— 2016 Full year revenue grows 57% to $5.9
million —— Year-over-year unit placements up 63%; favorable
insurance reimbursement decisions up 122% —
ReWalk Robotics Ltd. (Nasdaq:RWLK) (“ReWalk” or “the Company”)
today announced its financial results for the three- and
twelve-month periods ended December 31, 2016.
Highlights of and subsequent to the fourth
quarter include:
- Total revenue for the fourth quarter 2016 was $1.6 million;
total revenue for the full year 2016 grew 57% to $5.9 million
compared to 2015;
- 39 units were placed during the fourth quarter 2016; 119 units
were placed in 2016, up 63% over 2015;
- In 2016, a total of 51 favorable insurance coverage decisions
resulted in reimbursement for ReWalk devices: 13 from the U.S.
Department of Veterans Affairs and 38 favorable case by case
decisions from payors in the U.S. and Germany;
- The 522 post-market clinical study initiated at Stanford
University was expanded to two additional sites and the scope was
broadened to include utilization patterns and quality of life
measures; and
- Net proceeds of $34 million were secured during 2016 through a
combination of debt and equity to fund the Company’s strategic
market development and reimbursement activities.
“As ReWalk strives to create and lead this new
industry, we believe we made solid progress in 2016 to advance our
goals. More ReWalk devices are being used at home and in the
community than ever before and through our efforts with the U.S.
Department of Veterans Affairs, all qualified veterans now have a
path to a ReWalk system. Additionally, we are optimistic that
our advanced discussions with large national coverage providers in
the U.S. and Germany will result in broad coverage policies this
year, expanding access to potentially thousands of new users over
time,” stated Larry Jasinski, Chief Executive Officer.
“We are also focused on opportunities to treat
additional indications and have focused our R&D efforts on our
collaboration with Harvard’s Wyss Institute to develop a soft
exo-suit designed to meet the needs of stroke victims. As we
prepare for our first clinical trial of the soft exo-suit this
year, we are excited by the potential of the technology to serve as
a new standard of care in treating stroke patients in the
rehabilitation setting,” added Jasinski.
“In 2017, we intend to focus on supporting sales
growth, securing broad reimbursement coverage, and advancing our
product developments efforts,” concluded Jasinski.
Fourth Quarter 2016 Financial
Results
Total revenue was $1.6 million for the fourth
quarter of 2016, compared to $1.3 million in the fourth quarter of
2015, and up sequentially from $1.4 million in the third quarter of
2016. 39 ReWalk systems were placed during the fourth quarter
of 2016, compared to 25 ReWalk systems placed in the prior year
period, and 23 placed in the third quarter of 2016.
Total operating expenses in the fourth quarter of
2016 were $7.9 million compared to $7.5 million in the prior year
period.
Net loss was $8.5 million for the fourth quarter of
2016 compared to a net loss of $7.5 million in the fourth quarter
of 2015. Non-GAAP net loss for the fourth quarter was $7.2
million compared with a non-GAAP net loss of $6.7 million in the
fourth quarter of 2015.*
*A reconciliation of net loss to non-GAAP net loss
is included at the end of this press release.
Year-End 2016 Financial
Results
Total revenue was $5.9 million for the year ended
December 31, 2016, compared to $3.7 million in 2015. In 2016, 119
ReWalk systems were placed compared to 73 ReWalk systems placed
during 2015.
Full year 2016 operating expenses were $31.2
million compared to $25.4 million in 2015. In 2017, ReWalk is
implementing initiatives to reduce operating expenses including
staff reductions, savings from projects completed at the end of
2016 and other corporate spend.
Net loss for the year ended December 31, 2016 was
$32.5 million compared to a net loss of $25.4 million for the full
year 2015. Non-GAAP net loss was $27.7 million for the year
compared with a non-GAAP net loss of $22.6 million last year.*
*A reconciliation of net loss to non-GAAP net loss
is included at the end of this press release.
Liquidity
As of December 31, 2016, ReWalk had $23.7 million
in cash on its balance sheet. In 2016, ReWalk generated
approximately $34 million from debt and equity financing
activities.
Conference Call
ReWalk management will host its fourth quarter 2016
and year end conference call as follows:
Date |
|
Friday, February 17,
2017 |
Time |
|
8:30 AM EST |
Telephone |
U.S: |
|
(844) 423-9889 |
|
International: |
|
(716) 247-5804 |
|
Israel: |
|
18 09 31 53 62 |
Access
code |
|
66049360 |
Webcast
(live, listen-only and archive) |
|
www.rewalk.com under
the “Investors” section. |
A telephone replay will be available shortly after
the completion of the call for two weeks at (855) 859-2056 (U.S.)
or (404) 537-3406 (International). The passcode for the replay is
66049360.
About ReWalk Robotics
Ltd.
ReWalk Robotics Ltd. develops, manufactures and
markets wearable robotic exoskeletons for individuals with spinal
cord injury. Our mission is to fundamentally change the quality of
life for individuals with lower limb disability through the
creation and development of market leading robotic technologies.
Founded in 2001, ReWalk has headquarters in the U.S., Israel and
Germany. For more information on the ReWalk systems, please visit
http://www.rewalk.com.
ReWalk® is a registered trademark of ReWalk
Robotics Ltd. in Israel.
Forward-Looking Statements In
addition to historical information, this press release contains
forward-looking statements within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995, Section 27A of the U.S.
Securities Act of 1933, and Section 21E of the U.S. Securities
Exchange Act of 1934. Such forward-looking statements may include
projections regarding ReWalk’s future performance and, in some
cases, may be identified by words like “anticipate,” “assume,”
“believe,” “continue,” “could,” “estimate,” “expect,” “intend,”
“may,” “plan,” “potential,” “predict,” “project,” “future,” “will,”
“should,” “would,” “seek” and similar terms or phrases. The
forward-looking statements contained in this press release are
based on management’s current expectations, which are subject to
uncertainty, risks and changes in circumstances that are difficult
to predict and many of which are outside of ReWalk’s control.
Important factors that could cause ReWalk’s actual results to
differ materially from those indicated in the forward-looking
statements include, among others: ReWalk’s expectations regarding
future growth, including its ability to increase sales in its
existing geographic markets and to expand to new markets; the
conclusion of ReWalk’s management, and the opinion of ReWalk’s
auditors in their report on the Company’s consolidated financial
statements for the fiscal year ended December 31, 2016, that there
are substantial doubts as to ReWalk’s ability to continue as a
going concern; ReWalk’s ability to maintain and grow its reputation
and to achieve and maintain market acceptance of its products;
ReWalk’s ability to achieve reimbursement from third-party payors
for its products; ReWalk’s ability to repay its secured
indebtedness; ReWalk’s expectations as to its clinical research
program and clinical results; ReWalk’s expectations as to the
results of, and the Food and Drug Administration’s potential
regulatory actions with respect to, ReWalk’s mandatory post-market
522 surveillance study; the outcome of ongoing shareholder class
action litigation relating to ReWalk’s initial public offering;
ReWalk’s ability to improve its products and develop new products;
ReWalk’s ability to maintain adequate protection of its
intellectual property and to avoid violation of the intellectual
property rights of others; ReWalk’s ability to gain and maintain
regulatory approvals; ReWalk’s ability to use effectively the
proceeds of its 2016 follow-on offering; ReWalk’s ability to secure
capital from its at-the-market equity distribution program based on
the price range of its ordinary shares and conditions in the
financial markets; ReWalk’s ability to maintain relationships with
existing customers and develop relationships with new customers;
ReWalk’s ability to regain compliance with NASDAQ continued listing
requirements; and other factors discussed under the heading “Risk
Factors” in ReWalk’s Annual Report on Form 10-K for the year ended
December 31, 2016 filed with the U.S. Securities and Exchange
Commission and other documents subsequently filed with or furnished
to the U.S. Securities and Exchange Commission. Any forward-looking
statement made in this press release speaks only as of the date
hereof. Factors or events that could cause ReWalk’s actual results
to differ from the statements contained herein may emerge from time
to time, and it is not possible for ReWalk to predict all of them.
Except as required by law, ReWalk undertakes no obligation to
publicly update any forward-looking statements, whether as a result
of new information, future developments or otherwise.
Non-GAAP Financial MeasuresTo
supplement its consolidated financial statements, which are
prepared and presented in accordance with U.S. Generally Accepted
Accounting Principles (GAAP), ReWalk believes that the use of
non-GAAP accounting measures, including non-GAAP net loss, is
helpful to its investors. These measures, which the Company refers
to as non-GAAP financial measures, are not prepared in accordance
with GAAP.
For the three and twelve months ended December 31,
2016 and 2015, non-GAAP net loss is calculated as GAAP net loss
excluding (i) non-cash share-based compensation expense, (ii)
depreciation and (iii) non-cash financial expenses.
Because of varying available valuation
methodologies, subjective assumptions, and the variety of equity
instruments that can impact a company’s non-cash expenses, ReWalk
believes that providing non-GAAP financial measures that exclude
non-cash share-based compensation expense, depreciation and
non-cash financial (income) expenses allows for more meaningful
comparisons between operating results from period to period. Each
of the Company’s non-GAAP financial measures is an important tool
for financial and operational decision-making and for the Company’s
evaluation of its operating results over different periods of time.
The non-GAAP financial data are not measures of the Company’s
financial performance under U.S. GAAP, and should not be considered
as alternatives to operating loss or net loss or any other
performance measures derived in accordance with GAAP. Non-GAAP
financial measures may not provide information that is directly
comparable to that provided by other companies in ReWalk’s
industry, as other companies in the industry may calculate non-GAAP
financial results differently, particularly related to
non-recurring, unusual items. In addition, there are limitations in
using non-GAAP financial measures because the non-GAAP financial
measures are not prepared in accordance with GAAP, may be different
from non-GAAP financial measures used by other companies and
exclude expenses that may have a material impact on the Company’s
reported financial results. Further, share-based compensation
expense has been, and will continue to be for the foreseeable
future, a significant recurring expense in the Company’s business
and an important part of the compensation provided to its
employees. The presentation of non-GAAP financial information is
not meant to be considered in isolation or as a substitute for the
directly comparable financial measures prepared in accordance with
GAAP. ReWalk urges investors to review the reconciliation of the
Company’s non-GAAP financial measures to the comparable GAAP
financial measures included below, and not to rely on any single
financial measure to evaluate the Company’s business.
(tables follow)
ReWalk Robotics Ltd. |
|
|
Condensed Consolidated Statements of
Operations |
|
|
In thousands except per share
data |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Twelve months ended |
|
|
|
|
December 31, |
|
|
December 31, |
|
|
|
|
2016 |
|
|
2015 |
|
|
|
2016 |
|
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
$ |
1,591 |
|
$ |
1,336 |
|
|
$ |
5,869 |
|
$ |
3,746 |
|
|
|
Cost of
revenues |
|
1,723 |
|
|
1,302 |
|
|
|
5,133 |
|
|
3,532 |
|
|
|
Gross
profit (loss) |
|
(132 |
) |
|
34 |
|
|
|
736 |
|
|
214 |
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research
and development, net |
|
2,291 |
|
|
1,687 |
|
|
|
9,028 |
|
|
5,937 |
|
|
|
Sales and
marketing |
|
3,384 |
|
|
3,935 |
|
|
|
13,961 |
|
|
13,056 |
|
|
|
General
and administration |
|
2,228 |
|
|
1,917 |
|
|
|
8,188 |
|
|
6,395 |
|
|
|
Total
operating expenses |
|
7,903 |
|
|
7,539 |
|
|
|
31,177 |
|
|
25,388 |
|
|
|
Operating loss |
|
(8,035 |
) |
|
(7,505 |
) |
|
|
(30,441 |
) |
|
(25,174 |
) |
|
|
Financial expenses, net |
|
545 |
|
|
4 |
|
|
|
2,059 |
|
|
188 |
|
|
|
Loss
before income taxes |
|
(8,580 |
) |
|
(7,509 |
) |
|
|
(32,500 |
) |
|
(25,362 |
) |
|
|
Income
taxes |
|
(36 |
) |
|
(2 |
) |
|
|
3 |
|
|
53 |
|
|
|
Net
loss |
$ |
(8,544 |
) |
$ |
(7,507 |
) |
|
$ |
(32,503 |
) |
$ |
(25,415 |
) |
|
|
Net loss
per ordinary share, basic and diluted |
$ |
(0.56 |
) |
$ |
(0.62 |
) |
|
$ |
(2.47 |
) |
$ |
(2.10 |
) |
|
|
Weighted
average number of shares, basic and diluted |
|
15,227,211 |
|
|
12,175,430 |
|
|
|
13,178,107 |
|
|
12,115,038 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP to Non-GAAP net loss |
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
$ |
(8,544 |
) |
$ |
(7,507 |
) |
|
$ |
(32,503 |
) |
$ |
(25,415 |
) |
|
|
Non-cash
share-based compensation expense |
|
940 |
|
|
661 |
|
|
|
3,398 |
|
|
2,345 |
|
|
|
Depreciation |
|
193 |
|
|
189 |
|
|
|
696 |
|
|
438 |
|
|
|
Non-cash
financial expenses |
|
180 |
|
|
— |
|
|
|
675 |
|
|
— |
|
|
|
Non-GAAP
net loss |
$ |
(7,231 |
) |
$ |
(6,657 |
) |
|
$ |
(27,734 |
) |
$ |
(22,632 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ReWalk Robotics Ltd. |
|
|
Condensed Consolidated Balance
Sheets |
|
|
In thousands |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
|
|
|
|
|
2016 |
|
|
2015 |
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
|
|
|
|
|
Cash
& cash equivalents |
$ |
23,678 |
|
$ |
17,869 |
|
|
|
|
|
|
|
|
Trade
receivable, net |
|
1,254 |
|
|
2,146 |
|
|
|
|
|
|
|
|
Prepaid
expenses and other current assets |
|
1,291 |
|
|
1,227 |
|
|
|
|
|
|
|
|
Inventory |
|
3,264 |
|
|
2,534 |
|
|
|
|
|
|
|
|
Total
current assets |
|
29,487 |
|
|
23,776 |
|
|
|
|
|
|
|
|
Other
long-term assets |
|
1,018 |
|
|
470 |
|
|
|
|
|
|
|
|
Property
and equipment, net |
|
1,258 |
|
|
1,328 |
|
|
|
|
|
|
|
|
Total
assets |
$ |
31,763 |
|
$ |
25,574 |
|
|
|
|
|
|
|
|
Liabilities and equity |
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
|
|
|
|
Current
maturities of long term loan |
$ |
7,495 |
|
$ |
— |
|
|
|
|
|
|
|
|
Trade
payables |
|
3,424 |
|
|
2,474 |
|
|
|
|
|
|
|
|
Other
current liabilities |
|
1,479 |
|
|
1,869 |
|
|
|
|
|
|
|
|
Total
current liabilities |
|
12,398 |
|
|
4,343 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long
term loan, net of current maturities |
|
10,518 |
|
|
— |
|
|
|
|
|
|
|
|
Other
long-term liabilities |
|
587 |
|
|
311 |
|
|
|
|
|
|
|
|
Shareholders' equity |
|
8,260 |
|
|
20,920 |
|
|
|
|
|
|
|
|
Total
liabilities and shareholders’ equity |
$ |
31,763 |
|
$ |
25,574 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ReWalk Robotics Ltd. |
|
|
Condensed Consolidated Statements of Cash
Flows |
|
|
In thousands |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Twelve months ended |
|
|
|
|
|
|
|
December 31, |
|
|
|
|
|
|
|
2016 |
|
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash
used in operating activities |
$ |
(27,537 |
) |
$ |
(25,180 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash
provided by (used in) investing activities |
|
(437 |
) |
|
1,083 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash
provided by financing activities |
|
33,783 |
|
|
137 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase
(decrease) in cash and cash equivalents |
|
5,809 |
|
|
(23,960 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents at beginning of period |
|
17,869 |
|
|
41,829 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents at end of period |
$ |
23,678 |
|
$ |
17,869 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ReWalk Robotics Ltd. |
|
Revenue and Units Placed by Region and
Product |
|
In thousands except units |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Twelve months ended |
|
|
|
|
December 31, |
|
|
December 31, |
|
|
|
|
2016 |
|
|
2015 |
|
|
|
2016 |
|
|
2015 |
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
United
States |
$ |
765 |
|
$ |
764 |
|
|
$ |
3,741 |
|
$ |
2,439 |
|
|
|
Europe |
|
236 |
|
|
461 |
|
|
|
1,144 |
|
|
820 |
|
|
|
Asia
Pacific |
|
590 |
|
|
111 |
|
|
|
984 |
|
|
487 |
|
|
|
Total
Revenue |
$ |
1,591 |
|
$ |
1,336 |
|
|
$ |
5,869 |
|
$ |
3,746 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Units
Placed: |
|
|
|
|
|
|
|
|
|
|
|
United
States |
|
12 |
|
|
16 |
|
|
|
63 |
|
|
44 |
|
|
|
Europe |
|
5 |
|
|
7 |
|
|
|
25 |
|
|
19 |
|
|
|
Asia
Pacific |
|
22 |
|
|
2 |
|
|
|
31 |
|
|
10 |
|
|
|
Total
Units Placed |
|
39 |
|
|
25 |
|
|
|
119 |
|
|
73 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
Personal
units revenue |
$ |
1,268 |
|
$ |
1,196 |
|
|
$ |
5,197 |
|
$ |
2,766 |
|
|
|
Rehabilitation units revenue |
|
323 |
|
|
140 |
|
|
|
672 |
|
|
980 |
|
|
|
Total
Revenue |
$ |
1,591 |
|
$ |
1,336 |
|
|
$ |
5,869 |
|
$ |
3,746 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Units
Placed: |
|
|
|
|
|
|
|
|
|
|
|
Personal
units placed |
|
34 |
|
|
23 |
|
|
|
109 |
|
|
53 |
|
|
|
Rehabilitation units placed |
|
5 |
|
|
2 |
|
|
|
10 |
|
|
20 |
|
|
|
Total
Units Placed |
|
39 |
|
|
25 |
|
|
|
119 |
|
|
73 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investor Contact:
Lisa M. Wilson
President
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
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