rapid procedure
growth
•
SurgiBot will offer
versatility and cost
benefits
Mid/Small
Hospitals
Surgery Centers |
 Price
20
Traditional
Laparoscopy
>$10B Revenue
Low Growth
Surgical Robotics
>$2B Revenue
High Growth
Combining Advanced Technology AND
Maximizing Value |
 21
Highlights –
Instrumentation
Instrumentation Needs
By Procedure
Status
Chole
Bariatrics
GYN
SPIDER
SurgiBot
Grasper
Launched
Developed
Dissector
Launched
Developed
Hook
Launched
Developed
Clip Applier
Launched
Developed
Shears
Launched
Developed
Suction Irrigator
Launched
Developed
Needle Driver
Launched
Developed
Advanced Energy
Q2 2014
Development
Bipolar Energy
3
rd
Party
Development
Stapler
3
rd
Party
3
rd
Party
The SurgiBot System is currently under development |
 Operating Capabilities & Talent
22
Rapid Prototyping
R&D Team
Broad Experience
cGMP Manufacturing |
 Management Team
23
Prior Experience
Todd M. Pope
President and Chief Executive Officer
Joe Slattery
EVP and Chief Financial Officer
Richard Mueller
Chief Operating Officer
Mohan Nathan
Vice President of Global Marketing
Tammy Carrea
Vice President, Quality and Regulatory Affairs
Nicole Bell
Vice President, Research and Development
Larry Pope
Vice President, Operations |
 •
Phillip Frost, M.D.
–
CEO and Chairman of OPKO Health
–
Chairman of Teva Pharmaceuticals
•
Jane Hsiao, Ph.D., MBA
–
Former Chairman of SafeStitch
–
Vice Chairman and CTO of OPKO Health
•
Aftab Kherani, M.D.
–
Principal of Aisling Capital
•
Richard Pfenniger, Jr.
–
Former Chairman/CEO of Continucare
–
Former CEO of Whitman Education Group
•
Paul LaViolette
–
Chairman of TransEnterix
–
Partner, SV Life Sciences
•
Todd Pope
–
President and Chief Executive Officer, TransEnterix
•
Dennis Dougherty
–
Founder, Intersouth Partners
•
David Milne
–
Managing Partner, SV Life Sciences
•
William Starling
–
Managing Director, Synergy Life Science Partners
24
Board of Directors and Healthcare
Investors
Board of Directors
Healthcare Investors |
 Regulatory Strategy
25
•
510(k) pathway
•
General intended use for laparoscopic abdominal access
•
Design &
Pre-clinical Testing
•
Pre-submission
FDA Meeting
•
Regulatory
Clearances
•
Global Launch
2013
2014
2015
•
First Human
Procedures
•
Regulatory
Submissions |
 Financial
Information |
 Recurring Revenue Model
27
Instruments and
Accessories
Service
Capital Equipment
US Pricing:
The SurgiBot System is currently under development
•
Market-specific pricing
•
Distributors provide service/support
International:
•
Capital sale ~$500K
•
Instruments ~$1,000-1,500/procedure
•
Service ~$50K/year |
 •
Cash
–
Balance at 12/31/2013 $16.2M
–
Q4 ‘13 burn $8.7M, incl. $0.9M debt service and $0.7M capital
equipment
•
Capital Sales Reps
–
Hire 5-8 early 2015
–
~15 by launch
–
~30 to cover US
–
Supported by clinical and field service reps
•
Gross Margin
–
SurgiBot system >= 50%
–
Instruments scaling to >60%
–
Service break-even requires scale
Financial Highlights
28
The SurgiBot System is currently under development |
 •
FDA Pre-filing Submission -
Q1
•
Launch
Flexible
Advanced
Energy
Device
-
Q2
•
Clinical SurgiBot Cases Begin -
Q3
•
SurgiBot FDA/CE Filings -
Q4
2014 Key Objectives
29
Completed |
 •
Surgical robotics
Focus
•
Developing patient-side robotic platform: SurgiBot
Technology
•
Addresses unmet needs in today’s robotic offerings
•
Cost effective
•
Broad procedure applicability
Solution
•
Large
addressable
market
–
~2M
US
procedures
Market
•
Strong management team
Experience
Investment Highlights
30
The SurgiBot System is currently under development |