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Page
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F-2
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F-3
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F-4 – F-6
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F-7 – F-8
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F-9 – F-10
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June 30,
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December 31,
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|||||||||||
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2020
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2019
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2019
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||||||||||
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Unaudited
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Audited
|
|||||||||||
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CURRENT ASSETS:
|
||||||||||||
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Cash and cash equivalents
|
12,612
|
24,667
|
7,242
|
|||||||||
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Restricted deposits
|
179
|
175
|
180
|
|||||||||
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Short‑term bank deposits
|
11,591
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13,870
|
22,036
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|||||||||
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Trade receivables
|
2,764
|
570
|
4,107
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|||||||||
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Inventories
|
1,934
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1,535
|
1,613
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|||||||||
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Other receivables
|
728
|
4,098
|
450
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|||||||||
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29,808
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44,915
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35,628
|
||||||||||
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LONG‑TERM ASSETS:
|
||||||||||||
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Property, plant and equipment, net
|
2,326
|
2,183
|
2,304
|
|||||||||
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Right of-use assets, net
|
2,086
|
2,315
|
2,229
|
|||||||||
|
Intangible assets, net
|
396
|
462
|
429
|
|||||||||
|
4,808
|
4,960
|
4,962
|
||||||||||
|
34,616
|
49,875
|
40,590
|
||||||||||
|
CURRENT LIABILITIES:
|
||||||||||||
|
Current maturities of long-term liabilities
|
1,321
|
896
|
569
|
|||||||||
|
Trade payables and accrued expenses
|
2,423
|
3,993
|
4,067
|
|||||||||
|
Other payables
|
6,040
|
5,969
|
5,737
|
|||||||||
|
9,784
|
10,858
|
10,373
|
||||||||||
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LONG‑TERM LIABILITIES:
|
||||||||||||
|
Deferred revenues
|
1,174
|
1,144
|
1,135
|
|||||||||
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Liability in respect of IIA grants
|
7,130
|
6,919
|
6,811
|
|||||||||
|
Contingent consideration for purchase of shares
|
4,249
|
4,412
|
4,853
|
|||||||||
|
Liability in respect of discontinued operation
|
-
|
6,003
|
-
|
|||||||||
|
Lease liabilities
|
1,866
|
2,022
|
2,006
|
|||||||||
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Severance pay liabilities, net
|
281
|
338
|
243
|
|||||||||
|
14,700
|
20,838
|
15,048
|
||||||||||
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SHAREHOLDERS' EQUITY:
|
||||||||||||
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Ordinary shares of NIS 0.01 par value:
|
||||||||||||
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Authorized: 50,000,000 shares as of June 30, 2020, December 31, 2019 and 37,244,508 shares as of June 30, 2019; Issued and Outstanding: 27,211,128 as of June 30,
2020, 27,202,795 as of December 31, 2019 and 27,178,839 as of June 30, 2019
|
75
|
75
|
75
|
|||||||||
|
Share premium
|
141,390
|
140,236
|
140,871
|
|||||||||
|
Foreign currency translation adjustments
|
(16
|
)
|
(23
|
)
|
(17
|
)
|
||||||
|
Accumulated deficit
|
(131,317
|
)
|
(122,109
|
)
|
(125,760
|
)
|
||||||
|
10,132
|
18,179
|
15,169
|
||||||||||
|
34,616
|
49,875
|
40,590
|
||||||||||
|
Six months ended
June 30,
|
Three months ended
June 30,
|
Year ended
December 31,
|
||||||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
2019
|
||||||||||||||||
|
Unaudited
|
Audited
|
|||||||||||||||||||
|
Revenues from sale of products
|
1,662
|
1,309
|
1,015
|
895
|
3,393
|
|||||||||||||||
|
Revenues from development services
|
6,631
|
2,301
|
2,922
|
2,301
|
10,678
|
|||||||||||||||
|
Revenues from license agreements
|
172
|
17,597
|
90
|
17,550
|
17,718
|
|||||||||||||||
|
Total revenues
|
8,465
|
21,207
|
4,027
|
20,746
|
31,789
|
|||||||||||||||
|
Cost of revenues
|
6,018
|
3,520
|
2,810
|
3,481
|
11,849
|
|||||||||||||||
|
Gross profit
|
2,447
|
17,687
|
1,217
|
17,265
|
19,940
|
|||||||||||||||
|
Research and development, gross
|
3,312
|
6,343
|
1,593
|
1,893
|
10,070
|
|||||||||||||||
|
Participations by BARDA and IIA
|
19
|
(4,624
|
)
|
19
|
(1,721
|
)
|
(5,101
|
)
|
||||||||||||
|
Research and development, net of participations
|
3,331
|
1,719
|
1,612
|
172
|
4,969
|
|||||||||||||||
|
Selling and marketing
|
1,683
|
2,134
|
859
|
1,101
|
4,064
|
|||||||||||||||
|
General and administrative
|
2,345
|
2,574
|
1,452
|
1,242
|
5,242
|
|||||||||||||||
|
Other expenses
|
-
|
901
|
-
|
812
|
1,172
|
|||||||||||||||
|
Total operating expenses
|
7,359
|
7,328
|
3,923
|
3,327
|
15,447
|
|||||||||||||||
|
Operating profit (loss)
|
(4,912
|
)
|
10,359
|
(2,706
|
)
|
13,938
|
4,493
|
|||||||||||||
|
Financial income
|
323
|
153
|
101
|
92
|
556
|
|||||||||||||||
|
Financial expense
|
(968
|
)
|
(1,956
|
)
|
(491
|
)
|
(1,314
|
)
|
(2,983
|
)
|
||||||||||
|
Profit (loss) from continuing operation
|
(5,557
|
)
|
8,556
|
(3,096
|
)
|
12,716
|
2,066
|
|||||||||||||
|
Profit from discontinued operation
|
-
|
50
|
-
|
-
|
2,889
|
|||||||||||||||
|
Net Profit (loss)
|
(5,557
|
)
|
8,606
|
(3,096
|
)
|
12,716
|
4,955
|
|||||||||||||
|
Other comprehensive income (loss):
|
||||||||||||||||||||
|
Foreign currency translation adjustments
|
1
|
2
|
(7
|
)
|
(2
|
)
|
8
|
|||||||||||||
|
Total comprehensive income (loss)
|
(5,556
|
)
|
8,608
|
(3,103
|
)
|
12,714
|
4,963
|
|||||||||||||
|
Basic and diluted net profit (loss) per share from continuing operations
|
(0.20
|
)
|
0.32
|
(0.11
|
)
|
0.47
|
0.08
|
|||||||||||||
|
Basic and diluted net profit (loss) per share from discontinued operations
|
-
|
(*
|
)
|
-
|
-
|
0.10
|
||||||||||||||
|
Total Basic and diluted net profit (loss) per share
|
(0.20
|
)
|
0.32
|
(0.11
|
)
|
0.47
|
0.18
|
|||||||||||||
|
Share capital
|
Share premium
|
Foreign currency translation reserve
|
Accumulated
deficit
|
Total
Equity
|
||||||||||||||||
|
Balance as of December 31, 2019
|
75
|
140,871
|
(17
|
)
|
(125,760
|
)
|
15,169
|
|||||||||||||
|
Loss for the period
|
-
|
-
|
-
|
(5,557
|
)
|
(5,557
|
)
|
|||||||||||||
|
Other comprehensive income
|
-
|
-
|
1
|
-
|
1
|
|||||||||||||||
|
Total comprehensive loss
|
-
|
-
|
1
|
(5,557
|
)
|
(5,556
|
)
|
|||||||||||||
|
Share-based compensation
|
-
|
519
|
-
|
-
|
519
|
|||||||||||||||
|
Balance as of June 30, 2020 (unaudited)
|
75
|
141,390
|
(16
|
)
|
(131,317
|
)
|
10,132
|
|||||||||||||
|
Share capital
|
Share premium
|
Foreign currency translation reserve
|
Accumulated
deficit
|
Total
Equity
|
||||||||||||||||
|
Balance as of December 31, 2018
|
75
|
139,637
|
(25
|
)
|
(130,715
|
)
|
8,972
|
|||||||||||||
|
Profit for the period
|
-
|
-
|
-
|
8,606
|
8,606
|
|||||||||||||||
|
Other comprehensive income
|
-
|
-
|
2
|
-
|
2
|
|||||||||||||||
|
Total comprehensive income
|
-
|
-
|
2
|
8,606
|
8,608
|
|||||||||||||||
|
Share-based compensation
|
-
|
599
|
-
|
-
|
599
|
|||||||||||||||
|
Balance as of June 30, 2019 (unaudited)
|
75
|
140,236
|
(23
|
)
|
(122,109
|
)
|
18,179
|
|||||||||||||
|
Share capital
|
Share premium
|
Foreign currency translation reserve
|
Accumulated
deficit
|
Total
Equity
|
||||||||||||||||
|
Balance as of April 1, 2020
|
75
|
141,044
|
(9
|
)
|
(128,221
|
)
|
12,889
|
|||||||||||||
|
Loss for the period
|
-
|
-
|
-
|
(3,096
|
)
|
(3,096
|
)
|
|||||||||||||
|
Other comprehensive loss
|
-
|
-
|
(7
|
)
|
-
|
(7
|
)
|
|||||||||||||
|
Total comprehensive loss
|
-
|
-
|
(7
|
)
|
(3,096
|
)
|
(3,103
|
)
|
||||||||||||
|
Share-based compensation
|
-
|
346
|
-
|
-
|
346
|
|||||||||||||||
|
Balance as of June 30, 2020 (unaudited)
|
75
|
141,390
|
(16
|
)
|
(131,317
|
)
|
10,132
|
|||||||||||||
|
Share capital
|
Share premium
|
Foreign currency translation reserve
|
Accumulated
deficit
|
Total
Equity
|
||||||||||||||||
|
Balance as of April 1, 2019
|
75
|
139,912
|
(21
|
)
|
(134,825
|
)
|
5,141
|
|||||||||||||
|
Profit for the period
|
-
|
-
|
-
|
12,716
|
12,716
|
|||||||||||||||
|
Other comprehensive loss
|
-
|
-
|
(2
|
)
|
-
|
(2
|
)
|
|||||||||||||
|
Total comprehensive income
|
-
|
-
|
(2
|
)
|
12,716
|
12,714
|
||||||||||||||
|
Share-based compensation
|
-
|
324
|
-
|
-
|
324
|
|||||||||||||||
|
Balance as of June 30, 2019 (unaudited)
|
75
|
140,236
|
(23
|
)
|
(122,109
|
)
|
18,179
|
|||||||||||||
|
Share capital
|
Share premium
|
Foreign currency translation reserve
|
Accumulated
deficit
|
Total
Equity
|
||||||||||||||||
|
Balance as of December 31, 2018
|
75
|
139,637
|
(25
|
)
|
(130,715
|
)
|
8,972
|
|||||||||||||
|
Profit for the period
|
-
|
-
|
-
|
4,955
|
4,955
|
|||||||||||||||
|
Other comprehensive income
|
-
|
-
|
8
|
-
|
8
|
|||||||||||||||
|
Total comprehensive income
|
-
|
-
|
8
|
4,955
|
4,963
|
|||||||||||||||
|
Exercise of options
|
(*
|
)
|
-
|
-
|
-
|
(*
|
)
|
|||||||||||||
|
Share-based compensation
|
-
|
1,234
|
-
|
-
|
1,234
|
|||||||||||||||
|
Balance as of December 31, 2019
|
75
|
140,871
|
(17
|
)
|
(125,760
|
)
|
15,169
|
|||||||||||||
|
Six months ended
June 30,
|
Three months ended
June 30,
|
Year ended December 31,
|
||||||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
2019
|
||||||||||||||||
|
Unaudited
|
Audited
|
|||||||||||||||||||
|
Cash flows from operating activities:
|
||||||||||||||||||||
|
Net Profit (loss)
|
(5,557
|
)
|
8,606
|
(3,096
|
) |
12,716
|
4,955
|
|||||||||||||
|
Adjustments to reconcile net profit (loss) to net cash provided by (used in) continuing operating activities:
|
||||||||||||||||||||
|
Adjustments to profit and loss items:
|
||||||||||||||||||||
|
Profit from discontinued operation
|
-
|
(50
|
)
|
-
|
-
|
(2,889
|
)
|
|||||||||||||
|
Depreciation and amortization
|
539
|
552
|
271
|
278
|
1,149
|
|||||||||||||||
|
Share-based compensation
|
519
|
599
|
346
|
324
|
1,234
|
|||||||||||||||
|
Revaluation of liability in respect of IIA grants
|
424
|
(392
|
)
|
226
|
(466
|
)
|
(392
|
)
|
||||||||||||
|
Revaluation of contingent consideration for the purchase of shares
|
348
|
1,322
|
196
|
1,081
|
1,690
|
|||||||||||||||
|
Revaluation of lease liabilities
|
64
|
194
|
100
|
91
|
340
|
|||||||||||||||
|
Increase (decrease) in severance pay liabilities, net
|
40
|
(10
|
)
|
19
|
13
|
(105
|
)
|
|||||||||||||
|
Net financing income
|
(191
|
)
|
(149
|
)
|
(81
|
)
|
(87
|
)
|
(434
|
)
|
||||||||||
|
Un-realized foreign currency (gain) loss
|
28
|
(70
|
)
|
(51
|
)
|
60
|
(152
|
)
|
||||||||||||
|
1,771
|
1,996
|
1,026
|
1,294
|
441
|
||||||||||||||||
|
Changes in asset and liability items:
|
||||||||||||||||||||
|
Decrease (increase) in trade receivables
|
1,341
|
(9
|
)
|
444
|
(318
|
)
|
(3,553
|
)
|
||||||||||||
|
Decrease (increase) in inventories
|
(326
|
)
|
146
|
65
|
(62
|
)
|
67
|
|||||||||||||
|
Decrease (increase) in other receivables
|
(284
|
)
|
2,744
|
(383
|
)
|
2,482
|
6,376
|
|||||||||||||
|
Increase (decrease) in trade payables and accrued expenses
|
(1,649
|
)
|
1,277
|
(1,004
|
)
|
1,058
|
1,355
|
|||||||||||||
|
Increase in other payables and deferred revenues
|
86
|
609
|
133
|
95
|
247
|
|||||||||||||||
|
(832
|
)
|
4,767
|
(745
|
)
|
3,255
|
4,492
|
||||||||||||||
|
Net cash provided by (used in) continuing operating activities
|
(4,618
|
)
|
15,369
|
(2,815
|
)
|
17,265
|
9,888
|
|||||||||||||
|
Net cash provided by (used in) discontinued operating activities
|
-
|
50
|
-
|
-
|
(1,599
|
)
|
||||||||||||||
|
Net cash provided by (used in) operating activities
|
(4,618
|
)
|
15,419
|
(2,815
|
)
|
17,265
|
8,289
|
|||||||||||||
|
Six months ended
June 30,
|
Three months ended
June 30,
|
Year ended December 31,
|
||||||||||||||||||
| 2020 |
2019
|
2020 |
2019
|
2019
|
||||||||||||||||
|
Unaudited
|
Audited
|
|||||||||||||||||||
|
Cash Flows from Investing Activities:
|
||||||||||||||||||||
|
Purchase of property and equipment
|
(244
|
)
|
(433
|
)
|
(100
|
)
|
(194
|
)
|
(792
|
)
|
||||||||||
|
Interest received
|
42
|
44
|
39
|
14
|
184
|
|||||||||||||||
|
Proceeds from (investment in) short term bank deposits, net
|
10,595
|
2,977
|
7,603
|
412
|
(5,050
|
)
|
||||||||||||||
|
Net cash provided by (used in) continuing investing activities
|
10,393
|
2,588
|
7,542
|
232
|
(5,658
|
)
|
||||||||||||||
|
Net cash used in discontinued investing activities
|
-
|
-
|
-
|
-
|
(1,239
|
)
|
||||||||||||||
|
Net cash provided by (used in) investing activities
|
10,393
|
2,588
|
7,542
|
232
|
(6,897
|
)
|
||||||||||||||
|
Cash Flows from Financing Activities:
|
||||||||||||||||||||
|
Repayment of leases liabilities
|
(313
|
)
|
(312
|
)
|
(153
|
)
|
(157
|
)
|
(630
|
)
|
||||||||||
|
Proceeds from exercise of options
|
-
|
-
|
-
|
-
|
(*
|
)
|
||||||||||||||
|
Proceeds of IIA grant, net of repayments
|
(66
|
)
|
193
|
-
|
248
|
(376
|
)
|
|||||||||||||
|
Net cash (used in) provided by financing activities
|
(379
|
)
|
(119
|
)
|
(153
|
)
|
91
|
(1,006
|
)
|
|||||||||||
|
Exchange rate differences on cash and cash equivalent balances
|
(26
|
)
|
63
|
57
|
(55
|
)
|
140
|
|||||||||||||
|
Cash and cash equivalents:
|
||||||||||||||||||||
|
Increase in cash and cash equivalents from continuing activities
|
5,370
|
17,901
|
4,631
|
17,533
|
3,364
|
|||||||||||||||
|
Increase (decrease) in cash and cash equivalents from discontinued activities
|
-
|
50
|
-
|
-
|
(2,838
|
)
|
||||||||||||||
|
Balance of cash and cash equivalents at the beginning of the period
|
7,242
|
6,716
|
7,981
|
7,134
|
6,716
|
|||||||||||||||
|
Balance of cash and cash equivalents at the end of the period
|
12,612
|
24,667
|
12,612
|
24,667
|
7,242
|
|||||||||||||||
| NOTE 1: |
GENERAL
|
| a. |
General description of the Company and its operations:
MediWound Ltd. (the "Company" or "MediWound"), is a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet medical needs in severe burn and wound management, The Company's
first innovative biopharmaceutical product, NexoBrid, received marketing authorization from the European Medicines Agency ("EMA") as well as the Israeli, Argentinean, South-Korean, Russian and Peruvian Ministries of Health, for removal of
dead or damaged tissue, known as eschar, in adults with deep partial and full thickness thermal burns. The Company sells NexoBrid in Europe and in Israel through its commercial organizations and in other territories through local
distributers. In 2019, the Company entered into exclusive license and supply agreements with Vericel Corporation (“Vericel”) to commercialize NexoBrid in North America.
The Company second investigational innovative product, EscharEx, is a topical biological drug being developed for debridement of chronic and other hard-to-heal wounds.
|
| b. |
The Company's securities are listed for trading on NASDAQ since March 2014.
|
| c. |
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 10% of PolyHeal Ltd., a private life sciences company ("PolyHeal").
|
| d. |
The Company awarded two contracts with the U.S. Biomedical Advanced Research and Development Authority ("BARDA"), 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.
On March 3, 2020 BARDA has expanded its awarded contract with MediWound providing supplemental funding of $5.5 million to support emergency readiness for NexoBrid deployment.
|
| NOTE 2: |
SIGNIFICANT ACCOUNTING POLICIES
|
| a. |
Basis of presentation of financial statements:
These financial statements have been prepared in accordance with International Financial Reporting Standards ("IFRS") as issued by the International Accounting Standards Board ("IASB").
|
| NOTE 2: |
SIGNIFICANT ACCOUNTING POLICIES-Cont.
|
| b. |
Basis of preparation of the interim consolidated financial statements:
|
| c. |
Reclassification:
|
