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 third quarter of 2016.
- On July 29, 2016, the Company closed its first sale of the Senhance™ Surgical Robotic System (formerly known as the ALF-X System) to Humanitas Hospital, a research and teaching hospital partnered with Humanitas University Medical School, located in Milan, Italy.
- On October 4, 2016, the first radical hysterectomy for cervical cancer utilizing the Senhance system was performed by gynecologic surgeon Dr. Salvatore Gueli Alletti at the Policlinico A. Gemelli Foundation in Rome, Italy.
- On November 8, 2016, the Company announced that it has partnered with Getz Healthcare, a leading pan-Asian distributor of medical devices and equipment. Getz will be the exclusive distribution partner for the Senhance system in the Australian and New Zealand markets.
- Today, the Company announced the installation of a Senhance system at Imperial College, in partnership with Imperial College London and St. Mary’s Hospital. The Senhance system will be utilized within Imperial College’s Minimally Invasive Surgery program in general, bariatric and colorectal surgery.
"We are pleased with our recent progress, which included the first sale of a Senhance system and the continued development of our commercial pipeline," said Todd M. Pope, President and Chief Executive Officer of TransEnterix. "We remain enthusiastic about the potential of Senhance, and will continue to invest in global commercial expansion, including partnering with additional influential institutions to establish clinical reference sites."
The company reported revenue of $1.5 million for the three months ended September 30, 2016, representing the sale of one Senhance system and related instruments and service, net of deferred revenue.
Total operating expenses were $14.0 million for the three months ended September 30, 2016, as compared to $13.6 million in the three months ended September 30, 2015.
Net loss was $12.9 million, or $0.11 per share, for the three months ended September 30, 2016, as compared to $13.9 million, or $0.16 per share, in the three months ended September 30, 2015.
The Company had cash, cash equivalents and restricted cash of approximately $52.9 million as of September 30, 2016. The Company expects its existing cash, cash equivalents and restricted cash to fund operations into the fourth quarter of 2017.
TransEnterix, Inc. will host a conference call on Wednesday, November 9, 2016 at 4:30 PM ET to discuss its third quarter 2016 operating and financial results. To listen to the conference call on your telephone, please dial (888) 455-2238 for domestic callers or (719) 325-2237 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 is also developing 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 2016 third quarter financial 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 whether and when we will prepare a 510(k) submission for the Senhance Surgical Robotic System, whether our commercialization plans and the development of our pipeline will be successful, whether we will continue to invest in global commercial expansion, including partnering with additional influential institutions to establish clinical reference sites 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 filed on March 3, 2016, our other filings we make with the SEC and our Form 10-Q for the 2016 third quarter expected to be filed on or before its due date. 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||Nine Months Ended|
|September 30,||September 30,|
|Cost of revenue||1,031||—||1,031||—|
|Research and development||7,011||7,048||21,760||21,111|
|Sales and marketing||2,574||413||5,563||1,161|
|General and administrative||2,793||1,762||7,927||5,607|
|Amortization of intangible assets||1,709||338||5,312||589|
|Change in fair value of contingent consideration||(100||)||—||1,700||—|
|Inventory write-down related to restructuring||—||—||2,565||—|
|Restructuring and other charges||—||—||3,085||—|
|Acquisition related costs||—||4,003||—||4,003|
|Total Operating Expenses||13,987||13,564||109,696||32,471|
|Interest expense, net||(432||)||(436||)||(1,499||)||(997||)|
|Other (expense) income||(30||)||—||65||—|
|Total Other Expense, net||(462||)||(436||)||(1,434||)||(997||)|
|Loss before income taxes||$||(14,014||)||$||(14,000||)||$||(110,695||)||$||(33,468||)|
|Income tax benefit||1,070||99||4,707||99|
|Other comprehensive gain (loss)|
|Foreign currency translation gain (loss)||689||(429||)||2,199||(429||)|
|Net loss per share - basic and diluted||$||(0.11||)||$||(0.16||)||$||(0.95||)||$||(0.46||)|
Weighted average common shares outstanding -
basic and diluted
|Consolidated Balance Sheets|
|(in thousands, except share amounts)|
|September 30,||December 31,|
|Cash and cash equivalents||$||42,518||$||38,449|
|Accounts receivable, net||616||76|
|Other current assets||8,149||6,689|
|Total Current Assets||53,548||49,143|
|Accounts receivable, net of current portion||274|
|Inventories, net of current portion||—||709|
|Property and equipment, net||4,614||4,408|
|Intellectual property, net||41,260||46,898|
|In-process research and development||16,972||16,511|
|Other long term assets||63||64|
|Liabilities and Stockholders’ Equity|
|Contingent consideration – current portion||11,325||12,500|
|Notes payable - current portion||7,826||6,727|
|Total Current Liabilities||28,993||31,072|
|Long Term Liabilities|
|Contingent consideration – less current portion||13,875||11,000|
|Net deferred tax liabilities||11,971||16,263|
|Notes payable - less current portion, net of debt discount||7,059||12,990|
|Commitments and Contingencies|
Common stock $0.001 par value, 750,000,000 shares authorized at
September 30, 2016
and December 31, 2015; 115,086,256 and 100,180,872 shares issued at September 30,
2016 and December 31, 2015, respectively; and 115,014,711 and 100,149,453
shares outstanding at September 30, 2016 and December 31, 2015, respectively
|Additional paid-in capital||425,041||363,280|
Treasury stock at cost, 71,545 and 31,419 shares at September 30,
December 31, 2015, respectively
|Accumulated other comprehensive loss||(967||)||(3,166||)|
|Total Stockholders’ Equity||135,134||177,277|
|Total Liabilities and Stockholders’ Equity||$||197,032||$||248,602|
|Consolidated Statements of Cash Flows|
|Nine Months Ended|
Adjustments to reconcile net loss to net cash and cash equivalents
|Amortization of intangible assets||5,312||589|
|Amortization of debt discount and debt issuance costs||140||89|
|Common stock issued for services||116||—|
|Inventory write-down related to restructuring||2,565||—|
|Loss on disposal of property||—||34|
|Non-cash restructuring and other charges||2,551||—|
|Deferred tax benefit||(4,725||)||(99||)|
|Change in fair value of contingent consideration||1,700||—|
|Changes in operating assets and liabilities, net of effect of acquisition:|
|Other current and long term assets||(1,290||)||(248||)|
|Net cash and cash equivalents used in operating activities||(47,618||)||(24,575||)|
|Payment for acquisition||—||(25,000||)|
|Purchase of property and equipment||(878||)||(728||)|
|Net cash and cash equivalents used in investing activities||(878||)||(25,728||)|
|Payment of debt||(4,972||)||—|
|Proceeds from issuance of common stock, net of issuance costs||57,637||58,295|
|Proceeds from issuance of debt, net of debt discount||—||9,886|
|Taxes paid related to net share settlement of vesting of restricted stock units||(130||)||(3||)|
|Proceeds from exercise of stock options and warrants||163||252|
|Net cash and cash equivalents provided by financing activities||52,698||68,430|
|Effect of exchange rate changes on cash and cash equivalents||(133||)||—|
|Net increase in cash and cash equivalents||4,069||18,127|
|Cash and cash equivalents, beginning of period||38,449||34,766|
|Cash and cash equivalents, end of period||$||42,518||$||52,893|
|Supplemental Disclosure for Cash Flow Information|
|Supplemental Schedule of Noncash Investing Activities|
|Transfer of inventory to property and equipment||$||1,866||—|
|Issuance of common stock warrants||—||$||96|
|Contingent consideration related to acquisition||—||$||24,300|
|Issuance of common stock related to acquisition||—||$||43,677|