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x
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Israel
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Not applicable
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. employer identification no.)
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3 Hatnufa Street, Floor 6, Yokneam Ilit, Israel
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2069203
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(Address of principal executive offices)
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(Zip Code)
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Large accelerated filer
o
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Accelerated filer
o
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Non-accelerated filer
o
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Smaller reporting company
x
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(Do not check if a smaller reporting company)
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Emerging growth company
x
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Page No.
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September 30,
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December 31,
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2017
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2016
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ASSETS
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CURRENT ASSETS
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Cash and cash equivalents
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$
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12,928
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$
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23,678
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Trade receivable, net
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1,265
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1,254
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Prepaid expenses and other current assets
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1,703
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1,291
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Inventory
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3,500
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3,264
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Total current assets
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19,396
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29,487
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LONG-TERM ASSETS
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Other long term assets
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1,182
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1,018
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Property and equipment, net
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906
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1,258
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Total long-term assets
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2,088
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2,276
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Total assets
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$
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21,484
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$
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31,763
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September 30,
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December 31,
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2017
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2016
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LIABILITIES AND SHAREHOLDERS’ EQUITY
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CURRENT LIABILITIES
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Current maturities of long term loan
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$
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5,663
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$
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7,495
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Trade payables
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2,426
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3,424
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Employees and payroll accruals
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858
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1,019
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Deferred revenues and customers advances
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133
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54
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Other current liabilities
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537
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406
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Total current liabilities
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9,617
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12,398
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LONG-TERM LIABILITIES
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Long term loan, net of current maturities
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10,003
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10,518
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Deferred revenues
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250
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284
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Other long-term liabilities
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274
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303
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Total long-term liabilities
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10,527
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11,105
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Total liabilities
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20,144
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23,503
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COMMITMENTS AND CONTINGENT LIABILITIES
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Shareholders’ equity:
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Share capital
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Ordinary shares, par value NIS 0.01 per share-Authorized: 250,000,000 shares at September 30, 2017 and December 31, 2016; Issued and outstanding: 21,823,771 and 16,338,257 shares at September 30, 2017 and December 31, 2016, respectively
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60
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45
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Additional paid-in capital
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126,338
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114,707
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Accumulated deficit
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(125,058
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)
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(106,492
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)
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Total shareholders’ equity
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1,340
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8,260
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Total liabilities and shareholders’ equity
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$
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21,484
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$
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31,763
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Three Months Ended
September 30, |
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Nine Months Ended
September 30, |
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2017
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2016
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2017
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2016
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Revenues
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$
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1,732
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$
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1,400
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$
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6,238
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$
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4,278
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Cost of revenues
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1,024
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1,110
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3,740
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3,410
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Gross profit
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708
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290
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2,498
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868
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Operating expenses:
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Research and development, net
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1,618
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1,968
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4,433
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6,737
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Sales and marketing
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2,637
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3,774
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8,643
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10,577
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General and administrative
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1,805
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1,951
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5,796
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5,960
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Total operating expenses
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6,060
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7,693
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18,872
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23,274
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Operating loss
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(5,352
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(7,403
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(16,374
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(22,406
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)
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Loss on extinguishment of debt
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—
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—
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313
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—
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Financial expenses, net
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479
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508
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1,843
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1,514
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Loss before income taxes
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(5,831
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(7,911
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(18,530
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(23,920
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Income taxes
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15
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9
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25
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39
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Net loss
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$
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(5,846
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$
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(7,920
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$
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(18,555
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$
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(23,959
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Net loss per ordinary share, basic and diluted
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$
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(0.27
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$
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(0.62
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$
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(1.00
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$
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(1.92
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Weighted average number of shares used in computing net loss per ordinary share, basic and diluted
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21,660,757
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12,759,887
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18,463,444
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12,495,433
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Ordinary Share
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Additional
paid-in capital |
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Accumulated
deficit |
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Total
shareholders’ equity |
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Number
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Amount
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Balance as of January 1, 2016
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12,222,583
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33
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94,876
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(73,989
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)
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20,920
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Share-based compensation to employees and non-employees
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—
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—
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3,398
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—
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3,398
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Issuance of ordinary shares upon exercise of options to purchase ordinary shares and RSUs by employees and non-employees
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128,496
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1
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17
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—
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18
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Issuance of ordinary shares in at-the-market offering, net of issuance expenses in the amount of $468
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692,062
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2
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4,097
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—
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4,099
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Issuance of warrants to purchase ordinary shares
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—
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—
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1,239
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—
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1,239
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Cashless exercise of warrants into ordinary shares
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45,116
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*)
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*)
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—
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—
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Issuance of ordinary shares and warrants to purchase ordinary shares in follow-on public offering, net of issuance expenses
in an amount of $1,099 |
3,250,000
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9
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11,080
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—
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11,089
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Net loss
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—
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—
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—
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(32,503
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)
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(32,503
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)
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|||||
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Balance as of December 31, 2016
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16,338,257
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|
45
|
|
|
114,707
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(106,492
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)
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|
8,260
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Cumulative effect to stock based compensation from adoption of a new accounting standard
|
—
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|
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—
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|
11
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|
(11
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)
|
|
—
|
|
|
Share-based compensation to employees and non-employees
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—
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|
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—
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|
|
2,597
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|
|
—
|
|
|
2,597
|
|
|
Issuance of ordinary shares upon exercise of options to purchase ordinary shares and RSUs by employees and non-employees (1)
|
105,606
|
|
|
*)
|
|
|
28
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|
|
—
|
|
|
28
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|
|
Issuance of ordinary shares in at-the-market offering, net of issuance expenses in the amount of $439 (2)
|
5,379,908
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|
15
|
|
|
8,995
|
|
|
—
|
|
|
9,010
|
|
|
Net loss
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—
|
|
|
—
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|
|
—
|
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(18,555
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)
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|
(18,555
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)
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|
Balance as of September 30, 2017
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21,823,771
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|
|
60
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|
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126,338
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(125,058
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)
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|
1,340
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|
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*)
|
Represents an amount lower than $1.
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|
(1)
|
See Note 8b to the condensed consolidated financial statements
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(2)
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See Note 8e to the condensed consolidated financial statements
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Nine Months Ended September 30,
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||||||
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2017
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2016
|
||||
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Cash flows from operating activities:
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Net loss
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$
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(18,555
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)
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$
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(23,959
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)
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|
Adjustments to reconcile net loss to net cash used in operating activities:
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|||
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Depreciation
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516
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503
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Share-based compensation to employees and non- employees
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2,597
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2,458
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Deferred taxes
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(20
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)
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(64
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)
|
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Loss on extinguishment of debt
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313
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|
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—
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Financial expenses related to long term loan
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87
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|
495
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||||
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Changes in assets and liabilities:
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|||
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||||
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Trade receivables, net
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(11
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)
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|
1,202
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|
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Prepaid expenses and other current and long term assets
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(556
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)
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(804
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)
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||
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Inventories
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(381
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)
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|
(1,004
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)
|
||
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Trade payables
|
(1,048
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)
|
|
960
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|
||
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Employees and payroll accruals
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(161
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)
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|
(285
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)
|
||
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Deferred revenues and advances from customers
|
45
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|
|
116
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|
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Other current and long term liabilities
|
102
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|
|
182
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|
||
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Net cash used in operating activities
|
(17,072
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)
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|
(20,200
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)
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||
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Cash flows from investing activities:
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|
||||
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Purchase of property and equipment
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(19
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)
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(408
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)
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Net cash used in investing activities
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(19
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)
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|
(408
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)
|
||
|
|
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|
||||
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Cash flows from financing activities:
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|
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|
|
|||
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Issuance of ordinary shares upon exercise of options to purchase ordinary shares by employees and non-employees
|
28
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|
|
23
|
|
||
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Proceeds from long term loan
|
—
|
|
|
12,000
|
|
||
|
Debt issuance cost
|
—
|
|
|
(441
|
)
|
||
|
Repayment of long term loan
|
(2,747
|
)
|
|
(554
|
)
|
||
|
Issuance of ordinary shares in at-the-market offering, net of issuance expenses paid in the amount of $389 (1)
|
9,060
|
|
|
4,110
|
|
||
|
Net cash provided by financing activities
|
6,341
|
|
|
15,138
|
|
||
|
|
|
|
|
||||
|
Decrease in cash and cash equivalents
|
(10,750
|
)
|
|
(5,470
|
)
|
||
|
Cash and cash equivalents at beginning of period
|
23,678
|
|
|
17,869
|
|
||
|
Cash and cash equivalents at end of period
|
$
|
12,928
|
|
|
$
|
12,399
|
|
|
|
|
|
|
||||
|
Supplemental disclosures of non-cash flow information
|
|
|
|
||||
|
At-the-market offering expenses not yet paid
|
$
|
50
|
|
|
$
|
11
|
|
|
Classification of inventory to property and equipment, net
|
$
|
145
|
|
|
$
|
113
|
|
|
|
|
|
|
a.
|
ReWalk Robotics Ltd. (“RRL”, and together with its subsidiaries, the “Company”) was incorporated under the laws of the State of Israel on June 20, 2001 and commenced operations on the same date.
|
|
b.
|
RRL has
two
wholly-owned subsidiaries: (i) ReWalk Robotics Inc., incorporated under the laws of Delaware on February 15, 2012; and (ii) ReWalk Robotics GMBH. incorporated under the laws of Germany on January 14, 2013.
|
|
c.
|
During the
nine months ended September 30, 2017
, the Company issued and sold
5,379,908
ordinary shares at an average price of
$1.76
per share under its ATM Offering Program (as defined in Note 8e). The gross proceeds to the Company were
$9.4 million
, and the net aggregate proceeds after deducting commissions, fees and offering expenses in the amount of
$439 thousand
were
$9.0 million
. As a result, from the inception of the ATM Offering Program in May 2016 until
September 30, 2017
, the Company has issued and sold
6,071,970
ordinary shares at an average price of
$2.31
per share under its ATM Offering Program, with gross proceeds of
$14.0 million
, and net aggregate proceeds of
$13.1 million
after deducting commissions, fees and offering expenses in the amount of
$907 thousand
. The Company may raise up to
$25 million
under its ATM Offering Program pursuant to the terms of its agreement with the sales agent. However, due to limitations under the rules of Form S-3, which have applied to the Company since it filed its annual report on Form 10-K for the fiscal year ended December 31, 2016 on February 17, 2017, taking into account ordinary shares issued
and settled under the Company’s ATM Offering Program since February 17, 2017, as of
September 30, 2017
, the Company may issue up to
$4.3 million
in primary offerings under its effective shelf registration statement on Form S-3 (File No. 333- 209833) (the “Form S-3”), including its ATM Offering Program, during the 12 months following February 17, 2017, unless and until it is no longer subject to such limitations. See Note 8e for more information about the Company’s ATM Offering Program and the related limitations under its Form S-3.
|
|
d.
|
The Company depends on
one
contract manufacturer. Reliance on this vendor makes the Company vulnerable to possible capacity constraints and reduced control over component availability, delivery schedules, manufacturing yields and costs. This vendor accounted for
0%
and
12%
of the Company's total trade payables as of
September 30, 2017
and
December 31, 2016
, respectively.
|
|
e.
|
On January 9, 2017, the Company announced its plan to reduce total operating expenses in 2017 by up to
30%
as compared to 2016. The Company has been working toward such reductions through a combination of targeted savings, including by establishing quality improvement initiatives and lowering overall product cost, realigning the Company’s staffing priorities and reducing the size of its staff, including its reimbursement personnel, reducing spending on external appeals, and lowering other corporate spending.
|
|
f.
|
The Company had an accumulated deficit in the total amount of
$125.1 million
as of
September 30, 2017
and further losses are anticipated in the development of its business. Those factors raise substantial doubt about the Company’s ability to continue as a going concern. The ability to continue as a going concern is dependent upon the Company obtaining the necessary financing to meet its obligations and repay its liabilities arising from normal business operations when they become due.
|
|
|
|
|
|
a.
|
The significant accounting policies applied in the audited consolidated financial statements of the Company as disclosed in the Company's annual report on Form 10-K for the year ended December 31, 2016 filed with the SEC on February 17, 2017, as amended on Form 10-K/A filed with the SEC on April 27, 2017 (the “2016 Form 10-K”), are applied consistently in these unaudited interim condensed consolidated financial statements.
|
|
b.
|
Recent Accounting Pronouncements:
|
|
|
|
|
|
|
|
|
|
c.
|
Concentrations of Credit Risks:
|
|
d.
|
Warranty provision
|
|
|
US Dollars in thousands
|
|
|
|
Balance at December 31, 2016
|
$
|
498
|
|
|
Provision
|
311
|
|
|
|
Usage
|
(275
|
)
|
|
|
Balance at September 30, 2017
|
$
|
534
|
|
|
|
September 30,
|
|
December 31,
|
||||
|
|
2017
|
|
2016
|
||||
|
Finished products
|
3,500
|
|
|
3,264
|
|
||
|
|
$
|
3,500
|
|
|
$
|
3,264
|
|
|
|
|
|
|
a.
|
Purchase commitments:
|
|
b.
|
Royalties:
|
|
|
|
|
|
c.
|
Liens:
|
|
d.
|
Legal Claims:
|
|
•
|
Dismissed Actions:
|
|
◦
|
On September 20, November 3, November 9, and November 10, 2016, respectively,
four
putative class actions on behalf of alleged shareholders that purchased or acquired the Company's ordinary shares pursuant and/or traceable to the registration statement used in connection with the Company's IPO were commenced in the Superior Court of the State of California, County of San Mateo. The actions were filed against the Company, certain of the Company's current and former directors and officers, and the underwriters of the Company's IPO. We refer to these actions as the “California State Court Actions.” The complaints in the California State Court Actions asserted various claims under the Securities Act. Each of the California State Court Actions was dismissed for lack of personal jurisdiction in January 2017.
|
|
◦
|
On January 24, 2017, a substantially similar class action was commenced in the United States District Court for the Northern District of California (Case No. 4:17-cv-362) against the same defendants as in the California State Court Actions plus certain additional defendants. This action is referred to as the “California Federal Court Action.” On March 23, 2017, this case was voluntarily dismissed.
|
|
•
|
Pending Actions:
|
|
◦
|
On or about October 31, 2016, a class action with claims substantially similar to the California State Court Actions was commenced in the Massachusetts Superior Court, Suffolk County, by a different plaintiff (Civ. Action No. 16-3336), alleging claims under Section 11 of the Securities Act against the Company, certain of the Company's current and former directors and officers, and the underwriters of the Company's IPO, and alleging claims under Section 15 of the Securities Act against the Company and certain of the Company's current and former directors and officers.
|
|
|
|
|
|
◦
|
On or about November 30, 2016, a substantially similar class action was commenced in the Massachusetts Superior Court, Suffolk County, by a different plaintiff (Civ. Action No. 16-3670) alleging claims under Sections 11 and 15 of the Securities Act against the same defendants as in the action commenced on October 31, 2016, and also alleging claims under Section 12(a)(2) of the Securities Act against the Company, certain of the Company's current and former directors and officers, and the underwriters of the Company's IPO. This action was ordered consolidated in the Massachusetts Superior Court, Suffolk County on January 9, 2017 with the action commenced on October 31, 2016, and the two actions are referred to as the “Consolidated Massachusetts State Court Actions”. The plaintiffs in the Consolidated Massachusetts State Court Actions filed a consolidated amended complaint on March 20, 2017. The Company moved to dismiss the Consolidated Massachusetts State Court Actions on June 2, 2017.
For more information, see Note 11
.
|
|
◦
|
On or about January 31, 2017, a substantially similar class action was commenced in the United States District Court for the District of Massachusetts (Case No. 1:17-cv-10169) by four of the same plaintiffs who commenced the California State Court Actions, and two additional plaintiffs, alleging claims under Sections 11 and 12(a)(2) of the Securities Act against the Company, certain of the Company's current and former directors and officers, and the underwriters of the Company's IPO, and alleging claims under Section 15 of the Securities Act against certain of the Company's current and former directors and officers. This action is referred to as the “Massachusetts Federal Court Action.” On July 6, 2017, the Company moved to stay the Massachusetts Federal Court Action. The plaintiffs in the Massachusetts Federal Court Action filed a consolidated amended complaint on August 9, 2017.
For more information, see Note 11.
|
|
|
|
|
|
|
|
|
|
|
a.
|
Share option plans:
|
|
|
|
Nine Months Ended September 30,
|
||
|
|
|
2017
|
|
2016
|
|
Expected volatility
|
|
56% - 58%
|
|
53% - 60%
|
|
Risk-free rate
|
|
1.78% - 2.07%
|
|
1.16%-1.60%
|
|
Dividend yield
|
|
—%
|
|
—%
|
|
Expected term (in years)
|
|
5.31-6.11
|
|
5.31-6.11
|
|
Share price
|
|
$1.3- $2.1
|
|
$6.8- $11.88
|
|
|
|
|
|
|
Nine Months Ended September 30, 2017
|
|||||||||||
|
|
Number
|
|
Average
exercise
price
|
|
Average
remaining
contractual
life (in years) (1)
|
|
Aggregate
intrinsic
value (in
thousands)
|
|||||
|
Options and RSUs outstanding at the beginning of the period
|
2,251,014
|
|
|
$
|
6.47
|
|
|
7.80
|
|
$
|
1,740
|
|
|
Options granted
|
413,746
|
|
|
2.01
|
|
|
|
|
|
|
||
|
RSUs granted
|
230,484
|
|
|
—
|
|
|
|
|
|
|||
|
Options exercised (2)
|
(30,192
|
)
|
|
1.39
|
|
|
|
|
|
|||
|
RSUs vested (2)
|
(59,450
|
)
|
|
—
|
|
|
|
|
|
|||
|
RSUs forfeited
|
(44,196
|
)
|
|
—
|
|
|
|
|
|
|
||
|
Options forfeited
|
(169,008
|
)
|
|
2.99
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
|
|
|||||
|
Options and RSUs outstanding at the end of the period
|
2,592,398
|
|
|
$
|
5.39
|
|
|
7.45
|
|
$
|
578
|
|
|
|
|
|
|
|
|
|
|
|||||
|
Options exercisable at the end of the period
|
1,272,727
|
|
|
$
|
6.12
|
|
|
6.46
|
|
$
|
64
|
|
|
(1)
|
Calculation of weighted average remaining contractual term does not include RSUs, which have an indefinite contractual term.
|
|
(2)
|
During the nine months period ended
September 30, 2017
, the aggregate number of ordinary shares that were issued pursuant to RSUs that became vested and options that were exercised on a net basis was
87,795
ordinary shares.
|
|
|
|
|
|
Range of exercise price
|
|
Options and RSUs outstanding as of September 30, 2017
|
|
Weighted
average
remaining
contractual
life (years) (1)
|
|
Options exercisable as of September 30, 2017
|
|
Weighted
average
remaining
contractual
life (years) (1)
|
||||
|
RSUs only
|
|
353,437
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
$0.82
|
|
31,803
|
|
|
3.29
|
|
|
31,803
|
|
|
3.29
|
|
|
$1.32
|
|
335,095
|
|
|
4.75
|
|
|
330,095
|
|
|
4.67
|
|
|
$1.47 - $2.20
|
|
762,937
|
|
|
8.07
|
|
|
338,830
|
|
|
6.35
|
|
|
$6.80- $8.99
|
|
663,382
|
|
|
8.09
|
|
|
322,536
|
|
|
7.96
|
|
|
$9.22- $10.98
|
|
201,343
|
|
|
8.42
|
|
|
75,586
|
|
|
8.10
|
|
|
$19.62-$20.97
|
|
244,401
|
|
|
7.17
|
|
|
173,877
|
|
|
7.15
|
|
|
|
|
2,592,398
|
|
|
7.45
|
|
|
1,272,727
|
|
|
6.46
|
|
|
(1)
|
Calculation of weighted average remaining contractual term does not include the RSUs that were granted, which have an indefinite contractual term.
|
|
|
b.
|
Share-based awards to non-employee consultants:
|
|
|
c.
|
Warrants to purchase ordinary shares:
|
|
|
|
|
|
Issuance date
|
Warrants outstanding
|
|
Exercise
price per warrant |
|
Warrants
exercisable |
|
Contractual term
|
||||
|
|
(number)
|
|
|
|
(number)
|
|
|
||||
|
|
|
|
|
|
|
|
|
||||
|
July 14, 2014 (1)
|
403,804
|
|
|
$
|
10.08
|
|
|
403,804
|
|
|
July 13, 2018
|
|
December 30, 2015 (2)
|
119,295
|
|
|
$
|
9.64
|
|
|
119,295
|
|
|
See footnote (2)
|
|
November 1, 2016 (3)
|
2,437,500
|
|
|
$
|
4.75
|
|
|
2,437,500
|
|
|
November 1, 2021
|
|
December 28, 2016 (4)
|
47,717
|
|
|
$
|
9.64
|
|
|
47,717
|
|
|
See footnote (4)
|
|
|
3,008,316
|
|
|
|
|
3,008,316
|
|
|
|
||
|
(1)
|
Represents warrants to purchase ordinary shares at an exercise price of
$10.08
per share, which were granted on July 14, 2014 as part of our series E investment round.
|
|
(2)
|
Represents a warrant to purchase ordinary shares at an exercise price of
$9.64
per share, which was issued on December 31, 2015 to Kreos, in connection with a loan made by Kreos to us. The warrant is currently exercisable (in whole or in part) until the earlier of (i) December 30, 2025 or (ii) immediately prior to the consummation of a merger, consolidation, or reorganization of us with or into, or the sale or license of all or substantially all the assets or shares of us to, any other entity or person, other than a wholly-owned subsidiary of us, excluding any transaction in which our shareholders prior to the transaction will hold more than
50%
of the voting and economic rights of the surviving entity after the transaction. None of these warrants had been exercised as of
September 30, 2017
.
|
|
(3)
|
Represents warrants issued as part of our follow-on offering in November 2016.
|
|
(4)
|
Represents a warrant in the amount of
47,717
ordinary shares issued to Kreos as part of the
$8.0 million
drawdown under the Loan Agreement, which occurred on December 28, 2016. See footnote 2 above for exercisability terms.
|
|
|
d.
|
Share-based compensation expense for employees and non-employees:
|
|
|
Nine Months Ended September 30,
|
||||||
|
|
2017
|
|
2016
|
||||
|
Cost of revenues
|
$
|
57
|
|
|
$
|
78
|
|
|
Research and development, net
|
344
|
|
|
398
|
|
||
|
Sales and marketing, net
|
585
|
|
|
606
|
|
||
|
General and administrative
|
1,611
|
|
|
1,376
|
|
||
|
Total
|
$
|
2,597
|
|
|
$
|
2,458
|
|
|
|
|
|
|
|
e.
|
At-the-market offering program:
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
Foreign currency transactions and other
|
$
|
(37
|
)
|
|
$
|
17
|
|
|
$
|
(113
|
)
|
|
$
|
60
|
|
|
Financial expenses related to loan agreement with Kreos
|
510
|
|
|
495
|
|
|
1,932
|
|
|
1,462
|
|
||||
|
Bank commissions
|
6
|
|
|
5
|
|
|
24
|
|
|
28
|
|
||||
|
Income related to hedging transactions
|
—
|
|
|
(9
|
)
|
|
—
|
|
|
(36
|
)
|
||||
|
|
$
|
479
|
|
|
$
|
508
|
|
|
$
|
1,843
|
|
|
$
|
1,514
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
Revenues based on customer’s location:
|
|
|
|
|
|
|
|
||||||||
|
Israel
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
United States
|
801
|
|
|
710
|
|
|
4,242
|
|
|
2,976
|
|
||||
|
Europe
|
931
|
|
|
404
|
|
|
1,996
|
|
|
908
|
|
||||
|
Asia-Pacific
|
—
|
|
|
286
|
|
|
—
|
|
|
394
|
|
||||
|
Total revenues
|
$
|
1,732
|
|
|
$
|
1,400
|
|
|
$
|
6,238
|
|
|
$
|
4,278
|
|
|
|
September 30,
|
|
December 31,
|
||||
|
|
2017
|
|
2016
|
||||
|
Long-lived assets by geographic region (*):
|
|
|
|
||||
|
Israel
|
$
|
330
|
|
|
$
|
476
|
|
|
United States
|
361
|
|
|
565
|
|
||
|
Germany
|
215
|
|
|
217
|
|
||
|
|
$
|
906
|
|
|
$
|
1,258
|
|
|
|
September 30,
|
|
December 31,
|
||
|
|
2017
|
|
2016
|
||
|
Customer A
|
42.6
|
%
|
|
33.3
|
%
|
|
|
|
|
|
a.
|
Legal claims: class action litigation (see Note 5d)
|
|
•
|
Consolidated Massachusetts State Court Actions: The court heard oral argument on the Company's’ motion to dismiss on October 16, 2017.
|
|
•
|
Massachusetts Federal Court Action: The court denied the Company's motion to stay and has set the time for the Company's motion to dismiss to November 10, 2017.
|
|
b.
|
Share option plans: Equity Exchange Program (see Note 8a)
|
|
•
|
our expectations regarding future growth, including our ability to increase sales in our existing geographic markets expand to new markets and achieve our planned expense reductions;
|
|
•
|
our management’s conclusion in the notes to our unaudited condensed consolidated financial statements included in this report and to our audited consolidated financial statements for fiscal 2016, and our independent registered public accounting firm’s statement in its opinion relating to our audited consolidated financial statements for fiscal 2016, that there are a substantial doubts as to our ability to continue as a going concern;
|
|
•
|
our ability to maintain and grow our reputation and the market acceptance of our products;
|
|
•
|
our ability to achieve reimbursement from third-party payors for our products;
|
|
•
|
our expectations as to our clinical research program and clinical results;
|
|
•
|
our expectations as to the results of and Food and Drug Administration’s (the "FDA") potential
|
|
•
|
the outcome of ongoing shareholder class action litigation relating to our IPO;
|
|
•
|
our ability to repay our secured indebtedness;
|
|
•
|
our ability to improve our products and develop new products;
|
|
•
|
our ability to maintain adequate protection of our intellectual property and to avoid violation of the intellectual property rights of others;
|
|
•
|
our ability to gain and maintain regulatory approvals;
|
|
•
|
our ability to secure capital from equity and debt financings in light of limitations under our Form S-3,
|
|
•
|
our ability to use effectively the proceeds of any offerings of our securities;
|
|
•
|
the impact of the market price of our ordinary shares on the determination of whether we are a passive foreign investment company;
|
|
•
|
our ability to maintain relationships with existing customers and develop relationships with new customers.
|
|
•
|
our ability to comply with the continued listing requirements of the NASDAQ Capital Market and the risk that our ordinary shares will be delisted if we cannot do so; and
|
|
•
|
our compliance with medical device reporting regulations to report adverse events involving our products and the potential impact of such adverse events on our ability to market and sell its products.
|
|
•
|
Revenues grew 24% to $1.7 million and 46% to $6.2 million for the three and nine months ended September 30, 2017, respectively, compared to revenues of $1.4 million and $4.3 million for the three and nine months ended September 30, 2016, respectively.
|
|
•
|
We placed 16 ReWalk devices during the quarter ended
September 30, 2017
, of which 10 were placed in the Unites States, 3 were in our direct markets in Europe, and 3 were in other markets.
|
|
•
|
We secured 7 favorable case by case insurance reimbursement decisions.
|
|
•
|
We increased pending insurance claims to 218 in the U.S. and Germany, as of September 30, 2017, compared to 149 as of the end of the prior year period.
|
|
•
|
Barmer confirmed it will provide ReWalk systems to all qualifying beneficiaries. Barmer provides insurance coverage for nearly ten million people in Germany, as a member of the German Statutory Health Insurance network and one of the most significant national insurers in the country. Exoskeletons will be provided to users that meet certain inclusion criteria and assessment by the German Health Insurance Medical Service (
Medizinischer Dienst der Krankenversicherungen
) before and after training. Barmer has already begun processing claims with users entering training for in-home use of an exoskeleton.
|
|
•
|
Germany’s national social accident insurance provider, DGUV, signed a confirmation letter with ReWalk, stipulating that the DGUV's member payers, including the health insurance association
Berufsgenossenschaft
(also known as BG) and state insurers, will approve the supply of exoskeleton systems for qualifying beneficiaries on a case-by-case basis. DGUV is comprised of 35 different insurers, which provide coverage for more than 70 million individuals in Germany. Per the agreement, eligible individuals will go to BG clinics for evaluation as a part of the procurement.
|
|
•
|
Completed critical design review processes and began the pre-clinical testing of the Restore lightweight soft-exosuit base design in preparation for the clinical study and commercialization of an initial indication designed for stroke patients.
|
|
•
|
Total operating expenses in the third quarter of 2017 were
$6.1 million
, compared with
$7.7 million
in the prior year period. The reduction in operating expenses reflected our initiatives to reduce spending, as announced earlier in 2017.
|
|
•
|
During the quarter ended
September 30, 2017
, we sold
1,678,288
shares generating total net proceeds to the Company of
$2.9 million
(after commissions, fees and expenses) under our ATM Offering Program. For more information, see Note 8e to our unaudited condensed consolidated financial statements set forth in “Part I, Item 1. Financial Statements” above and “Liquidity and Capital Resources” below.
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
Revenues
|
$
|
1,732
|
|
|
$
|
1,400
|
|
|
$
|
6,238
|
|
|
$
|
4,278
|
|
|
Cost of revenues
|
1,024
|
|
|
1,110
|
|
|
3,740
|
|
|
3,410
|
|
||||
|
|
|
|
|
|
|
|
|
||||||||
|
Gross profit
|
708
|
|
|
290
|
|
|
2,498
|
|
|
868
|
|
||||
|
|
|
|
|
|
|
|
|
||||||||
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Research and development, net
|
1,618
|
|
|
1,968
|
|
|
4,433
|
|
|
6,737
|
|
||||
|
Sales and marketing
|
2,637
|
|
|
3,774
|
|
|
8,643
|
|
|
10,577
|
|
||||
|
General and administrative
|
1,805
|
|
|
1,951
|
|
|
5,796
|
|
|
5,960
|
|
||||
|
|
|
|
|
|
|
|
|
||||||||
|
Total operating expenses
|
6,060
|
|
|
7,693
|
|
|
18,872
|
|
|
23,274
|
|
||||
|
|
|
|
|
|
|
|
|
||||||||
|
Operating loss
|
(5,352
|
)
|
|
(7,403
|
)
|
|
(16,374
|
)
|
|
(22,406
|
)
|
||||
|
|
|
|
|
|
|
|
|
||||||||
|
Loss on extinguishment of debt
|
—
|
|
|
—
|
|
|
313
|
|
|
—
|
|
||||
|
Financial expenses, net
|
479
|
|
|
508
|
|
|
1,843
|
|
|
1,514
|
|
||||
|
|
|
|
|
|
|
|
|
||||||||
|
Loss before income taxes
|
(5,831
|
)
|
|
(7,911
|
)
|
|
(18,530
|
)
|
|
(23,920
|
)
|
||||
|
Income taxes
|
15
|
|
|
9
|
|
|
25
|
|
|
39
|
|
||||
|
Net loss
|
$
|
(5,846
|
)
|
|
$
|
(7,920
|
)
|
|
$
|
(18,555
|
)
|
|
$
|
(23,959
|
)
|
|
|
|
|
|
|
|
|
|
||||||||
|
Net loss per ordinary share, basic and diluted
|
$
|
(0.27
|
)
|
|
$
|
(0.62
|
)
|
|
$
|
(1.00
|
)
|
|
$
|
(1.92
|
)
|
|
|
|
|
|
|
|
|
|
||||||||
|
Weighted average number of shares used in computing net loss per ordinary share, basic and diluted
|
21,660,757
|
|
|
12,759,887
|
|
|
18,463,444
|
|
|
12,495,433
|
|
||||
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
|
(in thousands, except unit amounts)
|
|
(in thousands, except unit amounts)
|
||||||||||||
|
Personal units placed
|
15
|
|
|
20
|
|
|
81
|
|
|
75
|
|
||||
|
Rehabilitation units placed
|
1
|
|
|
3
|
|
|
3
|
|
|
5
|
|
||||
|
Total units placed
|
16
|
|
|
23
|
|
|
84
|
|
|
80
|
|
||||
|
Personal unit revenues
|
$
|
1,707
|
|
|
$
|
1,250
|
|
|
$
|
6,033
|
|
|
$
|
3,929
|
|
|
Rehabilitation unit revenues
|
$
|
25
|
|
|
$
|
150
|
|
|
$
|
205
|
|
|
$
|
349
|
|
|
Revenues
|
$
|
1,732
|
|
|
$
|
1,400
|
|
|
$
|
6,238
|
|
|
$
|
4,278
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
Gross profit
|
$
|
708
|
|
|
$
|
290
|
|
|
$
|
2,498
|
|
|
$
|
868
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
Research and development expenses, net
|
$
|
1,618
|
|
|
$
|
1,968
|
|
|
$
|
4,433
|
|
|
$
|
6,737
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
Sales and marketing expenses
|
$
|
2,637
|
|
|
$
|
3,774
|
|
|
$
|
8,643
|
|
|
$
|
10,577
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
General and administrative
|
$
|
1,805
|
|
|
$
|
1,951
|
|
|
$
|
5,796
|
|
|
$
|
5,960
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
Financial expenses, net
|
$
|
479
|
|
|
$
|
508
|
|
|
$
|
1,843
|
|
|
$
|
1,514
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
Income tax
|
$
|
15
|
|
|
$
|
9
|
|
|
$
|
25
|
|
|
$
|
39
|
|
|
|
Nine Months Ended September 30,
|
||||||
|
|
2017
|
|
2016
|
||||
|
Net cash used in operating activities
|
$
|
(17,072
|
)
|
|
$
|
(20,200
|
)
|
|
Net cash used in investing activities
|
(19
|
)
|
|
(408
|
)
|
||
|
Net cash provided by financing activities
|
6,341
|
|
|
15,138
|
|
||
|
Net cash flow
|
$
|
(10,750
|
)
|
|
$
|
(5,470
|
)
|
|
|
Payments due by period (in dollars, in thousands)
|
||||||||||||||||||
|
Contractual obligations
|
Total
|
|
Less than 1 year
|
1-3 years
|
3-5 years
|
More than 5 years
|
|||||||||||||
|
Purchase obligations (1)
|
$
|
806
|
|
|
$
|
806
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Collaboration Agreement and License Agreement obligations (2)
|
4,238
|
|
|
1,350
|
|
|
2,100
|
|
|
788
|
|
|
—
|
|
|||||
|
Operating lease obligations (3)
|
4,251
|
|
|
636
|
|
|
1,173
|
|
|
1,190
|
|
|
1,252
|
|
|||||
|
Long-term debt obligations (4)
|
19,288
|
|
|
5,663
|
|
|
13,625
|
|
|
—
|
|
|
—
|
|
|||||
|
Total
|
$
|
28,583
|
|
|
$
|
8,455
|
|
|
$
|
16,898
|
|
|
$
|
1,978
|
|
|
$
|
1,252
|
|
|
•
|
determining the composition of our board of directors, which has the authority to direct our business and to appoint and remove our officers;
|
|
•
|
approving or rejecting a merger, consolidation or other business combination;
|
|
•
|
raising future capital; and
|
|
•
|
amending our Second Amended and Restated Articles of Association, as amended by the First Amendment thereto, which govern the rights attached to our ordinary shares.
|
|
Exhibit Number
|
|
Description
|
|
31.1
|
|
|
|
31.2
|
|
|
|
32.1
|
|
|
|
32.2
|
|
|
|
101.INS
|
|
XBRL Instance Document
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
*
|
Furnished herewith.
|
|
|
ReWalk Robotics Ltd.
|
|
|
|
|
|
|
Date: November 2, 2017
|
By:
|
/s/ Larry Jasinski
|
|
|
|
Name: Larry Jasinski
|
|
|
|
Title: Chief Executive Officer
|
|
|
|
(Principal Executive Officer)
|
|
|
|
|
|
Date: November 2, 2017
|
By:
|
/s/ Kevin Hershberger
|
|
|
|
Name: Kevin Hershberger
|
|
|
|
Title: Chief Financial Officer
|
|
|
|
(Principal Financial Officer and Principal Accounting Officer)
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|