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 second quarter 2015.
Operating Highlights
- Completed Good Laboratory Practices (GLP) Studies using the SurgiBot™ System in April 2015
- SurgiBot System FDA 510(k) Application Submitted June 1, 2015
- Completed underwritten equity offering raising $52.2 million in net proceeds, including the underwriters exercise of additional shares in July 2015
"We are pleased to have submitted our 510(k) application to the FDA for the SurgiBot System," said Todd M. Pope, President and Chief Executive Officer of TransEnterix. "For the balance of the year, we will be working with the FDA to achieve our clearance and preparing for commercialization."
For the three months ended June 30, 2015, the Company reported a net loss of $9.3 million, or $0.14 net loss per share, which included research and development expenses of $6.6 million, sales and marketing expenses of $0.4 million, and general and administrative expenses of $2.1 million. Operating expenses were primarily associated with the development of the SurgiBot System. On June 30, 2015, the Company's cash and cash equivalents totaled $71.1 million.
Conference Call
TransEnterix, Inc. will host a conference call on Thursday, August 6, 2015 at 4:30 PM ET to discuss its 2015 second quarter operating and financial results. To listen to the conference call on your telephone, please dial (877) 419-6591 for domestic callers or (719) 325-4747 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 for approximately 90 days after the conference call.
About SurgiBot
The SurgiBot system, currently in development, is a minimally invasive, patient-side robotic surgery system. The system utilizes flexible instruments through articulating channels controlled directly by the surgeon, with robotic assistance, at the patient's bedside. The flexible nature of the system allows for multiple instruments to be introduced and deployed through a single incision. The SurgiBot System has not been cleared by the FDA for use in the United States.
About TransEnterix
TransEnterix is a medical device company that is pioneering the use of robotics and flexible instruments to improve minimally invasive surgery by addressing the economic and clinical challenges associated with current laparoscopic and robotic options. The Company is focused on the development and commercialization of the SurgiBot System, a robotically enhanced laparoscopic surgical platform 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, 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 be able to successfully commercialize the SurgiBot System and whether the SurgiBot System will be able to be utilized in a wide variety of surgical facilities with the potential to deliver critical benefits to surgeons, hospitals and patients. 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 will be cleared by the U.S. FDA. 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, 2014 filed on February 20, 2015, our Form 10-Q for the 2015 second quarter expected to be filed on August 6, 2015, 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) | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
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Three months ended June 30, |
Six months ended June 30, |
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| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Sales | $ | — | $ | 113 | $ | — | $ | 206 | ||||||||
| Operating Expenses | ||||||||||||||||
| Cost of goods sold | — | 238 | — | 458 | ||||||||||||
| Research and development | 6,579 | 7,882 | 14,063 | 12,893 | ||||||||||||
| Sales and marketing | 373 | 461 | 748 | 867 | ||||||||||||
| General and administrative | 2,116 | 1,913 | 4,096 | 3,527 | ||||||||||||
| Total Operating Expenses | 9,068 | 10,494 | 18,907 | 17,745 | ||||||||||||
| Operating Loss | (9,068 | ) | (10,381 | ) | (18,907 | ) | (17,539 | ) | ||||||||
| Other Expense | ||||||||||||||||
| Interest Expense, net | (280 | ) | (206 | ) | (561 | ) | (527 | ) | ||||||||
| Total Other Expense, net | (280 | ) | (206 | ) | (561 | ) | (527 | ) | ||||||||
| Net Loss | $ | (9,348 | ) | $ | (10,587 | ) | $ | (19,468 | ) | $ | (18,066 | ) | ||||
| Other comprehensive income (loss) | — | — | — | — | ||||||||||||
| Comprehensive loss | $ | (9,348 | ) | $ | (10,587 | ) | $ | (19,468 | ) | $ | (18,066 | ) | ||||
| Net loss per share - basic and diluted | $ | (0.14 | ) | $ | (0.18 | ) | $ | (0.30 | ) | $ | (0.33 | ) | ||||
| Weighted average common shares outstanding - basic and diluted | 68,105 | 59,673 | 65,937 | 54,264 | ||||||||||||
| TransEnterix, Inc. | ||||||||
| Consolidated Balance Sheets | ||||||||
| (in thousands, except share amounts) | ||||||||
| (Unaudited) | ||||||||
|
June 30, 2015 |
December 31, 2014 |
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| Assets | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents | $ | 71,112 | $ | 34,766 | ||||
| Accounts receivable, net | 8 | 133 | ||||||
| Interest receivable | 1 | 1 | ||||||
| Other current assets | 586 | 789 | ||||||
| Total Current Assets | 71,707 | 35,689 | ||||||
| Restricted cash | - | 250 | ||||||
| Property and equipment, net | 2,914 | 3,120 | ||||||
| Intellectual property, net | 1,991 | 2,241 | ||||||
| Trade names, net | 6 | 7 | ||||||
| Goodwill | 93,842 | 93,842 | ||||||
| Other long term assets | 90 | 62 | ||||||
| Total Assets | $ | 170,550 | $ | 135,211 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current Liabilities | ||||||||
| Accounts payable | $ | 1,606 | $ | 1,768 | ||||
| Accrued expenses | 2,259 | 1,769 | ||||||
| Notes payable - current portion | 2,487 | 610 | ||||||
| Total Current Liabilities | 6,352 | 4,147 | ||||||
| Long Term Liabilities | ||||||||
| Notes payable - less current portion, net of debt discount | 7,427 | 9,275 | ||||||
| Total Liabilities | 13,779 | 13,422 | ||||||
| Commitments and Contingencies | ||||||||
| Stockholders’ Equity | ||||||||
|
Common stock $0.001 par value, 750,000,000 shares authorized at June 30, 2015 and December 31, |
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2014; and 82,481,722 and 63,182,806 shares issued and outstanding at June 30, 2015 and |
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| December 31, 2014, respectively | 82 | 63 | ||||||
| Additional paid-in capital | 312,073 | 257,642 | ||||||
| Accumulated deficit | (155,384 | ) | (135,916 | ) | ||||
| Total Stockholders’ Equity | 156,771 | 121,789 | ||||||
| Total Liabilities and Stockholders’ Equity | $ | 170,550 | $ | 135,211 | ||||
| TransEnterix, Inc. | ||||||||
| Consolidated Statements of Cash Flows | ||||||||
| (in thousands) | ||||||||
| (Unaudited) | ||||||||
|
Six Months Ended June 30, |
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| 2015 | 2014 | |||||||
| Operating Activities | ||||||||
| Net loss | $ | (19,468 | ) | $ | (18,066 | ) | ||
| Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities: | ||||||||
| Depreciation and amortization | 768 | 594 | ||||||
| Amortization of debt discount | 29 | — | ||||||
| Amortization of debt issuance costs | 25 | 44 | ||||||
| Stock-based compensation | 1,667 | 1,202 | ||||||
| Loss on disposal of property and equipment | — | 19 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | 125 | 92 | ||||||
| Interest receivable | — | 66 | ||||||
| Inventory | — | 263 | ||||||
| Other current and long term assets | 150 | (13 | ) | |||||
| Restricted cash | 250 | 125 | ||||||
| Accounts payable | (162 | ) | 1,812 | |||||
| Accrued expenses | 490 | 500 | ||||||
| Net cash and cash equivalents used in operating activities | (16,126 | ) | (13,362 | ) | ||||
| Investing Activities | ||||||||
| Proceeds from sale and maturities of investments | — | 6,191 | ||||||
| Purchase of property and equipment | (311 | ) | (910 | ) | ||||
| Net cash and cash equivalents (used in) provided by investing activities | (311 | ) | 5,281 | |||||
| Financing Activities | ||||||||
| Payment of debt | — | (1,897 | ) | |||||
| Proceeds from issuance of common stock, net of issuance costs | 52,533 | 52,506 | ||||||
| Proceeds from exercise of stock options and warrants | 250 | 24 | ||||||
| Net cash and cash equivalents provided by financing activities | 52,783 | 50,633 | ||||||
| Net increase in cash and cash equivalents | 36,346 | 42,552 | ||||||
| Cash and Cash Equivalents, beginning of period | 34,766 | 10,014 | ||||||
| Cash and Cash Equivalents, end of period | $ | 71,112 | $ | 52,566 | ||||
| Supplemental Disclosure for Cash Flow Information | ||||||||
| Interest paid | $ | 375 | $ | 337 | ||||
