TransEnterix, Inc.
TRANSENTERIX INC. (Form: 8-K, Received: 01/08/2018 16:18:49)

 

 

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

January 8, 2018

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))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

 

 


Item 7.01 Regulation FD Disclosure

On January 8, 2018, TransEnterix, Inc. (the “Company”) posted a January 2018 corporate presentation on its website that provides a current overview about the Company. The corporate presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

 

Item 8.01 Other Events.

On January 8, 2018, the Company issued a press release summarizing its 2017 year-end results. The press release is attached to this Current Report on Form 8-K as Exhibit 99.2 and incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

 

Exhibit
No.

  

Description

99.1    Corporate Presentation of TransEnterix, Inc., January 2018
99.2    Press Release of TransEnterix, Inc., issued January 8, 2018.


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: January 8, 2018      

/s/ Joseph P. Slattery

      Joseph P. Slattery
      Executive Vice President and Chief Financial Officer

SLIDE 1

Exhibit 99.1


SLIDE 2

Todd M. Pope President & CEO JP Morgan Healthcare Conference January 8, 2018


SLIDE 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, 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.


SLIDE 4

Commercial Stage Clinically validated in multiple procedures and sites Senhance FDA cleared and CE Marked Sales and distribution in place in US and EU Strong financial position Compelling Platform Technology Senhance Surgical Robot Robotic benefits with responsible economics Focus: Surgical Robotics Category: Digital Laparoscopy TransEnterix: TRXC Significant addressable market opportunity Surgical robotics penetration remains low (< 10%)


SLIDE 5

Value-based healthcare is forcing hospitals to find new ways to improve outcomes, efficiencies and talent retention.


SLIDE 6

Surgical Robotics Poised for Growth in 2023 in 2017 Robotic surgery is <10% of surgery today Largest opportunity is to convert laparoscopic procedures; not enabled by current options Must meet value-based healthcare criteria and build off laparoscopy (>60% of surgery) Source: Abdominal Surgical Robots Market Shares, Strategies, and Forecasts, Worldwide, 2017 to 2023 WinterGreen Research, June 2017 Abdominal Robotic Surgery Market Size $2.9 Billion $15.8 Billion


SLIDE 7

Robotic Surgery Landscape 0.7 MM procedures EU & U.S. Historical Growth Drivers: Convert open surgeries to robotics Offset signficant per-procedure cost increase with length of stay benefit vs. open surgery Clinical and patient benefits have come from converting an open procedure to a minimally-invasive surgical approach Conversion of laparoscopy to robotics difficult due to substantial per-procedure cost Current abdominal robotic surgery Sources: TRXC Estimates, Millennium Research Group and Intuitive Surgical Open Surgery 4 MM procedures EU & U.S. Laparoscopic Surgery 6 MM procedures EU & U.S.


SLIDE 8

Future Growth Drivers: Convert laparoscopic surgeries to robotics Improve laparoscopy: designed for greater precision, efficiencies, safety, ergonomics Provide meaningful robotic benefits to laparoscopic surgery without significant per procedure cost increase Sources: TRXC Estimates and Millennium Research Group Digital Laparoscopy Opportunity Open Surgery 4 MM procedures EU & U.S. Laparoscopic Surgery 6 MM procedures EU & U.S.


SLIDE 9

Need for Robotic System that Addresses the Laparoscopic Market Familiar motion and approach Completed learning curve Significant investments in laparoscopic ecosystem Laparoscopy is Widespread Limitations of Laparoscopy Reliance on assistant to control camera Challenging ergonomics Imprecise instrument movement Torque at incision sites Hospitals Under Pressure Robotics has added procedure costs Hospitals feel pressured to offer robotic option or lose volume Majority of surgeons now hospital employees, need to retain and extend productivity


SLIDE 10

Senhance is Uniquely Positioned to Address Laparoscopic Market Senhance Robotic Benefits Precision Ergonomics Advanced Instrument-ation Eye- sensing camera control


SLIDE 11


SLIDE 12

Growing TransEnterix Patent Portfolio Issued Patents: 93 worldwide Includes 25 US issued Patent Applications: 92 worldwide Includes 54 pending US applications


SLIDE 13

Building Clinical Validation Imperial College, St. Mary’s, London, England C.H.U. ST Etienne, Saint-Etienne, France St. Marien-Krankenhaus, Siegen, Germany University Clinic Hamburg – Eppendorf (UKE), Hamburg, Germany Humanitas University, Milan, Italy Policlinico Gemelli, Rome, Italy Saitama Medical University, Hidaka-City, Japan Florida Hospital, Orlando, Florida BUILDING CLINICAL VALIDATION 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 19 PUBLICATIONS 500+ PATIENT COHORT


SLIDE 14


SLIDE 15

Senhance FDA Cleared and CE Marked First new entrant to abdominal robotics since 2000 Senhance received FDA clearance October 2017 Cleared for colorectal and gynecological laparoscopic surgery in US Indications cover 23 procedures Covers benign and oncologic treatments Initial market 1.5 million US procedures


SLIDE 16

Delivering on Open Architecture Strategy Robotic Microlap Open Source Visualization Introducing the first robotic microlap 3mm system Enabling virtually scarless surgery Using robotic precision, tremor filtration and surgeon camera control with microlaparoscopy Leverage existing hospital visualization systems Adapters for leading vision systems; Stryker, Novadaq, ConMed, Richard-Wolf Advanced imaging with fluorescence 5mm and 10mm scopes


SLIDE 17


SLIDE 18

Commercial Activity - US Sales resources 17 sales professionals Majority of 20 largest MSAs covered Established surgeon training center at the Institute for Surgical Advancement in Orlando Q3 ’17 Strong presence at major trade shows Sales activities First sale to Florida Hospital Orlando Q4 ’17 Anticipate 4-6 quarter capital sales cycle


SLIDE 19

Commercial Activity - OUS Strong foundation established Direct sales team covering Germany, Italy, France, Benelux & UK Distributors and agents expand coverage to other markets Sales activities Italian sale Q3 ’16 German sale in Q1 ’17 Japan sale Q2 ’17 Taiwan sale Q3 ’17 CIS sale Q4 ‘17


SLIDE 20

SurgiBot Commercialization Update/Strategy Enables TransEnterix to expand portfolio, increases cash, and develops partner relationship for China manufacturing and distribution Received minimum consideration of $29 million (cash, stock purchase and royalties) Retain rights for distribution and sales outside of China for SurgiBot, single port robotic system Manufacturing to be done in China Partnering with leading firms with China National Scientific and Instruments and Materials Company, a core enterprise of SinoPharm


SLIDE 21

Financial (unaudited) 2017 Revenue ~ $7.0 million 360% increase over 2016 December 31, 2017 Balance Sheet Highlights Cash & Restricted Cash ~ $97 million Debt ~ $14 million Common shares outstanding ~ 199 million


SLIDE 22

Key Priorities 2017 Continued focus on commercialization efforts in CE Mark countries ✓ Continue to demonstrate clinical success across multiple specialties and procedures ✓ Obtain Senhance US 510(k) clearance by year end ✓ Prepare for U.S. launch with focused market development activities ✓ 2018 Commercial results in US, EU and Asia Expand instrument portfolio to include advanced energy and articulating instrumentation Expand US 510(k) indications for use by mid-year Accelerating clinical adoption across multiple specialties and procedures

Exhibit 99.2

January 8, 2018

TransEnterix Provides 2017 Year End Corporate Update

RESEARCH TRIANGLE PARK, N.C.—(BUSINESS WIRE)— TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, today provided a year-end corporate update.

“2017 was a transformational year for TransEnterix that included the commencement of U.S. Senhance commercialization and progression towards the global commercialization of SurgiBot,” said Todd M. Pope, President and CEO at TransEnterix. “We are very excited about the opportunity that lies ahead in 2018 as we look to build upon our momentum and drive the global adoption of the Senhance.”

Senhance System Revenue

During the quarter ending December 31, 2017, the Company sold two Senhance Systems for total revenue of approximately $3.3 million. Total 2017 revenue is approximately $7.0 million, a 360% increase over 2016, representing a total of five Senhance Systems: Europe (two), Asia (two, including one sale for which the revenue was not recognized in 2017) and the United States (one).

The company currently has received one European Senhance System order that it expects to deliver and recognize revenue for in the quarter ending March 31, 2018.

Product Portfolio

During 2017, the company completed the following product portfolio initiatives:

 

    Obtained Senhance System FDA 510(k) clearance for use in colorectal and gynecologic laparoscopic surgery

 

    Obtained CE mark and began commercializing the world’s first robotic micro-laparoscopic (3 millimeter) instruments

 

    Expanded list of compatible visualization and fluorescence systems to include systems from Stryker, Novadaq (Stryker), Conmed and Richard Wolf

 

    Filed approximately 40 new US patent applications. The Company’s patent portfolio now includes approximately 93 issued patents, 25 of which are US Patents, as well as approximately 92 pending applications, 54 of which are US applications.


The Company expects to complete the following product portfolio initiatives in 2018:

 

    Expand the Senhance System US FDA clinical indications to include hernia and gallbladder, doubling the total addressable market

 

    Launch new ultrasonic energy device

 

    Launch new five-millimeter articulating instrument platform

SurgiBot Global System Agreement

On December 18, 2017, the Company announced that it had entered into an agreement with Great Belief International Limited (GBIL) to advance the SurgiBot System towards global commercialization.

The agreement provides the Company with proceeds of at least $29 million, of which $7.5 million was received in December of 2017. An additional $7.5 million is expected to be received by March 31, 2018, including a $3.0 million equity investment at $2.33 per share. The remaining $14 million, representing minimum royalties, will be paid beginning at the earlier of receipt of Chinese regulatory approval or five years.

This agreement transfers ownership of the SurgiBot System assets, while the Company retains the option to distribute or co-distribute the SurgiBot system outside of China. Upon completion of the transfer of all SurgiBot system assets, GBIL will have the SurgiBot system manufactured in China and obtain Chinese regulatory clearance from the China Food and Drug Administration (“CFDA”), while entering into a nationwide distribution agreement with China National Scientific and Instruments and Materials Company (CSIMC) for the Chinese market.

Balance Sheet

As of December 31, 2017, the Company’s cash and restricted cash balance was approximately $97 million. The Company believes that this capital is sufficient to fund operations through the year 2019.

As of December 31, 2017, there were approximately 199 million shares of common stock outstanding.

About TransEnterix, Inc.

TransEnterix is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today’s value-based healthcare environment. The company is focused on the


commercialization of the Senhance Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. The Senhance Surgical Robotic System is available for sale in the US, the EU and select other countries. For more information, visit the TransEnterix website at www.transenterix.com .

Forward-Looking Statements

This press release contains “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, which 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 be able to build upon our momentum and drive the global adoption of the Senhance in 2018; whether we will deliver and recognize revenue from the sale of a European Senhance System in the 2018 first quarter; whether we will expand the Senhance System US FDA clinical indications to include hernia and gallbladder; whether we will launch a new ultrasonic energy device, whether we will launch a new five-millimeter instrument platform; whether TransEnterix will receive at least $29 million (including minimum royalties) from GBIL; whether GBIL will be able to obtain the necessary clearances to sell the SurgiBot System in China; whether TransEnterix will be able to successfully distribute or co-distribute the SurgiBot System outside of China, and realize revenues beyond the initial consideration and minimum royalties; and whether our cash through December 31, 2017 will be sufficient capital to fund operations through the year 2019. We cannot assure you that our expectations will be realized. 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 filed on March 6, 2017 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 press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.


For TransEnterix, Inc.

Investors:

Mark Klausner, +1 443-213-0501

invest@transenterix.com

or

Media:

Joanna Rice, + 1 951-751-1858

joanna@greymattermarketing.com