MEDIWOUND LTD. | |||
Date: August 7, 2018
|
By:
|
/s/ Sharon Malka | |
Name: Sharon Malka | |||
Title: Chief Financial Officer | |||
Exhibit |
Description
|
· |
Revenues for the second quarter of 2018 were $1.0 million, a 50% increase from $0.7 million in the second quarter of 2017, underscoring the continued growth of NexoBrid® sales
|
· |
Completed enrollment of Phase 3 DETECT Study of NexoBrid®. Top-line data anticipated around year-end 2018
|
· |
Expanded NexoBrid Phase 3 Children Innovation Debridement Study (CIDS) to the United States following approval of the study protocol by the U.S. Food and Drug Administration (FDA) and BARDA funding of the study
|
· |
NexoBrid® received marketing authorization from South Korea’s Ministry of Health. BL&H Co., Ltd., the Company’s exclusive distribution partner in South Korea, intends to launch NexoBrid in the second half of 2018
|
· |
FDA cleared the development pathway for NexoBrid® in Sulfur Mustard injuries in accordance with FDA Animal Efficacy Rule (also known as the Animal Rule).
|
Contacts:
Sharon Malka
Chief Financial and Operations Officer
MediWound Ltd.
ir@mediwound.com
|
Jeremy Feffer
Managing Director, LifeSci Advisors
212-915-2568
jeremy@lifesciadvisors.com
|
June 30,
|
December 31,
|
|||||||||||
2018
|
2017
|
2017
|
||||||||||
Unaudited
|
Audited
|
|||||||||||
Cash, cash equivalents and short term deposits
|
27,004
|
20,922
|
36,069
|
|||||||||
Accounts and other receivable
|
5,224
|
3,089
|
3,565
|
|||||||||
Inventories
|
1,871
|
1,124
|
1,886
|
|||||||||
Total current assets
|
34,099
|
25,135
|
41,520
|
|||||||||
Long term deposits
|
65
|
75
|
56
|
|||||||||
Property, plant and equipment, net
|
2,051
|
1,425
|
1,924
|
|||||||||
Intangible assets, net
|
528
|
685
|
635
|
|||||||||
Total long term assets
|
2,644
|
2,185
|
2,615
|
|||||||||
Total assets
|
36,743
|
27,320
|
44,135
|
|||||||||
Trade payables and accrued expenses
|
3,327
|
2,121
|
3,251
|
|||||||||
Other payables
|
2,339
|
2,115
|
2,182
|
|||||||||
Total current liabilities
|
5,666
|
4,236
|
5,433
|
|||||||||
Deferred revenues
|
1,178
|
966
|
988
|
|||||||||
Liabilities in respect of Israeli Innovation Authority grants net of current maturities
|
7,793
|
7,153
|
7,380
|
|||||||||
Contingent consideration for the purchase of shares net of current maturities
|
14,737
|
15,082
|
14,381
|
|||||||||
Liability in respect of discontinued operation
|
6,003
|
-
|
6,003
|
|||||||||
Severance pay liability, net
|
336
|
239
|
330
|
|||||||||
Total long term liabilities
|
30,047
|
23,440
|
29,082
|
|||||||||
Shareholders' equity (deficiency)
|
1,030
|
(356
|
)
|
9,620
|
||||||||
Total liabilities & shareholder equity
|
36,743
|
27,320
|
44,135
|
Six months ended
|
Three months ended
|
|||||||||||||||
June 30,
|
June 30,
|
|||||||||||||||
2018
|
2017
|
2018
|
2017
|
|||||||||||||
Revenues
|
1,551
|
1,227
|
1,031
|
687
|
||||||||||||
Cost of revenues
|
1,010
|
824
|
629
|
484
|
||||||||||||
Gross profit
|
541
|
403
|
402
|
203
|
||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development, gross
|
9,027
|
6,622
|
4,987
|
3,181
|
||||||||||||
Participation by BARDA & IIA
|
(6,298
|
)
|
(3,187
|
)
|
(3,451
|
)
|
(1,517
|
)
|
||||||||
Research and development, net
|
2,729
|
3,435
|
1,536
|
1,664
|
||||||||||||
Selling, general & administrative
|
4,150
|
4,334
|
2,090
|
2,242
|
||||||||||||
Other expenses
|
662
|
-
|
62
|
-
|
||||||||||||
Total operating expenses
|
7,541
|
7,769
|
3,688
|
3,906
|
||||||||||||
Operating loss
|
(7,000
|
)
|
(7,366
|
)
|
(3,286
|
)
|
(3,703
|
)
|
||||||||
Financial income (expenses), net
|
(1,716
|
)
|
(1,410
|
)
|
(879
|
)
|
(759
|
)
|
||||||||
Loss for the period
|
(8,716
|
)
|
(8,776
|
)
|
(4,165
|
)
|
(4,462
|
)
|
||||||||
Foreign currency translation adjustments
|
8
|
(17
|
)
|
18
|
(14
|
)
|
||||||||||
Total comprehensive loss
|
(8,708
|
)
|
(8,793
|
)
|
(4,147
|
)
|
(4,476
|
)
|
||||||||
Net loss per share
|
(0.32
|
)
|
(0.40
|
)
|
(0.15
|
)
|
(0.20
|
)
|
||||||||
Weighted average number of ordinary shares used in the computation of basic and diluted loss per share (in thousands):
|
27,050
|
21,938
|
27,052
|
21,946
|
Six months ended
|
Three months ended
|
|||||||||||||||
June 30,
|
June 30,
|
|||||||||||||||
2018
|
2017
|
2018
|
2017
|
|||||||||||||
Loss for the period
|
(8,716
|
)
|
(8,776
|
)
|
(4,165
|
)
|
(4,462
|
)
|
||||||||
Adjustments:
|
||||||||||||||||
Financial (expenses) income, net
|
(1,716
|
)
|
(1,410
|
)
|
(879
|
)
|
(759
|
)
|
||||||||
Other expenses
|
(662
|
)
|
-
|
(62
|
)
|
-
|
||||||||||
Depreciation and amortization
|
(305
|
)
|
(302
|
)
|
(170
|
)
|
(146
|
)
|
||||||||
Share-based compensation expenses
|
(367
|
)
|
(665
|
)
|
(149
|
)
|
(337
|
)
|
||||||||
Total adjustments
|
(3,050
|
)
|
(2,377
|
)
|
(1,260
|
)
|
(1,242
|
)
|
||||||||
Adjusted EBITDA
|
(5,666
|
)
|
(6,399
|
)
|
(2,905
|
)
|
(3,220
|
)
|
Six months ended
|
Three months ended
|
|||||||||||||||
June 30,
|
June 30,
|
|||||||||||||||
2018
|
2017
|
2018
|
2017
|
|||||||||||||
Cash Flows from Operating Activities:
|
||||||||||||||||
Net loss
|
(8,716
|
)
|
(8,776
|
)
|
(4,165
|
)
|
(4,462
|
)
|
||||||||
Adjustments to reconcile net loss to net cash used in continuing operating activities:
|
||||||||||||||||
Adjustments to profit and loss items:
|
||||||||||||||||
Depreciation and amortization
|
305
|
302
|
170
|
146
|
||||||||||||
Share-based compensation
|
367
|
665
|
149
|
337
|
||||||||||||
Revaluation of liabilities in respect of IIA grants
|
404
|
402
|
218
|
221
|
||||||||||||
Revaluation of contingent consideration for the purchase of shares
|
1,112
|
1,120
|
569
|
570
|
||||||||||||
Increase (decrease) in severance liability, net
|
6
|
20
|
(5
|
)
|
12
|
|||||||||||
Financing income
|
(182
|
)
|
(174
|
)
|
(115
|
)
|
(88
|
)
|
||||||||
Unrealized foreign currency (gain) loss
|
126
|
(91
|
)
|
85
|
(39
|
)
|
||||||||||
2,138
|
2,244
|
1,071
|
1,159
|
|||||||||||||
Changes in asset and liability items:
|
||||||||||||||||
Increase in trade receivables
|
(421
|
)
|
(241
|
)
|
(494
|
)
|
(201
|
)
|
||||||||
Decrease (increase) in inventories
|
15
|
(279
|
)
|
149
|
(132
|
)
|
||||||||||
Decrease (increase) in other receivables
|
(1,572
|
)
|
(277
|
)
|
(1,690
|
)
|
278
|
|||||||||
Increase (decrease) in trade payables & accrued expenses
|
74
|
(1,210
|
)
|
(51
|
)
|
(2,487
|
)
|
|||||||||
Increase (decrease) in other payables & deferred revenues
|
(336
|
)
|
(459
|
)
|
(507
|
)
|
1,606
|
|||||||||
(2,240
|
)
|
(2,466
|
)
|
(2,593
|
)
|
(936
|
)
|
|||||||||
Net cash used in operating activities
|
(8,818
|
)
|
(8,998
|
)
|
(5,687
|
)
|
(4,239
|
)
|
||||||||
Cash Flows from Investment Activities:
|
||||||||||||||||
Purchase of property and equipment
|
(313
|
)
|
(365
|
)
|
(197
|
)
|
(169
|
)
|
||||||||
Purchase of intangible assets
|
(13
|
)
|
0
|
(13
|
)
|
0
|
||||||||||
Interest received
|
2
|
27
|
2
|
12
|
||||||||||||
Proceeds from (investment in) short term bank deposits, net of investments
|
(21,165
|
)
|
(16,837
|
)
|
1,680
|
3,007
|
||||||||||
Net cash provided by (used in) investing activities
|
(21,489
|
)
|
(17,175
|
)
|
1,472
|
2,850
|
||||||||||
Cash Flows from Financing Activities:
|
||||||||||||||||
Proceeds from issuance of shares and warrants, net
|
-
|
2
|
-
|
2
|
||||||||||||
Proceeds from IIA grants, net of repayments
|
30
|
(37
|
)
|
-
|
(65
|
)
|
||||||||||
Net cash provided by (used in) financing activities
|
30
|
(35
|
)
|
0
|
(63
|
)
|
||||||||||
Exchange rate differences on cash and cash equivalent balances
|
(133
|
)
|
117
|
(117
|
)
|
76
|
||||||||||
Decrease in cash and cash equivalents from continuing activities
|
(30,410
|
)
|
(26,091
|
)
|
(4,332
|
)
|
(1,376
|
)
|
||||||||
Balance of cash and cash equivalents at the beginning of the period
|
36,069
|
28,866
|
9,991
|
4,151
|
||||||||||||
Balance of cash and cash equivalents at the end of the period
|
5,659
|
2,775
|
5,659
|
2,775
|
Page
|
|
2
|
|
3
|
|
4 - 6
|
|
7 - 8
|
|
9 - 12
|
June 30,
|
December 31,
|
|||||||||||
2018
|
2017
|
2017
|
||||||||||
Unaudited
|
Audited
|
|||||||||||
CURRENT ASSETS:
|
||||||||||||
Cash and cash equivalents
|
5,659
|
2,775
|
36,069
|
|||||||||
Short‑term bank deposits
|
21,345
|
18,147
|
-
|
|||||||||
Trade receivables
|
779
|
612
|
369
|
|||||||||
Inventories
|
1,871
|
1,124
|
1,886
|
|||||||||
Other receivables
|
4,445
|
2,477
|
3,196
|
|||||||||
34,099
|
25,135
|
41,520
|
||||||||||
LONG‑TERM ASSETS:
|
||||||||||||
Long term deposits
|
65
|
75
|
56
|
|||||||||
Property, plant and equipment, net
|
2,051
|
1,425
|
1,924
|
|||||||||
Intangible assets, net
|
528
|
685
|
635
|
|||||||||
2,644
|
2,185
|
2,615
|
||||||||||
36,743
|
27,320
|
44,135
|
||||||||||
CURRENT LIABILITIES:
|
||||||||||||
Trade payables and accrued expenses
|
3,327
|
2,121
|
3,251
|
|||||||||
Other payables
|
2,339
|
2,115
|
2,182
|
|||||||||
5,666
|
4,236
|
5,433
|
||||||||||
LONG‑TERM LIABILITIES:
|
||||||||||||
Deferred revenues
|
1,178
|
966
|
988
|
|||||||||
Liabilities in respect of IIA grants
|
7,793
|
7,153
|
7,380
|
|||||||||
Contingent consideration for purchase of shares
|
14,737
|
15,082
|
14,381
|
|||||||||
Liability in respect of discontinued operation
|
6,003
|
-
|
6,003
|
|||||||||
Severance pay liability, net
|
336
|
239
|
330
|
|||||||||
30,047
|
23,440
|
29,082
|
||||||||||
SHAREHOLDERS' EQUITY (DEFICIENCY):
|
||||||||||||
Ordinary shares of NIS 0.01 par value:
|
||||||||||||
Authorized: 37,244,508 shares as of June 30, 2018, and 32,244,508 shares as of December 31, 2017 and June 30, 2017; Issued and Outstanding: 27,178,839 as of June 30, 2018 and 27,047,737 as of December 31, 2017 and 21,954,078 as of June 30, 2017
|
75
|
60
|
75
|
|||||||||
Share premium
|
139,359
|
115,646
|
138,992
|
|||||||||
Foreign currency translation adjustments
|
(30
|
)
|
(26
|
)
|
(38
|
)
|
||||||
Accumulated deficit
|
(138,374
|
)
|
(116,036
|
)
|
(129,409
|
)
|
||||||
1,030
|
(356
|
)
|
9,620
|
|||||||||
36,743
|
27,320
|
44,135
|
Six months ended
June 30,
|
Three months ended
June 30,
|
Year ended
December 31,
|
||||||||||||||||||
2018
|
2017
|
2018
|
2017
|
2017
|
||||||||||||||||
Unaudited
|
Audited
|
|||||||||||||||||||
Revenues
|
1,551
|
1,227
|
1,031
|
687
|
2,496
|
|||||||||||||||
Cost of revenues
|
1,010
|
824
|
629
|
484
|
1,578
|
|||||||||||||||
Gross profit
|
541
|
403
|
402
|
203
|
918
|
|||||||||||||||
Research and development, net of participations
|
2,729
|
3,435
|
1,536
|
1,664
|
5,462
|
|||||||||||||||
Selling and marketing
|
2,319
|
2,693
|
1,248
|
1,306
|
5,362
|
|||||||||||||||
General and administrative
|
1,831
|
1,641
|
842
|
936
|
3,781
|
|||||||||||||||
Other expenses
|
662
|
-
|
62
|
-
|
-
|
|||||||||||||||
Total operating expenses
|
7,541
|
7,769
|
3,688
|
3,906
|
14,605
|
|||||||||||||||
Operating loss
|
(7,000
|
)
|
(7,366
|
)
|
(3,286
|
)
|
(3,703
|
)
|
(13,687
|
)
|
||||||||||
Financial income
|
182
|
174
|
115
|
87
|
406
|
|||||||||||||||
Financial expense
|
(1,898
|
)
|
(1,584
|
)
|
(994
|
)
|
(846
|
)
|
(1,252
|
)
|
||||||||||
Loss from continuing operation
|
(8,716
|
)
|
(8,776
|
)
|
(4,165
|
)
|
(4,462
|
)
|
(14,533
|
)
|
||||||||||
Loss from discontinued operation
|
-
|
-
|
-
|
-
|
(7,616
|
)
|
||||||||||||||
Net loss
|
(8,716
|
)
|
(8,776
|
)
|
(4,165
|
)
|
(4,462
|
)
|
(22,149
|
)
|
||||||||||
Other comprehensive income (loss):
|
||||||||||||||||||||
Foreign currency translation adjustments
|
8
|
(17
|
)
|
18
|
(14
|
)
|
(29
|
)
|
||||||||||||
Total comprehensive loss
|
(8,708
|
)
|
(8,793
|
)
|
(4,147
|
)
|
(4,476
|
)
|
(22,178
|
)
|
||||||||||
Basic and diluted net loss per share from continuing operations
|
(0.32
|
)
|
(0.40
|
)
|
(0.15
|
)
|
(0.20
|
)
|
(0.62
|
)
|
||||||||||
Basic and diluted net loss per share from discontinued operations
|
-
|
-
|
-
|
-
|
(0.33
|
)
|
||||||||||||||
Total Basic and diluted net loss per share
|
(0.32
|
)
|
(0.40
|
)
|
(0.15
|
)
|
(0.20
|
)
|
(0.95
|
)
|
||||||||||
Weighted average number of ordinary shares used in the computation of basic and diluted loss per share (in thousands)
|
27,050
|
21,938
|
27,052
|
21,946
|
23,341
|
Share capital
|
Share premium
|
Foreign currency translation reserve
|
Accumulated
deficit
|
Total
Equity
|
||||||||||||||||
Balance as of December 31, 2017
|
75
|
138,992
|
(38
|
)
|
(129,409
|
)
|
9,620
|
|||||||||||||
Cumulative effect adjustment on accumulated deficit as a result of adopting IFRS 15
|
-
|
-
|
-
|
(249
|
)
|
(249
|
)
|
|||||||||||||
Balance as of January 1, 2018
|
75
|
138,992
|
(38
|
)
|
(129,658
|
)
|
9,371
|
|||||||||||||
Loss for the period
|
-
|
-
|
-
|
(8,716
|
)
|
(8,716
|
)
|
|||||||||||||
Other comprehensive loss
|
-
|
-
|
8
|
-
|
8
|
|||||||||||||||
Total comprehensive loss
|
-
|
-
|
8
|
(8,716
|
)
|
(8,708
|
)
|
|||||||||||||
Exercise of options
|
(*
|
) |
(*
|
) |
-
|
-
|
-
|
|||||||||||||
Share-based compensation
|
-
|
367
|
-
|
-
|
367
|
|||||||||||||||
Balance as of June 30, 2018 (unaudited)
|
75
|
139,359
|
(30
|
)
|
(138,374
|
)
|
1,030
|
Share capital
|
Share premium
|
Foreign currency translation reserve
|
Accumulated
deficit
|
Total
Equity (Deficiency)
|
||||||||||||||||
Balance as of January 1, 2017
|
60
|
114,979
|
(9
|
)
|
(107,260
|
)
|
7,770
|
|||||||||||||
Loss for the period
|
-
|
-
|
-
|
(8,776
|
)
|
(8,776
|
)
|
|||||||||||||
Other comprehensive loss
|
-
|
-
|
(17
|
)
|
-
|
(17
|
)
|
|||||||||||||
Total comprehensive loss
|
-
|
-
|
(17
|
)
|
(8,776
|
)
|
(8,793
|
)
|
||||||||||||
Exercise of options
|
-
|
2
|
-
|
-
|
2
|
|||||||||||||||
Share-based compensation
|
-
|
665
|
-
|
-
|
665
|
|||||||||||||||
Balance as of June 30, 2017 (unaudited)
|
60
|
115,646
|
(26
|
)
|
(116,036
|
)
|
(356
|
)
|
Share capital
|
Share premium
|
Foreign currency translation reserve
|
Accumulated
deficit
|
Total
Equity
|
||||||||||||||||
Balance as of April 1, 2018
|
75
|
139,210
|
(48
|
)
|
(134,209
|
)
|
5,028
|
|||||||||||||
Loss for the period
|
-
|
-
|
-
|
(4,165
|
)
|
(4,165
|
)
|
|||||||||||||
Other comprehensive loss
|
-
|
-
|
18
|
-
|
18
|
|||||||||||||||
Total comprehensive loss
|
-
|
-
|
18
|
(4,165
|
)
|
(4,147
|
)
|
|||||||||||||
Exercise of options
|
(*
|
) |
(*
|
) |
-
|
-
|
-
|
|||||||||||||
Share-based compensation
|
-
|
149
|
-
|
-
|
149
|
|||||||||||||||
Balance as of June 30, 2018 (unaudited)
|
75
|
139,359
|
(30
|
)
|
(138,374
|
)
|
1,030
|
Share capital
|
Share premium
|
Foreign currency translation reserve
|
Accumulated
deficit
|
Total
Equity (Deficiency)
|
||||||||||||||||
Balance as of April 1, 2017
|
60
|
115,307
|
(12
|
)
|
(111,574
|
)
|
3,781
|
|||||||||||||
Loss for the period
|
-
|
-
|
-
|
(4,462
|
)
|
(4,462
|
)
|
|||||||||||||
Other comprehensive loss
|
-
|
-
|
(14
|
)
|
-
|
(14
|
)
|
|||||||||||||
Total comprehensive loss
|
-
|
-
|
(14
|
)
|
(4,462
|
)
|
(4,476
|
)
|
||||||||||||
Exercise of options
|
-
|
2
|
-
|
-
|
2
|
|||||||||||||||
Share-based compensation
|
-
|
337
|
-
|
-
|
337
|
|||||||||||||||
Balance as of June 30, 2017 (unaudited)
|
60
|
115,646
|
(26
|
)
|
(116,036
|
)
|
(356
|
)
|
Share capital
|
Share premium
|
Foreign currency translation reserve
|
Accumulated
deficit
|
Total
equity
|
||||||||||||||||
Balance as of December 31, 2016
|
60
|
114,979
|
(9
|
)
|
(107,260
|
)
|
7,770
|
|||||||||||||
Loss for the period
|
-
|
-
|
-
|
(22,149
|
)
|
(22,149
|
)
|
|||||||||||||
Other comprehensive loss
|
-
|
-
|
(29
|
)
|
-
|
(29
|
)
|
|||||||||||||
Total comprehensive loss
|
-
|
-
|
(29
|
)
|
(22,149
|
)
|
(22,178
|
)
|
||||||||||||
Exercise of options
|
(*
|
)
|
7
|
-
|
-
|
7
|
||||||||||||||
Issuance of ordinary shares of NIS 0.01 par value net of issuance expenses
|
15
|
22,643
|
-
|
-
|
22,658
|
|||||||||||||||
Share-based compensation
|
-
|
1,363
|
-
|
-
|
1,363
|
|||||||||||||||
Balance as of December 31, 2017
|
75
|
138,992
|
(38
|
)
|
(129,409
|
)
|
9,620
|
Six months ended
June 30,
|
Three months ended
June 30,
|
Year ended
December 31,
|
||||||||||||||||||
2018
|
2017
|
2018
|
2017
|
2017
|
||||||||||||||||
Unaudited
|
Audited
|
|||||||||||||||||||
Cash flows from operating activities:
|
||||||||||||||||||||
Net loss
|
(8,716
|
)
|
(8,776
|
)
|
(4,165
|
)
|
(4,462
|
)
|
(18,885
|
)
|
||||||||||
Adjustments to reconcile net loss to net cash used in continuing operating activities:
|
||||||||||||||||||||
Adjustments to profit and loss items:
|
||||||||||||||||||||
Loss from discontinued operation
|
-
|
-
|
-
|
-
|
7,616
|
|||||||||||||||
Depreciation and amortization
|
305
|
302
|
170
|
146
|
567
|
|||||||||||||||
Share-based compensation
|
367
|
665
|
149
|
337
|
1,363
|
|||||||||||||||
Revaluation of liabilities in respect of IIA grants
|
404
|
402
|
218
|
221
|
229
|
|||||||||||||||
Revaluation of contingent consideration for the purchase of shares
|
1,112
|
1,120
|
569
|
570
|
351
|
|||||||||||||||
Increase (decrease) in severance liability
|
6
|
20
|
(5
|
)
|
12
|
111
|
||||||||||||||
Net financing income
|
(182
|
)
|
(174
|
)
|
(115
|
)
|
(88
|
)
|
(349
|
)
|
||||||||||
Un-realized foreign currency (gain) loss
|
126
|
(91
|
)
|
85
|
(39
|
)
|
(185
|
)
|
||||||||||||
2,138
|
2,244
|
1,071
|
1,159
|
9,703
|
||||||||||||||||
Changes in asset and liability items:
|
||||||||||||||||||||
Decrease (increase) in trade receivables
|
(421
|
)
|
(241
|
)
|
(494
|
)
|
(201
|
)
|
28
|
|||||||||||
Decrease (increase) in inventories
|
15
|
(279
|
)
|
149
|
(132
|
)
|
(1,042
|
)
|
||||||||||||
Decrease (increase) in other receivables
|
(1,572
|
)
|
(277
|
)
|
(1,690
|
)
|
278
|
(1,227
|
)
|
|||||||||||
Increase (decrease) in trade payables
|
74
|
(1,210
|
)
|
(51
|
)
|
(2,487
|
)
|
(135
|
)
|
|||||||||||
Increase (decrease) in other payables and deferred revenues
|
(336
|
)
|
(459
|
)
|
(507
|
)
|
1,606
|
(70
|
)
|
|||||||||||
(2,240
|
)
|
(2,466
|
)
|
(2,593
|
)
|
(936
|
)
|
(2,446
|
)
|
|||||||||||
Net cash flows used in operating activities
|
(8,818
|
)
|
(8,998
|
)
|
(5,687
|
)
|
(4,239
|
)
|
(14,892
|
)
|
||||||||||
Net cash used in discontinued operating activities
|
-
|
-
|
-
|
-
|
(1,563
|
)
|
||||||||||||||
(8,818
|
)
|
(8,998
|
)
|
(5,687
|
)
|
(4,239
|
)
|
(16,455
|
)
|
Six months ended
June 30,
|
Three months ended
June 30,
|
Year ended
December 31,
|
||||||||||||||||||
2018
|
2017
|
2018
|
2017
|
2017
|
||||||||||||||||
Unaudited
|
Audited
|
|||||||||||||||||||
Cash Flows from Investing Activities:
|
||||||||||||||||||||
Purchase of property and equipment
|
(313
|
)
|
(365
|
)
|
(197
|
)
|
(169
|
)
|
(1,045
|
)
|
||||||||||
Purchase of intangible assets
|
(13
|
)
|
-
|
(13
|
)
|
-
|
(30
|
)
|
||||||||||||
Interest received
|
2
|
27
|
2
|
12
|
349
|
|||||||||||||||
Proceeds from (investment in) short term bank deposits, net
|
(21,165
|
)
|
(16,837
|
)
|
1,680
|
3,007
|
1,163
|
|||||||||||||
Net cash provided by (used in) investing activities
|
(21,489
|
)
|
(17,175
|
)
|
1,472
|
2,850
|
437
|
|||||||||||||
Cash Flows from Financing Activities:
|
||||||||||||||||||||
Proceeds from exercise of options
|
(*
|
) |
2
|
(*
|
) |
2
|
7
|
|||||||||||||
Proceeds from issuance of shares, net
|
-
|
-
|
-
|
-
|
22,658
|
|||||||||||||||
Proceeds from IIA grants, net of repayments
|
30
|
(37
|
)
|
-
|
(65
|
)
|
330
|
|||||||||||||
Net cash provided by (used in) financing activities
|
30
|
(35
|
)
|
-
|
(63
|
)
|
22,995
|
|||||||||||||
Exchange rate differences on cash and cash equivalent balances
|
(133
|
)
|
117
|
(117
|
)
|
76
|
226
|
|||||||||||||
Increase (decrease) in cash and cash equivalents from continuing activities
|
(30,410
|
)
|
(26,091
|
)
|
(4,332
|
)
|
(1,376
|
)
|
8,766
|
|||||||||||
Decrease in cash and cash equivalents from discontinued activities
|
-
|
-
|
-
|
-
|
(1,563
|
)
|
||||||||||||||
Balance of cash and cash equivalents at the beginning of the period
|
36,069
|
28,866
|
9,991
|
4,151
|
28,866
|
|||||||||||||||
Balance of cash and cash equivalents at the end of the period
|
5,659
|
2,775
|
5,659
|
2,775
|
36,069
|
NOTE 1: |
GENERAL
|
a. |
General description of the company and its operations:
|
b. |
The Company has two wholly owned subsidiaries: MediWound Germany GmbH, acting as Europe (“EU”) marketing authorization holder and EU sales and marketing arm and MediWound UK Limited, an inactive company. In addition, the Company owns approximately 8% of PolyHeal Ltd., a private life sciences company ("PolyHeal").
|
c. |
The Company's securities are listed for trading on NASDAQ since March 2014. In September 2017, the Company completed a follow-on public offering. A total of 5,037,664 new ordinary shares were issued in consideration to net proceeds of $22,658, after deducting underwriter’s discounts, commissions and other offering expenses.
|
d. |
The Company has a contract with the U.S. Biomedical Advanced Research and Development Authority ("BARDA"), which was modified in July 2017, for the advancement of the development and manufacturing, as well as the procurement of NexoBrid, as a medical countermeasure as part of BARDA preparedness for mass casualty events. The modified contract includes $56,000 of funding to support development activities to complete the U.S. Food and Drug Administration (FDA) approval process for NexoBrid for use in thermal burn injuries, as well as $16,000 for procurement of NexoBrid, which is contingent upon FDA Emergency Use Authorization (EUA) and/or FDA marketing authorization for NexoBrid. In addition, the contract includes options for further funding of up to $10,000 for expanding NexoBrid’s indications and of up to $50,000 for additional procurement of NexoBrid.
|
NOTE 2: |
SIGNIFICANT ACCOUNTING POLICIES
|
a. |
Basis of presentation of financial statements:
|
b. |
Basis of preparation of the interim consolidated financial statements:
|
c. |
Changes in significant accounting policies
|
NOTE 2: |
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
|
1. |
Revenue from the Sale of products:
|
2. |
Revenue from distribution agreements with Multiple- element:
|
NOTE 2: |
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
|
As reported
|
Adjustments
|
Amounts without adoption of
IFRS 15
|
||||||||||
Deferred revenues*
|
1,365
|
(311
|
)
|
1,054
|
||||||||
Accumulated deficit
|
(138,374
|
)
|
311
|
(138,063
|
)
|
As reported
|
Adjustments
|
Amounts without adoption of
IFRS 15
|
||||||||||
Revenues
|
1,551
|
(20
|
)
|
1,531
|
||||||||
Financial expense
|
(1,898
|
)
|
82
|
(1,816
|
)
|
|||||||
Net loss
|
(8,716
|
)
|
62
|
(8,654
|
)
|
|||||||
Total Basic and diluted net loss per share
|
(0.32
|
)
|
(0.0
|
)
|
(0.32
|
)
|
As reported
|
Adjustments
|
Amounts without adoption of IFRS 15
|
||||||||||
Revenues
|
1,031
|
(11
|
)
|
1,020
|
||||||||
Financial expense
|
(994
|
)
|
41
|
(953
|
)
|
|||||||
Net loss
|
(4,165
|
)
|
30
|
(4,135
|
)
|
|||||||
Total Basic and diluted net loss per share
|
(0.15
|
)
|
(0.0
|
)
|
(0.15
|
)
|