EX-99.1 2 d713987dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

TransEnterix, Inc. Reports Operating and Financial Results for the Fourth Quarter and Full Year 2018

February 26, 2019 at 6:55 AM EDT

RESEARCH TRIANGLE PARK, N.C.—(BUSINESS WIRE)--Feb 26, 2019— TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced its operating and financial results for the fourth quarter and full year 2018.

Recent Highlights

 

 

Sold five Senhance Systems globally in the fourth quarter in 2018

 

 

Total revenue of $7.5 million in the fourth quarter of 2018

 

 

Received U.S. FDA clearance for Senhance Ultrasonic System subsequent to the end of the 2018 fourth quarter

 

 

Received U.S. FDA clearance for 3mm diameter instruments

 

 

Received CE Mark for articulating instruments and submitted its application for U.S. FDA 510(k) clearance during the fourth quarter

 

 

Received Taiwanese FDA approval for the Senhance System instruments in the fourth quarter of 2018

 

 

Closed acquisition of substantially all of the assets of MST Medical Surgery Technologies Ltd., an Israel-based medical technology company

“2018 was a transformative year for TransEnterix, as we continued to drive the global commercial adoption of the Senhance System – both in terms of expanding our installed base as well as expanding the applicability of the Senhance System by increasing its indications for use, expanding the variety of instruments available with the Senhance System, and expanding into new geographies by receiving additional regulatory clearances,” said Todd M. Pope, President and CEO of TransEnterix. “In 2019, we see a significant opportunity to leverage all of the progress we made in 2018 to continue to grow the adoption of the Senhance System globally.”

Commercial and Clinical Update

In the quarter ended December 31, 2018, the Company sold five Senhance Systems, with three sold in EMEA (Europe, Middle East, and Africa), one in the U.S., and one in Asia.

Instrument Portfolio Expansion

Ultrasonic Instrument System

On October 1, 2018, the Company announced that it had received a CE Mark for its Senhance Ultrasonic Instrument System, and during the fourth quarter this system was commercially launched in CE Mark countries. Advanced energy devices, including ultrasonic devices, represent some of the most versatile and critical tools for surgeons in minimally invasive surgery. These instruments deliver controlled energy to effectively ligate and divide tissue, and minimize thermal injury to surrounding structures.


On January 15, 2019, the Company announced it had received FDA 510(k) clearance for its Senhance Ultrasonic System.

3mm Diameter Instrument Set

On October 11, 2018, the Company received FDA 510(k) clearance for 3 millimeter diameter Senhance System instruments, as well as additional 5 millimeter Senhance System instruments. The clearance of the 3 millimeter diameter instruments will allow the Senhance System to be used for microlaparoscopic surgeries, enabling surgeons to operate through smaller incisions considered virtually scarless for patients, supporting the Company’s mission of advancing minimally invasive surgical capabilities within digital laparoscopy.

Articulating Instruments

The Company received CE Mark for its 5mm diameter articulating instruments during the fourth quarter of 2018.

The Company submitted its application for FDA 510(k) clearance for its 5mm diameter articulating instruments during the fourth quarter of 2018.

Expansion of Geographic Regulatory Approvals

The Company received Taiwanese FDA approval for the Senhance System instruments during the fourth quarter. This follows the approval of the Senhance System in the second quarter of 2018.

Acquisition Agreement with MST

On October 31, 2018, the Company announced the closing of the acquisition of substantially all of the assets of MST Medical Surgery Technologies Ltd. (“MST”), an Israel-based medical technology company. MST is a leader in the field of surgical technology, having developed a software-based image analytics platform powered by advanced visualization, scene recognition, artificial intelligence, machine learning and data analytics.

The addition of MST’s technology, IP portfolio and R&D team will support and accelerate TransEnterix’s vision to leverage its Senhance System to deliver digital laparoscopy, thereby increasing control in the surgical environment and reducing surgical variability. The acquisition also provides immediate access to an established R&D center in Israel with a core team of experienced engineers.

Fourth Quarter Financial Highlights

For the three months ended December 31, 2018, the Company reported revenue of $7.5 million as compared to revenue of $3.4 million in the three months ended December 31, 2017. Revenue in the fourth quarter of 2018 included $6.3 million in system sales, $820 thousand in instruments and accessories, and $383 thousand in services.


For the three months ended December 31, 2018, total net operating expenses were $20.1 million, as compared to $17.8 million in the three months ended December 31, 2017.

For the three months ended December 31, 2018, net loss was $6.4 million, or $0.03 per share, as compared to a net loss of $76.2 million, or $0.40 per share, in the three months ended December 31, 2017.

For the three months ended December 31, 2018, adjusted net loss was $14.7 million, or $0.07 per share, as compared to an adjusted net loss of $14.1 million, or $0.07 per share in the three months ended December 31, 2017, after adjusting for the following charges: change in fair value of warrant liabilities, amortization of intangible assets, change in fair value of contingent consideration, acquisition-related costs and SurgiBot sale gain/loss. Adjusted net loss is a non-GAAP measure. See the reconciliation from GAAP to Non-GAAP Measures below.

The Company had cash and cash equivalents and short term investments of approximately $72.9 million as of December 31, 2018. On October 23, 2018, Hercules Capital, Inc. funded the second tranche of $10.0 million under the Hercules loan agreement. The Company believes that it has sufficient cash and additional debt proceeds under the current agreement to fund the business into late 2020.

Conference Call

TransEnterix, Inc. will host a conference call on Tuesday, February 26, 2019 at 8:00 AM ET to discuss its fourth quarter and fiscal year 2018 operating and financial results. To listen to the conference call on your telephone, please dial (844) 804-5261 for domestic callers or (612) 979-9885 for international callers and reference conference ID 6086178 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 digitizing the interface between the surgeon and the patient 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 System, which digitizes laparoscopic minimally invasive surgery. The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing and improved ergonomics while offering responsible economics. The Senhance Surgical System is available for sale in the US, the EU and select other countries. For more information, visit www.transenterix.com.


Non-GAAP Measures

The adjusted net loss and adjusted net loss per share presented in this press release are non-GAAP measures. The adjustments relate to the change in fair value of warrant liabilities, reversal of transfer fee accrual, amortization of intangible assets, change in fair value of contingent consideration, acquisition-related costs, loss on extinguishment of debt and SurgiBot sale gain/loss. These financial measures are presented on a basis other than in accordance with U.S. generally accepted accounting principles (“Non-GAAP Measures”). In the tables that follow under “Reconciliation of Non-GAAP Measures,” we present adjusted net loss and adjusted net loss per share, reconciled to their comparable GAAP measures. These items are adjusted because they are not operational or because these charges are non-cash or non-recurring and management believes these adjustments are meaningful to understanding the Company’s performance during the periods presented. These Non-GAAP Measures should be considered a supplement to, not a substitute for, or superior to, the corresponding financial measures calculated in accordance with GAAP.

Forward-Looking Statements

This press release includes statements relating to the current regulatory and commercialization plans for the Senhance Surgical System, as well as 2018 fourth quarter and full year results and plans for 2019 and beyond. 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 and include whether we will be able to leverage all of the progress we made in 2018 to grow the adoption and purchase of the Senhance System globally; whether the clearance of the 3 millimeter diameter instruments will allow the Senhance System to be used for microlaparoscopic surgeries; whether the addition of MST’s technology, IP portfolio and R&D team will support and accelerate TransEnterix’s vision to leverage its Senhance System to deliver laparoscopy, thereby increasing control in the surgical environment and reducing surgical variability; and whether TransEnterix has sufficient cash and additional debt proceeds under the current agreement to fund the business into late 2020. 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, 2017, filed with the SEC on March 8, 2018 and our other filings we make with the SEC, including the Form 10-K for the year ended December 31, 2018 expected to be filed prior to its filing deadline. 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     Twelve Months Ended  
     December 31,     December 31,  
     2018     2017     2018     2017  

Revenue

   $ 7,524     $ 3,398     $ 24,102     $ 7,111  

Cost of revenue

     5,635       3,500       16,171       6,727  
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit (loss)

     1,889       (102     7,931       384  
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating Expenses (Income)

        

Research and development

     6,439       5,175       21,823       21,989  

Sales and marketing

     7,901       5,536       25,736       17,536  

General and administrative

     3,865       3,587       13,854       12,275  

Amortization of intangible assets

     2,624       2,714       10,868       7,858  

Change in fair value of contingent consideration

     (1,092     800       (1,011     2,026  

Issuance costs for warrants

                       627  

Acquisition related costs

     302             647        

Gain from sale of SurgiBot assets, net

     75             (11,840      

Reversal of transfer fee accrual

                 (2,994      
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Operating Expenses (Income)

     20,114       17,812       57,083       62,311  
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating Loss

     (18,225     (17,914     (49,152     (61,927
  

 

 

   

 

 

   

 

 

   

 

 

 

Other Income (Expense)

        

Change in fair value of warrant liabilities

     10,118       (58,521     (14,320     (83,734

Interest income

     418       184       1,400       308  

Interest expense

     (810     (862     (4,208     (2,443

Other income (expense)

     1,235       (6     1,126       (300
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Other Income (Expense), net

     10,961       (59,205     (16,002     (86,169
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

   $ (7,264   $ (77,119   $ (65,154   $ (148,096

Income tax benefit

     823       963       3,377       3,300  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (6,441   $ (76,156   $ (61,777   $ (144,796
  

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive loss

        

Foreign currency translation (loss) gain

     (1,039     1,282       (3,690     10,797  
  

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive loss

   $ (7,480   $ (74,874   $ (65,467   $ (133,999
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share – basic and diluted

   $ (0.03   $ (0.40   $ (0.30   $ (0.97
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average common shares outstanding – basic and diluted

     215,144       190,648       207,199       148,744  
  

 

 

   

 

 

   

 

 

   

 

 

 


TransEnterix, Inc.

Consolidated Balance Sheets

(in thousands, except share amounts)

(Unaudited)

 

     December 31,     December 31,  
     2018     2017  

Assets

    

Current Assets

    

Cash and cash equivalents

   $ 21,061     $ 91,217  

Short-term investments

     51,790        

Accounts receivable, net

     8,560       1,536  

Inventories

     10,941       10,817  

Interest receivable

     26       80  

Other current assets

     9,205       9,344  
  

 

 

   

 

 

 

Total Current Assets

     101,583       112,994  
  

 

 

   

 

 

 

Restricted cash

     590       6,389  

Property and equipment, net

     6,337       6,670  

Intellectual property, net

     39,716       52,638  

In-process research and development

     10,747        

Goodwill

     80,131       71,368  

Other long term assets

     203       192  
  

 

 

   

 

 

 

Total Assets

   $ 239,307     $ 250,251  
  

 

 

   

 

 

 

Liabilities and Stockholders’ Equity

    

Current Liabilities

    

Accounts payable

   $ 4,433     $ 3,771  

Accrued expenses

     9,619       10,974  

Deferred revenue – current portion

     1,733       1,088  

Deferred gain from sale of SurgiBot assets

           7,500  

Contingent consideration – current portion

     72       719  

Deferred consideration – MST Acquisition

     5,962        

Notes payable – current portion, net of debt discount

           4,788  
  

 

 

   

 

 

 

Total Current Liabilities

     21,819       28,840  

Long Term Liabilities

    

Deferred revenue – less current portion

     109        

Contingent consideration – less current portion

     10,565       11,699  

Notes payable – less current portion, net of debt discount

     28,937       8,385  

Warrant liabilities

     4,636       14,090  

Net deferred tax liabilities

     4,720       8,389  
  

 

 

   

 

 

 

Total Liabilities

     70,786       71,403  

Commitments and Contingencies

    

Stockholders’ Equity

    

Common stock $0.001 par value, 750,000,000 shares authorized at December 31, 2018 and December 31, 2017; 216,345,984 and 199,282,003 shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively

     216       199  

Additional paid-in capital

     676,373       621,261  

Accumulated deficit

     (509,406     (447,640

Accumulated other comprehensive income

     1,338       5,028  
  

 

 

   

 

 

 

Total Stockholders’ Equity

     168,521       178,848  
  

 

 

   

 

 

 

Total Liabilities and Stockholders’ Equity

   $ 239,307     $ 250,251  
  

 

 

   

 

 

 


TransEnterix, Inc.

Consolidated Statements of Cash Flows

(in thousands)

(Unaudited)

 

     Twelve Months Ended  
     December 31,  
     2018     2017  

Operating Activities

    

Net loss

   $ (61,777   $ (144,796

Adjustments to reconcile net loss to net cash and cash equivalents used in

operating activities:

    

Gain from sale of SurgiBot assets, net

     (11,840      

Depreciation

     2,420       2,486  

Amortization of intangible assets

     10,868       7,858  

Amortization of debt discount and debt issuance costs

     725       510  

Amortization of short-term investment discount

     (351      

Stock-based compensation

     9,039       7,078  

Non-employee warrant awards

           838  

Deferred tax benefit

     (3,377     (3,300

Loss on extinguishment of debt

     1,400       308  

Change in fair value of warrant liabilities

     14,320       83,734  

Change in fair value of contingent consideration

     (1,011     2,026  

Reversal of transfer fee accrual

     (2,994      

Changes in operating assets and liabilities (net of effect of acquisition):

    

Accounts receivable

     (7,225     (381

Interest receivable

     54       23  

Inventories

     (2,145     (2,981

Other current and long term assets

     (325     (3,348

Accounts payable

     767       (531

Accrued expenses

     2,134       2,093  

Deferred revenue

     825       1,088  
  

 

 

   

 

 

 

Net cash and cash equivalents used in operating activities

     (48,493     (47,295
  

 

 

   

 

 

 

Investing Activities

    

Purchase of short-term investments

     (55,439      

Proceeds from maturities of short-term investments

     4,000        

Payment for acquisition of a business

     (5,800      

Proceeds related to sale of SurgiBot assets, net

     4,496       7,500  

Purchase of property and equipment

     (770     (1,566

Purchase of intellectual property

           (425

Proceeds from sale of property and equipment

     32        
  

 

 

   

 

 

 

Net cash and cash equivalents (used in) provided by investing activities

     (53,481     5,509  
  

 

 

   

 

 

 

Financing Activities

    

Payment of notes payable

     (15,305     (13,343

Proceeds from issuance of debt and warrants, net of issuance costs

     28,507       13,005  

Payment of contingent consideration

     (770     (7,181

Proceeds from issuance of common stock and warrants, net of issuance costs

     279       77,579  

Taxes paid related to net share settlement of vesting of restricted stock units

     (1,662     (168

Proceeds from issuance of common stock related to sale of SurgiBot assets

     3,000        

Proceeds from exercise of stock options and warrants

     12,403       34,479  
  

 

 

   

 

 

 

Net cash and cash equivalents provided by financing activities

     26,452       104,371  
  

 

 

   

 

 

 

Effect of exchange rate changes on cash and cash equivalents

     (433     431  
  

 

 

   

 

 

 

Net (decrease) increase in cash, cash equivalents and restricted cash

     (75,955     63,016  

Cash, cash equivalents and restricted cash, beginning of period

     97,606       34,590  
  

 

 

   

 

 

 

Cash, cash equivalents and restricted cash, end of period

   $ 21,651     $ 97,606  
  

 

 

   

 

 

 

Supplemental Disclosure for Cash Flow Information

    

Interest paid

   $ 1,730     $ 899  

Supplemental Schedule of Noncash Investing and Financing Activities

    

Transfer of inventories to property and equipment

   $ 2,160     $ 1,258  

Transfer of property and equipment to inventories

   $ 637     $  

Issuance of common stock as contingent consideration

   $     $ 5,227  

Relative fair value of warrants issued with debt

   $     $ 300  

Reclass of warrant liability to common stock and additional paid-in capital

   $ 23,774     $ 78,359  

Transfer of in-process research and development to intellectual property

   $     $ 17,913  

Cashless exercise of warrants

   $ 4,272     $ 149  

Issuance of common stock related to acquisition

   $ 8,300     $  

Deferred consideration – MST acquisition

   $ 5,962     $  
  

 

 

   

 

 

 


TransEnterix, Inc.

Reconciliation of Non-GAAP Measures

Adjusted Net Loss and Net Loss per Share

(in thousands except per share amounts)

(Unaudited)

 

     Three Months Ended      Twelve Months Ended  
     December 31,      December 31,  
     2018     2017      2018     2017  

(Unaudited, U.S. Dollars, in thousands)

         

Net loss (GAAP Measure)

   $ (6,441)     $ (76,156)      $ (61,777)     $ (144,796)  

Adjustments

         

Gain from sale of SurgiBot assets, net

     75              (11,840      

Amortization of intangible assets

     2,624       2,714        10,868       7,858  

Change in fair value of contingent consideration

     (1,092     800        (1,011     2,026  

Acquisition related costs

     302              647        

Reversal of transfer fee accrual

                  (2,994      

Change in fair value of warrant liabilities

     (10,118     58,521        14,320       83,734  

Loss on extinguishment of debt

                  1,400       308  
  

 

 

   

 

 

    

 

 

   

 

 

 

Adjusted net loss (Non-GAAP Measure)

   $ (14,650)     $ (14,121)      $ (50,387)     $ (50,870)  
  

 

 

   

 

 

    

 

 

   

 

 

 
     Three Months Ended      Twelve Months Ended  
     December 31,      December 31,  
(Unaudited, per diluted share)    2018     2017      2018     2017  

Net loss per share (GAAP Measure)

   $ (0.03)     $ (0.40)      $ (0.30)     $ (0.97)  

Adjustments

         

Gain from sale of SurgiBot assets

     0.00              (0.06      

Amortization of intangible assets

     0.01       0.01        0.05       0.05  

Change in fair value of contingent consideration

     (0.01     0.00        0.00       0.01  

Acquisition related costs

     0.00              0.00        

Reversal of transfer fee accrual

                  (0.01      

Change in fair value of warrant liabilities

     (0.04     0.32        0.07       0.57  

Loss on extinguishment of debt

                  0.01       0.00  
  

 

 

   

 

 

    

 

 

   

 

 

 

Adjusted net loss per share (non-GAAP Measure)

   $ (0.07)     $ (0.07)      $ (0.24)     $ (0.34)  
  

 

 

   

 

 

    

 

 

   

 

 

 


The non-GAAP financial measures for the three and twelve months ended December 31, 2018 and 2017 provide management with additional insight into the Company’s results of operations from period to period without non-recurring and non-cash charges, and are calculated using the following adjustments:

a)    Gain from sale of SurgiBot assets relates to amounts received from Great Belief International Limited in excess of the carrying amount of the assets sold.

b)    Intangible assets that are amortized consist of developed technology and purchased patent rights recorded at cost and amortized over 5 to 10 years.

c)    Contingent consideration in connection with the acquisition of the Senhance System in 2015 is recorded as a liability and is the estimate of the fair value of potential milestone payments related to business acquisitions. Contingent consideration is measured at fair value using a discounted cash flow model utilizing significant unobservable inputs including the probability of achieving each of the potential milestones and an estimated discount rate associated with the risks of the expected cash flows attributable to the various milestones. Significant increases or decreases in any of the probabilities of success or changes in expected timelines for achievement of any of these milestones would result in a significantly higher or lower fair value of these milestones, respectively, and commensurate changes to the associated liability. The contingent consideration is revalued at each reporting period and changes in fair value are recognized in the consolidated statements of operations and comprehensive loss.

d)    Acquisition related costs were incurred in connection with the MST purchase agreement and consist of legal, accounting, and other costs.

e)    In connection with the Senhance acquisition, the Company recorded an accrual in 2015 third quarter for potential assessment of additional transfer fees. In September 2018, the Company determined that the accrual was no longer required and reversed the accrual.

f)    The Company’s Series B Warrants are measured at fair value using a simulation model which takes into account, as of the valuation date, factors including the current exercise price, the expected life of the warrant, the current price of the underlying stock, its expected volatility, holding cost and the risk-free interest rate for the term of the warrant. The warrant liability is revalued at each reporting period or upon exercise and changes in fair value are recognized in the consolidated statements of operations and comprehensive loss.


g)    In May 2018, in connection with its entrance into the Hercules Loan Agreement, the Company repaid its existing loan and security agreement with Innovatus Life Sciences Lending Fund I, LP. The Company recognized a loss of $1.4 million on the extinguishment of notes payable which is included in interest expense on the consolidated statement of operations and comprehensive loss for the twelve months ended December 31, 2018. In May 2017, in connection with its entrance into the Innovatus Loan Agreement, the Company repaid its then-existing credit facility with Silicon Valley Bank and Oxford Finance LLC. The Company recognized a loss of $308,000 on the extinguishment of notes payable which is included in interest expense on the consolidated statement of operations and comprehensive loss for the twelve months ended December 31, 2017.

Source: TransEnterix, Inc.

For TransEnterix, Inc.

Investors:

Mark Klausner, +1-443-213-0501

invest@transenterix.com

or

Media:

Joanna Rice, + 1-951-751-1858

joanna@greymattermarketing.com