UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
| Date of Report (Date of Earliest Event Reported): | February 24, 2015 |
TransEnterix, Inc.
__________________________________________
(Exact name of registrant as specified in its charter)
| Delaware | 0-19437 | 11-2962080 |
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_____________________ (State or other jurisdiction |
_____________ (Commission |
______________ (I.R.S. Employer |
| of incorporation) | File Number) | Identification No.) |
| 635 Davis Drive, Suite 300, Morrisville, North Carolina | 27560 | |
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_________________________________ (Address of principal executive offices) |
___________ (Zip Code) |
| Registrant’s telephone number, including area code: | 919-765-8400 |
Not Applicable
______________________________________________
Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02 Results of Operations and Financial Condition.
Item 2.02 Results of Operations and Financial Condition.
On February 24, 2015, TransEnterix, Inc., a Delaware corporation (the "Company") issued a press release announcing financial results for the fourth quarter and year ended December, 2014. A copy of the press release is attached hereto as Exhibit 99.1.
The information included herein and in Exhibit 99.1 shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 ("Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
Item 9.01 Financial Statements and Exhibits.
99.1 Press Release, dated February 24, 2015
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| TransEnterix, Inc. | ||||
| February 26, 2015 | By: |
Joseph P. Slattery
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| Name: Joseph P. Slattery | ||||
| Title: EVP and CFO | ||||
Exhibit Index
| Exhibit No. | Description | |
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99.1
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Press Release, dated February 24, 2015 |
Exhibit 99.1
TransEnterix, Inc. Reports Operating Results for the Fourth Quarter and Full Year 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 fourth quarter and full year 2014. TransEnterix filed its Form 10-K for the year ended December 31, 2014 on Friday, February 20, 2015.
2014 Operating Highlights
| • | Uplisted and began trading on NYSE MKT Market |
| • | Completed public offering of common stock, raising $52.4 million, net of issuance costs |
| • | Filed pre-submission documentation with FDA regarding the SurgiBot™ System |
| • | Completed 14 pre-clinical robotic surgical procedures using the SurgiBot System |
| • | Performed first human cases using SPIDER Flex Ligating Shears |
| • | Expanded loan agreement with Oxford Finance LLC and Silicon Valley Bank |
“We continue to make solid progress towards our 510(k) submission for the SurgiBot System. We recently increased the frequency of our pre-clinical cases and have completed multiple general surgery and urology procedures using SurgiBot in the porcine model,” said Todd M. Pope, President and Chief Executive Officer of TransEnterix. “We remain on track to submit our 510(k) in mid-2015 and continue to focus on our goal to commercialize the first patient-side robotic surgery system following FDA clearance.”
For the three months ended December 31, 2014, the Company reported a net loss of $8.1 million, or $0.13 per share, including research and development expenses of $6.0 million, sales and marketing expenses of $0.4 million, and general and administrative expenses of $1.1 million. Operating expenses were primarily associated with the development of the SurgiBot System. For the full year ended December 31, 2014, the Company reported a net loss of $37.7 million, or $0.64 per share. On December 31, 2014, the Company’s cash and cash equivalents totaled $34.8 million.
Conference Call
TransEnterix, Inc. will host a conference call on Tuesday, February 24, 2015 at 8:30 AM ET to discuss its 2014 fourth quarter and full year operating and financial results. To listen to the conference call on your telephone, please dial (888) 438-5449 for domestic callers or (719) 325-2142 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.
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 the in 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. 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. 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 will be submitted by mid-2015 or cleared by the U.S. FDA, the pace of adoption of our products by surgeons, the success and market opportunity of our products, most notably 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, 2014 filed with the SEC on February 20, 2015, and 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 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.
Investor Contact:
Westwicke Partners
Mark Klausner, 443-213-0501
transenterix@westwicke.com
Media Contact:
TransEnterix, Inc.
Mohan Nathan, 919-917-6559
mnathan@transenterix.com
TransEnterix, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
(in thousands, except per share amounts)
| Three months ended | Year ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
Sales |
$ | 134 | $ | 219 | $ | 401 | $ | 1,431 | ||||||||
Operating Expenses |
||||||||||||||||
Cost of goods sold |
435 | 714 | 1,095 | 4,810 | ||||||||||||
Research and development |
5,984 | 4,845 | 27,944 | 12,700 | ||||||||||||
Sales and marketing |
404 | 453 | 1,727 | 1,943 | ||||||||||||
General and administrative |
1,111 | 1,556 | 6,244 | 4,221 | ||||||||||||
Impairment loss on property and equipment |
— | 450 | — | 450 | ||||||||||||
Merger expenses |
— | 20 | — | 2,911 | ||||||||||||
Total Operating Expenses |
7,934 | 8,038 | 37,010 | 27,035 | ||||||||||||
Operating Loss |
(7,800 | ) | (7,819 | ) | (36,609 | ) | (25,604 | ) | ||||||||
Other Expense |
||||||||||||||||
Remeasurement of fair value of preferred stock warrant liability |
— | — | — | (1,800 | ) | |||||||||||
Interest expense, net |
(279 | ) | (212 | ) | (1,043 | ) | (954 | ) | ||||||||
Total Other Expense, net |
(279 | ) | (212 | ) | (1,043 | ) | (2,754 | ) | ||||||||
Net Loss |
$ | (8,079 | ) | $ | (8,031 | ) | $ | (37,652 | ) | $ | (28,358 | ) | ||||
Other comprehensive income (loss) |
— | — | — | — | ||||||||||||
Comprehensive loss |
$ | (8,079 | ) | $ | (8,031 | ) | $ | (37,652 | ) | $ | (28,358 | ) | ||||
Net loss per share — basic and diluted |
$ | (0.13 | ) | $ | (0.21 | ) | $ | (0.64 | ) | $ | (2.23 | ) | ||||
Weighted average common shares outstanding — basic and diluted |
63,171 | 37,435 | 58,714 | 12,731 | ||||||||||||
TransEnterix, Inc.
Consolidated Balance Sheets
(unaudited)
(in thousands, except share amounts)
| December 31, | December 31, | |||||||
| 2014 | 2013 | |||||||
Assets |
||||||||
Current Assets |
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Cash and cash equivalents |
$ | 34,766 | $ | 10,014 | ||||
Short-term investments |
— | 6,191 | ||||||
Accounts receivable, net |
133 | 188 | ||||||
Interest receivable |
1 | 68 | ||||||
Inventory, net |
— | 701 | ||||||
Other current assets |
789 | 593 | ||||||
Total Current Assets |
35,689 | 17,755 | ||||||
Restricted cash |
250 | 375 | ||||||
Property and equipment, net |
3,120 | 1,864 | ||||||
Intellectual property, net |
2,241 | 2,741 | ||||||
Trade names, net |
7 | 10 | ||||||
Goodwill |
93,842 | 93,842 | ||||||
Other long term assets |
62 | 127 | ||||||
Total Assets |
$ | 135,211 | $ | 116,714 | ||||
Liabilities and Stockholders’ Equity |
||||||||
Current Liabilities |
||||||||
Accounts payable |
$ | 1,768 | $ | 1,804 | ||||
Accrued expenses |
1,769 | 1,406 | ||||||
Note payable — current portion |
610 | 3,879 | ||||||
Total Current Liabilities |
4,147 | 7,089 | ||||||
Long Term Liabilities |
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Note payable — less current portion, net of debt discount |
9,275 | 4,602 | ||||||
Total Liabilities |
13,422 | 11,691 | ||||||
Commitments and Contingencies |
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Stockholders’ Equity |
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Common stock $0.001 par value, 750,000,000 shares
authorized at December 31, 2014 and 2013; 63,182,806 and
48,841,417 shares issued and outstanding at December 31,
2014 and December 31, 2013, respectively (1) |
63 | 49 | ||||||
Additional paid-in capital |
257,642 | 203,238 | ||||||
Accumulated deficit |
(135,916 | ) | (98,264 | ) | ||||
Total Stockholders’ Equity |
121,789 | 105,023 | ||||||
Total Liabilities and Stockholders’ Equity |
$ | 135,211 | $ | 116,714 | ||||
| (1) | Adjusted for 1:5 reverse stock split on March 31, 2014. |
TransEnterix, Inc.
Consolidated Statements of Cash Flows
(unaudited)
(in thousands)
| Year Ended | ||||||||
| December 31, | ||||||||
| 2014 | 2013 | |||||||
Operating Activities |
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Net loss |
$ | (37,652 | ) | $ | (28,358 | ) | ||
Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities: |
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Depreciation and amortization |
1,310 | 1,483 | ||||||
Amortization of debt discount |
14 | — | ||||||
Amortization of debt issuance costs |
69 | 103 | ||||||
Remeasurement of fair value of preferred stock warrant liability |
— | 1,800 | ||||||
Accretion/amortization of bond discount/premium |
— | 52 | ||||||
Stock-based compensation |
1,840 | 941 | ||||||
Loss on disposal of property and equipment |
86 | 31 | ||||||
Impairment loss on property and equipment |
— | 450 | ||||||
Changes in operating assets and liabilities: |
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Accounts receivable |
55 | 402 | ||||||
Interest receivable |
67 | (52 | ) | |||||
Inventory |
701 | 731 | ||||||
Other current and long term assets |
(170 | ) | (328 | ) | ||||
Restricted cash |
125 | — | ||||||
Accounts payable |
(36 | ) | 641 | |||||
Accrued expenses |
363 | 868 | ||||||
Net cash and cash equivalents used in operating activities |
(33,228 | ) | (21,236 | ) | ||||
Investing Activities |
||||||||
Purchase of investments |
— | (6,240 | ) | |||||
Proceeds from sale and maturities of investments |
6,191 | 904 | ||||||
Cash received in acquisition of a business, net of cash paid |
— | 246 | ||||||
Purchase of property and equipment |
(2,174 | ) | (1,377 | ) | ||||
Proceeds from sale of property and equipment |
25 | — | ||||||
Net cash and cash equivalents provided by (used in) investing activities |
4,042 | (6,467 | ) | |||||
Financing Activities |
||||||||
Proceeds from issuance of debt, net of debt discount |
4,321 | 1,998 | ||||||
Payment of debt |
(2,877 | ) | (1,519) | |||||
Proceeds from the issuance of common stock, net of issuance costs |
52,433 | — | ||||||
Proceeds from issuance of preferred stock, net of issuance costs |
— | 28,199 | ||||||
Debt issuance costs......................................................... |
(30 | ) | — | |||||
Proceeds from exercise of stock options and restricted stock units |
75 | — | ||||||
Proceeds from exercise of warrants |
16 | 143 | ||||||
Net cash and cash equivalents provided by financing activities |
53,938 | 28,821 | ||||||
Net increase in cash and cash equivalents |
24,752 | 1,118 | ||||||
Cash and Cash Equivalents, beginning of period |
10,014 | 8,896 | ||||||
Cash and Cash Equivalents, end of period |
$ | 34,766 | $ | 10,014 | ||||
Supplemental Disclosure for Cash Flow Information |
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Interest paid |
$ | 904 | $ | 824 | ||||
Supplemental Schedule of Noncash Investing and Financing Activities |
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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 | ||||
Conversion of preferred stock to common stock |
$ | — | $ | 30,197 | ||||