— 2016 Full year revenue grows 57% to $5.9 million —
— Year-over-year unit placements up 63%; favorable insurance reimbursement decisions up 122% —
YOKNEAM ILIT, Israel and MARLBOROUGH, Mass., Feb. 17, 2017 (GLOBE NEWSWIRE) -- 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 Measures
To 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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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Investor Contact: Lisa M. Wilson President In-Site Communications, Inc. T: 212-452-2793 E: lwilson@insitecony.com