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

Exhibit 99.1

November 6, 2014

TransEnterix, Inc. Reports Operating and Financial Results for the Third Quarter 2014

RESEARCH TRIANGLE PARK, N.C., — (BUSINESS WIRE) — TransEnterix, Inc. (NYSE MKT: TRXC), a medical device company that is pioneering the use of robotics and flexible instruments to improve minimally invasive surgery, today announced its operating and financial results for the third quarter 2014.

Operating Results

    In August 2014, Dr. Helmuth Billy performed a successful sleeve gastrectomy surgery using TransEnterix’s Flex Ligating Shears, which was broadcast at the 5th International Conference on Sleeve Gastrectomy. TransEnterix’s Flex Ligating Shears are the only fully flexible advanced energy device available that offers ligation and division of tissue with direct thermal fusion.

    In September 2014, the Company expanded its existing loan agreement with Oxford Finance LLC and Silicon Valley Bank to provide for up to $25.0 million in growth capital.

    The Company expects to make a 510(k) submission for the SurgiBot™ system in mid-2015. The Company previously anticipated making its 510(k) submission in the fourth quarter of 2014.

“We continue to make substantial progress toward the submission of a 510(k) for the SurgiBot system, having manufactured fully integrated SurgiBot systems, completed functional testing and conducted successful pre-clinical surgical procedures,” said Todd M. Pope, President and Chief Executive Officer of TransEnterix. “While we are disappointed to extend the timeline for our submission, it remains our top priority as a company and we are confident in our ability to make the submission in the middle of 2015.”

Financial Results

Comparison of Selected Consolidated Financial Results (in thousands, except net loss per share)

Three Months Ended September 30,

                 
    2014   2013
Total revenue
  $ 61     $ 362  
Net loss
  $ 11,507     $ 11,265  
Net loss per share
  $ 0.18     $ 1.06  
Weighted average common shares
    63,068       10,584  

Revenue was $61 thousand in the third quarter of 2014 as compared to $362 thousand in the third quarter of 2013. The decrease in revenue was attributable to lower sales volumes of SPIDER® Surgical System as we continue to focus resources on our SurgiBot system development.

Cost of goods sold was $202 thousand in the third quarter of 2014, compared with $2.1 million in the third quarter of 2013. The decrease was primarily the result of lower revenues as we limit sales of the SPIDER Surgical System to existing customers, discontinued production of the SPIDER Surgical System, and transferred employees from manufacturing and quality departments to research and development and regulatory functions.
Research and development expenses were $9.1 million in the third quarter of 2014, compared with $2.9 million in the third quarter of 2013. The increase in expenses was attributable to increased investment in SurgiBot development, including development materials, contract engineering and higher personnel-related costs as we expanded our research and development and regulatory capability.

Sales and marketing expenses remained relatively flat at $456 thousand for the third quarter in comparison to $438 thousand in the prior year period.

General and administrative expenses for the third quarter of 2014 were $1.6 million compared to $1.3 million in the third quarter of 2013. The increase in expenses was due to increased stock-based compensation costs, increased taxes, and increased professional development, offset by decreased compensation costs.

Net loss in the third quarter of 2014 was $11.5 million compared to a net loss of $11.3 million in the third quarter of 2013. Net loss per common share was $0.18 in the third quarter of 2014 based on 63.1 million weighted average common shares outstanding compared to a net loss per share of $1.06 in the third quarter of 2013 based on 10.6 million weighted average common shares outstanding.

Cash and cash equivalents were $44.3 million as of September 30, 2014.

Conference Call

TransEnterix, Inc. will host a conference call on Thursday, November 6, 2014 at 8:30 AM ET to discuss its third quarter operating and financial results. To listen to the conference call on your telephone, please dial (800) 263-8506 for domestic callers or (719) 457-2640 for international callers 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.

Financial Statements

On September 3, 2013, SafeStitch Medical, Inc. (now TransEnterix, Inc.) and TransEnterix Surgical, Inc., formerly known as TransEnterix, Inc., consummated a merger transaction (the “Reverse Merger”) whereby TransEnterix Surgical, Inc. merged with a merger subsidiary of SafeStitch Medical, Inc., with TransEnterix Surgical, Inc. as the surviving entity in the merger. As a result of the merger, TransEnterix Surgical, Inc. became a wholly owned subsidiary of SafeStitch Medical, Inc. On December 6, 2013, SafeStitch Medical, Inc. changed its corporate name to TransEnterix, Inc.

The Reverse Merger has been accounted for as a reverse acquisition under which TransEnterix Surgical, Inc. was considered the acquirer of SafeStitch Medical, Inc. As such, the financial statements of TransEnterix Surgical, Inc. are treated as the historical financial statements of the combined company, with the results of SafeStitch Medical, Inc. being included from September 3, 2013.

About TransEnterix

TransEnterix is a medical device company that is pioneering the use of robotics and flexible instruments to improve minimally invasive surgery. The company is focused on the development and commercialization of the SurgiBot™ system, a minimally invasive surgical robotic system that allows the surgeon to be patient-side within the sterile field. For more information, visit the company’s website at www.transenterix.com.

Forward Looking Statements

This press release includes statements relating to the SurgiBot system, our flexible energy device 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 successfully submit our SurgiBot system regulatory filings in mid-2015, and whether we will be able to bring the SurgiBot system to the market. Factors that could cause our results to differ materially from those described include, but are not limited to, whether the SurgiBot system’s 510(k) application(s) will be cleared by the U.S. FDA, whether the combined company will be successful in 2014 and beyond, the pace of adoption of our product technology by surgeons, the outcome of coverage and reimbursement decisions by the government and third party payors, the success and market opportunity of our continuing and new product development efforts, including the SurgiBot system, 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 Annual Report on Form 10-K for the year ended December 31, 2013 filed on March 5, 2014 as amended, and other filings we make with the Securities and Exchange Commission. 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 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   Nine months ended
    September 30,   September 30,
    2014   2013   2014   2013
 
                               
Sales
  $ 61     $ 362     $ 267     $ 1,212  
Operating Expenses
                               
Cost of goods sold
    202       2,058       660       4,096  
Research and development
    9,067       2,909       21,960       7,855  
Sales and marketing
    456       438       1,323       1,490  
General and administrative
    1,606       1,278       5,133       2,665  
Merger expenses
    —         2,891       —         2,891  
 
                               
Total Operating Expenses
    11,331       9,574       29,076       18,997  
 
                               
Operating Loss
    (11,270 )     (9,212 )     (28,809 )     (17,785 )
 
                               
Other Expense
                               
Remeasurement of fair value of preferred stock warrant liability
    —         (1,800 )     —         (1,800 )
Interest expense, net
    (237 )     (253 )     (764 )     (742 )
 
                               
Total Other Expense, net
    (237 )     (2,053 )     (764 )     (2,542 )
 
                               
Net Loss
  $ (11,507  )   $ (11,265  )   $ (29,573  )   $ (20,327  )
 
                               
Other comprehensive income (loss)
    —         —         —         —    
 
                               
Comprehensive loss
  $ (11,507  )   $ (11,265  )   $ (29,573 )   $ (20,327  )
 
                               
Net loss per share — basic and diluted
  $ (0.18  )   $ (1.06  )   $ (0.52  )   $ (4.75  )
 
                               
Weighted average common shares outstanding — basic and diluted
    63,068       10,584       57,212       4,282  
 
                               

TransEnterix, Inc.

Consolidated Balance Sheets

(in thousands, except share amounts)  

                 
    September 30,   December 31,
    2014   2013
 
               
 
  (unaudited)        
Assets
               
Current Assets
               
Cash and cash equivalents
  $ 44,344     $ 10,014  
Short-term investments
    —         6,191  
Accounts receivable, net
    38       188  
Interest receivable
          68  
Inventory, net
    267       701  
Other current assets
    833       593  
 
               
Total Current Assets
    45,482       17,755  
 
               
Restricted cash
    250       375  
Property and equipment, net
    2,901       1,864  
Intellectual property, net
    2,366       2,741  
Trade names, net
    8       10  
Goodwill
    93,842       93,842  
Other long term assets
    71       127  
 
               
Total Assets
  $ 144,920     $ 116,714  
 
               
Liabilities and Stockholders’ Equity
               
Current Liabilities
               
Accounts payable
  $ 3,265     $ 1,804  
Accrued expenses
    1,756       1,406  
Note payable — current portion
          3,879  
 
               
Total Current Liabilities
    5,021       7,089  
Long Term Liabilities
               
Note payable — less current portion, net of debt discount
    9,871       4,602  
 
               
Total Liabilities
    14,892       11,691  
Commitments and Contingencies
               
Stockholders’ Equity
               
Preferred stock, $0.01 par value, 25,000,000 shares authorized at September 30, 2014 and December 31, 2013, no shares issued and outstanding at September 30, 2014 and December 31, 2013, respectively
    —         —    
Common stock $0.001 par value, 750,000,000 shares authorized at September 30, 2014 and December 31, 2013; 63,096,816 and 48,841,417 shares issued and outstanding at September 30, 2014 and December 31, 2013, respectively(1)
    63       49  
Additional paid-in capital
    257,802       203,238  
Accumulated deficit
    (127,837 )     (98,264 )
 
               
Total Stockholders’ Equity
    130,028       105,023  
 
               
Total Liabilities and Stockholders’ Equity
  $ 144,920     $ 116,714  
 
               

(1)   Adjusted for 1:5 reverse stock split on March 31, 2014.  

TransEnterix, Inc.

Consolidated Statements of Cash Flows

(in thousands)

(Unaudited)  

                 
    Nine Months Ended
    September 30,
    2014   2013
 
               
Operating Activities
               
Net loss
  $ (29,573  )   $ (20,327  )
Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:
               
Depreciation and amortization
    936       1,064  
Amortization of debt issuance costs
    56       78  
Remeasurement of fair value of preferred stock warrant liability
          1,800  
Stock-based compensation
    2,018       484  
Accretion of bond discount
          (1 )
Loss on disposal of property and equipment
    5       32  
Impairment loss on property and equipment
          304  
Changes in operating assets and liabilities:
               
Accounts receivable
    150       251  
Interest receivable
    68       6  
Inventory
    434       667  
Other current and long term assets
    (240 )     (527 )
Restricted cash
    125       —    
Accounts payable
    1,461       1,617  
Accrued expenses
    350       505  
 
               
Net cash and cash equivalents used in operating activities
    (24,210 )     (14,047 )
 
               
Investing Activities
               
Purchase of investments
          (1,104 )
Proceeds from sale and maturities of investments
    6,191       907  
Proceeds from sale of property and equipment
    25        
Cash received in acquisition of a business, net of cash paid
          305  
Purchase of property and equipment
    (1,626 )     (724 )
 
               
Net cash and cash equivalents provided by (used in) investing activities
    4,590       (616 )
 
               
Financing Activities
               
Payment of debt
    (2,877 )     (601)    
Proceeds from the issuance of common stock, net of issuance costs
    52,433       —    
Proceeds from issuance of debt, net of debt discount
    4,321       1,998    
Proceeds from issuance of preferred stock, net of issuance costs
          28,199    
Proceeds from exercise of stock options and warrants
    73       —    
 
               
Net cash and cash equivalents provided by financing activities
    53,950       29,596    
 
               
Net increase in cash and cash equivalents
    34,330       14,933  
Cash and Cash Equivalents, beginning of period
    10,014       8,896  
 
               
Cash and Cash Equivalents, end of period
  $ 44,344     $ 23,829  
 
               
Supplemental Disclosure for Cash Flow Information
               
Interest paid
  $ 518     $ 625  
 
               
Supplemental Schedule of Noncash Investing and Financing Activities
               
Issuance of preferred stock warrants and debt issuance costs
  $     $ 128  
Issuance of common stock warrants
  $ 54     $  
Conversion of bridge notes to preferred stock
  $     $ 1,998  
Conversion of preferred stock warrants to common stock warrants
  $     $ 1,909  

Investor Contact:
Westwicke Partners

Mark Klausner, 443-213-0501
transenterix@westwicke.com

Media Contact:
TransEnterix, Inc.

Mohan Nathan, 919-917-6559
mnathan@transenterix.com