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

March 3, 2016 Exhibit 99.1

TransEnterix, Inc. Reports Operating Results for the Fourth Quarter and Full Year 2015

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 2015.

Full Year 2015 Operating Highlights
Completed Acquisition of the ALF-X® System from SOFAR S.p.A.

Submitted 510(k) Application to the FDA for the SurgiBot™ System

Raised $58.3 Million in Net Proceeds from Equity and Debt Transactions

Strengthened Global Leadership Team with the Appointment of Senior Executives

“2015 was a transformative year for TransEnterix, as we are now positioned as a global surgical robotics company. In 2016, our focus will shift from product development to commercial execution,” said Todd M. Pope, President and Chief Executive Officer of TransEnterix. “We will continue building the infrastructure to support the commercialization of the ALF-X in multiple countries that accept CE Mark, and we remain focused on achieving FDA clearance for the SurgiBot by the end of March, 2016, and preparing for a U.S. commercial launch.”

Financial Highlights
For the three months ended December 31, 2015, the Company reported research and development expenses of $8.6 million, sales and marketing expenses of $1.7 million, general and administrative expenses of $2.2 million, amortization of intangible assets of $1.6 million, and acquisition related costs of $0.2 million. Operating expenses were primarily associated with the commercialization of the ALF-X and the development of the SurgiBot.

For the full year ended December 31, 2015, the Company reported research and development expenses of $29.7 million, sales and marketing expenses of $2.9 million, general and administrative expenses of $7.8 million, amortization of intangible assets of $2.2 million, and acquisition related costs of $4.2 million. Operating expenses were primarily associated with the acquisition of the ALF-X and the development of the SurgiBot.

ALF-X Business Update
In the fourth quarter, the Company completed integration of the Surgical Robotics Division of SOFAR S.p.A. The commercialization team for the ALF-X was significantly expanded and now is comprised of 10 employees. The Company initiated digital marketing campaigns targeted at surgeons and hospital administrators across Europe and the Middle East. The Company participated in seven medical symposia, including four where the ALF-X was on-site for surgeon demonstrations. In addition, sales activities were commenced in targeted markets in Europe.

2016 Priorities and Expectations
During 2016, the Company will continue to expand its sales and service infrastructure for the ALF-X System in Europe and the Middle East. Following SurgiBot FDA clearance, the Company intends to expand its U.S. sales and service infrastructure, develop training sites and work with key opinion leaders to gain clinical experience on SurgiBot. The Company plans to submit a 510(K) application to the FDA for the ALF-X system in the fourth quarter of 2016 and capitalize on the U.S. market opportunity in 2017 with a dual-platform portfolio.

Cash Outlook
The Company had cash and cash equivalents of approximately $38.4 million as of December 31, 2015, and approximately $47.1 million as of February 29, 2016. The Company expects its existing cash and cash equivalents to fund operations through the end of 2016. 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, 2015, included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission expected to be filed on or about March 3, 2016, 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 Thursday, March 3, 2016 at 4:30 PM ET to discuss its fourth quarter and full year 2015 operating and financial results. To listen to the conference call on your telephone, please dial (888) 505-4369 for domestic callers or (719) 457-0820 for international callers approximately ten minutes prior to the start time. Management will refer to a presentation that is available for download on the Company’s website. To download the presentation or 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 development and commercialization of the SurgiBot System, a single-port, robotically enhanced laparoscopic surgical platform, and the commercialization of the ALF-X, 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 tracking camera control. The SurgiBot System is not yet available for sale in any market. The ALF-X has been granted a CE Mark but is not available for sale in the US. For more information, visit the TransEnterix website at www.transenterix.com.

Forward Looking Statements
This press release includes statements relating to initial fourth quarter and full year 2015 results and the SurgiBot System, the ALF-X® 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 and prepare for a U.S. launch; whether we will be able to successfully commercialize the SurgiBot System and the ALF-X System, and whether the Company’s existing cash and cash equivalents will fund operations through 2016. 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 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.

Investor Contact:
Westwicke Partners
Mark Klausner, 443-213-0501
invest@transenterix.com
or
Media Contact:
TransEnterix, Inc.
Mohan Nathan, 919-917-6559
mnathan@transenterix.com

1

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,
    2015   2014   2015   2014
 
                               
Sales
  $     $ 134   $     $ 401
Operating Expenses
                               
Cost of goods sold
    435     1,095
Research and development
    8,558       5,984       29,669       27,944  
Sales and marketing
    1,694       404       2,855       1,727  
General and administrative
    2,224       985       7,831       5,741  
Amortization of intangible assets
    1,596       126       2,185       503  
Change in fair value of contingent consideration
    (400 )     (400)     —   
Acquisition related costs
    228       4,231     —   
 
                               
Total Operating Expenses
    13,900       7,934       46,371       37,010  
 
                               
Operating Loss
    (13,900 )     (7,800 )     (46,371 )     (36,609 )
 
                               
Other Expense
                               
Interest expense, net
    (604 )     (279 )     (1,601 )     (1,043 )
 
                               
Total Other Expense, net
    (604 )     (279 )     (1,601 )     (1,043 )
 
                               
Loss before income taxes
  $ (14,504  )   $ (8,079  )   $ (47,972  )   $ (37,652  )
Income tax benefit
    925       1,024      
 
                               
Net loss
  $ (13,579  )   $ (8,079  )   $ (46,948 )   $ (37,652 )
Other comprehensive loss
                               
Foreign currency translation loss
  $ (2,737  )   $     $ (3,166 )   $  
 
                               
Comprehensive loss
  $ (16,316  )   $ (8,079  )   $ (50,114 )   $ (37,652 )
 
                               
Net loss per share — basic and diluted
  $ (0.13  )   $ (0.13  )   $ (0.59 )   $ (0.64 )
 
                               
Weighted average common shares outstanding — basic and diluted
    100,145       63,171       79,628       58,714  
 
                               

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

(unaudited)

                                                         
             
                    Year Ended        
            December 31,        
    2015           2014          
Assets
                                                       
Current Assets
                                                       
Cash and cash equivalents
          $ 38,449                              $ 34,766           
Accounts receivable, net
            76                                133           
Inventories
            3,923                                —             
Interest receivable
            6                                1           
Other current assets
            6,689                                740           
 
                                                       
Total Current Assets
            49,143                                35,640           
 
                                                       
Inventories
            709                                        
Restricted cash
            —                                  250           
Property and equipment, net
            4,408                                3,120           
Intellectual property, net
            46,898                                2,241           
In-process research and development
            16,511                                —             
Goodwill
            130,869                                93,842           
Other long term assets
            64                                18           
 
                                                       
Total Assets
  $                      248,602                      $                135,111           
 
                                                       
 
                                                       
Liabilities and Stockholders’ Equity
                                                       
Current Liabilities
                                                       
Accounts payable
          $ 4,450                              $ 1,768           
Accrued expenses
            7,395                                1,769           
Contingent consideration – current portion
            12,500                               —            
Notes payable — current portion
            6,727                                610           
 
                                                       
Total Current Liabilities
            31,072                                4,147           
Long Term Liabilities
                                                       
Contingent consideration – less current portion
            11,000                                —             
Net deferred tax liabilities
            16,263                                —             
Notes payable — less current portion, net of debt discount
            12,990                                9,175           
 
                                                       
Total Liabilities
            71,325                                13,322           
Commitments and Contingencies
                                                       
Stockholders’ Equity
                                                       
Common stock $0.001 par value, 750,000,000 shares authorized at December 31, 2015 and 2014; 100,180,872 and 63,182,806 shares issued at December 31, 2015 and December 31, 2014, respectively; and 100,149,453 and 63,182,806 shares outstanding at December 31, 2015 and December 31, 2014, respectively
            100                                63           
Additional paid-in capital
            363,280                                257,642           
Accumulated deficit
            (182,864 )                             (135,916 )        
Treasury stock at cost, 31,419 and 0 shares at December 31, 2015 and December 31, 2014, respectively
            (73 )                             —             
Accumulated other comprehensive loss
            (3,166 )                             —             
 
                                                       
Total Stockholders’ Equity
            177,277                                121,789           
 
                                                       
Total Liabilities and Stockholders’ Equity
  $                      248,602                      $                135,111           
 
                                                       

2

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

(unaudited)

                                                         
                                 
                          Year Ended        
                  December 31,        
         2015           2014        
Operating Activities
                                                        
Net loss
                   $ (46,948 )                   $ (37,652 )        
Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:
                                                        
Depreciation
                     1,248                        807            
Amortization of intangible assets
                    2,185                       503          
Amortization of debt discount and debt issuance costs
                     142                        83            
Stock-based compensation
                     3,311                        1,840            
Loss on disposal of property and equipment
                     34                        86            
Deferred tax benefit
                     (1,024 )                     —           
Change in fair value of contingent consideration
                    (400 )                     —           
Changes in operating assets and liabilities, net of effect of acquisition:
                                                        
Accounts receivable
                     133                        55            
Interest receivable
                     (5 )                     67          
Inventories
                     (1,928 )                     701          
Other current and long term assets
                     (1,974 )                     (170 )        
Restricted cash
                     250                        125            
Accounts payable
                     1,096                        (36)           
Accrued expenses
                     5,371                        363            
 
                                                         
Net cash and cash equivalents used in operating activities
                     (38,509 )                     (33,228 )        
 
                                                         
Investing Activities
                                                        
Proceeds from sale and maturities of investments
                                           6,191            
Proceeds from sale of property and equipment
                                           25             
Payments for acquisition of a business
                     (25,000 )                     —             
Purchase of property and equipment
                     (1,234 )                     (2,174 )        
 
                                                         
Net cash and cash equivalents (used in) provided by investing activities
                     (26,234 )                     4,042          
 
                                                         
Financing Activities
                                                        
Payment of debt
                     —                        (2,877)           
Proceeds from issuance of common stock, net of issuance costs
                     58,331                        52,433            
Proceeds from issuance of debt, net of debt discount
                     9,887                        4,291            
Taxes paid related to net share settlement of vesting of restricted stock units
                     (73 )                              
Proceeds from exercise of stock options and warrants
                     259                        91            
 
                                                         
Net cash and cash equivalents provided by financing activities
                     68,404                        53,938            
 
                                                         
Effect of exchange rate changes on cash and cash equivalents
                     22                        —              
 
                                                         
Net increase in cash and cash equivalents
                     3,683                        24,752            
Cash and Cash Equivalents, beginning of period
                     34,766                        10,014            
 
                                                         
Cash and Cash Equivalents, end of period
           $               38,449              $                34,766            
 
                                                       
 
                                                         
Supplemental Disclosure for Cash Flow Information
                                                        
Interest paid
                   $ 973                     $ 904            
Supplemental Schedule of Noncash Investing and Financing Activities
                                                        
Issuance of common stock warrants
                   $ 97                     $ 54            
Contingent consideration related to acquisition
                   $ 23,900             $         —             
Issuance of common stock related to acquisition
                   $ 43,677             $                  

3