EX-99.1 2 exhibit1.htm EX-99.1 EX-99.1

Exhibit 99.1

November 9, 2016

TransEnterix, Inc. Reports Operating Results for the Third Quarter 2016
RESEARCH TRIANGLE PARK, N.C.—(BUSINESS WIRE)— TransEnterix, Inc. (NYSE MKT: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, today announced its operating and financial results for the third quarter of 2016.

Recent Highlights

On July 29, 2016, the Company closed its first sale of the Senhance™ Surgical Robotic System (formerly known as the ALF-X System) to Humanitas Hospital, a research and teaching hospital partnered with Humanitas University Medical School, located in Milan, Italy.

On October 4, 2016, the first radical hysterectomy for cervical cancer utilizing the Senhance system was performed by gynecologic surgeon Dr. Salvatore Gueli Alletti at the Policlinico A. Gemelli Foundation in Rome, Italy.

On November 8, 2016, the Company announced that it has partnered with Getz Healthcare, a leading pan-Asian distributor of medical devices and equipment. Getz will be the exclusive distribution partner for the Senhance system in the Australian and New Zealand markets.

Today, the Company announced the installation of a Senhance system at Imperial College, in partnership with Imperial College London and St. Mary’s Hospital. The Senhance system will be utilized within Imperial College’s Minimally Invasive Surgery program in general, bariatric and colorectal surgery.

“We are pleased with our recent progress, which included the first sale of a Senhance system and the continued development of our commercial pipeline,” said Todd M. Pope, President and Chief Executive Officer of TransEnterix. “We remain enthusiastic about the potential of Senhance, and will continue to invest in global commercial expansion, including partnering with additional influential institutions to establish clinical reference sites.”

Financial Highlights

The company reported revenue of $1.5 million for the three months ended September 30, 2016, representing the sale of one Senhance system and related instruments and service, net of deferred revenue.

Total operating expenses were $14.0 million for the three months ended September 30, 2016, as compared to $13.6 million in the three months ended September 30, 2015.

Net loss was $12.9 million, or $0.11 per share, for the three months ended September 30, 2016, as compared to $13.9 million, or $0.16 per share, in the three months ended September 30, 2015.

The Company had cash, cash equivalents and restricted cash of approximately $52.9 million as of September 30, 2016. The Company expects its existing cash, cash equivalents and restricted cash to fund operations into the fourth quarter of 2017.

Conference Call

TransEnterix, Inc. will host a conference call on Wednesday, November 9, 2016 at 4:30 PM ET to discuss its third quarter 2016 operating and financial results. To listen to the conference call on your telephone, please dial (888) 455-2238 for domestic callers or (719) 325-2237 for international callers and reference TransEnterix Call approximately ten minutes prior to the start time. To access the live audio webcast or archived recording, use the following link http://ir.transenterix.com/events.cfm. The replay will be available on the Company’s website.

About TransEnterix

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. 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 company is also developing the SurgiBot™ System, a single-port, robotically enhanced laparoscopic surgical platform. The Senhance Surgical Robotic System has been granted a CE Mark but is not currently available for sale in the United States. For more information, visit the TransEnterix website at www.transenterix.com.

Forward Looking Statements
This press release includes statements relating to our 2016 third quarter financial results, the Senhance™ Surgical Robotic System and our current regulatory and commercialization plans for this product. 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 and when we will prepare a 510(k) submission for the Senhance Surgical Robotic System, whether our commercialization plans and the development of our pipeline will be successful, whether we will continue to invest in global commercial expansion, including partnering with additional influential institutions to establish clinical reference sites and whether existing cash, cash equivalents and restricted cash will fund operations into the fourth quarter of 2017. 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 3, 2016, our other filings we make with the SEC and our Form 10-Q for the 2016 third quarter expected to be filed on or before its due date. 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.
Investor Contact:
Mark Klausner, +1 443-213-0501
invest@transenterix.com
Or
Media Contact:
(For EU) Conrad Harrington, +44 (0)20 3178 8914
(For US) Hannah Dunning, +1 415-618-8750
TransEnterix-SVC@sardverb.com

TransEnterix, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands except per share amounts)
(Unaudited)
 

                                                         
    Three Months Ended   Nine Months Ended
    September 30,   September 30,
    2016           2015   2016   2015
Revenue
  $ 1,466           $           $ 1,466           $
Cost of revenue
  1,031                     1,031          
 
                                                       
Gross profit
  435                     435          
 
                                                       
Operating Expenses
                                                       
Research and development
  7,011           7,048           21,760           21,111
Sales and marketing
  2,574           413           5,563           1,161
General and administrative
  2,793           1,762           7,927           5,607
Amortization of intangible assets
  1,709           338           5,312           589
Change in fair value of contingent consideration
  (100 )                     1,700          
Inventory write-down related to restructuring
                      2,565          
Restructuring and other charges
                      3,085          
Goodwill impairment
                      61,784          
Acquisition related costs
            4,003                     4,003
Total Operating Expenses
  13,987           13,564           109,696           32,471
 
                                                       
Operating Loss
  (13,552 )           (13,564 )           (109,261 )           (32,471 )
 
                                                       
Other Expense
                                                       
Interest expense, net
  (432 )           (436 )           (1,499 )           (997 )
Other (expense) income
  (30 )                     65          
 
                                                       
Total Other Expense, net
  (462 )           (436 )           (1,434 )           (997 )
 
                                                       
Loss before income taxes
  $ (14,014 )           $ (14,000 )           $ (110,695 )           $ (33,468 )
Income tax benefit
  1,070           99           4,707           99
 
                                                       
Net loss
  $ (12,944 )           $ (13,901 )           $ (105,988 )           $ (33,369 )
 
                                                       
Other comprehensive gain (loss)
                                                       
Foreign currency translation gain (loss)
  689           (429 )           2,199           (429 )
 
                                                       
Comprehensive loss
  $ (12,255 )           $ (14,330 )           $ (103,789 )           $ (33,798 )
 
                                                       
Net loss per share — basic and diluted
  $ (0.11 )           $ (0.16 )           $ (0.95 )           $ (0.46 )
 
                                                       
Weighted average common shares outstanding - basic and diluted
  114,946           86,044           111,189           72,713
 
                                                       

TransEnterix, Inc.
Consolidated Balance Sheets
(in thousands, except share amounts)
(Unaudited)
 

                                 
            September 30,   December 31,
            2016   2015
Assets
                               
Current Assets
                               
Cash and cash equivalents
          $ 42,518           $ 38,449
Accounts receivable, net
          616           76
Inventories
          2,250           3,923
Interest receivable
          15           6
Other current assets
          8,149           6,689
 
                               
Total Current Assets
          53,548           49,143
 
                               
Restricted cash
          10,353          
Accounts receivable, net of current portion
          274                
Inventories, net of current portion
                    709
Property and equipment, net
          4,614           4,408
Intellectual property, net
          41,260           46,898
In-process research and development
          16,972           16,511
Goodwill
          69,948           130,869
Other long term assets
          63           64
 
                               
Total Assets
          $ 197,032           $ 248,602
 
                               
Liabilities and Stockholders’ Equity
                               
Current Liabilities
                               
Accounts payable
          $ 2,596           $ 4,450
Accrued expenses
          7,246           7,395
Contingent consideration – current portion
          11,325           12,500
Notes payable — current portion
          7,826           6,727
 
                               
Total Current Liabilities
          28,993           31,072
Long Term Liabilities
                               
Contingent consideration – less current portion
          13,875           11,000
Net deferred tax liabilities
          11,971           16,263
Notes payable — less current portion, net of debt discount
          7,059           12,990
 
                               
Total Liabilities
          61,898           71,325
Commitments and Contingencies
                               
Stockholders’ Equity
                               
Common stock $0.001 par value, 750,000,000 shares authorized at September 30, 2016 and December 31, 2015; 115,086,256 and 100,180,872 shares issued at September 30, 2016 and December 31, 2015, respectively; and 115,014,711 and 100,149,453 shares outstanding at September 30, 2016 and December 31, 2015, respectively
          115           100
Additional paid-in capital
          425,041           363,280
Accumulated deficit
          (288,852 )           (182,864 )
Treasury stock at cost, 71,545 and 31,419 shares at September 30, 2016 and December 31, 2015, respectively
          (203 )           (73 )
Accumulated other comprehensive loss
          (967 )           (3,166 )
 
                               
Total Stockholders’ Equity
          135,134           177,277
 
                               
Total Liabilities and Stockholders’ Equity
          $ 197,032           $ 248,602
 
                               

 

TransEnterix, Inc.
Consolidated Statements of Cash Flows
(in thousands)
(Unaudited)
 

                                 
            Nine Months Ended
            September 30,
            2016           2015
Operating Activities
                               
Net loss
          $ (105,988 )           $ (33,369 )
Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:
                               
Depreciation
          1,498           802
Amortization of intangible assets
          5,312           589
Amortization of debt discount and debt issuance costs
          140           89
Stock-based compensation
          3,858           2,388
Common stock issued for services
          116          
Inventory write-down related to restructuring
          2,565          
Loss on disposal of property
                    34
Non-cash restructuring and other charges
          2,551          
Goodwill impairment
          61,784          
Deferred tax benefit
          (4,725 )           (99 )
Change in fair value of contingent consideration
          1,700          
Changes in operating assets and liabilities, net of effect of acquisition:
                               
Accounts receivable
          (809 )           133
Interest receivable
          (9 )           (5 )
Inventories
          (1,883 )           (250 )
Other current and long term assets
          (1,290 )           (248 )
Accounts payable
          (1,917 )           984
Accrued expenses
          (168 )           4,127
Restricted cash
          (10,353 )           250
 
                               
Net cash and cash equivalents used in operating activities
          (47,618 )           (24,575 )
 
                               
Investing Activities
                               
Payment for acquisition
                    (25,000 )
Purchase of property and equipment
          (878 )           (728 )
 
                               
Net cash and cash equivalents used in investing activities
          (878 )           (25,728 )
 
                               
Financing Activities
                               
Payment of debt
          (4,972 )          
Proceeds from issuance of common stock, net of issuance costs
          57,637           58,295
Proceeds from issuance of debt, net of debt discount
                    9,886
Taxes paid related to net share settlement of vesting of restricted stock units
          (130 )           (3 )
Proceeds from exercise of stock options and warrants
          163           252
 
                               
Net cash and cash equivalents provided by financing activities
          52,698           68,430
 
                               
Effect of exchange rate changes on cash and cash equivalents
          (133 )          
 
                               
Net increase in cash and cash equivalents
          4,069           18,127
Cash and cash equivalents, beginning of period
          38,449           34,766
 
                               
Cash and cash equivalents, end of period
          $ 42,518           $ 52,893
 
                               
Supplemental Disclosure for Cash Flow Information
                               
Interest paid
          $ 1,019           $ 598
Supplemental Schedule of Noncash Investing Activities
                               
Transfer of inventory to property and equipment
          $ 1,866          
Issuance of common stock warrants
                    $ 96
Contingent consideration related to acquisition
                    $ 24,300
Issuance of common stock related to acquisition
                    $ 43,677