-- Revenue of $1.4 million ---- Placed 23
Personal units with 13 positive insurance decisions --
ReWalk Robotics Ltd. (Nasdaq:RWLK) (“ReWalk” or “the Company”)
today announced its financial results for the three- and nine-month
periods ended September 30, 2016.
Highlights of and subsequent to the third quarter
include:
- Total revenue of $1.4 million for the third quarter of 2016,
compared to $1.2 million for the third quarter of 2015;
- 23 and 80 ReWalk systems placed during the three and nine
months ended September 30, 2016, compared to 23 and 48 ReWalk
systems placed during the three and nine months ended September 30,
2015;
- 7 additional users initiated use of the ReWalk Personal 6.0 in
various clinical studies: 3 initiating the Stanford study and 4 in
the VA research study. All 7 are potential separate sales in
future quarters;
- 20 individual personal use systems placed during the
quarter;
- 13 favorable case-by-case insurance reimbursement decisions;
and,
- $12.2 million raised in a public offering of ReWalk ordinary
shares and warrants subsequent to the end of the quarter.
“We continue to focus on executing our strategic plan to build
the exoskeleton market. Our efforts with insurance providers have
resulted in 64 positive reimbursement decisions, including 41 so
far this year, and we ended the quarter with a strong pipeline of
149 pending insurance claims,” stated Larry Jasinski, Chief
Executive Officer.
“During the first nine months of 2016, 11 systems were provided
to veterans through the Department of Veteran Affairs (VA) Coverage
Policy (SOP) and 22 systems for the VA’s ongoing studies regarding
the potential benefits of walking in the ReWalk. We expanded
the clinical study initiated with Stanford University to focus more
broadly on quality of life, utilization and cost utility outcomes.
And, we made meaningful progress on our research and development
efforts on a soft exo-suit technology for stroke and multiple
sclerosis patients through our partnership with the Wyss Institute
at Harvard University,” he added.
“With our latest financing in place, we believe we are
well-positioned to continue building upon the positive trajectory
of our insurance coverage and R&D efforts, which will enable us
to deliver on our milestones,” concluded Jasinski.
Third Quarter 2016 Financial Results
Total revenue was $1.4 million for the third quarter of 2016, an
increase of 20%, compared with $1.2 million in the third quarter of
2015. 23 ReWalk systems were placed during the third quarter and 80
were placed in the nine months ended September 30, 2016, compared
with 23 and 48 ReWalk systems placed in the corresponding prior
year periods. The increase in revenue was driven by unit sales and
the conversion of prior period rentals.
R&D expense was $2.0 million for the third quarter of 2016,
compared to $1.3 million during the same period last year,
reflecting investment in product development programs.
SG&A expense grew to $5.7 million for the third quarter of
2016, compared to $5.1 million in the prior year period, primarily
reflecting investment in reimbursement activities.
Net loss was $7.9 million for the third quarter of 2016 compared
with a net loss of $6.4 million in the prior year quarter. Non-GAAP
net loss for the third quarter was $6.7 million compared with a
non-GAAP net loss of $5.8 million in the third quarter of 2015.
A reconciliation of net loss to non-GAAP net loss is included at
the end of this press release under our Condensed Consolidated
Statement of Operations.
Liquidity
As of September 30, 2016, ReWalk had $12.4 million in
cash. Subsequent to the end of the quarter, ReWalk raised
gross proceeds of $12.2 million in a public offering of ordinary
shares and warrants.
Guidance
Management is reiterating revenue guidance in the range of $6.2
to $7.0 million for the full year, subject to the timing of certain
key business catalysts including placements in our international
markets, timing of reimbursement decisions, rental unit conversions
and larger orders to support the VA’s research studies.
Conference Call
ReWalk management will host its third quarter conference call as
follows:
Date |
November 3, 2016 |
|
|
Time |
8:30 AM EDT |
|
|
Telephone |
U.S: |
(844) 423-9889 |
|
|
|
|
International: |
(716) 247-5804 |
|
|
|
|
Israel: |
18 09 45 78 77 |
|
|
|
Webcast (live and archive) |
www.rewalk.com under the
“Investors” section. |
|
|
A replay of the conference call will be available for two weeks
after the call's completion by dialing (855) 859-2056 (U.S.) or
(404) 537-3406 (International). The conference ID for the
replay is 7986124. The archived webcast will be available for 30
days via the aforementioned URL.
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; 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 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 repay its secured indebtedness; 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 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
use effectively the proceeds of its follow-on offering; ReWalk’s
ability to maintain relationships with existing customers and
develop relationships with new customers; and other factors
discussed under the heading “Risk Factors” in ReWalk’s Annual
Report on Form 10-K for the year ended December 31, 2015 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 nine months ended September 30, 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 |
|
|
Nine months ended |
|
|
September 30, |
|
|
September 30, |
|
|
|
2016 |
|
|
|
|
2015 |
|
|
|
|
2016 |
|
|
|
|
2015 |
|
|
|
|
|
|
|
Revenue |
$ |
|
1,400 |
|
|
$ |
|
1,165 |
|
|
$ |
|
4,278 |
|
|
$ |
|
2,410 |
|
Cost of revenues |
|
|
1,110 |
|
|
|
|
1,078 |
|
|
|
|
3,410 |
|
|
|
|
2,230 |
|
Gross profit |
|
|
290 |
|
|
|
|
87 |
|
|
|
|
868 |
|
|
|
|
180 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development, net |
|
|
1,968 |
|
|
|
|
1,263 |
|
|
|
|
6,737 |
|
|
|
|
4,250 |
|
Sales and marketing |
|
|
3,774 |
|
|
|
|
3,607 |
|
|
|
|
10,577 |
|
|
|
|
9,121 |
|
General and administration |
|
|
1,951 |
|
|
|
|
1,522 |
|
|
|
|
5,960 |
|
|
|
|
4,478 |
|
Total operating
expenses |
|
|
7,693 |
|
|
|
|
6,392 |
|
|
|
|
23,274 |
|
|
|
|
17,849 |
|
Operating loss |
|
|
(7,403 |
) |
|
|
|
(6,305 |
) |
|
|
|
(22,406 |
) |
|
|
|
(17,669 |
) |
Financial expenses, net |
|
|
(508 |
) |
|
|
|
(65 |
) |
|
|
|
(1,514 |
) |
|
|
|
(184 |
) |
Loss before income
taxes |
|
|
(7,911 |
) |
|
|
|
(6,370 |
) |
|
|
|
(23,920 |
) |
|
|
|
(17,853 |
) |
Income taxes |
|
|
9 |
|
|
|
|
24 |
|
|
|
|
39 |
|
|
|
|
55 |
|
Net loss |
$ |
|
(7,920 |
) |
|
$ |
|
(6,394 |
) |
|
$ |
|
(23,959 |
) |
|
$ |
|
(17,908 |
) |
Net loss per ordinary
share, basic and diluted |
$ |
|
(0.62 |
) |
|
$ |
|
(0.53 |
) |
|
$ |
|
(1.92 |
) |
|
$ |
|
(1.48 |
) |
Weighted average number
of shares, basic and diluted |
|
|
12,759,887 |
|
|
|
|
12,148,750 |
|
|
|
|
12,495,433 |
|
|
|
|
12,094,600 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP
to Non-GAAP net loss |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
|
(7,920 |
) |
|
$ |
|
(6,394 |
) |
|
$ |
|
(23,959 |
) |
|
$ |
|
(17,908 |
) |
Non-cash share-based
compensation expense |
|
|
915 |
|
|
|
|
513 |
|
|
|
|
2,458 |
|
|
|
|
1,684 |
|
Depreciation |
|
|
176 |
|
|
|
|
124 |
|
|
|
|
503 |
|
|
|
|
248 |
|
Non-cash financial
expenses |
|
|
173 |
|
|
|
|
- |
|
|
|
|
495 |
|
|
|
|
- |
|
Non-GAAP net loss |
$ |
|
(6,656 |
) |
|
$ |
|
(5,757 |
) |
|
$ |
|
(20,503 |
) |
|
$ |
|
(15,976 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ReWalk Robotics Ltd. |
|
|
|
|
|
|
Condensed Consolidated Balance
Sheets |
|
|
|
|
|
In thousands |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30, |
|
|
December
31, |
|
|
|
|
|
|
|
|
|
2016 |
|
|
|
|
2015 |
|
|
|
|
|
|
|
Assets |
|
Unaudited |
|
|
Audited |
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
|
|
|
Cash & cash equivalents |
$ |
|
12,399 |
|
|
$ |
|
17,869 |
|
|
|
|
|
|
|
Trade receivable, net |
|
|
944 |
|
|
|
|
2,146 |
|
|
|
|
|
|
|
Prepaid expenses and other current
assets |
|
|
1,604 |
|
|
|
|
1,227 |
|
|
|
|
|
|
|
Inventory |
|
|
3,425 |
|
|
|
|
2,534 |
|
|
|
|
|
|
|
Total current
assets |
|
|
18,372 |
|
|
|
|
23,776 |
|
|
|
|
|
|
|
Other long-term
assets |
|
|
1,101 |
|
|
|
|
470 |
|
|
|
|
|
|
|
Property and equipment,
net |
|
|
1,346 |
|
|
|
|
1,328 |
|
|
|
|
|
|
|
Total assets |
$ |
|
20,819 |
|
|
$ |
|
25,574 |
|
|
|
|
|
|
|
Liabilities and
equity |
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
|
|
|
|
Current maturities of long term
loan |
$ |
|
5,299 |
|
|
$ |
|
- |
|
|
|
|
|
|
|
Trade payables |
|
|
3,445 |
|
|
|
|
2,474 |
|
|
|
|
|
|
|
Other current liabilities |
|
|
1,752 |
|
|
|
|
1,869 |
|
|
|
|
|
|
|
Total current
liabilities |
|
|
10,496 |
|
|
|
|
4,343 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long term loan, net of
current maturities |
|
|
5,180 |
|
|
|
|
- |
|
|
|
|
|
|
|
Other long-term
liabilities |
|
|
441 |
|
|
|
|
311 |
|
|
|
|
|
|
|
Shareholders'
equity |
|
|
4,702 |
|
|
|
|
20,920 |
|
|
|
|
|
|
|
Total liabilities and
shareholders’ equity |
$ |
|
20,819 |
|
|
$ |
|
25,574 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ReWalk Robotics Ltd. |
|
|
|
|
|
Condensed Consolidated Statements of Cash
Flows |
|
|
|
|
|
In thousands |
|
|
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended |
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
|
|
2016 |
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash
used in operating activities |
$ |
|
(20,200 |
) |
|
$ |
|
(18,038 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash
provided by (used in) investing activities |
|
|
(408 |
) |
|
|
|
1,235 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash
provided by financing activities |
|
|
15,138 |
|
|
|
|
112 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decrease
in cash and cash equivalents |
|
|
(5,470 |
) |
|
|
|
(16,691 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents at beginning of period |
|
|
17,869 |
|
|
|
|
41,829 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents at end of period |
$ |
|
12,399 |
|
|
$ |
|
25,138 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ReWalk Robotics Ltd. |
Revenue and Units Placed by Region and
Product |
In thousands except units |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine months ended |
|
September 30, |
|
September 30, |
|
2016 |
|
2015 |
|
2016 |
|
2015 |
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
United
States |
$ |
|
710 |
|
|
$ |
|
725 |
|
|
$ |
|
2,976 |
|
|
$ |
|
1,675 |
|
Europe |
|
|
404 |
|
|
|
|
140 |
|
|
|
|
908 |
|
|
|
|
359 |
|
Asia
Pacific |
|
|
286 |
|
|
|
|
300 |
|
|
|
|
394 |
|
|
|
|
376 |
|
Total
Revenue |
$ |
|
1,400 |
|
|
$ |
|
1,165 |
|
|
$ |
|
4,278 |
|
|
$ |
|
2,410 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Units
Placed: |
|
|
|
|
|
|
|
|
|
|
|
United
States |
|
|
12 |
|
|
|
|
12 |
|
|
|
|
51 |
|
|
|
|
28 |
|
Europe |
|
|
5 |
|
|
|
|
5 |
|
|
|
|
20 |
|
|
|
|
12 |
|
Asia
Pacific |
|
|
6 |
|
|
|
|
6 |
|
|
|
|
9 |
|
|
|
|
8 |
|
Total
Units Placed |
|
|
23 |
|
|
|
|
23 |
|
|
|
|
80 |
|
|
|
|
48 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
Personal
units revenue |
$ |
|
1,250 |
|
|
$ |
|
555 |
|
|
$ |
|
3,929 |
|
|
$ |
|
1,570 |
|
Rehabilitation units revenue |
|
|
150 |
|
|
|
|
610 |
|
|
|
|
349 |
|
|
|
|
840 |
|
Total
Revenue |
$ |
|
1,400 |
|
|
$ |
|
1,165 |
|
|
$ |
|
4,278 |
|
|
$ |
|
2,410 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Units
Placed: |
|
|
|
|
|
|
|
|
|
|
|
Personal
units placed |
|
|
20 |
|
|
|
|
12 |
|
|
|
|
75 |
|
|
|
|
30 |
|
Rehabilitation units placed |
|
|
3 |
|
|
|
|
11 |
|
|
|
|
5 |
|
|
|
|
18 |
|
Total
Units Placed |
|
|
23 |
|
|
|
|
23 |
|
|
|
|
80 |
|
|
|
|
48 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Investor Contact:
Lisa M. Wilson
President
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
Media Contact:
Jennifer Wlach
Senior Vice President
Mercury LLC
T: 202-261-4000
E: jwlach@mercuryllc.com
ReWalk Robotics (NASDAQ:RWLK)
Historical Stock Chart
From Mar 2024 to Apr 2024
ReWalk Robotics (NASDAQ:RWLK)
Historical Stock Chart
From Apr 2023 to Apr 2024