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): August 4, 2016

 

ReWalk Robotics Ltd.

(Exact name of registrant as specified in its charter)

 

Israel	001-36612	N/A
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)
3 Hatnufa St., Floor 6, Yokneam Ilit, Israel		2069203
(Address of principal executive offices)		(Zip Code)

 

Registrant’s telephone number, including area code:                        +972.4.959.0123                         

 

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 (see General Instruction A.2. below):

 

¨

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))

 

 

TABLE OF CONTENTS

 

ITEM 2.02 — RESULTS OF OPERATIONS AND FINANCIAL CONDITION	3
ITEM 9.01 — FINANCIAL STATEMENTS AND EXHIBITS	3
SIGNATURES	4
EXHIBIT INDEX	5

 

 

Item 2.02  Results of Operations and Financial Condition.

 

On August 4, 2016, ReWalk Robotics Ltd. (the “Company”) issued a press release announcing its financial results for the second quarter ended June 30, 2016. A copy of the press release is being furnished herewith as Exhibit 99.1. As set forth in the press release, the Company will host a conference call to discuss its financial results for the second quarter ended June 30, 2016 on Thursday, August 4, 2016 at 8:30 AM EDT. A listen-only live webcast of the call may be accessed through the Company’s website at www.rewalk.com under the “Investors” section or by dialing (844) 423-9889 in the United States, 18 09 45 78 77 in Israel or (716) 247-5804 outside the United States and Israel. The access code is 54201193.

 

An archived recording of the call will be made available shortly after the completion of the call for two weeks at (855) 859-2056 in the United States or (404) 537-3406 outside of the United States. The access code is 54201193.

 

The information in this current report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “1934 Act”), nor shall it be deemed “incorporated by reference” into any filing under the Securities Act of 1933, as amended, or the 1934 Act, except as may be expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit Number		Description
99.1		Press release dated August 4, 2016 of ReWalk Robotics Ltd. announcing financial results for the second quarter ended June 30, 2016, furnished herewith.

 

 

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.

  

	ReWalk Robotics Ltd.
	By:	/s/ Kevin Hershberger
	Name: Title:	Kevin Hershberger Chief Financial Officer

 

Dated: August 4, 2016

 

 

EXHIBIT INDEX

 

Exhibit Number		Description
99.1		Press release dated August 4, 2016 of ReWalk Robotics Ltd. announcing financial results for the second quarter ended June 30, 2016, furnished herewith.

 

 

Exhibit 99.1

 

 

For Immediate Release

 

ReWalk Robotics Reports Second Quarter 2016 Financial Results
--Placed 24 Personal Units, 18 of which were covered by insurance--

 

YOKNEAM ILIT, ISRAEL / MARLBOROUGH, MA, August 4, 2016 – ReWalk Robotics Ltd. (Nasdaq: RWLK) (“ReWalk” or “the Company”) today announced its financial results for the three- and six-month periods ended June 30, 2016.

 

Highlights of and subsequent to the second quarter include:

 

	•	Total revenue for the second quarter of 2016 was $817,000, compared to $610,000 for the second quarter of 2015;
	•	Placed 25 ReWalk systems during the second quarter of 2016, compared to 12 ReWalk systems during the second quarter of 2015;
	•	Placed 24 individual personal use systems during the quarter, of which a record 18 were covered by insurance reimbursement;
	•	Five new U.S. Department of Veterans Affairs (“VA”) spinal cord injury centers initiated training programs, for a total of seven VA training centers. Six new personal ReWalk devices were placed with patients as part of the VA national coverage policy;
	•	German court ruled ReWalk exoskeleton is medically necessary, approving reimbursement on appeal;
	•	Independent Medical Review Organization in California determined that the ReWalk exoskeleton is likely to be more beneficial for treatment of a patient’s medical condition than any available standard therapy;
	•	Initiated post-market 522 study with Stanford University as the lead investigator site; and,
	•	Signed agreement with Harvard University’s Wyss Institute to develop wearable soft-exosuit technology to address a broad range of lower limb disabilities.

 

“As ReWalk’s technology and the benefits of exoskeleton use become increasingly accepted, ReWalk is uniquely positioned to remain the global leader in developing and marketing exoskeletons for lower limb disabilities,” stated Larry Jasinski, Chief Executive Officer.

 

“A record number of personal units were placed with customers, of which 75% were covered by insurance reimbursement. Our extensive efforts to support the VA continue to drive our commercialization activities, with seven centers across the U.S. now operating as ReWalk training facilities, allowing us to reach a broader universe of veterans. We continue to gain traction in Europe, with yet another German court approving reimbursement on appeal, ruling that the ReWalk exoskeleton is medically necessary. Importantly, we believe our new collaboration with Harvard’s Wyss Institute will, in time, help fill the need for soft wearable exoskeleton suits designed to support individuals affected by stroke, MS, Parkinson’s and senior citizens who require mobility assistance,” he added.

 

 

“While we believe that these elements, taken together, will allow ReWalk to remain the global leader in exoskeleton technology addressing a broad range of lower limb disabilities, we are adjusting our expectations on the timing of top line growth for the balance of 2016. Based on the increase in rental units during the second quarter, we believe a portion of our revenue dollars have shifted to subsequent periods, and we are providing top line guidance of approximately $1.3 million for the third quarter of 2016 and a range of $6.2 million to $7.0 million for the full year,” concluded Jasinski.

 

Second Quarter 2016 Financial Results

Total revenue was $817,000 for the second quarter of 2016, an increase of 34%, compared with $610,000 in the second quarter of 2015. 25 ReWalk systems were placed during the second quarter, compared with 12 ReWalk systems placed in the prior year period and 32 placed in the first quarter of 2016. 16 were rental units, including 6 units placed through the VA as part of its coverage policy. The increase in rental units during the quarter was driven by commercial insurance payers in Germany and units placed with veterans under the VA policy. At the end of the second quarter, rental units represented $1.1 million in potential revenue backlog.

 

R&D expense was $3.1 million for the second quarter of 2016, compared to $1.5 million during the same period last year, reflecting costs of increased investment in product development programs and clinical activities and a one-time charge related to ReWalk’s collaboration agreement with the Wyss Institute at Harvard University.

 

SG&A expense grew to $5.6 million for the second quarter of 2016, compared to $4.5 million in the prior year period, primarily reflecting investment in reimbursement activities.

 

Net loss was $9.1 million for the second quarter of 2016 compared with a net loss of $5.8 million in the prior year quarter. Non-GAAP net loss for the second quarter was $8.0 million compared with a non-GAAP net loss of $5.1 million in the second quarter of 2015.

 

A reconciliation of net loss to non-GAAP net loss is included at the end of this press release.

 

Liquidity

 

As of June 30, 2016, ReWalk had $15.7 million in cash and cash equivalents.

 

Guidance

 

Based on the increase in rental unit placements during the second quarter, we believe a portion of our revenue dollars have shifted to subsequent quarters, and as a result we are providing top line guidance of approximately $1.3 million for the third quarter of 2016 and a range of $6.2 million to $7.0 million for the full year. The timing of certain key business catalysts during the second half of 2016, such as placements in our international markets, timing of reimbursement decisions, rental unit conversions and larger orders to support the VA research study may shift from quarter to quarter.

 

Conference Call

 

ReWalk management will host its second quarter conference call as follows:

 

Date		August 4, 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 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 54201193.

 

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; 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 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 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 six months ended June 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.

 

Investor Contact:

Lisa M. Wilson

President

In-Site Communications, Inc.

T: 212-452-2793

E: lwilson@insitecony.com

 

 

(tables follow)

  

 

ReWalk Robotics Ltd.

Condensed Consolidated Statements of Operations

In thousands except per share data

(unaudited)

 

		Three Months Ended								Six months ended
		June 30,								June 30,
		2016				2015				2016				2015
Revenue		$	817			$	610			$	2,878			$	1,245
Cost of revenues			732				550				2,300				1,152
Gross profit			85				60				578				93
Operating expenses:
Research and development			3,074				1,450				4,769				2,987
Sales and marketing			3,504				2,996				6,803				5,514
General and administration			2,095				1,457				4,009				2,956
Total operating expenses			8,673				5,903				15,581				11,457
Operating loss			(8,588	)			(5,843	)			(15,003	)			(11,364	)
Financial income (expenses), net			(517	)			50				(1,006	)			(119	)
Loss before income taxes			(9,105	)			(5,793	)			(16,009	)			(11,483	)
Income taxes			12				15				30				31
Net loss		$	(9,117	)		$	(5,808	)		$	(16,039	)		$	(11,514	)
Net loss per ordinary share, basic and diluted		$	(0.00	)		$	(0.00	)		$	(0.00	)		$	(0.00	)
Weighted average number of shares, basic and diluted			12,403,541				12,126,563				12,363,698				12,066,945
Reconciliation of GAAP to Non-GAAP net loss
Net loss		$	(9,117	)		$	(5,808	)		$	(16,039	)		$	(11,514	)
Non-cash share- based compensation expense			826				585				1,543				1,171
Depreciation			164				81				327				124
Non-cash financial expenses			166				-				322				-
Non-GAAP net loss		$	(7,961	)		$	(5,142	)		$	(13,847	)		$	(10,219	)

 

 

ReWalk Robotics Ltd.

Condensed Consolidated Balance Sheets

In thousands

 

		June 30,				December 31,
		2016				2015
Assets		Unaudited				Audited
Current assets
Cash & cash equivalents		$	15,686			$	17,869
Trade receivable, net			1,187				2,146
Prepaid expenses and other current assets			1,792				1,227
Inventory			3,415				2,534
Total current assets			22,080				23,776
Other long-term assets			1,107				470
Property and equipment, net			1,451				1,328
Total assets		$	24,638			$	25,574
Liabilities and equity
Current liabilities
Current maturities of long term loan		$	3,963			$	-
Trade payables			4,239				2,474
Other current liabilities			1,633				1,869
Total current liabilities			9,835				4,343
Long term loan, net of current maturities			6,344				-
Other long-term liabilities			409				311
Shareholders' equity			8,050				20,920
Total liabilities and shareholders’ equity		$	24,638			$	25,574

 

 

ReWalk Robotics Ltd.

Condensed Consolidated Statements of Cash Flows

In thousands

(unaudited)

 

		Six months ended
		June 30,
		2016				2015
Net cash used in operating activities		$	(13,513	)		$	(12,039	)
Net cash provided by (used in) investing activities			(395	)			1,316
Net cash provided by financing activities			11,725				66
Decrease in cash and cash equivalents			(2,183	)			(10,657	)
Cash and cash equivalents at beginning of period			17,869				41,829
Cash and cash equivalents at end of period		$	15,686			$	31,172

 

ReWalk Robotics Ltd.

Revenue and Units Placed by Region and Product

In thousands except units

(unaudited)

 

		Three Months Ended								Six months ended
		June 30,								June 30,
		2016				2015				2016				2015
Revenue:
United States		$	527			$	376			$	2,266			$	950
Europe			244				162				504				219
Asia Pacific			46				72				108				76
Total Revenue		$	817			$	610			$	2,878			$	1,245
Units Placed:
United States			13				6				39				16
Europe			10				4				15				7
Asia Pacific			2				2				3				2
Total Units Placed			25				12				57				25
Revenue:
Personal units revenue		$	708			$	405			$	2,679			$	1,015
Rehabilitation units revenue			109				205				199				230
Total Revenue		$	817			$	610			$	2,878			$	1,245
Units Placed:
Personal units placed			24				7				55				18
Rehabilitation units placed			1				5				2				7
Total Units Placed			25				12				57				25