RESEARCH TRIANGLE PARK, N.C.--(EON: Enhanced Online News)--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.
“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.”
- 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."
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.
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.
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.
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.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except per share amounts)
|Three Months Ended||Year Ended|
|December 31,||December 31,|
|Cost of revenue||38||—||1,069||—|
|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||—|
|Acquisition related costs||—||228||—||4,231|
|Total Operating Expenses||14,403||13,900||124,099||46,371|
|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||)||$||(47,972||)|
|Income tax benefit||816||925||5,523||1,024|
|Other comprehensive gain (loss)|
|Foreign currency translation gain (loss)||(4,802||)||(2,737||)||(2,603||)||(3,166||)|
|Net loss per share - basic and diluted||$||(0.12||)||$||(0.13||)||$||(1.07||)||$||(0. 59||)|
Weighted average common shares outstanding -
basic and diluted
Consolidated Balance Sheets
(in thousands, except share amounts)
|Year Ended||Year Ended|
|December 31,||December 31,|
|Cash and cash equivalents||$||24,165||$||38,449|
|Accounts receivable, net||621||76|
|Other current assets||5,335||3,987|
|Total Current Assets||38,016||49,143|
|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|
|Other long term assets||63||64|
|Liabilities and Stockholders’ Equity|
|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|
|Commitments and Contingencies|
|Common stock $0.001 par value, 750,000,000 shares authorized at December|
|31, 2016 and 2015, respectively; 115,781,030 and 100,180,872 shares issued|
|at December 31, 2016 and 2015, respectively; and 115,687,351 and|
|100,149,453 shares outstanding at December 31, 2016 and 2015, respectively||115||100|
|Additional paid-in capital||426,609||363,280|
|Treasury stock at cost, 93,679 and 31,419 shares at December 31, 2016 and|
|Accumulated other comprehensive loss||(5,769||)||(3,166||)|
|Total Stockholders’ Equity||117,870||177,277|
|Total Liabilities and Stockholders’ Equity||$||176,249||$||248,602|
Consolidated Statements of Cash Flows
|Adjustments to reconcile net loss to net cash and cash equivalents used|
|in operating activities:|
|Amortization of intangible assets||6,967||2,185|
|Amortization of debt discount and debt issuance costs||177||142|
|Common stock issued for services||116||—|
|Inventory write-down related to restructuring||2,565||—|
|Loss on disposal of property||—||34|
|Non-cash restructuring and other charges||2,556||—|
|Deferred tax benefit||(5,562||)||(1,024||)|
|Change in fair value of contingent consideration||482||(400||)|
|Changes in operating assets and liabilities, net of effect of acquisition:|
|Other current and long term assets||(1,528||)||728|
|Net cash and cash equivalents used in operating activities||(52,386||)||(38,759||)|
|Payment for acquisition of a business||—||(25,000||)|
|Purchase of property and equipment||(1,361||)||(1,234||)|
|Net cash and cash equivalents (used in) provided by investing activities||(1,361||)||(26,234||)|
|Payment of debt||(6,902||)||—|
|Payment of contingent consideration||(1,182||)||—|
|Proceeds from issuance of common stock, net of issuance costs||58,029||58,331|
|Proceeds from issuance of debt, net of debt discount||—||9,887|
|Taxes paid related to net share settlement of vesting of restricted stock units||(168||)||(73||)|
|Proceeds from exercise of stock options and warrants||166||259|
|Net cash and cash equivalents provided by financing activities||49,943||68,404|
|Effect of exchange rate changes on cash and cash equivalents||(55||)||22|
|Net (decrease) increase in cash, cash equivalents and restricted cash||(3,859||)||3,433|
|Cash, cash equivalents and restricted cash, beginning of period||38,449||35,016|
|Cash, cash equivalents and restricted cash, end of period||$||34,590||$||38,449|
|Supplemental Disclosure for Cash Flow Information|
|Supplemental Schedule of Noncash Investing Activities|
|Transfer of inventory to property and equipment||$||3,198||—|
|Issuance of common stock warrants||—||$||97|
|Contingent consideration related to acquisition||—||$||23,900|
|Issuance of common stock related to acquisition||—||$||43,677|