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TransEnterix, Inc. Reports Operating Results for the Fourth Quarter and Full Year 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 fourth quarter and full year 2016.

Recent Highlights

  • On February 23, 2017, the Company sold a SenhanceTM Surgical Robotic System to St. Marien-Krankenhaus Siegen, a large multi-specialty hospital, establishing the hospital’s robotic surgical program.
  • We expanded our Clinical Leadership Program to three sites, which now includes installed systems in France, Italy and the United Kingdom.
  • On January 5, 2017, the Company received an additional €5 million investment, or approximately $5.2 million, from SOFAR S.p.A.
  • On December 15, 2016, the Company entered into a common stock purchase agreement, providing the Company with up to $25 million over 36-months from date of execution.

"We are pleased with the significant progress we made during the year in establishing a strong foundation for Senhance commercialization," said Todd M. Pope, President and Chief Executive Officer of TransEnterix. "We are excited about the opportunity to leverage that foundation to drive growth in Europe and other regions, and look forward to the submission of our Senhance 510(k) and anticipated approval in 2017."

Financial Highlights

For the three months ended December 31, 2016, the Company reported revenue of $53 thousand, consisting of the recognition of deferred and services revenue associated with existing placements.

For the three months ended December 31, 2016, total operating expenses were $14.4 million, as compared to $13.9 million in the three months ended December 31, 2015.

For the three months ended December 31, 2016, net loss was $14.0 million, or $(0.12) per share, as compared to $13.6 million, or $(0.13) per share, in the three months ended December 31, 2015.

For the full year ended December 31, 2016, the Company reported revenue of $1.5 million, representing the sale of a Senhance system, net of deferred revenue, as well as the recognition of deferred and service revenue associated with existing placements.

For the full year ended December 31, 2016, total operating expenses were $124.1 million, including primarily non-cash charges for goodwill impairment of $61.8 million and restructuring charges of $5.6 million taken in the second quarter of 2016, as compared to $46.4 million in the full year ended December 31, 2015.

For the full year ended December 31, 2016, net loss was $120.0 million, or $1.07 per share, as compared to $46.9 million, or $0.59 per share, in the full year ended December 31, 2015.

The Company had cash, cash equivalents and restricted cash of approximately $34.6 million as of December 31, 2016. The Company expects its existing cash, cash equivalents and restricted cash to fund operations into the fourth quarter of 2017. Pursuant to the disclosure requirements of the NYSE MKT Company Guide Section 610(b), the Company is reporting that its audited consolidated financial statements for the fiscal year ended December 31, 2016, included in the Company's Annual Report on Form 10-K filed expected to be filed with the Securities and Exchange Commission on or about March 6, 2017, contains an audit opinion from its independent registered public accounting firm that includes an explanatory paragraph related to the Company's ability to continue as a going concern.

Conference Call

TransEnterix, Inc. will host a conference call on Monday, March 6, 2017 at 4:30 PM ET to discuss its fourth quarter and full year 2016 operating and financial results. To listen to the conference call on your telephone, please dial (888) 724-9516 for domestic callers or (913) 312-0978 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 also developed 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 fourth quarter and full year 2016 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 when we will file the 510(k) submission for the Senhance Surgical Robotic System, whether the Senhance 510(k) will be approved by the FDA in 2017, whether our commercialization plans and the development of our pipeline will be successful, 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 for the year ended December 31, 2016, which we expect to file shortly, 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.

   

TransEnterix, Inc.

Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except per share amounts)

 

(unaudited)

 
Three Months Ended Year Ended
December 31, December 31,
2016   2015 2016   2015
Revenue $ 53 $ $ 1,519 $
Cost of revenue     38             1,069        
Gross profit     15             450        
Operating Expenses
Research and development 7,513 8,558 29,273 29,669
Sales and marketing 3,588 1,694 9,151 2,855
General and administrative 2,886 2,224 10,813 7,831
Amortization of intangible assets 1,655 1,596 6,967 2,185
Change in fair value of contingent consideration (1,218 ) (400 ) 482 (400 )
Inventory write-down related to restructuring 2,565
Restructuring and other charges (21 ) 3,064
Goodwill impairment 61,784
Acquisition related costs     228     4,231
Total Operating Expenses     14,403       13,900       124,099       46,371  
Operating Loss     (14,388 )     (13,900 )     (123,649 )     (46,371 )
Other Expense
Interest expense, net (390 ) (604 ) (1,889 ) (1,601 )
Other (expense) income     (30 )           35        
Total Other Expense, net     (420 )     (604 )     (1,854 )     (1,601 )
Loss before income taxes $ (14,808 ) $ (14,504 ) $ (125,503 ) $ (47,972 )
Income tax benefit     816       925       5,523       1,024  
Net loss   $ (13,992 )   $ (13,579 )   $ (119,980 )   $ (46,948 )
Other comprehensive gain (loss)
Foreign currency translation gain (loss)     (4,802 )     (2,737 )     (2,603 )     (3,166 )
Comprehensive loss   $ (18,794 )   $ (16,316 )   $ (122,583 )   $ (50,114 )
Net loss per share - basic and diluted   $ (0.12 )   $ (0.13 )   $ (1.07 )   $ (0. 59 )
Weighted average common shares outstanding -

basic and diluted

    115,151       100,145       112,185       79,628  
 
   

TransEnterix, Inc.

Consolidated Balance Sheets

(in thousands, except share amounts)

 

(unaudited)

 
Year Ended Year Ended
December 31, December 31,
2016 2015
Assets
Current Assets
Cash and cash equivalents $ 24,165 $ 38,449
Accounts receivable, net 621 76
Inventories 7,883 6,625
Interest receivable 12 6
Other current assets   5,335   3,987
Total Current Assets   38,016   49,143
Restricted cash 10,425
Accounts receivable, net of current portion 266
Inventories, net of current portion 709
Property and equipment, net 5,772 4,408
Intellectual property, net 37,090 46,898
In-process research and development 15,920 16,511
Goodwill 68,697 130,869
Other long term assets   63   64
Total Assets $ 176,249 $ 248,602
Liabilities and Stockholders’ Equity
Current Liabilities
Accounts payable $ 3,984 $ 4,450
Accrued expenses 8,206 7,395
Contingent consideration – current portion 10,502 12,500
Notes payable - current portion, net of debt discount   7,997   6,727
Total Current Liabilities 30,689 31,072
Long Term Liabilities
Contingent consideration – less current portion 12,298 11,000
Notes payable - less current portion, net of debt discount 4,995 12,990
Net deferred tax liabilities   10,397   16,263
Total Liabilities 58,379 71,325
Commitments and Contingencies
Stockholders’ Equity
Common stock $0.001 par value, 750,000,000 shares authorized at December
31, 2016 and 2015, respectively; 115,781,030 and 100,180,872 shares issued
at December 31, 2016 and 2015, respectively; and 115,687,351 and
100,149,453 shares outstanding at December 31, 2016 and 2015, respectively 115 100
Additional paid-in capital 426,609 363,280
Accumulated deficit (302,844 ) (182,864 )
Treasury stock at cost, 93,679 and 31,419 shares at December 31, 2016 and
2015, respectively (241 ) (73 )
Accumulated other comprehensive loss   (5,769 )   (3,166 )
Total Stockholders’ Equity   117,870   177,277
Total Liabilities and Stockholders’ Equity $ 176,249 $ 248,602
 
     

TransEnterix, Inc.

Consolidated Statements of Cash Flows

(in thousands)

 

(unaudited)

 
Year Ended

 

Year Ended

December 31,

 

December 31,

2016 2015
Operating Activities
Net loss $ (119,980 ) $ (46,948 )
Adjustments to reconcile net loss to net cash and cash equivalents used
in operating activities:
Depreciation 1,942 1,248
Amortization of intangible assets 6,967 2,185
Amortization of debt discount and debt issuance costs 177 142
Stock-based compensation 5,033 3,311
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 2,556
Goodwill impairment 61,784
Deferred tax benefit (5,562 ) (1,024 )
Change in fair value of contingent consideration 482 (400 )
Changes in operating assets and liabilities, net of effect of acquisition:
Accounts receivable (1,041 ) 133
Interest receivable (6 ) (5 )
Inventories (6,647 ) (4,630 )
Other current and long term assets (1,528 ) 728
Accounts payable (356 ) 1,096
Accrued expenses   1,112   5,371
Net cash and cash equivalents used in operating activities   (52,386 )   (38,759 )
Investing Activities
Payment for acquisition of a business (25,000 )
Purchase of property and equipment   (1,361 )   (1,234 )
Net cash and cash equivalents (used in) provided by investing activities   (1,361 )   (26,234 )
Financing Activities
Payment of debt (6,902 )
Payment of contingent consideration (1,182 )
Proceeds from issuance of common stock, net of issuance costs 58,029 58,331
Proceeds from issuance of debt, net of debt discount 9,887
Taxes paid related to net share settlement of vesting of restricted stock units (168 ) (73 )
Proceeds from exercise of stock options and warrants   166   259
Net cash and cash equivalents provided by financing activities   49,943   68,404
Effect of exchange rate changes on cash and cash equivalents   (55 )   22
Net (decrease) increase in cash, cash equivalents and restricted cash (3,859 ) 3,433
Cash, cash equivalents and restricted cash, beginning of period   38,449   35,016
Cash, cash equivalents and restricted cash, end of period $ 34,590 $ 38,449
Supplemental Disclosure for Cash Flow Information
Interest paid $ 1,289 $ 973
Supplemental Schedule of Noncash Investing Activities
Transfer of inventory to property and equipment $ 3,198
Issuance of common stock warrants $ 97
Contingent consideration related to acquisition $ 23,900
Issuance of common stock related to acquisition $ 43,677
 

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