Attached files
| file | filename |
|---|---|
| 8-K - LIVE FILING - ASENSUS SURGICAL, INC. | htm_53916.htm |
| EX-99.2 - EX-99.2 - ASENSUS SURGICAL, INC. | exhibit2.htm |
Exhibit 99.1
TransEnterix, Inc. Reports Operating Results for the Second Quarter 2016
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 second quarter of 2016.
ALF-X Commercial Update
On July 29, 2016, the Company closed its first sale of the ALF-X® Surgical Robotic System
to Humanitas Hospital, a highly-specialized research and teaching hospital partnered with
Humanitas University Medical School, located in Milan, Italy.
“We are very pleased with the progress we’ve made in the commercialization of ALF-X during the quarter, as well as having closed our first ALF-X sale in July,” said Todd M. Pope, President and Chief Executive Officer of TransEnterix. “We remain enthusiastic about the potential of ALF-X, and will continue to invest in global commercial expansion, including preparing for its 510(k) submission.”
Financial Highlights
On a consolidated GAAP basis, for the three months ended June 30, 2016, the Company
reported total operating expenses of $80.7 million. These results included one-time
restructuring charges of $5.6 million, of which $5.2 million were non-cash, as well as a
non-cash charge for goodwill impairment of $61.8 million. Adjusted operating expenses
excluding these charges were $13.3 million as compared to $9.1 million during the three
months ended June 30, 2015. Total adjusted operating expenses increased primarily as a
result of increased investment into the commercialization of the ALF-X. Adjusted operating
expenses for the three months ended June 30, 2016 included research and development
expenses of $6.4 million, sales and marketing expenses of $1.3 million, general and
administrative expenses of $2.9 million, amortization of intangible assets of $1.8 million
and change in contingent consideration of $0.9 million.
On a consolidated GAAP basis, for the three months ended June 30, 2016, net loss was $80.1 million and net loss per share was $0.70. Excluding the restructuring and goodwill impairment charges, adjusted net loss was $12.7 million or $0.11 per share.
The Company had cash and cash equivalents of approximately $64.6 million as of June 30, 2016, and approximately $61.0 million as of July 31, 2016. The Company expects its existing cash and cash equivalents to fund operations through the third quarter of 2017.
Conference Call
TransEnterix, Inc. will host a conference call on Friday, August 5, 2016 at 8:30 AM ET to
discuss its second quarter 2016 operating and financial results. To listen to the
conference call on your telephone, please dial (888) 364-3108 for domestic callers or (719)
352-2308 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.
About TransEnterix
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 ALF-X 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 ALF-X Surgical System has been granted a CE Mark but is not
available for sale in the US. For more information, visit the TransEnterix website at
www.transenterix.com.
Non-GAAP Measures
The adjusted operating expenses and adjusted net loss presented in this press release are
non-GAAP measures. In the tables that follow under “Reconciliation of Non-GAAP Measures”,
we present Adjusted Operating Expenses and Adjusted Net Loss, reconciled to their
comparable GAAP measures. These financial measures are presented on a basis other than in
accordance with U.S. generally accepted accounting principles (“Non-GAAP Measures”). These
items are adjusted because they are not operational or because these charges are non-cash
or non-recurring and management believes they 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 our 2016 second quarter financial
results, the ALF-X® System, 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 the potential of the ALF-X
System, whether and when we will we prepare a 510(k) submission for the ALF-X System and
whether existing cash and cash equivalents will fund operations through the third 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 second 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.
TransEnterix, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands except per share amounts)
(Unaudited)
| Three Months Ended | Six Months Ended | ||||||||||||||||||||||||||||||
| June 30, | June 30, | ||||||||||||||||||||||||||||||
| 2016 | 2015 2016 | 2015 | |||||||||||||||||||||||||||||
Operating Expenses |
|||||||||||||||||||||||||||||||
Research and development |
$ | 6,364 | $ | 6,579 | $ | 14,749 | $ | 14,063 | |||||||||||||||||||||||
Sales and marketing |
1,306 | 373 | 2,989 | 748 | |||||||||||||||||||||||||||
General and administrative |
2,895 | 1,990 | 5,134 | 3,845 | |||||||||||||||||||||||||||
Amortization of intangible assets |
1,786 | 126 | 3,603 | 251 | |||||||||||||||||||||||||||
Change in fair value of contingent consideration |
944 | — | 1,800 | — | |||||||||||||||||||||||||||
Inventory write-down related to restructuring |
2,565 | — | 2,565 | — | |||||||||||||||||||||||||||
Restructuring and other charges |
3,085 | — | 3,085 | — | |||||||||||||||||||||||||||
Goodwill impairment |
61,784 | — | 61,784 | — | |||||||||||||||||||||||||||
Total Operating Expenses |
80,729 | 9,068 | 95,709 | 18,907 | |||||||||||||||||||||||||||
Operating Loss |
(80,729 | ) | (9,068 | ) | (95,709 | ) | (18,907 | ) | |||||||||||||||||||||||
Other Expense |
|||||||||||||||||||||||||||||||
Interest expense, net |
(489 | ) | (280 | ) | (1,067 | ) | (561 | ) | |||||||||||||||||||||||
Other income |
95 | — | 95 | — | |||||||||||||||||||||||||||
Total Other Expense, net |
(394 | ) | (280 | ) | (972 | ) | (561 | ) | |||||||||||||||||||||||
Loss before income taxes |
$ | (81,123 | ) | $ | (9,348 | ) | $ | (96,681 | ) | $ | (19,468 | ) | |||||||||||||||||||
Income tax benefit |
992 | — | 3,637 | — | |||||||||||||||||||||||||||
Net loss |
$ | (80,131 | ) | $ | (9,348 | ) | $ | (93,044 | ) | $ | (19,468 | ) | |||||||||||||||||||
Other comprehensive loss |
|||||||||||||||||||||||||||||||
Foreign currency translation (loss) gains |
(2,286 | ) | — | 1,510 | — | ||||||||||||||||||||||||||
Comprehensive loss |
$ | (82,417 | ) | $ | (9,348 | ) | $ | (91,534 | ) | $ | (19,468 | ) | |||||||||||||||||||
Net loss per share — basic and diluted |
$ | (0.70 | ) | $ | (0.14 | ) | $ | (0.85 | ) | $ | (0.30 | ) | |||||||||||||||||||
Weighted average common shares outstanding — basic
and diluted |
114,319 | 68,105 | 109,290 | 65,937 | |||||||||||||||||||||||||||
TransEnterix, Inc.
Consolidated Balance Sheets
(in thousands, except share amounts)
(Unaudited)
| June 30, December 31, | ||||||||||||
| 2016 2015 | ||||||||||||
Assets |
||||||||||||
Current Assets |
||||||||||||
Cash and cash equivalents |
$ | 64,609 | $ | 38,449 | ||||||||
Accounts receivable, net |
77 | 76 | ||||||||||
Inventories |
4,247 | 3,923 | ||||||||||
Interest receivable |
19 | 6 | ||||||||||
Other current assets |
7,011 | 6,689 | ||||||||||
Total Current Assets |
75,963 | 49,143 | ||||||||||
Restricted cash |
289 | — | ||||||||||
Inventories, net of current portion |
— | 709 | ||||||||||
Property and equipment, net |
4,743 | 4,408 | ||||||||||
Intellectual property, net |
42,571 | 46,898 | ||||||||||
In-process research and development |
16,811 | 16,511 | ||||||||||
Goodwill |
69,756 | 130,869 | ||||||||||
Other long term assets |
63 | 64 | ||||||||||
Total Assets |
$ | 210,196 | $ | 248,602 | ||||||||
Liabilities and Stockholders’ Equity |
||||||||||||
Current Liabilities |
||||||||||||
Accounts payable |
$ | 2,002 | $ | 4,450 | ||||||||
Accrued expenses |
7,344 | 7,395 | ||||||||||
Contingent consideration – current portion |
12,500 | 12,500 | ||||||||||
Notes payable — current portion |
7,658 | 6,727 | ||||||||||
Total Current Liabilities |
29,504 | 31,072 | ||||||||||
Long Term Liabilities |
||||||||||||
Contingent consideration – less current portion |
12,800 | 11,000 | ||||||||||
Net deferred tax liabilities |
12,920 | 16,263 | ||||||||||
Notes payable — less current portion, net of debt discount |
9,080 | 12,990 | ||||||||||
Total Liabilities |
64,304 | 71,325 | ||||||||||
Commitments and Contingencies |
||||||||||||
Stockholders’ Equity |
||||||||||||
Common stock $0.001 par value, 750,000,000 shares authorized at June 30, 2016
and December 31, 2015; 115,000,003 and 100,180,872 shares issued at June 30,
2016 and December 31, 2015, respectively; and 114,928,458 and 100,149,453
shares outstanding at June 30, 2016 and December 31, 2015, respectively |
115 | 100 | ||||||||||
Additional paid-in capital |
423,544 | 363,280 | ||||||||||
Accumulated deficit |
(275,908 | ) | (182,864 | ) | ||||||||
Treasury stock at cost, 71,545 and 31,419 shares at June 30, 2016 and
December 31, 2015, respectively |
(203 | ) | (73 | ) | ||||||||
Accumulated other comprehensive loss |
(1,656 | ) | (3,166 | ) | ||||||||
Total Stockholders’ Equity |
145,892 | 177,277 | ||||||||||
Total Liabilities and Stockholders’ Equity |
$ | 210,196 | $ | 248,602 | ||||||||
TransEnterix, Inc.
Consolidated Statements of Cash Flows
(in thousands)
(Unaudited)
| Six Months Ended | ||||||||||||||||
| June 30, | ||||||||||||||||
| 2016 | 2015 | |||||||||||||||
Operating Activities |
||||||||||||||||
Net loss |
$ | (93,044 | ) | $ | (19,468 | ) | ||||||||||
Adjustments to reconcile net loss to net cash and cash equivalents used in
operating activities: |
||||||||||||||||
Depreciation |
1,052 | 517 | ||||||||||||||
Amortization of intangible assets |
3,603 | 251 | ||||||||||||||
Amortization of debt discount and debt issuance costs |
99 | 54 | ||||||||||||||
Stock-based compensation |
2,477 | 1,667 | ||||||||||||||
Inventory write-down related to restructuring |
2,565 | — | ||||||||||||||
Non-cash restructuring and other charges |
2,551 | — | ||||||||||||||
Goodwill impairment |
61,784 | — | ||||||||||||||
Deferred tax benefit |
(3,657 | ) | — | |||||||||||||
Change in fair value of contingent consideration |
1,800 | — | ||||||||||||||
Changes in operating assets and liabilities, net of effect of acquisition: |
||||||||||||||||
Accounts receivable |
— | 125 | ||||||||||||||
Interest receivable |
(13 | ) | — | |||||||||||||
Inventories |
(3,983 | ) | — | |||||||||||||
Other current and long term assets |
(213 | ) | 150 | |||||||||||||
Accounts payable |
(2,497 | ) | (162 | ) | ||||||||||||
Accrued expenses |
(60 | ) | 490 | |||||||||||||
Restricted cash |
(290 | ) | 250 | |||||||||||||
Net cash and cash equivalents used in operating activities |
(27,826 | ) | (16,126 | ) | ||||||||||||
Investing Activities |
||||||||||||||||
Purchase of property and equipment |
(517 | ) | (311 | ) | ||||||||||||
Net cash and cash equivalents used in investing activities |
(517 | ) | (311 | ) | ||||||||||||
Financing Activities |
||||||||||||||||
Payment of debt |
(3,078 | ) | — | |||||||||||||
Proceeds from issuance of common stock, net of issuance costs |
57,637 | 52,533 | ||||||||||||||
Taxes paid related to net share settlement of vesting of restricted stock units |
(130 | ) | — | |||||||||||||
Proceeds from exercise of stock options and warrants |
165 | 250 | ||||||||||||||
Net cash and cash equivalents provided by financing activities |
54,594 | 52,783 | ||||||||||||||
Effect of exchange rate changes on cash and cash equivalents |
(91 | ) | — | |||||||||||||
Net increase in cash and cash equivalents |
26,160 | 36,346 | ||||||||||||||
Cash and cash equivalents, beginning of period |
38,449 | 34,766 | ||||||||||||||
Cash and cash equivalents, end of period |
$ | 64,609 | $ | 71,112 | ||||||||||||
Supplemental Disclosure for Cash Flow Information |
||||||||||||||||
Interest paid |
$ | 713 | $ | 375 | ||||||||||||
Supplemental Schedule of Noncash Investing Activities |
||||||||||||||||
Transfer of inventory to property and equipment |
$ | 1,823 | $ | — | ||||||||||||
RECONCILIATION OF NON-GAAP MEASURES
Adjusted Operating Expenses
(in thousands)
(Unaudited)
| Three Months Ended | Six Months Ended | |||||||||||||||||||
| June 30, | June 30, | |||||||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||||||
GAAP total operating expenses |
$ | 80,729 | $ | 9,068 | $ | 95,709 | $ | 18,907 | ||||||||||||
Adjustments |
||||||||||||||||||||
Goodwill impairment |
61,784 | — | 61,784 | — | ||||||||||||||||
Restructuring and other charges |
3,085 | — | 3,085 | — | ||||||||||||||||
Inventory write-down related to restructuring |
2,565 | — | 2,565 | — | ||||||||||||||||
Total adjustments |
67,434 | — | 67,434 | — | ||||||||||||||||
Adjusted non-GAAP operating expenses |
$ | 13,295 | $ | 9,068 | $ | 28,275 | $ | 18,907 | ||||||||||||
RECONCILIATION OF NON-GAAP MEASURES
Adjusted Net Loss and Loss per Share
(in thousands except per share amounts)
(Unaudited)
| Three Months Ended | Six Months Ended | ||||||||||||||||||||||||||||||
| June 30, | June 30, | ||||||||||||||||||||||||||||||
| 2016 | 2015 2016 | 2015 | |||||||||||||||||||||||||||||
GAAP net loss |
$ | (80,131 | ) | $ | (9,348 | ) | $ | (93,044 | ) | $ | (19,468 | ) | |||||||||||||||||||
Adjustments |
|||||||||||||||||||||||||||||||
Goodwill impairment |
61,784 | — | 61,784 | — | |||||||||||||||||||||||||||
Restructuring and other charges |
3,085 | — | 3,085 | — | |||||||||||||||||||||||||||
Inventory write-down related to restructuring |
2,565 | — | 2,565 | — | |||||||||||||||||||||||||||
Total adjustments |
67,434 | — | 67,434 | — | |||||||||||||||||||||||||||
Adjusted non-GAAP net loss |
$ | (12,697 | ) | $ | (9,348 | ) | $ | (25,610 | ) | $ | (19,468 | ) | |||||||||||||||||||
GAAP net loss per share |
$ | (0.70 | ) | $ | (0.14 | ) | $ | (0.85 | ) | $ | (0.30 | ) | |||||||||||||||||||
Adjusted non-GAAP net loss per share |
$ | (0.11 | ) | $ | (0.14 | ) | $ | (0.23 | ) | $ | (0.30 | ) | |||||||||||||||||||
The non-GAAP adjustments for the three and six months ended June 30, 2016 include the following:
| a.) Goodwill impairment — the negative FDA response on the SurgiBot in April 2016 obligated us to conduct an impairment analysis of our goodwill during the second quarter. A significant input to this analysis was that our market value fell below our book value during the second quarter. Based on this analysis, we recorded a non-cash goodwill impairment loss of $61.8 million during the second quarter. |
| b.) Restructuring and other charges — as a result of our decision to reprioritize our efforts to focus on commercialization and regulatory clearance of the ALF-X system, the Company implemented a restructuring plan resulting in $3.1 million of restructuring charges. The non-cash restructuring charges amounted to $2.6 million related primarily to intellectual property and fixed assets. Cash restructuring charges were $0.5 million, primarily related to severance. |
| c.) Inventory write-down related to restructuring — as a result of our decision to reprioritize our efforts to focus on commercialization and regulatory clearance of the ALF-X system, the Company implemented a restructuring plan resulting in non-cash charges related to inventory write-down of $2.6 million. |
Investor Contact:
Westwicke
Mark Klausner, 443-213-0501
invest@transenterix.com
or
Media Contact:
TransEnterix, Inc.
Mohan Nathan, 919-765-8400
media@transenterix.com